Wyeth Biotech
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Wyeth Biotech Employees
Employee
Years
Job
Industry
Sharon (Brodeur) Wood Sharon (Brodeur) Wood's Wyeth Biotech Experience 2001 - 2006
Job Training Specialist at Pfizer
Industry Professional Training & Coaching
Experience
Pfizer 2006 - Present
Wyeth Pharmaceuticals 2006 - 2009
Greater Haverhill Adult Learning Program May 2007 - August 2007
Wyeth Biotech 2001 - 2006
Solutia Inc. 1998 - 2001
Skills
Articulate, Captivate, Plateau, Technology Needs..., Performance Consulting, Classroom, Sop, GMP, Technical Writing, Instructional Design, FDA, Validation, Pharmaceutical Industry, Biotechnology, Change Control, Needs Analysis, Training, CAPA, 21 CFR Part 11, Quality Assurance, Document Management, Quality System, Lean Six Sigma Yellow..., Blended Learning, Quality Control, Computer System..., Six Sigma, Aseptic Processing, Technology Transfer, E-Learning, GxP, Trackwise, SOP, Instructor-led Training, GLP, LIMS, Quality Auditing, Learning Management..., Regulatory Requirements, V&V
Education
Suffolk University 2006 — 2008
MS, Adult and Organizational Learning
Langevin Learning Services 2006 — 2006
Certified Instructor/Facilitator, Workforce Development and Training
Mount Holyoke College 1997 — 2001
BA, Environmental Studies (Minor:Information Systems)
Pfizer 2006 - Present
Wyeth Pharmaceuticals 2006 - 2009
Greater Haverhill Adult Learning Program May 2007 - August 2007
Wyeth Biotech 2001 - 2006
Solutia Inc. 1998 - 2001
Skills
Articulate, Captivate, Plateau, Technology Needs..., Performance Consulting, Classroom, Sop, GMP, Technical Writing, Instructional Design, FDA, Validation, Pharmaceutical Industry, Biotechnology, Change Control, Needs Analysis, Training, CAPA, 21 CFR Part 11, Quality Assurance, Document Management, Quality System, Lean Six Sigma Yellow..., Blended Learning, Quality Control, Computer System..., Six Sigma, Aseptic Processing, Technology Transfer, E-Learning, GxP, Trackwise, SOP, Instructor-led Training, GLP, LIMS, Quality Auditing, Learning Management..., Regulatory Requirements, V&V
Education
Suffolk University 2006 — 2008
MS, Adult and Organizational Learning
Langevin Learning Services 2006 — 2006
Certified Instructor/Facilitator, Workforce Development and Training
Mount Holyoke College 1997 — 2001
BA, Environmental Studies (Minor:Information Systems)
Daniel Pyburn Daniel Pyburn's Wyeth Biotech Experience June 2006 - August 2006
Job Project Director at University of New Hampshire
Industry Pharmaceuticals
Experience
University of New Hampshire July 2015 - Present
University of Massachusetts Lowell May 2008 - Present
North Shore Community College September 2014 - December 2014
NHTI, Concord Community College September 2013 - May 2014
University of New Hampshire August 2009 - May 2014
Great Bay Community College May 2010 - May 2011
GreenFuel Technologies Corporation April 2008 - May 2009
Formatech, Inc. September 2006 - April 2008
Wyeth Biotech June 2006 - August 2006
Formatech, Inc. June 2004 - May 2006
Skills
College Teaching, Research, Design of Experiments, Statistics, HPLC, Gas Chromatography, UV/Vis, Report Writing, Biotechnology, Fluorescence..., SPSS, R, IR spectroscopy, Karl Fisher, Reverse Phase, Size Exclusion, SOP development, Formulation Chemistry, chemistry education..., Chemistry, Characterization, IR, SOP, Science, NMR, Data Analysis, Laboratory
Education
University of New Hampshire 2009 — 2014
Doctor of Philosophy (Ph.D.), Chemistry
University of New Hampshire 2009 — 2014
Master of Science (M.S.), Mathematics (Statistics Option)
University of Massachusetts Lowell 2006 — 2008
Master of Science (M.S.), Analytical Chemistry
Merrimack College 2002 — 2006
Bachelor of Science (B.S.), Chemistry
University of New Hampshire July 2015 - Present
University of Massachusetts Lowell May 2008 - Present
North Shore Community College September 2014 - December 2014
NHTI, Concord Community College September 2013 - May 2014
University of New Hampshire August 2009 - May 2014
Great Bay Community College May 2010 - May 2011
GreenFuel Technologies Corporation April 2008 - May 2009
Formatech, Inc. September 2006 - April 2008
Wyeth Biotech June 2006 - August 2006
Formatech, Inc. June 2004 - May 2006
Skills
College Teaching, Research, Design of Experiments, Statistics, HPLC, Gas Chromatography, UV/Vis, Report Writing, Biotechnology, Fluorescence..., SPSS, R, IR spectroscopy, Karl Fisher, Reverse Phase, Size Exclusion, SOP development, Formulation Chemistry, chemistry education..., Chemistry, Characterization, IR, SOP, Science, NMR, Data Analysis, Laboratory
Education
University of New Hampshire 2009 — 2014
Doctor of Philosophy (Ph.D.), Chemistry
University of New Hampshire 2009 — 2014
Master of Science (M.S.), Mathematics (Statistics Option)
University of Massachusetts Lowell 2006 — 2008
Master of Science (M.S.), Analytical Chemistry
Merrimack College 2002 — 2006
Bachelor of Science (B.S.), Chemistry
Christine T. DeStefano Christine T. DeStefano's Wyeth Biotech Experience 2001 - 2009
Job Inflammation, Global Innovative Pharma
Industry Biotechnology
Experience
Pfizer July 2012 - Present
Pfizer May 2001 - July 2012
Wyeth Biotech 2001 - 2009
GlaxoSmithKline 1997 - 2001
West Point Association of Graduates 1995 - 1997
Mount Saint Mary College 1991 - 1995
Skills
Sales Management, Sales, Influence Others, Teamwork, Team Building, Rheumatology, Rheumatoid Arthritis, Inflammation, Injectable, Presentations, Sales Presentations, Biotechnology, Pharmaceutical Sales, Pharmaceutical Industry, Neurology, Sales Effectiveness, Selling Skills, Sales Force Development, Biologics, Biopharmaceuticals, Immunology, Diabetes, Healthcare, Managed Care, Product Launch, Leadership, Management, Hospital Sales, Strategy, Dermatology, Gastroenterology
Education
Mount Saint Mary College
MBA, Management and Business Administration
Mount Saint Mary College
BS, Business and Administration, Concentration Marketing
Bishop Kearney High School
Bishop Kearney High School
Monroe Woodbury High School
Pfizer July 2012 - Present
Pfizer May 2001 - July 2012
Wyeth Biotech 2001 - 2009
GlaxoSmithKline 1997 - 2001
West Point Association of Graduates 1995 - 1997
Mount Saint Mary College 1991 - 1995
Skills
Sales Management, Sales, Influence Others, Teamwork, Team Building, Rheumatology, Rheumatoid Arthritis, Inflammation, Injectable, Presentations, Sales Presentations, Biotechnology, Pharmaceutical Sales, Pharmaceutical Industry, Neurology, Sales Effectiveness, Selling Skills, Sales Force Development, Biologics, Biopharmaceuticals, Immunology, Diabetes, Healthcare, Managed Care, Product Launch, Leadership, Management, Hospital Sales, Strategy, Dermatology, Gastroenterology
Education
Mount Saint Mary College
MBA, Management and Business Administration
Mount Saint Mary College
BS, Business and Administration, Concentration Marketing
Bishop Kearney High School
Bishop Kearney High School
Monroe Woodbury High School
Henry Baez Henry Baez's Wyeth Biotech Experience June 2006 - January 2007
Job Compliance Audit Manager at Siemens
Industry Medical Devices
Experience
Siemens June 2014 - Present
Zimmer TMT February 2013 - May 2014
Zimmer TMT August 2012 - February 2013
Zimmer TMT August 2010 - August 2012
Pfizer Biotech January 2010 - August 2010
Pfizer/Wyeth Biotech June 2007 - December 2009
Wyeth Biotech June 2006 - January 2007
Skills
Technical Writing, Chemical Engineering, Commissioning, FDA, Validation, CAPA, Sop, V&V, Process Improvement, Project Management, Troubleshooting, Medical Devices, Software Documentation, Change Control, Quality Assurance, Process Simulation, Continuous Improvement, Kaizen, Biotechnology, Engineering, Risk Assessment, Six Sigma, GMP, Manufacturing, Pharmaceutical Industry, 21 CFR Part 11, Cleaning Validation, ISO 13485, Design Control, Aseptic Processing, Quality System, Root Cause Analysis, Computer System..., FDA GMP, GAMP, Design of Experiments, GxP, Minitab, 21 CFR, Quality Control, DMAIC, ISO 14971, Trackwise, Calibration, Quality Auditing, Mentoring, SOP
Education
Manhattan College 2003 — 2007
B.S., Chemical Engineering, Chemistry
Siemens June 2014 - Present
Zimmer TMT February 2013 - May 2014
Zimmer TMT August 2012 - February 2013
Zimmer TMT August 2010 - August 2012
Pfizer Biotech January 2010 - August 2010
Pfizer/Wyeth Biotech June 2007 - December 2009
Wyeth Biotech June 2006 - January 2007
Skills
Technical Writing, Chemical Engineering, Commissioning, FDA, Validation, CAPA, Sop, V&V, Process Improvement, Project Management, Troubleshooting, Medical Devices, Software Documentation, Change Control, Quality Assurance, Process Simulation, Continuous Improvement, Kaizen, Biotechnology, Engineering, Risk Assessment, Six Sigma, GMP, Manufacturing, Pharmaceutical Industry, 21 CFR Part 11, Cleaning Validation, ISO 13485, Design Control, Aseptic Processing, Quality System, Root Cause Analysis, Computer System..., FDA GMP, GAMP, Design of Experiments, GxP, Minitab, 21 CFR, Quality Control, DMAIC, ISO 14971, Trackwise, Calibration, Quality Auditing, Mentoring, SOP
Education
Manhattan College 2003 — 2007
B.S., Chemical Engineering, Chemistry
Derrick Laton's Wyeth Biotech Experience May 2007 - April 2008
Job Americas C4/C5 Supply Planning Supervisor at ExxonMobil
Industry Chemicals
Experience
ExxonMobil July 2015 - Present
ExxonMobil February 2014 - Present
SURGE Ventures September 2014 - April 2015
ExxonMobil July 2008 - February 2014
Wyeth Biotech May 2007 - April 2008
Skills
Process Simulation, Process Engineering, Process Control, Project Engineering, Chemical Engineering, Commissioning, Engineering, HAZOP, Process Safety, Root Cause Analysis, Refining, Petrochemical, FEED
Education
The University of Texas at Austin - The Red McCombs School of Business 2013 — 2015
Master of Business Administration (MBA)
North Carolina State University 2004 — 2008
Bachelor of Science (B.S.), Chemical and Biomolecular Engineering
ExxonMobil July 2015 - Present
ExxonMobil February 2014 - Present
SURGE Ventures September 2014 - April 2015
ExxonMobil July 2008 - February 2014
Wyeth Biotech May 2007 - April 2008
Skills
Process Simulation, Process Engineering, Process Control, Project Engineering, Chemical Engineering, Commissioning, Engineering, HAZOP, Process Safety, Root Cause Analysis, Refining, Petrochemical, FEED
Education
The University of Texas at Austin - The Red McCombs School of Business 2013 — 2015
Master of Business Administration (MBA)
North Carolina State University 2004 — 2008
Bachelor of Science (B.S.), Chemical and Biomolecular Engineering
Michael Amideneau's Wyeth Biotech Experience January 2006 - April 2009
Job Head Of Engineering and Maintenance at Novartis
Industry Pharmaceuticals
Matthew P. VonEsch Matthew P. VonEsch's Wyeth Biotech Experience June 2001 - November 2003
Job Sr. Director, Manufacturing at Sigma Tau PharmaSource
Industry Biotechnology
Experience
Sigma Tau PharmaSource January 2013 - Present
United Therapeutics November 2005 - December 2012
United Therapeutics March 2007 - July 2009
United Therapeutics November 2005 - March 2007
MedImmune May 2005 - November 2005
Human Genome Sciences November 2003 - May 2005
Wyeth Biotech June 2001 - November 2003
Skills
GMP, Validation, Aseptic Processing, Protein Purification, Biopharmaceuticals, 21 CFR Part 11, Aseptic Technique, Regulatory Submissions, FDA, Sterilization, Biotechnology, Pharmaceutical Industry, CAPA, Sop, Change Control, Manufacturing, GLP, Quality System, V&V, Lifesciences, LIMS, GxP, Purification, Technology Transfer, Chromatography, Cleaning Validation, Computer System..., Trackwise
Education
Merrimack College 1996 — 2001
Sigma Tau PharmaSource January 2013 - Present
United Therapeutics November 2005 - December 2012
United Therapeutics March 2007 - July 2009
United Therapeutics November 2005 - March 2007
MedImmune May 2005 - November 2005
Human Genome Sciences November 2003 - May 2005
Wyeth Biotech June 2001 - November 2003
Skills
GMP, Validation, Aseptic Processing, Protein Purification, Biopharmaceuticals, 21 CFR Part 11, Aseptic Technique, Regulatory Submissions, FDA, Sterilization, Biotechnology, Pharmaceutical Industry, CAPA, Sop, Change Control, Manufacturing, GLP, Quality System, V&V, Lifesciences, LIMS, GxP, Purification, Technology Transfer, Chromatography, Cleaning Validation, Computer System..., Trackwise
Education
Merrimack College 1996 — 2001
Denise Ansotegui Denise Ansotegui's Wyeth Biotech Experience 2003 - 2005
Job Leave of Absence Family
Industry Biotechnology
Experience
Self October 2011 - Present
Lonza December 2009 - October 2011
Lonza Biologics May 2006 - January 2010
Wyeth Biotech 2003 - 2005
Skills
GMP, Change Control, Sop, Pharmaceutical Industry, Quality System, Trackwise, Biopharmaceuticals, 21 CFR Part 11, CAPA, Quality Assurance, Validation, LIMS, FDA, Biotechnology, Aseptic Processing, CIP
Education
Montana State University-Bozeman 1991 — 1996
Bachelor of Science (BS), Microbiology, Honors
Self October 2011 - Present
Lonza December 2009 - October 2011
Lonza Biologics May 2006 - January 2010
Wyeth Biotech 2003 - 2005
Skills
GMP, Change Control, Sop, Pharmaceutical Industry, Quality System, Trackwise, Biopharmaceuticals, 21 CFR Part 11, CAPA, Quality Assurance, Validation, LIMS, FDA, Biotechnology, Aseptic Processing, CIP
Education
Montana State University-Bozeman 1991 — 1996
Bachelor of Science (BS), Microbiology, Honors
Billy Landahl Billy Landahl's Wyeth Biotech Experience September 2002 - October 2006
Job Automation Engineer at Castle Hill Technologites
Industry Pharmaceuticals
Experience
Castle Hill Technologites March 2009 - Present
GlaxoSmithKline November 2006 - March 2009
Wyeth Biotech September 2002 - October 2006
Education
North Carolina State University 1999 — 2001
Masters, Integrated Manufacturing Engineering
Castle Hill Technologites March 2009 - Present
GlaxoSmithKline November 2006 - March 2009
Wyeth Biotech September 2002 - October 2006
Education
North Carolina State University 1999 — 2001
Masters, Integrated Manufacturing Engineering
Katarzyna Szutkowski, MS Katarzyna Szutkowski, MS's Wyeth Biotech Experience October 2007 - April 2011
Job Record Management and Submission Support Team Leader, Vaccine Research at Pfizer
Industry Research
Experience
Pfizer May 2011 - Present
Pfizer October 2009 - April 2011
Wyeth Biotech October 2007 - April 2011
Wyeth Pharmaceuticals 2002 - 2007
Skills
Leadership, Sop, FDA, Software Documentation, Process Improvement, Regulatory Submissions, GMP, Knowledge Management, Root Cause Analysis, 21 CFR Part 11, Pharmaceutical Industry, Workshop Facilitation, Change Control, Clinical Development, Access, Quality Assurance, Computer System..., Quality Control, Quality Management, Validation, Vaccines, Regulatory Affairs, CAPA, SOP
Education
New York University 2009 — 2013
Master of Science, Global Affairs: Human Rights and Development Concentration
French Institute - Alliance Française 2007 — 2007
French
Iona College, Hagan School of Business 2003 — 2007
B.S., Business/Marketing
Pfizer May 2011 - Present
Pfizer October 2009 - April 2011
Wyeth Biotech October 2007 - April 2011
Wyeth Pharmaceuticals 2002 - 2007
Skills
Leadership, Sop, FDA, Software Documentation, Process Improvement, Regulatory Submissions, GMP, Knowledge Management, Root Cause Analysis, 21 CFR Part 11, Pharmaceutical Industry, Workshop Facilitation, Change Control, Clinical Development, Access, Quality Assurance, Computer System..., Quality Control, Quality Management, Validation, Vaccines, Regulatory Affairs, CAPA, SOP
Education
New York University 2009 — 2013
Master of Science, Global Affairs: Human Rights and Development Concentration
French Institute - Alliance Française 2007 — 2007
French
Iona College, Hagan School of Business 2003 — 2007
B.S., Business/Marketing
COL Domenick A Garzone PE COL Domenick A Garzone PE's Wyeth Biotech Experience 2002 - 2009
Job RC DCS ENG US Army Special Operations Command (Airborne)
Industry Military
Experience
US Army Special Operations Command (Airborne) January 2012 - Present
Pfizer 2009 - 2009
Wyeth Biotech 2002 - 2009
Skills
Pharmaceutical Industry, Regulatory Affairs, 21 CFR Part 11, Aseptic Processing, GxP, Trackwise, Computer System..., GMP, Cleaning Validation, Sop, Vaccines, Change Control, Analytical Chemistry, Biopharmaceuticals, Biotechnology, CAPA, CMC, Calibration, Chemistry, Chromatography, Clinical Development, Cross-functional Team..., Clinical Trials, Data Management, Design of Experiments, Document Management, FDA, Facilities Management, Formulation, GAMP, GCP, GLP, Government, HPLC, ISO, ISO 13485, LIMS, Laboratory, Leadership, Lifesciences, Management, Manufacturing, Medical Devices, Microbiology, Pharmaceutics, Pharmacovigilance, Process Improvement, Process Simulation, Protocol, Purification
Education
US Army War College 2010 — 2012
Master of Strategic Studies, Military and Strategic Leadership, Graduate
Temple University 2004 — 2009
MS, Quality Assurance & Regulatory Affairs
New Jersey Institute of Technology 2003 — 2005
MS, Pharmaceutical Engineering
The University of Connecticut School of Business 1984 — 1988
MBA, Finance and Real Estate
University of Wisconsin-Madison 1976 — 1979
Stuyvesant High School 1970 — 1974
US Army Special Operations Command (Airborne) January 2012 - Present
Pfizer 2009 - 2009
Wyeth Biotech 2002 - 2009
Skills
Pharmaceutical Industry, Regulatory Affairs, 21 CFR Part 11, Aseptic Processing, GxP, Trackwise, Computer System..., GMP, Cleaning Validation, Sop, Vaccines, Change Control, Analytical Chemistry, Biopharmaceuticals, Biotechnology, CAPA, CMC, Calibration, Chemistry, Chromatography, Clinical Development, Cross-functional Team..., Clinical Trials, Data Management, Design of Experiments, Document Management, FDA, Facilities Management, Formulation, GAMP, GCP, GLP, Government, HPLC, ISO, ISO 13485, LIMS, Laboratory, Leadership, Lifesciences, Management, Manufacturing, Medical Devices, Microbiology, Pharmaceutics, Pharmacovigilance, Process Improvement, Process Simulation, Protocol, Purification
Education
US Army War College 2010 — 2012
Master of Strategic Studies, Military and Strategic Leadership, Graduate
Temple University 2004 — 2009
MS, Quality Assurance & Regulatory Affairs
New Jersey Institute of Technology 2003 — 2005
MS, Pharmaceutical Engineering
The University of Connecticut School of Business 1984 — 1988
MBA, Finance and Real Estate
University of Wisconsin-Madison 1976 — 1979
Stuyvesant High School 1970 — 1974
Gary Burgess - PE Gary Burgess - PE's Wyeth Biotech Experience June 2001 - June 2002
Job Project Manager at 1Proengineer
Industry Mechanical or Industrial Engineering
Experience
1Proengineer June 2002 - Present
Wyeth Biotech June 2001 - June 2002
1 Proengineer June 2000 - June 2001
BioPort Corporation / Emergent BioSolutions February 1999 - October 1999
1 Proengineer January 1993 - December 1998
Marathon Engineers July 1991 - September 1992
Skills
Project Engineering, Engineering, Commissioning, Validation, Chemical Engineering, Process Engineering, GMP, Manufacturing, Biotechnology, Water, Root Cause Analysis, New Business Development, Process Control, Water Treatment, Start-ups, Facilities Management, Wastewater Treatment, HVAC, MS Project, Construction Management, Construction, Boilers, Piping, Filtration, Civil Engineering, Environmental..., Facilities Engineering, Plant Engineering, Microelectronics
Education
Marshall University 1977 — 1979
Masters Level Business and Chemical Engineering Study, Masters Chemical Engineering
Michigan State University 1974 — 1975
MSSE, Sanitary / Environmental Engineering
Michigan State University 1969 — 1973
BSME, Mechanical Engineering
1Proengineer June 2002 - Present
Wyeth Biotech June 2001 - June 2002
1 Proengineer June 2000 - June 2001
BioPort Corporation / Emergent BioSolutions February 1999 - October 1999
1 Proengineer January 1993 - December 1998
Marathon Engineers July 1991 - September 1992
Skills
Project Engineering, Engineering, Commissioning, Validation, Chemical Engineering, Process Engineering, GMP, Manufacturing, Biotechnology, Water, Root Cause Analysis, New Business Development, Process Control, Water Treatment, Start-ups, Facilities Management, Wastewater Treatment, HVAC, MS Project, Construction Management, Construction, Boilers, Piping, Filtration, Civil Engineering, Environmental..., Facilities Engineering, Plant Engineering, Microelectronics
Education
Marshall University 1977 — 1979
Masters Level Business and Chemical Engineering Study, Masters Chemical Engineering
Michigan State University 1974 — 1975
MSSE, Sanitary / Environmental Engineering
Michigan State University 1969 — 1973
BSME, Mechanical Engineering
Bill Landahl Bill Landahl's Wyeth Biotech Experience 2001 - 2006
Job Automation Project Engineer at Castle Hill Technologies
Industry Pharmaceuticals
Experience
Oak City Coffee, Inc. 2012 - Present
Castle Hill Technologies March 2009 - March 2012
Novartis Vaccines and Diagnostics 2012 - 2012
Eisai Pharmaceuticals 2009 - 2012
GSK November 2006 - March 2009
Wyeth Biotech 2001 - 2006
Skills
Validation, GAMP, Automation, SCADA, Commissioning, Testing, Integration, Process Control, SDLC, Manufacturing, Engineering, Fermentation
Education
North Carolina State University 1999 — 2001
Masters, Integrated Manufacturing Engineering
Oak City Coffee, Inc. 2012 - Present
Castle Hill Technologies March 2009 - March 2012
Novartis Vaccines and Diagnostics 2012 - 2012
Eisai Pharmaceuticals 2009 - 2012
GSK November 2006 - March 2009
Wyeth Biotech 2001 - 2006
Skills
Validation, GAMP, Automation, SCADA, Commissioning, Testing, Integration, Process Control, SDLC, Manufacturing, Engineering, Fermentation
Education
North Carolina State University 1999 — 2001
Masters, Integrated Manufacturing Engineering
Shawn Collard Shawn Collard's Wyeth Biotech Experience April 1999 - April 2002
Job Application Support Specialist at Ironwood Pharmaceuticals
Industry Computer Software
Experience
Ironwood Pharmaceuticals May 2012 - Present
Ironwood 2012 - 2015
Ironwood 2012 - 2015
Pfizer April 2002 - May 2012
Wyeth Biotech April 1999 - April 2002
Skills
GMP, HPLC, Chromatography, ELISA, Technical Support, Laboratory, Change Control, Validation, GLP, FDA, LIMS, Pharmaceutical Industry, 21 CFR Part 11, Computer System..., SDMS, SOP authoring
Education
Keene State College 1994 — 1998
BA, Biology
Boston College Corporate Education Center
Certification Training Courses
Ironwood Pharmaceuticals May 2012 - Present
Ironwood 2012 - 2015
Ironwood 2012 - 2015
Pfizer April 2002 - May 2012
Wyeth Biotech April 1999 - April 2002
Skills
GMP, HPLC, Chromatography, ELISA, Technical Support, Laboratory, Change Control, Validation, GLP, FDA, LIMS, Pharmaceutical Industry, 21 CFR Part 11, Computer System..., SDMS, SOP authoring
Education
Keene State College 1994 — 1998
BA, Biology
Boston College Corporate Education Center
Certification Training Courses
Cynthia (Cindy) Fliszar Cynthia (Cindy) Fliszar's Wyeth Biotech Experience December 2006 - December 2008
Job Associate Director, Business Technology Compliance at Pfizer
Industry Pharmaceuticals
Experience
Pfizer June 2010 - Present
Pfizer Pharmaceuticals December 2008 - June 2010
Wyeth Biotech December 2006 - December 2008
Wyeth Biotech September 2003 - December 2007
Wyeth Pharmaceuticals June 1998 - May 2001
Teva Pharmaceuticals 1991 - 1998
Skills
FDA, Validation, 21 CFR Part 11, GMP
Education
Temple University
Certification, Drug Development QA/RA
La Salle University 1986 — 1990
Pfizer June 2010 - Present
Pfizer Pharmaceuticals December 2008 - June 2010
Wyeth Biotech December 2006 - December 2008
Wyeth Biotech September 2003 - December 2007
Wyeth Pharmaceuticals June 1998 - May 2001
Teva Pharmaceuticals 1991 - 1998
Skills
FDA, Validation, 21 CFR Part 11, GMP
Education
Temple University
Certification, Drug Development QA/RA
La Salle University 1986 — 1990
Jason Thomason Jason Thomason's Wyeth Biotech Experience February 2003 - December 2011
Job Engineering and Validation
Industry Biotechnology
Experience
JT Consulting LLC 2014 - Present
Pfizer January 2012 - December 2013
Wyeth Biotech February 2003 - December 2011
Wyeth Biotech February 2002 - February 2003
Skills
GMP, Validation, Change Control, CAPA, Sop, FDA, Pharmaceutical Industry, Biotechnology, Aseptic Processing, GxP, LIMS, Quality Assurance, Quality Control
Education
Temple University 2004 — 2006
MS, Quality Assurance and Regulatory Affairs
North Carolina State University 1992 — 1996
BS, Biology
JT Consulting LLC 2014 - Present
Pfizer January 2012 - December 2013
Wyeth Biotech February 2003 - December 2011
Wyeth Biotech February 2002 - February 2003
Skills
GMP, Validation, Change Control, CAPA, Sop, FDA, Pharmaceutical Industry, Biotechnology, Aseptic Processing, GxP, LIMS, Quality Assurance, Quality Control
Education
Temple University 2004 — 2006
MS, Quality Assurance and Regulatory Affairs
North Carolina State University 1992 — 1996
BS, Biology
William W Taylor William W Taylor's Wyeth Biotech Experience December 2007 - October 2009
Job Project Manager at Sandoz (Fougera)
Industry Pharmaceuticals
Experience
Fougera Pharmaceuticals Inc., a Sandoz company June 2013 - Present
Pfizer October 2012 - June 2013
Pfizer November 2011 - October 2012
Pfizer October 2009 - October 2012
Wyeth Biotech December 2007 - October 2009
Wyeth Biotech June 2003 - December 2007
Ramylus International May 2002 - June 2003
Skills
Six Sigma, Training, Validation, GMP, Pharmaceutical Industry, Change Control, Sop, FDA, CAPA, Verification, OSHA SGE, OSHA 10, Excavation Safety, NFPA 70E, NFPA, OSHA, Aseptic Processing, Packaging, Granulation, Consumer Healthcare, Biotechnology, Vaccines, Project Planning, Project Management, Capital Projects, Capital Project Planning, CPM Scheduling, Engineering, 21 CFR Part 11, Computer System..., V&V, Quality System, Calibration, Project Engineering, Root Cause Analysis, Continuous Improvement, Process Simulation, GAMP, GxP, Process Engineering, Design of Experiments, Technology Transfer, Regulatory Affairs, Process Optimization, Quality Assurance, Regulatory Requirements, LIMS, Pharmaceutics, Quality Auditing, Quality Control
Education
Manhattan College 2002 — 2003
MS, Chemical Engineering
Manhattan College 1998 — 2002
BS, Chemical Engineering
Fougera Pharmaceuticals Inc., a Sandoz company June 2013 - Present
Pfizer October 2012 - June 2013
Pfizer November 2011 - October 2012
Pfizer October 2009 - October 2012
Wyeth Biotech December 2007 - October 2009
Wyeth Biotech June 2003 - December 2007
Ramylus International May 2002 - June 2003
Skills
Six Sigma, Training, Validation, GMP, Pharmaceutical Industry, Change Control, Sop, FDA, CAPA, Verification, OSHA SGE, OSHA 10, Excavation Safety, NFPA 70E, NFPA, OSHA, Aseptic Processing, Packaging, Granulation, Consumer Healthcare, Biotechnology, Vaccines, Project Planning, Project Management, Capital Projects, Capital Project Planning, CPM Scheduling, Engineering, 21 CFR Part 11, Computer System..., V&V, Quality System, Calibration, Project Engineering, Root Cause Analysis, Continuous Improvement, Process Simulation, GAMP, GxP, Process Engineering, Design of Experiments, Technology Transfer, Regulatory Affairs, Process Optimization, Quality Assurance, Regulatory Requirements, LIMS, Pharmaceutics, Quality Auditing, Quality Control
Education
Manhattan College 2002 — 2003
MS, Chemical Engineering
Manhattan College 1998 — 2002
BS, Chemical Engineering
William McDaniel William McDaniel's Wyeth Biotech Experience February 2002 - October 2009
Job Director, External Supply – Biotech Emerging Markets
Industry Biotechnology
Experience
Pfizer Pharmaceuticals January 2011 - Present
Pfizer October 2009 - February 2011
Wyeth Biotech February 2002 - October 2009
AEA / QSA 1997 - 2001
Amersham 1989 - 1997
Skills
Pharmaceutical Industry, Biotechnology, Technology Transfer, Vaccines, Medical Devices, GMP, Sop, CAPA, Computer System..., Process Simulation, Commercialization, Regulatory Submissions, Pharmaceutics, Lifesciences, Aseptic Processing, Quality System, Clinical Development, Manufacturing, Change Control, Biopharmaceuticals, Formulation, V&V, Regulatory Requirements, Validation, SOP, Life Sciences
Education
Keller Graduate School of Management of DeVry University 1983 — 1988
MBA, Operations & Marketing
University of Illinois at Chicago 1972 — 1977
BS, Biological Sciences
Pfizer Pharmaceuticals January 2011 - Present
Pfizer October 2009 - February 2011
Wyeth Biotech February 2002 - October 2009
AEA / QSA 1997 - 2001
Amersham 1989 - 1997
Skills
Pharmaceutical Industry, Biotechnology, Technology Transfer, Vaccines, Medical Devices, GMP, Sop, CAPA, Computer System..., Process Simulation, Commercialization, Regulatory Submissions, Pharmaceutics, Lifesciences, Aseptic Processing, Quality System, Clinical Development, Manufacturing, Change Control, Biopharmaceuticals, Formulation, V&V, Regulatory Requirements, Validation, SOP, Life Sciences
Education
Keller Graduate School of Management of DeVry University 1983 — 1988
MBA, Operations & Marketing
University of Illinois at Chicago 1972 — 1977
BS, Biological Sciences
Kimberly Lilley's Wyeth Biotech Experience February 2004 - April 2008
Job General Manager
Industry Financial Services
Experience
Sanford Broadcasting Group, Inc. March 2003 - Present
First Bank September 2013 - Present
PrimeLending July 2012 - May 2013
Woodmen of the World September 2011 - November 2012
Coty October 2010 - January 2011
Kelly Services, Inc. May 2010 - November 2010
SunTrust Mortgage February 2009 - March 2010
Kelly Services February 2009 - May 2009
Volt, Inc. July 2008 - December 2008
Wyeth Biotech February 2004 - April 2008
Skills
Insurance, Word, Microsoft Office, Accounting, Excel, PowerPoint, Mortgage Servicing, Sales, Microsoft Excel, Strategic Planning, Microsoft Word, Access, Management, Software Documentation, Human Resources, Teamwork, Banking, Analysis, Nonprofits, Process Improvement, Risk Management, Budgets, Employee Benefits, Mortgage Lending, Leadership, Team Building, Training
Education
Liberty University 2009 — 2009
MSM, Business Management
Liberty University 2006 — 2008
Bachelor's degree, Business management
Tennessee Temple University 1982 — 1985
Associates, General Business/Music
Sanford Broadcasting Group, Inc. March 2003 - Present
First Bank September 2013 - Present
PrimeLending July 2012 - May 2013
Woodmen of the World September 2011 - November 2012
Coty October 2010 - January 2011
Kelly Services, Inc. May 2010 - November 2010
SunTrust Mortgage February 2009 - March 2010
Kelly Services February 2009 - May 2009
Volt, Inc. July 2008 - December 2008
Wyeth Biotech February 2004 - April 2008
Skills
Insurance, Word, Microsoft Office, Accounting, Excel, PowerPoint, Mortgage Servicing, Sales, Microsoft Excel, Strategic Planning, Microsoft Word, Access, Management, Software Documentation, Human Resources, Teamwork, Banking, Analysis, Nonprofits, Process Improvement, Risk Management, Budgets, Employee Benefits, Mortgage Lending, Leadership, Team Building, Training
Education
Liberty University 2009 — 2009
MSM, Business Management
Liberty University 2006 — 2008
Bachelor's degree, Business management
Tennessee Temple University 1982 — 1985
Associates, General Business/Music
David Mitchell, CRM David Mitchell, CRM's Wyeth Biotech Experience September 2006 - April 2008
Job Director, Business Systems and ERecords at Copernicus Group IRB
Industry Pharmaceuticals
Experience
Copernicus Group IRB March 2013 - Present
Copernicus Group IRB May 2008 - March 2013
Wyeth Biotech September 2006 - April 2008
Teleflex Medical November 2005 - May 2006
Duke University November 2003 - October 2005
North Carolina State Archives June 2000 - October 2003
North Carolina State Archives September 1997 - May 2000
Education
North Carolina State University
Masters Degree, Public Administration
Wake Forest University
Bachelor of Arts, Speech Communications
Copernicus Group IRB March 2013 - Present
Copernicus Group IRB May 2008 - March 2013
Wyeth Biotech September 2006 - April 2008
Teleflex Medical November 2005 - May 2006
Duke University November 2003 - October 2005
North Carolina State Archives June 2000 - October 2003
North Carolina State Archives September 1997 - May 2000
Education
North Carolina State University
Masters Degree, Public Administration
Wake Forest University
Bachelor of Arts, Speech Communications
Donald Chamberlain Donald Chamberlain's Wyeth Biotech Experience January 1999 - April 2009
Job Technical Administrator at Chiller Technology Inc.
Industry Pharmaceuticals
Experience
Chiller Technology Inc. January 2013 - Present
Pfizer Pharmaceuticals April 2009 - July 2011
Wyeth Biotech January 1999 - April 2009
Skills
Project Planning, Training, Sop, GMP, Engineering, Change Control, Validation, CAPA, FDA, Instrumentation, Facilities Management, Biotechnology, 21 CFR Part 11, Pharmaceutical Industry
Education
Middlesex Community College 1988 — 1989
Certificate Progam, Business Administration
Coyne Electrical & Technical 1970 — 1972
Technical Certificate, Practical Electricity
Chiller Technology Inc. January 2013 - Present
Pfizer Pharmaceuticals April 2009 - July 2011
Wyeth Biotech January 1999 - April 2009
Skills
Project Planning, Training, Sop, GMP, Engineering, Change Control, Validation, CAPA, FDA, Instrumentation, Facilities Management, Biotechnology, 21 CFR Part 11, Pharmaceutical Industry
Education
Middlesex Community College 1988 — 1989
Certificate Progam, Business Administration
Coyne Electrical & Technical 1970 — 1972
Technical Certificate, Practical Electricity
Jennifer Weingarten's Wyeth Biotech Experience November 2006 - April 2008
Job Project Manager at The Harvard Drug Group
Industry Pharmaceuticals
Experience
The Harvard Drug Group July 2014 - Present
JHP Pharmaceuticals LLC September 2012 - July 2014
Par Pharmaceutical September 2012 - July 2014
Biogen Idec July 2009 - January 2011
Wyeth Biotech November 2006 - April 2008
Wyeth Biotech March 2002 - 2006
Williams-Sonoma, Inc. July 1999 - February 2002
Chevron February 1996 - July 1999
Skills
Packaging, GMP, Pharmaceutical Industry, Process Improvement, Supply Chain, Manufacturing, Change Control, Medical Devices
Education
Michigan State University 1991 — 1995
Bachelor of Science, Packaging
The Harvard Drug Group July 2014 - Present
JHP Pharmaceuticals LLC September 2012 - July 2014
Par Pharmaceutical September 2012 - July 2014
Biogen Idec July 2009 - January 2011
Wyeth Biotech November 2006 - April 2008
Wyeth Biotech March 2002 - 2006
Williams-Sonoma, Inc. July 1999 - February 2002
Chevron February 1996 - July 1999
Skills
Packaging, GMP, Pharmaceutical Industry, Process Improvement, Supply Chain, Manufacturing, Change Control, Medical Devices
Education
Michigan State University 1991 — 1995
Bachelor of Science, Packaging
Marc A. Roman Marc A. Roman's Wyeth Biotech Experience October 2004 - October 2005
Job QA Manager, US Distribution at GlaxoSmithKline LLC. (formerly Novartis Vaccines)
Industry Biotechnology
Experience
GlaxoSmthKline LLC (formerly Novartis Vaccines) August 2012 - Present
Novartis Vaccines and Diagnostics July 2010 - August 2012
Biolex Therapeutics February 2009 - April 2010
Biolex Therapeutics February 2007 - March 2009
Biolex Therapeutics October 2005 - February 2007
Wyeth Biotech October 2004 - October 2005
Wyeth Biotech May 2003 - October 2004
Wyeth Pharmaceuticals September 2002 - December 2002
Hoffmann-La Roche Inc. February 2000 - September 2002
Hoffmann-La Roche Inc. April 1998 - February 2000
Skills
GMP, Quality System, FDA, Validation, Vaccines, Quality Assurance, Manufacturing, Change Control, Biopharmaceuticals, Quality Control, cGMP, Quality Systems, CAPA, Sop, Quality Auditing, 21 CFR Part 11, Protein Chemistry, GLP, V&V, Purification, GxP, Aseptic Processing, Technology Transfer, Pharmaceutical Industry, R&D, Software Documentation, Chromatography, Recalls, Good Distribution..., Cold Chain, SOP
Education
Kean University 1990 — 1999
BA, Biology
Spalding University
GlaxoSmthKline LLC (formerly Novartis Vaccines) August 2012 - Present
Novartis Vaccines and Diagnostics July 2010 - August 2012
Biolex Therapeutics February 2009 - April 2010
Biolex Therapeutics February 2007 - March 2009
Biolex Therapeutics October 2005 - February 2007
Wyeth Biotech October 2004 - October 2005
Wyeth Biotech May 2003 - October 2004
Wyeth Pharmaceuticals September 2002 - December 2002
Hoffmann-La Roche Inc. February 2000 - September 2002
Hoffmann-La Roche Inc. April 1998 - February 2000
Skills
GMP, Quality System, FDA, Validation, Vaccines, Quality Assurance, Manufacturing, Change Control, Biopharmaceuticals, Quality Control, cGMP, Quality Systems, CAPA, Sop, Quality Auditing, 21 CFR Part 11, Protein Chemistry, GLP, V&V, Purification, GxP, Aseptic Processing, Technology Transfer, Pharmaceutical Industry, R&D, Software Documentation, Chromatography, Recalls, Good Distribution..., Cold Chain, SOP
Education
Kean University 1990 — 1999
BA, Biology
Spalding University
Patti Holdsworth's Wyeth Biotech Experience 1998 - 2002
Job Sr. Director, Product Strategy at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals June 2014 - Present
Shire Pharmaceuticals March 2013 - June 2014
Shire HGT November 2010 - March 2013
Shire HGT May 2006 - November 2010
ImmunoGen, Inc. 2002 - 2006
Wyeth Biotech 1998 - 2002
Genetics Institute, Inc. 1996 - 1998
Genetics Institute, Inc. 1994 - 1996
Genetics Institute, Inc. 1992 - 1994
U.S. Environmental Protection Agency 1990 - 1992
Skills
Technology Transfer, Biotechnology, Protein Purification, Validation, Global Alliance..., Commercialization, Biopharmaceuticals, Aseptic Processing, Clinical Development, Business Acumen, Contract Manufacturing, GMP, Process Simulation, FDA, CAPA, Sop, Change Control, Collaboration, SOP
Education
University of Massachusetts Lowell
Masters of Science, Chemical Engineering
University of Massachusetts Lowell
Bachelors of Science, Chemical Engineering
MIT Sloan School of Management
Executive Education Certificate, Strategies & Innovations
Shire Pharmaceuticals June 2014 - Present
Shire Pharmaceuticals March 2013 - June 2014
Shire HGT November 2010 - March 2013
Shire HGT May 2006 - November 2010
ImmunoGen, Inc. 2002 - 2006
Wyeth Biotech 1998 - 2002
Genetics Institute, Inc. 1996 - 1998
Genetics Institute, Inc. 1994 - 1996
Genetics Institute, Inc. 1992 - 1994
U.S. Environmental Protection Agency 1990 - 1992
Skills
Technology Transfer, Biotechnology, Protein Purification, Validation, Global Alliance..., Commercialization, Biopharmaceuticals, Aseptic Processing, Clinical Development, Business Acumen, Contract Manufacturing, GMP, Process Simulation, FDA, CAPA, Sop, Change Control, Collaboration, SOP
Education
University of Massachusetts Lowell
Masters of Science, Chemical Engineering
University of Massachusetts Lowell
Bachelors of Science, Chemical Engineering
MIT Sloan School of Management
Executive Education Certificate, Strategies & Innovations
M. Umar Sherwani M. Umar Sherwani's Wyeth Biotech Experience September 2006 - December 2009
Job Technical Services Manager at Pfizer Pharmaceuticals
Industry Pharmaceuticals
Experience
Pfizer Pharmaceuticals January 2010 - Present
Wyeth Biotech September 2006 - December 2009
Wyeth Pharmaceuticals December 2003 - August 2006
EZEM December 2002 - November 2003
EZEM November 1995 - November 2002
Skills
GMP, FDA, Validation, Pharmaceutical Industry, Sop
Education
New York Law School 2011 — 2015
Juris Doctor (J.D.), Patent/ IP Law
LIU Post 1997 — 2000
MS, Medical Biology
Stony Brook University 1993 — 1995
BS, Biochemistry
Pfizer Pharmaceuticals January 2010 - Present
Wyeth Biotech September 2006 - December 2009
Wyeth Pharmaceuticals December 2003 - August 2006
EZEM December 2002 - November 2003
EZEM November 1995 - November 2002
Skills
GMP, FDA, Validation, Pharmaceutical Industry, Sop
Education
New York Law School 2011 — 2015
Juris Doctor (J.D.), Patent/ IP Law
LIU Post 1997 — 2000
MS, Medical Biology
Stony Brook University 1993 — 1995
BS, Biochemistry
Joseph Dorando Joseph Dorando's Wyeth Biotech Experience June 2006 - January 2008
Job Complaints Manager at Prestige Brands
Industry Mechanical or Industrial Engineering
Experience
Prestige Brands February 2014 - Present
Parexel Consulting June 2012 - Present
Protocol Link July 2010 - Present
Lachman Consultants June 2008 - Present
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Wyeth Biotech June 2006 - January 2008
Wyeth May 1992 - January 2008
Skills
LIMS, Sop, 21 CFR Part 11, FDA, Validation, Quality Assurance, Management, Regulatory Affairs, Lifesciences, Pharmaceutical Industry, Medical Devices, Quality System, CAPA, Change Control, GLP, Computer System..., Quality Control, HPLC, Software Documentation, GCP, GMP, Cross-functional Team..., Quality Auditing, Document Management, Clinical Development
Education
Montclair State University 1973 — 1977
Bachelors Degree, Chemistry
Prestige Brands February 2014 - Present
Parexel Consulting June 2012 - Present
Protocol Link July 2010 - Present
Lachman Consultants June 2008 - Present
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Parexel Consulting 2012 - 2013
Wyeth Biotech June 2006 - January 2008
Wyeth May 1992 - January 2008
Skills
LIMS, Sop, 21 CFR Part 11, FDA, Validation, Quality Assurance, Management, Regulatory Affairs, Lifesciences, Pharmaceutical Industry, Medical Devices, Quality System, CAPA, Change Control, GLP, Computer System..., Quality Control, HPLC, Software Documentation, GCP, GMP, Cross-functional Team..., Quality Auditing, Document Management, Clinical Development
Education
Montclair State University 1973 — 1977
Bachelors Degree, Chemistry
Eric Hastings's Wyeth Biotech Experience 2004 - 2008
Job at
Industry Biotechnology
Experience
Biogen January 2015 - Present
Biogen Idec July 2011 - January 2015
Novartis Vaccines and Diagnostics August 2009 - August 2011
Biolex March 2009 - August 2009
Wyeth Biotech 2004 - 2008
Bayer HealthCare 1999 - 2004
Skills
Validation, LIMS, GMP, FDA, Pharmaceutical Industry, Sop, CAPA, Biotechnology, GLP, Lifesciences, Change Control, Trackwise, Microbiology, Analytical Chemistry, Aseptic Processing, 21 CFR Part 11, Quality Control
Education
North Carolina State University 1991 — 1998
BS, Microbiology; Genetics
Biogen January 2015 - Present
Biogen Idec July 2011 - January 2015
Novartis Vaccines and Diagnostics August 2009 - August 2011
Biolex March 2009 - August 2009
Wyeth Biotech 2004 - 2008
Bayer HealthCare 1999 - 2004
Skills
Validation, LIMS, GMP, FDA, Pharmaceutical Industry, Sop, CAPA, Biotechnology, GLP, Lifesciences, Change Control, Trackwise, Microbiology, Analytical Chemistry, Aseptic Processing, 21 CFR Part 11, Quality Control
Education
North Carolina State University 1991 — 1998
BS, Microbiology; Genetics
Sean Lowery Sean Lowery's Wyeth Biotech Experience 2000 - 2004
Job GxP Training Manager at Nesher Pharmaceuticals (USA) LLC
Industry Business Supplies and Equipment
Experience
Nesher Pharmaceuticals (USA) LLC February 2012 - Present
Nesher Pharmaceuticals (USA) LLC November 2010 - February 2012
United Stationers January 2010 - November 2010
OfficeSource June 2008 - January 2010
KV Pharmaceutical February 2007 - June 2008
Covidien February 2006 - January 2007
Centocor Biologics, LLC 2002 - 2006
Centocor 2000 - 2006
Wyeth Biotech 2000 - 2004
Skills
GMP, GxP, Quality System, Quality Assurance, Software Documentation, Quality Control, Validation, Biotechnology, Sop, FDA, Training, CAPA, Change Control, Quality Auditing, 21 CFR Part 11, Quality Management, Root Cause Analysis, Continuous Improvement, Technical Writing, Aseptic Processing, SOP development, Pharmaceutical Industry, V
Education
Monmouth College 1995 — 2000
Bachelor of Arts (B.A.), Biology and Secondary Education
Nesher Pharmaceuticals (USA) LLC February 2012 - Present
Nesher Pharmaceuticals (USA) LLC November 2010 - February 2012
United Stationers January 2010 - November 2010
OfficeSource June 2008 - January 2010
KV Pharmaceutical February 2007 - June 2008
Covidien February 2006 - January 2007
Centocor Biologics, LLC 2002 - 2006
Centocor 2000 - 2006
Wyeth Biotech 2000 - 2004
Skills
GMP, GxP, Quality System, Quality Assurance, Software Documentation, Quality Control, Validation, Biotechnology, Sop, FDA, Training, CAPA, Change Control, Quality Auditing, 21 CFR Part 11, Quality Management, Root Cause Analysis, Continuous Improvement, Technical Writing, Aseptic Processing, SOP development, Pharmaceutical Industry, V
Education
Monmouth College 1995 — 2000
Bachelor of Arts (B.A.), Biology and Secondary Education
Horace_ Rozier's Wyeth Biotech Experience June 2004 - June 2006
Job EHS Manager at Becton Dickinson Technologies
Industry Medical Devices
Experience
Becton Dickinson 2006 - Present
Alliance of Hazardous Materials Professionals 1998 - 2012
ASSE RTP Chapter 1994 - 2012
Wyeth Biotech June 2004 - June 2006
GlaxoSmithKline August 1992 - October 2003
Skills
EHS, Safety Management, Safety Management..., Auditing, Ergonomics, Hazardous Waste..., Compliance, Hazardous Materials, Emergency Management, Industrial Hygiene, Occupational Health, Industrial Safety, Radiation Safety, GMP, Environmental..., Root Cause Analysis, Environmental Compliance, Accident Investigation, Workplace Safety, Construction Safety, Training, ISO 14001, RCRA, Quality System, Environmental Awareness, Process Safety, HAZWOPER, EPA, Risk Assessment, Hazard Analysis
Education
North Carolina State University 1983 — 1989
BS, Double Major in Biochemistry and Microbiology
Becton Dickinson 2006 - Present
Alliance of Hazardous Materials Professionals 1998 - 2012
ASSE RTP Chapter 1994 - 2012
Wyeth Biotech June 2004 - June 2006
GlaxoSmithKline August 1992 - October 2003
Skills
EHS, Safety Management, Safety Management..., Auditing, Ergonomics, Hazardous Waste..., Compliance, Hazardous Materials, Emergency Management, Industrial Hygiene, Occupational Health, Industrial Safety, Radiation Safety, GMP, Environmental..., Root Cause Analysis, Environmental Compliance, Accident Investigation, Workplace Safety, Construction Safety, Training, ISO 14001, RCRA, Quality System, Environmental Awareness, Process Safety, HAZWOPER, EPA, Risk Assessment, Hazard Analysis
Education
North Carolina State University 1983 — 1989
BS, Double Major in Biochemistry and Microbiology
Erik Lemay Erik Lemay's Wyeth Biotech Experience January 2009 - October 2009
Job Director, Program Management at BristolMyers Squibb
Industry Biotechnology
Experience
Bristol-Myers Squibb May 2013 - Present
Pfizer October 2009 - May 2013
Wyeth Biotech January 2009 - October 2009
Wyeth Biotech January 2007 - January 2009
Wyeth Biotech September 2002 - January 2007
Wyeth Biotech March 2001 - September 2002
Bayer Diagnostics December 1997 - March 2001
Bayer Diagnostics December 1996 - December 1997
Bayer Diagnostics November 1995 - December 1996
Skills
Technology Transfer, Cross-functional Team..., Contract Manufacturing, Project Management, Strategic Planning, Product Launch, Business Development, Operations Management, Negotiation, Relationship Management, Lyophilization, Capacity Planning, Biotechnology, Pharmaceutical Industry, Medical Devices, Drug Development, Strategic Alliances, CMC development, Aseptic Processing, Regulatory Submissions, Drug Delivery, Biopharmaceuticals, GMP, Sop, Vaccines
Education
Ithaca College 1991 — 1995
B.A., Biochemistry
Bristol-Myers Squibb May 2013 - Present
Pfizer October 2009 - May 2013
Wyeth Biotech January 2009 - October 2009
Wyeth Biotech January 2007 - January 2009
Wyeth Biotech September 2002 - January 2007
Wyeth Biotech March 2001 - September 2002
Bayer Diagnostics December 1997 - March 2001
Bayer Diagnostics December 1996 - December 1997
Bayer Diagnostics November 1995 - December 1996
Skills
Technology Transfer, Cross-functional Team..., Contract Manufacturing, Project Management, Strategic Planning, Product Launch, Business Development, Operations Management, Negotiation, Relationship Management, Lyophilization, Capacity Planning, Biotechnology, Pharmaceutical Industry, Medical Devices, Drug Development, Strategic Alliances, CMC development, Aseptic Processing, Regulatory Submissions, Drug Delivery, Biopharmaceuticals, GMP, Sop, Vaccines
Education
Ithaca College 1991 — 1995
B.A., Biochemistry
Evelyn Chang, M.S., CLSSBB's Wyeth Biotech Experience December 2009 - December 2010
Job Corporate Manager, Entrepreneur, Certified Lean Six Sigma Black Belt
Industry Pharmaceuticals
Experience
Hotkist Creations June 2009 - Present
G&W Laboratories April 2015 - Present
G&W Laboratories August 2013 - August 2015
G&W Laboratories December 2012 - July 2013
Pfizer PGM December 2010 - September 2012
Pfizer Specialty and Biotechnology December 2009 - December 2010
Wyeth Biotech December 2009 - December 2010
Wyeth Biotech May 2007 - November 2009
Wyeth Biotech March 2006 - May 2007
for Wyeth Biotech July 2005 - March 2006
Skills
Validation, GMP, FDA, CAPA, Change Control, Computer System..., Quality Assurance, 21 CFR Part 11, GxP, Pharmaceutical Industry, V&V, Technology Transfer, Vaccines, Biotechnology, SOP, Quality System, Software Documentation, LIMS, Regulatory Submissions, Formulation, Cleaning Validation, Six Sigma, GLP, Laboratory, Manufacturing, Continuous Improvement, Lean Manufacturing, Process Improvement, Quality Control, ISO 13485, GAMP, Root Cause Analysis, Medical Devices, Aseptic Processing, Process Validation, Quality Engineering, cGMP, Technical Writing, Minitab, Process Engineering, Pharmaceuticals, Documentation, Lean Six Sigma, Project Management
Education
Rutgers University-New Brunswick
Master of Business Administration (M.B.A.), Supply Chain Management
New Jersey Institute of Technology
MS, Pharmaceutical Engineering
New Jersey Institute of Technology
BS, Computer Engineer
Hotkist Creations June 2009 - Present
G&W Laboratories April 2015 - Present
G&W Laboratories August 2013 - August 2015
G&W Laboratories December 2012 - July 2013
Pfizer PGM December 2010 - September 2012
Pfizer Specialty and Biotechnology December 2009 - December 2010
Wyeth Biotech December 2009 - December 2010
Wyeth Biotech May 2007 - November 2009
Wyeth Biotech March 2006 - May 2007
for Wyeth Biotech July 2005 - March 2006
Skills
Validation, GMP, FDA, CAPA, Change Control, Computer System..., Quality Assurance, 21 CFR Part 11, GxP, Pharmaceutical Industry, V&V, Technology Transfer, Vaccines, Biotechnology, SOP, Quality System, Software Documentation, LIMS, Regulatory Submissions, Formulation, Cleaning Validation, Six Sigma, GLP, Laboratory, Manufacturing, Continuous Improvement, Lean Manufacturing, Process Improvement, Quality Control, ISO 13485, GAMP, Root Cause Analysis, Medical Devices, Aseptic Processing, Process Validation, Quality Engineering, cGMP, Technical Writing, Minitab, Process Engineering, Pharmaceuticals, Documentation, Lean Six Sigma, Project Management
Education
Rutgers University-New Brunswick
Master of Business Administration (M.B.A.), Supply Chain Management
New Jersey Institute of Technology
MS, Pharmaceutical Engineering
New Jersey Institute of Technology
BS, Computer Engineer
Dominique Sexton's Wyeth Biotech Experience February 1993 - December 2009
Job Plant Manager at Zoetis
Industry Biotechnology
Experience
Zoetis July 2013 - Present
health and wellness industry May 2008 - Present
Pfizer Animal Health April 2012 - July 2013
Pfizer 2009 - April 2012
Wyeth Biotech February 1993 - December 2009
Genzyme Biosurgery September 1989 - February 1993
Skills
GMP, Pharmaceutical Industry, Operations Management, Operational Excellence, Manufacturing..., 21 CFR Part 11, Biopharmaceuticals, Biotechnology, CAPA, Change Control, Chemistry, Clinical Research, Clinical Trials, Coaching, Cross-functional Team..., FDA, GLP, LIMS, Laboratory, Lifesciences, Manufacturing, Medical Devices, Nutrition, Process Improvement, Quality Assurance, Quality System, Software Documentation, Sop, Technology Transfer, Validation, Wellness
Education
Wellcoaches 2008 — 2008
Lesley University 1995 — 1996
MS
Salve Regina University 1985 — 1989
BS
Zoetis July 2013 - Present
health and wellness industry May 2008 - Present
Pfizer Animal Health April 2012 - July 2013
Pfizer 2009 - April 2012
Wyeth Biotech February 1993 - December 2009
Genzyme Biosurgery September 1989 - February 1993
Skills
GMP, Pharmaceutical Industry, Operations Management, Operational Excellence, Manufacturing..., 21 CFR Part 11, Biopharmaceuticals, Biotechnology, CAPA, Change Control, Chemistry, Clinical Research, Clinical Trials, Coaching, Cross-functional Team..., FDA, GLP, LIMS, Laboratory, Lifesciences, Manufacturing, Medical Devices, Nutrition, Process Improvement, Quality Assurance, Quality System, Software Documentation, Sop, Technology Transfer, Validation, Wellness
Education
Wellcoaches 2008 — 2008
Lesley University 1995 — 1996
MS
Salve Regina University 1985 — 1989
BS
Robert Shaw Robert Shaw's Wyeth Biotech Experience 2002 - 2005
Job Vice President, Integrated Solutions and Product Management at Thermo Fisher Scientific (Life Technologies)
Industry Biotechnology
Experience
Thermo Fisher Scientific June 2015 - Present
Thermo Fisher Scientific (Life Technologies) December 2014 - Present
Progenitor Cell Therapy August 2013 - Present
Millipore Corp February 2010 - July 2013
Millipore 2005 - 2010
Wyeth BioPharma 2002 - 2005
Wyeth Biotech 2002 - 2005
Sanofi Pasteur 1985 - 1992
Skills
Biopharmaceuticals, Change Management, Biotechnology, Market Access, Lifesciences, Commercialization, Pharmaceutical Industry, Technology Transfer, Vaccines, Medical Devices, Immunology, GMP, Product Launch, Drug Discovery, FDA
Education
Loyola College in Maryland 1993 — 1996
Master of Business Administration (MBA), Business Administration and Management, General
Thermo Fisher Scientific June 2015 - Present
Thermo Fisher Scientific (Life Technologies) December 2014 - Present
Progenitor Cell Therapy August 2013 - Present
Millipore Corp February 2010 - July 2013
Millipore 2005 - 2010
Wyeth BioPharma 2002 - 2005
Wyeth Biotech 2002 - 2005
Sanofi Pasteur 1985 - 1992
Skills
Biopharmaceuticals, Change Management, Biotechnology, Market Access, Lifesciences, Commercialization, Pharmaceutical Industry, Technology Transfer, Vaccines, Medical Devices, Immunology, GMP, Product Launch, Drug Discovery, FDA
Education
Loyola College in Maryland 1993 — 1996
Master of Business Administration (MBA), Business Administration and Management, General
William Bieber's Wyeth Biotech Experience 2006 - 2010
Job Sr.Manager/TL Plant Eng/Maint/Utili at Pfizer
Industry Biotechnology
Experience
Pfizer September 2011 - Present
Pfizer May 1998 - Present
Wyeth/Pfizer June 2010 - May 2011
Wyeth Biotech 2006 - 2010
Wyeth September 2001 - June 2006
Wyeth Biotech May 1998 - September 2001
Sartorius Corporation January 1995 - January 1998
Helen Hayes Hospital January 1990 - January 1995
Jullien Enterprises January 1990 - May 1990
North Rockland Central School January 1982 - January 1990
Skills
Vaccines, GMP, FDA, Validation, Medical Devices, Sop, Root Cause Analysis, Technology Transfer, 21 CFR Part 11, Calibration, Project Engineering, Biotechnology, Process Control, PLC, Instrumentation, Project Management, Manufacturing, Pharmaceutical Industry, CAPA, Engineering, GAMP, Contract Manufacturing, V&V, GxP, Computer System..., Electronics, Change Control, Quality System, Troubleshooting
Education
Iona College
B.S, Behavioral Science
RCC 1989 — 1992
AOS, Electronics
Rockland Community College
AOS, Electrical Technology
DeVry Technical Institute
Pfizer September 2011 - Present
Pfizer May 1998 - Present
Wyeth/Pfizer June 2010 - May 2011
Wyeth Biotech 2006 - 2010
Wyeth September 2001 - June 2006
Wyeth Biotech May 1998 - September 2001
Sartorius Corporation January 1995 - January 1998
Helen Hayes Hospital January 1990 - January 1995
Jullien Enterprises January 1990 - May 1990
North Rockland Central School January 1982 - January 1990
Skills
Vaccines, GMP, FDA, Validation, Medical Devices, Sop, Root Cause Analysis, Technology Transfer, 21 CFR Part 11, Calibration, Project Engineering, Biotechnology, Process Control, PLC, Instrumentation, Project Management, Manufacturing, Pharmaceutical Industry, CAPA, Engineering, GAMP, Contract Manufacturing, V&V, GxP, Computer System..., Electronics, Change Control, Quality System, Troubleshooting
Education
Iona College
B.S, Behavioral Science
RCC 1989 — 1992
AOS, Electronics
Rockland Community College
AOS, Electrical Technology
DeVry Technical Institute
Kathleen Allan Kathleen Allan's Wyeth Biotech Experience May 2007 - August 2009
Job Customer Regulatory and Quality Inquiries Specialist at EMD Millipore
Industry Biotechnology
Experience
EMD Millipore August 2009 - Present
Wyeth Biotech May 2007 - August 2009
Baylor University Medical Center March 2002 - April 2007
Stephens & Associates May 2000 - February 2002
Genetics Institute April 1996 - September 1999
Skills
GMP, HPLC, GLP, SDS-PAGE, Protein Purification, Microbiology, Cell Culture, Biotechnology, Pharmaceutical Industry, ELISA, Cell Biology, Molecular Biology, FDA, Assay Development, Technology Transfer
Education
Michigan State University
BS/MA, Microbiology, Chemistry
EMD Millipore August 2009 - Present
Wyeth Biotech May 2007 - August 2009
Baylor University Medical Center March 2002 - April 2007
Stephens & Associates May 2000 - February 2002
Genetics Institute April 1996 - September 1999
Skills
GMP, HPLC, GLP, SDS-PAGE, Protein Purification, Microbiology, Cell Culture, Biotechnology, Pharmaceutical Industry, ELISA, Cell Biology, Molecular Biology, FDA, Assay Development, Technology Transfer
Education
Michigan State University
BS/MA, Microbiology, Chemistry
Robert Repetto Robert Repetto's Wyeth Biotech Experience December 2008 - October 2009
Job Senior Director at Pfizer
Industry Biotechnology
Experience
Pfizer April 2012 - Present
Pfizer October 2009 - June 2012
Wyeth Biotech December 2008 - October 2009
Wyeth Biotech January 2006 - December 2008
Lederle-Praxis Biologics 1995 - 1997
Skills
Biotechnology, Technology Transfer, Pharmaceutical Industry, GMP, Biopharmaceuticals, FDA, Validation, Lifesciences, Vaccines, R&D, Regulatory Affairs, Clinical Development, SOP, GLP, Drug Development, Change Control, CAPA, Cross-functional Team..., 21 CFR Part 11, V&V, Drug Discovery, Clinical Trials, Regulatory Submissions, Quality System
Education
Iona College 2001 — 2004
MBA, Decision Analysis
New York University - Polytechnic School of Engineering 1987 — 1988
Ms, Bioengineering
Manhattan College 1981 — 1986
be, Chemical Engineering
Pfizer April 2012 - Present
Pfizer October 2009 - June 2012
Wyeth Biotech December 2008 - October 2009
Wyeth Biotech January 2006 - December 2008
Lederle-Praxis Biologics 1995 - 1997
Skills
Biotechnology, Technology Transfer, Pharmaceutical Industry, GMP, Biopharmaceuticals, FDA, Validation, Lifesciences, Vaccines, R&D, Regulatory Affairs, Clinical Development, SOP, GLP, Drug Development, Change Control, CAPA, Cross-functional Team..., 21 CFR Part 11, V&V, Drug Discovery, Clinical Trials, Regulatory Submissions, Quality System
Education
Iona College 2001 — 2004
MBA, Decision Analysis
New York University - Polytechnic School of Engineering 1987 — 1988
Ms, Bioengineering
Manhattan College 1981 — 1986
be, Chemical Engineering
Emeka Chiedu Emeka Chiedu's Wyeth Biotech Experience March 2004 - December 2008
Job Senior Product Engineer at Siemens Healthcare
Industry Medical Devices
Experience
Siemens Healthcare April 2014 - Present
QLP Consulting LLC November 2009 - Present
MAKO Surgical Corp. February 2012 - April 2014
Zimmer January 2010 - November 2011
Pfizer January 2009 - November 2009
Wyeth Biotech March 2004 - December 2008
Skills
Project Portfolio..., Lean Six Sigma (Black &..., Quality Engineering, Six Sigma, Quality Control, Lean Manufacturing, Quality Assurance, Black, Management, Training, Manufacturing, MS Project, Project Management, Testing, Software Documentation, Process Improvement, Validation, Quality Management, Quality System, Continuous Improvement, Sop, 21 CFR Part 11, GMP, FDA, Leadership, Strategy, Computer System..., CAPA, Project Planning, Business Process..., GxP, GAMP, Process Simulation, Process Engineering, Technology Transfer, Pharmaceutical Industry, Cross-functional Team..., Quality Auditing, LIMS, V&V, Root Cause Analysis, FMEA, Medical Devices, Biotechnology, ISO 13485, Regulatory Affairs, Aseptic Processing, GLP
Education
St. Benedict's Preparatory School
New Jersey Institute of Technology 1995 — 2001
B.S., Chemical Engineering
Acuity Institute 2012 — 2013
Six Sigma Black Belt, Continuous Improvement
Siemens Healthcare April 2014 - Present
QLP Consulting LLC November 2009 - Present
MAKO Surgical Corp. February 2012 - April 2014
Zimmer January 2010 - November 2011
Pfizer January 2009 - November 2009
Wyeth Biotech March 2004 - December 2008
Skills
Project Portfolio..., Lean Six Sigma (Black &..., Quality Engineering, Six Sigma, Quality Control, Lean Manufacturing, Quality Assurance, Black, Management, Training, Manufacturing, MS Project, Project Management, Testing, Software Documentation, Process Improvement, Validation, Quality Management, Quality System, Continuous Improvement, Sop, 21 CFR Part 11, GMP, FDA, Leadership, Strategy, Computer System..., CAPA, Project Planning, Business Process..., GxP, GAMP, Process Simulation, Process Engineering, Technology Transfer, Pharmaceutical Industry, Cross-functional Team..., Quality Auditing, LIMS, V&V, Root Cause Analysis, FMEA, Medical Devices, Biotechnology, ISO 13485, Regulatory Affairs, Aseptic Processing, GLP
Education
St. Benedict's Preparatory School
New Jersey Institute of Technology 1995 — 2001
B.S., Chemical Engineering
Acuity Institute 2012 — 2013
Six Sigma Black Belt, Continuous Improvement
Marianne Reilly Marianne Reilly's Wyeth Biotech Experience 2006 - 2008
Job Suite Coordinator Specialist for Fabrazyme
Industry Biotechnology
Experience
Genzyme, a Sanofi company July 2014 - Present
Genzyme a Sanofi Co. February 2012 - June 2014
Genzyme August 2011 - February 2012
Pfizer Specialty Care 2008 - 2011
Wyeth Biotech 2006 - 2008
Wyeth 2001 - 2006
Phillips Academy 1981 - 1985
Skills
GMP, Cleaning Validation, LIMS, Auditing, Validation, SOP, Quality Assurance, Sop, Software Documentation, Change Control, CAPA, Quality System, Biotechnology, Biopharmaceuticals, Technology Transfer, FDA, 21 CFR Part 11, Trackwise
Education
Northern Essex Community College 2014 — 2015
Project Management Certificate
Lesley University 2002 — 2004
MS, Business Management
Katharine Gibbs
Certified, Exececutive Assistant
Merrimack College
Psychology
Saint Lawrence University
BS, Biology
Genzyme, a Sanofi company July 2014 - Present
Genzyme a Sanofi Co. February 2012 - June 2014
Genzyme August 2011 - February 2012
Pfizer Specialty Care 2008 - 2011
Wyeth Biotech 2006 - 2008
Wyeth 2001 - 2006
Phillips Academy 1981 - 1985
Skills
GMP, Cleaning Validation, LIMS, Auditing, Validation, SOP, Quality Assurance, Sop, Software Documentation, Change Control, CAPA, Quality System, Biotechnology, Biopharmaceuticals, Technology Transfer, FDA, 21 CFR Part 11, Trackwise
Education
Northern Essex Community College 2014 — 2015
Project Management Certificate
Lesley University 2002 — 2004
MS, Business Management
Katharine Gibbs
Certified, Exececutive Assistant
Merrimack College
Psychology
Saint Lawrence University
BS, Biology
Jeryl Dorsey Jeryl Dorsey's Wyeth Biotech Experience 2003 - 2006
Job Quality Assurance Specialist at Discovery Labs
Industry Biotechnology
Experience
Discovery Labs 2012 - Present
Pfizer 2006 - 2011
Wyeth Biotech 2003 - 2006
Wyeth-Lederle Vaccines, Pearl River, NY 2000 - 2003
Skills
Aseptic Technique, AQL, Pharmaceutical Industry, GMP, CAPA, SOP, Validation, 21 CFR Part 11, Change Control, FDA, LIMS, Quality Assurance, Batch Records, Trackwise
Education
Mercy College
B.S., Biology
State University of New York at Rockland
A.A.S, Nutrition
Discovery Labs 2012 - Present
Pfizer 2006 - 2011
Wyeth Biotech 2003 - 2006
Wyeth-Lederle Vaccines, Pearl River, NY 2000 - 2003
Skills
Aseptic Technique, AQL, Pharmaceutical Industry, GMP, CAPA, SOP, Validation, 21 CFR Part 11, Change Control, FDA, LIMS, Quality Assurance, Batch Records, Trackwise
Education
Mercy College
B.S., Biology
State University of New York at Rockland
A.A.S, Nutrition
Mario Villanueva Jr.'s Wyeth Biotech Experience October 2004 - November 2008
Job Pharmaceutical/Biotechnology Professional
Industry Biotechnology
Experience
Laboratory Corporations of America November 2010 - Present
Gorbec Pharmaceuticals Services Inc. February 2010 - April 2010
Wyeth Biotech October 2004 - November 2008
Schwarz Pharma February 2001 - September 2004
Kelly Scientic/Albermarle Corp. August 2000 - December 2000
Kaiser Aluminum September 1998 - August 2000
Lab Support/SGS Control Services February 1998 - August 1998
Skills
HPLC, Wet Chemistry, Conductivity, Analytical Chemistry, LIMS, UV/Vis, GMP, Gas Chromatography, Sop, FDA, Laboratory, LC-MS, Dissolution, UV, Biotechnology, Cleaning Validation, Quality Control, USP, Aseptic Technique, Titration, GLP, Chromatography, Mass Spectrometry, Environmental Monitoring, Vaccines, Trackwise, SOP
Education
Nicholls State University 1990 — 1995
BS, Marine Biology
Brother Martin High School 1981 — 1984
High School Diploma, College Prep
Laboratory Corporations of America November 2010 - Present
Gorbec Pharmaceuticals Services Inc. February 2010 - April 2010
Wyeth Biotech October 2004 - November 2008
Schwarz Pharma February 2001 - September 2004
Kelly Scientic/Albermarle Corp. August 2000 - December 2000
Kaiser Aluminum September 1998 - August 2000
Lab Support/SGS Control Services February 1998 - August 1998
Skills
HPLC, Wet Chemistry, Conductivity, Analytical Chemistry, LIMS, UV/Vis, GMP, Gas Chromatography, Sop, FDA, Laboratory, LC-MS, Dissolution, UV, Biotechnology, Cleaning Validation, Quality Control, USP, Aseptic Technique, Titration, GLP, Chromatography, Mass Spectrometry, Environmental Monitoring, Vaccines, Trackwise, SOP
Education
Nicholls State University 1990 — 1995
BS, Marine Biology
Brother Martin High School 1981 — 1984
High School Diploma, College Prep
Shaun LeBlanc's Wyeth Biotech Experience March 2003 - October 2009
Job Software Compliance & Control
Industry Medical Devices
Experience
Philips Healthcare January 2015 - Present
Genzyme (A Sanofi Company) December 2012 - December 2014
Vertex Pharmaceuticals September 2011 - December 2012
Pfizer 2009 - September 2011
Wyeth Biotech March 2003 - October 2009
Parexel June 2001 - March 2003
Meditech 1998 - 2000
Skills
Process Improvement, Business Analysis, Change Management, Project Portfolio..., Quality Management, Operational Excellence, Continuous Improvement, Project Planning, Computer System..., SDLC, 21 CFR Part 11, Change Control, GxP, GAMP, FDA, ITIL, Business Process..., Program Management, ITIL v3 Foundations..., Software Quality..., Requirements Analysis, Knowledge Management, Learning Management..., Lean Six Sigma, IT Compliance
Education
University of New Hampshire 1994 — 1998
Bachelor's degree, Biotechnology
Merrimack College
Project Management
Philips Healthcare January 2015 - Present
Genzyme (A Sanofi Company) December 2012 - December 2014
Vertex Pharmaceuticals September 2011 - December 2012
Pfizer 2009 - September 2011
Wyeth Biotech March 2003 - October 2009
Parexel June 2001 - March 2003
Meditech 1998 - 2000
Skills
Process Improvement, Business Analysis, Change Management, Project Portfolio..., Quality Management, Operational Excellence, Continuous Improvement, Project Planning, Computer System..., SDLC, 21 CFR Part 11, Change Control, GxP, GAMP, FDA, ITIL, Business Process..., Program Management, ITIL v3 Foundations..., Software Quality..., Requirements Analysis, Knowledge Management, Learning Management..., Lean Six Sigma, IT Compliance
Education
University of New Hampshire 1994 — 1998
Bachelor's degree, Biotechnology
Merrimack College
Project Management
Nathalie Hayduk's Wyeth Biotech Experience 2005 - 2010
Job
Industry Biotechnology
Experience
Pfizer 2010 - Present
Wyeth Biotech 2005 - 2010
Wyeth May 2001 - December 2004
Biogen 1997 - 2001
Serono 1996 - 1997
Skills
Product Launch, Commercialization, FDA, Cross-functional Team..., Pharmaceutical Industry, Product Development, Biotechnology, Regulatory Affairs, GMP, Lifesciences, Biopharmaceuticals, Project Management, Vaccines, Technology Transfer, Validation, Drug Discovery, GLP, Assay Development
Education
Rensselaer Polytechnic Institute 1992 — 1995
MS, Chemical Engineering
Manhattan College 1988 — 1992
BS, Chemical Engineering
Pfizer 2010 - Present
Wyeth Biotech 2005 - 2010
Wyeth May 2001 - December 2004
Biogen 1997 - 2001
Serono 1996 - 1997
Skills
Product Launch, Commercialization, FDA, Cross-functional Team..., Pharmaceutical Industry, Product Development, Biotechnology, Regulatory Affairs, GMP, Lifesciences, Biopharmaceuticals, Project Management, Vaccines, Technology Transfer, Validation, Drug Discovery, GLP, Assay Development
Education
Rensselaer Polytechnic Institute 1992 — 1995
MS, Chemical Engineering
Manhattan College 1988 — 1992
BS, Chemical Engineering
Prasanna Srinivasan's Wyeth Biotech Experience January 2007 - June 2008
Job Quality Manager
Industry Semiconductors
Experience
Entegris September 2015 - Present
ATMI May 2013 - August 2015
Nice-Pak Products, Inc. January 2012 - April 2013
Nicepak PDI July 2008 - December 2011
Wyeth Biotech January 2007 - June 2008
Wyeth Consumer Healthcare September 2006 - December 2006
Wyeth Pharmaceuticals March 2006 - August 2006
NJIT January 2005 - December 2005
Skills
Validation, Laboratory, Fermentation, Sterilization, Testing, LIMS, Aseptic Processing, FDA, GMP, Process Simulation, Purification, Organic Chemistry, Cell Culture, V&V, CAPA, Protein Purification, Cleaning Validation, GLP, Sop, Change Control, 21 CFR Part 11, Cross-functional Team..., Pharmaceutical Industry, Quality Management, SOP
Education
New Jersey Institute of Technology 2004 — 2005
M.S, Chemical Engineering
University of Madras 1999 — 2003
B.Tech, Chemical Engineer
Psbb
Entegris September 2015 - Present
ATMI May 2013 - August 2015
Nice-Pak Products, Inc. January 2012 - April 2013
Nicepak PDI July 2008 - December 2011
Wyeth Biotech January 2007 - June 2008
Wyeth Consumer Healthcare September 2006 - December 2006
Wyeth Pharmaceuticals March 2006 - August 2006
NJIT January 2005 - December 2005
Skills
Validation, Laboratory, Fermentation, Sterilization, Testing, LIMS, Aseptic Processing, FDA, GMP, Process Simulation, Purification, Organic Chemistry, Cell Culture, V&V, CAPA, Protein Purification, Cleaning Validation, GLP, Sop, Change Control, 21 CFR Part 11, Cross-functional Team..., Pharmaceutical Industry, Quality Management, SOP
Education
New Jersey Institute of Technology 2004 — 2005
M.S, Chemical Engineering
University of Madras 1999 — 2003
B.Tech, Chemical Engineer
Psbb
Tom Dawley's Wyeth Biotech Experience January 2005 - October 2009
Job Finance Manager at Pfizer
Industry Biotechnology
Experience
Pfizer October 2009 - Present
Wyeth Biotech January 2005 - October 2009
Wyeth Biotech January 2003 - January 2005
Wyeth Biotech January 2000 - January 2003
Schneider Automation January 1995 - January 1999
Eurotherm Gauging Systems January 1993 - January 1995
Skills
Cost Center Management, Expenses, Financial Forecasting, Pharmaceutical Industry, Forecasting, Biotechnology, Financial Modeling, SAP, Managerial Finance, Financial Analysis, Essbase, Hyperion Enterprise, Financial Reporting, Operational Excellence, Budgets, Six Sigma, FDA
Education
Merrimack College
B.S, Finance
Pfizer October 2009 - Present
Wyeth Biotech January 2005 - October 2009
Wyeth Biotech January 2003 - January 2005
Wyeth Biotech January 2000 - January 2003
Schneider Automation January 1995 - January 1999
Eurotherm Gauging Systems January 1993 - January 1995
Skills
Cost Center Management, Expenses, Financial Forecasting, Pharmaceutical Industry, Forecasting, Biotechnology, Financial Modeling, SAP, Managerial Finance, Financial Analysis, Essbase, Hyperion Enterprise, Financial Reporting, Operational Excellence, Budgets, Six Sigma, FDA
Education
Merrimack College
B.S, Finance
Praveen Prasanna's Wyeth Biotech Experience April 2000 - August 2002
Job Associate Director, Drug Product Manufacturing Sciences and Technology at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals August 2014 - Present
Shire Pharmaceuticals February 2011 - August 2014
Shire Pharmaceuticals August 2008 - March 2011
Tufts University September 2002 - May 2008
Wyeth Biotech April 2000 - August 2002
RTP Pharma June 1998 - December 1999
Skills
Technology Transfer, Validation, cGMP, GMP, Drug Product, Drug Product Development, Aseptic Processing, Drug Development, FDA, Biotechnology, R&D, Biopharmaceuticals, CAPA, Pharmaceutical Industry, Medical Devices, Sop, Filtration, Process Simulation, Chemical Engineering, Aseptic Technique, Formulation, Commercialization, Design of Experiments, Change Control, Quality System, Drug Delivery, Quality by Design
Education
Tufts University 2002 — 2008
Ph.D., Chemical Engineering
McGill University 1996 — 1998
M.Eng (Thesis), Chemical Engineering
McGill University 1992 — 1996
B.Eng., Chemical Engineering
Partners in Leadership
Certified Oz Facilitator
Presque Isle High School
Presque Isle High School
Presque Isle High School
Shire Pharmaceuticals August 2014 - Present
Shire Pharmaceuticals February 2011 - August 2014
Shire Pharmaceuticals August 2008 - March 2011
Tufts University September 2002 - May 2008
Wyeth Biotech April 2000 - August 2002
RTP Pharma June 1998 - December 1999
Skills
Technology Transfer, Validation, cGMP, GMP, Drug Product, Drug Product Development, Aseptic Processing, Drug Development, FDA, Biotechnology, R&D, Biopharmaceuticals, CAPA, Pharmaceutical Industry, Medical Devices, Sop, Filtration, Process Simulation, Chemical Engineering, Aseptic Technique, Formulation, Commercialization, Design of Experiments, Change Control, Quality System, Drug Delivery, Quality by Design
Education
Tufts University 2002 — 2008
Ph.D., Chemical Engineering
McGill University 1996 — 1998
M.Eng (Thesis), Chemical Engineering
McGill University 1992 — 1996
B.Eng., Chemical Engineering
Partners in Leadership
Certified Oz Facilitator
Presque Isle High School
Presque Isle High School
Presque Isle High School
Amy Spinello's Wyeth Biotech Experience 2004 - 2007
Job Clinical Trial Specialist II
Industry Biotechnology
Experience
PAREXEL October 2014 - Present
Dana-Farber Cancer Institute 2012 - October 2014
Momenta Pharmaceuticals 2011 - 2012
Cynosure, Inc. 2010 - 2011
Hyaluron Contract Manufacturing 2008 - 2009
Wyeth Biotech 2004 - 2007
Wyeth Biotech 2001 - 2004
Skills
Clinical Trials, Clinical Research, GCP, Regulatory Affairs, Project Management, Continuous Improvement, Streamlining Of..., Quality Assurance, GMP, Biotechnology, Pharmaceutical Industry, CAPA, GxP
Education
Merrimack College
PAREXEL October 2014 - Present
Dana-Farber Cancer Institute 2012 - October 2014
Momenta Pharmaceuticals 2011 - 2012
Cynosure, Inc. 2010 - 2011
Hyaluron Contract Manufacturing 2008 - 2009
Wyeth Biotech 2004 - 2007
Wyeth Biotech 2001 - 2004
Skills
Clinical Trials, Clinical Research, GCP, Regulatory Affairs, Project Management, Continuous Improvement, Streamlining Of..., Quality Assurance, GMP, Biotechnology, Pharmaceutical Industry, CAPA, GxP
Education
Merrimack College
Michael Lelito's Wyeth Biotech Experience March 2003 - November 2008
Job Owner / President at QualTec Services LLC
Industry Pharmaceuticals
Experience
QualTec Services LLC November 2012 - Present
Jacobs Engineering December 2008 - August 2011
Wyeth Biotech March 2003 - November 2008
Getinge Inc October 2001 - March 2003
STERIS Inc. March 1991 - October 2001
BOC / Edwards Freeze Drying Systems March 1982 - March 1991
Skills
Validation, GMP, Change Control, Troubleshooting, Technology Transfer, Lifesciences, FDA, Cross-functional Team..., Computer System..., Manufacturing, Pharmaceutics, GAMP, 21 CFR Part 11, Medical Devices, V&V, Engineering, Commissioning, Life Sciences
Education
Niagara University 1978 — 1980
NCCC
Service Engineering, Electrical Engineering
QualTec Services LLC November 2012 - Present
Jacobs Engineering December 2008 - August 2011
Wyeth Biotech March 2003 - November 2008
Getinge Inc October 2001 - March 2003
STERIS Inc. March 1991 - October 2001
BOC / Edwards Freeze Drying Systems March 1982 - March 1991
Skills
Validation, GMP, Change Control, Troubleshooting, Technology Transfer, Lifesciences, FDA, Cross-functional Team..., Computer System..., Manufacturing, Pharmaceutics, GAMP, 21 CFR Part 11, Medical Devices, V&V, Engineering, Commissioning, Life Sciences
Education
Niagara University 1978 — 1980
NCCC
Service Engineering, Electrical Engineering
Barry Womack's Wyeth Biotech Experience 1995 - December 2009
Job Plant Engineer at Pfizer
Industry Biotechnology
Experience
Pfizer (formerly Wyeth Biotech) 2009 - Present
Wyeth Biotech 1995 - December 2009
Skills
Project Engineering, Maintenance Management, GMP, Commissioning, Construction Management, Construction, Estimates, Validation, Troubleshooting, Automation, 21 CFR Part 11, Vaccines, Instrumentation, GAMP, DCS, Change Control, Technology Transfer, Purification, FDA, Computer System..., Biopharmaceuticals, Aseptic Processing, CAPA, Pharmaceutical Industry, SOP, Biotechnology
Education
North Carolina State University 1980 — 1985
Pfizer (formerly Wyeth Biotech) 2009 - Present
Wyeth Biotech 1995 - December 2009
Skills
Project Engineering, Maintenance Management, GMP, Commissioning, Construction Management, Construction, Estimates, Validation, Troubleshooting, Automation, 21 CFR Part 11, Vaccines, Instrumentation, GAMP, DCS, Change Control, Technology Transfer, Purification, FDA, Computer System..., Biopharmaceuticals, Aseptic Processing, CAPA, Pharmaceutical Industry, SOP, Biotechnology
Education
North Carolina State University 1980 — 1985
Vincent De Biasi, Jr MBA's Wyeth Biotech Experience September 2007 - November 2008
Job Strategic Project Manager, External Supply, North America
Industry Biotechnology
Experience
Novartis April 2014 - Present
Novartis July 2013 - April 2014
Pfizer April 2012 - July 2013
Pfizer October 2009 - April 2012
Wyeth Biotech September 2007 - November 2008
Wyeth October 2004 - September 2007
Wyeth Pharmaceuticals July 1998 - October 2004
Skills
Validation, GMP, Change Control, FDA, Pharmaceutical Industry, CAPA, 21 CFR Part 11, Sop, LIMS, Quality Assurance, Computer System..., Biotechnology, GxP, Technology Transfer, V&V, Quality System, Cross-functional Team..., Six Sigma, Process Improvement, Project Management, Strategy, Regulatory Affairs, GLP, Regulatory Requirements, GAMP, Pharmaceutics, Root Cause Analysis, Manufacturing, GCP, Regulatory Submissions, Trackwise, ISO 13485, Quality Auditing, Document Management, Aseptic Processing, Biopharmaceuticals, Analytical Chemistry, Clinical Trials, Vaccines, R&D, Lifesciences, Software Documentation, CRO, Program Management, Quality Management, Process Simulation, Clinical Development, Medical Devices
Education
Rath & Strong 2012 — 2012
Lean Six Sigma, Green Belt, Candidate
IONA 2005 — 2012
Master of Business Administration (MBA), Information Technology
New Jersey Institute of Technology 1990 — 1996
BS, Chemical Engineering
Novartis April 2014 - Present
Novartis July 2013 - April 2014
Pfizer April 2012 - July 2013
Pfizer October 2009 - April 2012
Wyeth Biotech September 2007 - November 2008
Wyeth October 2004 - September 2007
Wyeth Pharmaceuticals July 1998 - October 2004
Skills
Validation, GMP, Change Control, FDA, Pharmaceutical Industry, CAPA, 21 CFR Part 11, Sop, LIMS, Quality Assurance, Computer System..., Biotechnology, GxP, Technology Transfer, V&V, Quality System, Cross-functional Team..., Six Sigma, Process Improvement, Project Management, Strategy, Regulatory Affairs, GLP, Regulatory Requirements, GAMP, Pharmaceutics, Root Cause Analysis, Manufacturing, GCP, Regulatory Submissions, Trackwise, ISO 13485, Quality Auditing, Document Management, Aseptic Processing, Biopharmaceuticals, Analytical Chemistry, Clinical Trials, Vaccines, R&D, Lifesciences, Software Documentation, CRO, Program Management, Quality Management, Process Simulation, Clinical Development, Medical Devices
Education
Rath & Strong 2012 — 2012
Lean Six Sigma, Green Belt, Candidate
IONA 2005 — 2012
Master of Business Administration (MBA), Information Technology
New Jersey Institute of Technology 1990 — 1996
BS, Chemical Engineering
Ranga, Godavarti's Wyeth Biotech Experience September 2009 - February 2010
Job Senior Director at Pfizer
Industry Biotechnology
Experience
Pfizer February 2010 - Present
Wyeth Biotech September 2009 - February 2010
Wyeth Biotech September 2007 - August 2009
Skills
Technology Transfer, Biopharmaceuticals, Biotechnology, GMP, Chromatography, Vaccines, Validation, Pharmaceutical Industry, HPLC, Protein Chemistry, R&D, Clinical Development, Drug Discovery, Medicinal Chemistry, Purification, Cell Culture, Protein Purification, Lifesciences, Filtration, Assay Development, Commercialization, Formulation, Biochemistry, FDA, Chemical Engineering, Drug Delivery, Monoclonal Antibodies, Life Sciences
Education
Massachusetts Institute of Technology 1990 — 1996
MS; Sc. D, Chemical Engineering
National Institute of Technology Tiruchirappalli 1986 — 1990
B. Tech, Chemical Engineering
Pfizer February 2010 - Present
Wyeth Biotech September 2009 - February 2010
Wyeth Biotech September 2007 - August 2009
Skills
Technology Transfer, Biopharmaceuticals, Biotechnology, GMP, Chromatography, Vaccines, Validation, Pharmaceutical Industry, HPLC, Protein Chemistry, R&D, Clinical Development, Drug Discovery, Medicinal Chemistry, Purification, Cell Culture, Protein Purification, Lifesciences, Filtration, Assay Development, Commercialization, Formulation, Biochemistry, FDA, Chemical Engineering, Drug Delivery, Monoclonal Antibodies, Life Sciences
Education
Massachusetts Institute of Technology 1990 — 1996
MS; Sc. D, Chemical Engineering
National Institute of Technology Tiruchirappalli 1986 — 1990
B. Tech, Chemical Engineering
Harpreet Budhiraja's Wyeth Biotech Experience December 2004 - March 2006
Job Validation Manager Cleaning at Baxalta Inc.
Industry Biotechnology
Experience
Baxalta February 2014 - Present
Validation Technologies, Inc. November 2011 - December 2013
Merck Sharp & Dohme October 2010 - October 2011
Validation Technologies Inc June 2007 - October 2010
Allergan March 2006 - June 2007
Wyeth Biotech December 2004 - March 2006
Skills
21 CFR Part 11, Computer System..., GAMP, Change Control, Cleaning Validation, Validation, Biotechnology, GxP, V&V, GMP, CAPA, Sterilization, FDA, Sop, FDA GMP, GLP, Aseptic Processing, Quality Control, Biopharmaceuticals, ISO 13485, LIMS, Technology Transfer, Pharmaceutics, Pharmaceutical Industry, Quality Assurance, Analytical Chemistry, Quality System, Vaccines, Trackwise, Regulatory Requirements, Quality Auditing, Process Simulation, HPLC, SOP, TrackWise
Education
New Jersey Institute of Technology 2004 — 2006
Graduate, Chemical Engineering
Punjab Technical University 1999 — 2003
Undergraduate, Chemical Engineering
Baxalta February 2014 - Present
Validation Technologies, Inc. November 2011 - December 2013
Merck Sharp & Dohme October 2010 - October 2011
Validation Technologies Inc June 2007 - October 2010
Allergan March 2006 - June 2007
Wyeth Biotech December 2004 - March 2006
Skills
21 CFR Part 11, Computer System..., GAMP, Change Control, Cleaning Validation, Validation, Biotechnology, GxP, V&V, GMP, CAPA, Sterilization, FDA, Sop, FDA GMP, GLP, Aseptic Processing, Quality Control, Biopharmaceuticals, ISO 13485, LIMS, Technology Transfer, Pharmaceutics, Pharmaceutical Industry, Quality Assurance, Analytical Chemistry, Quality System, Vaccines, Trackwise, Regulatory Requirements, Quality Auditing, Process Simulation, HPLC, SOP, TrackWise
Education
New Jersey Institute of Technology 2004 — 2006
Graduate, Chemical Engineering
Punjab Technical University 1999 — 2003
Undergraduate, Chemical Engineering
Joshua Kidder's Wyeth Biotech Experience June 2000 - May 2008
Job Scientist
Industry Biotechnology
Experience
Biogen Idec 2008 - Present
Wyeth Biotech June 2000 - May 2008
Copley Pharmaceuticals 1999 - 2000
Skills
Validation, Quality Control, Assay Development, Microbiology, Troubleshooting, Biotechnology, FDA, LIMS, GMP, Pharmaceutical Industry, Biopharmaceuticals
Education
University of Wisconsin-Madison 2002 — 2004
MS, Medical Microbiology & Immunology
Ithaca College 1995 — 1999
Bachelor, Biochemistry
Biogen Idec 2008 - Present
Wyeth Biotech June 2000 - May 2008
Copley Pharmaceuticals 1999 - 2000
Skills
Validation, Quality Control, Assay Development, Microbiology, Troubleshooting, Biotechnology, FDA, LIMS, GMP, Pharmaceutical Industry, Biopharmaceuticals
Education
University of Wisconsin-Madison 2002 — 2004
MS, Medical Microbiology & Immunology
Ithaca College 1995 — 1999
Bachelor, Biochemistry
Amelia Ward's Wyeth Biotech Experience August 2002 - October 2009
Job Quality Control Scientist at Pfizer (formerly Wyeth)
Industry Biotechnology
Experience
Pfizer October 2009 - January 2010
Wyeth Biotech August 2002 - October 2009
Skills
Validation
Education
Massachusetts Institute of Technology 1998 — 2002
Pfizer October 2009 - January 2010
Wyeth Biotech August 2002 - October 2009
Skills
Validation
Education
Massachusetts Institute of Technology 1998 — 2002
Chee-Keng Ng's Wyeth Biotech Experience July 2001 - December 2006
Job Senior Principal Sci at Pfizer
Industry Biotechnology
Experience
Pfizer October 2011 - Present
Wyeth January 2007 - September 2011
Wyeth Biotech July 2001 - December 2006
Orquest September 1997 - June 2001
NIDR (NIH) June 1996 - May 1997
NIDR (NIH) June 1992 - May 1996
Skills
Biochemistry, Protein Chemistry, Cell Biology, Vaccines, Characterization, Analytical method..., Comparability and..., International Project..., Product Development, bioprocess development, Research Project..., Assay Development, Regulatory Affairs, Biotechnology, Project Management, Molecular Biology, Biopharmaceuticals, Bioprocessing, Laboratory Automation, Cell, Clinical Trials, Analytical Chemistry, IND, Analysis, Pharmaceutical Industry
Education
Monash University (Grad School) 1984 — 1992
PhD, Biochemistry
Monash University 1984 — 1987
BSc(Hons)/LLB, Biochemistry and Law
Taylors College (Pre-University) 1983 — 1984
SAME, Matriculation
Pfizer October 2011 - Present
Wyeth January 2007 - September 2011
Wyeth Biotech July 2001 - December 2006
Orquest September 1997 - June 2001
NIDR (NIH) June 1996 - May 1997
NIDR (NIH) June 1992 - May 1996
Skills
Biochemistry, Protein Chemistry, Cell Biology, Vaccines, Characterization, Analytical method..., Comparability and..., International Project..., Product Development, bioprocess development, Research Project..., Assay Development, Regulatory Affairs, Biotechnology, Project Management, Molecular Biology, Biopharmaceuticals, Bioprocessing, Laboratory Automation, Cell, Clinical Trials, Analytical Chemistry, IND, Analysis, Pharmaceutical Industry
Education
Monash University (Grad School) 1984 — 1992
PhD, Biochemistry
Monash University 1984 — 1987
BSc(Hons)/LLB, Biochemistry and Law
Taylors College (Pre-University) 1983 — 1984
SAME, Matriculation
Akbar Alinani's Wyeth Biotech Experience June 2006 - December 2008
Job Director, Global Procurement R&D Sciences at BristolMyers Squibb
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb February 2011 - Present
Pfizer December 2009 - January 2011
Wyeth Pharmaceuticals January 2009 - December 2009
Wyeth Biotech June 2006 - December 2008
Sanofi Pasteur January 2004 - June 2006
Aventis Pasteur January 1997 - December 2003
Skills
Procurement, Strategic Sourcing, Global Sourcing, Sourcing, Outsourcing, Purchasing, Supplier Development, Biotechnology, Pharmaceutics, Supply Management, Pharmaceutical Industry, Supply Chain, Contract Manufacturing, Materials Management, Supply Chain Management, Continuous Improvement, Cross-functional Team..., Spend Analysis, GMP, Contract Negotiation, eSourcing, Vendor Management, FDA, Six Sigma, SAP, Supplier Negotiation, Contract Management, Manufacturing, Supply Chain..., MRP, Ariba, E-procurement, Operational Excellence, Demand Planning, Supplier Evaluation, Production Planning, Procure-to-Pay, Quality System, Sop, Supplier Diversity, Lean Manufacturing, Supply, Manufacturing Operations, Technology Transfer, Process Improvement, Business Process..., Process Engineering
Education
University of Scranton 1994 — 1996
M.B.A, Marketing & Finance
Iowa State University 1987 — 1992
Bachelors in Electrical Engineering, Power Systems & Controls
Bristol-Myers Squibb February 2011 - Present
Pfizer December 2009 - January 2011
Wyeth Pharmaceuticals January 2009 - December 2009
Wyeth Biotech June 2006 - December 2008
Sanofi Pasteur January 2004 - June 2006
Aventis Pasteur January 1997 - December 2003
Skills
Procurement, Strategic Sourcing, Global Sourcing, Sourcing, Outsourcing, Purchasing, Supplier Development, Biotechnology, Pharmaceutics, Supply Management, Pharmaceutical Industry, Supply Chain, Contract Manufacturing, Materials Management, Supply Chain Management, Continuous Improvement, Cross-functional Team..., Spend Analysis, GMP, Contract Negotiation, eSourcing, Vendor Management, FDA, Six Sigma, SAP, Supplier Negotiation, Contract Management, Manufacturing, Supply Chain..., MRP, Ariba, E-procurement, Operational Excellence, Demand Planning, Supplier Evaluation, Production Planning, Procure-to-Pay, Quality System, Sop, Supplier Diversity, Lean Manufacturing, Supply, Manufacturing Operations, Technology Transfer, Process Improvement, Business Process..., Process Engineering
Education
University of Scranton 1994 — 1996
M.B.A, Marketing & Finance
Iowa State University 1987 — 1992
Bachelors in Electrical Engineering, Power Systems & Controls
Brian Winstead, PMP's Wyeth Biotech Experience 2002 - 2005
Job Senior Project Manager at DPS Consulting
Industry Pharmaceuticals
Experience
DPS Consulting April 2015 - Present
Sandoz May 2014 - April 2015
Sandoz April 2012 - April 2014
Pfizer September 2011 - March 2012
Pfizer / King Pharmaceuticals September 2006 - September 2011
Wyeth Biotech / Pfizer 2005 - 2006
Wyeth Biotech 2002 - 2005
O'Neal Engineering 2001 - 2002
Cooper Tools 1999 - 2001
Wix Filtration Products 1994 - 1999
Skills
Validation, GMP, FDA, Manufacturing, Lean Manufacturing, Change Control, Project Management, CAPA, Process Improvement, 21 CFR Part 11, Project Planning, V&V, Sop, Budgets, Cross-functional Team..., Technology Transfer, Aseptic Processing, Engineering, Management, R&D, Pharmaceutical Industry, Quality System, Mechanical Engineering, Procurement, Six Sigma, Process Simulation, PMP, AutoCAD, Troubleshooting, Continuous Improvement, Computer System..., Managerial, Consent Decree, Commissioning, Quality Assurance, Regulatory Affairs, Contract Manufacturing, Construction, Root Cause Analysis, Supply Chain, Medical Devices, GxP, Biopharmaceuticals, Process Engineering, LIMS, Quality Management, Kaizen, Quality Control, Project Engineering, Biotechnology
Education
North Carolina State University 1986 — 1991
BS, Mechanical Engineering
East Henderson High School 1983 — 1986
DPS Consulting April 2015 - Present
Sandoz May 2014 - April 2015
Sandoz April 2012 - April 2014
Pfizer September 2011 - March 2012
Pfizer / King Pharmaceuticals September 2006 - September 2011
Wyeth Biotech / Pfizer 2005 - 2006
Wyeth Biotech 2002 - 2005
O'Neal Engineering 2001 - 2002
Cooper Tools 1999 - 2001
Wix Filtration Products 1994 - 1999
Skills
Validation, GMP, FDA, Manufacturing, Lean Manufacturing, Change Control, Project Management, CAPA, Process Improvement, 21 CFR Part 11, Project Planning, V&V, Sop, Budgets, Cross-functional Team..., Technology Transfer, Aseptic Processing, Engineering, Management, R&D, Pharmaceutical Industry, Quality System, Mechanical Engineering, Procurement, Six Sigma, Process Simulation, PMP, AutoCAD, Troubleshooting, Continuous Improvement, Computer System..., Managerial, Consent Decree, Commissioning, Quality Assurance, Regulatory Affairs, Contract Manufacturing, Construction, Root Cause Analysis, Supply Chain, Medical Devices, GxP, Biopharmaceuticals, Process Engineering, LIMS, Quality Management, Kaizen, Quality Control, Project Engineering, Biotechnology
Education
North Carolina State University 1986 — 1991
BS, Mechanical Engineering
East Henderson High School 1983 — 1986
Rachael Brownstein's Wyeth Biotech Experience June 2008 - August 2011
Job Quality Engineer at DPT Laboratories
Industry Biotechnology
Experience
DPT Laboratories August 2011 - Present
Wyeth Biotech June 2008 - August 2011
Wyeth Pharmaceuitcals April 2007 - June 2008
Wyeth 2003 - 2007
Skills
Aseptic Processing...
Education
Stevens Institute of Technology 2007 — 2011
Masters in Engineering, Pharmaceutical Manufacturing
Lehigh University 1999 — 2003
Bachelor of Science, Chemical Engineering
DPT Laboratories August 2011 - Present
Wyeth Biotech June 2008 - August 2011
Wyeth Pharmaceuitcals April 2007 - June 2008
Wyeth 2003 - 2007
Skills
Aseptic Processing...
Education
Stevens Institute of Technology 2007 — 2011
Masters in Engineering, Pharmaceutical Manufacturing
Lehigh University 1999 — 2003
Bachelor of Science, Chemical Engineering
Melissa Hartford's Wyeth Biotech Experience 2003 - Present
Job Senior Quality Associate @ Pfizer
Industry Pharmaceuticals
Experience
Wyeth Quality SpecialistPfizer2009 - Present
Pfizer (formerly Wyeth) 2009 - Present
Wyeth Biotech 2003 - Present
Pfizer (formerly Wyeth Biotech) 2003 - Present
Skills
Quality Assurance
Education
Mount Washington College
Wyeth Quality SpecialistPfizer2009 - Present
Pfizer (formerly Wyeth) 2009 - Present
Wyeth Biotech 2003 - Present
Pfizer (formerly Wyeth Biotech) 2003 - Present
Skills
Quality Assurance
Education
Mount Washington College
Chris Albright's Wyeth Biotech Experience 2001 - April 2008
Job Sr. Process Engineer at Merck
Industry Biotechnology
Experience
Merck April 2009 - Present
Wyeth Biotech 2001 - April 2008
Schweizerhall 1998 - 2001
CT Specialities 1996 - 1998
Mallinckrodt 1992 - 1996
Skills
21 CFR Part 11, CAPA, Change Control, FDA, GMP, Pharmaceutical Industry, Process Optimization, Process Simulation, Quality System, R&D, Technology Transfer, Sop, V&V, Validation, Aseptic Processing, Manufacturing
Education
North Carolina State University
Merck April 2009 - Present
Wyeth Biotech 2001 - April 2008
Schweizerhall 1998 - 2001
CT Specialities 1996 - 1998
Mallinckrodt 1992 - 1996
Skills
21 CFR Part 11, CAPA, Change Control, FDA, GMP, Pharmaceutical Industry, Process Optimization, Process Simulation, Quality System, R&D, Technology Transfer, Sop, V&V, Validation, Aseptic Processing, Manufacturing
Education
North Carolina State University
Amanda Ashcraft's Wyeth Biotech Experience October 2004 - October 2006
Job Associate Director Manufacturing Sciences and Technology at Genzyme, a Sanofi company
Industry Biotechnology
Experience
Genzyme, a Sanofi company August 2015 - Present
Genzyme, a Sanofi company March 2012 - Present
Genzyme June 2010 - March 2012
Genzyme November 2006 - June 2010
Wyeth Biotech October 2004 - October 2006
Skills
cGMP, Technology Transfer, Validation, DeltaV, Root Cause Analysis
Education
Tufts University 2007 — 2009
MS
North Carolina State University 1999 — 2004
BS
Genzyme, a Sanofi company August 2015 - Present
Genzyme, a Sanofi company March 2012 - Present
Genzyme June 2010 - March 2012
Genzyme November 2006 - June 2010
Wyeth Biotech October 2004 - October 2006
Skills
cGMP, Technology Transfer, Validation, DeltaV, Root Cause Analysis
Education
Tufts University 2007 — 2009
MS
North Carolina State University 1999 — 2004
BS
Tricia Carle-Sutton's Wyeth Biotech Experience 2003 - 2006
Job Teacher, Regent's Biology and Chemistry at Yorktown Central School District
Industry Education Management
Experience
Yorktown Central School District August 2012 - Present
Clarkstown Central School District- Clarkstown North October 2011 - Present
Good Counsel Academy August 2010 - October 2011
The Harvey School April 2010 - August 2010
IIR 2006 - February 2010
Institute for International Research May 2006 - 2010
Wyeth Research 2003 - 2006
Wyeth Biotech 2003 - 2006
Education
Manhattanville College 2010 — 2011
M.A., Education
Siena College 1999 — 2003
Bachelor of Science, Biology
Clarkstown South 1995 — 1999
Yorktown Central School District August 2012 - Present
Clarkstown Central School District- Clarkstown North October 2011 - Present
Good Counsel Academy August 2010 - October 2011
The Harvey School April 2010 - August 2010
IIR 2006 - February 2010
Institute for International Research May 2006 - 2010
Wyeth Research 2003 - 2006
Wyeth Biotech 2003 - 2006
Education
Manhattanville College 2010 — 2011
M.A., Education
Siena College 1999 — 2003
Bachelor of Science, Biology
Clarkstown South 1995 — 1999
Tom Wittliff's Wyeth Biotech Experience 1990 - 2008
Job QA Validation Specialist at Argos Therapeutics
Industry Pharmaceuticals
Experience
Argos Therapeutics July 2015 - Present
Hospira July 2011 - July 2015
Novartis May 2009 - February 2011
Wyeth October 1990 - November 2008
Wyeth Biotech 1990 - 2008
Life Sciences, Inc 1989 - 1990
GIBCO 1985 - 1989
Skills
Ultrafiltration, Process Validation, cGMP, Validation, Vaccines, Biopharmaceuticals, GMP, V&V, Quality Assurance, Chromatography, Change Control, CAPA, Cleaning Validation, FDA, Equipment Qualification, Regulatory Submissions, Technology Transfer, Computer System..., 21 CFR Part 11, GxP
Education
North Carolina State University
B.S., Chemical Engineering
Argos Therapeutics July 2015 - Present
Hospira July 2011 - July 2015
Novartis May 2009 - February 2011
Wyeth October 1990 - November 2008
Wyeth Biotech 1990 - 2008
Life Sciences, Inc 1989 - 1990
GIBCO 1985 - 1989
Skills
Ultrafiltration, Process Validation, cGMP, Validation, Vaccines, Biopharmaceuticals, GMP, V&V, Quality Assurance, Chromatography, Change Control, CAPA, Cleaning Validation, FDA, Equipment Qualification, Regulatory Submissions, Technology Transfer, Computer System..., 21 CFR Part 11, GxP
Education
North Carolina State University
B.S., Chemical Engineering
H. Michael (Mickey) Koplove's Wyeth Biotech Experience January 1997 - October 2009
Job VP EMERITUS of Manufacturing, Engineering, Strategy, Whatever at PfizerWyethGI
Industry Biotechnology
Experience
Pleasant Valley Advisors April 2010 - Present
Pfizer Pharmaceuticals October 2009 - April 2010
Wyeth Biotech January 1997 - October 2009
Genetics Institute August 1987 - December 2006
Education
Massachusetts Institute of Technology 1972 — 1977
PhD, Biochemical Engineering
University of Pennsylvania 1966 — 1970
BS in ChE, Chemical Engineering, Biochemical Engineering
Pleasant Valley Advisors April 2010 - Present
Pfizer Pharmaceuticals October 2009 - April 2010
Wyeth Biotech January 1997 - October 2009
Genetics Institute August 1987 - December 2006
Education
Massachusetts Institute of Technology 1972 — 1977
PhD, Biochemical Engineering
University of Pennsylvania 1966 — 1970
BS in ChE, Chemical Engineering, Biochemical Engineering
Dominic Trione's Wyeth Biotech Experience January 2005 - May 2007
Job Manufacturing Specialist III at Genzyme
Industry Biotechnology
Experience
Genzyme January 2015 - Present
Genzyme January 2013 - January 2015
Genzyme November 2010 - January 2013
Genzyme May 2007 - October 2010
Wyeth Biotech January 2005 - May 2007
Pfizer November 2003 - January 2005
Education
Michigan State University 1998 — 2002
Bachelor of Science (B.S.), Microbiology
Genzyme January 2015 - Present
Genzyme January 2013 - January 2015
Genzyme November 2010 - January 2013
Genzyme May 2007 - October 2010
Wyeth Biotech January 2005 - May 2007
Pfizer November 2003 - January 2005
Education
Michigan State University 1998 — 2002
Bachelor of Science (B.S.), Microbiology
Kourosh Kahoussi's Wyeth Biotech Experience January 2008 - Present
Job Sr. Technical Scientist at Wyeth Biotech
Industry Biotechnology
Experience
Wyeth Biotech January 2008 - Present
Pfizer (legacy Wyeth) 2008 - Present
Skills
Validation, GLP, Pharmaceutical Industry, GMP, Biotechnology
Education
Iowa State University 1993 — 1997
Wyeth Biotech January 2008 - Present
Pfizer (legacy Wyeth) 2008 - Present
Skills
Validation, GLP, Pharmaceutical Industry, GMP, Biotechnology
Education
Iowa State University 1993 — 1997
Tom Koenig's Wyeth Biotech Experience June 2007 - December 2009
Job Sr. Director, Hemophilia Channel Marketing at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec January 2011 - Present
Octapharma USA inc. August 2010 - December 2010
Wyeth Biotech June 2007 - December 2009
Endo Pharmaceuticals 2004 - 2007
GSK 1991 - 2004
Skills
Managed Care, Market Access, Pharmaceutical Industry, Managed Markets, Biotechnology, Strategy, Pharmacy, Urology, Neurology, Pharmaceutical Sales, Biologics, Cardiology, Gastroenterology, Sales Effectiveness, Diabetes, Hospital Sales, Cross-functional Team..., Product Launch, Infectious Diseases, Endocrinology, Biopharmaceuticals
Education
Lehigh University 1982 — 1986
Biogen Idec January 2011 - Present
Octapharma USA inc. August 2010 - December 2010
Wyeth Biotech June 2007 - December 2009
Endo Pharmaceuticals 2004 - 2007
GSK 1991 - 2004
Skills
Managed Care, Market Access, Pharmaceutical Industry, Managed Markets, Biotechnology, Strategy, Pharmacy, Urology, Neurology, Pharmaceutical Sales, Biologics, Cardiology, Gastroenterology, Sales Effectiveness, Diabetes, Hospital Sales, Cross-functional Team..., Product Launch, Infectious Diseases, Endocrinology, Biopharmaceuticals
Education
Lehigh University 1982 — 1986
Jason D'Orlando's Wyeth Biotech Experience January 2003 - February 2005
Job Managing Director with Taurus PCC, Inc
Industry Management Consulting
Experience
Taurus Project Controls Consulting, Inc. April 2012 - Present
Shire Pharmaceuticals October 2009 - April 2012
Bristol-Myers Squibb February 2005 - October 2009
Wyeth Biotech January 2003 - February 2005
PMA Consultants January 2000 - January 2003
Skills
Project Control, Project Planning, Change Control, Contract Management, MS Project, Earned Value Management, Primavera P6, Cost Control, Cost Management, Project Management, Process Improvement, Cross-functional Team..., Resource Management, Budgets, Pharmaceutical Industry, Contract Negotiation, Construction, Program Management, Procurement, Construction Management, CPM Scheduling, Project Portfolio..., Risk Management, Process Scheduler, Management, Stakeholder Management, Cost Engineering, Strategy, FDA, Infrastructure, Biopharmaceuticals, Analysis, Process Engineering, Clinical Development, Forecasting, Engineering, Project Engineering, Validation, Visio, Facilities Management, Microsoft Project, Business Process..., Document Management, Six Sigma
Education
Isenberg School of Management, UMass Amherst 2003 — 2007
MBA, General MBA
Northeastern University 1995 — 2000
BS, Civil and Environmental Engineering
Taurus Project Controls Consulting, Inc. April 2012 - Present
Shire Pharmaceuticals October 2009 - April 2012
Bristol-Myers Squibb February 2005 - October 2009
Wyeth Biotech January 2003 - February 2005
PMA Consultants January 2000 - January 2003
Skills
Project Control, Project Planning, Change Control, Contract Management, MS Project, Earned Value Management, Primavera P6, Cost Control, Cost Management, Project Management, Process Improvement, Cross-functional Team..., Resource Management, Budgets, Pharmaceutical Industry, Contract Negotiation, Construction, Program Management, Procurement, Construction Management, CPM Scheduling, Project Portfolio..., Risk Management, Process Scheduler, Management, Stakeholder Management, Cost Engineering, Strategy, FDA, Infrastructure, Biopharmaceuticals, Analysis, Process Engineering, Clinical Development, Forecasting, Engineering, Project Engineering, Validation, Visio, Facilities Management, Microsoft Project, Business Process..., Document Management, Six Sigma
Education
Isenberg School of Management, UMass Amherst 2003 — 2007
MBA, General MBA
Northeastern University 1995 — 2000
BS, Civil and Environmental Engineering
Robert Dobres's Wyeth Biotech Experience Regulatory AffairsWyeth Pharmaceuticals2007 - Present
Job Regulatory Affairs at Wyeth Biotech
Industry Biotechnology
Experience
Wyeth Biotech Regulatory AffairsWyeth Pharmaceuticals2007 - Present
Pfizer 2006 - Present
Wyeth 1997 - Present
Skills
Change Control, FDA, Sop, Biotechnology, Regulatory Affairs, GMP, CMC, Computer System..., Validation, Technology Transfer, 21 CFR Part 11, Pharmaceutical Industry, CAPA, Vaccines, LIMS, Biopharmaceuticals
Education
Rutgers, The State University of New Jersey-Newark 1996 — 1999
MBA, Finance
New Jersey Institute of Technology 1988 — 1993
BS ChE
Wyeth Biotech Regulatory AffairsWyeth Pharmaceuticals2007 - Present
Pfizer 2006 - Present
Wyeth 1997 - Present
Skills
Change Control, FDA, Sop, Biotechnology, Regulatory Affairs, GMP, CMC, Computer System..., Validation, Technology Transfer, 21 CFR Part 11, Pharmaceutical Industry, CAPA, Vaccines, LIMS, Biopharmaceuticals
Education
Rutgers, The State University of New Jersey-Newark 1996 — 1999
MBA, Finance
New Jersey Institute of Technology 1988 — 1993
BS ChE
Kristen Dvorscak's Wyeth Biotech Experience December 2004 - September 2009
Job Manager Regulatory Compliance at LifeCell Corporation
Industry Medical Devices
Experience
LifeCell Corporation August 2013 - Present
Rendvo Consulting September 2010 - Present
Wyeth Biotech December 2004 - September 2009
Merck July 2003 - December 2004
Bayer HealthCare January 1998 - December 2001
Skills
Regulatory Affairs, Compliance, Compliance Audits, GLP, GMP, Quality Auditing, FDA, Quality System, Validation, Sop, Change Control, Software Documentation, Cross-functional Team..., Quality Assurance, SOP, Medical Devices, CAPA
Education
Miami University 1994 — 1998
Bachelor of Science (B.S.)
Penn State University
Chemistry
LifeCell Corporation August 2013 - Present
Rendvo Consulting September 2010 - Present
Wyeth Biotech December 2004 - September 2009
Merck July 2003 - December 2004
Bayer HealthCare January 1998 - December 2001
Skills
Regulatory Affairs, Compliance, Compliance Audits, GLP, GMP, Quality Auditing, FDA, Quality System, Validation, Sop, Change Control, Software Documentation, Cross-functional Team..., Quality Assurance, SOP, Medical Devices, CAPA
Education
Miami University 1994 — 1998
Bachelor of Science (B.S.)
Penn State University
Chemistry
Alan Butterfield's Wyeth Biotech Experience February 2007 - October 2009
Job Global Information Risk and Compliance Manager IGM at Novartis
Industry Biotechnology
Experience
Novartis February 2015 - Present
Novartis Vaccines and Diagnostics November 2013 - Present
Mangan Inc. June 2012 - November 2013
Pfizer August 2011 - June 2012
Pfizer October 2009 - August 2011
Wyeth Biotech February 2007 - October 2009
Wyeth Biotech June 2004 - February 2007
Wyeth Biotech March 2003 - May 2004
Serentec, Inc. 2001 - 2003
Skills
GAMP, GxP, 21 CFR Part 11, LIMS, Change Control, CAPA, GMP, Validation, Sop, GLP, FDA, Computer System..., Emerson DeltaV, SCADA, Process Control, Trackwise, Laboratory Informatics
Education
North Carolina State University 1989 — 1994
Bachelor of Science (B.S.), Statistics
Novartis February 2015 - Present
Novartis Vaccines and Diagnostics November 2013 - Present
Mangan Inc. June 2012 - November 2013
Pfizer August 2011 - June 2012
Pfizer October 2009 - August 2011
Wyeth Biotech February 2007 - October 2009
Wyeth Biotech June 2004 - February 2007
Wyeth Biotech March 2003 - May 2004
Serentec, Inc. 2001 - 2003
Skills
GAMP, GxP, 21 CFR Part 11, LIMS, Change Control, CAPA, GMP, Validation, Sop, GLP, FDA, Computer System..., Emerson DeltaV, SCADA, Process Control, Trackwise, Laboratory Informatics
Education
North Carolina State University 1989 — 1994
Bachelor of Science (B.S.), Statistics
Carol Sylvester's Wyeth Biotech Experience Technical WriterBristol-Myers Squibb Medical Imaging1997 - 2004
Job Lead Documentation Specialist at Wyeth Biotech
Industry Biotechnology
Experience
Wyeth Biotech Technical WriterBristol-Myers Squibb Medical Imaging1997 - 2004
Bristol Myers Squibb 1997 - 2004
Education
Middlesex Community College
Wyeth Biotech Technical WriterBristol-Myers Squibb Medical Imaging1997 - 2004
Bristol Myers Squibb 1997 - 2004
Education
Middlesex Community College
Lauren Gomes's Wyeth Biotech Experience September 2003 - September 2009
Job Pilot Plant Upstream Operations Leader at Pfizer
Industry Biotechnology
Experience
Pfizer September 2009 - Present
Wyeth Biotech September 2003 - September 2009
Skills
Biopharmaceuticals, GMP, Technology Transfer, Biotechnology
Education
Merrimack College 1999 — 2003
Pfizer September 2009 - Present
Wyeth Biotech September 2003 - September 2009
Skills
Biopharmaceuticals, GMP, Technology Transfer, Biotechnology
Education
Merrimack College 1999 — 2003
Clara Gil's Wyeth Biotech Experience May 2006 - August 2008
Job Director of Supply Chain at UniQure
Industry Pharmaceuticals
Experience
uniQure August 2014 - Present
Lonza March 2013 - August 2014
Shire HGT March 2011 - March 2013
Shire HGT January 2010 - March 2011
Textron August 2008 - January 2010
Wyeth Biotech May 2006 - August 2008
GE June 2005 - May 2006
Thoratec December 2004 - May 2005
EMD Millipore October 2000 - May 2004
Skills
Continuous Improvement, Cross-functional Team..., Process Improvement, Biotechnology, Six Sigma, SAP, Supply Chain, MRP, Medical Devices, Procurement, ERP, Supply Chain Management, Process Simulation, Validation, Quality Assurance, Lean Manufacturing, FDA, Quality System, Business Process, Root Cause Analysis, Operational Excellence, Process Engineering, Materials Management, Team Leadership, GMP, Project Management, Supply Management, Manufacturing, 5S, CAPA, Change Control, Contract Manufacturing, DMAIC, Demand Planning, ISO, Kaizen, Leadership, Management, Manufacturing Operations, Manufacturing..., Pharmaceutical Industry, Quality Control, Quality Management, Software Documentation, Sop, Strategic Sourcing, Strategy, Supply Chain..., V&V
Education
University of Massachusetts at Lowell 2010 — 2013
MBA, Management/Finance
Worcester Polytechnic Institute 2007 — 2009
Certificate, Project Manager
General Electric 2005 — 2005
Certificate, Black Belt/Six Sigma
University of Massachusetts Lowell 2002 — 2004
Certificate, Finance/Marketing
Middlesex Community College 1997 — 2001
ESL, English second language
Universidad Escuela de Administración y Finanzas y Tecnologías 1990 — 1997
B.S., Production Engineer
Colegio Maria Auxiliadora 1986 — 1989
uniQure August 2014 - Present
Lonza March 2013 - August 2014
Shire HGT March 2011 - March 2013
Shire HGT January 2010 - March 2011
Textron August 2008 - January 2010
Wyeth Biotech May 2006 - August 2008
GE June 2005 - May 2006
Thoratec December 2004 - May 2005
EMD Millipore October 2000 - May 2004
Skills
Continuous Improvement, Cross-functional Team..., Process Improvement, Biotechnology, Six Sigma, SAP, Supply Chain, MRP, Medical Devices, Procurement, ERP, Supply Chain Management, Process Simulation, Validation, Quality Assurance, Lean Manufacturing, FDA, Quality System, Business Process, Root Cause Analysis, Operational Excellence, Process Engineering, Materials Management, Team Leadership, GMP, Project Management, Supply Management, Manufacturing, 5S, CAPA, Change Control, Contract Manufacturing, DMAIC, Demand Planning, ISO, Kaizen, Leadership, Management, Manufacturing Operations, Manufacturing..., Pharmaceutical Industry, Quality Control, Quality Management, Software Documentation, Sop, Strategic Sourcing, Strategy, Supply Chain..., V&V
Education
University of Massachusetts at Lowell 2010 — 2013
MBA, Management/Finance
Worcester Polytechnic Institute 2007 — 2009
Certificate, Project Manager
General Electric 2005 — 2005
Certificate, Black Belt/Six Sigma
University of Massachusetts Lowell 2002 — 2004
Certificate, Finance/Marketing
Middlesex Community College 1997 — 2001
ESL, English second language
Universidad Escuela de Administración y Finanzas y Tecnologías 1990 — 1997
B.S., Production Engineer
Colegio Maria Auxiliadora 1986 — 1989
Amy Lane's Wyeth Biotech Experience 2002 - 2008
Job Sr. Project Manager at ARCADIS contingent worker for GlaxoSmithKline
Industry Pharmaceuticals
Experience
ARCADIS - contingent worker for GlaxoSmithKline October 2013 - Present
Jacobs Engineering -contingent worker for GlaxoSmithKline January 2008 - Present
Wyeth Biotech 2002 - 2008
Bayer 1999 - 2002
Wyeth September 1992 - November 1998
Skills
Project Engineering, cGMP, Staff Supervision, Lyophilization, Sterile Filling, Shutdown activities, Microsoft Office, Microsoft Project, Project Management, Capital Project Planning, Laboratory Design and..., AutoCAD, GMP, Project Planning, Process Engineering, MS Project, Six Sigma, Construction, Engineering, FDA, Change Control, Validation, Quality Assurance, 21 CFR Part 11, Process Simulation, GAMP, Technology Transfer, Commissioning, V&V, CAPA, Quality System, Biopharmaceuticals, GxP, Sop, Pharmaceutical Industry, Management, Biotechnology, Manufacturing, Cross-functional Team..., Aseptic Processing, Construction Management
Education
North Carolina State University
Bachelor's degree, Industrial Engineering
ARCADIS - contingent worker for GlaxoSmithKline October 2013 - Present
Jacobs Engineering -contingent worker for GlaxoSmithKline January 2008 - Present
Wyeth Biotech 2002 - 2008
Bayer 1999 - 2002
Wyeth September 1992 - November 1998
Skills
Project Engineering, cGMP, Staff Supervision, Lyophilization, Sterile Filling, Shutdown activities, Microsoft Office, Microsoft Project, Project Management, Capital Project Planning, Laboratory Design and..., AutoCAD, GMP, Project Planning, Process Engineering, MS Project, Six Sigma, Construction, Engineering, FDA, Change Control, Validation, Quality Assurance, 21 CFR Part 11, Process Simulation, GAMP, Technology Transfer, Commissioning, V&V, CAPA, Quality System, Biopharmaceuticals, GxP, Sop, Pharmaceutical Industry, Management, Biotechnology, Manufacturing, Cross-functional Team..., Aseptic Processing, Construction Management
Education
North Carolina State University
Bachelor's degree, Industrial Engineering
Colleen Gaumond's Wyeth Biotech Experience January 2002 - October 2009
Job Executive Administrative Assistant at Pfizer
Industry Pharmaceuticals
Experience
Pfizer Pharmaceuticals March 2002 - Present
Wyeth Biotech January 2002 - October 2009
VenturCom, Inc. (currently Ardence, Inc.) October 2000 - January 2002
Skills
Outlook, Document Management, Kronos, Concur, Budgeting, Event Planning, SharePoint, Customer Service, Event Management, International Logistics, Project Management, Emotional Intelligence, Soft Skills, Senior Administration, Microsoft Excel, Pharmaceutical Industry, Regulatory Affairs, CMC Regulatory Affairs, Business Travel, Microsoft Office 2007, Visio, Budgets, Quality Assurance, Administrative..., Groupwise, Trackwise, Software Documentation, Internet Explorer, SAP, FDA, GMP, Training, Travel Arrangements, Calendaring, Access, Management, Ariba, MS Project, Expenses, Time Management, Sop, Calendars, Human Resources, Analysis, Change Control, Quality Control, 21 CFR Part 11, Regulatory Submissions, Biotechnology, Regulatory Requirements
Education
Hesser College 2005 — 2007
Business Administration
Pfizer Pharmaceuticals March 2002 - Present
Wyeth Biotech January 2002 - October 2009
VenturCom, Inc. (currently Ardence, Inc.) October 2000 - January 2002
Skills
Outlook, Document Management, Kronos, Concur, Budgeting, Event Planning, SharePoint, Customer Service, Event Management, International Logistics, Project Management, Emotional Intelligence, Soft Skills, Senior Administration, Microsoft Excel, Pharmaceutical Industry, Regulatory Affairs, CMC Regulatory Affairs, Business Travel, Microsoft Office 2007, Visio, Budgets, Quality Assurance, Administrative..., Groupwise, Trackwise, Software Documentation, Internet Explorer, SAP, FDA, GMP, Training, Travel Arrangements, Calendaring, Access, Management, Ariba, MS Project, Expenses, Time Management, Sop, Calendars, Human Resources, Analysis, Change Control, Quality Control, 21 CFR Part 11, Regulatory Submissions, Biotechnology, Regulatory Requirements
Education
Hesser College 2005 — 2007
Business Administration
Allison Volpe's Wyeth Biotech Experience January 2009 - October 2009
Job Sr. Analyst Business Technology Quality & Compliance
Industry Biotechnology
Experience
Pfizer October 2009 - October 2010
Wyeth Biotech January 2009 - October 2009
Wyeth Biotech July 2002 - December 2008
Skills
Validation, 21 CFR Part 11
Education
Temple University 2008 — 2011
MS, QA/RA
James Madison University 1989 — 1993
Pfizer October 2009 - October 2010
Wyeth Biotech January 2009 - October 2009
Wyeth Biotech July 2002 - December 2008
Skills
Validation, 21 CFR Part 11
Education
Temple University 2008 — 2011
MS, QA/RA
James Madison University 1989 — 1993
Tony Robohn's Wyeth Biotech Experience January 2005 - October 2009
Job Engineer at Pfizer
Industry Biotechnology
Experience
Pfizer October 2009 - Present
Wyeth Biotech January 2005 - October 2009
ConEdison Solutions January 2002 - January 2005
Skills
Validation, Technology Transfer, FDA, Engineering, GMP, Quality System, V&V, Automation, Process Control, Lyophilization
Education
McGill University 1982 — 1987
Pfizer October 2009 - Present
Wyeth Biotech January 2005 - October 2009
ConEdison Solutions January 2002 - January 2005
Skills
Validation, Technology Transfer, FDA, Engineering, GMP, Quality System, V&V, Automation, Process Control, Lyophilization
Education
McGill University 1982 — 1987
Kimberly (Grumbine) Hartman's Wyeth Biotech Experience January 2010 - Present
Job Senior Director, External Supply at Pfizer
Industry Pharmaceuticals
Experience
Wyeth Biotech January 2010 - Present
Pfizer October 2009 - Present
Skills
21 CFR Part 11, Validation, Biotechnology, GMP, Sop, FDA, Pharmaceutical Industry, Change Control, CAPA, Technology Transfer, Clinical Trials
Education
James Madison University 1988 — 1992
Lower Dauphin High School
Wyeth Biotech January 2010 - Present
Pfizer October 2009 - Present
Skills
21 CFR Part 11, Validation, Biotechnology, GMP, Sop, FDA, Pharmaceutical Industry, Change Control, CAPA, Technology Transfer, Clinical Trials
Education
James Madison University 1988 — 1992
Lower Dauphin High School
Daniel Kedersha's Wyeth Biotech Experience 2001 - 2008
Job Sr. Quality Management Systems Auditor at Stryker
Industry Medical Devices
Experience
Stryker July 2015 - Present
Becton Dickinson May 2008 - June 2015
Wyeth Biotech 2001 - 2008
Par Pharmaceutical 1993 - 2000
Skills
CAPA, Process Validation, GMP, Quality Systems, Change Control, Validation, Compliance, ISO 13485, cGMP, FDA, Regulatory Affairs, Quality Assurance, QSR, Design Control, Medical Devices, Auditing, Regulatory Requirements, Quality Auditing, Process Improvement, Validations, Supplier Audits, Root Cause Analysis, Vaccines, Pharmaceutical Industry, 21 CFR Part 11, SOP
Education
Iona College 2002 — 2004
Master of Business Administration (M.B.A.), Business Administration and Management, General, 3.8 (Graduated with honors)
Montclair State University 1985 — 1990
Stryker July 2015 - Present
Becton Dickinson May 2008 - June 2015
Wyeth Biotech 2001 - 2008
Par Pharmaceutical 1993 - 2000
Skills
CAPA, Process Validation, GMP, Quality Systems, Change Control, Validation, Compliance, ISO 13485, cGMP, FDA, Regulatory Affairs, Quality Assurance, QSR, Design Control, Medical Devices, Auditing, Regulatory Requirements, Quality Auditing, Process Improvement, Validations, Supplier Audits, Root Cause Analysis, Vaccines, Pharmaceutical Industry, 21 CFR Part 11, SOP
Education
Iona College 2002 — 2004
Master of Business Administration (M.B.A.), Business Administration and Management, General, 3.8 (Graduated with honors)
Montclair State University 1985 — 1990
Aimee Washicosky's Wyeth Biotech Experience November 2008 - October 2009
Job Technical Services Lead, Drug Product
Industry Pharmaceuticals
Experience
Pfizer December 2011 - Present
Pfizer October 2009 - November 2011
Wyeth Biotech November 2008 - October 2009
Wyeth Biotech March 2007 - November 2008
Wyeth Biotech June 2002 - March 2007
Skills
Process Validation, Media Simulations, Change Control, GMP, Validation, FDA, Aseptic Processing, Pharmaceutical Industry, Technology Transfer, Vaccines, Biotechnology, Quality System, Trackwise, Computer System..., CAPA, 21 CFR Part 11
Education
Manhattan College 2001 — 2002
MS, Chemical Engineering
Manhattan College 1998 — 2001
BS, Chemical Engineering
Pfizer December 2011 - Present
Pfizer October 2009 - November 2011
Wyeth Biotech November 2008 - October 2009
Wyeth Biotech March 2007 - November 2008
Wyeth Biotech June 2002 - March 2007
Skills
Process Validation, Media Simulations, Change Control, GMP, Validation, FDA, Aseptic Processing, Pharmaceutical Industry, Technology Transfer, Vaccines, Biotechnology, Quality System, Trackwise, Computer System..., CAPA, 21 CFR Part 11
Education
Manhattan College 2001 — 2002
MS, Chemical Engineering
Manhattan College 1998 — 2001
BS, Chemical Engineering
Delphine Pittman's Wyeth Biotech Experience 2001 - 2008
Job Instructional Designer at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences April 2014 - Present
LexisNexis May 2012 - April 2014
TEKsystems December 2011 - April 2012
First Citizens Bank 2008 - 2011
Wyeth 2001 - 2008
Wyeth Biotech 2001 - 2008
Morganite 1997 - 2001
Eaton Corporation 1987 - 1997
Corning Glass Works 1984 - 1987
Skills
Supervisory Experience, Instructional Design, E-learning Development, Blended Learning, Curriculum Development, Technical Training, Coaching, Needs Analysis, Evaluation, Cross-functional Team..., Process Improvement, Captivate, Photoshop, SnagIt, Visio, Microsoft Office, Word, PowerPoint, Excel, MS Project, Outlook, Survey Monkey, Flash, Adobe Acrobat, Microsoft Excel, Microsoft Word, E-Learning, Training, Instructor-led Training, Leadership, Management, Technical Writing, ADDIE
Education
North Carolina State University
MEd, Training and Development
North Carolina State University
BS, Industrial Engineering
Kinston High School
PRA Health Sciences April 2014 - Present
LexisNexis May 2012 - April 2014
TEKsystems December 2011 - April 2012
First Citizens Bank 2008 - 2011
Wyeth 2001 - 2008
Wyeth Biotech 2001 - 2008
Morganite 1997 - 2001
Eaton Corporation 1987 - 1997
Corning Glass Works 1984 - 1987
Skills
Supervisory Experience, Instructional Design, E-learning Development, Blended Learning, Curriculum Development, Technical Training, Coaching, Needs Analysis, Evaluation, Cross-functional Team..., Process Improvement, Captivate, Photoshop, SnagIt, Visio, Microsoft Office, Word, PowerPoint, Excel, MS Project, Outlook, Survey Monkey, Flash, Adobe Acrobat, Microsoft Excel, Microsoft Word, E-Learning, Training, Instructor-led Training, Leadership, Management, Technical Writing, ADDIE
Education
North Carolina State University
MEd, Training and Development
North Carolina State University
BS, Industrial Engineering
Kinston High School
Sarah Mecouch's Wyeth Biotech Experience October 2007 - December 2008
Job Sr. QA Specialist at Pfizer
Industry Pharmaceuticals
Experience
Pfizer December 2008 - Present
Wyeth Biotech October 2007 - December 2008
Wyeth Biotech August 2004 - October 2007
Wyeth Biotech February 2003 - August 2004
Schering-Plough June 1997 - August 2002
Education
Lafayette College 1993 — 1997
BS, Chemical Engineering
Pfizer December 2008 - Present
Wyeth Biotech October 2007 - December 2008
Wyeth Biotech August 2004 - October 2007
Wyeth Biotech February 2003 - August 2004
Schering-Plough June 1997 - August 2002
Education
Lafayette College 1993 — 1997
BS, Chemical Engineering
Matthew Gagnon's Wyeth Biotech Experience May 2007 - October 2009
Job Scientist / Process Engineer III at Pfizer
Industry Biotechnology
Experience
Pfizer October 2009 - Present
Wyeth Biotech May 2007 - October 2009
RenaMed Biologics, Inc. 2006 - 2006
Education
McGill University
Chemical Engineering
Pfizer October 2009 - Present
Wyeth Biotech May 2007 - October 2009
RenaMed Biologics, Inc. 2006 - 2006
Education
McGill University
Chemical Engineering
Ed Kulak's Wyeth Biotech Experience February 1993 - February 1998
Job Purification Supervisor at Shire HGT
Industry Biotechnology
Experience
Shire HGT August 2011 - Present
wyeth February 1998 - September 2011
Wyeth Biotech February 1993 - February 1998
Genetics Institute February 1993 - February 1998
Education
Middlesex Community College 1995 — 1997
AS, biotechnology
Shire HGT August 2011 - Present
wyeth February 1998 - September 2011
Wyeth Biotech February 1993 - February 1998
Genetics Institute February 1993 - February 1998
Education
Middlesex Community College 1995 — 1997
AS, biotechnology
Robert Donovan's Wyeth Biotech Experience 2004 - Present
Job Director, Strategic Alliances, Pfizer Oncology
Industry Biotechnology
Experience
Pfizer 2009 - Present
Wyeth Biotech 2004 - Present
Pfizer January 2004 - October 2009
Wyeth July 2003 - January 2004
Wyeth June 2001 - January 2004
Wyeth June 2001 - June 2003
Wyeth April 2000 - June 2001
Wyeth April 1997 - April 2000
Wyeth November 1995 - April 1997
Wyeth Female Healthcare Rep January 1993 - November 1995
Skills
Hospitals, Sales Management, Oncology, Promotions, Management, Rheumatology, Cardiology, Leadership, Sales, Marketing, Sales Force Development
Education
Merrimack College 1979 — 1983
Merrimack College
Bachelor of Science, Political Science; Business Management
Pfizer 2009 - Present
Wyeth Biotech 2004 - Present
Pfizer January 2004 - October 2009
Wyeth July 2003 - January 2004
Wyeth June 2001 - January 2004
Wyeth June 2001 - June 2003
Wyeth April 2000 - June 2001
Wyeth April 1997 - April 2000
Wyeth November 1995 - April 1997
Wyeth Female Healthcare Rep January 1993 - November 1995
Skills
Hospitals, Sales Management, Oncology, Promotions, Management, Rheumatology, Cardiology, Leadership, Sales, Marketing, Sales Force Development
Education
Merrimack College 1979 — 1983
Merrimack College
Bachelor of Science, Political Science; Business Management
Kelly Maslin's Wyeth Biotech Experience June 2002 - July 2005
Job Lead Clinical Research Associate at Thoratec
Industry Medical Devices
Experience
Thoratec July 2013 - Present
PAREXEL June 2012 - June 2013
Synta Pharmaceuticals April 2010 - May 2012
Covidien March 2007 - March 2010
BattelleCRO July 2005 - December 2006
Wyeth Biotech June 2002 - July 2005
Skills
CRO, Pharmaceutical Industry, Clinical Trials, GCP, Clinical Research, Clinical Development, Clinical Operations, EDC, CTMS, Regulatory Submissions
Education
MGH Institute of Health Professions 2003 — 2005
University of Massachusetts Lowell 1996 — 2000
Thoratec July 2013 - Present
PAREXEL June 2012 - June 2013
Synta Pharmaceuticals April 2010 - May 2012
Covidien March 2007 - March 2010
BattelleCRO July 2005 - December 2006
Wyeth Biotech June 2002 - July 2005
Skills
CRO, Pharmaceutical Industry, Clinical Trials, GCP, Clinical Research, Clinical Development, Clinical Operations, EDC, CTMS, Regulatory Submissions
Education
MGH Institute of Health Professions 2003 — 2005
University of Massachusetts Lowell 1996 — 2000
Jennifer Albright's Wyeth Biotech Experience 2001 - 2008
Job QA Compliance Specialist at Novartis Vaccines
Industry Biotechnology
Experience
Novartis Vaccines September 2013 - Present
bioMerieux 2014 - 2015
Ajinomoto AminoScience LLC June 2008 - February 2013
Wyeth Biotech 2001 - 2008
Skills
GMP, CAPA, Change Control, Regulatory Affairs, Quality Assurance
Education
Temple University School of Pharmacy 2004 — 2008
Master's degree
North Carolina State University 1984 — 1988
Bachelor of Science (BS), Food Science and Technology
Novartis Vaccines September 2013 - Present
bioMerieux 2014 - 2015
Ajinomoto AminoScience LLC June 2008 - February 2013
Wyeth Biotech 2001 - 2008
Skills
GMP, CAPA, Change Control, Regulatory Affairs, Quality Assurance
Education
Temple University School of Pharmacy 2004 — 2008
Master's degree
North Carolina State University 1984 — 1988
Bachelor of Science (BS), Food Science and Technology
Marcy Wylie's Wyeth Biotech Experience April 2002 - December 2005
Job Sr. Compliance Auditor at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions February 2014 - Present
Hospira April 2011 - January 2014
Hospira April 2011 - January 2014
American Pharmaceutical Partners November 2009 - April 2011
Catalent Pharma Solutions November 2006 - November 2009
Wyeth January 2006 - November 2006
Wyeth Biotech April 2002 - December 2005
GSK August 1998 - April 2002
Skills
Quality Assurance, GMP, CAPA, Change Control, Validation, Aseptic Processing, GxP, Pharmaceutical Industry, RABQSA Lead Auditor..., Sop, Regulatory Requirements, SOP, GLP, Quality Control, V&V, Quality System
Education
North Carolina Central University
BS, Chemistry
Catalent Pharma Solutions February 2014 - Present
Hospira April 2011 - January 2014
Hospira April 2011 - January 2014
American Pharmaceutical Partners November 2009 - April 2011
Catalent Pharma Solutions November 2006 - November 2009
Wyeth January 2006 - November 2006
Wyeth Biotech April 2002 - December 2005
GSK August 1998 - April 2002
Skills
Quality Assurance, GMP, CAPA, Change Control, Validation, Aseptic Processing, GxP, Pharmaceutical Industry, RABQSA Lead Auditor..., Sop, Regulatory Requirements, SOP, GLP, Quality Control, V&V, Quality System
Education
North Carolina Central University
BS, Chemistry
Krishnaveni Rajagopalan's Wyeth Biotech Experience October 2007 - June 2008
Job Senior Quality Control Analyst at Agenus
Industry Pharmaceuticals
Experience
Agenus February 2013 - Present
Agenus August 2008 - February 2013
Wyeth Biotech October 2007 - June 2008
Pharmasol Corporation January 2007 - June 2007
Skills
Microbiology, Validation, Sop, LIMS, Laboratory, Environmental Monitoring, Biotechnology, Endotoxin
Education
NHTI, Concord's Community College 2004 — 2004
Discovery research
University of Madras 1996 — 1998
M.S, Applied Microbiology
University of Madras 1993 — 1996
B.S, Microbiology
Agenus February 2013 - Present
Agenus August 2008 - February 2013
Wyeth Biotech October 2007 - June 2008
Pharmasol Corporation January 2007 - June 2007
Skills
Microbiology, Validation, Sop, LIMS, Laboratory, Environmental Monitoring, Biotechnology, Endotoxin
Education
NHTI, Concord's Community College 2004 — 2004
Discovery research
University of Madras 1996 — 1998
M.S, Applied Microbiology
University of Madras 1993 — 1996
B.S, Microbiology
Dan Rousseau's Wyeth Biotech Experience July 1998 - September 2006
Job Senior Supervisor at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec September 2006 - Present
Wyeth Biotech July 1998 - September 2006
Skills
GMP, Biopharmaceuticals, Validation, Technology Transfer, CAPA, Sop, Technical Writing, 21 CFR Part 11, Lifesciences, Change Control, Manufacturing, Calibration, Biotechnology, FDA, Protein Chemistry, Pharmaceutical Industry, Purification, LIMS, Aseptic Processing, Fermentation, Downstream Processing, Trackwise, Aseptic Technique
Education
NHTI, Concord's Community College 2005 — 2006
Certificate, Biotechnology
Biogen Idec September 2006 - Present
Wyeth Biotech July 1998 - September 2006
Skills
GMP, Biopharmaceuticals, Validation, Technology Transfer, CAPA, Sop, Technical Writing, 21 CFR Part 11, Lifesciences, Change Control, Manufacturing, Calibration, Biotechnology, FDA, Protein Chemistry, Pharmaceutical Industry, Purification, LIMS, Aseptic Processing, Fermentation, Downstream Processing, Trackwise, Aseptic Technique
Education
NHTI, Concord's Community College 2005 — 2006
Certificate, Biotechnology
Rick Wylie's Wyeth Biotech Experience March 2004 - December 2007
Job Lead QC Associate III, Microbiology at Fujifilm Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies December 2007 - Present
Wyeth Biotech March 2004 - December 2007
Skills
GMP, LIMS, Sop, Biopharmaceuticals, CAPA, Biotechnology, 21 CFR Part 11, GLP, Aseptic Technique, Aseptic Processing, Microbiology, Quality Control, Technology Transfer, SOP, Validation, FDA
Education
North Carolina Central University 1988 — 1994
BS, Biology
Fujifilm Diosynth Biotechnologies December 2007 - Present
Wyeth Biotech March 2004 - December 2007
Skills
GMP, LIMS, Sop, Biopharmaceuticals, CAPA, Biotechnology, 21 CFR Part 11, GLP, Aseptic Technique, Aseptic Processing, Microbiology, Quality Control, Technology Transfer, SOP, Validation, FDA
Education
North Carolina Central University 1988 — 1994
BS, Biology
Frank Ventre's Wyeth Biotech Experience January 2005 - January 2009
Job Assoc Dir Development Engineering at Wyeth
Industry Biotechnology
Experience
Pfizer 2009 - Present
Wyeth Biotech January 2005 - January 2009
Education
Merrimack College
BSEE, Communications and RF Systems
Pfizer 2009 - Present
Wyeth Biotech January 2005 - January 2009
Education
Merrimack College
BSEE, Communications and RF Systems
Joe Varner's Wyeth Biotech Experience April 2003 - April 2007
Job Product Lifecycle Manager at GlaxoSmithKline Vaccines
Industry Biotechnology
Experience
GlaxoSmithKline Vaccines June 2013 - Present
GlaxoSmithKline Vaccines April 2011 - May 2013
GlaxoSmithKline Vaccines July 2012 - December 2012
GlaxoSmithKline Biologicals November 2010 - May 2011
GlaxoSmithKline Biologicals January 2009 - December 2010
GlaxoSmithKline Biologicals September 2009 - January 2010
GlaxoSmithKline Biologicals April 2007 - January 2009
Wyeth Biotech April 2003 - April 2007
Wyeth May 2000 - March 2003
Skills
Vaccines, Lyophilization, Aseptic Processing, Six Sigma, Cell Culture, Fermentation, Operational Excellence, Protein Chemistry, Sop, Biotechnology, Technology Transfer, Formulation, CAPA, FDA, V&V, Validation, 21 CFR Part 11, Manufacturing, GMP, Change Control, Clinical Trials, Leadership, Pharmaceutical Industry
Education
Malone University 1996 — 2000
Bachelors, Biology
GlaxoSmithKline Vaccines June 2013 - Present
GlaxoSmithKline Vaccines April 2011 - May 2013
GlaxoSmithKline Vaccines July 2012 - December 2012
GlaxoSmithKline Biologicals November 2010 - May 2011
GlaxoSmithKline Biologicals January 2009 - December 2010
GlaxoSmithKline Biologicals September 2009 - January 2010
GlaxoSmithKline Biologicals April 2007 - January 2009
Wyeth Biotech April 2003 - April 2007
Wyeth May 2000 - March 2003
Skills
Vaccines, Lyophilization, Aseptic Processing, Six Sigma, Cell Culture, Fermentation, Operational Excellence, Protein Chemistry, Sop, Biotechnology, Technology Transfer, Formulation, CAPA, FDA, V&V, Validation, 21 CFR Part 11, Manufacturing, GMP, Change Control, Clinical Trials, Leadership, Pharmaceutical Industry
Education
Malone University 1996 — 2000
Bachelors, Biology
Krishna (Mehta) Hayes, RN, BSN's Wyeth Biotech Experience November 2008 - March 2009
Job Manager, Product Life Cycle Management, Spine
Industry Biotechnology
Experience
Johnson & Johnson April 2015 - Present
Johnson & Johnson March 2013 - Present
Agenus August 2012 - March 2013
MGH Institute of Health Professions May 2011 - August 2012
Shire HGT October 2010 - May 2011
Shire HGT March 2009 - October 2010
Wyeth Biotech November 2008 - March 2009
Wyeth Biotech September 2006 - November 2008
Skills
GMP, FDA, Validation, Sop, CAPA, Quality Assurance, Quality System, Biotechnology, Regulatory Affairs, Quality Control, Software Documentation, Quality Auditing, Clinical Trials, Vaccines, Cross-functional Team..., Cell Culture, 21 CFR Part 11, Pharmaceutical Industry, Clinical Research, SOP
Education
MGH Institute of Health Professions
BSN, RN, Nursing
Massachusetts Biotechnology Education Foundation
Penn State University
Bachelor of Science, Biobehavioral Health
Johnson & Johnson April 2015 - Present
Johnson & Johnson March 2013 - Present
Agenus August 2012 - March 2013
MGH Institute of Health Professions May 2011 - August 2012
Shire HGT October 2010 - May 2011
Shire HGT March 2009 - October 2010
Wyeth Biotech November 2008 - March 2009
Wyeth Biotech September 2006 - November 2008
Skills
GMP, FDA, Validation, Sop, CAPA, Quality Assurance, Quality System, Biotechnology, Regulatory Affairs, Quality Control, Software Documentation, Quality Auditing, Clinical Trials, Vaccines, Cross-functional Team..., Cell Culture, 21 CFR Part 11, Pharmaceutical Industry, Clinical Research, SOP
Education
MGH Institute of Health Professions
BSN, RN, Nursing
Massachusetts Biotechnology Education Foundation
Penn State University
Bachelor of Science, Biobehavioral Health
Anita Ramaswamy's Wyeth Biotech Experience 2006 - 2009
Job Principal Scientist at BristolMyers Squibb
Industry Biotechnology
Experience
Bristol-Myers Squibb June 2014 - Present
Protein Sciences Corporation 2012 - June 2014
Pfizer 2009 - 2012
Wyeth Biotech 2006 - 2009
Wyeth Biotech 2003 - 2006
Wyeth Consumer Healthcare 2001 - 2003
Skills
UV/Vis, Technology Transfer, Six Sigma, Quality Assurance, Process Improvement, GMP, Biotechnology
Education
Iona College
MBA, General Management
S.N.D.T University
MS, Analytical and Medicinal Chemistry
University of Mumbai
BS, Chemistry
temple university
Certification in QA/ RA in Drug Development
Bristol-Myers Squibb June 2014 - Present
Protein Sciences Corporation 2012 - June 2014
Pfizer 2009 - 2012
Wyeth Biotech 2006 - 2009
Wyeth Biotech 2003 - 2006
Wyeth Consumer Healthcare 2001 - 2003
Skills
UV/Vis, Technology Transfer, Six Sigma, Quality Assurance, Process Improvement, GMP, Biotechnology
Education
Iona College
MBA, General Management
S.N.D.T University
MS, Analytical and Medicinal Chemistry
University of Mumbai
BS, Chemistry
temple university
Certification in QA/ RA in Drug Development
Chip Bulla's Wyeth Biotech Experience February 2004 - October 2008
Job Senior Services Project Manager at GE Hitachi Nuclear Energy
Industry Oil & Energy
Experience
GE Hitachi Nuclear Energy September 2009 - Present
Fox & Crow Brewing Company July 2013 - January 2015
GE Hitachi Nuclear Energy November 2008 - September 2009
Wyeth Biotech February 2004 - October 2008
Accudyne / Gul Technologies January 1997 - December 2002
Skills
Project Engineering, Engineering, Commissioning, Root Cause Analysis, Process Engineering, Continuous Improvement, Project Management, Lean Manufacturing, MS Project
Education
North Carolina State University
B.S., Nuclear Engineering
pine forest 1989 — 1991
pine forest high school 1989 — 1991
GE Hitachi Nuclear Energy September 2009 - Present
Fox & Crow Brewing Company July 2013 - January 2015
GE Hitachi Nuclear Energy November 2008 - September 2009
Wyeth Biotech February 2004 - October 2008
Accudyne / Gul Technologies January 1997 - December 2002
Skills
Project Engineering, Engineering, Commissioning, Root Cause Analysis, Process Engineering, Continuous Improvement, Project Management, Lean Manufacturing, MS Project
Education
North Carolina State University
B.S., Nuclear Engineering
pine forest 1989 — 1991
pine forest high school 1989 — 1991
Kimberly Wallbank's Wyeth Biotech Experience 2004 - 2008
Job Principal Consultant at Quality Systems Services, LLC
Industry Biotechnology
Experience
Quality Systems Services, LLC September 2010 - Present
Sultan Healthcare 2009 - 2010
Wyeth Biotech 2004 - 2008
Wyeth 2001 - 2004
Abbott Laboratories 2000 - 2001
Abbott Laboratories 1997 - 2000
Skills
GMP, Validation, Six Sigma, Biochemistry, Quality System, Quality Assurance, GLP, FDA, CAPA, Sop, Quality Auditing, 21 CFR Part 11, Quality Control
Education
Marquette University 1994 — 1997
BS, Biology
University of Phoenix
MBA, MBA
Quality Systems Services, LLC September 2010 - Present
Sultan Healthcare 2009 - 2010
Wyeth Biotech 2004 - 2008
Wyeth 2001 - 2004
Abbott Laboratories 2000 - 2001
Abbott Laboratories 1997 - 2000
Skills
GMP, Validation, Six Sigma, Biochemistry, Quality System, Quality Assurance, GLP, FDA, CAPA, Sop, Quality Auditing, 21 CFR Part 11, Quality Control
Education
Marquette University 1994 — 1997
BS, Biology
University of Phoenix
MBA, MBA
Gene Vetrone's Wyeth Biotech Experience June 2003 - February 2006
Job Facilities Engineering Manager at Actavis
Industry Pharmaceuticals
Experience
Allergan (formally Actavis / Watson Pharmaceuticals) March 2014 - Present
SUN PHARMA (formally Ohm Labs / Ranbaxy) June 2012 - March 2014
Fougera Pharmaceuticals Inc. (A Sandoz Company) June 2011 - June 2012
CorePharma LLC April 2010 - June 2011
Pfizer February 2006 - April 2010
Wyeth Biotech June 2003 - February 2006
Wyeth Pharmaceuticals March 2001 - June 2003
Pfizer Inc July 1999 - March 2001
Organon Pharmaceuticals September 1990 - July 1999
Tecknit Inc., Technical Wire Products November 1984 - September 1990
Skills
CAPA, Sop, Calibration, Cleaning Validation, Automation, GAMP, SDLC, Computer System..., Equipment Qualification, Process Validation, Preventive Maintenance, CCMS, CMMS, MES, Continuous Improvement, Validation, Project Management, SCADA, Software Documentation, Manufacturing, FDA, GMP, Pharmaceutical Industry, PLC, AutoCAD, V&V, Budgets, Project Planning, Change Management, HVAC, Engineering, Biotechnology, Aseptic Processing, Change Control, 21 CFR Part 11, Program Management, Sterilization, cGMP practices, Biopharmaceuticals, GxP, LIMS, Quality Control, GLP, Root Cause Analysis, Trackwise, Quality Assurance, Integration, Instrumentation, Quality Auditing, Process Control
Education
New Jersey Institute of Technology
BS, Mech. Eng
Allergan (formally Actavis / Watson Pharmaceuticals) March 2014 - Present
SUN PHARMA (formally Ohm Labs / Ranbaxy) June 2012 - March 2014
Fougera Pharmaceuticals Inc. (A Sandoz Company) June 2011 - June 2012
CorePharma LLC April 2010 - June 2011
Pfizer February 2006 - April 2010
Wyeth Biotech June 2003 - February 2006
Wyeth Pharmaceuticals March 2001 - June 2003
Pfizer Inc July 1999 - March 2001
Organon Pharmaceuticals September 1990 - July 1999
Tecknit Inc., Technical Wire Products November 1984 - September 1990
Skills
CAPA, Sop, Calibration, Cleaning Validation, Automation, GAMP, SDLC, Computer System..., Equipment Qualification, Process Validation, Preventive Maintenance, CCMS, CMMS, MES, Continuous Improvement, Validation, Project Management, SCADA, Software Documentation, Manufacturing, FDA, GMP, Pharmaceutical Industry, PLC, AutoCAD, V&V, Budgets, Project Planning, Change Management, HVAC, Engineering, Biotechnology, Aseptic Processing, Change Control, 21 CFR Part 11, Program Management, Sterilization, cGMP practices, Biopharmaceuticals, GxP, LIMS, Quality Control, GLP, Root Cause Analysis, Trackwise, Quality Assurance, Integration, Instrumentation, Quality Auditing, Process Control
Education
New Jersey Institute of Technology
BS, Mech. Eng
Sherry Yu's Wyeth Biotech Experience September 2003 - May 2006
Job
Industry Biotechnology
Experience
WuXi AppTec July 2015 - Present
life sciences sector September 2011 - June 2015
Warburg Pincus June 2011 - August 2011
MIT Sloan School of Management June 2009 - May 2011
Wyeth Biotech September 2003 - May 2006
Analog Devices September 1996 - October 2002
Skills
Finance, Strategy, Technology Transfer, Business Development, Leadership, Project Management, Market Analysis, Entrepreneurship, Mergers & Acquisitions, Market Research, Management, Process Improvement, Start-ups, Biotechnology, Operations Management, Manufacturing, Commercialization, Due Diligence, Venture Capital, Competitive Analysis, Cross-functional Team..., Business Strategy
Education
Massachusetts Institute of Technology - Sloan School of Management 2009 — 2011
M.B.A
University of Michigan 1991 — 1996
Ph. D.
University of Michigan 1989 — 1991
M. S.
University of Science and Technology of China 1984 — 1989
B. S.
WuXi AppTec July 2015 - Present
life sciences sector September 2011 - June 2015
Warburg Pincus June 2011 - August 2011
MIT Sloan School of Management June 2009 - May 2011
Wyeth Biotech September 2003 - May 2006
Analog Devices September 1996 - October 2002
Skills
Finance, Strategy, Technology Transfer, Business Development, Leadership, Project Management, Market Analysis, Entrepreneurship, Mergers & Acquisitions, Market Research, Management, Process Improvement, Start-ups, Biotechnology, Operations Management, Manufacturing, Commercialization, Due Diligence, Venture Capital, Competitive Analysis, Cross-functional Team..., Business Strategy
Education
Massachusetts Institute of Technology - Sloan School of Management 2009 — 2011
M.B.A
University of Michigan 1991 — 1996
Ph. D.
University of Michigan 1989 — 1991
M. S.
University of Science and Technology of China 1984 — 1989
B. S.
Jennifer Kindler's Wyeth Biotech Experience August 2006 - November 2008
Job Human Resource Professional
Industry Pharmaceuticals
Experience
Wyeth Biotech August 2006 - November 2008
Kelly Scientific Resources January 2004 - August 2006
Wyeth Research October 2000 - December 2002
Kelly Scientific at Wyeth-Ayerst June 2000 - October 2000
Education
Montclair State University
B.S, Biology
Wyeth Biotech August 2006 - November 2008
Kelly Scientific Resources January 2004 - August 2006
Wyeth Research October 2000 - December 2002
Kelly Scientific at Wyeth-Ayerst June 2000 - October 2000
Education
Montclair State University
B.S, Biology
Tom Last's Wyeth Biotech Experience August 1997 - February 2010
Job at Retired
Industry Biotechnology
Experience
Retired February 2010 - Present
Wyeth Biotech August 1997 - February 2010
Alkermes 1993 - 1997
SmithKline Beecham July 1983 - January 1993
Education
Michigan State University 1968 — 1980
Chemistry
University of Wisconsin-Oshkosh 1968 — 1972
B.S., Chemistry, Physics
Retired February 2010 - Present
Wyeth Biotech August 1997 - February 2010
Alkermes 1993 - 1997
SmithKline Beecham July 1983 - January 1993
Education
Michigan State University 1968 — 1980
Chemistry
University of Wisconsin-Oshkosh 1968 — 1972
B.S., Chemistry, Physics
Lloyd Goldstein's Wyeth Biotech Experience January 2007 - March 2009
Job Sr Territory Business Manager Oncology
Industry Pharmaceuticals
Julie Zerfas's Wyeth Biotech Experience Research AssociateMosaic Technologies2001 - 2003
Job Research Scientist II at Pfizer (formally Wyeth)
Industry Pharmaceuticals
Experience
Wyeth Biotech Research AssociateMosaic Technologies2001 - 2003
Scriptgen Pharmaceuticals 1998 - 1999
Education
University of Massachusetts Lowell 2003 — 2006
Masters of Science, Biological Sciences
Merrimack College 1994 — 1998
Bachelor of Arts, Biology
Wyeth Biotech Research AssociateMosaic Technologies2001 - 2003
Scriptgen Pharmaceuticals 1998 - 1999
Education
University of Massachusetts Lowell 2003 — 2006
Masters of Science, Biological Sciences
Merrimack College 1994 — 1998
Bachelor of Arts, Biology
Chris Mohr's Wyeth Biotech Experience June 2007 - August 2007
Job Associate at University Ventures
Industry Financial Services
Experience
University Ventures July 2015 - Present
HSBC July 2014 - July 2015
PwC August 2010 - February 2014
PwC June 2009 - August 2009
The Barson Group June 2008 - August 2008
Portfolio Evaluations, Inc. May 2008 - August 2008
Wyeth Biotech June 2007 - August 2007
Skills
Valuation, Financial Analysis, Financial Modeling, Financial Accounting, Accounting, Analysis, Portfolio Management, Internal Controls, Mergers & Acquisitions, Finance, Forensic Accounting, Financial Forecasting, Microsoft Excel, Microsoft Office, PowerPoint, Bloomberg, Investment Advisory, Investment Banking
Education
Lehigh University 2006 — 2010
Bachelor of Science (B.S.), Accounting
Randolph High School 2002 — 2006
University Ventures July 2015 - Present
HSBC July 2014 - July 2015
PwC August 2010 - February 2014
PwC June 2009 - August 2009
The Barson Group June 2008 - August 2008
Portfolio Evaluations, Inc. May 2008 - August 2008
Wyeth Biotech June 2007 - August 2007
Skills
Valuation, Financial Analysis, Financial Modeling, Financial Accounting, Accounting, Analysis, Portfolio Management, Internal Controls, Mergers & Acquisitions, Finance, Forensic Accounting, Financial Forecasting, Microsoft Excel, Microsoft Office, PowerPoint, Bloomberg, Investment Advisory, Investment Banking
Education
Lehigh University 2006 — 2010
Bachelor of Science (B.S.), Accounting
Randolph High School 2002 — 2006
Mark M. Carey's Wyeth Biotech Experience June 1990 - July 1997
Job QC Manager at Pfizer Specialty Care & Vaccines
Industry Pharmaceuticals
Experience
Pfizer Pharmaceuticals January 1981 - Present
Wyeth Pharmaceuticals (acquired by Pfizer Pharmaceuticals) 1981 - Present
wyeth July 1997 - September 2002
Wyeth Biotech June 1990 - July 1997
Education
Mercy College
MS ED, Biology, Secondary Education
Pfizer Pharmaceuticals January 1981 - Present
Wyeth Pharmaceuticals (acquired by Pfizer Pharmaceuticals) 1981 - Present
wyeth July 1997 - September 2002
Wyeth Biotech June 1990 - July 1997
Education
Mercy College
MS ED, Biology, Secondary Education
Bevin Philip's Wyeth Biotech Experience 2001 - 2004
Job VicePresident, Operations at 2U
Industry Education Management
Experience
2U 2011 - Present
Eudaimonia Foundation Corp. 2006 - 2012
TestPerfect, LLC 2009 - 2011
Cell Signaling Technology September 2004 - September 2006
Wyeth Biotech 2001 - 2004
Skills
E-Learning, Leadership, Educational Leadership, Strategic Planning, Higher Education, Public Speaking, Teaching, Program Management, K-12, Operations Management, Microsoft Excel, Non-profits, Research, Training, Staff Development, Leadership Development, Nonprofits
Education
Johns Hopkins Medical Institution/Public Health
PhD
Knox College
BA
The Johns Hopkins University - Carey Business School
MBA
2U 2011 - Present
Eudaimonia Foundation Corp. 2006 - 2012
TestPerfect, LLC 2009 - 2011
Cell Signaling Technology September 2004 - September 2006
Wyeth Biotech 2001 - 2004
Skills
E-Learning, Leadership, Educational Leadership, Strategic Planning, Higher Education, Public Speaking, Teaching, Program Management, K-12, Operations Management, Microsoft Excel, Non-profits, Research, Training, Staff Development, Leadership Development, Nonprofits
Education
Johns Hopkins Medical Institution/Public Health
PhD
Knox College
BA
The Johns Hopkins University - Carey Business School
MBA
Beverly Hendrick's Wyeth Biotech Experience 2004 - Present
Job QC Scientist IV at Wyeth
Industry Pharmaceuticals
Experience
Wyeth Quality Analytical Development ScientistPfizer2009 - Present
Pfizer (legacy Wyeth) 2008 - Present
Pfizer, 4300 Oak Park, Sanford, NC 2006 - Present
Wyeth Biotech 2004 - Present
Wyeth August 2006 - December 2008
Skills
Analytical Chemistry, Quality Control
Education
Meredith College 1983 — 1987
B.S, Mathematics, Chemistry
Wyeth Quality Analytical Development ScientistPfizer2009 - Present
Pfizer (legacy Wyeth) 2008 - Present
Pfizer, 4300 Oak Park, Sanford, NC 2006 - Present
Wyeth Biotech 2004 - Present
Wyeth August 2006 - December 2008
Skills
Analytical Chemistry, Quality Control
Education
Meredith College 1983 — 1987
B.S, Mathematics, Chemistry
Gary Wyrick's Wyeth Biotech Experience August 2002 - October 2009
Job Director, Technology, Global Manufacturing Services at Pfizer
Industry Biotechnology
Experience
Pfizer October 2009 - Present
Wyeth Biotech August 2002 - October 2009
DSM/Catalytica Pharmaceuticals Inc. 1997 - 2001
Glaxo/Burroughs Wellcome Co. 1993 - 1997
Skills
Biopharmaceuticals, Validation, Manufacturing, Biotechnology, Change Control, Technology Transfer, Pharmaceutical Industry, FDA, Engineering, GMP, Project Management, GLP, Cross-functional Team..., Pharmaceutics, Vaccines, Sop, Regulatory Affairs, V&V, CAPA, Medical Devices, Analytical Chemistry, Quality System, Six Sigma, Computer System..., Process Simulation, ISO 13485, R&D, 21 CFR Part 11, LIMS, Quality Control, Quality Assurance, Commercialization, GxP, Lifesciences, Aseptic Processing, Formulation, HPLC, Chromatography, SOP
Education
North Carolina State University 1966 — 1970
BSME, Engineering
Pfizer October 2009 - Present
Wyeth Biotech August 2002 - October 2009
DSM/Catalytica Pharmaceuticals Inc. 1997 - 2001
Glaxo/Burroughs Wellcome Co. 1993 - 1997
Skills
Biopharmaceuticals, Validation, Manufacturing, Biotechnology, Change Control, Technology Transfer, Pharmaceutical Industry, FDA, Engineering, GMP, Project Management, GLP, Cross-functional Team..., Pharmaceutics, Vaccines, Sop, Regulatory Affairs, V&V, CAPA, Medical Devices, Analytical Chemistry, Quality System, Six Sigma, Computer System..., Process Simulation, ISO 13485, R&D, 21 CFR Part 11, LIMS, Quality Control, Quality Assurance, Commercialization, GxP, Lifesciences, Aseptic Processing, Formulation, HPLC, Chromatography, SOP
Education
North Carolina State University 1966 — 1970
BSME, Engineering
Zhanfeng (Frank) Yin's Wyeth Biotech Experience October 2003 - July 2007
Job Sr. Manager at Baxter Healthcare
Industry Pharmaceuticals
Experience
Baxter Healthcare July 2011 - Present
WuXi AppTec June 2010 - December 2011
Pfizer/Wyeth R&D July 2007 - June 2010
Wyeth Biotech October 2003 - July 2007
Wyeth Vaccines March 2002 - October 2003
Bel-Ray Company, Inc June 2000 - December 2001
the National Institute November 1995 - June 2000
University of Western Ontario August 1990 - November 1995
University of Western September 1990 - July 1992
M.S September 1985 - August 1990
Skills
UV/Vis, GLP, Characterization, Coatings, Chemistry, FTIR, Formulation, GC-MS, GMP, Gas Chromatography, HPLC, NMR, Organic Chemistry, Purification, R, Sop, Spectroscopy, TGA, Validation
Education
The University of Western
Ph. D; M. BancroftM. S, Chemistry; Chemistry
Nanjing University
M. S., Chemistry
Nanjing University
B. S., Chemistry
National institute of Standards and Technology
Post-doctor
Baxter Healthcare July 2011 - Present
WuXi AppTec June 2010 - December 2011
Pfizer/Wyeth R&D July 2007 - June 2010
Wyeth Biotech October 2003 - July 2007
Wyeth Vaccines March 2002 - October 2003
Bel-Ray Company, Inc June 2000 - December 2001
the National Institute November 1995 - June 2000
University of Western Ontario August 1990 - November 1995
University of Western September 1990 - July 1992
M.S September 1985 - August 1990
Skills
UV/Vis, GLP, Characterization, Coatings, Chemistry, FTIR, Formulation, GC-MS, GMP, Gas Chromatography, HPLC, NMR, Organic Chemistry, Purification, R, Sop, Spectroscopy, TGA, Validation
Education
The University of Western
Ph. D; M. BancroftM. S, Chemistry; Chemistry
Nanjing University
M. S., Chemistry
Nanjing University
B. S., Chemistry
National institute of Standards and Technology
Post-doctor
Rick Wylie's Wyeth Biotech Experience March 2004 - December 2008
Job Lead QC Associate at Diosynth
Industry Biotechnology
Experience
Diosynth December 2008 - Present
Wyeth Biotech March 2004 - December 2008
Education
North Carolina Central University 1988 — 1994
Bachelor of Science, Biology
Diosynth December 2008 - Present
Wyeth Biotech March 2004 - December 2008
Education
North Carolina Central University 1988 — 1994
Bachelor of Science, Biology
David Vogt's Wyeth Biotech Experience 2007 - 2008
Job Director of Plant Operations at Xellia Pharmaceuticals
Industry Pharmaceuticals
Experience
Xellia Pharmaceuticals July 2014 - Present
Fresenius Kabi USA March 2014 - Present
Fresenius Kabi USA (formerly APP Pharmaceuticals) 2011 - Present
Pfizer 2010 - 2010
Pfizer 2008 - 2010
Wyeth Biotech 2007 - 2008
Wyeth Biotech 2002 - 2007
Elan Pharmaceuticals June 2001 - October 2002
Nabi Biopharmaceuticals June 1996 - February 2001
McNeil Consumer Healthcare April 1994 - June 1996
Skills
LIMS, FDA, QC, Analytical Chemistry, Quality Assurance, Quality Control, Lean Manufacturing, Laboratory, 21 CFR Part 11, Cleaning Validation, GxP, Aseptic Processing, CAPA
Education
North Carolina State University 1992 — 1993
Graduate Study in Biochemistry
Penn State University 1988 — 1992
B.S., Biochemistry
Xellia Pharmaceuticals July 2014 - Present
Fresenius Kabi USA March 2014 - Present
Fresenius Kabi USA (formerly APP Pharmaceuticals) 2011 - Present
Pfizer 2010 - 2010
Pfizer 2008 - 2010
Wyeth Biotech 2007 - 2008
Wyeth Biotech 2002 - 2007
Elan Pharmaceuticals June 2001 - October 2002
Nabi Biopharmaceuticals June 1996 - February 2001
McNeil Consumer Healthcare April 1994 - June 1996
Skills
LIMS, FDA, QC, Analytical Chemistry, Quality Assurance, Quality Control, Lean Manufacturing, Laboratory, 21 CFR Part 11, Cleaning Validation, GxP, Aseptic Processing, CAPA
Education
North Carolina State University 1992 — 1993
Graduate Study in Biochemistry
Penn State University 1988 — 1992
B.S., Biochemistry
Erik Westberg's Wyeth Biotech Experience December 2006 - November 2009
Job Automation Engineer at Pfizer
Industry Pharmaceuticals
Experience
Pfizer March 2013 - Present
Pfizer November 2009 - March 2013
Wyeth biotech December 2006 - November 2009
Automatech May 2002 - November 2006
Skills
Validation, GMP, Change Control, CAPA, Computer System..., Automation, PLC, SCADA, Sop, Instrumentation, Allen Bradley, Biotechnology, Pharmaceutical Industry, Technology Transfer, Control Logic, Process Automation, GxP, Process Engineering, Troubleshooting, Continuous Improvement, Control Systems Design, Testing, Software Documentation, Trackwise, HMIs, iFix, Quality Assurance, RSLogix, FDA GMP, PLC Programming, 21 CFR Part 11, Engineering, FDA, GAMP, MES, V
Education
New England Institute of Technology 1998 — 2001
BS, Electronic Engineering Technology
Pfizer March 2013 - Present
Pfizer November 2009 - March 2013
Wyeth biotech December 2006 - November 2009
Automatech May 2002 - November 2006
Skills
Validation, GMP, Change Control, CAPA, Computer System..., Automation, PLC, SCADA, Sop, Instrumentation, Allen Bradley, Biotechnology, Pharmaceutical Industry, Technology Transfer, Control Logic, Process Automation, GxP, Process Engineering, Troubleshooting, Continuous Improvement, Control Systems Design, Testing, Software Documentation, Trackwise, HMIs, iFix, Quality Assurance, RSLogix, FDA GMP, PLC Programming, 21 CFR Part 11, Engineering, FDA, GAMP, MES, V
Education
New England Institute of Technology 1998 — 2001
BS, Electronic Engineering Technology
Julie Chester's Wyeth Biotech Experience January 2001 - January 2004
Job Global Quality Systems Lead at Monsanto
Industry Biotechnology
Experience
Monsanto April 2010 - Present
Pfizer, Inc. January 2009 - March 2010
Centocor January 2006 - January 2009
Centocor January 2004 - January 2006
Wyeth Biotech January 2001 - January 2004
Forest Laboratories January 1999 - January 2001
Monsanto January 1998 - January 1999
Education
Maryville University of Saint Louis
MBA, Management
Truman State University
BS, Chemistry / Criminal Justice
Monsanto April 2010 - Present
Pfizer, Inc. January 2009 - March 2010
Centocor January 2006 - January 2009
Centocor January 2004 - January 2006
Wyeth Biotech January 2001 - January 2004
Forest Laboratories January 1999 - January 2001
Monsanto January 1998 - January 1999
Education
Maryville University of Saint Louis
MBA, Management
Truman State University
BS, Chemistry / Criminal Justice
Sarah Florenz's Wyeth Biotech Experience 2002 - 2006
Job Experienced Quality Assurance Manager
Industry Pharmaceuticals
Experience
Pfizer 2012 - 2014
Pfizer (Formerly Wyeth Biotech) 2006 - 2012
Wyeth Biotech 2002 - 2006
Bartels Diagnostics/Trinity Biotech 2001 - 2001
Bartels Diagnostics/Trinity Biotech 2000 - 2001
BioRad Laboratories 1999 - 2000
Skills
Trackwise, GMP, Clinical Trials, CAPA, Root Cause Analysis, HPLC, Microbiology, Pharmaceutical Industry, 21 CFR Part 11, Assay Development, Biopharmaceuticals, Biotechnology, Cell Culture, Change Control, FDA, Formulation, LIMS, Purification, ELISA, Quality Assurance, Quality Control, Quality System, Six Sigma, Sop, Technology Transfer, Vaccines, Validation, GLP
Education
Northeastern University 2005 — 2008
MS, Regulatory Affairs for Drugs, Biologics and Medical Devices
Middlebury College 1995 — 1999
BA, Molecular Biology and Biochemistry
Pfizer 2012 - 2014
Pfizer (Formerly Wyeth Biotech) 2006 - 2012
Wyeth Biotech 2002 - 2006
Bartels Diagnostics/Trinity Biotech 2001 - 2001
Bartels Diagnostics/Trinity Biotech 2000 - 2001
BioRad Laboratories 1999 - 2000
Skills
Trackwise, GMP, Clinical Trials, CAPA, Root Cause Analysis, HPLC, Microbiology, Pharmaceutical Industry, 21 CFR Part 11, Assay Development, Biopharmaceuticals, Biotechnology, Cell Culture, Change Control, FDA, Formulation, LIMS, Purification, ELISA, Quality Assurance, Quality Control, Quality System, Six Sigma, Sop, Technology Transfer, Vaccines, Validation, GLP
Education
Northeastern University 2005 — 2008
MS, Regulatory Affairs for Drugs, Biologics and Medical Devices
Middlebury College 1995 — 1999
BA, Molecular Biology and Biochemistry
Jeffrey Carvelli, PMP's Wyeth Biotech Experience June 2005 - September 2008
Job Manager, Facilities Engineering at Genzyme
Industry Biotechnology
Experience
Genzyme February 2015 - Present
Genzyme March 2014 - February 2015
Genzyme April 2012 - March 2014
Genzyme March 2011 - April 2012
Ipsen June 2010 - March 2011
Bristol-Myers Squibb September 2008 - July 2010
Wyeth Biotech June 2005 - September 2008
Building Technology Engineers 2002 - 2004
Skills
Change Control, Engineering, GMP, Management, Project Management, Quality System, Validation, CAPA, Biotechnology
Education
Clark University (GSOM) 2012 — 2016
Master of Business Administration (MBA)
Project Management Institute 2011 — 2011
PMP Certification, Project Management Professional
Massachusetts Maritime Academy 1998 — 2002
BS, Facilities and Environmental Engineering
Genzyme February 2015 - Present
Genzyme March 2014 - February 2015
Genzyme April 2012 - March 2014
Genzyme March 2011 - April 2012
Ipsen June 2010 - March 2011
Bristol-Myers Squibb September 2008 - July 2010
Wyeth Biotech June 2005 - September 2008
Building Technology Engineers 2002 - 2004
Skills
Change Control, Engineering, GMP, Management, Project Management, Quality System, Validation, CAPA, Biotechnology
Education
Clark University (GSOM) 2012 — 2016
Master of Business Administration (MBA)
Project Management Institute 2011 — 2011
PMP Certification, Project Management Professional
Massachusetts Maritime Academy 1998 — 2002
BS, Facilities and Environmental Engineering
Christian Ruitberg's Wyeth Biotech Experience June 2004 - May 2007
Job Principal Engineer at Amgen
Industry Biotechnology
Experience
Amgen May 2007 - Present
Wyeth Biotech June 2004 - May 2007
Merck June 2002 - May 2004
Biogen June 2001 - August 2001
NIST 1996 - 2001
Skills
Technology Transfer, Biopharmaceuticals, Process Engineering, Process Simulation, Validation, Biotechnology, R&D, Chemical Engineering, Aseptic Processing, Commercialization, Design of Experiments
Education
Lehigh University 2002 — 2005
M.Eng., Chemical Engineering
Rensselaer Polytechnic Institute 1998 — 2002
B.S., Chemical Engineering
Amgen May 2007 - Present
Wyeth Biotech June 2004 - May 2007
Merck June 2002 - May 2004
Biogen June 2001 - August 2001
NIST 1996 - 2001
Skills
Technology Transfer, Biopharmaceuticals, Process Engineering, Process Simulation, Validation, Biotechnology, R&D, Chemical Engineering, Aseptic Processing, Commercialization, Design of Experiments
Education
Lehigh University 2002 — 2005
M.Eng., Chemical Engineering
Rensselaer Polytechnic Institute 1998 — 2002
B.S., Chemical Engineering
Adam Tessneer's Wyeth Biotech Experience May 2002 - October 2007
Job Sr. Validation Engineer at Merck
Industry Pharmaceuticals
Experience
Merck October 2007 - Present
Wyeth Biotech May 2002 - October 2007
Education
North Carolina State University 2000 — 2002
M.S., Food Science
North Carolina State University 1995 — 1999
B.S., Food Science
Merck October 2007 - Present
Wyeth Biotech May 2002 - October 2007
Education
North Carolina State University 2000 — 2002
M.S., Food Science
North Carolina State University 1995 — 1999
B.S., Food Science
Stephanie Afzelius Neary's Wyeth Biotech Experience June 2006 - July 2006
Job Human Resources Professional / Seeking a new challenge
Industry Human Resources
Experience
Mortgage Assistance Services April 2011 - April 2011
Bank of America, Boston, MA October 2007 - June 2008
State Street Corporation August 2006 - October 2007
Wyeth Biotech June 2006 - July 2006
MIT Lincoln Laboratory 2002 - 2004
Cerner Corporation 2001 - 2002
Boston Magazine 2000 - 2001
Skills
Recruiting, Background Checks, Interviews
Education
Middlesex Community College 1999 — 2001
Associate in Science, Liberal Studies
Western New England University
Bachelor, Business Administration
Mortgage Assistance Services April 2011 - April 2011
Bank of America, Boston, MA October 2007 - June 2008
State Street Corporation August 2006 - October 2007
Wyeth Biotech June 2006 - July 2006
MIT Lincoln Laboratory 2002 - 2004
Cerner Corporation 2001 - 2002
Boston Magazine 2000 - 2001
Skills
Recruiting, Background Checks, Interviews
Education
Middlesex Community College 1999 — 2001
Associate in Science, Liberal Studies
Western New England University
Bachelor, Business Administration
jose cata's Wyeth Biotech Experience January 2000 - October 2009
Job Field Planner
Industry Pharmaceuticals
Experience
Pfizer Pharmaceuticals October 2009 - Present
Wyeth Biotech January 2000 - October 2009
JE Merit Construction July 1993 - January 2000
Skills
GMP, SAP, Pharmaceuticals, Planning, Project Planning, 21 CFR Part 11, Continuous Improvement, Software Documentation, Validation, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Sop, Change Control, FDA, Manufacturing, Aseptic Processing, Quality Assurance, Process Improvement, Quality System, CAPA, SOP
Education
Miami Dade College 1983 — 1985
Building Construction
St. Edward High School 1979 — 1983
Pfizer Pharmaceuticals October 2009 - Present
Wyeth Biotech January 2000 - October 2009
JE Merit Construction July 1993 - January 2000
Skills
GMP, SAP, Pharmaceuticals, Planning, Project Planning, 21 CFR Part 11, Continuous Improvement, Software Documentation, Validation, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Sop, Change Control, FDA, Manufacturing, Aseptic Processing, Quality Assurance, Process Improvement, Quality System, CAPA, SOP
Education
Miami Dade College 1983 — 1985
Building Construction
St. Edward High School 1979 — 1983
Sai Ping Truong's Wyeth Biotech Experience April 2008 - November 2008
Job QC Scientist III at Pfizer
Industry Pharmaceuticals
Experience
Pfizer November 2008 - Present
Wyeth Biotech April 2008 - November 2008
Wyeth Consumer Healthcare December 1999 - April 2008
Wyeth Pharmaceuticals 1998 - 1999
Nice-Pak Products, Inc. 1997 - 1998
Skills
Change Control, 21 CFR Part 11, Sop, GMP, FDA, Pharmaceutical Industry, Biotechnology, Quality Assurance, Trackwise, Regulatory Requirements, Technology Transfer, HPLC, EDMS, SAP ERP, ICP-OES, GXPharma, LIMS, Quality Control, Validation, SMS, Microsoft Excel, Microsoft Word, PDOCS, Analytical Chemistry
Education
Long Island University
MS, Computer Science
Stony Brook University
BS, Chemisty
Pfizer November 2008 - Present
Wyeth Biotech April 2008 - November 2008
Wyeth Consumer Healthcare December 1999 - April 2008
Wyeth Pharmaceuticals 1998 - 1999
Nice-Pak Products, Inc. 1997 - 1998
Skills
Change Control, 21 CFR Part 11, Sop, GMP, FDA, Pharmaceutical Industry, Biotechnology, Quality Assurance, Trackwise, Regulatory Requirements, Technology Transfer, HPLC, EDMS, SAP ERP, ICP-OES, GXPharma, LIMS, Quality Control, Validation, SMS, Microsoft Excel, Microsoft Word, PDOCS, Analytical Chemistry
Education
Long Island University
MS, Computer Science
Stony Brook University
BS, Chemisty
Matt Cahalane's Wyeth Biotech Experience May 2007 - October 2009
Job Sr. Process Technician II
Industry Pharmaceuticals
Experience
Pfizer December 2013 - Present
Pfizer April 2011 - December 2013
Pfizer October 2009 - April 2011
Wyeth Biotech May 2007 - October 2009
GNC October 2004 - May 2007
Olympia Sports June 2001 - November 2004
Skills
CAPA, Aseptic Technique, Media Preparation, Autoclave, Safety Leadership, Buffer Preparation, Cell Culture, System Trouble Shooting, Formulation, Cross-functional Team..., Inventory Management, cGMP manufacturing, Operational Excellence, Employee Training, Troubleshooting, Workplace Safety, Sop, GMP, Continuous Improvement, Aseptic Processing, SAP, Technology Transfer, Training, LIMS, FDA, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Root Cause Analysis, Process Improvement, SOP, Manufacturing, 21 CFR Part 11, Leadership
Education
Mount Washington College 2000 — 2004
Associates, Criminal Justice / Psychology / Criminlology, 3.8
Pinkerton Academy High School 1996 — 2000
Pfizer December 2013 - Present
Pfizer April 2011 - December 2013
Pfizer October 2009 - April 2011
Wyeth Biotech May 2007 - October 2009
GNC October 2004 - May 2007
Olympia Sports June 2001 - November 2004
Skills
CAPA, Aseptic Technique, Media Preparation, Autoclave, Safety Leadership, Buffer Preparation, Cell Culture, System Trouble Shooting, Formulation, Cross-functional Team..., Inventory Management, cGMP manufacturing, Operational Excellence, Employee Training, Troubleshooting, Workplace Safety, Sop, GMP, Continuous Improvement, Aseptic Processing, SAP, Technology Transfer, Training, LIMS, FDA, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Root Cause Analysis, Process Improvement, SOP, Manufacturing, 21 CFR Part 11, Leadership
Education
Mount Washington College 2000 — 2004
Associates, Criminal Justice / Psychology / Criminlology, 3.8
Pinkerton Academy High School 1996 — 2000
Lynne Schapira's Wyeth Biotech Experience January 2001 - January 2006
Job Facility Planner / Interior Designer and Home Stager
Industry Pharmaceuticals
Experience
Self Employed 2012 - Present
Diversified Project Management 2014 - February 2014
Pfizer Pharmaceuticals January 2006 - June 2011
Wyeth Biotech January 2001 - January 2006
Genetics Institute July 1998 - January 2001
Skills
Facilities Management, Space-planning, Outlook, Space planning, PowerPoint, GMP, Administrative..., SAP, Microsoft Word, Project Coordination
Education
Merrimack College
BA, Liberal Arts, summa cum laude, Fine Arts / Business Management
Merrimack College
BA, summa cum laude, Fine Arts / Business Management
NECC
Certificate Program, Interior Design and Staging
Self Employed 2012 - Present
Diversified Project Management 2014 - February 2014
Pfizer Pharmaceuticals January 2006 - June 2011
Wyeth Biotech January 2001 - January 2006
Genetics Institute July 1998 - January 2001
Skills
Facilities Management, Space-planning, Outlook, Space planning, PowerPoint, GMP, Administrative..., SAP, Microsoft Word, Project Coordination
Education
Merrimack College
BA, Liberal Arts, summa cum laude, Fine Arts / Business Management
Merrimack College
BA, summa cum laude, Fine Arts / Business Management
NECC
Certificate Program, Interior Design and Staging
Matt Efird's Wyeth Biotech Experience January 2007 - April 2008
Job Lead Maintenance Mechanic at Eisai
Industry Pharmaceuticals
Experience
Eisai November 2011 - Present
Eisai April 2008 - November 2011
Wyeth Biotech January 2007 - April 2008
NC State University August 2004 - January 2007
NC State University August 2003 - August 2004
Jiffy Lube Southeast May 2003 - August 2003
Buddy's Honda Repair June 2001 - May 2003
Stanly County Maintenance Department 1999 - August 2001
Skills
V, Validation, Technology Transfer, 21 CFR Part 11, Biotechnology, CAPA, Change Control, GMP, FDA, Pharmaceutical Industry, SOP, Sop, GLP
Education
Stanly Community College 2001 — 2003
Associate's degree, Electronics Engineering Technology
North Carolina State University
Diploma, Maintenance and Reliability Management
Eisai November 2011 - Present
Eisai April 2008 - November 2011
Wyeth Biotech January 2007 - April 2008
NC State University August 2004 - January 2007
NC State University August 2003 - August 2004
Jiffy Lube Southeast May 2003 - August 2003
Buddy's Honda Repair June 2001 - May 2003
Stanly County Maintenance Department 1999 - August 2001
Skills
V, Validation, Technology Transfer, 21 CFR Part 11, Biotechnology, CAPA, Change Control, GMP, FDA, Pharmaceutical Industry, SOP, Sop, GLP
Education
Stanly Community College 2001 — 2003
Associate's degree, Electronics Engineering Technology
North Carolina State University
Diploma, Maintenance and Reliability Management
Adam Kroft's Wyeth Biotech Experience November 2000 - January 2006
Job CMC Director at Biogen
Industry Biotechnology
Experience
Biogen February 2015 - Present
Biogen May 2014 - February 2015
Genzyme September 2011 - May 2014
Genzyme October 2010 - December 2011
Genzyme January 2006 - October 2010
Wyeth Biotech November 2000 - January 2006
Skills
Purification, GMP, Validation, Technology Transfer, Biopharmaceuticals, Biotechnology
Education
Tufts University 2003 — 2008
MEng, Chemical Engineering
Massachusetts Institute of Technology 1995 — 2000
BS, Chemical Engineering
Biogen February 2015 - Present
Biogen May 2014 - February 2015
Genzyme September 2011 - May 2014
Genzyme October 2010 - December 2011
Genzyme January 2006 - October 2010
Wyeth Biotech November 2000 - January 2006
Skills
Purification, GMP, Validation, Technology Transfer, Biopharmaceuticals, Biotechnology
Education
Tufts University 2003 — 2008
MEng, Chemical Engineering
Massachusetts Institute of Technology 1995 — 2000
BS, Chemical Engineering
Isabel Romulo's Wyeth Biotech Experience January 2005 - January 2008
Job QA Stability Specialist at Pfizer Pharmaceuticals
Industry Pharmaceuticals
Experience
Pfizer Pharmaceuticals January 2008 - Present
WYETH BIOTECH January 2005 - January 2008
WYETH Pharmaceutical January 2002 - January 2005
WYETH-AYERST Pharmaceutical 1988 - 2001
LEDERLE Laboratories 1983 - 1988
Skills
FDA, Sop, Change Control, LIMS, GLP, GMP, Pharmaceutical Industry, GxP, CAPA, 21 CFR Part 11, Validation
Education
Mapua Institute of Technology
B. S., Chemistry
Pfizer Pharmaceuticals January 2008 - Present
WYETH BIOTECH January 2005 - January 2008
WYETH Pharmaceutical January 2002 - January 2005
WYETH-AYERST Pharmaceutical 1988 - 2001
LEDERLE Laboratories 1983 - 1988
Skills
FDA, Sop, Change Control, LIMS, GLP, GMP, Pharmaceutical Industry, GxP, CAPA, 21 CFR Part 11, Validation
Education
Mapua Institute of Technology
B. S., Chemistry