North American Vaccine
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North American Vaccine Employees
Employee
Years
Job
Industry
Nolan Feintuch Nolan Feintuch's North American Vaccine Experience January 1998 - January 2001
Job Experienced Volunteer Manager and Program Organizer
Industry Real Estate
Experience
Harry Norman, Realtors January 2000 - Present
Just People Aktion Club March 2010 - Present
Sandy Springs Kiwanis October 2012 - September 2013
Dunwoody Soap Box Derby January 2010 - July 2010
Sandy Springs Kiwanis Club October 2008 - September 2009
Volunteer For A Better Sandy Springs September 2006 - September 2008
North American Vaccine January 1998 - January 2001
Centers For Disease Control and Prevention January 1993 - January 1998
Skills
Nonprofits
Education
Kennesaw State University
MBA, Business 2003
The University of Texas at Austin 1988 — 1989
M.A., Social Science
University of Michigan 1984 — 1988
B.A., Social Science
Georgia Tech University
Graduate Certificate Program, Business
Harry Norman, Realtors January 2000 - Present
Just People Aktion Club March 2010 - Present
Sandy Springs Kiwanis October 2012 - September 2013
Dunwoody Soap Box Derby January 2010 - July 2010
Sandy Springs Kiwanis Club October 2008 - September 2009
Volunteer For A Better Sandy Springs September 2006 - September 2008
North American Vaccine January 1998 - January 2001
Centers For Disease Control and Prevention January 1993 - January 1998
Skills
Nonprofits
Education
Kennesaw State University
MBA, Business 2003
The University of Texas at Austin 1988 — 1989
M.A., Social Science
University of Michigan 1984 — 1988
B.A., Social Science
Georgia Tech University
Graduate Certificate Program, Business
Carole Jones Carole Jones's North American Vaccine Experience January 1998 - February 1999
Job
Industry Medical Devices
Experience
FDA October 2013 - Present
FDA December 2012 - May 2013
FDA July 2010 - March 2013
Food and Drug Administration September 2008 - July 2010
Food and Drug Administration September 2002 - September 2008
Guilford Pharmaceuticals March 1999 - September 2002
North American Vaccine January 1998 - February 1999
Skills
FDA, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Validation, GMP, Sop, GCP, Regulations, Regulatory Requirements, Microbiology, Medical Devices, Lifesciences, Quality Control, Technology Transfer, CAPA, Drug Development, Clinical Development, Cross-functional Team..., Biopharmaceuticals, IND, Quality Auditing, Process Simulation, R&D, Cell Culture, Change Control, Clinical Research, Vaccines, Document Management, Chromatography, Science, Manufacturing, Quality Management, Leadership, Pharmacovigilance, Quality Assurance, GLP, 21 CFR Part 11, Pharmaceutics, Regulatory Submissions, LIMS, SOP, Life Sciences
Education
University of Maryland University College 2001 — 2005
Masters, Biotechnology Sciences
University of Maryland Baltimore County 1993 — 1997
BS, Biological Sciences
FDA October 2013 - Present
FDA December 2012 - May 2013
FDA July 2010 - March 2013
Food and Drug Administration September 2008 - July 2010
Food and Drug Administration September 2002 - September 2008
Guilford Pharmaceuticals March 1999 - September 2002
North American Vaccine January 1998 - February 1999
Skills
FDA, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Validation, GMP, Sop, GCP, Regulations, Regulatory Requirements, Microbiology, Medical Devices, Lifesciences, Quality Control, Technology Transfer, CAPA, Drug Development, Clinical Development, Cross-functional Team..., Biopharmaceuticals, IND, Quality Auditing, Process Simulation, R&D, Cell Culture, Change Control, Clinical Research, Vaccines, Document Management, Chromatography, Science, Manufacturing, Quality Management, Leadership, Pharmacovigilance, Quality Assurance, GLP, 21 CFR Part 11, Pharmaceutics, Regulatory Submissions, LIMS, SOP, Life Sciences
Education
University of Maryland University College 2001 — 2005
Masters, Biotechnology Sciences
University of Maryland Baltimore County 1993 — 1997
BS, Biological Sciences
Arlene Joyner Arlene Joyner's North American Vaccine Experience 1995 - 1999
Job Project Officer at BARDA, US Department of Health and Human Services
Industry Pharmaceuticals
Experience
US Department of Health and Human Services August 2011 - Present
Baxter Healthcare August 2010 - February 2011
Baxter Healthcare August 1995 - February 2011
North American Vaccine 1995 - 1999
Merck 1989 - 1995
Skills
GMP, Biotechnology, Vaccines, Pharmaceutical Industry, Sop, Technology Transfer, Validation, Six Sigma, Quality System, Regulatory Affairs, Change Management, Project Management, Cross-functional Team..., Quality Assurance, Lifesciences, Change Control, Supply Chain, Manufacturing, FDA, Process Improvement, Root Cause Analysis, Lean Manufacturing, Quality Management, Production Planning, Process Engineering
Education
Villanova University 1993 — 1996
MS, Chemical Engineering
Penn State University 1985 — 1989
BS, Chemical Engineering
Oxon Hill High School
Science and Technology Program
US Department of Health and Human Services August 2011 - Present
Baxter Healthcare August 2010 - February 2011
Baxter Healthcare August 1995 - February 2011
North American Vaccine 1995 - 1999
Merck 1989 - 1995
Skills
GMP, Biotechnology, Vaccines, Pharmaceutical Industry, Sop, Technology Transfer, Validation, Six Sigma, Quality System, Regulatory Affairs, Change Management, Project Management, Cross-functional Team..., Quality Assurance, Lifesciences, Change Control, Supply Chain, Manufacturing, FDA, Process Improvement, Root Cause Analysis, Lean Manufacturing, Quality Management, Production Planning, Process Engineering
Education
Villanova University 1993 — 1996
MS, Chemical Engineering
Penn State University 1985 — 1989
BS, Chemical Engineering
Oxon Hill High School
Science and Technology Program
Kathy Lee Kathy Lee's North American Vaccine Experience November 1999 - July 2000
Job Senior Vice President, Quality and Regulatory at KBI Biopharma, Inc.
Industry Biotechnology
Experience
KBI Biopharma, Inc. May 2004 - Present
Diosynth Biotechnology 1999 - 2004
North American Vaccine November 1999 - July 2000
Genetic Therapy, Inc. March 1988 - November 1999
Skills
Technology Transfer, Biopharmaceuticals, Validation, Project Management, Sop, FDA, GMP, Quality Assurance, Lifesciences, Biotechnology, V&V
Education
Penn State University 1977 — 1981
B.S., Biology and Education
KBI Biopharma, Inc. May 2004 - Present
Diosynth Biotechnology 1999 - 2004
North American Vaccine November 1999 - July 2000
Genetic Therapy, Inc. March 1988 - November 1999
Skills
Technology Transfer, Biopharmaceuticals, Validation, Project Management, Sop, FDA, GMP, Quality Assurance, Lifesciences, Biotechnology, V&V
Education
Penn State University 1977 — 1981
B.S., Biology and Education
Ricardo Barbet Ricardo Barbet's North American Vaccine Experience April 1991 - April 1996
Job Experienced Quality Professional
Industry Pharmaceuticals
Experience
Bracco Diagnostics March 2009 - Present
RadPharm January 2008 - February 2009
Palatin Technologies March 2005 - September 2007
GE Healthcare April 1996 - March 2005
United States Army Reserve May 1987 - May 1997
North American Vaccine April 1991 - April 1996
Cambridge Biotech January 1988 - April 1991
Skills
Validation, GxP, Aseptic Processing, SOP, GCP, GMP, Quality Assurance, cGMP, Quality Systems, Change Control, Medical Devices, CAPA, Pharmaceuticals, Auditing, GLP, Compliance, FDA, 21 CFR Part 11, Quality Management, Document Management, Clinical Trials, Clinical Research, Process Development, Process Validation, Computer System..., Technology Transfer, Documentation, Process Improvement, Clinical, Quality Auditing, Quality System, Sop, Pharmaceutical Industry, Sterilization, Process Simulation, Software Documentation, Trackwise, CRO, Regulatory Affairs, Vaccines, Drug Development, Regulatory Submissions, Pharmaceutics, Biopharmaceuticals, Regulatory Requirements, LIMS, FDA GMP, GAMP, Cleaning Validation, Quality Control
Education
The Johns Hopkins University 1985 — 1987
Officer, Military Science
University of Maryland Baltimore County 1983 — 1987
B.S., Biology
Bracco Diagnostics March 2009 - Present
RadPharm January 2008 - February 2009
Palatin Technologies March 2005 - September 2007
GE Healthcare April 1996 - March 2005
United States Army Reserve May 1987 - May 1997
North American Vaccine April 1991 - April 1996
Cambridge Biotech January 1988 - April 1991
Skills
Validation, GxP, Aseptic Processing, SOP, GCP, GMP, Quality Assurance, cGMP, Quality Systems, Change Control, Medical Devices, CAPA, Pharmaceuticals, Auditing, GLP, Compliance, FDA, 21 CFR Part 11, Quality Management, Document Management, Clinical Trials, Clinical Research, Process Development, Process Validation, Computer System..., Technology Transfer, Documentation, Process Improvement, Clinical, Quality Auditing, Quality System, Sop, Pharmaceutical Industry, Sterilization, Process Simulation, Software Documentation, Trackwise, CRO, Regulatory Affairs, Vaccines, Drug Development, Regulatory Submissions, Pharmaceutics, Biopharmaceuticals, Regulatory Requirements, LIMS, FDA GMP, GAMP, Cleaning Validation, Quality Control
Education
The Johns Hopkins University 1985 — 1987
Officer, Military Science
University of Maryland Baltimore County 1983 — 1987
B.S., Biology
Susan Cheng Susan Cheng's North American Vaccine Experience September 1994 - August 1998
Job Development Scientist II at MacroGenics, Inc.
Industry Pharmaceuticals
Experience
MacroGenics, Inc. September 2015 - Present
Teva Biopharmaceuticals USA June 2012 - July 2015
Teva Biopharmaceuticals USA April 2012 - June 2012
Nabi Biopharmaceuticals August 2004 - December 2011
Human Genome Sciences June 2001 - June 2004
Human Genome Sciences August 1999 - June 2001
Primedica Corporation August 1998 - August 1999
North American Vaccine September 1994 - August 1998
Skills
Assay Development, Purification, Immunology, Biopharmaceuticals, Validation, ELISA, Method Development, Analytical Chemistry, GLP, Protein Purification, Mammalian Cell Culture, Protein Chemistry, Vaccines, Biotechnology, Technology Transfer, CMC, GraphPad Prism
Education
University of Maryland College Park 1990 — 1994
Bachelors of Science, Microbiology
MacroGenics, Inc. September 2015 - Present
Teva Biopharmaceuticals USA June 2012 - July 2015
Teva Biopharmaceuticals USA April 2012 - June 2012
Nabi Biopharmaceuticals August 2004 - December 2011
Human Genome Sciences June 2001 - June 2004
Human Genome Sciences August 1999 - June 2001
Primedica Corporation August 1998 - August 1999
North American Vaccine September 1994 - August 1998
Skills
Assay Development, Purification, Immunology, Biopharmaceuticals, Validation, ELISA, Method Development, Analytical Chemistry, GLP, Protein Purification, Mammalian Cell Culture, Protein Chemistry, Vaccines, Biotechnology, Technology Transfer, CMC, GraphPad Prism
Education
University of Maryland College Park 1990 — 1994
Bachelors of Science, Microbiology
Denise Courbron, M.S., PMP Denise Courbron, M.S., PMP's North American Vaccine Experience January 1996 - September 1999
Job Novavax
Industry Biotechnology
Experience
Novavax, Inc. June 2014 - Present
Novavax, Inc. June 2010 - May 2014
Intercell AG (formerly IOMAI Corporation) October 2005 - January 2010
Consultant January 2004 - August 2005
Baxter BioScience--Vaccines December 2000 - November 2003
GloboMax October 1999 - December 2000
North American Vaccine January 1996 - September 1999
Sky Alland Research March 1992 - November 1995
US Dept of Defense - NSA November 1978 - December 1988
Skills
Cross-functional Team..., Program Management, Project Management, Management, Strategic Planning, Team Leadership, PMO, Biotechnology, Technology Transfer, R&D, Pharmaceutical Industry, FDA, Lifesciences, Clinical Development, Validation, GMP, Vaccines, Clinical Trials, Sop, Regulatory Affairs, Biopharmaceuticals, Leadership, PMP, Product Development
Education
University of Maryland University College
M.S., Technology Management/Biotechnology
Western Maryland College
BA, Political Science/Spanish
Novavax, Inc. June 2014 - Present
Novavax, Inc. June 2010 - May 2014
Intercell AG (formerly IOMAI Corporation) October 2005 - January 2010
Consultant January 2004 - August 2005
Baxter BioScience--Vaccines December 2000 - November 2003
GloboMax October 1999 - December 2000
North American Vaccine January 1996 - September 1999
Sky Alland Research March 1992 - November 1995
US Dept of Defense - NSA November 1978 - December 1988
Skills
Cross-functional Team..., Program Management, Project Management, Management, Strategic Planning, Team Leadership, PMO, Biotechnology, Technology Transfer, R&D, Pharmaceutical Industry, FDA, Lifesciences, Clinical Development, Validation, GMP, Vaccines, Clinical Trials, Sop, Regulatory Affairs, Biopharmaceuticals, Leadership, PMP, Product Development
Education
University of Maryland University College
M.S., Technology Management/Biotechnology
Western Maryland College
BA, Political Science/Spanish
John Salim's North American Vaccine Experience 1995 - 2001
Job Manager Engineering at GSK
Industry Biotechnology
Experience
Human Genome Sciences Manager EngineeringGSKDecember 2012 - Present
Human Genone Sciences 2001 - Present
North American Vaccine 1995 - 2001
Skills
Validation, GMP, Aseptic Processing, Technology Transfer, V&V, Biopharmaceuticals, FDA, CAPA
Education
Penn State University 1989 — 1995
Human Genome Sciences Manager EngineeringGSKDecember 2012 - Present
Human Genone Sciences 2001 - Present
North American Vaccine 1995 - 2001
Skills
Validation, GMP, Aseptic Processing, Technology Transfer, V&V, Biopharmaceuticals, FDA, CAPA
Education
Penn State University 1989 — 1995
Peter Liebermann's North American Vaccine Experience 1997 - 1997
Job Project Director at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL September 2012 - Present
United BioSource Corporation July 2011 - September 2012
United BioSource Corporation July 2009 - July 2011
Draeger Medical September 2008 - May 2009
Octagon Research Solutions April 2007 - September 2008
DynPort Vaccine Company LLC (DVC) 2001 - 2007
MedImmune September 1997 - January 2001
North American Vaccine 1997 - 1997
University of Virginia 1993 - 1997
Skills
FDA, Validation, Biotechnology, Cross-functional Team..., Program Management, Pharmaceutical Industry, Change Control, Medical Devices, SDLC, PMP, Project Management, Quality Assurance, Clinical Trials, Sop, Process Improvement, Product Development, Leadership, Product Management, Regulatory Affairs, CRO
Education
Frostburg State University 1999 — 2001
MBA, Management
Mansfield University of Pennsylvania 1992 — 1996
BS, Biology
PAREXEL September 2012 - Present
United BioSource Corporation July 2011 - September 2012
United BioSource Corporation July 2009 - July 2011
Draeger Medical September 2008 - May 2009
Octagon Research Solutions April 2007 - September 2008
DynPort Vaccine Company LLC (DVC) 2001 - 2007
MedImmune September 1997 - January 2001
North American Vaccine 1997 - 1997
University of Virginia 1993 - 1997
Skills
FDA, Validation, Biotechnology, Cross-functional Team..., Program Management, Pharmaceutical Industry, Change Control, Medical Devices, SDLC, PMP, Project Management, Quality Assurance, Clinical Trials, Sop, Process Improvement, Product Development, Leadership, Product Management, Regulatory Affairs, CRO
Education
Frostburg State University 1999 — 2001
MBA, Management
Mansfield University of Pennsylvania 1992 — 1996
BS, Biology
Chad Briggs's North American Vaccine Experience 1997 - 1999
Job Director Manufacturing
Industry Biotechnology
Experience
MedImmune November 1999 - Present
Medimmume June 2003 - September 2006
North American Vaccine 1997 - 1999
Amvax 1997 - 1999
Skills
Biopharmaceuticals, CAPA, GMP, Biotechnology, Computer System..., Validation, Purification, Technology Transfer, Sop, Vaccines, Aseptic Processing, GLP, Change Control, FDA, GxP, Chromatography, 21 CFR Part 11, Trackwise, IND
Education
Elon University 1993 — 1997
Bachelor of Science (B.S.), Biology, General
MedImmune November 1999 - Present
Medimmume June 2003 - September 2006
North American Vaccine 1997 - 1999
Amvax 1997 - 1999
Skills
Biopharmaceuticals, CAPA, GMP, Biotechnology, Computer System..., Validation, Purification, Technology Transfer, Sop, Vaccines, Aseptic Processing, GLP, Change Control, FDA, GxP, Chromatography, 21 CFR Part 11, Trackwise, IND
Education
Elon University 1993 — 1997
Bachelor of Science (B.S.), Biology, General
Peter Alexander's North American Vaccine Experience November 1996 - July 2000
Job Senior Director, Process Development at IDT Biologika, Corp.
Industry Biotechnology
Experience
IDT Biologika, Corp. June 2015 - Present
Aeras March 2013 - June 2015
SAIC-Frederick April 2008 - March 2013
Lonza Baltimore February 2007 - March 2008
Cambrex Bio Science Baltimore October 2002 - 2007
Baxter BioScience March 2001 - September 2002
Baxter Hyland Immuno August 2000 - February 2001
North American Vaccine November 1996 - July 2000
Seragen, Inc 1987 - 1996
Michigan Biotechnology Institute 1985 - 1987
Skills
Fermentation, Technology Transfer, Cell Culture, Biotechnology, Process Development, Purification, Vaccines, DNA, GMP, Process Validation, Filtration, Biopharmaceuticals, Protein Chemistry, recombinant DNA..., Microbiology, HPLC, Chromatography, Manufacturing, Validation, Sop, Lifesciences, Downstream Processing, Science, Change Control, Assay Development, Process Simulation, Biochemistry, V&V, Life Sciences, SOP
Education
University of Hawaii at Manoa 1978 — 1983
Ph.D, Microbiology
Rensselaer Polytechnic Institute 1976 — 1977
M.S., Biology
Rensselaer Polytechnic Institute 1972 — 1976
B.S., Biology
WHS 1968 — 1972
IDT Biologika, Corp. June 2015 - Present
Aeras March 2013 - June 2015
SAIC-Frederick April 2008 - March 2013
Lonza Baltimore February 2007 - March 2008
Cambrex Bio Science Baltimore October 2002 - 2007
Baxter BioScience March 2001 - September 2002
Baxter Hyland Immuno August 2000 - February 2001
North American Vaccine November 1996 - July 2000
Seragen, Inc 1987 - 1996
Michigan Biotechnology Institute 1985 - 1987
Skills
Fermentation, Technology Transfer, Cell Culture, Biotechnology, Process Development, Purification, Vaccines, DNA, GMP, Process Validation, Filtration, Biopharmaceuticals, Protein Chemistry, recombinant DNA..., Microbiology, HPLC, Chromatography, Manufacturing, Validation, Sop, Lifesciences, Downstream Processing, Science, Change Control, Assay Development, Process Simulation, Biochemistry, V&V, Life Sciences, SOP
Education
University of Hawaii at Manoa 1978 — 1983
Ph.D, Microbiology
Rensselaer Polytechnic Institute 1976 — 1977
M.S., Biology
Rensselaer Polytechnic Institute 1972 — 1976
B.S., Biology
WHS 1968 — 1972
Robert Eberwein's North American Vaccine Experience January 1995 - February 1996
Job VP, GMP Manufacturing at Paragon BioServices, Inc.
Industry Biotechnology
Experience
Paragon BioServices, Inc. 2007 - Present
LIC Manufacturing, LLC 2005 - 2007
Cambrex Bio Science Baltimore, Inc. 2001 - 2005
BioScience Contract Production Company 1999 - 2001
Bio Science Contract Production Corp 1996 - January 1999
North American Vaccine January 1995 - February 1996
Becton Dickinson January 1992 - December 1994
Frederick Cancer Research & Development Center, Fort Detrick September 1981 - December 1991
Skills
Biotechnology, Technology Transfer, GMP, FDA, Fermentation, Lifesciences, Biopharmaceuticals, Purification, V&V, Contract Manufacturing, Microbiology, Vaccines, Assay Development, Sop, Validation, CAPA, Clinical Trials, Pharmaceutical Industry, GLP, Protein Chemistry, 21 CFR Part 11, Cell Culture, Change Control
Education
Hood College 1985 — 1991
BA, Biology
Paragon BioServices, Inc. 2007 - Present
LIC Manufacturing, LLC 2005 - 2007
Cambrex Bio Science Baltimore, Inc. 2001 - 2005
BioScience Contract Production Company 1999 - 2001
Bio Science Contract Production Corp 1996 - January 1999
North American Vaccine January 1995 - February 1996
Becton Dickinson January 1992 - December 1994
Frederick Cancer Research & Development Center, Fort Detrick September 1981 - December 1991
Skills
Biotechnology, Technology Transfer, GMP, FDA, Fermentation, Lifesciences, Biopharmaceuticals, Purification, V&V, Contract Manufacturing, Microbiology, Vaccines, Assay Development, Sop, Validation, CAPA, Clinical Trials, Pharmaceutical Industry, GLP, Protein Chemistry, 21 CFR Part 11, Cell Culture, Change Control
Education
Hood College 1985 — 1991
BA, Biology
Heidi S. Bodenheimer's North American Vaccine Experience 1998 - 2000
Job Retired, on Disability
Industry Biotechnology
Experience
none September 2005 - Present
Baxter International Inc. 1998 - 2005
North American Vaccine 1998 - 2000
New Horizons Diagnostics 1984 - 1998
Becton Dickinson 1980 - 1984
Johns Hopkins University School of Medicine 1979 - 1980
Education
Goucher College 1975 — 1979
B.A.
Woodlawn Senior High 1973 — 1975
High School
none September 2005 - Present
Baxter International Inc. 1998 - 2005
North American Vaccine 1998 - 2000
New Horizons Diagnostics 1984 - 1998
Becton Dickinson 1980 - 1984
Johns Hopkins University School of Medicine 1979 - 1980
Education
Goucher College 1975 — 1979
B.A.
Woodlawn Senior High 1973 — 1975
High School
Joan Fusco's North American Vaccine Experience 1991 - 2001
Job VP Product Development at BioProtection Systems / NewLink Genetics Corp.
Industry Biotechnology
Experience
BioProtection Systems / NewLink Genetics Corp. March 2015 - Present
Vaccinologist October 2010 - Present
CBR International Corp. November 2013 - February 2015
PharmAthene February 2008 - September 2010
Acambis 2004 - 2008
Baxter BioScience 2000 - 2004
North American Vaccine 1991 - 2001
University of Pittsurgh 1978 - 1987
Skills
Biotechnology, Technology Transfer, Vaccines, Life Sciences, GMP, CAPA, Aseptic Processing, Lifesciences, Biopharmaceuticals, Quality System, Pharmaceutical Industry, Commercialization, 21 CFR Part 11, Clinical Development, Oncology, FDA, Regulatory Affairs, Validation
Education
University of Pittsburgh
Ph.D., Microbiology/Biological Sciences
BioProtection Systems / NewLink Genetics Corp. March 2015 - Present
Vaccinologist October 2010 - Present
CBR International Corp. November 2013 - February 2015
PharmAthene February 2008 - September 2010
Acambis 2004 - 2008
Baxter BioScience 2000 - 2004
North American Vaccine 1991 - 2001
University of Pittsurgh 1978 - 1987
Skills
Biotechnology, Technology Transfer, Vaccines, Life Sciences, GMP, CAPA, Aseptic Processing, Lifesciences, Biopharmaceuticals, Quality System, Pharmaceutical Industry, Commercialization, 21 CFR Part 11, Clinical Development, Oncology, FDA, Regulatory Affairs, Validation
Education
University of Pittsburgh
Ph.D., Microbiology/Biological Sciences
Michelle Irizarry Izzo's North American Vaccine Experience 1998 - 1999
Job
Industry Pharmaceuticals
Experience
Merck November 2009 - December 2011
Schering-Plough 2002 - August 2010
Deloitte 2000 - 2002
DuPont Pharmaceuticals 1999 - 2000
North American Vaccine 1998 - 1999
Skills
Sop, Change Control, 21 CFR Part 11, Pharmaceutical Industry, GxP, Computer System..., FDA, CAPA, Clinical Development, Biopharmaceuticals, Biotechnology, Drug Development, GMP
Education
Penn State University 1996 — 1998
MS
Massachusetts Institute of Technology 1991 — 1995
BS
Merck November 2009 - December 2011
Schering-Plough 2002 - August 2010
Deloitte 2000 - 2002
DuPont Pharmaceuticals 1999 - 2000
North American Vaccine 1998 - 1999
Skills
Sop, Change Control, 21 CFR Part 11, Pharmaceutical Industry, GxP, Computer System..., FDA, CAPA, Clinical Development, Biopharmaceuticals, Biotechnology, Drug Development, GMP
Education
Penn State University 1996 — 1998
MS
Massachusetts Institute of Technology 1991 — 1995
BS
Norma Griffin's North American Vaccine Experience November 1997 - February 1999
Job Regulatory Project Manager for CDER/OHOP/DOP2
Industry Government Administration
Experience
FDA/CDER/Office of Hematology and Oncology Products/Division of Oncology Products 2 October 2008 - Present
Meridian BioGroup, LLC March 2008 - October 2008
AMEC BioPharmaceuticals 2003 - 2008
AMEC 2000 - 2008
Phoenix Imperative March 2000 - March 2003
CapricornPharma February 1999 - March 2000
North American Vaccine November 1997 - February 1999
Cephalon 1992 - 1996
Pharmacia-ENI Diagnostics 1983 - 1992
Skills
Compliance, Biotechnology, Validation, cGMP, Quality Systems, Pharmaceuticals, Quality Assurance, Documentation, GMP, FDA, Regulatory Affairs, Auditing, Medical Devices, Cleaning Validation, SOP, Document Management
Education
Mary Washington College 1978 — 1982
Bachelor of Science, Biology
Medical College of Virginia, Virginia Commenwealth University 1980 — 1981
Medical Technology
FDA/CDER/Office of Hematology and Oncology Products/Division of Oncology Products 2 October 2008 - Present
Meridian BioGroup, LLC March 2008 - October 2008
AMEC BioPharmaceuticals 2003 - 2008
AMEC 2000 - 2008
Phoenix Imperative March 2000 - March 2003
CapricornPharma February 1999 - March 2000
North American Vaccine November 1997 - February 1999
Cephalon 1992 - 1996
Pharmacia-ENI Diagnostics 1983 - 1992
Skills
Compliance, Biotechnology, Validation, cGMP, Quality Systems, Pharmaceuticals, Quality Assurance, Documentation, GMP, FDA, Regulatory Affairs, Auditing, Medical Devices, Cleaning Validation, SOP, Document Management
Education
Mary Washington College 1978 — 1982
Bachelor of Science, Biology
Medical College of Virginia, Virginia Commenwealth University 1980 — 1981
Medical Technology
Jeannette Rowe's North American Vaccine Experience February 1989 - February 2001
Job Purchasing Agent at IntraCellular Therapies
Industry Biotechnology
Experience
Intra-Cellular Therapies December 2003 - Present
Functional Genetics February 2001 - December 2003
North American Vaccine February 1989 - February 2001
Skills
Inventory Management, Pricing, Microsoft Office, Microsoft Excel, Negotiation, Project Management, Budgets, Logistics, Procurement, Process Scheduler, Strategic Planning
Education
Howard Community College 1980 — 1980
N/A, Early Childhood Education and Teaching
Montgomery College 1972 — 1974
N/A, Liberal Arts and Sciences, General Studies and Humanities
Montgomery College 1972 — 1974
Liberal Arts and Sciences/Liberal Studies
Intra-Cellular Therapies December 2003 - Present
Functional Genetics February 2001 - December 2003
North American Vaccine February 1989 - February 2001
Skills
Inventory Management, Pricing, Microsoft Office, Microsoft Excel, Negotiation, Project Management, Budgets, Logistics, Procurement, Process Scheduler, Strategic Planning
Education
Howard Community College 1980 — 1980
N/A, Early Childhood Education and Teaching
Montgomery College 1972 — 1974
N/A, Liberal Arts and Sciences, General Studies and Humanities
Montgomery College 1972 — 1974
Liberal Arts and Sciences/Liberal Studies
Penny Hylton, MBA,PhD's North American Vaccine Experience 1990 - 2001
Job RQA Quality Branch Chief at HHS/ASPR/BARDA
Industry Biotechnology
Experience
HHS/ASPR/BARDA August 2015 - Present
Tunnell Consulting, Inc. March 2014 - Present
University of Phoenix April 2005 - Present
KP MEX,LLC October 2011 - March 2014
Quintiles Consulting 2012 - 2012
Novavax October 2005 - September 2011
Bowie State University 2006 - 2009
Alpharma 2003 - 2005
Baxter 1990 - 2003
North American Vaccine 1990 - 2001
Skills
Sop, Validation, Quality System, FDA, GMP, Quality Control, Change Control, Medical Devices, GLP, ISO 13485, GCP, Technology Transfer, Auditing, Product Development, Internal Audit, Quality Assurance, Pharmaceutical Industry, Biotechnology, Vaccines, Quality Auditing, Regulatory Affairs, Manufacturing, Laboratory, Program Management, Clinical Research, Training, Management, Biopharmaceuticals, 21 CFR Part 11, Lifesciences, V&V, CAPA, Aseptic Processing, Leadership
Education
Capella University 2003 — 2005
Doctor of Philosophy (Ph.D.), Organizational Leadership and Human Resources Management, GPA 4.0
University of Maryland University College 1998 — 2002
MBA, Business
North Carolina Central University 1972 — 1976
BS, Biology
HHS/ASPR/BARDA August 2015 - Present
Tunnell Consulting, Inc. March 2014 - Present
University of Phoenix April 2005 - Present
KP MEX,LLC October 2011 - March 2014
Quintiles Consulting 2012 - 2012
Novavax October 2005 - September 2011
Bowie State University 2006 - 2009
Alpharma 2003 - 2005
Baxter 1990 - 2003
North American Vaccine 1990 - 2001
Skills
Sop, Validation, Quality System, FDA, GMP, Quality Control, Change Control, Medical Devices, GLP, ISO 13485, GCP, Technology Transfer, Auditing, Product Development, Internal Audit, Quality Assurance, Pharmaceutical Industry, Biotechnology, Vaccines, Quality Auditing, Regulatory Affairs, Manufacturing, Laboratory, Program Management, Clinical Research, Training, Management, Biopharmaceuticals, 21 CFR Part 11, Lifesciences, V&V, CAPA, Aseptic Processing, Leadership
Education
Capella University 2003 — 2005
Doctor of Philosophy (Ph.D.), Organizational Leadership and Human Resources Management, GPA 4.0
University of Maryland University College 1998 — 2002
MBA, Business
North Carolina Central University 1972 — 1976
BS, Biology
Jay Nixon's North American Vaccine Experience 1996 - 1999
Job Global Director Operations at Baxter Healthcare
Industry Medical Devices
Experience
Baxter Healthcare November 2010 - Present
Baxter Healthcare February 2009 - October 2010
Baxter Healthcare November 2005 - February 2009
Baxter 2004 - 2005
North American Vaccine 1996 - 1999
Skills
Quality System, CAPA, Lean Manufacturing, Change Control, Process Improvement, GMP, FDA, Medical Devices, Continuous Improvement
Education
Towson University 1990 — 1995
BS, Biology
Baxter Healthcare November 2010 - Present
Baxter Healthcare February 2009 - October 2010
Baxter Healthcare November 2005 - February 2009
Baxter 2004 - 2005
North American Vaccine 1996 - 1999
Skills
Quality System, CAPA, Lean Manufacturing, Change Control, Process Improvement, GMP, FDA, Medical Devices, Continuous Improvement
Education
Towson University 1990 — 1995
BS, Biology
Lisa Szczepanik's North American Vaccine Experience 1994 - 1999
Job IT Systems Analyst at Baxter Healthcare
Industry Biotechnology
Experience
Baxter Healthcare 2002 - Present
Baxter Healthcare/North American Vaccine 1999 - 2002
North American Vaccine 1994 - 1999
Becton Dickinson 1990 - 1994
Education
Penn State University 1982 — 1986
BS, Industrial Engineering
Baxter Healthcare 2002 - Present
Baxter Healthcare/North American Vaccine 1999 - 2002
North American Vaccine 1994 - 1999
Becton Dickinson 1990 - 1994
Education
Penn State University 1982 — 1986
BS, Industrial Engineering
Dr. SyDar Wang's North American Vaccine Experience June 1993 - May 1996
Job Director of Technology Transfer and Special Projects at ChemGen Corporation
Industry Biotechnology
Experience
Elanco January 2013 - Present
ChemGen Corporation October 2010 - December 2012
Adimmune Corporation September 2003 - November 2009
Tanox June 2001 - June 2003
SAIC Frederick May 1996 - June 2001
North American Vaccine June 1993 - May 1996
ChemGen Corp February 1988 - June 1993
Education
Massachusetts Institute of Technology 1981 — 1988
Doctor of Philosophy (Ph.D.), Biochemical Engineering
Massachusetts Institute of Technology 1977 — 1979
Master's degree, Biochemical Engineering
National Taiwan University 1970 — 1974
Bachelor's degree, Agricultural Chemistry
Elanco January 2013 - Present
ChemGen Corporation October 2010 - December 2012
Adimmune Corporation September 2003 - November 2009
Tanox June 2001 - June 2003
SAIC Frederick May 1996 - June 2001
North American Vaccine June 1993 - May 1996
ChemGen Corp February 1988 - June 1993
Education
Massachusetts Institute of Technology 1981 — 1988
Doctor of Philosophy (Ph.D.), Biochemical Engineering
Massachusetts Institute of Technology 1977 — 1979
Master's degree, Biochemical Engineering
National Taiwan University 1970 — 1974
Bachelor's degree, Agricultural Chemistry
Anita Kijak's North American Vaccine Experience 1998 - 2001
Job Manufacturing Production Planner at Hydrasearch
Industry Biotechnology
Experience
Hydrasearch February 2011 - Present
Baxter BioScience 2001 - April 2011
North American Vaccine 1998 - 2001
American Environmental Network 1994 - 1998
Biospherics Incorporated 1987 - 1994
Skills
Manufacturing, Production Planning, Six Sigma, CAPA, Quality Assurance, 21 CFR Part 11, FDA, Forecasting, MRP, Purchasing, ERP, Continuous Improvement, Process Improvement, Sop, Change Control, Software Documentation, Materials Management, GMP, Quality System, Team Leadership, Analysis, Management, Root Cause Analysis, Project Planning, Pharmaceutical Industry, Biotechnology, SOP
Education
University of Maryland College Park 1982 — 1987
Master of Science (M.S.), Analytical Chemistry
Hydrasearch February 2011 - Present
Baxter BioScience 2001 - April 2011
North American Vaccine 1998 - 2001
American Environmental Network 1994 - 1998
Biospherics Incorporated 1987 - 1994
Skills
Manufacturing, Production Planning, Six Sigma, CAPA, Quality Assurance, 21 CFR Part 11, FDA, Forecasting, MRP, Purchasing, ERP, Continuous Improvement, Process Improvement, Sop, Change Control, Software Documentation, Materials Management, GMP, Quality System, Team Leadership, Analysis, Management, Root Cause Analysis, Project Planning, Pharmaceutical Industry, Biotechnology, SOP
Education
University of Maryland College Park 1982 — 1987
Master of Science (M.S.), Analytical Chemistry
Joyce Francis's North American Vaccine Experience 1993 - 1998
Job Associate Director/Head Florida Biologix
Industry Biotechnology
Experience
University of Florida - Florida Biologix June 2004 - Present
University of Florida Florida Biologix June 2001 - 2004
Baxter 1998 - 2000
North American Vaccine 1993 - 1998
Novartis 1990 - 1993
Lederle 1985 - 1992
Skills
Biopharmaceuticals, Clinical Trials, Lifesciences, Clinical Research, GMP, Validation, GLP, Assay Development, Quality Assurance, Vaccines, Cell, Quality Control
Education
Cornell University 1973 — 1978
Doctor of Philosophy (PhD), Microbiology, General
University of Florida - Florida Biologix June 2004 - Present
University of Florida Florida Biologix June 2001 - 2004
Baxter 1998 - 2000
North American Vaccine 1993 - 1998
Novartis 1990 - 1993
Lederle 1985 - 1992
Skills
Biopharmaceuticals, Clinical Trials, Lifesciences, Clinical Research, GMP, Validation, GLP, Assay Development, Quality Assurance, Vaccines, Cell, Quality Control
Education
Cornell University 1973 — 1978
Doctor of Philosophy (PhD), Microbiology, General