Catalent Company
Industry: Company
DescriptionCatalent, Inc. is a Somerset, New Jersey company involved in technology and development for drugs, biologics and consumer health products. It claimed production of more than 70 billion doses annually for nearly 7,000 customer products in 2014. Headquarters: Somerset, Ewing Township, NJ CEO: John R. Chiminski (Mar 17, 2009–) Revenue: 1.83 billion USD (2014) CFO: Wetteny Joseph
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Catalent Employees
Employee
Years
Job
Industry
Brett Michel Brett Michel's Catalent Experience July 2008 - September 2011
Job Manager, Proposal Management and Production System at Quintiles
Industry Pharmaceuticals
Experience
Quintiles August 2014 - Present
Catalent Pharma Solutions April 2014 - June 2014
Catalent Pharma Solutions October 2012 - April 2014
Catalent Pharma Solutions September 2011 - October 2012
Catalent July 2008 - September 2011
Catalent Pharma Solutions January 2007 - July 2008
Cardinal Health January 2004 - January 2007
Waters Corporation March 2002 - October 2003
Carlsbad Technology Inc March 2000 - March 2002
Skills
GMP, HPLC, Validation, Sop, FDA, Technology Transfer, Pharmaceutical Industry, Biotechnology, Analytical Chemistry, GLP, Chromatography, Gas Chromatography, UV/Vis, LIMS, CRO, Chemistry, LC-MS, Lifesciences, USP, Mass Spectrometry, Proposal Writing, Pricing Strategy, Proposal Leadership, Contract Management, Management, Contract Pricing, Pharmaceutics, Drug Development, Biopharmaceuticals, 21 CFR Part 11
Education
North Carolina State University - College of Management 2007 — 2010
MBA, Master of Buisness Administration
Oregon State University 1994 — 1999
BS, Chemistry
Aloha HIgh 1991 — 1994
General Education
Quintiles August 2014 - Present
Catalent Pharma Solutions April 2014 - June 2014
Catalent Pharma Solutions October 2012 - April 2014
Catalent Pharma Solutions September 2011 - October 2012
Catalent July 2008 - September 2011
Catalent Pharma Solutions January 2007 - July 2008
Cardinal Health January 2004 - January 2007
Waters Corporation March 2002 - October 2003
Carlsbad Technology Inc March 2000 - March 2002
Skills
GMP, HPLC, Validation, Sop, FDA, Technology Transfer, Pharmaceutical Industry, Biotechnology, Analytical Chemistry, GLP, Chromatography, Gas Chromatography, UV/Vis, LIMS, CRO, Chemistry, LC-MS, Lifesciences, USP, Mass Spectrometry, Proposal Writing, Pricing Strategy, Proposal Leadership, Contract Management, Management, Contract Pricing, Pharmaceutics, Drug Development, Biopharmaceuticals, 21 CFR Part 11
Education
North Carolina State University - College of Management 2007 — 2010
MBA, Master of Buisness Administration
Oregon State University 1994 — 1999
BS, Chemistry
Aloha HIgh 1991 — 1994
General Education
Ami E. Simunovich Ami E. Simunovich's Catalent Experience March 2013 - Present
Job Associate General Counsel, Regulatory at Catalent Pharma Solutions
Industry Law Practice
Experience
Catalent Pharma Solutions July 2015 - Present
Catalent March 2013 - Present
Skills
Intellectual Property, Patent Litigation, Patents, Licensing, Litigation, Due Diligence, Trials, Pharmaceutical Industry, Biotechnology, FDA, Patent Prosecution, Pharmaceutics, Trade Secrets, Lifesciences, Technology Transfer
Education
Seton Hall University School of Law 2004 — 2007
J.D., cum laude with a Concentration in Health Law
Ernest Mario School of Pharmacy, Rutgers, the State University of New Jersey-New Brunswick 1998 — 2004
Pharm.D., with honors
Catalent Pharma Solutions July 2015 - Present
Catalent March 2013 - Present
Skills
Intellectual Property, Patent Litigation, Patents, Licensing, Litigation, Due Diligence, Trials, Pharmaceutical Industry, Biotechnology, FDA, Patent Prosecution, Pharmaceutics, Trade Secrets, Lifesciences, Technology Transfer
Education
Seton Hall University School of Law 2004 — 2007
J.D., cum laude with a Concentration in Health Law
Ernest Mario School of Pharmacy, Rutgers, the State University of New Jersey-New Brunswick 1998 — 2004
Pharm.D., with honors
Ronald Peeler, MSSE, BSIE Ronald Peeler, MSSE, BSIE's Catalent Experience July 2008 - February 2009
Job Materials Manager at The Boeing Company
Industry Aviation & Aerospace
Experience
Boeing November 2014 - Present
Boeing September 2012 - Present
Boeing May 2009 - Present
Catalent July 2008 - February 2009
SWEMCO 2005 - 2008
Laser Technologies 2003 - 2005
Skills
Six Sigma, Process Improvement, Lean Manufacturing, Manufacturing, Validation, DMAIC, Systems Engineering, Engineering, Program Management, Microsoft Office, AutoCAD, Industrial Engineering, Solidworks, Troubleshooting, Analysis, Data Analysis, Project Management, Kaizen, 5S, Value Stream Mapping, Continuous Improvement, Engineering Management, Root Cause Analysis, Aerospace, Earned Value Management, Process Engineering, Minitab, MS Project, Cross-functional Team..., Microsoft Project
Education
Penn State University 2011 — 2013
Master of Science (MS), Systems Engineering, 3.6
University of Pittsburgh 1998 — 2003
Bachelors of Science, Industrial Engineering, 3.1
City Honors 1994 — 1998
high school diploma, math and science, 3.3
Boeing November 2014 - Present
Boeing September 2012 - Present
Boeing May 2009 - Present
Catalent July 2008 - February 2009
SWEMCO 2005 - 2008
Laser Technologies 2003 - 2005
Skills
Six Sigma, Process Improvement, Lean Manufacturing, Manufacturing, Validation, DMAIC, Systems Engineering, Engineering, Program Management, Microsoft Office, AutoCAD, Industrial Engineering, Solidworks, Troubleshooting, Analysis, Data Analysis, Project Management, Kaizen, 5S, Value Stream Mapping, Continuous Improvement, Engineering Management, Root Cause Analysis, Aerospace, Earned Value Management, Process Engineering, Minitab, MS Project, Cross-functional Team..., Microsoft Project
Education
Penn State University 2011 — 2013
Master of Science (MS), Systems Engineering, 3.6
University of Pittsburgh 1998 — 2003
Bachelors of Science, Industrial Engineering, 3.1
City Honors 1994 — 1998
high school diploma, math and science, 3.3
Naomi Rose Harbatuk Naomi Rose Harbatuk's Catalent Experience November 2004 - January 2010
Job Finance Coordinator at Phoenix Marketing Solutions
Industry Medical Practice
Experience
Phoenix Marketing Solutions June 2013 - Present
Princeton Windrows May 2013 - June 2013
Merck July 2012 - December 2012
Ranbaxy November 2010 - July 2011
Catalent November 2004 - January 2010
Guest Supply August 2004 - November 2004
Days Inn June 2004 - August 2004
Valairco March 2002 - June 2003
Katco, Inc. November 2001 - April 2002
Hilton Garden Inn September 2000 - November 2001
Skills
FDA, Pharmaceutical Industry, GMP, Quality System, Auditing, Process Improvement, Microsoft Office, Project Management, Six Sigma, Change Management, Validation, Training, V&V, Manufacturing, Lean Manufacturing, Continuous Improvement, Management, Quality Assurance, Pharmaceutics, Cleaning Validation, Sop, Change Control, 21 CFR Part 11, CAPA, SOP
Education
SkillPath Seminars 2009 — 2009
The Indispensable Assistant
The Office Professional 2008 — 2008
Minute Taking Made Easy
Corporate Training Group 2007 — 2007
Access 2000
Lean Six Sigma 2006 — 2006
LSS White Belt
Rockhurst University Continuing Education 2006 — 2006
Business Writing and Grammar Skills
The Professional School of Business 2004 — 2004
Property and Casualty Insurance
Raritan Valley Community College 1998 — 2001
Accounting
Hillsborough High 1995 — 1999
Diploma, college prep courses, 3.0
Phoenix Marketing Solutions June 2013 - Present
Princeton Windrows May 2013 - June 2013
Merck July 2012 - December 2012
Ranbaxy November 2010 - July 2011
Catalent November 2004 - January 2010
Guest Supply August 2004 - November 2004
Days Inn June 2004 - August 2004
Valairco March 2002 - June 2003
Katco, Inc. November 2001 - April 2002
Hilton Garden Inn September 2000 - November 2001
Skills
FDA, Pharmaceutical Industry, GMP, Quality System, Auditing, Process Improvement, Microsoft Office, Project Management, Six Sigma, Change Management, Validation, Training, V&V, Manufacturing, Lean Manufacturing, Continuous Improvement, Management, Quality Assurance, Pharmaceutics, Cleaning Validation, Sop, Change Control, 21 CFR Part 11, CAPA, SOP
Education
SkillPath Seminars 2009 — 2009
The Indispensable Assistant
The Office Professional 2008 — 2008
Minute Taking Made Easy
Corporate Training Group 2007 — 2007
Access 2000
Lean Six Sigma 2006 — 2006
LSS White Belt
Rockhurst University Continuing Education 2006 — 2006
Business Writing and Grammar Skills
The Professional School of Business 2004 — 2004
Property and Casualty Insurance
Raritan Valley Community College 1998 — 2001
Accounting
Hillsborough High 1995 — 1999
Diploma, college prep courses, 3.0
Jeff Boris Jeff Boris's Catalent Experience March 2007 - August 2008
Job Director Business Development at CoreRx
Industry Biotechnology
Experience
CoreRx April 2015 - Present
Harlan Laboratories, Inc. July 2013 - December 2014
Metrics Inc. 2009 - June 2013
Catalent March 2007 - August 2008
Aptuit/Quintiles 2000 - 2007
ProClinical 1997 - 1999
Colorcon 1987 - 1997
Skills
Pharmaceutical Industry, Biotechnology, CRO, Lifesciences, Drug Development, Clinical Trials, Clinical Development, GMP, Biopharmaceuticals, Sop, FDA, Medical Devices, Chemical
Education
Purdue University
BS, BioChemistry
CoreRx April 2015 - Present
Harlan Laboratories, Inc. July 2013 - December 2014
Metrics Inc. 2009 - June 2013
Catalent March 2007 - August 2008
Aptuit/Quintiles 2000 - 2007
ProClinical 1997 - 1999
Colorcon 1987 - 1997
Skills
Pharmaceutical Industry, Biotechnology, CRO, Lifesciences, Drug Development, Clinical Trials, Clinical Development, GMP, Biopharmaceuticals, Sop, FDA, Medical Devices, Chemical
Education
Purdue University
BS, BioChemistry
Halema Ali's Catalent Experience 2008 - 2009
Job QA Manager, Becton Dickinson
Industry Pharmaceuticals
Experience
Becton Dickinson QA SpecialistBecton DickinsonAugust 2010 - Present
Novartis Vaccines and Diagnostics November 2009 - August 2010
Catalent 2008 - 2009
Covidien 2004 - 2007
GSK 1993 - 2003
Skills
cGMP, GMP, Validation, Quality Systems, CAPA, Change Control, FDA, Quality System, Quality Control, Quality Assurance, 21 CFR Part 11, LIMS, GLP, Sop, Process Improvement, Software Documentation, SOP, V&V
Education
Montclair State University 1981 — 1991
Bachelor of Science (B.S.), Biology, General
Becton Dickinson QA SpecialistBecton DickinsonAugust 2010 - Present
Novartis Vaccines and Diagnostics November 2009 - August 2010
Catalent 2008 - 2009
Covidien 2004 - 2007
GSK 1993 - 2003
Skills
cGMP, GMP, Validation, Quality Systems, CAPA, Change Control, FDA, Quality System, Quality Control, Quality Assurance, 21 CFR Part 11, LIMS, GLP, Sop, Process Improvement, Software Documentation, SOP, V&V
Education
Montclair State University 1981 — 1991
Bachelor of Science (B.S.), Biology, General
Jennifer Wolfson Jennifer Wolfson's Catalent Experience August 2009 - September 2011
Job Life Sciences Attorney at Axiom
Industry Legal Services
Experience
Axiom May 2014 - Present
Infosys BPO January 2014 - May 2014
Bayne Law Group LLC May 2013 - January 2014
US Tech Solutions September 2012 - May 2013
Agennix September 2011 - September 2012
Catalent August 2009 - September 2011
Various October 2007 - August 2009
Arbinet May 2006 - October 2007
Skills
Legal Writing, Legal Research, Contract Negotiation, Negotiation, Contract Management, Licensing, Research, Telecommunications, PowerPoint, Leadership, Management, Customer Service, Analysis, Document Review, Healthcare Information..., Information Technology
Education
Seton Hall University School of Law 1999 — 2001
Juris Doctor, Law
SHEPHERD COLLEGE 1991 — 1996
BA, Cum Laude English Literature
Axiom May 2014 - Present
Infosys BPO January 2014 - May 2014
Bayne Law Group LLC May 2013 - January 2014
US Tech Solutions September 2012 - May 2013
Agennix September 2011 - September 2012
Catalent August 2009 - September 2011
Various October 2007 - August 2009
Arbinet May 2006 - October 2007
Skills
Legal Writing, Legal Research, Contract Negotiation, Negotiation, Contract Management, Licensing, Research, Telecommunications, PowerPoint, Leadership, Management, Customer Service, Analysis, Document Review, Healthcare Information..., Information Technology
Education
Seton Hall University School of Law 1999 — 2001
Juris Doctor, Law
SHEPHERD COLLEGE 1991 — 1996
BA, Cum Laude English Literature
Kevin Tilley Kevin Tilley's Catalent Experience February 2009 - May 2011
Job Packaging Consultant at Berlin Packaging
Industry Packaging and Containers
Experience
Berlin Packaging 2014 - Present
MeadWestvaco November 2013 - 2014
MeadWestvaco September 2012 - 2013
Clondalkin Pharma & Healthcare April 2011 - September 2012
Catalent February 2009 - May 2011
MeadWestvaco 2003 - 2009
Key Bank 1987 - 1995
Skills
Folding Cartons, Packaging, New Business Development, Account Management, Key Account Management, Product Development, Sales Management, Cross-functional Team..., B2B, Negotiation, Marketing Strategy, Pricing
Education
Allegheny College 1983 — 1987
BS, Economics
Berlin Packaging 2014 - Present
MeadWestvaco November 2013 - 2014
MeadWestvaco September 2012 - 2013
Clondalkin Pharma & Healthcare April 2011 - September 2012
Catalent February 2009 - May 2011
MeadWestvaco 2003 - 2009
Key Bank 1987 - 1995
Skills
Folding Cartons, Packaging, New Business Development, Account Management, Key Account Management, Product Development, Sales Management, Cross-functional Team..., B2B, Negotiation, Marketing Strategy, Pricing
Education
Allegheny College 1983 — 1987
BS, Economics
Sharon Granger Sharon Granger's Catalent Experience February 2008 - Present
Job Sr. QA Release Analyst at Catalent
Industry Pharmaceuticals
Experience
Catalent February 2008 - Present
Catalent Pharma Solutions 2000 - Present
Cardinal Health 2000 - Present
R. P. Scherer, North America (Florida Division) 2000 - Present
Ribozyme Pharmaceuticals January 1998 - June 1998
Mentor H.S. January 1997 - November 1997
Medeva Pharmaceuticals ( Adams Labs) April 1996 - January 1997
Allergan 1991 - 1994
Marathon Power Technologies 1988 - 1991
Skills
Documentation, Quality Assurance, Trackwise, LIMS, JDEdwards, workday, Software Documentation, HPLC, Six Sigma, Workday, GMP, V&V, JD Edwards, FDA, Sop, Validation, GxP, CAPA, Pharmaceutical Industry, SOP, TrackWise
Education
Henderson State University 1980 — 1985
BS, Biology/Chemistry
Catalent February 2008 - Present
Catalent Pharma Solutions 2000 - Present
Cardinal Health 2000 - Present
R. P. Scherer, North America (Florida Division) 2000 - Present
Ribozyme Pharmaceuticals January 1998 - June 1998
Mentor H.S. January 1997 - November 1997
Medeva Pharmaceuticals ( Adams Labs) April 1996 - January 1997
Allergan 1991 - 1994
Marathon Power Technologies 1988 - 1991
Skills
Documentation, Quality Assurance, Trackwise, LIMS, JDEdwards, workday, Software Documentation, HPLC, Six Sigma, Workday, GMP, V&V, JD Edwards, FDA, Sop, Validation, GxP, CAPA, Pharmaceutical Industry, SOP, TrackWise
Education
Henderson State University 1980 — 1985
BS, Biology/Chemistry
Kirk LaTorre Kirk LaTorre's Catalent Experience 2008 - 2009
Job Supply Chain Manager at PCI Packaging Coordinators Inc
Industry Pharmaceuticals
Experience
PCI - Packaging Coordinators Inc August 2014 - Present
QPSI August 2012 - October 2014
Catalent Pharma Solutions 2009 - 2012
Catalent 2008 - 2009
Catalent Pharma Solutions 2004 - 2008
Catalent Pharma Solutions 2002 - 2004
Lord & Taylor 1998 - 2002
InterMetro Industries Corporation (an Emerson Storage Solutions company) 1993 - 1998
BAE Systems 1987 - 1993
Skills
Inventory Control, Warehousing, Continuous Improvement, Shipping, Budgeting, Process Development, Material Handling, Lean Initiatives, 5S, Customer Focus, Employee Engagement
Education
Penn State University
Bachelor of Science (BS), Industrial Engineering
PCI - Packaging Coordinators Inc August 2014 - Present
QPSI August 2012 - October 2014
Catalent Pharma Solutions 2009 - 2012
Catalent 2008 - 2009
Catalent Pharma Solutions 2004 - 2008
Catalent Pharma Solutions 2002 - 2004
Lord & Taylor 1998 - 2002
InterMetro Industries Corporation (an Emerson Storage Solutions company) 1993 - 1998
BAE Systems 1987 - 1993
Skills
Inventory Control, Warehousing, Continuous Improvement, Shipping, Budgeting, Process Development, Material Handling, Lean Initiatives, 5S, Customer Focus, Employee Engagement
Education
Penn State University
Bachelor of Science (BS), Industrial Engineering
Harry Weininger Harry Weininger's Catalent Experience November 2005 - July 2011
Job Non Management Director at Beefeaters Holding Company
Industry Pharmaceuticals
Experience
Beefeaters Holding Company December 2011 - Present
Catalent November 2005 - July 2011
Catalent Pharma Solutions, Inc. 2005 - June 2011
Catalent Pharma Solutions (formerly Cardinal Health) 2004 - 2007
Campbell Soup Company 1997 - 2004
Pepsico 1990 - 1996
Skills
Succession Planning, Organizational Design, Deferred Compensation, Talent Management, Leadership Development, Onboarding, Executive Coaching, Workforce Planning, Change Management, Coaching, Culture Change, Leadership, Employee Engagement, Human Resources, HRIS, Labor Relations, Talent Acquisition, Organizational..., HR Transformation, Performance Management, HR Policies, Personnel Management, Employee Relations, HR Consulting, Recruiting, Employee Benefits
Education
Northwestern University
University of Michigan
The University of Western Ontario 1987 — 1987
MHR, Executive Management: Human Resources
The University of British Columbia 1970 — 1975
BComm, Organizational Development/Labor Relations
Beefeaters Holding Company December 2011 - Present
Catalent November 2005 - July 2011
Catalent Pharma Solutions, Inc. 2005 - June 2011
Catalent Pharma Solutions (formerly Cardinal Health) 2004 - 2007
Campbell Soup Company 1997 - 2004
Pepsico 1990 - 1996
Skills
Succession Planning, Organizational Design, Deferred Compensation, Talent Management, Leadership Development, Onboarding, Executive Coaching, Workforce Planning, Change Management, Coaching, Culture Change, Leadership, Employee Engagement, Human Resources, HRIS, Labor Relations, Talent Acquisition, Organizational..., HR Transformation, Performance Management, HR Policies, Personnel Management, Employee Relations, HR Consulting, Recruiting, Employee Benefits
Education
Northwestern University
University of Michigan
The University of Western Ontario 1987 — 1987
MHR, Executive Management: Human Resources
The University of British Columbia 1970 — 1975
BComm, Organizational Development/Labor Relations
Ryan Steele Ryan Steele's Catalent Experience January 2013 - Present
Job HR Director, HR Business Partner at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent January 2013 - Present
Catalent June 2011 - January 2013
Burger King Corporation October 2007 - September 2010
Burger King Corporation July 2005 - October 2007
Aggregate Industries February 2004 - July 2005
Pepsi Bottling Group September 2001 - February 2004
Pepsi Bottling Group November 1998 - September 2001
Lockheed Martin April 1996 - November 1998
Lockheed Martin June 1995 - July 1996
Skills
Labor Relations, Human Resources, HR Consulting, Succession Planning, Employee Relations, Talent Management, Performance Management
Education
Cornell University 1993 — 1995
Masters, Industrial and Labor Relations
Penn State University 1989 — 1993
Bachelor of Science, Labor and Industrial Relations
Catalent January 2013 - Present
Catalent June 2011 - January 2013
Burger King Corporation October 2007 - September 2010
Burger King Corporation July 2005 - October 2007
Aggregate Industries February 2004 - July 2005
Pepsi Bottling Group September 2001 - February 2004
Pepsi Bottling Group November 1998 - September 2001
Lockheed Martin April 1996 - November 1998
Lockheed Martin June 1995 - July 1996
Skills
Labor Relations, Human Resources, HR Consulting, Succession Planning, Employee Relations, Talent Management, Performance Management
Education
Cornell University 1993 — 1995
Masters, Industrial and Labor Relations
Penn State University 1989 — 1993
Bachelor of Science, Labor and Industrial Relations
Damjan Daskaloski Damjan Daskaloski's Catalent Experience May 2006 - July 2008
Job General Manager at DASKAL
Industry Design
Experience
DASKAL January 2010 - Present
TMZHosting.com November 2007 - Present
G-RAF Fashion May 2011 - Present
APS Contractors Inc. February 2010 - March 2011
Stryker Orthopaedics March 2009 - February 2011
Catalent May 2006 - July 2008
Skills
Product Development, Manufacturing, Six Sigma, Quality Assurance, Project Management, Engineering, R&D, Cross-functional Team..., Continuous Improvement, Process Engineering, Medical Devices, Project Planning, Process Improvement, Lean Manufacturing, Quality System, Product Management, Start-ups, Analysis, Budgets, Business Development, Business Planning, Business Strategy, Entrepreneurship, Leadership, Management, Quality Management, Strategic Planning, Strategy, Supply Chain Management, Team Building, Team Leadership, Troubleshooting, Validation
Education
Rutgers Business School 2012 — 2015
MBA
Rutgers, The State University of New Jersey-New Brunswick 2003 — 2008
Mechanical Aerospace Engineer
DASKAL January 2010 - Present
TMZHosting.com November 2007 - Present
G-RAF Fashion May 2011 - Present
APS Contractors Inc. February 2010 - March 2011
Stryker Orthopaedics March 2009 - February 2011
Catalent May 2006 - July 2008
Skills
Product Development, Manufacturing, Six Sigma, Quality Assurance, Project Management, Engineering, R&D, Cross-functional Team..., Continuous Improvement, Process Engineering, Medical Devices, Project Planning, Process Improvement, Lean Manufacturing, Quality System, Product Management, Start-ups, Analysis, Budgets, Business Development, Business Planning, Business Strategy, Entrepreneurship, Leadership, Management, Quality Management, Strategic Planning, Strategy, Supply Chain Management, Team Building, Team Leadership, Troubleshooting, Validation
Education
Rutgers Business School 2012 — 2015
MBA
Rutgers, The State University of New Jersey-New Brunswick 2003 — 2008
Mechanical Aerospace Engineer
Katrina Travis Katrina Travis's Catalent Experience 2003 - 2005
Job Quality Assurance Director who drives a quality culture by managing and implementing solid GxP Quality Systems
Industry Consumer Goods
Experience
Envisia Therapeutics / Liquidia Technologies 2014 - 2015
Impact Fulfillment Services 2011 - 2014
CATALENT PHARMA SOLUTIONS (previously Cardinal Health) 2007 - 2011
Compuchem Labs 2005 - 2007
Catalent 2003 - 2005
Dynea 2002 - 2003
Compuchem Labs 1998 - 2002
American Environmental Network 1990 - 1998
Skills
GMP, Quality Assurance, Six Sigma, FDA, Sop, Process Improvement, CAPA, Analytical Chemistry, Continuous Improvement, HPLC, Quality Control, Change Control, Manufacturing, Chemistry, Validation, ISO, Quality System, SOP
Education
Barton College 1986 — 1990
BS, Chemistry, Math
Envisia Therapeutics / Liquidia Technologies 2014 - 2015
Impact Fulfillment Services 2011 - 2014
CATALENT PHARMA SOLUTIONS (previously Cardinal Health) 2007 - 2011
Compuchem Labs 2005 - 2007
Catalent 2003 - 2005
Dynea 2002 - 2003
Compuchem Labs 1998 - 2002
American Environmental Network 1990 - 1998
Skills
GMP, Quality Assurance, Six Sigma, FDA, Sop, Process Improvement, CAPA, Analytical Chemistry, Continuous Improvement, HPLC, Quality Control, Change Control, Manufacturing, Chemistry, Validation, ISO, Quality System, SOP
Education
Barton College 1986 — 1990
BS, Chemistry, Math
Elizabeth Benjamin Elizabeth Benjamin's Catalent Experience June 2008 - August 2008
Job Process Engineer at Kellogg Company
Industry Consumer Goods
Experience
Kellogg Company August 2011 - Present
Colgate-Palmolive Co. May 2009 - July 2011
Catalent June 2008 - August 2008
Skills
GMP, Validation, SAP, Documentation, Process Engineering, Process Improvement, Sop, Quality System, Manufacturing, Software Documentation, Continuous Improvement, Chemical Engineering, Process Simulation, Design of Experiments, R&D, Engineering
Education
Michigan State University 2004 — 2009
BS, Chemical Engineering
Kellogg Company August 2011 - Present
Colgate-Palmolive Co. May 2009 - July 2011
Catalent June 2008 - August 2008
Skills
GMP, Validation, SAP, Documentation, Process Engineering, Process Improvement, Sop, Quality System, Manufacturing, Software Documentation, Continuous Improvement, Chemical Engineering, Process Simulation, Design of Experiments, R&D, Engineering
Education
Michigan State University 2004 — 2009
BS, Chemical Engineering
Reena Zachariah Reena Zachariah's Catalent Experience September 2008 - January 2010
Job Validation Specialist at Irvine Scientific
Industry Medical Devices
Experience
Irvine Scientific May 2010 - Present
Catalent September 2008 - January 2010
GMP Contractors, LLC January 2004 - September 2008
Skills
21 CFR Part 11, Aseptic Processing, Biopharmaceuticals, Biotechnology, CAPA, Change Control, Cleaning Validation, Computer System..., Cross-functional Team..., Design Control, FDA, GLP, GMP, GxP, ISO 13485, Lifesciences, Manufacturing, Medical Devices, Product Launch, Pharmaceutical Industry, Quality Assurance, Quality Control, Quality System, Sop, Technology Transfer, V&V, Validation, SOP
Education
Drexel University 1998 — 2003
B.S., Chemical Engineering
Irvine Scientific May 2010 - Present
Catalent September 2008 - January 2010
GMP Contractors, LLC January 2004 - September 2008
Skills
21 CFR Part 11, Aseptic Processing, Biopharmaceuticals, Biotechnology, CAPA, Change Control, Cleaning Validation, Computer System..., Cross-functional Team..., Design Control, FDA, GLP, GMP, GxP, ISO 13485, Lifesciences, Manufacturing, Medical Devices, Product Launch, Pharmaceutical Industry, Quality Assurance, Quality Control, Quality System, Sop, Technology Transfer, V&V, Validation, SOP
Education
Drexel University 1998 — 2003
B.S., Chemical Engineering
Scott Houlton Scott Houlton's Catalent Experience August 2009 - Present
Job President, Development and Clinical Services at Catalent
Industry Pharmaceuticals
Experience
Catalent August 2009 - Present
Aptuit February 2007 - January 2009
Aptuit September 2005 - February 2007
Quintiles June 2000 - September 2005
Quintiles January 1998 - June 2000
Cardinal Health January 1992 - December 1997
General Electric December 1988 - December 1991
Skills
Global Management, M&A experience, Biopharmaceuticals, Clinical Trials, Drug Development, Acquisition Integration, Contract Manufacturing, Strategic Planning, Financial Analysis, China, Private Equity, Pharmaceutical Industry, Mergers & Acquisitions, Change Management, Mergers, Six Sigma, P&L Management, Operational Excellence, New Business Development, FDA, R&D, Commercialization, Regulatory Affairs, CRO, Strategy, GMP, Technology Transfer, CRM, Cross-functional Team...
Education
The Ohio State University 1984 — 1988
Bachelor's Degree, Finance and International Business, Cum Laude
Catalent August 2009 - Present
Aptuit February 2007 - January 2009
Aptuit September 2005 - February 2007
Quintiles June 2000 - September 2005
Quintiles January 1998 - June 2000
Cardinal Health January 1992 - December 1997
General Electric December 1988 - December 1991
Skills
Global Management, M&A experience, Biopharmaceuticals, Clinical Trials, Drug Development, Acquisition Integration, Contract Manufacturing, Strategic Planning, Financial Analysis, China, Private Equity, Pharmaceutical Industry, Mergers & Acquisitions, Change Management, Mergers, Six Sigma, P&L Management, Operational Excellence, New Business Development, FDA, R&D, Commercialization, Regulatory Affairs, CRO, Strategy, GMP, Technology Transfer, CRM, Cross-functional Team...
Education
The Ohio State University 1984 — 1988
Bachelor's Degree, Finance and International Business, Cum Laude
Harry Cocolas Harry Cocolas's Catalent Experience June 2009 - Present
Job Technical Director at Catalent
Industry Pharmaceuticals
Experience
Catalent June 2009 - Present
Bayer HealthCare 2000 - 2008
Wyeth Consumer 1993 - 2000
Skills
Pharmaceutical Industry, Technology Transfer, GMP, Validation, Sop, Formulation, Product Development, CAPA, Quality Assurance, 21 CFR Part 11, Clinical Development, Change Control, Cross-functional Team..., Regulatory Affairs
Education
Rutgers University-New Brunswick 1989 — 1993
Ph.D., Pharmaceutical Sciences
Rutgers University-New Brunswick 1985 — 1989
MS, Pharmaceutical Sciences
University of North Carolina at Chapel Hill 1976 — 1981
BS, Pharmacy
Catalent June 2009 - Present
Bayer HealthCare 2000 - 2008
Wyeth Consumer 1993 - 2000
Skills
Pharmaceutical Industry, Technology Transfer, GMP, Validation, Sop, Formulation, Product Development, CAPA, Quality Assurance, 21 CFR Part 11, Clinical Development, Change Control, Cross-functional Team..., Regulatory Affairs
Education
Rutgers University-New Brunswick 1989 — 1993
Ph.D., Pharmaceutical Sciences
Rutgers University-New Brunswick 1985 — 1989
MS, Pharmaceutical Sciences
University of North Carolina at Chapel Hill 1976 — 1981
BS, Pharmacy
Debra Purrington Debra Purrington's Catalent Experience August 2008 - January 2010
Job Senior Business Process Management Specialist for the Defense Health Agency, Health Information Technology (DHAHIT)
Industry Information Technology and Services
Experience
Defense Health Agency (DHA) November 2012 - Present
TIAG January 2010 - November 2012
Catalent August 2008 - January 2010
Merck 2001 - 2008
Visible Genetics 1998 - 2001
Amersham 1996 - 1998
Life Technologies 1994 - 1996
Clontech 1993 - 1994
Molecular Oncology 1992 - 1993
FDA 1991 - 1992
Skills
Program Management, PMP, Six Sigma, MBA, Project Management, Business Development, Sales, Government, Cross-functional Team..., Pharmaceutical Industry, Leadership, Medical Devices, Healthcare, Process Improvement, Biotechnology, Strategic Planning, Lifesciences, Project Planning, Training, Change Management, Business Analysis, Team Building, Contract Negotiation, Technical Writing, SharePoint, Proposal Writing, Management
Education
The Johns Hopkins University - Carey Business School 1998 — 2001
MBA, concentration Marketing and Management
Bucknell University 1986 — 1990
BS, Biology, minors: Chemistry and Education
Defense Health Agency (DHA) November 2012 - Present
TIAG January 2010 - November 2012
Catalent August 2008 - January 2010
Merck 2001 - 2008
Visible Genetics 1998 - 2001
Amersham 1996 - 1998
Life Technologies 1994 - 1996
Clontech 1993 - 1994
Molecular Oncology 1992 - 1993
FDA 1991 - 1992
Skills
Program Management, PMP, Six Sigma, MBA, Project Management, Business Development, Sales, Government, Cross-functional Team..., Pharmaceutical Industry, Leadership, Medical Devices, Healthcare, Process Improvement, Biotechnology, Strategic Planning, Lifesciences, Project Planning, Training, Change Management, Business Analysis, Team Building, Contract Negotiation, Technical Writing, SharePoint, Proposal Writing, Management
Education
The Johns Hopkins University - Carey Business School 1998 — 2001
MBA, concentration Marketing and Management
Bucknell University 1986 — 1990
BS, Biology, minors: Chemistry and Education
Coleen Burke Coleen Burke's Catalent Experience April 2007 - October 2007
Job Sr. Manager, QA at Fujifilm Diosynth Biotechnologies
Industry Pharmaceuticals
Experience
Fujifilm Diosynth Biotechnologies May 2013 - Present
Fujifilm Diosynth Biotechnologies October 2009 - May 2013
Diosynth October 2007 - October 2009
Catalent April 2007 - October 2007
Cardinal Health 2004 - 2007
Magellan Laboratories 1998 - 2004
O'Brien & Gere April 1989 - July 1998
Nanco Laboratories 1987 - 1989
Skills
FDA, Biotechnology, Software Documentation, Cleaning Validation, GMP, Validation, Medical Devices, Quality System, Quality Assurance, 21 CFR Part 11, Pharmaceutical Industry, Sop, HPLC, CAPA, GLP, V&V, Change Control, Biopharmaceuticals, Technology Transfer, Analytical Chemistry, Quality Auditing, Chemistry, Process Improvement, LIMS
Education
State University of New York College at Geneseo 1983 — 1987
BA, Mathematics
Fujifilm Diosynth Biotechnologies May 2013 - Present
Fujifilm Diosynth Biotechnologies October 2009 - May 2013
Diosynth October 2007 - October 2009
Catalent April 2007 - October 2007
Cardinal Health 2004 - 2007
Magellan Laboratories 1998 - 2004
O'Brien & Gere April 1989 - July 1998
Nanco Laboratories 1987 - 1989
Skills
FDA, Biotechnology, Software Documentation, Cleaning Validation, GMP, Validation, Medical Devices, Quality System, Quality Assurance, 21 CFR Part 11, Pharmaceutical Industry, Sop, HPLC, CAPA, GLP, V&V, Change Control, Biopharmaceuticals, Technology Transfer, Analytical Chemistry, Quality Auditing, Chemistry, Process Improvement, LIMS
Education
State University of New York College at Geneseo 1983 — 1987
BA, Mathematics
David Rain David Rain's Catalent Experience November 1998 - June 2013
Job Manager Manufacturing Systems at Catalent
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions June 2013 - Present
Catalent November 1998 - June 2013
Cardinal Health December 2000 - December 2006
RP Scherer November 1998 - December 2000
Cabot Corporation January 1990 - November 1998
USG October 1986 - December 1989
Oce Printing Systems March 1986 - October 1986
Daseke & Co. January 1986 - March 1986
Omicron Consulting January 1984 - January 1986
Skills
21 CFR Part 11, Change Control, Validation, FDA, Quality System, Computer System..., Cross-functional Team..., Pharmaceutical Industry, MES, GxP, Sop, CAPA, GMP, GAMP, V&V, Six Sigma, Process Improvement, SOP
Education
State University of New York College at Oswego 1980 — 1983
BS, Meteorology, Minor Computer Science
Hudson Valley Community College 1979 — 1980
Catalent Pharma Solutions June 2013 - Present
Catalent November 1998 - June 2013
Cardinal Health December 2000 - December 2006
RP Scherer November 1998 - December 2000
Cabot Corporation January 1990 - November 1998
USG October 1986 - December 1989
Oce Printing Systems March 1986 - October 1986
Daseke & Co. January 1986 - March 1986
Omicron Consulting January 1984 - January 1986
Skills
21 CFR Part 11, Change Control, Validation, FDA, Quality System, Computer System..., Cross-functional Team..., Pharmaceutical Industry, MES, GxP, Sop, CAPA, GMP, GAMP, V&V, Six Sigma, Process Improvement, SOP
Education
State University of New York College at Oswego 1980 — 1983
BS, Meteorology, Minor Computer Science
Hudson Valley Community College 1979 — 1980
Jamie Magnuson Jamie Magnuson's Catalent Experience July 2005 - September 2007
Job Sr. Associate Director, Third Party Manufacturing Quality Organization at BIVI
Industry Pharmaceuticals
Experience
Boehringer Ingelheim January 2015 - Present
Novartis May 2010 - January 2015
Sirion Therapeutics September 2007 - February 2010
Catalent July 2005 - September 2007
Novartis October 1997 - June 2005
Skills
FDA, Pharmaceutical Industry, Quality Assurance, Change Control, Technology Transfer, HPLC, Quality Control, Pharmaceutics, Trackwise, Manufacturing, Validation, GMP, Quality System, Contract Manufacturing, Clinical Research, V&V, GxP, CAPA, Sop, QAQC, FDA GMP, Supply Chain Management, SOP, TrackWise
Education
Nebraska Wesleyan University 1992 — 1996
Bachelor of Science (BS), Biology, General
Boehringer Ingelheim January 2015 - Present
Novartis May 2010 - January 2015
Sirion Therapeutics September 2007 - February 2010
Catalent July 2005 - September 2007
Novartis October 1997 - June 2005
Skills
FDA, Pharmaceutical Industry, Quality Assurance, Change Control, Technology Transfer, HPLC, Quality Control, Pharmaceutics, Trackwise, Manufacturing, Validation, GMP, Quality System, Contract Manufacturing, Clinical Research, V&V, GxP, CAPA, Sop, QAQC, FDA GMP, Supply Chain Management, SOP, TrackWise
Education
Nebraska Wesleyan University 1992 — 1996
Bachelor of Science (BS), Biology, General
Dawn (Eggler) Irons Dawn (Eggler) Irons's Catalent Experience 2005 - 2008
Job Systems Engineer at EMC
Industry Information Technology and Services
Experience
EMC August 2015 - Present
CSC March 2013 - August 2015
Emerson Process Management April 2011 - March 2013
Emerson Process Management January 2008 - April 2011
Catalent 2005 - 2008
Centocor 2005 - 2005
GlaxoSmithKline 2002 - 2005
GlaxoSmithKline 2001 - 2002
Skills
GMP, MES, Quality Assurance, Operational Excellence, GAMP, CAPA, Pharmaceutical Industry, Software Project..., Document Management, Biopharmaceuticals, Analysis, Software Development, Change Control, 21 CFR Part 11, Lifesciences
Education
Saint Joseph's University 2014 — 2016
Master of Science (MS), Business Intelligence & Analytics
Pennsylvania State University- University Park 1996 — 2000
Bachelor of Science (BS), Biochemistry and Molecular Biology
EMC August 2015 - Present
CSC March 2013 - August 2015
Emerson Process Management April 2011 - March 2013
Emerson Process Management January 2008 - April 2011
Catalent 2005 - 2008
Centocor 2005 - 2005
GlaxoSmithKline 2002 - 2005
GlaxoSmithKline 2001 - 2002
Skills
GMP, MES, Quality Assurance, Operational Excellence, GAMP, CAPA, Pharmaceutical Industry, Software Project..., Document Management, Biopharmaceuticals, Analysis, Software Development, Change Control, 21 CFR Part 11, Lifesciences
Education
Saint Joseph's University 2014 — 2016
Master of Science (MS), Business Intelligence & Analytics
Pennsylvania State University- University Park 1996 — 2000
Bachelor of Science (BS), Biochemistry and Molecular Biology
Timothy Shawn Conver, Ph.D., PMP Timothy Shawn Conver, Ph.D., PMP's Catalent Experience 2001 - 2006
Job Senior Manager at Cognizant Technology Solutions
Industry Pharmaceuticals
Experience
Pfizer March 2010 - September 2011
Pfizer BioTherapeutics R&D December 2009 - March 2010
Pfizer BioTherapeutics R&D October 2009 - December 2009
Wyeth Research October 2006 - October 2009
Catalent 2001 - 2006
Cardinal Health 2001 - 2006
Cardinal Health, PTS (formerly Magellan Laboratories) 2001 - 2006
Magellan Laboratories 2000 - 2001
Skills
CA Claris PM Software, SAP, Ariba, MS Project, Vendor Management, Contract Negotiations, Manufacturing, Vaccines, cGMP, Budgeting, Validation, Pharmaceuticals, Analytical Chemistry, 21 CFR Part 11, Cross-functional Team..., Documentation, Change Management, Project Planning, Visio, HP Quality Center V10, Software Documentation
Education
Southern Illinois University, Carbondale 1991 — 1996
PhD, Chemistry
Truman State University 1986 — 1991
BS, Chemistry
Pfizer March 2010 - September 2011
Pfizer BioTherapeutics R&D December 2009 - March 2010
Pfizer BioTherapeutics R&D October 2009 - December 2009
Wyeth Research October 2006 - October 2009
Catalent 2001 - 2006
Cardinal Health 2001 - 2006
Cardinal Health, PTS (formerly Magellan Laboratories) 2001 - 2006
Magellan Laboratories 2000 - 2001
Skills
CA Claris PM Software, SAP, Ariba, MS Project, Vendor Management, Contract Negotiations, Manufacturing, Vaccines, cGMP, Budgeting, Validation, Pharmaceuticals, Analytical Chemistry, 21 CFR Part 11, Cross-functional Team..., Documentation, Change Management, Project Planning, Visio, HP Quality Center V10, Software Documentation
Education
Southern Illinois University, Carbondale 1991 — 1996
PhD, Chemistry
Truman State University 1986 — 1991
BS, Chemistry
Rick Kueller's Catalent Experience 2007 - 2012
Job VP Operations at Pfanstiehl, Inc
Industry Pharmaceuticals
Experience
Pfanstiehl, Inc June 2013 - Present
Perflow Consulting October 2012 - June 2013
Catalent Pharma Solutions August 1998 - June 2012
Catalent Pharma Solutions December 2010 - March 2012
Catalent 2007 - 2012
Cardinal Health August 1998 - August 2004
Dow Chemical July 1989 - June 1998
The Dow Chemical Company (DowBrands) 1989 - 1998
Dow Chemical - GmbH May 1986 - June 1987
Skills
CAPA, GMP, FDA, Quality System, Operational Excellence, Six Sigma, Contract Manufacturing, Pharmaceutical Industry, Sop, Lean Manufacturing, Continuous Improvement, Aseptic Processing, Black Belt, Process Improvement, Cross-functional Team..., Leadership, Technology Transfer, Manufacturing, Change Management, Product Development, Strategy, Kaizen, Supply Chain, DMAIC, Root Cause Analysis, Quality Management, Manufacturing Operations, Value Stream Mapping, SOP
Education
The Ohio State University 1987 — 1989
MS, Chemical Engineering
Iowa State University 1983 — 1985
BS, Chemical Engineering
Pfanstiehl, Inc June 2013 - Present
Perflow Consulting October 2012 - June 2013
Catalent Pharma Solutions August 1998 - June 2012
Catalent Pharma Solutions December 2010 - March 2012
Catalent 2007 - 2012
Cardinal Health August 1998 - August 2004
Dow Chemical July 1989 - June 1998
The Dow Chemical Company (DowBrands) 1989 - 1998
Dow Chemical - GmbH May 1986 - June 1987
Skills
CAPA, GMP, FDA, Quality System, Operational Excellence, Six Sigma, Contract Manufacturing, Pharmaceutical Industry, Sop, Lean Manufacturing, Continuous Improvement, Aseptic Processing, Black Belt, Process Improvement, Cross-functional Team..., Leadership, Technology Transfer, Manufacturing, Change Management, Product Development, Strategy, Kaizen, Supply Chain, DMAIC, Root Cause Analysis, Quality Management, Manufacturing Operations, Value Stream Mapping, SOP
Education
The Ohio State University 1987 — 1989
MS, Chemical Engineering
Iowa State University 1983 — 1985
BS, Chemical Engineering
Firouz Asgarzadeh Firouz Asgarzadeh's Catalent Experience November 2002 - August 2007
Job Director of Technical Services at Evonik Corporation
Industry Pharmaceuticals
Experience
Evonik Corporation February 2010 - Present
Merck August 2007 - February 2010
Catalent November 2002 - August 2007
Alkermes April 2001 - September 2002
University of Pennsylvania January 2000 - February 2001
Skills
Pharmaceutics, Characterization, Polymers, Coatings, Drug Delivery, Chemistry, Extrusion, Formulation, HPLC, Materials Science, Pharmaceutical Industry, Polymer Chemistry, R&D, Biopharmaceuticals, GMP, Medical Devices, Technology Transfer
Education
Université Claude Bernard Lyon 1 1996 — 1999
Ph.D., Polymeric Materials and Composites
Université Louis Pasteur (Strasbourg I) 1995 — 1996
M.Sc. (DEA), Physical Chemistry of Molecular and Macromolecular Materials
Amirkabir University of Technology - Tehran Polytechnic 1992 — 1994
M.Sc., Polymer Technology and Industry
Amirkabir University of Technology - Tehran Polytechnic 1987 — 1991
B.Sc., Polymer Technology and Industry
Evonik Corporation February 2010 - Present
Merck August 2007 - February 2010
Catalent November 2002 - August 2007
Alkermes April 2001 - September 2002
University of Pennsylvania January 2000 - February 2001
Skills
Pharmaceutics, Characterization, Polymers, Coatings, Drug Delivery, Chemistry, Extrusion, Formulation, HPLC, Materials Science, Pharmaceutical Industry, Polymer Chemistry, R&D, Biopharmaceuticals, GMP, Medical Devices, Technology Transfer
Education
Université Claude Bernard Lyon 1 1996 — 1999
Ph.D., Polymeric Materials and Composites
Université Louis Pasteur (Strasbourg I) 1995 — 1996
M.Sc. (DEA), Physical Chemistry of Molecular and Macromolecular Materials
Amirkabir University of Technology - Tehran Polytechnic 1992 — 1994
M.Sc., Polymer Technology and Industry
Amirkabir University of Technology - Tehran Polytechnic 1987 — 1991
B.Sc., Polymer Technology and Industry
Charles Silvey's Catalent Experience April 2008 - Present
Job Vice President Internal Audit at Catalent
Industry Pharmaceuticals
Experience
Catalent April 2008 - Present
Jefferson Wells September 2007 - April 2008
Cambrex 2004 - 2007
ADP 2002 - 2004
Lucent Technologies 1997 - 2002
CR Bard inc. 1995 - 1998
KPMG Peat Marwick 1990 - 1995
Skills
SOX, Internal Audit, Compliance, Internal Controls, Audit, Auditing, Risk, Risk Assessment, Sarbanes-Oxley, Financial Risk, Risk Management, Sarbanes-Oxley Act, Financial Reporting, Enterprise Risk..., SEC filings, Strategy, Analysis, Accounting, Forecasting, Governance, Budgets, Business Process..., Corporate Finance, Human Resources, Training, Management, Executive Management
Education
Monmouth University 1987 — 1991
BS, Business
Monmouth University 1985 — 1991
Cranford High School 1974 — 1976
HS
Brookside School, Cranford NJ
Catalent April 2008 - Present
Jefferson Wells September 2007 - April 2008
Cambrex 2004 - 2007
ADP 2002 - 2004
Lucent Technologies 1997 - 2002
CR Bard inc. 1995 - 1998
KPMG Peat Marwick 1990 - 1995
Skills
SOX, Internal Audit, Compliance, Internal Controls, Audit, Auditing, Risk, Risk Assessment, Sarbanes-Oxley, Financial Risk, Risk Management, Sarbanes-Oxley Act, Financial Reporting, Enterprise Risk..., SEC filings, Strategy, Analysis, Accounting, Forecasting, Governance, Budgets, Business Process..., Corporate Finance, Human Resources, Training, Management, Executive Management
Education
Monmouth University 1987 — 1991
BS, Business
Monmouth University 1985 — 1991
Cranford High School 1974 — 1976
HS
Brookside School, Cranford NJ
Peter Sosalski Peter Sosalski's Catalent Experience August 2005 - December 2007
Job QA Specialist at Bracket
Industry Pharmaceuticals
Experience
Bracket January 2014 - Present
Sharp Clinical Services/Bilcare Global Clinical Supplies February 2011 - January 2014
Inteprod LLC August 2010 - March 2011
BioClinica September 2008 - August 2010
Merck May 2008 - October 2008
Lonza December 2007 - April 2008
Catalent August 2005 - December 2007
Lannett Company April 2003 - December 2004
Skills
Product Development, Manufacturing, Pharmaceutics, Testing, GMP, Sop, FDA, Pharmaceutical Industry, Validation, 21 CFR Part 11, Quality Assurance, GCP, Software Documentation, Data Management, Clinical Trials, Trackwise, R&D, Computer System..., CAPA, GxP, CRO, Change Control, Regulatory Affairs, V&V, Quality System, CTMS, Regulatory Submissions, Clinical Development, Clinical Data Management, Biopharmaceuticals, EDC, GLP, Cleaning Validation, Vaccines, Quality Auditing, Quality Control, Regulatory Requirements, Technology Transfer, Software Quality..., SOP
Education
Temple University 1997 — 2000
English, Education
Bracket January 2014 - Present
Sharp Clinical Services/Bilcare Global Clinical Supplies February 2011 - January 2014
Inteprod LLC August 2010 - March 2011
BioClinica September 2008 - August 2010
Merck May 2008 - October 2008
Lonza December 2007 - April 2008
Catalent August 2005 - December 2007
Lannett Company April 2003 - December 2004
Skills
Product Development, Manufacturing, Pharmaceutics, Testing, GMP, Sop, FDA, Pharmaceutical Industry, Validation, 21 CFR Part 11, Quality Assurance, GCP, Software Documentation, Data Management, Clinical Trials, Trackwise, R&D, Computer System..., CAPA, GxP, CRO, Change Control, Regulatory Affairs, V&V, Quality System, CTMS, Regulatory Submissions, Clinical Development, Clinical Data Management, Biopharmaceuticals, EDC, GLP, Cleaning Validation, Vaccines, Quality Auditing, Quality Control, Regulatory Requirements, Technology Transfer, Software Quality..., SOP
Education
Temple University 1997 — 2000
English, Education
Sarah Hauer, MBA Sarah Hauer, MBA's Catalent Experience September 2010 - December 2012
Job Vice President, Global Business Development at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions January 2013 - Present
Catalent September 2010 - December 2012
Catalent Pharma Solutions September 2006 - September 2010
Eli Lilly and Company April 2006 - September 2006
PII January 2003 - April 2006
Skills
Pharmaceutics, Biotechnology, Pharmaceutical Industry, Lifesciences, Technology Transfer, CRO, Biopharmaceuticals, Drug Development, Business Development, Clinical Development, CAPA
Education
Loyola College in Maryland 2011 — 2013
Master of Business Administration (MBA), EMBA
Washington College 1997 — 2001
BS, Neuroscience
Archbishop Spalding 1993 — 1997
Catalent Pharma Solutions January 2013 - Present
Catalent September 2010 - December 2012
Catalent Pharma Solutions September 2006 - September 2010
Eli Lilly and Company April 2006 - September 2006
PII January 2003 - April 2006
Skills
Pharmaceutics, Biotechnology, Pharmaceutical Industry, Lifesciences, Technology Transfer, CRO, Biopharmaceuticals, Drug Development, Business Development, Clinical Development, CAPA
Education
Loyola College in Maryland 2011 — 2013
Master of Business Administration (MBA), EMBA
Washington College 1997 — 2001
BS, Neuroscience
Archbishop Spalding 1993 — 1997
Linh Nguyenle, Ph.D. Linh Nguyenle, Ph.D.'s Catalent Experience July 2007 - July 2010
Job Director, Operations at Advantar Labs
Industry Pharmaceuticals
Experience
Advantar Labs July 2012 - Present
Advantar Labs September 2011 - July 2012
Advantar Labs / Teva Pharmaceuticals December 2010 - September 2011
Catalent July 2007 - July 2010
UCSC 1997 - 2004
Roche Bioscience June 1996 - September 1997
SRI International September 1990 - June 1996
Analytical Department in Life Sciences Division SRI International September 1990 - June 1996
John J. Harada June 1989 - March 1990
Laboratory of Reen Wu Veterinary Department March 1989 - June 1989
Skills
Project Management, Biotechnology, Protein Chemistry, Molecular Biology, GMP, Validation, DNA, Clinical Development, Genomics, Drug Delivery, Formulation, Laboratory, HPLC, Chromatography, GLP, Lifesciences, Technology Transfer
Education
University of California, Santa Cruz 1997 — 2004
Ph.D., Biochemistry
University of California, Davis 1986 — 1990
BS, Biochemistry
Advantar Labs July 2012 - Present
Advantar Labs September 2011 - July 2012
Advantar Labs / Teva Pharmaceuticals December 2010 - September 2011
Catalent July 2007 - July 2010
UCSC 1997 - 2004
Roche Bioscience June 1996 - September 1997
SRI International September 1990 - June 1996
Analytical Department in Life Sciences Division SRI International September 1990 - June 1996
John J. Harada June 1989 - March 1990
Laboratory of Reen Wu Veterinary Department March 1989 - June 1989
Skills
Project Management, Biotechnology, Protein Chemistry, Molecular Biology, GMP, Validation, DNA, Clinical Development, Genomics, Drug Delivery, Formulation, Laboratory, HPLC, Chromatography, GLP, Lifesciences, Technology Transfer
Education
University of California, Santa Cruz 1997 — 2004
Ph.D., Biochemistry
University of California, Davis 1986 — 1990
BS, Biochemistry
Gerald Logan's Catalent Experience November 2006 - June 2007
Job Manager Steriles South Operation
Industry Pharmaceuticals
Experience
Patheon May 2014 - Present
DSM June 2007 - May 2014
Catalent November 2006 - June 2007
Catalent Pharma Solutions 2006 - 2007
DSM November 2000 - November 2006
Skills
Lyophilization, GMP, SAP, Six Sigma, cGMP, Validation, CAPA, FDA, Root Cause Analysis, Aseptic Processing, Biotechnology, Quality System, Technology Transfer, V, V&V
Education
East Carolina University 2004 — 2009
BA, Management Information Systems
Patheon May 2014 - Present
DSM June 2007 - May 2014
Catalent November 2006 - June 2007
Catalent Pharma Solutions 2006 - 2007
DSM November 2000 - November 2006
Skills
Lyophilization, GMP, SAP, Six Sigma, cGMP, Validation, CAPA, FDA, Root Cause Analysis, Aseptic Processing, Biotechnology, Quality System, Technology Transfer, V, V&V
Education
East Carolina University 2004 — 2009
BA, Management Information Systems
Jay Moir Jay Moir's Catalent Experience September 2003 - May 2007
Job West Pharmaceutical Services
Industry Pharmaceuticals
Experience
West Pharmaceutical Services January 2014 - Present
West Pharmaceutical Services February 2011 - January 2014
West Pharmaceutical Services February 2011 - January 2014
Catalent Pharma Solutions May 2007 - May 2011
Catalent September 2003 - May 2007
Catalent April 2002 - September 2003
Lockheed Martin 1999 - 2002
Skills
5S, Business Process, CAPA, Change Management, Cross-functional Team..., ERP, FDA, GMP, Leadership, Lean Manufacturing, Master Scheduling, Operational Excellence, Pharmaceutical Industry, Process Improvement, Quality Assurance, Quality System, Root Cause Analysis, Six Sigma, Sop, Supply Chain Management, Validation
Education
University of Phoenix 2000 — 2002
Business Management
Middle Tennessee State University 1997 — 1999
General Education
West Pharmaceutical Services January 2014 - Present
West Pharmaceutical Services February 2011 - January 2014
West Pharmaceutical Services February 2011 - January 2014
Catalent Pharma Solutions May 2007 - May 2011
Catalent September 2003 - May 2007
Catalent April 2002 - September 2003
Lockheed Martin 1999 - 2002
Skills
5S, Business Process, CAPA, Change Management, Cross-functional Team..., ERP, FDA, GMP, Leadership, Lean Manufacturing, Master Scheduling, Operational Excellence, Pharmaceutical Industry, Process Improvement, Quality Assurance, Quality System, Root Cause Analysis, Six Sigma, Sop, Supply Chain Management, Validation
Education
University of Phoenix 2000 — 2002
Business Management
Middle Tennessee State University 1997 — 1999
General Education
Keshia Jones, MBA, PHR Keshia Jones, MBA, PHR's Catalent Experience 2007 - 2009
Job HR Systems & Data Professional at GSK
Industry Human Resources
Experience
GSK June 2015 - Present
GlaxoSmithKline May 2012 - Present
Revlon December 2010 - May 2012
Catalent 2007 - 2009
Nortel 2006 - 2007
Duke University 2004 - 2006
Mellon HR Solutions 1998 - 2004
Skills
HRIS, Employee Benefits, Deferred Compensation, Employee Relations, Performance Management, Human Resources, Benefits Administration, Onboarding, Training, PeopleSoft, Process Improvement
Education
Campbell University 2000 — 2003
MBA, Business Administration
North Carolina Agricultural and Technical State University 1988 — 1993
BS, Business Management
Hillside High
GSK June 2015 - Present
GlaxoSmithKline May 2012 - Present
Revlon December 2010 - May 2012
Catalent 2007 - 2009
Nortel 2006 - 2007
Duke University 2004 - 2006
Mellon HR Solutions 1998 - 2004
Skills
HRIS, Employee Benefits, Deferred Compensation, Employee Relations, Performance Management, Human Resources, Benefits Administration, Onboarding, Training, PeopleSoft, Process Improvement
Education
Campbell University 2000 — 2003
MBA, Business Administration
North Carolina Agricultural and Technical State University 1988 — 1993
BS, Business Management
Hillside High
Bill Stockton Bill Stockton's Catalent Experience June 2008 - September 2009
Job Quality Remidiation Specialists for bwdesigngroup/GSK
Industry Pharmaceuticals
Experience
Barry-Wehmiller Design Group/GSK December 2014 - Present
Merck January 2012 - August 2013
GE Healthcare January 2010 - August 2011
Catalent June 2008 - September 2009
CATALENT June 2008 - September 2009
Nanosphere September 2007 - June 2008
Nanosphere October 2007 - May 2008
Baxter Healthcare June 2006 - September 2007
Baxter Healthcare May 2006 - September 2007
DENTSPLY PHARMACEUTICAL October 2004 - June 2006
Skills
cGMP, GMP, FDA, SOP, Pharmaceutical Industry, GLP, CAPA, Pharmaceutics, Laboratory, 21 CFR Part 11, Manufacturing, Sop, Aseptic Processing, Medical Devices, Microbiology, Lean Manufacturing, Quality Assurance, Cross-functional Team..., Quality System, Regulatory Affairs, Leadership
Education
Computer Tech. Training 2005 — 2005
n/a, computer
Kankakee Community College 2004 — 2005
n/a, Computer, creative writing, english
hoopeston area high school 1973 — 1977
Kankakee Community College
Barry-Wehmiller Design Group/GSK December 2014 - Present
Merck January 2012 - August 2013
GE Healthcare January 2010 - August 2011
Catalent June 2008 - September 2009
CATALENT June 2008 - September 2009
Nanosphere September 2007 - June 2008
Nanosphere October 2007 - May 2008
Baxter Healthcare June 2006 - September 2007
Baxter Healthcare May 2006 - September 2007
DENTSPLY PHARMACEUTICAL October 2004 - June 2006
Skills
cGMP, GMP, FDA, SOP, Pharmaceutical Industry, GLP, CAPA, Pharmaceutics, Laboratory, 21 CFR Part 11, Manufacturing, Sop, Aseptic Processing, Medical Devices, Microbiology, Lean Manufacturing, Quality Assurance, Cross-functional Team..., Quality System, Regulatory Affairs, Leadership
Education
Computer Tech. Training 2005 — 2005
n/a, computer
Kankakee Community College 2004 — 2005
n/a, Computer, creative writing, english
hoopeston area high school 1973 — 1977
Kankakee Community College
Daniel Gourley's Catalent Experience March 2006 - April 2014
Job Director Global Logistics at Sharp Clinical Services
Industry Pharmaceuticals
Experience
Sharp Clinical Services July 2014 - Present
Catalent March 2006 - April 2014
Catalent Pharm October 2003 - March 2006
Skills
Sop, FDA, Pharmaceutical Industry, CAPA, GMP, Management, Supply Chain Management, Logistics, Cross-functional Team..., Validation, Regulatory Affairs, Biotechnology, Change Control, Clinical Trials, SOP, 21 CFR Part 11, Budgets, Training, Process Improvement, Supply Chain, Quality System
Education
Slippery Rock University of Pennsylvania 1986 — 1990
BSBA, Accounting
Sharp Clinical Services July 2014 - Present
Catalent March 2006 - April 2014
Catalent Pharm October 2003 - March 2006
Skills
Sop, FDA, Pharmaceutical Industry, CAPA, GMP, Management, Supply Chain Management, Logistics, Cross-functional Team..., Validation, Regulatory Affairs, Biotechnology, Change Control, Clinical Trials, SOP, 21 CFR Part 11, Budgets, Training, Process Improvement, Supply Chain, Quality System
Education
Slippery Rock University of Pennsylvania 1986 — 1990
BSBA, Accounting
Teresa Rocks Teresa Rocks's Catalent Experience July 2007 - February 2012
Job HR Coordinator/Generalist
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions July 2007 - February 2012
Catalent July 2007 - February 2012
Catalent Pharma Solutions July 2007 - February 2012
Cardinal Health July 2006 - June 2007
EHRO 2006 - 2007 April 2005 - June 2007
Cardinal Health January 1999 - January 2006
COUNTRY HOLLOWS January 1998 - January 1999
BROOKVIEW APTS January 1995 - January 1998
Skills
HRIS, Employee Relations, Benefits Administration, Onboarding, ADP, HR Policies, Orientation, Kronos, Benefits, AP & AR
Education
Bucks County School of Beauty Culture
Community College of Philadelphia
General studies
Schlicher-Kratz Real-Estate School
West Philadelphia Catholic Girls High
High School Diploma
Catalent Pharma Solutions July 2007 - February 2012
Catalent July 2007 - February 2012
Catalent Pharma Solutions July 2007 - February 2012
Cardinal Health July 2006 - June 2007
EHRO 2006 - 2007 April 2005 - June 2007
Cardinal Health January 1999 - January 2006
COUNTRY HOLLOWS January 1998 - January 1999
BROOKVIEW APTS January 1995 - January 1998
Skills
HRIS, Employee Relations, Benefits Administration, Onboarding, ADP, HR Policies, Orientation, Kronos, Benefits, AP & AR
Education
Bucks County School of Beauty Culture
Community College of Philadelphia
General studies
Schlicher-Kratz Real-Estate School
West Philadelphia Catholic Girls High
High School Diploma
Rosemary Stefanek Rosemary Stefanek's Catalent Experience May 2008 - September 2008
Job Sr. Supplier Quality Specialist at Bausch & Lomb
Industry Medical Devices
Experience
Bausch & Lomb September 2011 - August 2015
Teleflex Medical September 2008 - October 2011
ASQ 2004 - January 2011
SQA Services October 2001 - September 2010
Catalent May 2008 - September 2008
Baxter Healthcare August 2007 - May 2008
Premier, Inc. March 2004 - June 2007
Battelle January 2001 - September 2001
BioPort Corporation January 2000 - December 2000
BioPort Corporation June 1999 - January 2000
Skills
Quality Assurance, Cross-functional Team..., FDA, Quality Management, CAPA, Process Improvement
Education
Aquinas College 1992 — 1997
Bausch & Lomb September 2011 - August 2015
Teleflex Medical September 2008 - October 2011
ASQ 2004 - January 2011
SQA Services October 2001 - September 2010
Catalent May 2008 - September 2008
Baxter Healthcare August 2007 - May 2008
Premier, Inc. March 2004 - June 2007
Battelle January 2001 - September 2001
BioPort Corporation January 2000 - December 2000
BioPort Corporation June 1999 - January 2000
Skills
Quality Assurance, Cross-functional Team..., FDA, Quality Management, CAPA, Process Improvement
Education
Aquinas College 1992 — 1997
Joe Nawrocki Joe Nawrocki's Catalent Experience 2003 - Present
Job Director of Structural Characterization at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions March 2003 - Present
Catalent 2003 - Present
Cardinal Health PTS, LLC 2003 - 2007
Charles River Laboratories May 2001 - February 2003
Education
University of Florida 1991 — 1997
Ph.D., Analytical Chemistry
Catalent Pharma Solutions March 2003 - Present
Catalent 2003 - Present
Cardinal Health PTS, LLC 2003 - 2007
Charles River Laboratories May 2001 - February 2003
Education
University of Florida 1991 — 1997
Ph.D., Analytical Chemistry
Mary Snider Mary Snider's Catalent Experience November 1998 - Present
Job Chemistry Laboratory Supervisor
Industry Pharmaceuticals
Experience
Catalent November 1998 - Present
Cardinal Health 1998 - Present
Testor Corporation November 1996 - November 1998
Valspar 1998 - 1998
North Safety Products May 1995 - November 1996
Automatic Liquid Packaging May 1993 - May 1995
TRW 1990 - 1992
ICI FIBERITE 1989 - 1990
Talley Defense Systems 1987 - 1989
Pillsbury Green Giant 1982 - 1985
Skills
HPLC, Validation, Chemistry, SOP, Pharmaceuticals, USP, QC, Coatings, GLP, GMP, Analytical Chemistry, UV-Vis, Chromatography, IR, cGMP, Analytical Techniques, Dissolution, FTIR, Quality Control, UV, Sop, Pharmaceutical Industry, UV/Vis, Wet Chemistry, Gas Chromatography, FDA, Laboratory, Change Control, R&D, Quality System
Education
Mesa Community College 1988 — 1992
chemistry
Catalent November 1998 - Present
Cardinal Health 1998 - Present
Testor Corporation November 1996 - November 1998
Valspar 1998 - 1998
North Safety Products May 1995 - November 1996
Automatic Liquid Packaging May 1993 - May 1995
TRW 1990 - 1992
ICI FIBERITE 1989 - 1990
Talley Defense Systems 1987 - 1989
Pillsbury Green Giant 1982 - 1985
Skills
HPLC, Validation, Chemistry, SOP, Pharmaceuticals, USP, QC, Coatings, GLP, GMP, Analytical Chemistry, UV-Vis, Chromatography, IR, cGMP, Analytical Techniques, Dissolution, FTIR, Quality Control, UV, Sop, Pharmaceutical Industry, UV/Vis, Wet Chemistry, Gas Chromatography, FDA, Laboratory, Change Control, R&D, Quality System
Education
Mesa Community College 1988 — 1992
chemistry
Ashley Durusky's Catalent Experience May 2007 - August 2007
Job QC Supervisor at Biogen Idec
Industry Pharmaceuticals
Experience
Biogen Idec December 2011 - Present
Biogen Idec June 2008 - January 2012
North Carolina State University 2006 - 2008
Catalent May 2007 - August 2007
GlaxoSmithKline December 2005 - August 2006
LabCorp 2002 - 2002
Education
North Carolina State University 2009 — 2011
Master of Business Administration, Biosciences Management
North Carolina State University 2006 — 2008
Professional Science Master's, Microbial Biotechnology
North Carolina State University 2002 — 2005
Bachelor of Science, Biological Sciences
Biogen Idec December 2011 - Present
Biogen Idec June 2008 - January 2012
North Carolina State University 2006 - 2008
Catalent May 2007 - August 2007
GlaxoSmithKline December 2005 - August 2006
LabCorp 2002 - 2002
Education
North Carolina State University 2009 — 2011
Master of Business Administration, Biosciences Management
North Carolina State University 2006 — 2008
Professional Science Master's, Microbial Biotechnology
North Carolina State University 2002 — 2005
Bachelor of Science, Biological Sciences
Donald Stogner Donald Stogner's Catalent Experience 1997 - 2009
Job Senior Chemist Group Leader at Lancaster Laboratories, Inc
Industry Chemicals
Experience
Lancaster Laboratories, Inc 2009 - Present
Catalent 1997 - 2009
Magellan 1997 - 2009
Catalent 1997 - 2009
Industrial and Environmental Analysts, Inc. 1991 - 1997
CompuChem Labortories 1985 - 1991
Education
North Carolina State University 1980 — 1985
BS, Chemistry
Lancaster Laboratories, Inc 2009 - Present
Catalent 1997 - 2009
Magellan 1997 - 2009
Catalent 1997 - 2009
Industrial and Environmental Analysts, Inc. 1991 - 1997
CompuChem Labortories 1985 - 1991
Education
North Carolina State University 1980 — 1985
BS, Chemistry
Paul Kestran Paul Kestran's Catalent Experience 2008 - Present
Job Sr. Global Catagory Manager at Catalent
Industry Pharmaceuticals
Experience
Catalent 2008 - Present
Bio-Rad Lab's 1998 - 2007
Chiron Diagnostics 1994 - 1999
CIba-Corning 1988 - 1993
Skills
Continuous Improvement, Budgets, Management, Project Planning, Leadership, ISO, Project Management, Procurement, FDA, Training, Quality Assurance, Manufacturing, Six Sigma, Medical Devices, Pharmaceutical Industry, Supply Chain Management, Validation, Inventory Management, Strategic Planning, Regulatory Affairs
Education
Cleveland State University
Bachelors, Chemistry
Catalent 2008 - Present
Bio-Rad Lab's 1998 - 2007
Chiron Diagnostics 1994 - 1999
CIba-Corning 1988 - 1993
Skills
Continuous Improvement, Budgets, Management, Project Planning, Leadership, ISO, Project Management, Procurement, FDA, Training, Quality Assurance, Manufacturing, Six Sigma, Medical Devices, Pharmaceutical Industry, Supply Chain Management, Validation, Inventory Management, Strategic Planning, Regulatory Affairs
Education
Cleveland State University
Bachelors, Chemistry
Harold Slatore Harold Slatore's Catalent Experience June 2005 - December 2007
Job Sr. QA Associate at Epic Sciences
Industry Pharmaceuticals
Experience
Epic Sciences July 2014 - Present
Intertek November 2013 - June 2014
AltheaDx October 2011 - August 2013
ACON Laboratories September 2008 - September 2011
Catalent June 2005 - December 2007
Biogen September 2002 - June 2005
Qualigen Inc. May 2000 - March 2002
Gen Probe November 1998 - May 2000
First Medical November 1997 - June 1998
Hybritech Inc. 1989 - 1998
Skills
Validation, FDA, Medical Devices, cGMP, Pharmaceuticals, Biotechnology, CAPA, Oncology, HPLC, Pharmaceutical Industry, GLP, Biopharmaceuticals, Technology Transfer, 21 CFR Part 11, Manufacturing, R&D, Clinical Trials, PCR, Biochemistry, Lifesciences, Quality System, Chromatography, Change Control, V&V, Microbiology, ELISA, Aseptic Processing, Sop, Hardware Diagnostics, Immunoassays, Molecular Biology, Quality Assurance, Cell Culture, Purification, Protein Purification, ISO 13485, GMP, Immunology, IND, Assay Development, Quality Control
Education
San Diego State University-California State University 1986 — 1988
BS, Applied Microbiology
Epic Sciences July 2014 - Present
Intertek November 2013 - June 2014
AltheaDx October 2011 - August 2013
ACON Laboratories September 2008 - September 2011
Catalent June 2005 - December 2007
Biogen September 2002 - June 2005
Qualigen Inc. May 2000 - March 2002
Gen Probe November 1998 - May 2000
First Medical November 1997 - June 1998
Hybritech Inc. 1989 - 1998
Skills
Validation, FDA, Medical Devices, cGMP, Pharmaceuticals, Biotechnology, CAPA, Oncology, HPLC, Pharmaceutical Industry, GLP, Biopharmaceuticals, Technology Transfer, 21 CFR Part 11, Manufacturing, R&D, Clinical Trials, PCR, Biochemistry, Lifesciences, Quality System, Chromatography, Change Control, V&V, Microbiology, ELISA, Aseptic Processing, Sop, Hardware Diagnostics, Immunoassays, Molecular Biology, Quality Assurance, Cell Culture, Purification, Protein Purification, ISO 13485, GMP, Immunology, IND, Assay Development, Quality Control
Education
San Diego State University-California State University 1986 — 1988
BS, Applied Microbiology
Chris Hinson, ASP, CHMM's Catalent Experience February 2008 - October 2008
Job Senior HSE Specialist, North American Commercial Operations at bioMérieux, Inc.
Industry Biotechnology
Experience
bioMérieux, Inc. September 2015 - Present
bioMérieux, Inc. June 2013 - September 2015
Liquidia Technologies March 2010 - June 2013
Liquidia Technologies November 2009 - June 2013
Liquidia Technologies November 2009 - July 2012
Stiefel Laboratories October 2008 - October 2009
Catalent February 2008 - October 2008
Hospira January 2007 - April 2007
Campbell University Pharmaceutical Sciences Research Institute June 2006 - October 2006
Skills
CHMM, Hazardous Materials..., Hazardous Waste..., EHS, Occupational Health, Industrial Safety, Environmental..., ISO 14001, OHSAS 18001, Certified Lead Auditor, Safety Auditing, HAZWOPER, Industrial Hygiene, Chemical Handling, Safety, Safety Committee, Workplace Safety, Laboratory Safety, Manufacturing Safety, Fire Safety, Hazard Analysis, Hazard Recognition, Safety Training, Recycling, RCRA, OSHA 30-Hour, Research, System Administration, SOP development, Biotechnology, Pharmaceutical Industry, Analytical Chemistry, Analytical Skills, HPLC, GMP, GLP, R&D, Method Development
Education
Campbell University 2003 — 2007
Bachelor of Science, Pharmaceutical Sciences
Concord High School 1999 — 2003
High School Diploma
bioMérieux, Inc. September 2015 - Present
bioMérieux, Inc. June 2013 - September 2015
Liquidia Technologies March 2010 - June 2013
Liquidia Technologies November 2009 - June 2013
Liquidia Technologies November 2009 - July 2012
Stiefel Laboratories October 2008 - October 2009
Catalent February 2008 - October 2008
Hospira January 2007 - April 2007
Campbell University Pharmaceutical Sciences Research Institute June 2006 - October 2006
Skills
CHMM, Hazardous Materials..., Hazardous Waste..., EHS, Occupational Health, Industrial Safety, Environmental..., ISO 14001, OHSAS 18001, Certified Lead Auditor, Safety Auditing, HAZWOPER, Industrial Hygiene, Chemical Handling, Safety, Safety Committee, Workplace Safety, Laboratory Safety, Manufacturing Safety, Fire Safety, Hazard Analysis, Hazard Recognition, Safety Training, Recycling, RCRA, OSHA 30-Hour, Research, System Administration, SOP development, Biotechnology, Pharmaceutical Industry, Analytical Chemistry, Analytical Skills, HPLC, GMP, GLP, R&D, Method Development
Education
Campbell University 2003 — 2007
Bachelor of Science, Pharmaceutical Sciences
Concord High School 1999 — 2003
High School Diploma
Chris Wisniewski Chris Wisniewski's Catalent Experience January 2008 - August 2009
Job Senior Research Associate II at Gilead Sciences
Industry Biotechnology
Experience
Gilead Sciences October 2014 - Present
Prometheus January 2012 - September 2014
Vical October 2011 - February 2012
Pacira Pharmaceuticals, Inc. April 2011 - October 2011
Gen Probe February 2010 - March 2011
Polypeptide Laboratory Group November 2009 - February 2010
Catalent January 2008 - August 2009
The University of Arizona December 2005 - May 2007
Skills
Protein Purification, HPLC, Cell Culture, ELISA, Biotechnology, Chromatography, Protein Chemistry, Lifesciences, SDS-PAGE, Molecular Biology, GMP, Assay Development, Validation, Chemistry, Sop, GLP, Analytical Chemistry, PCR, Spectrophotometry, Biochemistry, Drug Development, Biopharmaceuticals, Gel Electrophoresis, Technology Transfer, qPCR, UV/Vis, DNA, Transfection, Quality Control, Laboratory, Formulation, V&V, FDA, Drug Discovery, Immunoassays, Purification, Cell, Protein Expression, Organic Chemistry, Western Blotting, Cell Biology, Immunology, Life Sciences
Education
San Diego State University-California State University 2008 — 2011
MS, Biomedical Quality Systems and Regulatory Affairs
University of Arizona 2002 — 2007
BS, Biology
Gilead Sciences October 2014 - Present
Prometheus January 2012 - September 2014
Vical October 2011 - February 2012
Pacira Pharmaceuticals, Inc. April 2011 - October 2011
Gen Probe February 2010 - March 2011
Polypeptide Laboratory Group November 2009 - February 2010
Catalent January 2008 - August 2009
The University of Arizona December 2005 - May 2007
Skills
Protein Purification, HPLC, Cell Culture, ELISA, Biotechnology, Chromatography, Protein Chemistry, Lifesciences, SDS-PAGE, Molecular Biology, GMP, Assay Development, Validation, Chemistry, Sop, GLP, Analytical Chemistry, PCR, Spectrophotometry, Biochemistry, Drug Development, Biopharmaceuticals, Gel Electrophoresis, Technology Transfer, qPCR, UV/Vis, DNA, Transfection, Quality Control, Laboratory, Formulation, V&V, FDA, Drug Discovery, Immunoassays, Purification, Cell, Protein Expression, Organic Chemistry, Western Blotting, Cell Biology, Immunology, Life Sciences
Education
San Diego State University-California State University 2008 — 2011
MS, Biomedical Quality Systems and Regulatory Affairs
University of Arizona 2002 — 2007
BS, Biology
Paul Burns Paul Burns's Catalent Experience November 2009 - January 2012
Job Managing Consultant at Futurestep, A Korn Ferry Company
Industry Human Resources
Experience
Futurestep, A Korn Ferry Company April 2015 - Present
University City Science Center June 2009 - Present
Healthcare Consulting May 2014 - April 2015
CSS Inc. February 2012 - April 2014
Catalent November 2009 - January 2012
Brighter Ideas Inc July 2008 - November 2009
Emergency Cardiac Imaging April 2007 - May 2008
GE Healthcare February 1996 - April 2007
DePuy Orthopaedics August 1993 - January 1996
Information Dynamics 1990 - 1993
Skills
Medical Devices, Lifesciences, Business Development, Start-ups, Technology Transfer, Leadership, Product Development, Pharmaceutical Industry, Biotechnology, Marketing Strategy, Cross-functional Team..., Product Management, Strategic Planning, Process Improvement, Strategy, Product Launch, Product Marketing, Healthcare, Strategic Policy..., Market Development, Team Building, Management, Strategic Partnerships, Sales, New Business Development, Marketing, Sales Management, Market Research, Six Sigma, Life Sciences
Education
La Salle University - School of Business Administration 1986 — 1990
GE training
Futurestep, A Korn Ferry Company April 2015 - Present
University City Science Center June 2009 - Present
Healthcare Consulting May 2014 - April 2015
CSS Inc. February 2012 - April 2014
Catalent November 2009 - January 2012
Brighter Ideas Inc July 2008 - November 2009
Emergency Cardiac Imaging April 2007 - May 2008
GE Healthcare February 1996 - April 2007
DePuy Orthopaedics August 1993 - January 1996
Information Dynamics 1990 - 1993
Skills
Medical Devices, Lifesciences, Business Development, Start-ups, Technology Transfer, Leadership, Product Development, Pharmaceutical Industry, Biotechnology, Marketing Strategy, Cross-functional Team..., Product Management, Strategic Planning, Process Improvement, Strategy, Product Launch, Product Marketing, Healthcare, Strategic Policy..., Market Development, Team Building, Management, Strategic Partnerships, Sales, New Business Development, Marketing, Sales Management, Market Research, Six Sigma, Life Sciences
Education
La Salle University - School of Business Administration 1986 — 1990
GE training
Mary Tichi PhD, MBA Mary Tichi PhD, MBA's Catalent Experience December 2008 - April 2010
Job ***
Industry Biotechnology
Experience
Affymetrix January 2013 - July 2013
Affymetrix January 2012 - December 2012
Affymetrix August 2010 - January 2012
Catalent December 2008 - April 2010
PharmaDirections 2007 - August 2008
Independent Consultant 2006 - 2007
Ambion 2004 - 2006
Invitrogen 2001 - 2004
Skills
Pharmaceutical Industry, Biotechnology, Business Development, Oncology, Molecular Diagnostics, Molecular Biology, Clinical Development, Toxicology, Infectious Diseases, Immunoassays, Cancer, Technology Transfer, Pharmaceutics, FDA, Biomarker Discovery, Strategy, Cell Biology, Vaccines, Biochemistry, R&D, Cell, DNA sequencing
Education
The Ohio State University
Ph.D.
University of California, San Diego - The Rady School of Management
MBA
University of Washington
BS
Affymetrix January 2013 - July 2013
Affymetrix January 2012 - December 2012
Affymetrix August 2010 - January 2012
Catalent December 2008 - April 2010
PharmaDirections 2007 - August 2008
Independent Consultant 2006 - 2007
Ambion 2004 - 2006
Invitrogen 2001 - 2004
Skills
Pharmaceutical Industry, Biotechnology, Business Development, Oncology, Molecular Diagnostics, Molecular Biology, Clinical Development, Toxicology, Infectious Diseases, Immunoassays, Cancer, Technology Transfer, Pharmaceutics, FDA, Biomarker Discovery, Strategy, Cell Biology, Vaccines, Biochemistry, R&D, Cell, DNA sequencing
Education
The Ohio State University
Ph.D.
University of California, San Diego - The Rady School of Management
MBA
University of Washington
BS
Simon Greenstreet's Catalent Experience December 2009 - Present
Job Facility Manager at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent December 2009 - Present
King Pharmaceuticals 2006 - April 2009
King Pharmaceuticals 1996 - 2006
Vectech Pharmaceutical Consultants 1993 - 1996
Education
University of Wisconsin-Stout 2009 — 2010
BS
Oakland Community College
Catalent December 2009 - Present
King Pharmaceuticals 2006 - April 2009
King Pharmaceuticals 1996 - 2006
Vectech Pharmaceutical Consultants 1993 - 1996
Education
University of Wisconsin-Stout 2009 — 2010
BS
Oakland Community College
Cathy Gutman's Catalent Experience 2007 - 2008
Job Recruiter Consultant at Novo Nordisk, Inc.
Industry Pharmaceuticals
Experience
Novo Nordisk A/S November 2010 - Present
Novo Nordisk September 2008 - July 2010
Catalent 2007 - 2008
Empyrean Management Group, Inc. December 2005 - June 2007
The Higgins Group 2003 - 2004
Wyeth Research 2002 - 2003
Wyeth Research 2001 - 2002
Wyeth Research 1998 - 2001
Wyeth Research 1995 - 1998
Skills
Sourcing, Talent Acquisition, Applicant Tracking..., Interviewing, Resume Writing, Technical Recruiting, Pharmaceuticals, Hiring, Strategic Sourcing, Coaching, Onboarding, Succession Planning, Vendor Management, Pharmaceutical Industry, Recruiting, Screening Resumes, Internet Recruiting, Interviews, Contract Recruitment, Talent Management, Human Resources, Executive Search, Employee Relations, College Recruiting, Screening, HRIS, Benefits Negotiation, Workforce Planning, Staffing Services, Temporary Placement, Employer Branding, Temporary Staffing, Deferred Compensation, Taleo, HR Consulting, Recruitment Advertising, Personnel Management, Employee Engagement, Cold Calling, HR Policies
Education
East Stroudsburg University of Pennsylvania
BS
Villanova University
PHR
Novo Nordisk A/S November 2010 - Present
Novo Nordisk September 2008 - July 2010
Catalent 2007 - 2008
Empyrean Management Group, Inc. December 2005 - June 2007
The Higgins Group 2003 - 2004
Wyeth Research 2002 - 2003
Wyeth Research 2001 - 2002
Wyeth Research 1998 - 2001
Wyeth Research 1995 - 1998
Skills
Sourcing, Talent Acquisition, Applicant Tracking..., Interviewing, Resume Writing, Technical Recruiting, Pharmaceuticals, Hiring, Strategic Sourcing, Coaching, Onboarding, Succession Planning, Vendor Management, Pharmaceutical Industry, Recruiting, Screening Resumes, Internet Recruiting, Interviews, Contract Recruitment, Talent Management, Human Resources, Executive Search, Employee Relations, College Recruiting, Screening, HRIS, Benefits Negotiation, Workforce Planning, Staffing Services, Temporary Placement, Employer Branding, Temporary Staffing, Deferred Compensation, Taleo, HR Consulting, Recruitment Advertising, Personnel Management, Employee Engagement, Cold Calling, HR Policies
Education
East Stroudsburg University of Pennsylvania
BS
Villanova University
PHR
Tran N. Tilghman's Catalent Experience May 2007 - February 2009
Job Formex, LLC
Industry Medical Devices
Experience
Formex August 2012 - Present
Waters December 2009 - August 2012
Hisamitsu Pharmaceuticals February 2009 - December 2009
Catalent May 2007 - February 2009
Skills
Technical Training, Analytical Chemistry, Chromatography, Empower Chromatography..., Course Development, Empower, HPLC, 21 CFR Part 11, Biotechnology, Calibration, Chemistry, GLP, GMP, Gas Chromatography, Instructional Design, Instrumentation, Laboratory, Life Sciences, Mass Spectrometry, Pharmaceutical Industry, Quality Control, Validation
Education
Keck Graduate Institute 2005 — 2007
MBS (MS/MBA), Pharmaceutical Science/Marketing
California State University-Long Beach 2000 — 2004
BS, Chemistry, minor in math
Formex August 2012 - Present
Waters December 2009 - August 2012
Hisamitsu Pharmaceuticals February 2009 - December 2009
Catalent May 2007 - February 2009
Skills
Technical Training, Analytical Chemistry, Chromatography, Empower Chromatography..., Course Development, Empower, HPLC, 21 CFR Part 11, Biotechnology, Calibration, Chemistry, GLP, GMP, Gas Chromatography, Instructional Design, Instrumentation, Laboratory, Life Sciences, Mass Spectrometry, Pharmaceutical Industry, Quality Control, Validation
Education
Keck Graduate Institute 2005 — 2007
MBS (MS/MBA), Pharmaceutical Science/Marketing
California State University-Long Beach 2000 — 2004
BS, Chemistry, minor in math
Thomas Schmid, ECRE's Catalent Experience May 2007 - July 2008
Job Recruiting Manager Northern California at Wyndham Vacation Ownership
Industry Staffing and Recruiting
Experience
Wyndham Vacation Ownership August 2014 - Present
Wyndham Worldwide March 2012 - July 2014
Dynamic Search Solutions August 2010 - March 2012
BlueChip Search March 2007 - July 2010
Bausch & Lomb January 2009 - June 2010
Novo Nordisk March 2008 - March 2009
Catalent May 2007 - July 2008
Priority Business Services January 2004 - March 2007
AppleOne January 2002 - January 2004
Skills
Contract Negotiation, Accounting, Engineering, Technical Recruiting, Executive Search, Cold Calling, Hiring, Human Resources, Interviews, Management, Onboarding, Recruiting, Sourcing, Temporary Placement, Training, Sales, Marketing
Education
California State University-Fullerton 2000 — 2004
BS, Business Management
Fullerton College 2000 — 2002
AA, Liberal Arts
Wyndham Vacation Ownership August 2014 - Present
Wyndham Worldwide March 2012 - July 2014
Dynamic Search Solutions August 2010 - March 2012
BlueChip Search March 2007 - July 2010
Bausch & Lomb January 2009 - June 2010
Novo Nordisk March 2008 - March 2009
Catalent May 2007 - July 2008
Priority Business Services January 2004 - March 2007
AppleOne January 2002 - January 2004
Skills
Contract Negotiation, Accounting, Engineering, Technical Recruiting, Executive Search, Cold Calling, Hiring, Human Resources, Interviews, Management, Onboarding, Recruiting, Sourcing, Temporary Placement, Training, Sales, Marketing
Education
California State University-Fullerton 2000 — 2004
BS, Business Management
Fullerton College 2000 — 2002
AA, Liberal Arts
Cynthia Eitel's Catalent Experience April 2008 - May 2010
Job Scientist at Advantar
Industry Biotechnology
Experience
Advantar Labs October 2011 - Present
Traversa Therapeutics May 2010 - March 2012
Catalent April 2008 - May 2010
Monosol Rx, LLC October 2006 - April 2008
Skills
GLP, HPLC, LC-MS, UV/Vis, Assay Development, GMP, Formulation, Sop, Laboratory, Protein Chemistry, Analytical Chemistry, SOP
Education
Indiana University Bloomington 2002 — 2006
B.S., Chemistry, Minor in Mathematics
Advantar Labs October 2011 - Present
Traversa Therapeutics May 2010 - March 2012
Catalent April 2008 - May 2010
Monosol Rx, LLC October 2006 - April 2008
Skills
GLP, HPLC, LC-MS, UV/Vis, Assay Development, GMP, Formulation, Sop, Laboratory, Protein Chemistry, Analytical Chemistry, SOP
Education
Indiana University Bloomington 2002 — 2006
B.S., Chemistry, Minor in Mathematics
Thomas Spoerel Thomas Spoerel's Catalent Experience July 2009 - September 2015
Job VP Finance Deputy Controller
Industry Medical Devices
Experience
BD September 2015 - Present
Catalent July 2009 - September 2015
Ernst &Young LLP May 2002 - May 2009
Arthur Andersen September 2000 - April 2002
Education
Columbia University - Columbia Business School 2008 — 2009
MBA, MBA
Fordham University 1996 — 2000
BS, Public Accounting
CHAMINADE 1992 — 1996
BD September 2015 - Present
Catalent July 2009 - September 2015
Ernst &Young LLP May 2002 - May 2009
Arthur Andersen September 2000 - April 2002
Education
Columbia University - Columbia Business School 2008 — 2009
MBA, MBA
Fordham University 1996 — 2000
BS, Public Accounting
CHAMINADE 1992 — 1996
Susan L. Hoffman's Catalent Experience March 2008 - August 2008
Job Purdon & Hoffman Valuation Group LLC, CoOwner
Industry Real Estate
Experience
Maryland Residential Appraisals March 2013 - Present
Novo Nordisk Pharmaceuticals June 2009 - March 2013
Catalent March 2008 - August 2008
ARCADIS September 2006 - March 2008
Skills
GMP, Pharmaceutical Industry, Validation, Manufacturing, FDA, 21 CFR Part 11, CAPA, GxP, Medical Devices, Quality Assurance, Sop, Quality System, Biotechnology, Regulatory Affairs, Six Sigma, Lean Manufacturing, Root Cause Analysis, Change Control
Education
Indiana University Bloomington 2000 — 2005
Bachelor of Science (B.S.), Occupational Safety and Health
Maryland Residential Appraisals March 2013 - Present
Novo Nordisk Pharmaceuticals June 2009 - March 2013
Catalent March 2008 - August 2008
ARCADIS September 2006 - March 2008
Skills
GMP, Pharmaceutical Industry, Validation, Manufacturing, FDA, 21 CFR Part 11, CAPA, GxP, Medical Devices, Quality Assurance, Sop, Quality System, Biotechnology, Regulatory Affairs, Six Sigma, Lean Manufacturing, Root Cause Analysis, Change Control
Education
Indiana University Bloomington 2000 — 2005
Bachelor of Science (B.S.), Occupational Safety and Health
Terry Robinson Terry Robinson's Catalent Experience August 2011 - January 2013
Job Senior Director, Pharmaceutical Practice at Appian Corporation
Industry Pharmaceuticals
Experience
Appian Corporation July 2015 - Present
Catalent Pharma Solutions February 2013 - Present
Catalent August 2011 - January 2013
Catalent Pharma Solutions June 2008 - August 2011
Amgen 2004 - 2008
Eli Lilly & Company 2000 - 2004
Eli Lilly and Company 1993 - 1996
Skills
Account Management, Contract Negotiation, Strategic Planning, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Medical Devices, Lifesciences, Pharmaceutical Sales, Key Account Management, New Business Development, Product Development, Global Marketing, Competitive Analysis, cross functional team..., Leadership, Management, Strategy, Oncology, Six Sigma, GMP, Selling, Product Launch, FDA, Validation, Life Sciences, Commercialization, Biopharmaceuticals, Sales
Education
University of Virginia 1983 — 1985
BA, Psychobiology
Southern Methodist University 1981 — 1983
Appian Corporation July 2015 - Present
Catalent Pharma Solutions February 2013 - Present
Catalent August 2011 - January 2013
Catalent Pharma Solutions June 2008 - August 2011
Amgen 2004 - 2008
Eli Lilly & Company 2000 - 2004
Eli Lilly and Company 1993 - 1996
Skills
Account Management, Contract Negotiation, Strategic Planning, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Medical Devices, Lifesciences, Pharmaceutical Sales, Key Account Management, New Business Development, Product Development, Global Marketing, Competitive Analysis, cross functional team..., Leadership, Management, Strategy, Oncology, Six Sigma, GMP, Selling, Product Launch, FDA, Validation, Life Sciences, Commercialization, Biopharmaceuticals, Sales
Education
University of Virginia 1983 — 1985
BA, Psychobiology
Southern Methodist University 1981 — 1983
James E. Wilson's Catalent Experience June 2007 - August 2008
Job Pharmaceutical Consultant available for specific assignments
Industry Pharmaceuticals
Experience
Retired but available for specific assignments Quality Assurance Product Release SpecialistWarner ChilcottAugust 2010 - April 2013
Alpharma Pharmaceuticals, Inc. August 2008 - June 2009
Catalent June 2007 - August 2008
GSK Consumer Healthcare August 2004 - December 2006
BASF Corporation December 1998 - August 2004
Pfizer (Warner-Lambert Company) October 1991 - December 1998
Bristol-Myers Squibb (E.R. Squibb Co.) May 1983 - October 1991
Skills
Technology Transfer, Quality Assurance, Pharmaceutics, Change Control, Manufacturing, Product Development, Process Engineering, Software Documentation, Management, Laboratory, Pharmaceutical Industry, GMP
Education
Fairleigh Dickinson University 1989 — 1994
MBA (39 credits completed), Pharmaceitical / Chemical Industry
Columbia University in the City of New York 1967 — 1972
B.Sc., Pharmaceutical Chemistry
Retired but available for specific assignments Quality Assurance Product Release SpecialistWarner ChilcottAugust 2010 - April 2013
Alpharma Pharmaceuticals, Inc. August 2008 - June 2009
Catalent June 2007 - August 2008
GSK Consumer Healthcare August 2004 - December 2006
BASF Corporation December 1998 - August 2004
Pfizer (Warner-Lambert Company) October 1991 - December 1998
Bristol-Myers Squibb (E.R. Squibb Co.) May 1983 - October 1991
Skills
Technology Transfer, Quality Assurance, Pharmaceutics, Change Control, Manufacturing, Product Development, Process Engineering, Software Documentation, Management, Laboratory, Pharmaceutical Industry, GMP
Education
Fairleigh Dickinson University 1989 — 1994
MBA (39 credits completed), Pharmaceitical / Chemical Industry
Columbia University in the City of New York 1967 — 1972
B.Sc., Pharmaceutical Chemistry
Ron Bailey's Catalent Experience February 2012 - Present
Job Director of Operations at Catalent
Industry Pharmaceuticals
Experience
Catalent February 2012 - Present
Aptuit, Inc January 2003 - February 2012
Oread Pharmaceuticals 1997 - 2000
Skills
Pharmaceutical Industry, Sop, GMP, GLP, Validation, FDA, Quality Assurance, R&D, Process Improvement, Project Management, Drug Development, Technology Transfer, 21 CFR Part 11, Change Control, CRO, Analytical Chemistry, Software Documentation, CAPA, Lifesciences, Quality System, Product Development, SOP
Education
Baker University 2000 — 2002
Masters, Business Administration
University of Kansas 1992 — 1996
Bachelor's degree, Environmental Science
Catalent February 2012 - Present
Aptuit, Inc January 2003 - February 2012
Oread Pharmaceuticals 1997 - 2000
Skills
Pharmaceutical Industry, Sop, GMP, GLP, Validation, FDA, Quality Assurance, R&D, Process Improvement, Project Management, Drug Development, Technology Transfer, 21 CFR Part 11, Change Control, CRO, Analytical Chemistry, Software Documentation, CAPA, Lifesciences, Quality System, Product Development, SOP
Education
Baker University 2000 — 2002
Masters, Business Administration
University of Kansas 1992 — 1996
Bachelor's degree, Environmental Science
Justin Lacombe's Catalent Experience June 2007 - August 2011
Job Manager Process Development at Teva Pharmaceuticals
Industry Pharmaceuticals
Experience
Teva Pharmaceuticals July 2013 - Present
MicroDose Therapeutx September 2012 - July 2013
MicroDose Therapeutx July 2011 - September 2012
Catalent June 2007 - August 2011
Rutgers University May 2006 - May 2007
Skills
Formulation Development, Research, GMP, SOP, cGMP, Pharmaceuticals, Clinical Development, Generics, Chemical Engineering, R&D, Pharmaceutical..., Formulation, CRO, HPLC, Product Development, Sop, Pharmaceutical Industry, Laboratory, Process Simulation, Drug Delivery
Education
Rutgers University-New Brunswick 1999 — 2006
M.S., PhD., Chemical Engineering
Virginia Polytechnic Institute and State University 1994 — 1999
B.S., Chemical Engineering
Teva Pharmaceuticals July 2013 - Present
MicroDose Therapeutx September 2012 - July 2013
MicroDose Therapeutx July 2011 - September 2012
Catalent June 2007 - August 2011
Rutgers University May 2006 - May 2007
Skills
Formulation Development, Research, GMP, SOP, cGMP, Pharmaceuticals, Clinical Development, Generics, Chemical Engineering, R&D, Pharmaceutical..., Formulation, CRO, HPLC, Product Development, Sop, Pharmaceutical Industry, Laboratory, Process Simulation, Drug Delivery
Education
Rutgers University-New Brunswick 1999 — 2006
M.S., PhD., Chemical Engineering
Virginia Polytechnic Institute and State University 1994 — 1999
B.S., Chemical Engineering
Carole Evans's Catalent Experience 2006 - 2007
Job Director, Inhalation at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions June 2011 - Present
Merck (legacy Inspire) 2008 - June 2011
Inspire Pharmaceuticals September 2007 - June 2011
Catalent 2006 - 2007
Cardinal Health 2002 - 2006
Magellan Laboratories 1999 - 2001
Magellan Labs 1997 - 1999
Smithkline Beecham 1993 - 1997
Delphi 1991 - 1992
Skills
FDA, GMP, GLP, Technology Transfer, Analysis, Inhalation Toxicology, GCP, Pharmaceutical Industry, Sop, Validation, CAPA, Analytical Chemistry, Regulatory Submissions, Drug Delivery, CRO, Clinical Development, Aseptic Processing, Pharmaceutics, Drug Discovery, Regulatory Affairs, Biotechnology, HPLC, Drug Development, Clinical Trials, R&D
Education
UWIST 1979 — 1984
PhD, Microbiology
Aberystwyth University 1976 — 1979
BSc, Microbiology
Catalent Pharma Solutions June 2011 - Present
Merck (legacy Inspire) 2008 - June 2011
Inspire Pharmaceuticals September 2007 - June 2011
Catalent 2006 - 2007
Cardinal Health 2002 - 2006
Magellan Laboratories 1999 - 2001
Magellan Labs 1997 - 1999
Smithkline Beecham 1993 - 1997
Delphi 1991 - 1992
Skills
FDA, GMP, GLP, Technology Transfer, Analysis, Inhalation Toxicology, GCP, Pharmaceutical Industry, Sop, Validation, CAPA, Analytical Chemistry, Regulatory Submissions, Drug Delivery, CRO, Clinical Development, Aseptic Processing, Pharmaceutics, Drug Discovery, Regulatory Affairs, Biotechnology, HPLC, Drug Development, Clinical Trials, R&D
Education
UWIST 1979 — 1984
PhD, Microbiology
Aberystwyth University 1976 — 1979
BSc, Microbiology
Ella W. Wilson's Catalent Experience 2007 - July 2010
Job Regional Director of Human Resources at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions 2010 - Present
Catalent 2007 - July 2010
Cardinal Health 2005 - 2007
Alaris Medical Systems 1982 - 2005
Skills
Onboarding, Human Resources, Leadership, Succession Planning, Deferred Compensation, Policy, Employee Engagement, Training, Employer Branding, Temporary Placement
Education
Barton College
BS, Business Administration
North Carolina State University
Certificate, Business Coach
Catalent Pharma Solutions 2010 - Present
Catalent 2007 - July 2010
Cardinal Health 2005 - 2007
Alaris Medical Systems 1982 - 2005
Skills
Onboarding, Human Resources, Leadership, Succession Planning, Deferred Compensation, Policy, Employee Engagement, Training, Employer Branding, Temporary Placement
Education
Barton College
BS, Business Administration
North Carolina State University
Certificate, Business Coach
Jennifer Robles's Catalent Experience March 2010 - October 2012
Job QA/RA experience
Industry Pharmaceuticals
Experience
Catalent March 2010 - October 2012
Nuvilex, Inc February 2008 - February 2010
Baxter August 2007 - January 2008
Osteotech, Inc November 2006 - August 2007
L’Oreal USA November 2004 - November 2006
Skills
CAPA, GMP, Sop, Regulatory Affairs, Quality Assurance, Medical Devices, Regulatory Requirements, Quality Auditing, Pharmaceutical Industry, EU GMPs, ICH guidelines
Education
Northeastern University 2004 — 2006
Graduate Certificate, Biopharmaceutical QA/International RA
William Paterson University of New Jersey 1997 — 2002
Bachelor of Science (BS), Biology, General
Catalent March 2010 - October 2012
Nuvilex, Inc February 2008 - February 2010
Baxter August 2007 - January 2008
Osteotech, Inc November 2006 - August 2007
L’Oreal USA November 2004 - November 2006
Skills
CAPA, GMP, Sop, Regulatory Affairs, Quality Assurance, Medical Devices, Regulatory Requirements, Quality Auditing, Pharmaceutical Industry, EU GMPs, ICH guidelines
Education
Northeastern University 2004 — 2006
Graduate Certificate, Biopharmaceutical QA/International RA
William Paterson University of New Jersey 1997 — 2002
Bachelor of Science (BS), Biology, General
Glen Goff's Catalent Experience July 2003 - January 2009
Job CQA, Sr. Quality Auditor at Eisai
Industry Pharmaceuticals
Experience
Eisai January 2009 - Present
Catalent (Formerly Cardinal Health PTS) July 2006 - January 2009
Catalent July 2003 - January 2009
Catalent Pharma Solutions July 2003 - July 2006
Cell Robotics February 1999 - July 2003
Skills
GMP, CAPA, Quality System, Quality Assurance, Sop, FDA, Change Control, Pharmaceutical Industry, Trackwise, 21 CFR Part 11, Manufacturing, Auditing, Validation, V&V, Internal Audit, Sterilization, ASQ-CQA
Education
The University of New Mexico 1988 — 1989
None, General Studies
Liberal Area Vo-Tech 1986 — 1987
Two Technical Certificate, Electrical and Electronics Engineering, 3.0
Eisai January 2009 - Present
Catalent (Formerly Cardinal Health PTS) July 2006 - January 2009
Catalent July 2003 - January 2009
Catalent Pharma Solutions July 2003 - July 2006
Cell Robotics February 1999 - July 2003
Skills
GMP, CAPA, Quality System, Quality Assurance, Sop, FDA, Change Control, Pharmaceutical Industry, Trackwise, 21 CFR Part 11, Manufacturing, Auditing, Validation, V&V, Internal Audit, Sterilization, ASQ-CQA
Education
The University of New Mexico 1988 — 1989
None, General Studies
Liberal Area Vo-Tech 1986 — 1987
Two Technical Certificate, Electrical and Electronics Engineering, 3.0
Blake Snaguski's Catalent Experience December 2008 - February 2014
Job Associate Research Scientist (PPDi Contractor) at BristolMyers Squibb
Industry Pharmaceuticals
Experience
Johnson & Johnson August 2015 - Present
Bristol-Myers Squibb February 2014 - Present
Catalent December 2008 - February 2014
Barr Pharmaceuticals April 2008 - November 2008
Teva Pharmaceuticals May 2007 - April 2008
Skills
HPLC, GMP, FDA, Quality Control, Sop, FTIR, Dissolution, GLP, UV/Vis, Chromatography, Analytical Chemistry, LIMS, Pharmaceutical Industry, Validation, Technology Transfer, ICH Guidelines, TrackWise, Change Control, IND, Laboratory, NDA
Education
Rutgers University-New Brunswick 2005 — 2007
BS, Biochemistry
Johnson & Johnson August 2015 - Present
Bristol-Myers Squibb February 2014 - Present
Catalent December 2008 - February 2014
Barr Pharmaceuticals April 2008 - November 2008
Teva Pharmaceuticals May 2007 - April 2008
Skills
HPLC, GMP, FDA, Quality Control, Sop, FTIR, Dissolution, GLP, UV/Vis, Chromatography, Analytical Chemistry, LIMS, Pharmaceutical Industry, Validation, Technology Transfer, ICH Guidelines, TrackWise, Change Control, IND, Laboratory, NDA
Education
Rutgers University-New Brunswick 2005 — 2007
BS, Biochemistry
Andy Polywacz's Catalent Experience Sr. Director of QualityCardinal HealthMarch 2003 - May 2005
Job General Manager at Catalent
Industry Pharmaceuticals
Experience
Catalent Sr. Director of QualityCardinal HealthMarch 2003 - May 2005
Cardinal Health 2003 - 2005
Cardinal Health 1999 - 2001
Education
National Louis University 1991 — 1995
BA, Business Management
Catalent Sr. Director of QualityCardinal HealthMarch 2003 - May 2005
Cardinal Health 2003 - 2005
Cardinal Health 1999 - 2001
Education
National Louis University 1991 — 1995
BA, Business Management
Ana Tuckman's Catalent Experience Sr. Director of Bioassays & BiosafetyCatalent2001 - 2008
Job Sr. Director of Bioassays & Biosafety Testing at Catalent
Industry Biotechnology
Experience
Catalent Sr. Director of Bioassays & BiosafetyCatalent2001 - 2008
Education
New York Medical College 1989 — 1994
PhD, Microbiology/Immunology
Catalent Sr. Director of Bioassays & BiosafetyCatalent2001 - 2008
Education
New York Medical College 1989 — 1994
PhD, Microbiology/Immunology
Pamela L. Frederich, SPHR's Catalent Experience June 2008 - June 2014
Job Area DirectorHuman Resources at Catalent Pharma Solutions
Industry Medical Devices
Experience
Catalent Pharma Solutions June 2014 - Present
Catalent June 2008 - June 2014
PayNet, Inc. April 2008 - June 2008
Pactiv July 2007 - 2008
Abbott Laboratories (Point of Care Division) 2004 - 2007
Abbott 1999 - 2004
Abbott Laboratories (Hospital Products Division) 1997 - 1999
Independent Consultant 1994 - 1997
Waste Management, Inc 1992 - 1994
Walgreens 1989 - 1992
Skills
Organizational..., Human Resources, Change Management, Recruiting, Leadership Development, Sourcing, Strategy, Leadership, Training, Deferred Compensation, Program Management, Coaching, Technical Recruiting, Employee Benefits, Management, College Recruiting
Education
DePaul University
BS, Business Management
DePaul University - Charles H. Kellstadt Graduate School of Business
MBA, Human Resources
Catalent Pharma Solutions June 2014 - Present
Catalent June 2008 - June 2014
PayNet, Inc. April 2008 - June 2008
Pactiv July 2007 - 2008
Abbott Laboratories (Point of Care Division) 2004 - 2007
Abbott 1999 - 2004
Abbott Laboratories (Hospital Products Division) 1997 - 1999
Independent Consultant 1994 - 1997
Waste Management, Inc 1992 - 1994
Walgreens 1989 - 1992
Skills
Organizational..., Human Resources, Change Management, Recruiting, Leadership Development, Sourcing, Strategy, Leadership, Training, Deferred Compensation, Program Management, Coaching, Technical Recruiting, Employee Benefits, Management, College Recruiting
Education
DePaul University
BS, Business Management
DePaul University - Charles H. Kellstadt Graduate School of Business
MBA, Human Resources
Mary Foster's Catalent Experience 2007 - Present
Job Chair Expert Committee, Packaging, Storage and Distribution of Drug Products at United States Pharmacopeia
Industry Pharmaceuticals
Experience
United States Pharmacopeia May 2010 - Present
Catalent Pharma Solutions November 2009 - Present
Catalent 2007 - Present
United States Pharmacopeia 2005 - Present
Cardinal Health Inc. 2003 - 2007
Education
University of Kentucky 1979 — 1983
United States Pharmacopeia May 2010 - Present
Catalent Pharma Solutions November 2009 - Present
Catalent 2007 - Present
United States Pharmacopeia 2005 - Present
Cardinal Health Inc. 2003 - 2007
Education
University of Kentucky 1979 — 1983
Frank Shen's Catalent Experience September 2007 - March 2009
Job Project Manager at SSOE
Industry Design
Experience
Evergreen EDC (SSOE) December 2010 - Present
Genentech November 2009 - November 2010
Catalent September 2007 - March 2009
Wyeth July 2003 - August 2007
Bayer Pharmaceuticals November 1998 - June 2003
Skills
GMP, Technology Transfer, Pharmaceutical Industry, FDA, Project Management, Validation, Cross-functional Team..., Biotechnology, Quality Assurance, Process Simulation
Education
University of Connecticut 1993 — 1996
Evergreen EDC (SSOE) December 2010 - Present
Genentech November 2009 - November 2010
Catalent September 2007 - March 2009
Wyeth July 2003 - August 2007
Bayer Pharmaceuticals November 1998 - June 2003
Skills
GMP, Technology Transfer, Pharmaceutical Industry, FDA, Project Management, Validation, Cross-functional Team..., Biotechnology, Quality Assurance, Process Simulation
Education
University of Connecticut 1993 — 1996
Fran Ford's Catalent Experience 2003 - Present
Job Sr. Operations Manager at Aptuit
Industry Pharmaceuticals
Experience
Catalent 2003 - Present
Education
Nassau Community College 1974 — 1976
Catalent 2003 - Present
Education
Nassau Community College 1974 — 1976
Deirdre (Dee) Abelha's Catalent Experience October 2005 - February 2006
Job Director, Global compliance Auidts at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions July 2012 - Present
Catalent Pharma Solutions March 2006 - June 2012
Catalent October 2005 - February 2006
Catalent November 2004 - November 2005
Schering-Plough Pharmaceuticals November 2001 - November 2004
Skills
cGMP, FDA, Auditing, Change Control, Regulatory Affairs, Metrology, Metrics, CAPA, Root Cause Analysis, Complaint Management, Compliance Management, Quality Assurance, Budgeting, Quality Agreements, DMFs, SMFs, APRs, Validations, Laboratory Techniques, Six Sigma, Continuous Improvement
Education
Fairleigh Dickinson University 1997 — 2004
MBA, Pharmaceutical Chemical Studies
Newbury College 1985 — 1987
AS, Business Management
Merrimack College 1979 — 1983
BA, Biology
Catalent Pharma Solutions July 2012 - Present
Catalent Pharma Solutions March 2006 - June 2012
Catalent October 2005 - February 2006
Catalent November 2004 - November 2005
Schering-Plough Pharmaceuticals November 2001 - November 2004
Skills
cGMP, FDA, Auditing, Change Control, Regulatory Affairs, Metrology, Metrics, CAPA, Root Cause Analysis, Complaint Management, Compliance Management, Quality Assurance, Budgeting, Quality Agreements, DMFs, SMFs, APRs, Validations, Laboratory Techniques, Six Sigma, Continuous Improvement
Education
Fairleigh Dickinson University 1997 — 2004
MBA, Pharmaceutical Chemical Studies
Newbury College 1985 — 1987
AS, Business Management
Merrimack College 1979 — 1983
BA, Biology
Linda Hinish's Catalent Experience January 2001 - October 2013
Job Estimator at Catalent
Industry Packaging and Containers
Experience
Packaging Coordinators November 2013 - Present
Catalent January 2001 - October 2013
Catalent Pharma Solutions 2001 - October 2013
Cardinal Health 2001 - 2007
Skills
New Business Development, GMP, Pharmaceutical Industry, Supply Chain Management, Quality System, Change Control, Quality Assurance, Process Improvement, Strategic Planning, Six Sigma, Packaging, Sop, Cross-functional Team..., Forecasting, Manufacturing
Education
Bucks County Community College 1976 — 1978
Packaging Coordinators November 2013 - Present
Catalent January 2001 - October 2013
Catalent Pharma Solutions 2001 - October 2013
Cardinal Health 2001 - 2007
Skills
New Business Development, GMP, Pharmaceutical Industry, Supply Chain Management, Quality System, Change Control, Quality Assurance, Process Improvement, Strategic Planning, Six Sigma, Packaging, Sop, Cross-functional Team..., Forecasting, Manufacturing
Education
Bucks County Community College 1976 — 1978
Dorie Hall's Catalent Experience February 2008 - Present
Job Senior Proposal Lead
Industry Accounting
Experience
Catalent February 2008 - Present
Catalent Pharma Solutions April 2007 - February 2008
Cardinal Health, SPS April 1995 - April 2007
PCI January 1989 - April 1995
Skills
Pharmaceutical Industry, JD Edwards, Process Improvement, Supply Chain, Budgets, Variance Analysis, Sales Operations, Six Sigma, Project Management, Sop, Pharmaceutics, Forecasting, SAP, Accounting, Invoicing, GMP, Accounts Receivable, Cross-functional Team..., Manufacturing, FDA, SOP
Education
Community College of Philadelphia 2008 — 2012
Business
Little Flower High School 1979 — 1983
High School Diploma
Catalent February 2008 - Present
Catalent Pharma Solutions April 2007 - February 2008
Cardinal Health, SPS April 1995 - April 2007
PCI January 1989 - April 1995
Skills
Pharmaceutical Industry, JD Edwards, Process Improvement, Supply Chain, Budgets, Variance Analysis, Sales Operations, Six Sigma, Project Management, Sop, Pharmaceutics, Forecasting, SAP, Accounting, Invoicing, GMP, Accounts Receivable, Cross-functional Team..., Manufacturing, FDA, SOP
Education
Community College of Philadelphia 2008 — 2012
Business
Little Flower High School 1979 — 1983
High School Diploma
Jayme Corbell's Catalent Experience March 2008 - Present
Job Research Scientist
Industry Pharmaceuticals
Brad Disch's Catalent Experience 2007 - 2010
Job Quality Director, Validations and QA Technical Services at PCI (Packaging Coordinators Inc)
Industry Pharmaceuticals
Experience
PCI (Packaging Coordinators Inc) March 2014 - Present
Packaging Coordinators, Inc. 2010 - March 2014
Catalent 2007 - 2010
Catalent 2002 - 2007
Skills
Validation, Quality Assurance, Validations, GMP, CAPA, Cleaning Validation, Quality Systems, Change Control, cGMP, Process Validation, SOP, Computer System..., GxP, 21 CFR Part 11, GAMP, Root Cause Analysis, Regulatory Affairs, Pharmaceuticals, Environmental Monitoring, QC, Packaging, Quality Management, Medical Devices, FMEA, Auditing
Education
California National University for Advanced Studies 2004 — 2007
Illinois State University 1989 — 1991
PCI (Packaging Coordinators Inc) March 2014 - Present
Packaging Coordinators, Inc. 2010 - March 2014
Catalent 2007 - 2010
Catalent 2002 - 2007
Skills
Validation, Quality Assurance, Validations, GMP, CAPA, Cleaning Validation, Quality Systems, Change Control, cGMP, Process Validation, SOP, Computer System..., GxP, 21 CFR Part 11, GAMP, Root Cause Analysis, Regulatory Affairs, Pharmaceuticals, Environmental Monitoring, QC, Packaging, Quality Management, Medical Devices, FMEA, Auditing
Education
California National University for Advanced Studies 2004 — 2007
Illinois State University 1989 — 1991
william wessel's Catalent Experience 2004 - Present
Job Downstream Process Development Scientist at Catalent Pharma Solutions
Industry Biotechnology
Experience
Catalent 2004 - Present
Scientific Protein Labs 1994 - 2004
Skills
Biotechnology, Protein Purification, Chromatography, Validation, Biopharmaceuticals, Cell Culture, ELISA, FDA, HPLC, Protein Chemistry, Sop, Technology Transfer, GMP, GLP, Lifesciences, Pharmaceutical Industry, Purification
Education
School of Pharmacy, U. of London 1983 — 1987
Ph.D., Biochemistry
Saint Lawrence University
Bachelor of Science (BS), Biology/Chemistry
Catalent 2004 - Present
Scientific Protein Labs 1994 - 2004
Skills
Biotechnology, Protein Purification, Chromatography, Validation, Biopharmaceuticals, Cell Culture, ELISA, FDA, HPLC, Protein Chemistry, Sop, Technology Transfer, GMP, GLP, Lifesciences, Pharmaceutical Industry, Purification
Education
School of Pharmacy, U. of London 1983 — 1987
Ph.D., Biochemistry
Saint Lawrence University
Bachelor of Science (BS), Biology/Chemistry
Monaca Richardson's Catalent Experience April 2007 - Present
Job Associate Scientist, Technical Reviewer at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent April 2007 - Present
Cardinal Health 2002 - 2007
Magellan Laboratories 2001 - 2002
AAIPharma 1998 - 2001
Labcorp 1990 - 1998
Skills
Pharmaceutical Industry, GMP, Sop, Laboratory, Software Documentation, Quality Control, GLP, Analytical Chemistry, V&V, HPLC, CRO, UV/Vis, Validation, FDA, Biotechnology, Chromatography
Education
North Carolina State University 1984 — 1989
BS, Biological Sciences
Catalent April 2007 - Present
Cardinal Health 2002 - 2007
Magellan Laboratories 2001 - 2002
AAIPharma 1998 - 2001
Labcorp 1990 - 1998
Skills
Pharmaceutical Industry, GMP, Sop, Laboratory, Software Documentation, Quality Control, GLP, Analytical Chemistry, V&V, HPLC, CRO, UV/Vis, Validation, FDA, Biotechnology, Chromatography
Education
North Carolina State University 1984 — 1989
BS, Biological Sciences
David Loar's Catalent Experience 2006 - Present
Job at
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions General ManagerPharmadyne, LLC2013 - Present
Catalent 2006 - Present
Catalent Pharma Solutions Inc 2005 - Present
Catalent Pharma Solutions, Inc 2005 - Present
Synthon Pharmaceuticals Inc January 2004 - December 2004
Purdue Pharma January 1999 - January 2004
GlaxoSmithKline January 1984 - January 1999
GSK 1984 - 1999
Skills
21 CFR Part 11, Aseptic Processing, Biotechnology, Automation, Change Control, CAPA, Calibration, Continuous Improvement, Contract Manufacturing, Cross-functional Team..., FDA, Engineering, GMP, GxP, LIMS, Lean Manufacturing, Manufacturing, Medical Devices, Operational Excellence, Pharmaceutical Industry, Project Management, Quality Assurance, R, Quality System, Six Sigma, Software Documentation, Sop, Technical Writing, V, Validation, SOP
Education
Varies over the years 1990 — 2000
No, Mechanical
North Carolina State University
Catalent Pharma Solutions General ManagerPharmadyne, LLC2013 - Present
Catalent 2006 - Present
Catalent Pharma Solutions Inc 2005 - Present
Catalent Pharma Solutions, Inc 2005 - Present
Synthon Pharmaceuticals Inc January 2004 - December 2004
Purdue Pharma January 1999 - January 2004
GlaxoSmithKline January 1984 - January 1999
GSK 1984 - 1999
Skills
21 CFR Part 11, Aseptic Processing, Biotechnology, Automation, Change Control, CAPA, Calibration, Continuous Improvement, Contract Manufacturing, Cross-functional Team..., FDA, Engineering, GMP, GxP, LIMS, Lean Manufacturing, Manufacturing, Medical Devices, Operational Excellence, Pharmaceutical Industry, Project Management, Quality Assurance, R, Quality System, Six Sigma, Software Documentation, Sop, Technical Writing, V, Validation, SOP
Education
Varies over the years 1990 — 2000
No, Mechanical
North Carolina State University
Kurt Nielsen, Ph.D.'s Catalent Experience February 2010 - March 2015
Job Vice President, US Development, Portfolio and Launch Management at Sandoz
Industry Pharmaceuticals
Experience
Sandoz March 2015 - Present
Catalent February 2010 - March 2015
URL Pharma March 2004 - February 2010
TEVA December 1998 - March 2004
McNeil Consumer Healthcare August 1997 - December 1998
Energy Biosystems Corporation 1995 - 1997
Skills
Drug Development, R&D, Biotechnology, Clinical Development, Pharmaceutics, Project Management, Lifesciences, GLP, Analytical Chemistry, Pharmaceutical Industry, Regulatory Affairs, Clinical Trials, FDA, Drug Delivery, LIMS, Leadership, GMP, Technology Transfer, Validation, 21 CFR Part 11, CAPA, HPLC, Six Sigma, Drug Discovery, Quality System, Sop, UV/Vis, Life Sciences, SOP, Biosimilars
Education
Villanova University 1990 — 1994
Ph.D., Chemistry
University of Delaware 1985 — 1989
BS, Chemistry
Sandoz March 2015 - Present
Catalent February 2010 - March 2015
URL Pharma March 2004 - February 2010
TEVA December 1998 - March 2004
McNeil Consumer Healthcare August 1997 - December 1998
Energy Biosystems Corporation 1995 - 1997
Skills
Drug Development, R&D, Biotechnology, Clinical Development, Pharmaceutics, Project Management, Lifesciences, GLP, Analytical Chemistry, Pharmaceutical Industry, Regulatory Affairs, Clinical Trials, FDA, Drug Delivery, LIMS, Leadership, GMP, Technology Transfer, Validation, 21 CFR Part 11, CAPA, HPLC, Six Sigma, Drug Discovery, Quality System, Sop, UV/Vis, Life Sciences, SOP, Biosimilars
Education
Villanova University 1990 — 1994
Ph.D., Chemistry
University of Delaware 1985 — 1989
BS, Chemistry
Richard Sobien's Catalent Experience February 2008 - May 2008
Job Quality Engineer at bioMerieux
Industry Medical Devices
Experience
bioMerieux October 2013 - Present
OSO BioPharmaceuticals Manufacturing May 2008 - February 2013
Catalent February 2008 - May 2008
Progressive Insurance June 2007 - February 2008
E.C.I. January 2003 - February 2008
The MIND Institute March 2003 - June 2007
US Army March 1997 - September 2001
New Mexico Tech February 1997 - December 1999
New Mexico Tech February 1997 - December 1999
US Army September 1993 - February 1997
Skills
Documentation, GMP, Investigations, Compliance, Quality Assurance, Manufacturing, Quality Systems, Auditing, Problem Solving, Mentoring, Pharmaceuticals, Data Analysis, Training, Teamwork, cGMP manufacturing, Pharmaceutical Industry, Time Management, Linux, Computer Hardware, Work Well Independently, Government, Biopharmaceuticals, Biomedical Engineering, Quality System, Protocol, Aseptic Technique, Biotechnology, Software Documentation, Microbiology, Private Investigations, CAPA, Sop, USP, EP, Exception Management, Parenteral, ASQ, FDA, Root Cause Analysis, Change Control, Risk Assessment, Contamination Control, Aseptic Processing, line clearance, Investigation, Environmental Monitoring, Metrics, Troubleshooting, Validation, Sterilization
Education
New Mexico Institute of Mining and Technology 1997 — 2001
BS, Biology
New Mexico Institute of Mining and Technology
bioMerieux October 2013 - Present
OSO BioPharmaceuticals Manufacturing May 2008 - February 2013
Catalent February 2008 - May 2008
Progressive Insurance June 2007 - February 2008
E.C.I. January 2003 - February 2008
The MIND Institute March 2003 - June 2007
US Army March 1997 - September 2001
New Mexico Tech February 1997 - December 1999
New Mexico Tech February 1997 - December 1999
US Army September 1993 - February 1997
Skills
Documentation, GMP, Investigations, Compliance, Quality Assurance, Manufacturing, Quality Systems, Auditing, Problem Solving, Mentoring, Pharmaceuticals, Data Analysis, Training, Teamwork, cGMP manufacturing, Pharmaceutical Industry, Time Management, Linux, Computer Hardware, Work Well Independently, Government, Biopharmaceuticals, Biomedical Engineering, Quality System, Protocol, Aseptic Technique, Biotechnology, Software Documentation, Microbiology, Private Investigations, CAPA, Sop, USP, EP, Exception Management, Parenteral, ASQ, FDA, Root Cause Analysis, Change Control, Risk Assessment, Contamination Control, Aseptic Processing, line clearance, Investigation, Environmental Monitoring, Metrics, Troubleshooting, Validation, Sterilization
Education
New Mexico Institute of Mining and Technology 1997 — 2001
BS, Biology
New Mexico Institute of Mining and Technology
Gary Wada's Catalent Experience August 2008 - July 2009
Job Exec VP/General Manager
Industry Pharmaceuticals
Experience
CMIC CMO USA Corporation July 2009 - Present
Catalent August 2008 - July 2009
MPT Delivery Systems 2007 - 2008
Watson Foods Co., Inc. 2001 - 2007
Glatt Air Techniques, Inc. 1988 - 2001
Skills
Sop, GMP, Pharmaceutical Industry, Validation, Technology Transfer, Product Development, Manufacturing, FDA, CAPA, Operations Management, Fluid Bed Technology, Contract Services..., R&D, Leadership
Education
Stevens Institute of Technology 1979 — 1983
B. Eng., Chemical Engineering
CMIC CMO USA Corporation July 2009 - Present
Catalent August 2008 - July 2009
MPT Delivery Systems 2007 - 2008
Watson Foods Co., Inc. 2001 - 2007
Glatt Air Techniques, Inc. 1988 - 2001
Skills
Sop, GMP, Pharmaceutical Industry, Validation, Technology Transfer, Product Development, Manufacturing, FDA, CAPA, Operations Management, Fluid Bed Technology, Contract Services..., R&D, Leadership
Education
Stevens Institute of Technology 1979 — 1983
B. Eng., Chemical Engineering
Ron Paradise's Catalent Experience Lead Quality InvestigatorCatalent
Job Lead Quality Investigator at Catalent
Industry Pharmaceuticals
Experience
Catalent Lead Quality InvestigatorCatalent
Education
Clarkson University
Catalent Lead Quality InvestigatorCatalent
Education
Clarkson University
Harry O'Grady, CPA's Catalent Experience October 2008 - December 2009
Job CFO at Cormedix Inc.
Industry Pharmaceuticals
Experience
Cormedix Inc. July 2014 - Present
Mylan Specialty January 2010 - April 2014
Catalent October 2008 - December 2009
Bayer Healthcare November 2006 - June 2008
Berlex / Schering A.G. June 2001 - October 2006
Berlex Laboratories Inc. February 1998 - June 2001
Berlex Laboratories Inc. June 1995 - January 1998
HOECHST ROUSEL PHARMACEUTICAL INC. January 1993 - May 1995
HOECHST CELANESE CORPORATION November 1989 - December 1992
DELOITTE & TOUCHE LLC August 1984 - October 1989
Skills
Negotiation, Mergers, Business Strategy, Core Competences, Business Planning, Forecasting, Managed Care, Pharmaceutical Industry, Strategy, Mergers & Acquisitions, Start-ups, Budgets, Leadership, Business Development, Cross-functional Team..., Financial Reporting, Team Leadership, Process Improvement, Team Building, Sales, Strategic Planning, Finance, Management, Change Management, Biotechnology, Product Launch, Project Planning, Auditing, Financial Analysis, Accounting, Competitive Analysis, Sarbanes-Oxley Act, Pricing, SAP, Financial Modeling, Analysis, Cost Accounting, US GAAP, Acquisition Integration, Strategic Financial..., Due Diligence, Hyperion Enterprise, Variance Analysis, Financial Planning
Education
Lehigh University 1991 — 1993
MBA, Management
Pace University 1981 — 1984
BBA, Accounting
Cormedix Inc. July 2014 - Present
Mylan Specialty January 2010 - April 2014
Catalent October 2008 - December 2009
Bayer Healthcare November 2006 - June 2008
Berlex / Schering A.G. June 2001 - October 2006
Berlex Laboratories Inc. February 1998 - June 2001
Berlex Laboratories Inc. June 1995 - January 1998
HOECHST ROUSEL PHARMACEUTICAL INC. January 1993 - May 1995
HOECHST CELANESE CORPORATION November 1989 - December 1992
DELOITTE & TOUCHE LLC August 1984 - October 1989
Skills
Negotiation, Mergers, Business Strategy, Core Competences, Business Planning, Forecasting, Managed Care, Pharmaceutical Industry, Strategy, Mergers & Acquisitions, Start-ups, Budgets, Leadership, Business Development, Cross-functional Team..., Financial Reporting, Team Leadership, Process Improvement, Team Building, Sales, Strategic Planning, Finance, Management, Change Management, Biotechnology, Product Launch, Project Planning, Auditing, Financial Analysis, Accounting, Competitive Analysis, Sarbanes-Oxley Act, Pricing, SAP, Financial Modeling, Analysis, Cost Accounting, US GAAP, Acquisition Integration, Strategic Financial..., Due Diligence, Hyperion Enterprise, Variance Analysis, Financial Planning
Education
Lehigh University 1991 — 1993
MBA, Management
Pace University 1981 — 1984
BBA, Accounting
Brad LaPlaca's Catalent Experience August 2007 - January 2008
Job Drug Supply Coordinator at Merck
Industry Pharmaceuticals
Experience
Merck November 2008 - Present
Almac Clinical Technologies January 2008 - November 2008
Catalent August 2007 - January 2008
Shire Pharmaceuticals April 2005 - August 2007
Wyeth 2001 - 2004
Education
Temple University 2002 — 2004
Millersville University of Pennsylvania 1994 — 1998
Merck November 2008 - Present
Almac Clinical Technologies January 2008 - November 2008
Catalent August 2007 - January 2008
Shire Pharmaceuticals April 2005 - August 2007
Wyeth 2001 - 2004
Education
Temple University 2002 — 2004
Millersville University of Pennsylvania 1994 — 1998
Daniel Shollenberger's Catalent Experience June 2007 - February 2009
Job Director of Analytics at Sobek Therapeutics, LLC
Industry Pharmaceuticals
Experience
Sobek Therapeutics, LLC May 2013 - Present
Catalent Pharma Solutions May 2012 - May 2013
Catalent Pharma Solutions February 2009 - May 2012
Catalent June 2007 - February 2009
Catalent Pharma Solutions 2006 - 2007
Cardinal Health 2002 - 2006
Merck February 1999 - June 2002
Skills
Certified Black Belt, Analytical Chemistry, Research, Method Development, Stability Studies, Analytical Instruments, method vali, Quality Control, GMP, HPLC, Sop, Dissolution, Analytical Method..., Cleaning Validation, Validation, Change Control, UV/Vis, USP, Wet Chemistry, IR, Analytical Methods...
Education
Delaware Valley College 1995 — 2008
BS, Chemistry
Sobek Therapeutics, LLC May 2013 - Present
Catalent Pharma Solutions May 2012 - May 2013
Catalent Pharma Solutions February 2009 - May 2012
Catalent June 2007 - February 2009
Catalent Pharma Solutions 2006 - 2007
Cardinal Health 2002 - 2006
Merck February 1999 - June 2002
Skills
Certified Black Belt, Analytical Chemistry, Research, Method Development, Stability Studies, Analytical Instruments, method vali, Quality Control, GMP, HPLC, Sop, Dissolution, Analytical Method..., Cleaning Validation, Validation, Change Control, UV/Vis, USP, Wet Chemistry, IR, Analytical Methods...
Education
Delaware Valley College 1995 — 2008
BS, Chemistry
Subrata Das's Catalent Experience October 2005 - May 2008
Job Director of Product Development at Axar Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Axar Pharmaceuticals, Inc. May 2014 - Present
Actavis plc December 2013 - April 2014
Watson Pharmaceuticals May 2008 - November 2013
Catalent October 2005 - May 2008
Morton Grove Pharmaceuticals April 2004 - October 2005
CBR Institute for Biomedical Research, Harvard Medical School February 2001 - April 2004
Yale University School of Medicine October 1998 - February 2001
Skills
GLP, GMP, HPLC, Technology Transfer, Drug Delivery, Pharmaceutical Industry, Analytical Chemistry, Validation, Sop, FDA, Chromatography, Regulatory Affairs, Formulation, Drug Development, Biotechnology, Pharmaceutics, Dissolution, Regulatory Submissions, R&D, LIMS, CRO, ANDA, IND, SOP
Education
Louisiana State University and Agricultural and Mechanical College 1987 — 1992
Ph.D., Physiology and Biochemistry
University of Calcutta
MS, Zoology
Axar Pharmaceuticals, Inc. May 2014 - Present
Actavis plc December 2013 - April 2014
Watson Pharmaceuticals May 2008 - November 2013
Catalent October 2005 - May 2008
Morton Grove Pharmaceuticals April 2004 - October 2005
CBR Institute for Biomedical Research, Harvard Medical School February 2001 - April 2004
Yale University School of Medicine October 1998 - February 2001
Skills
GLP, GMP, HPLC, Technology Transfer, Drug Delivery, Pharmaceutical Industry, Analytical Chemistry, Validation, Sop, FDA, Chromatography, Regulatory Affairs, Formulation, Drug Development, Biotechnology, Pharmaceutics, Dissolution, Regulatory Submissions, R&D, LIMS, CRO, ANDA, IND, SOP
Education
Louisiana State University and Agricultural and Mechanical College 1987 — 1992
Ph.D., Physiology and Biochemistry
University of Calcutta
MS, Zoology
Jacob Coreano's Catalent Experience January 2008 - March 2010
Job Business & Planning Analyst at Boeing
Industry Accounting
Experience
Boeing March 2010 - Present
Catalent January 2008 - March 2010
Standex International November 2004 - November 2007
EmCare November 2003 - November 2004
HBO Latin America September 2002 - May 2003
Unisys May 1999 - January 2002
Skills
Variance Analysis, Financial Reporting, Accounting, Financial Analysis, Forecasting, GAAP, Financial Accounting, Process Improvement, JD Edwards, Budgets, Cash Flow, Microsoft Excel, Cost Accounting, Sarbanes-Oxley Act, General Ledger, Analysis, Pricing, Account Reconciliation, Internal Controls, Payroll, Finance, Cost Benefit, Financial Statements
Education
Liberty University 2006 — 2009
MBA, Business Administration
West Chester University of Pennsylvania 1995 — 1999
BS, Accounting
Boeing March 2010 - Present
Catalent January 2008 - March 2010
Standex International November 2004 - November 2007
EmCare November 2003 - November 2004
HBO Latin America September 2002 - May 2003
Unisys May 1999 - January 2002
Skills
Variance Analysis, Financial Reporting, Accounting, Financial Analysis, Forecasting, GAAP, Financial Accounting, Process Improvement, JD Edwards, Budgets, Cash Flow, Microsoft Excel, Cost Accounting, Sarbanes-Oxley Act, General Ledger, Analysis, Pricing, Account Reconciliation, Internal Controls, Payroll, Finance, Cost Benefit, Financial Statements
Education
Liberty University 2006 — 2009
MBA, Business Administration
West Chester University of Pennsylvania 1995 — 1999
BS, Accounting
Thomas Brown III's Catalent Experience February 2008 - August 2008
Job Chemist/Scientist with Medtronic Minimed Diabetes
Industry Medical Devices
Experience
Medtronic September 2010 - Present
Medtronic December 2008 - August 2010
Catalent February 2008 - August 2008
Skills
cGMP, HPLC, GMP, Pharmaceuticals, SOP, Gas Chromatography, Electrochemistry, Polymers, ICP-OES, IR, UV-Vis, DSC, R, Analytical Chemistry, Chromatography, Wet Chemistry, FDA, CAPA, GLP, 21 CFR Part 11, Design of Experiments, Organic Chemistry, Laboratory, Biotechnology, Polymer Chemistry, Drug Delivery, Medical Devices, Quality Control, SDS-PAGE, Biochemistry, Validation, FTIR, LC-MS, Chemistry, ISO 13485, FDA GMP, Spectroscopy, Quality System, Polymer Characterization, Biomaterials, Aseptic Technique, Biomedical Engineering, ISO 14971, Gel Electrophoresis, Microscopy, LIMS, V&V, Pharmaceutical Industry, Microsoft Excel, Data Analysis
Education
North Carolina State University 2003 — 2007
Bachelor of Science (BS), Biochemistry
Cape Fear Community College 2001 — 2003
Associate of Arts (AA), Transfer Studies
Medtronic September 2010 - Present
Medtronic December 2008 - August 2010
Catalent February 2008 - August 2008
Skills
cGMP, HPLC, GMP, Pharmaceuticals, SOP, Gas Chromatography, Electrochemistry, Polymers, ICP-OES, IR, UV-Vis, DSC, R, Analytical Chemistry, Chromatography, Wet Chemistry, FDA, CAPA, GLP, 21 CFR Part 11, Design of Experiments, Organic Chemistry, Laboratory, Biotechnology, Polymer Chemistry, Drug Delivery, Medical Devices, Quality Control, SDS-PAGE, Biochemistry, Validation, FTIR, LC-MS, Chemistry, ISO 13485, FDA GMP, Spectroscopy, Quality System, Polymer Characterization, Biomaterials, Aseptic Technique, Biomedical Engineering, ISO 14971, Gel Electrophoresis, Microscopy, LIMS, V&V, Pharmaceutical Industry, Microsoft Excel, Data Analysis
Education
North Carolina State University 2003 — 2007
Bachelor of Science (BS), Biochemistry
Cape Fear Community College 2001 — 2003
Associate of Arts (AA), Transfer Studies
Anish Parikh's Catalent Experience September 2008 - September 2012
Job Senior Director Business Development at Ajinomoto Althea
Industry Pharmaceuticals
Experience
Ajinomoto Althea, Inc. June 2014 - Present
Ajinomoto Althea September 2012 - May 2014
Catalent September 2008 - September 2012
Skills
Technology Transfer, Biopharmaceuticals, Business Development, Microsoft Office, Drug Development, FDA, Product Management, CRO, Contract Negotiation, Clinical Trials, Pharmaceutical Industry, Competitive Intelligence, Clinical Development, Pharmaceutics, Commercialization, Formulation, Drug Discovery, Cross-functional Team..., Biotechnology, GMP, Life Sciences
Education
Rutgers University-New Brunswick
BS, Molecular Biology and Biochemistry
Ajinomoto Althea, Inc. June 2014 - Present
Ajinomoto Althea September 2012 - May 2014
Catalent September 2008 - September 2012
Skills
Technology Transfer, Biopharmaceuticals, Business Development, Microsoft Office, Drug Development, FDA, Product Management, CRO, Contract Negotiation, Clinical Trials, Pharmaceutical Industry, Competitive Intelligence, Clinical Development, Pharmaceutics, Commercialization, Formulation, Drug Discovery, Cross-functional Team..., Biotechnology, GMP, Life Sciences
Education
Rutgers University-New Brunswick
BS, Molecular Biology and Biochemistry
Kumar Goonewardene's Catalent Experience February 2012 - Present
Job Quality Assurance at Aptuit
Industry Pharmaceuticals
Experience
Catalent February 2012 - Present
Catalent Pharma Solutions 2004 - Present
Aptuit January 2004 - January 2012
Quintiles Clinical Supplies January 2001 - January 2004
Alliance Data Systems January 1998 - January 2000
Skills
GMP, 21 CFR Part 11, CAPA, Pharmaceutical Industry
Education
Rowan University
Bachelor of Arts (B.A.), Speech\Communication
Rowan University
Bachelor of Arts, Speech/Theatre
Catalent February 2012 - Present
Catalent Pharma Solutions 2004 - Present
Aptuit January 2004 - January 2012
Quintiles Clinical Supplies January 2001 - January 2004
Alliance Data Systems January 1998 - January 2000
Skills
GMP, 21 CFR Part 11, CAPA, Pharmaceutical Industry
Education
Rowan University
Bachelor of Arts (B.A.), Speech\Communication
Rowan University
Bachelor of Arts, Speech/Theatre
David Boerschel's Catalent Experience January 2009 - November 2010
Job Program Manager Sterile Products at Catalent
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions Program Manager; PMP certifiedCatalent Pharma SolutionsNovember 2010 - Present
Catalent January 2009 - November 2010
Catalent Pharm Solutions November 2003 - January 2009
Catalent Pharma Solutions January 2002 - October 2003
Motorola 1995 - 2001
Skills
GMP, Contract Manufacturing, MRP, Materials Management, Manufacturing Operations, Production Planning, PMP certified
Education
Iowa State University 1986 — 1990
Finance, Business
Catalent Pharma Solutions Program Manager; PMP certifiedCatalent Pharma SolutionsNovember 2010 - Present
Catalent January 2009 - November 2010
Catalent Pharm Solutions November 2003 - January 2009
Catalent Pharma Solutions January 2002 - October 2003
Motorola 1995 - 2001
Skills
GMP, Contract Manufacturing, MRP, Materials Management, Manufacturing Operations, Production Planning, PMP certified
Education
Iowa State University 1986 — 1990
Finance, Business
Stephen Paton's Catalent Experience December 2007 - May 2008
Job Director Operations Integrated Managed Services/Professional Services
Industry Pharmaceuticals
Experience
Advanced Testing Laboratory July 2009 - Present
Advanced Testing Laboratory 2009 - February 2012
Catalent December 2007 - May 2008
Eli Lilly January 2004 - November 2007
Eli Lilly July 1998 - December 2003
Skills
Lean Manufacturing, GMP, Quality Assurance, Cross-functional Team..., Contract Manufacturing, Chemistry, cGMP, Change Management, Analytical Chemistry, Pharmaceuticals, Operations Management, Pharmaceutical Industry, Manufacturing, Validation, Process Improvement, Leadership, Quality Management, FDA, Continuous Improvement, Six Sigma, Quality Control
Education
Kingston University 2002 — 2004
Masters, Pharmaceutical Analysis
Advanced Testing Laboratory July 2009 - Present
Advanced Testing Laboratory 2009 - February 2012
Catalent December 2007 - May 2008
Eli Lilly January 2004 - November 2007
Eli Lilly July 1998 - December 2003
Skills
Lean Manufacturing, GMP, Quality Assurance, Cross-functional Team..., Contract Manufacturing, Chemistry, cGMP, Change Management, Analytical Chemistry, Pharmaceuticals, Operations Management, Pharmaceutical Industry, Manufacturing, Validation, Process Improvement, Leadership, Quality Management, FDA, Continuous Improvement, Six Sigma, Quality Control
Education
Kingston University 2002 — 2004
Masters, Pharmaceutical Analysis
Jaime Powell's Catalent Experience October 2005 - Present
Job Planner at Catalent
Industry Pharmaceuticals
Experience
Catalent October 2005 - Present
Catalent Pharma Solutions October 2001 - October 2005
Catalent Pharma Solutions August 1996 - October 2001
Catalent Pharma Solutions November 1995 - August 1996
Skills
GMP, Pharmaceutical Industry, Change Control, Validation, FDA, SOP, CAPA, Regulatory Affairs, Biotechnology, 21 CFR Part 11, GLP
Education
Bluegrass Community and Technical College
Catalent October 2005 - Present
Catalent Pharma Solutions October 2001 - October 2005
Catalent Pharma Solutions August 1996 - October 2001
Catalent Pharma Solutions November 1995 - August 1996
Skills
GMP, Pharmaceutical Industry, Change Control, Validation, FDA, SOP, CAPA, Regulatory Affairs, Biotechnology, 21 CFR Part 11, GLP
Education
Bluegrass Community and Technical College
Charlie Gustin's Catalent Experience February 2012 - Present
Job Manager at Catalent
Industry Pharmaceuticals
Experience
Catalent February 2012 - Present
Aptuit March 2006 - February 2012
Quintiles December 1998 - March 2006
HMR December 1996 - December 1998
Marion Merrell Dow September 1992 - December 1996
Hercules Aerospace/SFAAP October 1984 - September 1992
Skills
Method Development, GLP, GMP, Sop, Laboratory, Pharmaceutical Industry, Analytical Chemistry, Quality Control, Validation, HPLC, FDA, CRO, Biotechnology, Regulatory Affairs, Lifesciences, Chromatography, Technology Transfer, Chemistry, CAPA, Clinical Trials, Dissolution Testing
Education
University of Kansas 1979 — 1983
Bachelor of Science (BS), Environmental Studies
Catalent February 2012 - Present
Aptuit March 2006 - February 2012
Quintiles December 1998 - March 2006
HMR December 1996 - December 1998
Marion Merrell Dow September 1992 - December 1996
Hercules Aerospace/SFAAP October 1984 - September 1992
Skills
Method Development, GLP, GMP, Sop, Laboratory, Pharmaceutical Industry, Analytical Chemistry, Quality Control, Validation, HPLC, FDA, CRO, Biotechnology, Regulatory Affairs, Lifesciences, Chromatography, Technology Transfer, Chemistry, CAPA, Clinical Trials, Dissolution Testing
Education
University of Kansas 1979 — 1983
Bachelor of Science (BS), Environmental Studies
Angela Fuller's Catalent Experience July 2006 - October 2008
Job Principal Partner at IntegriQual LLC
Industry Research
Experience
IntegriQual LLC June 2015 - Present
Eurofins AgroSciences July 2009 - June 2015
Compliance Assessment October 2008 - June 2009
Catalent July 2006 - October 2008
Cardinal Health September 2003 - July 2006
Bluegrass Family Health January 2000 - September 2003
PTRL East, Inc. September 1988 - December 1999
Skills
Quality Assurance, EPA, GLP, GMP, Regulatory Affairs, FDA, Quality System, Biotechnology, SOP, Pharmaceutical Industry, Life Sciences, Validation, Auditing, CAPA, R&D, Laboratory, DEA, HPLC, Quality Auditing, Microbiology, Software Documentation, 21 CFR Part 11, Aseptic Processing, Minitab, Lifesciences, Analytical Chemistry, Six Sigma, Quality Control, GxP, Change Control, Quality Systems, Documentation
Education
Eastern Kentucky University 1985 — 1991
Bachelors
IntegriQual LLC June 2015 - Present
Eurofins AgroSciences July 2009 - June 2015
Compliance Assessment October 2008 - June 2009
Catalent July 2006 - October 2008
Cardinal Health September 2003 - July 2006
Bluegrass Family Health January 2000 - September 2003
PTRL East, Inc. September 1988 - December 1999
Skills
Quality Assurance, EPA, GLP, GMP, Regulatory Affairs, FDA, Quality System, Biotechnology, SOP, Pharmaceutical Industry, Life Sciences, Validation, Auditing, CAPA, R&D, Laboratory, DEA, HPLC, Quality Auditing, Microbiology, Software Documentation, 21 CFR Part 11, Aseptic Processing, Minitab, Lifesciences, Analytical Chemistry, Six Sigma, Quality Control, GxP, Change Control, Quality Systems, Documentation
Education
Eastern Kentucky University 1985 — 1991
Bachelors
Brian Rhatigan's Catalent Experience November 2005 - December 2008
Job Director, Quality and Regulatory Affairs at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions October 2014 - Present
Catalent Pharma Solutions April 2013 - Present
Catalent Pharma Solutions March 2012 - April 2013
Catalent Pharma Solutions August 2011 - June 2012
Catalent Pharma Solutions December 2008 - August 2011
Catalent November 2005 - December 2008
Siegfried (USA) January 2001 - November 2005
Skills
CAPA, Quality Assurance, GMP, Quality Control, Pharmaceutical Industry, GLP, FDA, Change Control, V&V, Sop, Quality Auditing, Quality System, GAMP, Technology Transfer, Cleaning Validation, 21 CFR Part 11, Validation, GxP, Computer System..., SOP
Education
University of Delaware 2001 — 2004
MBA
University of Delaware 1998 — 2000
M.A., Chemistry
SUNY Oneonta 1994 — 1998
BS, Chemistry
Catalent Pharma Solutions October 2014 - Present
Catalent Pharma Solutions April 2013 - Present
Catalent Pharma Solutions March 2012 - April 2013
Catalent Pharma Solutions August 2011 - June 2012
Catalent Pharma Solutions December 2008 - August 2011
Catalent November 2005 - December 2008
Siegfried (USA) January 2001 - November 2005
Skills
CAPA, Quality Assurance, GMP, Quality Control, Pharmaceutical Industry, GLP, FDA, Change Control, V&V, Sop, Quality Auditing, Quality System, GAMP, Technology Transfer, Cleaning Validation, 21 CFR Part 11, Validation, GxP, Computer System..., SOP
Education
University of Delaware 2001 — 2004
MBA
University of Delaware 1998 — 2000
M.A., Chemistry
SUNY Oneonta 1994 — 1998
BS, Chemistry
Renee Collette-Mull's Catalent Experience 2004 - June 2009
Job Manufacturing Quality Manager at Elanco
Industry Pharmaceuticals
Experience
Elanco (Formerly Novartis Animal Health) June 2012 - Present
Banner Pharmacaps July 2009 - June 2012
Catalent Pharma Services January 2004 - June 2009
Catalent 2004 - June 2009
Cardinal Health 1999 - 2006
Richarson Vicks 1989 - 1992
Skills
GMP, CAPA, Sop, FDA, GLP, Validation, Regulatory Affairs, Pharmaceutical Industry, Technology Transfer, GCP, V&V, Pharmaceutics, Change Control, Quality System, Regulatory Requirements, Cleaning Validation, Formulation, Biotechnology, CRO, Analytical Chemistry, Chromatography, Aseptic Processing, Clinical Trials, GxP, Quality Auditing, R&D, Clinical Development, Quality Assurance, Trackwise, LIMS, Generic Programming, Biopharmaceuticals, Chemistry, Root Cause Analysis, Regulatory Submissions, Contract Manufacturing, Lifesciences, IND, Pharmacovigilance, Computer System..., ISO 13485, Dissolution, Drug Delivery, Drug Development, Quality Control, Quality Management, Manufacturing, eCTD, Medical Devices, HPLC
Education
Florida Metropolitan University 2000 — 2002
MBA, Business
University of Rhode Island 1986 — 1989
MS, Food Science
Simmons College 1982 — 1986
BS, Nutrition
Elanco (Formerly Novartis Animal Health) June 2012 - Present
Banner Pharmacaps July 2009 - June 2012
Catalent Pharma Services January 2004 - June 2009
Catalent 2004 - June 2009
Cardinal Health 1999 - 2006
Richarson Vicks 1989 - 1992
Skills
GMP, CAPA, Sop, FDA, GLP, Validation, Regulatory Affairs, Pharmaceutical Industry, Technology Transfer, GCP, V&V, Pharmaceutics, Change Control, Quality System, Regulatory Requirements, Cleaning Validation, Formulation, Biotechnology, CRO, Analytical Chemistry, Chromatography, Aseptic Processing, Clinical Trials, GxP, Quality Auditing, R&D, Clinical Development, Quality Assurance, Trackwise, LIMS, Generic Programming, Biopharmaceuticals, Chemistry, Root Cause Analysis, Regulatory Submissions, Contract Manufacturing, Lifesciences, IND, Pharmacovigilance, Computer System..., ISO 13485, Dissolution, Drug Delivery, Drug Development, Quality Control, Quality Management, Manufacturing, eCTD, Medical Devices, HPLC
Education
Florida Metropolitan University 2000 — 2002
MBA, Business
University of Rhode Island 1986 — 1989
MS, Food Science
Simmons College 1982 — 1986
BS, Nutrition
Brian Birt's Catalent Experience September 2008 - Present
Job Sr. QA Technical Specialist at Catalent
Industry Pharmaceuticals
Experience
Catalent September 2008 - Present
Catalent Pharma Solutions 1999 - 2008
Education
Keller Graduate School of Management of DeVry University 2006 — 2009
MBA and MISM, Business and Information Systems
MBA and MISM
Catalent September 2008 - Present
Catalent Pharma Solutions 1999 - 2008
Education
Keller Graduate School of Management of DeVry University 2006 — 2009
MBA and MISM, Business and Information Systems
MBA and MISM
Holly Rackett's Catalent Experience May 2011 - December 2012
Job Owner & Event Planner at Feather + Rock Events
Industry Events Services
Experience
Feather + Rock Events January 2015 - Present
Catalent Pharma Solutions December 2012 - June 2014
Catalent May 2011 - December 2012
Catalent Pharma Solutions December 2007 - May 2011
PFS Marketwyse September 2006 - October 2007
Skills
Marketing Communications, Marketing, Digital Marketing, Account Management, Advertising, Marketing Management, Public Relations, Social Media Marketing, Salesforce.com, Internal Communications, Trade Shows, Corporate Events, Private Events, Corporate Communications, Event Management, Event Planning, Coordinating Special..., Collateral Writing, Collateral Materials..., Booth Staff Training, Cross-functional Team..., Product Launch, CRM
Education
Montclair State University 2004 — 2007
Bachelor of Arts, Public Relations/Marketing, Cum Laude
Brookdale: The County College of Monmouth 2003 — 2004
The College of Mount Saint Vincent 2002 — 2003
Feather + Rock Events January 2015 - Present
Catalent Pharma Solutions December 2012 - June 2014
Catalent May 2011 - December 2012
Catalent Pharma Solutions December 2007 - May 2011
PFS Marketwyse September 2006 - October 2007
Skills
Marketing Communications, Marketing, Digital Marketing, Account Management, Advertising, Marketing Management, Public Relations, Social Media Marketing, Salesforce.com, Internal Communications, Trade Shows, Corporate Events, Private Events, Corporate Communications, Event Management, Event Planning, Coordinating Special..., Collateral Writing, Collateral Materials..., Booth Staff Training, Cross-functional Team..., Product Launch, CRM
Education
Montclair State University 2004 — 2007
Bachelor of Arts, Public Relations/Marketing, Cum Laude
Brookdale: The County College of Monmouth 2003 — 2004
The College of Mount Saint Vincent 2002 — 2003
Carolyn LaPrairie's Catalent Experience November 2005 - December 2009
Job Chief, USCENTCOM Human Capital at DIA USCENTCOM
Industry Pharmaceuticals
Experience
DIA USCENTCOM March 2009 - Present
Catalent November 2005 - December 2009
Cardinal Health January 2004 - November 2005
Advantec April 2000 - October 2003
United States Air Force February 1978 - July 1992
Education
Auburn University at Montgomery 1992 — 1996
B.S., Psychology
DIA USCENTCOM March 2009 - Present
Catalent November 2005 - December 2009
Cardinal Health January 2004 - November 2005
Advantec April 2000 - October 2003
United States Air Force February 1978 - July 1992
Education
Auburn University at Montgomery 1992 — 1996
B.S., Psychology
Stephen Buckner's Catalent Experience May 2006 - February 2008
Job Compliance Specialist at Tecan
Industry Medical Devices
Experience
Tecan April 2015 - Present
TransEnterix, Inc. November 2013 - April 2015
Sequence, Inc. September 2011 - October 2013
Stiefel, a GSK company February 2008 - September 2010
Catalent May 2006 - February 2008
PCI, LLC May 2006 - February 2008
DSM Pharmaceuticals, Inc. June 2004 - May 2006
DSM Pharma Chemicals, Inc. May 2003 - June 2004
Skills
Technical Documentation, Investigation, Validation, HPLC, GMP, Analytical Chemistry, UV, Pharmaceuticals, Quality Assurance, Biotechnology, QC, 21 CFR Part 11, Computer System..., GxP, Change Control, Chromatography, Life Sciences, Microbiology, Root Cause Analysis, LIMS, Compliance, Quality Systems, Technology Transfer, cGMP, Six Sigma, SOP, Change Management, Microsoft Office, Document Management, FDA, CAPA, Excel, R&D, Validations, Problem Solving, Molecular Biology, Access, Quality Management, Chemistry, Manufacturing, Calibration, Medical Devices, SDLC, Documentation, Process Improvement, SAP, Technical Writing, Environmental Monitoring, Lean Manufacturing, Automation
Education
East Carolina University 2002 — 2006
Bachelor of Science, Chemistry
East Carolina University 2002 — 2005
Bachelors of Science, Biochemistry and Molecular Biology
Erskine College 2000 — 2002
Bachelor's degree, Chemistry
Tecan April 2015 - Present
TransEnterix, Inc. November 2013 - April 2015
Sequence, Inc. September 2011 - October 2013
Stiefel, a GSK company February 2008 - September 2010
Catalent May 2006 - February 2008
PCI, LLC May 2006 - February 2008
DSM Pharmaceuticals, Inc. June 2004 - May 2006
DSM Pharma Chemicals, Inc. May 2003 - June 2004
Skills
Technical Documentation, Investigation, Validation, HPLC, GMP, Analytical Chemistry, UV, Pharmaceuticals, Quality Assurance, Biotechnology, QC, 21 CFR Part 11, Computer System..., GxP, Change Control, Chromatography, Life Sciences, Microbiology, Root Cause Analysis, LIMS, Compliance, Quality Systems, Technology Transfer, cGMP, Six Sigma, SOP, Change Management, Microsoft Office, Document Management, FDA, CAPA, Excel, R&D, Validations, Problem Solving, Molecular Biology, Access, Quality Management, Chemistry, Manufacturing, Calibration, Medical Devices, SDLC, Documentation, Process Improvement, SAP, Technical Writing, Environmental Monitoring, Lean Manufacturing, Automation
Education
East Carolina University 2002 — 2006
Bachelor of Science, Chemistry
East Carolina University 2002 — 2005
Bachelors of Science, Biochemistry and Molecular Biology
Erskine College 2000 — 2002
Bachelor's degree, Chemistry
Ghia Bacani's Catalent Experience August 2005 - January 2007
Job Research Associate 2 at Halozyme Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Halozyme Therapeutics, Inc. April 2009 - Present
Amylin Pharmaceuticals January 2007 - November 2008
Catalent August 2005 - January 2007
Skills
HPLC, Protein Chemistry, SDS-PAGE, UV-Vis, Lyophilization
Education
University of California, San Diego
Chemistry, Chemistry
Halozyme Therapeutics, Inc. April 2009 - Present
Amylin Pharmaceuticals January 2007 - November 2008
Catalent August 2005 - January 2007
Skills
HPLC, Protein Chemistry, SDS-PAGE, UV-Vis, Lyophilization
Education
University of California, San Diego
Chemistry, Chemistry
Rick Malinowski's Catalent Experience November 2003 - February 2007
Job Deputy Director Clinical Logistics at Sanofi Pasteur
Industry Pharmaceuticals
Experience
Sanofi Pasteur February 2007 - Present
Catalent November 2003 - February 2007
Fisher Clinical Services June 2000 - November 2003
Accupac September 1998 - June 2000
Accupac April 1997 - September 1998
Skills
GMP, GCP, CTMS, Clinical Trials, Protocol, Clinical Research, CRO, Data Management, Oncology, Pharmaceutical Industry, Vaccines, Clinical Development, 21 CFR Part 11, ICH-GCP, EDC, FDA, Sop, Regulatory Affairs, SOP, Logistics Management
Education
Drexel University - College of Business and Administration 1987 — 1993
Bachelor of Science in Business Administration, Operations Management
Sanofi Pasteur February 2007 - Present
Catalent November 2003 - February 2007
Fisher Clinical Services June 2000 - November 2003
Accupac September 1998 - June 2000
Accupac April 1997 - September 1998
Skills
GMP, GCP, CTMS, Clinical Trials, Protocol, Clinical Research, CRO, Data Management, Oncology, Pharmaceutical Industry, Vaccines, Clinical Development, 21 CFR Part 11, ICH-GCP, EDC, FDA, Sop, Regulatory Affairs, SOP, Logistics Management
Education
Drexel University - College of Business and Administration 1987 — 1993
Bachelor of Science in Business Administration, Operations Management
Mike Choquette's Catalent Experience July 2005 - August 2009
Job Director Quality and Regulatory Affairs at Typenex Medical
Industry Pharmaceuticals
Experience
Typenex Medical July 2013 - Present
Catalent Pharma Solutions August 2009 - Present
Catalent July 2005 - August 2009
Cardinal Health July 2004 - July 2005
RenalTech International, LLC August 2000 - July 2004
Surgical Sealants, Inc. November 1997 - August 2000
Skills
Quality System, Cross-functional Team..., Biotechnology, Quality Assurance, Medical Devices, GxP, Continuous Improvement, Lean Manufacturing, Process Improvement, Internal Audit, Quality Auditing, Six Sigma, Supplier Quality...
Education
Keene State College 1986 — 1990
BS, Industrial Chemistry
Typenex Medical July 2013 - Present
Catalent Pharma Solutions August 2009 - Present
Catalent July 2005 - August 2009
Cardinal Health July 2004 - July 2005
RenalTech International, LLC August 2000 - July 2004
Surgical Sealants, Inc. November 1997 - August 2000
Skills
Quality System, Cross-functional Team..., Biotechnology, Quality Assurance, Medical Devices, GxP, Continuous Improvement, Lean Manufacturing, Process Improvement, Internal Audit, Quality Auditing, Six Sigma, Supplier Quality...
Education
Keene State College 1986 — 1990
BS, Industrial Chemistry
Keyur Upadhyay's Catalent Experience June 2006 - April 2010
Job Sr. Principal Engineer at Baxter
Industry Pharmaceuticals
Experience
Baxter April 2010 - Present
Catalent June 2006 - April 2010
Dentsply 2003 - 2006
Morton Grove Pharmaceuticals 2000 - 2003
Education
Illinois Institute of Technology
Masters, Chemical Enginering
Baxter April 2010 - Present
Catalent June 2006 - April 2010
Dentsply 2003 - 2006
Morton Grove Pharmaceuticals 2000 - 2003
Education
Illinois Institute of Technology
Masters, Chemical Enginering
Greg Barnard's Catalent Experience February 2006 - June 2008
Job Director, Biologics Manufacturing at BristolMyers Squibb
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb August 2013 - Present
Endo Pharmaceuticals September 2012 - June 2013
Endo Pharmaceuticals February 2012 - September 2012
Sigma-Tau Pharmasource November 2008 - February 2012
Catalent February 2006 - June 2008
Microtest Laboratories 2008 - 2008
Ben Venue Laboratories February 2002 - February 2006
Skills
Aseptic Processing, GMP, Quality System, Pharmaceutical Industry, Lean Manufacturing, Six Sigma, Validation, Manufacturing, Quality Auditing, FDA, Continuous Improvement, Biotechnology, V&V, CAPA, Sop
Education
University of Rochester - Simon Business School 2000 — 2002
MBA, Operations Management
Rochester Institute of Technology 1986 — 1989
BS, Chemistry
Bristol-Myers Squibb August 2013 - Present
Endo Pharmaceuticals September 2012 - June 2013
Endo Pharmaceuticals February 2012 - September 2012
Sigma-Tau Pharmasource November 2008 - February 2012
Catalent February 2006 - June 2008
Microtest Laboratories 2008 - 2008
Ben Venue Laboratories February 2002 - February 2006
Skills
Aseptic Processing, GMP, Quality System, Pharmaceutical Industry, Lean Manufacturing, Six Sigma, Validation, Manufacturing, Quality Auditing, FDA, Continuous Improvement, Biotechnology, V&V, CAPA, Sop
Education
University of Rochester - Simon Business School 2000 — 2002
MBA, Operations Management
Rochester Institute of Technology 1986 — 1989
BS, Chemistry
Justin Hamler's Catalent Experience July 2008 - August 2008
Job Specialty Gas Territory Manager at Praxair
Industry Chemicals
Experience
Praxair August 2013 - Present
Praxair April 2012 - July 2013
Praxair April 2011 - April 2012
Praxair August 2010 - April 2011
Eclipse Channel Online Network, Inc. March 2010 - August 2010
Eclipse Channel Online Network, Inc. September 2009 - March 2010
Morehouse College August 2004 - December 2008
Catalent July 2008 - August 2008
GlaxoSmithKline July 2007 - December 2007
Wharton Business School June 2005 - August 2007
Skills
Marketing, Marketing Research, Data Analysis, Program Management, Management, Advertising, Strategic Planning, Customer Service, Public Relations, Leadership, Project Management, Cross-functional Team..., Product Development, Sales, Business Strategy
Education
Morehouse College 2004 — 2008
Bachelor's of Art, Business Administration with a concentration in Marketing
Saint Joseph's Preparatory School 2000 — 2004
H.S. Diploma
Praxair August 2013 - Present
Praxair April 2012 - July 2013
Praxair April 2011 - April 2012
Praxair August 2010 - April 2011
Eclipse Channel Online Network, Inc. March 2010 - August 2010
Eclipse Channel Online Network, Inc. September 2009 - March 2010
Morehouse College August 2004 - December 2008
Catalent July 2008 - August 2008
GlaxoSmithKline July 2007 - December 2007
Wharton Business School June 2005 - August 2007
Skills
Marketing, Marketing Research, Data Analysis, Program Management, Management, Advertising, Strategic Planning, Customer Service, Public Relations, Leadership, Project Management, Cross-functional Team..., Product Development, Sales, Business Strategy
Education
Morehouse College 2004 — 2008
Bachelor's of Art, Business Administration with a concentration in Marketing
Saint Joseph's Preparatory School 2000 — 2004
H.S. Diploma
Duc Dang, PMP's Catalent Experience October 2006 - August 2008
Job Associate Director, Global Clinical Supply at ARIAD Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
ARIAD Pharmaceuticals, Inc. January 2015 - Present
RPS/Merck 2012 - Present
Merck May 2009 - October 2012
Bilcare September 2008 - May 2009
Catalent October 2006 - August 2008
Fisher Clinical Services September 2003 - October 2006
Skills
Vaccines, Continuous Improvement, GMP, Manufacturing, Process Improvement, Forecasting, Strategic Planning, Cross-functional Team..., Operations Management, Supply Chain, FDA, Packaging, Procurement, Pharmaceuticals, Pharmaceutical Industry, 21 CFR Part 11, CTMS, Sop, Validation, Supply Chain Management, V&V, Logistics, Medical Devices, Clinical Trials
Education
Villanova University 2014 — 2016
MBA, Masters of Business Administration
Lehigh University 2007 — 2008
PMP, Project Management
Kutztown University of Pennsylvania 2001 — 2003
BS, Microbiology and Molecular Biology
ARIAD Pharmaceuticals, Inc. January 2015 - Present
RPS/Merck 2012 - Present
Merck May 2009 - October 2012
Bilcare September 2008 - May 2009
Catalent October 2006 - August 2008
Fisher Clinical Services September 2003 - October 2006
Skills
Vaccines, Continuous Improvement, GMP, Manufacturing, Process Improvement, Forecasting, Strategic Planning, Cross-functional Team..., Operations Management, Supply Chain, FDA, Packaging, Procurement, Pharmaceuticals, Pharmaceutical Industry, 21 CFR Part 11, CTMS, Sop, Validation, Supply Chain Management, V&V, Logistics, Medical Devices, Clinical Trials
Education
Villanova University 2014 — 2016
MBA, Masters of Business Administration
Lehigh University 2007 — 2008
PMP, Project Management
Kutztown University of Pennsylvania 2001 — 2003
BS, Microbiology and Molecular Biology
Holly Christian's Catalent Experience 2006 - 2008
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Medela August 2011 - Present
Ohio Medical Corporation April 2009 - August 2011
Catalent Pharma Solutions May 2005 - October 2008
Catalent 2006 - 2008
Education
Indiana University Bloomington 1993 — 1997
BS, Biology, Chemisty
Medela August 2011 - Present
Ohio Medical Corporation April 2009 - August 2011
Catalent Pharma Solutions May 2005 - October 2008
Catalent 2006 - 2008
Education
Indiana University Bloomington 1993 — 1997
BS, Biology, Chemisty
Ideleen Keiser's Catalent Experience January 2006 - December 2010
Job Learning Management Specialist
Industry Pharmaceuticals
Experience
VALSPEC - assigned to GlaxoSmithKline March 2013 - August 2015
Catalent January 2006 - December 2010
Cardinal Health August 2002 - July 2005
Skills
21 CFR Part 11, Quality Assurance, Trackwise, GMP, Documentum, Sop, Learning Management..., FDA, CAPA, GxP, Validation, Software Documentation, V&V, Computer System..., Change Control, Pharmaceutical Industry, Quality System, SOP
Education
DeVry University 2012 — 2015
Bachelor's degree, Health Services Management
Bucks County Community College 2007 — 2009
Associates, Information Science and Technology
VALSPEC - assigned to GlaxoSmithKline March 2013 - August 2015
Catalent January 2006 - December 2010
Cardinal Health August 2002 - July 2005
Skills
21 CFR Part 11, Quality Assurance, Trackwise, GMP, Documentum, Sop, Learning Management..., FDA, CAPA, GxP, Validation, Software Documentation, V&V, Computer System..., Change Control, Pharmaceutical Industry, Quality System, SOP
Education
DeVry University 2012 — 2015
Bachelor's degree, Health Services Management
Bucks County Community College 2007 — 2009
Associates, Information Science and Technology
Jessica Anderson, RAC's Catalent Experience May 2008 - June 2010
Job Manager, Regulatory Affairs at Chiesi USA, Inc.
Industry Pharmaceuticals
Experience
Chiesi USA, Inc. September 2014 - Present
Chiesi USA, Inc. June 2013 - Present
Cornerstone Therapeutics June 2010 - Present
Catalent May 2008 - June 2010
Altea Therapeutics October 2004 - May 2008
Mikart, Inc. December 2003 - October 2004
Skills
HPLC, Analytical Chemistry, FDA GMP, CMC Regulatory Affairs, DDMAC, Package Inserts, Regulatory Submissions, Dissolution, Chromatography, FDA, Sop, GLP, GMP, Regulatory Affairs
Education
East Carolina University 1999 — 2003
B.S., Biology
Chiesi USA, Inc. September 2014 - Present
Chiesi USA, Inc. June 2013 - Present
Cornerstone Therapeutics June 2010 - Present
Catalent May 2008 - June 2010
Altea Therapeutics October 2004 - May 2008
Mikart, Inc. December 2003 - October 2004
Skills
HPLC, Analytical Chemistry, FDA GMP, CMC Regulatory Affairs, DDMAC, Package Inserts, Regulatory Submissions, Dissolution, Chromatography, FDA, Sop, GLP, GMP, Regulatory Affairs
Education
East Carolina University 1999 — 2003
B.S., Biology
Duane Gosser's Catalent Experience July 2007 - February 2009
Job Manager of Project Planning at Summit Biosciences
Industry Pharmaceuticals
Experience
Summit Biosciences Inc. February 2014 - Present
Catalent Pharma Solutions May 2012 - February 2014
Catalent Pharma Solutions February 2009 - May 2012
Catalent July 2007 - February 2009
Cardinal Health March 2005 - July 2007
PTRL 1988 - 1996
Skills
GMP, FDA, MHRA, Lean Tools, Black Belt, Kaizen, GLP, Trackwise, Pharmaceutical Industry, Quality Management, SOP development, Batch Records, Raw Material Vendor..., Deviation Management, Project Management, Training, Laboratory Skills, Quality Assurance, TrackWise
Education
University of Kentucky 1986 — 1991
BS, Microbiology
Summit Biosciences Inc. February 2014 - Present
Catalent Pharma Solutions May 2012 - February 2014
Catalent Pharma Solutions February 2009 - May 2012
Catalent July 2007 - February 2009
Cardinal Health March 2005 - July 2007
PTRL 1988 - 1996
Skills
GMP, FDA, MHRA, Lean Tools, Black Belt, Kaizen, GLP, Trackwise, Pharmaceutical Industry, Quality Management, SOP development, Batch Records, Raw Material Vendor..., Deviation Management, Project Management, Training, Laboratory Skills, Quality Assurance, TrackWise
Education
University of Kentucky 1986 — 1991
BS, Microbiology
Ann Owens Cherry's Catalent Experience December 2008 - March 2009
Job Senior Validation Associate at Patheon Manufacturing Services, LLC
Industry Pharmaceuticals
Experience
Patheon July 2012 - Present
MKCS, Inc. April 2009 - July 2012
Catalent December 2008 - March 2009
DSM Pharmaceuticals December 2005 - December 2008
O'Neal, Inc. December 1996 - December 2005
Skills
Validation, GMP, Documentation, Pharmaceuticals, Microsoft Office, 21 CFR Part 11, Computer System..., Quality Assurance, Problem Solving, Testing, Compliance, Technology Transfer, Quality Auditing, GxP, Quality System, Quality Control, V&V, Pharmaceutical Industry, GLP, Software Documentation, CAPA, LIMS, Change Control, SAP, Automation, Aseptic Processing, Biopharmaceuticals, GAMP, Cleaning Validation, Biotechnology, Regulatory Affairs, Process Simulation, Root Cause Analysis
Education
North Carolina State University 1996 — 1998
Engineering
University of North Carolina at Chapel Hill 1986 — 1991
BA, English
Northeastern High
Northeastern High
Patheon July 2012 - Present
MKCS, Inc. April 2009 - July 2012
Catalent December 2008 - March 2009
DSM Pharmaceuticals December 2005 - December 2008
O'Neal, Inc. December 1996 - December 2005
Skills
Validation, GMP, Documentation, Pharmaceuticals, Microsoft Office, 21 CFR Part 11, Computer System..., Quality Assurance, Problem Solving, Testing, Compliance, Technology Transfer, Quality Auditing, GxP, Quality System, Quality Control, V&V, Pharmaceutical Industry, GLP, Software Documentation, CAPA, LIMS, Change Control, SAP, Automation, Aseptic Processing, Biopharmaceuticals, GAMP, Cleaning Validation, Biotechnology, Regulatory Affairs, Process Simulation, Root Cause Analysis
Education
North Carolina State University 1996 — 1998
Engineering
University of North Carolina at Chapel Hill 1986 — 1991
BA, English
Northeastern High
Northeastern High
Christopher Lockwood's Catalent Experience July 2005 - June 2008
Job Senior Manager, Process Technology at Patheon Inc.
Industry Pharmaceuticals
Experience
Patheon Inc. June 2012 - Present
Patheon Inc. March 2011 - July 2012
Xanodyne Pharmaceuticals December 2010 - July 2011
Xanodyne Pharmaceuticals June 2008 - December 2010
Catalent July 2005 - June 2008
Cardinal Health October 2003 - June 2005
Cardinal Health April 2002 - October 2004
Boehringer Ingelheim Pharmaceuticals January 2001 - March 2002
Boehringer Ingelheim Pharmaceuticals October 1997 - January 2001
Skills
Sop, Technology Transfer, Drug Development, Product Development, Validation, Pharmaceutical Industry, GMP, FDA, Pharmaceutics, Change Control, GLP, Regulatory Affairs, SOP, 21 CFR Part 11, Formulation, Drug Delivery, Biotechnology, CAPA
Education
University of Kentucky 1993 — 1997
Ph.D., Medicinal Chemistry and Pharmaceutics
University of Kentucky 1989 — 1993
B.S., Chemical Engineering
Patheon Inc. June 2012 - Present
Patheon Inc. March 2011 - July 2012
Xanodyne Pharmaceuticals December 2010 - July 2011
Xanodyne Pharmaceuticals June 2008 - December 2010
Catalent July 2005 - June 2008
Cardinal Health October 2003 - June 2005
Cardinal Health April 2002 - October 2004
Boehringer Ingelheim Pharmaceuticals January 2001 - March 2002
Boehringer Ingelheim Pharmaceuticals October 1997 - January 2001
Skills
Sop, Technology Transfer, Drug Development, Product Development, Validation, Pharmaceutical Industry, GMP, FDA, Pharmaceutics, Change Control, GLP, Regulatory Affairs, SOP, 21 CFR Part 11, Formulation, Drug Delivery, Biotechnology, CAPA
Education
University of Kentucky 1993 — 1997
Ph.D., Medicinal Chemistry and Pharmaceutics
University of Kentucky 1989 — 1993
B.S., Chemical Engineering
Dan Beidler's Catalent Experience 1999 - 2009
Job Sr. Scientist, Sr. Manager, Formulation and Analytical Development Project Director
Industry Biotechnology
Experience
Catalent 1999 - 2009
Cardinal Health 2005 - 2007
magellan 1998 - 2007
Amylin Pharmaceuticals 1994 - 1998
Hybritech, Inc 1985 - 1994
Skills
Validation, Analytical Chemistry, GMP, HPLC, Biopharmaceuticals, Chemistry, Protein Chemistry, Pharmaceutical Industry
Education
University of California, San Diego 1977 — 1980
BA, Biology
Catalent 1999 - 2009
Cardinal Health 2005 - 2007
magellan 1998 - 2007
Amylin Pharmaceuticals 1994 - 1998
Hybritech, Inc 1985 - 1994
Skills
Validation, Analytical Chemistry, GMP, HPLC, Biopharmaceuticals, Chemistry, Protein Chemistry, Pharmaceutical Industry
Education
University of California, San Diego 1977 — 1980
BA, Biology
Bill Bolding's Catalent Experience 2006 - 2009
Job Chief Operating Officer (COO) at Packaging Coordinators Inc. (PCI)
Industry Pharmaceuticals
Experience
Packaging Coordinators Inc. (PCI) June 2012 - Present
Tunnell Consulting July 2009 - June 2012
Catalent 2006 - 2009
Cardinal Health 2004 - 2005
Smurfit-Stone 1978 - 1999
Smurfit 1978 - 1999
Education
Ball State University - College of Business
MBA, Finance Concentration
Colorado State University
Masters, Mathematics
United States Air Force Academy
BS, Mathematics and Aeronautical Engineering
Packaging Coordinators Inc. (PCI) June 2012 - Present
Tunnell Consulting July 2009 - June 2012
Catalent 2006 - 2009
Cardinal Health 2004 - 2005
Smurfit-Stone 1978 - 1999
Smurfit 1978 - 1999
Education
Ball State University - College of Business
MBA, Finance Concentration
Colorado State University
Masters, Mathematics
United States Air Force Academy
BS, Mathematics and Aeronautical Engineering
Victoria Caporaso's Catalent Experience May 2008 - October 2010
Job Global Op Ex Leader at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions October 2010 - Present
Catalent Pharma Solutions May 2008 - October 2010
Catalent May 2008 - October 2010
Catalent May 2007 - November 2009
Cardinal Health August 2005 - May 2007
Cardinal Health January 2003 - August 2005
Skills
Six Sigma Black Belt, Lean Pharmaceutical..., Lean Manufacturing, CAPA, Quality System, 21 CFR Part 11, Validation, V&V, Contract Manufacturing, Six Sigma, Black Belt, Cleaning Validation, Technology Transfer, Manufacturing, Cross-functional Team..., Aseptic Processing, GLP, Training, GxP, GMP
Education
Boston University
B.A., Biology
Villanova University 2014 — 2014
Catalent Pharma Solutions October 2010 - Present
Catalent Pharma Solutions May 2008 - October 2010
Catalent May 2008 - October 2010
Catalent May 2007 - November 2009
Cardinal Health August 2005 - May 2007
Cardinal Health January 2003 - August 2005
Skills
Six Sigma Black Belt, Lean Pharmaceutical..., Lean Manufacturing, CAPA, Quality System, 21 CFR Part 11, Validation, V&V, Contract Manufacturing, Six Sigma, Black Belt, Cleaning Validation, Technology Transfer, Manufacturing, Cross-functional Team..., Aseptic Processing, GLP, Training, GxP, GMP
Education
Boston University
B.A., Biology
Villanova University 2014 — 2014
Joe Nawrocki's Catalent Experience March 2003 - Present
Job Director at Catalent
Industry Pharmaceuticals
Experience
Catalent March 2003 - Present
Charles River Laboratories August 2001 - February 2003
National Institutes of Health August 1997 - August 2001
Skills
Pharmaceutical Industry, GMP, Validation, FDA, Sop, Technology Transfer, Biotechnology, 21 CFR Part 11, HPLC, CAPA, Drug Development, Analytical Chemistry, Biopharmaceuticals, Protein Structure
Education
Ph.D., University of Florida 1985 — 1997
Doctor of Philosophy (Ph.D.), Analytical Chemistry
University of Florida 1985 — 1990
Bachelor's degree, Chemistry
Catalent March 2003 - Present
Charles River Laboratories August 2001 - February 2003
National Institutes of Health August 1997 - August 2001
Skills
Pharmaceutical Industry, GMP, Validation, FDA, Sop, Technology Transfer, Biotechnology, 21 CFR Part 11, HPLC, CAPA, Drug Development, Analytical Chemistry, Biopharmaceuticals, Protein Structure
Education
Ph.D., University of Florida 1985 — 1997
Doctor of Philosophy (Ph.D.), Analytical Chemistry
University of Florida 1985 — 1990
Bachelor's degree, Chemistry
Ed Thiele's Catalent Experience December 2010 - December 2011
Job Principal at ECT Consulting
Industry Pharmaceuticals
Experience
ECT Consulting April 2010 - Present
Catalent December 2010 - December 2011
Catalent Pharma Solutions 2002 - 2010
Catalent / Cardinal Health March 2002 - December 2004
Hoffmann-La Roche 1991 - 2000
Schering-Plough 1970 - 1991
Skills
Pharmaceutical Industry, GMP, FDA, CAPA, Regulatory Affairs, 21 CFR Part 11, Technology Transfer, Validation, Operational Excellence, Quality Control, Sop, GLP, Quality System, Clinical Trials, Quality Assurance, Change Control, Cross-functional Team..., Biotechnology, Lifesciences, V&V, Biopharmaceuticals, Pharmaceutics, Drug Development, Computer System..., Analytical Chemistry, Life Sciences, SOP
Education
Rutgers University-New Brunswick 1962 — 1966
B.A., Chemistry
ECT Consulting April 2010 - Present
Catalent December 2010 - December 2011
Catalent Pharma Solutions 2002 - 2010
Catalent / Cardinal Health March 2002 - December 2004
Hoffmann-La Roche 1991 - 2000
Schering-Plough 1970 - 1991
Skills
Pharmaceutical Industry, GMP, FDA, CAPA, Regulatory Affairs, 21 CFR Part 11, Technology Transfer, Validation, Operational Excellence, Quality Control, Sop, GLP, Quality System, Clinical Trials, Quality Assurance, Change Control, Cross-functional Team..., Biotechnology, Lifesciences, V&V, Biopharmaceuticals, Pharmaceutics, Drug Development, Computer System..., Analytical Chemistry, Life Sciences, SOP
Education
Rutgers University-New Brunswick 1962 — 1966
B.A., Chemistry
Shawn Gallagher's Catalent Experience January 2004 - July 2008
Job President, Partnership Management
Industry Pharmaceuticals
Experience
Eisai, Inc. July 2008 - Present
Catalent January 2004 - July 2008
Introgen Therapeutics, Inc. 1996 - 2003
Magenta, Inc. January 1995 - August 1996
ImmunoGen, Inc. 1991 - 1995
Skills
FDA, Pharmaceutical Industry, Validation, Technology Transfer, Biotechnology, GMP, Biopharmaceuticals, Clinical Development, Regulatory Affairs, Lifesciences, Sop, Drug Development, Oncology, Pharmaceutics, Cross-functional Team..., V&V, Medical Devices, CRO, 21 CFR Part 11, Commercialization, Vaccines, Change Control, CAPA, Clinical Trials, Drug Discovery, Regulatory Submissions, R&D, GLP, HPLC, Quality System, Formulation, GxP, Regulatory Requirements, Analytical Chemistry, Infectious Diseases, Immunology, Chemistry, CTMS, Drug Delivery, Life Sciences, SOP
Education
University of St. Thomas (TX) 2000 — 2002
MBA, Finance
University of California, San Diego 1985 — 1987
MS, Biochemical Engineering
University of Colorado Boulder 1979 — 1985
BS, Chemical Engneering
Eisai, Inc. July 2008 - Present
Catalent January 2004 - July 2008
Introgen Therapeutics, Inc. 1996 - 2003
Magenta, Inc. January 1995 - August 1996
ImmunoGen, Inc. 1991 - 1995
Skills
FDA, Pharmaceutical Industry, Validation, Technology Transfer, Biotechnology, GMP, Biopharmaceuticals, Clinical Development, Regulatory Affairs, Lifesciences, Sop, Drug Development, Oncology, Pharmaceutics, Cross-functional Team..., V&V, Medical Devices, CRO, 21 CFR Part 11, Commercialization, Vaccines, Change Control, CAPA, Clinical Trials, Drug Discovery, Regulatory Submissions, R&D, GLP, HPLC, Quality System, Formulation, GxP, Regulatory Requirements, Analytical Chemistry, Infectious Diseases, Immunology, Chemistry, CTMS, Drug Delivery, Life Sciences, SOP
Education
University of St. Thomas (TX) 2000 — 2002
MBA, Finance
University of California, San Diego 1985 — 1987
MS, Biochemical Engineering
University of Colorado Boulder 1979 — 1985
BS, Chemical Engneering
Katherine Lay's Catalent Experience September 2007 - August 2010
Job Supply Chain Planner at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions March 2010 - Present
Catalent September 2007 - August 2010
Strides Inc April 2005 - September 2007
Skills
Pharmaceutical Industry, Contract Manufacturing, Supply Chain, Supply Chain Management, Six Sigma, Manufacturing, GMP
Education
Rutgers University-New Brunswick
BA, Economics
Catalent Pharma Solutions March 2010 - Present
Catalent September 2007 - August 2010
Strides Inc April 2005 - September 2007
Skills
Pharmaceutical Industry, Contract Manufacturing, Supply Chain, Supply Chain Management, Six Sigma, Manufacturing, GMP
Education
Rutgers University-New Brunswick
BA, Economics
Julie Muller's Catalent Experience 2000 - 2005
Job QA
Industry Research
Experience
Sagent Pharmaceuticals, Inc. July 2012 - Present
First Priority September 2008 - June 2012
Sage Products 2005 - 2008
Catalent 2000 - 2005
The Dow Chemical Company 1987 - 2000
Baxter 1983 - 1987
Education
Lakeland College 1978 — 1982
BA, Biology
Sagent Pharmaceuticals, Inc. July 2012 - Present
First Priority September 2008 - June 2012
Sage Products 2005 - 2008
Catalent 2000 - 2005
The Dow Chemical Company 1987 - 2000
Baxter 1983 - 1987
Education
Lakeland College 1978 — 1982
BA, Biology
Clive Finney's Catalent Experience November 2006 - March 2014
Job Scientist, Manufacturing at Pearl Therapeutics
Industry Pharmaceuticals
Experience
Pearl Therapeutics March 2014 - Present
Catalent November 2006 - March 2014
AstraZeneca June 2002 - August 2006
AstraZeneca September 1996 - September 1998
Sanofi July 1994 - September 1998
Skills
Formulation Development, GMP, Technology Transfer, Process Development, Characterization, Validation, cGMP, Pharmaceuticals, R&D
Education
Sheffield Hallam University 1989 — 1993
BSc, Chemistry
Pearl Therapeutics March 2014 - Present
Catalent November 2006 - March 2014
AstraZeneca June 2002 - August 2006
AstraZeneca September 1996 - September 1998
Sanofi July 1994 - September 1998
Skills
Formulation Development, GMP, Technology Transfer, Process Development, Characterization, Validation, cGMP, Pharmaceuticals, R&D
Education
Sheffield Hallam University 1989 — 1993
BSc, Chemistry
Christopher Janik's Catalent Experience June 2006 - April 2008
Job MS/TS Scientist at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company April 2014 - Present
Bausch + Lomb November 2011 - March 2014
Bausch & Lomb September 2009 - November 2011
CATALENT PHARMACTIUCAL 2008 - 2009
Catalent June 2006 - April 2008
Skills
Aseptic Processing, Manufacturing, CAPA, GMP, FDA, Validation, Quality System, Sop, Pharmaceutical Industry, ISO 13485, Regulatory Affairs, V&V, Quality Assurance, 21 CFR Part 11, Six Sigma, Change Control, Root Cause Analysis, Lean Manufacturing, GxP, GLP
Education
Purdue University 2001 — 2006
Bachelors in Science, Pharmaceutical Science
Eli Lilly and Company April 2014 - Present
Bausch + Lomb November 2011 - March 2014
Bausch & Lomb September 2009 - November 2011
CATALENT PHARMACTIUCAL 2008 - 2009
Catalent June 2006 - April 2008
Skills
Aseptic Processing, Manufacturing, CAPA, GMP, FDA, Validation, Quality System, Sop, Pharmaceutical Industry, ISO 13485, Regulatory Affairs, V&V, Quality Assurance, 21 CFR Part 11, Six Sigma, Change Control, Root Cause Analysis, Lean Manufacturing, GxP, GLP
Education
Purdue University 2001 — 2006
Bachelors in Science, Pharmaceutical Science
Ron Swank's Catalent Experience
Job SR. ENGINEER at Catalent
Industry Pharmaceuticals
Experience
Catalent
Skills
Aseptic Processing
Education
Iowa State University 1967 — 1971
Food Technology, Food Microbiology
Catalent
Skills
Aseptic Processing
Education
Iowa State University 1967 — 1971
Food Technology, Food Microbiology
Mike Hitchingham's Catalent Experience 2005 - April 2010
Job Director of Quality Systems at Hospira
Industry Pharmaceuticals
Experience
Hospira December 2013 - Present
Hospira January 2013 - December 2013
Hospira September 2011 - December 2012
LifeWatch April 2010 - September 2011
Catalent 2005 - April 2010
Hospira 2004 - 2005
Abbott Laboratories 1991 - 2004
Skills
FDA, CAPA, Aseptic Processing, Quality Systems, Quality Assurance, Investigations, Complaint Handling, Change Control, GxP, Complaint Management, Medical Devices, Sop, V&V, Trackwise, Manufacturing, Quality System, Lean Manufacturing, GMP, Regulatory Affairs, 21 CFR Part 11, Pharmaceutical Industry, Validation, Private Investigations, Contract Manufacturing, Document Management, GLP, ISO 14971, FDA GMP, Regulatory Requirements, LIMS, Continuous Improvement, Technology Transfer, Regulatory Submissions, Design Control, ISO 13485, GAMP, Quality Control, Computer System..., 21 CFR, Biopharmaceuticals, Cleaning Validation, Sterilization, Quality Management, Pharmaceutics, Biotechnology, Root Cause Analysis, ISO, Supplier Quality, SOP development, GCP
Education
Hope College 1987 — 1991
BA, Biology & Business Administration
Hospira December 2013 - Present
Hospira January 2013 - December 2013
Hospira September 2011 - December 2012
LifeWatch April 2010 - September 2011
Catalent 2005 - April 2010
Hospira 2004 - 2005
Abbott Laboratories 1991 - 2004
Skills
FDA, CAPA, Aseptic Processing, Quality Systems, Quality Assurance, Investigations, Complaint Handling, Change Control, GxP, Complaint Management, Medical Devices, Sop, V&V, Trackwise, Manufacturing, Quality System, Lean Manufacturing, GMP, Regulatory Affairs, 21 CFR Part 11, Pharmaceutical Industry, Validation, Private Investigations, Contract Manufacturing, Document Management, GLP, ISO 14971, FDA GMP, Regulatory Requirements, LIMS, Continuous Improvement, Technology Transfer, Regulatory Submissions, Design Control, ISO 13485, GAMP, Quality Control, Computer System..., 21 CFR, Biopharmaceuticals, Cleaning Validation, Sterilization, Quality Management, Pharmaceutics, Biotechnology, Root Cause Analysis, ISO, Supplier Quality, SOP development, GCP
Education
Hope College 1987 — 1991
BA, Biology & Business Administration
Tony Grigoropoulos, PMP's Catalent Experience July 2009 - October 2014
Job Sr. Project Manager at Baxter International Inc.
Industry Pharmaceuticals
Experience
Baxter International Inc. October 2014 - Present
PROTAGON LLC October 2014 - Present
Catalent July 2009 - October 2014
FMC Technologies January 2007 - March 2009
Morton Grove Pharmaceuticals February 2002 - December 2006
Sterigenics December 1997 - January 2002
SoloPak Pharmaceuticals April 1996 - November 1997
ITW Magnaflux March 1991 - April 1996
Skills
GMP, Quality Assurance, R&D, Six Sigma, Quality Systems, Quality System, 21 CFR Part 11, CAPA, Change Control, Validation, FDA, Sop, Product Development, V&V, Software Documentation, Engineering, Technology Transfer, Medical Devices, Pharmaceutical Industry, Manufacturing, Regulatory Affairs, SOP
Education
Keller Graduate School of Management of DeVry University 2011 — 2013
Master's degree, Project Management
Roosevelt University 1987 — 1990
MBA, International Business
University of Illinois at Chicago 1982 — 1984
BSEE, Electrical Engineering
Baxter International Inc. October 2014 - Present
PROTAGON LLC October 2014 - Present
Catalent July 2009 - October 2014
FMC Technologies January 2007 - March 2009
Morton Grove Pharmaceuticals February 2002 - December 2006
Sterigenics December 1997 - January 2002
SoloPak Pharmaceuticals April 1996 - November 1997
ITW Magnaflux March 1991 - April 1996
Skills
GMP, Quality Assurance, R&D, Six Sigma, Quality Systems, Quality System, 21 CFR Part 11, CAPA, Change Control, Validation, FDA, Sop, Product Development, V&V, Software Documentation, Engineering, Technology Transfer, Medical Devices, Pharmaceutical Industry, Manufacturing, Regulatory Affairs, SOP
Education
Keller Graduate School of Management of DeVry University 2011 — 2013
Master's degree, Project Management
Roosevelt University 1987 — 1990
MBA, International Business
University of Illinois at Chicago 1982 — 1984
BSEE, Electrical Engineering
Jeff Tripp's Catalent Experience January 2008 - February 2009
Job Director of Manufacturing at Genentech
Industry Pharmaceuticals
Experience
Genentech February 2011 - Present
Oso BioPharmaceuticals Manufacturing, LLC February 2009 - February 2011
Catalent January 2008 - February 2009
Cardinal Health 2004 - 2008
Aventis Behring 1991 - 2004
Skills
CAPA, Aseptic Processing, FDA, Change Control, Sop, Validation, GMP, Biopharmaceuticals, 21 CFR Part 11, Quality System, Cross-functional Team..., Quality Assurance, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, GxP, Contract Manufacturing, V&V, LIMS, Technology Transfer, Computer System..., Quality Control, Cleaning Validation, Trackwise, GLP, Quality Auditing, Regulatory Requirements, ISO 13485, Medical Devices, Regulatory Submissions, FDA GMP, Sterilization, Pharmaceutics, Root Cause Analysis, Design Control, Lifesciences, Vaccines, Process Simulation, Chromatography, Microbiology, Formulation, Clinical Development, Drug Development, Commercialization, GCP, Manufacturing Operations, SOP
Education
Olivet Nazarene University 1980 — 1994
MBA, Business
Olivet Nazarene University
Bachelor of Science (BS), Business Administration and Management, General
Genentech February 2011 - Present
Oso BioPharmaceuticals Manufacturing, LLC February 2009 - February 2011
Catalent January 2008 - February 2009
Cardinal Health 2004 - 2008
Aventis Behring 1991 - 2004
Skills
CAPA, Aseptic Processing, FDA, Change Control, Sop, Validation, GMP, Biopharmaceuticals, 21 CFR Part 11, Quality System, Cross-functional Team..., Quality Assurance, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, GxP, Contract Manufacturing, V&V, LIMS, Technology Transfer, Computer System..., Quality Control, Cleaning Validation, Trackwise, GLP, Quality Auditing, Regulatory Requirements, ISO 13485, Medical Devices, Regulatory Submissions, FDA GMP, Sterilization, Pharmaceutics, Root Cause Analysis, Design Control, Lifesciences, Vaccines, Process Simulation, Chromatography, Microbiology, Formulation, Clinical Development, Drug Development, Commercialization, GCP, Manufacturing Operations, SOP
Education
Olivet Nazarene University 1980 — 1994
MBA, Business
Olivet Nazarene University
Bachelor of Science (BS), Business Administration and Management, General
Fabio Palazzo's Catalent Experience ScientistAbbott LaboratoriesNovember 2000 - February 2007
Job Program Manager at Catalent
Industry Pharmaceuticals
Experience
Catalent ScientistAbbott LaboratoriesNovember 2000 - February 2007
GlaxoSmithKline November 1997 - November 2000
Skills
FDA, Technology Transfer, Medical Devices, Validation, GMP, Sop, Change Control, Pharmaceutical Industry, CAPA
Education
North Carolina State University 1994 — 1997
M.S., Organic Chemistry
Rochester Institute of Technology 1989 — 1994
B.S., Chemistry
Catalent ScientistAbbott LaboratoriesNovember 2000 - February 2007
GlaxoSmithKline November 1997 - November 2000
Skills
FDA, Technology Transfer, Medical Devices, Validation, GMP, Sop, Change Control, Pharmaceutical Industry, CAPA
Education
North Carolina State University 1994 — 1997
M.S., Organic Chemistry
Rochester Institute of Technology 1989 — 1994
B.S., Chemistry
Fred Winters's Catalent Experience Material Prep OperatorCatalent2000 - 2008
Job Inventory Control Specialist at Catalent
Industry Pharmaceuticals
Experience
Catalent Material Prep OperatorCatalent2000 - 2008
Skills
CAPA, Lean Manufacturing, GMP, FDA, Sop, Validation, Pharmaceutical Industry
Education
Tarrant County College 1989 — 1991
Catalent Material Prep OperatorCatalent2000 - 2008
Skills
CAPA, Lean Manufacturing, GMP, FDA, Sop, Validation, Pharmaceutical Industry
Education
Tarrant County College 1989 — 1991
Chris Southworth's Catalent Experience April 1999 - May 2009
Job Project Manager at Noblis
Industry Pharmaceuticals
Experience
Noblis April 2010 - Present
Catalent April 1999 - May 2009
Cardinal Health PTS, LLC 2001 - 2007
Common Wealth Technologies, Inc. August 1998 - March 1999
ETS Analytical Services, Inc. May 1985 - December 1997
Skills
Biotechnology, Sop, GMP, Pharmaceutical Industry, Validation, FDA, Technology Transfer, Lifesciences, Change Control, Program Management, Leadership, Management, Project Management, CRO, Analytical Chemistry, Cross-functional Team..., R&D, Quality Assurance, Biopharmaceuticals, GLP, Drug Development, Regulatory Affairs, Quality Auditing, Clinical Development, Clinical Trials
Education
Roanoke College 1980 — 1985
Bachelors, Biology
Noblis April 2010 - Present
Catalent April 1999 - May 2009
Cardinal Health PTS, LLC 2001 - 2007
Common Wealth Technologies, Inc. August 1998 - March 1999
ETS Analytical Services, Inc. May 1985 - December 1997
Skills
Biotechnology, Sop, GMP, Pharmaceutical Industry, Validation, FDA, Technology Transfer, Lifesciences, Change Control, Program Management, Leadership, Management, Project Management, CRO, Analytical Chemistry, Cross-functional Team..., R&D, Quality Assurance, Biopharmaceuticals, GLP, Drug Development, Regulatory Affairs, Quality Auditing, Clinical Development, Clinical Trials
Education
Roanoke College 1980 — 1985
Bachelors, Biology
Pragya Agrawal's Catalent Experience 2007 - 2007
Job Biotechnology Professional
Industry Biotechnology
Experience
Catalent 2007 - 2007
Education
Chhatrapati Shahu Ji Maharaj University 1997 — 2000
MS, BIOLOGY
Catalent 2007 - 2007
Education
Chhatrapati Shahu Ji Maharaj University 1997 — 2000
MS, BIOLOGY
Conell Pierce's Catalent Experience October 1994 - Present
Job sr. machinist at Catalent
Industry Pharmaceuticals
Experience
Catalent October 1994 - Present
GE July 1977 - September 1994
Skills
Process Improvement, Quality Control, MRP, Continuous Improvement, Management, Six Sigma, Quality System, Manufacturing, Team Building, Cross-functional Team..., GMP, Strategic Planning
Education
North Florida Community College
hamilton county high school
diploma
Catalent October 1994 - Present
GE July 1977 - September 1994
Skills
Process Improvement, Quality Control, MRP, Continuous Improvement, Management, Six Sigma, Quality System, Manufacturing, Team Building, Cross-functional Team..., GMP, Strategic Planning
Education
North Florida Community College
hamilton county high school
diploma
Donna Foti's Catalent Experience 2006 - December 2012
Job Global Compliance Auditor at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions December 2012 - Present
Catalent 2006 - December 2012
Schering Plough 1987 - 2005
Skills
Sop, GMP, FDA, GLP, Pharmaceutical Industry, CAPA, Technology Transfer, Cleaning Validation, 21 CFR Part 11, Change Control, Quality System, V&V, Regulatory Affairs, Validation, GxP, Formulation, Biotechnology, Trackwise, R&D, Aseptic Processing, Biopharmaceuticals, Drug Development, Computer System..., SOP, Quality Assurance, Quality Control, Pharmaceutics
Education
University of Phoenix 2006 — 2008
MBA, Business Administration
Thomas Edison State College
BA, Natural Sciences and Math
Catalent Pharma Solutions December 2012 - Present
Catalent 2006 - December 2012
Schering Plough 1987 - 2005
Skills
Sop, GMP, FDA, GLP, Pharmaceutical Industry, CAPA, Technology Transfer, Cleaning Validation, 21 CFR Part 11, Change Control, Quality System, V&V, Regulatory Affairs, Validation, GxP, Formulation, Biotechnology, Trackwise, R&D, Aseptic Processing, Biopharmaceuticals, Drug Development, Computer System..., SOP, Quality Assurance, Quality Control, Pharmaceutics
Education
University of Phoenix 2006 — 2008
MBA, Business Administration
Thomas Edison State College
BA, Natural Sciences and Math
George Smutko's Catalent Experience May 2007 - May 2010
Job IT Software at LMD Integrated Logistic Services
Industry Pharmaceuticals
Experience
LMD Integrated Logistic Services November 2013 - Present
Siemens August 2013 - October 2013
Church & Dwight, Co., Inc. December 2012 - May 2013
Michaels Inn 2011 - 2013
Catalent May 2007 - May 2010
Novartis January 2005 - May 2007
Johnson & Johnson April 2001 - May 2003
Skills
General Ledger, Process Improvement, Budgets, Financial Reporting, Account Reconciliation, Management, Leadership, Financial Analysis, Invoicing, Hyperion Enterprise, Sales, Change Management, Analysis, Payroll, Auditing, Forecasting, Negotiation, Strategic Planning, Customer Satisfaction, Sarbanes-Oxley Act, Business Development, Internal Audit, PowerPoint, Consolidation, Bookkeeping, Financial Forecasting, Financial Statements, Human Resources, Variance Analysis, Cost Accounting, Accounts Payable, Cash Flow, Sarbanes-Oxley, Cash Flow Forecasting, Cash Management, IT Service Management, 20, Customer Service, Accounting
Education
College of St. Joseph 1980 — 1984
AS, Business
College of St. Joseph 1979 — 1981
Associate's degree, Accounting
LMD Integrated Logistic Services November 2013 - Present
Siemens August 2013 - October 2013
Church & Dwight, Co., Inc. December 2012 - May 2013
Michaels Inn 2011 - 2013
Catalent May 2007 - May 2010
Novartis January 2005 - May 2007
Johnson & Johnson April 2001 - May 2003
Skills
General Ledger, Process Improvement, Budgets, Financial Reporting, Account Reconciliation, Management, Leadership, Financial Analysis, Invoicing, Hyperion Enterprise, Sales, Change Management, Analysis, Payroll, Auditing, Forecasting, Negotiation, Strategic Planning, Customer Satisfaction, Sarbanes-Oxley Act, Business Development, Internal Audit, PowerPoint, Consolidation, Bookkeeping, Financial Forecasting, Financial Statements, Human Resources, Variance Analysis, Cost Accounting, Accounts Payable, Cash Flow, Sarbanes-Oxley, Cash Flow Forecasting, Cash Management, IT Service Management, 20, Customer Service, Accounting
Education
College of St. Joseph 1980 — 1984
AS, Business
College of St. Joseph 1979 — 1981
Associate's degree, Accounting
Jennifer True's Catalent Experience May 2008 - August 2009
Job QA Supervisor at Sagent Pharmaceuticals
Industry Pharmaceuticals
Experience
Sagent Pharmaceuticals February 2013 - Present
Sagent Pharmaceuticals, Inc. August 2009 - February 2013
Catalent May 2008 - August 2009
Catalent April 2005 - May 2008
Baxter April 2002 - April 2005
Baxter June 2000 - April 2002
Baxter July 1997 - June 2000
Baxter November 1996 - July 1997
Skills
Pharmaceutical Industry, Validation, GMP, FDA, Sop, Change Control, Regulatory Affairs, CAPA, GLP, Internal Investigations, Product Complaints, Management Review, Product Launch, Trackwise, 21 CFR Part 11, GxP, Pharmaceutics, Regulatory Requirements, Medical Devices, Quality Control, Technology Transfer, Cross-functional Team...
Education
Elmhurst College 1994 — 1996
BS, Biochemistry
Sagent Pharmaceuticals February 2013 - Present
Sagent Pharmaceuticals, Inc. August 2009 - February 2013
Catalent May 2008 - August 2009
Catalent April 2005 - May 2008
Baxter April 2002 - April 2005
Baxter June 2000 - April 2002
Baxter July 1997 - June 2000
Baxter November 1996 - July 1997
Skills
Pharmaceutical Industry, Validation, GMP, FDA, Sop, Change Control, Regulatory Affairs, CAPA, GLP, Internal Investigations, Product Complaints, Management Review, Product Launch, Trackwise, 21 CFR Part 11, GxP, Pharmaceutics, Regulatory Requirements, Medical Devices, Quality Control, Technology Transfer, Cross-functional Team...
Education
Elmhurst College 1994 — 1996
BS, Biochemistry
Arthur Baran's Catalent Experience April 2008 - Present
Job Vice President at Baran & Associates, LLC
Industry Pharmaceuticals
Experience
Baran & Associates, LLC November 2011 - Present
Catalent April 2008 - Present
Automatic Precision Inc. January 2007 - June 2007
Abraxis BioScience 2005 - 2007
Education
Loyola University of Chicago 1997 — 2000
BS, Molecular Cellular Biology Physiology
Keller Graduate
MBA, Accounting, Finance, Investment
Baran & Associates, LLC November 2011 - Present
Catalent April 2008 - Present
Automatic Precision Inc. January 2007 - June 2007
Abraxis BioScience 2005 - 2007
Education
Loyola University of Chicago 1997 — 2000
BS, Molecular Cellular Biology Physiology
Keller Graduate
MBA, Accounting, Finance, Investment
Jan Gearhart's Catalent Experience 1998 - 2007
Job QA Specialist at Dermazone Solutions
Industry Medical Devices
Experience
Dermazone Solutions June 2010 - Present
Smith & Nephew December 2007 - November 2009
Catalent 1998 - 2007
Cardinal Health / Catalent Pharma Solutions 2000 - 2006
Cardinal Health 1998 - 2006
R. P. Scherer 1998 - 2006
R. P. Scherer 1998 - 2006
Nabisco Foods 1993 - 1998
Central Soya 1989 - 1993
Kingsford Packing 1986 - 1989
Skills
CAPA, FDA, GMP, Sop, Validation, Medical Devices, Aseptic Processing, Quality System, V&V, Root Cause Analysis, R&D, GLP, Six Sigma, Pharmaceutical Industry, Technology Transfer
Education
Penn State University 1977 — 1981
BS, Food Science
Dermazone Solutions June 2010 - Present
Smith & Nephew December 2007 - November 2009
Catalent 1998 - 2007
Cardinal Health / Catalent Pharma Solutions 2000 - 2006
Cardinal Health 1998 - 2006
R. P. Scherer 1998 - 2006
R. P. Scherer 1998 - 2006
Nabisco Foods 1993 - 1998
Central Soya 1989 - 1993
Kingsford Packing 1986 - 1989
Skills
CAPA, FDA, GMP, Sop, Validation, Medical Devices, Aseptic Processing, Quality System, V&V, Root Cause Analysis, R&D, GLP, Six Sigma, Pharmaceutical Industry, Technology Transfer
Education
Penn State University 1977 — 1981
BS, Food Science
Mark Einziger's Catalent Experience February 2005 - Present
Job Senior Project manager at Catalent
Industry Pharmaceuticals
Experience
Catalent February 2005 - Present
Catalent Pharma Solutions formerly Cardinal Health February 2005 - Present
Catalent Pharma Solutions 2005 - Present
CHURCH & DWIGHT CO., INC January 1997 - January 2005
Church & Dwight 1998 - 2005
Church & Dwight January 1993 - January 1997
LANOTONE PRODUCTS INC January 1984 - January 1993
AMTEC January 1981 - January 1984
Education
University of Dayton 1973 — 1977
BA, Chemistry
University of Dayton
BA
Catalent February 2005 - Present
Catalent Pharma Solutions formerly Cardinal Health February 2005 - Present
Catalent Pharma Solutions 2005 - Present
CHURCH & DWIGHT CO., INC January 1997 - January 2005
Church & Dwight 1998 - 2005
Church & Dwight January 1993 - January 1997
LANOTONE PRODUCTS INC January 1984 - January 1993
AMTEC January 1981 - January 1984
Education
University of Dayton 1973 — 1977
BA, Chemistry
University of Dayton
BA
Robert Romance's Catalent Experience November 2009 - May 2011
Job Certified Safety Professional
Industry Packaging and Containers
Experience
Amazon.com October 2012 - April 2013
Clondalkin Group May 2011 - October 2012
Catalent November 2009 - May 2011
Skills
CSP
Education
Indiana University of PA 1992 — 1995
Master of Science (M.S.), Safety Sciences
Indiana University of PA 1989 — 1992
Bachelor of Science (B.S.), Safety Sciences
Amazon.com October 2012 - April 2013
Clondalkin Group May 2011 - October 2012
Catalent November 2009 - May 2011
Skills
CSP
Education
Indiana University of PA 1992 — 1995
Master of Science (M.S.), Safety Sciences
Indiana University of PA 1989 — 1992
Bachelor of Science (B.S.), Safety Sciences
Wyatt Humphrey's Catalent Experience February 1991 - April 2014
Job Plant Manager at J & D Laboratories
Industry Pharmaceuticals
Experience
J & D Laboratories April 2014 - Present
Catalent February 1991 - April 2014
RP Scherer January 1991 - March 1993
Skills
Lean Manufacturing, Manufacturing, Production, cGMP, Operational Excellence, SOP, GMP, Packaging, Kaizen, 5S, Six Sigma, Continuous Improvement, CAPA, On Time Delivery, Value Stream Mapping, DMAIC, Supervisory Skills, Contract Manufacturing, Word, Excel, PowerPoint, Kronos, IPC, JD Edwards, Documentum, TrackWise, ComplianceWire, V&V, Microsoft Word, Sop, Trackwise, Quality Assurance, Process Improvement, FDA, Quality System, Microsoft Excel, Cross-functional Team...
Education
Ashworth University 2009 — 2011
Associates Degree, Business Management
J & D Laboratories April 2014 - Present
Catalent February 1991 - April 2014
RP Scherer January 1991 - March 1993
Skills
Lean Manufacturing, Manufacturing, Production, cGMP, Operational Excellence, SOP, GMP, Packaging, Kaizen, 5S, Six Sigma, Continuous Improvement, CAPA, On Time Delivery, Value Stream Mapping, DMAIC, Supervisory Skills, Contract Manufacturing, Word, Excel, PowerPoint, Kronos, IPC, JD Edwards, Documentum, TrackWise, ComplianceWire, V&V, Microsoft Word, Sop, Trackwise, Quality Assurance, Process Improvement, FDA, Quality System, Microsoft Excel, Cross-functional Team...
Education
Ashworth University 2009 — 2011
Associates Degree, Business Management
Daron Riebe's Catalent Experience GM Global Sourcing Medical DiagnosticsGE Healthcare2007 - 2009
Job VP Procurement at Catalent
Industry Pharmaceuticals
Experience
Catalent GM Global Sourcing Medical DiagnosticsGE Healthcare2007 - 2009
Nicor Gas 1988 - 1995
Education
Illinois State University 1978 — 1980
Bachelor of Science (BS), Business Administration and Management, General
Catalent GM Global Sourcing Medical DiagnosticsGE Healthcare2007 - 2009
Nicor Gas 1988 - 1995
Education
Illinois State University 1978 — 1980
Bachelor of Science (BS), Business Administration and Management, General
Angie L. Cormier's Catalent Experience January 2001 - January 2011
Job Labor Law Administrator at State of New Mexico
Industry Law Enforcement
Experience
NM Government July 2012 - Present
The National Judicial College August 2012 - August 2012
Oso BioPharmaceuticals Manufacturing, LLC September 2001 - July 2012
OSO BIO January 2001 - July 2012
Catalent January 2001 - January 2011
Skills
Aseptic Processing, GMP, Sop, Biopharmaceuticals, CAPA, FDA, Pharmaceutical Industry, Change Control, Technology Transfer, Contract Manufacturing, Lyophilization, Quality System, Aseptic Technique, Sterilization, Microbiology, Regulatory Affairs, Quality Assurance, Biotechnology, cGMP practices, Cleaning Validation, Investigation, Clinical Trials, SOP development, cGMP manufacturing, 21 CFR Part 11, LIMS, SOP, Quality Control
Education
Final Notice Investigations Services Group 2012 — 2012
Private Investigation
University of Phoenix 2005 — 2009
Master of Science, Administration of Justice and Security
University of Phoenix 2003 — 2009
Bachelor of Science, Criminal Justice Administration
National American University
Associate of Science, General Education
NM Government July 2012 - Present
The National Judicial College August 2012 - August 2012
Oso BioPharmaceuticals Manufacturing, LLC September 2001 - July 2012
OSO BIO January 2001 - July 2012
Catalent January 2001 - January 2011
Skills
Aseptic Processing, GMP, Sop, Biopharmaceuticals, CAPA, FDA, Pharmaceutical Industry, Change Control, Technology Transfer, Contract Manufacturing, Lyophilization, Quality System, Aseptic Technique, Sterilization, Microbiology, Regulatory Affairs, Quality Assurance, Biotechnology, cGMP practices, Cleaning Validation, Investigation, Clinical Trials, SOP development, cGMP manufacturing, 21 CFR Part 11, LIMS, SOP, Quality Control
Education
Final Notice Investigations Services Group 2012 — 2012
Private Investigation
University of Phoenix 2005 — 2009
Master of Science, Administration of Justice and Security
University of Phoenix 2003 — 2009
Bachelor of Science, Criminal Justice Administration
National American University
Associate of Science, General Education
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY