FDA CDER
The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. Parent agency: Food and Drug Administration
FDA CDER List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at FDA CDER. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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FDA CDER Employees
FDA-CDER May 2014 - Present
National Human Genome Research Institute (NHGRI) July 2012 - June 2014
National Cancer Institute July 2010 - July 2012
National Institutes of Health July 2007 - January 2010
Rockefeller University June 2003 - May 2007
The Wistar Institute September 2003 - June 2004
Skills
Cell Culture, Cancer, Stem Cells, DNA, Biology, Research, Molecular Biology, Western Blotting, Cell Biology, Surgery, Molecular Cloning, PCR, qPCR, Biochemistry, Protein Expression, Transfection, Laboratory, Sequencing, Genetics, Mouse Models, Life Sciences, ELISA, Science, Microscopy, Cell, Protein Purification
Education
NIH-George Washinton University 2007 — 2009
Advanced biomedical studies, molecular medicine and biology
Presidency College 1990 — 1992
BS, Molecular Biology
Sanofi/Genzyme July 2014 - Present
Bristol-Myers Squibb, Princeton, New Jersey November 2011 - July 2014
Roche/Genentech September 2005 - October 2011
HGSI Inc. 2002 - 2005
FDA, CDER 1999 - 2001
Skills
Clinical Development, Clinical Trials, Clinical Research, Translational Medicine, Rheumatology, Immunology, Pharmacovigilance, GCP, Pharmaceuticals, Clinical, Protocol Development, Regulatory Affairs, Regulatory Submissions, Biotechnology, Phase I, R&D, Research, Cross-functional Team..., Strategic Planning, Compliance, Clinical Monitoring, Biomarkers, Rheumatoid Arthritis, Endocrinology, Personalized Medicine, Life Sciences, Biopharmaceuticals, FDA, Osteoporosis, Translational Research, Drug Development, Pharmaceutical Industry, Protocol, Biologics, CTMS, Medicine, Oncology, Lifesciences
Education
The Hebrew University 2011 — 2011
MD, Medicine
FDA - CDER August 2008 - Present
GlobalNet Services, Inc. 2010 - 2012
IntraLinks March 2008 - August 2008
Corporate Technologies (Business Objects Platinum Partner), Boston, MA November 2007 - August 2008
FDA July 2006 - October 2007
FedEx Kinko's April 2006 - June 2006
Blue Hammock, PA (Business Objects Bronze Partner) January 2006 - March 2006
Cardinal Health January 2005 - December 2005
Wipro Technologies 2002 - 2005
Pinnacle Systems Inc December 1999 - October 2001
Skills
Data Integration, Business Objects, Data Warehousing, Data Modeling, PL/SQL, Web Intelligence, ETL, Crystal Reports, Business Intelligence, Informatica, OLAP, Erwin, SQL Server, Oracle SQL, Databases, SQL, Business Intelligence..., Dimensional Modeling, Data Analysis, Business Analysis, Visio, Access, Data Warehouse..., Requirements Analysis, Database Design, SDLC, Software Project..., Unix, Data Management, SAP Data Services, Data Quality, Data Mining, Microsoft SQL Server, Data Migration, Integration
Education
Osmania University 1993 — 1996
Masters Degree in Computer Applications
Osmania University 1989 — 1992
Bachelors
SVNHS 1985 — 1987
Shrikant Dighe Associates 1995 - Present
FDA September 1984 - March 1994
US Food & Drug Administration 1984 - 1994
FDA CDER 1984 - 1994
U.S. Food and Drug Administration 1984 - 1994
Skills
Regulatory Strategy, Pharmaceutical Industry, Strategy, Bioequivalence, Regulatory Affairs
Education
University of Cincinnati 1959 — 1964
University of Mumbai and University of Cincinnati, USA
B. Sc. from U. of Bombay; Ph.D. from Univ. of Cincinnati (USA)
Stage 2 Innovations February 2015 - Present
Johns Hopkins University September 2011 - Present
FDA CDER OSI October 2013 - January 2015
FDA CDER December 2010 - August 2012
FDA CDRH May 2006 - November 2010
Skills
FDA, Clinical Trials, GCP, Regulatory Affairs, Medical Devices, Regulatory Requirements, CRO, Infectious Diseases, CAPA, Regulatory Submissions, GLP, Public Health, Lifesciences, Pharmaceutical Industry, Oncology, Sop, Biotechnology, Clinical Development, Regulations, Healthcare, GMP, Validation, Drug Development, Life Sciences, SOP
Education
The Johns Hopkins University 2005 — 2007
Master's degree, Bioscience Regulatory Affairs
University of Maryland College Park 2000 — 2004
B.S., Cell/Molecular Biology & Genetics
FDA-CDER May 2013 - Present
FDA-CDER May 2009 - May 2013
GlaxoSmithKline March 1999 - May 2009
Skills
LC-MS, Quality System, Characterization, HPLC, Monoclonal Antibodies, Chromatography, Analytical Chemistry, GLP, Mass Spectrometry, Drug Development, Drug Discovery, Pharmaceutical Industry, FDA, GMP, Validation, Technology Transfer, Organic Chemistry, Regulatory Affairs, UV/Vis, CMC, LIMS, Chemistry, Pharmacokinetics, Protein Chemistry
Education
North Carolina State University 1983 — 1987
Doctor of Philosophy (Ph.D.), Physical Chemistry
Southeastern Oklahoma State University 1977 — 1981
Bachelor of Science (BS), Chemistry
FDA July 2010 - Present
FDA September 2002 - Present
FDA, CDER November 1996 - September 2002
FDA, CDER July 1995 - November 1996
Skills
FDA, Rheumatology, Medicine, Global Health, Epidemiology, Clinical Study Design, Drug Development, Pharmacoepidemiology, Public Health, Infectious Diseases, Health Services Research, Biology, Cancer, Biostatistics, Health Policy, Biotechnology, Policy
Education
The University of Connecticut School of Medicine 1978 — 1982
MD, Medicine
University of Michigan School of Public Health 1976 — 1978
MPH, Epidemiology
University of Pennsylvania 1973 — 1976
BA, Biology
FDA, CDER 2001 - 2014
DuPont Pharmaceuticals 1989 - 2000
Fox Chase Cancer Center 1985 - 1989
Terumo Medical Corp 1981 - 1984
School of Life and Health Sciences, University of Delaware 1977 - 1980
Skills
Pharmaceutical Industry, Life Sciences, Research, Biotechnology, Regulatory Affairs, Pharmacology, Toxicology, Immunoassays, Molecular & Cellular..., Mammalian Cell Culture, Gene Expression
Education
University of Delaware 1977 — 1980
Doctor of Philosophy (Ph.D.), Molecular Biology
FAES, NIH 2003 — 2005
Pharmacology and Toxicology
The University of Texas at Austin 1974 — 1977
Master of Arts (M.A.), Biological Science
Vassar College 1964 — 1968
Bachelor of Arts (B.A.), Chemistry