FDA 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. Headquarters: Silver Spring, Maryland, United States Employees: 14,824 (2010) Jurisdiction: United States of America Founded: 30 June 1906 Subsidiaries: Center for Drug Evaluation and Research, Founders: Theodore Roosevelt, Harvey Washington Wiley
FDA List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at FDA. You can filter them based on skills, years of employment, job, education, department, and prior employment.
FDA Salaries. You can even request information on how much does FDA pay if you want to. Learn about salaries, pros and cons of working for FDA directly from the past employees.
Find People by Employers You can rekindle an old relationship, reconnect with a long-lost friend, former boss, business acquaintance who might be useful in your new line of work. With our employee database, the possibilities are endless. All you have to do is type in a couple of keywords and we'll bring you the exact information you wanted!
4,886 FDA employees in database. Find out everything there's to know about FDA employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
FDA Employees
NIH Clinical Center (CC) September 2014 - Present
FDA June 2014 - Present
washington hospital center August 2011 - Present
Skills
Quality Assurance, Quality Control, Microbiology, Clinical Research, Laboratory, Competency Assessment, Public Health, Biotechnology, SOP, Immunology, Infectious Diseases, Life Sciences, Epidemiology, Process Improvement, Clinical Trials
Education
University of Maryland College Park 2012 — 2014
Master's degree, Health/Health Care Administration/Management
Bowie State University 2005 — 2009
Bachelor's degree, Biology/Biological Sciences, General
Ultragenyx Pharmaceutical Inc. August 2015 - Present
FDA March 2015 - August 2015
Keck Medicine of USC October 2014 - January 2015
California Polytechnic State University January 2014 - April 2014
California Polytechnic State University September 2012 - September 2013
Skills
GCP, FDA, Clinical Trials, Regulatory Affairs, Organic Chemistry, 21 CFR, GMP, NMR, Pharmaceutical Industry, Biochemistry, ICH-GCP, Source Document..., CRFs, ICH Guidelines, EDC, CTMS, Quality Assurance, Medical Terminology, GC-MS, FTIR, IND, CTD, NDA, ANDA, Life Sciences, Pharmacology, Technical Writing, Risk Management, Chromatography, FDA Registrations
Education
University of Southern California 2014 — 2016
MS, Regulatory Science
California Polytechnic State University-San Luis Obispo 2010 — 2014
BS, Biochemistry, 3.55/4.00
San Francisco State University
Certificate, Clinical Trials Design and Management
Dietitians of Orange County August 2015 - Present
FDA May 2011 - June 2014
Healthy For Life April 2011 - May 2013
UCI Campus Recreation January 2009 - July 2011
Maggie Moo's Ice Cream & Treatery August 2007 - September 2008
Skills
Customer Service, Fundraising, Research, PowerPoint, Microsoft Word, Outlook, Community Outreach, Microsoft Excel, Marketing, Diet Planning, Recipe Modification, Data Entry, Management, Project Planning, Time Management, Software Documentation, Administration, Public Speaking, Data Analysis, Event Planning, Administrative..., Healthcare, Microsoft Office, Teamwork, Leadership
Education
California State University-Long Beach 2013 — 2017
Bachelor’s Degree, Dietetics & Food Administration, minor in Food Science
Saddleback College 2009 — 2013
Associate of Science (A.S.), Nutrition
University of California, Irvine 2008 — 2010
Tesoro High School 2004 — 2008
San Francisco State University August 1994 - Present
FDA November 2003 - Present
NASA Ames Research Center August 1989 - August 1994
Procter & Gamble August 1988 - August 1989
Skills
R&D, Analytical Chemistry, Environmental Analysis, Food Safety, University Teaching, X-ray spectroscopy, Atomic Spectroscopy, Mass Spectrometry, GC-MS, Ambient Air Monitoring, Data Analysis
Education
Michigan State University 1983 — 1988
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Canisius College 1979 — 1983
Bachelor of Science (B.S.), Chemistry
FDA December 2008 - Present
FDA December 2008 - Present
National Institutes of Health July 2007 - June 2008
Skills
Qualitative Research, Quantitative Research, Survey Design, Literature Reviews
Education
Bowling Green State University 2002 — 2007
Doctor of Philosophy (Ph.D.), Sociology, 3.81
Bowling Green State University 2002 — 2004
Master of Science (M.S.), Applied Statistics, 3.78
University of Nebraska-Lincoln 1999 — 2002
Master of Arts (M.A.) Sociology, Shanghai International Studies University
Shanghai International Studies University 1992 — 1996
Bachelor of Arts (B.A.), English Language and Literature/Letters
Amgen June 2015 - Present
FDA/Office of Generic Drug Policy January 2015 - June 2015
FDA January 2014 - January 2015
California Pharmacists Association February 2012 - December 2013
California Pharmacists Association March 2010 - December 2013
Raincross Pharmacy September 2009 - December 2013
University of Southern California August 2012 - April 2013
FDA/CDER/OCD, Controlled Substances Staff February 2013 - March 2013
American Society of Pharmacy Law (ASPL) March 2010 - January 2012
American Society of Consultant Pharmacist April 2010 - August 2011
Skills
Pharmacy, Pharmacy Benefit..., Policy, Legislation, Health Policy, Pharmaceutical Industry, Managed Care, Healthcare, Hospital Pharmacy, Drug Development, Public Health, Clinical Trials, Regulatory Affairs, Medication Therapy..., Pharmacists, Community Pharmacy, Compounding, Pharmacoeconomics, Pharmacy Practice, Hospitals, Ambulatory Care, Regulatory Submissions, Legislative Relations, Patents, Administrative Law, Intellectual Property, FDA GMP, Scientific..., ICH guidelines, Regulations, CMC, Regulatory Documentation, Regulatory Guidelines, Generic Drugs, Policy Research, ANDA, Committees, 21 CFR Part 11, Regulatory Intelligence, Regulatory Filings, Regulatory Coordination, FDA
Education
University of Southern California 2009 — 2013
Pharm.D, Pharmacy
California State University-San Bernardino 2004 — 2008
B.S, Biology; Pre-medicine option
Genomics Institute of the Novartis Research Foundation (GNF) May 2014 - Present
MedImmune August 2009 - April 2014
FDA April 2009 - August 2009
La Jolla Institute for Allergy and Immunology(LIAI) November 2005 - March 2009
UC Irvine 2000 - 2005
Canji, Inc. June 1999 - September 1999
Skills
Cell, Protein Chemistry, FDA, Characterization, Flow Cytometry, ELISA, Western Blotting, Cell Culture, Confocal Microscopy, PCR, Protein Purification, Antibodies, Immunology, Drug Discovery, Tissue Culture, RT-PCR, FACS, Immunofluorescence, Molecular Cloning, Immunoprecipitation, Animal Models, Virology, Cell Signaling, Signal Transduction, Infectious Diseases, Vaccines, recombinant DNA...
Education
University of California, Irvine 2000 — 2005
PhD, Biological Sciences
California Polytechnic State University-San Luis Obispo 1995 — 1999
B.S., Microbiology
FDA June 2013 - Present
Naval Research Laboratory June 2012 - May 2013
Brown University September 2007 - May 2012
Department of Veterans Affairs October 2010 - October 2011
NSF GK-12 Fellow June 2008 - May 2009
National Science Leadership Conference July 2007 - August 2007
Brown University June 2006 - May 2007
Naval Research Laboratory June 2005 - August 2005
Rutgers University June 2004 - August 2004
Brown University January 2004 - May 2004
Skills
Matlab, Microfluidics, Labview, Nanotechnology, AFM, Confocal Microscopy, Cell Culture, Mammalian Cell Culture, Animal Surgery, Fluorescence Microscopy, Microscopy, Scanning Electron..., Mentoring, Soft Lithography, Protein Chemistry, Science, Biomaterials, Transfection
Education
Brown University 2007 — 2012
PhD, Biomedical Engineering
Brown University 2003 — 2007
Sc.B, Biomedical Engineering
FDA May 2015 - Present
Skills
Mechanical Engineering, Biomechanical..., Critical Thinking, Communication, Solidworks, Project Management, Abaqus, Matlab, Teamwork, Time Management, Data Entry, PowerPoint, Pianist, Community Outreach
Education
California Polytechnic State University-San Luis Obispo 2010 — 2014
Bachelor’s Degree
Academy of Our Lady of Peace High School 2006 — 2010
FDA June 2015 - Present
MICROS Systems Inc June 2013 - June 2015
Hewlett-Packard May 2012 - May 2013
The Home Depot March 2008 - May 2012
Skills
Technical Support, Software Documentation, Help Desk Support, Outlook, Customer Service, Access, Laptops, System Administration, Microsoft Office, Windows 7, Active Directory, Customer Satisfaction, Databases, Networking, Windows, Wireless Networking, Troubleshooting, Security, Computer Hardware, Hardware, Clerical Skills, Recruiting, Human Resources, Software Installation, Sales, Windows Server, PowerPoint, Operating Systems, Data Entry, Time Management, E-Learning, Microsoft Publisher, Microsoft Word
Education
University of Maryland University College 2012 — 2016
Master's degree, Biotechnology
Bowie State University 2007 — 2011
Bachelor's degree, Computer Technology/Computer Systems Technology
Rite Aid Pharmacy June 2015 - Present
FDA January 2015 - Present
Asante May 2014 - Present
Community Regional Medical Center - Residency Applicant 2014 - 2015
Community Regional Medical Center - Residency Applicant 2014 - 2015
Rogue Valley Rx October 2014 - November 2014
CVS Caremark Corporation August 2009 - July 2012
Skills
Hospitals, Home Infusion, Internal Medicine, Patient Safety, Pharmacy, Healthcare, Clinical Pharmacy, Pharmacists, Immunization, Community Pharmacy, Microsoft Word, Clinical Research, Clinical Pharmacology, Microsoft Excel, Patient Counseling, Medication Therapy..., Patient Education, Certified Immunizer, CPR Certified, Pharmacy Automation
Education
Pacific University Oregon, School of Pharmacy 2012 — 2015
Doctor of Pharmacy (Pharm.D.) Candidate
California State University, Fresno 2007 — 2011
Bachelor's Degree, Chemistry, Cum Laude
Home June 2014 - Present
FDA 2000 - June 2014
Scientech 1989 - 2000
Santa Barbara County Environmental Health 1985 - 1989
Chapman University 1979 - 1989
Lockheed Space Operations Command (LSOC) 1984 - 1985
Santa Barbara County 1979 - 1984
College of the Redwoods 1978 - 1979
Skills
Public Policy, Government, Analysis, Policy Analysis, Risk Management, Program Evaluation, Environmental Policy, Federal Government, Public Administration, Public Health, Legislative Relations, Report Writing, Policy, Grants, Emergency Management
Education
Humboldt State University 1976 — 1978
MS, Biology
Humboldt State University 1973 — 1975
BA, Biology
California State University-Los Angeles 1969 — 1971
BS, Criminal Justice
CSL Plasma February 2015 - Present
Walter Reed Army Institute of Research September 2014 - Present
Johns Hopkins University July 1995 - Present
Walter Reed Army Institute of Research June 1987 - May 2011
Johns Hopkins University Applied Physics Laboratory September 2007 - May 2010
FDA November 1995 - September 2001
Johns Hopkins University July 1993 - June 1995
National Institute of Allergy and Infectious Diseases (NIAID) July 1979 - June 1987
Duke University & Durham Veterans Affairs Medical Centers July 1978 - June 1979
North Carolina Memorial Hosptial / UNC - Chapel Hill July 1977 - June 1978
Skills
Molecular Biology, Laboratory, Microbiology, Science, Epidemiology, PCR, Laboratory Medicine, Public Health, Cell Culture, Bioinformatics, Pathology, Virology, Teaching, Medicine, Research, Clinical Pathology, Clinical Microbiology, Infectious Diseases
Education
Duke University School of Medicine 1973 — 1977
Doctor of Medicine, (electives foci: molecular microbiology, infectious diseases, immunology)
Brown University 1969 — 1973
ScB in Biology, (foci: molecular, developmental, & ultrastructural biology)
Rumson-Fair Haven Regional High School 1965 — 1969
diploma
FDA July 2015 - Present
TestAmerica October 2013 - December 2014
Focus Diagnostics September 2011 - September 2013
Esoterix May 2004 - August 2011
The Racketdoctor February 1998 - January 2005
Skills
Sop, Biotechnology, Logistics, Pharmaceutical Industry, FDA, Management, Validation, Lifesciences, Oncology, Quality Assurance, Laboratory, GMP, Life Sciences, Medical Devices, Molecular Biology
Education
California State University-Northridge 2000 — 2003
Bachelor of Science (BS), Cell/Cellular and Molecular Biology
Glendale Community College 1996 — 2000
Associate of Arts and Sciences (AAS), Biological and Physical Sciences
FDA September 2010 - Present
Weber Shandwick July 2009 - September 2010
Danya International, Inc August 2003 - July 2009
Skills
Public Health, Health Communication
Education
Emerson College 2007 — 2009
MA, Health Communication
Bryn Mawr College 1999 — 2003
FDA May 2015 - Present
NorthStar Technology Corporation January 2014 - May 2015
University of California, Riverside October 2013 - December 2013
University of California, Riverside June 2010 - June 2013
Virginia Tech January 2009 - June 2010
Virginia Tech August 2008 - January 2009
Orange Unified School District August 2007 - June 2008
West Contra Costa Unified School District August 2006 - October 2006
City of Berkeley June 2004 - August 2005
Skills
Biotechnology, Molecular Biology, Entomology, Plant Pathology, Biological Control, Teaching, Microsoft Excel, PowerPoint, Integrated Pest..., Public Speaking, People Skills, Outdoor Education, Lifesciences, Laboratory, Biology, Scientific Writing, Life Sciences, Microbiology, Research, Genetics
Education
UC Riverside 2009 — 2013
Master's degree, Entomology
Virginia Tech 2008 — 2010
Master's program (partial), Plant Pathology
California State University-Hayward 2006 — 2007
Single-Subject Teaching Credential, Biology/Life Sciences
UC Berkeley 2002 — 2006
Bachelor of Science (BS), Natural Resources and Conservation
Deloitte September 2015 - Present
FDA September 2014 - August 2015
University of Pennsylvania January 2014 - August 2014
University of Pennsylvania September 2008 - December 2013
Dana-Farber Cancer Institute July 2006 - August 2008
Boston Museum of Science September 2006 - June 2008
Skills
Cell Culture, Fluorescence Microscopy, Western Blotting, Tissue Culture, PCR, Lifesciences, Molecular Biology, Microscopy, Biomedical Engineering, Microsoft Office, Data Analysis, Research, Biotechnology, Tissue Engineering, Microsoft Project, Statistics, Matlab, Microsoft Excel, PowerPoint, Laboratory, Life Sciences
Education
University of Pennsylvania 2008 — 2013
Doctor of Philosophy (PhD), Bioengineering
Brown University 2002 — 2006
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
FDA November 2014 - Present
UnitedHealth Group October 2012 - January 2014
National Institutes of Health May 2008 - July 2012
Naval Hospital Camp Pendleton May 2006 - May 2008
Loma Linda University Medical Center July 2005 - July 2006
Kaiser Permanente June 2002 - January 2005
Diabetes Research Center March 2000 - August 2003
Allergan January 1999 - January 2000
Skills
Leadership, Research, Microsoft Excel, Microsoft Word, Clinical Research, Healthcare, Social Media, Outlook, PowerPoint, Analysis, Healthcare Information..., Inpatient, Managed Care, Management
Education
Loma Linda University 2005 — 2006
Post Doctoral Training, Doctor Of Pharmacy, Residency
Western University of Health Sciences 2001 — 2005
Doctor of Pharmacy (Pharm.D.), Doctor of Pharmacy
California State University-Fullerton 1995 — 1999
Bachelor of Science (B.S.), Biology/Biological Sciences, General
U.S. Department of Veterans Affairs May 2014 - Present
FDA November 2013 - May 2014
Nordstrom November 2013 - February 2014
Nordstrom June 2013 - August 2013
Bank of America October 2011 - December 2012
Skills
Bilingual Communications, Human Resources, Microsoft Technologies, Customer Service, Sales, Business Networking, Social Networking, Social Media, Sales Presentations, Event Planning, Microsoft Office, Management, Leadership
Education
California State University-Long Beach 2013 — 2015
Master's Degree, MPA, Second Year Graduate Student
California State Polytechnic University-Pomona 2011 — 2013
Bachelor of Science, Business Administration/Management and Human Resources
Dana-Farber Cancer Institute September 2009 - Present
Harvard Medical School September 2009 - Present
Brigham and Women's Hospital September 2009 - Present
FDA 2010 - 2013
Mayo Clinic June 1996 - September 2009
University of Oxford December 2002 - August 2004
Calvin College September 1989 - May 1992
Atlantic Stewardship Bank 1989 - 1990
Skills
Clinical Trials, Leukemia, Medical Education, Cancer, Clinical Research, Translational Research, Medicine, Oncology, Healthcare, Hospitals, Hematology, Healthcare Management, Immunology, Healthcare Information..., Molecular Biology, Surgery, Flow Cytometry, Cell Biology, Clinical Development, Lifesciences, Infectious Diseases, Life Sciences
Education
University of Oxford 2002 — 2004
Molecular Haematology
Mayo Graduate School 1996 — 2002
Internal Medicine, Hematology, Oncology
University of Chicago - The Pritzker School of Medicine 1992 — 1996
M.D., Medicine
Calvin College 1988 — 1992
B.S., Physics and Astronomy
FDA July 2013 - Present
DAI / STAR-Vietnam August 2008 - June 2013
Office of the United States Trade Representative 2004 - 2008
Office of the U.S. Trade Representative 2000 - 2004
Office of Majority Leader Gephardt 1990 - 1993
Skills
International Trade, WTO, International..., International Trade Law, Trade Policy, International Relations, Policy Analysis, Public Policy, Free Trade Agreements, Economic Development, Economics, Government, Customs Regulations, Foreign Policy, Policy, International Law, Diplomacy, NGOs, Legislation, Capacity Building, Strategy, European Union, Africa, Foreign Investment, Program Management, Politics, Research, Legislative Relations, Strategic Planning, Strategic Communications, Legal Writing
Education
The Johns Hopkins University - Paul H. Nitze School of Advanced International Studies (SAIS) 1993 — 1996
M.A., International Relations and International Economics
University of Missouri-Columbia School of Law 1987 — 1990
JD, Law
Brown University 1985 — 1987
Bachelor of Arts (B.A.), English - Dramatic Literature
Vassar College 1982 — 1984
English
Rock Bridge High School
Defense Health Agency (DHA) November 2012 - Present
TIAG January 2010 - November 2012
Catalent August 2008 - January 2010
Merck 2001 - 2008
Visible Genetics 1998 - 2001
Amersham 1996 - 1998
Life Technologies 1994 - 1996
Clontech 1993 - 1994
Molecular Oncology 1992 - 1993
FDA 1991 - 1992
Skills
Program Management, PMP, Six Sigma, MBA, Project Management, Business Development, Sales, Government, Cross-functional Team..., Pharmaceutical Industry, Leadership, Medical Devices, Healthcare, Process Improvement, Biotechnology, Strategic Planning, Lifesciences, Project Planning, Training, Change Management, Business Analysis, Team Building, Contract Negotiation, Technical Writing, SharePoint, Proposal Writing, Management
Education
The Johns Hopkins University - Carey Business School 1998 — 2001
MBA, concentration Marketing and Management
Bucknell University 1986 — 1990
BS, Biology, minors: Chemistry and Education
FDA September 2003 - Present
USDA-AMS June 1997 - September 2003
Puerto Rico Senate January 1997 - June 1997
Skills
Regulatory Affairs, FDA, Regulatory Requirements, Regulatory Submissions, Public Health, GMP, Lifesciences, Clinical Trials, Infectious Diseases, Regulations, Microbiology, GLP, Sop, HACCP, Good Agricultural..., Bioterrorism, Import/Export Operations, Vaccines, Government, IND, Life Sciences, Policy, SOP, Leadership
Education
Bowling Green State University 1985 — 1986
Master's degree, Zoology/Animal Biology
University of Puerto Rico-Mayaguez 1979 — 1985
Bachelor of Science (BS), Agriculture, General
Daniel A. Shames Consulting, Inc October 2008 - Present
FDA August 1996 - October 2008
FDA 1996 - 2008
GI and Inborn Error Products January 2001 - January 2006
DRUP January 2000 - January 2001
Urology, Endocrine, DRUP January 1998 - January 2000
Surgery (Urology) January 1997 - January 2000
Urology, DRUP January 1996 - January 1998
Carolina Urocorp January 1985 - January 1997
Surgery (Urology) January 1980 - January 1996
Skills
Clinical Trials, Clinical Research, FDA, Urology, Medicine, Regulatory Affairs, Clinical Development, Drug Development, Pharmaceutics, Regulatory Submissions, Cancer, Endocrinology, Clinical Pharmacology, Toxicology, Epidemiology, Pharmaceutical Industry
Education
University of Pennsylvania School of Medicine 1971 — 1977
Residency, Urology, General Surgery
Georgetown University School of Medicine 1967 — 1971
MD, Medicine
Brandeis University 1963 — 1967
BA, Biology
GlaxoSmithKline September 2011 - Present
FDA June 2003 - September 2011
FDA August 1998 - June 2003
Skills
CMC development, Pharmaceutical..., Analytical Sciences, Regulatory Requirements, Regulatory Affairs, Pharmaceutical Industry, Technology Transfer, FDA, Regulatory Submissions, IND, Drug Development, GMP, Validation, Biotechnology, Clinical Development, Biopharmaceuticals, Analytical Chemistry, Pharmaceutics, Lifesciences, Chemistry, GLP, Formulation, Drug Discovery, Organic Chemistry, HPLC, Quality System, Clinical Trials, R&D, Strategy, V&V, Drug Delivery, 21 CFR Part 11, CAPA, Sop, CRO, Change Control, Commercialization, Oncology, Medicinal Chemistry, GCP, Pharmacology, Vaccines, Toxicology, Protein Chemistry, Pharmacovigilance, Medical Devices, Infectious Diseases, Clinical Pharmacology, Biologics, Immunology
Education
University of Minnesota-Twin Cities 1975 — 1979
Doctor of Philosophy (Ph.D.), Chemistry
Cairo University 1971 — 1975
Master of Science (M.S.), Pharmaceutical Analysis
FDA November 2014 - Present
House of Bear Enterprises July 2007 - Present
University of North Carolina at Chapel Hill August 2008 - November 2014
Boehringer Ingelheim May 2012 - August 2012
University of Toledo August 2007 - May 2008
Tufts University May 2002 - May 2007
Vertex Pharmaceuticals November 1997 - February 2002
Encysive Pharmaceuticals November 1996 - November 1997
Rice University January 1995 - October 1996
Frederick Cancer Research and Development Center October 1993 - December 1994
Skills
Computational Chemistry, Computational Biology, Bioinformatics, Molecular Modeling, Drug Discovery, Chemistry, Linux, Cheminformatics, Medicinal Chemistry, High Performance..., Data Mining, Drug Design, Scientific Computing, Science, QSAR, Lifesciences, Biotechnology, R, Unix, Information Technology, Databases, Virtual Screening, Pharmacology, Big Data, Machine Learning, Data Science, Systems Biology, Life Sciences
Education
University of North Carolina at Chapel Hill 2008 — 2014
Ph.D.
University of Toledo 2007 — 2008
University of Maryland Baltimore County 1991 — 1992
Bowling Green State University 1988 — 1990
BS
FDA September 2012 - Present
Brown University August 2007 - August 2012
Foster Corporation February 2008 - August 2008
Magee Rehabilitation March 2006 - September 2006
The Childrens Hospital of Philadelphia April 2005 - September 2005
Novaflora March 2004 - September 2004
Skills
Medical Devices, Microfluidics, Biomedical Engineering, disease diagnostics, Biomaterials, Fluorescence Microscopy, Biomechanics, Bioengineering, Labview, COMSOL, Tissue Engineering, Matlab, Mechanical Testing, ImageJ, SigmaPlot, Microscopy, Soft Lithography, Neuroengineering, Lab-on-a-chip, Confocal Microscopy, AFM, Nanotechnology, Microfabrication, Scanning Electron..., FDA
Education
Brown University 2008 — 2013
Ph.D., Biomedical Engineering
Brown University 2007 — 2008
Sc.M., Biomedical Engineering
Drexel University 2002 — 2007
B.S., Biomedical Engineering
FDA September 2012 - Present
Meso Scale Discovery February 2011 - September 2012
Johns Hopkins University August 2008 - December 2010
Emory University School of Medicine March 2003 - August 2008
University of Utah 1998 - 2003
Massachusetts Eye and Ear Infirmary December 1996 - September 1998
American Red Cross, National Testing Laboratory June 1995 - December 1996
Boston Biomedica, Inc. May 1994 - June 1995
Oliveira Environmental Laboratories January 1993 - May 1994
Education
University of Utah 1998 — 2003
Ph.D., Medicinal Chemistry
Bridgewater State University 1994 — 1998
M.S., Chemistry
Bridgewater State University 1989 — 1994
B.S., Chemistry
Foxboro High School
US Army June 2014 - Present
US Army August 2013 - June 2014
US Army August 2011 - August 2013
FDA February 2010 - August 2011
Department of the Interior November 2007 - February 2010
Skills
Security Clearance, Military, Leadership, Army, Military Operations, Training, Military Experience, Security, Logistics, Team Building, Command, DoD, Operational Planning, Transportation..., Military Decision..., Management, Tactics, Security Operations, Logistical Analysis, Ethical Decision Making, Detachment Safety..., Multi Modal Shipping..., United States Army..., United States Army..., Judo, Multi-Functional..., Personnel Management
Education
United States Army Officer Candidate School 2011 — 2011
Commissioned Officer with the United States Army, Military Education
Bowie State University School of Business 2008 — 2010
Masters of Public Administration (M.P.A.), Public Policy and Management
Bowie State University 2001 — 2005
Bachelor of Science (BS), Sociology
FEMA December 2012 - Present
FDA June 2010 - December 2012
Internal Revenue Service January 2008 - June 2010
Skills
Budget Process, Operating Budgets, Budget Monitoring, Budget Forecasts, Department Budgeting, Budget Reconciliation, Budgetary..., Account Reconciliation, Program Management, Human Resources, Management, Budgets, Procurement, Policy, Analysis, Strategic Planning, Government, Microsoft Office, Federal Government, Leadership, Data Analysis, Public Speaking, Customer Service, Training
Education
Capella University 2008 — 2012
Master's degree, Industrial and Organizational Psychology
Bowie State University 2000 — 2002
Bachelor's degree, Psychology
FDA July 2014 - Present
Johns Hopkins Bayview July 2014 - Present
MedStar Franklin Square Hospital July 2014 - Present
Johns Hopkins Hospital July 2013 - June 2014
Johns Hopkins Hospital July 2012 - June 2014
Johns Hopkins Hospital July 2011 - June 2012
University of Maryland Medical Center July 2011 - June 2012
Johns Hopkins Hospital July 2009 - June 2012
Mercy July 2008 - June 2009
Education
Washington University in St. Louis 1999 — 2008
MD, PhD (MSTP), Neuroscience
Brown University 1995 — 1999
Bachelor of Science (BS), Neuroscience
San Francisco University High School 1991 — 1995
Stuart Hall for Boys 1984 — 1991
San Francisco Waldorf School 1981 — 1984
US Food and Drug Administration June 2011 - Present
FDA May 2002 - June 2011
Most Holy Redeemer Church January 2008 - May 2009
Skills
Analytical Chemistry, Wet Chemistry, UV-Vis, LC-MS, Chemistry, GC-MS, Chromatography, Mass Spectrometry, GC/MS, HPLC, UV, Spectroscopy, Titration, Fluorescence, Regulatory Affairs, TLC
Education
Rutgers, The State University of New Jersey-Camden 2004 — 2008
MS, Chemistry
Bryn Mawr College 1998 — 2002
Bachelor of Arts (BA), chemistry
Kaiser Permanente December 2012 - Present
Kaiser Permanente October 2011 - December 2012
Kaiser Permanente June 2011 - October 2011
Kaiser Permanente January 2011 - October 2011
Kaiser Permanente August 2009 - January 2011
California State University December 2009 - June 2010
Insurance Auto Auctions February 2005 - July 2009
FDA June 2007 - January 2008
Skills
Analysis, Healthcare, Workshop Facilitation, Project Management, Hospitals, Microsoft Excel, Healthcare Management
Education
California State University-East Bay 2009 — 2011
MS, Health Care Administration
California State University-East Bay 2006 — 2008
BA, Human Development
California State Board of Equalization September 2014 - Present
California State Board of Equalization April 2013 - September 2014
California State Board of Equalization January 2011 - March 2013
FDA June 2010 - August 2010
LPL Financial June 2009 - August 2009
The Sports Authority May 2007 - August 2007
Skills
Microsoft Office, Teamwork, Spanish, Communication, Budgets, Data Analysis, Tax Law, Sales Tax, Tax Advisory
Education
California State University, Fresno 2006 — 2010
B.S., Finance
FDA March 2014 - Present
Advancia Corporation October 2013 - March 2014
Independent Consultant February 2013 - March 2014
Eagle Systems October 2010 - March 2013
Eagle Systems Inc September 2008 - March 2013
Eagle Systems Inc September 2008 - February 2013
US Navy February 1993 - September 2008
COMNAVAIRLANT 2006 - 2008
Naval Air Systems Command 2001 - 2004
Naval Air Systems Command 2001 - 2004
Skills
Program Management, Logistics, Proposal Writing, Instructional Design, Military, Strategic Planning, Security Clearance, Public Speaking, Defense, Research, Problem Solving, Technical Writing, Analysis, Quality Assurance, Teaching, Procurement, Editing, Supervisory Skills, Command, Navy, DoD, Military Operations, Leadership, Cross-functional Team..., Government Contracting, Government, Systems Engineering, Strategy, Operations Management, Team Building, ADDIE, Aviation, Organizational..., Process Improvement, Management, Instructor-led Training, Aircraft, Military Experience, Policy, Aircraft Maintenance, E-Learning, Avionics, Air Force, Military Training, Weapons, Aerospace, Top Secret, Operational Planning, National Security, Captivate
Education
Capella University 2010 — 2015
PhD, Instructional Design for Online Learning, 4.0
TUI - Trident University International (formerly Touro) 2007 — 2010
MBA, Information Technology Mgmt, 3.8
Excelsior University 1990 — 1991
BS, Sociology, 3.2
Lubbock Christian University 1972 — 1975
AA, Humanities, 3.4
Odessa High School 1969 — 1971
US Department of Health and Human Services February 2015 - Present
US Army September 2014 - Present
US Department of Health and Human Services February 2013 - February 2015
U.S. Coast Guard February 2008 - January 2013
Department of Health and Human Services January 2007 - February 2008
FDA October 2005 - January 2007
US Air Force 2003 - 2005
United States Air Force 2002 - 2003
US Air Force 1999 - 2002
United States Air Force 1996 - 1999
Skills
Emergency Management, Preparedness, Public Health, Disaster Response, Government, Military, Interagency Coordination, DoD, Policy, Security Clearance, Air Force, Program Management, Healthcare, Command, Healthcare Management, Logistics, Healthcare Information..., Readiness, Public Health Emergency..., Process Improvement, Strategic Planning, Project Management, Humanitarian Assistance, Pharmacy Automation, PMP, International, Humanitarian Logistics, Interagency, Planners
Education
Bowie State University 1999 — 2003
MS, Management Information Systems
University of Connecticut 1988 — 1993
Bachelor's Degree, Pharmacy
FDA 2015 - Present
Columbia University Medical Center 2010 - 2015
Steadman-Hawkins Research Foundation 2008 - 2008
Rhode Island Hospital 2006 - 2008
Skills
Finite Element Analysis, Biomechanics, CAD, Statistics, Numerical Analysis, Data Analysis, Mathematica, Engineering, Orthopedic, Matlab, Programming, Mathematical Modeling, Algorithms, Mechanical Testing, Arthroplasty, Mimics, Magics, Labview
Education
Columbia University - Fu Foundation School of Engineering and Applied Science
PhD, Mechanical Engineering
Brown University
ScM, Solid Mechanics
Brown University
ScB, Mechanical Engineering
Andrews Consultants January 2005 - Present
FDA March 1988 - July 2005
FDA 1988 - 2005
Skills
FDA, GxP, GCP, CAPA, cGMP, Quality Auditing, GMP, Clinical Research, Regulatory Affairs, 21 CFR Part 11, Clinical Trials, Drug Development, Regulatory Requirements, Regulatory Submissions, Sop, GLP, Pharmacovigilance, SOP
Education
Butler University
Masters, Pharmacology
Purdue University
FDA December 2014 - Present
FDA April 2014 - November 2014
FDA October 2012 - April 2014
University of Utah September 2009 - September 2012
Georgia Institute of Technology August 2003 - August 2009
Education
Georgia Institute of Technology 2003 — 2009
PhD, Bioengineering
Brigham Young University 2000 — 2003
BS, Chemical Engineering
FDA September 2014 - Present
NYU College of Dentistry May 2013 - May 2014
Novartis Institutes for BioMedical Research June 2010 - August 2010
Brandeis University October 2009 - May 2010
IRX Therapeutics May 2008 - August 2009
New York Hospital of Queens Epidemiology Laboratory June 2006 - August 2006
Skills
ELISA, PCR, Molecular Biology, Lifesciences, Gel Electrophoresis, Biotechnology, Flow Cytometry, Cell Culture, Western Blotting, Purification, SDS-PAGE, DNA extraction, Protein Purification, Protein Chemistry, Tissue Culture, Biochemistry, NMR spectroscopy, Column Chromatography, Public Speaking, Management, Laboratory, Bacterial Culture
Education
NYU 2012 — 2014
Master of Science (M.S.), Molecular Biology
Brandeis University 2007 — 2011
B.S., Biology
Brandeis University 2007 — 2011
Bachelor of Science, Biology
Amgen June 2015 - Present
FDA January 2015 - May 2015
Procter & Gamble September 2014 - November 2014
Western University of Health Sciences February 2014 - November 2014
FDA June 2014 - August 2014
CVS Caremark Corporation June 2012 - February 2014
Alliance to Save Energy May 2010 - May 2011
FDA 2010 - 2010
Department of Chemistry & Biochemistry 2009 - 2010
U.S. Salinity Laboratory 2009 - 2009
Education
Western University of Health Sciences 2011 — 2015
Doctor of Pharmacy (PharmD)
Cal State San Bernardino 2007 — 2011
Bachelor of Science (BS), Biochemistry
Ambry Genetics November 2013 - Present
BusinessGhost, Inc. August 2013 - November 2013
Investment Property Group November 2010 - August 2013
FDA June 2008 - November 2010
Skills
Social Media, PowerPoint, Microsoft Office, Microsoft Excel, Microsoft Word, Marketing Communications, Facebook, Newsletters, Social Media Marketing, Strategic Communications, Advertising, Training, Data Entry, InDesign, Marketing
Education
California State University-Fullerton 2006 — 2010
Bachelor of Arts (BA), Communications
Army National Guard June 2011 - Present
FDA May 2008 - June 2011
National Labor Relations Board February 2006 - April 2008
U.S. Department of State September 2004 - March 2006
Skills
Cisco Technologies, Networking, Network Administration, Network Security, CCNA, Windows Server, Troubleshooting, Active Directory, System Administration, VPN, Firewalls, VMware, Dameware, Marketing Communications, Management, SCCM, Technical Support, Software Installation, Public Speaking, Leadership
Education
Howard University
Computer Science
Bryant University
Computer Engineering
The Kraft Heinz January 2015 - Present
FDA February 2013 - December 2014
Caltech/ JPL February 2012 - January 2013
Jet Propulsion Laboratory September 2009 - January 2012
Caltech/ Jet Propulsion Laboratory September 2008 - August 2009
North Carolina State University January 2003 - August 2008
Zacky Farms 2001 - 2001
Dreyer's Grand Ice Cream 2000 - 2000
Education
North Carolina State University 2005 — 2008
Doctor of Philosophy (Ph.D.)
North Carolina State University 2003 — 2005
Master of Science (M.S.)
California Polytechnic State University-San Luis Obispo 1998 — 2002
Bachelor of Science (B.S.)
The Joint Pathology Center, Silver Spring, MD January 2013 - Present
George Washington University August 2005 - Present
FDA July 2007 - September 2012
US Department of Health and Human Services August 2009 - August 2012
AABB October 2008 - August 2012
Joint Staff 2008 - 2012
Walter Reed Army Medical Center June 2005 - September 2008
Seoul, ROK July 2004 - June 2005
Walter Reed Army Institute of Research July 2001 - July 2004
Skills
Program Management, DoD, Military, Security Clearance, Healthcare, Healthcare Management, Strategic Planning, Policy, Leadership, Leadership Development, Public Speaking, Research, Clinical Research, Process Improvement, Laboratory, Training, Data Analysis, Analysis, Emergency Management, Infectious Diseases, Government, Public Health, Quality Assurance, Informatics, Teaching, Molecular Biology, Organizational..., Lifesciences, Biotechnology, Hospitals, Medicine
Education
The Catholic University of America 1997 — 2001
PhD, Molecular Biology
Bowling Green State University 1990 — 1992
Master of Science (MS) Blood Bank Fellowship (SBB), Immunohematology
PhRMA 2007 - Present
Biogen Idec 2005 - 2007
FDA 2003 - 2005
Arnold & Porter 2000 - 2003
Morgan Stanley 1993 - 1995
Skills
Pharmaceutical Industry, FDA, Privacy Law, Legal Advice, Legal Issues, Litigation, Regulatory Affairs, Biotechnology, Compliance, Policy, Healthcare, Health Policy, Governmental Affairs, Public Policy, Biotechnology Industry, Clinical Development, Clinical Trials, Intellectual Property, Legislative Relations, Life Sciences, Medical Devices, Policy Analysis
Education
University of Virginia School of Law 1996 — 1999
J.D.
Harvard University Kennedy School of Government 1995 — 1998
M.P.P.
Brown University 1989 — 1993
B.A.
The Palm Beach Institute July 2015 - Present
Jerome Golden Center for Behavioral Health July 2014 - Present
Rainbow Apparel Co May 2012 - Present
Deb Shops, Inc. September 2009 - May 2012
FDA June 2006 - August 2010
Skills
Customer Service, Data Entry, Office Administration, Microsoft Office, Mentoring, Interpersonal Skill, Communication Skills, Interpersonal Skills, Management
Education
Bowie State University 2008 — 2013
Bachelor of Science (B.S.), Psychology
Econ One Research April 2014 - Present
University of Phoenix October 2013 - Present
FDA June 2012 - March 2014
Texas A&M University December 2011 - May 2012
Texas A&M University January 2009 - May 2012
Texas A&M University August 2007 - May 2012
PBTK Consulting August 2006 - August 2007
Skills
Econometrics, Matlab, Microeconomics, Health Economics, Stata, Applied Microeconomics, Demand Analysis, Microsoft Excel, Benefit Cost Analysis, Public Economics, Real Estate..., Industrial Organization, Plain Language, Technical Presentations, PowerPoint, Antitrust Economics, Wage & Hour, Analysis, Statistics, Statistical Modeling, Policy Analysis
Education
Texas A&M University 2007 — 2012
Doctor of Philosophy (Ph.D.), Agricultural & Applied Economics
Brigham Young University 1999 — 2006
Bachelor of Arts (B.A.), Economics
Wilson Family Pharmacies, Inc. April 2011 - Present
Campbell University College of Pharmacy & Health Sciences August 2007 - May 2011
FDA 2010 - 2010
The Chase Manhattan Bank 1990 - 1997
The New York Times Company 1988 - 1989
People Express / Continental Airlines 1984 - 1988
Oak Ridge Associated Universities 1980 - 1982
Oak Ridge National Laboratory 1980 - 1980
Skills
Coaching, Training, Performance Management, Leadership, Program Management, Strategic Planning, Management, Microsoft Office, Pharmacists, Medication Therapy..., Certified Immunizer, Leadership Development
Education
Campbell University 2007 — 2011
Doctor of Pharmacy
Sewanee-The University of the South
Bachelor of Science
FDA July 2013 - Present
National Institutes of Health April 2012 - July 2013
National Institutes of Health March 2009 - April 2012
Department of Veterans Affairs February 2007 - February 2009
VA Eastern Colorado Heatlhcare System May 2001 - February 2007
Skills
Healthcare Management, Clinical Research, Public Health, Research, Program Management, Community Outreach, Program Development, Epidemiology, Healthcare, Strategic Planning, Quantitative Research, Grant Writing, Analysis, Policy Analysis, Policy, Program Evaluation, Grants, Management, Government, Nonprofits, Health Policy, Clinical Trials, Public Speaking, Lifesciences, Public Policy, Data Analysis, Qualitative Research, Health Education, Mental Health, Proposal Writing, SPSS, Social Services, Statistics, Teaching
Education
University of Colorado Health Sciences Center 1996 — 2000
Doctor of Philosophy (Ph.D.), Registered Nursing, Nursing Administration, Nursing Research and Clinical Nursing
University of Virginia 1989 — 1992
BSN, MSN, Home Health, Complex Illness
Bryn Mawr College 1984 — 1988
A.B., French Language and Literature
EIMS October 2011 - Present
Democratic Party 2010 - 2014
East Carolina University July 2002 - September 2012
Vidant Medical Center 2011 - 2012
Vidant Medical Center 2002 - 2012
Dartmouth-Hitchcock July 1998 - June 2002
FDA September 1995 - October 1996
National Institutes of Health September 1990 - August 1995
Skills
Molecular Biology, Biochemistry, Science, Public Health, Western Blotting, Clinical Research, Cell Biology, Cell Culture, PCR, Cancer, Lifesciences, Microbiology, Genetics, Biotechnology, Oncology, Healthcare, Clinical Trials, Medicine, Hematology, Cell, Research
Education
Brown University 2013 — 2015
Masters expected May 2015, Health Care Leadership
Brown University School of Professional Studies 2013 — 2015
Master's degree, Healthcare Leadership
University of Minnesota Medical School 1975 — 1979
Doctor of Medicine (MD)
University of Minnesota-Twin Cities 1974 — 1975
Bachelor of Science (BS), Microbiology, General
Macalester College 1969 — 1973
Bachelor of Arts (B.A.), Chemistry
FDA June 2015 - Present
American Red Cross Los Angeles Region January 2015 - Present
U.S. Coast Guard October 2013 - Present
United States Department of Defense June 2009 - Present
Second Harvest Food Bank October 2013 - May 2014
U.S. Coast Guard September 2011 - October 2013
U.S. Coast Guard June 2006 - September 2011
American Red Cross 2007 - 2011
Skills
Security Clearance, Military Operations, Military, Emergency Management, National Security, Management, Team-oriented, Small Boat Operations, Search and Rescue, Volunteer Management, Training Facilitation, Command, CPR Instructor, First-AId Instructor, Coordinating Events, Active DoD Secret..., Critical Incident..., Volunteer Recruiting, Database Monitoring, Large Scale Change..., Dietary Maintenance, Nutrition Education, Personal Injury, Stress Management, Fitness Consulting, Wellness Coaching, Food Safety Management..., USDA, FDA
Education
Brandman University, Part of the Chapman University System 2014 — 2016
Master's Degree, Health/Health Care Administration/Management
Webster Univeristy 2010 — 2013
Bachelor of Arts (B.A.), Organizational Management
Orange Coast College 2013 — 2014
Dietetic Technician
Centers for Disease Control and Prevention January 2015 - Present
Centers for Disease Control and Prevention November 2012 - April 2015
Centers for Disease Control and Prevention April 2008 - November 2012
FDA August 2007 - April 2008
Indian Health Service October 2004 - August 2007
Honda of America Mfg., Inc. December 2003 - August 2004
Acrux Investigations, Ltd. June 2000 - July 2004
Indian Health Service May 2003 - August 2003
Indian Health Service May 2002 - August 2002
Skills
Environmental Health, Public Health, Industrial Hygiene, Emergency Management, Disaster Response, Infection Control, Policy, Public Health Emergency..., Preparedness, Occupational Health, Epidemiology, Incident Command, Community Health, Environmental Awareness, Emergency Services, Health Promotion, Prevention, Exercises, Global Health, Program Evaluation, Health Education, Health Policy, Teaching, Cpr Certified, Public Speaking, Government, Program Development, Policy Analysis, Program Management, Research, Analysis, Community Outreach, Grant Writing, Grants, Disease Surveillance, FDA, Public Health..., Public Policy, Data Analysis, Project Planning, NIMS, Team Building, Risk Assessment, Safety, CBRN
Education
University of South Florida 2009 — 2011
Master of Public Health (MPH), Public Health Practice and Infection Control
Oregon Health and Science University School of Medicine 2009 — 2009
Masters Certificate, Public Health Informatics
Bowling Green State University 2000 — 2003
Bachelor of Science (BS), Environmnetal Health Sciences
Benjamin Logan Local Schools
Emergency Management Institute
Crisis/Emergency/Disaster Management
FDA February 2014 - June 2015
Peace Corps January 2011 - March 2013
Skills
Community Outreach, Youth Development, Global Health, Public Health, Nonprofits, Program Evaluation, Capacity Building, Community Development, Fundraising, Grant Writing, International..., PowerPoint, Public Speaking, Teaching, Volunteer Management
Education
California State University-Hayward 2013 — 2014
San Francisco State University 2006 — 2010
Bachelor of Science (BS), Cell/Cellular and Molecular Biology
FDA August 2012 - Present
Commissioner's Fellow October 2010 - August 2012
Dr. Peter Palese laboratory January 2010 - August 2010
Mount Sinai School of Medicine August 2005 - December 2009
NYS Department of Health 2003 - 2005
Skills
Regulatory Affairs, Virology, Influenza, RNA viruses, Immunology, Microbiology, Infectious Diseases, Clinical Research, Viruses, FDA, Medical Devices, Lifesciences, Cell, Protein Chemistry, Molecular Biology, IND, Chemistry, Cell Culture, In Vitro
Education
Icahn School of Medicine at Mount Sinai 2005 — 2010
PhD, Microbiology
Mount Sinai School of Medicine Graduate School 2010 2005 — 2010
Ph.D, Biomedical Sciences
Bucknell University 1999 — 2003
Bachelor's of Science, Biochemistry/Cell Biology
John H. Glenn High School 1994 — 1999
S.A.Regents Diploma
FDA June 2015 - Present
FDA July 2011 - June 2015
FDA June 2009 - July 2011
LAPD December 2005 - January 2008
Skills
Food Safety, FDA GMP, Research, Data Analysis, Federal Government, Strategic Planning, Management, Social Media, HACCP, Microsoft Office, Team Leadership, Public Speaking, Outbreak Investigation, Public Health, Epidemiology, Food Manufacturing, Food Technology
Education
California State Polytechnic University-Pomona 2004 — 2008
Bachelor's Degree, Biotechnology
Syracuse University December 2013 - Present
Utica College, State University of New York January 2013 - Present
FDA 2014 - 2015
4D Metrics Inc. March 2013 - January 2014
ASTD 2013 - 2014
Maryland State Department of Education November 2012 - March 2013
US Department of Homeland Security November 2011 - November 2012
Concurrent Technologies Corporation June 2007 - September 2011
Skills
Training, Instructional Design, Instructional Technology, Proposal Writing, Blackboard, Pilot testing, Articulate Studio, Survey design evaluation, Sakai, Playwrite, Curriculum reform, Leadership, E-Learning, Analysis, ADDIE, Instructor-led Training, Project Management, Mobile Learning, Playwriting, Curriculum Design
Education
Syracuse University 2002 — 2007
Ph.D., Instructional Design Development and Evaluation
California State University-Sacramento
California State University-Sacramento
California State University-Sacramento
San Jose State University
FDA January 2015 - Present
Icahn School of Medicine at Mount Sinai January 2014 - January 2015
Icahn School of Medicine at Mount Sinai September 2012 - January 2014
Brown University September 2008 - August 2012
Georgia Institute of Technology August 2006 - August 2008
Skills
R, Monte Carlo Simulation, Matlab, Quantitative Finance, Statistics, Stochastic Processes, Algorithms, Probability, Applied Mathematics, Mathematics, C++, Programming, Simulations, LaTeX, Mathematica
Education
Brown University 2008 — 2012
Doctor of Philosophy (Ph.D.), Applied Mathematics
Georgia Institute of Technology 2006 — 2008
Master's Degree, Mathematics
University of Science and Technology of China 2002 — 2006
Bachelor's Degree, Mathematics
FDA November 2014 - Present
Gibson, Dunn & Crutcher LLP October 2011 - October 2014
Adli Law Group P.C. August 2010 - December 2010
Morrison & Foerster LLP June 2010 - August 2010
Dr. Joseph Finns June 2009 - August 2009
Truth June 2007 - August 2008
Friends of the Earth January 2008 - May 2008
New York League of Conservation Voters August 2007 - December 2007
Hillary Rodham Clinton New York Senatorial Office June 2005 - August 2005
Skills
Public Policy, Policy Analysis, Patent Litigation, Biotechnology Industry
Education
New York University 2008 — 2011
Doctor of Law (J.D.)
Brown University 2003 — 2007
Bachelor of Science (B.S.), Cognitive Neuroscience
FDA February 2015 - Present
Epimer LLC February 2014 - February 2015
National Institute of Standards and Technology July 2011 - February 2014
Skills
Nanotechnology, Microfluidics, Materials Science, Spectroscopy, Biomedical Engineering, Characterization, UV/Vis, Mass Spectrometry, FTIR, Nanoparticles, Microfabrication, Nanomaterials, NMR spectroscopy, NMR, Electrochemistry, Protein Chemistry
Education
Brown University 2005 — 2011
Doctor of Philosophy (PhD), Biomedical/Medical Engineering
University of California, Berkeley 2000 — 2004
Bachelor of Science (BS), Bioengineering
BIOTRONIK January 2014 - Present
FDA June 2012 - December 2013
Virginia Tech - Wake Forest School of Biomedical Engineering and Science May 2008 - June 2012
Engineers without Borders - Virginia Tech September 2009 - September 2011
Virginia Tech Center for Vehicle Systems and Safety July 2006 - May 2008
NASA Langley Research Center May 2007 - July 2007
Education
Virginia Polytechnic Institute and State University 2008 — 2012
Ph.D.
Virginia Polytechnic Institute and State University 2006 — 2008
M.S.
Brigham Young University 2003 — 2006
B.S.
GE Healthcare June 2015 - Present
Abbott Medical Optics with Keck Graduate Institute September 2014 - May 2015
GE Healthcare May 2014 - August 2014
Eli Lilly and Company January 2014 - May 2014
Michelson Laboratories June 2013 - February 2014
Children's Hospital Los Angeles (CHLA) Saban Research Institute October 2013 - December 2013
FDA June 2011 - September 2011
Skills
HPLC, GC-MS, Project Management, Team Leadership, Microsoft Word, Microsoft Excel, PCR, Microbiology, NMR spectroscopy, Hazardous Waste..., Employee Training, ELISA, Streak Plating, Species Identification, Regulatory Requirements, Life Sciences, Molecular Biology, Biotechnology, NMR, Cell Culture, Laboratory, FDA, Medical Devices, Regulatory Affairs
Education
Keck Graduate Institute 2013 — 2015
Master of Bioscience, Clinical Regulatory Affairs
Southwestern Law School 2014 — 2015
Certificate in Bioscience Industry Law and Practice
California State Polytechnic University-Pomona 2009 — 2013
Bachelor's degree, Biotechnology - Microbiology & Pathology Emphasis, Magna Cum Laude 3.8 GPA
Home. April 2009 - August 2015
FDA August 2004 - April 2009
FDA July 2002 - August 2004
Oak Hills Local School District August 2001 - May 2002
Whittier Union High School Dst August 1998 - July 2001
NOAA: National Oceanic & Atmospheric Administration July 1992 - August 1998
Skills
Science, Chemistry, Research, Analysis, Teaching, Mathematics, Data Analysis, Statistics, Community Outreach
Education
California State University-Fullerton 1998 — 2001
Teaching Certification, Secondary Education: Science & Math, 4.00/4.00
University of Washington 1989 — 1992
Master of Science (M.S.), Analytical Chemistry, 3.71/4.00
Western Washington University 1985 — 1989
Bachelor of Science (B.S.), Chemistry and Physics, 3.80/4.00 Magna Cum Laude
FDA October 2011 - Present
FDA October 2009 - September 2011
Therapyx Inc. September 2005 - June 2009
Brown University 2000 - 2009
Spherics, Inc. April 2000 - June 2005
Brown University 1999 - 2000
Skills
FDA, Medical Devices, Cell Culture, Drug Delivery, Biomaterials, Regulatory Affairs, Pharmaceuticals, R&D, Research, Science, Start-ups, GMP, Technical Writing, Clinical Development, Biotechnology, Microscopy, Oncology, Clinical Trials, Technology Transfer
Education
Brown University
PhD, Medical Science (Polymeric Drug Delivery Systems)
Northeastern University
BS, Neuropsychology
U.S. Department of Veterans Affairs June 2014 - Present
FDA October 2011 - Present
BGSU Music Library/Sound Recording Archives June 2006 - July 2007
Skills
New Media, Web Content Management, Social Media, Strategic Communications, Digital Media, Editing, Writing, Blogging, Plain Language, Technical Writing, SharePoint, Section 508, LMS Management, LMS, Learning Management..., Training
Education
George Mason University 2010 — 2012
Bachelor of Arts, Communication, Journalism
Bowling Green State University 2005 — 2007
Bachelor of Arts (B.A.), Popular Culture
FDA January 2015 - Present
FDA August 2010 - January 2015
Merck & Co., Inc July 1999 - June 2010
Skills
FDA, Technology Transfer, GMP, Quality Assurance, Biotechnology, Validation, Pharmaceutical Industry, Regulatory Affairs, V
Education
Carnegie Mellon University 1994 — 1999
PhD, Chemical Engineering
Brown University 1990 — 1994
Sc.B., Chemical Engineering
FDA July 2011 - Present
FDA 2000 - Present
US Food & Drug Administration July 2009 - July 2011
Skills
FDA, Regulatory Submissions, Regulatory Affairs, Regulatory Requirements, GMP, Pharmaceutical Industry, Validation, CAPA, Quality Auditing, Sop, Biotechnology, Change Control, Quality System, Biopharmaceuticals, 21 CFR Part 11
Education
Brown University 1995 — 1999
FDA
Skills
SAS, Microsoft Excel, Predictive Modeling, SAS programming, Statistical Modeling, R, Biostatistics, Data Analysis, Business Analysis, Statistics, Statistical Programming, Logistic Regression, Research
Education
North Carolina State University 2001 — 2007
Brigham Young University 1995 — 2001
BS, Statistics
FDA September 2005 - Present
Education
Georgetown University 2010 — 2011
Public Health
Bowie State University 2006 — 2008
MPA, Public Administration
Mary Baldwin College 2000 — 2004
Keck Graduate Institute 2012 - Present
InCompliance Solutions 2011 - Present
SQA Services 2010 - Present
SpineWorks 2005 - June 2012
Watson Pharmaceuticals 2003 - 2005
FDA 2002 - 2003
Porex Medical Products (Medegen) 1999 - 2001
Techniclone (Peregrine) 1996 - 1999
Baxter International Inc. 1994 - 1996
Grifols (Alpha Therapeutic) 1988 - 1993
Skills
ISO 13485, Regulatory Affairs, FDA, Medical Devices, Quality System, Sop, Quality Auditing, CAPA, GMP, Validation, Change Control, Cross-functional Team..., Biotechnology, V&V, Lifesciences, Biopharmaceuticals, Quality Assurance, Pharmaceutical Industry
Education
University of Southern California 2008 — 2011
DRSc, Regulatory Science
University of Southern California 2000 — 2003
MSc, Regulatory Science
California State Polytechnic University-Pomona 1974 — 1978
BS, Biology
Walnut High School 1969 — 1973
Diploma
FDA January 2009 - Present
Yale University June 2000 - December 2008
Education
Brown University 1995 — 2000
PhD, Pathobiology
Rochester Institute of Technology 1991 — 1995
B.S., Biotechnology
FDA Regulatory Affairs ManagerLyons Magnus1991 - 2002
Education
California State University, Fresno 1985 — 1994
Comprehensive Cardiac Care February 2009 - Present
Helen Barold Consulting April 2008 - Present
CryoCor, Inc. August 2006 - April 2008
FDA 2000 - 2002
Skills
Medical Devices, Healthcare, Clinical Trials, Clinical, Electrophysiology, Research, Clinical Research, Cardiac, Board Certified, Cardiology, Hospitals, Surgery, Medicine, Internal Medicine, Interventional..., Physicians, Heart Failure, Critical Care, Echocardiography, Radiology
Education
The Johns Hopkins University 2002 — 2003
MPH, Clinical Trial Design and Statistics
University of Rochester 1987 — 1991
MD, Medicine
Brown University 1983 — 1987
FDA March 2015 - Present
FDA January 2015 - March 2015
FDA September 2013 - January 2015
Beckman Coulter, a Danaher Company June 2010 - September 2013
Beckman Coulter June 2010 - June 2011
Olympiad Academia November 2009 - 2010
MIT September 2004 - December 2009
MIT Career Fair 2007 May 2007 - April 2008
Brandeis University February 2002 - June 2004
ARAMARK September 2000 - June 2002
Skills
FDA, Protein Chemistry, HPLC, Protein Purification, Biochemistry, R&D, GLP, Immunoassays, Chemistry, Assay Development, Matlab, Data Analysis, Statistics, Mathematica, Research, Analytical Chemistry, Lifesciences, Molecular Biology, MALDI-TOF, FPLC, Fluorescence..., Enzyme Kinetics, Technical Presentations, Purification, Spectroscopy, Experimental Design, Organic Chemistry, NMR, Fluorescence, Fluorescence Microscopy, Laboratory, Chromatography, Cell Culture, Biotechnology, Science, Design of Experiments, JMP, FRET, Clinical Chemistry, NMR spectroscopy, Microsoft Office, Mentoring, Cross-functional Team..., LC-MS, Protein Characterization, cGMP manufacturing, Medical Devices
Education
Massachusetts Institute of Technology 2004 — 2009
PhD, Physical Chemistry
Brandeis University 2003 — 2004
MS, Chemistry
Brandeis University 2000 — 2004
BA, Physics and Chemistry
Queen Elizabeth High School 1997 — 2000
High School
Pfizer July 2014 - Present
Novartis August 2013 - July 2014
New York City Department of Health and Mental Hygiene July 2009 - August 2013
New York City Department of Health and Mental Hygiene August 2005 - July 2009
Centers for Disease Control and Prevention July 2003 - June 2005
FDA 2002 - 2003
U.S. Public Health Service Commissioned Corps September 1997 - September 1999
Skills
Epidemiology, Infectious Diseases, Public Health, Global Health, Community Health, Medicine, Prevention, International Health, Program Evaluation, Vaccines, Program Development, Health Promotion, Health Policy, Family Medicine, Informatics, Clinical Research, Statistics, Biostatistics, Healthcare, Grants, Preventive Medicine, Healthcare Management, Environmental Health, Quality Improvement, Reproductive Health, Health Education, Healthcare Information...
Education
Johns Hopkins School of Public Health 2000 — 2002
Preventive Medicine Residency, Preventive Medicine
The Johns Hopkins University 2000 — 2001
MPH, Epidemiology/Public Health
Brown University 1994 — 1997
Family Medicine Residency, Family Medicine
University of Pennsylvania School of Medicine 1990 — 1994
MD, Medicine
Princeton University 1985 — 1989
A.B., Biology
Agnes Irwin School 1981 — 1985
The Baldwin School 1975 — 1981
FDA January 2013 - Present
FDA April 2009 - January 2013
FDA September 2005 - April 2009
Skills
Science, Matlab, Simulations, Research, FDA, Data Analysis, LaTeX, Mathematical Modeling, Mathematica, Biomedical Engineering
Education
University of Arizona 2002 — 2005
PhD, Applied Mathematics
University of Arizona 2000 — 2002
Master of Science (MS), Applied Mathematics
California State University-Fullerton 1995 — 2000
BS, Physics
Santa Margarita Catholic High School 1989 — 1993
Santa Margarita Catholic High School
FDA January 2015 - Present
FDA March 2011 - January 2015
The Empower Foundation Inc. December 2010 - December 2014
FDA October 2009 - March 2011
UCSF September 2004 - October 2009
UCSF September 2005 - February 2006
Mount Sinai School of Medicine August 2003 - July 2004
Schering Plough June 2002 - August 2002
Skills
FDA, Clinical Development, Cancer, Life Sciences, Data Analysis, Research, Lifesciences, Management, Drug Delivery, Strategy, Oncology, Pharmaceutics, Public Health, Public Speaking, Science, Statistics, Program Management, Technical Writing, Team Leadership, Entrepreneurship, Strategic Planning, Marketing Strategy, Project Management, Communication, Cross-cultural Teams, Global Health, Nanotechnology, Report Writing, Competitive Analysis, Business Analysis
Education
Duke University - Fuqua School of Business 2013 — 2014
Master of Business Administration (MBA)
Johns Hopkins Bloomberg School of Public Health 2010 — 2010
University of California, San Francisco 2004 — 2009
Ph.D., Pharmaceutical Sciences and Pharmacogenomics
Brown University 1999 — 2003
Sc.B., Chemical Engineering
The Lawrenceville School 1995 — 1999
Sanofi Pasteur March 2015 - Present
Sanofi Pasteur November 2013 - February 2015
FDA July 2010 - November 2013
Lowell General Hospital 2008 - December 2010
Lawrence Memorial Hospital 2008 - 2009
Skills
Clinical Research, Healthcare, Pharmacoepidemiology, Hospitals, Public Health, Epidemiology, Patient Safety, Pharmacy, Healthcare Management, Healthcare Information..., Medicine, Evidence-based Medicine, Clinical Pharmacology, Data Analysis, Nursing, Research, FDA, Global Health, Environmental Health, Medication Therapy..., Pharmacists, Infectious Diseases, Pharmacokinetics, Health Policy, Cancer, Pharmaceutical Industry, Clinical Trials
Education
University of Massachusetts at Lowell 2008 — 2012
Doctor of Science (ScD)
Massachusetts College of Pharmacy and Health Sciences 2008 — 2010
Doctor of Pharmacy (PharmD)
University of Massachusetts at Lowell 2006 — 2008
MS
Cairo University 1996 — 2001
Bachelor of Science (BSc)
Fitworks Fitness Center January 2013 - Present
Soza Fitness January 2013 - Present
FDA January 1990 - Present
Skills
Fitness Training, Personal Training, FDA, Regulatory Affairs, Public Speaking, Kickboxing Instructor, Auditing
Education
Bowling Green State University 1985 — 1989
Bachelor of Science, Biology/Chemistry
Brunswick High School
Biology, Chemistry
FDA January 2015 - Present
National Institutes of Health January 2013 - December 2014
Weill Cornell Medical College July 2008 - December 2012
California Institute of Technology June 2006 - July 2008
Skills
Biochemistry, Molecular Biology, Cell Culture, Western Blotting, Protein Purification, Molecular Cloning, Protein Chemistry, Protein Expression, PCR, Lifesciences, High Throughput..., Enzyme Kinetics, Purification, Laboratory, Cloning, Teaching
Education
Weill Medical College of Cornell University 2008 — 2012
PhD, Pharmacology
California Institute of Technology 2006 — 2008
MS, Chemistry
Cornell University 2002 — 2006
BA, Chemistry
FDA September 2010 - Present
American Society of Health-Systems Pharmacists March 2007 - August 2010
Horizon NJ Health July 2004 - December 2006
University Medical Center at Princeton June 2003 - June 2004
Rutgers University June 2003 - June 2004
Skills
Managed Care, Clinical Research, Pharmacists, Pharmacy, Clinical Pharmacy, Clinical Trials, Informatics, Medicaid, Research, Oncology, Pharmacology, Pharmaceutical Industry, Healthcare Management, Healthcare, Hospitals, Pharmacy Benefit..., Software Documentation, Scientific/medical..., Scientific Analysis, Interpersonal..., Orphan drugs, Federal grants, Regulations, Regulatory requirements, Proofreading, Team player, Rare Diseases, Project Coordination, Leadership
Education
Butler University 1997 — 2003
Doctor of Pharmacy, Pharmacy
Duke University December 2012 - Present
Duke University April 2008 - November 2012
Duke University June 2006 - March 2008
North Carolina State University March 2004 - June 2005
University of North Carolina at Chapel Hill October 2000 - March 2004
University of North Carolina at Chapel Hill July 1995 - September 2000
Unity College August 1994 - June 1995
FDA October 1985 - May 1989
Skills
Research Administration, Nonprofits, Clinical Research, NIH, Academic Administration, Higher Education, Student Affairs, Compliance, IP, Organization, Onboarding, Qualitative Research, Vendor Management, Employee Training, Contract Negotiation, Federal Grants..., Federal Government..., Grants, Science, Pharmaceutical Industry, Research, Clinical Trials, CRO, Data Analysis, Statistics, Protocol, GCP, Clinical Development, ICH-GCP, Clinical Data Management, Clinical Monitoring, Oncology, Infectious Diseases
Education
University of Maine
Master of Education (M.Ed.)
Canisius College
Bachelor of Science (B.S.), Chemistry
FDA, Center for Tobacco Products January 2015 - Present
FDA June 2014 - October 2014
FDA October 2013 - June 2014
FDA November 2012 - October 2013
FDA (Center for Tobacco Products) August 2011 - November 2012
The White House (Office of National Drug Control Policy) March 2012 - June 2012
Life Span Center for Legal Advocacy August 2010 - November 2011
Law Offices of the Cook County Public Defender January 2011 - May 2011
DePaul University College of Law May 2009 - December 2010
Kings County District Attorneys Office June 2010 - August 2010
Skills
Policy Analysis, International Education, Legal Research, Legal Writing, Event Management, Community Outreach, Policy, Research
Education
DePaul University College of Law 2008 — 2011
J.D.
Fordham University 2005 — 2007
M.S., Bilingual Education
Bryn Mawr College 2001 — 2005
B.A., Major in English, Minor in Spanish
FDA August 2014 - Present
Education
University of Iowa 2009 — 2014
Doctor of Philosophy (Ph.D.)
Butler University 2006 — 2009
MS
University of Mumbai 2001 — 2005
B.Pharm
FDA January 2013 - Present
FDA June 2004 - January 2013
FDA April 1992 - June 1995
Skills
English, Microsoft Excel, Microsoft Word, Microsoft Office, HPLC, Strategic Planning, Validation, PowerPoint, Data Analysis, Teaching, Analysis, Chemistry, Government, Laboratory, Windows, Quality Control, Outlook
Education
California State University-San Bernardino 1982 — 1986
Bachelor's Degree, Chemistry
California State University-San Bernardino 1982 — 1986
Bachelor of Arts in Chemistry, Chemistry
Unilife Corporation July 2012 - Present
West Pharmaceutical Services June 2011 - May 2012
Medical Electronic Systems October 2010 - January 2011
Camp Harlam June 2010 - August 2010
FDA June 2009 - August 2009
Skills
Biomedical Engineering, Labview, Medical Devices, Minitab, Solidworks, Matlab, COMSOL, ISO 13485, ImageJ, Design of Experiments, Mechanical Testing, Biomechanics, Biomaterials, Design Control, SolidWorks, R&D
Education
Cornell University 2011 — 2012
Master of Engineering, Biomedical Engineering
Bucknell University 2006 — 2010
Bachelor of Science, Biomedical Engineering
FDA November 2012 - Present
University of Delaware September 2006 - November 2012
Skills
Microbiology, Food Science, Food Microbiology, PCR, Statistics, Science, Chemistry, Data Analysis, Research, Food Safety, Molecular Biology, Cell Culture
Education
University of Delaware 2008 — 2012
Doctor of Philosophy (PhD), Food Microbiology
University of Delaware 2006 — 2008
Master of Science (MS), Food Science
Bucknell University 2002 — 2006
Bachelor of Science (B.S.), Cell Biology/Biochemistry
FDA July 2009 - Present
Ready Pac Foods, Inc. 2008 - 2009
Education
California State University-Dominguez Hills 2013 — 2015
Pre-Professional Program, Speech-Language Pathology/Pathologist
California State University-Long Beach 2005 — 2007
Bachelor of Science (BS), Food Science and Technology
FDA March 2013 - Present
FDA October 2011 - March 2013
The Scripps Research Institute December 2009 - October 2011
GNF December 2009 - October 2011
Skills
Protein Expression, Molecular Cloning, Protein Purification, Western Blotting, High Throughput..., Molecular Biology, Tissue Culture, Fluorescence Microscopy, Automation, Regulatory Affairs, Microbiology, Genetics, Regulatory Science
Education
Harvard University 2004 — 2009
Doctor of Philosophy (Ph.D.), Chemistry and Chemical Biology
Harvard University 2004 — 2005
Master of Science (M.S.), Chemistry and Chemical Biology
Princeton University 2003 — 2004
Candidate for Doctor of Philosophy (Ph.D.), Chemistry and Chemical Biology
Brown University 1999 — 2003
B. Sc., Biochemistry
University of Cambridge 2001 — 2002
Study Abroad
FDA July 2001 - Present
Publix March 1994 - June 2001
Skills
Public Policy, Government, Policy Analysis, Policy, Regulatory Analysis, Regulatory Affairs, Legal Research, Federal Government, Enforcement, Health Law, Public Health, Regulatory Policy, Evidence, Criminal Law, IT Management, IT Strategy, IT Operations, Legislative Relations, Data Analysis, FDA, Law Enforcement, Leadership, Program Management, Management, Research, Strategic Planning, Analysis
Education
Broward Community College
Associate of Science (A.S.)
Coconut Creek HS
Coconut Creek HS
FDA December 2009 - Present
Skills
Microsoft Office
Education
County College of Morris 1999 — 2013
Business Administration, Management and Operations
Brookdale Community College 1993 — 1994
Accounting
FDA April 2013 - Present
FDA January 2011 - April 2013
Panera Bread June 2003 - January 2011
Skills
Food Microbiology, Molecular Microbiology, MALDI-TOF, Laboratory Skills, Laboratory Automation, Laboratory Techniques, Microbiology, Laboratory, Biology, Molecular Biology, PCR, ELISA
Education
Brandeis University 2013 — 2015
Master's Degree, Cell/Cellular and Molecular Biology
Rivier College 2007 — 2010
Bachelor of Science, Biology, Chemistry
FDA February 2005 - Present
MedImmune February 2007 - August 2009
Ethicon Endo-Surgery April 1992 - April 2004
Education
Bowling Green State University
B.S of Ed, Health and Physical Education
Xavier University
M.S. Ed, Human Resource Development
FDA September 2013 - Present
Indiana University School of Medicine December 2010 - June 2013
Indiana University November 2012 - January 2013
Stony Brook University July 2010 - August 2010
Stony Brook University August 2005 - August 2010
Stony Brook University June 2010 - July 2010
Stony Brook University August 2008 - May 2009
Stony Brook University June 2008 - August 2008
Department of Chemistry/Polymer Lab Stony University, Stony Brook, NY June 2006 - November 2006
Stony Brook University August 2005 - May 2006
Skills
Characterization, Molecular Biology, QRT-PCR/analysis of..., Protein Subcellular..., Enzyme Activity Assays, Mammalian Cell culture..., Invitro..., Pharmoco-kinectics..., Pharmaco-dynamics..., Immunofluorescence, PCR, Chromatin..., Flow Cytometry, Western Blot, Transfection/Transductio..., Drug Delivery Methods..., Rheological Studies, Particle Sizing and..., Gel Electrophoresis, chemoprevention, Structure Activity..., Chemistry, Cancer, DNA, Enzyme Assays, Protein Chemistry, Stem Cells, Nanotechnology, Mass Spectrometry, Spectroscopy
Education
State University of New York at Stony Brook 2005 — 2010
PhD, Chemistry, Cancer biology
Cameron University 2002 — 2005
BS, Chemistry
Deb Shops, Inc. September 2009 - Present
FDA June 2006 - August 2010
Education
Bowie State University 2008 — 2012
Psychology
self employed part-time March 1999 - Present
U.S Food and Drug Administration May 1976 - March 1999
FDA 1976 - 1991
Education
California State University-East Bay 1971 — 1976
MA, American Lit.
California State University-Sacramento 1970 — 1976
BA, U.S. History
FDA October 2010 - Present
Trader Joe's November 2003 - December 2010
Neutrogena August 2007 - October 2010
Education
California State University-Long Beach 2001 — 2007
Biology, Physiology
FDA 2010 - Present
FDA 2000 - 2010
Scientech 1989 - 2000
County of Santa Barbara, Environmental Health 1985 - 1989
Lockheed Space and Missile Command 1984 - 1985
County of Santa Barbara, Environmental Health 1979 - 1984
Skills
Data Analysis, Epidemiology, Grant Writing, Federal Government, Policy Analysis, Public Health, Program Management, Community Outreach, Policy, Government, Analysis, Project Management, Program Evaluation, Research, Qualitative Research, Statistics, Public Policy, Public Administration, Technical Writing, Stata, SAS, Proposal Writing
Education
Humboldt State University 1973 — 1978
Bachelor's degree / Master's degree, Biology
California State University-Long Beach 1972 — 1973
Biology, General
California State University-Los Angeles 1969 — 1971
Bachelor's degree, Criminal Justice
Los Angeles Harbor College 1967 — 1969
Criminal Justice
OCAPICA August 2013 - January 2015
FDA June 2012 - August 2012
Orange County Asian and Pacific Islander Community Alliance September 2011 - May 2012
OCAPICA June 2011 - September 2011
City of Irvine 2006 - 2009
Education
California State University-Fullerton
BA
FDA September 2006 - December 2010
National Cancer Institute 1978 - 2006
Skills
Writing Skills, Program Management, Problem Solving, Technical Writing, Government, Research, Strategic Planning, Policy, Strategic Communications, Nonprofits, Public Health, Proposal Writing, Policy Analysis, Grants, Editing
Education
Syracuse University - Maxwell School of Citizenship and Public Affairs 1977 — 1978
Graduate Studies, International Relations
Bridgewater State College 1973 — 1977
BA, Political Science
FDA January 2009 - Present
Skills
Regulatory Affairs, Regulatory Analysis, PMA, IND, Regulatory Submissions, Auditing, Federal Government, Drug Development, Regulatory Requirements, Clinical Trials, 21 CFR, NDA, GMP, GLP, Biotechnology, CAPA, Customer Service, FDA, Microsoft Excel, Microsoft Office, Policy, Validation
Education
University of Southern California 2008 — 2011
MS, Regulatory Science
CSU Sacramento 2004 — 2008
BS, Biology
FDA Director of ComplianceFood and Drug AdministrationMarch 2003 - September 2011
FDA July 1972 - September 2011
United States Air Force November 1966 - October 1970
Skills
Regulatory Affairs, Policy, Regulatory Requirements, Policy Analysis, Government, Regulations, Public Policy, FDA, Health Policy, Regulatory Submissions, Health Law, Administrative Law, Legislation, Regulatory Analysis
Education
California State University-Sacramento
None, Public Health
Solano Community College
Associate of Arts, Biological Science
FDA January 2014 - Present
FDA December 2011 - January 2014
U.S. Public Health Service Commissioned Corps June 2009 - December 2011
FDA August 2006 - June 2009
US Department of Health and Human Services February 2005 - August 2006
FDA 2003 - 2005
St. Agnes Hospital 1998 - 2001
Loma Linda VA Hospital (Jerry L Pettis Memorial Hospital) 1994 - 1997
US Navy 1987 - 1993
Skills
Emergency Management, Public Health, Military, DoD, Policy, Government, Disaster Response, Navy, Global Health, Army, Federal Government, National Security, Medicine, Training, Organizational..., Homeland Security, Crisis Management, Epidemiology, Prevention, Program Management, Emergency Services, Contingency Planning, Infectious Diseases, Preparedness, Policy Analysis, Drug Development, FDA, Risk Assessment, Healthcare, Program Evaluation, Command, Health Policy, Government Contracting, International Health, Counterterrorism, Environmental Health, Security Clearance, Program Development, Defense, CBRN, Exercises, Intelligence Analysis, IND, Project Management, Data Analysis, Incident Command, Radiopharmaceuticals, Emergency Medicine, Hazardous Materials
Education
University of Maryland Baltimore
Doctor of Pharmacy, PharmD
California State University-San Bernardino
Bachelor's Degree, Chemistry
United States Military Academy at West Point
History, Military Science (non-grad)
FDA October 2009 - Present
FDA 2009 - 2011
Education
Bowie State University 2006 — 2009
BS, Criminal Justice
University of Maryland College Park 2000 — 2003
US Department of Health and Human Services January 1989 - Present
FDA 1989 - Present
a private lab January 1983 - January 1989
Skills
Statistics, Experimental Design, SPSS, Data Analysis, Quantitative Research, Qualitative Research, Biochemistry, Laboratory, Scientific Writing, Literature Reviews, Data Collection, Biostatistics, Science, Field Work, R, Research Design, Microscopy, Report Writing, Public Health, Global Health, Food Microbiology, Science Policy, Survey Design
Education
California State University-Long Beach 1980 — 1983
Bachelor of Arts (BA), Entomology
ClearView Healthcare Partners September 2013 - Present
CR Bard June 2012 - August 2012
University of Pittsburgh May 2011 - August 2011
FDA June 2009 - January 2011
Skills
Biomedical Engineering
Education
Brown University 2009 — 2013
Bachelor of Science (B.S.), Biomedical Engineering
FDA June 2009 - Present
FDA February 2006 - June 2009
FDA February 2002 - February 2006
All About Pets May 1994 - February 2002
Skills
Management, Microsoft Excel, Microsoft Office, Microsoft Word, Research, Windows, Government
Education
Brigham Young University 1995 — 2001
Bachelor of Science (B.S.), Animal Sciences (Pre-vet emphasis)
Moorpark College 1993 — 1994
General Studies
Regulatory Consultant's Group January 2014 - Present
Regulatory Consultants Group (RCG) /Jeff Yuen & Associates June 2011 - December 2013
FDA October 2000 - June 2011
County of Orange October 1990 - October 2000
Skills
Regulatory Affairs, Auditing, Quality Auditing, Internal Audit, Field Inspection, Inspection, Consulting, Quality Consulting, Regulatory Consulting, FDA, FDA GMP, GMP Consulting, ISO 13485, GMP, Regulatory Submissions, Regulatory Requirements, Regulations, Medical Devices, Pharmaceutics, Clinical Research, Quality System, CAPA, Pharmaceutical Industry, V&V
Education
California State University-Fullerton
Master's degree, Environmental Health Engineering
California State University-Northridge
Bachelor of Science (B.S.), Environmental and Occupational Health Science
FDA October 2004 - Present
FDA January 1988 - October 2004
FDA February 1986 - January 1988
Education
Gordon Conwell Theological Seminary 1975 — 1978
Masters in Religious Education, Education
Bowling Green State University 1970 — 1974
Bachelor of Science (B.S.), Biology, General
FDA January 1990 - Present
Skills
Quality/Regulatory, QSR...
Education
Bowling Green State University
Bachelor's degree, Biology/Chemistry
Brunswick High School
Dow Corning April 2004 - Present
USDA-FSIS 2002 - 2004
FDA 1995 - 2002
Naval Research Laboratory November 1993 - November 1995
Skills
Chemistry, Risk Assessment, Regulatory Affairs, Polymers, Research, Science, Coatings, Life Sciences
Education
The University of Chicago 1988 — 1993
Doctor of Philosophy (PhD), Physical Chemistry
Bryn Mawr College 1984 — 1988
Chemistry, French Language and Literature
FDA March 1965 - Present
FDA May 1968 - May 1998
Education
Brigham Young University
Bachelor of Science (B.S.), Medical Microbiology and Bacteriology
Brigham Young University
Bachelor of Science (B.S.), Bacteriology
FDA February 2002 - March 2004
Education
Brigham Young University
BS Microbiology, minor Chemistry