USFDA Company

Industry: Federal agency

Description

The 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

Employee
Years
Job
Industry
Murali (Mike) Gavini, Ph.D Murali (Mike) Gavini, Ph.D Las Vegas, Nevada Details
Murali (Mike) Gavini, Ph.D's USFDA Experience December 1996 - April 2014
Job Founder and President, DPLCM, LLC
Industry Pharmaceuticals
Experience
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

Jacqueline Spaulding Jacqueline Spaulding Washington D.C. Metro Area Details
Jacqueline Spaulding's USFDA Experience March 2009 - Present
Job Physician/Pediatrician
Industry Government Administration
Experience
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

Christopher Grim Christopher Grim Washington D.C. Metro Area Details
Christopher Grim's USFDA Experience November 2009 - Present
Job ORISE fellow and microbiologist at USFDA
Industry Higher Education
Experience
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

Fernbach Stephen Fernbach Stephen Greater New York City Area Details
Fernbach Stephen's USFDA Experience September 1990 - March 2002
Job CST at US Department of Health & Human Services
Industry Government Administration
Experience
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

J. Marc Gentry J. Marc Gentry Pine Bluff, Arkansas Area Details
J. Marc Gentry's USFDA Experience January 2001 - Present
Job Analyst at USFDA
Industry Public Safety
Experience
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

Shonoi Ming Shonoi Ming Pikesville, Maryland Details
Shonoi Ming's USFDA Experience December 2014 - Present
Job Staff Fellow at USFDA
Industry Research
Experience
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

Victoria Nadershahi Victoria Nadershahi Redondo Beach, California Details
Victoria Nadershahi's USFDA Experience October 2007 - May 2011
Job RA/QA Manager at Proa Medical, Inc.
Industry Medical Devices
Experience
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.

Charles Ahn Charles Ahn Washington D.C. Metro Area Details
Charles Ahn's USFDA Experience March 2006 - March 2012
Job GMP, Quality Systems, Process Validation, 21cfr Part 11
Industry Pharmaceuticals
Experience
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

Pal Mayasandra Pal Mayasandra Greater Seattle Area Details
Pal Mayasandra's USFDA Experience
Job Scientist/chemist at USFDA
Industry Government Administration
Experience
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

Joseph Salyer Joseph Salyer Washington D.C. Metro Area Details
Joseph Salyer's USFDA Experience July 2007 - Present
Job Compliance Officer at USFDA
Industry Government Relations
Experience
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

Divya Menon-Andersen Divya Menon-Andersen Silver Spring, Maryland Details
Divya Menon-Andersen's USFDA Experience April 2008 - April 2015
Job Clinical pharmacology reviewer
Industry Pharmaceuticals
Experience
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

Beverly Ritter Beverly Ritter Decatur, Illinois Area Details
Beverly Ritter's USFDA Experience February 1989 - January 1999
Job QSM at Decatur Foundry,inc.
Industry Mining & Metals
Experience
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

Erica Hoagland Erica Hoagland Scottsville, Kentucky Details
Erica Hoagland's USFDA Experience September 2009 - July 2011
Job Teacher at Allen County Schools, KY
Industry Research
Experience
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

Stephen Fernbach Stephen Fernbach Greater New York City Area Details
Stephen Fernbach's USFDA Experience Consumer Safety TechUSFDA2002 - Present
Job Consumer Safety Tech at USFDA
Industry Government Administration
Experience
USFDA   Consumer Safety TechUSFDA2002 - Present

Education
Rutgers University-New Brunswick   1977 — 1981
Bachelor of Science (BS), Environmental Studies, B

John Balian, MD John Balian, MD Greater New York City Area Details
John Balian, MD's USFDA Experience 1994 - 1998
Job Chief Medical Officer at Johnson & Johnson; CPC
Industry Pharmaceuticals
Experience
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

Sauna (Fda/Cber) Sauna (Fda/Cber) Washington D.C. Metro Area Details
Sauna (Fda/Cber)'s USFDA Experience November 2009 - Present
Job Research Reviewer at USFDA
Industry Biotechnology
Experience
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

James Kewley James Kewley Buffalo/Niagara, New York Area Details
James Kewley's USFDA Experience January 2009 - December 2012
Job Principal Consultant at PAREXEL International
Industry Government Administration
Experience
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.)

William Dardick William Dardick Baltimore, Maryland Area Details
William Dardick's USFDA Experience October 2008 - October 2012
Job Assistant Professor of Quantitative Research Methods at George Washington University
Industry Government Administration
Experience
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

Tiana McKinley-Kelly Tiana McKinley-Kelly Alpharetta, Georgia Details
Tiana McKinley-Kelly's USFDA Experience January 2010 - August 2012
Job Quality Assurance
Industry Biotechnology
Experience
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

Ellis Dandy Ellis Dandy Upatoi, Georgia Details
Ellis Dandy's USFDA Experience August 1967 - November 1968
Job Government Administration Professional
Industry Government Administration
Experience
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

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