Resumes
Resumes

Cmc And Qa-Qc Senior Consultant
View pageLocation:
1 High Rock Rd, Dover, MA 02030
Industry:
Pharmaceuticals
Work:
Rondaxe Pharma - Syracuse, New York Area since Dec 2010
Senior Quality Advisor
Biotech and CROs since Aug 2008
Senior Consultant for QA and Manufacturing (GXP Consulting, LLC)
TransMolecular Nov 2005 - May 2010
VP of Manufacturing and Control
Biovest International May 2005 - Nov 2005
VP of Quality Systems
Diacrin/Genvec Oct 1995 - Apr 2004
VP of QA
Senior Quality Advisor
Biotech and CROs since Aug 2008
Senior Consultant for QA and Manufacturing (GXP Consulting, LLC)
TransMolecular Nov 2005 - May 2010
VP of Manufacturing and Control
Biovest International May 2005 - Nov 2005
VP of Quality Systems
Diacrin/Genvec Oct 1995 - Apr 2004
VP of QA
Education:
Northeastern University 1980 - 1985
PhD, Biomedical sciences University of California, San Francisco 1977 - 1979
MS courses, Biomedical sciences Université Montpellier I 1976 - 1976
National Certification, Parasitology & Mycology Université Paul Sabatier (Toulouse III) 1968 - 1976
BS and national certifications, Pharmacy and Biomedical Sciences
PhD, Biomedical sciences University of California, San Francisco 1977 - 1979
MS courses, Biomedical sciences Université Montpellier I 1976 - 1976
National Certification, Parasitology & Mycology Université Paul Sabatier (Toulouse III) 1968 - 1976
BS and national certifications, Pharmacy and Biomedical Sciences
Skills:
Technology Transfer
Aseptic Processing
Change Control
Formulation
Gmp
Biotechnology
Capa
Fda
Validation
V&V
Biopharmaceuticals
Pharmaceutical Industry
Regulatory Affairs
Glp
Sop
Quality System
21 Cfr Part 11
Medical Devices
Lifesciences
Vaccines
Gxp
Gcp
Computer System Validation
Quality Assurance
Regulatory Submissions
Drug Discovery
Cro
Clinical Trials
Drug Development
Microbiology
Drug Delivery
Chemistry
Quality Control
Immunology
Oncology
Pharmacology
Assay Development
Life Sciences
Cell
Clinical Development
Standard Operating Procedure
Good Laboratory Practice
U.s. Food and Drug Administration
Aseptic Processing
Change Control
Formulation
Gmp
Biotechnology
Capa
Fda
Validation
V&V
Biopharmaceuticals
Pharmaceutical Industry
Regulatory Affairs
Glp
Sop
Quality System
21 Cfr Part 11
Medical Devices
Lifesciences
Vaccines
Gxp
Gcp
Computer System Validation
Quality Assurance
Regulatory Submissions
Drug Discovery
Cro
Clinical Trials
Drug Development
Microbiology
Drug Delivery
Chemistry
Quality Control
Immunology
Oncology
Pharmacology
Assay Development
Life Sciences
Cell
Clinical Development
Standard Operating Procedure
Good Laboratory Practice
U.s. Food and Drug Administration
Interests:
Traveling
Soccer
Languages
Soccer
Languages
Languages:
French
Arabic
Arabic