FDA CDER

Description

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

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FDA CDER Employees

Employee
Years
Job
Industry
sujata bupp sujata bupp Rockville, Maryland Details
sujata bupp's FDA CDER Experience May 2014 - Present
Job Biologist/Lab manager at FDACDER
Industry Research
Experience
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

Moshe Zilberstein MD, FACMG Moshe Zilberstein MD, FACMG Greater New York City Area Details
Moshe Zilberstein MD, FACMG's FDA CDER Experience 1999 - 2001
Job Senior Clinical Director, Immune Mediated Diseases/Translational Medicine at Sanofi/Genzyme
Industry Pharmaceuticals
Experience
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

Ramakrishna (Ramky) Vuppala Ramakrishna (Ramky) Vuppala Chantilly, Virginia Details
Ramakrishna (Ramky) Vuppala's FDA CDER Experience August 2008 - Present
Job
Industry Information Technology and Services
Experience
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 Shrikant Dighe Washington D.C. Metro Area Details
Shrikant Dighe's FDA CDER Experience 1984 - 1994
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
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)

Jonathan Helfgott Jonathan Helfgott Washington D.C. Metro Area Details
Jonathan Helfgott's FDA CDER Experience December 2010 - August 2012
Job Director of Regulatory Affairs at Stage 2 Innovations
Industry Biotechnology
Experience
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

Hamid Shafiei Hamid Shafiei Raleigh-Durham, North Carolina Area Details
Hamid Shafiei's FDA CDER Experience May 2013 - Present
Job Senior Review Chemist at FDACDER
Industry Pharmaceuticals
Experience
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

Linda Katz Linda Katz Washington D.C. Metro Area Details
Linda Katz's FDA CDER Experience November 1996 - September 2002
Job Director Office of Cosmetics and Colors, CFSAN at FDA
Industry Government Administration
Experience
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

Patricia Harlow Patricia Harlow Albany, New York Area Details
Patricia Harlow's FDA CDER Experience 2001 - 2014
Job Retired Pharmacologist from FDA, CDER
Industry Higher Education
Experience
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