FDA/CDER Company

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
Dr. STUART CANTOR Dr. STUART CANTOR Redwood City, California Details
Dr. STUART CANTOR's FDA/CDER Experience January 2012 - June 2013
Job Pharmaceutical R&D Scientist at Proteus Digital Health, Inc
Industry Pharmaceuticals
Experience
Proteus Digital Health, Inc  December 2014 - Present
Greater maryland discussion group (GMDG)   January 2014 - February 2015
J. AOAC (Association of Official Analytical Chemists) Intl.   April 2013 - December 2014
TreMonti   April 2011 - December 2014
Advanced BioNutrition: Fluid bed, Spray drying, Lyophilization, & Encapsulation   June 2013 - July 2014
FDA/CDER   January 2012 - June 2013
Pfizer Consumer Healthcare  October 2009 - April 2011
Technical and Management Consultants (now 3DDD Market Research)   February 2009 - December 2009
ICON Development Solutions  June 2008 - June 2009
University of Maryland School of Pharmacy  2003 - 2008

Skills
NIR Spectroscopy, CMC Writing, Quality by Design (QbD), DSC/TGA, HPLC-Analytical Method..., Tablet/Capsule..., Extrusion-spheronization, Coating: Fluid Bed, Intellectual Property, ISO 9000, Pharmaceutics, Drug Delivery, Formulation, HPLC, Statistics, Quality Control, Regulations, Project Management, FDA, Iso 9000, NIR spectroscopy, Technology Transfer, V&V, Regulatory Affairs, Pharmaceutical Industry, GMP, Chemistry, R&D, FTIR, Change Control, CAPA, Analytical Chemistry, Clinical Trials, IND, Quality Assurance, Regulatory Submissions, Regulatory Requirements, Commercialization, Drug Development, Drug Discovery, Characterization, Chromatography, CRO, Microbiology, Quality by Design, Spectroscopy, GLP, Laboratory

Education
University of Maryland Baltimore   2003 — 2008
PhD, Pharmaceutical Science

Caitlin Pennington Caitlin Pennington Washington D.C. Metro Area Details
Caitlin Pennington's FDA/CDER Experience October 2011 - March 2013
Job Program Support Specialist at FDA
Industry Government Administration
Experience
FDA  March 2014 - Present
FDA/OC   March 2013 - March 2014
National Consortium for the Study of Terrorism and Responses to Terrorism (START)   August 2013 - December 2013
FDA/CDER   October 2011 - March 2013
DCMA  June 2011 - October 2011
Maryland General Assembly  January 2011 - April 2011
Office of Congressman Roscoe Bartlett   September 2010 - December 2010
Office of Congressman Aaron Schock   May 2010 - August 2010

Skills
Grassroots Organizing, Government, Office Management, Public Policy, Policy Analysis, Budgets, Management, Research, Policy, International Relations, Nonprofits, Public Speaking, PowerPoint, Microsoft Office

Education
University of Maryland University College   2011 — 2014
Master's Degree, Homeland Security Management

McDaniel College   2007 — 2010
Bachelors of Art, Political Science and International Studies

CERT

CERT

Huifang Li Huifang Li Washington D.C. Metro Area Details
Huifang Li's FDA/CDER Experience October 2010 - Present
Job Postdoc at FDA/CDER
Industry Biotechnology
Experience
FDA/CDER   October 2010 - Present
Georgetown University  October 2006 - June 2010

Skills
primary cell culture, stable transfection..., cell proliferation assay, Apoptosis assay, Molecular cloning, Single cell RT-PCR, multicolor fluorescence, reporter gene assay, Immunohistochemistry, Immunofluorescence, protein purification, Western Blotting, Immunoprecipitation, kinase assay, calcium influx assay, confocal microscopy, Electron Microscopy, virus production..., Thin-layer..., Cell Culture, Confocal Microscopy, Molecular Cloning

Education
University of Miami Leonard M. Miller School of Medicine   2001 — 2006
PhD, Molecular and cellular Phamacology

Shanghai Institute of Cell Biology, Chinese Academy of Sciences   1995 — 1998
Master's degree, Cell Biology

Eastern China University of Science & Technology   1991 — 1995
Bachelor of Science (B.S.), Biochemistry

Chiang Syin Chiang Syin Washington D.C. Metro Area Details
Chiang Syin's FDA/CDER Experience 2003 - 2003
Job Associate Country Director, China Office at FDA
Industry Government Administration
Experience
FDA/ Office of International Programs   September 2012 - Present
FDA/CBER/OCBQ/DMPQ   2006 - September 2012
FDA/CBER  2004 - 2006
FDA/CDER   2003 - 2003

Skills
FDA, Lifesciences, Regulatory Submissions, Biotechnology, Vaccines, Chemistry, Regulatory Affairs, Government, GMP, Policy, Protein Chemistry, Public Health, Federal Government, Infectious Diseases, Biopharmaceuticals, Quality Assurance

Education
The Catholic University of America
Ph.D., Chemistry

Tunghai University   1973 — 1977
B.S., Biology

Juliun Davis Davis Juliun Davis Davis Silver Spring, Maryland Details
Juliun Davis Davis's FDA/CDER Experience August 2014 - Present
Job Administrative Officer at FDA/CDER
Industry Human Resources
Experience
FDA/CDER   August 2014 - Present
USAID/OHR   January 2013 - August 2014
National Institutes of Health  March 2009 - January 2013

Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Public Speaking, Event Planning, Time Management, Training, Government, Team Building, Leadership, Strategic Planning

Education
Columbia College
Bachelor of Arts (B.A.), Business Administration and Management, General

Florida Community College at Jacksonville
Associate of Science (AS), Industrial Management Technology

Shu Chin Ma Shu Chin Ma Washington D.C. Metro Area Details
Shu Chin Ma's FDA/CDER Experience April 2013 - January 2015
Job Reviewer/Interdisciplinary scientist at FDA/OGD
Industry Research
Experience
FDA/OGD   January 2015 - Present
FDA/CDER   April 2013 - January 2015
Auckland University of Technology  March 2011 - March 2013
Auckland UniServices Limited   March 2011 - March 2013
University of Auckland  September 2007 - March 2013
CSL  March 2011 - April 2012
Nova Eco-Tech   June 2009 - April 2012
GTR Design Solutions   January 2009 - August 2010
University of Auckland  September 2007 - December 2009
Genesis Research & Development   January 2007 - July 2007

Skills
SAS, Medical Research, NONMEM, Clinical Development, Biomedical Engineering, Pharmacometrics, PRINCE2, PK/PD, Pharmacology, Science, Drug Delivery, Clinical Research, Drug Development, Bioinformatics, Immunohistochemistry, Epidemiology, Neuroscience, In Vivo, Clinical Pharmacology, Cell, Clinical Trials, Validation, PCR, Cancer, Animal Models, In Vitro, Biotechnology, Pharmaceutical Industry, Biochemistry, Lifesciences, Biostatistics, Medicine, Pharmaceutical Research, Molecular Biology, Drug Discovery, Oncology, Immunology, R&D, Genomics, Protein Chemistry, Regulatory Affairs, Cell Biology, Cell Culture, Commercialization, Microbiology, Technology Transfer, Infectious Diseases, Genetics, Project Management, Histology

Education
Yale University   2002 — 2004
Ph.D

Yale University   2002 — 2004
M.Phil

Cornell University   1999 — 2002
MSc

University of California, San Diego   2011 — 2012
Certificate

Uppsala University   2011 — 2011
Certificate

University of Auckland   2008 — 2008
Graduate class

University of Auckland   1996 — 1998
BE (1st hon)

University of Otago   1993 — 1995
BS

Epsom Girls Grammar School   1988 — 1993

Jackie Ware Jackie Ware Washington D.C. Metro Area Details
Jackie Ware's FDA/CDER Experience July 2008 - Present
Job Regulatory Project Manager at FDA/CDER
Industry Pharmaceuticals
Experience
FDA/CDER   July 2008 - Present
FDA  May 1996 - June 2008

Education
University of North Carolina at Chapel Hill   1985 — 1991
Pharm.D., pharmacy

Mona Zarifa Mona Zarifa Washington D.C. Metro Area Details
Mona Zarifa's FDA/CDER Experience 1993 - 2002
Job Senior Consultant at Salamandra, former FDA CMC reviewer for 10 years
Industry Pharmaceuticals
Experience
Salamandra   January 2003 - Present
FDA/CDER   1993 - 2002

Skills
FDA, IND, Regulatory Affairs, Clinical Development, Strategy, Microsoft Office, GMP, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Clinical Trials, Technology Transfer, Project Management

Education
American University   1982 — 1985

Howard Josefberg Howard Josefberg Greater New York City Area Details
Howard Josefberg's FDA/CDER Experience July 2002 - July 2008
Job Board of Diectors at PhRMA
Industry Pharmaceuticals
Experience
PhRMA  December 2012 - Present
Smart EHR   March 2010 - Present
CTD Consulting, LLC   2008 - Present
Boehringer Ingelheim Pharmaceuticals  May 2009 - January 2010
FDA/CDER   July 2002 - July 2008
Mount Sinai School of Medicine  1997 - 2002
Columbia University Medical Center  1996 - 1997

Skills
Clinical Trials, Medical Writing, Clinical Research, Pharmacovigilance, Clinical Development

Education
Brown Medical School   1988 — 1994
M.D.

Columbia University in the City of New York

Cornell University
B,A.

Stanford University Graduate School of Business
ABD

Yale University School of Medicine
Residency

Ebla Ali Ibrahim Ebla Ali Ibrahim Washington D.C. Metro Area Details
Ebla Ali Ibrahim's FDA/CDER Experience April 2008 - Present
Job Lead Regulatory Health Project Manager at Department of Health and Human Services
Industry Government Relations
Experience
FDA/CDER   April 2008 - Present

Skills
Strategic Planning, Project Management, Microsoft Office, Analysis, Regulatory Affairs, Microsoft Excel, Policy Analysis, FDA, Research, Biotechnology, Regulatory Submissions, Microsoft Word

Education
The Johns Hopkins University   2005 — 2008
MS

Ephrem Hunde Ephrem Hunde Orangeburg, New York Details
Ephrem Hunde's FDA/CDER Experience September 2015 - Present
Job Senior Scientist at Instrumentation Laboratory
Industry Medical Devices
Experience
FDA/CDER   September 2015 - Present
Instrumentation Laboratory  May 2011 - September 2015
University of Connecticut  August 2009 - August 2011
Rogers Corporation  March 2007 - May 2009
GE Silicones  April 2004 - March 2007

Skills
Polymers, Process Simulation, Rheology, Formulation, Supercritical Fluids, Chemical Engineering, Design of Experiments, Polymer Science, Polymer Characterization, Chemistry, Materials Science, R&D

Education
University of Massachusetts, Amherst   1999 — 2004
PhD, chemical engineering

University of Pittsburgh   1997 — 1999
MS, chemical engineering

Università degli Studi di Trieste   1994 — 1997
laurea, ingegneria chimica

Addis Ababa University   1985 — 1990
BSc, Chemical Engineering

Josie Yang Josie Yang Greater New York City Area Details
Josie Yang's FDA/CDER Experience 1995 - 2006
Job Associate VP Regulatory Affairs at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company  2008 - Present
Eisai Medical Research  2006 - 2008
FDA/CDER   1995 - 2006

Skills
IND, Regulatory Submissions, NDA, Drug Development, Regulatory Affairs, Clinical Development

Education
Auburn University, School of Vet Medicine
PhD, Immunotoxicology, Clinical Pathology

National Taiwan University
DVM, Veterinary Medicine

Jie (Jenni) Li Jie (Jenni) Li Washington D.C. Metro Area Details
Jie (Jenni) Li's FDA/CDER Experience November 2012 - Present
Job Epidemiologist at FDA/CDER
Industry Pharmaceuticals
Experience
FDA/CDER   November 2012 - Present
Medimmune/AstraZeneca  December 2011 - September 2012
HealthCore, Inc.   July 2010 - November 2011
The Degge Group  March 2007 - June 2010
National Foundation of Alternative Medicine   August 2005 - February 2007
University of Maryland School of Public Health, College Park   August 2000 - August 2005

Skills
Outcomes Research, Pharmacoepidemiology, Clinical Trials, Epidemiology, Biotechnology

Education
University of Maryland College Park   2000 — 2005
PhD, Public Health

Tianjin University of Chinese Medicine, Tianjin China   1992 — 1997
Bachelor of Medicine, Bachelor of Surgery (MBBS), Medicine

Julia Phung Julia Phung Silver Spring, Maryland Details
Julia Phung's FDA/CDER Experience January 2014 - Present
Job Ethics and Integrity Management Analyst
Industry Government Relations
Experience
FDA/CDER   January 2014 - Present
FDA/CDRH/OCD   September 2013 - January 2014
FDA/CDER/OEP/DACCM   January 2011 - September 2013

Skills
Government, Microsoft Office, Public Policy, Community Outreach, Policy, Research, Grant Writing, Public Health, Health Promotion, Prevention, Organizational..., Public Health Education, Literature Reviews, Health Communication, Public Administration, Data Analysis, Policy Analysis

Education
University of Maryland College Park   2012 — 2013
Bachelor of Science in Community Health

Montgomery College

Paul Roney Paul Roney Arlington, Virginia Details
Paul Roney's FDA/CDER Experience 1999 - 2007
Job Regulatory Affairs Specialist at BARDA
Industry Pharmaceuticals
Experience
BARDA   May 2015 - Present
INC Research  March 2007 - May 2015
FDA/CDER   1999 - 2007

Skills
CRO

Education
University of Texas Health Science   1981 — 1988
Doctor of Philosophy (Ph.D.), Toxicology

University of Notre Dame   1977 — 1981
Bachelors of Science, Microbiology