USFDA Company
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Customer service: 1 (888) 463-6332 Emergency: 1 (866) 300-4374 Headquarters: Silver Spring, MD Jurisdiction: United States of America Founded: June 30, 1906 Founders: Theodore Roosevelt, Harvey Washington Wiley
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USFDA Employees
DPLCM, LLC December 2014 - Present
USFDA December 1996 - April 2014
Skills
Public Health, Regulatory Affairs, Government, Policy, Federal Government, Epidemiology, FDA, Environmental Health, Regulations, Policy Analysis, Regulatory Requirements, Microbiology, Infectious Diseases, Health Communication, Emergency Management, Public Policy, Food Microbiology, Life Sciences, Regulatory Submissions, Global Health
Education
University of Arkansas 1973 — 1976
Doctor of Philosophy (Ph.D.), Chemistry
Andhra University 1970 — 1972
Master of Science (MSc), Chemistry
Andhra Christian College 1967 — 1970
Bachelor's degree, Chemistry, Physics and Math
USFDA March 2009 - Present
Skills
Public Health
Education
The Ohio State University 1993 — 1997
Doctor of Medicine (M.D.), Medicine
University of Pittsburgh 1988 — 1989
Master of Public Health (M.P.H.), Community Health and Preventive Medicine
Spelman College 1984 — 1988
Bachelor of Science (B.S.), Health Professions and Related Clinical Sciences, Other
USFDA November 2009 - Present
University of Maryland November 2006 - November 2009
Skills
Genetics, Microbiology, Biochemistry, PCR, Molecular Biology, Functional Genomics, Comparative Genomics, Animal Models, Bioinformatics, Cell Biology, Cell Culture, DNA, Data Analysis, ELISA, Experimental Design, Genomics, Lifesciences, Molecular Cloning, Protein Purification, RT-PCR, Science, Scientific Writing, Tissue Culture, Virology, Western Blotting, qPCR
Education
University of Maryland College Park 1999 — 2006
Doctor of Philosophy (PhD), Microbiology
University of Miami 1988 — 1993
Bachelor of Science (BS), Marine Biology
US Department of Health & Human Services April 2002 - Present
USFDA September 1990 - March 2002
NY Health Dept August 1987 - March 1988
Skills
Public Speaking, Research, Editing, Leadership, Microsoft Office, Customer Service, Teaching, Microsoft Word, Microsoft Excel
Education
City University of New York-Hunter College 1989 — 1993
Master of Science (MS), EO Health Sciences
Rutger University 1977 — 1981
Bachelor of Science (BS), Environmental Studies, B
USFDA January 2001 - Present
North Little Rock wastewater July 2000 - January 2001
Truesdail Laboratories, Inc. - Tustin, CA June 1995 - September 1999
Chevron Petroleum Technology - La Habra, CA January 1995 - May 1995
Skills
Gas Chromatography, Mass Spectrometry, Laboratory, Organic Chemistry, Environmental Awareness, Quality Control, Management
Education
Jacksonville University 1990 — 1994
BS, Environmental Science
USFDA December 2014 - Present
FDA January 2014 - December 2014
Johns Hopkins School of Medicine November 2009 - December 2013
Skills
Biochemistry, Cell Biology, Cell Culture, Enzyme Kinetics, Molecular Biology, Protein Purification, Proteomics, Western Blotting
Education
University at Buffalo 2004 — 2010
Doctor of Philosophy (Ph.D.), Chemistry
University at Buffalo 1999 — 2003
Bachelor of Science (BS), Medicinal and Pharmaceutical Chemistry
Proa Medical June 2012 - Present
FDA Forte May 2012 - Present
USFDA October 2007 - May 2011
Krishtal Consulting September 2006 - October 2007
Discus Dental, Inc. September 2005 - August 2006
Discus Dental October 2004 - September 2005
Glidewell Laboratories December 2003 - October 2004
Skills
Medical Devices, FDA, Quality System, Regulatory Affairs, Regulatory Submissions, Quality Assurance, CAPA, Product Development, ISO 13485, GMP, Cross-functional Team..., Sop, Strategic Planning, Validation, Software Documentation
Education
The Johns Hopkins University 2009 — 2010
MS
University of California, Irvine 2000 — 2003
B.S.
Aegis Beacon Consulting, Inc. March 2012 - Present
USFDA March 2006 - March 2012
USFDA May 1994 - March 2012
USFDA June 2009 - July 2011
Consulate General Of the USA in Shanghai, P.R. China 2009 - 2011
Skills
Compliance, Government Compliance, Compliance Management, GMP, Quality System, Sop, Quality Assurance, V&V, Pharmaceutical Industry, Regulatory Affairs, FDA, Quality Auditing, CAPA, Software Documentation, Quality Management, Regulatory Submissions, Manufacturing, Technology Transfer, GLP, 21 CFR Part 11, Change Control, Validation, Medical Devices, SOP
Education
Queens College 1988 — 1989
Non-matriculate Graduate Level Program, Computer Science
Columbia University in the City of New York
Bachelor of Science (BSc), Physical Chemistry
USFDA
Skills
Analysis, Regulatory Affairs, Qualitative Research, Biochemistry, Cell Culture, Policy Analysis, Lifesciences, Clinical Trials, Clinical Research, Program Evaluation, Public Policy, Government, Epidemiology, Public Health
Education
University of Alaska Fairbanks 1986 — 1989
USFDA July 2007 - Present
Skills
Public Health, Medical Devices, Training, HACCP, FDA, Regulatory Requirements, Regulatory Affairs, Government, Policy, Risk Management, Pharmaceutical Industry, Nonprofits, Regulatory Submissions
Education
The Johns Hopkins University
Masters, Public Health
USFDA April 2008 - April 2015
The Childrens Hospital of Philadelphia November 2005 - April 2008
Skills
Clinical Pharmacology, Drug Development, Clinical Trials, Pharmacokinetics, Pharmacodynamics, Regulatory research, Pharmacometrics, Pharmaceutics, Pharmacology, Life Sciences, Clinical Research, Lifesciences
Education
University of Maryland Baltimore 2001 — 2005
PhD, Pharmaceutical Sciences
Decatur Foundry,inc. GCP AuditorPPD2002 - 2003
Neurocrine Biosciences 2002 - 2002
Maxim Pharmaceuticals 2001 - 2002
Biogen Idec 1999 - 2000
USFDA February 1989 - January 1999
Education
University of Illinois Springfield 1984 — 1987
biology, biology
Allen County Schools, KY July 2011 - Present
USFDA September 2009 - July 2011
University of Illinois at Urbana-Champaign November 2007 - February 2009
University of Illinois at Urbana-Champaign December 2005 - November 2007
University of Kentucky July 2004 - December 2005
University of Kentucky August 1999 - July 2004
Skills
Cell Culture, Western Blotting, Assay Development, DNA sequencing, High Throughput..., Laboratory, Phage Display, Public Health, Molecular Biology, Epidemiology, PCR, Science, SAS, Statistics, Microbiology, Biochemistry, Data Analysis, Program Evaluation, R, ELISA
Education
Eastern Kentucky University 1995 — 2003
B.A., English, Writing Emphasis
Eastern Kentucky University 1995 — 1999
B.S., Pre-med Biology, Chemistry minor
USFDA Consumer Safety TechUSFDA2002 - Present
Education
Rutgers University-New Brunswick 1977 — 1981
Bachelor of Science (BS), Environmental Studies, B
Johnson & Johnson September 2012 - Present
Johnson & Johnson; CPC September 2012 - April 2014
Pfizer inc January 2010 - September 2012
Bristol-Myers Squibb 2005 - 2010
Pfizer Inc 1998 - 2005
USFDA 1994 - 1998
Skills
Physician Executive, Author of a novel, Pharmaceutical Industry, Clinical Trials, Clinical Development, Drug Discovery, Oncology, Regulatory Affairs, Medical Affairs, Clinical Pharmacology, Regulatory Submissions, Drug Development, Informatics, Pharmacovigilance, CRO, Biotechnology, Medicine, FDA, Clinical Operations, GCP, Life Sciences, Epidemiology, Lifesciences, Clinical Research, Medical Devices, Strategy, Infectious Diseases, Writing
Education
Tufts University School of Medicine 1985 — 1989
MD, Medicine
Columbia University in the City of New York 1981 — 1985
BA, Liberal Arts
USFDA November 2009 - Present
National Cancer Institute June 2005 - November 2009
National Cancer Institute July 1997 - June 2005
Education
University of Pune 1990 — 1996
Ph.D., Biotechnology
Bhopal University 1982 — 1986
B.Sc.Ed., Science education
PAREXEL International January 2013 - Present
USFDA January 2009 - December 2012
NYK-DO Compliance Branch January 1989 - December 2009
US FDA 1982 - 1988
Education
State University of New York College at Oneonta
Bachelor of Science (B.S.)
American National Standards Institute December 2013 - Present
George Washington University August 2013 - Present
George Washington University September 2012 - August 2013
USFDA October 2008 - October 2012
University of Maryland September 2005 - August 2012
JBS International Inc. August 2007 - October 2008
University of Maryland College Park March 2002 - August 2007
Evidence-Centered Assessment Design. Cisco Learning Institute June 2006 - June 2007
Academic Achievement Center, Towson University 1997 - March 2002
Towson University June 1998 - June 2001
Skills
Psychometrics, Item Response Theory, Quantitative Research, Statistics, Bayesian statistics, Artificial Neural..., Structural Equation..., Job Analysis, Accreditation, Certifications, Training, Latent Class Analysis, Test Development, Educational Measurement, Assessment Methodologies, Research Design, Factor Analysis, Food Safety, Federal Government, SPSS, SAS, Data Analysis, Survey Design, Program Evaluation, Statistical Modeling, Research, Quantitative Analytics, Teaching, Psychology, Qualitative Research, Educational Research, Data Collection, Experimental Design, Measurements, Educational Assessment, Data Mining, FDA, Adult Learning Theory, University Teaching
Education
University of Maryland College Park 2003 — 2010
Doctor of Philosophy, Measurement, Statistics and Evaluation
Towson University 1998 — 2001
Master of Arts, Experimental Psychology
Towson University 1996 — 1998
Bachelors of Science, Philosophy & Psychology
Biotech, Pharm, Regulated Industry August 2014 - Present
NA August 2014 - Present
Cognate BioServices July 2012 - 2013
USFDA January 2010 - August 2012
Papa Johns April 2000 - July 2008
Urgent Medical Care April 2007 - September 2007
Skills
Self-driven, Team-oriented, Validation, Quality Auditing, Quality Assurance, cGMP practices, Biologics, Clinical Monitoring, Medical Devices, 21 CFR, FDA, GMP, Laboratory, CAPA, Regulatory Affairs, Microbiology, Quality System, Biotechnology, Lifesciences, Regulatory Requirements, Training, FDA GMP, Aseptic Technique, Sop, Life Sciences, SOP
Education
Eastern Kentucky University 2008 — 2010
BS, Environmental Health Science
Somerset Community College 1998 — 2007
AAS, Clinical Laboratory Science/Medical Technology/Technologist
DoD-US Army September 2013 - Present
US Government (DoD-Army) 1961 - 2013
USFDA August 1967 - November 1968
Skills
Program Management, Mediation, EEO, Team Building, Policy, Employee Training, Employment..., Customer Service, Management, Job Coaching, Employment Counseling, Civil Rights Law, Workshop Facilitation, Conflict Resolution, Building Relationships, Motivational Speaker, Multi-cultural team..., Crisis Communications, Small group facilitation, Coaching, Public Speaking, Training, Team Leadership, Event Planning, Strategic Planning, Leadership
Education
Troy State University 1987 — 1989
Master of Science (MS), Management Science
University of Maryland College Park 1976 — 1985
Bachelor of Science (BS), Sociology/Business Management