Food and Drug Administration
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
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Food and Drug Administration Employees
Food and Drug Administration October 2011 - Present
The Johns Hopkins University January 2010 - October 2011
Bioactive Surgical September 2009 - May 2011
Johns Hopkins University September 2009 - December 2009
University Hospitals May 2008 - August 2009
Skills
Cell, Stem Cells, Biomedical Engineering, PCR, Biomaterials, Medical Devices, Molecular Biology, Matlab, Clinical Trials, Biochemistry
Education
The Johns Hopkins University 2009 — 2011
M.S.E., Biomedical Engineering, Highest Honors
The Johns Hopkins University 2006 — 2010
B.S., Biomedical Engineering, Highest Honors
BioBridges Consulting May 2014 - Present
Translational Pharmacology Consulting February 2011 - Present
Radius Health, Inc. September 2014 - December 2014
Genzyme Sanofi June 2006 - February 2012
Genzyme December 1999 - March 2006
Diatide 1996 - 1999
DuPont Merck 1992 - 1995
Food and Drug Administration 1984 - 1988
Skills
Drug Discovery, In Vitro, Pharmacology, In Vivo, Clinical Development, IND, Animal Models, Pharmaceutical Industry, Assay Development, Cancer, Lifesciences, CRO, ELISA, Biomarker Discovery, Technology Transfer, Cell Biology, High Throughput..., Antibodies, Regulatory Submissions, Drug Development, Protein Chemistry, Toxicology, Pharmacokinetics, Biotechnology Industry, Rare Diseases, Translational Medicine, Clinical Trials, Pharmacodynamics, Genetics, Immunology, GLP, Immunohistochemistry, FDA, Validation, Biomarkers, Biopharmaceuticals, Oncology, Biotechnology, Medical writing, Medical Writing, Life Sciences, Molecular Biology
Education
University of Florida School of Medicine 1981 — 1986
Ph.D., Pharmacology and Toxicology, 3.9
Skidmore College
Bachelor of Arts (B.A.), Chemistry and Biology
ONCORD, INC. January 2006 - Present
Summer Science Program 2006 - Present
Amgen, Inc. September 2003 - August 2005
Food and Drug Administration 1995 - 2003
FDA 1995 - 2003
Skills
Clinical Development, Drug Development, Pharmaceutical Industry, Oncology, Regulatory Affairs, IND, Biotechnology, Medical Writing, Medicine, Science, FDA, Regulatory Submissions, Drug Discovery, Medical Affairs, GCP, Immunology, CTMS, Clinical Research, Vaccines, Lifesciences, Clinical Trials, CRO, Infectious Diseases, Hematology, Cancer, Biopharmaceuticals, Health Economics, Biologics, Pharmacovigilance, Pharmacology
Education
The George Washington University School of Medicine and Health Sciences 1984 — 1988
MD, Medicine
Occidental College 1980 — 1984
AB, Biology, Psychology
Food and Drug Administration January 2005 - Present
Food and Drug Administration February 1996 - January 2005
Argonne National Laboratory June 1990 - January 1996
Skills
Process Engineering, Data Analysis, Federal Government, Project Management, Program Management, Research, Government, Analysis, Microsoft Office, Process Simulation, Technical Writing, Technology Transfer, Medical Devices, Chemical Engineering, Product Development, Testing, Engineering, Quality Assurance, Chemistry, Microbiology, R&D, Materials Science
Education
Penn State University 1985 — 1990
Doctor of Philosophy (PhD), Chemical Engineering
Penn State University 1985 — 1990
Master of Science (M.S.), Chemical Engineering
University of Florida 1982 — 1985
Bachelor of Science in Chemical Engineering, Chemical Engineering
Food and Drug Administration July 1990 - Present
Pharmaceutical Industry January 1985 - July 1990
Skills
Pharmaceutics, FDA, Leadership, GMP, Biotechnology, Management, Analytical Chemistry, Laboratory, Training, Chemistry, V&V, Operations Management, Clinical Trials, Policy, Auditing, Lifesciences, Regulatory Submissions, Regulatory Affairs, Inspection, Sop, Pharmaceutical Industry, LIMS, Technology Transfer, CAPA, Quality Auditing, Quality System, Regulatory Requirements, R&D, Microbiology, Validation, Testing, 21 CFR Part 11, Biopharmaceuticals, Quality Assurance, Regulations, Vaccines, IND, Data Analysis, Clinical Research, Change Control, SOP, Life Sciences
Education
Temple University
Master of Science (MSc), Pharmaceutical Quality Assurance-Regulatory Affairs
Universidad del Sagrado Corazón
Bachelor of Science (BSc), Chemistry
Food and Drug Administration 2015 - Present
Naval Air Systems Command (NAVAIR) 2011 - 2015
Education
North Carolina A&T State University 2007 — 2011
Bachelor of Science (B.S.)
Food and Drug Administration August 2009 - Present
USDA November 2006 - August 2009
Pharmacia/Pfizer 2001 - 2001
Skills
Epidemiology, Science, Public Health, Program Evaluation, Research, Molecular Biology, Public Policy, Policy Analysis, Statistics, Data Analysis, Cell Culture, Lifesciences, Biochemistry, Microbiology, PCR, Policy, Clinical Research, Regulatory Affairs, Health Education, Government, Western Blotting, Scientific Writing
Education
Harvard Medical School/MGH 2005 — 2006
PostDoctoral, Mucosal Immunology
North Carolina State University 2001 — 2005
Doctor of Philosophy (Ph.D.), Nutrition Sciences
CDW June 2013 - Present
The Advisory Board Company 2014 - 2014
Cisco Systems February 2010 - June 2013
International Monetary Fund 2013 - 2013
Citigroup October 1999 - March 2011
Saddlebrook West Homeowners Association October 2000 - January 2009
Vertical Software Inc. 2003 - 2004
R.O.W. Science September 2000 - September 2001
Applied Theory September 1997 - September 1999
Food and Drug Administration September 1992 - September 1997
Skills
Data Center, Cisco Technologies, Network Design, Routing, Security, Network Engineering, Networking, WAN, Firewalls, Integration, DHCP, Network Security, Routers, Switches, OSPF, TCP/IP, VoIP, BGP, VPN, Virtualization, VMware, Disaster Recovery, Vendor Management, Cisco Routers, MPLS, LAN-WAN, Business Continuity, DNS, Servers, Network Architecture, Juniper, EIGRP, Start-ups, Management, IT Management, CCNA, Project Management, Software Documentation, QoS, Cloud Computing, Cisco Nexus, Palo Alto Networks
Education
Strayer University 1999 — 2004
Blackboard June 2011 - Present
Food and Drug Administration 2010 - 2010
Skills
Java, Spring, JSP, AngularJS, Typescript, jQuery, JavaScript, XML, SQL, CSS, Web Applications, Java Enterprise Edition, J2EE, MVC, Eclipse, JSTL, HTML/XML
Education
Penn State University 2007 — 2011
BS, Information Sciences and Technology
University of Maryland September 2013 - Present
University of Maryland September 2012 - August 2013
University of Maryland June 2012 - August 2013
University of Maryland August 2012 - May 2013
Huntington Learning Center December 2011 - February 2012
Food and Drug Administration January 2011 - June 2011
Seton Hall University School of Law 2009 - 2009
Food and Drug Administration 2008 - 2008
University of Maryland Baltimore County 2008 - 2008
National Institutes of Health 2004 - 2004
Skills
Research, Teaching, Neuroscience, Neuroimaging, Applied Linguistics, SPSS, Pharmaceutical Policy, Molecular Biology, Web Design, Digital Photography, Statistics, Higher Education, Clinical Research, Cognition, Cognitive Neuroscience, Experimentation, Cognitive Science, Research Design, Science, Western Blotting, Literature Reviews, Cell Biology, Cell Culture, Genetics, Biochemistry, Lifesciences, Data Analysis, Computational Biology, Life Sciences
Education
University of Maryland College Park 2012 — 2017
MA-PhD, Speech and Hearing Sciences
University College London, U. of London 2009 — 2010
M.Sc., Cognitive Neuroscience
Seton Hall University School of Law 2008 — 2009
University of Maryland Baltimore County 2005 — 2008
B.A., Modern Languages and Linguistics - Applied Linguistics
FDA Center for Drug Evaluation and Research February 2013 - Present
Food and Drug Administration July 2009 - Present
U.S. Department of the Interior February 1993 - January 2001
Steptoe & Johnson LLP September 1985 - February 1993
Skills
Legal Writing, Litigation, Politics, Legal Research, Administrative Law, Intellectual Property, Health Law, Public Policy, Legislation, Legislative Relations, Policy Analysis, Policy
Education
College of Notre Dame of Maryland 2000 — 2002
N/A, Masters in Education
The Catholic University of America, Columbus School of Law 1981 — 1985
Juris Doctor, Law
Saint Anselm College
B.A., Political Science; Russian Studies
National Institutes of Health 1998 - Present
Food and Drug Administration 1997 - 1998
National Institutes of Health 1997 - 1997
Suburban Hospital 1990 - 1995
Holy Cross Hospital 1986 - 1990
SACON, Inc. 1984 - 1986
Washington Adventist Hospital 1981 - 1984
Shady Grove Adventist Hospital 1980 - 1981
Shady Grove Adventist Hospital 1979 - 1980
Washington Adventist Hospital 1976 - 1979
Skills
Supervisory Skills, Events Planning, Team Building, Teaching, Technical Recruiting, Public Speaking, Meeting Planning, Volunteer Management, Word process 90 wpm, Remedy, Excel, Problem Solving
Education
Southern Adventist University 1970 — 1974
Bachelor of Science (BS)
Food and Drug Administration December 2014 - Present
Infectious Disease Pharmacokinetics Laboratory - University of Florida College of Pharmacy May 2014 - November 2014
ENCO Environmental Conservation Laboratories January 2008 - August 2008
Skills
Chemistry, Inorganic Synthesis, Mass Spectrometry, NMR, Spectroscopy, UV/Vis, HPLC, Science, Analytical Chemistry, Organic Synthesis, LC-MS, Research, Materials Science
Education
University of Florida 2008 — 2014
Ph.D., Inorganic Chemistry
North Carolina State University 2004 — 2007
BS, Chemistry, Spanish
FDA Center for Devices and Radiological Health January 2013 - Present
FDA Center for Devices and Radiological Health November 2011 - January 2013
FDA Center for Devices and Radiological Health September 2009 - October 2011
Food and Drug Administration May 2008 - September 2009
University of North Carolina at Chapel Hill August 2004 - May 2008
MedStar Health September 2001 - August 2004
Skills
Epidemiology, Research, Public Health, Biostatistics, Global Health, SAS, Program Evaluation, Data Analysis, Statistics, Literature Reviews, Clinical Trials, Clinical Research, Statistical Modeling, Prevention, Grant Writing, Clinical Study Design, Stata, Teaching
Education
University of North Carolina at Chapel Hill
Doctor of Philosophy (PhD), Epidemiology
The George Washington University 1999 — 2001
Master of Public Health (MPH), Epidemiology
University of Cincinnati 1995 — 1998
Bachelor of Arts (BA), Psychology
St. X
FDA October 2012 - Present
Food and Drug Administration January 2009 - Present
US Department of Health & Human Services, Food and Drug Administration January 2009 - October 2012
Kraft Foods May 2008 - September 2008
Education
University of Arkansas at Fayetteville 2006 — 2008
Master of Science, Agricultiure Economics
Purdue University 2000 — 2006
Bachelor, Food Science and Agriculture Economics
Food and Drug Administration February 2008 - Present
Systems Integration Group 2006 - 2008
US Forest Service 2002 - 2002
Skills
Lifesciences, Molecular Biology, Biotechnology
Education
Penn State University
Bachelor of Applied Science (B.A.Sc.), Environmental Economics
Fogarty International Center at NIH August 2015 - Present
Department of Health and Human Services October 2008 - September 2014
U.S. Department of Health and Human Services July 2001 - October 2008
Food and Drug Administration September 2000 - July 2001
Food and Drug Administration September 1998 - September 2000
CVS Caremark Corporation May 1998 - September 1998
Skills
Public Health, Epidemiology, Global Health, Infectious Diseases, Health Policy, Regulatory Affairs, Community Health, Health Education, Healthcare Management, International Health, Program Evaluation, Clinical Research, Science, Pharmacy, Healthcare, Health Promotion, Clinical Trials, Informatics, Healthcare Information..., Patient Safety, Hospitals, Healthcare Consulting, Vaccines, Lifesciences, Managed Care, Pharmaceutical Industry, Oncology
Education
Rutgers University-New Brunswick 1993 — 1998
B.S., Pharmacy
Food and Drug Administration 1989 - Present
Skills
Biomedical Engineering, Medical Devices, Ultrasound, Acoustics, Matlab, Medical Imaging, Signal Processing, Engineering, Physics, Research, Imaging, Modeling, Experimentation, R&D, Simulation, Image Analysis, Algorithms, MRI, Numerical Analysis, Mathematical Modeling, Optics, Image Processing, Science, FDA, Medical Physics, Simulations, Radiology, Digital Imaging, Labview, X-ray, MATLAB
Education
Stanford University 1980 — 1986
Ph.D., Applied Physics
Aragen Biosciences May 2014 - Present
Sanofi Pasteur January 2013 - December 2013
Selecta Biosciences February 2012 - April 2012
Selecta Biosciences September 2011 - December 2011
Massachusetts General Hospital May 2011 - September 2011
Northeastern University September 2010 - December 2010
Food And Drug Administration January 2009 - February 2009
Care-well Health Care Pharmaceuticals November 2008 - January 2009
Gujarat University, Ahmedabad, India October 2005 - January 2007
Lallubhai Gorthandas General Hospital June 2005 - September 2005
Skills
ELISA, Western Blotting, RT-PCR, RNA isolation, Transfection, Cell, Lifesciences, In Vitro, Biotechnology, In Vivo, Assay Development, SDS-PAGE, HPLC, FACS, Laboratory, DNA, Nanoparticle formulation, Tablet and Capsule..., Quality control test of..., UV spectroscopy, Affinity Chromatography
Education
Northeastern University 2009 — 2011
Master, Biotechnology in Pharmaceutical Track
Gujarat University, LM College of Pharmacy 2005 — 2009
Bachelor, Pharmacy
Gujarat University, LM College of Pharmacy 2003 — 2005
Diploma, Pharmacy
Best Higher Secondary School 1994 — 2003
Mylan Technologies February 2013 - Present
Food and Drug Administration May 2010 - February 2013
Pfizer October 2009 - May 2010
Wyeth April 2000 - October 2009
Wyeth Research January 1996 - April 2000
Wyeth Pharmaceuticals 1993 - 1996
CVPH Medical Center 1990 - 1993
Skills
GLP, FDA, 21 CFR Part 11, Validation, Regulatory Submissions
Education
State University of New York College at Plattsburgh 1990 — 1992
B.S, Biology
University of Bridgeport
M.S. (ongoing), Nutrition
Bristol-Myers Squibb June 2014 - Present
Janssen Therapeutics, Johnson & Johnson March 2013 - May 2014
Janssen Therapeutics, Pharmaceutical Companies of Johnson & Johnson September 2010 - March 2013
Food and Drug Administration October 2008 - September 2010
BioCareers.com June 2008 - 2010
University of Pennsylvania August 2008 - October 2008
University of Pennsylvania September 2003 - August 2008
Pfizer May 2002 - September 2002
Education
Northeastern University 2012 — 2014
Master of Business Administration (MBA), International Management and Marketing
University of Pennsylvania 2003 — 2008
PhD, MS, Chemical and Biomolecular Engineering
New York University 1998 — 2003
BS, Chemistry
Stevens Institute of Technology 1998 — 2003
BE, Chemical Engineering
Food and Drug Administration April 2011 - Present
Johns Hopkins University July 2009 - Present
FDA October 2009 - October 2011
DAIDS Regulatory Compliance Center, NIH October 2007 - October 2009
Uniformed Services University of the Health Sciences (USUHS) February 2006 - October 2007
NIH May 2001 - February 2006
Skills
Life Sciences, Clinical Trials, FDA, Regulatory Affairs, Biopharmaceuticals, Vaccines, Clinical Development, IND, Biotechnology, Infectious Diseases, Molecular Biology, cGMP, Virology, GCP, Regulatory Submissions, Lifesciences, Drug Discovery, Flow Cytometry, GLP, Immunology, Microbiology, Cell Biology, Biochemistry, In Vivo, Protocol, Cell, Drug Development, Clinical Research, Laboratory, Pharmacology, Toxicology, ELISA, Animal Models, Cancer, Cell Culture
Education
The Johns Hopkins University 2006 — 2009
MS-MBA dual degree, Regulatory Affairs and Biopahrmaceutical Business
Universität zu Köln, Köln (Cologne), Germany 1997 — 2001
PhD, Cell and Molecular Biology
CCS Haryana Agricultural University 1994 — 1997
MS, Veterinary Microbiology (Virology)
CCS Haryana Agricultural University 1989 — 1994
DVM, Veterinary Medicine
The Wharton School July 2015 - Present
Food and Drug Administration July 2012 - June 2015
Food and Drug Administration July 2010 - July 2012
Food and Drug Administration October 2008 - July 2010
UCSF August 2007 - September 2008
Skills
FDA, Business Process, Regulatory Submissions, Lifesciences, Clinical Development, Neuroscience, qPCR, In Vivo, Tissue Culture, Animal Models, Cell Biology, Molecular Biology, Medical Devices, Regenerative Medicine, Cell Culture, Cell, Stem Cells, Microscopy, Drug Development, In Vitro, ELISA, Transfection, Immunohistochemistry, Drug Discovery, Biochemistry, Assay Development, Immunology, Flow Cytometry, Toxicology, Fluorescence Microscopy, Genetics, Confocal Microscopy, Scientific Writing, Life Sciences
Education
FDA Office of Orphan Product Development 2009 — 2009
Certification, Science of Small Clinical Trial Design
Food and Drug Administration Fellowship Training 2008 — 2010
FDA Regulation of Regenerative Medicine Medical Products
Northwestern University 2000 — 2007
Doctor of Philosophy (Ph.D.), Neuroscience
University of Illinois at Chicago 1997 — 2000
Bachelor of Science (B.S.), Biochemistry
US Food and Drug Administration September 2013 - Present
US Department of Health and Human Services July 2010 - September 2013
National Alliance for Hispanic Health January 2008 - June 2010
Forum for Collaborative HIV Research - The George Washington University September 2007 - January 2008
Food and Drug Administration July 2007 - September 2007
Food and Drug Administration August 2006 - July 2007
Adult Health and Development Program - University of Maryland College Park August 2004 - August 2006
University of Maryland - Student Association August 2004 - June 2006
Skills
Program Evaluation, Program Management, Data Analysis, Epidemiology, Teaching, Proposal Writing, Research, Public Health, Health Communication, Government, SAS, Policy Analysis, Analysis, Prevention, Global Health, Clinical Trials, Policy
Education
The George Washington University 2007 — 2009
Master of Public Health (MPH), Maternal & Child Health
University of Maryland College Park 2002 — 2006
Bachelor of Science (BS), Biological and Biomedical Sciences
Food and Drug Administration 1987 - Present
Education
Strayer University-Maryland 2001 — 2005
Bachelor of Science (BS), Accounting
Blair High school, Virginia Union Univ, Montgomery College, Strayer College
Bachelor of Science (BS), Accounting
Food and Drug Administration February 2014 - Present
SANZIE HEALTHCARE SERVICES, INC/ SANZIE HEALTHCARE NURSE TRAINING PROGRAM January 2010 - Present
Emory University Hospital February 2006 - December 2012
MOXEY RESIDENTIAL AND NURSING CARE FACILITY February 2008 - January 2010
NORTHSIDE HOSPITAL January 2004 - February 2006
Skills
BLS, ACLS, Medical/Surgical, Acute Care, Inpatient, Hospitals, PALS, NRP, TNCC, Healthcare, Direct Patient Care, BCLS, IV, Patient Advocacy, Patient Safety, Registered Nurses, Nursing Process, JCAHO, Quality Patient Care, Vital Signs, Disease Management, Medicare, Infection Control, Patient Education, Medication..., Nursing Care, Home Care, Pyxis, HIPAA, PICC lines, CPOE, Long Term Acute Care, Ambulatory Care, Medicaid, Therapeutic..., Cpr Certified, Elder Care, Orthopedic, Ambulatory, Quality Improvement, Central Lines, Patient Support, Nursing Management, Critical Care, Clinical Research, EMR, ICU, Healthcare Management, Health Education, Long-term Care
Education
Southern Crescent Technical College 2011 — 2011
DIRECT SUPPORT PROFESSIONAL, DSP, 4.0
CLAYTON STATE UNIVERSITY 2001 — 2004
BACHELORS IN NURSING, NURSING, 3.1
Food and Drug Administration June 2002 - Present
Skills
Microbiology, Bacterial Transformation, PCR, Molecular Biology, qPCR, Microarray Analysis, DNA extraction, Electroporation, Electrophoresis, DNA analysis, Molecular Cloning, DNA sequencing
Education
The Johns Hopkins University
MS, Biotechnology
West Chester University of Pennsylvania
BS, Microbiology
Booz Allen Hamilton July 2013 - Present
Booz Allen Hamilton June 2012 - July 2013
University of Notre Dame - Residence Life and Housing September 2011 - May 2012
University of Notre Dame August 2008 - May 2012
University of Notre Dame - Debartolo Performing Arts Center August 2008 - May 2012
Booz Allen Hamilton June 2011 - August 2011
Food and Drug Administration May 2007 - June 2011
Skills
PowerPoint, Excel, Word, C, C++, Python, Java, Research, Data Analysis, Microsoft Excel
Education
The George Washington University 2012 — 2015
Master's degree, Computer Science
University of Notre Dame 2008 — 2012
BS, Science-Computing
Georgetown Visitation Preparatory School 2004 — 2008
High School
Food and Drug Administration April 2013 - Present
The Visionairee June 2009 - Present
Maryland Board of Physicians July 2011 - June 2015
Advanced Medical Technology Association (AdvaMed) June 2008 - June 2009
Advanced Medical Technology Association (AdvaMed) March 1999 - June 2008
National Public Radio (NPR) January 1999 - March 1999
National Association of Black Journalists (NABJ) December 1997 - November 1998
GEICO Insurance Company July 1997 - November 1997
US Airways May 1997 - May 1997
American Council of Life Insurance (ACLI) May 1996 - February 1997
Skills
Writing, Web Editing, Public Relations, Media Relations, Editing, Content Management, Newsletters, Web Content, Journalism, Social Media, Strategic Communications, Copywriting, Internal Communications, Press Releases, Marketing Communications, Crisis Communications, Advertising, Public Speaking, Event Planning, Marketing, Storytelling, Management, Publications, Editorial, Program Management, Speech Writing, Nonprofits, Corporate Communications, Publishing, Public Affairs, Social Media Marketing, Magazines, Government, Copy Editing, Blogging, Newspapers, Message Development, Web Design, CMS, Content Strategy, Spokesperson, New Media, Communications Planning, AP Style, Publicity, News Writing, Creative Writing
Education
The George Washington University
Bachelors of Arts, Journalism
The Wharton School, University of Pennsylvania
Attended, Management
Notre Dame Academy
Walter Reed National Military Medical Center Bethesda September 2009 - Present
Costco Wholesale May 2008 - Present
Notre Dame of Maryland University September 2012 - October 2012
NeighborCare January 2008 - September 2009
Costco Wholesale May 2005 - May 2008
Walter Reed Army Medical Center July 2007 - August 2007
Food and Drug Administration June 2007 - July 2007
Johns Hopkins Hospital May 2004 - January 2005
Howard Hughes Medical Institute December 2002 - January 2004
Education
The Catholic University of America 2010 — 2012
Master of Science (M.S.), Health IT
University of Maryland School of Pharmacy 2004 — 2008
Pharm.D., Pharmacy
University of Maryland Baltimore County 2002 — 2004
Pre-pharmacy
Liberty High School
FDA/CDER/Office of Compliance/Office of Manufacturing Quality/Division 1/Branch 1 January 2015 - Present
FDA/CDER/Office of Compliance/Office of Manufacturing and Product Quality December 2011 - Present
U.S. Food and Drug Administration/Center for Drug Evaluation and Research March 2009 - December 2011
United States Pharmacopeia December 1999 - December 2008
Food and Drug Administration December 1992 - December 1999
United States Department of Agriculture August 1988 - October 1992
The Pennsylvania State University August 1986 - August 1988
Dickinson College July 1985 - June 1986
Skills
GMP, FDA, Clinical Research, Protein Chemistry, HPLC, Microbiology, Biotechnology, Regulatory Affairs, Pharmaceutical Industry, Sop, Pharmacokinetics, Pharmaceutics, Pharmacology, V&V, Healthcare, Program Management, Biopharmaceuticals, Validation, CAPA, Regulatory Requirements, Drug Development, 21 CFR Part 11, Regulatory Submissions, Quality Assurance, Drug Safety, Laboratory, Lifesciences, GLP, Technology Transfer, Chromatography, Clinical Trials, IND, Toxicology, Vaccines, Science, Drug Discovery, Analytical Chemistry, Clinical Development, UV/Vis, Infectious Diseases, Chemistry, LIMS, GCP, R&D, Change Control, Formulation, ELISA, Biochemistry, Molecular Biology, CRO
Education
Foundation for Advanced Education in the Sciences - Graduate School at NIH 1993 — 1995
Pharmacology
Penn State University 1979 — 1988
Ph.D., Biology - Botany
State University of New York College at Buffalo 1974 — 1978
B.A., Biology - Chemistry
Copiague High School 1970 — 1974
Food and Drug Administration June 2013 - Present
Food and Drug Administration February 2015 - August 2015
Food and Drug Administration September 2012 - June 2013
Food and Drug Administration February 2007 - June 2013
Food and Drug Administration 2011 - 2013
Food and Drug Administration December 2010 - September 2011
Skills
FDA, Biomedical Engineering, Medical Devices, Stem Cells, Orthopedic, Biomaterials, Clinical Trials, Tissue Engineering, Pharmacology, Science, Clinical Development, Healthcare, Biochemistry, Surgery, Regulatory Affairs, Lifesciences
Education
The Johns Hopkins University School of Medicine 2000 — 2006
Ph.D., Biomedical Engineering
The Johns Hopkins University 1996 — 2000
B.S., Biomedical Engineering
Susan E. Wagner High School 1992 — 1996
Andrea Leonard-Segal MD and Melissa Furness Consulting, LLC 2013 - Present
George Washington University Center for Integrative Medicine 1998 - Present
Food and Drug Administration 2005 - 2013
Skills
Healthcare Management, Ultrasound, Medical Education, Family Medicine, Non-profits, Policy, Teaching, Drug Development, Pharmacology, Healthcare, Clinical Trials, Clinical Development, FDA, Infectious Diseases, Nonprofits, Board Certified, Regulatory Affairs, Public Health, Clinical Research, Cancer, Epidemiology, Medicine, Pharmaceutical Industry
Education
The George Washington University School of Medicine and Health Sciences 1972 — 1976
Doctor of Medicine (MD)
Fellowship in Rheumatic Diseases - Georgetown University Hospital
Residency in Internal Medicine - George Washington University Hospital
University of Michigan
Bachelor of Science (B.S.), Biological Sciences
Environmental Protection Agency , Office of Criminal Enforcement and Forensic Training, National Enf June 2011 - Present
Environmental Protection Agency , Office of Criminal Enforcement and Forensic Training, National Enf August 2009 - June 2011
United States Department of Justice - Drug Enforcement Administration Forensic Sciences Division November 1987 - July 2009
New Jersey State Police Criminalistics Laboratory September 1986 - September 1987
Food and Drug Administration 1985 - 1986
National Gallery of Art Conservation Lab 1984 - 1985
The George Washington University 1983 - 1985
Education
The George Washington University 1983 — 1986
Master of Science (MS), Forensic Chemistry
Syracuse University 1980 — 1983
Bachelor of Science (BS), Organic Chemistry
St Louis University 1979 — 1980
Metereology
St Peters Preparatory School 1975 — 1979
High School
FDA April 2015 - Present
FDA April 2013 - April 2015
Food and Drug Administration November 2009 - April 2013
HPTi July 2007 - November 2009
SRA International March 2004 - May 2006
Skills
MS Project, Project Portfolio..., Project Planning, Risk Management, Communications..., PMP, SDLC, Resource Management, Requirements Analysis, Enterprise Architecture, Program Management, PMO, Software Project..., Data Warehousing, Project Management, Business Intelligence, IT Strategy, Governance
Education
The George Washington University 2012 — 2015
Master of Science (M.S.), Project Management
The George Washington University - School of Business 2010 — 2011
Master's Certificate Project Management
Potomac College 2002 — 2004
BS, Information Systems Management
University of Rochester February 2015 - Present
Thomson Reuters August 2014 - August 2014
Del Vecchio & Stadler January 2013 - July 2013
Del Vecchio & Stadler December 2011 - December 2012
Celgene January 2011 - May 2011
Rutgers Law School-Newark September 2010 - May 2011
Bristol-Myers Squibb June 2010 - August 2010
Rutgers University May 2009 - August 2009
National Institutes of Health August 2004 - August 2008
Food and Drug Administration August 2002 - August 2004
Skills
Intellectual Property, Trademarks, Copyright Law, Patents, Nonprofits, Genomics, DNA microarray, Bioinformatics, Licensing, Invention, Legal Research, Patent Prosecution, Patentability, Legal Writing, Westlaw, Commercial Litigation, Civil Litigation
Education
Rutgers University School of Law - Newark 2008 — 2011
J.D.
The George Washington University 2004 — 2007
M.S., Genomics and Bioinformatics
The College of William and Mary 1998 — 2002
B.S., Biology (Minor in Chemistry)
Food and Drug Administration February 2011 - Present
Navajo Area Indian Health Service January 2009 - February 2011
Toledo-Lucas County Health Department December 2002 - January 2009
Hull & Associates, Inc January 2001 - December 2002
Skills
Public Health, Data Collection, GIS, Data Analysis, Epidemiology, Environmental Health, ArcGIS, Program Evaluation, Data Management, Policy Analysis, Program Development, Government, Environmental Awareness, Policy, Infectious Diseases, Scuba Diving, Research, Transportation, Spatial Modeling, Spatial Analysis
Education
Penn State University 2011 — 2014
MGIS, Geographic Information Systems
Penn State University 2010 — 2011
Graduate Certificate, Geospatial Intelligence
University of Michigan 1996 — 2000
M.S., Natural Resources & Environment
University of Toledo 1989 — 1994
B.A., Biology
Center for Food Safety and Security Systems, University of Maryland July 2008 - Present
Food and Drug Administration 1998 - 2008
Skills
Agriculture, Analysis, Analytical Chemistry, Biochemistry, Biotechnology, Cell Culture, Chemistry, Data Analysis, Epidemiology, FDA, Food, Food Industry, Food Microbiology, Food Processing, Food Safety, Food Science, Food Technology, GMP, Genetics, HACCP, HPLC, Higher Education, Immunology, Infectious Diseases, Laboratory, Leadership, Life Sciences, Lifesciences, Microbiology, Microsoft Office, Molecular Biology, Nutrition, PCR, Policy, Policy Analysis, Product Development, Project Management, Protein Chemistry, Public Health, Public Speaking, Quality Assurance, Quality Management, R, Regulatory Affairs, Research, Science, Statistics, Strategic Planning, Teaching, Training
Education
Rutgers University-New Brunswick
Ph.D., Food Science
California Institute for Regenerative Medicine January 2011 - Present
Food and Drug Administration October 2008 - November 2010
U.S. House of Representatives January 2008 - October 2008
US House of Representatives September 2006 - December 2007
Booz Allen Hamilton May 2006 - September 2006
Aastrom Biosciences December 2005 - May 2006
National Academy of Sciences September 2005 - November 2005
Northwestern University September 1999 - August 2005
National Institutes of Health January 1998 - August 1999
National Institutes of Health August 1996 - December 1997
Skills
Molecular Biology, Biotechnology, Science, Regenerative Medicine, Lifesciences, Science Policy, Biomaterials, Tissue Engineering, Regulatory Policy, Public Policy, Science Communication, Cell Therapy, Biochemistry, Federal Government..., Governmental Affairs, Spinal Cord Injury, Research Funding, R&D funding, Product Development, Drug Delivery, Gene Delivery, Regulatory Affairs, CMC Regulatory Affairs, FDA, Regulatory Submissions, Stem Cells
Education
Northwestern University 1999 — 2005
PhD, Biological Sciences
Occidental College 1992 — 1996
B.A., Biochemistry
Phillips Consulting Group, LLC July 2009 - Present
Becker & Associates Consulting, Inc. April 2005 - June 2009
Food and Drug Administration April 1981 - February 2005
FDA 1993 - 2005
Skills
Regulatory Affairs, FDA, Medical Devices, Quality System
Education
The George Washington University - School of Business 1979 — 1982
M.B.A., Finance and Procurement
University of Maryland College Park 1972 — 1976
B.S., Microbiology and Chemistry
Semantica LLC July 2015 - Present
Food and Drug Administration July 2010 - July 2015
Avilo Consulting LLC June 2009 - July 2010
Food and Drug Administration July 1996 - May 2009
Skills
Data Management, Informatics, FDA, Clinical Trials, Clinical Research, Regulatory Submissions, Regulatory Affairs, Regulatory Requirements, EHR, Bioinformatics, Lifesciences, Integration, Program Management, Pharmaceutical Industry, Policy, Clinical Development, Biotechnology, Drug Development, Validation, Data Analysis, Strategic Planning, Healthcare
Education
University of Pennsylvania School of Medicine 1979 — 1983
M.D., Medicine
Princeton University 1975 — 1979
B.A., Chemistry
US Food and Drug Administration June 2015 - Present
FDA October 2012 - Present
Food and Drug Administration March 2009 - October 2012
Food and Drug Administration (HHS) December 2004 - March 2009
Skills
Government, Operations Management, Policy, Risk Management, Program Management, Risk Assessment, Training, Leadership, Analysis, Business Process..., Federal Government, Security Clearance, Management, Process Improvement, Project Management, Professional Mentoring, Public Policy, Strategic Planning
Education
The Johns Hopkins University 1991 — 1993
Masters of Administrative Science, Management
Towson University 1982 — 1986
Bachelor's degree, Elementary Education and Teaching
Food and Drug Administration August 2008 - Present
NMRC April 2006 - August 2008
NMRC July 2005 - April 2006
Johns Hopkins School of Medicine September 2004 - July 2005
Johns Hopkins University September 2000 - May 2004
Skills
FDA, Pharmaceutical Industry, Regulatory Affairs, Regulatory Requirements, GMP, Regulations, Policy, Biotechnology
Education
The Johns Hopkins University 2004 — 2005
Master of Science (MS), Biotechnology
The Johns Hopkins University 2000 — 2004
Bachelor of Science (BS), Biomedical Engineering
Food and Drug Administration July 2015 - Present
Consumer Federation of America January 2007 - July 2015
Consumer Federation of America 2003 - 2006
U.S. Peace Corps September 1999 - November 2001
Skills
Public Policy, Non-profits, Policy Analysis, Research, Public Health, Public Speaking, Public Relations, Volunteer Management, Food Safety, Nonprofits, Coalitions, Fundraising, Government, Policy, Proposal Writing, Strategic Communications, Program Management
Education
The Johns Hopkins University 2005 — 2008
Master of Public Health
Texas Tech University 1991 — 1995
Bachelor of Arts (B.A.), Advertising
Food and Drug Administration January 2011 - Present
A. M. E. Zion Church June 2010 - July 2011
North Carolina A&T State University July 2010 - January 2011
University of North Carolina at Chapel Hill January 2010 - June 2010
Kraft Foods July 2007 - January 2010
North Carolina A&T State University January 2006 - May 2007
Education
North Carolina Agricultural and Technical State University 2005 — 2007
MS, Food & Nutritional Sciences (Food Science)
Bennett College 1997 — 2000
BS, Biology
PAREXEL 2014 - Present
Nike February 2015 - May 2015
Rothman Institute May 2013 - July 2014
University of Pennsylvania Health System May 2012 - May 2013
Food and Drug Administration 2010 - 2011
Syracuse University 2009 - 2010
Skills
Research, Business Modeling, Pharmaceutical Industry, Business Analysis, Marathon Running, Long Distance Running, Sports Medicine, SPSS, Data Analysis, Statistics, Management, Laboratory, Event Planning
Education
University of Pennsylvania 2012 — 2013
Certificate of Completion, Specialized Studies
Syracuse University 2007 — 2012
Bachelor's Degree, Economics, Biochemistry
Food and Drug Administration February 2015 - Present
Food and Drug Administration June 2000 - February 2015
Univax/NABI October 1988 - May 2000
Skills
Drug Development, FDA, Project Management, Regulatory Submissions
Education
West Virginia Wesleyan College 1983 — 1988
BS, Biology, General
The Johns Hopkins University
Master of Science (MS), Biotechnology
Adino Inc./Precision Infrastructure Inc/US Securities Exchange Commission December 2013 - Present
KeyPoint Government Solutions January 2012 - May 2013
Howard University Student Financial Services February 2010 - December 2011
University of Maryland Eastern Shore Public Relations Department September 2008 - December 2008
Food and Drug Administration May 2008 - August 2008
Skills
Investigations, Investigative Reporting, Conducting Interviews, Briefing, Security Clearance, Communication Written, Oral Communications, MS Office Suite, Public Relations, Press Releases, Data Entry, Databases, Database Administration, Call Center, Customer Service, Retail, Staff Training, Technical Communication, Training Manuals, Program Planning, Program Implementation, Administration, Clerical Skills, Clerical Duties, Time Management, Adobe Acrobat, Microsoft Works, Microsoft Office, Private Investigations, Outlook, Background Checks
Education
Strayer University 2009 — 2011
Master of Business Administration (MBA), Business Administration; MBA, 3.8
University of Maryland Eastern Shore 2005 — 2008
Bachelors, English, 3.1
North Carolina Agricultural and Technical State University 2004 — 2005
None, None
Woodrow Wilson Senior High 2001 — 2004
Diploma, General Studies, 2.8
Food and Drug Administration August 2014 - August 2015
Northwestern University Feinberg School of Medicine September 2009 - August 2014
UC San Diego 2008 - 2009
Relypsa, Inc. June 2008 - September 2008
UC San Diego 2007 - 2008
Threshold Pharmaceuticals June 2006 - September 2006
Education
Northwestern University - The Feinberg School of Medicine 2009 — 2014
Doctor of Philosophy (Ph.D.), Microbiology
Northwestern University 2013 — 2013
Management for Scientists and Engineers Certificate Program
UC San Diego 2005 — 2009
Bachelor of Science (BS), Biochemistry & Cell Biology
Ross Clinical Research Organizartion June 2015 - Present
McGuire Air Force Base August 2015 - August 2015
Food and Drug Administration May 2015 - June 2015
Janssen, Pharmaceutical Companies of Johnson and Johnson June 2014 - August 2014
Industry Pharmacists Association May 2014 - August 2014
Riverview Medical Center May 2014 - June 2014
Novartis June 2013 - August 2013
Walmart May 2013 - June 2013
Tiffany Natural Pharmacy August 2012 - May 2013
CVS Caremark Corporation May 2011 - April 2013
Skills
Pharmacy, Pharmacists, Healthcare, Clinical Research, Clinical Pharmacy, Project Planning, Quantitative Research, Project Implementation, Microsoft Office, Clinical Pharmacology, Public Relations, Graphic Design, Adobe Creative Suite, WiX, Regulatory Affairs, Regulatory Guidelines, Pharmaceutical Industry, Medical Writing, Oncology
Education
Rutgers University 2010 — 2016
Doctor of Pharmacy (PharmD)
Eastern Regional High School 2006 — 2010
High School Diploma
Food and Drug Administration January 2010 - Present
U.S. Department of Veterans Affairs July 2008 - January 2010
Berkeley County Sheriff's Ofc September 2006 - July 2008
State of West Virginia September 2005 - September 2006
City of Norfolk April 2002 - December 2004
City of Norfolk February 2001 - April 2002
City of Norfolk January 2000 - February 2001
Skills
Data Entry, Case Managment, Policy, Microsoft Office, Customer Service, Filing, Software Documentation, Community Outreach, Mental Health, Inventory Management, Public Speaking, Microsoft Word, Field Work, Social Services, Public Health, Government, Administrative..., Records Management, Outlook, Research, Microsoft Excel, Wordperfect, Timekeeping, Dispatching, Computer Aided Dispatch, Supply Management, Databases, Field, Recalls, Time Management, Legal Writing
Education
Norfolk State University 1999 — 2000
Psychology
AstraZeneca February 2014 - Present
Parenteral Drug Association (PDA) February 2012 - February 2015
MedImmune April 2012 - February 2014
MedImmune November 2010 - April 2012
Johns Hopkins University January 2007 - January 2011
MedImmune LLC, an Astra Zeneca Company June 2007 - November 2010
MedImmune May 2006 - June 2007
Food and Drug Administration 2003 - May 2006
FDA 2004 - 2004
FDA 2000 - 2003
Skills
Regulatory Affairs, Vaccines, FDA, GMP, Biologics, Biopharmaceuticals, Biotechnology, Regulatory Policy, Regulatory Requirements, Validation, Microbiology, CMC, Strategy, Protein Purification, Pharmaceutical Industry, Aseptic Processing, Chemistry, Drug Development, IND, Regulations, Monoclonal Antibodies, Regulatory Submissions, Purification, Pharmaceutics
Education
Penn State University 1982 — 1989
PhD, Protein Purification/Characterization
University of Central Florida 1978 — 1982
BS, Chemistry, Microbiology
NASA Goddard Space Flight Center July 2010 - Present
OMB: E-Gov and IT, Budget Formulation and execution LOB September 2011 - April 2012
Food and Drug Administration January 2010 - July 2010
Federal Aviation Administration June 2009 - August 2009
Radio One July 2006 - October 2008
United States Air Force October 1999 - October 2005
Skills
ITIL, Public Speaking, Presenter, Leadership, Strategic Planning, Cross-functional Team..., Program Management, Government, Proposal Writing, SharePoint, Process Improvement, Change Management, Governance, Policy Analysis, Manage Complex Projects, Simplifying the Complex, Management, Management Consulting, Data Analysis, Policy, Project Planning
Education
North Carolina Central University 2007 — 2009
MBA & MIS, Business & Technology
Mansfield University 1995 — 1999
B.S, Business Administration and Economics
FDA February 2012 - Present
Food and drug administration May 2009 - January 2012
United Nations February 2006 - May 2009
Skills
Financial Analysis, Grants, Policy, Management, Managerial Finance, Budgets, Accounting, Team Leadership, Finance, Risk Management, Financial Reporting, Data Analysis, Leadership, Federal Government, Process Improvement, Human Resources, Program Management, Government, Project Planning, Access, Auditing, Management Consulting, Nonprofits, Procurement, Strategic Planning, Public Administration, Project Management, Analysis, Public Policy, Internal Controls, Microsoft Excel, Program Evaluation, Strategic Financial..., Business Analysis, Business Development, Program Development, Contract Negotiation, Financial Planning
Education
Strayer University 1999 — 2001
Master, Accounting, Business Administration
Planned Parenthood Federation of America May 2011 - August 2014
Association of State and Territorial Health Officials August 2010 - May 2011
Assoc. of State and Territorial Health Officials June 2008 - August 2010
Food and Drug Administration September 2006 - May 2008
New Hampshire Department of Health and Human Services June 2006 - August 2006
George Washington University SPHHS 2005 - 2006
Skills
Research, Data Analysis, Leadership, Public Health, Public Policy, Program Evaluation, Policy Analysis, Health Policy, Grants, Grant Writing, Qualitative Research, Policy, Community Outreach, Global Health, Government, International..., Technical Assistance, Healthcare, Program Management, SPSS, Legislative Relations, Community Health, Stata, Proposal Writing, SAS, Reproductive Health, Nonprofits, Program Development, Coalitions, Prevention, Literature Reviews, Health Equity, Capacity Building, Epidemiology
Education
The George Washington University 2004 — 2006
MPH, Global Health, Epidemiology
University of Illinois at Urbana-Champaign 1999 — 2004
B.S., Molecular and Integrative Physiology, Minor Religious Studies
King & Spalding September 2015 - Present
Food and Drug Administration March 2010 - July 2015
FDA November 2011 - January 2013
Sonnenschein, Nath & Rosenthal February 2009 - February 2010
Patton Boggs LLP September 1999 - March 2005
Morgan, Lewis & Bockius August 1998 - August 1999
Skills
Strategy, Policy, Legislation, Management, Legislative Relations, Litigation, Government, FDA, Public Policy, Policy Analysis
Education
The George Washington University Law School 1995 — 1998
J.D., Law
Wesleyan University 1989 — 1993
B.A., American Studies, Environmental Policy
U.City HS
Department of Housing and Urban Development October 2011 - Present
U.S. Department of Energy November 2008 - November 2010
Department of Health and Human Services February 2008 - November 2008
Dept of Treasury August 2007 - February 2008
Food and Drug Administration October 2006 - August 2007
FDA 2005 - 2006
USDA-APHIS 1990 - 1998
USDA 1990 - 1998
Skills
Certified Enterprise...
Education
University of Maryland Eastern Shore 1981 — 1984
BS, Math and Computer Science
The George Washington University
Statistics
Self January 2009 - Present
CYC Enterprises February 2011 - July 2011
City of Atlanta October 2008 - January 2009
LifeScapes June 2007 - October 2008
Food and Drug Administration January 2007 - June 2007
Site Maintenance Companies August 2005 - January 2007
Protocol Communications September 2001 - January 2002
Skills
QuickBooks, Deltek, Accounts Payable, Account Reconciliation, Accounts Receivable, Accruals, Accounting, Financial Accounting, Bookkeeping, Small Business
Education
University of Maryland Eastern Shore 2002 — 2006
Accounting and Business/Management
Prince George's Community College
Certification, Nursing
University of Maryland University College
Accounting
Northrop Grumman Corporation June 2015 - Present
DISYS November 2013 - May 2015
Environmental Resources Management (ERM) August 2011 - November 2013
Amtrak 2010 - 2011
US Congress January 2010 - June 2010
Methanol Institute 2009 - 2010
Food and Drug Administration 2008 - 2009
Skills
Environmental Awareness, Environmental..., Occupational Health, Industrial Hygiene, EHS, Environmental Impact..., Program Management, Management, ISO 14001, Program Development, Research, Inspection, Training, Hazardous Waste..., Microsoft Excel, Sustainability, Environmental Compliance, Auditing
Education
The George Washington University 2009 — 2011
Master's in Public Health, Environmental and Occupational Health
University of Delaware 2005 — 2009
Bachelor's of Science, Biology, Animal Science
KCTCS January 2015 - Present
The Christ Hospital Health Network 2015 - Present
Northern Kentucky University July 2011 - Present
Madison-Design Group April 2012 - March 2015
Northlich September 2009 - April 2012
Northlich January 2010 - October 2010
Northern Kentucky University August 2009 - May 2010
Northlich September 2009 - January 2010
Food and Drug Administration May 2005 - September 2009
Skills
Traditional Public..., Word of Mouth Marketing, Healthcare Marketing, Public Speaking, Advertising, Strategy, Marketing Strategy, Marketing, Marketing Communications
Education
Northern Kentucky University 2008 — 2010
MA, Communication
Northern Kentucky University 2004 — 2008
BA, Communication/PR
Newport Central Catholic High School 2000 — 2004
Food and Drug Administration August 2010 - Present
Various Companies January 2009 - August 2010
ALZA Corporation July 1998 - December 2008
ALZA Corporation July 1987 - July 1998
Skills
Compliance, Investigations, Auditing, Administration, Policy, FDA, GMP, Sop, Private Investigations, Software Documentation, R&D, CAPA, Research, Training, Quality Assurance, Security, Team Building, Validation, Pharmaceutical Industry, Testing, Program Management, Analysis, Regulatory Affairs, Process Improvement, Management, System Administration, Human Resources, Quality System, Project Planning, Drug Development, Laboratory, Time Management, Medical Devices, V&V, Technology Transfer, Regulatory Submissions
Education
University of Phoenix 2004 — 2006
MBA, Business Administration
San Jose State University 1982 — 1986
BA, Biology
Food and Drug Administration December 2009 - Present
Medical College of Wisconsin November 2001 - November 2004
Education
San Jose State University 2007 — 2008
MBA, Business
San Jose State University 2006 — 2008
MA-Economics, Applied Economics
University of Notre Dame 1993 — 1998
B.A., History
U.S. Nuclear Regulatory Commission April 2013 - Present
U.S. Nuclear Regulatory Commission September 2008 - April 2013
Food and Drug Administration February 2006 - September 2008
National Library of Medicine (NLM) October 2004 - February 2006
National Library of Medicine (NLM) November 1996 - October 2004
National Library of Medicine (NLM) June 1995 - November 1996
NASA May 1991 - June 1995
Rutgers University June 1988 - August 1989
Skills
Library Science, Library, Editing, Research, Library Research, Academic Libraries, Information Literacy, Content Management, Digital Libraries, Library Instruction, Collection Development, Library Reference, Social Media, Books, Electronic Resources, Metadata, Indexing, Information Architecture, Interlibrary Loan, Virtual Reference, Microsoft Office, Web Design, Web Development, Usability Testing, Usability, Writing, Creative Writing, HTML, Dreamweaver, Web Content, Photography, Blogging, Blogger
Education
The George Washington University 2009 — 2010
Master's Certificate, IT Project Management
The Catholic University of America 1995 — 1996
MSLS, Library Science
Rutgers University-New Brunswick 1986 — 1990
BA, English/Creative Writing
Clifton High School 1984 — 1986
Food And Drug Administration February 2008 - Present
Education
Osmania University
Corpus Christi Chamber of Commerce May 2013 - Present
Corpus Christi Chamber of Commerce January 2013 - May 2013
Nueces County, Precinct 4 January 2011 - December 2012
Food and Drug Administration April 2008 - April 2011
U.S. Department of Health and Human Services March 2003 - March 2008
Bush-Cheney 2000/Victory 2000 2000 - 2001
Office of Governor Tommy G. Thompson, Wisconsin April 1999 - August 2000
Skills
Public Policy, Policy Analysis, Government, Legislative Relations, Policy, Politics, Legislation, Coalitions, Health Policy, Federal Government, Public Health, Political Campaigns, Community Outreach, Public Affairs, Non-profits
Education
University of Wisconsin-Madison 1996 — 1998
Bachelor of Arts, Political Science and Government
Texas State University-San Marcos 1992 — 1995
Food and Drug Administration July 2010 - Present
University of Pittsburgh May 2002 - July 2010
Center for Minority Health, University of Pittsburgh Graduate School of Public Health 2002 - July 2010
Dance Alloy Theater 2006 - 2009
University of Pittsburgh Medical Center 2000 - 2003
Skills
Data Analysis, Public Health, Epidemiology, Research, Qualitative Research, Statistics, Biostatistics, Community Outreach, SAS, Literature Reviews, Public Speaking, Higher Education, Nonprofits, University Teaching, Teaching, Public Policy, Clinical Research, Health Education, Health Policy, Community Health, Health Communication, Health Equity, Quantitative Research, Health Disparities
Education
University of Pittsburgh 2003 — 2010
MS, PhD, Epidemiology
University of Chicago 1996 — 1999
Honors BA, Psychology
Northwestern University 1994 — 1996
University of Pittsburgh
FDA January 2015 - Present
Food and Drug Administration August 2006 - December 2014
Rehabilitation Institute of Chicago May 2005 - July 2005
Stryker Orthopaedics September 2004 - January 2005
National Aeronautics and Space Administration May 2004 - August 2004
Wadsworth Center, NYS Department of Health June 2003 - July 2003
Education
The Johns Hopkins University 2007 — 2009
MS, Applied Biomedical Engineering
Rensselaer Polytechnic Institute 2002 — 2006
BS, Biomedical Engineering
Food and Drug Administration May 2009 - Present
National Institute of Standards and Technology July 2008 - May 2009
University of Massachusetts at Amherst 2002 - 2008
Department of Polymer Science and Engineering, Umass Amherst 2002 - 2008
Skills
Python, C++, Simulations, Characterization, Perl, Programming, Data Analysis, Matlab, Bash, Biotechnology, Physics, Chemistry, Materials Science, Analysis, R&D
Education
Albany High School
Oberlin College
B. S., Biochemistry
The University of Connecticut
M. S., Polymer Science
University of Massachusetts, Amherst
Ph. D., Polymer Science and Engineering
University of Massachusetts, Amherst
M. S., Polymer Science and Engineering
Food and Drug Administration Quality Assurance AnalystWyeth PharmaceuticalsMay 2001 - November 2001
Education
Rutgers University – Camden 1997 — 2001
BA, Biology
FDA/CBER/OVRR/DVRPA May 2012 - Present
Food and Drug Administration September 2006 - June 2012
Henry M. Jackson Foundation, Clinical Breast Care Project April 2004 - September 2006
Virion Systems Inc 2001 - 2003
Skills
FDA, Clinical Trials, Virology, Tissue Culture, Cell Culture, ELISA, Assay Development, Molecular Biology, Microbiology, In Vivo, Animal Models, Flow Cytometry, PCR, RT-PCR, Infectious Diseases, Regulatory Submissions
Education
The Johns Hopkins University 2009 — 2011
Master of Science (M.S.), Regulatory Science
University of Maryland College Park 2000 — 2003
Bachelor of Science (BS), Biological Sciences
Food and Drug Administration September 2003 - Present
SpectRx, Inc. June 1998 - September 2003
Skills
Biomedical Engineering, R&D, Medical Devices, Spectroscopy
Education
The Catholic University of America 2007 — 2014
Doctor of Philosophy (Ph.D.), Electrical Engineering
The University of Texas at Austin 1995 — 1998
Master's Degree, Electrical Engineering
University of Virginia 1991 — 1995
Bachelor's Degree, Electrical Engineering
FDA November 2010 - Present
FDA November 2009 - Present
Food and Drug Administration July 2003 - October 2009
Washington Group International August 1998 - September 2001
Education
Rutgers University-New Brunswick 1994 — 1998
Food and Drug Administration January 2008 - Present
Skills
Nanotechnology, Policy Analysis, Characterization, Biomaterials, Materials Science, Nanoparticles, Research, Nanomaterials, Microscopy, HPLC
Education
University of Maryland - A. James Clark School of Engineering 2004 — 2007
Chemical Engineering
University of Maryland College Park 2004 — 2007
Ph.D., Chemical Engineering
The Johns Hopkins University 2000 — 2004
B.S., Chemical Engineering
Food And Drug Administration February 2008 - Present
Fannie Mae 2006 - 2008
Education
Osmania University 1991 — 1994
State Water Resources Control Board July 2014 - Present
California Department of Public Health August 2012 - Present
Food and Drug Administration October 2010 - May 2013
State of California - Department of Public Health May 2010 - August 2012
State of California - Department of Pesticide Regulation February 2009 - May 2010
University of California, Davis - Medical Center 2004 - February 2009
Skills
Epidemiology, Public Health, Infectious Diseases, Science, Clinical Research, Biochemistry, Medicine, Literature Reviews, Scientific Writing, Global Health, Toxicology, Neuroscience, Pharmacology, Immunology, Cancer, Animal Models, Lifesciences, Drug Development, Immunohistochemistry, Medical Devices, Life Sciences
Education
Our Lady of Fatima University 1997 — 2002
M.D., Medicine
University of California, Davis 1986 — 1991
B.S., Psycho-Biology/Pre-Med
Tokay High School
FDA March 2013 - Present
Food and Drug Administration December 2009 - March 2013
food and drug administration June 1991 - December 2009
Skills
FDA, Regulatory Affairs, Medical Devices, Regulatory Requirements, Policy, Legal Research, Manufacturing, Policy Analysis, Training, Quality Auditing, Software Documentation, Government, Outlook
Education
Texas Woman's University 2011 — 2013
Master of Business Administration (M.B.A.), 3.7
Texas Woman's University 1988 — 1993
FDA January 2011 - Present
FDA June 2009 - January 2011
Food and Drug Administration September 2008 - November 2009
Food and Drug Administration September 1993 - September 2008
Skills
Biomedical Engineering, Medical Devices, Clinical Research, FDA, Healthcare, Healthcare Management, Hardware Diagnostics, Ultrasound, Leadership, Regulatory Affairs, Biomaterials, Risk Management, ISO 13485, Healthcare Information..., Informatics, Biomechanics, Lifesciences, Process Improvement, Radiology, Clinical Trials, Policy, Public Health, MRI, X-ray, Engineering, Medical Imaging, PACS, Hospitals, Design Control, Quality System, Management, Biotechnology, Digital Imaging, Cardiology, Validation, HL7, Regulatory Submissions, Medical Technology
Education
The Catholic University of America 1983 — 1987
Bachelor of Science (BS), Biomedical Engineering
Dartmouth HS
Food and Drug Administration DermatologistThe Washington ClinicJune 1996 - September 2002
Education
Northwestern University - The Feinberg School of Medicine 1982 — 1988
Food and Drug Administration December 2003 - Present
Telecommunications Reports June 1999 - September 2002
Education
Prince George's Community College
Psychology, Biology, English Lit
Food and Drug Administration November 2009 - Present
Walgreens Pharmacy April 2001 - February 2012
Walgreens Pharmacy April 2001 - August 2006
Skills
Microsoft Office, Customer Service, Pharmacists, Data Analysis, Microsoft Excel
Education
St. Louis College of Pharmacy 2000 — 2006
PharmaPolaris 2005 - Present
chiron corporation November 1998 - November 2005
Abbott Laboratories March 1993 - November 1998
Food and Drug Administration November 1989 - March 1993
Skills
Clinical Development, Clinical Trials, Clinical Pharmacology, Drug Development, Pharmaceutics, Biotechnology, Drug Discovery, Pharmaceutical Industry, Regulatory Submissions
Education
The Hebrew University 1984 — 1989
PhD, Pharmacokinetics and Drug metabolism
Food and Drug Administration November 1999 - Present
CVS Caremark Corporation 1999 - September 2014
Skills
Pharmacology, Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, Drug Development, Biotechnology, Clinical Pharmacology, Pharmacy, Infectious Diseases, Public Health, Pharmacists, FDA, Life Sciences, Clinical Development, Pharmacokinetics, Clinical Research
Education
Rutgers University 1994 — 1999
BS, Pharmacy
Dauphin Island Sea Lab October 2012 - Present
Consulting Toxicologist 2008 - Present
al dept public health October 1999 - January 2010
SMi Group 1970 - December 2009
FDA, Center for Food Safety & Applied Nutrition 1977 - 2000
Commissioned Corps 1977 - 2000
Food and Drug Administration July 1977 - December 1999
PHS-1 DMAT 1988 - 1999
Skills
Food, Public Health, Toxicology, Food Safety, Nutrition, Policy, Pharmacology, Environmental Health, Health, Employee Relations, Health Promotion, Public Health Policy, Hygiene, Performance Management, Community Health, In Vivo, Health Communication, Counterterrorism, Life Sciences, Healthcare, Emergency Management, Prevention, Strategic Planning, Risk Assessment, Analysis, Compliance, Mentoring, Research, Program Management, Team Building, Problem Solving, Lifesciences, Clinical Research, Public Speaking, Health Policy, Data Analysis, Program Evaluation, Program Development, Scientific Writing, Community Outreach, Health Education, Statistics, Infectious Diseases, Global Health, Leadership, Environmental Education, Nonprofits, Environmental Awareness, Biostatistics, ELISA
Education
The Johns Hopkins University 1981 — 1984
M.S., Applied Human Behavior
West Virginia University 1969 — 1971
Ph.D., Biochemistry
West Virginia University 1966 — 1969
M.S., Physiology
Wake Forest College 1962 — 1966
b.s., biology
Food and Drug Administration August 2012 - Present
National Institutes of Health July 2009 - September 2012
University of Michigan July 2006 - July 2009
Skills
Lifesciences, Animal Husbandry, In Vivo, Laboratory Animal..., Medicine, Infectious Diseases, Epidemiology, Dogs, Clinical Research, Animal Models, Research, Veterinary, Veterinary Medicine, Immunology, Biostatistics, Laboratory, Life Sciences, Vaccines, Toxicology, Animal Work
Education
The Johns Hopkins University 2005 — 2006
Infectious Disease Epidemiology
North Carolina State University 2001 — 2005
DVM, Veterinary Medicine
University of North Carolina at Chapel Hill 1999 — 2003
MPH, Biostatistics
University of North Carolina at Chapel Hill 1995 — 1999
BSPH, Biostatistics
University of Michigan Medical School
Comparative and Laboratory Animal Medicine
Oregon State University September 2012 - Present
IEH Laboratories and Consulting October 2011 - July 2012
Food and Drug Administration October 2009 - October 2011
The Ohio State University January 2008 - October 2009
Skills
Microbiology, Food Science, Molecular Biology, Food Microbiology, PCR, GMP, Food Safety, FDA, Food Processing, HACCP, Laboratory, Research
Education
The Ohio State University 2004 — 2007
Ph.D., Food Science and Nutrition
Oregon State University 2002 — 2004
M.S., Microbiology
Oregon State University 1999 — 2002
B.S., Food Science and Technology
Siuslaw High School 1994 — 1998
Food and Drug Administration Congressional Liaison U.S. Census BureauCensusSeptember 2009 - September 2011
Toybox, Inc. July 2008 - July 2009
Public Defender Service January 1995 - January 1998
Prince George's County Public Defender 1988 - 1993
Education
The George Washington University Law School 1985 — 1988
J.D
Food and Drug Administration August 2010 - Present
US Food and Drug Administration January 2008 - August 2010
FDA September 2004 - December 2008
Skills
Biomedical Engineering, Biomaterials, Public Policy, Public Health, Medical Devices, Clinical Trials, Women's Health, Project Management, Program Development, Program Evaluation, FDA, Regulatory Requirements, Regulatory Submissions, Regulatory Affairs, Policy, Public Speaking, Change Management, Leadership, Program Management, Community Outreach, Research, Strategic Planning, Biotechnology, Data Analysis, Lifesciences, Clinical Research, Statistics, Life Sciences
Education
The Johns Hopkins University 2007 — 2009
Master of Public Health (MPH)
Queen Mary, U. of London 2001 — 2002
Master of Science (M.Sc.), Biomaterials, Honors
Queen Mary, U. of London 1998 — 2001
Bachelor of Engineering (BEng), Biomedical Materials Science and Engineering, Honors 2:1
Food and Drug Administration September 2010 - Present
Schering-Plough Research Institute (SPRI) July 2003 - July 2005
Merck & Co., Inc November 2001 - July 2003
Merck & Co., Inc. August 2000 - November 2001
Skills
GMP, Formulation, Vaccines, Manufacturing, Technology Transfer, FDA, Validation, Pharmaceutical Industry, Drug Development, Analytical Chemistry, Software Documentation, Chemistry, Pharmaceutics
Education
Purdue University 2005 — 2009
Ph.D., Industrial and Physical Pharmacy
University of Virginia 1996 — 2000
BS, Chemical Engineering
Food and Drug Administration May 2009 - December 2009
David Gracias Laboratory February 2007 - August 2009
Education
The Johns Hopkins University 2005 — 2009
Food and Drug Administration May 2013 - Present
FDA November 2010 - May 2013
Syracuse University Graduate Student Organization July 2010 - July 2011
Veterans Administration May 2009 - November 2010
Syracuse University August 2009 - May 2010
Syracuse University August 2007 - May 2009
Syracuse University August 2006 - May 2009
Syracuse University January 2000 - January 2006
Skills
Risk Assessment, Food Defense, Statistical Forecasting, Public Health, Statistics, Epidemiology, Biochemistry, Food Science, Data Analysis, Research, SPSS, Teaching, Government, Stata, Health, Higher Education, Database Management, Modeling, Public Policy, Psychology, Nonprofits, Grant Writing, Qualitative Research, Research Design, Policy Analysis, Policy, Data Collection, University Teaching, Program Development, Community Outreach
Education
Syracuse University 2002 — 2006
Master's Degree, Science Education
Saint Francis Borgia Regional High School 1992 — 2006
Syracuse University 1996 — 2001
Bachelor's Degree, Biochemistry
FDA Regulatory Consulting, Inc March 1994 - Present
Medeikon, Inc. August 2003 - June 2007
Johnson Matthey, Inc July 1990 - March 1994
Lemmon Company March 1987 - August 1989
Food and Drug Administration September 1976 - March 1987
FDA 1976 - 1984
Skills
Regulatory Affairs, FDA, Medical Devices, GMP, Validation, Pharmaceutical Industry, Sop, Regulatory Submissions, Technology Transfer, Biotechnology, Quality Assurance, Product Development, Quality System, Clinical Trials, R&D, CAPA, Quality Control, ISO 13485, Pharmaceutics, IND, Quality Auditing, Oncology, Change Control, Lifesciences, V&V, Auditing, Quality Management, Training, ISO, Cross-functional Team..., 21 CFR Part 11, Document Management, GCP, Biopharmaceuticals, GLP, Software Documentation, Clinical Research, Process Simulation, HPLC, Start-ups, CRO
Education
Temple University, School of Pharmacy 1980 — 1988
MS, Pharmaceutical Quality Assurance Control
Penn State University 1972 — 1976
BS, Pre-Medicine
Food and Drug Administration September 2001 - Present
FBI September 1998 - September 2001
National Archives December 1995 - August 1998
Skills
Freedom of Information..., Privacy Act, Federal Government
Education
Salisbury University 1987 — 1991
Bachelor, Liberal Arts/Urban Planning
HRSA August 2007 - Present
HRSA Pharmacy Services Support Center at APhA 2007 - Present
National Bioterrorism Hospital Preparedness Program 2005 - 2007
Food and Drug Administration 2000 - 2005
Education
The George Washington University 2005 — 2008
MS, Engingeering Management and Systems Engineering
University of Pittsburgh 1994 — 2000
PharmD
U.S. Secret Service September 2013 - Present
VetsFirst July 2009 - Present
Food and Drug Administration January 2011 - September 2013
United Spinal Association July 2009 - July 2012
Sherick Project Management October 2007 - January 2011
Pennsylvania Army National Guard October 2001 - December 2007
Skills
Policy, Fundraising, Project Management, Team Leadership, Government, Non-profits, Policy Analysis, Community Outreach, Public Policy, Strategic Planning, Public Speaking, Research, Program Evaluation, Nonprofits, Grants, Program Development, Program Management, Analysis, Leadership
Education
University of Pennsylvania 2008 — 2010
Masters, Governmental Adminstration
University of Pennsylvania 2008 — 2009
Certificate, Non-Profit Adminstration
Temple University 2002 — 2006
BA, Politcial Science and English
RN November 2013 - Present
J-3 Designs May 2013 - Present
Somerset Medical Center May 2012 - Present
CAST June 2011 - Present
Spar, Inc. May 2011 - Present
Hallmark 2008 - 2009
Food and Drug Administration June 1991 - June 1998
Education
Raritan Valley Community College 2011 — 2013
Nursing
Rutgers University-New Brunswick 1982 — 1986
BS, Foods/Nutrition
Food and Drug Administration April 1991 - Present
Skills
R&D, Leadership, FDA, Cell Culture, Data Analysis, Analysis, Biomedical Engineering, Microsoft Office, Biotechnology, Quality Assurance, Life Sciences
Education
The Johns Hopkins University 1984 — 1988
Bachelor of Science, Biomedical Engineering
Food and Drug Administration December 2013 - Present
National Cancer Institute, National Institutes of Health March 2008 - December 2013
Rutgers Cancer Institute of NJ, Rutgers University 2003 - 2008
Institute of Immunology, Polish Academy of Sciences 2002 - 2003
Skills
Pharmacology, Drug Development, Cancer, Clinical Pharmacology, Pediatric Drug..., Regulatory Science, Medical Countermeasures, Science, Regulatory Affairs, Cell, Molecular Cloning, Cell Biology, Molecular Biology, Western Blotting, Cell Culture, Biochemistry, Confocal Microscopy, Cancer Research, Flow Cytometry, Biotechnology, Transfection, Protein Expression, PCR, Genetics, Fluorescence Microscopy, Microscopy, qPCR, Bioinformatics, Protein Purification, Immunohistochemistry, Animal Models, MOA Studies
Education
Rutgers University-New Brunswick 2003 — 2008
Doctor of Philosophy (Ph.D.), Molecular Pharmacology
Wroclaw University of Technology 1997 — 2003
Master's degree, Biotechnology
Wroclaw University of Technology 1997 — 2002
Master of Engineering (M.Eng.), Molecular Biotechnology and Biocatalysis, Department of Chemistry
Spark Therapeutics, Inc. November 2014 - Present
Food & Drug Administration March 2006 - November 2014
Food and Drug Administration June 2001 - February 2006
Food & Drug Administration March 1999 - June 2001
Skills
Government, Federal Government, Policy Analysis, Cell Culture, Policy, Biopharmaceuticals, Clinical Development
Education
Rush University
Doctor of Philosophy (Ph.D.), Immunology
University of Iowa
Bachelor of Science (B.S.), Microbiology
Food and Drug Administration August 2010 - Present
Education
The University of Texas at Austin 2000 — 2001
Master's of Science, Social Work
Texas Tech University 1997 — 1999
BA, Social Work
Food and Drug Administration 2010 - Present
ADA Paffenbarger Research Center at National Institute of Standards and Technology 2002 - 2010
Nanyang Technological University 1996 - 1998
Skills
Nanotechnology
Education
Shanghai Jiao Tong University
BE, ME
State University of New York at Stony Brook
Ph.D.
Food and Drug Administration May 2003 - Present
FDA 2003 - 2015
Skills
Chemistry, Pharmaceutical Sciences, CMC Regulatory Affairs, Quality by Design, Chemometrics, FDA
Education
Stevens Institute of Technology
Ph.D., Chemistry
Stevens Institute of Technology
Ph.D., Chemistry
FDA February 2012 - Present
Food and Drug Administration November 1998 - February 2012
FDA November 1998 - February 2012
EEOC September 1992 - July 1996
Skills
Federal Government, Government, Data Analysis, Policy Analysis, Policy, Public Policy, Public Administration, Budgets, Program Management, Customer Service, Government Contracting, Strategic Planning, Microsoft Office, Security, Research, Analysis, Management, Nonprofits, Emergency Management
Education
Our Lady of the Lake University
Public Administration
San Antonio College 1989 — 1991
Associate of Applied Science, Public Administration
FDA April 2012 - Present
Food and Drug Administration 2007 - 2012
State of Vermont 2003 - 2007
Vermont Technical College 2001 - 2003
Vermont Department of Banking, Insurance, Securities and Health Care Administration 1997 - 2001
Vermont Attorney General's Office 1993 - 1997
Windsor County State's Attorney 1989 - 1993
City of Worcester 1983 - 1989
Skills
FDA, Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Regulatory Requirements, CAPA, Drug Development, Clinical Trials, Policy, Biotechnology, GMP, Lifesciences, Sop, Technology Transfer, Medical Devices, IND
Education
Suffolk University Law School 1979 — 1982
Doctor of Law (J.D.)
University of Vermont
Biology and Chemistry
Food and Drug Administration February 1990 - Present
Education
Rutgers University-New Brunswick 1969 — 1977
Ph.D., Food Science
FDA Center for Veterinary Medicine January 2014 - Present
FDA Center for Veterinary Medicine December 2007 - Present
HHS Office of Inspector General 2004 - 2007
Food and Drug Administration 2000 - 2004
Skills
Social Media, Health Communication, Newsletters, Strategic Communications, Media Relations, Public Policy, Editing, Spokesperson, Press Releases, Public Relations, Government, Corporate Communications, Crisis Communications, Copy Editing, Policy, Journalism, Speech Writing, Communications Planning, Internal Communications, Policy Analysis, Message Development, Blogging, Research, Public Health, Technical Writing, Web Content, Proposal Writing, Publications, Public Affairs, Publicity, Content Management, Public Speaking, Web Content Management, Community Outreach
Education
The Johns Hopkins University 2003 — 2005
Masters, Government
University of Maryland College Park 1973 — 1977
B.A., English
Hood College, Secondary Education Teacher Certification, 1991
Food and Drug Administration Chief Nurse, National Disaster Medical SystemFEMASeptember 2003 - March 2009
Division of Commissioned Personnel 1990 - 2003
Education
The College of New Rochelle
Vanderbilt University Medical Center July 2012 - Present
Vanderbilt University Medical Center July 2012 - Present
Food and Drug Administration June 2013 - August 2013
Independent Pharmacy and Pharmaceutics Consultant August 2011 - June 2012
Temple University School of Pharmacy August 2005 - May 2011
Accenture, Lagos March 2003 - August 2005
Military Hospital Lagos May 2000 - May 2001
Skills
Pharmaceutical Industry, Clinical Development, Clinical Trials, Clinical Research, CRO, Project Management, Validation, Pharmaceutics, Change Management, Biotechnology, Pharmacokinetics, Drug Metabolism, Pharmacy, Clinical Pharmacology, Pharmacology, Life Sciences
Education
Temple University 2005 — 2011
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
University of Ibadan School of Pharmacy 1995 — 2000
Bachelor of Pharmacy with Distinction, Pharmacy
Food and Drug Administration, Center for Food Safety and Applied Nutrition January 2014 - Present
Food and Drug Administration August 2001 - Present
Education
Ohio University 1997 — 2001
Doctor of Philosophy (PhD), Analytical Chemistry
Rhodes University 1993 — 1996
Bachelor of Science (BSc), Chemistry and Biochemistry
Food and Drug Administration Associate Director for Research PolicyFDA/CDERMarch 2007 - Present
Skills
Molecular Biology, Research, Lifesciences, Regulatory Affairs, Policy Analysis, Toxicology, Pharmacology, Cell Culture, Biotechnology, Data Analysis, Science, Drug Development, Biochemistry
Education
New York Medical College 1963 — 1968
M.Sc.; Ph.D., Pharmacology
Rutgers University-New Brunswick 1958 — 1962
Bachelor of Science (B.S.), Chemistry
Food and Drug Administration Associate Professor of Neurology, Psychiatry and Brain & Cognitive ScienceUniversity of Rochester Medical CenterAugust 1984 - August 2009
Skills
Clinical Research, Healthcare, Neuroscience, Treatment, Research, Clinical Trials, Neurology, FDA, Medicine, Public Health, Psychology, Psychiatry, Epidemiology, Mental Health, Neuropsychology, Life Sciences
Education
University of Delaware 1977 — 1981
PhD, Psychology
Saint Bonaventure University 1971 — 1975
BS, Psychology
Food and Drug Administration September 2002 - Present
Skills
Epidemiology, Clinical Trials
Education
Shanghai Jiao Tong University
Food and Drug Administration ChemistUS FDADecember 2012 - Present
FDA 2004 - 2012
Education
Texas Tech University Health Sciences Center 2000 — 2004
PhD, Pharmaceutical Sciences
UDCT 1998 — 2000
MS (Tech), Bioprocess Technology
ICT 1994 — 1998
BPharm, Pharmaceutical Sciences
Food and Drug Administration (FDA) Center for Tobacco Products September 2014 - Present
Food and Drug Administration May 2011 - September 2014
National Institutes of Health September 2008 - May 2011
Skills
User Acceptance Testing, Business Analysis, Requirements Analysis, Analysis, Systems Analysis, Business Process..., Business Process
Education
The George Washington University
Master's Certificate in Business Analysis
University of Maryland University College
MS, IT Project Management
Orphan solutions April 2013 - Present
HaffnerAssociates, LLC April 2009 - Present
VP File Bank, Inc 2009 - 2010
Kakkis EveryLife Foundation 2009 - 2010
Amgen Inc 2007 - 2009
Food and Drug Administration 1986 - 2007
FDA/HHS 1986 - 2007
FDA 1986 - 2007
USPHS 1971 - 2007
Skills
Hematology, Health Policy, Internal Medicine, Regulatory Affairs, Biotechnology, Clinical Development, Pharmaceutical Industry, Clinical Trials, Drug Development, FDA, Regulatory Submissions, IND, Medical Devices, Drug Discovery, Pharmacology, Clinical Pharmacology, Immunology, Orphan Drugs, Clinical Research, Neurology, V&V, Medical Affairs, Vaccines, Pharmaceutics, CAPA, Diabetes, 21 CFR Part 11, Regulatory Requirements, Healthcare, Medicine, Protocol, Biopharmaceuticals, Biologics, Cardiology, Technology Transfer, Toxicology, Validation, Molecular Biology, Pharmacovigilance, Biostatistics, Oncology, GCP, Medical Writing, CRO, Commercialization, Sop, GLP, GMP, CTMS, Cancer
Education
Johns Hopkins Bloomberg School of Public Health 1988 — 1991
Master of Public Health (MPH), Health Policy and Management
The George Washington University School of Medicine and Health Sciences 1961 — 1965
MD
Northern Virginia Area Health Center December 2012 - Present
Food and Drug Administration May 2012 - November 2012
Food and Drug Administration April 2008 - April 2011
Skills
Molecular Biology, Cell Culture, Biochemistry, Western Blotting, PCR, Cell Biology, Science, Microbiology, Microscopy, ELISA, Agarose Gel..., Flow Cytometry
Education
Ross University School of Medicine 2000 — 2007
Medical Doctorate
Penn State University 1991 — 1995
Bachelor of Science (BS), Pre-medical Sciences
Food and Drug Administration February 2010 - Present
Greater Baltimore Medical Center June 2004 - January 2010
Education
The Johns Hopkins University 1999 — 2000
MPH, Epidemiology
Ross University School of Medicine 1995 — 1999
Doctor of Medicine (MD)
LeRoy Schroeder Consulting March 2006 - Present
Food and Drug Administration August 1977 - January 2006
Skills
FDA
Education
Northwestern University 1964 — 1969
Ph.D., Chemistry
Food and Drug Administration January 2011 - Present
United States Department of Justice January 2004 - 2010
United States Office of Personel Management April 1993 - March 2004
Skills
Financial Accounting, IT Systems Development, Systems Analysis
Education
The George Washington University 1996 — 1998
Master of Science, Management Information Systems
Merichem Company 2001 - 2011
Richmond/Johnsburg School Districts 1998 - 2008
ARI Environmental, Inc 1994 - 2000
Wheelabrator Clean Air Systems, Inc 1991 - 1994
MDA Scientific 1990 - 1991
ARI Technologies, Inc 1989 - 1991
Midland Chicago Corporation 1988 - 1989
Food and Drug Administration 1987 - 1988
Skills
Refining, Process Engineering, Chemical Engineering, Gas Processing, EPC, Additives, Upstream, Air Compressors, P&ID, Process Improvement, Pumps, Petrochemical, Process Safety, Factory, Energy, Leadership, Petroleum, Training, Project Management, Gas Chromatography, Oil & Gas Industry, Process Simulation, Downstream Oil & Gas, Oil/Gas, Project Engineering, Coatings, Polymers, Instrumentation, Process Design, Commissioning, Cooling Towers, Process Control, Onshore, Product Development, Procurement, Troubleshooting, Gas, Engineering, Water Treatment, Refinery, Fuel, Analysis, Natural Gas, Engineering Design, Materials, HAZOP, Process Optimization, FEED, LNG, Pipelines
Education
Southern Illinois University, Edwardsville 1987 — 1988
MS, Chemistry
University of Jamestown 1982 — 1986
BA, Chemistry, Mathematics
AAIPharma Services Corp. July 2013 - Present
Euroifin Lancaster Laboratories, INC July 2011 - June 2013
Ohio University September 2009 - June 2011
Food and Drug Administration June 2010 - August 2010
Ohio University October 2008 - June 2009
Skills
HPLC, Microsoft Office, UV/Vis, Chemistry, Chromatography, Analytical Chemistry, Dissolution
Education
Ohio University 2007 — 2011
Bachelor of Science, Chemistry
Food and Drug Administration September 2003 - Present
NINDS, NIH September 1999 - September 2003
NEI, NIH November 1997 - September 1999
Skills
Molecular Biology, PCR, Cell Culture, ELISA, Western Blotting, Cell Biology, Biochemistry, Lifesciences
Education
Texas Tech University 1995 — 1997
PhD, Biology
Texas Tech University 1993 — 1995
MS, Biology
AcKnowledge Regulatory Strategies May 2014 - Present
Neozene May 2014 - November 2014
PaxMed International March 2012 - April 2014
Alfa Scientific Designs, Inc. April 2011 - March 2012
Food and Drug Administration February 2010 - February 2011
University of Pennsylvania August 2003 - August 2004
Life Technologies 1999 - 1999
Skills
Medical Devices, FDA, Life Sciences, Molecular Biology, 510 K, ISO 13485, Regulatory Affairs, Design Control, Regulatory Submissions, R&D, Quality Systems, Quality Assurance, SOP, Neuroscience, Lifesciences, Biocompatibility, Genetics, Biochemistry, PCR, Laboratory, Quality System
Education
Stanford University 2004 — 2009
Ph.D.
University of California, Berkeley 1999 — 2003
B.A.
Food and Drug Administration 2009 - Present
National Institutes of Health 2002 - 2009
DC Public Schools (Theodore Roosevelt High School August 1999 - February 2002
Antex Biologics, In. 1997 - 1999
Cephalon Manufacturing Corporation 1994 - 1996
Skills
Regulatory Affairs, In Vivo, Science Policy, Toxicology, Gel Electrophoresis, qPCR, Western Blotting, Public Health, Tissue Culture, PCR, Microbiology, IND, Immunology, Fermentation, RNA isolation, Drug Development, Process Simulation, Biology, Purification, Infectious Diseases, Protein Purification, Cell Biology, Virology
Education
University of Maryland University College 2003 — 2009
MS, Biotechnology
Spelman College
BS, Natural Science
Northwestern University Library August 2005 - Present
Northwestern University September 2007 - March 2011
Northwestern University January 2010 - March 2010
Northwestern University September 2007 - December 2007
Rehabilitation Institute of Chicago June 2006 - September 2006
Food and Drug Administration June 2004 - September 2004
Food and Drug Administration June 2003 - September 2003
Skills
AutoCAD, Laboratory Research, Design Engineering, Biomedical research
Education
Northwestern University 2007 — 2011
MS, Biomedical Engineering
Northwestern University 2002 — 2007
BS, Biomedical Engineering: Biomechanics and Rehabilitation
Northwestern University 2002 — 2007
BM, Music Ad Hoc: Bassoon Technology and Practice
Food and Drug Administration November 1993 - Present
Skills
Public Policy, Policy, Federal Government, Government, Policy Analysis, Public Administration, Legislative Relations, Public Health, Legislation, Program Evaluation
Education
Rutgers, The State University of New Jersey-New Brunswick
BS and MBA, Pharmacy and Business
FDA Strategic Compliance LLC September 2011 - Present
Roche Diagnostics April 2000 - October 2011
Roche Corporate August 1989 - April 2000
FDA 1976 - 1989
Food and Drug Administration March 1972 - 1976
Skills
Regulatory Submissions, FDA, GMP, Pharmaceutical Industry, 21 CFR Part 11, Regulatory Affairs, CAPA, Oncology, Quality Control, Validation, Drug Development, Sop, Biotechnology, Technology Transfer, Medical Devices, Clinical Development, GCP, Regulatory Requirements, Pharmaceutics, Clinical Trials
Education
Rutgers University
BS, Physiology, Pathology and Related Sciences
Rutgers, The State University of New Jersey-Newark
Physiology, General
Food and Drug Administration May 2005 - Present
Education
North Carolina Central University
BA
T.S. Inborden
High School Diploma
Walmart November 2014 - Present
Walmart May 2012 - November 2014
Food and Drug Administration January 2012 - February 2012
Indian Health Service November 2011 - December 2011
Department of Veterans Affairs October 2011 - November 2011
Wheeler Pharmacy September 2011 - October 2011
Eastern State Hospital July 2011 - August 2011
Winkelmann Sons Drug Co. June 2011 - July 2011
Saint Francis Hospital May 2011 - June 2011
SUPERVALU June 2008 - September 2009
Skills
Compounding, Counseling, Immunizations, Medication Therapy..., Pharmacy, Patient Counseling, Healthcare, Patient Education, Pharmacists, SOP, Pharmacy Automation, Community Pharmacy, Immunization, Hiring, Employee Training
Education
St. Louis College of Pharmacy 2006 — 2012
Doctorate of Pharmacy, Therapeutics and Pharmaceutics, Professional year 4
Food and Drug Administration 2008 - Present
National Institutes of Health 2002 - 2008
American Red Cross 1991 - 1996
Skills
Biocompatibility, Microarray, Toxicology, Medical Devices, Regulatory Science, Neuroscience, Molecular & Cellular..., Developmental Biology, Bioinformatics, Immunohistochemistry, Regulatory Affairs, Molecular Biology, Cell Culture, PCR, Gel Electrophoresis, In Vivo, DNA
Education
Uniformed Services University of the Health Sciences
Doctor of Philosophy (Ph.D.), Molecular and Cell Biology
St. Mary's College of Maryland
Bachelor of Arts (B.A.), Biology
Food and Drug Administration July 2008 - Present
FDA 2006 - 2008
Skills
Policy, Management, FDA, Research, Healthcare, Software Documentation, Process Improvement, Auditing, Public Policy, Nonprofits, Analysis, Data Analysis, Governance, Policy Analysis, Proposal Writing
Education
Saint Francis Univerisity, Loretto, PA 1966 — 1971
Bachelor of Arts (B.A.), Political Science and Government
The George Washington University
Food and Drug Administration October 2010 - Present
HPTi August 2009 - October 2010
Minitab March 2007 - July 2009
Skills
CAPM - Certified..., OCJA - Oracle Certified..., CompTIA A+ Certification
Education
Penn State University 2006 — 2009
Bachelor of Science (BS), Information Sciences and Technology, 3.38
Rochester Institute of Technology 2004 — 2005
Food and Drug Administration Associate Chief CounselFDASeptember 2012 - Present
Commonwealth of Pennsylvania Office of Attorney General June 2000 - September 2012
Skills
Criminal Law, Legal Research, Administrative Law, Government, Courts, Legal Writing, Litigation, Westlaw, Public Policy, Legislative Relations, Appeals, Policy Analysis, Mediation, Enforcement, Trials, Commercial Litigation, Fraud, Criminal Justice, Law Enforcement
Education
The Dickinson School of Law 1984 — 1987
Juris Doctor, Law
Penn State University 1980 — 1984
Bachelor of Arts (B.A.), Pre-law and English