Wyeth Biotech
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Wyeth Biotech Employees
Employee
Years
Job
Industry
Veda Burns, MBA Veda Burns, MBA's Wyeth Biotech Experience March 1998 - November 2009
Job Accomplished Hematology / Oncology Specialist Delivers Solutions & Expands Market Presence
Industry Biotechnology
Experience
Eisai, Inc. June 2011 - Present
The Leukemia & Lymphoma Society January 2009 - Present
Eisai Pharmaceuticals December 2010 - April 2011
National Black MBA Association 1990 - 2010
Wyeth Biotech March 1998 - November 2009
Skills
Competitive Analysis, Oncology, Medical Devices, Sales Operations, Account Management, Hematology, Pharmaceutical Industry, Pharmaceutical Sales, Managed Care, Cancer, Cardiology, Leadership, Marketing, Endocrinology, Healthcare, Neurology, Biotechnology, Gastroenterology, Diabetes, Rheumatology, Business Development, Sales Effectiveness, Strategy, Cross-functional Team...
Education
MBA - University of Georgia, Terry College of Business
MBA, Marketing Management
Savannah State University
Master of Business Administration (MBA), Marketing, Summa Cum Laude
Eisai, Inc. June 2011 - Present
The Leukemia & Lymphoma Society January 2009 - Present
Eisai Pharmaceuticals December 2010 - April 2011
National Black MBA Association 1990 - 2010
Wyeth Biotech March 1998 - November 2009
Skills
Competitive Analysis, Oncology, Medical Devices, Sales Operations, Account Management, Hematology, Pharmaceutical Industry, Pharmaceutical Sales, Managed Care, Cancer, Cardiology, Leadership, Marketing, Endocrinology, Healthcare, Neurology, Biotechnology, Gastroenterology, Diabetes, Rheumatology, Business Development, Sales Effectiveness, Strategy, Cross-functional Team...
Education
MBA - University of Georgia, Terry College of Business
MBA, Marketing Management
Savannah State University
Master of Business Administration (MBA), Marketing, Summa Cum Laude
Jennifer Tam Jennifer Tam's Wyeth Biotech Experience May 2005 - October 2009
Job Senior Process Automation Engineer at ADVENT
Industry Biotechnology
Experience
ADVENT Engineering Services, Inc. July 2014 - Present
Merck December 2012 - June 2014
Pfizer Pharmaceuticals October 2009 - December 2012
Wyeth Biotech May 2005 - October 2009
Wyeth Biotech May 2004 - May 2005
Best Buy May 2004 - October 2004
Skills
Validation, GMP, FDA, Pharmaceutical Industry, Automation, Six Sigma, Troubleshooting, CAPA, Cross-functional Team..., Quality Assurance, Sop, PLC, Software Documentation, Allen Bradley, 21 CFR Part 11, WebDAV, SCADA, DCS, GAMP, HMIs
Education
North Carolina State University 2001 — 2005
Bachelor of Science, Electrical Engineering
ADVENT Engineering Services, Inc. July 2014 - Present
Merck December 2012 - June 2014
Pfizer Pharmaceuticals October 2009 - December 2012
Wyeth Biotech May 2005 - October 2009
Wyeth Biotech May 2004 - May 2005
Best Buy May 2004 - October 2004
Skills
Validation, GMP, FDA, Pharmaceutical Industry, Automation, Six Sigma, Troubleshooting, CAPA, Cross-functional Team..., Quality Assurance, Sop, PLC, Software Documentation, Allen Bradley, 21 CFR Part 11, WebDAV, SCADA, DCS, GAMP, HMIs
Education
North Carolina State University 2001 — 2005
Bachelor of Science, Electrical Engineering
Jim Good (ASQ/CQA) Jim Good (ASQ/CQA)'s Wyeth Biotech Experience February 1982 - November 2008
Job Quality and Compliance Deviation and CAPA Management
Industry Biotechnology
Experience
Merck (Contract) June 2013 - June 2015
Hospira June 2009 - April 2013
Wyeth Biotech February 1982 - November 2008
Skills
Validation, Auditing, FDA, Technical Writing, GMP, Supervision, Technology Transfer, Biotechnology, CAPA, V&V, Quality Assurance, Sop, Manufacturing, Change Control, 21 CFR Part 11, Pharmaceutical Industry, Quality System, Aseptic Processing, Pharmaceutics
Education
Penn State University
Business, Business Administration
Merck (Contract) June 2013 - June 2015
Hospira June 2009 - April 2013
Wyeth Biotech February 1982 - November 2008
Skills
Validation, Auditing, FDA, Technical Writing, GMP, Supervision, Technology Transfer, Biotechnology, CAPA, V&V, Quality Assurance, Sop, Manufacturing, Change Control, 21 CFR Part 11, Pharmaceutical Industry, Quality System, Aseptic Processing, Pharmaceutics
Education
Penn State University
Business, Business Administration
Ira Goldfarb, CPIP, CQA Ira Goldfarb, CPIP, CQA's Wyeth Biotech Experience August 2004 - November 2006
Job Lead Validation Drug Safety
Industry Biotechnology
Experience
Gilead Sciences May 2015 - Present
GSK Consumer Health: formally Novartis Consumer Health July 2014 - May 2015
Shire Pharmaceuticals November 2013 - April 2014
Shire Pharmaceuticals June 2012 - November 2013
Rho, Inc. December 2007 - June 2012
EduQuest May 2007 - July 2007
Wyeth Biotech August 2004 - November 2006
Skills
SOP, 21 CFR Part 11, cGMP, Auditing, Validation, Computer System..., Change Control, Document Management, Sop, GMP, FDA, CAPA, GLP, Pharmaceutical Industry, GxP, V&V, Biopharmaceuticals, Medical Devices, Quality Assurance, GCP, Regulatory Submissions, Software Quality..., GAMP, Regulatory Affairs, ISO 13485, Technical Writing, Testing, Clinical Trials, Quality System, Biotechnology, Protocol, LIMS, Software Documentation, Quality Auditing, Quality Control, Cleaning Validation, Regulatory Requirements, Clinical Data Management, Technology Transfer, Clinical Research, Aseptic Processing, Trackwise, Lifesciences, Clinical Development, Visio, EDC, CRO, CTMS, Equipment Qualification, Life Sciences
Education
Strayer University 2001 — 2004
MS, Management Information Systems
Nova Southeastern University 1987 — 1990
BS, Professional Management
Bauder College 1984 — 1987
AS, Electrical Engineering
Windsor High School 1975 — 1978
Diploma, General
Wake Technical Community College
Gilead Sciences May 2015 - Present
GSK Consumer Health: formally Novartis Consumer Health July 2014 - May 2015
Shire Pharmaceuticals November 2013 - April 2014
Shire Pharmaceuticals June 2012 - November 2013
Rho, Inc. December 2007 - June 2012
EduQuest May 2007 - July 2007
Wyeth Biotech August 2004 - November 2006
Skills
SOP, 21 CFR Part 11, cGMP, Auditing, Validation, Computer System..., Change Control, Document Management, Sop, GMP, FDA, CAPA, GLP, Pharmaceutical Industry, GxP, V&V, Biopharmaceuticals, Medical Devices, Quality Assurance, GCP, Regulatory Submissions, Software Quality..., GAMP, Regulatory Affairs, ISO 13485, Technical Writing, Testing, Clinical Trials, Quality System, Biotechnology, Protocol, LIMS, Software Documentation, Quality Auditing, Quality Control, Cleaning Validation, Regulatory Requirements, Clinical Data Management, Technology Transfer, Clinical Research, Aseptic Processing, Trackwise, Lifesciences, Clinical Development, Visio, EDC, CRO, CTMS, Equipment Qualification, Life Sciences
Education
Strayer University 2001 — 2004
MS, Management Information Systems
Nova Southeastern University 1987 — 1990
BS, Professional Management
Bauder College 1984 — 1987
AS, Electrical Engineering
Windsor High School 1975 — 1978
Diploma, General
Wake Technical Community College
Ian O'Reilly Ian O'Reilly's Wyeth Biotech Experience July 2006 - August 2007
Job QA Project & Audit Manager Singapore at Lonza
Industry Pharmaceuticals
Experience
Lonza March 2015 - Present
Lonza: A Global Leader In Life Sciences August 2014 - March 2015
Lonza November 2013 - August 2014
Lonza September 2012 - November 2013
Lonza August 2010 - September 2012
Shire February 2010 - July 2010
Compliance Implementation Services CIS January 2010 - July 2010
Pfizer (Wyeth Biotech) July 2006 - January 2010
Wyeth Biotech July 2006 - August 2007
Wyeth Biotech June 2005 - July 2006
Skills
CAPA, GMP, Sop, Project Management, Risk Management, Cross-functional Team..., Pharmaceutical Industry, Lifesciences, 21 CFR Part 11, LIMS, GxP, Biotechnology, HPLC, GLP, Validation, Change Control, Microbiology, Computer System..., FDA, Quality Control, Quality System, Assay Development, Quality Assurance, Trackwise, Clinical Trials, Software Documentation, Biopharmaceuticals, SOP, Regulatory Affairs, Technology Transfer, Quality Auditing, Medical Devices
Education
Southern New Hampshire University 2007 — 2009
Master of Business Administration (MBA), Global Studies
Rochester Institute of Technology 2001 — 2005
Bachelor of Science, Biotechnology
Lonza March 2015 - Present
Lonza: A Global Leader In Life Sciences August 2014 - March 2015
Lonza November 2013 - August 2014
Lonza September 2012 - November 2013
Lonza August 2010 - September 2012
Shire February 2010 - July 2010
Compliance Implementation Services CIS January 2010 - July 2010
Pfizer (Wyeth Biotech) July 2006 - January 2010
Wyeth Biotech July 2006 - August 2007
Wyeth Biotech June 2005 - July 2006
Skills
CAPA, GMP, Sop, Project Management, Risk Management, Cross-functional Team..., Pharmaceutical Industry, Lifesciences, 21 CFR Part 11, LIMS, GxP, Biotechnology, HPLC, GLP, Validation, Change Control, Microbiology, Computer System..., FDA, Quality Control, Quality System, Assay Development, Quality Assurance, Trackwise, Clinical Trials, Software Documentation, Biopharmaceuticals, SOP, Regulatory Affairs, Technology Transfer, Quality Auditing, Medical Devices
Education
Southern New Hampshire University 2007 — 2009
Master of Business Administration (MBA), Global Studies
Rochester Institute of Technology 2001 — 2005
Bachelor of Science, Biotechnology
Clayton Parr Clayton Parr's Wyeth Biotech Experience May 2005 - June 2009
Job Technical Program Manager at Lake Region Medical
Industry Medical Devices
Experience
Lake Region Medical (formerly Accellent) December 2013 - Present
Accellent October 2010 - December 2013
Accellent July 2009 - October 2010
Wyeth Biotech May 2005 - June 2009
Biometrix October 2004 - May 2005
US Navy November 1998 - November 2004
Skills
Six Sigma, Manufacturing, Engineering, Root Cause Analysis, Validation, Calibration, Medical Devices, ISO 13485, Minitab, Solidworks, Manufacturing..., CAPA, FDA, Quality System, Instrumentation, Design of Experiments, Continuous Improvement, FMEA, GMP, Lean Manufacturing
Education
The University of Tennessee at Chattanooga 2012 — 2013
Executive Master of Business Administration (EMBA), Business
University of Massachusetts at Lowell 2006 — 2009
Bachelor of Science (BS), Mechanical Engineering
Northern Essex Community College 2005 — 2006
Engineering
Lake Region Medical (formerly Accellent) December 2013 - Present
Accellent October 2010 - December 2013
Accellent July 2009 - October 2010
Wyeth Biotech May 2005 - June 2009
Biometrix October 2004 - May 2005
US Navy November 1998 - November 2004
Skills
Six Sigma, Manufacturing, Engineering, Root Cause Analysis, Validation, Calibration, Medical Devices, ISO 13485, Minitab, Solidworks, Manufacturing..., CAPA, FDA, Quality System, Instrumentation, Design of Experiments, Continuous Improvement, FMEA, GMP, Lean Manufacturing
Education
The University of Tennessee at Chattanooga 2012 — 2013
Executive Master of Business Administration (EMBA), Business
University of Massachusetts at Lowell 2006 — 2009
Bachelor of Science (BS), Mechanical Engineering
Northern Essex Community College 2005 — 2006
Engineering
Robert Bergeron Robert Bergeron's Wyeth Biotech Experience January 2004 - November 2010
Job Health & Safety Officer at Toxikon Corporation
Industry Biotechnology
Experience
Toxikon Corporation October 2014 - Present
Auxillary Police September 2011 - November 2014
Genzyme March 2014 - October 2014
Genzyme November 2010 - February 2014
Wyeth Biotech January 2004 - November 2010
Wyeth Pharmaceuticals 2004 - November 2010
Skills
Hazardous Waste..., HAZWOPER, Emergency Management, Hazardous Materials, Inspection, GMP, EHS, First Aid, Sop, Quality System, Pharmaceutical Industry, FDA, Validation, Training, Facilities Management, Environmental Awareness, SOP
Education
Northern Essex Community College 1997 — 2001
Criminal Justice
Toxikon Corporation October 2014 - Present
Auxillary Police September 2011 - November 2014
Genzyme March 2014 - October 2014
Genzyme November 2010 - February 2014
Wyeth Biotech January 2004 - November 2010
Wyeth Pharmaceuticals 2004 - November 2010
Skills
Hazardous Waste..., HAZWOPER, Emergency Management, Hazardous Materials, Inspection, GMP, EHS, First Aid, Sop, Quality System, Pharmaceutical Industry, FDA, Validation, Training, Facilities Management, Environmental Awareness, SOP
Education
Northern Essex Community College 1997 — 2001
Criminal Justice
Derrell Troche Derrell Troche's Wyeth Biotech Experience August 2005 - June 2007
Job Supervisor Upstream Operations at Genzyme sanofi
Industry Biotechnology
Experience
Genzyme sanofi October 2012 - Present
Genzyme June 2007 - November 2012
Wyeth Biotech August 2005 - June 2007
Boston Analytical June 2000 - August 2005
Anika Therapeutics June 1998 - June 2000
US Air Force May 1992 - November 1996
Skills
LIMS, GMP, Root Cause Analysis, Troubleshooting, Aseptic Technique, Cell Culture, Aseptic Processing, Trackwise, MFG-Pro, Leadership, Delta V, Biotechnology
Education
Northern Essex Community College 1997 — 1999
Biotechnology Certificate
Genzyme sanofi October 2012 - Present
Genzyme June 2007 - November 2012
Wyeth Biotech August 2005 - June 2007
Boston Analytical June 2000 - August 2005
Anika Therapeutics June 1998 - June 2000
US Air Force May 1992 - November 1996
Skills
LIMS, GMP, Root Cause Analysis, Troubleshooting, Aseptic Technique, Cell Culture, Aseptic Processing, Trackwise, MFG-Pro, Leadership, Delta V, Biotechnology
Education
Northern Essex Community College 1997 — 1999
Biotechnology Certificate
Stan Reid Stan Reid's Wyeth Biotech Experience February 2006 - January 2009
Job Senior Director of Regulatory Affairs,Quality Assurance,QC Labs
Industry Biotechnology
Experience
Dennison Pharmaceuticals January 2013 - Present
Biogen January 2008 - December 2012
Biogen January 2009 - December 2009
Wyeth Biotech February 2006 - January 2009
nephros Therapuetics 2002 - 2006
Amgen 2002 - 2005
Bayer Pharmaceuticals 1998 - 2003
Bayer 1998 - 2003
Skills
Validation, Pharmaceuticals, FDA, Quality Assurance, Clinical, cGMP, CAPA, SOP, Process Validation, Regulatory Affairs, Quality Auditing, Medical Devices, Quality Systems, Life Sciences, Manufacturing, GLP, Change Control, 21 CFR Part 11, Clinical Trials, Quality Management, Biotechnology, Compliance, Auditing, ISO 13485, ISO, Six Sigma, Document Management, Continuous Improvement, Documentation, Process Improvement, Technology Transfer, Product Development, GxP, Problem Solving, LIMS, Risk Management, Cleaning Validation, GMP, Inspection, Root Cause Analysis, Lean Manufacturing, Cross-functional Team..., Change Management, Process Development, Sop, Quality System, Pharmaceutical Industry, V&V, Computer System..., Regulatory Requirements
Education
Roger Williams University 1983 — 1986
BS, Biology, Management
University of Rhode Island 1975 — 1979
B.S., Science
University of Rhode Island 1974 — 1977
AS, Business
Dennison Pharmaceuticals January 2013 - Present
Biogen January 2008 - December 2012
Biogen January 2009 - December 2009
Wyeth Biotech February 2006 - January 2009
nephros Therapuetics 2002 - 2006
Amgen 2002 - 2005
Bayer Pharmaceuticals 1998 - 2003
Bayer 1998 - 2003
Skills
Validation, Pharmaceuticals, FDA, Quality Assurance, Clinical, cGMP, CAPA, SOP, Process Validation, Regulatory Affairs, Quality Auditing, Medical Devices, Quality Systems, Life Sciences, Manufacturing, GLP, Change Control, 21 CFR Part 11, Clinical Trials, Quality Management, Biotechnology, Compliance, Auditing, ISO 13485, ISO, Six Sigma, Document Management, Continuous Improvement, Documentation, Process Improvement, Technology Transfer, Product Development, GxP, Problem Solving, LIMS, Risk Management, Cleaning Validation, GMP, Inspection, Root Cause Analysis, Lean Manufacturing, Cross-functional Team..., Change Management, Process Development, Sop, Quality System, Pharmaceutical Industry, V&V, Computer System..., Regulatory Requirements
Education
Roger Williams University 1983 — 1986
BS, Biology, Management
University of Rhode Island 1975 — 1979
B.S., Science
University of Rhode Island 1974 — 1977
AS, Business
Doug Bullard Doug Bullard's Wyeth Biotech Experience 2007 - 2008
Job Senior Consultant of Compliance at ProPharma Group | Experience in Quality, Validation and GMP training | Author
Industry Biotechnology
Experience
ProPharma Group October 2013 - Present
Quality Core Consulting, LLC June 2013 - Present
Sprout Pharmaceuticals June 2013 - October 2013
Regulatory Compliance Associates, Inc. February 2013 - April 2013
Quintiles November 2011 - September 2012
Pfizer Pharmaceuticals October 2008 - November 2010
Wyeth Biotech 2007 - 2008
Wyeth Vaccines 2005 - 2007
Bayer July 1994 - January 2005
Skills
Quality Assurance, Quality Management, Quality Operations, Quality Systems, Quality Auditing, cGMP, Batch Release, Documentation Practices, Document Control, Annual Reports, Change Control, LIMS, SAP, Livelink, Lean Manufacturing, Root Cause Analysis, Validation, Process Validation, Cleaning Validation, Pharmaceuticals, Biotechnology, Vaccines, Aseptic Processing, Trending, Collaboration, Strategic Communications, Pharmaceutical Industry, V&V, GMP, Quality System, FDA, Software Documentation, Document Management, Manufacturing, CAPA, Cross-functional Team..., Technology Transfer, Process Simulation, 21 CFR Part 11, GLP, Computer System..., Sop, Biopharmaceuticals, Continuous Improvement, Pharmaceutics, Regulatory Submissions, Trackwise, Regulatory Requirements, ISO 13485, Deviations
Education
North Carolina State University - College of Management 1990 — 1993
BA, Business Administration, concentration in Marketing
Wayne Community College 1988 — 1990
ProPharma Group October 2013 - Present
Quality Core Consulting, LLC June 2013 - Present
Sprout Pharmaceuticals June 2013 - October 2013
Regulatory Compliance Associates, Inc. February 2013 - April 2013
Quintiles November 2011 - September 2012
Pfizer Pharmaceuticals October 2008 - November 2010
Wyeth Biotech 2007 - 2008
Wyeth Vaccines 2005 - 2007
Bayer July 1994 - January 2005
Skills
Quality Assurance, Quality Management, Quality Operations, Quality Systems, Quality Auditing, cGMP, Batch Release, Documentation Practices, Document Control, Annual Reports, Change Control, LIMS, SAP, Livelink, Lean Manufacturing, Root Cause Analysis, Validation, Process Validation, Cleaning Validation, Pharmaceuticals, Biotechnology, Vaccines, Aseptic Processing, Trending, Collaboration, Strategic Communications, Pharmaceutical Industry, V&V, GMP, Quality System, FDA, Software Documentation, Document Management, Manufacturing, CAPA, Cross-functional Team..., Technology Transfer, Process Simulation, 21 CFR Part 11, GLP, Computer System..., Sop, Biopharmaceuticals, Continuous Improvement, Pharmaceutics, Regulatory Submissions, Trackwise, Regulatory Requirements, ISO 13485, Deviations
Education
North Carolina State University - College of Management 1990 — 1993
BA, Business Administration, concentration in Marketing
Wayne Community College 1988 — 1990
Cyndi Cox Cyndi Cox's Wyeth Biotech Experience March 2006 - December 2008
Job Stay at home mom
Industry Consumer Services
Experience
Wiggles & Wags, LLC July 2011 - October 2012
Pfizer October 2009 - June 2011
Wyeth December 2008 - June 2011
Wyeth Biotechnology March 2006 - December 2008
Wyeth Biotech March 2006 - December 2008
Shire Pharmaceuticals 2004 - 2006
Veterinary Referral and Critical Care, Inc February 2004 - May 2004
Central Veterinary Emergency Services August 2002 - December 2003
Shire 2000 - 2002
Skills
FDA, Pets, Veterinary, GMP, CAPA, 21 CFR Part 11, Validation, Sop, Pharmaceutical Industry, LIMS, Aseptic Processing, Quality System, Technology Transfer, Biotechnology, Change Control, Quality Assurance
Education
Bel-Rea Institute of Animal Technology 2002 — 2003
Applied Science, Veterinary Medicine
Penn State University 1996 — 2000
BS, Biology
Wiggles & Wags, LLC July 2011 - October 2012
Pfizer October 2009 - June 2011
Wyeth December 2008 - June 2011
Wyeth Biotechnology March 2006 - December 2008
Wyeth Biotech March 2006 - December 2008
Shire Pharmaceuticals 2004 - 2006
Veterinary Referral and Critical Care, Inc February 2004 - May 2004
Central Veterinary Emergency Services August 2002 - December 2003
Shire 2000 - 2002
Skills
FDA, Pets, Veterinary, GMP, CAPA, 21 CFR Part 11, Validation, Sop, Pharmaceutical Industry, LIMS, Aseptic Processing, Quality System, Technology Transfer, Biotechnology, Change Control, Quality Assurance
Education
Bel-Rea Institute of Animal Technology 2002 — 2003
Applied Science, Veterinary Medicine
Penn State University 1996 — 2000
BS, Biology
Susan Blatti Susan Blatti's Wyeth Biotech Experience August 2001 - September 2002
Job Quality Assurance Manager at Safecor Health, LLC
Industry Pharmaceuticals
Experience
Safecor Health, LLC January 2011 - Present
Pfizer Pharmaceuticals September 1992 - August 2010
Wyeth Biotech August 2001 - September 2002
Wyeth Biotech January 2000 - August 2001
Wyeth Biotech January 1999 - January 2000
Wyeth Biotech January 1998 - January 1999
Wyeth Biotech August 1993 - January 1998
Raytheon June 1982 - June 1993
Skills
GMP, Quality Assurance, CAPA, Change Control, Quality Control, Biotechnology, Trackwise, Manufacturing, Testing, Project Management, Regulatory Requirements, 21 CFR Part 11, Sop, LIMS, Validation, Operational Excellence, Auditing, FDA, Access, Pharmaceutical Industry
Education
Northern Essex Community College 1980 — 1982
Safecor Health, LLC January 2011 - Present
Pfizer Pharmaceuticals September 1992 - August 2010
Wyeth Biotech August 2001 - September 2002
Wyeth Biotech January 2000 - August 2001
Wyeth Biotech January 1999 - January 2000
Wyeth Biotech January 1998 - January 1999
Wyeth Biotech August 1993 - January 1998
Raytheon June 1982 - June 1993
Skills
GMP, Quality Assurance, CAPA, Change Control, Quality Control, Biotechnology, Trackwise, Manufacturing, Testing, Project Management, Regulatory Requirements, 21 CFR Part 11, Sop, LIMS, Validation, Operational Excellence, Auditing, FDA, Access, Pharmaceutical Industry
Education
Northern Essex Community College 1980 — 1982
Flaviu Gruia Flaviu Gruia's Wyeth Biotech Experience October 2007 - August 2009
Job Scientist II at MedImmune
Industry Biotechnology
Experience
MedImmune February 2013 - Present
MedImmune August 2009 - December 2012
Wyeth Biotech October 2007 - August 2009
Skills
Monoclonal Antibodies, Antibodies, Characterization, Technology Transfer, Molecular Biology, Biophysics, Formulation Development, Biotechnology, Protein Purification, Biopharmaceuticals, Biochemistry, Life Sciences, Protein Characterization, Protein Chemistry, Assay Development, Drug Discovery, Pharmaceutical Industry, Chromatography, Purification, GMP
Education
Northeastern University 2000 — 2007
MSc, Ph.D, physics, optics, biophysics
Bucharest University 1992 — 1998
MS, BS, Physics
MedImmune February 2013 - Present
MedImmune August 2009 - December 2012
Wyeth Biotech October 2007 - August 2009
Skills
Monoclonal Antibodies, Antibodies, Characterization, Technology Transfer, Molecular Biology, Biophysics, Formulation Development, Biotechnology, Protein Purification, Biopharmaceuticals, Biochemistry, Life Sciences, Protein Characterization, Protein Chemistry, Assay Development, Drug Discovery, Pharmaceutical Industry, Chromatography, Purification, GMP
Education
Northeastern University 2000 — 2007
MSc, Ph.D, physics, optics, biophysics
Bucharest University 1992 — 1998
MS, BS, Physics
Stephen P Paquette's Wyeth Biotech Experience September 2007 - February 2008
Job Quality Assurance Director
Industry Pharmaceuticals
Experience
Pfizer (Previously Wyeth) February 2008 - Present
Wyeth September 2007 - July 2009
Wyeth Biotech September 2007 - February 2008
Wyeth January 2007 - February 2008
Wyeth Biotech October 2005 - September 2007
Wyeth Biotech January 2005 - October 2005
Wyeth Biotech April 2001 - January 2005
Muro Pharmaceutical October 1990 - April 2001
Skills
CAPA, GMP
Education
Plymouth State University 1986 — 1989
BS, Biological Science and Education
Pfizer (Previously Wyeth) February 2008 - Present
Wyeth September 2007 - July 2009
Wyeth Biotech September 2007 - February 2008
Wyeth January 2007 - February 2008
Wyeth Biotech October 2005 - September 2007
Wyeth Biotech January 2005 - October 2005
Wyeth Biotech April 2001 - January 2005
Muro Pharmaceutical October 1990 - April 2001
Skills
CAPA, GMP
Education
Plymouth State University 1986 — 1989
BS, Biological Science and Education
Steve Roof, CMR Steve Roof, CMR's Wyeth Biotech Experience January 2006 - December 2006
Job Senior Hospital Specialty Sales and Sales Trainer at ScheringPlough
Industry Pharmaceuticals
Experience
Schering-Plough August 2007 - Present
Schering-plough January 2007 - Present
Schering-Plough Pharmaceuticals 2007 - Present
Wyeth Biotech January 2006 - December 2006
Wyeth Biotech May 1999 - December 2006
Wyeth Pharmaceuticals October 1991 - May 1999
Wyeth June 1988 - September 1991
Education
Northern Michigan University 1976 — 1980
BS, Chemistry, Pre-Medicine
Schering-Plough August 2007 - Present
Schering-plough January 2007 - Present
Schering-Plough Pharmaceuticals 2007 - Present
Wyeth Biotech January 2006 - December 2006
Wyeth Biotech May 1999 - December 2006
Wyeth Pharmaceuticals October 1991 - May 1999
Wyeth June 1988 - September 1991
Education
Northern Michigan University 1976 — 1980
BS, Chemistry, Pre-Medicine
Kevin Overcash Kevin Overcash's Wyeth Biotech Experience 2005 - 2008
Job Capital Project Development at Piedmont Service Group
Industry Utilities
Experience
Energy Services Coalition of NC January 2014 - Present
Piedmont Service Group May 2011 - Present
Siemens July 2008 - May 2011
North Carolina State University, Jenkins Graduate School of Management 2007 - 2010
Wyeth Biotech 2005 - 2008
Merck 2002 - 2005
Calpine 2000 - 2002
Duke Energy / DukeSolutions 1998 - 2000
Skills
Root Cause Analysis, Energy Efficiency, Six Sigma, Project Engineering, Maintenance Management, Change Management, HVAC, Automation, Energy Conservation, Commissioning, GMP, Engineering, Lean Manufacturing, Energy, Preventive Maintenance, Project Management, Power Plants, Electricians, Quality Assurance, Facilities Management, Renewable Energy, Mechanical Engineering, Boilers, Construction, Cross-functional Team..., Energy Management, Process Improvement, DCS, Program Management, Software Documentation, Building Automation, Energy Audits, Budgets, Process Engineering, Analysis
Education
North Carolina State University - College of Management 2008 — 2011
MBA, Finance
North Carolina State University 1993 — 1997
BSEE, Electrical Engineering
Energy Services Coalition of NC January 2014 - Present
Piedmont Service Group May 2011 - Present
Siemens July 2008 - May 2011
North Carolina State University, Jenkins Graduate School of Management 2007 - 2010
Wyeth Biotech 2005 - 2008
Merck 2002 - 2005
Calpine 2000 - 2002
Duke Energy / DukeSolutions 1998 - 2000
Skills
Root Cause Analysis, Energy Efficiency, Six Sigma, Project Engineering, Maintenance Management, Change Management, HVAC, Automation, Energy Conservation, Commissioning, GMP, Engineering, Lean Manufacturing, Energy, Preventive Maintenance, Project Management, Power Plants, Electricians, Quality Assurance, Facilities Management, Renewable Energy, Mechanical Engineering, Boilers, Construction, Cross-functional Team..., Energy Management, Process Improvement, DCS, Program Management, Software Documentation, Building Automation, Energy Audits, Budgets, Process Engineering, Analysis
Education
North Carolina State University - College of Management 2008 — 2011
MBA, Finance
North Carolina State University 1993 — 1997
BSEE, Electrical Engineering
Robert Zehr's Wyeth Biotech Experience February 2008 - July 2010
Job Consulting Process Engineer with PharmaBioServ for Johnson & Johnson
Industry Biotechnology
Experience
PharmaBioServ for Johnson & Johnson November 2010 - Present
Pfizer 2009 - July 2010
Wyeth Biotech February 2008 - July 2010
Wyeth June 2005 - January 2008
GSK June 2004 - December 2004
Skills
cGMP, Process Validation, Biotechnology, Technology Transfer, GLP, Chemistry, Process Development, GMP, Documentation, Characterization, Pharmaceuticals, Change Control, R&D, Filtration, Root Cause Analysis, Process Engineering, Design of Experiments, CAPA, LIMS, FMEA, Statistics, 21 CFR Part 11, SAP, Biochemical Engineering
Education
North Carolina State University 2004 — 2006
BS, Chemical and Biomolecular Engineering
The Ohio State University 2000 — 2003
ABD, Organic Chemistry
North Carolina State University 1995 — 1999
BS, Chemistry
PharmaBioServ for Johnson & Johnson November 2010 - Present
Pfizer 2009 - July 2010
Wyeth Biotech February 2008 - July 2010
Wyeth June 2005 - January 2008
GSK June 2004 - December 2004
Skills
cGMP, Process Validation, Biotechnology, Technology Transfer, GLP, Chemistry, Process Development, GMP, Documentation, Characterization, Pharmaceuticals, Change Control, R&D, Filtration, Root Cause Analysis, Process Engineering, Design of Experiments, CAPA, LIMS, FMEA, Statistics, 21 CFR Part 11, SAP, Biochemical Engineering
Education
North Carolina State University 2004 — 2006
BS, Chemical and Biomolecular Engineering
The Ohio State University 2000 — 2003
ABD, Organic Chemistry
North Carolina State University 1995 — 1999
BS, Chemistry
Steve Roof, CMR Steve Roof, CMR's Wyeth Biotech Experience January 1995 - May 1998
Job Executive Inpatient Hospital Rep at Merck
Industry Biotechnology
Experience
Merck January 2010 - Present
Merck (legacy Schering Plough) February 2007 - February 2010
Wyeth Biotech (legacy Genetics Institute) May 1998 - December 2006
Wyeth Biotech January 1995 - May 1998
Wyeth Pharmaceuticals January 1992 - January 1995
Wyeth (legacy Lederle Labs) June 1988 - January 1992
Wyeth (legacy Lederle Labs) October 1985 - June 1988
Wyeth (legacy Lederle Labs) August 1984 - October 1985
Wyeth (legacy Lederle Labs) June 1980 - August 1984
Education
Northern Michigan University 1976 — 1980
BS, Chemistry, Human Biology
Univ of Medicine and Dentistry of NJ
MS, Disease Management (pending)
Merck January 2010 - Present
Merck (legacy Schering Plough) February 2007 - February 2010
Wyeth Biotech (legacy Genetics Institute) May 1998 - December 2006
Wyeth Biotech January 1995 - May 1998
Wyeth Pharmaceuticals January 1992 - January 1995
Wyeth (legacy Lederle Labs) June 1988 - January 1992
Wyeth (legacy Lederle Labs) October 1985 - June 1988
Wyeth (legacy Lederle Labs) August 1984 - October 1985
Wyeth (legacy Lederle Labs) June 1980 - August 1984
Education
Northern Michigan University 1976 — 1980
BS, Chemistry, Human Biology
Univ of Medicine and Dentistry of NJ
MS, Disease Management (pending)
Philip Stickney Philip Stickney's Wyeth Biotech Experience June 2005 - February 2008
Job Validation Engineer Contractor at Biogen Idec/Yoh Scientific/Cambridge
Industry Biotechnology
Experience
Biogen Idec September 2014 - Present
Integrated Project Services (IPS) January 2012 - December 2012
Shire July 2011 - December 2011
Teleflex Medical January 2011 - July 2011
Bristol-Myers Squibb October 2010 - December 2010
AMAG Pharmaceuticals May 2010 - October 2010
Genzyme Corporation Allston Landing February 2008 - November 2009
Wyeth Biotech June 2005 - February 2008
Wyeth Biotech December 2000 - June 2005
Anika Therapeutics June 1998 - November 2000
Skills
GMP, Validation, Quality Assurance, Biotechnology, Manufacturing, CAPA, Engineering, Sop, Change Control, Microsoft Office, Process Scheduler, FDA, Regulatory Affairs, Technology Transfer, LEED AP, V&V, Software Documentation, Aseptic Processing, Computer System..., GxP, Biopharmaceuticals, Quality System, ISO 13485, LIMS, GLP, Pharmaceutical Industry, Quality Control, Process Simulation, Continuous Improvement, 21 CFR Part 11, Trackwise, Deviation Management, Troubleshooting, Microsoft Certified..., Regulatory Requirements, Scheduling, SOP
Education
Everblue Training Institute 2009 — 2009
LEED AP, Green Building Professional
North Shore Community College 1970 — 1973
Associates, Business and General Studies
Harris Real Estate School
Mass Real Estate Sales Education, Residential Real Estate, Passed State Exam
Biogen Idec September 2014 - Present
Integrated Project Services (IPS) January 2012 - December 2012
Shire July 2011 - December 2011
Teleflex Medical January 2011 - July 2011
Bristol-Myers Squibb October 2010 - December 2010
AMAG Pharmaceuticals May 2010 - October 2010
Genzyme Corporation Allston Landing February 2008 - November 2009
Wyeth Biotech June 2005 - February 2008
Wyeth Biotech December 2000 - June 2005
Anika Therapeutics June 1998 - November 2000
Skills
GMP, Validation, Quality Assurance, Biotechnology, Manufacturing, CAPA, Engineering, Sop, Change Control, Microsoft Office, Process Scheduler, FDA, Regulatory Affairs, Technology Transfer, LEED AP, V&V, Software Documentation, Aseptic Processing, Computer System..., GxP, Biopharmaceuticals, Quality System, ISO 13485, LIMS, GLP, Pharmaceutical Industry, Quality Control, Process Simulation, Continuous Improvement, 21 CFR Part 11, Trackwise, Deviation Management, Troubleshooting, Microsoft Certified..., Regulatory Requirements, Scheduling, SOP
Education
Everblue Training Institute 2009 — 2009
LEED AP, Green Building Professional
North Shore Community College 1970 — 1973
Associates, Business and General Studies
Harris Real Estate School
Mass Real Estate Sales Education, Residential Real Estate, Passed State Exam
Randy Hutt, Ph.D. Randy Hutt, Ph.D.'s Wyeth Biotech Experience September 1995 - April 2008
Job Associate Director Sterility Assurance and Microbiology at Luitpold Pharmaceuticals
Industry Pharmaceuticals
Experience
Luitpold Pharmaceuticals August 2014 - Present
Independent for MicroDoc LLC, QXP, Tunnell and Libra Tech. Ctr. January 2013 - August 2014
SML Acquisition, LLC. (formerly San-Mar Labs, Inc.) May 2011 - December 2012
The Lachman Group August 2008 - May 2011
Wyeth Biotech September 1995 - April 2008
Burroughs Wellcome Co. July 1985 - September 1995
Schering-Plough Pharmaceuticals 1980 - 1985
Skills
Coaching, Mentoring, Troubleshooting, SOP development, Project Management, Compliance, Aseptic Processing, Quality Assurance, Quality Systems Design, Quality Auditing, Teaching, Team Management, Leadership, GMP, FDA, Team Building, Auditing, Validation, Pharmaceutical Industry, CAPA, Change Control, Vaccines, Biopharmaceuticals, Microbiology, Quality System, Quality Control, Biotechnology, Aseptic Technique, Sop, Pharmaceutics, 21 CFR Part 11, GLP, V&V, GxP, Lifesciences, Laboratory, Technology Transfer, Computer System..., LIMS, Cleaning Validation, Regulatory Requirements, Sterilization, Trackwise, Regulatory Submissions, Deviations, Regulatory Affairs, GAMP, Formulation, Pharmaceutical..., Life Sciences
Education
Pennsylvania State University College of Medicine 1972 — 1977
Ph.D, Microbiology
U. of Florida
MS, Microbiology/Virology
SUNY at Buffalo
BA, Biology/Microbiology
Bronx HS of Science
Luitpold Pharmaceuticals August 2014 - Present
Independent for MicroDoc LLC, QXP, Tunnell and Libra Tech. Ctr. January 2013 - August 2014
SML Acquisition, LLC. (formerly San-Mar Labs, Inc.) May 2011 - December 2012
The Lachman Group August 2008 - May 2011
Wyeth Biotech September 1995 - April 2008
Burroughs Wellcome Co. July 1985 - September 1995
Schering-Plough Pharmaceuticals 1980 - 1985
Skills
Coaching, Mentoring, Troubleshooting, SOP development, Project Management, Compliance, Aseptic Processing, Quality Assurance, Quality Systems Design, Quality Auditing, Teaching, Team Management, Leadership, GMP, FDA, Team Building, Auditing, Validation, Pharmaceutical Industry, CAPA, Change Control, Vaccines, Biopharmaceuticals, Microbiology, Quality System, Quality Control, Biotechnology, Aseptic Technique, Sop, Pharmaceutics, 21 CFR Part 11, GLP, V&V, GxP, Lifesciences, Laboratory, Technology Transfer, Computer System..., LIMS, Cleaning Validation, Regulatory Requirements, Sterilization, Trackwise, Regulatory Submissions, Deviations, Regulatory Affairs, GAMP, Formulation, Pharmaceutical..., Life Sciences
Education
Pennsylvania State University College of Medicine 1972 — 1977
Ph.D, Microbiology
U. of Florida
MS, Microbiology/Virology
SUNY at Buffalo
BA, Biology/Microbiology
Bronx HS of Science
Laura Maness Laura Maness's Wyeth Biotech Experience May 2004 - January 2007
Job Health, Safety and Environment Specialist at Novartis Vaccines
Industry Pharmaceuticals
Experience
Novartis Vaccines July 2013 - Present
Pfizer January 2007 - July 2013
Wyeth Biotech May 2004 - January 2007
Community College and Public School Systems 1990 - 2003
Alcatel North America 1983 - 1988
Hickory City Public Schools 1981 - 1983
Skills
EHS, Document Management, Training, Incident Management, Auditing, Process Improvement, Risk Assessment, Ergonomics, Document Review, Organizational..., Emergency Management, SharePoint, Technical Writing, Business Continuity, Environmental..., ISO 14001, PPE, Microsoft Excel, Microsoft Word, PowerPoint, Documentation, FDA, Quality System, Change Control, CAPA, SOP, Validation, 21 CFR Part 11, Biotechnology, GMP, Pharmaceutical Industry
Education
North Carolina State University
Bachelor's Degree, Biology/Biological Sciences, General
North Carolina State University
Bachelor's Degree, Science Teacher Education/General Science Teacher Education
Novartis Vaccines July 2013 - Present
Pfizer January 2007 - July 2013
Wyeth Biotech May 2004 - January 2007
Community College and Public School Systems 1990 - 2003
Alcatel North America 1983 - 1988
Hickory City Public Schools 1981 - 1983
Skills
EHS, Document Management, Training, Incident Management, Auditing, Process Improvement, Risk Assessment, Ergonomics, Document Review, Organizational..., Emergency Management, SharePoint, Technical Writing, Business Continuity, Environmental..., ISO 14001, PPE, Microsoft Excel, Microsoft Word, PowerPoint, Documentation, FDA, Quality System, Change Control, CAPA, SOP, Validation, 21 CFR Part 11, Biotechnology, GMP, Pharmaceutical Industry
Education
North Carolina State University
Bachelor's Degree, Biology/Biological Sciences, General
North Carolina State University
Bachelor's Degree, Science Teacher Education/General Science Teacher Education
Dan LaCasse Dan LaCasse's Wyeth Biotech Experience June 2008 - June 2011
Job Senior Scientist Biotherapuetics R&D Purification Process Development at Pfizer
Industry Biotechnology
Experience
Pfizer June 2011 - Present
Wyeth Biotech June 2008 - June 2011
Wyeth August 2005 - June 2008
Millipore Corporation 2000 - 2005
Skills
Biotechnology, Technology Transfer, Validation, Purification, R&D, CAPA, Process Simulation, Chemical Engineering, Chromatography, Product Development, Biopharmaceuticals, Process Improvement, Design of Experiments, Filtration, FDA, Laboratory, GMP, HPLC, Change Control, Aseptic Processing, Sop, 21 CFR Part 11, V&V
Education
Rensselaer Polytechnic Institute 1995 — 2000
BS, Chemical Engineering
Pfizer June 2011 - Present
Wyeth Biotech June 2008 - June 2011
Wyeth August 2005 - June 2008
Millipore Corporation 2000 - 2005
Skills
Biotechnology, Technology Transfer, Validation, Purification, R&D, CAPA, Process Simulation, Chemical Engineering, Chromatography, Product Development, Biopharmaceuticals, Process Improvement, Design of Experiments, Filtration, FDA, Laboratory, GMP, HPLC, Change Control, Aseptic Processing, Sop, 21 CFR Part 11, V&V
Education
Rensselaer Polytechnic Institute 1995 — 2000
BS, Chemical Engineering
Leslie Osmera Leslie Osmera's Wyeth Biotech Experience 2001 - 2004
Job Sr. Consultant, NL Associates, LLC Quality Systems consulting to Biotech,Pharmaceutical & Healthcare
Industry Pharmaceuticals
Experience
NL Associates, LLC November 2010 - Present
Veltek Associates 2004 - 2010
Wyeth Biotech 2001 - 2004
Novartis August 1994 - September 2001
Advanced BioHealing, Inc. 1992 - 1994
Hybritech Incorporated 1984 - 1993
Skills
Quality Systems, Biotechnology, Aseptic Processing, cGMP, CAPA, Pharmaceuticals, Tableting, Investigations, Training, Documentation, Quality System, Medical Devices, IND, Biopharmaceuticals, Technology Transfer, GLP, Clinical Research, Quality Assurance, GMP, USP, Microbiology, Regulatory Affairs, Clinical Development, Vaccines, Quality Control, Manufacturing, Pharmaceutical Industry, ISO 13485, ISO, Change Control, Regulatory Requirements, Cleaning Validation, Commercialization, Sop, Sterilization, 21 CFR Part 11, Drug Development, Aseptic Technique, Biologics, Assay Development, Validation, Clean Rooms, Laboratory, Leadership, GxP, Quality Auditing, Contract Manufacturing, FDA, Computer System..., Analytical Chemistry
Education
San Diego State University-California State University 1982 — 1984
Bachelor of Science (BS), Biology
NL Associates, LLC November 2010 - Present
Veltek Associates 2004 - 2010
Wyeth Biotech 2001 - 2004
Novartis August 1994 - September 2001
Advanced BioHealing, Inc. 1992 - 1994
Hybritech Incorporated 1984 - 1993
Skills
Quality Systems, Biotechnology, Aseptic Processing, cGMP, CAPA, Pharmaceuticals, Tableting, Investigations, Training, Documentation, Quality System, Medical Devices, IND, Biopharmaceuticals, Technology Transfer, GLP, Clinical Research, Quality Assurance, GMP, USP, Microbiology, Regulatory Affairs, Clinical Development, Vaccines, Quality Control, Manufacturing, Pharmaceutical Industry, ISO 13485, ISO, Change Control, Regulatory Requirements, Cleaning Validation, Commercialization, Sop, Sterilization, 21 CFR Part 11, Drug Development, Aseptic Technique, Biologics, Assay Development, Validation, Clean Rooms, Laboratory, Leadership, GxP, Quality Auditing, Contract Manufacturing, FDA, Computer System..., Analytical Chemistry
Education
San Diego State University-California State University 1982 — 1984
Bachelor of Science (BS), Biology
Sahil Parikh's Wyeth Biotech Experience February 2008 - August 2009
Job Senior Microbiologist at Boston Analytical
Industry Biotechnology
Experience
Boston Analytical October 2014 - Present
Sahil Parikh Photography September 2012 - Present
Rapid Micro Biosystems August 2009 - September 2014
Wyeth Biotech February 2008 - August 2009
Skills
Validation, Product Development, Microbiology, Lean Thinking, Project Management, Bioburden, Materials Science, Design for Manufacturing, Environmental..., Cell Culture, FDA, R&D, Quality Control, Testing, Manufacturing, Biopharmaceuticals, GMP, CAPA, Biotechnology, Life Sciences, SOP, GLP, Medical Devices, Technology Transfer, Pharmaceutical Industry, Quality System
Education
Northeastern University 2012 — 2014
Master of Science (MS), Project Management
University of Connecticut 2002 — 2007
B.S., Biological Sciences, English Studies
Boston Analytical October 2014 - Present
Sahil Parikh Photography September 2012 - Present
Rapid Micro Biosystems August 2009 - September 2014
Wyeth Biotech February 2008 - August 2009
Skills
Validation, Product Development, Microbiology, Lean Thinking, Project Management, Bioburden, Materials Science, Design for Manufacturing, Environmental..., Cell Culture, FDA, R&D, Quality Control, Testing, Manufacturing, Biopharmaceuticals, GMP, CAPA, Biotechnology, Life Sciences, SOP, GLP, Medical Devices, Technology Transfer, Pharmaceutical Industry, Quality System
Education
Northeastern University 2012 — 2014
Master of Science (MS), Project Management
University of Connecticut 2002 — 2007
B.S., Biological Sciences, English Studies
Jason Lieske Jason Lieske's Wyeth Biotech Experience 1995 - 2010
Job Principle Scientist at Pizer
Industry Biotechnology
Experience
Pfizer October 1995 - Present
Pizer October 1995 - Present
Wyeth Biotech 1995 - 2010
Skills
HPLC, Method Development, UV/Vis, GC-MS, ICP-OES, FTIR, NIR spectroscopy, EDX, Chromatography, Analytical Chemistry, Protein Chemistry, LIMS, Validation, Biotechnology, GMP, Technology Transfer, Pharmaceutical Industry, Sop, Assay Development, SDS-PAGE
Education
Northeastern University 2008 — 2012
PhD, Analytical Chemistry
Pfizer October 1995 - Present
Pizer October 1995 - Present
Wyeth Biotech 1995 - 2010
Skills
HPLC, Method Development, UV/Vis, GC-MS, ICP-OES, FTIR, NIR spectroscopy, EDX, Chromatography, Analytical Chemistry, Protein Chemistry, LIMS, Validation, Biotechnology, GMP, Technology Transfer, Pharmaceutical Industry, Sop, Assay Development, SDS-PAGE
Education
Northeastern University 2008 — 2012
PhD, Analytical Chemistry
David MacKay David MacKay's Wyeth Biotech Experience 2000 - 2009
Job Senior Manager Engineering at Pfizer in Andover, MA
Industry Biotechnology
Experience
Pfizer Specialty Care 2000 - Present
Wyeth Biotech 2000 - 2009
Wyeth 2000 - 2009
Biokinetics 1997 - 2000
bioKinetics 1993 - 1997
Skills
Facility Design, Equipment Design, People Management, Facilities Management, Management, GMP, Biotechnology
Education
Northeastern University 1986 — 1991
BS, Mechanical Engineering
University of Rhode Island 1984 — 1986
Chemical & Ocean Eng
WNHS
Pfizer Specialty Care 2000 - Present
Wyeth Biotech 2000 - 2009
Wyeth 2000 - 2009
Biokinetics 1997 - 2000
bioKinetics 1993 - 1997
Skills
Facility Design, Equipment Design, People Management, Facilities Management, Management, GMP, Biotechnology
Education
Northeastern University 1986 — 1991
BS, Mechanical Engineering
University of Rhode Island 1984 — 1986
Chemical & Ocean Eng
WNHS
John Furey John Furey's Wyeth Biotech Experience January 2000 - December 2002
Job Senior Vice President and Head, Global Operations
Industry Pharmaceuticals
Experience
Baxalta November 2014 - Present
Baxter International Inc. April 2014 - October 2014
Baxter International Inc. February 2013 - March 2014
Pfizer China April 2011 - January 2013
Pfizer Vaccines May 2007 - March 2011
Wyeth Vaccines July 2004 - April 2007
Wyeth Biotech, Collegeville, PA. January 2003 - June 2004
Wyeth Biotech January 2000 - December 2002
Wyeth July 1998 - December 1999
Wyeth January 1993 - June 1998
Skills
Pharmaceutical Industry, Vaccines, Cross-functional Team..., Biopharmaceuticals, Biotechnology, P&L Management, Strategy
Education
Saint Joseph's University - Erivan K. Haub School of Business
MBA, Pharma Marketing
Trinity College Dublin
B. Sc., Environmental Health
Baxalta November 2014 - Present
Baxter International Inc. April 2014 - October 2014
Baxter International Inc. February 2013 - March 2014
Pfizer China April 2011 - January 2013
Pfizer Vaccines May 2007 - March 2011
Wyeth Vaccines July 2004 - April 2007
Wyeth Biotech, Collegeville, PA. January 2003 - June 2004
Wyeth Biotech January 2000 - December 2002
Wyeth July 1998 - December 1999
Wyeth January 1993 - June 1998
Skills
Pharmaceutical Industry, Vaccines, Cross-functional Team..., Biopharmaceuticals, Biotechnology, P&L Management, Strategy
Education
Saint Joseph's University - Erivan K. Haub School of Business
MBA, Pharma Marketing
Trinity College Dublin
B. Sc., Environmental Health
Jessica Williams-Smith Jessica Williams-Smith's Wyeth Biotech Experience September 2003 - May 2008
Job Quality Information Systems Administrator at AgaMatrix
Industry Biotechnology
Experience
AgaMatrix April 2015 - Present
AgaMatrix October 2013 - April 2015
Anika Therapeutics March 2013 - October 2013
Seaside Therapeutics October 2012 - March 2013
Genzyme September 2011 - October 2012
Shire HGT January 2011 - September 2011
Shire HGT August 2009 - January 2011
Shire HGT May 2008 - August 2009
Wyeth Biotech September 2003 - May 2008
Wyeth Biotech 2001 - 2003
Skills
Microsoft Word, Microsoft Excel, Visual D Base, Access 97 & 98, Windows NT Explorer, Adobe Professional, PowerPoint, Windows 98 & 2000, Office XP, Oracle, Vista, MAXIMO, AGILE PLM, TagLink, SAP, Drawing Document..., TrackWise, Microsoft Visio, DataStream (Infor), TrueView, File Maker Pro, Maximo, Access, Document Management, Visio, FDA, GMP, Change Control, Trackwise, Software Documentation, Biotechnology, Pharmaceutical Industry, Sop, CAPA, Product Lifecycle..., Quality System, Microsoft Office Xp, GLP, FileMaker, SOP, Quality Assurance, Validation, Microsoft Office, Windows Vista
Education
Northern Essex Community College
Associates, Business Management with Computer Applications Option
Salem High School
University of Phoenix
Masters, Management
University of Phoenix
Bachelors, Management
AgaMatrix April 2015 - Present
AgaMatrix October 2013 - April 2015
Anika Therapeutics March 2013 - October 2013
Seaside Therapeutics October 2012 - March 2013
Genzyme September 2011 - October 2012
Shire HGT January 2011 - September 2011
Shire HGT August 2009 - January 2011
Shire HGT May 2008 - August 2009
Wyeth Biotech September 2003 - May 2008
Wyeth Biotech 2001 - 2003
Skills
Microsoft Word, Microsoft Excel, Visual D Base, Access 97 & 98, Windows NT Explorer, Adobe Professional, PowerPoint, Windows 98 & 2000, Office XP, Oracle, Vista, MAXIMO, AGILE PLM, TagLink, SAP, Drawing Document..., TrackWise, Microsoft Visio, DataStream (Infor), TrueView, File Maker Pro, Maximo, Access, Document Management, Visio, FDA, GMP, Change Control, Trackwise, Software Documentation, Biotechnology, Pharmaceutical Industry, Sop, CAPA, Product Lifecycle..., Quality System, Microsoft Office Xp, GLP, FileMaker, SOP, Quality Assurance, Validation, Microsoft Office, Windows Vista
Education
Northern Essex Community College
Associates, Business Management with Computer Applications Option
Salem High School
University of Phoenix
Masters, Management
University of Phoenix
Bachelors, Management
Kim Batts's Wyeth Biotech Experience October 2004 - June 2007
Job Supply Chain Coordinator at Fujifilm Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies November 2011 - Present
Merck (Diosynth Biotechnology) May 2010 - November 2011
Diosynth June 2007 - April 2010
Wyeth Biotech October 2004 - June 2007
Wyeth Biotech March 2002 - October 2004
Wyeth Biotech October 2000 - May 2002
Abbott Laboratories September 1998 - October 2000
Abbott Laboratories September 1995 - September 1998
Skills
Microbiology, Fermentation, Testing, GMP, Biopharmaceuticals, LIMS, 21 CFR Part 11, Biotechnology, GLP, Change Control, Sop, Pharmaceutical Industry, CAPA, Formulation, Quality Control, Regulatory Affairs, Vaccines, Validation, Analytical Chemistry, Aseptic Processing, FDA, Laboratory, Quality System, Quality Assurance, SOP
Education
UMUC 2004 — 2006
Courses in Microbiology, Ethics, and Bioinformatics, Biotechnology
North Carolina Wesleyan College 1990 — 1995
BS, Biology
Fujifilm Diosynth Biotechnologies November 2011 - Present
Merck (Diosynth Biotechnology) May 2010 - November 2011
Diosynth June 2007 - April 2010
Wyeth Biotech October 2004 - June 2007
Wyeth Biotech March 2002 - October 2004
Wyeth Biotech October 2000 - May 2002
Abbott Laboratories September 1998 - October 2000
Abbott Laboratories September 1995 - September 1998
Skills
Microbiology, Fermentation, Testing, GMP, Biopharmaceuticals, LIMS, 21 CFR Part 11, Biotechnology, GLP, Change Control, Sop, Pharmaceutical Industry, CAPA, Formulation, Quality Control, Regulatory Affairs, Vaccines, Validation, Analytical Chemistry, Aseptic Processing, FDA, Laboratory, Quality System, Quality Assurance, SOP
Education
UMUC 2004 — 2006
Courses in Microbiology, Ethics, and Bioinformatics, Biotechnology
North Carolina Wesleyan College 1990 — 1995
BS, Biology
Lauren Seabrook's Wyeth Biotech Experience 2005 - 2008
Job Federal Regulatory Manager at ADAMA USA
Industry Chemicals
Experience
ADAMA USA April 2015 - Present
Syngenta July 2012 - April 2015
Bayer CropScience September 2009 - July 2012
Talecris Plasma Resources February 2009 - September 2009
Wyeth Biotech 2005 - 2008
Wyeth Biotech 2003 - 2005
Skills
FDA, Regulatory Affairs, GMP, Biotechnology, CAPA, Validation, Quality Assurance, GLP, SOP, Change Control, Pharmaceutical Industry, Quality System, Technology Transfer
Education
North Carolina State University 1998 — 2003
BS, Bioengineering and Biomedical Engineering
ADAMA USA April 2015 - Present
Syngenta July 2012 - April 2015
Bayer CropScience September 2009 - July 2012
Talecris Plasma Resources February 2009 - September 2009
Wyeth Biotech 2005 - 2008
Wyeth Biotech 2003 - 2005
Skills
FDA, Regulatory Affairs, GMP, Biotechnology, CAPA, Validation, Quality Assurance, GLP, SOP, Change Control, Pharmaceutical Industry, Quality System, Technology Transfer
Education
North Carolina State University 1998 — 2003
BS, Bioengineering and Biomedical Engineering
Scott Bender's Wyeth Biotech Experience June 2004 - August 2006
Job Senior Manager / Team Leader at Pfizer
Industry Pharmaceuticals
Experience
Pfizer March 2015 - Present
Pfizer June 2012 - February 2015
Pfizer Pharmaceuticals February 2011 - June 2012
Johnson & Johnson January 2011 - February 2011
Johnson & Johnson October 2010 - January 2011
Pfizer March 2008 - October 2010
Wyeth September 2006 - March 2008
Wyeth Biotech June 2004 - August 2006
Wyeth Vaccines - Marietta July 1999 - May 2004
Skills
Sterilization, Quality Assurance, Environmental Monitoring, GMP, CAPA, FDA, Aseptic Processing, Change Control, Contamination Control, Validation, Cleaning Validation, 21 CFR Part 11, Sop, Pharmaceutical Industry, Clean Room Design, GxP, Quality System
Education
Villanova University 2010 — 2010
Certificate, Lean Six Sigma Black Belt
Temple University 2003 — 2005
M.S., Quality Assurance / Regulatory Affairs
Penn State University 1994 — 1999
B.S., Chemical Engineering
Pfizer March 2015 - Present
Pfizer June 2012 - February 2015
Pfizer Pharmaceuticals February 2011 - June 2012
Johnson & Johnson January 2011 - February 2011
Johnson & Johnson October 2010 - January 2011
Pfizer March 2008 - October 2010
Wyeth September 2006 - March 2008
Wyeth Biotech June 2004 - August 2006
Wyeth Vaccines - Marietta July 1999 - May 2004
Skills
Sterilization, Quality Assurance, Environmental Monitoring, GMP, CAPA, FDA, Aseptic Processing, Change Control, Contamination Control, Validation, Cleaning Validation, 21 CFR Part 11, Sop, Pharmaceutical Industry, Clean Room Design, GxP, Quality System
Education
Villanova University 2010 — 2010
Certificate, Lean Six Sigma Black Belt
Temple University 2003 — 2005
M.S., Quality Assurance / Regulatory Affairs
Penn State University 1994 — 1999
B.S., Chemical Engineering
Stephanie Bittner Stephanie Bittner's Wyeth Biotech Experience March 2005 - April 2007
Job Document Control Specialist at CutisPharma, Inc.
Industry Pharmaceuticals
Experience
CutisPharma, Inc. September 2014 - Present
Bristol-Myers Squibb August 2008 - August 2014
Shire HGT June 2007 - November 2007
Wyeth Biotech March 2005 - April 2007
Skills
Documentum, FileMaker, Sop, Document Management, FDA, GMP, Technical Writing, Microsoft Office, Change Control, 21 CFR Part 11, Pharmaceutical Industry, Validation, Biotechnology, Software Documentation, GLP, Quality Assurance, SharePoint, CAPA, Data Management
Education
Salem State College 1998 — 2004
BS, Geography
CutisPharma, Inc. September 2014 - Present
Bristol-Myers Squibb August 2008 - August 2014
Shire HGT June 2007 - November 2007
Wyeth Biotech March 2005 - April 2007
Skills
Documentum, FileMaker, Sop, Document Management, FDA, GMP, Technical Writing, Microsoft Office, Change Control, 21 CFR Part 11, Pharmaceutical Industry, Validation, Biotechnology, Software Documentation, GLP, Quality Assurance, SharePoint, CAPA, Data Management
Education
Salem State College 1998 — 2004
BS, Geography
Lisa Holowiak, CQA, PMP Lisa Holowiak, CQA, PMP's Wyeth Biotech Experience May 2007 - October 2009
Job QA Specialist IV at Pfizer
Industry Pharmaceuticals
Experience
Pfizer September 2011 - Present
Pfizer October 2010 - September 2011
Pfizer (formerly Wyeth) October 2009 - September 2010
Wyeth Biotech May 2007 - October 2009
Bristol-Myers Squibb March 2004 - May 2007
Skills
Quality Assurance, Vendor Management, cGMP manufacturing, Aseptic Processing, Auditing, Continuous Improvement, Biotechnology, Project Management, Technology Transfer, GMP, Validation, Cross-functional Team..., Quality Control, Aseptic Technique, Vaccines, 21 CFR Part 11, FDA, Quality System, CAPA, Change Control, LIMS
Education
University of Texas at Dallas - Naveen Jindal School of Management 2005 — 2008
MBA, Project Management
Rochester Institute of Technology 2001 — 2004
B.S., Biotechnology
Pfizer September 2011 - Present
Pfizer October 2010 - September 2011
Pfizer (formerly Wyeth) October 2009 - September 2010
Wyeth Biotech May 2007 - October 2009
Bristol-Myers Squibb March 2004 - May 2007
Skills
Quality Assurance, Vendor Management, cGMP manufacturing, Aseptic Processing, Auditing, Continuous Improvement, Biotechnology, Project Management, Technology Transfer, GMP, Validation, Cross-functional Team..., Quality Control, Aseptic Technique, Vaccines, 21 CFR Part 11, FDA, Quality System, CAPA, Change Control, LIMS
Education
University of Texas at Dallas - Naveen Jindal School of Management 2005 — 2008
MBA, Project Management
Rochester Institute of Technology 2001 — 2004
B.S., Biotechnology
Jay Workman Jay Workman's Wyeth Biotech Experience August 2001 - August 2010
Job Quality Assurance Manager
Industry Pharmaceuticals
Experience
Combat Medical Systems April 2012 - Present
COTY Inc April 2011 - April 2012
Wyeth Biotech August 2001 - August 2010
Skills
GMP, Sop, FDA, CAPA, GLP, Cleaning Validation, Technology Transfer, Change Control, Laboratory, Validation, V&V, Aseptic Processing, 21 CFR Part 11, Quality Assurance, GxP, LIMS, Computer System..., Quality System, Regulatory Affairs, Biopharmaceuticals, Quality Auditing, Trackwise, Quality Control, Regulatory Requirements, Analytical Chemistry, SOP
Education
Oral Roberts University
Bachelor of Science, Biology - Chemistry
Combat Medical Systems April 2012 - Present
COTY Inc April 2011 - April 2012
Wyeth Biotech August 2001 - August 2010
Skills
GMP, Sop, FDA, CAPA, GLP, Cleaning Validation, Technology Transfer, Change Control, Laboratory, Validation, V&V, Aseptic Processing, 21 CFR Part 11, Quality Assurance, GxP, LIMS, Computer System..., Quality System, Regulatory Affairs, Biopharmaceuticals, Quality Auditing, Trackwise, Quality Control, Regulatory Requirements, Analytical Chemistry, SOP
Education
Oral Roberts University
Bachelor of Science, Biology - Chemistry
Heather McInnes Heather McInnes's Wyeth Biotech Experience June 2005 - July 2009
Job Scientist at Pfizer
Industry Biotechnology
Experience
Pfizer June 2014 - Present
Pfizer July 2009 - May 2014
Wyeth Biotech June 2005 - July 2009
University of New Hampshire January 2005 - May 2005
Wyeth Biotech May 2004 - August 2004
Skills
Assay Development, ELISA, Protein Chemistry, Western Blotting, PCR, Antibodies, HPLC, Gel Electrophoresis, GMP, Drug Delivery, Biotherapeutics, Protein Characterization, LIMS, Formulation
Education
Northeastern University 2005 — 2009
MS, Biotechnology: Molecular Biology
University of New Hampshire 2002 — 2005
BS, Animal Sciences: Bioscience and Technology
Pfizer June 2014 - Present
Pfizer July 2009 - May 2014
Wyeth Biotech June 2005 - July 2009
University of New Hampshire January 2005 - May 2005
Wyeth Biotech May 2004 - August 2004
Skills
Assay Development, ELISA, Protein Chemistry, Western Blotting, PCR, Antibodies, HPLC, Gel Electrophoresis, GMP, Drug Delivery, Biotherapeutics, Protein Characterization, LIMS, Formulation
Education
Northeastern University 2005 — 2009
MS, Biotechnology: Molecular Biology
University of New Hampshire 2002 — 2005
BS, Animal Sciences: Bioscience and Technology
Tanya Silva Alcorn Tanya Silva Alcorn's Wyeth Biotech Experience 2006 - 2008
Job Sr. Director, Biotech Network Strategy Implementation Leader at Pfizer
Industry Pharmaceuticals
Experience
Pfizer July 2010 - Present
Wyeth Pharmaceuticals - Biotech (Pfizer) October 2008 - July 2010
Wyeth Biotech 2006 - 2008
Wyeth Pharmaceuticals 2004 - 2006
Skills
GMP, Change Control, CAPA, 21 CFR Part 11, Validation, Computer System...
Education
Stevens Institute of Technology 2003 — 2005
Masters in Engineering, Systems Engineering
Rutgers, The State University of New Jersey-New Brunswick
Bachelor's degree, Biological Science
Pfizer July 2010 - Present
Wyeth Pharmaceuticals - Biotech (Pfizer) October 2008 - July 2010
Wyeth Biotech 2006 - 2008
Wyeth Pharmaceuticals 2004 - 2006
Skills
GMP, Change Control, CAPA, 21 CFR Part 11, Validation, Computer System...
Education
Stevens Institute of Technology 2003 — 2005
Masters in Engineering, Systems Engineering
Rutgers, The State University of New Jersey-New Brunswick
Bachelor's degree, Biological Science
Russel B. Arvidson, MBA Russel B. Arvidson, MBA's Wyeth Biotech Experience October 2004 - October 2005
Job Sr. Healthcare Representative at Pfizer
Industry Pharmaceuticals
Experience
Pfizer October 2009 - Present
Wyeth Pharmaceuticals October 2005 - October 2009
Wyeth Biotech October 2004 - October 2005
Wyeth October 2003 - October 2004
Wyeth Biotech April 2002 - October 2004
Bristol-Myers Squibb April 1997 - April 2002
Hollister February 1995 - April 1997
Skills
Hospital Sales, Neurology, Pharmaceutical Sales, Pharmaceutical Industry, GI, Sales Operations, Diabetes, Cardiology, Gastroenterology, Hospitals, Leadership, Oncology, Pain Management, Product Launch, Psychiatry, Rheumatology, Sales, Sales Effectiveness, Sales Management, Sales Process, Selling, Selling Skills, Endocrinology, Pulmonology
Education
University of Hartford 1998 — 2001
MBA, Business Admin
Roger Williams University 1989 — 1993
BS, Business Admin
Pfizer October 2009 - Present
Wyeth Pharmaceuticals October 2005 - October 2009
Wyeth Biotech October 2004 - October 2005
Wyeth October 2003 - October 2004
Wyeth Biotech April 2002 - October 2004
Bristol-Myers Squibb April 1997 - April 2002
Hollister February 1995 - April 1997
Skills
Hospital Sales, Neurology, Pharmaceutical Sales, Pharmaceutical Industry, GI, Sales Operations, Diabetes, Cardiology, Gastroenterology, Hospitals, Leadership, Oncology, Pain Management, Product Launch, Psychiatry, Rheumatology, Sales, Sales Effectiveness, Sales Management, Sales Process, Selling, Selling Skills, Endocrinology, Pulmonology
Education
University of Hartford 1998 — 2001
MBA, Business Admin
Roger Williams University 1989 — 1993
BS, Business Admin
Ron Shook's Wyeth Biotech Experience 2002 - 2007
Job Vice President at AquaChem, Inc.
Industry Machinery
Experience
Aqua-Chem, Inc. October 2014 - Present
Aqua-Chem September 2012 - October 2014
Aqua-Chem June 2012 - October 2012
Aqua-Chem September 2011 - June 2012
ConvaTec March 2011 - September 2011
Baxter May 2009 - July 2011
Baxter June 2007 - April 2009
Wyeth 2002 - 2007
Wyeth Biotech 2002 - 2007
Skills
Engineering Management, New Business Development, Engineering, Water Treatment, Utilities, Energy Management, Project Engineering, Project Planning, Project Implementation, Project Coordinating, Project Delivery, Pharmaceuticals, Biotechnology, Medical Devices, Semiconductor Industry, GMP, Validation, FDA, Product Development, Pharmaceutical Industry, Water, Quality Assurance, Lean Manufacturing, Project Management, Manufacturing, Commissioning, Procurement, Process Engineering, Reverse Osmosis, Project Coordination, Process Simulation, HVAC, Quality System, Continuous Improvement, Process Control, Six Sigma, V&V, Cross-functional Team..., Root Cause Analysis, CAPA, FMEA, Quality Control, R&D, DMAIC, Kaizen, Automation, Manufacturing...
Education
North Carolina State University 1993 — 1996
BS, Mechanical Engineering
Aqua-Chem, Inc. October 2014 - Present
Aqua-Chem September 2012 - October 2014
Aqua-Chem June 2012 - October 2012
Aqua-Chem September 2011 - June 2012
ConvaTec March 2011 - September 2011
Baxter May 2009 - July 2011
Baxter June 2007 - April 2009
Wyeth 2002 - 2007
Wyeth Biotech 2002 - 2007
Skills
Engineering Management, New Business Development, Engineering, Water Treatment, Utilities, Energy Management, Project Engineering, Project Planning, Project Implementation, Project Coordinating, Project Delivery, Pharmaceuticals, Biotechnology, Medical Devices, Semiconductor Industry, GMP, Validation, FDA, Product Development, Pharmaceutical Industry, Water, Quality Assurance, Lean Manufacturing, Project Management, Manufacturing, Commissioning, Procurement, Process Engineering, Reverse Osmosis, Project Coordination, Process Simulation, HVAC, Quality System, Continuous Improvement, Process Control, Six Sigma, V&V, Cross-functional Team..., Root Cause Analysis, CAPA, FMEA, Quality Control, R&D, DMAIC, Kaizen, Automation, Manufacturing...
Education
North Carolina State University 1993 — 1996
BS, Mechanical Engineering
Jason Hyde's Wyeth Biotech Experience December 2007 - December 2009
Job Director of Manufacturing at Pfizer
Industry Biotechnology
Experience
Pfizer November 2014 - Present
Pfizer April 2011 - October 2014
Pfizer Pharmaceuticals January 2010 - March 2011
Wyeth Biotech December 2007 - December 2009
Wyeth Biotech October 2004 - November 2007
Wyeth Biotech September 2003 - September 2004
Wyeth BioPharma April 2001 - September 2003
Bayer Corp November 1999 - April 2001
Chiron September 1995 - October 1999
Education
Saint Michael's College 1992 — 1995
BS
St. John's Prep 1988 — 1991
High School
Pfizer November 2014 - Present
Pfizer April 2011 - October 2014
Pfizer Pharmaceuticals January 2010 - March 2011
Wyeth Biotech December 2007 - December 2009
Wyeth Biotech October 2004 - November 2007
Wyeth Biotech September 2003 - September 2004
Wyeth BioPharma April 2001 - September 2003
Bayer Corp November 1999 - April 2001
Chiron September 1995 - October 1999
Education
Saint Michael's College 1992 — 1995
BS
St. John's Prep 1988 — 1991
High School
Keir Evans's Wyeth Biotech Experience July 2005 - May 2008
Job
Industry Information Technology and Services
Experience
Lantheus Medical Imaging May 2008 - Present
Wyeth Biotech July 2005 - May 2008
Bristol-Myers Squibb January 2000 - June 2005
Thermo LabSystems 1993 - 1999
Textron Lycoming (later purchased by Honeywell) 1987 - 1992
Skills
LIMS, Change Control, Software Development, IT Strategy, Leadership, Business Analysis, Cross-functional Team..., Software Documentation, SharePoint, 21 CFR Part 11, Document Management, Computer System..., FDA, Business Process, Business Process..., Quality Assurance, Data Management, Project Management, Management, Outsourcing, Integration, Technical Support, IT Management, Program Management, Pharmaceutical Industry
Education
Sacred Heart University 1989 — 1991
Masters
Southern Connecticut State University 1981 — 1984
BS
Lantheus Medical Imaging May 2008 - Present
Wyeth Biotech July 2005 - May 2008
Bristol-Myers Squibb January 2000 - June 2005
Thermo LabSystems 1993 - 1999
Textron Lycoming (later purchased by Honeywell) 1987 - 1992
Skills
LIMS, Change Control, Software Development, IT Strategy, Leadership, Business Analysis, Cross-functional Team..., Software Documentation, SharePoint, 21 CFR Part 11, Document Management, Computer System..., FDA, Business Process, Business Process..., Quality Assurance, Data Management, Project Management, Management, Outsourcing, Integration, Technical Support, IT Management, Program Management, Pharmaceutical Industry
Education
Sacred Heart University 1989 — 1991
Masters
Southern Connecticut State University 1981 — 1984
BS
Mania Kavosi's Wyeth Biotech Experience June 2007 - 2009
Job
Industry Research
Experience
Pfizer March 2009 - Present
Wyeth Biotech June 2007 - 2009
Bristol-Myers Squibb Medical Imaging January 2001 - June 2007
Skills
Drug Discovery, LC-MS, HPLC, In Vivo, Biotechnology, In Vitro, Chromatography, GLP, Clinical Development, Lifesciences, Pharmaceutical Industry, Pharmacology, Drug Development, ELISA, Immunology, Cell, Oncology, Sop, GMP, 21 CFR Part 11, FDA, Validation, Purification, Pharmacokinetics, Cell Culture, Assay Development
Education
Northeastern University 2004 — 2006
Master in Biomedical science
UMass Lowell
Bachelor of Science (BS), Biotechnology
Pfizer March 2009 - Present
Wyeth Biotech June 2007 - 2009
Bristol-Myers Squibb Medical Imaging January 2001 - June 2007
Skills
Drug Discovery, LC-MS, HPLC, In Vivo, Biotechnology, In Vitro, Chromatography, GLP, Clinical Development, Lifesciences, Pharmaceutical Industry, Pharmacology, Drug Development, ELISA, Immunology, Cell, Oncology, Sop, GMP, 21 CFR Part 11, FDA, Validation, Purification, Pharmacokinetics, Cell Culture, Assay Development
Education
Northeastern University 2004 — 2006
Master in Biomedical science
UMass Lowell
Bachelor of Science (BS), Biotechnology
Robert McKenna's Wyeth Biotech Experience 2001 - 2007
Job Validation Specialist at Pfizer's Global Manufacturing (PGM) Specialty/Biotechnology Operating Unit
Industry Pharmaceuticals
Experience
Pfizer's Global Manufacturing (PGM) Specialty/Biotechnology Operating Unit September 2007 - Present
Wyeth Pharmaceuticals 2007 - 2009
Wyeth Biotech 2001 - 2007
Skills
Change Control, Validation, 21 CFR Part 11, GxP, LIMS, V&V, HPLC, Pharmaceutical Industry, Sop, FDA, Gas Chromatography, Software Documentation, Chromatography, Analytical Chemistry, Aseptic Processing, CAPA, Computer System..., GMP, Quality System, Regulatory Requirements, Cleaning Validation, GLP, GAMP, Technology Transfer, USP, Biopharmaceuticals, Regulatory Affairs, Quality Control, Trackwise, Vaccines, Quality Auditing, GCP, Quality Assurance, Regulatory Submissions, Biotechnology, Sterilization, Formulation, Aseptic Technique, Protocol, Environmental Monitoring, Lifesciences, Calibration, UV/Vis, FDA GMP, cGMP practices, Wet Chemistry, Dissolution, Deviations, Clinical Trials, SOP
Education
Ramapo College of New Jersey 1976 — 1981
BA, Environmental Studies
Pfizer's Global Manufacturing (PGM) Specialty/Biotechnology Operating Unit September 2007 - Present
Wyeth Pharmaceuticals 2007 - 2009
Wyeth Biotech 2001 - 2007
Skills
Change Control, Validation, 21 CFR Part 11, GxP, LIMS, V&V, HPLC, Pharmaceutical Industry, Sop, FDA, Gas Chromatography, Software Documentation, Chromatography, Analytical Chemistry, Aseptic Processing, CAPA, Computer System..., GMP, Quality System, Regulatory Requirements, Cleaning Validation, GLP, GAMP, Technology Transfer, USP, Biopharmaceuticals, Regulatory Affairs, Quality Control, Trackwise, Vaccines, Quality Auditing, GCP, Quality Assurance, Regulatory Submissions, Biotechnology, Sterilization, Formulation, Aseptic Technique, Protocol, Environmental Monitoring, Lifesciences, Calibration, UV/Vis, FDA GMP, cGMP practices, Wet Chemistry, Dissolution, Deviations, Clinical Trials, SOP
Education
Ramapo College of New Jersey 1976 — 1981
BA, Environmental Studies
Craig Bradbury, CSCP's Wyeth Biotech Experience April 2006 - November 2008
Job Senior Manager Supply Chain, U.S. at Ipsen Biopharmaceuticals Inc.
Industry Biotechnology
Experience
Ipsen Biopharmaceuticals Inc. June 2013 - Present
Ipsen Biopharma November 2012 - June 2013
AstraZeneca Pharmaceuticals June 2010 - November 2012
Astra Zeneca November 2008 - June 2010
Wyeth BioTech April 2006 - November 2008
Wyeth Biotech December 2003 - April 2006
Wyeth Biotech June 1998 - December 2003
Wyeth Biotech February 1996 - June 1998
Skills
Validation, Sop, FDA, Quality Assurance, Continuous Improvement, Supply Chain, Manufacturing, Software Documentation, Procurement, SAP, GMP, Logistics, Management, Change Management
Education
Northeastern University 2004 — 2007
BS, Operations Technology
Ipsen Biopharmaceuticals Inc. June 2013 - Present
Ipsen Biopharma November 2012 - June 2013
AstraZeneca Pharmaceuticals June 2010 - November 2012
Astra Zeneca November 2008 - June 2010
Wyeth BioTech April 2006 - November 2008
Wyeth Biotech December 2003 - April 2006
Wyeth Biotech June 1998 - December 2003
Wyeth Biotech February 1996 - June 1998
Skills
Validation, Sop, FDA, Quality Assurance, Continuous Improvement, Supply Chain, Manufacturing, Software Documentation, Procurement, SAP, GMP, Logistics, Management, Change Management
Education
Northeastern University 2004 — 2007
BS, Operations Technology
Gilbert Perez's Wyeth Biotech Experience September 2008 - October 2009
Job Pfizer Sr. Compliance Specialist
Industry Pharmaceuticals
Experience
Pfizer January 2013 - Present
Atrium Staffing September 2011 - December 2012
Dendreon July 2011 - September 2011
Pfizer Pharmaceuticals October 2009 - July 2011
Wyeth Biotech September 2008 - October 2009
Wyeth Biotech April 2007 - September 2008
Roche Molecular Systems 2006 - April 2007
Roche Molecular Systems 2001 - 2006
Education
Saint Peter's University 1996 — 2000
B.S., Biology
Hudson Catholic HS 1992 — 1996
Pfizer January 2013 - Present
Atrium Staffing September 2011 - December 2012
Dendreon July 2011 - September 2011
Pfizer Pharmaceuticals October 2009 - July 2011
Wyeth Biotech September 2008 - October 2009
Wyeth Biotech April 2007 - September 2008
Roche Molecular Systems 2006 - April 2007
Roche Molecular Systems 2001 - 2006
Education
Saint Peter's University 1996 — 2000
B.S., Biology
Hudson Catholic HS 1992 — 1996
Walter Mason's Wyeth Biotech Experience October 2006 - September 2009
Job Production Equipment Asset Manager Suite E/F at Pfizer Specialty/Biotechnology Unit
Industry Biotechnology
Experience
Pfizer Specialty/Biotechnology Unit September 2009 - Present
Wyeth Biotech October 2006 - September 2009
Wyeth Biotech June 2000 - September 2006
Education
University of Massachusetts Lowell 1990 — 1995
BSME, Mechanical Engineering
Northeastern University
Bachelor of Science (BS), Mechanical Engineering
Pfizer Specialty/Biotechnology Unit September 2009 - Present
Wyeth Biotech October 2006 - September 2009
Wyeth Biotech June 2000 - September 2006
Education
University of Massachusetts Lowell 1990 — 1995
BSME, Mechanical Engineering
Northeastern University
Bachelor of Science (BS), Mechanical Engineering
Symon Syjongtian's Wyeth Biotech Experience June 2004 - August 2008
Job Sr. Manager, Quality Operations
Industry Pharmaceuticals
Experience
Bracco January 2015 - Present
McNeil Consumer Healthcare October 2012 - January 2015
Pfizer October 2011 - October 2012
Pfizer February 2011 - October 2011
Pfizer August 2008 - February 2011
Wyeth Biotech June 2004 - August 2008
Schering Plough Corporation September 2002 - June 2004
Roche Molecular Systems July 2000 - September 2002
Skills
CAPA, Disposition, Quality Auditing, SOP authoring, Batch Records, Annual Product Reviews, Investigation, Compliance, Aseptic Processing, Vaccines, Sop, GMP, Change Control, LIMS, 21 CFR Part 11, QRM, Risk Management, Validation, Biopharmaceuticals, Biotechnology, FDA, Quality Assurance, Reviews, SOP, Trackwise, Quality System
Education
Rutgers, The State University of New Jersey-New Brunswick
Biological Sciences / Psychology
Bracco January 2015 - Present
McNeil Consumer Healthcare October 2012 - January 2015
Pfizer October 2011 - October 2012
Pfizer February 2011 - October 2011
Pfizer August 2008 - February 2011
Wyeth Biotech June 2004 - August 2008
Schering Plough Corporation September 2002 - June 2004
Roche Molecular Systems July 2000 - September 2002
Skills
CAPA, Disposition, Quality Auditing, SOP authoring, Batch Records, Annual Product Reviews, Investigation, Compliance, Aseptic Processing, Vaccines, Sop, GMP, Change Control, LIMS, 21 CFR Part 11, QRM, Risk Management, Validation, Biopharmaceuticals, Biotechnology, FDA, Quality Assurance, Reviews, SOP, Trackwise, Quality System
Education
Rutgers, The State University of New Jersey-New Brunswick
Biological Sciences / Psychology
Brian Picard's Wyeth Biotech Experience December 2008 - October 2009
Job QC Scientist IV Method Transfer and Validation at Pfizer
Industry Pharmaceuticals
Experience
Pfizer October 2014 - Present
Pfizer March 2011 - October 2014
Pfizer July 2010 - March 2011
Pfizer October 2009 - September 2010
Wyeth Biotech December 2008 - October 2009
Wyeth Biotech May 2008 - December 2008
Wyeth Biotech June 2006 - May 2008
Wyeth September 2001 - June 2006
Delta Rocky Mountain Petroleum May 1998 - August 1998
Delta Rocky Mountain Petroleum May 1997 - August 1997
Skills
HPLC, Chemistry, UV, Dissolution, UV/Vis, SEC-MALS, LIMS, UPLC, Instrumentation, Wet Chemistry, Analytical Chemistry, GLP, QC, Chemstation, Chromatography, cGMP, Validation, Technology Transfer, Sop, Quality Control, SOP
Education
Northern Arizona University 1999 — 2001
MS, Chemistry
South Dakota School of Mines and Technology 1995 — 1999
BS, Chemistry
Light Scattering Univeristy - Wyatt Technology
Pfizer October 2014 - Present
Pfizer March 2011 - October 2014
Pfizer July 2010 - March 2011
Pfizer October 2009 - September 2010
Wyeth Biotech December 2008 - October 2009
Wyeth Biotech May 2008 - December 2008
Wyeth Biotech June 2006 - May 2008
Wyeth September 2001 - June 2006
Delta Rocky Mountain Petroleum May 1998 - August 1998
Delta Rocky Mountain Petroleum May 1997 - August 1997
Skills
HPLC, Chemistry, UV, Dissolution, UV/Vis, SEC-MALS, LIMS, UPLC, Instrumentation, Wet Chemistry, Analytical Chemistry, GLP, QC, Chemstation, Chromatography, cGMP, Validation, Technology Transfer, Sop, Quality Control, SOP
Education
Northern Arizona University 1999 — 2001
MS, Chemistry
South Dakota School of Mines and Technology 1995 — 1999
BS, Chemistry
Light Scattering Univeristy - Wyatt Technology
Alvarado, Jose's Wyeth Biotech Experience 2005 - May 2008
Job Head of Methods and Systems
Industry Biotechnology
Experience
Genzyme February 2015 - Present
Genzyme August 2013 - Present
PCM Consulting Inc. October 2011 - August 2013
A/Z Corporation May 2011 - October 2011
Gilbane Building Company June 2008 - May 2011
Wyeth Biotech 2005 - May 2008
JE Merit 2002 - 2005
Applied Mechanical 2000 - 2002
Decco 1999 - 2001
Kinetics 1995 - 1998
Skills
Construction Management, Contract Management, Construction, Project Estimation, Project Management, Value Engineering, Management, Budgets, MS Project, Energy, Project Planning, Facilities Management, Leadership, Change Orders, Project Engineering, CPM Scheduling, Primavera P6, Commissioning, Engineering, Procurement
Education
Northeastern University 1990 — 1995
BSME, Mechanical Engineering
Genzyme February 2015 - Present
Genzyme August 2013 - Present
PCM Consulting Inc. October 2011 - August 2013
A/Z Corporation May 2011 - October 2011
Gilbane Building Company June 2008 - May 2011
Wyeth Biotech 2005 - May 2008
JE Merit 2002 - 2005
Applied Mechanical 2000 - 2002
Decco 1999 - 2001
Kinetics 1995 - 1998
Skills
Construction Management, Contract Management, Construction, Project Estimation, Project Management, Value Engineering, Management, Budgets, MS Project, Energy, Project Planning, Facilities Management, Leadership, Change Orders, Project Engineering, CPM Scheduling, Primavera P6, Commissioning, Engineering, Procurement
Education
Northeastern University 1990 — 1995
BSME, Mechanical Engineering
Lorie Aziz's Wyeth Biotech Experience 2002 - 2004
Job Training Manager at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec May 2004 - Present
Biogen Idec 2004 - 2007
Wyeth Biotech 2002 - 2004
Wyeth Biotech 2001 - 2002
Wyeth Biotech 1999 - 2001
Bayer Diagnotics 1997 - 1999
Education
GBMP 2010 — 2010
Lean Production
North Carolina State University 2009 — 2009
Six Sigma Green Belt Course
Regis College 1993 — 1997
BA, Biochemistry, Spanish
Biogen Idec May 2004 - Present
Biogen Idec 2004 - 2007
Wyeth Biotech 2002 - 2004
Wyeth Biotech 2001 - 2002
Wyeth Biotech 1999 - 2001
Bayer Diagnotics 1997 - 1999
Education
GBMP 2010 — 2010
Lean Production
North Carolina State University 2009 — 2009
Six Sigma Green Belt Course
Regis College 1993 — 1997
BA, Biochemistry, Spanish
Kurt Willner's Wyeth Biotech Experience 2000 - 2002
Job Senior Process Engineer at Integrated Process Techonologies
Industry Biotechnology
Experience
Integrated Process Techonologies Senior Process EngineerIntegrated Process Technologies2002 - Present
Amgen - Contract Process Engineer 2002 - 2005
Amgen Rhode Island 2002 - 2005
Amgen 2002 - 2005
Wyeth Biotech 2000 - 2002
Skills
Biopharmaceuticals, Validation, GMP, Technology Transfer, Aseptic Processing, Process Control, Process Engineering, Process Simulation, Filtration, Sop, Biotechnology, R&D, Chromatography, Chemical Engineering, Fermentation, Process Optimization, V&V, GAMP, Design of Experiments, Purification, Process Equipment, Change Control, Instrumentation, Process Design, WebDAV, Ultrafiltration
Education
Northeastern University 1995 — 2000
Integrated Process Techonologies Senior Process EngineerIntegrated Process Technologies2002 - Present
Amgen - Contract Process Engineer 2002 - 2005
Amgen Rhode Island 2002 - 2005
Amgen 2002 - 2005
Wyeth Biotech 2000 - 2002
Skills
Biopharmaceuticals, Validation, GMP, Technology Transfer, Aseptic Processing, Process Control, Process Engineering, Process Simulation, Filtration, Sop, Biotechnology, R&D, Chromatography, Chemical Engineering, Fermentation, Process Optimization, V&V, GAMP, Design of Experiments, Purification, Process Equipment, Change Control, Instrumentation, Process Design, WebDAV, Ultrafiltration
Education
Northeastern University 1995 — 2000
Patrick Owen's Wyeth Biotech Experience May 2007 - November 2008
Job Owner at P L Owen Consulting
Industry Biotechnology
Experience
P L Owen Consulting October 2014 - Present
Nuron Biotech Inc July 2012 - Present
Nuron Biotech January 2011 - June 2012
Pfizer (Legacy Wyeth) November 2008 - October 2009
Wyeth Biotech May 2007 - November 2008
Wyeth Vaccines January 2004 - May 2007
Wyeth Vaccines April 2003 - January 2004
Wyeth-Lederle Vaccines and Pediatrics July 1999 - March 2003
Wyeth-Lederle Vaccines and Pediatrics 1997 - 1999
Wyeth-Lederle Vaccines and Pediatrics 1991 - 1995
Skills
Validation, Quality System, GMP, Quality Control, Quality Assurance, FDA, CAPA, Sop, Manufacturing, Vaccines, Reviews, Software Documentation, 21 CFR Part 11, Change Control, Fermentation, LIMS, Leadership, ISO, Cross-functional Team..., Purification, Pharmaceutical Industry, Quality Auditing, Management, Biotechnology, Auditing, Training
Education
North Carolina State University 1975 — 1979
BS in Wildlife Biology, Wildlife Biology
Lees-McRae College 1973 — 1975
Associate of Science, Biology
P L Owen Consulting October 2014 - Present
Nuron Biotech Inc July 2012 - Present
Nuron Biotech January 2011 - June 2012
Pfizer (Legacy Wyeth) November 2008 - October 2009
Wyeth Biotech May 2007 - November 2008
Wyeth Vaccines January 2004 - May 2007
Wyeth Vaccines April 2003 - January 2004
Wyeth-Lederle Vaccines and Pediatrics July 1999 - March 2003
Wyeth-Lederle Vaccines and Pediatrics 1997 - 1999
Wyeth-Lederle Vaccines and Pediatrics 1991 - 1995
Skills
Validation, Quality System, GMP, Quality Control, Quality Assurance, FDA, CAPA, Sop, Manufacturing, Vaccines, Reviews, Software Documentation, 21 CFR Part 11, Change Control, Fermentation, LIMS, Leadership, ISO, Cross-functional Team..., Purification, Pharmaceutical Industry, Quality Auditing, Management, Biotechnology, Auditing, Training
Education
North Carolina State University 1975 — 1979
BS in Wildlife Biology, Wildlife Biology
Lees-McRae College 1973 — 1975
Associate of Science, Biology
Susan Knowles's Wyeth Biotech Experience 2000 - 2007
Job Sr Project Manager
Industry Biotechnology
Experience
OvaScience August 2015 - Present
Shire HGT June 2011 - Present
Cubist Pharmaceuticals May 2007 - June 2011
Wyeth Biotech 2000 - 2007
Skills
Technology Transfer, Biotechnology, Validation, GMP, Biopharmaceuticals, CAPA, FDA
Education
Post University 2013 — 2016
MBA
University of Massachusetts Lowell 1997 — 2006
MS, Chemical Engineering
OvaScience August 2015 - Present
Shire HGT June 2011 - Present
Cubist Pharmaceuticals May 2007 - June 2011
Wyeth Biotech 2000 - 2007
Skills
Technology Transfer, Biotechnology, Validation, GMP, Biopharmaceuticals, CAPA, FDA
Education
Post University 2013 — 2016
MBA
University of Massachusetts Lowell 1997 — 2006
MS, Chemical Engineering
Abraham L. Hurdle's Wyeth Biotech Experience 2006 - 2007
Job Law Offices of Abraham L. Hurdle
Industry Law Practice
Experience
Law Offices of Abraham L. Hurdle Temporary Assistant ClerkConnecticut Judicial BranchJanuary 2011 - March 2013
Quinnipiac University August 2008 - May 2010
Wyeth May 2007 - July 2007
Wyeth Biotech 2006 - 2007
Skills
Mediation, Litigation, Legal Research, Civil Litigation, Legal Writing, Dispute Resolution, Alternative Dispute..., Family Law, Criminal Law, Trials, Personal Injury, Arbitration, Administrative Law, Employment Litigation
Education
Quinnipiac University School of Law 2007 — 2010
Juris Doctor (J.D.), Civil Advocacy and Dispute Resolution
University of Massachusetts Lowell 2004 — 2007
MS, Work Environment Policy
Villanova University 2000 — 2004
Bachelor of Science (BS), Mechanical Engineering
Law Offices of Abraham L. Hurdle Temporary Assistant ClerkConnecticut Judicial BranchJanuary 2011 - March 2013
Quinnipiac University August 2008 - May 2010
Wyeth May 2007 - July 2007
Wyeth Biotech 2006 - 2007
Skills
Mediation, Litigation, Legal Research, Civil Litigation, Legal Writing, Dispute Resolution, Alternative Dispute..., Family Law, Criminal Law, Trials, Personal Injury, Arbitration, Administrative Law, Employment Litigation
Education
Quinnipiac University School of Law 2007 — 2010
Juris Doctor (J.D.), Civil Advocacy and Dispute Resolution
University of Massachusetts Lowell 2004 — 2007
MS, Work Environment Policy
Villanova University 2000 — 2004
Bachelor of Science (BS), Mechanical Engineering
Jonathan Roy's Wyeth Biotech Experience November 2006 - October 2008
Job Senior Engineer at Process Design Solutions
Industry Biotechnology
Experience
Process Design Solutions August 2009 - Present
NNE Pharmaplan October 2008 - August 2009
Wyeth Biotech November 2006 - October 2008
Wyeth Biotech June 2002 - November 2006
Universal Pharma Technologies (UPT) March 2001 - June 2001
Genzyme June 2000 - December 2000
Salem Hospital May 1998 - May 2000
New England Biolabs May 1997 - September 1997
Skills
Validation, Biotechnology, HPLC, GAMP, Computer System..., Automation, Commissioning, Testing, Troubleshooting, GMP, 21 CFR Part 11, CAPA, FDA, V&V, DCS, Manufacturing Operations, Purification, Process Simulation, Biopharmaceuticals, Change Control, Aseptic Processing, Sop, GxP, Laboratory, Cleaning Validation, Technology Transfer, Filtration, LIMS, Fermentation, SOP
Education
Northeastern University 1997 — 2002
BS, Chemical Engineering
Salem State College 2003 — 2004
Pre-Medicine/Pre-Medical Studies
Process Design Solutions August 2009 - Present
NNE Pharmaplan October 2008 - August 2009
Wyeth Biotech November 2006 - October 2008
Wyeth Biotech June 2002 - November 2006
Universal Pharma Technologies (UPT) March 2001 - June 2001
Genzyme June 2000 - December 2000
Salem Hospital May 1998 - May 2000
New England Biolabs May 1997 - September 1997
Skills
Validation, Biotechnology, HPLC, GAMP, Computer System..., Automation, Commissioning, Testing, Troubleshooting, GMP, 21 CFR Part 11, CAPA, FDA, V&V, DCS, Manufacturing Operations, Purification, Process Simulation, Biopharmaceuticals, Change Control, Aseptic Processing, Sop, GxP, Laboratory, Cleaning Validation, Technology Transfer, Filtration, LIMS, Fermentation, SOP
Education
Northeastern University 1997 — 2002
BS, Chemical Engineering
Salem State College 2003 — 2004
Pre-Medicine/Pre-Medical Studies
Gloria Montesanto's Wyeth Biotech Experience April 1992 - August 1996
Job at
Industry Biotechnology
Experience
Genzyme, a sanofi company July 2014 - Present
Synageva BioPharma Corp. September 2012 - July 2014
Vertex Pharmaceuticals November 2010 - September 2012
Genzyme June 2006 - November 2010
Gilead Sciences 2003 - 2006
Schering-Plough August 1996 - June 2003
Wyeth Biotech April 1992 - August 1996
Skills
Pharmaceutical Industry, Biotechnology, Pharmaceutical Sales, Oncology, Product Launch, Infectious Diseases, Cardiology, Neurology, Managed Care, Gastroenterology
Education
Ohio University 1986 — 1990
Bachelor of Science (BS), Communications/Journalism
Genzyme, a sanofi company July 2014 - Present
Synageva BioPharma Corp. September 2012 - July 2014
Vertex Pharmaceuticals November 2010 - September 2012
Genzyme June 2006 - November 2010
Gilead Sciences 2003 - 2006
Schering-Plough August 1996 - June 2003
Wyeth Biotech April 1992 - August 1996
Skills
Pharmaceutical Industry, Biotechnology, Pharmaceutical Sales, Oncology, Product Launch, Infectious Diseases, Cardiology, Neurology, Managed Care, Gastroenterology
Education
Ohio University 1986 — 1990
Bachelor of Science (BS), Communications/Journalism
Tracy Schoolcraft's Wyeth Biotech Experience October 2005 - July 2009
Job Manager, Engineering Systems at Pfizer
Industry Biotechnology
Experience
Pfizer August 2014 - Present
Pfizer July 2009 - August 2014
Wyeth Biotech October 2005 - July 2009
Wyeth May 2004 - October 2005
National Starch and Chemical January 2002 - August 2003
Skills
Change Control, CAPA, FDA, Validation, V&V, GMP, Process Improvement, Manufacturing, Sop, Biotechnology, Quality System, Continuous Improvement
Education
North Carolina State University 1999 — 2004
Bachelor's degree, Chemical Engineering
Pfizer August 2014 - Present
Pfizer July 2009 - August 2014
Wyeth Biotech October 2005 - July 2009
Wyeth May 2004 - October 2005
National Starch and Chemical January 2002 - August 2003
Skills
Change Control, CAPA, FDA, Validation, V&V, GMP, Process Improvement, Manufacturing, Sop, Biotechnology, Quality System, Continuous Improvement
Education
North Carolina State University 1999 — 2004
Bachelor's degree, Chemical Engineering
Jo Tsai's Wyeth Biotech Experience 2001 - 2003
Job CMC Regulatory Affairs Manager at Shire
Industry Biotechnology
Experience
Shire 2014 - Present
Shire Pharmaceuticals 2012 - 2014
Lonza 2010 - 2012
Lonza Biologics Inc. 2007 - 2010
Altus Pharmaceuticals 2005 - 2007
Neose Technologies 2004 - 2005
Northeastern University 2003 - 2004
Wyeth Biotech 2001 - 2003
Beth Israel Deaconess Medical Center/Harvard Medical School 1997 - 2001
Skills
R&D, LC-MS, Analytical Chemistry, Assay Development, Proteomics, NMR, Validation, Formulation, Mass Spectrometry, DNA, Gel Electrophoresis, Drug Development, Immunoassays, Pharmaceutical Industry, CMC, Regulatory Affairs
Education
Purdue University
MS, Biological Sciences/ X-ray Crystallography
Purdue University
Ph.D., Biochemistry
Shire 2014 - Present
Shire Pharmaceuticals 2012 - 2014
Lonza 2010 - 2012
Lonza Biologics Inc. 2007 - 2010
Altus Pharmaceuticals 2005 - 2007
Neose Technologies 2004 - 2005
Northeastern University 2003 - 2004
Wyeth Biotech 2001 - 2003
Beth Israel Deaconess Medical Center/Harvard Medical School 1997 - 2001
Skills
R&D, LC-MS, Analytical Chemistry, Assay Development, Proteomics, NMR, Validation, Formulation, Mass Spectrometry, DNA, Gel Electrophoresis, Drug Development, Immunoassays, Pharmaceutical Industry, CMC, Regulatory Affairs
Education
Purdue University
MS, Biological Sciences/ X-ray Crystallography
Purdue University
Ph.D., Biochemistry
Stacy Dion's Wyeth Biotech Experience 2005 - 2008
Job Product Manager at 123Compliance Corporation
Industry Biotechnology
Experience
123Compliance Corporation 2015 - Present
ALPCO 2013 - 2015
AVEO Oncology 2012 - 2013
CRC Consulting 2010 - 2012
Bristol-Myers Squibb 2008 - 2010
Wyeth Biotech 2005 - 2008
Alkermes 2002 - 2004
Skills
21 CFR Part 11, Aseptic Processing, Biopharmaceuticals, Biotechnology, CAPA, Cleaning Validation, Commissioning, Computer System..., Environmental Monitoring, FDA, GMP, GxP, Quality Assurance, Quality System, Sop, Technology Transfer, V, Validation, V&V, SOP, Change Control
Education
Northeastern University 1998 — 2001
MS, Engineering Management, Quality and Reliability Engineering
Northeastern University 1991 — 1996
BS, Chemical Engineering
123Compliance Corporation 2015 - Present
ALPCO 2013 - 2015
AVEO Oncology 2012 - 2013
CRC Consulting 2010 - 2012
Bristol-Myers Squibb 2008 - 2010
Wyeth Biotech 2005 - 2008
Alkermes 2002 - 2004
Skills
21 CFR Part 11, Aseptic Processing, Biopharmaceuticals, Biotechnology, CAPA, Cleaning Validation, Commissioning, Computer System..., Environmental Monitoring, FDA, GMP, GxP, Quality Assurance, Quality System, Sop, Technology Transfer, V, Validation, V&V, SOP, Change Control
Education
Northeastern University 1998 — 2001
MS, Engineering Management, Quality and Reliability Engineering
Northeastern University 1991 — 1996
BS, Chemical Engineering
Steven T. Strickland's Wyeth Biotech Experience January 2000 - March 2010
Job Method Development Chemist
Industry Pharmaceuticals
Experience
UCB July 2013 - Present
Wyeth Biotech January 2000 - March 2010
Skills
Validation, GMP, GLP, LIMS, Sop, Technology Transfer, HPLC, Chromatography, Change Control, Vaccines, CAPA, GxP, Aseptic Processing, Biopharmaceuticals, 21 CFR Part 11, SOP
Education
Pfeiffer University 1983 — 1987
UCB July 2013 - Present
Wyeth Biotech January 2000 - March 2010
Skills
Validation, GMP, GLP, LIMS, Sop, Technology Transfer, HPLC, Chromatography, Change Control, Vaccines, CAPA, GxP, Aseptic Processing, Biopharmaceuticals, 21 CFR Part 11, SOP
Education
Pfeiffer University 1983 — 1987
Jason Fiorello's Wyeth Biotech Experience August 2007 - June 2008
Job Brand Supply Leader, Global Established Products
Industry Pharmaceuticals
Experience
Pfizer July 2008 - Present
Wyeth Biotech August 2007 - June 2008
Merck February 2006 - July 2007
AND 1 September 2003 - July 2005
Dopaco June 2001 - July 2002
Skills
Cross-functional Team..., Management, Supply Chain Management, Leadership, SAP, Process Improvement, Logistics, Manufacturing, Strategic Planning, SAP ERP
Education
Penn State University 1997 — 2001
B.S., Business Logistics
Pfizer July 2008 - Present
Wyeth Biotech August 2007 - June 2008
Merck February 2006 - July 2007
AND 1 September 2003 - July 2005
Dopaco June 2001 - July 2002
Skills
Cross-functional Team..., Management, Supply Chain Management, Leadership, SAP, Process Improvement, Logistics, Manufacturing, Strategic Planning, SAP ERP
Education
Penn State University 1997 — 2001
B.S., Business Logistics
Edward J. Smith's Wyeth Biotech Experience 2002 - 2008
Job Principal at Packaging Science Resources
Industry Pharmaceuticals
Experience
Packaging Science Resources, LLC March 2008 - Present
Genesis Technical Advisors 2008 - Present
Packaging Science Resources 2002 - 2008
Wyeth Pharmaceuticals 2002 - 2008
Wyeth Biotech 2002 - 2008
Wyeth 2002 - 2008
Helvoet Pharma 1995 - 1999
Datwyler - Pharma Packaging 1995 - 1999
West Pharmaceutical Services 1978 - 1995
The West Company 1978 - 1995
Skills
GMP, Pharmaceutical Industry, Validation, FDA, Cold Chain, Pharmaceutics, Biotechnology
Education
Seton Hall University 1964 — 1968
Ph.D., Analytical Chemistry
Villanova University 1960 — 1964
B.S., Chemistry
Packaging Science Resources, LLC March 2008 - Present
Genesis Technical Advisors 2008 - Present
Packaging Science Resources 2002 - 2008
Wyeth Pharmaceuticals 2002 - 2008
Wyeth Biotech 2002 - 2008
Wyeth 2002 - 2008
Helvoet Pharma 1995 - 1999
Datwyler - Pharma Packaging 1995 - 1999
West Pharmaceutical Services 1978 - 1995
The West Company 1978 - 1995
Skills
GMP, Pharmaceutical Industry, Validation, FDA, Cold Chain, Pharmaceutics, Biotechnology
Education
Seton Hall University 1964 — 1968
Ph.D., Analytical Chemistry
Villanova University 1960 — 1964
B.S., Chemistry
Leo Margolf-Culhane's Wyeth Biotech Experience August 2003 - June 2008
Job Project Mangement and Project Controls Consultant to the Biotechnology Industry
Industry Biotechnology
Experience
Taurus Project Controls Consulting, Inc. September 2014 - Present
Shire 2008 - September 2014
Wyeth Biotech August 2003 - June 2008
Cell Genesys, Inc 2001 - 2003
Genentech 1995 - 2001
Skills
Technology Transfer, Project Management, Project Scheduling, Program Management, GMP, Biotechnology, Pharmaceutical Industry, Leadership, Change Control, Biopharmaceuticals, FDA, Validation
Education
San Francisco State University 1993 — 1995
BS Microbiology, Microbiology, General
Taurus Project Controls Consulting, Inc. September 2014 - Present
Shire 2008 - September 2014
Wyeth Biotech August 2003 - June 2008
Cell Genesys, Inc 2001 - 2003
Genentech 1995 - 2001
Skills
Technology Transfer, Project Management, Project Scheduling, Program Management, GMP, Biotechnology, Pharmaceutical Industry, Leadership, Change Control, Biopharmaceuticals, FDA, Validation
Education
San Francisco State University 1993 — 1995
BS Microbiology, Microbiology, General
Kristen Backus's Wyeth Biotech Experience March 2007 - November 2008
Job Quality Assurance Regulatory Inspections at Merck
Industry Pharmaceuticals
Experience
Merck October 2012 - Present
Merck January 2011 - October 2012
Pfizer November 2008 - January 2011
Wyeth Biotech March 2007 - November 2008
Wyeth Biotech July 2006 - March 2007
Wyeth Biotech October 2005 - June 2006
Wyeth Biotech February 2003 - October 2005
Wyeth July 2002 - February 2003
Skills
Compliance, Compliance Management, Compliance Audits, Lean Manufacturing, Six Sigma, Quality Assurance, Quality Systems, Quality Auditing, Quality Inspection, Pharmaceuticals, Computer System..., Validation, Investigations, Change Control, Change Management, Risk Management, SAP, LIMS, GMP, Process Improvement, Documentation, Training & Development, Documentum, CAPA, Manufacturing Operations, Environmental Monitoring, Pharmaceutical Industry, Trackwise, 21 CFR Part 11, Aseptic Processing, FDA, Quality Control, Quality System, GxP, Software Documentation, Sop, GLP, Biotechnology, Cleaning Validation, SOP
Education
Temple University 2005 — 2011
MS, QA/RA
Shippensburg University of Pennsylvania 1998 — 2002
BS, Biology
Merck October 2012 - Present
Merck January 2011 - October 2012
Pfizer November 2008 - January 2011
Wyeth Biotech March 2007 - November 2008
Wyeth Biotech July 2006 - March 2007
Wyeth Biotech October 2005 - June 2006
Wyeth Biotech February 2003 - October 2005
Wyeth July 2002 - February 2003
Skills
Compliance, Compliance Management, Compliance Audits, Lean Manufacturing, Six Sigma, Quality Assurance, Quality Systems, Quality Auditing, Quality Inspection, Pharmaceuticals, Computer System..., Validation, Investigations, Change Control, Change Management, Risk Management, SAP, LIMS, GMP, Process Improvement, Documentation, Training & Development, Documentum, CAPA, Manufacturing Operations, Environmental Monitoring, Pharmaceutical Industry, Trackwise, 21 CFR Part 11, Aseptic Processing, FDA, Quality Control, Quality System, GxP, Software Documentation, Sop, GLP, Biotechnology, Cleaning Validation, SOP
Education
Temple University 2005 — 2011
MS, QA/RA
Shippensburg University of Pennsylvania 1998 — 2002
BS, Biology
Carolyn Silva's Wyeth Biotech Experience March 2009 - Present
Job Document Specialist at Wyeth Biotech
Industry Computer Software
Experience
Wyeth Biotech March 2009 - Present
Education
Northern Essex Community College 2004 — 2012
Wyeth Biotech March 2009 - Present
Education
Northern Essex Community College 2004 — 2012
Armen Nahabedian's Wyeth Biotech Experience January 2013 - Present
Job Senior Principal Process Engineer
Industry Biotechnology
Experience
Wyeth Biotech January 2013 - Present
Wyeth 2008 - Present
Pfizer Biotech 1984 - Present
Pfizer 1984 - Present
Pfizer 1984 - Present
Education
Northeastern University 1978 — 1982
Wyeth Biotech January 2013 - Present
Wyeth 2008 - Present
Pfizer Biotech 1984 - Present
Pfizer 1984 - Present
Pfizer 1984 - Present
Education
Northeastern University 1978 — 1982
Jenn Manfra's Wyeth Biotech Experience QC Scinetist IIWyeth2004 - Present
Job QC Scientist II at Wyeth Biotech
Industry Biotechnology
Experience
Wyeth Biotech QC Scinetist IIWyeth2004 - Present
Wyeth Research December 2003 - February 2004
Phylos August 2001 - April 2003
Formatech November 2000 - July 2001
Tufts University School of Medicine October 1999 - November 2000
Education
University of Massachusetts Lowell 2002 — 2007
MS, Biology
Regis College 1995 — 1999
BA, Biology
Wyeth Biotech QC Scinetist IIWyeth2004 - Present
Wyeth Research December 2003 - February 2004
Phylos August 2001 - April 2003
Formatech November 2000 - July 2001
Tufts University School of Medicine October 1999 - November 2000
Education
University of Massachusetts Lowell 2002 — 2007
MS, Biology
Regis College 1995 — 1999
BA, Biology
Jeffrey Neault's Wyeth Biotech Experience 2005 - 2008
Job Senior Lead Investigator II at Shire
Industry Biotechnology
Experience
Shire May 2015 - Present
Shire Pharmaceuticals January 2014 - May 2015
Shire HGT April 2010 - January 2014
Shire HGT April 2010 - September 2011
Biovex July 2008 - March 2010
Wyeth Biotech 2005 - 2008
Skills
Biopharmaceuticals, GMP, Biotechnology, Technology Transfer, Validation, CAPA, V&V, FDA, Pharmaceutical Industry
Education
Northeastern University
Bachelor of Science (BS), Chemical Engineer
Shire May 2015 - Present
Shire Pharmaceuticals January 2014 - May 2015
Shire HGT April 2010 - January 2014
Shire HGT April 2010 - September 2011
Biovex July 2008 - March 2010
Wyeth Biotech 2005 - 2008
Skills
Biopharmaceuticals, GMP, Biotechnology, Technology Transfer, Validation, CAPA, V&V, FDA, Pharmaceutical Industry
Education
Northeastern University
Bachelor of Science (BS), Chemical Engineer
Amy Genest's Wyeth Biotech Experience January 2007 - December 2007
Job Contract Manager, Pfizer Global External Supply
Industry Biotechnology
Experience
Pfizer January 2008 - Present
Wyeth Biotech January 2007 - December 2007
Wyeth Biotech January 2006 - January 2007
Wyeth October 2004 - December 2005
Wyeth May 2000 - October 2004
Genetics Institute August 1999 - May 2000
Genetics Institute October 1996 - August 1999
Skills
GMP, Validation, Sop, Change Control, Quality Assurance, Biotechnology, Quality System, Technology Transfer, Biopharmaceuticals, Cross-functional Team..., V&V, Aseptic Processing
Education
University of Phoenix 2004 — 2008
MBA, Business
Saint Anselm College 1992 — 1996
BA, Natural Science
Pfizer January 2008 - Present
Wyeth Biotech January 2007 - December 2007
Wyeth Biotech January 2006 - January 2007
Wyeth October 2004 - December 2005
Wyeth May 2000 - October 2004
Genetics Institute August 1999 - May 2000
Genetics Institute October 1996 - August 1999
Skills
GMP, Validation, Sop, Change Control, Quality Assurance, Biotechnology, Quality System, Technology Transfer, Biopharmaceuticals, Cross-functional Team..., V&V, Aseptic Processing
Education
University of Phoenix 2004 — 2008
MBA, Business
Saint Anselm College 1992 — 1996
BA, Natural Science
Hank Liu's Wyeth Biotech Experience January 2007 - October 2009
Job Director at Sanofi Pasteur
Industry Biotechnology
Experience
Sanofi Pasteur November 2009 - Present
Wyeth Biotech January 2007 - October 2009
Wyeth Biotech January 2002 - December 2006
Wyeth Biotech June 1997 - December 2001
CytoTherapeutics January 1996 - May 1997
Alkermes 1991 - 1995
Skills
Technology Transfer, GMP, Validation, FDA, Characterization, V&V, Quality by Design, Quality System, Assay Development, Protein Chemistry, Method Development, Biotechnology, Vaccines, Change Control, Analytical Chemistry, Laboratory, Purification, Clinical Development, Regulatory Submissions, Monoclonal Antibodies, Aseptic Processing, CAPA, Drug Development, 21 CFR Part 11, Chromatography, Biopharmaceuticals, GxP, HPLC, Quality Control, Fermentation, GLP, Drug Delivery, Pharmaceutical Industry, Commercialization, GCP, Clinical Trials, Pharmaceutics, Regulatory Affairs, Sop, Regulatory Requirements, Chemistry, Lifesciences, CRO, Science, Formulation, Process Simulation, Drug Discovery, Manufacturing, LIMS, R&D
Education
The University of Kansas 1989 — 1990
Post-Doc, Immunochemistry
University of Alberta 1983 — 1988
Ph.D., Analytical Chemistry
Shandong University 1978 — 1982
B.Sc, Chemistry
Sanofi Pasteur November 2009 - Present
Wyeth Biotech January 2007 - October 2009
Wyeth Biotech January 2002 - December 2006
Wyeth Biotech June 1997 - December 2001
CytoTherapeutics January 1996 - May 1997
Alkermes 1991 - 1995
Skills
Technology Transfer, GMP, Validation, FDA, Characterization, V&V, Quality by Design, Quality System, Assay Development, Protein Chemistry, Method Development, Biotechnology, Vaccines, Change Control, Analytical Chemistry, Laboratory, Purification, Clinical Development, Regulatory Submissions, Monoclonal Antibodies, Aseptic Processing, CAPA, Drug Development, 21 CFR Part 11, Chromatography, Biopharmaceuticals, GxP, HPLC, Quality Control, Fermentation, GLP, Drug Delivery, Pharmaceutical Industry, Commercialization, GCP, Clinical Trials, Pharmaceutics, Regulatory Affairs, Sop, Regulatory Requirements, Chemistry, Lifesciences, CRO, Science, Formulation, Process Simulation, Drug Discovery, Manufacturing, LIMS, R&D
Education
The University of Kansas 1989 — 1990
Post-Doc, Immunochemistry
University of Alberta 1983 — 1988
Ph.D., Analytical Chemistry
Shandong University 1978 — 1982
B.Sc, Chemistry
Stephen Hattan's Wyeth Biotech Experience 1999 - 2001
Job Scientist at Virgin Instruments
Industry Biotechnology
Experience
Virgin Instruments January 2006 - Present
Virgin Instruments 2006 - Present
Applied Biosystems 2002 - 2006
Wyeth Biotech 1999 - 2001
Skills
Mass Spectrometry, MALDI-TOF, Proteomics, LC-MS, Chromatography, HPLC, Protein Chemistry, Biomarker Discovery, Analytical Chemistry, Peptides, Sample Preparation, Bioanalysis, Biotechnology, Biomarkers, Purification, Biochemistry, Lifesciences, Assay Development, Chemistry, Immunoassays, UV/Vis, Gas Chromatography
Education
University of New Hampshire 1990 — 1995
PhD, Analytical Chemistry
Saint Anselm College 1986 — 1988
BA, Chemistry
Virgin Instruments January 2006 - Present
Virgin Instruments 2006 - Present
Applied Biosystems 2002 - 2006
Wyeth Biotech 1999 - 2001
Skills
Mass Spectrometry, MALDI-TOF, Proteomics, LC-MS, Chromatography, HPLC, Protein Chemistry, Biomarker Discovery, Analytical Chemistry, Peptides, Sample Preparation, Bioanalysis, Biotechnology, Biomarkers, Purification, Biochemistry, Lifesciences, Assay Development, Chemistry, Immunoassays, UV/Vis, Gas Chromatography
Education
University of New Hampshire 1990 — 1995
PhD, Analytical Chemistry
Saint Anselm College 1986 — 1988
BA, Chemistry
Wendy Clinard Gillis PE's Wyeth Biotech Experience March 2002 - November 2008
Job Asst Chief of FMS, Engineering at VA Medical Center
Industry Biotechnology
Experience
VA Medical Center March 2009 - Present
Wyeth Biotech March 2002 - November 2008
Bayer April 1993 - March 2002
Plasma Energy Corporation December 1989 - March 1993
Education
North Carolina State University 1986 — 1989
BS, Computer Engineering
North Carolina State University 1986 — 1988
BS, Electrical Engineering
North Carolina State University 1982 — 1986
BS, Computer Science
VA Medical Center March 2009 - Present
Wyeth Biotech March 2002 - November 2008
Bayer April 1993 - March 2002
Plasma Energy Corporation December 1989 - March 1993
Education
North Carolina State University 1986 — 1989
BS, Computer Engineering
North Carolina State University 1986 — 1988
BS, Electrical Engineering
North Carolina State University 1982 — 1986
BS, Computer Science
Joseph Hildebrand's Wyeth Biotech Experience August 2008 - October 2009
Job R&D Scientist at PepsiCo
Industry Food & Beverages
Experience
PepsiCo January 2015 - Present
NC State University - NCSU Brewery January 2013 - Present
PepsiCo June 2014 - August 2014
NC State University July 2013 - June 2014
PepsiCo June 2013 - August 2013
Cree August 2010 - August 2012
Pfizer October 2009 - August 2010
Wyeth Biotech August 2008 - October 2009
North Carolina State University October 2007 - May 2008
North Carolina State University January 2005 - May 2008
Skills
PCR, ELISA, Electrophoresis, Photolithography, RIE, SAP, PECVD, HPLC, Biotechnology, Biochemistry, Technology Transfer, GMP, Mass Spectrometry
Education
North Carolina State University 2012 — 2014
Master of Food Science, Fermentation
North Carolina State University 2004 — 2008
Molecular and Structural Biochemistry, Proteomics
PepsiCo January 2015 - Present
NC State University - NCSU Brewery January 2013 - Present
PepsiCo June 2014 - August 2014
NC State University July 2013 - June 2014
PepsiCo June 2013 - August 2013
Cree August 2010 - August 2012
Pfizer October 2009 - August 2010
Wyeth Biotech August 2008 - October 2009
North Carolina State University October 2007 - May 2008
North Carolina State University January 2005 - May 2008
Skills
PCR, ELISA, Electrophoresis, Photolithography, RIE, SAP, PECVD, HPLC, Biotechnology, Biochemistry, Technology Transfer, GMP, Mass Spectrometry
Education
North Carolina State University 2012 — 2014
Master of Food Science, Fermentation
North Carolina State University 2004 — 2008
Molecular and Structural Biochemistry, Proteomics
Margie Henrichon's Wyeth Biotech Experience March 1992 - April 2008
Job Independent Biotechnology Professional
Industry Biotechnology
Experience
Wyeth Biotech March 1992 - April 2008
Wyeth BioPharma 1992 - 2008
Wyeth Pharmaceuticals 1992 - 2008
Skills
GMP, HPLC, Technical Writing
Education
Notre Dame of Maryland University 1960 — 1964
BA, Chemistry
Purdue University
MS, Chemistry
Wyeth Biotech March 1992 - April 2008
Wyeth BioPharma 1992 - 2008
Wyeth Pharmaceuticals 1992 - 2008
Skills
GMP, HPLC, Technical Writing
Education
Notre Dame of Maryland University 1960 — 1964
BA, Chemistry
Purdue University
MS, Chemistry
John P. Moynihan's Wyeth Biotech Experience March 1997 - October 2005
Job Associate Director of Quality Control at Aastrom Bioscience (formally Genzyme Biosurgery)
Industry Biotechnology
Experience
Vericel Corporation January 2013 - Present
Genzyme Biosurgery April 2010 - February 2013
Pfizer October 2005 - March 2010
Wyeth Biotech March 1997 - October 2005
Wyeth Biotech March 1992 - February 1997
Skills
Change Control, CAPA, GMP, 21 CFR Part 11, LIMS, Sop, Validation, FDA, Aseptic Processing, Biotechnology, Computer System..., Trackwise, Quality System, Quality Control, Quality Assurance, Microbiology, Pharmaceutical Industry, SOP
Education
University of Massachusetts Lowell 1995 — 1998
M.S., Biology
Salem State University 1987 — 1991
B.S., Biology
Vericel Corporation January 2013 - Present
Genzyme Biosurgery April 2010 - February 2013
Pfizer October 2005 - March 2010
Wyeth Biotech March 1997 - October 2005
Wyeth Biotech March 1992 - February 1997
Skills
Change Control, CAPA, GMP, 21 CFR Part 11, LIMS, Sop, Validation, FDA, Aseptic Processing, Biotechnology, Computer System..., Trackwise, Quality System, Quality Control, Quality Assurance, Microbiology, Pharmaceutical Industry, SOP
Education
University of Massachusetts Lowell 1995 — 1998
M.S., Biology
Salem State University 1987 — 1991
B.S., Biology
Randall Thompson's Wyeth Biotech Experience 1993 - 2008
Job Principal Scientist at Shire
Industry Biotechnology
Experience
Shire September 2014 - Present
Shire HGT February 2010 - August 2014
Cytosol Laboratories 2009 - February 2010
Wyeth Biotech 1993 - 2008
Wyeth Biotech 2005 - 2007
Wyeth Biotech 2002 - 2004
Wyeth Biotech 2000 - 2001
Wyeth Biotech 1999 - 2000
Wyeth Biotech 1998 - 1999
Wyeth Biotech (Genetics Institute) 1995 - 1997
Skills
GMP, CAPA, Validation, Biotechnology, Change Control, FDA, SOP, Pharmaceutical Industry, Quality System, Biopharmaceuticals, 21 CFR Part 11, Aseptic Processing, 5S, Assay Development, Auditing, Cell, Cell Culture, Clinical Development, Computer System..., Contract Manufacturing, Drug Development, GLP, GxP, Inspection, LIMS, Laboratory, Lean Manufacturing, Leadership, Lifesciences, Management, Manufacturing, Medical Devices, Microbiology, Operational Excellence, Program Management, Project Management, Quality Assurance, Quality Control, Regulatory Affairs, Regulatory Submissions, Six Sigma, Sop, Technology Transfer, Testing, Trackwise, V
Education
Salem State University 1988 — 1992
Bachelor, Biology
Shire September 2014 - Present
Shire HGT February 2010 - August 2014
Cytosol Laboratories 2009 - February 2010
Wyeth Biotech 1993 - 2008
Wyeth Biotech 2005 - 2007
Wyeth Biotech 2002 - 2004
Wyeth Biotech 2000 - 2001
Wyeth Biotech 1999 - 2000
Wyeth Biotech 1998 - 1999
Wyeth Biotech (Genetics Institute) 1995 - 1997
Skills
GMP, CAPA, Validation, Biotechnology, Change Control, FDA, SOP, Pharmaceutical Industry, Quality System, Biopharmaceuticals, 21 CFR Part 11, Aseptic Processing, 5S, Assay Development, Auditing, Cell, Cell Culture, Clinical Development, Computer System..., Contract Manufacturing, Drug Development, GLP, GxP, Inspection, LIMS, Laboratory, Lean Manufacturing, Leadership, Lifesciences, Management, Manufacturing, Medical Devices, Microbiology, Operational Excellence, Program Management, Project Management, Quality Assurance, Quality Control, Regulatory Affairs, Regulatory Submissions, Six Sigma, Sop, Technology Transfer, Testing, Trackwise, V
Education
Salem State University 1988 — 1992
Bachelor, Biology
Michael Carberry's Wyeth Biotech Experience October 2006 - July 2010
Job Automation Engineer at Genzyme
Industry Pharmaceuticals
Experience
Genzyme, a Sanofi company August 2015 - Present
Stonyfield Farm November 2012 - August 2015
GT Solar June 2011 - November 2012
Pfizer Pharmaceuticals October 2009 - June 2011
Wyeth Biotech October 2006 - July 2010
Schott solar January 2006 - October 2006
Michael J. Carberry Inc January 2000 - December 2005
Anheuser-Busch, Inc 1998 - 2003
Skills
PLC Programming, SCADA, VBA, Variable Frequency..., cGMP manufacturing, Allen Bradley, Automation, Allen-Bradley, Continuous Improvement, Control Logic, Engineering, GAMP, GMP, Instrumentation, Lean Manufacturing, MES, Manufacturing, PLC, Process Automation, Process Control, Process Engineering, Process Improvement, Visual Basic, Wonderware, iFix
Education
Northeastern University 1993 — 1998
BS, Chemical Engineering
Genzyme, a Sanofi company August 2015 - Present
Stonyfield Farm November 2012 - August 2015
GT Solar June 2011 - November 2012
Pfizer Pharmaceuticals October 2009 - June 2011
Wyeth Biotech October 2006 - July 2010
Schott solar January 2006 - October 2006
Michael J. Carberry Inc January 2000 - December 2005
Anheuser-Busch, Inc 1998 - 2003
Skills
PLC Programming, SCADA, VBA, Variable Frequency..., cGMP manufacturing, Allen Bradley, Automation, Allen-Bradley, Continuous Improvement, Control Logic, Engineering, GAMP, GMP, Instrumentation, Lean Manufacturing, MES, Manufacturing, PLC, Process Automation, Process Control, Process Engineering, Process Improvement, Visual Basic, Wonderware, iFix
Education
Northeastern University 1993 — 1998
BS, Chemical Engineering
Donna Altopiedi's Wyeth Biotech Experience 2001 - 2006
Job Senior Facilitation and Training Professional
Industry Pharmaceuticals
Experience
self employed 2008 - Present
Wyeth November 1993 - May 2008
Wyeth Biotech 2001 - 2006
CIGNA Group Insurance 1986 - 1992
Skills
Pharmaceutical Industry, Change Control, FDA, 21 CFR Part 11, GMP, Workshop Facilitation, Training, Management, Sop, Cross-functional Team..., Leadership, Employee Training, Quality System, Strategy, Project Planning, Consulting, E-Learning, Instructional Design, Strategic Planning, SOP, Change Management
Education
Temple University 1977 — 1979
MEd, Instructional Design and Educational Media
Rowan University 1970 — 1974
Bachelor's degree, Communication Educations, Graduated Cum Laude
self employed 2008 - Present
Wyeth November 1993 - May 2008
Wyeth Biotech 2001 - 2006
CIGNA Group Insurance 1986 - 1992
Skills
Pharmaceutical Industry, Change Control, FDA, 21 CFR Part 11, GMP, Workshop Facilitation, Training, Management, Sop, Cross-functional Team..., Leadership, Employee Training, Quality System, Strategy, Project Planning, Consulting, E-Learning, Instructional Design, Strategic Planning, SOP, Change Management
Education
Temple University 1977 — 1979
MEd, Instructional Design and Educational Media
Rowan University 1970 — 1974
Bachelor's degree, Communication Educations, Graduated Cum Laude
Adam Tripi's Wyeth Biotech Experience 2008 - Present
Job Master Scheduler at Wyeth Pharmaceuticals
Industry Biotechnology
Experience
Wyeth Pharmaceuticals Master SchedulerPfizer
Pfizer Pharmaceuticals 2009 - Present
Wyeth 2008 - Present
Wyeth Biotech 2008 - Present
Pfizer Global Manufacturing 2008 - Present
Skills
GMP, Sop, Pharmaceutical Industry, Change Control, FDA, Protein Purification, Biotechnology, Validation, Technology Transfer, CAPA, Cross-functional Team...
Education
Saint Michael's College 1998 — 2001
Biology
Wyeth Pharmaceuticals Master SchedulerPfizer
Pfizer Pharmaceuticals 2009 - Present
Wyeth 2008 - Present
Wyeth Biotech 2008 - Present
Pfizer Global Manufacturing 2008 - Present
Skills
GMP, Sop, Pharmaceutical Industry, Change Control, FDA, Protein Purification, Biotechnology, Validation, Technology Transfer, CAPA, Cross-functional Team...
Education
Saint Michael's College 1998 — 2001
Biology
Doug German's Wyeth Biotech Experience 2003 - 2006
Job VP Human Resources at GSK
Industry Pharmaceuticals
Experience
GSK July 2015 - Present
Telerx April 2014 - July 2015
Endo Pharmaceuticals 2009 - 2013
Wyeth May 2006 - June 2009
Wyeth Biotech 2003 - 2006
Wyeth Pharmaceuticals 2003 - 2003
Wyeth Pharmaceuticals 2001 - 2003
Unisys 1998 - 2001
Conrail 1986 - 1998
Skills
Biotechnology, Vaccines, Pharmaceutical Industry, Labor Relations, Leadership, Manufacturing, Human Resources, Talent Management, Succession Planning, Onboarding, Deferred Compensation, Workforce Planning, Talent Acquisition, HRIS, Employee Engagement, Organizational Design, Organizational..., Personnel Management, Performance Management
Education
Shippensburg University of Pennsylvania 1981 — 1985
BSBA, Labor Relations
Pennsylvania State University-Great Valley Graduate Center
MS, Business
GSK July 2015 - Present
Telerx April 2014 - July 2015
Endo Pharmaceuticals 2009 - 2013
Wyeth May 2006 - June 2009
Wyeth Biotech 2003 - 2006
Wyeth Pharmaceuticals 2003 - 2003
Wyeth Pharmaceuticals 2001 - 2003
Unisys 1998 - 2001
Conrail 1986 - 1998
Skills
Biotechnology, Vaccines, Pharmaceutical Industry, Labor Relations, Leadership, Manufacturing, Human Resources, Talent Management, Succession Planning, Onboarding, Deferred Compensation, Workforce Planning, Talent Acquisition, HRIS, Employee Engagement, Organizational Design, Organizational..., Personnel Management, Performance Management
Education
Shippensburg University of Pennsylvania 1981 — 1985
BSBA, Labor Relations
Pennsylvania State University-Great Valley Graduate Center
MS, Business
Keith Craig's Wyeth Biotech Experience January 1988 - May 1996
Job Strategic Sourcing and Procurement Manager
Industry Biotechnology
Experience
Amgen 1996 - April 2013
Wyeth Biotech January 1988 - May 1996
Skills
Strategic Sourcing, Change Management, Continuous Improvement, Ariba, Process Improvement, SAP, Contract Management, Procurement, Purchasing, Spend Analysis, Sourcing, Contract Negotiation, Supply Management, ERP, E-procurement, Strategy, Strategic Planning, Management, Six Sigma, Project Management, Operations Management
Education
Rochester Institute of Technology 1984 — 1988
BS, Mechanical Engineering
Amgen 1996 - April 2013
Wyeth Biotech January 1988 - May 1996
Skills
Strategic Sourcing, Change Management, Continuous Improvement, Ariba, Process Improvement, SAP, Contract Management, Procurement, Purchasing, Spend Analysis, Sourcing, Contract Negotiation, Supply Management, ERP, E-procurement, Strategy, Strategic Planning, Management, Six Sigma, Project Management, Operations Management
Education
Rochester Institute of Technology 1984 — 1988
BS, Mechanical Engineering
Shannon Cox's Wyeth Biotech Experience May 2001 - November 2008
Job Senior Consultant at Sequence, Inc.
Industry Pharmaceuticals
Experience
Sequence, Inc. April 2013 - Present
Barry-Wehmiller Design Group June 2012 - April 2013
Covidien April 2010 - June 2012
Barry-Wehmiller Design Group January 2009 - April 2010
Wyeth Biotech May 2001 - November 2008
Monsanto 1998 - 2000
Bayer 1996 - 1998
Skills
CAPA, Validation, GMP, Technology Transfer, Cleaning Validation, GAMP, Sop, Quality System, FDA, Computer System..., V&V, Aseptic Processing, Change Control, Pharmaceutical Industry, 21 CFR Part 11, Biopharmaceuticals, LIMS, Lean Manufacturing, Root Cause Analysis, Biotechnology, Six Sigma, Continuous Improvement, Manufacturing, Software Documentation, Process Engineering, Quality Assurance, ISO 13485, Chromatography, GLP, Quality Auditing, Quality Control, GxP, Design of Experiments, Quality Management, Trackwise, R&D, Regulatory Requirements, Medical Devices, Regulatory Affairs
Education
North Carolina State University 1993 — 1996
BS, Chemical Engineering
Sandhills Community College 1991 — 1993
Associates Degree, Pre-Engineering
Sequence, Inc. April 2013 - Present
Barry-Wehmiller Design Group June 2012 - April 2013
Covidien April 2010 - June 2012
Barry-Wehmiller Design Group January 2009 - April 2010
Wyeth Biotech May 2001 - November 2008
Monsanto 1998 - 2000
Bayer 1996 - 1998
Skills
CAPA, Validation, GMP, Technology Transfer, Cleaning Validation, GAMP, Sop, Quality System, FDA, Computer System..., V&V, Aseptic Processing, Change Control, Pharmaceutical Industry, 21 CFR Part 11, Biopharmaceuticals, LIMS, Lean Manufacturing, Root Cause Analysis, Biotechnology, Six Sigma, Continuous Improvement, Manufacturing, Software Documentation, Process Engineering, Quality Assurance, ISO 13485, Chromatography, GLP, Quality Auditing, Quality Control, GxP, Design of Experiments, Quality Management, Trackwise, R&D, Regulatory Requirements, Medical Devices, Regulatory Affairs
Education
North Carolina State University 1993 — 1996
BS, Chemical Engineering
Sandhills Community College 1991 — 1993
Associates Degree, Pre-Engineering
Shane Hoover's Wyeth Biotech Experience 2005 - 2009
Job Senior Manager, EHS at United Therapeutics
Industry Biotechnology
Experience
United Therapeutics March 2015 - Present
United Therapeutics July 2009 - Present
Wyeth Pharmaceuticals January 2005 - July 2009
Wyeth Biotech 2005 - 2009
Wyeth Biotech 2005 - 2009
Wyeth 2005 - 2009
Freudenberg Nonwovens 2001 - 2005
Aeroquip 1994 - 1997
Skills
FDA, Quality System, GMP, Industrial Hygiene, EHS, Root Cause Analysis, CAPA, Continuous Improvement, Pharmaceutical Industry, Biotechnology, Sop, Change Control, Safety Management..., Risk Assessment, Regulatory Affairs, Validation, Medical Devices, Ergonomics, Quality Auditing
Education
Western Carolina University 1988 — 1990
B.S., Industrial Engineering Technology
Rowan-Cabarrus Community College 1986 — 1988
A.A.S., Industrial Engineering Technology
United Therapeutics March 2015 - Present
United Therapeutics July 2009 - Present
Wyeth Pharmaceuticals January 2005 - July 2009
Wyeth Biotech 2005 - 2009
Wyeth Biotech 2005 - 2009
Wyeth 2005 - 2009
Freudenberg Nonwovens 2001 - 2005
Aeroquip 1994 - 1997
Skills
FDA, Quality System, GMP, Industrial Hygiene, EHS, Root Cause Analysis, CAPA, Continuous Improvement, Pharmaceutical Industry, Biotechnology, Sop, Change Control, Safety Management..., Risk Assessment, Regulatory Affairs, Validation, Medical Devices, Ergonomics, Quality Auditing
Education
Western Carolina University 1988 — 1990
B.S., Industrial Engineering Technology
Rowan-Cabarrus Community College 1986 — 1988
A.A.S., Industrial Engineering Technology
Michelle Lisowski's Wyeth Biotech Experience November 1999 - October 2010
Job Principal Scientist at Pfizer
Industry Biotechnology
Experience
Pfizer June 2009 - Present
Wyeth Biotech November 1999 - October 2010
DuPont Pharmaceuticals January 1987 - November 1999
Skills
HPLC, UV/Vis, Protein Chemistry, IND, Monoclonal Antibodies, Chromatography, Pharmaceutical Industry, Biotechnology, Biochemistry, Formulation, SDS-PAGE
Education
Rivier College 1982 — 1986
BS, Biology, Medical Technology Program
Pfizer June 2009 - Present
Wyeth Biotech November 1999 - October 2010
DuPont Pharmaceuticals January 1987 - November 1999
Skills
HPLC, UV/Vis, Protein Chemistry, IND, Monoclonal Antibodies, Chromatography, Pharmaceutical Industry, Biotechnology, Biochemistry, Formulation, SDS-PAGE
Education
Rivier College 1982 — 1986
BS, Biology, Medical Technology Program
Liz Chiao's Wyeth Biotech Experience February 2008 - January 2009
Job
Industry Biotechnology
Experience
AMAG Pharmaceuticals March 2009 - August 2009
Wyeth Biotech February 2008 - January 2009
Starbucks Coffee Company August 2007 - January 2009
Beth Israel Deaconess Medical Center August 2007 - February 2008
Skills
Music, Theatre, Pianist, GMP, FDA, Band, Sop, Validation, HPLC
Education
Northeastern University 2002 — 2007
B.S./B.A.
Taipei American School 1998 — 2002
High School Diploma
AMAG Pharmaceuticals March 2009 - August 2009
Wyeth Biotech February 2008 - January 2009
Starbucks Coffee Company August 2007 - January 2009
Beth Israel Deaconess Medical Center August 2007 - February 2008
Skills
Music, Theatre, Pianist, GMP, FDA, Band, Sop, Validation, HPLC
Education
Northeastern University 2002 — 2007
B.S./B.A.
Taipei American School 1998 — 2002
High School Diploma
Jolanda Westerlaken's Wyeth Biotech Experience June 2005 - April 2010
Job Director Global Regulatory AffairsCMC, CoE Biologics at UCB
Industry Pharmaceuticals
Experience
UCB January 2015 - Present
UCB January 2013 - Present
UCB Pharma April 2010 - December 2012
Wyeth Biotech June 2005 - April 2010
Diosynth March 2002 - May 2005
Univeristy of Nijmegen 1996 - 2001
Skills
Biotechnology, Regulatory Affairs, regulatory strategy, Clinical Trials, Medical Devices, Manufacturing, Biopharmaceuticals, Strategy, CMC, Biologics, R&D, Pharmaceutical Industry, IND, CMC Regulatory Affairs, eCTD, Regulatory Submissions, Drug Development, Clinical Development
Education
Radboud University Nijmegen 1996 — 2001
PhD, medical sciences
Wageningen Universiteit en Researchcentrum 1990 — 1996
Master of Science (MSc), Bioprocess technologie
UCB January 2015 - Present
UCB January 2013 - Present
UCB Pharma April 2010 - December 2012
Wyeth Biotech June 2005 - April 2010
Diosynth March 2002 - May 2005
Univeristy of Nijmegen 1996 - 2001
Skills
Biotechnology, Regulatory Affairs, regulatory strategy, Clinical Trials, Medical Devices, Manufacturing, Biopharmaceuticals, Strategy, CMC, Biologics, R&D, Pharmaceutical Industry, IND, CMC Regulatory Affairs, eCTD, Regulatory Submissions, Drug Development, Clinical Development
Education
Radboud University Nijmegen 1996 — 2001
PhD, medical sciences
Wageningen Universiteit en Researchcentrum 1990 — 1996
Master of Science (MSc), Bioprocess technologie
Olga Moundous's Wyeth Biotech Experience March 2005 - November 2010
Job Consultant at Alera Labs, LLC
Industry Biotechnology
Experience
Alera Labs, LLC July 2011 - Present
Hyde Engineering + Consulting 2012 - 2012
Wyeth Biotech March 2005 - November 2010
GSK 1999 - 2005
Skills
Pharmaceuticals, Quality Assurance, Compliance, Cleaning Validation, CAPA
Education
Novosibirsk State University (NSU) 1980 — 1988
MS, Chemistry
Alera Labs, LLC July 2011 - Present
Hyde Engineering + Consulting 2012 - 2012
Wyeth Biotech March 2005 - November 2010
GSK 1999 - 2005
Skills
Pharmaceuticals, Quality Assurance, Compliance, Cleaning Validation, CAPA
Education
Novosibirsk State University (NSU) 1980 — 1988
MS, Chemistry
Michelle Rumsey's Wyeth Biotech Experience 2000 - 2002
Job Sr. Quality Specialist at Amgen
Industry Biotechnology
Experience
Amgen September 2015 - Present
Amgen April 2015 - Present
Amgen December 2002 - April 2015
Wyeth Biotech 2000 - 2002
Crosspoint Engineering 1998 - 2000
Skills
GAMP, Computer System..., Change Control, GMP, Validation, Biotechnology, Aseptic Processing, 21 CFR Part 11, Biopharmaceuticals, CAPA, FDA, Cleaning Validation, GxP, V&V, cGMP manufacturing, FDA GMP, Technology Transfer, Validation Master Plans, Trackwise, Aseptic Technique, CIP, LIMS, GLP, SOP, Deviations, Deviation Management, Process Control, SOP development, Regulatory Requirements, 21 CFR, S88, Batch Records, Root Cause Analysis, Cross-functional Team..., Risk Assessment, Quality System
Education
Northeastern University 2006 — 2007
Graduate Certificate, Domestic Pharmaceutical Regulatory Affairs
Northeastern University 1993 — 1998
BS, Chemical Engineering
Amgen September 2015 - Present
Amgen April 2015 - Present
Amgen December 2002 - April 2015
Wyeth Biotech 2000 - 2002
Crosspoint Engineering 1998 - 2000
Skills
GAMP, Computer System..., Change Control, GMP, Validation, Biotechnology, Aseptic Processing, 21 CFR Part 11, Biopharmaceuticals, CAPA, FDA, Cleaning Validation, GxP, V&V, cGMP manufacturing, FDA GMP, Technology Transfer, Validation Master Plans, Trackwise, Aseptic Technique, CIP, LIMS, GLP, SOP, Deviations, Deviation Management, Process Control, SOP development, Regulatory Requirements, 21 CFR, S88, Batch Records, Root Cause Analysis, Cross-functional Team..., Risk Assessment, Quality System
Education
Northeastern University 2006 — 2007
Graduate Certificate, Domestic Pharmaceutical Regulatory Affairs
Northeastern University 1993 — 1998
BS, Chemical Engineering
Hanh Vo's Wyeth Biotech Experience July 2006 - April 2009
Job Engineer IV at Millennium Pharmaceuticals
Industry Biotechnology
Experience
Takeda Oncology June 2011 - Present
Millennium Pharmaceuticals April 2009 - June 2011
Wyeth Biotech July 2006 - April 2009
Shire Pharmaceuticals July 2005 - July 2006
Wyeth Biotech March 2003 - June 2005
CIS-US September 2001 - March 2003
Beth Israel Deaconess Medical Center June 1999 - September 2001
Skills
UV-Vis, ELISA, Microsoft Office, IR, JMP, HPLC, PCR, SDS-PAGE, Validation, Cell, Microbiology, UV/Vis, Analytical Chemistry, Biotechnology, Pharmaceutical Industry, Lifesciences, Purification, LC-MS, GLP, Quality Control, FDA, FTIR, Chromatography, Assay Development, Organic Chemistry, Laboratory, GMP, Gel Electrophoresis, Technology Transfer, Drug Discovery, Sop
Education
University of Massachusetts Lowell 2001 — 2007
Master of Science, Biological Science
Salem State College 1994 — 1999
Bachelor of Science, Biology and Chemistry
Takeda Oncology June 2011 - Present
Millennium Pharmaceuticals April 2009 - June 2011
Wyeth Biotech July 2006 - April 2009
Shire Pharmaceuticals July 2005 - July 2006
Wyeth Biotech March 2003 - June 2005
CIS-US September 2001 - March 2003
Beth Israel Deaconess Medical Center June 1999 - September 2001
Skills
UV-Vis, ELISA, Microsoft Office, IR, JMP, HPLC, PCR, SDS-PAGE, Validation, Cell, Microbiology, UV/Vis, Analytical Chemistry, Biotechnology, Pharmaceutical Industry, Lifesciences, Purification, LC-MS, GLP, Quality Control, FDA, FTIR, Chromatography, Assay Development, Organic Chemistry, Laboratory, GMP, Gel Electrophoresis, Technology Transfer, Drug Discovery, Sop
Education
University of Massachusetts Lowell 2001 — 2007
Master of Science, Biological Science
Salem State College 1994 — 1999
Bachelor of Science, Biology and Chemistry
Lisa R. Smith's Wyeth Biotech Experience September 1995 - March 2002
Job Biopharmaceutical Principal Quality Engineer, Certified Lean Six Sigma Master Black Belt
Industry Pharmaceuticals
Experience
Dendreon October 2009 - Present
Working Words, Inc. September 2008 - December 2009
Biogen Idec April 2002 - September 2008
Wyeth Biotech September 1995 - March 2002
Bespak June 1999 - January 2000
Herman Miller October 1992 - June 1995
W.L. Gore & Associates January 1992 - September 1992
The Boeing Company October 1985 - January 1992
Skills
Master Black Belt -..., Black Belt - Lean Six..., Green Belt - Lean Six..., ASQ Certified Quality..., CAPA, Validation, GMP, Quality System, FDA, V&V, Change Control, 21 CFR Part 11, GxP, Sop, Biotechnology, Pharmaceutical Industry, Technology Transfer, Quality Assurance, Quality Management, Six Sigma, SPC, Lean Process Improvement, Lean Manufacturing
Education
North Carolina State University 2007 — 2008
Master Black Belt, Lean Six Sigma
University of Phoenix 2004 — 2006
Masters of Arts in Education, Adult Education and Distance Learning
University of Illinois at Urbana-Champaign 1980 — 1984
Bachelor of Science, Biology
UW Continuing Professional Education
UW Continuing Professional Education
Dendreon October 2009 - Present
Working Words, Inc. September 2008 - December 2009
Biogen Idec April 2002 - September 2008
Wyeth Biotech September 1995 - March 2002
Bespak June 1999 - January 2000
Herman Miller October 1992 - June 1995
W.L. Gore & Associates January 1992 - September 1992
The Boeing Company October 1985 - January 1992
Skills
Master Black Belt -..., Black Belt - Lean Six..., Green Belt - Lean Six..., ASQ Certified Quality..., CAPA, Validation, GMP, Quality System, FDA, V&V, Change Control, 21 CFR Part 11, GxP, Sop, Biotechnology, Pharmaceutical Industry, Technology Transfer, Quality Assurance, Quality Management, Six Sigma, SPC, Lean Process Improvement, Lean Manufacturing
Education
North Carolina State University 2007 — 2008
Master Black Belt, Lean Six Sigma
University of Phoenix 2004 — 2006
Masters of Arts in Education, Adult Education and Distance Learning
University of Illinois at Urbana-Champaign 1980 — 1984
Bachelor of Science, Biology
UW Continuing Professional Education
UW Continuing Professional Education
Joe Humphreys's Wyeth Biotech Experience 2001 - 2004
Job Project Manager at Bilfinger Industrial ServicesEngineering
Industry Food & Beverages
Experience
BIS Engineering, INC, Division of BiLFINGER April 1991 - Present
BIS Frucon Engineers 1991 - Present
Bilfinger Industrial Services Inc. 1991 - 2013
Wyeth Biotech 2001 - 2004
Skills
Manufacturing, Project Management, Packaging, Engineering, Project Engineering, Project Planning, Process Engineering, Continuous Improvement, MS Project, Strategic Planning
Education
Southern Illinois University, Edwardsville 1984 — 1986
Master of Business Administration (M.B.A.), Finance and Marketing
University of Missouri-Columbia 1963 — 1968
Mechanical Engineering
BIS Engineering, INC, Division of BiLFINGER April 1991 - Present
BIS Frucon Engineers 1991 - Present
Bilfinger Industrial Services Inc. 1991 - 2013
Wyeth Biotech 2001 - 2004
Skills
Manufacturing, Project Management, Packaging, Engineering, Project Engineering, Project Planning, Process Engineering, Continuous Improvement, MS Project, Strategic Planning
Education
Southern Illinois University, Edwardsville 1984 — 1986
Master of Business Administration (M.B.A.), Finance and Marketing
University of Missouri-Columbia 1963 — 1968
Mechanical Engineering
Philip Stickney's Wyeth Biotech Experience December 2004 - February 2008
Job Validation Engineer at Genzyme Corporation
Industry Biotechnology
Experience
Genzyme Corporation February 2008 - Present
Wyeth Biotech December 2004 - February 2008
Education
North Shore Community College 1970 — 1973
General Studies, Business
Genzyme Corporation February 2008 - Present
Wyeth Biotech December 2004 - February 2008
Education
North Shore Community College 1970 — 1973
General Studies, Business
Donald Poor's Wyeth Biotech Experience May 2000 - April 2009
Job Administrator at MITRE Corporation
Industry Think Tanks
Experience
MITRE February 2010 - Present
Self Employed 2009 - March 2010
Wyeth Biotech May 2000 - April 2009
Genetics Institute July 1997 - May 2000
Skills
Access, Visio, Outlook
Education
Southern New Hampshire University 2004 — 2006
English Language & Literature
Northern Essex Community College 2002 — 2004
Associate of Arts, Liberal Arts
MITRE February 2010 - Present
Self Employed 2009 - March 2010
Wyeth Biotech May 2000 - April 2009
Genetics Institute July 1997 - May 2000
Skills
Access, Visio, Outlook
Education
Southern New Hampshire University 2004 — 2006
English Language & Literature
Northern Essex Community College 2002 — 2004
Associate of Arts, Liberal Arts
Jill Evans's Wyeth Biotech Experience April 2001 - June 2008
Job Delivery Manager in the Advanced Analytics Center of Excellence at GlaxoSmithKline
Industry Insurance
Experience
GSK December 2013 - Present
GlaxoSmithKline May 2012 - December 2013
BCBSNC June 2008 - April 2012
Wyeth Biotech April 2001 - June 2008
Skills
Analytics, SAS programming, R, Data Analysis, Informatics, SAS, Predictive Modeling, Data Mining, Data Warehousing, Segmentation, Text Mining, Healthcare, Pharmaceutical Industry, Validation, Statistical Modeling, Analysis, Clinical Trials, Data Modeling, Lifesciences, Statistics, Predictive Analytics, SQL, Business Intelligence, Biotechnology, Business Analysis, Data Management
Education
North Carolina State University 2007 — 2008
MSA, Master of Science in Advanced Analytics
North Carolina State University 1996 — 2000
B.S, Biology, Minor Genetics
GSK December 2013 - Present
GlaxoSmithKline May 2012 - December 2013
BCBSNC June 2008 - April 2012
Wyeth Biotech April 2001 - June 2008
Skills
Analytics, SAS programming, R, Data Analysis, Informatics, SAS, Predictive Modeling, Data Mining, Data Warehousing, Segmentation, Text Mining, Healthcare, Pharmaceutical Industry, Validation, Statistical Modeling, Analysis, Clinical Trials, Data Modeling, Lifesciences, Statistics, Predictive Analytics, SQL, Business Intelligence, Biotechnology, Business Analysis, Data Management
Education
North Carolina State University 2007 — 2008
MSA, Master of Science in Advanced Analytics
North Carolina State University 1996 — 2000
B.S, Biology, Minor Genetics
Brian Feloney's Wyeth Biotech Experience June 2006 - October 2009
Job Associate Director, External Drug Substance Manufacturing at Shire Pharmaceuticals
Industry Biotechnology
Experience
Shire Pharmaceuticals November 2014 - Present
Shire HGT December 2010 - November 2014
Pfizer October 2009 - September 2010
Wyeth Biotech June 2006 - October 2009
Wyeth September 2003 - June 2006
Skills
Pharmaceutical Industry, Change Control, GMP, Biopharmaceuticals, Technology Transfer, Biotechnology, CMC, Validation
Education
Tufts University, The Gordon Institute 2006 — 2008
MS, Engineering Management
Saint Anselm College 1991 — 1995
BA, Natural Science
Shire Pharmaceuticals November 2014 - Present
Shire HGT December 2010 - November 2014
Pfizer October 2009 - September 2010
Wyeth Biotech June 2006 - October 2009
Wyeth September 2003 - June 2006
Skills
Pharmaceutical Industry, Change Control, GMP, Biopharmaceuticals, Technology Transfer, Biotechnology, CMC, Validation
Education
Tufts University, The Gordon Institute 2006 — 2008
MS, Engineering Management
Saint Anselm College 1991 — 1995
BA, Natural Science
Christina Philibert's Wyeth Biotech Experience 2000 - 2002
Job Senior Specialist, GMP QA at Cubist Pharmaceuticals
Industry Biotechnology
Experience
Cubist Pharmaceuticals March 2011 - March 2012
Alnara Pharmaceuticals, Inc. October 2010 - March 2011
Acceleron Pharma January 2010 - July 2010
Lonza Biologics 2002 - 2007
Wyeth Biotech 2000 - 2002
BAS Analytics, Inc 1996 - 1999
Skills
Documentum, cGMP, GMP, FDA, Compliance, Trackwise, Quality Assurance, Pharmaceutical Industry, Quality Control, Sop, 21 CFR Part 11, Biopharmaceuticals, TrackWise, SOP
Education
Quinnipiac University 1987 — 1991
B.S., Chemistry
Cubist Pharmaceuticals March 2011 - March 2012
Alnara Pharmaceuticals, Inc. October 2010 - March 2011
Acceleron Pharma January 2010 - July 2010
Lonza Biologics 2002 - 2007
Wyeth Biotech 2000 - 2002
BAS Analytics, Inc 1996 - 1999
Skills
Documentum, cGMP, GMP, FDA, Compliance, Trackwise, Quality Assurance, Pharmaceutical Industry, Quality Control, Sop, 21 CFR Part 11, Biopharmaceuticals, TrackWise, SOP
Education
Quinnipiac University 1987 — 1991
B.S., Chemistry
Dawn Volpacchio's Wyeth Biotech Experience 1993 - 2008
Job Quality Assurance Specialist at PCI Synthesis
Industry Biotechnology
Experience
Wyeth Biotech 1993 - 2008
Wyeth BioPharma 1993 - 2008
Lawrence Memorial Hospital 1992 - 1994
Education
Rutgers University-New Brunswick 1982 — 1986
Bachelors, Biology
Monmouth Regional
Wyeth Biotech 1993 - 2008
Wyeth BioPharma 1993 - 2008
Lawrence Memorial Hospital 1992 - 1994
Education
Rutgers University-New Brunswick 1982 — 1986
Bachelors, Biology
Monmouth Regional
Stavroula Meimeteas's Wyeth Biotech Experience 1998 - 2000
Job Project Manager/Sr. Project Engineer
Industry Biotechnology
Experience
DPS Engineering January 2012 - Present
B&D Technology Group June 2010 - January 2012
Lonza 2004 - 2009
Jacobs Engineering 1998 - 2003
Wyeth Biotech 1998 - 2000
Process Equipment Unlimited 1996 - 1998
Eastman Kodak/Eastman Gelatine Corp 1990 - 1995
Skills
Process Scheduler, HVAC, Budgets, Quality Assurance, Contractors, Project Engineering, Contract Management, Factory, Team Leadership, Proposal Writing, Training, Energy, Project Management, Change Control, Commissioning, Testing, AutoCAD
Education
Northeastern University
BS, Industrial Engineering
DPS Engineering January 2012 - Present
B&D Technology Group June 2010 - January 2012
Lonza 2004 - 2009
Jacobs Engineering 1998 - 2003
Wyeth Biotech 1998 - 2000
Process Equipment Unlimited 1996 - 1998
Eastman Kodak/Eastman Gelatine Corp 1990 - 1995
Skills
Process Scheduler, HVAC, Budgets, Quality Assurance, Contractors, Project Engineering, Contract Management, Factory, Team Leadership, Proposal Writing, Training, Energy, Project Management, Change Control, Commissioning, Testing, AutoCAD
Education
Northeastern University
BS, Industrial Engineering
Michael Kowolenko's Wyeth Biotech Experience November 2007 - November 2009
Job Principal Research Scholar at NCSU College of Management
Industry Biotechnology
Experience
NCSU College of Management April 2010 - Present
NC State Center for Innovation Management Studies January 2010 - Present
Wyeth Biotech November 2007 - November 2009
Biogen Idec January 2002 - November 2007
Skills
Manufacturing, Natural Language..., Clinical Trials, Biotechnology, Fermentation, Predictive Analytics, FDA, Pharmaceutical Industry, Technology Transfer, Molecular Biology, Biopharmaceuticals, Big Data, Cloud Computing, Clinical Development, Biochemistry, Protein Purification, HPLC
Education
Northeastern University 1973 — 1985
Ph.D., Immunology, Pharmacology, Pharmacy
Northeastern University
Ph.D., Medical Lab Sciences - Immunology
NCSU College of Management April 2010 - Present
NC State Center for Innovation Management Studies January 2010 - Present
Wyeth Biotech November 2007 - November 2009
Biogen Idec January 2002 - November 2007
Skills
Manufacturing, Natural Language..., Clinical Trials, Biotechnology, Fermentation, Predictive Analytics, FDA, Pharmaceutical Industry, Technology Transfer, Molecular Biology, Biopharmaceuticals, Big Data, Cloud Computing, Clinical Development, Biochemistry, Protein Purification, HPLC
Education
Northeastern University 1973 — 1985
Ph.D., Immunology, Pharmacology, Pharmacy
Northeastern University
Ph.D., Medical Lab Sciences - Immunology
Joi Weeks's Wyeth Biotech Experience 2007 - 2008
Job Graduate Teaching Assistant at San Diego State University
Industry Research
Experience
UC San Diego Graduate Teaching AssistantSan Diego State UniversitySeptember 2014 - Present
Kelly Scientific / Duke University February 2010 - January 2011
Wyeth Biotech 2007 - 2008
Skills
Western Blotting, Fluorescence Microscopy, Protein Purification, Microscopy, Molecular Biology, qPCR, Confocal Microscopy, Cell Culture, Tissue Culture, Cell Biology, Molecular Cloning, Immunohistochemistry, Research, Flow Cytometry
Education
San Diego State University-California State University 2013 — 2015
Master's Degree, Cellular and Molecular Biology
University of North Carolina at Chapel Hill 2003 — 2007
Bachelor's Degree, Chemistry
UC San Diego Graduate Teaching AssistantSan Diego State UniversitySeptember 2014 - Present
Kelly Scientific / Duke University February 2010 - January 2011
Wyeth Biotech 2007 - 2008
Skills
Western Blotting, Fluorescence Microscopy, Protein Purification, Microscopy, Molecular Biology, qPCR, Confocal Microscopy, Cell Culture, Tissue Culture, Cell Biology, Molecular Cloning, Immunohistochemistry, Research, Flow Cytometry
Education
San Diego State University-California State University 2013 — 2015
Master's Degree, Cellular and Molecular Biology
University of North Carolina at Chapel Hill 2003 — 2007
Bachelor's Degree, Chemistry
Todd Spohn's Wyeth Biotech Experience November 2007 - December 2009
Job Tech Transfer Lead at Pfizer
Industry Pharmaceuticals
Experience
Pfizer February 2011 - Present
Pfizer February 2011 - Present
Pfizer Pharmaceuticals December 2009 - January 2011
Wyeth Biotech November 2007 - December 2009
Skills
Aseptic Processing, Technology Transfer, Process Engineering, Formulation, Manufacturing, GMP, FDA, Pharmaceutical Industry, CAPA, Medical Devices, Sop, Validation, 21 CFR Part 11, GLP, V&V, GxP, Biopharmaceuticals, LIMS, Cleaning Validation, Computer System..., Vaccines, Trackwise, Regulatory Requirements, Regulatory Submissions, GAMP, Aseptic Technique, SOP
Education
Rutgers University-New Brunswick 1976 — 1980
BS, Microbiology
Rutgers, The State University of New Jersey-New Brunswick
Microbiology, General
Pfizer February 2011 - Present
Pfizer February 2011 - Present
Pfizer Pharmaceuticals December 2009 - January 2011
Wyeth Biotech November 2007 - December 2009
Skills
Aseptic Processing, Technology Transfer, Process Engineering, Formulation, Manufacturing, GMP, FDA, Pharmaceutical Industry, CAPA, Medical Devices, Sop, Validation, 21 CFR Part 11, GLP, V&V, GxP, Biopharmaceuticals, LIMS, Cleaning Validation, Computer System..., Vaccines, Trackwise, Regulatory Requirements, Regulatory Submissions, GAMP, Aseptic Technique, SOP
Education
Rutgers University-New Brunswick 1976 — 1980
BS, Microbiology
Rutgers, The State University of New Jersey-New Brunswick
Microbiology, General
James Malavich's Wyeth Biotech Experience April 2005 - November 2007
Job QC Microbiology Scientist
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb June 2011 - Present
Bristol-Myers Squibb June 2010 - June 2011
Bristol-Myers Squibb November 2007 - June 2010
Wyeth Biotech April 2005 - November 2007
EMD Pharmaceuticals January 2003 - April 2005
EMD Pharmaceuticals October 2001 - January 2003
Alkermes April 2001 - October 2001
Transkaryotic Therapies Inc. September 1999 - April 2001
Skills
GMP, Biotechnology, Pharmaceutical Industry, Quality Control, SOP, FDA, Validation, 21 CFR Part 11, CAPA, Change Control
Education
University of Massachusetts at Lowell 1999 — 2001
Graduate Certificate, Bioprocessing/Engineering
Salem State College 1995 — 1999
Bachelors, Biology
Bristol-Myers Squibb June 2011 - Present
Bristol-Myers Squibb June 2010 - June 2011
Bristol-Myers Squibb November 2007 - June 2010
Wyeth Biotech April 2005 - November 2007
EMD Pharmaceuticals January 2003 - April 2005
EMD Pharmaceuticals October 2001 - January 2003
Alkermes April 2001 - October 2001
Transkaryotic Therapies Inc. September 1999 - April 2001
Skills
GMP, Biotechnology, Pharmaceutical Industry, Quality Control, SOP, FDA, Validation, 21 CFR Part 11, CAPA, Change Control
Education
University of Massachusetts at Lowell 1999 — 2001
Graduate Certificate, Bioprocessing/Engineering
Salem State College 1995 — 1999
Bachelors, Biology
Gwen Cunningham's Wyeth Biotech Experience 2005 - 2009
Job Purification Manufacturing Department Associate
Industry Biotechnology
Experience
Lonza Biologics, Inc. October 2011 - Present
Open to Opportunities August 2010 - March 2012
Pfizer Pharmaceuticals 2009 - August 2010
Wyeth Biotech 2005 - 2009
Wyeth Biotech 2004 - 2005
Wyeth Biotech 2003 - 2004
Wyeth Biotech 2002 - 2003
American Home Products (formerly Genetics Institute) 1998 - 2002
Genetics Institute Company 1997 - 1998
Skills
Sop, Biotechnology, GMP, Chemistry, Management, LIMS, Biopharmaceuticals, Regulatory Affairs, Analysis, Software Documentation, Quality Assurance, Training, Trackwise, Analytical Chemistry, Aseptic Processing, FDA, GxP, Records, Aseptic Technique, Manufacturing, Laboratory, Quality Control, Quality System, Microbiology, Technology Transfer, GLP, Computer System..., Microsoft Excel, Environmental Monitoring, Cell Culture, CAPA, Validation, Pharmaceutical Industry, Cleaning Validation, Raw Materials, 21 CFR Part 11, Vaccines, Chromatography, Regulatory Submissions, Change Control, Testing, Document Management, HPLC, Lifesciences, Leadership, Assay Development, V&V, Clinical Trials, SOP
Education
Northern Essex Community College
Preschool Education, Liberal Arts
Lonza Biologics, Inc. October 2011 - Present
Open to Opportunities August 2010 - March 2012
Pfizer Pharmaceuticals 2009 - August 2010
Wyeth Biotech 2005 - 2009
Wyeth Biotech 2004 - 2005
Wyeth Biotech 2003 - 2004
Wyeth Biotech 2002 - 2003
American Home Products (formerly Genetics Institute) 1998 - 2002
Genetics Institute Company 1997 - 1998
Skills
Sop, Biotechnology, GMP, Chemistry, Management, LIMS, Biopharmaceuticals, Regulatory Affairs, Analysis, Software Documentation, Quality Assurance, Training, Trackwise, Analytical Chemistry, Aseptic Processing, FDA, GxP, Records, Aseptic Technique, Manufacturing, Laboratory, Quality Control, Quality System, Microbiology, Technology Transfer, GLP, Computer System..., Microsoft Excel, Environmental Monitoring, Cell Culture, CAPA, Validation, Pharmaceutical Industry, Cleaning Validation, Raw Materials, 21 CFR Part 11, Vaccines, Chromatography, Regulatory Submissions, Change Control, Testing, Document Management, HPLC, Lifesciences, Leadership, Assay Development, V&V, Clinical Trials, SOP
Education
Northern Essex Community College
Preschool Education, Liberal Arts
Matthew Vernak's Wyeth Biotech Experience 2003 - 2006
Job Sr. Manager, Quality Management Systems
Industry Medical Devices
Experience
Pentax Medical February 2014 - Present
LifeCell Corporation February 2011 - February 2014
Pfizer Pharmaceuticals 2009 - February 2011
Pfizer 2006 - 2009
Wyeth Biotech 2003 - 2006
Wyeth Pharmaceuticals 2002 - 2003
Merck 2000 - 2002
Merck 1999 - 2001
Merck 1997 - 1999
Skills
CAPA, FDA, V&V, Validation, GMP, Change Control, 21 CFR Part 11, Quality System, Sop, GxP, ISO 13485, Computer System...
Education
Rutgers University-New Brunswick 1993 — 1997
BS, Mechanical Engineering
Pentax Medical February 2014 - Present
LifeCell Corporation February 2011 - February 2014
Pfizer Pharmaceuticals 2009 - February 2011
Pfizer 2006 - 2009
Wyeth Biotech 2003 - 2006
Wyeth Pharmaceuticals 2002 - 2003
Merck 2000 - 2002
Merck 1999 - 2001
Merck 1997 - 1999
Skills
CAPA, FDA, V&V, Validation, GMP, Change Control, 21 CFR Part 11, Quality System, Sop, GxP, ISO 13485, Computer System...
Education
Rutgers University-New Brunswick 1993 — 1997
BS, Mechanical Engineering
Matthew Borkush's Wyeth Biotech Experience February 2001 - August 2009
Job Process Supervisor at Genzyme
Industry Pharmaceuticals
Experience
Genzyme October 2011 - Present
Pfizer August 2009 - October 2011
Wyeth Biotech February 2001 - August 2009
Hassey Dental Associates September 1996 - January 2001
Skills
cGMP, Manufacturing, GMP, Documentation, Filtration, Supervisory Skills, Scheduling, Inventory Management, Troubleshooting, Data Analysis, Compliance, Biotechnology, Pharmaceuticals, Problem Solving, Commissioning, Team Building, Excel, Outlook, Word, Lean Manufacturing, Microsoft Office, Process Improvement, Coaching, SOP, Biopharmaceuticals, Pharmaceutical Industry, Software Documentation, Sop, Trackwise, Training, Validation
Education
Central Catholic High School
Northern Essex Community College
Genzyme October 2011 - Present
Pfizer August 2009 - October 2011
Wyeth Biotech February 2001 - August 2009
Hassey Dental Associates September 1996 - January 2001
Skills
cGMP, Manufacturing, GMP, Documentation, Filtration, Supervisory Skills, Scheduling, Inventory Management, Troubleshooting, Data Analysis, Compliance, Biotechnology, Pharmaceuticals, Problem Solving, Commissioning, Team Building, Excel, Outlook, Word, Lean Manufacturing, Microsoft Office, Process Improvement, Coaching, SOP, Biopharmaceuticals, Pharmaceutical Industry, Software Documentation, Sop, Trackwise, Training, Validation
Education
Central Catholic High School
Northern Essex Community College