Teva Pharmaceuticals - Orange County, California Area since Sep 2011
Associate Director, Quality Assurance
Amgen - Boulder, CO 2006 - 2011
Director of Manufacturing
MedImmune Sep 1997 - Sep 2006
Associate Director
North American Vaccine/Cephalon 1995 - 1997
Production Manager
Serono Laboratories, Inc. 1993 - 1995
Production Manager
Education:
Frostburg State University 2000 - 2003
MBA, Business Administration
Rensselaer Polytechnic Institute 1982 - 1986
BS, Chemistry
Rensselaer Polytechnic Institute 1982 - 1986
BS, Biology
Skills:
Gmp Validation Capa Change Control Technology Transfer Quality Assurance Quality System Biotechnology Fda Pharmaceutical Industry Aseptic Processing Quality Control 21 Cfr Part 11 Biopharmaceuticals Purification Manufacturing Quality Management Operational Excellence Regulatory Affairs Sop Fermentation Quality Auditing Glp Strategic Leadership Continuous Improvement Gxp Process Engineering Cell Culture Lean Manufacturing Process Simulation V&V Regulatory Submissions Vaccines Lims Drug Development Analytical Chemistry Technical Support Cleaning Validation Medical Devices Chromatography Hplc Trackwise Lifesciences Computer System Validation Iso 13485 Chemistry Clinical Development Monoclonal Antibodies Regulatory Requirements
Interests:
Civil Rights and Social Action Education Environment Science and Technology Human Rights Animal Welfare Health
Oct 2014 to 2000 Site Head of Quality AssuranceB. Braun Medical, Inc. Irvine, CA Aug 2013 to Jul 2014 Quality Assurance ManagerTeva Parenteral Medicines Irvine, CA 2011 to 2013 Associate Director, Quality AssuranceAMGEN, Inc., Longmont and Boulder, CO Boulder, CO 2006 to 2011 Director of ManufacturingMEDIMMUNE Frederick, MD 1997 to 2006 Associate Director, ManufacturingCEPHALON / NORTH AMERICAN VACCINE Beltsville, MD 1995 to 1997 Manager, ProductionSERONO LABORATORIES Randolph, MA 1993 to 1995 Manager, Protein Purification/Technical SupportALEXION PHARMACEUTICALS New Haven, CT 1992 to 1993 Manager, Process DevelopmentGENETICS INSTITUTE, Cambridge and Andover Andover, MA 1987 to 1992 Section Head, Purification and Production Support
Education:
Frostburg State University 2003 Master of Business AdministrationRensselaer Polytechnic Institute Dec 1986 Bachelor of Science in ChemistryRensselaer Polytechnic Institute May 1986 Bachelor of Science in Biology