ISPE Company
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ISPE Employees
Employee
Years
Job
Industry
David Bendet David Bendet's ISPE Experience 2010 - Present
Job HDR Vice President, Science+Technology Director West Region
Industry Architecture & Planning
Experience
HDR November 2014 - Present
Architectural Foundation of San Francisco March 2015 - Present
California Technology Council March 2015 - Present
ISPE 2010 - Present
Stanford University January 1998 - Present
Perkins+Will October 2008 - November 2014
University of California, San Francisco 2007 - 2008
HOK 2005 - 2007
Perkins+Will 1994 - 2005
Heery International 1992 - 1994
Skills
Sustainable Design, LEED AP, Architecture, LEED, Architectural Design, Submittals, Green Building, Construction Management, BIM, Space planning, Sustainability, Design Research, Comprehensive Planning, Project Planning, Strategic Planning, Design Management, Project Management, Renovation, Research, AIA, Interior Design, Master Planning, Green, Planning, Design Development, Integrated Project..., Construction Documents, Scheduling, Institutional, Organizational...
Education
University of California, Berkeley 1988 — 1990
Master's, Architecture
University of Colorado Boulder 1983 — 1987
Bachelor's, Environmental Design
HDR November 2014 - Present
Architectural Foundation of San Francisco March 2015 - Present
California Technology Council March 2015 - Present
ISPE 2010 - Present
Stanford University January 1998 - Present
Perkins+Will October 2008 - November 2014
University of California, San Francisco 2007 - 2008
HOK 2005 - 2007
Perkins+Will 1994 - 2005
Heery International 1992 - 1994
Skills
Sustainable Design, LEED AP, Architecture, LEED, Architectural Design, Submittals, Green Building, Construction Management, BIM, Space planning, Sustainability, Design Research, Comprehensive Planning, Project Planning, Strategic Planning, Design Management, Project Management, Renovation, Research, AIA, Interior Design, Master Planning, Green, Planning, Design Development, Integrated Project..., Construction Documents, Scheduling, Institutional, Organizational...
Education
University of California, Berkeley 1988 — 1990
Master's, Architecture
University of Colorado Boulder 1983 — 1987
Bachelor's, Environmental Design
Morgan George Morgan George's ISPE Experience May 2011 - May 2012
Job Chemical Engineer at Proton OnSite
Industry Research
Experience
Proton OnSite June 2013 - Present
Duracell March 2013 - June 2013
IBM July 2012 - March 2013
Two Steps Restaurant July 2010 - November 2012
ISPE May 2011 - May 2012
Middlesex Gymnastics Academy February 2011 - May 2012
Staples June 2010 - September 2010
Skills
Gymnastics, Matlab, Statistics, PowerPoint, Research, Microsoft Office, Microsoft Word, Microsoft Excel, Team Leadership, Outlook, Photoshop, Data Analysis, Chemical Engineering, Event Planning, Design of Experiments, Engineering, Process Simulation, Process Engineering, Technical Writing, Chemistry, R&D, Materials Science, Solidworks, Laboratory
Education
Arizona State University 2015 — 2018
Master of Engineering (M.Eng.), Engineering/Industrial Management
Rutgers University-New Brunswick 2008 — 2012
Bachelor of Science (BS), Chemical Engineering
Proton OnSite June 2013 - Present
Duracell March 2013 - June 2013
IBM July 2012 - March 2013
Two Steps Restaurant July 2010 - November 2012
ISPE May 2011 - May 2012
Middlesex Gymnastics Academy February 2011 - May 2012
Staples June 2010 - September 2010
Skills
Gymnastics, Matlab, Statistics, PowerPoint, Research, Microsoft Office, Microsoft Word, Microsoft Excel, Team Leadership, Outlook, Photoshop, Data Analysis, Chemical Engineering, Event Planning, Design of Experiments, Engineering, Process Simulation, Process Engineering, Technical Writing, Chemistry, R&D, Materials Science, Solidworks, Laboratory
Education
Arizona State University 2015 — 2018
Master of Engineering (M.Eng.), Engineering/Industrial Management
Rutgers University-New Brunswick 2008 — 2012
Bachelor of Science (BS), Chemical Engineering
Charles DiMarco Charles DiMarco's ISPE Experience March 2011 - November 2011
Job Vice President of Marketing and Operations, FitPro North America
Industry Education Management
Experience
St. Petersburg College November 2011 - Present
FitPro North America June 2012 - December 2014
ISPE March 2011 - November 2011
Lifestyle Family Fitness June 2006 - March 2011
Lifestyle Family Fitness May 2004 - June 2006
Transitions Optical August 2003 - May 2004
Transitions Optical December 2000 - August 2003
Transitions Optical January 2000 - December 2000
Transitions Optical December 1995 - January 2000
Skills
Sales Operations, Marketing, Market Research, Social Media Marketing, Marketing Communications, Entrepreneurship, Social Media, People Skills, Marketing Strategy, Strategic Planning, Product Management, Media Relations, Leadership, Product Development, Marketing Management, Statistics, Project Management, Business Strategy, Sales Management
Education
University of South Florida
MBA, International Business, Marketing Strategy, Leadership
University of South Florida
B.S., Marketing
St. Petersburg College November 2011 - Present
FitPro North America June 2012 - December 2014
ISPE March 2011 - November 2011
Lifestyle Family Fitness June 2006 - March 2011
Lifestyle Family Fitness May 2004 - June 2006
Transitions Optical August 2003 - May 2004
Transitions Optical December 2000 - August 2003
Transitions Optical January 2000 - December 2000
Transitions Optical December 1995 - January 2000
Skills
Sales Operations, Marketing, Market Research, Social Media Marketing, Marketing Communications, Entrepreneurship, Social Media, People Skills, Marketing Strategy, Strategic Planning, Product Management, Media Relations, Leadership, Product Development, Marketing Management, Statistics, Project Management, Business Strategy, Sales Management
Education
University of South Florida
MBA, International Business, Marketing Strategy, Leadership
University of South Florida
B.S., Marketing
Cynthia Brysch CQA-QMD, ASQ Cynthia Brysch CQA-QMD, ASQ's ISPE Experience 2010 - 2011
Job QA Manager at MSCI
Industry Biotechnology
Experience
RealTime Laboratories, Inc. June 2015 - Present
NovoSci November 2014 - April 2015
Alcon, a Novartis company April 2014 - September 2014
Stillmeadow Inc. February 2013 - April 2014
Stillmeadow Inc. 2013 - April 2014
University of Houston January 2012 - August 2012
Texas Center for Superconductivity January 2009 - January 2012
University of Houston Translational Biomechanics Laboratory 2010 - 2012
Center for Life Science Technology January 2008 - May 2011
ISPE 2010 - 2011
Skills
Management, Biotechnology, Regulatory Affairs, Quality Assurance, Quality Control, Materials Science, Communication, HPLC, FTIR, Sintering, recombinant DNA..., Computer Proficiency, Team Building, Strategic Leadership, Clinical Pharmacology, Biological Systems, Problem Solving, Pro Engineer, CAD, Bioinformatics, Polymer Science, Polymer Nanocomposites, Polymer Composites, Standards Development, Standards Compliance, GMP, Laboratory, Continuous Improvement, Purification, UV/Vis, Chromatography, Protein Purification, SDS-PAGE, Microbiology, Mass Spectrometry, Gas Chromatography, Protein Chemistry, LIMS, Protein Expression, Stem Cells, Fluorescence Microscopy, Spectrophotometry, ELISA, Gel Electrophoresis, Analytical Chemistry, Proteomics, Column Chromatography, Flow Cytometry, Biomaterials, DNA sequencing
Education
University of Houston 2009 — 2012
Biotechnology, Materials Science and Pharmacology, 3.5
Oklahoma State University 2006 — 2009
Biochemistry, Biochemical Engineering, 3.5
RealTime Laboratories, Inc. June 2015 - Present
NovoSci November 2014 - April 2015
Alcon, a Novartis company April 2014 - September 2014
Stillmeadow Inc. February 2013 - April 2014
Stillmeadow Inc. 2013 - April 2014
University of Houston January 2012 - August 2012
Texas Center for Superconductivity January 2009 - January 2012
University of Houston Translational Biomechanics Laboratory 2010 - 2012
Center for Life Science Technology January 2008 - May 2011
ISPE 2010 - 2011
Skills
Management, Biotechnology, Regulatory Affairs, Quality Assurance, Quality Control, Materials Science, Communication, HPLC, FTIR, Sintering, recombinant DNA..., Computer Proficiency, Team Building, Strategic Leadership, Clinical Pharmacology, Biological Systems, Problem Solving, Pro Engineer, CAD, Bioinformatics, Polymer Science, Polymer Nanocomposites, Polymer Composites, Standards Development, Standards Compliance, GMP, Laboratory, Continuous Improvement, Purification, UV/Vis, Chromatography, Protein Purification, SDS-PAGE, Microbiology, Mass Spectrometry, Gas Chromatography, Protein Chemistry, LIMS, Protein Expression, Stem Cells, Fluorescence Microscopy, Spectrophotometry, ELISA, Gel Electrophoresis, Analytical Chemistry, Proteomics, Column Chromatography, Flow Cytometry, Biomaterials, DNA sequencing
Education
University of Houston 2009 — 2012
Biotechnology, Materials Science and Pharmacology, 3.5
Oklahoma State University 2006 — 2009
Biochemistry, Biochemical Engineering, 3.5
Kenneth Ng's ISPE Experience April 2010 - May 2011
Job Operations Rotational Development Program (ORDP) Analyst at Genentech
Industry Biotechnology
Experience
Genentech December 2014 - August 2015
Genentech August 2012 - December 2014
globALLhealth March 2013 - June 2013
Genentech June 2011 - December 2011
ISPE April 2010 - May 2011
Alere, Inc. June 2009 - March 2010
Skills
Cross-functional Team..., Analytical Skills, Strategic Thinking, Data Analysis, Project Management, Process Improvement, Change Control, SAP APO, SAP BW, SAP R/3, Demand Planning, Validation, Trackwise, Matlab, Process Engineering, Biotechnology, Biomedical Engineering, Cell Culture, R&D, Microsoft Office, JMP, Engineering, SIMCA-P+, Photoshop
Education
Stanford University 2013 — 2014
Graduate Certificate, Management Science and Engineering
University of California, San Diego 2007 — 2011
Bachelor of Science, Bioengineering
Genentech December 2014 - August 2015
Genentech August 2012 - December 2014
globALLhealth March 2013 - June 2013
Genentech June 2011 - December 2011
ISPE April 2010 - May 2011
Alere, Inc. June 2009 - March 2010
Skills
Cross-functional Team..., Analytical Skills, Strategic Thinking, Data Analysis, Project Management, Process Improvement, Change Control, SAP APO, SAP BW, SAP R/3, Demand Planning, Validation, Trackwise, Matlab, Process Engineering, Biotechnology, Biomedical Engineering, Cell Culture, R&D, Microsoft Office, JMP, Engineering, SIMCA-P+, Photoshop
Education
Stanford University 2013 — 2014
Graduate Certificate, Management Science and Engineering
University of California, San Diego 2007 — 2011
Bachelor of Science, Bioengineering
Alessandro Anzalone's ISPE Experience 2008 - 2009
Job Program Manager, Engineering Technology at Hillsborough Community College
Industry Higher Education
Experience
Hillsborough Community College August 2009 - Present
Polytechnic University of Puerto Rico August 2008 - August 2009
Polytechnic University of Puerto Rico August 2008 - August 2009
ISPE 2008 - 2009
Polytechnic University of Puerto Rico August 2005 - August 2008
University of South Florida 2003 - 2005
Skills
Process Engineering, Engineering, Research, Process Simulation, Microsoft Office, Six Sigma, Management, Chemical Engineering, Project Management, Data Analysis, Teaching, Matlab, Manufacturing, Public Speaking, Program Management, Process Improvement, Simulations, Design of Experiments, Cross-functional Team..., Higher Education, R&D, Lean Manufacturing, Quality Assurance, Technical Writing, Leadership, Product Development, FDA, Troubleshooting, Statistics, Training, Analysis, Customer Service, MS Project, Strategic Planning, Instructional Design, Team Building, Process Control, Science, Environmental..., Air Pollution
Education
University of South Florida 1997 — 2003
Ph.D., Chemical Engineering
New York University - Polytechnic School of Engineering 1995 — 1996
M.S., Chemical Engineering
Universidad Nacional Experimental Politécnica 'Antonio José de Sucre' 1986 — 1993
B.S., Chemical Engineering
Hillsborough Community College August 2009 - Present
Polytechnic University of Puerto Rico August 2008 - August 2009
Polytechnic University of Puerto Rico August 2008 - August 2009
ISPE 2008 - 2009
Polytechnic University of Puerto Rico August 2005 - August 2008
University of South Florida 2003 - 2005
Skills
Process Engineering, Engineering, Research, Process Simulation, Microsoft Office, Six Sigma, Management, Chemical Engineering, Project Management, Data Analysis, Teaching, Matlab, Manufacturing, Public Speaking, Program Management, Process Improvement, Simulations, Design of Experiments, Cross-functional Team..., Higher Education, R&D, Lean Manufacturing, Quality Assurance, Technical Writing, Leadership, Product Development, FDA, Troubleshooting, Statistics, Training, Analysis, Customer Service, MS Project, Strategic Planning, Instructional Design, Team Building, Process Control, Science, Environmental..., Air Pollution
Education
University of South Florida 1997 — 2003
Ph.D., Chemical Engineering
New York University - Polytechnic School of Engineering 1995 — 1996
M.S., Chemical Engineering
Universidad Nacional Experimental Politécnica 'Antonio José de Sucre' 1986 — 1993
B.S., Chemical Engineering
Will Bian's ISPE Experience November 2011 - December 2012
Job Senior Analyst at Campbell Alliance
Industry Pharmaceuticals
Experience
Campbell Alliance April 2015 - Present
Campbell Alliance October 2013 - April 2015
Hay Group June 2013 - August 2013
ISPE November 2011 - December 2012
Bain & Company June 2012 - July 2012
University of Pennsylvania September 2011 - April 2012
Pennsylvania Economic Development Office June 2011 - August 2011
University of Michigan May 2010 - July 2010
University of Michigan September 2008 - April 2009
Skills
Biomedical Engineering, PCR, Biotechnology, Western Blotting, Lifesciences, Microscopy, Biochemistry, FDA, Cell Biology, Microsoft Excel, Macro, VBA, Statistics, Strategy, Data Analysis, Life Sciences
Education
University of Pennsylvania 2011 — 2012
Master of Bioteachnology, Biotechnology, Biopharmaceutical Engineering Concentration
University of Pennsylvania - The Wharton School 2011 — 2012
Master Degree, Healthcare Management, Corporate Finance, Economics, Financial Accounting
University of Michigan 2006 — 2010
Bachelor of Engineering (B.Eng.), Bioengineering and Biomedical Engineering
Campbell Alliance April 2015 - Present
Campbell Alliance October 2013 - April 2015
Hay Group June 2013 - August 2013
ISPE November 2011 - December 2012
Bain & Company June 2012 - July 2012
University of Pennsylvania September 2011 - April 2012
Pennsylvania Economic Development Office June 2011 - August 2011
University of Michigan May 2010 - July 2010
University of Michigan September 2008 - April 2009
Skills
Biomedical Engineering, PCR, Biotechnology, Western Blotting, Lifesciences, Microscopy, Biochemistry, FDA, Cell Biology, Microsoft Excel, Macro, VBA, Statistics, Strategy, Data Analysis, Life Sciences
Education
University of Pennsylvania 2011 — 2012
Master of Bioteachnology, Biotechnology, Biopharmaceutical Engineering Concentration
University of Pennsylvania - The Wharton School 2011 — 2012
Master Degree, Healthcare Management, Corporate Finance, Economics, Financial Accounting
University of Michigan 2006 — 2010
Bachelor of Engineering (B.Eng.), Bioengineering and Biomedical Engineering
Avihai Guzy Avihai Guzy's ISPE Experience September 2012 - June 2013
Job UC San Diego Alumnus
Industry Biotechnology
Experience
Villa Marin July 2015 - Present
UC San Diego September 2009 - June 2014
International Society of Pharmaceutical Engineers July 2013 - October 2013
Nyhart Epler August 2013 - September 2013
ISPE September 2012 - June 2013
Union of Jewish Students September 2012 - June 2013
University of California, San Diego August 2012 - June 2013
Burnham Medical Research Institute April 2012 - September 2012
Marshall Activities Committee January 2012 - June 2012
Albany Community Center July 2011 - August 2011
Skills
MS Office Suite, Gel Electrophoresis, Research, centrifugation, MiniPrep, Western Blotting, Bacterial Culture, Bacterial Transformation, Restriction Enzyme..., Buffer Preparation, UV/Vis, Protein Purification, MaxiPrep, CH1230A ElectroChemical..., Molecular Biology, Biotechnology
Education
University of California, San Diego 2009 — 2014
Bioengineering: Biotechnology, Biotechnology
Villa Marin July 2015 - Present
UC San Diego September 2009 - June 2014
International Society of Pharmaceutical Engineers July 2013 - October 2013
Nyhart Epler August 2013 - September 2013
ISPE September 2012 - June 2013
Union of Jewish Students September 2012 - June 2013
University of California, San Diego August 2012 - June 2013
Burnham Medical Research Institute April 2012 - September 2012
Marshall Activities Committee January 2012 - June 2012
Albany Community Center July 2011 - August 2011
Skills
MS Office Suite, Gel Electrophoresis, Research, centrifugation, MiniPrep, Western Blotting, Bacterial Culture, Bacterial Transformation, Restriction Enzyme..., Buffer Preparation, UV/Vis, Protein Purification, MaxiPrep, CH1230A ElectroChemical..., Molecular Biology, Biotechnology
Education
University of California, San Diego 2009 — 2014
Bioengineering: Biotechnology, Biotechnology
Renee Beckford, MBA's ISPE Experience September 2013 - January 2015
Job Sr Financial Analyst Contractor at Robert Half Management Resources
Industry Mining & Metals
Experience
Robert Half Management Resources January 2015 - Present
ISPE September 2013 - January 2015
Leslie Controls April 2012 - January 2013
MDSi, Inc. November 2010 - April 2012
Mosaic December 2007 - November 2010
Teltronics July 2005 - August 2007
Equity LifeStyle Properties, Inc. March 2003 - October 2004
Skills
Financial Reporting, Tax Compliance, Budgeting, Tax Reporting, US GAAP, SEC reporting, Cost Accounting, Fixed Assets, Budgets, Financial Analysis, Accounts Receivable, Due Diligence, Accounts Payable, Cash Flow, Accounting, SEC filings, Financial Accounting, Financial Statements, Tax, Corporate Finance, Account Reconciliation, Analysis, Variance Analysis, QuickBooks, SAP, Internal Audit, GAAP, Auditing, Cash Management, Internal Controls, Revenue Recognition, General Ledger, Forecasting, Sarbanes-Oxley Act, Financial Forecasting, Managerial Finance, Management, CPA, Process Improvement, Journal Entries
Education
Nova Southeastern University 2001 — 2003
MBA, Finance
Nova Southeastern University 2001 — 2003
Masters Degree of Finance, Finance and Financial Management Services
Robert Half Management Resources January 2015 - Present
ISPE September 2013 - January 2015
Leslie Controls April 2012 - January 2013
MDSi, Inc. November 2010 - April 2012
Mosaic December 2007 - November 2010
Teltronics July 2005 - August 2007
Equity LifeStyle Properties, Inc. March 2003 - October 2004
Skills
Financial Reporting, Tax Compliance, Budgeting, Tax Reporting, US GAAP, SEC reporting, Cost Accounting, Fixed Assets, Budgets, Financial Analysis, Accounts Receivable, Due Diligence, Accounts Payable, Cash Flow, Accounting, SEC filings, Financial Accounting, Financial Statements, Tax, Corporate Finance, Account Reconciliation, Analysis, Variance Analysis, QuickBooks, SAP, Internal Audit, GAAP, Auditing, Cash Management, Internal Controls, Revenue Recognition, General Ledger, Forecasting, Sarbanes-Oxley Act, Financial Forecasting, Managerial Finance, Management, CPA, Process Improvement, Journal Entries
Education
Nova Southeastern University 2001 — 2003
MBA, Finance
Nova Southeastern University 2001 — 2003
Masters Degree of Finance, Finance and Financial Management Services
Rohit Murthy Rohit Murthy's ISPE Experience October 2013 - June 2014
Job Los Angeles Manufacturing Development Program at Baxter International Inc.
Industry Chemicals
Experience
Baxalta August 2014 - Present
UC Irvine BioMEMS Research Group May 2012 - March 2015
ISPE October 2013 - June 2014
Kappa Sigma Mu Delta December 2012 - December 2013
Greek Songfest June 2012 - June 2013
Endocrine Technologies June 2011 - September 2011
Champion Paintball & Card September 2006 - June 2009
Skills
Enzyme Assays, Spectrophotometry, Column Chromatography, Microsoft Office, Excel, Word, PowerPoint, Customer Service, Cyclic Voltammetry, Microsoft Excel, Technical Writing, Marketing, Research, Electrochemistry, Data Analysis, Time Management, Microsoft Word, ELISA, Sales, Leadership, Teamwork, Team Leadership, Matlab, Budgets, AFM, Public Speaking, Biotechnology, Market Research, Materials Science, Event Planning, Social Media, Project Management, Financial Analysis, Social Networking, Social Media Marketing, Fundraising, Photoshop, Microfluidics, ImageJ
Education
University of California, Irvine 2009 — 2014
Bachelor's Degree, Chemical Engineering with minor in Materials Science Engineering, 3.15/4.0
Baxalta August 2014 - Present
UC Irvine BioMEMS Research Group May 2012 - March 2015
ISPE October 2013 - June 2014
Kappa Sigma Mu Delta December 2012 - December 2013
Greek Songfest June 2012 - June 2013
Endocrine Technologies June 2011 - September 2011
Champion Paintball & Card September 2006 - June 2009
Skills
Enzyme Assays, Spectrophotometry, Column Chromatography, Microsoft Office, Excel, Word, PowerPoint, Customer Service, Cyclic Voltammetry, Microsoft Excel, Technical Writing, Marketing, Research, Electrochemistry, Data Analysis, Time Management, Microsoft Word, ELISA, Sales, Leadership, Teamwork, Team Leadership, Matlab, Budgets, AFM, Public Speaking, Biotechnology, Market Research, Materials Science, Event Planning, Social Media, Project Management, Financial Analysis, Social Networking, Social Media Marketing, Fundraising, Photoshop, Microfluidics, ImageJ
Education
University of California, Irvine 2009 — 2014
Bachelor's Degree, Chemical Engineering with minor in Materials Science Engineering, 3.15/4.0
Ginger Phillips, EDD, CMM Ginger Phillips, EDD, CMM's ISPE Experience March 2007 - March 2011
Job
Industry Education Management
Experience
Financial Therapy Associaition January 2013 - Present
American Council on Consumer Interests June 2012 - Present
Arden Solutions, LLC July 2011 - Present
ISPE March 2007 - March 2011
NAAC, FEFPA, Nat'l Perinatal, etc. 1991 - 2010
University of South Florida 2005 - March 2007
USF College of Public Health January 2003 - 2005
University of South Florida 1991 - 2002
Tioga County Women's Coalition 1985 - 1989
Skills
Leadership, Program Development, Non-profits, Nonprofits, Strategic Planning, Research, Adult Education, Program Management, Event Management, Event Planning, Higher Education, Conference Coordination, Public Speaking, Educational Leadership, Association Management, Staff Development, Management, Volunteer Management, Grant Writing, Events, Marketing, Meeting Planning, Leadership Development, Program Evaluation, Curriculum Design, Registration, Organizational..., Workshop Facilitation, Budgets
Education
University of South Florida 2004 — 2011
EDD, Education Program Planning, Adult Education
Penn State
M.Ed., Education
Mansfield State University 1970 — 1974
B.S., Education
Financial Therapy Associaition January 2013 - Present
American Council on Consumer Interests June 2012 - Present
Arden Solutions, LLC July 2011 - Present
ISPE March 2007 - March 2011
NAAC, FEFPA, Nat'l Perinatal, etc. 1991 - 2010
University of South Florida 2005 - March 2007
USF College of Public Health January 2003 - 2005
University of South Florida 1991 - 2002
Tioga County Women's Coalition 1985 - 1989
Skills
Leadership, Program Development, Non-profits, Nonprofits, Strategic Planning, Research, Adult Education, Program Management, Event Management, Event Planning, Higher Education, Conference Coordination, Public Speaking, Educational Leadership, Association Management, Staff Development, Management, Volunteer Management, Grant Writing, Events, Marketing, Meeting Planning, Leadership Development, Program Evaluation, Curriculum Design, Registration, Organizational..., Workshop Facilitation, Budgets
Education
University of South Florida 2004 — 2011
EDD, Education Program Planning, Adult Education
Penn State
M.Ed., Education
Mansfield State University 1970 — 1974
B.S., Education
Rod Freeman, PMP Rod Freeman, PMP's ISPE Experience January 2012 - December 2014
Job President at ISPE San Diego Chapter
Industry Pharmaceuticals
Experience
Beckman Coulter January 2011 - Present
ISPE San Diego Chapter September 2014 - September 2015
ISPE January 2012 - December 2014
ISPE San Diego Chapter September 2013 - September 2014
ISPE San Diego Chapter August 2009 - September 2013
Teva Parenteral Medicines August 2008 - January 2011
Abbott Vascular January 2007 - August 2008
The Pharmaceutical Training Institute 2007 - 2008
Pfizer, Inc. March 2005 - January 2007
Eli Lilly April 2003 - March 2005
Skills
Process Validation, Troubleshooting, Packaging, Operation, CAPA, Engineering, Pharmaceuticals, Water Systems, Quality Systems, Project Management, Management, Pharmaceutical System..., Compliance, Remediation, Compliance Audits, 483 Responses and..., V&V, Pharmaceutical Industry, Quality System, GMP, Quality Auditing, Validation, Root Cause Analysis, FDA, Biotechnology, Quality Assurance, 21 CFR Part 11, Aseptic Processing, Cleaning Validation, Medical Devices, Regulatory Requirements, Cross-functional Team..., Manufacturing, ISO 13485, Change Control, Technology Transfer, Lifesciences, Biopharmaceuticals, Pharmaceutics, GAMP, R&D, Sop, Process Engineering, Regulatory Affairs, Process Simulation, FDA GMP, GxP, Quality Control, Process Improvement, Analytical Chemistry
Education
The Johns Hopkins University 2013 — 2016
Master of Science (MS), Regulatory Affairs
Virginia Polytechnic Institute and State University 1988 — 1992
B.S., Chemical Engineering
Beckman Coulter January 2011 - Present
ISPE San Diego Chapter September 2014 - September 2015
ISPE January 2012 - December 2014
ISPE San Diego Chapter September 2013 - September 2014
ISPE San Diego Chapter August 2009 - September 2013
Teva Parenteral Medicines August 2008 - January 2011
Abbott Vascular January 2007 - August 2008
The Pharmaceutical Training Institute 2007 - 2008
Pfizer, Inc. March 2005 - January 2007
Eli Lilly April 2003 - March 2005
Skills
Process Validation, Troubleshooting, Packaging, Operation, CAPA, Engineering, Pharmaceuticals, Water Systems, Quality Systems, Project Management, Management, Pharmaceutical System..., Compliance, Remediation, Compliance Audits, 483 Responses and..., V&V, Pharmaceutical Industry, Quality System, GMP, Quality Auditing, Validation, Root Cause Analysis, FDA, Biotechnology, Quality Assurance, 21 CFR Part 11, Aseptic Processing, Cleaning Validation, Medical Devices, Regulatory Requirements, Cross-functional Team..., Manufacturing, ISO 13485, Change Control, Technology Transfer, Lifesciences, Biopharmaceuticals, Pharmaceutics, GAMP, R&D, Sop, Process Engineering, Regulatory Affairs, Process Simulation, FDA GMP, GxP, Quality Control, Process Improvement, Analytical Chemistry
Education
The Johns Hopkins University 2013 — 2016
Master of Science (MS), Regulatory Affairs
Virginia Polytechnic Institute and State University 1988 — 1992
B.S., Chemical Engineering
LeAnna Pearson LeAnna Pearson's ISPE Experience 2008 - 2010
Job Lead Validation Engineer at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions May 2015 - Present
SpecLine Consulting, Inc. August 2013 - May 2015
CaSA ISPE 2011 - 2014
Catalent Pharma Solutions August 2010 - August 2013
Biogen Idec May 2010 - August 2010
BRITE, North Carolina Central University January 2009 - May 2010
Social and Scientific Systems March 2005 - May 2010
ISPE 2008 - 2010
BRITE, North Carolina Central University 2008 - 2010
North Carolina Central University January 2008 - December 2009
Skills
Statistics, Data Analysis, Research, Optimization, Protocol, Communications Audits, Cell Culture, Assay Development, Column Chromatography, FDA, GMP, Mammalian Cell Culture, HPLC, Purification, Cell, Validation, Laboratory, Chromatography, Protein Purification, Sop, DNA extraction, Molecular Biology, PCR, Biochemistry, ELISA, GLP, Design of Experiments, SDS-PAGE, Western Blotting, Training, LIMS, Gel Electrophoresis, Biotechnology, Protein Chemistry, Aseptic Technique, Pharmaceutical Industry, Biopharmaceuticals, CAPA, Change Control, DNA Extraction
Education
North Carolina Central University 2008 — 2010
M.S., Pharmaceutical Sciences
Salisbury University 2000 — 2003
B.S., Biology
Catalent Pharma Solutions May 2015 - Present
SpecLine Consulting, Inc. August 2013 - May 2015
CaSA ISPE 2011 - 2014
Catalent Pharma Solutions August 2010 - August 2013
Biogen Idec May 2010 - August 2010
BRITE, North Carolina Central University January 2009 - May 2010
Social and Scientific Systems March 2005 - May 2010
ISPE 2008 - 2010
BRITE, North Carolina Central University 2008 - 2010
North Carolina Central University January 2008 - December 2009
Skills
Statistics, Data Analysis, Research, Optimization, Protocol, Communications Audits, Cell Culture, Assay Development, Column Chromatography, FDA, GMP, Mammalian Cell Culture, HPLC, Purification, Cell, Validation, Laboratory, Chromatography, Protein Purification, Sop, DNA extraction, Molecular Biology, PCR, Biochemistry, ELISA, GLP, Design of Experiments, SDS-PAGE, Western Blotting, Training, LIMS, Gel Electrophoresis, Biotechnology, Protein Chemistry, Aseptic Technique, Pharmaceutical Industry, Biopharmaceuticals, CAPA, Change Control, DNA Extraction
Education
North Carolina Central University 2008 — 2010
M.S., Pharmaceutical Sciences
Salisbury University 2000 — 2003
B.S., Biology
Andrew Range's ISPE Experience August 2013 - December 2013
Job Flood Specialist at Wright Flood
Industry Insurance
Experience
Wright Flood June 2014 - Present
ISPE August 2013 - December 2013
Heekin Orthopedic Specialists November 2011 - January 2012
University of North Florida December 2010 - December 2011
1010XL-92.5 FM Jacksonville Sports Radio August 2009 - January 2010
Skills
Public Health, Data Entry, Computer Proficiency, People Skills, People-oriented, Organizational..., Promotions, Microsoft Excel, PowerPoint, Pharmaceutical Industry, Flood Insurance, Customer Service, FEMA Elevation..., Flood Risk
Education
University of South Florida 2013 — 2013
Bachelor's degree, Public Health
University of North Florida 2012 — 2012
Public Health
Wright Flood June 2014 - Present
ISPE August 2013 - December 2013
Heekin Orthopedic Specialists November 2011 - January 2012
University of North Florida December 2010 - December 2011
1010XL-92.5 FM Jacksonville Sports Radio August 2009 - January 2010
Skills
Public Health, Data Entry, Computer Proficiency, People Skills, People-oriented, Organizational..., Promotions, Microsoft Excel, PowerPoint, Pharmaceutical Industry, Flood Insurance, Customer Service, FEMA Elevation..., Flood Risk
Education
University of South Florida 2013 — 2013
Bachelor's degree, Public Health
University of North Florida 2012 — 2012
Public Health
Sandra Medlin's ISPE Experience 2010 - Present
Job SaniSure Marketing Manager at SaniSure, Inc.
Industry Biotechnology
Experience
SaniSure, Inc. August 2015 - Present
SaniSure. Inc. A Division of Sani-tech West March 2014 - Present
ISPE 2010 - Present
Sani-tech West October 2003 - Present
Saint-Gobain Performance Plastics 1999 - 2003
Skills
Manufacturing, GMP, Product Development, Cross-functional Team..., New Business Development, Sales Management, Plastics, Validation, R&D, Continuous Improvement, Negotiation, Product Management, Strategic Planning, Project Management, Forecasting, Budgets, Filtration, Biopharmaceuticals, ISO, Process Simulation
Education
Appalachian State University
School name:
SaniSure, Inc. August 2015 - Present
SaniSure. Inc. A Division of Sani-tech West March 2014 - Present
ISPE 2010 - Present
Sani-tech West October 2003 - Present
Saint-Gobain Performance Plastics 1999 - 2003
Skills
Manufacturing, GMP, Product Development, Cross-functional Team..., New Business Development, Sales Management, Plastics, Validation, R&D, Continuous Improvement, Negotiation, Product Management, Strategic Planning, Project Management, Forecasting, Budgets, Filtration, Biopharmaceuticals, ISO, Process Simulation
Education
Appalachian State University
School name:
Ryan Smith's ISPE Experience March 2010 - September 2010
Job Consultant | Inbound Marketing | Specializes in SEO, Social Media Marketing, PPC, Analytics and Content Marketing
Industry Marketing and Advertising
Experience
EduPristine July 2015 - Present
Araxam June 2013 - Present
University of South Florida May 2014 - February 2015
Accusoft February 2011 - May 2014
ISPE March 2010 - September 2010
Cryo-Cell International January 2009 - October 2009
Cryo-Cell International January 2008 - December 2008
Cryo-Cell International January 2006 - December 2007
Trans World Entertainment February 2003 - January 2006
Mercedes-Benz Cup 2002 - 2003
Skills
Public Relations, Marketing Communications, SEO, Online Marketing, Marketing Strategy, Inbound Marketing, Social Media, Event Management, Social Media Marketing, SEM, Corporate Communications, PPC, Promotions, Media Relations, Marketing Management, Press Releases, Trade Shows, Brand Development, Web Analytics, Product Marketing, Google Adwords, Blogging, Advertising, Public Speaking, International Marketing, Email Marketing, Google Analytics, Social Networking, Event Planning, Digital Marketing, Facebook, B2B, Web 2.0, Strategic Planning, Market Planning, B2C, LinkedIn, Twitter, Strategic Communications, Marketing, Internal Communications, Lead Generation, Content Management, B2B Marketing, Digital Strategy, Analytics, Sales, Online Advertising, New Business Development, Management
Education
Boston University 2011 — 2013
Master of Science (M.S.), International Marketing Management
University of South Florida 2004 — 2005
Bachelor of Arts (B.A.), Interpersonal and Organizational Communications
University of Florida 1998 — 2000
Public Relations
St. Petersburg Junior College
Associate of Arts (A.A.), Mass Communications
EduPristine July 2015 - Present
Araxam June 2013 - Present
University of South Florida May 2014 - February 2015
Accusoft February 2011 - May 2014
ISPE March 2010 - September 2010
Cryo-Cell International January 2009 - October 2009
Cryo-Cell International January 2008 - December 2008
Cryo-Cell International January 2006 - December 2007
Trans World Entertainment February 2003 - January 2006
Mercedes-Benz Cup 2002 - 2003
Skills
Public Relations, Marketing Communications, SEO, Online Marketing, Marketing Strategy, Inbound Marketing, Social Media, Event Management, Social Media Marketing, SEM, Corporate Communications, PPC, Promotions, Media Relations, Marketing Management, Press Releases, Trade Shows, Brand Development, Web Analytics, Product Marketing, Google Adwords, Blogging, Advertising, Public Speaking, International Marketing, Email Marketing, Google Analytics, Social Networking, Event Planning, Digital Marketing, Facebook, B2B, Web 2.0, Strategic Planning, Market Planning, B2C, LinkedIn, Twitter, Strategic Communications, Marketing, Internal Communications, Lead Generation, Content Management, B2B Marketing, Digital Strategy, Analytics, Sales, Online Advertising, New Business Development, Management
Education
Boston University 2011 — 2013
Master of Science (M.S.), International Marketing Management
University of South Florida 2004 — 2005
Bachelor of Arts (B.A.), Interpersonal and Organizational Communications
University of Florida 1998 — 2000
Public Relations
St. Petersburg Junior College
Associate of Arts (A.A.), Mass Communications
Chris Grab's ISPE Experience March 2004 - February 2015
Job Web Designer, Developer, and Consultant
Industry Internet
Experience
Grab Creative LLC March 2010 - Present
ISPE March 2004 - February 2015
TurboTrip.com 2002 - 2003
Bent Media 2001 - 2001
CDI Information Services 2000 - 2001
Webivore Knowledge Systems 1998 - 2000
Lenk and Associates 1997 - 1998
Bitwise Internet Technologies 1996 - 1996
Skills
Web Design, Web Development, Web Content Management, Content Management, Information Architecture, SEO, User Experience, Online Marketing, Illustration, Graphic Design, PHP, ColdFusion, Adobe Creative Suite, Wordpress, Website Development, Usability, HTML, jQuery, JavaScript, CSS, MySQL, MS Office Suite, SQL Server, Publications, E-commerce, HTML 5, WordPress
Education
Massachusetts College of Art and Design 1994 — 1999
BFA, Media & Performing Arts
Grab Creative LLC March 2010 - Present
ISPE March 2004 - February 2015
TurboTrip.com 2002 - 2003
Bent Media 2001 - 2001
CDI Information Services 2000 - 2001
Webivore Knowledge Systems 1998 - 2000
Lenk and Associates 1997 - 1998
Bitwise Internet Technologies 1996 - 1996
Skills
Web Design, Web Development, Web Content Management, Content Management, Information Architecture, SEO, User Experience, Online Marketing, Illustration, Graphic Design, PHP, ColdFusion, Adobe Creative Suite, Wordpress, Website Development, Usability, HTML, jQuery, JavaScript, CSS, MySQL, MS Office Suite, SQL Server, Publications, E-commerce, HTML 5, WordPress
Education
Massachusetts College of Art and Design 1994 — 1999
BFA, Media & Performing Arts
Michael Shelp Michael Shelp's ISPE Experience January 2014 - Present
Job Systems Administrator I
Industry Information Technology and Services
Experience
ISPE January 2014 - Present
ISPE March 2008 - Present
Cardinal Health May 1993 - January 2008
Catalent Pharma Solutions 2002 - 2008
Skills
Software Documentation, Process Improvement, Cross-functional Team..., Sop, Troubleshooting, Pharmaceutical Industry, SharePoint, Vendor Management, VMware Server, VMware ESX, Disaster Recovery, System Administration, Management, Project Management, Microsoft SQL Server, Strategic Planning, Visio, Integration, Leadership, Continuous Improvement, Team Building, Project Planning, Budgets, Analysis, Business Analysis, Team Leadership, Access, Risk Management, VMware, SOP, Customer Service, Quality System, Program Management, Process Engineering, Operations Management
Education
St. Petersburg College 2003 — 2007
AS-MCSA, Network Technology Management
ISPE January 2014 - Present
ISPE March 2008 - Present
Cardinal Health May 1993 - January 2008
Catalent Pharma Solutions 2002 - 2008
Skills
Software Documentation, Process Improvement, Cross-functional Team..., Sop, Troubleshooting, Pharmaceutical Industry, SharePoint, Vendor Management, VMware Server, VMware ESX, Disaster Recovery, System Administration, Management, Project Management, Microsoft SQL Server, Strategic Planning, Visio, Integration, Leadership, Continuous Improvement, Team Building, Project Planning, Budgets, Analysis, Business Analysis, Team Leadership, Access, Risk Management, VMware, SOP, Customer Service, Quality System, Program Management, Process Engineering, Operations Management
Education
St. Petersburg College 2003 — 2007
AS-MCSA, Network Technology Management
Charles Hartman Charles Hartman's ISPE Experience September 2013 - May 2014
Job EIT, BS Chemical and Biological Engineering Minor Electrical Engineering CU Boulder, FE Certified Chemical
Industry Biotechnology
Experience
Joule Unlimited Technologies, Inc. November 2014 - Present
21st Century July 2014 - September 2014
ISPE September 2013 - May 2014
Medlin Research Group CU Boulder February 2011 - December 2013
HP Bar Ranch January 2000 - August 2009
Sedgwick Computers May 2004 - September 2008
Skills
Matlab, Design of Experiments, Microsoft Office, Research, Visual Basic, Mathematica, C++, Solidworks, Simulink, Aspen Plus, Aspen HYSYS, Microsoft Excel, Gas Chromatography, Systems Analysis, HTML, Controls System Design, Super Pro, Business Statements, Arduino, GC, Data Analysis, Employee Training, GMP, LabVIEW, Hazardous Materials, Biohazard
Education
University of Colorado at Boulder 2009 — 2014
Bachelor of Science (BS), Chemical and Biological Engineering Minor Electrical Engineering
Revere High School 2005 — 2009
High School Diploma, High School Diploma
Joule Unlimited Technologies, Inc. November 2014 - Present
21st Century July 2014 - September 2014
ISPE September 2013 - May 2014
Medlin Research Group CU Boulder February 2011 - December 2013
HP Bar Ranch January 2000 - August 2009
Sedgwick Computers May 2004 - September 2008
Skills
Matlab, Design of Experiments, Microsoft Office, Research, Visual Basic, Mathematica, C++, Solidworks, Simulink, Aspen Plus, Aspen HYSYS, Microsoft Excel, Gas Chromatography, Systems Analysis, HTML, Controls System Design, Super Pro, Business Statements, Arduino, GC, Data Analysis, Employee Training, GMP, LabVIEW, Hazardous Materials, Biohazard
Education
University of Colorado at Boulder 2009 — 2014
Bachelor of Science (BS), Chemical and Biological Engineering Minor Electrical Engineering
Revere High School 2005 — 2009
High School Diploma, High School Diploma
Tiffany Amber Norzagaray's ISPE Experience July 2009 - Present
Job Director of Business Development and Marketing at LCS Constructors, Inc.
Industry Marketing and Advertising
Experience
OCTANE 2011 - Present
LCS Constructors, Inc. July 2009 - Present
ISPE July 2009 - Present
CLMA 2009 - Present
SoCalBio 2009 - Present
IFMA Los Angeles Chapter 2014 - 2015
IFMA Los Angeles Chapter 2014 - 2015
Rauxa Direct January 2007 - December 2007
Skills
Marketing Strategy, New Business Development, Project Management, Business Development, Budgets, Contract Management, Contract Negotiation, Strategic Partnerships, Process Improvement, Sales Management, Business Strategy, Construction, Team Building, Marketing, Marketing Management, Organizational..., Management, Event Producing, Operations Management, Project Planning, Goal Oriented, Leadership, Sales Operations, Proposal Writing, Forecasting, Trade Shows, Competitive Analysis, Business Planning, Negotiation, Strategy
Education
Chapman University, The George L. Argyros School of Business and Economics 2005 — 2007
Masters in Business Admidistration (MBA), Business Administration - Emphasis in Strategic Marketing
University of California, Irvine 2002 — 2005
Psychology & Social Behavior, Pyschology and Business Management
OCTANE 2011 - Present
LCS Constructors, Inc. July 2009 - Present
ISPE July 2009 - Present
CLMA 2009 - Present
SoCalBio 2009 - Present
IFMA Los Angeles Chapter 2014 - 2015
IFMA Los Angeles Chapter 2014 - 2015
Rauxa Direct January 2007 - December 2007
Skills
Marketing Strategy, New Business Development, Project Management, Business Development, Budgets, Contract Management, Contract Negotiation, Strategic Partnerships, Process Improvement, Sales Management, Business Strategy, Construction, Team Building, Marketing, Marketing Management, Organizational..., Management, Event Producing, Operations Management, Project Planning, Goal Oriented, Leadership, Sales Operations, Proposal Writing, Forecasting, Trade Shows, Competitive Analysis, Business Planning, Negotiation, Strategy
Education
Chapman University, The George L. Argyros School of Business and Economics 2005 — 2007
Masters in Business Admidistration (MBA), Business Administration - Emphasis in Strategic Marketing
University of California, Irvine 2002 — 2005
Psychology & Social Behavior, Pyschology and Business Management
Brenda Kendrick's ISPE Experience February 2011 - Present
Job Public Training Coordinator at ISPE
Industry Pharmaceuticals
Experience
ISPE February 2011 - Present
ELECTRONIC LEARNING PRODUCTS January 2008 - December 2008
SCI COMPANIES August 2005 - January 2008
United State Army 1978 - 2000
Skills
Training, Program Management, Software Documentation, Human Resources, Management, Project Planning, Coaching, Strategic Planning, Analysis, Budgets, Project Management, Instructional Design, CRM, Staff Development, Sales, Performance Management, Employee Relations
Education
DeVry University-Florida
Bachelor of Business Administration (BBA), Business Administration and Management, General
ISPE February 2011 - Present
ELECTRONIC LEARNING PRODUCTS January 2008 - December 2008
SCI COMPANIES August 2005 - January 2008
United State Army 1978 - 2000
Skills
Training, Program Management, Software Documentation, Human Resources, Management, Project Planning, Coaching, Strategic Planning, Analysis, Budgets, Project Management, Instructional Design, CRM, Staff Development, Sales, Performance Management, Employee Relations
Education
DeVry University-Florida
Bachelor of Business Administration (BBA), Business Administration and Management, General
Susan Obarski, MPA's ISPE Experience February 2013 - Present
Job Executive Project Manager at ISPE
Industry Nonprofit Organization Management
Experience
ISPE February 2013 - Present
ISPE January 2011 - February 2013
Florida State Fair Authority July 2007 - January 2011
Crowley Museum and Nature Center July 2005 - July 2007
Milwaukee Public Schools February 2005 - June 2005
Skills
Program Management, Nonprofits, Project Management, Volunteer Management, Leadership, Teaching, Community Outreach, Project Planning, Budgets, Program Development, Research, Analysis, Volunteer Training, Publications, Event Management, Management, Strategy, Training, Quality Assurance, Fundraising, Grant Writing, Strategic Planning, Cross-functional Team..., Customer Service, Process Improvement, Team Building, Public Relations, Event Planning, Change Management
Education
University of South Florida 2011 — 2014
Master's Degree, Public Administration
University of South Florida 2011 — 2013
Graduate Certificate in Nonprofit Management
University of Wisconsin-Whitewater 1999 — 2004
Bachelor of Music, Music Education
ISPE February 2013 - Present
ISPE January 2011 - February 2013
Florida State Fair Authority July 2007 - January 2011
Crowley Museum and Nature Center July 2005 - July 2007
Milwaukee Public Schools February 2005 - June 2005
Skills
Program Management, Nonprofits, Project Management, Volunteer Management, Leadership, Teaching, Community Outreach, Project Planning, Budgets, Program Development, Research, Analysis, Volunteer Training, Publications, Event Management, Management, Strategy, Training, Quality Assurance, Fundraising, Grant Writing, Strategic Planning, Cross-functional Team..., Customer Service, Process Improvement, Team Building, Public Relations, Event Planning, Change Management
Education
University of South Florida 2011 — 2014
Master's Degree, Public Administration
University of South Florida 2011 — 2013
Graduate Certificate in Nonprofit Management
University of Wisconsin-Whitewater 1999 — 2004
Bachelor of Music, Music Education
Noel Maestre, PE LEED AP Noel Maestre, PE LEED AP's ISPE Experience January 2014 - Present
Job PM / Process Utilities Engineer
Industry Biotechnology
Experience
ISPE January 2014 - Present
CRB Consulting Engineers September 2009 - Present
CRB Consulting Engineers February 2007 - September 2009
Skills
Life Sciences, Process Utilities, Central Plant Design, Project Management, Cleanroom Design, HVAC, Biocontainment, Energy Modeling, 3D Design, AutoCAD, PipeFlo, eQuest, Lifesciences, Energy, GMP, Biotechnology, Commissioning, Project Engineering, Engineering, Process Engineering, Energy Efficiency, Mechanical Engineering, Steam, CAPA, Engineering Design, Piping, P&ID, Process Equipment, Process Simulation, Instrumentation, V&V
Education
Penn State University 2002 — 2006
BS, Mechanical Engineering
ISPE January 2014 - Present
CRB Consulting Engineers September 2009 - Present
CRB Consulting Engineers February 2007 - September 2009
Skills
Life Sciences, Process Utilities, Central Plant Design, Project Management, Cleanroom Design, HVAC, Biocontainment, Energy Modeling, 3D Design, AutoCAD, PipeFlo, eQuest, Lifesciences, Energy, GMP, Biotechnology, Commissioning, Project Engineering, Engineering, Process Engineering, Energy Efficiency, Mechanical Engineering, Steam, CAPA, Engineering Design, Piping, P&ID, Process Equipment, Process Simulation, Instrumentation, V&V
Education
Penn State University 2002 — 2006
BS, Mechanical Engineering
Rameeza Shaikh Rameeza Shaikh's ISPE Experience August 2015 - Present
Job Program Manager, Continuing Education at ISPE
Industry Hospital & Health Care
Experience
ISPE August 2015 - Present
Children's Hospital Association May 2011 - July 2015
NAESP May 2007 - September 2010
NAESP August 2006 - May 2007
Subway Development Corporation Of Washington August 2003 - August 2006
C&S Restaurant Group August 2001 - August 2003
Deutsche Bank Securities January 1999 - August 2001
Skills
Microsoft Office, SharePoint, iMIS, CRM, WebEx, Adobe Creative Suite, Zoomerang, SurveyMonkey, Skype, TurningPoint, Program Management, Management, Health Policy, Program Development, Organizational...
Education
Strayer University (VA) 2009 — 2012
Master of Business Administration (M.B.A.), Public Administration
Karachi University
Master's degree, English Language and Literature, General
ISPE August 2015 - Present
Children's Hospital Association May 2011 - July 2015
NAESP May 2007 - September 2010
NAESP August 2006 - May 2007
Subway Development Corporation Of Washington August 2003 - August 2006
C&S Restaurant Group August 2001 - August 2003
Deutsche Bank Securities January 1999 - August 2001
Skills
Microsoft Office, SharePoint, iMIS, CRM, WebEx, Adobe Creative Suite, Zoomerang, SurveyMonkey, Skype, TurningPoint, Program Management, Management, Health Policy, Program Development, Organizational...
Education
Strayer University (VA) 2009 — 2012
Master of Business Administration (M.B.A.), Public Administration
Karachi University
Master's degree, English Language and Literature, General
Chad Happ Chad Happ's ISPE Experience 2013 - Present
Job Project Manager
Industry Industrial Automation
Experience
ISPE 2013 - Present
Barry-Wehmiller Design Group 2003 - Present
Rockwell Automation June 2001 - 2002
Skills
Automation, PLC, SCADA, Allen Bradley, MES, Process Automation, Process Control, HMIs, Project Engineering, Industrial Control, Instrumentation, Control Systems Design, Engineering Management, DeviceNet, PLC Programming, Electrical Engineering, Commissioning, Manufacturing, Validation, GAMP, Project Planning, Project Management, Allen-Bradley
Education
Pennsylvania State University 1997 — 2001
ISPE 2013 - Present
Barry-Wehmiller Design Group 2003 - Present
Rockwell Automation June 2001 - 2002
Skills
Automation, PLC, SCADA, Allen Bradley, MES, Process Automation, Process Control, HMIs, Project Engineering, Industrial Control, Instrumentation, Control Systems Design, Engineering Management, DeviceNet, PLC Programming, Electrical Engineering, Commissioning, Manufacturing, Validation, GAMP, Project Planning, Project Management, Allen-Bradley
Education
Pennsylvania State University 1997 — 2001
Celina Yang Celina Yang's ISPE Experience September 2014 - March 2015
Job Student, Undergraduate Researcher UCLA
Industry Medical Practice
Experience
Golshani's Lab December 2013 - Present
UCLA September 2014 - June 2015
ISPE September 2014 - March 2015
Walsh Laboratory June 2014 - September 2014
Metropolitan Grill June 2014 - September 2014
JACOS (Japan Canada Oil Sands Ltd) August 2013 - September 2013
Tundra Swan Dance School September 2010 - September 2013
Skills
Biochemistry, Leadership, Research, Public Speaking, Life Sciences, Public Relations, Teaching, Microsoft Office, Teamwork, Community Outreach
Education
University of California, Los Angeles 2013 — 2017
Bachelor's of Science, Biochemistry
Sir Winston Churchill High School 2010 — 2013
High School, High School/Secondary Diplomas and Certificates
Lakehead University
Shad Valley
Golshani's Lab December 2013 - Present
UCLA September 2014 - June 2015
ISPE September 2014 - March 2015
Walsh Laboratory June 2014 - September 2014
Metropolitan Grill June 2014 - September 2014
JACOS (Japan Canada Oil Sands Ltd) August 2013 - September 2013
Tundra Swan Dance School September 2010 - September 2013
Skills
Biochemistry, Leadership, Research, Public Speaking, Life Sciences, Public Relations, Teaching, Microsoft Office, Teamwork, Community Outreach
Education
University of California, Los Angeles 2013 — 2017
Bachelor's of Science, Biochemistry
Sir Winston Churchill High School 2010 — 2013
High School, High School/Secondary Diplomas and Certificates
Lakehead University
Shad Valley
Wendy Perez, MS, SPHR, SHRM-SCP's ISPE Experience July 2012 - Present
Job Senior Director, Human Resources
Industry Education Management
Experience
ISPE July 2012 - Present
The Art Institute of Tampa 2007 - 2011
WRS Infrastructure & Environment 2000 - 2006
Skills
Employee Relations, Performance Management, Talent Management, Partnering, Coaching, Talent Acquisition, Legal Compliance, Succession Planning, Benefits Administration, Organizational..., Recruiting, Leadership, Strategy, Management, Program Management, Human Resources, Onboarding
Education
Troy University
Masters, Human Resources
Bethel College
Bachelor of Art
ISPE July 2012 - Present
The Art Institute of Tampa 2007 - 2011
WRS Infrastructure & Environment 2000 - 2006
Skills
Employee Relations, Performance Management, Talent Management, Partnering, Coaching, Talent Acquisition, Legal Compliance, Succession Planning, Benefits Administration, Organizational..., Recruiting, Leadership, Strategy, Management, Program Management, Human Resources, Onboarding
Education
Troy University
Masters, Human Resources
Bethel College
Bachelor of Art
Gus Roman's ISPE Experience December 2012 - April 2014
Job Analyst at Campbell Alliance
Industry Management Consulting
Experience
Campbell Alliance September 2014 - Present
University of Pennsylvania September 2010 - May 2014
ISPE December 2012 - April 2014
GlaxoSmithKline April 2013 - August 2013
University of Pennsylvania’s Medical Emergency Response Team January 2011 - May 2013
Penn Course Review September 2010 - May 2013
Stellar-Chance Labs May 2012 - August 2012
The Wistar Institute September 2010 - May 2012
American Eagle Outfitters 2010 - 2010
Skills
Biochemistry, Market Landscape..., Market Access, Presentation Development, Product Strategy, Organizational..., Data Analysis, Product Launch, PCR, Primary Research, Payer Insights, Commercial Models, Matlab, Protein Chemistry, Protein Expression, Biotechnology Industry, Pharmaceutical Industry, Market Research
Education
University of Pennsylvania 2010 — 2014
B.S.E., Chemical and Biomolecular Engineering
Campbell Alliance September 2014 - Present
University of Pennsylvania September 2010 - May 2014
ISPE December 2012 - April 2014
GlaxoSmithKline April 2013 - August 2013
University of Pennsylvania’s Medical Emergency Response Team January 2011 - May 2013
Penn Course Review September 2010 - May 2013
Stellar-Chance Labs May 2012 - August 2012
The Wistar Institute September 2010 - May 2012
American Eagle Outfitters 2010 - 2010
Skills
Biochemistry, Market Landscape..., Market Access, Presentation Development, Product Strategy, Organizational..., Data Analysis, Product Launch, PCR, Primary Research, Payer Insights, Commercial Models, Matlab, Protein Chemistry, Protein Expression, Biotechnology Industry, Pharmaceutical Industry, Market Research
Education
University of Pennsylvania 2010 — 2014
B.S.E., Chemical and Biomolecular Engineering
Nicole Granda-Alvarez, LEED AP BD+C Nicole Granda-Alvarez, LEED AP BD+C's ISPE Experience March 2013 - December 2014
Job Process & Validation Consultant
Industry Medical Devices
Experience
Ultimate Solutions Corp. May 2015 - Present
MENTOR Technical Group Corporation May 2013 - May 2015
ISPE March 2013 - December 2014
Commissioning Agents, Inc August 2010 - May 2013
USGBC Caribbean Chapter February 2011 - February 2012
V Architecture September 2009 - December 2009
University of Puerto Rico August 2007 - May 2009
CaboCoco Corp. May 2007 - September 2007
CaboCoco Corp. July 2006 - August 2006
Skills
LEED, LEED AP, Engineering, Architectural Design, Commissioning, Validation, Green Building, CAD, Sustainable Design, Construction Drawings, Project Management, Change Control, GMP, Construction, Sustainability, HVAC, Energy Audits, Renovation, Project Coordination, Proposal Writing, Medical Devices, Architecture, CAPA, Energy Conservation, HVAC Controls, LEED Consulting, Building Commissioning, Energy Efficiency, 21 CFR Part 11, MEP, Energy Management, Building Automation, FDA, Technical Writing, Biotechnology, Water Efficiency, Energy Services, Sustainability..., Sustainable Architecture, GAMP, Project Estimation, Adaptive Reuse, Quality System, Lean Manufacturing, Technology Transfer, V&V, AutoCAD, MS Project, Process Improvement, OSD
Education
Universidad de Puerto Rico 2007 — 2009
Master of Architecture (M.Arch.), Architecture, Suma cum Laude
University of Puerto Rico-Rio Piedras 2003 — 2007
Bachelor of Environmental Design, Architecture, Magna cum Laude
Ultimate Solutions Corp. May 2015 - Present
MENTOR Technical Group Corporation May 2013 - May 2015
ISPE March 2013 - December 2014
Commissioning Agents, Inc August 2010 - May 2013
USGBC Caribbean Chapter February 2011 - February 2012
V Architecture September 2009 - December 2009
University of Puerto Rico August 2007 - May 2009
CaboCoco Corp. May 2007 - September 2007
CaboCoco Corp. July 2006 - August 2006
Skills
LEED, LEED AP, Engineering, Architectural Design, Commissioning, Validation, Green Building, CAD, Sustainable Design, Construction Drawings, Project Management, Change Control, GMP, Construction, Sustainability, HVAC, Energy Audits, Renovation, Project Coordination, Proposal Writing, Medical Devices, Architecture, CAPA, Energy Conservation, HVAC Controls, LEED Consulting, Building Commissioning, Energy Efficiency, 21 CFR Part 11, MEP, Energy Management, Building Automation, FDA, Technical Writing, Biotechnology, Water Efficiency, Energy Services, Sustainability..., Sustainable Architecture, GAMP, Project Estimation, Adaptive Reuse, Quality System, Lean Manufacturing, Technology Transfer, V&V, AutoCAD, MS Project, Process Improvement, OSD
Education
Universidad de Puerto Rico 2007 — 2009
Master of Architecture (M.Arch.), Architecture, Suma cum Laude
University of Puerto Rico-Rio Piedras 2003 — 2007
Bachelor of Environmental Design, Architecture, Magna cum Laude
Bo Crouse-Feuerhelm Bo Crouse-Feuerhelm's ISPE Experience 1993 - 2009
Job Euphoria is nonexistent, but respect and courtesy to clients and fellow colleagues should always be paramount!!
Industry Pharmaceuticals
Experience
M+W U.S., Inc. June 2015 - Present
M+W Group June 2012 - Present
On Vacation June 2012 - June 2012
CH2M HILL September 2007 - June 2012
Society for Marketing Professional Services (SMPS) August 1993 - 2010
ISPE 1993 - 2009
AMEC E & C Services/AMEC BioPharmaceuticals, Inc. March 2005 - September 2007
CRB Consulting Engineers, Inc. 1997 - 2005
Gilbane Building Company December 1993 - July 1997
Sverdrup Corporation 1988 - 1993
Skills
Marketing, Business Development, Client Development, New Business Development, Pharmaceutical Industry, Strategic Planning, Contract Negotiation, CRM, Management, Validation, Relationship Management, Leadership, Customer Service, Business Intelligence, Project Management, Biotechnology, Engineering, Contract Management, Manufacturing, Marketing Strategy, Change Management, Negotiation, Networking, Process Engineering, Process Improvement, Procurement, Product Development, Program Management, Project Planning, Proposal Writing, Quality Assurance, Sales Management, Start-ups, Strategy, Team Building, Six Sigma
Education
Shepherd University 1978 — 1979
Society for Marketing Professional Services
Certification, Professional Services Sales & Marketing
M+W U.S., Inc. June 2015 - Present
M+W Group June 2012 - Present
On Vacation June 2012 - June 2012
CH2M HILL September 2007 - June 2012
Society for Marketing Professional Services (SMPS) August 1993 - 2010
ISPE 1993 - 2009
AMEC E & C Services/AMEC BioPharmaceuticals, Inc. March 2005 - September 2007
CRB Consulting Engineers, Inc. 1997 - 2005
Gilbane Building Company December 1993 - July 1997
Sverdrup Corporation 1988 - 1993
Skills
Marketing, Business Development, Client Development, New Business Development, Pharmaceutical Industry, Strategic Planning, Contract Negotiation, CRM, Management, Validation, Relationship Management, Leadership, Customer Service, Business Intelligence, Project Management, Biotechnology, Engineering, Contract Management, Manufacturing, Marketing Strategy, Change Management, Negotiation, Networking, Process Engineering, Process Improvement, Procurement, Product Development, Program Management, Project Planning, Proposal Writing, Quality Assurance, Sales Management, Start-ups, Strategy, Team Building, Six Sigma
Education
Shepherd University 1978 — 1979
Society for Marketing Professional Services
Certification, Professional Services Sales & Marketing
Ankit Chovatia's ISPE Experience February 2011 - May 2012
Job Validation Consultant at Regeneron Pharmaceuticals
Industry Pharmaceuticals
Experience
Regeneron Pharmaceuticals (Intracom LLC) April 2013 - Present
Genzyme (Intracom LLC) September 2012 - April 2013
Stevens Pharmaceutical Research Center August 2010 - June 2012
Stevens Institute of Technology June 2011 - May 2012
ISPE February 2011 - May 2012
Stevens Institute of Technology August 2010 - May 2012
Rise Remedies Ltd. May 2009 - August 2010
Bluecross laboratories Ltd September 2009 - March 2010
Skills
Minitab, Validation, GMP, Root Cause Analysis, Quality Assurance, Quality Control, TOC analyzer, Track-Pro, M-files, Qualification, CAPA, Installation..., Operational..., Performance..., Cleaning Validation, Calibration Protocol..., Risk Management tools..., Process Simulation and..., Design of Experiments, Quality by Design (QbD), Six Sigma and..., Fishbone, TOC, Chart, Commissioning, Quality Management, CIP, SIP, Calibration, Software Documentation, Biotechnology, Regulatory Affairs, Pharmaceutical Industry, HPLC, Sop, 21 CFR Part 11, SOP
Education
Stevens Institute of Technology 2010 — 2012
Master of Science in Pharmaceutical Manufacturing, Commissioning, Qualification and Validation, 3.7
M.S.University of Baroda 2005 — 2009
B.Pharm, Pharmacy, 3.63
Regeneron Pharmaceuticals (Intracom LLC) April 2013 - Present
Genzyme (Intracom LLC) September 2012 - April 2013
Stevens Pharmaceutical Research Center August 2010 - June 2012
Stevens Institute of Technology June 2011 - May 2012
ISPE February 2011 - May 2012
Stevens Institute of Technology August 2010 - May 2012
Rise Remedies Ltd. May 2009 - August 2010
Bluecross laboratories Ltd September 2009 - March 2010
Skills
Minitab, Validation, GMP, Root Cause Analysis, Quality Assurance, Quality Control, TOC analyzer, Track-Pro, M-files, Qualification, CAPA, Installation..., Operational..., Performance..., Cleaning Validation, Calibration Protocol..., Risk Management tools..., Process Simulation and..., Design of Experiments, Quality by Design (QbD), Six Sigma and..., Fishbone, TOC, Chart, Commissioning, Quality Management, CIP, SIP, Calibration, Software Documentation, Biotechnology, Regulatory Affairs, Pharmaceutical Industry, HPLC, Sop, 21 CFR Part 11, SOP
Education
Stevens Institute of Technology 2010 — 2012
Master of Science in Pharmaceutical Manufacturing, Commissioning, Qualification and Validation, 3.7
M.S.University of Baroda 2005 — 2009
B.Pharm, Pharmacy, 3.63
Sneha Deshpande Sneha Deshpande's ISPE Experience June 2008 - June 2011
Job Sr. Engineer at Amgen
Industry Biotechnology
Experience
Amgen September 2015 - Present
BioSPEQ, An Azzur Group company April 2013 - August 2015
Ortho Clinical Diagnostics August 2012 - March 2013
Ortho Clinical Diagnostics February 2012 - July 2012
Optimum Validation Inc January 2012 - February 2012
Ortho Clinical Diagnostics April 2011 - December 2011
ISPE June 2008 - June 2011
Azzurgroup LLC August 2010 - April 2011
Stevens Institute of Technology June 2009 - August 2010
Core Pharma LLC January 2010 - May 2010
Skills
Validation, GMP, FDA, Quality System, Change Control, Pharmaceutical Industry, Quality Assurance, V&V, Six Sigma, 21 CFR Part 11, Root Cause Analysis, CAPA, Manufacturing, Process Improvement, Minitab, ICH guidelines, Microsoft Office 2007, Lean Manufacturing, Document Management, Formulation, Lean Initiatives, Process Validation, LIMS, SAP, Documentum, Process Performance..., Trackwise, Cleaning Validation, Quality Control
Education
Stevens Institute of Technology 2008 — 2010
MS, Pharmaceutical Manufacturing, GPA: 4.0
Pune University 2004 — 2008
Bachelor of Science, Pharmacy
IES CPV
SSC
Amgen September 2015 - Present
BioSPEQ, An Azzur Group company April 2013 - August 2015
Ortho Clinical Diagnostics August 2012 - March 2013
Ortho Clinical Diagnostics February 2012 - July 2012
Optimum Validation Inc January 2012 - February 2012
Ortho Clinical Diagnostics April 2011 - December 2011
ISPE June 2008 - June 2011
Azzurgroup LLC August 2010 - April 2011
Stevens Institute of Technology June 2009 - August 2010
Core Pharma LLC January 2010 - May 2010
Skills
Validation, GMP, FDA, Quality System, Change Control, Pharmaceutical Industry, Quality Assurance, V&V, Six Sigma, 21 CFR Part 11, Root Cause Analysis, CAPA, Manufacturing, Process Improvement, Minitab, ICH guidelines, Microsoft Office 2007, Lean Manufacturing, Document Management, Formulation, Lean Initiatives, Process Validation, LIMS, SAP, Documentum, Process Performance..., Trackwise, Cleaning Validation, Quality Control
Education
Stevens Institute of Technology 2008 — 2010
MS, Pharmaceutical Manufacturing, GPA: 4.0
Pune University 2004 — 2008
Bachelor of Science, Pharmacy
IES CPV
SSC
Barbara A. Myers, CAE's ISPE Experience April 2013 - February 2014
Job Vice President Association Services at IMN Solutions
Industry Nonprofit Organization Management
Experience
IMN Solutions February 2014 - Present
ISPE April 2013 - February 2014
Frost Miller Group, Inc. November 2011 - April 2013
APCO International May 2002 - November 2011
Skills
Non-profits, Research, Blogging, Integrated Marketing, Marketing Communications, Event Management, Trade Shows, Event Planning, Social Media, Public Relations, Strategic Planning, Marketing Strategy, Social Media Marketing, Budgets, Public Speaking, Fundraising, Sponsorship, Online Advertising, Advertising, Media Relations, Non-profit Leadership, Non-profit Boards, Non-profit..., Program Management, Sales, Leadership, Strategy, Government, Management, Contract Negotiation, Team Building, Marketing, Nonprofits, Project Planning, Product Marketing, Policy, Association Management, Email Marketing, Strategic Partnerships, Proposal Writing, Social Networking, Copywriting, Strategic Communications, Training, Newsletters, Leadership Development, Online Marketing, Direct Marketing, Meeting Planning, Lead Generation
Education
University of Central Florida 2007 — 2014
Masters, Nonprofit Management
University of Maryland College Park 1994 — 1998
Bachelor of Science, Psychology
BAHS
IMN Solutions February 2014 - Present
ISPE April 2013 - February 2014
Frost Miller Group, Inc. November 2011 - April 2013
APCO International May 2002 - November 2011
Skills
Non-profits, Research, Blogging, Integrated Marketing, Marketing Communications, Event Management, Trade Shows, Event Planning, Social Media, Public Relations, Strategic Planning, Marketing Strategy, Social Media Marketing, Budgets, Public Speaking, Fundraising, Sponsorship, Online Advertising, Advertising, Media Relations, Non-profit Leadership, Non-profit Boards, Non-profit..., Program Management, Sales, Leadership, Strategy, Government, Management, Contract Negotiation, Team Building, Marketing, Nonprofits, Project Planning, Product Marketing, Policy, Association Management, Email Marketing, Strategic Partnerships, Proposal Writing, Social Networking, Copywriting, Strategic Communications, Training, Newsletters, Leadership Development, Online Marketing, Direct Marketing, Meeting Planning, Lead Generation
Education
University of Central Florida 2007 — 2014
Masters, Nonprofit Management
University of Maryland College Park 1994 — 1998
Bachelor of Science, Psychology
BAHS
Joyce Chiu 裘錦澐, MBA, CPIP Joyce Chiu 裘錦澐, MBA, CPIP's ISPE Experience October 2007 - Present
Job Associate Director Program Management Office at Shire
Industry Biotechnology
Experience
Shire Pharmaceuticals July 2015 - Present
ISPE October 2007 - Present
Honeywell Industrial Safety September 2010 - February 2015
PAREXEL October 2007 - September 2010
GE Healthcare 2005 - 2007
Hologic 2004 - 2005
Cooley/Group 2003 - 2004
E Ink Corporation 2001 - 2002
Polaroid Corporation 1999 - 2001
Dow Chemical 1991 - 1999
Skills
Technology Transfer, Biotechnology, Design of Experiments, Project Management, Process Engineering, Product Development, R&D, Validation, Continuous Improvement, Cross-functional Team..., Negotiation, Risk Management, Root Cause Analysis, Engineering Management, Process Simulation, CAPA, Program Management, Quality Management, Start-ups, ISO 13485, 21 CFR Part 11, Process Improvement
Education
Babson College - Franklin W. Olin Graduate School of Business
MBA, Summa Cum Laude, 2006
Cornell University
B.S.
Shire Pharmaceuticals July 2015 - Present
ISPE October 2007 - Present
Honeywell Industrial Safety September 2010 - February 2015
PAREXEL October 2007 - September 2010
GE Healthcare 2005 - 2007
Hologic 2004 - 2005
Cooley/Group 2003 - 2004
E Ink Corporation 2001 - 2002
Polaroid Corporation 1999 - 2001
Dow Chemical 1991 - 1999
Skills
Technology Transfer, Biotechnology, Design of Experiments, Project Management, Process Engineering, Product Development, R&D, Validation, Continuous Improvement, Cross-functional Team..., Negotiation, Risk Management, Root Cause Analysis, Engineering Management, Process Simulation, CAPA, Program Management, Quality Management, Start-ups, ISO 13485, 21 CFR Part 11, Process Improvement
Education
Babson College - Franklin W. Olin Graduate School of Business
MBA, Summa Cum Laude, 2006
Cornell University
B.S.
Courtney Bowersox Courtney Bowersox's ISPE Experience June 2013 - October 2014
Job Instructional Designer/eLearning Developer
Industry Higher Education
Experience
Federal Reserve Bank of St. Louis October 2014 - Present
PricewaterhouseCoopers (PwC) March 2014 - December 2014
ISPE June 2013 - October 2014
Institute for Corporate and Continuing Education at HCC May 2011 - June 2013
Institute for Corporate and Continuing Education at HCC November 2009 - June 2013
Corinthian Colleges; Everest Online Division August 2009 - May 2011
Columbus Technical College August 2007 - July 2009
Skills
Adult Education, Higher Education, Curriculum Development, Resume Writing, Instructional Design, Public Speaking, Teaching, E-Learning, Curriculum Design, Career Development, Leadership Development, Career Counseling, Moodle, Event Planning, Learning Management..., Staff Development, Customer Service, Training Delivery, Microsoft Office, Technical Writing, Adobe Creative Suite, SoftChalk, Captivate, Camtasia, SharePoint, Articulate Studio, Lectora, WebEx, Program Management, Leadership, Distance Learning, Nonprofits, Recruiting, Training, Instructor-led Training, ADDIE, Software Documentation, Editing, Employee Training
Education
Saint Leo University 2010 — 2013
M.S Education, Instructional Design
Columbus State University 2004 — 2007
BA Communication/ Media Relations, Communications
Federal Reserve Bank of St. Louis October 2014 - Present
PricewaterhouseCoopers (PwC) March 2014 - December 2014
ISPE June 2013 - October 2014
Institute for Corporate and Continuing Education at HCC May 2011 - June 2013
Institute for Corporate and Continuing Education at HCC November 2009 - June 2013
Corinthian Colleges; Everest Online Division August 2009 - May 2011
Columbus Technical College August 2007 - July 2009
Skills
Adult Education, Higher Education, Curriculum Development, Resume Writing, Instructional Design, Public Speaking, Teaching, E-Learning, Curriculum Design, Career Development, Leadership Development, Career Counseling, Moodle, Event Planning, Learning Management..., Staff Development, Customer Service, Training Delivery, Microsoft Office, Technical Writing, Adobe Creative Suite, SoftChalk, Captivate, Camtasia, SharePoint, Articulate Studio, Lectora, WebEx, Program Management, Leadership, Distance Learning, Nonprofits, Recruiting, Training, Instructor-led Training, ADDIE, Software Documentation, Editing, Employee Training
Education
Saint Leo University 2010 — 2013
M.S Education, Instructional Design
Columbus State University 2004 — 2007
BA Communication/ Media Relations, Communications
Pamela Bruen Docherty Pamela Bruen Docherty's ISPE Experience 2011 - 2012
Job Life Sciences Industry Manager at Siemens Industry US
Industry Pharmaceuticals
Experience
Siemens Industry US March 2013 - Present
Honeywell Process Solutions July 2007 - March 2013
ISPE 2011 - 2012
Merck September 2002 - July 2007
Siemens/Moore Products 1997 - 2002
Roche 1996 - 1997
Skills
MES, GAMP, 21 CFR Part 11, Automation, Biotechnology, CAPA, Change Control, Commissioning, Computer System..., Control Systems Design, DCS, Engineering, FDA, Instrumentation, Integration, Manufacturing, Modbus, PLC, Process Automation, Process Control, Process Engineering, Process Optimization, Process Simulation, Project Engineering, Quality Assurance, Quality System, SCADA, Six Sigma, Software Documentation, V, Validation, GMP
Education
Villanova University 1998 — 2002
Master of Chemical Engineering, Chemical Engineering
Lehigh University 1993 — 1997
Bachelor of Science (B.S.), Chemical Engineering
Bangor Area High School
Siemens Industry US March 2013 - Present
Honeywell Process Solutions July 2007 - March 2013
ISPE 2011 - 2012
Merck September 2002 - July 2007
Siemens/Moore Products 1997 - 2002
Roche 1996 - 1997
Skills
MES, GAMP, 21 CFR Part 11, Automation, Biotechnology, CAPA, Change Control, Commissioning, Computer System..., Control Systems Design, DCS, Engineering, FDA, Instrumentation, Integration, Manufacturing, Modbus, PLC, Process Automation, Process Control, Process Engineering, Process Optimization, Process Simulation, Project Engineering, Quality Assurance, Quality System, SCADA, Six Sigma, Software Documentation, V, Validation, GMP
Education
Villanova University 1998 — 2002
Master of Chemical Engineering, Chemical Engineering
Lehigh University 1993 — 1997
Bachelor of Science (B.S.), Chemical Engineering
Bangor Area High School
Kim Ray Kim Ray's ISPE Experience January 2014 - January 2015
Job A. Director, Project Management at Oso BioPharmaceuticals Manufacturing LLc
Industry Pharmaceuticals
Experience
Oso BioPharmaceuticals Manufacturing LLc July 2000 - Present
ISPE January 2014 - January 2015
Cardinal Health 2002 - 2008
PDA - Parenteral Drug Association 2004 - 2007
Skills
GMP, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Six Sigma, Quality Assurance, Project Management, FDA, Aseptic Processing, Process Improvement, CAPA, V&V, 21 CFR Part 11, Contract Manufacturing, Change Control, Biopharmaceuticals, Cross-functional Team..., Validation, Technology Transfer, Sop, Trackwise, GxP, Quality System, Technical Writing, SOP
Education
Villanova University 2011 — 2012
Master's degree, Project Management
The University of New Mexico 1990 — 1995
Chemistry/Biology/Criminology, Biology, General, Chemistry
Oso BioPharmaceuticals Manufacturing LLc July 2000 - Present
ISPE January 2014 - January 2015
Cardinal Health 2002 - 2008
PDA - Parenteral Drug Association 2004 - 2007
Skills
GMP, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Six Sigma, Quality Assurance, Project Management, FDA, Aseptic Processing, Process Improvement, CAPA, V&V, 21 CFR Part 11, Contract Manufacturing, Change Control, Biopharmaceuticals, Cross-functional Team..., Validation, Technology Transfer, Sop, Trackwise, GxP, Quality System, Technical Writing, SOP
Education
Villanova University 2011 — 2012
Master's degree, Project Management
The University of New Mexico 1990 — 1995
Chemistry/Biology/Criminology, Biology, General, Chemistry
Jim Breen Jim Breen's ISPE Experience November 2011 - Present
Job VP Engineering and Technical Operations at Johnson & Johnson
Industry Program Development
Experience
Johnson & Johnson September 2012 - Present
ISPE November 2011 - Present
Drexel University September 2007 - Present
Johnson & Johnson November 2011 - August 2012
Johnson & Johson October 2007 - October 2011
Johnson & Johnson October 2003 - October 2007
Johnson & Johnson January 2001 - October 2003
Johnson & Johnson January 1997 - January 2001
General Electric Company August 1992 - January 1997
GE November 1989 - August 1992
Skills
Cross-functional Team..., Project Management, Program Management, Manufacturing, Engineering, Project Planning, Engineering Management, Pharmaceutical Industry, Management, Six Sigma, R&D, Process Improvement, Supply Chain, Risk Management, Process Engineering, Project Engineering, Team Building
Education
U of Penn - The Wharton School / Penn Engineering 2005 — 2007
MSE, Technology Management
University of Pennsylvania - The Wharton School 2005 — 2007
EMTM, Technology Management
Drexel University 1990 — 1994
MBA, Finance
Stevens Institute of Technology 1980 — 1983
Bachelor of Engineering (B.Eng.), Mechanical Engineering
Johnson & Johnson September 2012 - Present
ISPE November 2011 - Present
Drexel University September 2007 - Present
Johnson & Johnson November 2011 - August 2012
Johnson & Johson October 2007 - October 2011
Johnson & Johnson October 2003 - October 2007
Johnson & Johnson January 2001 - October 2003
Johnson & Johnson January 1997 - January 2001
General Electric Company August 1992 - January 1997
GE November 1989 - August 1992
Skills
Cross-functional Team..., Project Management, Program Management, Manufacturing, Engineering, Project Planning, Engineering Management, Pharmaceutical Industry, Management, Six Sigma, R&D, Process Improvement, Supply Chain, Risk Management, Process Engineering, Project Engineering, Team Building
Education
U of Penn - The Wharton School / Penn Engineering 2005 — 2007
MSE, Technology Management
University of Pennsylvania - The Wharton School 2005 — 2007
EMTM, Technology Management
Drexel University 1990 — 1994
MBA, Finance
Stevens Institute of Technology 1980 — 1983
Bachelor of Engineering (B.Eng.), Mechanical Engineering
Angie Brumley Angie Brumley's ISPE Experience August 2010 - January 2015
Job Certification Test Development at American Association of Physician Specialists
Industry Nonprofit Organization Management
Experience
ISPE August 2010 - January 2015
ISPE October 2006 - August 2010
MCI 1998 - 2002
Skills
Publications, Feature Articles, Publishing, Proofreading, Internal Communications, Nonprofits, Web Content Management, Research, Leadership, Program Management, Cross-functional Team..., Biotechnology, Pharmaceutical Industry, Project Management, FDA, Strategic Planning, Process Improvement
Education
University of South Florida 1990 — 1995
B.A.
ISPE August 2010 - January 2015
ISPE October 2006 - August 2010
MCI 1998 - 2002
Skills
Publications, Feature Articles, Publishing, Proofreading, Internal Communications, Nonprofits, Web Content Management, Research, Leadership, Program Management, Cross-functional Team..., Biotechnology, Pharmaceutical Industry, Project Management, FDA, Strategic Planning, Process Improvement
Education
University of South Florida 1990 — 1995
B.A.
Ellis Daw Ellis Daw's ISPE Experience 1998 - Present
Job Director, Quality Technology and Projects at GlaxoSmithKline
Industry Pharmaceuticals
Experience
GlaxoSmithKline January 2011 - Present
ISPE 1998 - Present
GlaxoSmithKline January 2009 - December 2010
GlaxoSmithKline June 2005 - December 2008
Burroughs Wellcome 1985 - 1996
Burroughs Wellcome 1985 - 1996
CSSC 1994 - 1994
Skills
Change Control, Training, Business Process, Validation, Quality Assurance, GMP, Pharmaceutical Industry, Management, 21 CFR Part 11, Computer System..., Change Management, FDA, CAPA, Software Documentation, Sop
Education
East Carolina University - College of Business 1987 — 1992
MBA, Business
East Carolina University 1982 — 1985
Bachelors, Computer Science
Belhaven 1977 — 1979
GlaxoSmithKline January 2011 - Present
ISPE 1998 - Present
GlaxoSmithKline January 2009 - December 2010
GlaxoSmithKline June 2005 - December 2008
Burroughs Wellcome 1985 - 1996
Burroughs Wellcome 1985 - 1996
CSSC 1994 - 1994
Skills
Change Control, Training, Business Process, Validation, Quality Assurance, GMP, Pharmaceutical Industry, Management, 21 CFR Part 11, Computer System..., Change Management, FDA, CAPA, Software Documentation, Sop
Education
East Carolina University - College of Business 1987 — 1992
MBA, Business
East Carolina University 1982 — 1985
Bachelors, Computer Science
Belhaven 1977 — 1979
Ralph Donnelly Ralph Donnelly's ISPE Experience 1980 - 2011
Job Technical and Qualiy Systems Consultant to 503B Compounding, Pharmaceutical and Medical Device Companies
Industry Management Consulting
Experience
R. Donnelly & Associates, Inc. May 1990 - Present
R. Donnelly & Associates, Inc. 1990 - Present
Gallus BioPharmaceuticals August 2011 - May 2012
Topical Ointment and Creme Manufacturer January 2011 - August 2011
ISPE 1980 - 2011
Cardinal Health 2003 - 2005
Cook BioPharma 2000 - 2001
Invitron 1985 - 1990
Armour Pharmaceuticals 1978 - 1983
Skills
GMP, Validation, Quality Systems, Remediation, Project Planning, Construction Management, Project Implementation, Commissioning, Qualiy Systems, Quality System, Systems, FDA, Technology Transfer, Sop, Facilities Management, Medical Devices, CAPA, V&V, Project Management, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Product Development, Solution Implementation, Process Simulation, LIMS, GAMP, Quality Assurance, Quality Auditing, Process Engineering, Process Optimization, Start-ups, Regulatory Affairs, Vaccines, Cross-functional Team..., Aseptic Processing, Biotechnology, GLP, Software Documentation, Regulatory Requirements, Clinical Trials, ISO, Biopharmaceuticals, Computer System..., Pharmaceutics, Cleaning Validation, Six Sigma, Leadership, Quality Management, Manufacturing
Education
LeTourneau University 1965 — 1969
BSME, Mechanical Engineering
Bradley Bourbounais HS 1961 — 1965
high school, college prep
R. Donnelly & Associates, Inc. May 1990 - Present
R. Donnelly & Associates, Inc. 1990 - Present
Gallus BioPharmaceuticals August 2011 - May 2012
Topical Ointment and Creme Manufacturer January 2011 - August 2011
ISPE 1980 - 2011
Cardinal Health 2003 - 2005
Cook BioPharma 2000 - 2001
Invitron 1985 - 1990
Armour Pharmaceuticals 1978 - 1983
Skills
GMP, Validation, Quality Systems, Remediation, Project Planning, Construction Management, Project Implementation, Commissioning, Qualiy Systems, Quality System, Systems, FDA, Technology Transfer, Sop, Facilities Management, Medical Devices, CAPA, V&V, Project Management, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Product Development, Solution Implementation, Process Simulation, LIMS, GAMP, Quality Assurance, Quality Auditing, Process Engineering, Process Optimization, Start-ups, Regulatory Affairs, Vaccines, Cross-functional Team..., Aseptic Processing, Biotechnology, GLP, Software Documentation, Regulatory Requirements, Clinical Trials, ISO, Biopharmaceuticals, Computer System..., Pharmaceutics, Cleaning Validation, Six Sigma, Leadership, Quality Management, Manufacturing
Education
LeTourneau University 1965 — 1969
BSME, Mechanical Engineering
Bradley Bourbounais HS 1961 — 1965
high school, college prep
Andre Michel Andre Michel's ISPE Experience January 2011 - Present
Job President at Efficient Plant Inc.
Industry Management Consulting
Experience
Efficient Plant Inc. January 2010 - Present
SKILLPAD October 2009 - Present
ISA January 2014 - Present
ISA July 2013 - Present
Project Management Institute January 2013 - Present
ISPE January 2011 - Present
ISA June 2010 - Present
ISA - FPID December 2008 - February 2014
Eli Lilly and Company 2013 - 2014
Eli Lilly and Company 2013 - 2014
Skills
Automation, Engineering Management, DCS, PLC, Commissioning, Validation, GMP, Engineering, Process Control, Manufacturing, Instrumentation, Planning, Process Automation, Process Improvement, System Design, Start-ups, MES, Integration, Strategic Planning, Testing, Quality Assurance, Project Execution, SCADA, Program Management, Problem Solving, Analysis, Change Management, Project Engineering, MS Project, Team Leadership, GAMP, Project Delivery, Project Planning, Cross-functional Team..., Project Management, Computer System..., Project Portfolio..., Vendor Management, Continuous Improvement, Leadership, International Project..., Process Engineering, Factory, Control Systems Design, Strategy, Management, Process Simulation, 21 CFR Part 11, Software Documentation, Process Optimization
Education
Université du Québec 1985 — 1992
Master, Project Management
Université Laval 1980 — 1983
Bacc in Electrical Engineering, Automation
Efficient Plant Inc. January 2010 - Present
SKILLPAD October 2009 - Present
ISA January 2014 - Present
ISA July 2013 - Present
Project Management Institute January 2013 - Present
ISPE January 2011 - Present
ISA June 2010 - Present
ISA - FPID December 2008 - February 2014
Eli Lilly and Company 2013 - 2014
Eli Lilly and Company 2013 - 2014
Skills
Automation, Engineering Management, DCS, PLC, Commissioning, Validation, GMP, Engineering, Process Control, Manufacturing, Instrumentation, Planning, Process Automation, Process Improvement, System Design, Start-ups, MES, Integration, Strategic Planning, Testing, Quality Assurance, Project Execution, SCADA, Program Management, Problem Solving, Analysis, Change Management, Project Engineering, MS Project, Team Leadership, GAMP, Project Delivery, Project Planning, Cross-functional Team..., Project Management, Computer System..., Project Portfolio..., Vendor Management, Continuous Improvement, Leadership, International Project..., Process Engineering, Factory, Control Systems Design, Strategy, Management, Process Simulation, 21 CFR Part 11, Software Documentation, Process Optimization
Education
Université du Québec 1985 — 1992
Master, Project Management
Université Laval 1980 — 1983
Bacc in Electrical Engineering, Automation
Dragutin Stoicovici Dragutin Stoicovici's ISPE Experience 2008 - 2009
Job Cozzoli Machine Company, Director of QA
Industry Pharmaceuticals
Experience
Cozzoli Machine Company May 1992 - Present
ISPE North American South American Afiliate Cuncil (NASAAC) 2009 - 2009
ISPE 2008 - 2009
Cozzoli Machine Company May 1992 - August 1996
Skills
Electricians, Project Management, Quality Assurance, Validation, PLC, Commissioning, GMP, Automation, SCADA, Management, Manufacturing, FDA, Engineering, Continuous Improvement, Computer System..., GAMP, Product Development, Quality System, Root Cause Analysis, Cross-functional Team..., Six Sigma, Process Engineering, Lean Manufacturing, CAPA
Education
New York University - Polytechnic School of Engineering
MSEE, Electrical Engineering
Cozzoli Machine Company May 1992 - Present
ISPE North American South American Afiliate Cuncil (NASAAC) 2009 - 2009
ISPE 2008 - 2009
Cozzoli Machine Company May 1992 - August 1996
Skills
Electricians, Project Management, Quality Assurance, Validation, PLC, Commissioning, GMP, Automation, SCADA, Management, Manufacturing, FDA, Engineering, Continuous Improvement, Computer System..., GAMP, Product Development, Quality System, Root Cause Analysis, Cross-functional Team..., Six Sigma, Process Engineering, Lean Manufacturing, CAPA
Education
New York University - Polytechnic School of Engineering
MSEE, Electrical Engineering
Erik Reinertsen's ISPE Experience October 2009 - March 2012
Job MD/PhD student
Industry Research
Experience
Georgia Institute of Technology July 2014 - Present
Forge February 2014 - Present
ISPE October 2009 - March 2012
UCLA August 2009 - March 2012
Skills
Biomaterials, Public Speaking, Clinical Research, Tissue Engineering, Technical Presentations, Scientific Writing, Lifesciences, Biomedical Engineering, Team Management, Nanotechnology, Clinical informatics, Matlab, Mobile health
Education
Emory University School of Medicine
MD
Georgia Institute of Technology
PhD, Biomedical Engineering, Statistics
University of California, Los Angeles
BS, Bioengineering, Chemical Engineering
Georgia Institute of Technology July 2014 - Present
Forge February 2014 - Present
ISPE October 2009 - March 2012
UCLA August 2009 - March 2012
Skills
Biomaterials, Public Speaking, Clinical Research, Tissue Engineering, Technical Presentations, Scientific Writing, Lifesciences, Biomedical Engineering, Team Management, Nanotechnology, Clinical informatics, Matlab, Mobile health
Education
Emory University School of Medicine
MD
Georgia Institute of Technology
PhD, Biomedical Engineering, Statistics
University of California, Los Angeles
BS, Bioengineering, Chemical Engineering
Rachel Leahy, PhD's ISPE Experience September 2014 - Present
Job Pharmaceutical Engagement Manager, Larvol
Industry Biotechnology
Experience
Larvol September 2014 - Present
ISPE September 2014 - Present
Johnston Community College April 2014 - Present
Paradigm Counseling October 2008 - October 2014
Cleveland Clinic July 2013 - January 2014
Confidential March 2011 - June 2011
Cleveland Clinic June 2006 - June 2011
Cleveland Clinic May 2004 - June 2006
Lorain County Community College January 2006 - May 2006
Energizer June 2000 - December 2000
Skills
Competitive Intelligence, KOL, KOL Identification, Pharmaceutical Industry, cGMP manufacturing, Medical Affairs, Regulatory Affairs, Higher Education, Project Management, Research, Project Planning, Teaching, Clinical Research, Science, Public Speaking, SPSS, Academic Advising, Grant Writing, Program Evaluation, Student Development, Student Affairs, Student Leadership, University Teaching, Statistics, Data Analysis, Community Outreach, Microsoft Office, Editing, Qualitative Research, College Teaching, Student Engagement, Molecular Biology, Biotechnology, Cell, Life Sciences, Management, PCR, Cell Culture, Training, Biochemistry, Cell Biology, Customer Engagement, Upstream Processing
Education
Kent State University 2003 — 2012
Doctor of Philosophy (Ph.D.), Cellular and Molecular Biology
Larvol September 2014 - Present
ISPE September 2014 - Present
Johnston Community College April 2014 - Present
Paradigm Counseling October 2008 - October 2014
Cleveland Clinic July 2013 - January 2014
Confidential March 2011 - June 2011
Cleveland Clinic June 2006 - June 2011
Cleveland Clinic May 2004 - June 2006
Lorain County Community College January 2006 - May 2006
Energizer June 2000 - December 2000
Skills
Competitive Intelligence, KOL, KOL Identification, Pharmaceutical Industry, cGMP manufacturing, Medical Affairs, Regulatory Affairs, Higher Education, Project Management, Research, Project Planning, Teaching, Clinical Research, Science, Public Speaking, SPSS, Academic Advising, Grant Writing, Program Evaluation, Student Development, Student Affairs, Student Leadership, University Teaching, Statistics, Data Analysis, Community Outreach, Microsoft Office, Editing, Qualitative Research, College Teaching, Student Engagement, Molecular Biology, Biotechnology, Cell, Life Sciences, Management, PCR, Cell Culture, Training, Biochemistry, Cell Biology, Customer Engagement, Upstream Processing
Education
Kent State University 2003 — 2012
Doctor of Philosophy (Ph.D.), Cellular and Molecular Biology
Mark Rezac, PE Mark Rezac, PE's ISPE Experience October 2014 - Present
Job Director Compliance Consulting at IPSIntegrated Project Services
Industry Pharmaceuticals
Experience
ISPE October 2014 - Present
IPS-Integrated Project Services December 2013 - Present
Merck November 1986 - November 2013
United States Steel Corporation May 1979 - May 1984
Skills
FDA, Quality System, Validation, CAPA, Root Cause Analysis, Quality Assurance, Six Sigma, GMP, Engineering, R&D, Cross-functional Team..., Project Management, Manufacturing, Lean Manufacturing, Compliance, Commissioning, Equipment Qualification, Facilities Engineering, Change Management, Managing Start-ups
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business 1981 — 1984
Master of Business Administration (MBA)
University of Pittsburgh-Johnstown 1975 — 1979
Bachelor of Science (BS), Civil Engineering Technology/Technician
ISPE October 2014 - Present
IPS-Integrated Project Services December 2013 - Present
Merck November 1986 - November 2013
United States Steel Corporation May 1979 - May 1984
Skills
FDA, Quality System, Validation, CAPA, Root Cause Analysis, Quality Assurance, Six Sigma, GMP, Engineering, R&D, Cross-functional Team..., Project Management, Manufacturing, Lean Manufacturing, Compliance, Commissioning, Equipment Qualification, Facilities Engineering, Change Management, Managing Start-ups
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business 1981 — 1984
Master of Business Administration (MBA)
University of Pittsburgh-Johnstown 1975 — 1979
Bachelor of Science (BS), Civil Engineering Technology/Technician
David Jury David Jury's ISPE Experience August 2014 - Present
Job Senior Process Engineer | Project Management | Food & Beverage | Life Sciences | Chemical Processing
Industry Biotechnology
Experience
Barry-Wehmiller Design Group February 2015 - Present
ISPE August 2014 - Present
St. Vrain Valley School District September 2012 - Present
Amgen May 2014 - January 2015
Amgen February 2005 - January 2015
Toastmasters International July 2009 - March 2014
Cargill July 2003 - February 2005
Imperial Sugar Company September 1989 - July 2003
Education
University of California, Davis 1996 — 1998
Bachelor of Science, Mechanical Engineering
Shasta College 1983 — 1986
AA, General Studies, Chemistry & Engineering
Barry-Wehmiller Design Group February 2015 - Present
ISPE August 2014 - Present
St. Vrain Valley School District September 2012 - Present
Amgen May 2014 - January 2015
Amgen February 2005 - January 2015
Toastmasters International July 2009 - March 2014
Cargill July 2003 - February 2005
Imperial Sugar Company September 1989 - July 2003
Education
University of California, Davis 1996 — 1998
Bachelor of Science, Mechanical Engineering
Shasta College 1983 — 1986
AA, General Studies, Chemistry & Engineering
Dave DiProspero's ISPE Experience May 2013 - Present
Job Pharmaceutical Engineering Professional
Industry Pharmaceuticals
Experience
CRB Consulting Engineers April 2013 - Present
ISPE May 2013 - Present
Skills
Engineering, Validation, FDA, GMP, Technology Transfer, Pharmaceutical Industry, V&V, Change Control, Process Engineering, Quality System, Biotechnology, Sop, Process Simulation, Manufacturing, CAPA, Cross-functional Team..., Quality Assurance, R&D, Medical Devices, Project Management, Pharmaceutics
Education
Rochester Institute of Technology 1983 — 1991
BS, Business and Electo/Mechanical Engineering
Rochester Institute of Technology 1981 — 1983
AAS, Applied Mechanical Design Technology
CRB Consulting Engineers April 2013 - Present
ISPE May 2013 - Present
Skills
Engineering, Validation, FDA, GMP, Technology Transfer, Pharmaceutical Industry, V&V, Change Control, Process Engineering, Quality System, Biotechnology, Sop, Process Simulation, Manufacturing, CAPA, Cross-functional Team..., Quality Assurance, R&D, Medical Devices, Project Management, Pharmaceutics
Education
Rochester Institute of Technology 1983 — 1991
BS, Business and Electo/Mechanical Engineering
Rochester Institute of Technology 1981 — 1983
AAS, Applied Mechanical Design Technology
Diana Carolina Castano Diana Carolina Castano's ISPE Experience March 2015 - March 2015
Job Novartis
Industry Pharmaceuticals
Experience
Novartis April 2015 - Present
NC State College of Veterinary Medicine July 2013 - April 2015
ISPE March 2015 - March 2015
Merck June 2014 - August 2014
Merck June 2014 - June 2014
Triangle SciTech Expo April 2014 - April 2014
NC State College of Veterinary Medicine June 2013 - August 2013
North Carolina Museum of Natural Sciences June 2013 - August 2013
Skills
Microsoft Excel, PowerPoint, Teamwork, Aseptic Technique, Cell Culture, Microsoft Office, Microsoft Word, Windows, Lifesciences, real-time PCR, viral plaque assay, Organization, integrity and..., Collaboration, DNA cloning and..., Prezi, Gel Electrophoresis, SDS-PAGE, Pipetting, ELISA, Opsonophagocytic Assay, Life Sciences
Education
North Carolina State University 2010 — 2014
Bachelor of Science (B.S.) in Biological Sciences with a concentration in Human Biology, Minor in Microbiology
North Carolina State University 2010 — 2014
Undergraduate Certificate in Biomanufacturing at BTEC
South Central High School 2006 — 2010
Novartis April 2015 - Present
NC State College of Veterinary Medicine July 2013 - April 2015
ISPE March 2015 - March 2015
Merck June 2014 - August 2014
Merck June 2014 - June 2014
Triangle SciTech Expo April 2014 - April 2014
NC State College of Veterinary Medicine June 2013 - August 2013
North Carolina Museum of Natural Sciences June 2013 - August 2013
Skills
Microsoft Excel, PowerPoint, Teamwork, Aseptic Technique, Cell Culture, Microsoft Office, Microsoft Word, Windows, Lifesciences, real-time PCR, viral plaque assay, Organization, integrity and..., Collaboration, DNA cloning and..., Prezi, Gel Electrophoresis, SDS-PAGE, Pipetting, ELISA, Opsonophagocytic Assay, Life Sciences
Education
North Carolina State University 2010 — 2014
Bachelor of Science (B.S.) in Biological Sciences with a concentration in Human Biology, Minor in Microbiology
North Carolina State University 2010 — 2014
Undergraduate Certificate in Biomanufacturing at BTEC
South Central High School 2006 — 2010
Scott Silvers Scott Silvers's ISPE Experience 1999 - 2004
Job Director of Technology at Accuform Signs
Industry Information Technology and Services
Experience
Accuform Signs 2004 - Present
ISPE 1999 - 2004
Aerial Communications 1998 - 1999
Allstate Insurance 1993 - 1998
Skills
Customer Service, Strategic Planning, Microsoft Office, Project Management, Team Leadership, Problem Solving, Process Improvement, IT Infrastructure..., Information Technology, Disaster Recovery, Virtualization, Servers, Databases, Firewalls, Technology Integration, Access Control, IP Cameras, Cisco Call Manager, Data Center, Contract Negotiation, Call Centers, Cellular Communications, Telecommunications, IT Operations, VMware, Hyper-V, Technology, IT Risk Management, Mobile Technology, Microsoft Exchange, Microsoft SQL Server, Vendor Management, Business Intelligence, Surveillance, Needs Analysis, Storage, Biometrics, Management, WAN, Troubleshooting, Leadership
Education
University of Phoenix 2001 — 2003
BS, Business, Information Technology
St. Petersburg College 1994 — 1996
AA, Business
Seminole High School 1990 — 1994
Accuform Signs 2004 - Present
ISPE 1999 - 2004
Aerial Communications 1998 - 1999
Allstate Insurance 1993 - 1998
Skills
Customer Service, Strategic Planning, Microsoft Office, Project Management, Team Leadership, Problem Solving, Process Improvement, IT Infrastructure..., Information Technology, Disaster Recovery, Virtualization, Servers, Databases, Firewalls, Technology Integration, Access Control, IP Cameras, Cisco Call Manager, Data Center, Contract Negotiation, Call Centers, Cellular Communications, Telecommunications, IT Operations, VMware, Hyper-V, Technology, IT Risk Management, Mobile Technology, Microsoft Exchange, Microsoft SQL Server, Vendor Management, Business Intelligence, Surveillance, Needs Analysis, Storage, Biometrics, Management, WAN, Troubleshooting, Leadership
Education
University of Phoenix 2001 — 2003
BS, Business, Information Technology
St. Petersburg College 1994 — 1996
AA, Business
Seminole High School 1990 — 1994
Eddie Luchs Eddie Luchs's ISPE Experience 2001 - Present
Job Sr. Manager, Facilities at Pacira Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Pacira Pharmaceuticals, Inc. April 2014 - Present
ISPE 2001 - Present
Shire Regenerative Medicine December 2012 - April 2014
Advanced BioHealing December 2009 - December 2012
Capital Power Corporation February 2009 - September 2009
Artes Medical February 2006 - February 2009
La Jolla Pharmaceutical Company April 2001 - April 2005
US Navy October 1976 - March 2001
Skills
GMP, Biotechnology, Medical Devices, Quality System, Change Control, Manufacturing, Project Management, Clean Rooms, CAPA, Sop, FDA, Quality Assurance, Biopharmaceuticals, Computer System..., V&V, Calibration, Quality Control, Validation, 21 CFR Part 11, Facilities Management, ISO 13485, Process Improvement, Maintenance Management, Root Cause Analysis, Process Simulation, Pharmaceutical Industry
Education
Ferris State University 2006 — 2008
Bachelor of Science (B.S.), HVAC&R Engineering Technology, 3.84
San Diego Mesa College
Associate of Science (A.S.), Building Construction Technology, High Honors
San Diego Mesa College
Associate of Science (AS), Business Administration and Management, General, Honors
UCSD Extension
Professional Certificate, HVAC Design & Controls
Pacira Pharmaceuticals, Inc. April 2014 - Present
ISPE 2001 - Present
Shire Regenerative Medicine December 2012 - April 2014
Advanced BioHealing December 2009 - December 2012
Capital Power Corporation February 2009 - September 2009
Artes Medical February 2006 - February 2009
La Jolla Pharmaceutical Company April 2001 - April 2005
US Navy October 1976 - March 2001
Skills
GMP, Biotechnology, Medical Devices, Quality System, Change Control, Manufacturing, Project Management, Clean Rooms, CAPA, Sop, FDA, Quality Assurance, Biopharmaceuticals, Computer System..., V&V, Calibration, Quality Control, Validation, 21 CFR Part 11, Facilities Management, ISO 13485, Process Improvement, Maintenance Management, Root Cause Analysis, Process Simulation, Pharmaceutical Industry
Education
Ferris State University 2006 — 2008
Bachelor of Science (B.S.), HVAC&R Engineering Technology, 3.84
San Diego Mesa College
Associate of Science (A.S.), Building Construction Technology, High Honors
San Diego Mesa College
Associate of Science (AS), Business Administration and Management, General, Honors
UCSD Extension
Professional Certificate, HVAC Design & Controls
Marc-André Richer Marc-André Richer's ISPE Experience July 2011 - Present
Job Associé chez GCM Consultants
Industry Mechanical or Industrial Engineering
Experience
ISPE July 2011 - Present
GCM Pharma May 2010 - Present
ISPE May 2010 - Present
GCM Consultants April 2010 - Present
GCM Consultants January 2010 - Present
GCM Consultants September 2008 - Present
GCM Consultants January 2004 - Present
General Dynamics January 2009 - May 2010
Marsulex Inc. October 2007 - May 2010
Ville de Montréal May 2009 - September 2009
Education
2004 — 2010
Maitrise, Gestion de l'ingénierie
1999 — 2003
Bacc, Génie informatique
ISPE July 2011 - Present
GCM Pharma May 2010 - Present
ISPE May 2010 - Present
GCM Consultants April 2010 - Present
GCM Consultants January 2010 - Present
GCM Consultants September 2008 - Present
GCM Consultants January 2004 - Present
General Dynamics January 2009 - May 2010
Marsulex Inc. October 2007 - May 2010
Ville de Montréal May 2009 - September 2009
Education
2004 — 2010
Maitrise, Gestion de l'ingénierie
1999 — 2003
Bacc, Génie informatique
Lori M. Kelman Lori M. Kelman's ISPE Experience January 2010 - Present
Job Professor of Biotechnology
Industry Higher Education
Experience
Beta Beta Beta Biological Society September 1998 - Present
Montgomery College August 2001 - Present
ISPE January 2010 - Present
IBBR Institute for Bioscience and Biotechnology Research January 2011 - August 2011
National Institutes of Health September 2000 - August 2001
Iona College 1991 - 2001
Memorial Sloan-Kettering Cancer Center 1987 - 1996
Weill Cornell Medical College 1986 - 1994
Rockefeller University 1984 - 1986
Skills
Molecular Biology, Cell Culture, qPCR, RT-PCR, Biotechnology, Bioethics, Life Sciences, Genetics, Writing, Lifesciences, Western Blotting, Scientific Writing, Laboratory, Biology, Protein Purification, Science, PCR, Genomics, ELISA, Purification, Research, DNA, Cell, Microbiology, Gel Electrophoresis, Cell Biology, Immunology, Biochemistry, Bioinformatics, Assay Development, Molecular Genetics, SDS-PAGE, Higher Education, Public Speaking, Teaching, Academic Publishing
Education
Cornell University 1986 — 1994
Ph.D., Molecular biology
Mount Holyoke College 1978 — 1982
AB, Biochemistry
Iona College 1997 — 2000
MBA, Management
Saint John's University 1982 — 1984
M.S., Biology
Irvington High School 1974 — 1978
High School diploma
PS 22 1966 — 1973
Elementary school
Beta Beta Beta Biological Society September 1998 - Present
Montgomery College August 2001 - Present
ISPE January 2010 - Present
IBBR Institute for Bioscience and Biotechnology Research January 2011 - August 2011
National Institutes of Health September 2000 - August 2001
Iona College 1991 - 2001
Memorial Sloan-Kettering Cancer Center 1987 - 1996
Weill Cornell Medical College 1986 - 1994
Rockefeller University 1984 - 1986
Skills
Molecular Biology, Cell Culture, qPCR, RT-PCR, Biotechnology, Bioethics, Life Sciences, Genetics, Writing, Lifesciences, Western Blotting, Scientific Writing, Laboratory, Biology, Protein Purification, Science, PCR, Genomics, ELISA, Purification, Research, DNA, Cell, Microbiology, Gel Electrophoresis, Cell Biology, Immunology, Biochemistry, Bioinformatics, Assay Development, Molecular Genetics, SDS-PAGE, Higher Education, Public Speaking, Teaching, Academic Publishing
Education
Cornell University 1986 — 1994
Ph.D., Molecular biology
Mount Holyoke College 1978 — 1982
AB, Biochemistry
Iona College 1997 — 2000
MBA, Management
Saint John's University 1982 — 1984
M.S., Biology
Irvington High School 1974 — 1978
High School diploma
PS 22 1966 — 1973
Elementary school
Catherine McNamara Catherine McNamara's ISPE Experience 2008 - 2010
Job Bioprocess Technician at Merck Sharp & Dohme
Industry Pharmaceuticals
Experience
Merck Sharp & Dohme March 2010 - Present
Merck 2010 - 2010
ISPE 2008 - 2010
GlaxoSmithKline Summer Talent Identification Program May 2009 - July 2009
GlaxoSmithKline 2009 - 2009
North Carolina Central University (NCCU) January 2008 - August 2008
Piedmont Communications Co, Inc August 2002 - August 2007
Piedmont Communications Co 2002 - 2007
Georgia Pacific Corporation Distribution Center May 1998 - May 2001
Education
NC Central University 2007 — 2009
B.S., Pharmaceutical Sciences
North Carolina Central University 2007 — 2009
North Carolina Central University 2007 — 2009
B.S. Pharmaceutical Science, Chemistry
NC State University BTEC cGMP Fermentation Operations
Vance Granville Community College (VGCC)
A.A.S, Information Systems
Merck Sharp & Dohme March 2010 - Present
Merck 2010 - 2010
ISPE 2008 - 2010
GlaxoSmithKline Summer Talent Identification Program May 2009 - July 2009
GlaxoSmithKline 2009 - 2009
North Carolina Central University (NCCU) January 2008 - August 2008
Piedmont Communications Co, Inc August 2002 - August 2007
Piedmont Communications Co 2002 - 2007
Georgia Pacific Corporation Distribution Center May 1998 - May 2001
Education
NC Central University 2007 — 2009
B.S., Pharmaceutical Sciences
North Carolina Central University 2007 — 2009
North Carolina Central University 2007 — 2009
B.S. Pharmaceutical Science, Chemistry
NC State University BTEC cGMP Fermentation Operations
Vance Granville Community College (VGCC)
A.A.S, Information Systems
Phil Boncer Phil Boncer's ISPE Experience 2002 - 2006
Job Validation and Engineering Consultant at P Boncer Consulting; available for projects at this time
Industry Pharmaceuticals
Experience
P Boncer Consulting December 2013 - Present
Shire Pharmaceuticals January 2013 - December 2013
P Boncer Consulting May 1999 - December 2012
PSC Biotech 2011 - 2012
ProPharma Group 2010 - 2011
ISPE 2002 - 2006
Alliance Pharmaceuticals January 1992 - April 1999
Skills
European Union, Analytical Chemistry, Pharmaceutical Industry, Validation, Medical Devices, Environmental Monitoring, Engineering, Sop, Technology Transfer, Pharmaceutics, Quality Assurance, GMP, FDA, 21 CFR Part 11, Regulatory Affairs, ISO 13485, Quality System, CAPA, Aseptic Processing, Lifesciences, Clinical Trials, R&D, Biopharmaceuticals, Computer System..., GAMP, LIMS, Root Cause Analysis, Vaccines, Cleaning Validation, GxP, V&V, Change Control, Chromatography, Quality Auditing, Design Control, Process Engineering, Document Management, HPLC, Quality Control, Microbiology, Biotechnology, Regulatory Submissions, Manufacturing, Quality Management, Cross-functional Team..., Process Simulation, Regulatory Requirements, GLP, GCP, SOP
Education
University of California, Santa Barbara 1981 — 1986
BA, Geology
P Boncer Consulting December 2013 - Present
Shire Pharmaceuticals January 2013 - December 2013
P Boncer Consulting May 1999 - December 2012
PSC Biotech 2011 - 2012
ProPharma Group 2010 - 2011
ISPE 2002 - 2006
Alliance Pharmaceuticals January 1992 - April 1999
Skills
European Union, Analytical Chemistry, Pharmaceutical Industry, Validation, Medical Devices, Environmental Monitoring, Engineering, Sop, Technology Transfer, Pharmaceutics, Quality Assurance, GMP, FDA, 21 CFR Part 11, Regulatory Affairs, ISO 13485, Quality System, CAPA, Aseptic Processing, Lifesciences, Clinical Trials, R&D, Biopharmaceuticals, Computer System..., GAMP, LIMS, Root Cause Analysis, Vaccines, Cleaning Validation, GxP, V&V, Change Control, Chromatography, Quality Auditing, Design Control, Process Engineering, Document Management, HPLC, Quality Control, Microbiology, Biotechnology, Regulatory Submissions, Manufacturing, Quality Management, Cross-functional Team..., Process Simulation, Regulatory Requirements, GLP, GCP, SOP
Education
University of California, Santa Barbara 1981 — 1986
BA, Geology
Doug Schwab Doug Schwab's ISPE Experience 2001 - 2012
Job Senior Project Manager at Laporte Consultants Inc. / Laporte Experts Conseils inc.
Industry Chemicals
Experience
Laporte Consultants Inc. / Laporte Experts Consultants inc. April 2015 - Present
Air Products and Chemicals January 2011 - April 2015
ISPE 2001 - 2012
RPA Engineering June 2009 - January 2011
TSD/Optimations 2003 - 2009
Wyeth Pharmaceuticals 1998 - 2003
Bayer 1998 - 1999
Dairy Farmers of America 1997 - 1998
Merck 1996 - 1997
The Hershey Company 1985 - 1996
Skills
Controls, Installation, Instrumentation, Engineering, Commissioning, Pharmaceutical Industry, Construction Management, Construction, FDA, GMP, Validation, Biotechnology, Process Simulation, Process Engineering, Facilities Management, Manufacturing, Process Optimization, Cross-functional Team..., Internal Controls, Project Engineering, Project Management, Project Planning, Six Sigma, Software Installation, Sop, V
Education
University of Connecticut 1985 — 1996
Master of Business Administration (M.B.A.), Business Economics, 3.78
Penn State University 1977 — 1980
Bachelor's Degree, Mechanical Engineering, 3.25GPA
Laporte Consultants Inc. / Laporte Experts Consultants inc. April 2015 - Present
Air Products and Chemicals January 2011 - April 2015
ISPE 2001 - 2012
RPA Engineering June 2009 - January 2011
TSD/Optimations 2003 - 2009
Wyeth Pharmaceuticals 1998 - 2003
Bayer 1998 - 1999
Dairy Farmers of America 1997 - 1998
Merck 1996 - 1997
The Hershey Company 1985 - 1996
Skills
Controls, Installation, Instrumentation, Engineering, Commissioning, Pharmaceutical Industry, Construction Management, Construction, FDA, GMP, Validation, Biotechnology, Process Simulation, Process Engineering, Facilities Management, Manufacturing, Process Optimization, Cross-functional Team..., Internal Controls, Project Engineering, Project Management, Project Planning, Six Sigma, Software Installation, Sop, V
Education
University of Connecticut 1985 — 1996
Master of Business Administration (M.B.A.), Business Economics, 3.78
Penn State University 1977 — 1980
Bachelor's Degree, Mechanical Engineering, 3.25GPA
Nicholas Belly Nicholas Belly's ISPE Experience 2010 - 2010
Job Sound Designer/Audio Editor
Industry Entertainment
Experience
PharmaConsult US, Inc October 2002 - Present
ISPE 2010 - 2010
Skills
Pro Tools, Audio Editing, Video Editing, Microsoft Office, Adobe Creative Suite, Dreamweaver, Sound Mixing, Sound Editing, Sound Equipment, Computer Hardware, Computer Repair, Computer Maintenance, Wireless Networking, Adobe Audition, Pinnacle Studio, Apple OS, Windows, C++, Logic Pro, Sound Forge
Education
Full Sail University 2009 — 2010
Bachelor of Science, Recording Arts
Full Sail University 2009 — 2009
Associate, Recording Arts
Penn State University 2006 — 2008
Information Technology Systems
PharmaConsult US, Inc October 2002 - Present
ISPE 2010 - 2010
Skills
Pro Tools, Audio Editing, Video Editing, Microsoft Office, Adobe Creative Suite, Dreamweaver, Sound Mixing, Sound Editing, Sound Equipment, Computer Hardware, Computer Repair, Computer Maintenance, Wireless Networking, Adobe Audition, Pinnacle Studio, Apple OS, Windows, C++, Logic Pro, Sound Forge
Education
Full Sail University 2009 — 2010
Bachelor of Science, Recording Arts
Full Sail University 2009 — 2009
Associate, Recording Arts
Penn State University 2006 — 2008
Information Technology Systems
Karl Wilks, PhD, PE, CSP Karl Wilks, PhD, PE, CSP's ISPE Experience 2010 - 2012
Job Engineering Team Leader at Amec Foster Wheeler Inc.
Industry Pharmaceuticals
Experience
Amec Foster Wheeler July 2013 - Present
WCS, Inc March 2012 - July 2013
Gilead July 2006 - March 2012
ISPE 2010 - 2012
Gilead Sciences July 2006 - March 2011
Phylmar Group 2006 - 2011
WCS, Inc. September 1996 - July 2006
Skills
Compliance, Inspection, Environmental, Program Management, Risk Assessment, Writing, Product Development, Process Development, Process Engineering, Auditing, Engineering Design, Environmental Awareness, Process Simulation, EHS, Occupational Health, Engineering, CAPA, Cross-functional Team..., Environmental Compliance, Industrial Hygiene, Biotechnology, Validation
Education
Case Western Reserve University 1967 — 1976
BS, MS, PhD, Chemical Engineering
Amec Foster Wheeler July 2013 - Present
WCS, Inc March 2012 - July 2013
Gilead July 2006 - March 2012
ISPE 2010 - 2012
Gilead Sciences July 2006 - March 2011
Phylmar Group 2006 - 2011
WCS, Inc. September 1996 - July 2006
Skills
Compliance, Inspection, Environmental, Program Management, Risk Assessment, Writing, Product Development, Process Development, Process Engineering, Auditing, Engineering Design, Environmental Awareness, Process Simulation, EHS, Occupational Health, Engineering, CAPA, Cross-functional Team..., Environmental Compliance, Industrial Hygiene, Biotechnology, Validation
Education
Case Western Reserve University 1967 — 1976
BS, MS, PhD, Chemical Engineering
Timothy Javan's ISPE Experience August 2014 - Present
Job Project Manager/Real Estate Investor
Industry Real Estate
Experience
Javan Engineering January 2012 - Present
T&T Property Investments July 2012 - Present
ISPE August 2014 - Present
BrainLAB September 2010 - January 2012
Brooks Instrument March 2010 - September 2010
Javan Engineering 2009 - February 2010
Javan Engineering May 2009 - July 2009
Pennsylvania State University September 2008 - May 2009
Colorcon May 2007 - August 2007
Javan Engineering May 2006 - September 2006
Skills
Project Management, Product Development, Medical Devices, GMP, MS Project, FDA, Pressure Relief Devices, AutoCAD, cGMP, Capital Budgeting, Pressure Vessels, NFPA, Programming, Customer Service, HIPAA, API, P&ID, Earned Value Management, Construction Management, Financial Reporting, Capital Management, Asset Management, Fixed Asset Management, HVAC, HVAC Controls, Project Scope..., Gantt, Managing Project Budgets, Capital Project Planning, Real Estate
Education
Penn State University 2005 — 2009
B.S, Biomedical Engineering with Chemical Engineering Discipline
Javan Engineering January 2012 - Present
T&T Property Investments July 2012 - Present
ISPE August 2014 - Present
BrainLAB September 2010 - January 2012
Brooks Instrument March 2010 - September 2010
Javan Engineering 2009 - February 2010
Javan Engineering May 2009 - July 2009
Pennsylvania State University September 2008 - May 2009
Colorcon May 2007 - August 2007
Javan Engineering May 2006 - September 2006
Skills
Project Management, Product Development, Medical Devices, GMP, MS Project, FDA, Pressure Relief Devices, AutoCAD, cGMP, Capital Budgeting, Pressure Vessels, NFPA, Programming, Customer Service, HIPAA, API, P&ID, Earned Value Management, Construction Management, Financial Reporting, Capital Management, Asset Management, Fixed Asset Management, HVAC, HVAC Controls, Project Scope..., Gantt, Managing Project Budgets, Capital Project Planning, Real Estate
Education
Penn State University 2005 — 2009
B.S, Biomedical Engineering with Chemical Engineering Discipline
Raphael Dozzi Raphael Dozzi's ISPE Experience 2008 - 2009
Job Technical Writing Manager at Technical Safety Services
Industry Environmental Services
Experience
Technical Safety Services March 2013 - Present
Technical Safety Services October 2010 - March 2013
Yoshis May 2010 - August 2011
Envirocern April 2010 - October 2010
Smithsonian Institution July 2010 - September 2010
ISPE 2008 - 2009
City and County of San Francisco June 2008 - September 2008
Slav Hermanowicz Laboratory, University of California Berkeley January 2008 - June 2008
UC Berkeley January 2007 - September 2007
Tang Soo Do 1999 - 2005
Skills
Matlab, Research, Word, Excel, Microsoft Office, AutoCad, Quality Assurance, Technical Documentation, Document Control, Quality Engineering, Quality Control, Microsoft Excel, Microsoft Word, Chemical Engineering, Environmental..., Technical Writing, AutoCAD, Chromatography, HPLC, Engineering, Biotechnology, Chemistry, Document Management, Validation, Product Development, Mass Spectrometry, Gas Chromatography
Education
University of California, Berkeley 2006 — 2009
B.S, Chemical Engineering
Sierra College 2002 — 2006
A.S., Engineering, Physical Sciences
Technical Safety Services March 2013 - Present
Technical Safety Services October 2010 - March 2013
Yoshis May 2010 - August 2011
Envirocern April 2010 - October 2010
Smithsonian Institution July 2010 - September 2010
ISPE 2008 - 2009
City and County of San Francisco June 2008 - September 2008
Slav Hermanowicz Laboratory, University of California Berkeley January 2008 - June 2008
UC Berkeley January 2007 - September 2007
Tang Soo Do 1999 - 2005
Skills
Matlab, Research, Word, Excel, Microsoft Office, AutoCad, Quality Assurance, Technical Documentation, Document Control, Quality Engineering, Quality Control, Microsoft Excel, Microsoft Word, Chemical Engineering, Environmental..., Technical Writing, AutoCAD, Chromatography, HPLC, Engineering, Biotechnology, Chemistry, Document Management, Validation, Product Development, Mass Spectrometry, Gas Chromatography
Education
University of California, Berkeley 2006 — 2009
B.S, Chemical Engineering
Sierra College 2002 — 2006
A.S., Engineering, Physical Sciences
Doyle Johnson Doyle Johnson's ISPE Experience November 2009 - November 2013
Job Life Sciences Industry Leader, Hargrove Life Sciences and Member of the Board of Directors ECC
Industry Biotechnology
Experience
Hargrove & Associates, Inc. December 2011 - Present
Engineering and Construction Contracting Association August 2013 - Present
ISPE November 2009 - November 2013
Genzyme February 2010 - October 2011
ISPE Boston Chapter August 2004 - July 2010
MassBiologics (UMass Medical School) June 2005 - September 2009
CDI 1994 - 2005
PerSeptive Biosystems 1992 - 1994
ChemDesign Corp. 1984 - 1991
Polaroid 1977 - 1984
Skills
Project Management, Engineering, GMP, Pharmaceutical Industry, Biotechnology, Process Engineering, LIMS, Lean Manufacturing, Validation, Sop, Product Development, Cross-functional Team..., Change Management, Biopharmaceuticals, 21 CFR Part 11, Six Sigma, Leadership, Regulatory Submissions, Process Improvement, FDA, Software Documentation, Manufacturing, CAPA, Quality Control, Continuous Improvement, GxP, Quality Auditing, Aseptic Processing, Medical Devices, Technology Transfer, Root Cause Analysis, Lifesciences, Change Control, Quality System, Pharmaceutics, V&V, Process Optimization, R&D, Quality Assurance, Life Sciences, Management, SOP
Education
Cornell University 1972 — 1976
BS, Chemical Engineering
Babson College - Franklin W. Olin Graduate School of Business 1988 — 1992
MBA, Finance
Northeastern University 1982 — 1986
MS, Organic Chemistry
St Stephens 1969 — 1970
Overseas School of Rome 1966 — 1968
Hargrove & Associates, Inc. December 2011 - Present
Engineering and Construction Contracting Association August 2013 - Present
ISPE November 2009 - November 2013
Genzyme February 2010 - October 2011
ISPE Boston Chapter August 2004 - July 2010
MassBiologics (UMass Medical School) June 2005 - September 2009
CDI 1994 - 2005
PerSeptive Biosystems 1992 - 1994
ChemDesign Corp. 1984 - 1991
Polaroid 1977 - 1984
Skills
Project Management, Engineering, GMP, Pharmaceutical Industry, Biotechnology, Process Engineering, LIMS, Lean Manufacturing, Validation, Sop, Product Development, Cross-functional Team..., Change Management, Biopharmaceuticals, 21 CFR Part 11, Six Sigma, Leadership, Regulatory Submissions, Process Improvement, FDA, Software Documentation, Manufacturing, CAPA, Quality Control, Continuous Improvement, GxP, Quality Auditing, Aseptic Processing, Medical Devices, Technology Transfer, Root Cause Analysis, Lifesciences, Change Control, Quality System, Pharmaceutics, V&V, Process Optimization, R&D, Quality Assurance, Life Sciences, Management, SOP
Education
Cornell University 1972 — 1976
BS, Chemical Engineering
Babson College - Franklin W. Olin Graduate School of Business 1988 — 1992
MBA, Finance
Northeastern University 1982 — 1986
MS, Organic Chemistry
St Stephens 1969 — 1970
Overseas School of Rome 1966 — 1968
Jeff Wenner's ISPE Experience 2008 - June 2011
Job Project Executive/Senior Associate/Partner at IPS Integrated Project Services
Industry Construction
Experience
IPS Integrated Project Services September 2003 - Present
Trinity Christian Chapel January 1995 - Present
ISPE 2008 - June 2011
Fluidics, Inc. January 1998 - September 2003
Skills
Project Management, Prolog, Project Finance, Scheduling, Process & Procedure..., Process Scheduler, HVAC, Validation, Engineering, Construction, MS Project, Project Planning, Construction Management, Project Estimation, Contract Negotiation, GMP, Commissioning, Project Control, MEP, 21 CFR Part 11, Value Engineering, LEED, LEED AP, Project Engineering, Contract Management, Change Control, Facilities Management, Energy Audits, AutoCAD, Green Building, Feasibility Studies, Submittals, Primavera P6, Energy Efficiency, Contractors, CPM Scheduling, Biopharmaceuticals, Proposal Writing, BIM, CAPA, V&V, FDA, Process Engineering, Technology Transfer, Energy Management, CAD, Energy Conservation, Construction Drawings, Microstation, Plumbing
Education
Drexel University 1987 — 1995
BS, Mechanical Engineering
Washington Township High School 1976 — 1979
High School Diploma, College Prep
IPS Integrated Project Services September 2003 - Present
Trinity Christian Chapel January 1995 - Present
ISPE 2008 - June 2011
Fluidics, Inc. January 1998 - September 2003
Skills
Project Management, Prolog, Project Finance, Scheduling, Process & Procedure..., Process Scheduler, HVAC, Validation, Engineering, Construction, MS Project, Project Planning, Construction Management, Project Estimation, Contract Negotiation, GMP, Commissioning, Project Control, MEP, 21 CFR Part 11, Value Engineering, LEED, LEED AP, Project Engineering, Contract Management, Change Control, Facilities Management, Energy Audits, AutoCAD, Green Building, Feasibility Studies, Submittals, Primavera P6, Energy Efficiency, Contractors, CPM Scheduling, Biopharmaceuticals, Proposal Writing, BIM, CAPA, V&V, FDA, Process Engineering, Technology Transfer, Energy Management, CAD, Energy Conservation, Construction Drawings, Microstation, Plumbing
Education
Drexel University 1987 — 1995
BS, Mechanical Engineering
Washington Township High School 1976 — 1979
High School Diploma, College Prep
Chuck Stock's ISPE Experience November 2010 - November 2013
Job Sr. Vice President at IPS
Industry Pharmaceuticals
Experience
Integrated Project Sevices, Inc. (IPS) 1998 - Present
Integrated Project Services, Inc. December 2012 - Present
XCell Strategic Consulting April 2014 - Present
ISPE November 2010 - November 2013
ISPE November 2008 - November 2010
The Validation Group, Inc. 1994 - 1998
Raytheon Engineers 1991 - 1994
Verax 1989 - 1991
Coulter Diagnostics (Now Beckman Coulter) June 1977 - 1989
Skills
Validation, GMP, FDA, Pharmaceutical Industry, Biotechnology, V&V, Medical Devices, Biopharmaceuticals, Manufacturing, Quality Management, Project Management, Start-ups, Product Development, Lean Manufacturing, Management, Training, Engineering, Operations Management, Aseptic Processing, Process Engineering, Computer System..., Designing, Process Improvement, Pharmaceutics, Quality System, CAPA, GxP, Business Analysis, Process Simulation, Technology Transfer, Sop, Commissioning, Change Control, GLP, 21 CFR Part 11, Sterilization, LIMS, Regulatory Requirements, Quality Control, Regulatory Affairs, Quality Auditing, Vaccines, Cleaning Validation, Quality Assurance, Lifesciences, ISO 13485, Drug Development, Regulatory Submissions, R&D, Trackwise
Education
Delaware Valley Industrial Resource Corporation 2010 — 2011
Lean Certification, Lean, N/A
Florida International University - College of Business 1980 — 1983
MBA, General MBA with Operations Science focus
University of Miami 1973 — 1977
BS Chem/Bio, Chemistry and Biology
Belen Jesuit 1967 — 1973
High School Graduate
Belen Jesuit
Integrated Project Sevices, Inc. (IPS) 1998 - Present
Integrated Project Services, Inc. December 2012 - Present
XCell Strategic Consulting April 2014 - Present
ISPE November 2010 - November 2013
ISPE November 2008 - November 2010
The Validation Group, Inc. 1994 - 1998
Raytheon Engineers 1991 - 1994
Verax 1989 - 1991
Coulter Diagnostics (Now Beckman Coulter) June 1977 - 1989
Skills
Validation, GMP, FDA, Pharmaceutical Industry, Biotechnology, V&V, Medical Devices, Biopharmaceuticals, Manufacturing, Quality Management, Project Management, Start-ups, Product Development, Lean Manufacturing, Management, Training, Engineering, Operations Management, Aseptic Processing, Process Engineering, Computer System..., Designing, Process Improvement, Pharmaceutics, Quality System, CAPA, GxP, Business Analysis, Process Simulation, Technology Transfer, Sop, Commissioning, Change Control, GLP, 21 CFR Part 11, Sterilization, LIMS, Regulatory Requirements, Quality Control, Regulatory Affairs, Quality Auditing, Vaccines, Cleaning Validation, Quality Assurance, Lifesciences, ISO 13485, Drug Development, Regulatory Submissions, R&D, Trackwise
Education
Delaware Valley Industrial Resource Corporation 2010 — 2011
Lean Certification, Lean, N/A
Florida International University - College of Business 1980 — 1983
MBA, General MBA with Operations Science focus
University of Miami 1973 — 1977
BS Chem/Bio, Chemistry and Biology
Belen Jesuit 1967 — 1973
High School Graduate
Belen Jesuit
Sarah Daly Sarah Daly's ISPE Experience August 2015 - Present
Job Marketing Communications Specialist at ISPE
Industry Pharmaceuticals
Experience
ISPE August 2015 - Present
WUFT-TV (PBS Affiliate) August 2014 - May 2015
Student Government Television (SGTV) August 2014 - May 2015
WUFT-FM 89.1 (NPR Affiliate) January 2014 - May 2015
WESH 2 News (NBC Affiliate) June 2014 - August 2014
ACCENT Speakers Bureau January 2014 - May 2014
Action SG September 2013 - May 2014
Florida Blue Key March 2012 - December 2012
Skills
Public Speaking, Social Media, Editing, Social Networking, Microsoft Office, Social Media Marketing, Public Relations, Customer Service, Television, Broadcast Journalism, Press Releases, Leadership Development, Final Cut Pro, Adobe Creative Suite, Television Producing, News Writing, Camera Skills, Event Planning, Interviews, Facebook, Leadership, PowerPoint, Microsoft Word
Education
University of Florida 2011 — 2015
Bachelor's degree, Telecommunication News
ISPE August 2015 - Present
WUFT-TV (PBS Affiliate) August 2014 - May 2015
Student Government Television (SGTV) August 2014 - May 2015
WUFT-FM 89.1 (NPR Affiliate) January 2014 - May 2015
WESH 2 News (NBC Affiliate) June 2014 - August 2014
ACCENT Speakers Bureau January 2014 - May 2014
Action SG September 2013 - May 2014
Florida Blue Key March 2012 - December 2012
Skills
Public Speaking, Social Media, Editing, Social Networking, Microsoft Office, Social Media Marketing, Public Relations, Customer Service, Television, Broadcast Journalism, Press Releases, Leadership Development, Final Cut Pro, Adobe Creative Suite, Television Producing, News Writing, Camera Skills, Event Planning, Interviews, Facebook, Leadership, PowerPoint, Microsoft Word
Education
University of Florida 2011 — 2015
Bachelor's degree, Telecommunication News
Danielle Hould Danielle Hould's ISPE Experience July 2013 - June 2014
Job MultiFaceted Marketing Management Professional
Industry Marketing and Advertising
Experience
New York Life Insurance Company August 2015 - Present
Freelance Marketing, Copywriting and Design January 2010 - Present
American Association for Physician Leadership June 2014 - July 2015
ISPE July 2013 - June 2014
ISPE September 2010 - July 2013
Dosatron International, Inc August 2008 - September 2010
First Advantage June 2005 - July 2008
Quality Distribution 2004 - 2005
Raymond James January 2001 - June 2004
Skills
Copywriting, Marketing Communications, Email Marketing, Press Releases, Social Media, Marketing Strategy, Corporate Communications, Public Relations, Media Relations, Newsletters, Marketing, Editing, Event Planning, Strategy, Management, Marketing Management, Brand Management, Blogging, Project Management, Graphic Design, Event Management, B2B, SEO, Leadership, Strategic Communications, Strategic Planning, Writing, Internal Communications, Constant Contact, Informz, Adobe Creative Suite, Microsoft Office, Vocus, Trade Shows, Social Media Marketing, Budgets, Advertising, Social Networking, Web Content, Technical Writing, Account Management, Integrated Marketing, Online Advertising, Digital Marketing, Brand Development, Program Management, Facebook, Market Planning, Lead Generation, Online Marketing
Education
Eckerd College 1996 — 2000
Bachelor of Arts, Music
New York Life Insurance Company August 2015 - Present
Freelance Marketing, Copywriting and Design January 2010 - Present
American Association for Physician Leadership June 2014 - July 2015
ISPE July 2013 - June 2014
ISPE September 2010 - July 2013
Dosatron International, Inc August 2008 - September 2010
First Advantage June 2005 - July 2008
Quality Distribution 2004 - 2005
Raymond James January 2001 - June 2004
Skills
Copywriting, Marketing Communications, Email Marketing, Press Releases, Social Media, Marketing Strategy, Corporate Communications, Public Relations, Media Relations, Newsletters, Marketing, Editing, Event Planning, Strategy, Management, Marketing Management, Brand Management, Blogging, Project Management, Graphic Design, Event Management, B2B, SEO, Leadership, Strategic Communications, Strategic Planning, Writing, Internal Communications, Constant Contact, Informz, Adobe Creative Suite, Microsoft Office, Vocus, Trade Shows, Social Media Marketing, Budgets, Advertising, Social Networking, Web Content, Technical Writing, Account Management, Integrated Marketing, Online Advertising, Digital Marketing, Brand Development, Program Management, Facebook, Market Planning, Lead Generation, Online Marketing
Education
Eckerd College 1996 — 2000
Bachelor of Arts, Music
Marcela Iannini's ISPE Experience January 2004 - June 2006
Job Academic Program Director, School of Business, Columbia Southern University
Industry Education Management
Experience
Miami International University October 2011 - Present
Columbia Southern University 2015 - 2015
Columbia Southern University 2015 - 2015
Columbia Southern University 2015 - 2015
Solution Factory January 2004 - December 2011
The Art Institute of Tampa January 2004 - September 2010
Universida de La Sabana 2007 - 2010
ISPE January 2004 - June 2006
CAPITAL ONE 2000 - 2003
Skills
Strategic Design, Advertising, Design Management, Management Consulting, InDesign, Research, Writing, Creative Direction, Market Research, Marketing, Public Relations, Marketing Strategy, Adobe Creative Suite, Graphic Design, Illustrator, Dreamweaver, Web Design, Photoshop, Entrepreneurship, Corporate Identity, Brand Development, Typography, Art, Branding, Concept Development, Copywriting, Corporate Branding, Creative Strategy, Design Thinking, Email Marketing, Facebook, Illustration, Interaction Design, Layout, Leadership, Logo Design, Mac, Management, Marketing Communications, Multimedia, Online Marketing, Photography, Social Media, Social Media Marketing, Social Networking, Strategy, User Experience, User Interface Design, Visual Communication, WordPress
Education
Argosy University Tampa 2005 — 2012
DBA, Doctorate in Business Administration
University of South Florida 1994 — 1998
MFA, Fine Arts
Miami International University October 2011 - Present
Columbia Southern University 2015 - 2015
Columbia Southern University 2015 - 2015
Columbia Southern University 2015 - 2015
Solution Factory January 2004 - December 2011
The Art Institute of Tampa January 2004 - September 2010
Universida de La Sabana 2007 - 2010
ISPE January 2004 - June 2006
CAPITAL ONE 2000 - 2003
Skills
Strategic Design, Advertising, Design Management, Management Consulting, InDesign, Research, Writing, Creative Direction, Market Research, Marketing, Public Relations, Marketing Strategy, Adobe Creative Suite, Graphic Design, Illustrator, Dreamweaver, Web Design, Photoshop, Entrepreneurship, Corporate Identity, Brand Development, Typography, Art, Branding, Concept Development, Copywriting, Corporate Branding, Creative Strategy, Design Thinking, Email Marketing, Facebook, Illustration, Interaction Design, Layout, Leadership, Logo Design, Mac, Management, Marketing Communications, Multimedia, Online Marketing, Photography, Social Media, Social Media Marketing, Social Networking, Strategy, User Experience, User Interface Design, Visual Communication, WordPress
Education
Argosy University Tampa 2005 — 2012
DBA, Doctorate in Business Administration
University of South Florida 1994 — 1998
MFA, Fine Arts
Bryan Coiscou Bryan Coiscou's ISPE Experience January 2004 — November 2006
Job IT Consultant at Hightech Backup
Industry Information Technology and Services
Experience
HighTech Backup Corp. July 2012 — Present
ACEA Dominicana (ACEA SPA) December 2006 — May 2011
ISPE January 2004 — November 2006
Miramar School September 2001 — January 2004
Skills
Remote Desktop, VMware, Virtualization, DFS, Terminal Services, File Sharing, Windows Server, VMware Infrastructure, Microsoft Certified..., Windows 7, Windows Vista, Microsoft SQL Server, HP-UX, AIX, Solaris, Windows, Norton Ghost, Symantec Antivirus, Backup Exec, Linux, Hardware
Education
Universidad APEC 2002 — 2008
BS, Computer Science
HighTech Backup Corp. July 2012 — Present
ACEA Dominicana (ACEA SPA) December 2006 — May 2011
ISPE January 2004 — November 2006
Miramar School September 2001 — January 2004
Skills
Remote Desktop, VMware, Virtualization, DFS, Terminal Services, File Sharing, Windows Server, VMware Infrastructure, Microsoft Certified..., Windows 7, Windows Vista, Microsoft SQL Server, HP-UX, AIX, Solaris, Windows, Norton Ghost, Symantec Antivirus, Backup Exec, Linux, Hardware
Education
Universidad APEC 2002 — 2008
BS, Computer Science
Nick Davies's ISPE Experience October 2014 - Present
Job Life Sciences Manufacturing, Supply
Industry Pharmaceuticals
Experience
NDA Life Sciences July 2014 - Present
NDA Consultants November 2009 - Present
ISPE October 2014 - Present
Skills
Strategic Planning, Biotechnology, Pharmaceuticals, Pharmaceutical Industry, Supply Chain Management, Six Sigma, Technology Transfer, Mergers, Lean Manufacturing, Outsourcing, FDA, In-licensing, Management, Validation, Mergers & Acquisitions, Leadership, GMP, Business Process..., Change Management, Strategy, Cross-functional Team..., Process Improvement, Manufacturing, Product Launch, Regulatory Affairs, Operational Excellence, Program Management, Start-ups, Business Strategy, Product Development, Medical Devices, Quality Management, Project Management, Strategic Sourcing, Strategic Partnerships, Supply Chain, V&V, Process Engineering, Quality System, Process Simulation, Executive Management, Pharmaceutics, R&D, Quality Assurance
Education
Loughborough University 1980 — 1981
MSc
University of Warwick 1977 — 1980
BSc
NDA Life Sciences July 2014 - Present
NDA Consultants November 2009 - Present
ISPE October 2014 - Present
Skills
Strategic Planning, Biotechnology, Pharmaceuticals, Pharmaceutical Industry, Supply Chain Management, Six Sigma, Technology Transfer, Mergers, Lean Manufacturing, Outsourcing, FDA, In-licensing, Management, Validation, Mergers & Acquisitions, Leadership, GMP, Business Process..., Change Management, Strategy, Cross-functional Team..., Process Improvement, Manufacturing, Product Launch, Regulatory Affairs, Operational Excellence, Program Management, Start-ups, Business Strategy, Product Development, Medical Devices, Quality Management, Project Management, Strategic Sourcing, Strategic Partnerships, Supply Chain, V&V, Process Engineering, Quality System, Process Simulation, Executive Management, Pharmaceutics, R&D, Quality Assurance
Education
Loughborough University 1980 — 1981
MSc
University of Warwick 1977 — 1980
BSc
Stephen Mons's ISPE Experience 1995 - 2006
Job Vice President of Sales at Aesus Packaging Systems, Inc.
Industry Machinery
Experience
Aesus 2005 - Present
ISPE 1995 - 2006
EDT - Encore Design & Technology January 2000 - April 2005
Kalish 1995 - 2001
DT Industries, Inc, 1994 - 2000
Skills
Automation, Product Development, Manufacturing, Sales Management, Packaging, New Business Development, Key Account Management, Account Management, Strategic Planning, Continuous Improvement, Pharmaceutical Industry, Negotiation, Contract Negotiation, Cross-functional Team..., Operations Management, Team Building, International Sales, Process Improvement, Supply Chain Management, Packaging Engineering, Project Management, Machinery, Lean Manufacturing, Engineering, Product Management, Forecasting, Food Packaging, Sales Operations, Process Engineering, Six Sigma, B2B, Manufacturing..., Motion Control, Logistics, Market Development, Supply Chain, Plastics, Automotive, Sales, Leadership, Pricing, PLC, P&L Management, Blow Molding, Labels, Industrial Control, Purchasing, Pneumatics, Folding Cartons, Machine Vision
Education
St. Lawrence College Cornwall 1985 — 1987
Industrial Maintenance, Industrial Mechanics and Maintenance Technology
St. Lawrence College 1985 — 1986
Degree, Industrial Maintenance Mechanic
CEGEP - John Abbott College
Riverdale HS
Aesus 2005 - Present
ISPE 1995 - 2006
EDT - Encore Design & Technology January 2000 - April 2005
Kalish 1995 - 2001
DT Industries, Inc, 1994 - 2000
Skills
Automation, Product Development, Manufacturing, Sales Management, Packaging, New Business Development, Key Account Management, Account Management, Strategic Planning, Continuous Improvement, Pharmaceutical Industry, Negotiation, Contract Negotiation, Cross-functional Team..., Operations Management, Team Building, International Sales, Process Improvement, Supply Chain Management, Packaging Engineering, Project Management, Machinery, Lean Manufacturing, Engineering, Product Management, Forecasting, Food Packaging, Sales Operations, Process Engineering, Six Sigma, B2B, Manufacturing..., Motion Control, Logistics, Market Development, Supply Chain, Plastics, Automotive, Sales, Leadership, Pricing, PLC, P&L Management, Blow Molding, Labels, Industrial Control, Purchasing, Pneumatics, Folding Cartons, Machine Vision
Education
St. Lawrence College Cornwall 1985 — 1987
Industrial Maintenance, Industrial Mechanics and Maintenance Technology
St. Lawrence College 1985 — 1986
Degree, Industrial Maintenance Mechanic
CEGEP - John Abbott College
Riverdale HS
Michael Wacks Michael Wacks's ISPE Experience 2009 - September 2011
Job Project Manager at Integrated Project Services
Industry Pharmaceuticals
Experience
Integrated Project Services February 2012 - Present
PS&S December 2009 - February 2012
ISPE 2009 - September 2011
Process Vision Consultants, Inc. 1997 - December 2009
PMK Group Inc. 2005 - 2007
Hatch Associates 1994 - 1997
Chas. T. Main 1987 - 1993
Skills
GMP, Pharmaceutical Industry, Engineering, Biotechnology, Project Management, Process Engineering, Biopharmaceuticals, Business Development, Program Management, Project Planning, Cross-functional Team..., Computer System..., Product Development, Quality Assurance, Budgets, Process Improvement, Management, Construction, MS Project, Project Engineering, Chemical Engineering, GxP, Proposal Writing, Engineering Management
Education
The Cooper Union for the Advancement of Science and Art 1978 — 1982
B.E., Chemical Engineering
New York University - Leonard N. Stern School of Business
MBA, Operations/Operations Management
University of Massachusetts, Amherst
M.S., Environmental Engineering
Integrated Project Services February 2012 - Present
PS&S December 2009 - February 2012
ISPE 2009 - September 2011
Process Vision Consultants, Inc. 1997 - December 2009
PMK Group Inc. 2005 - 2007
Hatch Associates 1994 - 1997
Chas. T. Main 1987 - 1993
Skills
GMP, Pharmaceutical Industry, Engineering, Biotechnology, Project Management, Process Engineering, Biopharmaceuticals, Business Development, Program Management, Project Planning, Cross-functional Team..., Computer System..., Product Development, Quality Assurance, Budgets, Process Improvement, Management, Construction, MS Project, Project Engineering, Chemical Engineering, GxP, Proposal Writing, Engineering Management
Education
The Cooper Union for the Advancement of Science and Art 1978 — 1982
B.E., Chemical Engineering
New York University - Leonard N. Stern School of Business
MBA, Operations/Operations Management
University of Massachusetts, Amherst
M.S., Environmental Engineering
Gordon Leichter's ISPE Experience 2003 - Present
Job East Coast sales Manager at Belimed inc.
Industry Pharmaceuticals
Experience
Belimed inc. February 2009 - Present
ISPE 2003 - Present
ISPE 1980 - Present
NNE Pharmaplan July 2008 - January 2009
Pharmadule April 2003 - June 2008
Getinge 1980 - 2003
American Sterilizer (AMSCO) 1992 - 1995
Education
TUI University 2000 — 2006
Ph.D., Business Administration - Marketing
Belimed inc. February 2009 - Present
ISPE 2003 - Present
ISPE 1980 - Present
NNE Pharmaplan July 2008 - January 2009
Pharmadule April 2003 - June 2008
Getinge 1980 - 2003
American Sterilizer (AMSCO) 1992 - 1995
Education
TUI University 2000 — 2006
Ph.D., Business Administration - Marketing
Jack Schmitt Jack Schmitt's ISPE Experience 2005 - November 2014
Job Transportation Engineering Manager at Structure Designs, Inc.
Industry Civil Engineering
Experience
Red Pencil Limited February 2005 - Present
Structure Designs, Inc. November 2012 - November 2014
ISPE 2005 - November 2014
Road Fabrics, Inc. September 2011 - November 2012
SPAAN Tech, Inc. 2006 - May 2011
Red Pencil/Western, LLC April 2009 - December 2009
HNTB 1999 - 2005
CEMCON, Ltd. 1992 - 1995
Illinois State Toll Highway Authority 1979 - 1988
Skills
Plan Review, Managerial Training, Construction Management, Road, Civil Engineering, Management, Engineering, Construction, Transportation, Rail, Concrete, Project Planning, Value Engineering, Primavera P6, Feasibility Studies, Contract Management, Sewer, Stormwater Management, Project Management, Highways, Drainage, Land Development, Transportation Planning, Water, Site Development, Bridge, Project Estimation, Surveying, Municipalities, Traffic Engineering, Erosion Control, Geotechnical Engineering, Transportation..., Pavement Engineering
Education
Midwest College of Engineering 1980 — 1982
Masters, Engineering Management
Illinois Institute of Technology 1970 — 1973
BSCE, Civil Engineering
Red Pencil Limited February 2005 - Present
Structure Designs, Inc. November 2012 - November 2014
ISPE 2005 - November 2014
Road Fabrics, Inc. September 2011 - November 2012
SPAAN Tech, Inc. 2006 - May 2011
Red Pencil/Western, LLC April 2009 - December 2009
HNTB 1999 - 2005
CEMCON, Ltd. 1992 - 1995
Illinois State Toll Highway Authority 1979 - 1988
Skills
Plan Review, Managerial Training, Construction Management, Road, Civil Engineering, Management, Engineering, Construction, Transportation, Rail, Concrete, Project Planning, Value Engineering, Primavera P6, Feasibility Studies, Contract Management, Sewer, Stormwater Management, Project Management, Highways, Drainage, Land Development, Transportation Planning, Water, Site Development, Bridge, Project Estimation, Surveying, Municipalities, Traffic Engineering, Erosion Control, Geotechnical Engineering, Transportation..., Pavement Engineering
Education
Midwest College of Engineering 1980 — 1982
Masters, Engineering Management
Illinois Institute of Technology 1970 — 1973
BSCE, Civil Engineering
Dennis M. Gross, MS, PhD Dennis M. Gross, MS, PhD's ISPE Experience 1996 - Present
Job CEO & Treasurer, Pennsylvania Drug Discovery Institute
Industry Research
Experience
BIO Biotechnology Entrepreneurship Boot Camp June 2015 - Present
Pennsylvania Drug Discovery Institute June 2014 - Present
Baruch S. Blumberg Institute of the Hepatitis B Foundation August 2014 - Present
Thomas Jefferson University June 2014 - Present
ISPE 1996 - Present
Thomas Jefferson University July 2013 - June 2014
Pennsylvania Drug Discovery Institute November 2011 - June 2014
Jefferson Medical College January 2006 - June 2014
Thomas Jefferson University 2006 - June 2013
Merck Research Labs January 2005 - January 2006
Skills
Strategic Planning, Capital Projects, Due Diligence, Operations Management, Business Continuity, Emergency Management, Oversight, Project Management, Cancer, Strategy, Program Management, Cell Biology, Pharmaceutical Industry, Drug Discovery, Facility Master Planning, Facility Start-up, Facility Closures, M&A experience, Biotechnology, Lifesciences, Project Planning, Pharmacology, Molecular Biology, Clinical Trials, Healthcare, Technology Transfer, Science, Vaccines, Immunology, Laboratory, Drug Development, Life Sciences
Education
Tulane University School of Medicine 1974 — 1977
Postdoctoral, Pharmacology
University of California, Los Angeles 1970 — 1974
PhD, Cell Biology; Electron Microscopy
California State University-Northridge 1969 — 1970
M.S., Biology
California State University-Northridge 1966 — 1969
BA, Biology, English
Thomas Jefferson University College
Master's, and
BIO Biotechnology Entrepreneurship Boot Camp June 2015 - Present
Pennsylvania Drug Discovery Institute June 2014 - Present
Baruch S. Blumberg Institute of the Hepatitis B Foundation August 2014 - Present
Thomas Jefferson University June 2014 - Present
ISPE 1996 - Present
Thomas Jefferson University July 2013 - June 2014
Pennsylvania Drug Discovery Institute November 2011 - June 2014
Jefferson Medical College January 2006 - June 2014
Thomas Jefferson University 2006 - June 2013
Merck Research Labs January 2005 - January 2006
Skills
Strategic Planning, Capital Projects, Due Diligence, Operations Management, Business Continuity, Emergency Management, Oversight, Project Management, Cancer, Strategy, Program Management, Cell Biology, Pharmaceutical Industry, Drug Discovery, Facility Master Planning, Facility Start-up, Facility Closures, M&A experience, Biotechnology, Lifesciences, Project Planning, Pharmacology, Molecular Biology, Clinical Trials, Healthcare, Technology Transfer, Science, Vaccines, Immunology, Laboratory, Drug Development, Life Sciences
Education
Tulane University School of Medicine 1974 — 1977
Postdoctoral, Pharmacology
University of California, Los Angeles 1970 — 1974
PhD, Cell Biology; Electron Microscopy
California State University-Northridge 1969 — 1970
M.S., Biology
California State University-Northridge 1966 — 1969
BA, Biology, English
Thomas Jefferson University College
Master's, and
Mike Fenzau's ISPE Experience June 2012 - Present
Job ISPE
Industry Pharmaceuticals
Experience
ISPE June 2012 - Present
Skills
Manufacturing, GMP, Process Improvement, Continuous Improvement, Project Management, Cross-functional Team..., V&V, Change Control, Biotechnology, Customer Service
Education
Florida Metropolitan University 2000 — 2004
Criminal Justice, Criminal Justice/Law Enforcement Administration, 3.6 GPA
Traviss Career Center 1996 — 1998
Electrical Degree, Electrical and Electronics Engineering, 3.3 GPA
ISPE June 2012 - Present
Skills
Manufacturing, GMP, Process Improvement, Continuous Improvement, Project Management, Cross-functional Team..., V&V, Change Control, Biotechnology, Customer Service
Education
Florida Metropolitan University 2000 — 2004
Criminal Justice, Criminal Justice/Law Enforcement Administration, 3.6 GPA
Traviss Career Center 1996 — 1998
Electrical Degree, Electrical and Electronics Engineering, 3.3 GPA
Catalina McChesney Catalina McChesney's ISPE Experience May 2014 - April 2015
Job Experienced project manager / operations manager
Industry Management Consulting
Experience
Experienced project manager / operations manager May 2015 - Present
ISPE May 2014 - April 2015
Firm Solutions, LLC July 2013 - October 2013
The WorkCare Group, Inc. March 1994 - January 2013
Skills
Project Management, Management, Leadership, Project Planning, Time Management, Change Management, Team Building, Training, Interpersonal..., Analysis, Quality Assurance, Strategic Planning, Product Development, Customer Service, Editing, Customer Satisfaction, Public Speaking, Health Promotion, Wellness, Fitness, Nutrition, Strategy
Education
Piedmont Virginia Community College 2012 — 2012
Certificate/24 PDUs, Project Management Fundamentals, 4.0
Piedmont Virginia Community College 2012 — 2012
Certificate 24 CEUs, Project Management Applications, 4.0
Piedmont Virginia Community College 2011 — 2011
Certificate/2.4 CEUs, Creating Web Pages, 4.0
Piedmont Virginia Community College 2011 — 2011
Certificate, 2.4 CEUs, Intermediate HTML and CSS, 4.0
Keye Productivity Center 2002 — 2003
Certificate, Writing, copy-editing, substantive editing, and advanced proofreading, 4.0
Career Track 2000 — 2000
Certificate, Communicating as Professionals, 4.0
Indiana University of Pennsylvania
Bachelor’s Degree, Education English and Spanish, 3.0
Universidad de Valladolid, Spain
Diploma, Spanish language and culture, 3.95
Experienced project manager / operations manager May 2015 - Present
ISPE May 2014 - April 2015
Firm Solutions, LLC July 2013 - October 2013
The WorkCare Group, Inc. March 1994 - January 2013
Skills
Project Management, Management, Leadership, Project Planning, Time Management, Change Management, Team Building, Training, Interpersonal..., Analysis, Quality Assurance, Strategic Planning, Product Development, Customer Service, Editing, Customer Satisfaction, Public Speaking, Health Promotion, Wellness, Fitness, Nutrition, Strategy
Education
Piedmont Virginia Community College 2012 — 2012
Certificate/24 PDUs, Project Management Fundamentals, 4.0
Piedmont Virginia Community College 2012 — 2012
Certificate 24 CEUs, Project Management Applications, 4.0
Piedmont Virginia Community College 2011 — 2011
Certificate/2.4 CEUs, Creating Web Pages, 4.0
Piedmont Virginia Community College 2011 — 2011
Certificate, 2.4 CEUs, Intermediate HTML and CSS, 4.0
Keye Productivity Center 2002 — 2003
Certificate, Writing, copy-editing, substantive editing, and advanced proofreading, 4.0
Career Track 2000 — 2000
Certificate, Communicating as Professionals, 4.0
Indiana University of Pennsylvania
Bachelor’s Degree, Education English and Spanish, 3.0
Universidad de Valladolid, Spain
Diploma, Spanish language and culture, 3.95
Tarang Lal Tarang Lal's ISPE Experience October 2009 - June 2011
Job Graduate Research at Texas A&M University
Industry Oil & Energy
Experience
Texas A&M University September 2014 - Present
Aera Energy LLC June 2015 - August 2015
Aera Energy LLC July 2011 - August 2014
Society of Petroleum Engineers July 2013 - July 2014
American Institute of Chemical Engineers September 2010 - June 2011
ISPE October 2009 - June 2011
EWB-USA September 2009 - June 2011
UCLA Extension 2011 - 2011
Procter and Gamble June 2010 - September 2010
Loyalty Solutions and Research Limited (LSRL) July 2009 - September 2009
Skills
Chemical Engineering, Engineering, Process Engineering, Matlab, Leadership, Energy, Management, Petroleum, Manufacturing, Project Engineering, Project Management, Process Simulation, Strategy, Gas, Lean Manufacturing, Process Optimization
Education
Texas A&M University 2014 — 2016
Master's Degree, Petroleum Engineering
University of California, Los Angeles 2007 — 2011
BS, Chemical Engineering
Mission San Jose 2003 — 2007
High School
Texas A&M University September 2014 - Present
Aera Energy LLC June 2015 - August 2015
Aera Energy LLC July 2011 - August 2014
Society of Petroleum Engineers July 2013 - July 2014
American Institute of Chemical Engineers September 2010 - June 2011
ISPE October 2009 - June 2011
EWB-USA September 2009 - June 2011
UCLA Extension 2011 - 2011
Procter and Gamble June 2010 - September 2010
Loyalty Solutions and Research Limited (LSRL) July 2009 - September 2009
Skills
Chemical Engineering, Engineering, Process Engineering, Matlab, Leadership, Energy, Management, Petroleum, Manufacturing, Project Engineering, Project Management, Process Simulation, Strategy, Gas, Lean Manufacturing, Process Optimization
Education
Texas A&M University 2014 — 2016
Master's Degree, Petroleum Engineering
University of California, Los Angeles 2007 — 2011
BS, Chemical Engineering
Mission San Jose 2003 — 2007
High School
Joseph Famulare Joseph Famulare's ISPE Experience November 2014 - Present
Job Vice Chair,International Board of Directors at ISPE
Industry Biotechnology
Experience
ISPE November 2014 - Present
Genentech January 2012 - Present
Genentech October 2009 - January 2012
FDA January 2006 - September 2009
Skills
Pharmaceutical Industry, GMP, SOP, Technology Transfer, Biotechnology, CAPA, Validation, FDA, 21 CFR Part 11, Regulatory Affairs, Cell Culture, Regulatory Submissions, Life Sciences, Clinical Trials, Change Control, Lifesciences, Clinical Development, Molecular Biology, Oncology, Microsoft Excel, Management, Biopharmaceuticals, Quality System
Education
St. John's University 1972 — 1976
Bachelor’s Degree, Biology, General, Enviornmental Studies
Bishop Edmund J Reilly High School, Fresh Meadows, NY
ISPE November 2014 - Present
Genentech January 2012 - Present
Genentech October 2009 - January 2012
FDA January 2006 - September 2009
Skills
Pharmaceutical Industry, GMP, SOP, Technology Transfer, Biotechnology, CAPA, Validation, FDA, 21 CFR Part 11, Regulatory Affairs, Cell Culture, Regulatory Submissions, Life Sciences, Clinical Trials, Change Control, Lifesciences, Clinical Development, Molecular Biology, Oncology, Microsoft Excel, Management, Biopharmaceuticals, Quality System
Education
St. John's University 1972 — 1976
Bachelor’s Degree, Biology, General, Enviornmental Studies
Bishop Edmund J Reilly High School, Fresh Meadows, NY
Alfonso J. LaRocca, CPE Alfonso J. LaRocca, CPE's ISPE Experience 1990 - 2000
Job Regional Facilities & Project Manager at TITAN BUILDING SERVICES
Industry Facilities Services
Experience
Titan Buildings Services January 2011 - Present
Mayo Clinic March 2007 - December 2010
All Children's Hospital 2001 - 2007
Alliance Pharmaceuticals June 1992 - June 2000
ISPE 1990 - 2000
Skills
Operations Management, Strategic Planning, Facilities Management, Contract Negotiation, Project Management, Contract Management, Process Improvement, Team Building, Process Scheduler, Inventory Management, Quality Management, Budgets, Customer Service, Customer Satisfaction, Vendor Management, Cross-functional Team..., Project Planning, Change Management, MS Project, Continuous Improvement, Team Leadership, Engineering, Leadership, Negotiation, Program Management, Manufacturing, Management, Software Documentation, Employee Relations, Procurement, Healthcare, Construction Management, Purchasing, Quality Assurance, Training, Construction, PowerPoint, Supervisory Skills, GMP, Energy Management, Preventive Maintenance, Electricians, FDA, Biotechnology, Maintenance & Repair, Quality System, HVAC, SOP, Validation, Maintenance Management
Education
University of California, San Diego 1998 — 2002
St. Augustine Vocational Inistute 1980 — 1982
Plumbing & Pipefitting, Construction Engineering
Titan Buildings Services January 2011 - Present
Mayo Clinic March 2007 - December 2010
All Children's Hospital 2001 - 2007
Alliance Pharmaceuticals June 1992 - June 2000
ISPE 1990 - 2000
Skills
Operations Management, Strategic Planning, Facilities Management, Contract Negotiation, Project Management, Contract Management, Process Improvement, Team Building, Process Scheduler, Inventory Management, Quality Management, Budgets, Customer Service, Customer Satisfaction, Vendor Management, Cross-functional Team..., Project Planning, Change Management, MS Project, Continuous Improvement, Team Leadership, Engineering, Leadership, Negotiation, Program Management, Manufacturing, Management, Software Documentation, Employee Relations, Procurement, Healthcare, Construction Management, Purchasing, Quality Assurance, Training, Construction, PowerPoint, Supervisory Skills, GMP, Energy Management, Preventive Maintenance, Electricians, FDA, Biotechnology, Maintenance & Repair, Quality System, HVAC, SOP, Validation, Maintenance Management
Education
University of California, San Diego 1998 — 2002
St. Augustine Vocational Inistute 1980 — 1982
Plumbing & Pipefitting, Construction Engineering
Christopher G. Rowan PhD's ISPE Experience 2005 - Present
Job Adjunct Associate Member at Rutgers University; Institute for Health, Health Care Policy, and Aging Research
Industry Research
Experience
Rutgers University; Institute for Health, Health Care Policy, and Aging Research 2014 - Present
American Medical Group Association (AMGA) & Anceta August 2013 - Present
ISPE 2005 - Present
Quintiles-Outcome November 2011 - August 2013
Amgen 2010 - 2011
Amgen 2010 - 2011
Kaiser Permanente Northern California - Divison of Research 2009 - 2009
University of Pennsylvania - Department of Biostatistics and Epidemiology 2008 - 2009
Abstracts and Publications 1994 - 2009
Food and Drug Administration 2006 - 2008
Skills
Pharmacoepidemiology, Epidemiology, Biostatistics, Outcomes Research, Clinical Study Design, Clinical Trials, Infectious Diseases, Public Health, Health Services Research, SAS, Health Economics, Clinical Research, Oncology, Clinical Development, Immunology, Drug Safety, Pharmacology, CRO, Cancer, Medical Writing, FDA, Drug Development
Education
University of Pennsylvania 2005 — 2010
PhD, epidemiology - 2010
University of Pennsylvania School of Medicine 2005 — 2010
PhD, Epidemiology
Harvard School of Public Health 2005 — 2005
none, Public health Studies 2005
The University of Michigan 1989 — 1993
Bachelor of Science, Bio-psychology
Rutgers University; Institute for Health, Health Care Policy, and Aging Research 2014 - Present
American Medical Group Association (AMGA) & Anceta August 2013 - Present
ISPE 2005 - Present
Quintiles-Outcome November 2011 - August 2013
Amgen 2010 - 2011
Amgen 2010 - 2011
Kaiser Permanente Northern California - Divison of Research 2009 - 2009
University of Pennsylvania - Department of Biostatistics and Epidemiology 2008 - 2009
Abstracts and Publications 1994 - 2009
Food and Drug Administration 2006 - 2008
Skills
Pharmacoepidemiology, Epidemiology, Biostatistics, Outcomes Research, Clinical Study Design, Clinical Trials, Infectious Diseases, Public Health, Health Services Research, SAS, Health Economics, Clinical Research, Oncology, Clinical Development, Immunology, Drug Safety, Pharmacology, CRO, Cancer, Medical Writing, FDA, Drug Development
Education
University of Pennsylvania 2005 — 2010
PhD, epidemiology - 2010
University of Pennsylvania School of Medicine 2005 — 2010
PhD, Epidemiology
Harvard School of Public Health 2005 — 2005
none, Public health Studies 2005
The University of Michigan 1989 — 1993
Bachelor of Science, Bio-psychology
Susan Humphreys Klein Susan Humphreys Klein's ISPE Experience 1990 - 2006
Job Finance Volunteer at Suncoast Hospice
Industry Nonprofit Organization Management
Experience
Suncoast Hospice March 2014 - Present
Self-employed Non-profit advisor June 2006 - Present
ISPE 1990 - 2006
OPERA America August 1987 - August 1989
ASPH June 1982 - August 1987
Skills
Budgets, Leadership Development, Management Consulting, Microsoft Excel, Volunteer Management, Business Strategy, Human Resources, Policy, Strategic Planning, Nonprofits, Program Management, Organizational..., Recruiting, Training, Leadership, Community Outreach, Public Speaking
Education
University of Maryland University College 1968 — 1975
Bachelor of Science (BS), Labor Relations
Lasell College 1962 — 1964
AS, Retailing
Suncoast Hospice March 2014 - Present
Self-employed Non-profit advisor June 2006 - Present
ISPE 1990 - 2006
OPERA America August 1987 - August 1989
ASPH June 1982 - August 1987
Skills
Budgets, Leadership Development, Management Consulting, Microsoft Excel, Volunteer Management, Business Strategy, Human Resources, Policy, Strategic Planning, Nonprofits, Program Management, Organizational..., Recruiting, Training, Leadership, Community Outreach, Public Speaking
Education
University of Maryland University College 1968 — 1975
Bachelor of Science (BS), Labor Relations
Lasell College 1962 — 1964
AS, Retailing
Dr. Jacqueline B. Saldana, MBA, CALLA, DM Dr. Jacqueline B. Saldana, MBA, CALLA, DM's ISPE Experience June 2008 - December 2010
Job Assistant Professor at DeVry University and Keller Graduate School of Management, College of Management and Business
Industry Management Consulting
Experience
DeVry University April 2013 - Present
Ana G. Mendez University System & Concorde Career Institute June 2011 - April 2013
ISPE June 2008 - December 2010
Northside Mental Health Care 2004 - 2008
Andres Grillasca Oncology Hospital/Association for the Fight Against Cancer February 1995 - October 2000
Skills
Event Management, Project Management, Program Management, Strategic Planning, Non-profits, Grant Writing, Training, Public Relations, Management, Leadership, Strategic Communications, Fundraising, Nonprofits, Community Outreach, Documentations, Program Development, Public Speaking, Marketing Communications, Spanish, Microsoft Excel, Team Leadership, Higher Education
Education
University of Phoenix 2008 — 2014
Doctoral Degree in Management, Organizational Leadership
University of Phoenix 2005 — 2007
MBA, Business Administration
Ponce High School, Commerce
Universidad del Sagrado Corazón
BA, Communications
DeVry University April 2013 - Present
Ana G. Mendez University System & Concorde Career Institute June 2011 - April 2013
ISPE June 2008 - December 2010
Northside Mental Health Care 2004 - 2008
Andres Grillasca Oncology Hospital/Association for the Fight Against Cancer February 1995 - October 2000
Skills
Event Management, Project Management, Program Management, Strategic Planning, Non-profits, Grant Writing, Training, Public Relations, Management, Leadership, Strategic Communications, Fundraising, Nonprofits, Community Outreach, Documentations, Program Development, Public Speaking, Marketing Communications, Spanish, Microsoft Excel, Team Leadership, Higher Education
Education
University of Phoenix 2008 — 2014
Doctoral Degree in Management, Organizational Leadership
University of Phoenix 2005 — 2007
MBA, Business Administration
Ponce High School, Commerce
Universidad del Sagrado Corazón
BA, Communications
Sorin Sorlescu Sorin Sorlescu's ISPE Experience September 1992 - February 1995
Job LTE & MS RBS Senior Engineer at Ericsson
Industry Telecommunications
Experience
Ericsson November 2009 - Present
Nortel January 1998 - November 2009
ThyssenKrupp May 1995 - December 1997
ISPE September 1992 - February 1995
Skills
LTE, Wireless, UMTS, 3GPP, CDMA, 4G, GSM, WCDMA, SIP, Ethernet, ClearCase, GPRS, ATM networks, IP, Telecommunications, WiMAX, 3G, VoIP, Embedded Systems, Open Source Software, RF, SNMP, TCP/IP, VxWorks, Embedded Software, Core Network, RTOS, WiFi, HSPA, Mobile Communications, RAN, Device Drivers, Debugging, BSS, UTRAN, System Architecture, Digital Signal..., RNC, Cellular Communications, Embedded Linux, 2G, Perl, RF Engineering, IPTV
Education
Carleton University 2008 — 2010
MASc - Master of Applied Sciences
Polytechnic University Bucharest 1987 — 1992
Dipl.Eng.
Ericsson November 2009 - Present
Nortel January 1998 - November 2009
ThyssenKrupp May 1995 - December 1997
ISPE September 1992 - February 1995
Skills
LTE, Wireless, UMTS, 3GPP, CDMA, 4G, GSM, WCDMA, SIP, Ethernet, ClearCase, GPRS, ATM networks, IP, Telecommunications, WiMAX, 3G, VoIP, Embedded Systems, Open Source Software, RF, SNMP, TCP/IP, VxWorks, Embedded Software, Core Network, RTOS, WiFi, HSPA, Mobile Communications, RAN, Device Drivers, Debugging, BSS, UTRAN, System Architecture, Digital Signal..., RNC, Cellular Communications, Embedded Linux, 2G, Perl, RF Engineering, IPTV
Education
Carleton University 2008 — 2010
MASc - Master of Applied Sciences
Polytechnic University Bucharest 1987 — 1992
Dipl.Eng.
Jennifer Lauria Clark, CPIP's ISPE Experience 2003 - Present
Job Director of Technical Services and KAM Program at Commissioning Agents, Inc
Industry Pharmaceuticals
Experience
Commissioning Agents, Inc January 2013 - Present
ISPE 2003 - Present
Biotech Company 2012 - 2012
Biotech Company June 2011 - December 2011
Yonkers Industries, Inc February 2007 - November 2011
OSD Facility 2007 - January 2009
Client 2007 - 2008
AMEC BioPharmaceuticals 2005 - 2007
Key Club and Circle K International 1996 - 2005
Skills
General Utility..., FDA, Validation, GMP, V&V, Sop, Biotechnology, Change Control, Pharmaceutical Industry, Process Simulation, Quality Assurance, Quality System, CAPA, Process Engineering, Commissioning, GLP, Technical Writing, Software Documentation, Microbiology, LIMS, Aseptic Processing, Cross-functional Team..., Manufacturing, Project Management, Lifesciences, Cleaning Validation, Computer System..., 21 CFR Part 11, Testing, GAMP, GxP, SOP, Life Sciences, Technology Transfer
Education
North Carolina State University 2000 — 2005
BS, Industrial Engineering
Wake Forest-Rolesville High School 1996 — 2000
Commissioning Agents, Inc January 2013 - Present
ISPE 2003 - Present
Biotech Company 2012 - 2012
Biotech Company June 2011 - December 2011
Yonkers Industries, Inc February 2007 - November 2011
OSD Facility 2007 - January 2009
Client 2007 - 2008
AMEC BioPharmaceuticals 2005 - 2007
Key Club and Circle K International 1996 - 2005
Skills
General Utility..., FDA, Validation, GMP, V&V, Sop, Biotechnology, Change Control, Pharmaceutical Industry, Process Simulation, Quality Assurance, Quality System, CAPA, Process Engineering, Commissioning, GLP, Technical Writing, Software Documentation, Microbiology, LIMS, Aseptic Processing, Cross-functional Team..., Manufacturing, Project Management, Lifesciences, Cleaning Validation, Computer System..., 21 CFR Part 11, Testing, GAMP, GxP, SOP, Life Sciences, Technology Transfer
Education
North Carolina State University 2000 — 2005
BS, Industrial Engineering
Wake Forest-Rolesville High School 1996 — 2000
Ellixis Julio Ellixis Julio's ISPE Experience September 2012 - June 2013
Job Research Assistant at UCSD Biodynamics Lab
Industry Biotechnology
Experience
UCSD Biodynamics Lab September 2014 - Present
UCSD Biodynamics Lab February 2012 - Present
UCSD Biodynamics Lab June 2014 - September 2014
Qualcomm Institute June 2013 - September 2013
ISPE September 2012 - June 2013
Skills
PCR, CPEC, Bacterial Culturing, Tissue Cell Culturing, Heavy Metal Handling, Spectrophotometry, Solidworks, Matlab, AutoCAD, Arduino, 3D Printing, Restriction Enzyme..., Microfabrication, Photolithography
Education
UCSD 2011 — 2015
Bachelor of Science (BS), Bioengineering
UCSD Biodynamics Lab September 2014 - Present
UCSD Biodynamics Lab February 2012 - Present
UCSD Biodynamics Lab June 2014 - September 2014
Qualcomm Institute June 2013 - September 2013
ISPE September 2012 - June 2013
Skills
PCR, CPEC, Bacterial Culturing, Tissue Cell Culturing, Heavy Metal Handling, Spectrophotometry, Solidworks, Matlab, AutoCAD, Arduino, 3D Printing, Restriction Enzyme..., Microfabrication, Photolithography
Education
UCSD 2011 — 2015
Bachelor of Science (BS), Bioengineering
D Tracey Ryan D Tracey Ryan's ISPE Experience November 2006 - Present
Job Manager, Affiliate/Chapter Relations at ISPE
Industry Pharmaceuticals
Experience
ISPE November 2006 - Present
USF Health Office of Continuing Professional Development August 2003 - March 2006
USF College of Public Health April 1994 - August 2003
Greater Washington Society of Association Executives August 1988 - August 1992
Skills
Program Development, Convention/Trade Show..., Marketing, Component Relations, Membership Development..., Fiscal Management, Grant Writing and..., Association Management, Fiscal Policy, Nonprofits, Management, Newsletters, Event Management, Editing, Fundraising, Event Planning, Trade Shows, Leadership, Public Relations, Quality Assurance, Program Management, Strategic Planning, Pharmaceutical Industry, Cross-functional Team...
Education
Georgetown University
Bachelor of Science (BS), Foreign Service
University of Chicago
Master of Arts (MA), General Studies in Humanities
ISPE November 2006 - Present
USF Health Office of Continuing Professional Development August 2003 - March 2006
USF College of Public Health April 1994 - August 2003
Greater Washington Society of Association Executives August 1988 - August 1992
Skills
Program Development, Convention/Trade Show..., Marketing, Component Relations, Membership Development..., Fiscal Management, Grant Writing and..., Association Management, Fiscal Policy, Nonprofits, Management, Newsletters, Event Management, Editing, Fundraising, Event Planning, Trade Shows, Leadership, Public Relations, Quality Assurance, Program Management, Strategic Planning, Pharmaceutical Industry, Cross-functional Team...
Education
Georgetown University
Bachelor of Science (BS), Foreign Service
University of Chicago
Master of Arts (MA), General Studies in Humanities
Binh Le's ISPE Experience September 2014 - Present
Job Director, Facilities Operations & Corporate Engineering HQ, Americas, Asia
Industry Pharmaceuticals
Experience
ISPE September 2014 - Present
Gilead Sciences 2008 - Present
PDL Biopharma July 2006 - July 2008
Vaxgen 2006 - 2006
JM Hyde Consulting 2004 - 2006
Nektar Therapeutics 2003 - 2004
Nektar Therapeutics 2001 - 2003
Skills
Validation, FDA, GMP, Technology Transfer, CAPA, Pharmaceutical Industry, Strategy, Manufacturing, V&V, Sop, Process Simulation, Biotechnology, Biopharmaceuticals
Education
University of California, Davis
BS, BioSystems Engineering
ISPE September 2014 - Present
Gilead Sciences 2008 - Present
PDL Biopharma July 2006 - July 2008
Vaxgen 2006 - 2006
JM Hyde Consulting 2004 - 2006
Nektar Therapeutics 2003 - 2004
Nektar Therapeutics 2001 - 2003
Skills
Validation, FDA, GMP, Technology Transfer, CAPA, Pharmaceutical Industry, Strategy, Manufacturing, V&V, Sop, Process Simulation, Biotechnology, Biopharmaceuticals
Education
University of California, Davis
BS, BioSystems Engineering
Julianne Rill's ISPE Experience May 2013 - February 2015
Job Administrative Officer at National Technical Investigators Association
Industry Security and Investigations
Experience
National Technical Investigators Association February 2015 - Present
ISPE May 2013 - February 2015
ISPE May 2010 - May 2013
Express Dental Care December 2008 - April 2010
Georgia State Ethics Commission June 2008 - December 2008
Skills
Event Planning, Non-profits, Fundraising, Event Management, Volunteer Management, Project Management, Program Development, Marketing Communications, Nonprofits, Leadership, Management, Strategic Planning, Program Management, Strategic Communications, Project Planning, Cross-functional Team..., Budgets, Analysis, Strategy, Public Relations, Proposal Writing, Team Building, Leadership Development, Public Speaking, Marketing Strategy, Marketing
Education
Florida State University 2004 — 2008
Bachelor of Arts (B.A.), Political Science
National Technical Investigators Association February 2015 - Present
ISPE May 2013 - February 2015
ISPE May 2010 - May 2013
Express Dental Care December 2008 - April 2010
Georgia State Ethics Commission June 2008 - December 2008
Skills
Event Planning, Non-profits, Fundraising, Event Management, Volunteer Management, Project Management, Program Development, Marketing Communications, Nonprofits, Leadership, Management, Strategic Planning, Program Management, Strategic Communications, Project Planning, Cross-functional Team..., Budgets, Analysis, Strategy, Public Relations, Proposal Writing, Team Building, Leadership Development, Public Speaking, Marketing Strategy, Marketing
Education
Florida State University 2004 — 2008
Bachelor of Arts (B.A.), Political Science
Raffy Espiritu, FMP Raffy Espiritu, FMP's ISPE Experience 2011 - 2012
Job Advisory Board Member at UC Berkeley Extension
Industry Facilities Services
Experience
Impec Group ( formerly Clean Innovation ) January 1991 - Present
UC Berkeley Extension September 2014 - Present
Association for Facilities Engineering January 2013 - Present
Clean Innovation ( Now rebranded as Impec Group ) 1991 - Present
ISPE 2011 - 2012
Advance Facility Solutions 2010 - January 2011
Silicon Valley Chapter of IFMA 2007 - 2008
Skills
Facilities Management, HVAC, Contractors, Energy Management, Corporate Real Estate, Clean Rooms, Sustainability, Building Maintenance, IFMA, Contract Negotiation, Leadership, Business Development, Contract Management, Energy Efficiency, Facilities Operations, Team Building, Strategic Planning, Vendor Management, Management, New Business Development, Program Management, Construction, Operations Management, Construction Management, Negotiation, Budgets, Customer Service, Customer Satisfaction, Facilities Engineering, Recruiting, Energy Conservation, Project Planning, Energy Audits, CFM, LEED, Occupancy Planning, Proposal Writing, Tenant Improvement, Green Building, Project Management, Plumbing, Process Scheduler, Move Management, Building Automation, LEED AP, Workplace Design, Water Damage, MS Project
Education
Ateneo de Manila University 1972 — 2009
MA Philosophy, Philosophy, Anthropology, Facility Management
San Carlos Seminary 1968 — 1972
AB in Philosophy, Philosophy and Religious Studies
Impec Group ( formerly Clean Innovation ) January 1991 - Present
UC Berkeley Extension September 2014 - Present
Association for Facilities Engineering January 2013 - Present
Clean Innovation ( Now rebranded as Impec Group ) 1991 - Present
ISPE 2011 - 2012
Advance Facility Solutions 2010 - January 2011
Silicon Valley Chapter of IFMA 2007 - 2008
Skills
Facilities Management, HVAC, Contractors, Energy Management, Corporate Real Estate, Clean Rooms, Sustainability, Building Maintenance, IFMA, Contract Negotiation, Leadership, Business Development, Contract Management, Energy Efficiency, Facilities Operations, Team Building, Strategic Planning, Vendor Management, Management, New Business Development, Program Management, Construction, Operations Management, Construction Management, Negotiation, Budgets, Customer Service, Customer Satisfaction, Facilities Engineering, Recruiting, Energy Conservation, Project Planning, Energy Audits, CFM, LEED, Occupancy Planning, Proposal Writing, Tenant Improvement, Green Building, Project Management, Plumbing, Process Scheduler, Move Management, Building Automation, LEED AP, Workplace Design, Water Damage, MS Project
Education
Ateneo de Manila University 1972 — 2009
MA Philosophy, Philosophy, Anthropology, Facility Management
San Carlos Seminary 1968 — 1972
AB in Philosophy, Philosophy and Religious Studies
Barbara Peck Barbara Peck's ISPE Experience January 2014 - Present
Job Manager, Community and Industry Recognition at ISPE
Industry Nonprofit Organization Management
Experience
ISPE January 2014 - Present
American Society For Metabolic And Bariatric Surgery April 2003 - September 2013
Skills
Healthcare, Program Development, Hospitals, Healthcare Management, Clinical Research, Integrated Marketing, Research, Blogging, Public Health, Social Media, Public Speaking, Surgery, Recruiting, Nonprofits, General Surgery, Strategic Planning, Program Management, Treatment, Medicine, Prevention, Medical Education, Community Outreach, Health Promotion, Customer Service, Practice Management, Management, Wellness, Nutrition, Leadership, Health Education, Microsoft Office, Medical Devices, Event Planning, Fundraising, Leadership Development, Newsletters, Case Managment, Team Building
Education
University of Florida 1995 — 1997
Bachelor of Science (B.S.), Advertising
Santa Fe College 1992 — 1994
Associate of Arts (A.A.)
ISPE January 2014 - Present
American Society For Metabolic And Bariatric Surgery April 2003 - September 2013
Skills
Healthcare, Program Development, Hospitals, Healthcare Management, Clinical Research, Integrated Marketing, Research, Blogging, Public Health, Social Media, Public Speaking, Surgery, Recruiting, Nonprofits, General Surgery, Strategic Planning, Program Management, Treatment, Medicine, Prevention, Medical Education, Community Outreach, Health Promotion, Customer Service, Practice Management, Management, Wellness, Nutrition, Leadership, Health Education, Microsoft Office, Medical Devices, Event Planning, Fundraising, Leadership Development, Newsletters, Case Managment, Team Building
Education
University of Florida 1995 — 1997
Bachelor of Science (B.S.), Advertising
Santa Fe College 1992 — 1994
Associate of Arts (A.A.)
Margaret O'Toole Margaret O'Toole's ISPE Experience 2009 - 2010
Job Director, Global Engineering at Pfizer
Industry Pharmaceuticals
Experience
Pfizer January 2012 - Present
Pfizer August 2011 - January 2012
Pfizer March 2011 - August 2011
ISPE 2009 - 2010
Wyeth December 2008 - October 2009
Wyeth Consumer Healthcare January 2007 - December 2008
International Paper 2000 - 2001
Howmet 1997 - 2000
NYCDEP 1990 - 1992
Ethicon 1988 - 1990
Skills
Engineering, Validation, cGMP, Process Improvement, Biotechnology, Pharmaceutical Industry, GMP, Change Control, FDA, Sop, Quality System, Cross-functional Team..., CAPA, V&V, Pharmaceutics, Root Cause Analysis, Quality Assurance, Regulatory Requirements, Technology Transfer, Six Sigma, Leadership, Calibration, Product Launch, Commercialization, R&D, 21 CFR Part 11, Manufacturing, Strategic Planning, Regulatory Submissions, Quality Auditing, Commissioning, Management, Product Development, Project Management, Continuous Improvement, Process Engineering, GxP, Software Documentation, Process Simulation, Budgets, Aseptic Processing, GLP, Vaccines, Lean Manufacturing, Quality Control, ISO 13485, Computer System..., GAMP, Biopharmaceuticals, Quality Management
Education
Iona College
MBA, Business
Manhattan College 1984 — 1989
Bachelors, Mechanical Engineering
Pfizer January 2012 - Present
Pfizer August 2011 - January 2012
Pfizer March 2011 - August 2011
ISPE 2009 - 2010
Wyeth December 2008 - October 2009
Wyeth Consumer Healthcare January 2007 - December 2008
International Paper 2000 - 2001
Howmet 1997 - 2000
NYCDEP 1990 - 1992
Ethicon 1988 - 1990
Skills
Engineering, Validation, cGMP, Process Improvement, Biotechnology, Pharmaceutical Industry, GMP, Change Control, FDA, Sop, Quality System, Cross-functional Team..., CAPA, V&V, Pharmaceutics, Root Cause Analysis, Quality Assurance, Regulatory Requirements, Technology Transfer, Six Sigma, Leadership, Calibration, Product Launch, Commercialization, R&D, 21 CFR Part 11, Manufacturing, Strategic Planning, Regulatory Submissions, Quality Auditing, Commissioning, Management, Product Development, Project Management, Continuous Improvement, Process Engineering, GxP, Software Documentation, Process Simulation, Budgets, Aseptic Processing, GLP, Vaccines, Lean Manufacturing, Quality Control, ISO 13485, Computer System..., GAMP, Biopharmaceuticals, Quality Management
Education
Iona College
MBA, Business
Manhattan College 1984 — 1989
Bachelors, Mechanical Engineering
Joseph Mulvey, PMP Joseph Mulvey, PMP's ISPE Experience 1992 - 2012
Job Midwest Regional Manager
Industry Biotechnology
Experience
ProPharma Group March 2014 - Present
Illinois Institute of Technology Alumni Association 2010 - Present
Avarent LLC April 2012 - January 2014
Tunnell Consulting 2010 - March 2012
University of Illinois Alumni Association 2006 - 2012
ISPE 1992 - 2012
Stantec Consulting 2008 - 2010
AECOM Technology Corporation 2001 - 2008
Ernst & Young, LLP 1996 - 2001
Centeon (now CSL Behring) 1990 - 1996
Skills
FDA, Lifesciences, Biotechnology, Pharmaceutical Industry, GMP, Project Management, Cross-functional Team..., Strategic Planning, Process Improvement, Business Development, Data Analysis, Sop, Statistics, Process Engineering, Proposal Writing, Project Planning, Manufacturing, Business Strategy, Management Consulting, Strategy, Engineering, Software Documentation, Quality Control, Contract Negotiation, Validation, Chemistry, ISO 13485, Budgets, Program Management, Leadership, Management, Medical Devices, Forecasting, Quality System, Biopharmaceuticals, CAPA, Troubleshooting, Six Sigma, Design of Experiments, Process Simulation, Quality Assurance, Product Development, Regulatory Affairs, Quality Management, Analysis, Quality Auditing, Recruiting, Energy, New Business Development, Life Sciences
Education
University of Chicago Booth School of Business 1994 — 1996
M.B.A., Finance & Operations Management
Illinois Institute of Technology 1989 — 1991
B.S., Electrical and Computer Engineering
University of Illinois at Chicago 1980 — 1985
B.S., BioEngineering
ProPharma Group March 2014 - Present
Illinois Institute of Technology Alumni Association 2010 - Present
Avarent LLC April 2012 - January 2014
Tunnell Consulting 2010 - March 2012
University of Illinois Alumni Association 2006 - 2012
ISPE 1992 - 2012
Stantec Consulting 2008 - 2010
AECOM Technology Corporation 2001 - 2008
Ernst & Young, LLP 1996 - 2001
Centeon (now CSL Behring) 1990 - 1996
Skills
FDA, Lifesciences, Biotechnology, Pharmaceutical Industry, GMP, Project Management, Cross-functional Team..., Strategic Planning, Process Improvement, Business Development, Data Analysis, Sop, Statistics, Process Engineering, Proposal Writing, Project Planning, Manufacturing, Business Strategy, Management Consulting, Strategy, Engineering, Software Documentation, Quality Control, Contract Negotiation, Validation, Chemistry, ISO 13485, Budgets, Program Management, Leadership, Management, Medical Devices, Forecasting, Quality System, Biopharmaceuticals, CAPA, Troubleshooting, Six Sigma, Design of Experiments, Process Simulation, Quality Assurance, Product Development, Regulatory Affairs, Quality Management, Analysis, Quality Auditing, Recruiting, Energy, New Business Development, Life Sciences
Education
University of Chicago Booth School of Business 1994 — 1996
M.B.A., Finance & Operations Management
Illinois Institute of Technology 1989 — 1991
B.S., Electrical and Computer Engineering
University of Illinois at Chicago 1980 — 1985
B.S., BioEngineering
Dave Stadolnik Dave Stadolnik's ISPE Experience 2000 - 2002
Job Engineering Manager at Amgen, Inc
Industry Biotechnology
Experience
Friends of THE HAVEN October 2009 - Present
Fairway Oaks at the Broadlands January 2008 - Present
Bold Venture Quarterhorses, LLC June 2007 - Present
Amgen June 2006 - Present
FIRST Robotics January 2010 - January 2010
St. Anthony's Hospital Foundation 2000 - 2003
ISPE 2000 - 2002
Education
Georgia Institute of Technology 1989 — 1993
BS Mechanical Engineering, Fluid System Dynamics
Friends of THE HAVEN October 2009 - Present
Fairway Oaks at the Broadlands January 2008 - Present
Bold Venture Quarterhorses, LLC June 2007 - Present
Amgen June 2006 - Present
FIRST Robotics January 2010 - January 2010
St. Anthony's Hospital Foundation 2000 - 2003
ISPE 2000 - 2002
Education
Georgia Institute of Technology 1989 — 1993
BS Mechanical Engineering, Fluid System Dynamics
John Clapham, RAC John Clapham, RAC's ISPE Experience August 1991 - Present
Job CEO at PSC Biotech
Industry Biotechnology
Experience
PSC Biotech 1996 - Present
ISPE August 1991 - Present
Skills
Validation, FDA, Pharmaceutical Industry, GMP, Quality System, Biotechnology, Biopharmaceuticals, Computer System..., Medical Devices, GxP, V&V, Project Management, CAPA, Regulatory Affairs, Cleaning Validation, 21 CFR Part 11, Quality Assurance, Lifesciences, Sop, Engineering, Process Engineering, Quality Auditing, GLP, Technology Transfer, Regulatory Submissions, Fermentation, Inspection, Auditing, Start-ups, Testing, ISO 13485, Continuous Improvement, Technical Recruiting, Purification, Steam, Computerized Systems, PMA, Personnel Management, CIP, HVAC, Autoclave, Process Control, Commissioning, Process Optimization, PAI, Medical Diagnostics, RAC Certified, Computerized Systems..., Audit Utopia(TM)..., PDA Computerized...
Education
University of Rhode Island 1985 — 1989
B.S., Chemical Engineering
Westerly (Ward) High School 1981 — 1985
PSC Biotech 1996 - Present
ISPE August 1991 - Present
Skills
Validation, FDA, Pharmaceutical Industry, GMP, Quality System, Biotechnology, Biopharmaceuticals, Computer System..., Medical Devices, GxP, V&V, Project Management, CAPA, Regulatory Affairs, Cleaning Validation, 21 CFR Part 11, Quality Assurance, Lifesciences, Sop, Engineering, Process Engineering, Quality Auditing, GLP, Technology Transfer, Regulatory Submissions, Fermentation, Inspection, Auditing, Start-ups, Testing, ISO 13485, Continuous Improvement, Technical Recruiting, Purification, Steam, Computerized Systems, PMA, Personnel Management, CIP, HVAC, Autoclave, Process Control, Commissioning, Process Optimization, PAI, Medical Diagnostics, RAC Certified, Computerized Systems..., Audit Utopia(TM)..., PDA Computerized...
Education
University of Rhode Island 1985 — 1989
B.S., Chemical Engineering
Westerly (Ward) High School 1981 — 1985
Linh (Bella) Do's ISPE Experience October 2014 - October 2014
Job B.S. Chemical Engineering Candidate
Industry Pharmaceuticals
Experience
San Jose State University September 2015 - Present
Intergrated Engineering Services June 2015 - August 2015
San Jose State University January 2015 - April 2015
ISPE October 2014 - October 2014
UC Davis September 2013 - August 2014
Diablo Valley College February 2013 - May 2014
Skills
Microsoft Office, PowerPoint, Chemistry, Microsoft Excel, Microsoft Word, Leadership, NMR Spectroscopy, IR Spectroscopy, Gas Chromatography, Distillation, Purification, Seperation, Crystallization, UV/Vis, Titration, Laboratory, SimSci, Minitab, AutoCAD
Education
San Jose State University 2014 — 2016
Bachelor's Degree
Diablo Valley College 2012 — 2014
San Jose State University September 2015 - Present
Intergrated Engineering Services June 2015 - August 2015
San Jose State University January 2015 - April 2015
ISPE October 2014 - October 2014
UC Davis September 2013 - August 2014
Diablo Valley College February 2013 - May 2014
Skills
Microsoft Office, PowerPoint, Chemistry, Microsoft Excel, Microsoft Word, Leadership, NMR Spectroscopy, IR Spectroscopy, Gas Chromatography, Distillation, Purification, Seperation, Crystallization, UV/Vis, Titration, Laboratory, SimSci, Minitab, AutoCAD
Education
San Jose State University 2014 — 2016
Bachelor's Degree
Diablo Valley College 2012 — 2014
Mike Byrd's ISPE Experience 2014 - 2014
Job
Industry Information Technology and Services
Experience
ProPharma Group September 2007 - Present
ISPE 2014 - 2014
ProPharma Group September 2007 - August 2009
sanofi-aventis August 2001 - July 2007
Hoechst Marion Roussell 1995 - 2001
Marion Merrell Dow 1990 - 1995
Perkin Elmer 1983 - 1985
Skills
Process Improvement, Computer System..., Cross-functional Team..., Quality System, GxP, ITIL, Integration, Project Management, Quality Management, Quality Auditing, Medical Devices, 21 CFR Part 11, Validation, Business Process, Change Control, GMP, FDA, Quality Control, CAPA, Pharmaceutical Industry
Education
Northwest Missouri State University
BS
The University of Kansas
MBA
ProPharma Group September 2007 - Present
ISPE 2014 - 2014
ProPharma Group September 2007 - August 2009
sanofi-aventis August 2001 - July 2007
Hoechst Marion Roussell 1995 - 2001
Marion Merrell Dow 1990 - 1995
Perkin Elmer 1983 - 1985
Skills
Process Improvement, Computer System..., Cross-functional Team..., Quality System, GxP, ITIL, Integration, Project Management, Quality Management, Quality Auditing, Medical Devices, 21 CFR Part 11, Validation, Business Process, Change Control, GMP, FDA, Quality Control, CAPA, Pharmaceutical Industry
Education
Northwest Missouri State University
BS
The University of Kansas
MBA
Tina Brudnicki's ISPE Experience September 2012 - April 2013
Job Engineer at Baxter
Industry Medical Devices
Experience
Baxter August 2014 - July 2015
ISPE (International Society for Pharmaceutical Engineering) April 2013 - December 2013
ISPE September 2012 - April 2013
FLATE (Florida Advanced Technological Education Center) April 2012 - August 2012
Society of Manufacturing Engineers November 2004 - January 2012
Baxter Healthcare October 2002 - November 2004
Baxter Healthcare April 1996 - October 2002
Baxter Healthcare May 1995 - April 1996
Skills
CRM, Troubleshooting, Lean Manufacturing, Process Improvement, Six Sigma, Manufacturing, Manufacturing..., Root Cause Analysis, Process Engineering, Team Building, Manufacturing..., Continuous Improvement, Leadership, Management, Cross-functional Team..., Quality System, Engineering, Project Planning, Problem Solving, Team Leadership, Program Management, Project Management, Strategic Planning, Operations Management, Product Development, Kaizen, Automotive, 5S, Value Stream Mapping, Design for Manufacturing, MS Project, New Business Development, Budgets, Training, Negotiation, Supply Chain Management, Business Process..., Quality Management, Quality Assurance, Medical Devices, Engineering Management, Operational Excellence, Strategy, DMAIC, R&D, Software Documentation, Business Planning, Design of Experiments, Change Management, Machining
Education
University of South Florida
Bachelor's Degree
Pinellas Technical Education Center-Clearwater
Machine Tool Technology/Machinist
Baxter August 2014 - July 2015
ISPE (International Society for Pharmaceutical Engineering) April 2013 - December 2013
ISPE September 2012 - April 2013
FLATE (Florida Advanced Technological Education Center) April 2012 - August 2012
Society of Manufacturing Engineers November 2004 - January 2012
Baxter Healthcare October 2002 - November 2004
Baxter Healthcare April 1996 - October 2002
Baxter Healthcare May 1995 - April 1996
Skills
CRM, Troubleshooting, Lean Manufacturing, Process Improvement, Six Sigma, Manufacturing, Manufacturing..., Root Cause Analysis, Process Engineering, Team Building, Manufacturing..., Continuous Improvement, Leadership, Management, Cross-functional Team..., Quality System, Engineering, Project Planning, Problem Solving, Team Leadership, Program Management, Project Management, Strategic Planning, Operations Management, Product Development, Kaizen, Automotive, 5S, Value Stream Mapping, Design for Manufacturing, MS Project, New Business Development, Budgets, Training, Negotiation, Supply Chain Management, Business Process..., Quality Management, Quality Assurance, Medical Devices, Engineering Management, Operational Excellence, Strategy, DMAIC, R&D, Software Documentation, Business Planning, Design of Experiments, Change Management, Machining
Education
University of South Florida
Bachelor's Degree
Pinellas Technical Education Center-Clearwater
Machine Tool Technology/Machinist
Kathleen McKinnon's ISPE Experience February 2009 - Present
Job Web Associate at ISPE
Industry Internet
Experience
ISPE February 2009 - Present
Simple Kat Inc October 2007 - April 2011
The Nielsen Company October 2000 - December 2007
Harris Corporation November 1990 - September 2000
Skills
Web Design, SQL Server, CSS, C#, PHP, XHTML, MySQL, ASP.NET, People Skills, Photography, HTML, JavaScript, XML, SEO, SQL, Databases, Photoshop, Microsoft Office, Research, Software Development, Documentation, Web Development, Information Architecture, OOP, Microsoft SQL Server, Software Documentation, Business Analysis, Project Management, C++, jQuery, Unix, Web Applications, WordPress, SharePoint
Education
University of Maryland University College 1983 — 1986
Bachelors, Computer Science, Information Systems, Art
ISPE February 2009 - Present
Simple Kat Inc October 2007 - April 2011
The Nielsen Company October 2000 - December 2007
Harris Corporation November 1990 - September 2000
Skills
Web Design, SQL Server, CSS, C#, PHP, XHTML, MySQL, ASP.NET, People Skills, Photography, HTML, JavaScript, XML, SEO, SQL, Databases, Photoshop, Microsoft Office, Research, Software Development, Documentation, Web Development, Information Architecture, OOP, Microsoft SQL Server, Software Documentation, Business Analysis, Project Management, C++, jQuery, Unix, Web Applications, WordPress, SharePoint
Education
University of Maryland University College 1983 — 1986
Bachelors, Computer Science, Information Systems, Art
Ed Pedersen's ISPE Experience 1993 - 2002
Job Process Architect / Project Management
Industry Architecture & Planning
Experience
Independent consultant for Life Science & Cleanroom Industries September 2014 - June 2015
NNE Pharmaplan January 2014 - September 2014
Independent Consultant for Project Management & Process Architecture June 2013 - December 2013
Jacobs Engineering September 2010 - June 2013
Jacobs Engineering 2006 - January 2010
Fluor 2002 - 2005
ISPE 1993 - 2002
Sear Brown Sikorsky (Stantec, Inc) 1999 - 2001
BE&K Building Group 1997 - 1999
O'Neal, Inc. 1995 - 1997
Skills
Project Management, Construction, Feasibility Studies, Submittals, Engineering, Comprehensive Planning, Construction Management, Manufacturing, Construction Drawings, GMP, Project Engineering, AutoCAD, Architectural Design, Architecture, Design Management, Architectures, Building Design, Facilities Management, CAD, Construction..., Design Research, Revit, Facility Master Planning, API Suite Design, OSD Design, Warehousing, Pharmaceutical Industry, Facility Programming, cGMP Facility Design, Laboratory Planning, Construction Documents, Construction Technical..., Forensic Evaluation, International Travel..., R&D & QC Lab Design, Vivarium Design, Pilot Plant Design, Small & Medium Scale..., BSL-2 & 3 Experience, Biopharm Primary..., Wafer Fabrication..., Thin Film Facilities..., Warehouse Design, Government Facilities..., FEMA Project Officer..., Corporate Office Design, 2D & 3D hand sketching, New Business Development, Display Booth Design, Marketing Brochure...
Education
Columbia University - Graduate School of Architecture, Planning and Preservation 1970 — 1972
MSUP, Urban Design & Urban Planning, Top 3 of 22
Naval Aviation Schools Command, Pensacola, Fla 1968 — 1969
USNR Officer, Flight Training - Ground School
Pratt Institute 1963 — 1968
Bachelor Of Architecture, Architecture, Top 5 of 72
Independent consultant for Life Science & Cleanroom Industries September 2014 - June 2015
NNE Pharmaplan January 2014 - September 2014
Independent Consultant for Project Management & Process Architecture June 2013 - December 2013
Jacobs Engineering September 2010 - June 2013
Jacobs Engineering 2006 - January 2010
Fluor 2002 - 2005
ISPE 1993 - 2002
Sear Brown Sikorsky (Stantec, Inc) 1999 - 2001
BE&K Building Group 1997 - 1999
O'Neal, Inc. 1995 - 1997
Skills
Project Management, Construction, Feasibility Studies, Submittals, Engineering, Comprehensive Planning, Construction Management, Manufacturing, Construction Drawings, GMP, Project Engineering, AutoCAD, Architectural Design, Architecture, Design Management, Architectures, Building Design, Facilities Management, CAD, Construction..., Design Research, Revit, Facility Master Planning, API Suite Design, OSD Design, Warehousing, Pharmaceutical Industry, Facility Programming, cGMP Facility Design, Laboratory Planning, Construction Documents, Construction Technical..., Forensic Evaluation, International Travel..., R&D & QC Lab Design, Vivarium Design, Pilot Plant Design, Small & Medium Scale..., BSL-2 & 3 Experience, Biopharm Primary..., Wafer Fabrication..., Thin Film Facilities..., Warehouse Design, Government Facilities..., FEMA Project Officer..., Corporate Office Design, 2D & 3D hand sketching, New Business Development, Display Booth Design, Marketing Brochure...
Education
Columbia University - Graduate School of Architecture, Planning and Preservation 1970 — 1972
MSUP, Urban Design & Urban Planning, Top 3 of 22
Naval Aviation Schools Command, Pensacola, Fla 1968 — 1969
USNR Officer, Flight Training - Ground School
Pratt Institute 1963 — 1968
Bachelor Of Architecture, Architecture, Top 5 of 72
Olimpiu Cantilli's ISPE Experience 1972 - 1981
Job Independent Investment Management Professional
Industry Investment Management
Experience
ISPE 1972 - 1981
Education
1976 — 1981
Liceul George Cosbuc 1966 — 1970
Bacalaureat, high school
ISPE 1972 - 1981
Education
1976 — 1981
Liceul George Cosbuc 1966 — 1970
Bacalaureat, high school
Carol Winfield's ISPE Experience 2014 - Present
Job Director of Regulatory Operations at ISPE
Industry Nonprofit Organization Management
Experience
ISPE 2014 - Present
Skills
Knowledge Management, Web Content Management, Information Architecture, Search Solutions, Taxonomy Development, Cataloguing and..., User Experience, Web Design, Graphic Design, Association Management, Content Management, User Experience Design, Taxonomy
Education
Regulatory Affairs Professionals (RAPs)
Certificate in Regulatory Affairs: Pharmaceuticals
University of South Florida
MLIS, Information Science/Studies
Dowling College
Bachelor's degree
ISPE 2014 - Present
Skills
Knowledge Management, Web Content Management, Information Architecture, Search Solutions, Taxonomy Development, Cataloguing and..., User Experience, Web Design, Graphic Design, Association Management, Content Management, User Experience Design, Taxonomy
Education
Regulatory Affairs Professionals (RAPs)
Certificate in Regulatory Affairs: Pharmaceuticals
University of South Florida
MLIS, Information Science/Studies
Dowling College
Bachelor's degree
Daniel Figola's ISPE Experience July 2009 - July 2010
Job National Engineering Program Manager
Industry Civil Engineering
Experience
Advanced Drainage Systems, Inc. June 2006 - Present
ISPE July 2009 - July 2010
Illionis Society of Professional Engineers July 2008 - July 2009
Hancor 2003 - 2006
IG Consulting, Inc. June 2003 - December 2003
Hettler Engineering July 1998 - June 2003
Skills
Civil Engineering, Construction Management, Land Development, Sales Management, Water Quality, Contract Negotiation, Stormwater Management, Sewer, Proposal Writing, Water Treatment, AutoCAD, Microsoft Excel, Water, Microsoft Office, CAD, Municipalities, Construction, Drainage, Engineering, Erosion Control, Stormwater
Education
Ohio University 1992 — 1998
Bachelor of Science (B.S.), Civil Engineering
Advanced Drainage Systems, Inc. June 2006 - Present
ISPE July 2009 - July 2010
Illionis Society of Professional Engineers July 2008 - July 2009
Hancor 2003 - 2006
IG Consulting, Inc. June 2003 - December 2003
Hettler Engineering July 1998 - June 2003
Skills
Civil Engineering, Construction Management, Land Development, Sales Management, Water Quality, Contract Negotiation, Stormwater Management, Sewer, Proposal Writing, Water Treatment, AutoCAD, Microsoft Excel, Water, Microsoft Office, CAD, Municipalities, Construction, Drainage, Engineering, Erosion Control, Stormwater
Education
Ohio University 1992 — 1998
Bachelor of Science (B.S.), Civil Engineering
Meredith Ellison, MBA, CAE's ISPE Experience May 2015 - Present
Job Director at ISPE
Industry Nonprofit Organization Management
Experience
ISPE May 2015 - Present
YPO - Young Presidents' Organization May 2012 - May 2015
AdvaMed August 2010 - May 2012
NAHB October 2007 - August 2010
RAPS July 2005 - October 2007
DMAW June 2002 - June 2004
Skills
Team Building, Strategic Planning, Budgeting, Program Development, Volunteer Management, Staff Development, Program Management, Problem Solving, New Business Development, Non-profits, Association Management, Board Relations, Policy, Growing Revenue, Expense Reduction, Budgets, Marketing, Media Relations, Fundraising, Nonprofits, Strategic Communications, Public Relations, Management, Leadership, Strategy, Leadership Development, Event Management, Proposal Writing, Process Improvement, Organizational..., Training, Public Speaking, Community Outreach, Event Planning, Public Policy, Marketing Communications, Government, Expenses, Project Management, Business Development, Social Media, Management Consulting, Membership Relations
Education
University of Maryland University College 2010 — 2012
Master of Business Administration (M.B.A.)
University of Maryland University College 2007 — 2010
Master's Degree, Association Management
Cambridge Rindge and Latin School 1990 — 1992
Tabor Academy 1988 — 1990
ISPE May 2015 - Present
YPO - Young Presidents' Organization May 2012 - May 2015
AdvaMed August 2010 - May 2012
NAHB October 2007 - August 2010
RAPS July 2005 - October 2007
DMAW June 2002 - June 2004
Skills
Team Building, Strategic Planning, Budgeting, Program Development, Volunteer Management, Staff Development, Program Management, Problem Solving, New Business Development, Non-profits, Association Management, Board Relations, Policy, Growing Revenue, Expense Reduction, Budgets, Marketing, Media Relations, Fundraising, Nonprofits, Strategic Communications, Public Relations, Management, Leadership, Strategy, Leadership Development, Event Management, Proposal Writing, Process Improvement, Organizational..., Training, Public Speaking, Community Outreach, Event Planning, Public Policy, Marketing Communications, Government, Expenses, Project Management, Business Development, Social Media, Management Consulting, Membership Relations
Education
University of Maryland University College 2010 — 2012
Master of Business Administration (M.B.A.)
University of Maryland University College 2007 — 2010
Master's Degree, Association Management
Cambridge Rindge and Latin School 1990 — 1992
Tabor Academy 1988 — 1990
Stephanie Belly Wilkins's ISPE Experience November 2005 - November 2009
Job Owner, PharmaConsult US, Inc
Industry Pharmaceuticals
Experience
PharmaConsult US, Inc November 1999 - Present
ISPE November 2005 - November 2009
CUH2A 1996 - 1999
PS&S 1995 - 1996
Bala Consulting Engineers 1984 - 1994
RJ Siegel Associates 1984 - 1984
STV 1983 - 1984
Skills
Project Management, Risk Assessment, Risk Management, GMP, Six Sigma, Team Building, Problem Solving, FDA, cGMP, Pharmaceuticals, Quality Management, Pharmaceutical Industry, Board of Director..., cross-contamination, Engineering, Quality Assurance, Sop, Board of Directors, Quality System, Cross-functional Team..., cross contamination..., Lecturing, Training, Management, Project Planning, Program Management, Cleaning Validation, Lean Manufacturing, Technology Transfer, Validation, Testing, Regulatory Affairs, Root Cause Analysis, HVAC, Strategy, Protocol Design, Process Improvement, Strategic Planning, Facilities Management, Process Engineering, Continuous Improvement, Quality Auditing, SOP
Education
Penn State University 1978 — 1983
Bachelor of Architectural Engineering, Architectural Engineering
Raritan Valley Community College
Lean Six Sigma Green Belt
PharmaConsult US, Inc November 1999 - Present
ISPE November 2005 - November 2009
CUH2A 1996 - 1999
PS&S 1995 - 1996
Bala Consulting Engineers 1984 - 1994
RJ Siegel Associates 1984 - 1984
STV 1983 - 1984
Skills
Project Management, Risk Assessment, Risk Management, GMP, Six Sigma, Team Building, Problem Solving, FDA, cGMP, Pharmaceuticals, Quality Management, Pharmaceutical Industry, Board of Director..., cross-contamination, Engineering, Quality Assurance, Sop, Board of Directors, Quality System, Cross-functional Team..., cross contamination..., Lecturing, Training, Management, Project Planning, Program Management, Cleaning Validation, Lean Manufacturing, Technology Transfer, Validation, Testing, Regulatory Affairs, Root Cause Analysis, HVAC, Strategy, Protocol Design, Process Improvement, Strategic Planning, Facilities Management, Process Engineering, Continuous Improvement, Quality Auditing, SOP
Education
Penn State University 1978 — 1983
Bachelor of Architectural Engineering, Architectural Engineering
Raritan Valley Community College
Lean Six Sigma Green Belt
Paula Ravest-Webster's ISPE Experience 2007 - 2007
Job Knowledge Management Professional
Industry Biotechnology
Experience
ISPE 2007 - 2007
Bespak 2006 - 2007
ConMed Linvatec 2003 - 2006
Inion Oy 2001 - 2003
Education
Eastern Michigan University 1999 — 2000
MBA, International Business
California State University
Bachelor, Microbiology/Chemistry
ISPE 2007 - 2007
Bespak 2006 - 2007
ConMed Linvatec 2003 - 2006
Inion Oy 2001 - 2003
Education
Eastern Michigan University 1999 — 2000
MBA, International Business
California State University
Bachelor, Microbiology/Chemistry
Rochelle Torres May's ISPE Experience January 2006 - July 2013
Job Technical Writer, R&D at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions February 2015 - Present
Binder & Binder November 2013 - January 2015
ISPE January 2006 - July 2013
University of South Florida December 2004 - October 2005
Dow Jones & Co. December 2003 - July 2004
Rutgers University March 2001 - November 2003
Mayor's Office, Hamilton, NJ April 2000 - November 2000
New Jersey Legislature January 2000 - March 2000
The Times of Trenton May 1996 - January 2000
Skills
Editing, Public Relations, Media Relations, Publications, Corporate Communications, Writing, Social Media, Press Releases, Pharmaceuticals, Marketing Communications, Content Management, Blogging, Technical Writing, Strategic Communications, Newsletters, Healthcare, Speech Writing, Public Policy, Policy Analysis, Policy Writing, Pharmaceutical Industry, Strategic Planning, Research, Regulatory Affairs, FDA, Program Management, Content Development, GMP, Validation, GxP, Biotechnology, 21 CFR Part 11, Publicity
Education
University of Florida 2009 — 2011
MS
The College of New Jersey 1995 — 1997
BA, Journalism
Catalent Pharma Solutions February 2015 - Present
Binder & Binder November 2013 - January 2015
ISPE January 2006 - July 2013
University of South Florida December 2004 - October 2005
Dow Jones & Co. December 2003 - July 2004
Rutgers University March 2001 - November 2003
Mayor's Office, Hamilton, NJ April 2000 - November 2000
New Jersey Legislature January 2000 - March 2000
The Times of Trenton May 1996 - January 2000
Skills
Editing, Public Relations, Media Relations, Publications, Corporate Communications, Writing, Social Media, Press Releases, Pharmaceuticals, Marketing Communications, Content Management, Blogging, Technical Writing, Strategic Communications, Newsletters, Healthcare, Speech Writing, Public Policy, Policy Analysis, Policy Writing, Pharmaceutical Industry, Strategic Planning, Research, Regulatory Affairs, FDA, Program Management, Content Development, GMP, Validation, GxP, Biotechnology, 21 CFR Part 11, Publicity
Education
University of Florida 2009 — 2011
MS
The College of New Jersey 1995 — 1997
BA, Journalism
Robert Matje, PE's ISPE Experience November 2013 - Present
Job Vice President at Endo Pharmaceuticals
Industry Pharmaceuticals
Experience
Endo Pharmaceuticals March 2015 - Present
ISPE November 2013 - Present
Endo Pharmaceuticals October 2014 - March 2015
Endo Pharmaceuticals May 2014 - October 2014
Endo Pharmaceuticals June 2012 - May 2014
ISPE 2009 - July 2012
Pfizer October 2009 - June 2012
Wyeth Pharmaceuticals 1999 - October 2009
Wyeth Medica Ireland 2004 - 2006
Skills
Validation, GMP, Pharmaceutical Industry, FDA, Management, Leadership, V&V, Integration, Project Management, Engineering, Technology Transfer, CAPA, Sop, Process Improvement, Continuous Improvement, Change Control, Regulatory Affairs, Cross-functional Team..., Quality System, Computer System..., Process Optimization, Biopharmaceuticals, Aseptic Processing, 21 CFR Part 11, Process Simulation, Medical Devices, Quality Assurance, R&D, Biotechnology, GxP, GLP, Cleaning Validation, Six Sigma, Vaccines, Process Engineering, ISO 13485, SOP
Education
Villanova University 1993 — 1997
MS, Engineering
Lafayette College 1985 — 1989
BS CE, Engineering
Endo Pharmaceuticals March 2015 - Present
ISPE November 2013 - Present
Endo Pharmaceuticals October 2014 - March 2015
Endo Pharmaceuticals May 2014 - October 2014
Endo Pharmaceuticals June 2012 - May 2014
ISPE 2009 - July 2012
Pfizer October 2009 - June 2012
Wyeth Pharmaceuticals 1999 - October 2009
Wyeth Medica Ireland 2004 - 2006
Skills
Validation, GMP, Pharmaceutical Industry, FDA, Management, Leadership, V&V, Integration, Project Management, Engineering, Technology Transfer, CAPA, Sop, Process Improvement, Continuous Improvement, Change Control, Regulatory Affairs, Cross-functional Team..., Quality System, Computer System..., Process Optimization, Biopharmaceuticals, Aseptic Processing, 21 CFR Part 11, Process Simulation, Medical Devices, Quality Assurance, R&D, Biotechnology, GxP, GLP, Cleaning Validation, Six Sigma, Vaccines, Process Engineering, ISO 13485, SOP
Education
Villanova University 1993 — 1997
MS, Engineering
Lafayette College 1985 — 1989
BS CE, Engineering
Haleh Hughes's ISPE Experience January 1999 - January 2000
Job Founder/Director Total Validation Services, Inc.
Industry Biotechnology
Experience
Total Validation Services, Inc. October 1992 - Present
ISPE January 1999 - January 2000
Life Sciences, Inc. March 1992 - October 1992
Fluor June 1989 - March 1992
Education
Saint Mary's College of California 1998 — 2000
Master of Business Administration (MBA)
UCSB 1985 — 1989
Bachelor of Science (BS), Biopsychology
Total Validation Services, Inc. October 1992 - Present
ISPE January 1999 - January 2000
Life Sciences, Inc. March 1992 - October 1992
Fluor June 1989 - March 1992
Education
Saint Mary's College of California 1998 — 2000
Master of Business Administration (MBA)
UCSB 1985 — 1989
Bachelor of Science (BS), Biopsychology
Aarash Navabi, CPIP's ISPE Experience 2002 - 2011
Job Validation Engineer at Genzyme
Industry Pharmaceuticals
Experience
Genzyme May 2010 - Present
ISPE 2002 - 2011
ISPE 2002 - 2011
Invensys Operations Management March 2010 - May 2010
Invensys September 2009 - March 2010
Invensys, Validation Engineer @ Lonza Biologics 2008 - 2009
Invensys 2008 - 2009
Massachusetts Biologic Laboratories June 2005 - January 2008
Invensys, Validation Engineer @ Sanofi P. November 2008 - 2008
Skills
FDA, Validation, Aseptic Processing, GMP, V&V, Cleaning Validation, Fermentation, Computer System..., Medical Devices, Autoclave, GAMP, Biopharmaceuticals, Pharmaceutical Industry, Change Control, CAPA, Sop, Technology Transfer, LIMS, 21 CFR Part 11, Regulatory Affairs, Trackwise, Biotechnology, CIP, GLP, GxP
Education
University of Massachusetts at Lowell 2009 — 2011
Masters Certificate, Biopharmaceutical Engineering
University of Massachusetts, Amherst 1999 — 2004
Bachelor of Science (BS), Chemical Engineering
Genzyme May 2010 - Present
ISPE 2002 - 2011
ISPE 2002 - 2011
Invensys Operations Management March 2010 - May 2010
Invensys September 2009 - March 2010
Invensys, Validation Engineer @ Lonza Biologics 2008 - 2009
Invensys 2008 - 2009
Massachusetts Biologic Laboratories June 2005 - January 2008
Invensys, Validation Engineer @ Sanofi P. November 2008 - 2008
Skills
FDA, Validation, Aseptic Processing, GMP, V&V, Cleaning Validation, Fermentation, Computer System..., Medical Devices, Autoclave, GAMP, Biopharmaceuticals, Pharmaceutical Industry, Change Control, CAPA, Sop, Technology Transfer, LIMS, 21 CFR Part 11, Regulatory Affairs, Trackwise, Biotechnology, CIP, GLP, GxP
Education
University of Massachusetts at Lowell 2009 — 2011
Masters Certificate, Biopharmaceutical Engineering
University of Massachusetts, Amherst 1999 — 2004
Bachelor of Science (BS), Chemical Engineering
Jack Campion, P.E.'s ISPE Experience 1992 - 1995
Job Principal at The Hart Companies
Industry Biotechnology
Experience
The Hart Companies September 2013 - Present
ISPE, Boston September 2012 - Present
Genzyme April 2011 - September 2013
Genzyme 2010 - April 2011
MassBiologics October 1999 - November 2009
ISPE 1992 - 1995
Skills
Biopharmaceuticals, Biochemical Engineering, Business Development, Project Controls, Validation, Project Management, GMP, Biotechnology, FDA
Education
College of the Holy Cross
Bachelor of Arts (B.A.), Chemistry
Holy Cross High School
Holy Cross High School
Holy Cross High School
Holy Cross High School
Tufts University
Master of Science (M.S.), Chemical Engineering
The Hart Companies September 2013 - Present
ISPE, Boston September 2012 - Present
Genzyme April 2011 - September 2013
Genzyme 2010 - April 2011
MassBiologics October 1999 - November 2009
ISPE 1992 - 1995
Skills
Biopharmaceuticals, Biochemical Engineering, Business Development, Project Controls, Validation, Project Management, GMP, Biotechnology, FDA
Education
College of the Holy Cross
Bachelor of Arts (B.A.), Chemistry
Holy Cross High School
Holy Cross High School
Holy Cross High School
Holy Cross High School
Tufts University
Master of Science (M.S.), Chemical Engineering
Brian Vaughn's ISPE Experience September 2011 - Present
Job Director of Business Development CRB Consulting Engineers
Industry Design
Experience
CRB Consulting Engineers August 2012 - Present
ISPE September 2011 - Present
Banks Integration Group May 2004 - August 2012
Accu-Sort Systems January 1999 - March 2004
Skills
New Business Development, Business Development, Business Planning, Project Management, Operations Management, Sales Management, Validation, Automation, Account Management, Technology Transfer, Engineering, Marketing, Process Automation, Manufacturing, Sales, Control Systems Design
Education
California State University-Sacramento 1992 — 1996
Bachelor of Science, Business Administration
CRB Consulting Engineers August 2012 - Present
ISPE September 2011 - Present
Banks Integration Group May 2004 - August 2012
Accu-Sort Systems January 1999 - March 2004
Skills
New Business Development, Business Development, Business Planning, Project Management, Operations Management, Sales Management, Validation, Automation, Account Management, Technology Transfer, Engineering, Marketing, Process Automation, Manufacturing, Sales, Control Systems Design
Education
California State University-Sacramento 1992 — 1996
Bachelor of Science, Business Administration
Dave Dolgin's ISPE Experience January 2013 - February 2014
Job Validation Consultant
Industry Pharmaceuticals
Experience
Biotechnique LLC July 2015 - Present
AbbVie January 2013 - January 2015
ISPE January 2013 - February 2014
Abbott January 2004 - January 2013
Abbott Labs - Specialty Products Division January 2001 - January 2004
Abbott Labs - Pharmaceutical products Division November 1996 - January 2001
Abbott Labs - Pharmaceutical Products Division January 1991 - November 1996
Davy McKee Corp. September 1989 - January 1991
Bionetics Research - Organon Teknika September 1988 - October 1989
Skills
Validation, FDA, Quality Systems, Pharmaceuticals, Biotechnology, Risk Management, Process Validation, cGMP, Quality Auditing, Change Control, Quality Assurance, Quality Management, FMEA, GAMP, Technology Transfer, Quality Engineering, Cleaning Validation, Technical Writing, Microbiology, Pharmaceutical Industry, V&V, Manufacturing, Quality System, 21 CFR Part 11, GMP, Quality Control, Six Sigma, CAPA, Biopharmaceuticals, Regulatory Submissions, Sop, Regulatory Affairs, Medical Devices, Aseptic Processing, GxP, ISO 13485, Computer System..., GLP, Regulatory Requirements, LIMS, Design Control, Pharmaceutics, ISO 14971, Sterilization, FDA GMP, HPLC, Trackwise, Calibration, Analytical Chemistry, cGMP practices
Education
Northeastern Illinois University 1972 — 1980
B.S., Biology
Northeastern Illinois University
BS Biology, Biology/Biological Sciences, General
Biotechnique LLC July 2015 - Present
AbbVie January 2013 - January 2015
ISPE January 2013 - February 2014
Abbott January 2004 - January 2013
Abbott Labs - Specialty Products Division January 2001 - January 2004
Abbott Labs - Pharmaceutical products Division November 1996 - January 2001
Abbott Labs - Pharmaceutical Products Division January 1991 - November 1996
Davy McKee Corp. September 1989 - January 1991
Bionetics Research - Organon Teknika September 1988 - October 1989
Skills
Validation, FDA, Quality Systems, Pharmaceuticals, Biotechnology, Risk Management, Process Validation, cGMP, Quality Auditing, Change Control, Quality Assurance, Quality Management, FMEA, GAMP, Technology Transfer, Quality Engineering, Cleaning Validation, Technical Writing, Microbiology, Pharmaceutical Industry, V&V, Manufacturing, Quality System, 21 CFR Part 11, GMP, Quality Control, Six Sigma, CAPA, Biopharmaceuticals, Regulatory Submissions, Sop, Regulatory Affairs, Medical Devices, Aseptic Processing, GxP, ISO 13485, Computer System..., GLP, Regulatory Requirements, LIMS, Design Control, Pharmaceutics, ISO 14971, Sterilization, FDA GMP, HPLC, Trackwise, Calibration, Analytical Chemistry, cGMP practices
Education
Northeastern Illinois University 1972 — 1980
B.S., Biology
Northeastern Illinois University
BS Biology, Biology/Biological Sciences, General
Chuck Reed's ISPE Experience 2008 - 2010
Job Principal at Reeds and Rushes, LLC
Industry Pharmaceuticals
Experience
Reeds and Rushes, LLC September 2015 - Present
Weiler Engineering, Inc. 2000 - September 2015
ISPE 2008 - 2010
ALP 1997 - 2000
Skills
Manufacturing, Product Launch, Quality System, R&D, Engineering, Quality Assurance, Pharmaceutical Industry, GLP, CAPA, Biotechnology, Commercialization, Cross-functional Team..., Business Strategy, New Business Development, Strategic Planning, Technology Transfer, Product Marketing, Product Management, Project Management, Project Engineering, Marketing Strategy, Marketing Communications, Marketing Management, Executive Management, Export, Sales Management, Sales Process, Sales Operations, Technical Writing, Service Delivery, Service Management, Content Marketing, Content Writing
Education
National Louis University 1990 — 1992
MS
Clarkson University 1969 — 1973
BS
Reeds and Rushes, LLC September 2015 - Present
Weiler Engineering, Inc. 2000 - September 2015
ISPE 2008 - 2010
ALP 1997 - 2000
Skills
Manufacturing, Product Launch, Quality System, R&D, Engineering, Quality Assurance, Pharmaceutical Industry, GLP, CAPA, Biotechnology, Commercialization, Cross-functional Team..., Business Strategy, New Business Development, Strategic Planning, Technology Transfer, Product Marketing, Product Management, Project Management, Project Engineering, Marketing Strategy, Marketing Communications, Marketing Management, Executive Management, Export, Sales Management, Sales Process, Sales Operations, Technical Writing, Service Delivery, Service Management, Content Marketing, Content Writing
Education
National Louis University 1990 — 1992
MS
Clarkson University 1969 — 1973
BS
Connie Muia's ISPE Experience 1992 - 2006
Job Independent Writing and Editing Professional
Industry Writing and Editing
Experience
International Society of Pharmaceutical Engineering 1992 - 2006
ISPE 1992 - 2006
J.F.Kennedy Center for the Performing Arts 1989 - 1992
JF Kennedy Center for the Performing Arts 1989 - 1991
Education
Shippensburg University of Pennsylvania
English, History
International Society of Pharmaceutical Engineering 1992 - 2006
ISPE 1992 - 2006
J.F.Kennedy Center for the Performing Arts 1989 - 1992
JF Kennedy Center for the Performing Arts 1989 - 1991
Education
Shippensburg University of Pennsylvania
English, History
Danielle Shelton's ISPE Experience April 2006 - May 2010
Job Events & Technology Coordinator at McKinsey & Company
Industry Events Services
Experience
McKinsey & Company July 2014 - Present
University of Tampa October 2013 - July 2014
AHDI May 2010 - August 2013
ISPE April 2006 - May 2010
Jessica McClintock April 2004 - April 2006
Allen Weddings February 2004 - April 2006
Best Buy 2001 - 2004
Logan Daily News 1999 - 2000
Skills
Photography, Marketing, Editing, Project Planning, Event Planning, Proofreading, Training, Sales, Microsoft Office, Budgets, Marketing Communications, Microsoft Word, Customer Service, Newsletters, Project Management, Management, Strategic Planning, Nonprofits, Public Relations, Feature Articles, HIPAA, PowerPoint, Data Entry, Social Media, Time Management, Public Speaking, Corporate Events, Copy Editing, Event Management, Healthcare, Volunteer Management, Market Research, Team Building, Social Media Marketing, Leadership, Online Marketing, Fundraising, Email Marketing, Social Networking, Facebook, Research, Advertising, Process Scheduler, Human Resources, Association Management, Marketing Strategy, Press Releases, Outlook, Community Outreach, Blogging
Education
Ohio University 1997 — 2000
BA, English - Creative Writing Major; Film Minor
McKinsey & Company July 2014 - Present
University of Tampa October 2013 - July 2014
AHDI May 2010 - August 2013
ISPE April 2006 - May 2010
Jessica McClintock April 2004 - April 2006
Allen Weddings February 2004 - April 2006
Best Buy 2001 - 2004
Logan Daily News 1999 - 2000
Skills
Photography, Marketing, Editing, Project Planning, Event Planning, Proofreading, Training, Sales, Microsoft Office, Budgets, Marketing Communications, Microsoft Word, Customer Service, Newsletters, Project Management, Management, Strategic Planning, Nonprofits, Public Relations, Feature Articles, HIPAA, PowerPoint, Data Entry, Social Media, Time Management, Public Speaking, Corporate Events, Copy Editing, Event Management, Healthcare, Volunteer Management, Market Research, Team Building, Social Media Marketing, Leadership, Online Marketing, Fundraising, Email Marketing, Social Networking, Facebook, Research, Advertising, Process Scheduler, Human Resources, Association Management, Marketing Strategy, Press Releases, Outlook, Community Outreach, Blogging
Education
Ohio University 1997 — 2000
BA, English - Creative Writing Major; Film Minor
Monika Heydt's ISPE Experience 2009 - Present
Job Senior EngineerMerck and Co. Inc
Industry Pharmaceuticals
Experience
Merck March 2009 - Present
ISPE 2009 - Present
Nucleonics Inc. 2004 - 2008
Education
Temple University 2007 — 2010
MS, Quality Assurance/Regulatory Affairs
Merck March 2009 - Present
ISPE 2009 - Present
Nucleonics Inc. 2004 - 2008
Education
Temple University 2007 — 2010
MS, Quality Assurance/Regulatory Affairs
Victor Di Chiara's ISPE Experience 1979 - 2010
Job GLOBAL MARKET SPECIALIST at WLGORE
Industry Pharmaceuticals
Experience
WLGORE Founding MemberISPE1979 - 2010
ISPE 1979 - 2010
AMESIL CORP 1997 - 2007
Sanitech 1987 - 1997
Pall Corp 1979 - 1987
Education
Rutgers University-New Brunswick 1970 — 1972
Industrial Pharmacy, Grad School Off Campus
Wagner University 1969 — 1971
microbiology/hemotology
Delaware Valley University
BS, Pre Veterinary Med/Microbiology/Pharmaceutical Engineering/ Merchant marine
WLGORE Founding MemberISPE1979 - 2010
ISPE 1979 - 2010
AMESIL CORP 1997 - 2007
Sanitech 1987 - 1997
Pall Corp 1979 - 1987
Education
Rutgers University-New Brunswick 1970 — 1972
Industrial Pharmacy, Grad School Off Campus
Wagner University 1969 — 1971
microbiology/hemotology
Delaware Valley University
BS, Pre Veterinary Med/Microbiology/Pharmaceutical Engineering/ Merchant marine
Victoria Smoke's ISPE Experience July 2006 - Present
Job VP of Admin/CFO at ISPE
Industry Management Consulting
Experience
ISPE July 2006 - Present
ISPE February 1996 - June 2006
Alston & Bird 1988 - 1992
Fried Frank Harris Shriver & Kampleman 1979 - 1987
Skills
Pharmaceutical Industry
Education
Georgetown University 1977 — 1979
BA, Political Science
Boston College 1975 — 1977
Political Science, History
ISPE July 2006 - Present
ISPE February 1996 - June 2006
Alston & Bird 1988 - 1992
Fried Frank Harris Shriver & Kampleman 1979 - 1987
Skills
Pharmaceutical Industry
Education
Georgetown University 1977 — 1979
BA, Political Science
Boston College 1975 — 1977
Political Science, History
Gloria Natale Hall's ISPE Experience July 1989 - 1991
Job Publisher ♦ Editorial Director ♦ Content Strategist ♦ Marketing Professional
Industry Nonprofit Organization Management
Experience
International Society for Pharmaceutical Engineering July 1991 - January 2015
ISPE July 1989 - 1991
National Association for the Remodeling Industry (NARI) June 1986 - June 1989
Skills
Pharmaceutical Industry, GMP, Biotechnology, Quality Assurance, SOP, Quality System, Cross-functional Team..., Publications, V&V, Validation, Magazines, Publishing, Association Management, Strategic Communications, Content Development, Corporate Communications, Public Relations, Marketing Communications, Project Management, Non-profits, Advertising, Newsletters, Budgets, Editing, Web Content Management, Strategic Planning, Social Media, Press Releases, Product Marketing, Copy Editing, Marketing Strategy, Media Relations
Education
Cedar Crest College
BS, Business and Marketing
International Society for Pharmaceutical Engineering July 1991 - January 2015
ISPE July 1989 - 1991
National Association for the Remodeling Industry (NARI) June 1986 - June 1989
Skills
Pharmaceutical Industry, GMP, Biotechnology, Quality Assurance, SOP, Quality System, Cross-functional Team..., Publications, V&V, Validation, Magazines, Publishing, Association Management, Strategic Communications, Content Development, Corporate Communications, Public Relations, Marketing Communications, Project Management, Non-profits, Advertising, Newsletters, Budgets, Editing, Web Content Management, Strategic Planning, Social Media, Press Releases, Product Marketing, Copy Editing, Marketing Strategy, Media Relations
Education
Cedar Crest College
BS, Business and Marketing
Elizabeth Pierre-Saint's ISPE Experience 2008 - 2009
Job Marketing Professional and Photographer
Industry Marketing and Advertising
Experience
TCS - Time Customer Service, Inc. August 2015 - Present
Ely's Keepsakes & Photography March 2013 - Present
Mangrove Software March 2014 - August 2015
Bell Shoals Baptist Church August 2013 - March 2014
Bell Shoals Baptist Church January 2011 - August 2013
ISPE 2008 - 2009
ISPE 2004 - 2008
Skills
Marketing Communications, Public Relations, Microsoft Office, Adobe Creative Suite, Administrative..., Integrated Marketing, Internal Communications, Communication, Corporate Communications, Marketing Strategy, Social Media Marketing, Email Marketing, Marketing Management, Non-profits, Non-profit..., Social Media, Social Services, Contract Negotiation, Vendor Management..., Strategic Planning, Cross-functional Team..., Team Building, Strategic Thinking, Web Content, Copy Editing, Marketing Copy, Print Management, Spanish-speaking, Multilingual, Press Releases, Portrait Photography, Graphic Design, Digital Photography, Handmade Jewelry
Education
Springfield College 2011 — 2013
Master of Science (M.S.), Human Services, Organizational Management & Leadership
University of Tampa 2001 — 2005
Bachelors of Science, Marketing
TCS - Time Customer Service, Inc. August 2015 - Present
Ely's Keepsakes & Photography March 2013 - Present
Mangrove Software March 2014 - August 2015
Bell Shoals Baptist Church August 2013 - March 2014
Bell Shoals Baptist Church January 2011 - August 2013
ISPE 2008 - 2009
ISPE 2004 - 2008
Skills
Marketing Communications, Public Relations, Microsoft Office, Adobe Creative Suite, Administrative..., Integrated Marketing, Internal Communications, Communication, Corporate Communications, Marketing Strategy, Social Media Marketing, Email Marketing, Marketing Management, Non-profits, Non-profit..., Social Media, Social Services, Contract Negotiation, Vendor Management..., Strategic Planning, Cross-functional Team..., Team Building, Strategic Thinking, Web Content, Copy Editing, Marketing Copy, Print Management, Spanish-speaking, Multilingual, Press Releases, Portrait Photography, Graphic Design, Digital Photography, Handmade Jewelry
Education
Springfield College 2011 — 2013
Master of Science (M.S.), Human Services, Organizational Management & Leadership
University of Tampa 2001 — 2005
Bachelors of Science, Marketing
Christian DeSousa's ISPE Experience September 2001 - July 2010
Job Customer Relationship Manager at Silvergate Pharmaceuticals Inc
Industry Information Technology and Services
Experience
Silvergate Pharmaceuticals Inc May 2014 - Present
Denver Public Library January 2012 - May 2014
ISPE September 2001 - July 2010
ISPE May 2000 - September 2001
ISPE April 1999 - May 2000
CITICORP October 1998 - April 1999
Skills
Microsoft Office, Public Relations, Project Management, Access, Training, Program Management, Customer Service, Software Documentation, Databases
Education
University of South Florida 1995 — 1998
Bachelor of Science, Management Information Systems
Silvergate Pharmaceuticals Inc May 2014 - Present
Denver Public Library January 2012 - May 2014
ISPE September 2001 - July 2010
ISPE May 2000 - September 2001
ISPE April 1999 - May 2000
CITICORP October 1998 - April 1999
Skills
Microsoft Office, Public Relations, Project Management, Access, Training, Program Management, Customer Service, Software Documentation, Databases
Education
University of South Florida 1995 — 1998
Bachelor of Science, Management Information Systems
Marni Schribman's ISPE Experience January 2008 - February 2010
Job Retirement Communications & Content Manager at North Carolina Dept. of State Treasurer
Industry Public Relations and Communications
Experience
North Carolina Dept. of State Treasurer January 2015 - Present
North Carolina Museum of Art 2010 - Present
N.C. Dept. of Insurance & Office of State Fire Marshal May 2011 - January 2015
Compliance Implementation Services March 2010 - April 2011
ISPE January 2008 - February 2010
PinnacleOne, Inc December 2005 - January 2008
Chanen Construction Co July 2002 - August 2004
Hole Montes, Inc. July 2001 - May 2002
Allen Systems Group July 1997 - March 2000
ASG Software Solutions 1997 - 2000
Skills
Speech Writing, Public Relations, Event Planning, Corporate Communications, Strategic Planning, Graphic Design, Social Networking, Volunteer Management, Media Relations, Marketing Communications, Social Media, Writing, Press Releases, Editing, Internal Communications, Event Management, Strategic Communications, Public Speaking, Marketing Strategy, Newsletters, Blogging, Copywriting, Publications, Fundraising, Marketing, SEO, Management, Facebook, Advertising, Nonprofits, Leadership, Web Content, Strategy
Education
University of Phoenix 2003 — 2005
M.Ed., Elementary Education
State University of New York at New Paltz 1990 — 1992
B.A., English/Journalism
Marist College 1988 — 1990
Journalism
North Carolina Dept. of State Treasurer January 2015 - Present
North Carolina Museum of Art 2010 - Present
N.C. Dept. of Insurance & Office of State Fire Marshal May 2011 - January 2015
Compliance Implementation Services March 2010 - April 2011
ISPE January 2008 - February 2010
PinnacleOne, Inc December 2005 - January 2008
Chanen Construction Co July 2002 - August 2004
Hole Montes, Inc. July 2001 - May 2002
Allen Systems Group July 1997 - March 2000
ASG Software Solutions 1997 - 2000
Skills
Speech Writing, Public Relations, Event Planning, Corporate Communications, Strategic Planning, Graphic Design, Social Networking, Volunteer Management, Media Relations, Marketing Communications, Social Media, Writing, Press Releases, Editing, Internal Communications, Event Management, Strategic Communications, Public Speaking, Marketing Strategy, Newsletters, Blogging, Copywriting, Publications, Fundraising, Marketing, SEO, Management, Facebook, Advertising, Nonprofits, Leadership, Web Content, Strategy
Education
University of Phoenix 2003 — 2005
M.Ed., Elementary Education
State University of New York at New Paltz 1990 — 1992
B.A., English/Journalism
Marist College 1988 — 1990
Journalism
Niranjan Kulkarni's ISPE Experience March 2015 - Present
Job Sr. Operations Specialist at CRB
Industry Pharmaceuticals
Experience
CRB Consulting Engineers October 2010 - Present
ISPE March 2015 - Present
Argus Information and Advisory Services June 2010 - October 2010
IBM CORPORATION 2006 - 2010
Motorola Inc. 2005 - 2006
Imaging & Sensing Technology 2004 - 2004
Dalal Engineering Pvt. Ltd. 2003 - 2004
Skills
Data Analysis, Lean Manufacturing, Process Improvement, Six Sigma, Business Analysis, Modeling and Simulation, Minitab, Project Planning, Business Process, Business Process..., Leadership, Process Engineering, Manufacturing, Supply Chain Management, Change Management, Training, Kaizen, Value Stream Mapping, Forecasting, Operations Management, Validation, FMEA, Design of Experiments, Engineering, Operational Excellence, Quality Assurance, Process Simulation, Continuous Improvement, Cross-functional Team..., Quality System, MS Project, Process Optimization, 5S, Industrial Engineering, Root Cause Analysis, Quality Control
Education
Binghamton University 2006 — 2010
PhD, Industrial and Systems Engineering
Binghamton University 2004 — 2006
MS, Industrial and Systems Engineering
University of Mumbai
BE, Mechanical Engineering
CRB Consulting Engineers October 2010 - Present
ISPE March 2015 - Present
Argus Information and Advisory Services June 2010 - October 2010
IBM CORPORATION 2006 - 2010
Motorola Inc. 2005 - 2006
Imaging & Sensing Technology 2004 - 2004
Dalal Engineering Pvt. Ltd. 2003 - 2004
Skills
Data Analysis, Lean Manufacturing, Process Improvement, Six Sigma, Business Analysis, Modeling and Simulation, Minitab, Project Planning, Business Process, Business Process..., Leadership, Process Engineering, Manufacturing, Supply Chain Management, Change Management, Training, Kaizen, Value Stream Mapping, Forecasting, Operations Management, Validation, FMEA, Design of Experiments, Engineering, Operational Excellence, Quality Assurance, Process Simulation, Continuous Improvement, Cross-functional Team..., Quality System, MS Project, Process Optimization, 5S, Industrial Engineering, Root Cause Analysis, Quality Control
Education
Binghamton University 2006 — 2010
PhD, Industrial and Systems Engineering
Binghamton University 2004 — 2006
MS, Industrial and Systems Engineering
University of Mumbai
BE, Mechanical Engineering
Danielle E. Chandonnet's ISPE Experience May 2000 - June 2001
Job Admissions Counselor at LakeSumter State College
Industry Higher Education
Experience
Lake-Sumter State College March 2015 - Present
Winter Park Technical Education Center August 2014 - March 2015
Pine Technical & Community College May 2009 - June 2013
City of Mount Dora June 2006 - May 2009
University of South Florida August 2004 - June 2006
Eastern Florida State College February 2003 - August 2004
Eastern Florida State College June 2001 - February 2003
ISPE May 2000 - June 2001
Skills
Higher Education, Public Relations, Marketing, PowerPoint, Program Development, Admissions, Student Affairs, Enrollment Management, Public Speaking, Recruiting, Teaching, Community Outreach, Marketing Communications, Grant Writing, Nonprofits, Workforce Development, Non-profits, Career Counseling, Strategic Planning, Event Planning, Customer Service, Leadership Development, Social Media, Research, Fundraising
Education
St. Cloud State University
Ed.D., Higher Education Administration
Troy University
MPA, Public Administration
University of South Florida
BA, Mass Communications/Public Relations
Lake-Sumter State College March 2015 - Present
Winter Park Technical Education Center August 2014 - March 2015
Pine Technical & Community College May 2009 - June 2013
City of Mount Dora June 2006 - May 2009
University of South Florida August 2004 - June 2006
Eastern Florida State College February 2003 - August 2004
Eastern Florida State College June 2001 - February 2003
ISPE May 2000 - June 2001
Skills
Higher Education, Public Relations, Marketing, PowerPoint, Program Development, Admissions, Student Affairs, Enrollment Management, Public Speaking, Recruiting, Teaching, Community Outreach, Marketing Communications, Grant Writing, Nonprofits, Workforce Development, Non-profits, Career Counseling, Strategic Planning, Event Planning, Customer Service, Leadership Development, Social Media, Research, Fundraising
Education
St. Cloud State University
Ed.D., Higher Education Administration
Troy University
MPA, Public Administration
University of South Florida
BA, Mass Communications/Public Relations
Eldon Kiel's ISPE Experience 2013 - December 2013
Job Sr. Project Manager at Howard S. Wright
Industry Construction
Experience
Howard S. Wright, a Balfour Beatty company January 2014 - Present
ISPE 2013 - December 2013
Turner Construction Company June 1998 - December 2013
Skills
Pre-construction, Value Engineering, Construction Management, Cost Estimating, Project Management, Project Estimation, Contract Negotiation, CPM Scheduling, Project Coordination
Education
The University of British Columbia 1996 — 1998
BASc, Civil Engineering
Northern Alberta Institute of Technology 1993 — 1995
Bachelor of Technology (B.Tech.), Civil Engineering Technology/Technician
Howard S. Wright, a Balfour Beatty company January 2014 - Present
ISPE 2013 - December 2013
Turner Construction Company June 1998 - December 2013
Skills
Pre-construction, Value Engineering, Construction Management, Cost Estimating, Project Management, Project Estimation, Contract Negotiation, CPM Scheduling, Project Coordination
Education
The University of British Columbia 1996 — 1998
BASc, Civil Engineering
Northern Alberta Institute of Technology 1993 — 1995
Bachelor of Technology (B.Tech.), Civil Engineering Technology/Technician
Blair Tyson's ISPE Experience 2001 - 2004
Job Sr. Manager Aseptic Operations at Eisai
Industry Pharmaceuticals
Experience
Eisai November 2006 - Present
Mallinckrodt 2003 - 2006
ISPE 2001 - 2004
CRB Consulting Engineers 2001 - 2004
Tyco Healthcare 1997 - 2000
Skills
FDA, GMP, Sop, V&V, Change Control, Validation, CAPA, Pharmaceutical Industry, Quality Assurance, 21 CFR Part 11, Quality System, Medical Devices, Manufacturing, Biopharmaceuticals, Biotechnology, Automation, Computer System..., Technology Transfer, Aseptic Processing, Regulatory Affairs, GxP, GLP
Education
Duke University - Fuqua School of Business 1991 — 1993
Masters, Business Administration
NC State University 1988 — 1991
BS, Mechanical Engineering
Eisai November 2006 - Present
Mallinckrodt 2003 - 2006
ISPE 2001 - 2004
CRB Consulting Engineers 2001 - 2004
Tyco Healthcare 1997 - 2000
Skills
FDA, GMP, Sop, V&V, Change Control, Validation, CAPA, Pharmaceutical Industry, Quality Assurance, 21 CFR Part 11, Quality System, Medical Devices, Manufacturing, Biopharmaceuticals, Biotechnology, Automation, Computer System..., Technology Transfer, Aseptic Processing, Regulatory Affairs, GxP, GLP
Education
Duke University - Fuqua School of Business 1991 — 1993
Masters, Business Administration
NC State University 1988 — 1991
BS, Mechanical Engineering
Randy Perez's ISPE Experience November 2005 - Present
Job Director, Information Governance and Management at Novartis
Industry Pharmaceuticals
Experience
ISPE November 2005 - Present
Novartis 2000 - Present
GAMP Americas 2002 - 2007
Novartis 1997 - 2000
Ciba-Geigy 1983 - 1997
Skills
Compliance, Risk Management, SOX, GMP, Process Validation, FDA, Process Improvement, Quality Assurance, GxP, GAMP, cGMP, Validation, 21 CFR Part 11, Computer System..., Pharmaceuticals, SOP, Pharmaceutical Industry, Sop, Quality System, V&V, Change Control, Technology Transfer, Biotechnology, Leadership, Chemistry, Pharmaceutics, LIMS, Lifesciences, Sarbanes-Oxley Act, HPLC, Regulatory Affairs, Cross-functional Team..., GLP, CSV, Team Leadership, CAPA
Education
University of Michigan 1977 — 1983
Ph.D., Organic Chemistry
Massachusetts Institute of Technology 1973 — 1977
SB, Chemistry
ISPE November 2005 - Present
Novartis 2000 - Present
GAMP Americas 2002 - 2007
Novartis 1997 - 2000
Ciba-Geigy 1983 - 1997
Skills
Compliance, Risk Management, SOX, GMP, Process Validation, FDA, Process Improvement, Quality Assurance, GxP, GAMP, cGMP, Validation, 21 CFR Part 11, Computer System..., Pharmaceuticals, SOP, Pharmaceutical Industry, Sop, Quality System, V&V, Change Control, Technology Transfer, Biotechnology, Leadership, Chemistry, Pharmaceutics, LIMS, Lifesciences, Sarbanes-Oxley Act, HPLC, Regulatory Affairs, Cross-functional Team..., GLP, CSV, Team Leadership, CAPA
Education
University of Michigan 1977 — 1983
Ph.D., Organic Chemistry
Massachusetts Institute of Technology 1973 — 1977
SB, Chemistry
Rose Mary Dollard's ISPE Experience 2010 - 2012
Job Director of Regulatory Compliance at Johnson & Johnson
Industry Pharmaceuticals
Experience
Johnson & Johnson April 2011 - Present
ISPE 2010 - 2012
Johnson & Johnson June 2005 - April 2011
McNeil Consumer Healthcare June 2003 - June 2005
McNeil Consumer Healthcare January 2001 - June 2003
McNeil Consumer Healthcare August 1998 - December 2000
McNeil Consumer Healthcare February 1996 - August 1998
Education
Temple University 1981 — 1984
Bachelor of Arts, Chemistry
Johnson & Johnson April 2011 - Present
ISPE 2010 - 2012
Johnson & Johnson June 2005 - April 2011
McNeil Consumer Healthcare June 2003 - June 2005
McNeil Consumer Healthcare January 2001 - June 2003
McNeil Consumer Healthcare August 1998 - December 2000
McNeil Consumer Healthcare February 1996 - August 1998
Education
Temple University 1981 — 1984
Bachelor of Arts, Chemistry
Camil Daniel Ghiu's ISPE Experience 1994 - 1999
Job Research Scientist at Advanced Thermal Solutions
Industry Electrical/Electronic Manufacturing
Experience
Advanced Thermal Solutions January 2013 - Present
Osram Sylvania November 2008 - December 2012
Jacket Micro Devices 2005 - 2008
ISPE 1994 - 1999
Skills
Injection Molding, R&D, Solidworks, Design for Manufacturing, Thermal, Simulations, Product Development, Thermal Management, Product Design, Semiconductors, Heat Transfer, Engineering Management, CFD, Finite Element Analysis
Education
Georgia Institute of Technology 2001 — 2007
PH. D., Mechanical Engineering
Universitatea „Politehnica” din București
Master of Science (M.S.), Mechanical Engineering
University of Maryland College Park
University of Maryland College Park
University of Maryland College Park
Advanced Thermal Solutions January 2013 - Present
Osram Sylvania November 2008 - December 2012
Jacket Micro Devices 2005 - 2008
ISPE 1994 - 1999
Skills
Injection Molding, R&D, Solidworks, Design for Manufacturing, Thermal, Simulations, Product Development, Thermal Management, Product Design, Semiconductors, Heat Transfer, Engineering Management, CFD, Finite Element Analysis
Education
Georgia Institute of Technology 2001 — 2007
PH. D., Mechanical Engineering
Universitatea „Politehnica” din București
Master of Science (M.S.), Mechanical Engineering
University of Maryland College Park
University of Maryland College Park
University of Maryland College Park
David Swaim's ISPE Experience 2004 - 2005
Job president at validation agents
Industry Pharmaceuticals
Experience
validation agents May 2005 - Present
Schering-Plough Pharmaceuticals 2005 - 2009
A&J Engineering and Consultants LTD 2005 - 2006
ISPE 2004 - 2005
Foster Wheeler Inc. 1995 - 1996
Education
Bucknell University 1984 — 1988
BSChE, Chemical Engineering
validation agents May 2005 - Present
Schering-Plough Pharmaceuticals 2005 - 2009
A&J Engineering and Consultants LTD 2005 - 2006
ISPE 2004 - 2005
Foster Wheeler Inc. 1995 - 1996
Education
Bucknell University 1984 — 1988
BSChE, Chemical Engineering
Mircea Cretu's ISPE Experience September 1986 - May 1994
Job Product Manager at Université de Montréal
Industry Higher Education
Experience
Université de Montréal January 2009 - Present
SNC Lavalin October 2006 - December 2007
Corporatek July 2001 - September 2002
DTI Software October 1996 - May 2001
IGM September 1995 - March 1996
ISPE September 1986 - May 1994
ISPE October 1980 - September 1986
Skills
Software Development, C#, SQL, Databases, Software Engineering, Data Mining, Software Project..., Programming, Scrum, Business Intelligence, Requirements Analysis, ERP, Cloud Computing, PL/SQL, Project Management, Agile Methodologies, Agile Project Management
Education
Academia de Studii Economice din București 1981 — 1986
Cibernetica
Université de Montréal January 2009 - Present
SNC Lavalin October 2006 - December 2007
Corporatek July 2001 - September 2002
DTI Software October 1996 - May 2001
IGM September 1995 - March 1996
ISPE September 1986 - May 1994
ISPE October 1980 - September 1986
Skills
Software Development, C#, SQL, Databases, Software Engineering, Data Mining, Software Project..., Programming, Scrum, Business Intelligence, Requirements Analysis, ERP, Cloud Computing, PL/SQL, Project Management, Agile Methodologies, Agile Project Management
Education
Academia de Studii Economice din București 1981 — 1986
Cibernetica
Mark Hannon, CQA's ISPE Experience 1998 - 2011
Job Principal Compliance Specialist
Industry Pharmaceuticals
Experience
Genentech June 2011 - Present
Genentech June 1995 - June 2011
ASQ June 2009 - 2011
ISPE 1998 - 2011
Skills
Validation, Biotechnology, GMP, Sop, FDA, 21 CFR Part 11, Quality Auditing, Medical Devices, Technology Transfer, Change Control, Quality System, CAPA, Computer System..., Process Simulation, V&V, Lifesciences, Biopharmaceuticals, Pharmaceutical Industry, GLP, Regulatory Affairs
Education
St. Mary's College of California
BA with Honors, Management
Genentech June 2011 - Present
Genentech June 1995 - June 2011
ASQ June 2009 - 2011
ISPE 1998 - 2011
Skills
Validation, Biotechnology, GMP, Sop, FDA, 21 CFR Part 11, Quality Auditing, Medical Devices, Technology Transfer, Change Control, Quality System, CAPA, Computer System..., Process Simulation, V&V, Lifesciences, Biopharmaceuticals, Pharmaceutical Industry, GLP, Regulatory Affairs
Education
St. Mary's College of California
BA with Honors, Management
Ilya Getsin's ISPE Experience April 2011 - June 2013
Job Graduate Student at Cornell University
Industry Medical Devices
Experience
BioCurious January 2015 - Present
Boston Scientific February 2015 - August 2015
Lenthor Engineering September 2013 - February 2015
University of California, San Diego April 2013 - June 2013
Society for Automotive Engineers March 2013 - June 2013
ISPE April 2011 - June 2013
VA San Diego Hospital June 2012 - May 2013
Saier Laboratory - UCSD September 2011 - May 2013
Sanford-Burnham Medical Research Institute June 2012 - December 2012
Adperio June 2011 - August 2011
Skills
Public Speaking, Java, Microsoft Office, Microsoft Excel, Cell Culture, Competitive Analysis, Sales, Statistics, Matlab, Advertising, Market Research, Solidworks, Research, Technical Writing, AutoCAD, Inventor, Labview, Customer Service, Analysis, Data Analysis, Medical Devices, SolidWorks, Autodesk Inventor
Education
Cornell University 2015 — 2016
Master of Engineering (MEng), Biomedical/Medical Engineering
University of California, San Diego 2009 — 2013
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
UCSD 2009 — 2013
Minor, Economics
BioCurious January 2015 - Present
Boston Scientific February 2015 - August 2015
Lenthor Engineering September 2013 - February 2015
University of California, San Diego April 2013 - June 2013
Society for Automotive Engineers March 2013 - June 2013
ISPE April 2011 - June 2013
VA San Diego Hospital June 2012 - May 2013
Saier Laboratory - UCSD September 2011 - May 2013
Sanford-Burnham Medical Research Institute June 2012 - December 2012
Adperio June 2011 - August 2011
Skills
Public Speaking, Java, Microsoft Office, Microsoft Excel, Cell Culture, Competitive Analysis, Sales, Statistics, Matlab, Advertising, Market Research, Solidworks, Research, Technical Writing, AutoCAD, Inventor, Labview, Customer Service, Analysis, Data Analysis, Medical Devices, SolidWorks, Autodesk Inventor
Education
Cornell University 2015 — 2016
Master of Engineering (MEng), Biomedical/Medical Engineering
University of California, San Diego 2009 — 2013
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
UCSD 2009 — 2013
Minor, Economics
Kaili Qian's ISPE Experience February 2012 - January 2015
Job Process Development Associate II at BASF
Industry Pharmaceuticals
Experience
BASF February 2015 - Present
Amphastar Pharmaceuticals, Inc. May 2012 - January 2015
ISPE February 2012 - January 2015
Skills
Pharmaceutical Industry, FDA, Statistical Process..., Quality By Design, Design of Experiments, Quality by Design, SOP, R&D, 21 CFR Part 11, Process Simulation, GMP, SPC, Validation, CAPA, Purification, Biotechnology, Fermentation
Education
University of california,Riverside 2008 — 2010
Master's degree, Chemical Engineering
Beijing University of Chemical Technology 2004 — 2008
Pharmaceutical Engineering
BASF February 2015 - Present
Amphastar Pharmaceuticals, Inc. May 2012 - January 2015
ISPE February 2012 - January 2015
Skills
Pharmaceutical Industry, FDA, Statistical Process..., Quality By Design, Design of Experiments, Quality by Design, SOP, R&D, 21 CFR Part 11, Process Simulation, GMP, SPC, Validation, CAPA, Purification, Biotechnology, Fermentation
Education
University of california,Riverside 2008 — 2010
Master's degree, Chemical Engineering
Beijing University of Chemical Technology 2004 — 2008
Pharmaceutical Engineering
Harry Dowling's ISPE Experience November 1994 - November 1995
Job Independent Management Consulting Professional
Industry Pharmaceuticals
Experience
International Society of Pharmaceutical Engineering 1987 - Present
ISPE November 1994 - November 1995
Skills
GMP, Biotechnology, CAPA, R&D, Regulatory Affairs, Pharmaceutical Industry, Supply Chain Management, Technology Transfer, Pharmaceutics, FDA, Quality System, Pharmacueticals, Lifesciences, Cleaning Validation, Validation, Supply Chain, Quality Assurance, Computer System..., Quality Auditing, International..., Sop, Manufacturing, ISO 13485, GLP, Biopharmaceuticals, GxP, Medical Devices, SOP
Education
Louisiana State University 1957 — 1959
MS, Analytical Chemistry
Millsaps College 1953 — 1957
Bachelor of Science (BS), Chemistry
International Society of Pharmaceutical Engineering 1987 - Present
ISPE November 1994 - November 1995
Skills
GMP, Biotechnology, CAPA, R&D, Regulatory Affairs, Pharmaceutical Industry, Supply Chain Management, Technology Transfer, Pharmaceutics, FDA, Quality System, Pharmacueticals, Lifesciences, Cleaning Validation, Validation, Supply Chain, Quality Assurance, Computer System..., Quality Auditing, International..., Sop, Manufacturing, ISO 13485, GLP, Biopharmaceuticals, GxP, Medical Devices, SOP
Education
Louisiana State University 1957 — 1959
MS, Analytical Chemistry
Millsaps College 1953 — 1957
Bachelor of Science (BS), Chemistry
Sherri Oliver's ISPE Experience October 2006 - May 2007
Job Senior Consultant
Industry Information Technology and Services
Experience
CSpring April 2015 - Present
Roche Diagnostics October 2012 - March 2015
Allegient, LLC September 2010 - May 2012
Eli Lilly and Company October 2007 - September 2010
WellCare May 2007 - October 2007
ISPE October 2006 - May 2007
United Landmark Associates October 2005 - October 2006
Madden, Inc May 2005 - October 2005
Martin Lithograph July 2002 - May 2005
Skills
SharePoint, SharePoint Designer, HTML, Photoshop, Web Development, Web Design, CSS, Project Management, Dreamweaver, Business Process, HTML 5, Illustrator, Flash, JavaScript, InfoPath, OS X, Illustration, Mac OS X, Adobe Creative Suite, InDesign, Fireworks, QuarkXPress, Graphic Design, Visual Arts
Education
Minneapolis Community and Technical College 2000 — 2002
Internet and Web Technology
Eastern Florida State College 1997 — 1999
Fine Arts and Graphic Design
CSpring April 2015 - Present
Roche Diagnostics October 2012 - March 2015
Allegient, LLC September 2010 - May 2012
Eli Lilly and Company October 2007 - September 2010
WellCare May 2007 - October 2007
ISPE October 2006 - May 2007
United Landmark Associates October 2005 - October 2006
Madden, Inc May 2005 - October 2005
Martin Lithograph July 2002 - May 2005
Skills
SharePoint, SharePoint Designer, HTML, Photoshop, Web Development, Web Design, CSS, Project Management, Dreamweaver, Business Process, HTML 5, Illustrator, Flash, JavaScript, InfoPath, OS X, Illustration, Mac OS X, Adobe Creative Suite, InDesign, Fireworks, QuarkXPress, Graphic Design, Visual Arts
Education
Minneapolis Community and Technical College 2000 — 2002
Internet and Web Technology
Eastern Florida State College 1997 — 1999
Fine Arts and Graphic Design