Covance Biotechnology Services
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Covance Biotechnology Services Employees
Salix Pharmaceuticals January 2004 - April 2015
Intellect Neurosciences, Inc. June 2007 - January 2010
Genta, Inc October 2002 - September 2005
Bristol-Myers Squibb April 2001 - October 2002
Covance Biotechnology Services August 2000 - April 2001
Skills
Biotechnology
Education
Rutgers, The State University of New Jersey-Newark 1977 — 1981
Master of Business Administration (MBA), Finance
Rutgers University-New Brunswick 1972 — 1976
Bachelor's Degree, Microbiology
Grifols March 2009 - Present
Novartis Vaccines and Diagnostics December 2008 - March 2009
BiogenIdec January 1999 - December 2008
Covance Biotechnology Services 1996 - 1999
Diosynth 1996 - 1999
Covance Biotechnology now Diosynth September 1996 - December 1998
GlaxoWellcome January 1993 - August 1996
Skills
Biopharmaceuticals, CAPA, GMP, Change Control, Cell Culture, Aseptic Processing, Technology Transfer, Biotechnology, Validation, FDA, Fermentation, Plant Maintenance, Computer System..., GLP, Laboratory, Medical Devices, Cleaning Validation, Vaccines, Protein Chemistry, 21 CFR Part 11, Quality Assurance, GAMP, Quality Auditing, R&D, Metrology, Operations Management, Quality System, Factory, Pharmaceutical Industry, V&V, Chromatography, Trackwise, Facilities Management, GxP, Process Simulation, Sop, Cross-functional..., Quality Control, Cross-functional Team..., Purification, Downstream Processing, Filtration, Root Cause Analysis, WebDAV, Ultrafiltration, LIMS
Education
Maine Maritime Academy 1982 — 1986
BS Marine Engineering
Celldex Therapeutics June 2015 - Present
Targanox Inc. July 2013 - June 2015
MIT July 2006 - February 2013
Altus Pharmaceuticals 2005 - 2006
CuraGen Corporation 2005 - 2005
Applied Biosystems 2002 - 2004
EMD Pharmaceuticals 2001 - 2002
AstraZeneca R&D 1998 - 2000
Covance Biotechnology Services 1996 - 1998
Biogen 1993 - 1996
Skills
Mass Spectrometry, Protein Chemistry, Pharmaceuticals, Biomarker Discovery, Proteomics, LC-MS, HPLC, Chemistry, Characterization, Analytical Chemistry, Pharmaceutical Industry, NMR spectroscopy, Biotechnology, Gas Chromatography, Chromatography, Immunoassays, R&D, Biomarkers, Laboratory, Drug Development, Formulation, Purification, NMR, Drug Discovery, UV/Vis, Assay Development, Science, Lifesciences, GC-MS, Biochemistry, Organic Chemistry, Spectroscopy, Protein Purification, Cell
Education
Massachusetts Institute of Technology 1981 — 1987
Ph.D., Organic Chemistry - Mass Spectrometry
Bowdoin College 1977 — 1981
A.B., Chemistry
GlaxoSmithKline September 2011 - Present
GlaxoSmithKline June 2006 - August 2011
SEC Associates, Inc. March 2002 - June 2006
Bertek Pharmaceuticals May 2001 - March 2002
Covance Biotechnology Services May 2000 - April 2001
Skills
GMP, Computer System..., Sop, Quality Assurance, Project Management, Internal Audit, Manufacturing, GxP, GCP, Change Control, 21 CFR Part 11, SOP, GLP, Pharmaceutical Industry, Validation, FDA
Education
University of North Carolina at Chapel Hill 1996 — 2000
Bachelor of Science, Chemistry
Lung Biotechnology (United Therapeutics) January 2015 - Present
CONRAD April 2008 - January 2015
MedImmune October 2007 - April 2008
Shire Pharmaceuticals September 2005 - October 2007
Biogen Idec 1998 - 2005
Covance Biotechnology Services December 1996 - May 1998
Skills
Quality Auditing, Staff Training, Project Coordination, cGMP, Quality Systems, SOP, Pharmaceuticals, CAPA, Quality Assurance, Biotechnology, Microbiology, Investigations, FDA, GMP, Change Control, Sop, Private Investigations, Pharmaceutical Industry
Education
University of North Carolina at Chapel Hill 1993 — 1995
MS, Environmental Science
Duke University 1989 — 1993
BS, Biology
Biogen Idec July 2010 - Present
Integrated Process Technologies, Inc April 2008 - July 2010
Diosynth Biotechnology August 2006 - April 2008
Diosynth Biotechnology June 2001 - August 2006
Covance Biotechnology Services August 1999 - June 2001
Tosco Corporation 1997 - 1999
Skills
Technology Transfer, GMP, Process Equipment, Manufacturing..., Manufacturing, Troubleshooting, Problem Solving
Education
University of Michigan 1991 — 1995
BSE
Novartis Vaccines December 2014 - Present
Hospira August 2012 - November 2014
Novartis Vaccines July 2007 - August 2012
Amgen March 2001 - July 2007
Covance Biotechnology Services 1996 - 2001
Searle December 1993 - December 1996
Skills
Validation, GMP, FDA, CAPA, Biotechnology, Sop, Pharmaceutical Industry, Change Control, Biopharmaceuticals, Technology Transfer, 21 CFR Part 11, V&V, Quality System, Computer System..., Medical Devices, Aseptic Processing, R&D, Process Simulation, Quality Assurance, Lifesciences, Cleaning Validation, Cross-functional Team..., Fermentation, Filtration, Manufacturing, GxP, Purification, SOP, Life Sciences
Education
University of Rhode Island - College of Business Administration 2005 — 2007
MBA
Truman State University 1989 — 1993
BS, microbiology
PDS Biotechnology August 2006 - Present
Diosynth Akzo Nobel 2000 - 2004
Covance Biotechnology Services 1998 - 2000
Regeneron Pharmaceuticals 1990 - 1998
Merck Research Laboratories, Rahway, New Jersey 1986 - 1990
Skills
Analytical Chemistry, Drug Discovery, Biochemistry, Biotechnology, Chemistry, FDA, Molecular Biology, Formulation, Infectious Diseases, Biopharmaceuticals, Chromatography, Purification
Education
Albert Einstein College of Medicine of Yeshiva University 1981 — 1985
BioTechLogic, Inc. January 2004 - Present
Pfizer January 2002 - January 2004
Diosynth 1996 - 2002
Covance Biotechnology Services 1996 - 2000
Skills
Biopharmaceuticals, GMP, Technology Transfer, FDA, Validation, CAPA, Biotechnology, Sop, Pharmaceutical Industry, Aseptic Processing, Contract Manufacturing, Change Control, 21 CFR Part 11, Vaccines, Lifesciences, Statistical Tools, Root Cause Analysis, Medical Devices, Drug Development, GLP, Process Simulation
Education
Elon University - Martha and Spencer Love School of Business 2000 — 2003
Master's, Business Administration and Management, General
Penn State University 1989 — 1995
Bachelor of Science (B.S.), Chemical Engineering
Full Circle Pilates October 2013 - Present
Biotech/ Pharma/ CRO/ Medical Device Companies November 2012 - Present
The EMMES Corporation March 2010 - November 2012
Biotech, Pharmaceutical and Medical Device Companies November 2009 - April 2010
Invitrogen November 2007 - July 2009
Alpha-Tech 2006 - 2007
Wyeth 2004 - 2006
Diosynth 2002 - 2004
Covance Biotechnology Services 1999 - 2002
Skills
Quality Assurance
Education
University of North Carolina at Chapel Hill 1995 — 1997
BS, Biology
North Carolina State University 1993 — 1995
Kimberly-Clark July 2013 - May 2014
Upsher-Smith Laboratories October 2011 - June 2013
Synthon Pharmaceuticals, Inc. October 2007 - June 2009
Synthon Pharmaceuticals, Inc. April 2003 - September 2007
Covance Biotechnology Services 1998 - 2001
Skills
Pharmaceuticals, Regulatory Affairs, GMP, SOP, Regulatory Submissions, Regulatory Strategy, Quality Assurance, cGMP, Change Control, Generics, FDA, GxP, Sop, Pharmacovigilance, Pharmaceutical Industry, Laboratory, Regulatory Requirements, Quality Management, Technology Transfer, GCP, 21 CFR Part 11, Drug Discovery, GLP, CAPA, Validation, Quality Auditing, Lifesciences, R&D, Chromatography, Computer System..., Drug Development, Generic Programming, eCTD, Cross-functional Team..., CRO, Analytical Chemistry, HPLC, Biotechnology, Six Sigma, Biopharmaceuticals, Quality Control, Pharmaceutics, Quality System, SOP development, Dissolution, V&V, Clinical Trials, Clinical Development, Strategy, Chemistry
Education
University of North Carolina at Chapel Hill 1993 — 1997
BioCryst Pharmaceuticals, Inc. February 2015 - Present
FHI 360 February 2012 - Present
US Data Management August 2011 - February 2012
Inspire Pharmaceuticals January 2006 - August 2011
Amphora Discovery Corporation October 2001 - January 2006
Covance Biotechnology Services January 2000 - January 2001
Eli Lilly and Company - RTP Labs January 1997 - January 2000
Eli Lilly and Company January 1995 - January 1997
USF&G Insurance Company January 1992 - January 1995
USF&G Insurance Company January 1986 - January 1992
Skills
SOX, 21 CFR Part 11, Compliance, IT Governance, Process Improvement, Validation, IT Management, Sarbanes-Oxley Act, Governance, Information Technology, FDA, GMP, Quality Assurance, Pharmaceutical Industry, Budgets, Disaster Recovery, Cross-functional Team..., Data Center, Integration, Leadership, Management, Program Management, Project Management, SharePoint, Strategy
Education
University of Maryland Baltimore County 1983 — 1986
BS, Information Systems Management
Villanova University
Masters Certificate, Advanced Information Assurance and Security
Novartis Vaccines January 2015 - Present
Novartis September 2008 - February 2015
Jacobs Engineering Group November 2007 - September 2008
IDEA Engineering of NC 2006 - 2007
Fluid Flow of the Carolinas November 2005 - August 2006
Biogen Idec December 2004 - September 2005
Diosynth September 2002 - October 2004
Covance Biotechnology Services April 1997 - September 2002
Skills
Validation, Commissioning, Process Engineering, Downstream Processing, Biotechnology, Technology Transfer, Engineering Process, Biopharmaceuticals
Education
University of California, Santa Barbara 1990 — 1994
BS, Chemical Engineering
GSK April 2015 - Present
Baxter International Inc. June 2014 - March 2015
Hospira September 2013 - December 2013
Ricerca Biosciences April 2008 - July 2013
Argos Therapeutics 2003 - 2005
Biolex 2001 - 2003
Covance Biotechnology Services 1998 - 2000
Skills
cGMP, SOP, HPLC, Quality Assurance, Chromatography, Methods Development, Process Development, Sop, V&V, CAPA, GMP, Immunoassays, ELISA, Protein Purification, Fermentation, Protein Chemistry, Cell Culture, Purification, FDA, Analytical Chemistry, Pharmaceutical Industry, Assay Development, Technology Transfer, LIMS, Biopharmaceuticals, Change Control, Drug Development, IND, Biochemistry, Gas Chromatography, Chemistry, LC-MS, 21 CFR Part 11, SDS-PAGE, Cell, Organic Chemistry, Molecular Biology, Clinical Development, Clinical Trials, GLP, Quality Control, Vaccines, Organic Synthesis, CRO, Quality Auditing
Education
Benedictine College
Bachelor of Arts (BA), Biology, General
Iowa State University
Ph.D., Biochemistry
FUJIFILM Diosynth Biotechnologies July 2005 - Present
Diosynth February 2001 - July 2005
Covance Biotechnology Services September 1999 - February 2001
Bayer HealthCare January 1999 - May 1999
North Carolina State University 1998 - 1999
Education
North Carolina State University
Bachelor of Arts (BA)
North Carolina State University
Bachelor of Science (BS)