Wyeth Biotech
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Wyeth Biotech Employees
Accenture September 2013 - Present
Accenture November 2012 - Present
Intertek September 2011 - November 2012
ApoCell, Inc. August 2010 - September 2011
ApoCell, Inc. November 2009 - October 2010
Wyeth Biotech January 2008 - November 2009
Genentech, Inc August 2007 - December 2007
Tanox, Inc. October 2003 - December 2007
Skills
Data Mining, Black Belt / Continuous..., Process Improvement, Software Implementation, Financial Analysis, Lean six sigma, MS Visio, MS Project, Product Management, Business Analysis, Chromatography, Biotechnology, Cost Analysis, Excel, Process Excellence, Business Process..., Process Engineering, Multilingual, Protein Purification, Laboratory Information..., LIMS, Budgeting, Market Analysis, Microsoft Excel, Project Management, Visio, Lean Manufacturing, Technology Transfer, Continuous Improvement, Six Sigma, Technical Writing, Analysis, Management, GMP, Validation, System Integrators, Enterprise Systems..., Software Solution..., distributed control..., Requirements Workshops, Analyzer Information..., Statistical Data..., Process Simulation, Sop, CAPA, Systems Analysis
Education
Kapur Training Online 2012 — 2012
Project Management Professional Training
BLACK BELT, LEAN SIX SIGMA 2009 — 2011
BLACK BELT
University of Massachusetts Lowell 2008 — 2010
Masters in Business Administration
University of Houston 2001 — 2004
Master of Science
University of Houston 1996 — 2000
Bachelor of Science
ProPharma Group November 2012 - Present
ProPharma Group July 2012 - Present
Genzyme 2007 - July 2012
Wyeth Biopharma 2002 - 2007
Wyeth Biotech 2002 - 2007
UMass Biologics Laboratory 2000 - 2002
Skills
GMP, Validation, Cleaning Validation, cGMP, Aseptic Processing, Process Validation, Quality Systems, CAPA, Biotechnology, SOP, Change Control, Cell Culture, FDA, Vaccines, Purification, Root Cause Analysis, Quality Assurance, Document Management, QC, Commissioning, Sop, 21 CFR Part 11, V&V, Quality System, Technology Transfer, Quality Control, Pharmaceutical Industry, Manufacturing, GxP, Laboratory, Computer System..., GAMP, Biopharmaceuticals, Software Documentation, LIMS, Chromatography, Trackwise, GLP, Cross-functional Team..., TrackWise
Education
Dana-Farber Cancer Institute; Harvard Medical School 1998 — 2000
Post Doctoral Fellowship, Cell/Cellular and Molecular Biology
University of South Carolina-Columbia 1992 — 1997
Ph.D., BioChemistry
University of Massachusetts, Amherst 1988 — 1992
BS, BioChemistry
Pfizer July 2014 - Present
Pfizer Pharmaceuticals 2008 - Present
Wyeth Biotech 2005 - 2008
Dover Middle School September 2004 - June 2005
Wyeth Biotech June 2001 - September 2004
Skills
Instructional Design, E-Learning, Instructor-led Training, Captivate, Training, Technical Training, Performance Consulting, Needs Analysis, Employee Training, Curriculum Design, Document Management, Quality Assurance, SnagIt, Learning Management, Blended Learning, Learning Management..., Software Documentation, Cross-functional Team..., GMP, Curriculum Development, Change Control, Sop, Quality System, Training Delivery, 21 CFR Part 11, CAPA, Management, Workshop Facilitation, Validation, Pharmaceutical Industry, Technical Writing, Adult Education, Visio, Lectora, Quality Control, FDA, Biotechnology, Six Sigma, Regulatory Requirements, Facilitators, Organizational..., Process Improvement, Adult Learning Theory, Business Process Mapping, Coaching, Facilitation, Leadership Development, Organizational..., Process Simulation, SharePoint
Education
UMass Boston 2007 — 2009
Masters Certificate, Instructional Design
University of New Hampshire 2004 — 2005
Masters, Education
University of New Hampshire 2000 — 2004
Bachelors, History, Minor in Education
Biomanufacturing Training and Education Center (BTEC) at NC State University March 2006 - Present
Independent Contractor March 2006 - Present
Wyeth Biotech March 2004 - March 2006
Wyeth Biotech April 2002 - March 2004
Wyeth Biotech May 2000 - May 2002
Wyeth Biotech July 1997 - May 2000
Johnson & Johnson - Ortho Clinical Diagnostics April 1990 - July 1997
Eastman Kodak June 1985 - April 1990
Skills
Grantwriting, Technical Writing, Online Instruction, Technical Training, Strategic Planning, Presenter, Curriculum Development, Curriculum Writing, Fermentation, Grant Writing, Curriculum Design, cGMP manufacturing, Vaccines, Biotechnology, Contract Manufacturing, Commercialization, Training, Strategy, Proposal Writing, Start-ups, Leadership, Quality System, Aseptic Processing, CAPA, Program Management, Lifesciences, Biochemistry, Biopharmaceuticals, Cross-functional Team..., E-Learning, FDA, GMP, Instructional Design, Manufacturing, Process Simulation, Sop, Technology Transfer, Validation, SOP, Life Sciences
Education
State University of New York at Buffalo - School of Management 1989 — 1991
MBA, Business Administration and Management, General
University of Michigan 1979 — 1985
BS, BSE, Microbiology, Chemical Engineering
Clawson High School 1975 — 1979
HS, College/University Preparatory and Advanced High School/Secondary Diploma Program
Genzyme September 2012 - Present
Genzyme August 2011 - September 2012
Pfizer March 2002 - August 2011
Wyeth Biotech August 1997 - May 2002
Skills
HPLC, Chromatography, GMP, Validation, UV/Vis, SDS-PAGE, Pharmaceutical Industry, Antibodies, Sop, Biotechnology, SOP, GLP, Change Control, Laboratory, Biopharmaceuticals, Quality Control
Education
Suffolk University 1993 — 1997
Bachelors, Biology
Shire Pharmaceuticals December 2014 - Present
AgaMatrix July 2010 - November 2014
Pfizer (formerly Wyeth Biotech) October 2006 - July 2010
Wyeth Biotech August 2002 - July 2006
Wyeth BioPharma - Genetics Institute January 2000 - January 2002
Skills
Team oriented, Strategic Thinking, Technical Management, V&V, Quality System, Six Sigma, Contract Manufacturing, Lean Manufacturing, Protocol, Raw Materials, GMP, Technology Transfer, Medical Devices, FDA, Validation, Sop, CAPA, Cross-functional Team..., Change Control, Quality Control, Regulatory Affairs, SOP, Biotechnology
Education
Villanova University 2009 — 2010
Certificate
Tufts University
MS
Novartis July 2015 - Present
Bayer August 2012 - July 2015
Stryker Orthopaedics December 2009 - August 2012
Wyeth Biotech February 2007 - November 2009
Pfizer March 2004 - February 2007
Skills
Orthopedics, Operating Room, Oncology
Education
The University of Connecticut School of Business
MBA
University of Michigan
BS, Mechanical Engineering
Pfizer March 2003 - Present
Wyeth Biotech March 2003 - 2009
Diacrin, Inc 2001 - 2003
Skills
LIMS, GMP, 21 CFR Part 11, Sop, CAPA, Change Control, Validation, Trackwise, FDA, GLP, Aseptic Processing, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Analytical Chemistry, SOP
Education
University of Massachusetts Lowell 1996 — 2000
BS, Biological Science
Symbiota, LLC July 2014 - Present
Pronutria Biosciences April 2011 - June 2014
Tufts University September 2007 - April 2011
Wyeth Biotech May 2007 - August 2007
Tufts University May 2005 - May 2007
Tufts University October 2004 - May 2005
PerkinElmer LAS June 2004 - August 2004
Skills
Metabolic Engineering, Fermentation, Analytical Chemistry, Protein Purification, Purification, Protein Expression, Process Simulation, Proteomics, Computational Biology, Synthetic Biology, Biochemical Engineering, Start-ups, Chemical Engineering, Natural Products, Systems Biology, Chromatography, Cell Culture, Design of Experiments
Education
Tufts University 2007 — 2010
Ph.D., Chemical Engineering
Tufts University 2003 — 2007
B.S., Chemical Engineering, Philosophy
Bedford High School 1999 — 2003
High School Diploma
Solotech Inc. Operations DirectorDAV Productions2001 - 2008
Wyeth Biotech August 2000 - August 2001
Skills
AV, Sound, Live Events, Lighting, Production Managment, Live Sound, Video, Entertainment, Theatre, Audio Engineering, Stage Management, Projection, Sound Design, Lighting Design, Video Conferencing, Professional Audio, Digital Signage, Video Production, Corporate Events, Digital Video, Crestron, Camera, Projectors, Sound Reinforcement, Stage Lighting, Production Management
Education
University of Illinois at Urbana-Champaign 1996 — 2000
Biochemistry, Cell and Structural Biology
Sigma-Aldrich October 2013 - Present
bioMerieux February 2013 - October 2013
Covidien September 2010 - January 2013
Covidien July 2007 - September 2010
Centocor October 2004 - July 2007
American Red Cross January 2004 - October 2004
Wyeth Biotech July 2002 - November 2003
Abbott April 2001 - April 2002
Skills
Quality Assurance..., Software Quality..., CAPA, Validation, GMP, Deviations, 21 CFR Part 11, Computer System..., GAMP, Sop, Change Control, Quality Assurance, Pharmaceutical Industry, ISO 13485, GxP, GLP, FDA, Testing, Quality Control, LIMS, Quality Auditing, Aseptic Processing, ISO 14971, V&V, FDA GMP, Trackwise, Design Control, Regulatory Affairs, Regulatory Requirements, Quality System
Education
University of Illinois at Urbana-Champaign 1996 — 2000
Bachelor of Science (B.S.), Biology, General
Pfizer Oncology October 2009 - Present
Wyeth Biotech March 2007 - October 2009
Wyeth Pharmaceuticals April 2004 - April 2007
Skills
Managed Markets, Buy & Bill, Rheumatology, Pharmaceutical Sales, Hospital Sales, Gastroenterology, Pharmaceutical Industry, Endocrinology, Sales Effectiveness, Oncology, Cardiology, Managed Care, Infectious Diseases, Healthcare, Medical Devices, Clinical Development, Product Launch, Market Access, Psychiatry
Education
Southern Oregon University
Bachelor of Science, Math, Business
Washington State University
MBA
Herman-Marsh Consulting December 2014 - Present
Tutto! Wood-fired Pizza August 2014 - Present
University of Phoenix March 2011 - November 2014
Pfizer Biotech January 2007 - March 2011
Wyeth Biotech October 2004 - December 2006
Lonza Biologics December 2001 - July 2003
UMass Biologics Laboratories September 2000 - December 2001
Aventis Behring August 1997 - July 2000
Diamond Animal Health September 1996 - July 1997
Genencor International September 1986 - August 1994
Skills
Validation, GMP, Biotechnology, SOP, FDA, 21 CFR Part 11, Pharmaceutical Industry, Biopharmaceuticals, Quality System, Cross-functional Team..., Quality Assurance, Change Control, Quality Control, GLP, GxP, Technology Transfer
Education
University of Phoenix 2006 — 2014
Doctor, Management
University of Phoenix 2004 — 2006
Master, Management
University of Northern Iowa 1993 — 1995
Bachelor's, Biotechnology
SUNY Canton 1983 — 1985
Applied Associate in Science, Science Laboratory Technology - Microbiology
Biogen August 2015 - Present
Triangle Special Hockey Assoc, Inc January 2007 - Present
Eisai May 2007 - August 2015
SEC Associates, Inc. August 2000 - May 2007
Wyeth Biotech 2002 - 2007
Honeywell March 1983 - August 2000
Skills
Microsoft Office, Validation, Automation, Testing, Engineering, Troubleshooting, 21 CFR Part 11, GMP, Computer System..., Instrumentation, Software Documentation, Allen Bradley, Wonderware, DCS, GAMP, cGMP, Commissioning, Documentation, SQL, Visio, Pharmaceuticals, Integration, Visual Basic, SCADA, PLC, Programming, Excel, MES, SDLC, Word, Windows, Access, Change Management, Databases, Problem Solving, Sled Hockey, Special Needs Hockey, Disabled Sports, Autism Spectrum..., Developmental..., Boy Scouts, V&V, FDA, Change Control, Technology Transfer, GxP, Quality System, Process Automation, Pharmaceutical Industry, Microsoft Word
Education
Texas Tech University 1978 — 1984
BSEE, Electrical Engineering
Wake Technical Community College 2005 — 2011
Certificate, Visual Basic
GE Aviation May 2013 - Present
LA Fitness November 2011 - Present
GE Aviation August 2011 - May 2013
GE Aviation July 2009 - July 2011
Draper Laboratory September 2008 - June 2009
Tufts University September 2005 - May 2009
Federal Energy Regulatory Commission June 2008 - August 2008
Wyeth Biotech June 2007 - August 2007
Skills
Process Improvement, Risk Assessment, Chemical Engineering, Matlab, Leadership, Chemistry, Engineering, Inspection, Six Sigma, AutoCAD, Environmental Awareness
Education
Penn State University 2012 — 2014
Master's degree, Logistics, Materials, and Supply Chain Management
Tufts University 2005 — 2009
BS, Chemical Engineering
Contractor on assignment at Seres Therapeutics through StratAcuity July 2015 - Present
AMRI (Albany Molecular Research Inc.) April 2014 - Present
Wyeth Biotech 2007 - 2008
Wyeth Biotech 2007 - 2008
Skills
Quality Assurance, Quality Control, CAPA, GMP, Sop, Validation, FDA, GLP, Change Control, Aseptic Processing, 21 CFR Part 11, Quality System, Biopharmaceuticals, GxP, LIMS, SOP, V
Education
University of Massachusetts, Amherst 2001 — 2005
Biology
Pfizer 2009 - Present
Wyeth Biotech December 2008 - October 2009
Wyeth Biotech December 2007 - December 2008
Wyeth Biotech January 2003 - December 2007
Monsanto April 2001 - January 2003
Centeon LLC 1999 - 2001
Aventis Behring October 1997 - April 1999
Abbott Laboratories February 1996 - October 1997
Sanofi Pasteur June 1991 - February 1996
Skills
Lean Six Sigma Black..., Validation, Technical Services, Operational Excellence, Lean Manufacturing, Project Engineering, HVAC, GMP, Aseptic Technique, Autoclave, Six Sigma
Education
University of Tennessee-Knoxville 1987 — 1989
MS, Engineering
Tennessee Technological University 1984 — 1986
BS, Engineering
Pfizer 2009 - Present
Pfizer Pharmaceuticals April 2001 - Present
Pfizer April 2001 - Present
Wyeth Biotech 2001 - 2009
Law Office of CR Buckley March 1999 - April 2001
Law Office of CR Buckley March 1999 - March 2001
Franklin Electric/Little Giant Pump Co. February 1990 - May 1998
Systematics, Inc. 1985 - 1986
Skills
Biotechnology, Time Management, Microsoft Excel, Technical Writing, System Administration, Pharmaceutical Industry, Sop, PowerPoint, Microsoft Office, SAP, Process Scheduler, Budgets, GMP, Interviews, Event Management, Microsoft Word, Validation, Customer Service, Event Planning, Networking
Education
University of Massachusetts Lowell 2005 — 2006
Nutrition
Burdett School of Business 1984 — 1985
1 Year Certificate Program, Office Admininstration
Andover High School High School
Burdett School of Business
Business Administration
Pfizer September 2009 - November 2014
Wyeth Pharmaceuticals January 2008 - September 2009
Wyeth Biotech January 2005 - January 2008
Skills
Rheumatology, Gastroenterology, Pharmaceutical Sales, Buy & Bill, Cardiology, Product Launch, Managed Care, Sales Effectiveness, Endocrinology, Oncology, Neurology, Management, Sales Operations, Pharmaceutical Industry, Urology, Sales Force Development, Pulmonology, Vaccines, Hospital Sales
Education
St. Catherine University
BA, Nursing
University of Minnesota-Twin Cities
BS
Microsoft September 2014 - Present
Microsoft September 2012 - August 2014
Microsoft August 2010 - August 2012
University of Massachusetts January 2008 - May 2010
Microsoft June 2009 - August 2009
Cisco Systems May 2008 - August 2008
Wyeth Biotech May 2007 - January 2008
Groton School July 2006 - January 2007
Skills
Software Engineering, C#, Java, Web Services, Software Development, Distributed Systems, Perl, C++, Windows Azure, REST, Cloud Storage, Cloud Computing, Databases
Education
University of Massachusetts, Amherst 2006 — 2010
Bachelor of Science; Bachelor of Science, Computer Science; Mathematics
Paleo Solutions, Inc. May 2015 - Present
Outbound Adventurer December 2013 - Present
Houston ISD May 2014 - May 2015
Harmony Public Schools May 2012 - May 2014
Adams 12 Five Star Schools March 2012 - May 2012
University of Colorado at Boulder July 2010 - May 2012
Geological Society of America June 2011 - August 2011
Wyeth Biotech January 2007 - April 2010
Ecotarium December 2006 - December 2007
The Mammoth Site of Hot Springs, SD August 2006 - November 2006
Skills
Teaching, Paleontology, Museums, Science Education, Science, Museum Education, Research, Field Work, Grant Writing, Museum Collections, Biology, Exhibit Design, Public Speaking, Curriculum Development, Community Outreach, Molecular Biology, Education, Science Journalism, Gifted Education, Science Writing, Intermediate Italian, Basic Photoshop, Fiction Writing, Writing, Curriculum Design, Social Media, Editing
Education
University of Colorado at Boulder 2010 — 2012
M.S., Museum and Field Studies
University of Massachusetts, Amherst 2002 — 2006
B.S., Biology
CTD Quality Consulting June 2004 - Present
Millennium (Takeda) Pharmaceuticals March 2004 - Present
- April 2003 - Present
Wyeth Biotech 2000 - 2003
Biogen March 1997 - May 2000
Biogen March 1996 - May 1997
Biogen February 1993 - March 1996
Biogen June 1989 - April 1993
Skills
Regulatory Submissions, MAA, IND, eCTD, Regulatory Affairs, CMC, GMP
Education
University of Massachusetts, Amherst
BS, Microbiology/Epidemiology
Pfizer June 2014 - Present
Pfizer 2009 - Present
Wyeth Biotech 2004 - 2009
Monsanto May 1999 - March 2004
Skills
Validation, Process Engineering, Technology Transfer, V&V, Change Control, Aseptic Processing, CAPA, FDA, Biopharmaceuticals, Process Optimization, Biotechnology, Pharmaceutical Industry, Root Cause Analysis, Six Sigma, Sop, R&D, Quality System, Chemical Engineering, GMP, Process Simulation, Start-ups, Lyophilization, Troubleshooting, Manufacturing, SOP
Education
University of Missouri-Rolla 1994 — 1999
BS, Chemical Engineering
Forest Laboratories April 2011 - August 2011
Trovis Pharmaceuticals, LLC, a subsidiary of Clinical Data, Inc. January 2011 - April 2011
Maxiom Group February 2010 - December 2010
"" January 2010 - September 2010
Wyeth October 2006 - July 2009
Wyeth Biotech July 2003 - September 2006
Wyeth January 1999 - June 2003
Genetics Institute (now Wyeth) April 1992 - December 1998
Repligen Corporation June 1988 - April 1992
Skills
Cross-functional Team..., Supply Chain, Supply Chain Management, Pharmaceutical Industry, Strategy, Project Management, Business Process..., Biopharmaceuticals, Program Management, Product Launch, Strategic Planning, Strategic Sourcing, Operational Excellence, Leadership
Education
Southern New Hampshire University 1991 — 1995
MBA
University of New Hampshire 1983 — 1987
BS
working at Home Project April 2012 - Present
private projects April 2012 - April 2012
HR.com January 2007 - August 2007
Wyeth Biotech February 2002 - September 2006
Skills
Account Management, Sales, Marketing Strategy, Marketing, New Business Development
Education
The University of British Columbia 1986 — 1991
MBA, Marketing
UNB 1971 — 1975
Bristol-Myers Squibb September 2008 - Present
Wyeth Biotech July 1997 - Present
Serono July 1990 - July 1997
Education
University of Michigan
MS, Biochemistry
Biogen Idec October 2013 - Present
Biogen Idec July 2010 - September 2013
Pfizer October 2009 - June 2010
Wyeth Biotech March 2008 - October 2009
Wyeth October 1994 - February 2008
Washington State University November 1990 - September 1994
Skills
GMP, Validation, Biotechnology, Technology Transfer, Purification, Biochemistry, Vaccines, Chemistry, Fermentation, Quality Assurance, Cleaning Validation, Process Simulation
Education
The University of Georgia 1985 — 1990
Ph.D., Biochemistry
University of Colorado Boulder 1982 — 1985
ABD, Chemistry
University of North Carolina at Chapel Hill 1978 — 1982
B.S. with highest honors, Botany, emphasis in Chemistry
Thermo Fisher Scientific October 2012 - Present
Johns Hopkins University September 2007 - September 2012
Tufts University January 2005 - May 2007
Wyeth Biotech May 2006 - August 2006
Skills
Flow Cytometry, Molecular Biology, Microfluidics, Cell Culture, Biotechnology, Cancer, Confocal Microscopy, Biomaterials, Nanotechnology, Experimental Design, Protein Purification, Fluorescence Microscopy, Western Blotting, Cell Biology
Education
The Johns Hopkins University 2007 — 2012
Ph.D., Chemical and Biomolecular Engineering, Cancer biology
Tufts University 2003 — 2007
B.S., Chemical and Biological Engineering
Pfizer 2009 - 2013
Wyeth Biotech April 2008 - 2009
Wyeth Pharmaceuticals October 2002 - 2008
Wyeth 1997 - 2002
Johnson & Johnson 1989 - 1997
Skills
Talent Management, Performance Management, Employee Relations, Strategic HR, Change Management, Divestitures, Labor Relations, Human Resources, Recruiting, Temporary Placement, Succession Planning, Workforce Planning, Leadership, Strategic Planning, Training, Leadership Development, Personnel Management, Strategy, Process Improvement, Management, Talent Acquisition, Employee Engagement, Deferred Compensation, Organizational Design, Onboarding, Organizational..., Employee Benefits, Organizational..., HRIS, HR Transformation, HR Policies, Compensation & Benefit, Executive Coaching, HR Consulting, Applicant Tracking..., Management Development, Culture Change, Career Development, Employer Branding, Benefits Administration, Employee Training, Interviews, Employment Law, Executive Pay, College Recruiting, Hiring, Job Evaluation, Incentive Programs, Sourcing, PeopleSoft
Education
Université de Montréal 1984 — 1990
Bachelor, Industrial Relations
College Ahunstic 1974 — 1977
DEC, Production
Genzyme April 2013 - Present
Genzyme August 2012 - Present
Fresenius Medical Care March 2012 - October 2012
Pharmalucence April 2011 - March 2012
AMAG Pharmaceuticals April 2009 - April 2011
Wyeth Biotech January 2007 - March 2009
Wyeth Biopharma 2002 - January 2007
PerkinElmer Life and Analytical Sciences 2002 - 2002
Arqule 2001 - 2002
Skills
Instructional Design, E-learning Development, Classroom Training, Curriculum Creation, Technical Training, Assessment Development, Articulate Presenter, Learning Theory, Classroom, Captivate, CAPA, Root Cause Analysis, Learning Management..., Auditing, Documentation Practices, Plateau, ISOtrain, Training Management, Training Programs, Master Control, Project Management, Supervising, Pharmaceutical Industry, FDA, GLP, Curriculum Design, Quality System, Presenter, E-Learning, Quality Management, Training, Software Documentation, 21 CFR Part 11, GMP, Change Control, GxP, Biotechnology, Instructor-led Training, Biopharmaceuticals, Quality Control, Validation, Quality Assurance, Quality Auditing, Trackwise, Needs Analysis, Sop, Six Sigma, LIMS, GCP, V&V
Education
University of Massachusetts Boston 2007 — 2009
Masters, Instructional Design, 4.0 GPA
University of Massachusetts, Amherst 1997 — 2001
BS, Animal Science
The Hospital for Sick Children November 2013 - Present
The Hospital for Sick Children November 2009 - November 2013
Wyeth Biotech October 2006 - August 2009
Skills
Protein Chemistry, Biochemistry, Molecular Biology, Neuroscience, Cell Culture, Purification, Confocal Microscopy, Immunofluorescence, Chromatography, Data Analysis, Western Blotting, ELISA, Biotechnology, Immunoprecipitation, Mammalian Cell Culture, Immunocytochemistry, GLP
Education
University College Dublin 2003 — 2007
PhD, Biochemistry
University College Dublin 2000 — 2003
BSc Biochemistry (hons)
Waterford Institute of Technology 1998 — 2000
National Certificate in Applied Biology (hons)
PDI, Inc. & Interpace Diagnostics November 2014 - Present
Bio Med Affairs LLC March 2012 - Present
CSL Behring November 2013 - November 2014
inVentiv Health December 2012 - November 2013
LEO Pharma November 2010 - March 2012
Wyeth Biotech May 2009 - March 2010
Wyeth Biotech January 2006 - April 2009
Wyeth July 2005 - December 2005
Wyeth Pharmaceuticals July 2004 - June 2005
Centocor May 2000 - June 2004
Skills
Rheumatology, Dermatology, Clinical Development, Gastroenterology, Oncology, Hematology, Immunology, Therapeutic Areas, Medical Affairs, Clinical Trials, Biotechnology, CTMS, Pharmaceutical Industry, GCP, Biopharmaceuticals, Sop, FDA, CRO, Medical Writing, Regulatory Affairs, Clinical Research, Medicine, Pharmacovigilance, Drug Development, Hospital Sales, Vaccines, Cardiology, Regulatory Submissions, Pharmaceutics, Lifesciences, Market Access, Competitive Intelligence, Diabetes, R&D, Medical Communications, Health Economics, Life Sciences
Education
Creighton Cardiac Center, Clinical Research Fellowship 1997 — 1999
Fellowship, Clinical Research/Cardiology Fellow
Creighton University School of Pharmacy 1993 — 1997
PharmD, Doctor of Pharmacy
University of California, Los Angeles 1989 — 1992
B.S., Biochemistry
Pfizer Pharmaceuticals October 2009 - Present
Wyeth Biotech March 1996 - October 2009
Genetics Institute July 1992 - March 1996
Biotechnica Diagnostics 1989 - 1992
Skills
Biotechnology, Microbiology, Cell, Tissue Culture, Transfection, In Vitro, Antibodies, Assay Development, Biochemistry, Biopharmaceuticals, Cell Biology, Cell Culture, Chromatography, Drug Design, Drug Discovery, ELISA, Immunology, Laboratory, Lifesciences, Molecular Biology, Monoclonal Antibodies
Education
Tufts University 1991 — 1994
Masters in Science, Biochemistry
University of Massachusetts, Amherst 1985 — 1989
Bachelor in Science, Biochemistry
Merrimack Pharmaceuticals 2013 - Present
Inspiration Biopharmaceuticals, Inc 2012 - 2013
Aegerion Pharma. 2011 - 2012
Shire Pharmaceuticals 2006 - 2011
TKT (Transkaryotic Therapies, Inc.) 2002 - 2006
Wyeth Biotech 1989 - 2002
SmithKline Beecham 1986 - 1989
Chesebrough-Ponds USA 1985 - 1986
Cell Products, Inc. 1983 - 1985
Skills
Quality, Quality Assurance, Quality Control, Quality Systems, Validations, Regulatory Affairs, Site Inspections, Manufacturing Operations, Supply Chain Operations, Product Development, Methods Development, Laboratory Automation, Laboratory Analysis, LIMS, Quality Management, Operational Excellence, Continuous Improvement, Quality System, V&V, Validation, Laboratory, GMP, Clinical Development, Pharmaceutical Industry, Regulatory Submissions, FDA, Analytical Chemistry, Biotechnology, Sop, CAPA, Biopharmaceuticals, 21 CFR Part 11, GLP, GxP, Aseptic Processing, GCP, Cleaning Validation, Drug Development, IND, Lifesciences, Change Control, Technology Transfer, SOP, Life Sciences
Education
University of Massachusetts at Lowell 1990 — 1994
MS, Biological Sciences
The Catholic University of America 1979 — 1983
BS, Biological Sciences
Pfizer October 2009 - Present
Wyeth 2006 - 2009
Johnson & Johnson 2004 - 2006
Wyeth Biotech 2002 - 2004
Tyco Healthcare/Mallinckrodt 1998 - 2002
Warner Lambert 1995 - 1997
Skills
Operational Excellence, Organizational Design, Six Sigma, Business Case, Lean Manufacturing, MBTI, Business Process..., Talent Management, Supply Chain, Succession Planning, Organizational..., Computer System..., GxP, 21 CFR Part 11, Change Control, FDA, Pharmaceutical Industry, CAPA, Technology Transfer, Validation
Education
Southern Illinois University, Edwardsville 1992 — 1994
Masters, Applied Statistics and Operations Research
Southern Illinois University, Edwardsville 1983 — 1988
Bachelor’s Degree, Applied Mathematics and Industrial Engineering
Pfizer December 2009 - Present
Wyeth BioPharma 2001 - March 2010
Wyeth Biotech 1999 - 2001
Wyeth Pharmaceuticals 1998 - 1999
Genetics Institute 1996 - 1998
Waters Chromatography Corp. October 1989 - November 1996
Cambridge Medical Technology 1988 - 1989
GTE 1982 - 1986
Skills
Operations Management, Product Development, Supply Chain, Biotechnology, GMP, Life Sciences, Strategic Planning, Planning, Procurement, Biopharmaceuticals, Medical Devices, Cross-functional Team..., Process Improvement, cGMP, FDA, Supply Chain Management, R&D, Negotiation, Program Management, Budgeting, Risk Management, Business Strategy, Problem Solving, Business Process..., Forecasting, Vaccines, SOP, Contract Negotiation, Biochemistry, Project Management, Project Planning, Budgets, Sop, Validation, Drug Development, Quality Assurance, Strategy, Technology Transfer, Oncology, IND, Drug Discovery, Pharmaceutical Industry, Clinical Trials, Regulatory Affairs, CRO, GCP, 21 CFR Part 11, LIMS, Lifesciences
Education
Suffolk University - Sawyer Business School 1989 — 1993
MBA, Business Administration and Operations
Suffolk University 1980 — 1984
BS, Biochemistry
EMD Millipore March 2015 - Present
Merck Millipore July 2011 - March 2015
Amgen September 2003 - May 2011
Wyeth Biotech 2000 - 2003
Wyeth 1996 - 2000
Wheelabrator Water Technologies January 1996 - November 1996
Skills
Biopharmaceuticals, Filtration, Pilot Plant, Purification, Biotechnology, Technology Transfer, GMP, Protein Purification, Chromatography, Process Simulation, Chemical Engineering, Pharmaceutical Industry, HPLC, Validation, FDA
Education
University of Colorado Boulder 2009 — 2012
Completed, MBA
Tufts University 1999 — 2002
Masters, Chemical Engineering
University of New Hampshire 1990 — 1995
Chemical Engineering
Pfizer 2009 - Present
Wyeth Biotech 2006 - 2009
Ortho Clinical Diagnostics 1991 - 2001
Skills
Process Improvement, Continuous Improvement, Six Sigma, Lean Manufacturing, DMAIC, Cross-functional Team..., GMP, Project Management, Value Stream Mapping, Quality System, Quality Assurance, Green Belt, Manufacturing, Process Simulation, Operational Excellence, Pharmaceutical Industry, Validation, FDA, CAPA, Change Control, Sop, V&V, Aseptic Processing, 21 CFR Part 11
Education
University of Connecticut
Cimpress, global leader in mass customization July 2014 - Present
Vistaprint October 2012 - July 2014
Self-employed 2004 - 2014
Pfizer September 2007 - September 2012
Wyeth Biotech August 2007 - September 2012
Sanborn Regional High School 2004 - August 2007
Hilton Head Preparatory School 2005 - 2006
IBM 2000 - 2003
Iris Associates 2000 - 2002
MotherNature.com 1999 - 2000
Skills
Cross-functional Team..., Project Management, Technical Writing, Continuous Improvement, Training, Project Planning, Instructional Design, Change Management, Microsoft Office, Program Management, SharePoint, MS Project, Six Sigma, E-Learning, Training Delivery, Captivate, Plateau, Coaching, Green Belt, SQL, HTML, Innovation, Survey Design, Software Development..., Data Analysis, Metrics, Marketing Communications, Adult Education, DMAIC, Viral Marketing, Method 1, Internal Communications, Technical Documentation, Cultural Transformation, Event Planning, User Acceptance Testing, Camtasia, Requirement..., Incentive Programs, Development of Training..., Requirements..., E-learning Development, Writing Newsletters, Cross-group..., Human Error Reduction, Large Group Facilitation, Recognition Programs, Articulate Storyline, VideoScribe, Employee Training
Education
University of Massachusetts Boston 2007 — 2009
Masters, Instructional Design
The Ohio State University 1991 — 1994
BS, Chemical Engineering
Pfizer 2009 - Present
Wyeth, Biotech 2009 - 2010
Wyeth Biotech 2005 - 2009
Abbott / Abbott Diabetes Care June 1995 - December 2004
Skills
CAPA
Education
Temple University
Quantic Group, Ltd June 2014 - Present
SSI Inc June 2014 - Present
Taro Pharmaceuticals 2010 - 2010
Consulting Services, Inc. 2010 - 2010
LAB 2007 - 2010
Wyeth Biotech 2000 - 2004
Vyteris January 1999 - June 2001
Skills
V&V, Quality Management, GMP, Chemistry, GLP, Technology Transfer, 21 CFR Part 11, Pharmaceutics, Regulatory Affairs, Quality Control, Sop, LIMS, Medical Devices, GxP, Software Documentation, Auditing, Biotechnology, Product Development, HPLC, Lifesciences, R&D, Laboratory, Microbiology, SOP
Education
The University of Manchester 1976 — 1979
Ph.D., Chemistry
Mallinckrodt Pharmaceuticals June 2014 - Present
Mallinckrodt Pharmaceuticals September 2013 - June 2014
Mallinckrodt July 2011 - September 2013
Mallinckrodt Pharmaceuticals January 2011 - July 2011
Covidien May 2008 - January 2011
Centocor April 2004 - May 2008
Wyeth Biotech October 2000 - April 2004
Biomerieux July 1999 - October 2000
Celsis January 1998 - August 1999
Skills
Validation, Process Validation, Quality Assurance, API, GMP, Technology Transfer, Biopharmaceuticals, cGMP, Quality Systems, Microbiology, Quality Management, Biotechnology, Protein Purification, Cell Culture, V&V, Quality System, Computer System..., CAPA, Six Sigma, Sop, 21 CFR Part 11, Change Control, Cleaning Validation, APIs, Manufacturing, FDA, Quality Control, Aseptic Processing, Mountain Biking, Pharmaceutics, Laboratory, GxP, GLP, Equipment Qualification, ISO 13485, GAMP, Lifesciences, Pharmaceutical..., SOP development, Purification, Deviations, cGMP manufacturing, Quality by Design, SOP, Pharmaceutical Industry
Education
University of Missouri-Saint Louis 1992 — 1998
BS, Biology with Minor in Chemistry
Wyeth Biotech September 2002 - Present
Education
St. Thomas Aquinas College
B.S., Business
CDM Smith March 2010 - Present
Seledog Real Estate March 2002 - September 2011
ZymoGenetics January 2009 - August 2009
Amgen, Inc. March 2004 - September 2008
Adaptis, Inc. August 2001 - March 2004
xSides, Inc. 2000 - 2001
Wyeth Biotech June 1999 - September 1999
University of Washington 1996 - 1999
Aerojet June 1996 - September 1996
Skills
Biotechnology, Technical Writing, Process Development, Cell Culture, Statistics, Environmental..., Anaerobic Digestion, Bioremediation, Wastewater Treatment, Drinking Water
Education
University of Washington 1995 — 2005
BS/MS, BSChemEngr/MSMedEngr
The University of Edinburgh 1999 — 2000
BSChE, Chemical Engineering
MedImmune September 2007 - Present
MedImmune September 2007 - June 2011
CoGenesys November 2006 - September 2007
Wyeth Biotech June 2003 - November 2006
Wyeth Biotech August 2004 - November 2005
CRB Consulting Engineers June 2002 - June 2003
O'Neal, Inc. September 2000 - June 2003
Skills
Biotechnology, Change Control, Validation, Biopharmaceuticals, GMP, SOP, CAPA
Education
University of Maryland University College 2002 — 2005
M.S., Biotechnology
CSL Behring 2007 - Present
Wyeth Biotech 2004 - 2007
Jacobs Engineering 2001 - 2004
Skills
Filtration, cGMP, Commissioning, GMP, Biopharmaceuticals, FDA, Process Validation, P&ID, Process Equipment, Change Control, Equipment Design, Engineering, Chromatography, SOP, Chemical Engineering, Process Engineering, GxP, Biotechnology, Project Engineering
Education
University of Cincinnati 1995 — 2000
BS, Chemical Engineering
Genzyme, a Sanofi company May 2015 - Present
Genzyme September 2012 - April 2015
Genzyme October 2011 - September 2012
Genzyme September 2008 - October 2011
Alkermes March 2008 - September 2008
Alkermes October 2006 - March 2008
Wyeth Biotech April 2001 - October 2006
Primedica August 2000 - April 2001
Skills
LIMS, GMP, CAPA, 21 CFR Part 11, Sop, Validation, FDA, Change Control, Trackwise, Biotechnology, Quality System, GLP, Quality Management
Education
Springfield College 1996 — 2000
Bachelor's degree
Pfizer Inc.; Quality Compliance Standard & System Support October 2009 - Present
Wyeth Biotech December 2000 - October 2009
Parenteral Drug Association 1995 - 2006
Millipore Corporation July 1995 - December 2000
Wyeth Pharmaceuticals June 1993 - June 1995
Education
State University of New York College at Plattsburgh 1989 — 1993
Bachelors of Science, Microbiology
Cazenovia High School 1985 — 1993
Pfizer 2009 - Present
Wyeth Biotech July 2003 - Present
Wyeth 2003 - Present
Shire Pharmaceutical (formerly TKT) August 2002 - July 2003
Parsons/PFI 1999 - 2002
Biokinetics 1998 - 1999
Earth Tech 1988 - 1996
Skills
Biotechnology, cGMP, Pharmaceuticals, Vaccines, Chemical Engineering, Technology Transfer, Manufacturing, Cell Culture, Harvest, Purification, Troubleshooting, Debottlenecking, Plant Design, Process Simulation, Sizing, Detail Engineering, Pilot Plant, Data Sheets, P&ID, Process Equipment, GMP, Chromatography, Pharmaceutical Industry, Mammalian Cell Culture, Process Design, Process Engineering, Biopharmaceuticals, Process Optimization, Process Control, R&D, Validation, Change Control, CAPA, Fermentation
Education
University of Connecticut 1984 — 1988
Taurus Project Controls Consulting, Inc. May 2013 - February 2015
T2 Biosystems 2015 - 2015
T2 Biosystems 2015 - 2015
T2 Biosystems 2015 - 2015
T2 Biosystems 2015 - 2015
T2 Biosystems 2015 - 2015
T2 Biosystems 2015 - 2015
Xcellerex December 2010 - March 2013
Shire Human Genetic Therapies 2008 - June 2010
Wyeth Biotech 2006 - April 2008
Skills
GMP, Biotechnology, Manufacturing, Process Optimization, Purification, Protein Purification, Validation, Quality Assurance, Cell Culture, Sop, Laboratory, Technology Transfer, FDA, SOP, Biopharmaceuticals
Education
Tulane University
BS in Biology
Pfizer October 2009 - Present
Wyeth Research July 2004 - October 2009
Wyeth Biotech January 2001 - July 2004
National Starch and Chemical April 1994 - July 1999
The Dial Corporation September 1990 - April 1993
Quantum Chemical Company July 1981 - October 1990
Education
University of Cincinnati 1976 — 1981
Wyeth April 2001 - Present
Wyeth Biotech 2001 - Present
Wyeth Biotech 2001 - 2009
Education
Southern New Hampshire University 1996 — 2004
Genzyme August 2011 - Present
Shire HGT 2009 - 2011
Wyeth Biotech June 2001 - 2009
Skills
Technology Transfer, GMP, Validation, Biopharmaceuticals, Biotechnology
Education
Stevens Institute of Technology
Graduate Courses, Chemical Engineering
Tufts University
Graduate Courses, Biochemical Engineering
University of Delaware
BS, Chemical Engineering
Shire HGT December 2012 - Present
Genzyme January 2011 - December 2012
Bristol-Myers Squibb 2007 - January 2011
Wyeth Biotech 2003 - 2007
Monsanto 2001 - 2003
Education
University of Massachusetts, Amherst
CNM69 LLC September 2015 - Present
Spherix Global Insights May 2015 - August 2015
Regeneron Pharmaceuticals April 2012 - April 2015
Pfizer Pharmaceuticals February 2010 - March 2012
Wyeth Biotech March 2009 - February 2010
Wyeth June 2007 - March 2009
Wyeth Pharmaceuticals April 2005 - June 2007
Wyeth Pharmaceuticals 2000 - 2003
Skills
Pharmaceutical Sales, Pharmaceutical Industry, Oncology, Product Marketing, Sales Effectiveness, Marketing, Infectious Diseases, Market Analysis, Diabetes, Neurology, Cross-functional Team..., Digital Marketing, Managed Care, Biotechnology, Product Launch, Strategic Planning, Sales Operations, Clinical Trials, Marketing Strategy, Market Research, Competitive Analysis, Rheumatology, Market Access, Hospital Sales, Gastroenterology, Pulmonology, Urology, Therapeutic Areas, Medical Writing
Education
State University of New York College at Cortland 1987 — 1991
BS, Political Science
State University of New York College at Cortland 1987 — 1991
Bachelor's degree, Political Science and Government
Pfizer 2011 - Present
Pfizer 2009 - 2011
Wyeth Biotech 2002 - 2009
Biogen Idec 1995 - 2002
Skills
Technology Transfer, Antibodies, Column Chromatography, Biotechnology, Process Simulation, Pharmaceutical Industry, Drug Development, Protein Chemistry, Validation, Protein Purification, Cell, Cell Culture, Biochemistry, Biopharmaceuticals, Assay Development
Education
The University of Connecticut Health Center 1990 — 1995
Post-Doc., Biochemistry
University of California, Davis 1984 — 1990
Ph.D., Biochemistry
University of New Hampshire 1981 — 1984
M.S., Biochemistry
University of New Hampshire 1977 — 1981
B.S., Animal Science
Pfizer January 2010 - Present
Wyeth Biotech January 2008 - January 2012
Wyeth Biotech April 2006 - December 2007
Enzon Pharmaceuticals October 2004 - March 2006
Enzon Pharmaceuticals October 2003 - December 2004
Cardinal Health April 2003 - October 2003
Cardinal Health April 2001 - April 2003
SEBRA 1999 - 2000
Skills
Cleaning Validation, Validation, Process Validation, Aseptic Processing
Education
University of Arizona 1995 — 1999
B.S, Biosystems Engineering
Eleven Biotherapeutics September 2011 - Present
Alexion Pharmaceuticals February 2011 - October 2011
Taligen Therapeutics Inc. 2006 - February 2011
Novartis 2006 - 2008
Millennium Pharmaceuticals, Inc. 2000 - 2006
Wyeth Biotech 1998 - 2000
Genetics Institute 1993 - 1998
Genentech 1986 - 1993
Education
University of Arizona College of Medicine – Tucson 1981 — 1986
PhD, Molecular Biology
University of California, San Diego 1976 — 1980
Bachelor of Sciences, Biology
Grifols Therapeutics, Inc. (Formerly Talecris) April 2011 - Present
Talecris Biotherapeutics, Inc. September 2009 - April 2011
Talecris May 2009 - September 2009
Wyeth 2008 - November 2008
Wyeth Biotech April 2005 - May 2008
Wyeth Biotech August 2001 - April 2005
AAIPharma 1998 - 2001
CompuChem January 1987 - August 1996
Triangle Laboratories July 1985 - December 1987
Skills
Microsoft Office, Documentum, Document Management, Supervisory Skills, Technical Writing, Training Delivery, Proofreading, Data Compilation, Data Quality, Analytical Chemistry, Data Collection, Sop, Quality Assurance, CAPA, GMP, HPLC, GLP, Quality System, Pharmaceutical Industry, Validation, Software Documentation, LIMS, GxP, Biotechnology, Change Control, FDA, Aseptic Processing, Computer System..., V&V, Quality Control, SOP, Trackwise, 21 CFR Part 11
Education
Temple University 2012 — 2016
MS Quality Assurance/Regulatory Affairs
University of North Carolina at Chapel Hill 1981 — 1985
BS, Chemistry
EMD Millipore October 2013 - Present
Terumo BCT January 2012 - September 2013
Encision September 2011 - January 2012
Thermo Fisher Scientific June 2009 - March 2011
Smith & Nephew Endoscopy September 2008 - February 2009
Fusion Optix July 2007 - September 2008
Wyeth Biotech May 2005 - August 2006
Skills
Validation, Testing, Manufacturing, Product Development, Management, Mechanical Engineering, Design for Manufacturing, Automation, Continuous Improvement, Integration, Medical Devices, R&D, Injection Molding, Engineering Management, Supply Chain, Engineering, Solidworks, Quality Control, Manufacturing..., V&V, Analysis, Leadership, Machining, CAD, Product Management, Training, Project Management, Six Sigma, FMEA
Education
The University of Connecticut 2003 — 2007
Bachelor of Science (BS), Mechanical Engineering
Lexington Christian Academy
Process Design Solutions July 2009 - Present
Shire HGT July 2009 - December 2013
NNE Pharmaplan October 2007 - July 2009
Wyeth Biotech September 2006 - September 2007
Wyeth BioPharma 2001 - 2006
Skills
FDA, GMP, Fermentation, Technology Transfer, Biopharmaceuticals, Validation, Filtration, CAPA, Aseptic Processing, Biotechnology, V&V, Purification, Cell Culture, Change Control, Chromatography, Sop, Downstream Processing, Pharmaceutical Industry
Education
Tufts University 2004 — 2008
ME, Biotechnology Engineering
University of Massachusetts, Amherst 1997 — 2001
BS, Microbiology
CSols Inc. 2013 - Present
Becton, Dickinson and Company August 2009 - September 2013
Talecris Biotherapeutics May 2008 - August 2009
Wyeth Biotech September 2005 - May 2008
Guilford Pharmaceuticals Inc. 1999 - 2005
Atlantic Pharmaceutical Services Inc March 1997 - April 1999
Pharmaceutics International September 1996 - March 1997
Savannah Labs 1992 - 1993
Skills
FDA, Computer System..., GMP, GLP, Pharmaceutical Industry, GCP, Drug Development, CAPA, Validation, 21 CFR Part 11, Change Control, Sop, V&V, Quality System, GxP, Biotechnology, LIMS, Quality Assurance, Project Management, Technology Transfer, Dissolution, Laboratory, GAMP, Aseptic Processing, Quality Control, Trackwise, Biopharmaceuticals, Regulatory Affairs, Cleaning Validation
Education
Towson University 2000 — 2002
MS, Applied Information Technology, Graduate Certificate in Database Management Systems
University of Florida 1990 — 1992
BS, Chemistry
Part 11 Conference in Washington DC
Eli Lilly and Company September 2011 - Present
Amgen 2009 - 2009
Wyeth Biotech 2003 - 2004
Wyeth BioPharma 2003 - 2003
Skills
Chemical Engineering, Chromatography, Chemistry, Filtration, Protein Chemistry, HPLC, Technology Transfer, Biotechnology, Matlab, GMP, Ion Exchange, Membrane
Education
University of Delaware 2005 — 2011
Doctor of Philosophy (Ph.D.), Chemical Engineering
Catalent Pharma Solutions May 2013 - Present
CTG September 2012 - March 2013
Maternity Leave September 2011 - September 2012
Yoh @ Novartis January 2010 - September 2011
Kelly Services June 2009 - January 2010
Invensys Validation Technologies 2007 - 2009
Wyeth Biotech 2003 - 2006
Diosynth 2001 - 2003
Perigon 2000 - 2001
Baxter 1999 - 2000
Skills
CAPA, Computer System..., Validation, Change Control, 21 CFR Part 11, Cleaning Validation, GMP, LIMS, Vaccines, FDA, Regulatory Affairs, Pharmaceutical Industry, Quality Control, Quality System, Technology Transfer, Medical Devices, Sop, GxP, Biotechnology, ISO 13485, Quality Assurance, GAMP, Process Engineering
Education
Tulane University 1996 — 1998
BS, Biomedical Engineering
Xavier University of Louisiana 1993 — 1998
BS, Physics
Wyeth Biotech February 2008 - Present
Wyeth Biotech January 2005 - February 2008
Homeyer Consulting Services, Inc. July 2003 - January 2005
Education
University of Massachusetts Lowell 2006 — 2010
MS, Biotechnology
University of New Hampshire 1999 — 2003
BS, Biology
Mersana Therapeutics 2015 - 2015
Synta Pharmaceuticals Corp. November 2006 - June 2014
Wyeth Biotech April 2004 - August 2005
Serono Laboratories 1987 - 1998
Serono Laboratories 1987 - 1998
Cambridge Medical Diagnostics 1984 - 1985
Cambridge Medical Diagnostics 1984 - 1985
Skills
Sop, Quality Assurance, Document Management, CAPA, GMP, 21 CFR Part 11, FDA, GLP, Pharmaceutical Industry, Biotechnology
Education
Springfield College 1979 — 1983
Bachelor’s Degree, Biology
Pfizer March 2011 - Present
Wyeth Biotech June 2009 - April 2011
Education
University of New Hampshire 1997 — 2001
Southern New Hampshire University
EMD Millipore January 2015 - Present
EMD Millipore October 2010 - January 2015
Pfizer Pharmaceuticals (formerly Wyeth) April 2008 - July 2010
Wyeth Biotech July 2003 - May 2008
Boston Sports Club January 2002 - April 2003
ClickZ Network 1999 - 2001
Skills
WebEx, eRoom, SAP, Outlook, MS Office Suite, Lotus Notes, Visio, Windows 7, Microsoft Office, Training, Microsoft Excel, Management, Customer Service
Education
University of Massachusetts, Amherst
Psychology
Aeris Therapeutics Inc. July 2008 - October 2008
Wyeth Biotech November 2007 - March 2008
boston scientific corp. 1999 - 2003
Skills
FDA, Medical Devices, Biotechnology, Pharmaceutical Industry, Technology Transfer, R&D, Laboratory, Aseptic Processing, Chromatography, HPLC, V&V
Education
University of Massachusetts Lowell 1994 — 1999
Wyeth Biotech Submission Ready Component CoordinatorWyeth BiotechApril 2009 - Present
Wyeth 2000 - Present
Wyeth BioPharma 2000 - Present
Education
Southern New Hampshire University 2000 — 2009
Vyola Myst January 2010 - Present
CTD Quality Consulting January 2000 - May 2014
CFPIE September 2007 - June 2009
Wyeth Biotech 2000 - 2003
Biogen 1994 - 1999
Biogen Idec 1994 - 1999
DuPont Medical Products 1989 - 1994
DuPont Pharmaceuticals 1987 - 1994
Skills
Regulatory Affairs, Regulatory Submissions, IND, Strategy, CMC, Chemistry, Biologics, Technical Writing, Analytical Chemistry, Project Management, Training, Project Planning, Manufacturing, Medical Devices, Validation, Drug Development, Regulatory Requirements, Pharmaceutical Industry, CRO, Lifesciences, GCP, Technology Transfer, Clinical Research, Clinical Study Design, Medical Writing, Clinical Trials, Quality System, V&V, FDA, R&D, Clinical Development, Quality Assurance, Sop, GMP, CTD, Oncology, Biotechnology
Education
University of Massachusetts, Amherst
Ph.D., Chemistry
Pfizer January 2014 - Present
Pfizer Biotech August 2009 - January 2014
Wyeth Biotech November 2004 - August 2010
Millipore Corporation January 2000 - January 2004
NutraMax Prods January 1991 - January 2000
Skills
SOP, cGMP, Manufacturing, Lean Manufacturing, SAP, Excel, Word, Pharmaceuticals, Biotechnology, GMP, Continuous Improvement, Root Cause Analysis, Process Improvement, Supervisory Skills, Technology Transfer, Inventory Management, LIMS, Scheduling, Mentoring, PowerPoint, Coaching, Microsoft Office, CAPA, Documentation, 21 CFR Part 11, Sop, Software Documentation, V&V, Aseptic Processing, Validation, FDA, Purification, Pharmaceutical Industry, Process Scheduler, Microsoft Excel
Education
University of MA 1983 — 1989
BS, Psychology; Neuroscience and behavior
University of Massachusetts, Amherst 1983 — 1989
BS, Neuroscience and Behavior
Pfizer 2009 - Present
Wyeth Biotech 1996 - Present
Wyeth BioPharma 1996 - Present
Pfizer 1988 - Present
Genetics Institute 1988 - 1996
Melrose Wakefield Hospital July 1981 - November 1988
Education
University of Massachusetts Lowell 1977 — 1981
BS, Clinical Laboratory Science
YMCA of Greater Boston April 2014 - Present
YMCA of Greater Boston May 2013 - April 2014
YMCA of Greater Boston June 2011 - May 2013
Fit Lifestyle Studios July 2008 - June 2011
Pfizer August 2007 - November 2010
Wyeth Biotech August 2007 - November 2010
US Army September 1998 - September 2006
Skills
Fitness, Wellness, Personal Training, Health Promotion, Exercise Physiology, Fitness Training, Strength Training, Nutrition, Wellness Coaching, Nutritional Counseling, Weight Training, Athletics, Sports Nutrition, Athletic Training, Cpr Certified, Leadership, Facilitation, Operations Management, CPR Certified
Education
University of Massachusetts Boston 2001 — 2007
Bachelor, Exercise Science
Biogen Idec September 2013 - Present
Genzyme December 2010 - September 2013
Genzyme January 2010 - November 2010
Genzyme December 2008 - December 2009
University of Connecticut August 2004 - December 2008
Wyeth Biotech May 2005 - August 2006
University of Connecticut January 2002 - August 2004
Skills
HPLC, Formulation, Protein Chemistry, Technology Transfer, UV/Vis, Validation, SDS-PAGE, R&D, V&V, Characterization, FTIR, Monoclonal Antibodies, Lyophilization, Laboratory, Scale Up, Analytical Chemistry, Product Development, Powder X-ray Diffraction, Differential Scanning..., DLS, Fluorescence, Quality by Design, Biopharmaceuticals, Design of Experiments, Purification, CMC
Education
University of Connecticut 2004 — 2008
pharmaceutical sciences
Changchun Institute of Applied Chemistry, Chinese Academy of Sciences 1995 — 2000
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Pfizer July 2009 - Present
Wyeth Biotech July 2008 - October 2009
Wyeth Biotech September 2004 - July 2008
Wyeth Research January 2000 - August 2004
Skills
Sop, GMP, 21 CFR Part 11, LIMS, Validation, GxP, Computer System..., Quality Control, FDA, CAPA, Pharmaceutical Industry, Change Control, GLP, Biopharmaceuticals, Vaccines, Analytical Chemistry, Aseptic Processing, Biotechnology, V, SOP
Education
State University of New York College at Plattsburgh 1994 — 1999
B.S., Cellular Biochemistry
Pfizer July 2008 - Present
Wyeth Biotech July 2004 - July 2008
Wyeth Biotech June 2002 - July 2004
Wyeth Research January 2001 - June 2002
Wyeth Research June 1999 - January 2001
Skills
SDLC, GMP, GLP, Project Management, XML, Quality Assurance, Software Documentation, Integration, 21 CFR Part 11, Pharmaceutical Industry, Validation, Oracle, Manufacturing, GxP, Change Control, FDA, Computer System..., LIMS, CAPA, Sop, GAMP, Quality System, Technology Transfer, Laboratory, Regulatory Requirements, MES, Document Management, SOP
Education
Villanova University 2006 — 2006
Masters Certificate, Project Management
American Sentinel University
BS, Information Systems
State University of New York College at Oswego
BA, Biology; Minor Chemistry
Genzyme January 2013 - Present
Validation Specialists, LLC January 2004 - Present
Genzyme August 2010 - December 2012
Genzyme April 2009 - August 2010
Wyeth Biotech January 2009 - April 2009
Wyeth Biotech January 2006 - December 2008
Wyeth Biotech January 2006 - January 2007
Wyeth Biotech January 2004 - December 2005
Skills
21 CFR Part 11, Biotechnology, Chromatography, Engineering, FDA, GMP, LIMS, Manufacturing, Pharmaceutical Industry, Process Engineering, Sop, Technology Transfer, V, Validation, SOP
Education
Union College 1998 — 2002
Bachelor of Science (BS)
Genzyme November 2011 - May 2012
Genzyme 2011 - 2012
Stryker Instruments 2009 - 2010
Zimmer Spine July 2008 - 2009
Zimmer Orthopaedic Surgical Products 2007 - 2009
Sanofi Pasteur June 2007 - March 2008
Boston Scientific April 2006 - June 2007
Wyeth Biotech March 2005 - April 2006
Amgen 2003 - 2005
B.Braun 2001 - 2002
Skills
SDLC, MicroLogix, IQ, Validation, Sop, Biotechnology, FDA, 21 CFR Part 11, Computer System..., GMP, CAPA, V&V, Change Control, GAMP, ISO 13485, Quality System, Medical Devices, Six Sigma, Regulatory Affairs, Quality Assurance, GxP, Process Simulation, Pharmaceutical Industry, Design Control, Testing, Quality Auditing, Quality Management, Quality Control, Minitab, ISO 14971, ISO, FMEA, Design of Experiments, Manufacturing, DMAIC, Lean Manufacturing, Biopharmaceuticals, Aseptic Processing, Cleaning Validation
Education
Villanova University Online 2009 — 2009
SSGB, Six Sigma Certification
University of Calabar 1985 — 1991
B.Sc., Biochemistry
ADVENTRX Pharmaceuticals August 2012 - Present
Ludwig Institute for Cancer Research January 2008 - July 2012
Accentia Biopharmaceuticals September 2005 - December 2007
Purdue Pharma April 2003 - September 2005
Wyeth Biotech January 2000 - April 2003
Skills
Project Management, GxP, Process Simulation, Biotechnology, CMC Regulatory Affairs, Biopharmaceuticals, Vaccines, Pharmaceutical Industry, GMP, Technology Transfer, FDA, Sop, Validation, CAPA, Lifesciences, GLP, Regulatory Affairs, Clinical Development, Regulatory Submissions, Clinical Trials
Education
University of New Hampshire 1977 — 1982
MS, Chemical Engineering, Biochemistry
Temple University
RA/QA
Mettler-Toledo Process Analytics January 2012 - Present
Integra Companies, Inc. September 2008 - September 2010
Integrated Process Technologies June 2004 - August 2008
Wyeth Biotech May 2001 - June 2004
Kinetics May 1997 - May 2001
Skills
Team Building, Budget Analysis, Problem Solving, Business Relations, Cross-functional Team..., Budgets, Quality Control, Validation, Business, Program Management, Project Portfolio..., Leadership, Strategic Planning, Procurement, Management, Strategy, Construction Management, Analysis, Risk Management, Testing, Purchasing, Construction, Contract Negotiation, Competitive Analysis, Negotiation, Product Management, Contract Management
Education
Wentworth Institute of Technology
Bachelor's degree, Project Management, Magna Cum Laude
University of Massachusetts at Lowell
Mechanical Engineering
Wyeth Biotech December 1997 - May 2008
Wyeth Biotech 1997 - 2008
Wyeth/Genetics Institute 1997 - 2008
Wyeth Research 1997 - 2008
Education
University of Massachusetts, Amherst 1982 — 1986
B.S., Business/Hotel Restaurant Travel Administration
ATEX Technologies, Inc. August 2010 - January 2014
ATEX Technologies August 2010 - January 2014
RCM Technologies 2014 - 2014
RCM Technologies 2014 - 2014
Teleflex Medical April 2009 - August 2010
QualPak December 2007 - April 2009
Wyeth Biotech June 2004 - December 2007
IPS 1998 - June 2004
Education
Stevens Institute of Technology 1992 — 1996
BS, Chemical Engineering
Pfizer July 2001 - Present
Wyeth Biotech January 2007 - November 2009
Wyeth Biotech July 2001 - January 2007
Skills
HPLC, Chromatography, Protein Chemistry, Capillary..., Assay Development, GLP, LC-MS, Monoclonal Antibodies, Purification
Education
University of Massachusetts, Amherst 1996 — 2000
BS, Biochemistry
Pfizer September 2013 - Present
Pfizer October 2009 - August 2013
Wyeth December 2002 - October 2009
Wyeth Biotech December 2002 - October 2009
GEA 1998 - 2002
GEA Process Technologies Ireland Ltd. 1998 - 2002
Hewlett Packard Co November 1995 - October 1998
Skills
Automation, Validation, Computer System..., FDA, GAMP, GMP, Change Control, 21 CFR Part 11, CAPA, Quality System, Commissioning, Process Control, Six Sigma, PLC, Biotechnology, SCADA, Sop, Instrumentation, Process Engineering, Process Simulation, Cross-functional Team..., Engineering, Technology Transfer, Change Management, Process Improvement, DCS, Process Automation, Quality Assurance, Control Logic, MES, Project Management, Continuous Improvement, Integration, Lean Manufacturing, Manufacturing, Testing, Program Management
Education
University College Dublin 2003 — 2005
MIE, Engineering Masters
University College Dublin 1989 — 1993
BE, Electronic Engineering
IEEE January 2014 - Present
Hexaware Technologies April 2011 - December 2013
Agma Systems November 2004 - April 2011
Canon USA June 2010 - January 2011
Wells Fargo February 2010 - June 2010
Pfizer December 2005 - December 2009
Wyeth Biotech 2005 - 2006
Skills
Documentum, Enterprise Content..., Web Services, Information Technology, Integration, SOA, Business Process Design, Web Applications, Document Management, SDLC, SharePoint, Data Migration, Requirements Gathering, Weblogic, Java Enterprise Edition
Education
Wright State University 2002 — 2004
MS, Electrical engineering
University of Mumbai 1997 — 2001
BE, Electronics Engineering
Jeff Yuen Asssociates August 2008 - Present
STIEFEL LABORATORIES Inc November 2006 - August 2008
Wyeth Biotech 2005 - 2006
GSK 1989 - 1996
Skills
ISO, FDA, CAPA, Quality System, cGMP manufacturing, Process Simulation, Validation, Quality Assurance, GMP, Change Control, Quality Management, Sop, Technology Transfer, GxP, Process Improvement, V&V, 21 CFR Part 11, Regulatory Affairs, Pharmaceutical Industry
Education
University of Miami 1967 — 1972
BS, Biology/Chemistry
Fujifilm Diosynth Biotechnologies March 2011 - Present
Wyeth Biotech 2006 - 2008
Wyeth Biotech 2003 - 2006
Altana 1989 - 2003
Skills
ICH guidelines, Microbiology, GMP, Validation, LIMS, Sop, Quality Control, Laboratory, USP, Biotechnology, FDA, Quality Assurance, GxP, Quality System, Vaccines, Technology Transfer, Quality Auditing, Biopharmaceuticals, GLP, Change Control, Assay Development, Testing, 21 CFR Part 11, Aseptic Processing, SOP, CAPA, Pharmaceutical Industry
Education
State University of New York at New Paltz
BS, Biology
ValSource, LLC December 2008 - Present
Wyeth Biotech March 2005 - November 2008
Serentec 2002 - 2005
Cardinal Health 2004 - 2004
CRB Consulting Engineers 2000 - 2002
Skills
Aseptic Processing, GMP, Validation, Quality Control, Software Documentation, Engineering, FDA, V&V, Quality Assurance, CAPA, Computer System..., Sop, Cell Culture, Change Control, GxP, Biopharmaceuticals, Sterilization, USP, Pharmaceutical Industry, Clean Rooms, Biotechnology, SOP, Vaccines
Education
Southern Polytechnic State University 1989 — 1992
BSIE, Industrial Engineering
Meridian Medical Technologies February 2004 - Present
Centocor Biologics April 2004 - January 2009
Centocor 2004 - 2009
Wyeth Biotech October 1999 - April 2004
Wyeth BioPharma 1999 - 2004
Skills
GMP, Change Control, Pharmaceutical Industry, CAPA, Validation, FDA, Sop, Aseptic Processing, V&V, Quality Assurance, Biotechnology, Cleaning Validation, GLP, Manufacturing, GxP, Biopharmaceuticals, Quality System, 21 CFR Part 11, SOP
Education
Southern Illinois University, Edwardsville
Bachelor of Applied Science (BASc), Biology
Genzyme July 2011 - Present
Legacy May 2009 - June 2011
Centocor January 2005 - January 2009
Wyeth Biotech March 2002 - November 2003
Nestle 1995 - 2000
Skills
FDA, Quality System, Six Sigma, Sop, GMP, Pharmaceutical Industry, CAPA, Validation, Manufacturing, Change Control, Process Improvement, Biotechnology
Education
University of Phoenix
BS Degree Program in Business Management
St. Louis Community College 1991 — 1995
Management
Johnson & Johnson December 2014 - Present
McNeil Consumer Healthcare February 2012 - December 2014
Johnson & Johnson September 2010 - February 2012
Johnson & Johnson March 2006 - September 2010
Centocor April 2003 - March 2006
Wyeth Biotech September 2001 - April 2004
Heideman Associates January 2000 - September 2001
Morrison Knudsen January 1999 - June 2000
Landis & Gyr 1994 - 1998
Skills
Engineering, Supply Chain, Operational Excellence, Strategic Planning, Strategy Development, Business Planning, Biopharmaceuticals, Aseptic Processing, Quality System, Consent Decree, Project Management, Program Management, Leadership, Product Development, Manufacturing, Management, Strategy, Process Engineering, Quality Assurance, Process Improvement, Validation, Supply Chain Management, Pharmaceutical Industry, Integration, Biotechnology
Education
Villanova University 2008 — 2010
EMBA, Finance, Technology, Leadership
University of Missouri-Rolla 1984 — 1988
BS, Mechanical Engineering
Pfizer Pharmaceuticals January 2011 - Present
Wyeth Biotech November 2008 - January 2011
Wyeth Biotech June 2006 - November 2008
Wyeth Biotech August 2003 - June 2006
Little Creek Builders 2005 - 2006
Wyeth Biotech August 2000 - August 2003
Silliker February 1998 - August 2000
U.C. Davis 1990 - 1997
U.C. Davis 1990 - 1997
U.C. Davis 1990 - 1997
Education
University of California, Davis 1990 — 1997
Ph.D., Chemistry
University of California, Irvine
Pfizer October 2009 - Present
Wyeth Biotech January 2001 - December 2008
Wyeth Biotech July 1999 - January 2001
Wyeth Biotech March 1998 - July 1999
Education
University of Massachusetts, Amherst 1991 — 1996
BS, Chemical Engineering
Pfizer September 2009 - Present
Wyeth Biotech October 2001 - September 2009
Ascent Pediatrics August 1996 - September 2001
Ophthalmic Research Associates June 1994 - August 1996
Skills
Clinical Trials, Clinical Research, FDA, GMP, R&D, Infectious Diseases, Validation, Biopharmaceuticals, SOP, Biotechnology, Quality Assurance, Therapeutic Areas
Education
Tufts Gordon Institute 2010 — 2012
MS, Engineering Management
Tufts University 1990 — 1994
BS, Chemistry, Biology (Dual Degree)
AMRI (Albany Molecular Research Inc.) June 2015 - Present
Pfizer June 2009 - January 2014
Wyeth Biotech December 2006 - June 2009
ESA Biosciences October 1998 - December 2006
ESA Laboratories May 1998 - October 1998
ESA Laboratories September 1997 - May 1998
ESA, Incorporated November 1993 - September 1997
Skills
cGMP, Change Control, Investigations, HPLC, LIMS, SAP, QC, CAPA, Biotechnology, Pharmaceuticals, 21 CFR Part 11, Quality Assurance, Excel, Word, Manufacturing, Microsoft Office, Supervisory Skills, Quality System, Continuous Improvement, Laboratory, Sop, FDA, Investigation, People Skills, Interviews, Technical Writing, Laboratory Skills, Data Analysis, Analytical Skills, Wet Chemistry, Medical Devices, Pharmaceutical Industry, GxP, Quality Control, GMP, SOP
Education
Stonehill College 1989 — 1993
Bachelor's of Science, Major: Biology; Minor: Chemistry
Shire HGT April 2010 - Present
Wyeth Biotech February 2004 - April 2010
Genzyme November 2001 - February 2004
Lucent Technologies May 2000 - August 2001
Skills
Calibration, Computer Hardware, Software Installation, Validation, Manufacturing, FDA, SOP, GMP
Education
University of Massachusetts Lowell
Information Technology, IT
Meridian BioGroup, LLC May 2014 - Present
AstraZeneca Biologics (MedImmune) June 2010 - May 2014
Wyeth Biotech 2007 - 2010
Wyeth Vaccines 2005 - 2007
Wyeth BioPharma 1998 - 2005
CytoTherapeutics 1996 - 1998
Skills
Vaccines, Validation, Quality Assurance, Biotechnology, Biopharmaceuticals, GMP, Technology Transfer, CAPA, Change Control, 21 CFR Part 11, GxP, Sop, Regulatory Requirements, Aseptic Processing, LIMS, FDA, V&V, Computer System..., Regulatory Affairs, Cleaning Validation, GLP, Pharmaceutical Industry, Regulatory Submissions, Quality System, GCP, Chromatography, Pharmaceutics, Drug Development, Trackwise, GAMP, Clinical Trials, ISO 13485, Quality Auditing, HPLC, FDA GMP, Clinical Development, Quality Control, Analytical Chemistry, IND, Lifesciences, SOP
Education
University of Dayton 1975 — 1977
MS, Clinical Chemistry
University of Michigan 1968 — 1972
BS, Chemistry, Mathematics
Bristol-Myers Squibb May 2010 - August 2010
Wyeth Biotech October 2006 - July 2009
Wyeth Biotech December 2004 - May 2006
Wyeth Biotech June 2002 - November 2004
Genetics Institute (Now Wyeth Biotech) October 2001 - June 2002
Education
University of Massachusetts Lowell 1989 — 1993
B.S., Clinical Laboratory Sciences / Medical Technology
Consultant February 2011 - Present
Artisan Pharma June 2009 - January 2011
Self Employed August 2007 - June 2009
Wyeth Biotech July 2003 - April 2007
Watson Pharmaceuticals May 2002 - June 2003
Education
Stony Brook University
BA, Social Science Interdisciplinary
MPHS
Shire HGT 2006 - 2009
Wyeth Biotech 1997 - 2001
Genetics Institute 1993 - 1997
Genetics Institute 1990 - 1993
Millipore 1984 - 1990
Education
Southern New Hampshire University
MBA
University of Connecticut 1975 — 1979
BS
Shire HGT August 2011 - Present
Zajac LLC October 2010 - September 2011
Parsons February 2007 - August 2010
Wyeth Biotech March 2004 - February 2007
Skills
GMP, Testing, Automation, Chemical Engineering, Manufacturing, Troubleshooting, Process Equipment, Validation, Process Engineering, Process Simulation, Process Control, Quality System, Process Optimization, Commissioning, Design of Experiments, Technology Transfer
Education
University of Massachusetts Lowell 1998 — 2003
BS, Chemical Engineering
Baxalta April 2015 - Present
Pacira Pharmaceuticals, Inc. November 2012 - Present
PSC Biotech May 2012 - November 2012
Hyde Engineering + Consulting June 2011 - April 2012
Pfizer November 2010 - June 2011
Parsons November 2006 - June 2010
Amgen March 2004 - October 2005
CRB Consulting Engineers 2005 - 2005
Wyeth Biotech August 2000 - February 2004
Jacobs Engineering 2000 - 2004
Skills
CIP, V&V, Change Control, Validation, Process Simulation, Technology Transfer, GMP, FDA, Process Equipment, Sop, Quality System, Process Engineering, Cleaning Validation
Education
University of Cincinnati
Bachelor's Degree, Chemical Engineering
Genzyme September 2012 - Present
Genzyme November 2011 - September 2012
Genzyme July 2011 - November 2011
Pfizer January 2009 - July 2011
Wyeth Biotech September 2007 - January 2009
Wyeth Biotech October 2005 - September 2007
Skills
Sop, Validation, CAPA, GMP, Change Control, LIMS, FDA, Software Documentation
Education
University of Massachusetts Dartmouth 2002 — 2005
Biology / Pre Med
University of South Florida 2001 — 2002
Criminology
Pfizer November 2007 - Present
Pfizer April 2006 - Present
Wyeth Biotech June 1990 - December 2005
Skills
Pharmaceutical Industry, Technology Transfer, Biotechnology, GMP, Cross-functional Team..., Sop, Validation, Regulatory Affairs, Biopharmaceuticals, FDA, Change Control, Process Simulation, Manufacturing, Strategy, CAPA, Commercialization, Quality System, Drug Development, 21 CFR Part 11, V&V, Vaccines, Formulation, Lifesciences, Regulatory Requirements, HPLC, GLP, Clinical Development, Regulatory Submissions, Program Management, Medical Devices, Life Sciences
Education
Tufts University 1985 — 1990
PhD, Chemical Engineering
Shire Pharmaceuticals December 2013 - Present
Merck January 2011 - December 2013
Pfizer Pharmaceuticals 2009 - January 2011
Wyeth Biotech 2007 - 2009
Amylin Pharmaceuticals 2003 - 2007
Pharmaceutical Services Corporation 2002 - 2003
Formatech, Inc. December 2001 - May 2002
Alkermes 1995 - 2001
Biopure 1995 - 1995
Repligen Corporation 1993 - 1995
Skills
Manufacturing, SAP, Document Management, Microbiology, Regulatory Filings, Formulation, Filling, Bulk, Catridges, Technology Transfer, Biotechnology, Vaccines, Trackwise, Quality Control, Pharmaceutics, Validation, TrackWise, CAPA, FDA
Education
University of Massachusetts, Amherst 1989 — 1993
BS, Zoology
Wyeth Biotech Senior Supervisor, Pilot PurificationPfizer1992 - Present
Education
University of Massachusetts Lowell 1989 — 1991
BS, Biology
Pfizer Pharmaceuticals September 2002 - March 2015
Wyeth Biotech 2002 - 2009
Pfizer April 2002 - September 2002
Celltech, UK February 1999 - April 2002
International Food Information Service (IFIS) 1995 - 1998
Skills
Regulatory Submissions, Pharmaceutical Industry, Regulatory Affairs, eCTD, Sop, Biopharmaceuticals, GMP, FDA, Regulatory Requirements, Pharmacovigilance, IND, CAPA, 21 CFR Part 11, GLP, Vaccines
Education
UCL 1993 — 1994
MSc, Bioprocessing
The University of Hull 1989 — 1993
Bachelor of Applied Science (BASc), Biotechnology
Pfizer July 2011 - Present
Pfizer PGM, SCBU/BioTherapeutics June 2010 - July 2011
Pfizer August 2002 - June 2010
Wyeth Biotech August 2002 - June 2010
Skills
LIMS, Aseptic Processing, Process Validation, Vaccines, GMP, Validation
Education
The University of Texas at El Paso 1994 — 1997
MS, Microbiology
Saint Joseph's College 1990 — 1994
BS, Biology/ PreVeterinary Medicine
Pfizer Pharmaceuticals July 2009 - Present
Wyeth Biotech 1991 - 2009
Genetics Institute 1989 - 1991
Cambridge Medical Technology 1988 - 1989
Choate/Symmes Health Services 1986 - 1988
Skills
Change Control, GMP, 21 CFR Part 11, LIMS, Pharmaceutical Industry, Sop, Validation, CAPA, Computer System..., FDA, Biotechnology, Technology Transfer, Aseptic Processing, BOH inspections, Regulatory Submissions, Method Transfer, meeting facilitation, Quality Control, GxP, Biopharmaceuticals, V&V, Trackwise, Vaccines, Laboratory, GLP, Regulatory Affairs, Workshop Facilitation, Cleaning Validation, HPLC, Quality Assurance, SOP, Regulatory Requirements
Education
University of Massachusetts at Lowell
Bachelor of Science, Clinical Laboratory Science/Medical Technology/Technologist
Biotech Assistance 2008 - Present
Wyeth Biotech 1987 - 2008
Education
Tulane University 1968 — 1972
Spirax Sarco USA August 2014 - Present
Spirax Sarco USA March 2012 - August 2014
Lonza June 2010 - March 2012
Powerspan Corp. September 2008 - April 2010
Wyeth Biotech December 2007 - September 2008
Wyeth Biotech October 2000 - December 2007
Fives North American Combustion, Inc. August 1997 - August 1998
Skills
Validation, Engineering, Manufacturing, Instrumentation, GMP, P&ID, HVAC, Process Engineering, Commissioning, Project Engineering
Education
Wentworth Institute of Technology 2000 — 2003
BS, Mechanical Engineering
Springfield Technical Community College 1994 — 1997
AS, Electrical Engineering Technology
DynPort Vaccine Company LLC, A CSC Company June 2014 - Present
Pfizer January 2010 - August 2013
Wyeth Biotech 2004 - 2010
Berlex-Schering AG April 2002 - April 2004
Omnicare 2000 - 2001
Skills
GMP, Pharmaceutical Industry, Sop, Drug Discovery, Change Control, FDA, GLP, Clinical Development, CAPA, GxP, R&D, IND, Quality System, CRO, Chemistry, LC-MS, Analytical Chemistry, Drug Delivery, CMC, V&V, SOP
Education
New Mexico State University
Ph.D., Chemistry
University of Kansas
Post-doc Pharmaceutical chemistry / Bioanalytical chemistry