U.S. 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. Customer service: 1 (888) 463-6332 Emergency: 1 (866) 300-4374 Headquarters: Silver Spring, MD Jurisdiction: United States of America Founded: June 30, 1906 Founders: Theodore Roosevelt, Harvey Washington Wiley
U.S. Food and Drug Administration List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at U.S. Food and Drug Administration. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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U.S. Food and Drug Administration Employees
Employee
Years
Job
Industry
John Maiers John Maiers's U.S. Food and Drug Administration Experience September 2010 - Present
Job Regulatory Attorney at U.S. Food and Drug Administration
Industry Medical Devices
Experience
U.S. Food and Drug Administration September 2010 - Present
Education
Georgetown University Law Center 1971 — 1974
J.D.
U.S. Food and Drug Administration September 2010 - Present
Education
Georgetown University Law Center 1971 — 1974
J.D.
Shewit Woldu Shewit Woldu's U.S. Food and Drug Administration Experience July 2010 - January 2011
Job Healthcare Strategy Consultant at CSC
Industry Hospital & Health Care
Experience
CSC August 2011 - Present
Centers for Disease Control and Prevention October 2009 - May 2011
U.S. Food and Drug Administration July 2010 - January 2011
Walter Reed Army Institute of Research October 2007 - May 2009
The Burgess Group June 2006 - August 2006
Skills
Public Health, Policy, Business Process..., Policy Analysis, Community Outreach
Education
Emory University 2009 — 2011
MPH Candidate, Health Policy & Management
University of Maryland College Park 2005 — 2009
Bachelors, Neurobiology
CSC August 2011 - Present
Centers for Disease Control and Prevention October 2009 - May 2011
U.S. Food and Drug Administration July 2010 - January 2011
Walter Reed Army Institute of Research October 2007 - May 2009
The Burgess Group June 2006 - August 2006
Skills
Public Health, Policy, Business Process..., Policy Analysis, Community Outreach
Education
Emory University 2009 — 2011
MPH Candidate, Health Policy & Management
University of Maryland College Park 2005 — 2009
Bachelors, Neurobiology
Pegah Yazdy Pegah Yazdy's U.S. Food and Drug Administration Experience September 2014 - September 2015
Job AttorneyAdvisor at U.S. Department of Labor
Industry Law Practice
Experience
U.S. Department of Labor September 2015 - Present
U.S. Food and Drug Administration September 2014 - September 2015
D.C. Superior Court June 2014 - August 2014
U.S. Department of Homeland Security, Office for Civil Rights and Civil Liberties September 2013 - August 2014
American University Law Review September 2011 - May 2013
International Human Rights Law Clinic, American University Washington College of Law August 2012 - January 2013
Center for Human Rights and Humanitarian Law August 2012 - December 2012
United States District Court, Southern District of New York June 2012 - August 2012
White House Office of Science and Technology Policy January 2012 - May 2012
Public International Law and Policy Group August 2011 - May 2012
Skills
International Law, Westlaw, Legal Writing, Legal Research, Litigation, Research, Lexis, Public Policy, Human Rights, Community Outreach, Policy Analysis, Politics, Immigration Law, Political Science, Courts, Mediation, International Relations, Criminal Law, Legislation, Legislative Relations, Public International Law, International Human..., International..., Legal Issues, Intellectual Property
Education
American University, Washington College of Law 2011 — 2013
Doctor of Law (J.D.), cum laude
University of California, Los Angeles 2005 — 2009
B.S., B.A., Psychobiology, Political Science
U.S. Department of Labor September 2015 - Present
U.S. Food and Drug Administration September 2014 - September 2015
D.C. Superior Court June 2014 - August 2014
U.S. Department of Homeland Security, Office for Civil Rights and Civil Liberties September 2013 - August 2014
American University Law Review September 2011 - May 2013
International Human Rights Law Clinic, American University Washington College of Law August 2012 - January 2013
Center for Human Rights and Humanitarian Law August 2012 - December 2012
United States District Court, Southern District of New York June 2012 - August 2012
White House Office of Science and Technology Policy January 2012 - May 2012
Public International Law and Policy Group August 2011 - May 2012
Skills
International Law, Westlaw, Legal Writing, Legal Research, Litigation, Research, Lexis, Public Policy, Human Rights, Community Outreach, Policy Analysis, Politics, Immigration Law, Political Science, Courts, Mediation, International Relations, Criminal Law, Legislation, Legislative Relations, Public International Law, International Human..., International..., Legal Issues, Intellectual Property
Education
American University, Washington College of Law 2011 — 2013
Doctor of Law (J.D.), cum laude
University of California, Los Angeles 2005 — 2009
B.S., B.A., Psychobiology, Political Science
Milton Sloan Milton Sloan's U.S. Food and Drug Administration Experience
Job Chemist at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration
Skills
Chemistry, Analytical Chemistry, Mass Spectrometry, Customer Service, Community Outreach, Federal Government, Government, Leadership, Management, Research, Microsoft Office, Program Management, Public Speaking, Strategic Planning, Volunteering, Team Building, Nonprofits, Leadership Development, Policy
Education
Fisk University
Bachelor's degree
Fisk University
Master's degree, Organic Chemistry, Honors
Nashville State Technical Institute
Associate's in Electronic Technology, Electrical, Electronics and Communications Engineering, Honors
The University of Georgia
Doctor of Philosophy (PhD)
U.S. Food and Drug Administration
Skills
Chemistry, Analytical Chemistry, Mass Spectrometry, Customer Service, Community Outreach, Federal Government, Government, Leadership, Management, Research, Microsoft Office, Program Management, Public Speaking, Strategic Planning, Volunteering, Team Building, Nonprofits, Leadership Development, Policy
Education
Fisk University
Bachelor's degree
Fisk University
Master's degree, Organic Chemistry, Honors
Nashville State Technical Institute
Associate's in Electronic Technology, Electrical, Electronics and Communications Engineering, Honors
The University of Georgia
Doctor of Philosophy (PhD)
Aden Asefa's U.S. Food and Drug Administration Experience May 2012 - May 2015
Job Regulatory Health Project Manager at FDA/Center for Devices and Radiological Health/Office of Device Evaluation
Industry Government Administration
Experience
FDA/Center for Devices and Radiological Health/Office of Device Evaluation May 2015 - Present
U.S. Food and Drug Administration May 2012 - May 2015
Skills
Public Health, Program Evaluation, Epidemiology, Data Analysis, Research, Statistics, Policy Analysis, Public Policy, SPSS, Quality Assurance, Qualitative Research, Program Development, Policy, Grant Writing
Education
University of Michigan 2004 — 2007
Master's in Public Health
Michigan State University 2000 — 2004
B.S., Nutrition Science
FDA/Center for Devices and Radiological Health/Office of Device Evaluation May 2015 - Present
U.S. Food and Drug Administration May 2012 - May 2015
Skills
Public Health, Program Evaluation, Epidemiology, Data Analysis, Research, Statistics, Policy Analysis, Public Policy, SPSS, Quality Assurance, Qualitative Research, Program Development, Policy, Grant Writing
Education
University of Michigan 2004 — 2007
Master's in Public Health
Michigan State University 2000 — 2004
B.S., Nutrition Science
Lena Karkar Lena Karkar's U.S. Food and Drug Administration Experience June 2014 - December 2014
Job Associate Test Engineer at Medtronic
Industry Biotechnology
Experience
Medtronic January 2015 - Present
U.S. Food and Drug Administration June 2014 - December 2014
Knowledge Engineers, Inc. April 2014 - September 2014
California Pizza Kitchen June 2012 - January 2014
F. Mclintocks June 2011 - June 2012
Chino's Rock & Tacos June 2010 - June 2011
Bronico Inc May 2010 - June 2010
Barnes And Noble June 2009 - February 2010
Bronico Inc August 2009 - October 2009
Skills
Matlab, Microsoft Office, AutoCAD, Solidworks, SPICE, Pro-Engineering 5, Access, ImageJ, Minitab, JMP, Abaqus, AWT, Biomedical Engineering, Teamwork
Education
California Polytechnic State University-San Luis Obispo 2007 — 2013
Bachelor's degree, Biomedical Engineering
Medtronic January 2015 - Present
U.S. Food and Drug Administration June 2014 - December 2014
Knowledge Engineers, Inc. April 2014 - September 2014
California Pizza Kitchen June 2012 - January 2014
F. Mclintocks June 2011 - June 2012
Chino's Rock & Tacos June 2010 - June 2011
Bronico Inc May 2010 - June 2010
Barnes And Noble June 2009 - February 2010
Bronico Inc August 2009 - October 2009
Skills
Matlab, Microsoft Office, AutoCAD, Solidworks, SPICE, Pro-Engineering 5, Access, ImageJ, Minitab, JMP, Abaqus, AWT, Biomedical Engineering, Teamwork
Education
California Polytechnic State University-San Luis Obispo 2007 — 2013
Bachelor's degree, Biomedical Engineering
Arnold Borsetti Arnold Borsetti's U.S. Food and Drug Administration Experience October 1975 - December 2005
Job Scientist/Health Professional
Industry Automotive
Experience
U.S. Food and Drug Administration October 1975 - December 2005
Education
Georgetown University 1968 — 1974
Ph.D., Chemistry
Pennsylvania Military College 1964 — 1968
Bachelor of Science, Chemistry; Commissioned 2nd Lt. US Army
U.S. Food and Drug Administration October 1975 - December 2005
Education
Georgetown University 1968 — 1974
Ph.D., Chemistry
Pennsylvania Military College 1964 — 1968
Bachelor of Science, Chemistry; Commissioned 2nd Lt. US Army
Jana McAninch Jana McAninch's U.S. Food and Drug Administration Experience July 2013 - Present
Job M.D., M.P.H, M.S.
Industry Pharmaceuticals
Experience
U.S. Food and Drug Administration July 2013 - Present
University of Maryland Baltimore School of Medicine July 2011 - June 2013
North Slope Borough Health Department June 2008 - May 2013
University of Alaska Anchorage Student Health and Counseling Center August 2008 - August 2009
Banner Health Fairbanks Memorial Hospital Home Health Care August 2008 - August 2009
University of Alaska Fairbanks Center for Health and Counseling December 2006 - August 2008
Tanana Chiefs Conference Diabetes Program January 2006 - August 2008
Northern Hospitalist Associates June 2007 - August 2007
Chief Andrew Isaac Health Center January 2007 - June 2007
Interior Community Health Center October 2003 - December 2006
Skills
Primary Care Medicine, Epidemiology, Public Health, Health Promotion, Community Health
Education
University of Maryland Baltimore 2011 — 2012
Master of Science (MS), Epidemiology and Public Health
University of California, San Francisco - School of Medicine 1993 — 1998
Doctor of Medicine (M.D.)
University of California, Berkeley 1996 — 1997
Master of Public Health (M.P.H.), Epidemiology
Brown University 1988 — 1992
Bachelor of Arts (BA), Russian Studies
U.S. Food and Drug Administration July 2013 - Present
University of Maryland Baltimore School of Medicine July 2011 - June 2013
North Slope Borough Health Department June 2008 - May 2013
University of Alaska Anchorage Student Health and Counseling Center August 2008 - August 2009
Banner Health Fairbanks Memorial Hospital Home Health Care August 2008 - August 2009
University of Alaska Fairbanks Center for Health and Counseling December 2006 - August 2008
Tanana Chiefs Conference Diabetes Program January 2006 - August 2008
Northern Hospitalist Associates June 2007 - August 2007
Chief Andrew Isaac Health Center January 2007 - June 2007
Interior Community Health Center October 2003 - December 2006
Skills
Primary Care Medicine, Epidemiology, Public Health, Health Promotion, Community Health
Education
University of Maryland Baltimore 2011 — 2012
Master of Science (MS), Epidemiology and Public Health
University of California, San Francisco - School of Medicine 1993 — 1998
Doctor of Medicine (M.D.)
University of California, Berkeley 1996 — 1997
Master of Public Health (M.P.H.), Epidemiology
Brown University 1988 — 1992
Bachelor of Arts (BA), Russian Studies
Chris Henjum's U.S. Food and Drug Administration Experience September 2011 - November 2012
Job Attorney + Analyst + Entrepreneur
Industry Law Practice
Experience
Flaherty & Hood, P.A. January 2013 - Present
Esqyr April 2014 - Present
U.S. Food and Drug Administration September 2011 - November 2012
League of Minnesota Cities October 2008 - September 2011
KARE-TV September 2004 - January 2005
Skills
Public Policy, Policy, Health Law, Legal Issues, Legislation, Civil Litigation, Administrative Law, Constitutional Law, Municipal Law, Regulatory Affairs, State Government, Local Government, Legal Writing, Nonprofits, Economic Development, Governmental Affairs, Statistical Data..., Financial Analysis, Budget Process, Policy Analysis, Westlaw, Mediation, Legal Research, Political Campaigns, Public Affairs, SPSS, Lobbying, Analytics, Forecasting, Hierarchical Cluster..., Statistics, Legislative Research, Motion Graphics, Infographics, Final Cut Pro, Legislative Relations, Information Graphics
Education
University of Minnesota Law School 2006 — 2010
JD
Humphrey School of Public Affairs 2007 — 2010
MPP, Concentration in Local Government
University of Wisconsin-Madison 2001 — 2004
BA, JBA, Political Science and Journalism
Eastview High School 1997 — 2001
Flaherty & Hood, P.A. January 2013 - Present
Esqyr April 2014 - Present
U.S. Food and Drug Administration September 2011 - November 2012
League of Minnesota Cities October 2008 - September 2011
KARE-TV September 2004 - January 2005
Skills
Public Policy, Policy, Health Law, Legal Issues, Legislation, Civil Litigation, Administrative Law, Constitutional Law, Municipal Law, Regulatory Affairs, State Government, Local Government, Legal Writing, Nonprofits, Economic Development, Governmental Affairs, Statistical Data..., Financial Analysis, Budget Process, Policy Analysis, Westlaw, Mediation, Legal Research, Political Campaigns, Public Affairs, SPSS, Lobbying, Analytics, Forecasting, Hierarchical Cluster..., Statistics, Legislative Research, Motion Graphics, Infographics, Final Cut Pro, Legislative Relations, Information Graphics
Education
University of Minnesota Law School 2006 — 2010
JD
Humphrey School of Public Affairs 2007 — 2010
MPP, Concentration in Local Government
University of Wisconsin-Madison 2001 — 2004
BA, JBA, Political Science and Journalism
Eastview High School 1997 — 2001
Larry Thompson Larry Thompson's U.S. Food and Drug Administration Experience October 1995 - February 2001
Job Senior Director, Communications, Johnson & Johnson Office of the Chief Medical Officer
Industry Pharmaceuticals
Experience
Johnson & Johnson May 2014 - Present
National Human Genome Research Institute February 2001 - May 2014
U.S. Food and Drug Administration October 1995 - February 2001
Medical News Network January 1993 - September 1994
The Washington Post October 1984 - January 1992
San Jose Mercury News September 1982 - October 1984
Call-Chronicle Newspapers 1974 - 1982
Skills
Science Journalism, Science Communication, Health Communication, Public Health, Publications, Science, Editing, Strategic Communications, Lifesciences, Research, Community Outreach, Public Policy, Public Speaking, Policy Analysis, Grants, Social Media, Media Relations, Epidemiology, Crisis Communications
Education
American University 1997 — 1999
M.F.A., with Distinction, Film and Digital Media
Lehigh University 1980 — 1982
M.S., Molecular Biology
Yale University School of Medicine 1977 — 1978
Fellow, Public Health
Kutztown University of Pennsylvania 1973 — 1976
B.S., Biology
Johnson & Johnson May 2014 - Present
National Human Genome Research Institute February 2001 - May 2014
U.S. Food and Drug Administration October 1995 - February 2001
Medical News Network January 1993 - September 1994
The Washington Post October 1984 - January 1992
San Jose Mercury News September 1982 - October 1984
Call-Chronicle Newspapers 1974 - 1982
Skills
Science Journalism, Science Communication, Health Communication, Public Health, Publications, Science, Editing, Strategic Communications, Lifesciences, Research, Community Outreach, Public Policy, Public Speaking, Policy Analysis, Grants, Social Media, Media Relations, Epidemiology, Crisis Communications
Education
American University 1997 — 1999
M.F.A., with Distinction, Film and Digital Media
Lehigh University 1980 — 1982
M.S., Molecular Biology
Yale University School of Medicine 1977 — 1978
Fellow, Public Health
Kutztown University of Pennsylvania 1973 — 1976
B.S., Biology
Leigh Anne Myers's U.S. Food and Drug Administration Experience October 2000 - August 2005
Job President at Myers Quality Consulting, LLC
Industry Pharmaceuticals
Experience
Myers Quality Consulting, LLC March 2009 - Present
Targanta Therapeutics March 2008 - February 2009
Roche Diagnostics February 2007 - March 2008
Blood Systems August 2005 - February 2007
U.S. Food and Drug Administration October 2000 - August 2005
Skills
GLP, Quality Systems, FDA, Auditing, Quality Auditing, GCP, Medical Devices, Life Sciences, Quality Assurance, Compliance, Clinical Research, CAPA, Diagnostics, SOP, Pharmaceuticals, Biotechnology, Sop, Pharmaceutical Industry, Lifesciences, Quality System, 21 CFR Part 11
Education
Indiana University-Purdue University at Indianapolis
Myers Quality Consulting, LLC March 2009 - Present
Targanta Therapeutics March 2008 - February 2009
Roche Diagnostics February 2007 - March 2008
Blood Systems August 2005 - February 2007
U.S. Food and Drug Administration October 2000 - August 2005
Skills
GLP, Quality Systems, FDA, Auditing, Quality Auditing, GCP, Medical Devices, Life Sciences, Quality Assurance, Compliance, Clinical Research, CAPA, Diagnostics, SOP, Pharmaceuticals, Biotechnology, Sop, Pharmaceutical Industry, Lifesciences, Quality System, 21 CFR Part 11
Education
Indiana University-Purdue University at Indianapolis
Stephanie Fishel-Brown, Ph.D. Stephanie Fishel-Brown, Ph.D.'s U.S. Food and Drug Administration Experience June 2004 - August 2004
Job Research Psychologist Using data to positively impact the user experience and behavior
Industry Research
Experience
UserTesting February 2015 - Present
User Experience Magazine May 2013 - Present
Freelance March 2011 - Present
AutoTrader.com September 2011 - February 2015
SA Technologies August 2008 - May 2011
Clemson University June 2003 - July 2008
Clemson University January 2007 - December 2007
U.S. Food and Drug Administration June 2004 - August 2004
Wake Forest University Baptist Medical Center October 2001 - May 2003
High Point University August 2001 - May 2003
Skills
Mobile Usability, Leadership, Qualitative Research, Usability Testing, Remote Research, User Research, Heuristic Evaluation, User Experience, Task Analysis, Human Factors, User Interface Design, Usability, Persona, Psychology, Research Design, Wireframes, Statistics, User-centered Design, Contextual Inquiry, Card Sorting, Experimental Design, Iterative Design, Research, Interaction Design, Usability Engineering, Human Computer..., User Scenarios, Wire Framing, Information Architecture, Data Analysis, Human Factors..., Ethnography, Cognitive Psychology, Heuristic Analysis, Requirements Gathering, SPSS, Axure, Participatory Design, Experience Design, Scientific Writing, Experimental Research, Personas, Sitemaps, User Profiling, User Journeys, Human-computer..., Cognitive Walkthrough, User Experience Design, Professional Mentoring
Education
Clemson University 2005 — 2010
Ph.D., Human Factors Psychology
Clemson University 2003 — 2005
M.S., Applied Psychology
High Point University 1999 — 2003
B.S., Biology, Psychology
UserTesting February 2015 - Present
User Experience Magazine May 2013 - Present
Freelance March 2011 - Present
AutoTrader.com September 2011 - February 2015
SA Technologies August 2008 - May 2011
Clemson University June 2003 - July 2008
Clemson University January 2007 - December 2007
U.S. Food and Drug Administration June 2004 - August 2004
Wake Forest University Baptist Medical Center October 2001 - May 2003
High Point University August 2001 - May 2003
Skills
Mobile Usability, Leadership, Qualitative Research, Usability Testing, Remote Research, User Research, Heuristic Evaluation, User Experience, Task Analysis, Human Factors, User Interface Design, Usability, Persona, Psychology, Research Design, Wireframes, Statistics, User-centered Design, Contextual Inquiry, Card Sorting, Experimental Design, Iterative Design, Research, Interaction Design, Usability Engineering, Human Computer..., User Scenarios, Wire Framing, Information Architecture, Data Analysis, Human Factors..., Ethnography, Cognitive Psychology, Heuristic Analysis, Requirements Gathering, SPSS, Axure, Participatory Design, Experience Design, Scientific Writing, Experimental Research, Personas, Sitemaps, User Profiling, User Journeys, Human-computer..., Cognitive Walkthrough, User Experience Design, Professional Mentoring
Education
Clemson University 2005 — 2010
Ph.D., Human Factors Psychology
Clemson University 2003 — 2005
M.S., Applied Psychology
High Point University 1999 — 2003
B.S., Biology, Psychology
Heike Sichtig Heike Sichtig's U.S. Food and Drug Administration Experience August 2012 - Present
Job Principal Investigator and Regulatory Scientist at FDA
Industry Government Administration
Experience
U.S. Food and Drug Administration August 2012 - Present
University of Florida May 2009 - August 2012
SUNY Binghamton May 2006 - May 2009
Binghamton University May 2004 - May 2009
University of Hawaii at Manoa December 2003 - May 2004
University of Hawaii at Manoa May 2003 - December 2003
Kean University March 1999 - August 2002
CAG/ ICPH June 2001 - October 2001
Skills
LaTeX, Matlab, R, Bioinformatics, Python, Pattern Recognition, Computer Simulation, C++ Language, Machine Learning, Perl, Lisp, spiking neural networks, Genetic Algorithms, Transcriptional..., complex systems, Complex Systems, Neural Networks, Java, Artificial Intelligence, Computer Science, Statistics, Linux, Algorithms, Programming, Computational Biology, Mathematical Modeling, Mathematica, Scientific Writing, Molecular Biology, Systems Biology, Data Mining, Simulations, Science, Data Analysis, Optimization, Signal Processing, Genomics, Biomedical Engineering
Education
State University of New York at Binghamton 2004 — 2009
PhD, Bioengineering and Biomedical Engineering
Massachusetts Institute of Technology 2006 — 2006
Certificate, Complex Physical, Biological & Social Systems
University of Hawaii at Manoa 2003 — 2004
Post Graduate Work, Computer Science
Kean University 1998 — 2003
B.S., M.S., Computer Science; Computing, Statistics and Math
U.S. Food and Drug Administration August 2012 - Present
University of Florida May 2009 - August 2012
SUNY Binghamton May 2006 - May 2009
Binghamton University May 2004 - May 2009
University of Hawaii at Manoa December 2003 - May 2004
University of Hawaii at Manoa May 2003 - December 2003
Kean University March 1999 - August 2002
CAG/ ICPH June 2001 - October 2001
Skills
LaTeX, Matlab, R, Bioinformatics, Python, Pattern Recognition, Computer Simulation, C++ Language, Machine Learning, Perl, Lisp, spiking neural networks, Genetic Algorithms, Transcriptional..., complex systems, Complex Systems, Neural Networks, Java, Artificial Intelligence, Computer Science, Statistics, Linux, Algorithms, Programming, Computational Biology, Mathematical Modeling, Mathematica, Scientific Writing, Molecular Biology, Systems Biology, Data Mining, Simulations, Science, Data Analysis, Optimization, Signal Processing, Genomics, Biomedical Engineering
Education
State University of New York at Binghamton 2004 — 2009
PhD, Bioengineering and Biomedical Engineering
Massachusetts Institute of Technology 2006 — 2006
Certificate, Complex Physical, Biological & Social Systems
University of Hawaii at Manoa 2003 — 2004
Post Graduate Work, Computer Science
Kean University 1998 — 2003
B.S., M.S., Computer Science; Computing, Statistics and Math
Ravi Bharwani Ravi Bharwani's U.S. Food and Drug Administration Experience September 2013 - Present
Job International Trade Analyst at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration September 2013 - Present
U.S. Food and Drug Administration March 2009 - Present
U.S. Food and Drug Administration September 2007 - March 2009
Skills
Quality Management, Business Analysis, Data Analysis, Qualitative Research, Quantitative Research, Budget Monitoring, Budget Setting, Microsoft Office, Analysis, Quality System, Quality Assurance, Operations Management, Regulatory Affairs, Management, Government, Policy Analysis, Research, Policy, Budgets, Federal Government, Program Management, Microsoft Excel, Strategic Planning, Leadership
Education
University of Maryland - Robert H. Smith School of Business 2012 — 2015
Master of Business Administration (M.B.A.) & M.S. Finance, Finance, General
American University 2005 — 2009
Bachelor of Arts (B.A.), Communications, Law, Economics & Government
Long Island Lutheran 2001 — 2005
Northport Middle School
U.S. Food and Drug Administration September 2013 - Present
U.S. Food and Drug Administration March 2009 - Present
U.S. Food and Drug Administration September 2007 - March 2009
Skills
Quality Management, Business Analysis, Data Analysis, Qualitative Research, Quantitative Research, Budget Monitoring, Budget Setting, Microsoft Office, Analysis, Quality System, Quality Assurance, Operations Management, Regulatory Affairs, Management, Government, Policy Analysis, Research, Policy, Budgets, Federal Government, Program Management, Microsoft Excel, Strategic Planning, Leadership
Education
University of Maryland - Robert H. Smith School of Business 2012 — 2015
Master of Business Administration (M.B.A.) & M.S. Finance, Finance, General
American University 2005 — 2009
Bachelor of Arts (B.A.), Communications, Law, Economics & Government
Long Island Lutheran 2001 — 2005
Northport Middle School
Tesfa Alexander Tesfa Alexander's U.S. Food and Drug Administration Experience May 2010 - January 2014
Job Lead Health Scientist in Health Communication and Education at FDA
Industry Research
Experience
U.S. Food and Drug Administration, Center for Tobacco Products January 2014 - Present
University of Memphis August 2011 - Present
U.S. Food and Drug Administration May 2010 - January 2014
University of Virginia January 2010 - May 2010
National Cancer Institute August 2009 - February 2010
National Institutes of Health May 2008 - September 2009
Methodist Healthcare August 2007 - May 2009
Ogilvy Public Relations Worldwide 2006 - 2007
Weber Shandwick 2004 - 2006
Skills
Grant Writing, Strategic Communications, Internal Communications, Community Outreach, Public Relations, Constant Contact, Event Planning, Program Evaluation, Health Communication, Healthcare, Crisis Communications, Corporate Communications, Editing, Qualitative Research, Higher Education, Media Relations, Program Development, Teaching, Intercultural..., Kindness, Nonprofits, Research, Public Health, Reputation Management, Press Releases, Public Speaking, Policy Analysis, Speech Writing, Community Development
Education
The University of Memphis 2007 — 2010
PhD, Cross-Cultural Health Communication
Emerson College 2002 — 2003
MA, Organizational Communication
State University of New York College at Potsdam 1998 — 2002
BA, English Writing/Speech Communication
U.S. Food and Drug Administration, Center for Tobacco Products January 2014 - Present
University of Memphis August 2011 - Present
U.S. Food and Drug Administration May 2010 - January 2014
University of Virginia January 2010 - May 2010
National Cancer Institute August 2009 - February 2010
National Institutes of Health May 2008 - September 2009
Methodist Healthcare August 2007 - May 2009
Ogilvy Public Relations Worldwide 2006 - 2007
Weber Shandwick 2004 - 2006
Skills
Grant Writing, Strategic Communications, Internal Communications, Community Outreach, Public Relations, Constant Contact, Event Planning, Program Evaluation, Health Communication, Healthcare, Crisis Communications, Corporate Communications, Editing, Qualitative Research, Higher Education, Media Relations, Program Development, Teaching, Intercultural..., Kindness, Nonprofits, Research, Public Health, Reputation Management, Press Releases, Public Speaking, Policy Analysis, Speech Writing, Community Development
Education
The University of Memphis 2007 — 2010
PhD, Cross-Cultural Health Communication
Emerson College 2002 — 2003
MA, Organizational Communication
State University of New York College at Potsdam 1998 — 2002
BA, English Writing/Speech Communication
Jon Daugherty Jon Daugherty's U.S. Food and Drug Administration Experience June 2015 - Present
Job Chief, CMC Review Branch 1 at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration June 2015 - Present
U.S. Food and Drug Administration January 2000 - June 2015
National Institutes of Health March 1998 - December 1999
Walter Reed Army Institute of Research April 1993 - January 1998
U.S. Army 28th Combat Support Hospital January 1982 - August 1982
U.S. Army 5th General Hospital/Bad Cannstatt MEDDAC July 1979 - December 1981
Skills
Regulatory Affairs, Biologics, Vaccines, Life Sciences, Microbiology, Infectious Diseases, Molecular Biology, Immunology, Laboratory Medicine, Public Health, Science, Research, Northern Blotting, SDS-PAGE, Western Blotting, Yeast, Protein Expression, PCR, Public Speaking, FDA
Education
University of Tennessee-Health Science Center 1986 — 1992
Ph.D., Microbiology
Florida State University 1982 — 1986
B.S., Medical Technology
U.S. Army Academy of Health Sciences, Medical Laboratory Specialist (MOS92B) Course
Diploma, Clinical Laboratory Science/Medical Technology/Technologist
U.S. Food and Drug Administration June 2015 - Present
U.S. Food and Drug Administration January 2000 - June 2015
National Institutes of Health March 1998 - December 1999
Walter Reed Army Institute of Research April 1993 - January 1998
U.S. Army 28th Combat Support Hospital January 1982 - August 1982
U.S. Army 5th General Hospital/Bad Cannstatt MEDDAC July 1979 - December 1981
Skills
Regulatory Affairs, Biologics, Vaccines, Life Sciences, Microbiology, Infectious Diseases, Molecular Biology, Immunology, Laboratory Medicine, Public Health, Science, Research, Northern Blotting, SDS-PAGE, Western Blotting, Yeast, Protein Expression, PCR, Public Speaking, FDA
Education
University of Tennessee-Health Science Center 1986 — 1992
Ph.D., Microbiology
Florida State University 1982 — 1986
B.S., Medical Technology
U.S. Army Academy of Health Sciences, Medical Laboratory Specialist (MOS92B) Course
Diploma, Clinical Laboratory Science/Medical Technology/Technologist
Elisabeth Walther Elisabeth Walther's U.S. Food and Drug Administration Experience August 2008 - Present
Job Regulatory Counsel at U.S. Food and Drug Administration
Industry Public Policy
Experience
U.S. Food and Drug Administration August 2008 - Present
Walgreen Co. June 2006 - Present
Skills
Policy, Policy Analysis, Public Policy, Regulatory Affairs, Public Health, Health Policy, Healthcare, Government, Public Speaking, Legal Research, Pharmaceutical Industry, Legal Writing, Regulations, Administrative Law, Community Outreach
Education
Drake University
Doctor of Pharmacy (Pharm.D.)
Drake University
Doctor of Law (J.D.)
U.S. Food and Drug Administration August 2008 - Present
Walgreen Co. June 2006 - Present
Skills
Policy, Policy Analysis, Public Policy, Regulatory Affairs, Public Health, Health Policy, Healthcare, Government, Public Speaking, Legal Research, Pharmaceutical Industry, Legal Writing, Regulations, Administrative Law, Community Outreach
Education
Drake University
Doctor of Pharmacy (Pharm.D.)
Drake University
Doctor of Law (J.D.)
Purushottam Mahindrakar Purushottam Mahindrakar's U.S. Food and Drug Administration Experience May 2012 - May 2013
Job Sr. Oracle Pl/SQL Developer at Georgia Department Of Education
Industry Computer Software
Experience
Georgia Department of Education July 2015 - Present
VoAPPs, Inc June 2013 - July 2015
U.S. Food and Drug Administration May 2012 - May 2013
Florida Blue February 2011 - May 2012
Vensai Technologies, Inc July 2005 - February 2011
Logica infotech May 2002 - July 2005
Oxford collage of engineering September 1999 - April 2002
Skills
PL/SQL, Oracle, SQL, Toad, Oracle Applications, SDLC, Unix, Databases, XML, Java, Database Design, Unix Shell Scripting, Requirements Gathering, Requirements Analysis, C, JSP
Education
Gulbarga University 1995 — 1999
Bachelor of Engineering (B.E.), Computer Science
Gulbarga University 1995 — 1999
CSE, Computers
Georgia Department of Education July 2015 - Present
VoAPPs, Inc June 2013 - July 2015
U.S. Food and Drug Administration May 2012 - May 2013
Florida Blue February 2011 - May 2012
Vensai Technologies, Inc July 2005 - February 2011
Logica infotech May 2002 - July 2005
Oxford collage of engineering September 1999 - April 2002
Skills
PL/SQL, Oracle, SQL, Toad, Oracle Applications, SDLC, Unix, Databases, XML, Java, Database Design, Unix Shell Scripting, Requirements Gathering, Requirements Analysis, C, JSP
Education
Gulbarga University 1995 — 1999
Bachelor of Engineering (B.E.), Computer Science
Gulbarga University 1995 — 1999
CSE, Computers
Sylvester Mosley, Ph.D.'s U.S. Food and Drug Administration Experience January 2007 - September 2008
Job Consumer Safety Officer at FDA
Industry Food & Beverages
Experience
FDA September 2008 - Present
U.S. Food and Drug Administration January 2007 - September 2008
Skills
Food Safety, HPLC, Vaccines, Chromatography, Chemistry, FDA, Science, Food, Regulatory Affairs, R&D, GMP, Biotechnology, Lifesciences, UV/Vis, Molecular Biology, Microbiology, Toxicology, Life Sciences
Education
University of Maryland Baltimore County 2003 — 2006
Ph.D., Organic Chemistry
Georgia Institute of Technology 1998 — 2001
M.S., Organic Chemistry
Tuskegee University 1994 — 1998
B.S., Chemistry
FDA September 2008 - Present
U.S. Food and Drug Administration January 2007 - September 2008
Skills
Food Safety, HPLC, Vaccines, Chromatography, Chemistry, FDA, Science, Food, Regulatory Affairs, R&D, GMP, Biotechnology, Lifesciences, UV/Vis, Molecular Biology, Microbiology, Toxicology, Life Sciences
Education
University of Maryland Baltimore County 2003 — 2006
Ph.D., Organic Chemistry
Georgia Institute of Technology 1998 — 2001
M.S., Organic Chemistry
Tuskegee University 1994 — 1998
B.S., Chemistry
Brandon Restrepo's U.S. Food and Drug Administration Experience October 2014 - Present
Job Economist at U.S. FDA
Industry Public Policy
Experience
U.S. Food and Drug Administration October 2014 - Present
Athens University of Economics and Business June 2014 - November 2014
European University Institute September 2012 - September 2014
The Ohio State University September 2008 - September 2011
Skills
Research, Economics, Econometrics, Stata, Teaching, Qualitative Research, Quantitative Research, Applied Economics, Health Economics, Labor Economics, Demography, Public Health, Time Series Analysis, Public Policy, Statistics
Education
European University Institute 2013 — 2014
Teaching Certificate
The Ohio State University 2007 — 2012
Doctor of Philosophy (Ph.D.), Economics
Saint John's University 2002 — 2006
Bachelor of Science (B.S.), Economics
U.S. Food and Drug Administration October 2014 - Present
Athens University of Economics and Business June 2014 - November 2014
European University Institute September 2012 - September 2014
The Ohio State University September 2008 - September 2011
Skills
Research, Economics, Econometrics, Stata, Teaching, Qualitative Research, Quantitative Research, Applied Economics, Health Economics, Labor Economics, Demography, Public Health, Time Series Analysis, Public Policy, Statistics
Education
European University Institute 2013 — 2014
Teaching Certificate
The Ohio State University 2007 — 2012
Doctor of Philosophy (Ph.D.), Economics
Saint John's University 2002 — 2006
Bachelor of Science (B.S.), Economics
Paul F. Bove Paul F. Bove's U.S. Food and Drug Administration Experience April 2012 - Present
Job Social Media Lead at U.S. Food and Drug Administration
Industry Public Relations and Communications
Experience
U.S. Food and Drug Administration April 2012 - Present
American University May 2011 - Present
Skills
Social Media, Public Relations, Editing, Corporate Communications, Policy, Teaching, Public Speaking, Blogging, Strategic Communications, Writing, Social Networking, Internal Communications, Communications Strategy, New Media, Crisis Communications, Facebook, Web 2.0, Government Liaison, Digital Strategy, Wordpress, Digital Media, Strategy, Copy Editing, Journalism, Leadership, Media Relations, WordPress, SEO, Marketing Communications
Education
Georgetown University 2008 — 2009
MPS, Public Relations and Corporate Communications
Canisius College 1991 — 1995
BA, English, Political Science, Classics
The George Washington University 1999 — 2000
Editing and Desktop Publishing
U.S. Food and Drug Administration April 2012 - Present
American University May 2011 - Present
Skills
Social Media, Public Relations, Editing, Corporate Communications, Policy, Teaching, Public Speaking, Blogging, Strategic Communications, Writing, Social Networking, Internal Communications, Communications Strategy, New Media, Crisis Communications, Facebook, Web 2.0, Government Liaison, Digital Strategy, Wordpress, Digital Media, Strategy, Copy Editing, Journalism, Leadership, Media Relations, WordPress, SEO, Marketing Communications
Education
Georgetown University 2008 — 2009
MPS, Public Relations and Corporate Communications
Canisius College 1991 — 1995
BA, English, Political Science, Classics
The George Washington University 1999 — 2000
Editing and Desktop Publishing
Phil Barnett Phil Barnett's U.S. Food and Drug Administration Experience January 1996 - December 1996
Job Attorney
Industry Law Practice
Experience
Committee on Energy and Commerce, U.S. House of Representatives January 2009 - December 2014
Committee on Oversight and Government Reform, U.S. House of Representatives January 1997 - December 2008
U.S. Food and Drug Administration January 1996 - December 1996
Rep. Henry A. Waxman, U.S. House of Representatives January 1995 - December 1995
Subcommittee on Health and the Environment, U.S. House of Representatives January 1989 - December 1994
Sierra Club Legal Defense Fund 1984 - 1988
Judge William C. Canby, Jr., U.S. Ninth Circuit Court of Appeals 1983 - 1984
Skills
Policy Analysis, Public Policy, Policy, Legislation, Government, Legislative Relations, Strategic Communications, Nonprofits, Coalitions
Education
Harvard Law School 1980 — 1983
J.D.
Princeton University 1975 — 1979
A.B., Philosophy
Committee on Energy and Commerce, U.S. House of Representatives January 2009 - December 2014
Committee on Oversight and Government Reform, U.S. House of Representatives January 1997 - December 2008
U.S. Food and Drug Administration January 1996 - December 1996
Rep. Henry A. Waxman, U.S. House of Representatives January 1995 - December 1995
Subcommittee on Health and the Environment, U.S. House of Representatives January 1989 - December 1994
Sierra Club Legal Defense Fund 1984 - 1988
Judge William C. Canby, Jr., U.S. Ninth Circuit Court of Appeals 1983 - 1984
Skills
Policy Analysis, Public Policy, Policy, Legislation, Government, Legislative Relations, Strategic Communications, Nonprofits, Coalitions
Education
Harvard Law School 1980 — 1983
J.D.
Princeton University 1975 — 1979
A.B., Philosophy
Rachel Rogers (Hammond) Rachel Rogers (Hammond)'s U.S. Food and Drug Administration Experience October 2009 - April 2011
Job Senior Biostatistician at Westat
Industry Biotechnology
Experience
Westat April 2012 - Present
UPENN June 2006 - April 2012
University of Pennsylvania School of Medicine June 2007 - May 2011
U.S. Food and Drug Administration October 2009 - April 2011
University of Pennsylvania School of Medicine June 2007 - April 2011
University of Pennsylvania School of Medicine May 2005 - May 2006
Drexel University January 2004 - May 2004
North Penn School District September 2001 - May 2002
Skills
SAS, SAS Macros, Stata, R Programming, Windows,..., CART, Statistics, Biostatistics, Survival Analysis, Multivariate Analysis, Epidemiology, Logistic Regression, R, Time Series Analysis, Analysis, Data Analysis, Research, Clinical Trials
Education
University of Pennsylvania School of Medicine 2004 — 2006
M.S., Biostatistics
Drexel University 2002 — 2004
M.S., Mathematics
Penn State University 1996 — 2001
B.S., Secondary Education, Mathematics
Westat April 2012 - Present
UPENN June 2006 - April 2012
University of Pennsylvania School of Medicine June 2007 - May 2011
U.S. Food and Drug Administration October 2009 - April 2011
University of Pennsylvania School of Medicine June 2007 - April 2011
University of Pennsylvania School of Medicine May 2005 - May 2006
Drexel University January 2004 - May 2004
North Penn School District September 2001 - May 2002
Skills
SAS, SAS Macros, Stata, R Programming, Windows,..., CART, Statistics, Biostatistics, Survival Analysis, Multivariate Analysis, Epidemiology, Logistic Regression, R, Time Series Analysis, Analysis, Data Analysis, Research, Clinical Trials
Education
University of Pennsylvania School of Medicine 2004 — 2006
M.S., Biostatistics
Drexel University 2002 — 2004
M.S., Mathematics
Penn State University 1996 — 2001
B.S., Secondary Education, Mathematics
Daniel Gordin Daniel Gordin's U.S. Food and Drug Administration Experience December 1988 - January 1994
Job Executive Director, Drug Regulatory Affairs
Industry Pharmaceuticals
Experience
Novartis Pharmaceuticals US January 2009 - Present
NOVARTIS PHARMACEUTICALS June 2002 - December 2008
FOREST LABORATORIES 1999 - 2002
SYNTHELABO RESEARCH, INC. November 1997 - June 1999
OTSUKA AMERICA PHARMACEUTICAL, INC 1996 - 1997
LEIRAS PHARMACEUTICALS, INC 1994 - 1996
U.S. FOOD AND DRUG ADMINISTRATION December 1988 - January 1994
Skills
Infectious Diseases, Transplant, Neuroscience, Dermatology, Autoimmune Diseases, FDA, Regulatory Affairs, Healthcare, Therapeutic Areas, Pharmacokinetics, Phase I, Immunology, Drug Development, Clinical Trials, Clinical Development, Pharmacodynamics, Regulatory Submissions, IND, Clinical Pharmacology
Education
Medical University of South Carolina 1983 — 1989
Ph.D., Pharmaceutical Science
Medical University of South Carolina 1981 — 1983
B.S., Laboratory Science
University of South Carolina-Columbia 1976 — 1980
B.S., Biology
Novartis Pharmaceuticals US January 2009 - Present
NOVARTIS PHARMACEUTICALS June 2002 - December 2008
FOREST LABORATORIES 1999 - 2002
SYNTHELABO RESEARCH, INC. November 1997 - June 1999
OTSUKA AMERICA PHARMACEUTICAL, INC 1996 - 1997
LEIRAS PHARMACEUTICALS, INC 1994 - 1996
U.S. FOOD AND DRUG ADMINISTRATION December 1988 - January 1994
Skills
Infectious Diseases, Transplant, Neuroscience, Dermatology, Autoimmune Diseases, FDA, Regulatory Affairs, Healthcare, Therapeutic Areas, Pharmacokinetics, Phase I, Immunology, Drug Development, Clinical Trials, Clinical Development, Pharmacodynamics, Regulatory Submissions, IND, Clinical Pharmacology
Education
Medical University of South Carolina 1983 — 1989
Ph.D., Pharmaceutical Science
Medical University of South Carolina 1981 — 1983
B.S., Laboratory Science
University of South Carolina-Columbia 1976 — 1980
B.S., Biology
Matt Wojtkun's U.S. Food and Drug Administration Experience January 2010 - August 2011
Job Press Secretary at U.S. House of Representatives
Industry Public Relations and Communications
Experience
U.S. House of Representatives April 2014 - Present
Powell Tate Weber Shandwick August 2011 - April 2014
Mark Herring for Attorney General August 2013 - November 2013
Mark Herring for Attorney General March 2013 - July 2013
Obama for America November 2012 - November 2012
U.S. Food and Drug Administration January 2010 - August 2011
German Marshall Fund of the United States May 2006 - August 2009
Skills
German, Media Relations, Advocacy, Public Relations, Public Administration, Government, Strategic Communications, Drums, Guitar, Golf, Public Affairs, Foreign Policy, International Relations, Politics, Policy Analysis, Public Policy, State and Federal Tax..., Legislative Relations, Crisis Management, Editing, Grassroots Organizing, Speech Writing
Education
The George Washington University 2011 — 2013
Master of Public Administration (M.P.A.), Federal Policy, Politics and Management
American University 2002 — 2006
B.A., Public Communication/German Language
Freie Universität Berlin 2004 — 2004
Political Science
St. John's Prep 1998 — 2002
U.S. House of Representatives April 2014 - Present
Powell Tate Weber Shandwick August 2011 - April 2014
Mark Herring for Attorney General August 2013 - November 2013
Mark Herring for Attorney General March 2013 - July 2013
Obama for America November 2012 - November 2012
U.S. Food and Drug Administration January 2010 - August 2011
German Marshall Fund of the United States May 2006 - August 2009
Skills
German, Media Relations, Advocacy, Public Relations, Public Administration, Government, Strategic Communications, Drums, Guitar, Golf, Public Affairs, Foreign Policy, International Relations, Politics, Policy Analysis, Public Policy, State and Federal Tax..., Legislative Relations, Crisis Management, Editing, Grassroots Organizing, Speech Writing
Education
The George Washington University 2011 — 2013
Master of Public Administration (M.P.A.), Federal Policy, Politics and Management
American University 2002 — 2006
B.A., Public Communication/German Language
Freie Universität Berlin 2004 — 2004
Political Science
St. John's Prep 1998 — 2002
Danny Akacki's U.S. Food and Drug Administration Experience September 2011 - January 2012
Job Consultant at Mandiant
Industry Information Technology and Services
Experience
Mandiant August 2015 - Present
GE Capital October 2014 - June 2015
Mandiant October 2013 - August 2014
Foot Locker August 2012 - September 2013
U.S. Food and Drug Administration September 2011 - January 2012
Graystone Tower Bank September 2010 - September 2011
Widener University September 2005 - September 2010
Skills
Splunk, Intrusion Detection, Cybercrime, APT, Security Operations..., Packet Capture, Wireshark, Network Security, Information Security, Linux, Penetration Testing, Malware Analysis, Vulnerability Assessment, System Administration, Troubleshooting, Disaster Recovery, Cisco Routers, Network Administration, Security+, Deep Packet Inspection, McAfee ePolicy..., Servers, Cisco Technologies, McAfee Network Security..., NetWitness, Encryption, Virus Removal, Port Security, DNS, DHCP, Business Continuity..., Business Impact Analysis, Wireless Security, Firewalls, Help Desk Support
Education
Berks Technical Institute 2000 — 2002
Associate's degree, Network and System Administration/Administrator
Mandiant August 2015 - Present
GE Capital October 2014 - June 2015
Mandiant October 2013 - August 2014
Foot Locker August 2012 - September 2013
U.S. Food and Drug Administration September 2011 - January 2012
Graystone Tower Bank September 2010 - September 2011
Widener University September 2005 - September 2010
Skills
Splunk, Intrusion Detection, Cybercrime, APT, Security Operations..., Packet Capture, Wireshark, Network Security, Information Security, Linux, Penetration Testing, Malware Analysis, Vulnerability Assessment, System Administration, Troubleshooting, Disaster Recovery, Cisco Routers, Network Administration, Security+, Deep Packet Inspection, McAfee ePolicy..., Servers, Cisco Technologies, McAfee Network Security..., NetWitness, Encryption, Virus Removal, Port Security, DNS, DHCP, Business Continuity..., Business Impact Analysis, Wireless Security, Firewalls, Help Desk Support
Education
Berks Technical Institute 2000 — 2002
Associate's degree, Network and System Administration/Administrator
Alan Tart Alan Tart's U.S. Food and Drug Administration Experience May 1997 - September 1999
Job Retail Food Program Specialist at FDA
Industry Government Administration
Experience
U.S. Food and Drug Administration, ORA/Office of Partnerships March 2013 - Present
U.S. Food and Drug Administration, ORA/Division of Human Resource Development October 2010 - March 2013
Avensong Community Association February 2007 - May 2012
Milton, GA January 2008 - December 2011
U.S. Food and Drug Administration, Southeast Region September 1999 - October 2010
U.S. Food and Drug Administration May 1997 - September 1999
Hardaway High School/Muscogee County School District September 1996 - May 1997
Skills
Food Safety, HACCP, Food Microbiology, Policy, FDA, Sanitation, Food, Compliance, Quality Assurance, Strategic Planning, Problem Solving, Microbiology, Auditing, Team Building, Public Health, Microsoft Office, Regulatory Affairs, Food Industry, Negotiation, Risk Assessment, Coaching, Inspection, PowerPoint, Training, Leadership, Public Speaking, Program Management, Infectious Diseases, Laboratory, Time Management, Management, Analysis, Process Improvement, Quality Control, Research, Project Planning, Food Processing, Sop, Continuous Improvement, Food Science, Employee Training, Budgets, Recruiting, Quality Management, GMP, Chemistry, Emergency Management, Quality Auditing, Government, Quality System
Education
Atlanta Federal Executive Board Leadership Government Program 2007 — 2008
Graduate
Columbus State University 1996 — 1997
Graduate courses towards M.Ed. in Biology
Berry College 1992 — 1996
BS, Biology
U.S. Food and Drug Administration, ORA/Office of Partnerships March 2013 - Present
U.S. Food and Drug Administration, ORA/Division of Human Resource Development October 2010 - March 2013
Avensong Community Association February 2007 - May 2012
Milton, GA January 2008 - December 2011
U.S. Food and Drug Administration, Southeast Region September 1999 - October 2010
U.S. Food and Drug Administration May 1997 - September 1999
Hardaway High School/Muscogee County School District September 1996 - May 1997
Skills
Food Safety, HACCP, Food Microbiology, Policy, FDA, Sanitation, Food, Compliance, Quality Assurance, Strategic Planning, Problem Solving, Microbiology, Auditing, Team Building, Public Health, Microsoft Office, Regulatory Affairs, Food Industry, Negotiation, Risk Assessment, Coaching, Inspection, PowerPoint, Training, Leadership, Public Speaking, Program Management, Infectious Diseases, Laboratory, Time Management, Management, Analysis, Process Improvement, Quality Control, Research, Project Planning, Food Processing, Sop, Continuous Improvement, Food Science, Employee Training, Budgets, Recruiting, Quality Management, GMP, Chemistry, Emergency Management, Quality Auditing, Government, Quality System
Education
Atlanta Federal Executive Board Leadership Government Program 2007 — 2008
Graduate
Columbus State University 1996 — 1997
Graduate courses towards M.Ed. in Biology
Berry College 1992 — 1996
BS, Biology
Patrice Hall Patrice Hall's U.S. Food and Drug Administration Experience June 2013 - Present
Job Investigator / Consumer Safety Officer at U.S. Food and Drug Administration
Industry Research
Experience
U.S. Food and Drug Administration June 2013 - Present
U.S. Food and Drug Administration September 2008 - June 2013
Centers for Disease Control and Prevention July 2006 - August 2008
Atlanta Research and Education Foundation July 2004 - July 2006
Education
Georgia State University 2010 — 2012
Master's degree, Biology
University of Alabama 1991 — 1996
Bachelor of Science (BS), Microbiology
U.S. Food and Drug Administration June 2013 - Present
U.S. Food and Drug Administration September 2008 - June 2013
Centers for Disease Control and Prevention July 2006 - August 2008
Atlanta Research and Education Foundation July 2004 - July 2006
Education
Georgia State University 2010 — 2012
Master's degree, Biology
University of Alabama 1991 — 1996
Bachelor of Science (BS), Microbiology
Craig Andrews Craig Andrews's U.S. Food and Drug Administration Experience November 2008 - February 2013
Job Professor and Charles H. Kellstadt Chair in Marketing, Marquette University
Industry Education Management
Experience
Marquette University August 1984 - Present
U.S. Food and Drug Administration, Center for Tobacco Products March 2014 - August 2014
U.S. Food and Drug Administration, Center for Food Safety & Applied Nutrition September 2013 - February 2014
U.S. Food and Drug Administration November 2008 - February 2013
National Youth Anti-Drug Media Campaign 2003 - 2005
U.S. Federal Trade Commission July 1992 - June 1993
Skills
Higher Education, Data Analysis, Marketing, Public Speaking, Social Media, Event Planning, Research, SPSS, Market Research, Qualitative Research, Statistics
Education
University of South Carolina - Darla Moore School of Business 1978 — 1985
MBA, Ph.D., Marketing
Clarion University of Pennsylvania 1974 — 1978
BSBA, Marketing and Management
Cathedral Prep, Erie, PA 1970 — 1974
Marquette University August 1984 - Present
U.S. Food and Drug Administration, Center for Tobacco Products March 2014 - August 2014
U.S. Food and Drug Administration, Center for Food Safety & Applied Nutrition September 2013 - February 2014
U.S. Food and Drug Administration November 2008 - February 2013
National Youth Anti-Drug Media Campaign 2003 - 2005
U.S. Federal Trade Commission July 1992 - June 1993
Skills
Higher Education, Data Analysis, Marketing, Public Speaking, Social Media, Event Planning, Research, SPSS, Market Research, Qualitative Research, Statistics
Education
University of South Carolina - Darla Moore School of Business 1978 — 1985
MBA, Ph.D., Marketing
Clarion University of Pennsylvania 1974 — 1978
BSBA, Marketing and Management
Cathedral Prep, Erie, PA 1970 — 1974
Blair Sondea's U.S. Food and Drug Administration Experience January 2011 - Present
Job Contract Specialist at US Department of Health and Human Services
Industry Government Administration
Experience
U.S. Food and Drug Administration January 2011 - Present
Internal Revenue Service May 2009 - February 2011
Performance Food Group July 1995 - May 2009
Skills
Auditing, Proposal Writing, Analysis, Procurement, Management, Negotiation, Program Management, Strategy, Contract Management, Mergers & Acquisitions, Software Documentation, Business Process, Logistics, Marketing, Finance, Accounting, New Business Development, Marketing Strategy, Process Improvement, Budgets
Education
Henderson State University
Bachelor of Science (BS), Business Management
University of Phoenix
Master of Science (MS), Accounting
University of Phoenix
Master of Business Administration (MBA), Business Administration, Management and Operations
U.S. Food and Drug Administration January 2011 - Present
Internal Revenue Service May 2009 - February 2011
Performance Food Group July 1995 - May 2009
Skills
Auditing, Proposal Writing, Analysis, Procurement, Management, Negotiation, Program Management, Strategy, Contract Management, Mergers & Acquisitions, Software Documentation, Business Process, Logistics, Marketing, Finance, Accounting, New Business Development, Marketing Strategy, Process Improvement, Budgets
Education
Henderson State University
Bachelor of Science (BS), Business Management
University of Phoenix
Master of Science (MS), Accounting
University of Phoenix
Master of Business Administration (MBA), Business Administration, Management and Operations
Gretchen Opper Gretchen Opper's U.S. Food and Drug Administration Experience 2012 - Present
Job Regulatory Counsel at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration 2012 - Present
Federation of American Societies for Experimental Biology 2007 - 2009
U.S. Department of Justice, Disability Rights Section 2005 - 2007
U.S. Department of Justice, DC U.S. Attorney's Office 2004 - 2005
Litman Law Offices, Ltd. 2003 - 2004
The National Academies, Institute of Medicine 2001 - 2002
National Institutes of Health, Office of the General Counsel 2000 - 2000
The National Academies, National Research Council 1999 - 1999
National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases 1998 - 1998
U.S. Senate Committee on Commerce, Science, and Transportation 1996 - 1997
Skills
Public Policy, Policy Analysis, Legal Research, Policy, Administrative Law, Government, Legal Writing, Project Management, FDA Regulations, FDA, Legislation, Legislative Relations, Regulations, Environmental Policy, Research, Federal Government
Education
American University, Washington College of Law 1998 — 2001
J.D.
Georgetown University
B.S., Biology and Pre-Med
The Hotchkiss School
U.S. Food and Drug Administration 2012 - Present
Federation of American Societies for Experimental Biology 2007 - 2009
U.S. Department of Justice, Disability Rights Section 2005 - 2007
U.S. Department of Justice, DC U.S. Attorney's Office 2004 - 2005
Litman Law Offices, Ltd. 2003 - 2004
The National Academies, Institute of Medicine 2001 - 2002
National Institutes of Health, Office of the General Counsel 2000 - 2000
The National Academies, National Research Council 1999 - 1999
National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases 1998 - 1998
U.S. Senate Committee on Commerce, Science, and Transportation 1996 - 1997
Skills
Public Policy, Policy Analysis, Legal Research, Policy, Administrative Law, Government, Legal Writing, Project Management, FDA Regulations, FDA, Legislation, Legislative Relations, Regulations, Environmental Policy, Research, Federal Government
Education
American University, Washington College of Law 1998 — 2001
J.D.
Georgetown University
B.S., Biology and Pre-Med
The Hotchkiss School
David Bodge David Bodge's U.S. Food and Drug Administration Experience November 1992 - April 2004
Job Security Specialist/Adjudicator at U.S. Department of State
Industry Security and Investigations
Experience
U.S. Department of State July 2012 - Present
Sava Workforce Solutions March 2012 - September 2012
USIS October 2011 - January 2012
Guidepost Solutions February 2011 - June 2011
U.S. Department of the Interior, Office of Inspector General April 2004 - February 2011
U.S. Food and Drug Administration November 1992 - April 2004
U.S Department of State November 1985 - November 1992
U.S. Secret Service Uniformed Division June 1984 - November 1985
Skills
Security Investigations, Risk Management, Law Enforcement, Physical Security, Fraud, Counterintelligence, Clearances, Enforcement, Background Checks, Criminal Investigations, Private Investigations, Police, Crisis Management, Criminal Law, Risk Assessment, Counterterrorism, Security Clearance, Security, Government, Investigation, Executive Protection, Security Management
Education
Indiana University of Pennsylvania 1981 — 1982
MA, Criminal Justice
Indiana University of Pennsylvania
BA, Criminology
Indiana University of Pennsylvania
BA, Political Science
U.S. Department of State July 2012 - Present
Sava Workforce Solutions March 2012 - September 2012
USIS October 2011 - January 2012
Guidepost Solutions February 2011 - June 2011
U.S. Department of the Interior, Office of Inspector General April 2004 - February 2011
U.S. Food and Drug Administration November 1992 - April 2004
U.S Department of State November 1985 - November 1992
U.S. Secret Service Uniformed Division June 1984 - November 1985
Skills
Security Investigations, Risk Management, Law Enforcement, Physical Security, Fraud, Counterintelligence, Clearances, Enforcement, Background Checks, Criminal Investigations, Private Investigations, Police, Crisis Management, Criminal Law, Risk Assessment, Counterterrorism, Security Clearance, Security, Government, Investigation, Executive Protection, Security Management
Education
Indiana University of Pennsylvania 1981 — 1982
MA, Criminal Justice
Indiana University of Pennsylvania
BA, Criminology
Indiana University of Pennsylvania
BA, Political Science
Bob Guldin Bob Guldin's U.S. Food and Drug Administration Experience May 2013 - September 2013
Job Writer/editor/consultant at NRDC
Industry Writing and Editing
Experience
Naural Resources Defense Council (NRDC) January 2014 - Present
Independent July 2001 - Present
U.S. Food and Drug Administration May 2013 - September 2013
Federal Occupational Health March 2012 - November 2012
40 Plus of Greater Washington DC March 2006 - March 2012
NASA February 2011 - October 2011
U.S. Department of Justice, Office of Community Policing February 2010 - September 2010
Smithsonian Institution March 2009 - August 2009
FAA 2008 - 2008
American Legacy Foundation 2007 - 2007
Skills
technical writing, Writing For The Web, Editing, Public Policy, Higher Education, Lifestyle, Foreign Relations, Writing, Newsletters, Publications, International Relations, Non-profits, Press Releases, Blogging, Politics, Government, Proofreading, Publishing, Journalism, U.S. foreign policy, Policy Analysis, Web Content, Research, Copy Editing, Feature Articles, Media Relations, Facebook, Proposal Writing, Nonprofits, Magazines, Books, Technical Writing, Public Speaking, Newspapers, Freelance Writing, Federal Government
Education
Columbia University - School of International and Public Affairs
MIA - Master of International Affairs, Russian/Soviet studies, international security policy
Cornell University
BA, political science, English
Naural Resources Defense Council (NRDC) January 2014 - Present
Independent July 2001 - Present
U.S. Food and Drug Administration May 2013 - September 2013
Federal Occupational Health March 2012 - November 2012
40 Plus of Greater Washington DC March 2006 - March 2012
NASA February 2011 - October 2011
U.S. Department of Justice, Office of Community Policing February 2010 - September 2010
Smithsonian Institution March 2009 - August 2009
FAA 2008 - 2008
American Legacy Foundation 2007 - 2007
Skills
technical writing, Writing For The Web, Editing, Public Policy, Higher Education, Lifestyle, Foreign Relations, Writing, Newsletters, Publications, International Relations, Non-profits, Press Releases, Blogging, Politics, Government, Proofreading, Publishing, Journalism, U.S. foreign policy, Policy Analysis, Web Content, Research, Copy Editing, Feature Articles, Media Relations, Facebook, Proposal Writing, Nonprofits, Magazines, Books, Technical Writing, Public Speaking, Newspapers, Freelance Writing, Federal Government
Education
Columbia University - School of International and Public Affairs
MIA - Master of International Affairs, Russian/Soviet studies, international security policy
Cornell University
BA, political science, English
Melissa Yu Melissa Yu's U.S. Food and Drug Administration Experience September 2011 - March 2015
Job Marketing & Communication Strategist
Industry Marketing and Advertising
Experience
U.S. Department of Transportation (DOT) 2015 - Present
U.S. Food and Drug Administration September 2011 - March 2015
Armed Services Blood Program 2008 - 2011
Lockheed Martin 2006 - 2008
Tysons Corner Center 2003 - 2006
Westfield 2002 - 2003
Skills
Strategy, Change Management, Marketing, Management, Marketing Strategy, Analysis, Customer Service, Public Relations, Brand Management, Data Analysis, Branding & Identity, Project Management, Strategic Communications, Digital Marketing, Social Media Marketing, Social Media, Press Releases, Advertising, Leadership, Newsletters
Education
Marymount University 2007 — 2009
MBA
University of Maryland College Park 1998 — 2002
BS
U.S. Department of Transportation (DOT) 2015 - Present
U.S. Food and Drug Administration September 2011 - March 2015
Armed Services Blood Program 2008 - 2011
Lockheed Martin 2006 - 2008
Tysons Corner Center 2003 - 2006
Westfield 2002 - 2003
Skills
Strategy, Change Management, Marketing, Management, Marketing Strategy, Analysis, Customer Service, Public Relations, Brand Management, Data Analysis, Branding & Identity, Project Management, Strategic Communications, Digital Marketing, Social Media Marketing, Social Media, Press Releases, Advertising, Leadership, Newsletters
Education
Marymount University 2007 — 2009
MBA
University of Maryland College Park 1998 — 2002
BS
Caitlin Aponté Caitlin Aponté's U.S. Food and Drug Administration Experience June 2008 - September 2011
Job Enhanced Baseline Team Lead/Associate Project Manager at CSC
Industry Information Technology and Services
Experience
CSC October 2014 - Present
CSC September 2011 - October 2014
U.S. Food and Drug Administration June 2008 - September 2011
Skills
Active DoD Secret..., Appointment Scheduling, Phone Etiquette, Microsoft Excel, Formatting Documents, Phone Skills, Answering Phones, Microsoft Office, Microsoft Word, Critical Thinking, Customer Service, PowerPoint, Communication Skills, Outlook, Timekeeping, Reports, E-mail Ettiquette, Organization, Filing, Data Entry, Spreadsheets, Windows 7, Telephone Skills, Help Desk Support, Software Documentation, Analysis, System Administration, Communication, Active Directory, Project Management, Security
Education
Towson University 2010 — 2012
Bachelor of Science (B.S.), Business Administration - Finance
Harford Community College 2007 — 2010
Associate of Science (A.S.), Business Administration
CSC October 2014 - Present
CSC September 2011 - October 2014
U.S. Food and Drug Administration June 2008 - September 2011
Skills
Active DoD Secret..., Appointment Scheduling, Phone Etiquette, Microsoft Excel, Formatting Documents, Phone Skills, Answering Phones, Microsoft Office, Microsoft Word, Critical Thinking, Customer Service, PowerPoint, Communication Skills, Outlook, Timekeeping, Reports, E-mail Ettiquette, Organization, Filing, Data Entry, Spreadsheets, Windows 7, Telephone Skills, Help Desk Support, Software Documentation, Analysis, System Administration, Communication, Active Directory, Project Management, Security
Education
Towson University 2010 — 2012
Bachelor of Science (B.S.), Business Administration - Finance
Harford Community College 2007 — 2010
Associate of Science (A.S.), Business Administration
Chuck Eirkson Chuck Eirkson's U.S. Food and Drug Administration Experience 1983 - June 2012
Job Environmental Scientist, Environmental Risk Assessment, Scientific Writing and Editing at Environmental Considerations
Industry Pharmaceuticals
Experience
Environmental Considerations June 2012 - Present
U.S. Food and Drug Administration 1983 - June 2012
Retired U.S. Food and Drug Administration August 1976 - June 2012
Skills
Environmental Awareness, Environmental Monitoring, Toxicology, Environmental Compliance, Marine Biology, Leadership, Science, Regulatory Analysis, Regulatory Affairs, Regulatory Requirements, Lifesciences, Data Analysis, Literature Reviews, Writing, Editing, Environmental Leadership, Environmental Chemistry, Environmental Consulting, Risk Assessment, Management, Supervising Others, Regulations, International..., Infectious Diseases, Sop, Water Quality, Life Sciences
Education
Hood College 1983 — 1989
Masters, Environmental Science
University of Pittsburgh 1973 — 1975
BS
Environmental Considerations June 2012 - Present
U.S. Food and Drug Administration 1983 - June 2012
Retired U.S. Food and Drug Administration August 1976 - June 2012
Skills
Environmental Awareness, Environmental Monitoring, Toxicology, Environmental Compliance, Marine Biology, Leadership, Science, Regulatory Analysis, Regulatory Affairs, Regulatory Requirements, Lifesciences, Data Analysis, Literature Reviews, Writing, Editing, Environmental Leadership, Environmental Chemistry, Environmental Consulting, Risk Assessment, Management, Supervising Others, Regulations, International..., Infectious Diseases, Sop, Water Quality, Life Sciences
Education
Hood College 1983 — 1989
Masters, Environmental Science
University of Pittsburgh 1973 — 1975
BS
X James Li X James Li's U.S. Food and Drug Administration Experience July 1997 - July 2002
Job Chairman of the Board at Avioq, CEO at Cellex, Inc.
Industry Biotechnology
Experience
Avioq August 2007 - Present
Cellex Incorporated August 2002 - Present
U.S. Food and Drug Administration July 1997 - July 2002
Skills
Biotechnology, Lifesciences, FDA, GMP, Biochemistry, Pharmaceutical Industry, GLP, Cell Culture, Medical Devices, Clinical Trials, PCR, ELISA
Education
Harvard University
Postdoctoral Fellow, Biochemistry
Stanford University
Postdoctoral Fellow, Biochemistry
Washington State University
Ph.D., Genetics
Avioq August 2007 - Present
Cellex Incorporated August 2002 - Present
U.S. Food and Drug Administration July 1997 - July 2002
Skills
Biotechnology, Lifesciences, FDA, GMP, Biochemistry, Pharmaceutical Industry, GLP, Cell Culture, Medical Devices, Clinical Trials, PCR, ELISA
Education
Harvard University
Postdoctoral Fellow, Biochemistry
Stanford University
Postdoctoral Fellow, Biochemistry
Washington State University
Ph.D., Genetics
Joedy Tracey Joedy Tracey's U.S. Food and Drug Administration Experience January 2015 - Present
Job International Research Analyst at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration January 2015 - Present
US Govt - FDA 2009 - Present
US Food & Drug Administration September 2008 - September 2009
U.S. Food & Drug Administration 1990 - August 2008
Skills
Government, Emergency Management, Disaster Recovery, Business Process..., Risk Assessment, Leadership Development, Training, Project Management, Policy, Management, Incident Management, Leadership, Criminal Justice, Program Management, System Administration, Public Safety, Change Management, Analysis, Process Improvement, Private Investigations
Education
Loyola Marymount University 1972 — 1975
Biology, General
U.S. Food and Drug Administration January 2015 - Present
US Govt - FDA 2009 - Present
US Food & Drug Administration September 2008 - September 2009
U.S. Food & Drug Administration 1990 - August 2008
Skills
Government, Emergency Management, Disaster Recovery, Business Process..., Risk Assessment, Leadership Development, Training, Project Management, Policy, Management, Incident Management, Leadership, Criminal Justice, Program Management, System Administration, Public Safety, Change Management, Analysis, Process Improvement, Private Investigations
Education
Loyola Marymount University 1972 — 1975
Biology, General
Ben England Ben England's U.S. Food and Drug Administration Experience May 2000 - July 2003
Job Owner, FDAImports.com, LLC & Benjamin L. England & Assoc., LLC
Industry Law Practice
Experience
Benjamin L. England & Associates, LLC February 2008 - Present
FDAImports.com, LLC 2005 - Present
Jones, Walker, Waechter, Poitevent, Carrère & Denègre L.L.P 2006 - 2008
Rodriguez O'Donnell Ross Fuerst Gonzalez Williams & England PC 2004 - 2006
U.S. Food and Drug Administration May 2000 - July 2003
U.S. Food and Drug Administration February 1998 - May 2000
U.S. Food and Drug Administration November 1992 - February 1998
U.S. Food and Drug Administration April 1990 - November 1992
U.S. Food and Drug Administration January 1986 - April 1990
Skills
FDA, Food, Medical Devices, Pharmaceuticals, International Trade, Export, Import, Regulatory Affairs, Import/Export, Pharmaceutical Industry, Customs Regulations, Patents, Leadership, Corporate Law, Corporate Governance, Policy, Criminal Law, Regulations, Legal Research, International Business, Licensing, Risk Management, Mergers & Acquisitions, Intellectual Property, Legal Writing, International Law, Government, Administrative Law, Private Investigations, Trademarks, Copyright Law
Education
University of Miami School of Law 1996 — 1999
J.D., Law
University of Maryland Baltimore County 1984 — 1990
B.A., Biology, Microbiology strength
Grace College and Seminary 1983 — 1984
None, General Undergrad
Benjamin L. England & Associates, LLC February 2008 - Present
FDAImports.com, LLC 2005 - Present
Jones, Walker, Waechter, Poitevent, Carrère & Denègre L.L.P 2006 - 2008
Rodriguez O'Donnell Ross Fuerst Gonzalez Williams & England PC 2004 - 2006
U.S. Food and Drug Administration May 2000 - July 2003
U.S. Food and Drug Administration February 1998 - May 2000
U.S. Food and Drug Administration November 1992 - February 1998
U.S. Food and Drug Administration April 1990 - November 1992
U.S. Food and Drug Administration January 1986 - April 1990
Skills
FDA, Food, Medical Devices, Pharmaceuticals, International Trade, Export, Import, Regulatory Affairs, Import/Export, Pharmaceutical Industry, Customs Regulations, Patents, Leadership, Corporate Law, Corporate Governance, Policy, Criminal Law, Regulations, Legal Research, International Business, Licensing, Risk Management, Mergers & Acquisitions, Intellectual Property, Legal Writing, International Law, Government, Administrative Law, Private Investigations, Trademarks, Copyright Law
Education
University of Miami School of Law 1996 — 1999
J.D., Law
University of Maryland Baltimore County 1984 — 1990
B.A., Biology, Microbiology strength
Grace College and Seminary 1983 — 1984
None, General Undergrad
J Paul Kirwan, PhD J Paul Kirwan, PhD's U.S. Food and Drug Administration Experience November 2013 - December 2014
Job Protein Chemistry | Biophysics | Regulatory CMC
Industry Biotechnology
Experience
U.S. Food and Drug Adminstration (FDA) September 2015 - Present
U.S. Food and Drug Administration (FDA) December 2014 - September 2015
U.S. Food and Drug Administration November 2013 - December 2014
University of Colorado School of Medicine September 2012 - October 2013
University of Colorado School of Medicine August 2006 - September 2012
Alternatives in Science Career Club 2006 - 2012
University of Colorado School of Medicine June 2002 - February 2004
University of Colorado Denver August 2001 - May 2002
Midwest Research Institute September 1999 - July 2001
Skills
HPLC, Structural Analysis, Peptide Synthesis, Molecular Biology, Chemistry, Protein Chemistry, Circular Dichroism, Differential Scanning..., Purification, Protein Purification
Education
University of Colorado School of Medicine 2006 — 2012
Ph.D., Biochemistry
University of Colorado Denver 2001 — 2003
MS, Chemistry
Benedictine College 1995 — 1999
BS, Chemistry
U.S. Food and Drug Adminstration (FDA) September 2015 - Present
U.S. Food and Drug Administration (FDA) December 2014 - September 2015
U.S. Food and Drug Administration November 2013 - December 2014
University of Colorado School of Medicine September 2012 - October 2013
University of Colorado School of Medicine August 2006 - September 2012
Alternatives in Science Career Club 2006 - 2012
University of Colorado School of Medicine June 2002 - February 2004
University of Colorado Denver August 2001 - May 2002
Midwest Research Institute September 1999 - July 2001
Skills
HPLC, Structural Analysis, Peptide Synthesis, Molecular Biology, Chemistry, Protein Chemistry, Circular Dichroism, Differential Scanning..., Purification, Protein Purification
Education
University of Colorado School of Medicine 2006 — 2012
Ph.D., Biochemistry
University of Colorado Denver 2001 — 2003
MS, Chemistry
Benedictine College 1995 — 1999
BS, Chemistry
Victor Gangi Victor Gangi's U.S. Food and Drug Administration Experience August 1997 - November 2000
Job
Industry Biotechnology
Experience
Genzyme, a sanofi company August 2014 - Present
Genzyme June 2012 - August 2014
Pfizer October 2009 - June 2012
Wyeth Biotech June 2008 - October 2009
Wyeth BioPharma February 2006 - June 2008
Biogen Idec November 2000 - February 2006
U.S. Food and Drug Administration August 1997 - November 2000
U.S. Food and Drug Administration January 1992 - August 2000
Skills
Regulatory Affairs, Clinical Development, Biopharmaceuticals, Online Communications, Vaccines, Pharmaceutical Industry, FDA, Regulatory Requirements, Formulation, Oncology, Biologics, GMP, Pharmaceutics, Medical Devices, CMC, Clinical Research, Regulatory Submissions, Drug Development, NDA, Microbiology, GLP, 21 CFR Part 11, Sop, Biotechnology
Education
University of Massachusetts Lowell 1994 — 1996
MS, Biology
University of Massachusetts, Amherst 1989 — 1992
BS, Microbiology
University of Southern California
DRSc, Regulatory Science
Florida Institute of Technology
Genzyme, a sanofi company August 2014 - Present
Genzyme June 2012 - August 2014
Pfizer October 2009 - June 2012
Wyeth Biotech June 2008 - October 2009
Wyeth BioPharma February 2006 - June 2008
Biogen Idec November 2000 - February 2006
U.S. Food and Drug Administration August 1997 - November 2000
U.S. Food and Drug Administration January 1992 - August 2000
Skills
Regulatory Affairs, Clinical Development, Biopharmaceuticals, Online Communications, Vaccines, Pharmaceutical Industry, FDA, Regulatory Requirements, Formulation, Oncology, Biologics, GMP, Pharmaceutics, Medical Devices, CMC, Clinical Research, Regulatory Submissions, Drug Development, NDA, Microbiology, GLP, 21 CFR Part 11, Sop, Biotechnology
Education
University of Massachusetts Lowell 1994 — 1996
MS, Biology
University of Massachusetts, Amherst 1989 — 1992
BS, Microbiology
University of Southern California
DRSc, Regulatory Science
Florida Institute of Technology
Daniel Michels Daniel Michels's U.S. Food and Drug Administration Experience 1982 - 1992
Job Retired from Michels Consulting LLC
Industry Pharmaceuticals
Experience
Michels Consulting LLC October 2014 - Present
Michels Consulting LLC June 2004 - October 2014
KMI, a division of PAREXEL International, LLC August 2000 - May 2004
U.S. Food and Drug Administration (FDA) January 1993 - June 2000
U.S. Food and Drug Administration 1982 - 1992
Skills
FDA, Compliance, Regulatory Affairs, Pharmaceutical Industry, GMP, Auditing, Policy, Strategy, Regulatory Requirements, Drug Development, Change Control, Clinical Trials, Quality Control, Regulations, Quality Management, IND, Internal Audit, GxP
Education
Harvard Kennedy School of Government 1981 — 1981
Massachusetts Institute of Technology 1971 — 1972
Systems Analysis
University of California, Berkeley 1959 — 1963
Bachelor of Arts (B.A.), Chemistry
Michels Consulting LLC October 2014 - Present
Michels Consulting LLC June 2004 - October 2014
KMI, a division of PAREXEL International, LLC August 2000 - May 2004
U.S. Food and Drug Administration (FDA) January 1993 - June 2000
U.S. Food and Drug Administration 1982 - 1992
Skills
FDA, Compliance, Regulatory Affairs, Pharmaceutical Industry, GMP, Auditing, Policy, Strategy, Regulatory Requirements, Drug Development, Change Control, Clinical Trials, Quality Control, Regulations, Quality Management, IND, Internal Audit, GxP
Education
Harvard Kennedy School of Government 1981 — 1981
Massachusetts Institute of Technology 1971 — 1972
Systems Analysis
University of California, Berkeley 1959 — 1963
Bachelor of Arts (B.A.), Chemistry
Cariny Nunez's U.S. Food and Drug Administration Experience March 2015 - Present
Job Public Health Advisor at U.S Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration March 2015 - Present
U.S Food and Drug Administration October 2010 - June 2015
Healthy Start Coalition of Miami-Dade September 2007 - January 2009
YWCA of Greater Miami-Dade, Inc June 2006 - September 2007
Florida International University June 2005 - March 2006
Skills
Health Education, Public Speaking, Community Health, Healthcare, Spanish, Newsletters, Management, Nonprofits, Program Evaluation, Grant Writing
Education
Walden University 2009 — 2012
PhD, 03/2009
Florida International University 2008 — 2008
Graduate Certificate, Health Care Risk Management
Florida International University 2004 — 2007
Masters of Science, Public Health; Health Policy and Management
Florida International University 2004 — 2007
Graduate Certificate, Health Promotion and Disease Prevention
Interamerican University 1993 — 2000
Bachelors, Science; Biology
U.S. Food and Drug Administration March 2015 - Present
U.S Food and Drug Administration October 2010 - June 2015
Healthy Start Coalition of Miami-Dade September 2007 - January 2009
YWCA of Greater Miami-Dade, Inc June 2006 - September 2007
Florida International University June 2005 - March 2006
Skills
Health Education, Public Speaking, Community Health, Healthcare, Spanish, Newsletters, Management, Nonprofits, Program Evaluation, Grant Writing
Education
Walden University 2009 — 2012
PhD, 03/2009
Florida International University 2008 — 2008
Graduate Certificate, Health Care Risk Management
Florida International University 2004 — 2007
Masters of Science, Public Health; Health Policy and Management
Florida International University 2004 — 2007
Graduate Certificate, Health Promotion and Disease Prevention
Interamerican University 1993 — 2000
Bachelors, Science; Biology
Ivy Kupec Ivy Kupec's U.S. Food and Drug Administration Experience January 1995 - April 2000
Job Public Affairs Specialist at National Science Foundation
Industry Public Relations and Communications
Experience
National Science Foundation June 2013 - Present
IvyInk October 2007 - Present
U.S. Pacific Command October 2007 - Present
U.S. European Command October 2007 - December 2014
University of Miami June 2004 - July 2007
Office of Naval Research October 2001 - November 2002
Chief of Naval Information October 1999 - November 2002
Self-Employed August 2000 - October 2001
U.S. Food and Drug Administration January 1995 - April 2000
U.S. Department of Health Human Services 2000 - 2000
Skills
Speech Writing, Crisis Communications, Strategic Communications, Public Affairs, Public Relations, Media Relations, Newsletters, Science Communication, Copywriting, Editing, Health Communication
Education
The Ohio State University 1989 — 1991
M.A., English--Creative Writing (Nonfiction)
Butler University 1982 — 1986
B.A., English
Chillicothe High School
National Science Foundation June 2013 - Present
IvyInk October 2007 - Present
U.S. Pacific Command October 2007 - Present
U.S. European Command October 2007 - December 2014
University of Miami June 2004 - July 2007
Office of Naval Research October 2001 - November 2002
Chief of Naval Information October 1999 - November 2002
Self-Employed August 2000 - October 2001
U.S. Food and Drug Administration January 1995 - April 2000
U.S. Department of Health Human Services 2000 - 2000
Skills
Speech Writing, Crisis Communications, Strategic Communications, Public Affairs, Public Relations, Media Relations, Newsletters, Science Communication, Copywriting, Editing, Health Communication
Education
The Ohio State University 1989 — 1991
M.A., English--Creative Writing (Nonfiction)
Butler University 1982 — 1986
B.A., English
Chillicothe High School
Adrienne Stephenson's U.S. Food and Drug Administration Experience May 2005 - August 2005
Job Assistant Dean, Director of the Office of Graduate Fellowships and Awards, Florida State University
Industry Higher Education
Experience
Florida State University June 2015 - Present
Tallahassee Community College August 2014 - June 2015
Florida Department of Education 2011 - 2014
Florida A&M University January 2003 - 2010
U.S. Food and Drug Administration May 2005 - August 2005
Skills
Cell Culture, Science, Research, Higher Education, Pharmacology, Grant Writing, Professional..., Life Sciences, Public Speaking
Education
Florida Agricultural and Mechanical University
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology
Pharmacology/Toxicology Florida A&M University 2000 — 2004
M.S, Pharmacology and Toxicology
Lincoln University 1996 — 2000
BA, Chemistry
Florida State University June 2015 - Present
Tallahassee Community College August 2014 - June 2015
Florida Department of Education 2011 - 2014
Florida A&M University January 2003 - 2010
U.S. Food and Drug Administration May 2005 - August 2005
Skills
Cell Culture, Science, Research, Higher Education, Pharmacology, Grant Writing, Professional..., Life Sciences, Public Speaking
Education
Florida Agricultural and Mechanical University
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology
Pharmacology/Toxicology Florida A&M University 2000 — 2004
M.S, Pharmacology and Toxicology
Lincoln University 1996 — 2000
BA, Chemistry
Ronald Stellon Ronald Stellon's U.S. Food and Drug Administration Experience 1978 - 1989
Job Vice President, Quality at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca 2011 - Present
AstraZeneca 2003 - 2011
AstraZeneca 2002 - 2003
DuPont Pharmaceuticals/DuPont-Merck Pharmaceuticals 1989 - 2002
U.S. Food and Drug Administration 1978 - 1989
Skills
GMP, cGMP, GLP, Lean Manufacturing, GCP, Pharmaceuticals, GxP, Quality Assurance, Quality Control, FDA, 21 CFR Part 11, Pharmaceutical Industry, Pharmaceutics, Six Sigma, Product Launch, Validation, CAPA, Quality Auditing, R&D, Quality System, Regulatory Requirements
Education
Adelphi University
Bachelor's degree, Biology, General
Lehigh University
MS, Quality Engineering
AstraZeneca 2011 - Present
AstraZeneca 2003 - 2011
AstraZeneca 2002 - 2003
DuPont Pharmaceuticals/DuPont-Merck Pharmaceuticals 1989 - 2002
U.S. Food and Drug Administration 1978 - 1989
Skills
GMP, cGMP, GLP, Lean Manufacturing, GCP, Pharmaceuticals, GxP, Quality Assurance, Quality Control, FDA, 21 CFR Part 11, Pharmaceutical Industry, Pharmaceutics, Six Sigma, Product Launch, Validation, CAPA, Quality Auditing, R&D, Quality System, Regulatory Requirements
Education
Adelphi University
Bachelor's degree, Biology, General
Lehigh University
MS, Quality Engineering
Alex Hoffman's U.S. Food and Drug Administration Experience May 2003 - December 2004
Job Marketing Director, Client Services at Ivie; Knowledgeable in Advertising, Creative, Digital, Print and Social
Industry Marketing and Advertising
Experience
Six Flags America March 2013 - October 2013
SUPERVALU September 2008 - March 2013
SUPERVALU June 2007 - September 2008
SUPERVALU December 2006 - June 2007
SUPERVALU July 2006 - December 2006
Nickelodeon May 2005 - August 2005
U.S. Food and Drug Administration May 2003 - December 2004
Skills
Advertising, Social Media Marketing, Graphic Design, Creative Direction, Retail, Photography, Project Management, Brand Development, Digital Marketing, User Experience, Direct Marketing, Strategic Planning, Team Building, Leadership, Coaching, Radio
Education
Kelby Training Live 2012 — 2012
SkillPath Seminars 2012 — 2012
Bowling Green State University 2002 — 2006
Bachelor of Science (BS)
Watkins Mill High School 1998 — 2002
Six Flags America March 2013 - October 2013
SUPERVALU September 2008 - March 2013
SUPERVALU June 2007 - September 2008
SUPERVALU December 2006 - June 2007
SUPERVALU July 2006 - December 2006
Nickelodeon May 2005 - August 2005
U.S. Food and Drug Administration May 2003 - December 2004
Skills
Advertising, Social Media Marketing, Graphic Design, Creative Direction, Retail, Photography, Project Management, Brand Development, Digital Marketing, User Experience, Direct Marketing, Strategic Planning, Team Building, Leadership, Coaching, Radio
Education
Kelby Training Live 2012 — 2012
SkillPath Seminars 2012 — 2012
Bowling Green State University 2002 — 2006
Bachelor of Science (BS)
Watkins Mill High School 1998 — 2002
Kausar Riaz Ahmed, PhD's U.S. Food and Drug Administration Experience March 2015 - Present
Job ORISE Research Fellow Toxicology at FDA
Industry Pharmaceuticals
Experience
U.S. Food and Drug Administration March 2015 - Present
The University of Texas MD Anderson Cancer Center August 2008 - February 2015
Eli Lilly and Company June 2013 - August 2013
University of Utah - Employment August 2006 - July 2008
SuperGen May 2007 - August 2007
Madras Veterinary College January 2006 - April 2006
Skills
Toxicological risk..., QSAR, Global Regulatory..., Project Management, LeadsScope Model Applier, Vitic Nexus, Good Laboratory..., microsoft project, Pharmacology, Small-molecule..., Presentation Skills, Genotoxicity, Mutagenicity, Carcinogenicity, Cell, Protein Chemistry, Flow Cytometry, Molecular Biology, ELISA, Clinical Development, Immunoprecipitation, Western Blotting, Metabolism, Autophagy, Transfection, Fluorescence Microscopy, Cytotoxicity, Cell Culture, Luminex, Confocal Microscopy, Radioactivity, GraphPad Prism, JMP, Gene Expression..., Spotfire, Ingenuity Pathway..., real-time PCR, Cancer drug discovery, si/shRNA studies, Tissue Culture, qPCR, In Vivo, In Vitro, Cell Signaling, Cancer Biology
Education
University of Texas M.D Anderson Cancer Center 2008 — 2014
Ph.D, Biomedical Sciences (Experimental Therapeutics Academic Program), 4.0
University of Utah - David Eccles School of Business 2007 — 2008
Graduate Certificate in Business Studies
University of Utah 2006 — 2008
MS, Biotechnology
Anna University 2002 — 2006
Bachelor of Technology (B.Tech.), Industrial Biotechnology
U.S. Food and Drug Administration March 2015 - Present
The University of Texas MD Anderson Cancer Center August 2008 - February 2015
Eli Lilly and Company June 2013 - August 2013
University of Utah - Employment August 2006 - July 2008
SuperGen May 2007 - August 2007
Madras Veterinary College January 2006 - April 2006
Skills
Toxicological risk..., QSAR, Global Regulatory..., Project Management, LeadsScope Model Applier, Vitic Nexus, Good Laboratory..., microsoft project, Pharmacology, Small-molecule..., Presentation Skills, Genotoxicity, Mutagenicity, Carcinogenicity, Cell, Protein Chemistry, Flow Cytometry, Molecular Biology, ELISA, Clinical Development, Immunoprecipitation, Western Blotting, Metabolism, Autophagy, Transfection, Fluorescence Microscopy, Cytotoxicity, Cell Culture, Luminex, Confocal Microscopy, Radioactivity, GraphPad Prism, JMP, Gene Expression..., Spotfire, Ingenuity Pathway..., real-time PCR, Cancer drug discovery, si/shRNA studies, Tissue Culture, qPCR, In Vivo, In Vitro, Cell Signaling, Cancer Biology
Education
University of Texas M.D Anderson Cancer Center 2008 — 2014
Ph.D, Biomedical Sciences (Experimental Therapeutics Academic Program), 4.0
University of Utah - David Eccles School of Business 2007 — 2008
Graduate Certificate in Business Studies
University of Utah 2006 — 2008
MS, Biotechnology
Anna University 2002 — 2006
Bachelor of Technology (B.Tech.), Industrial Biotechnology
Kevin Betts's U.S. Food and Drug Administration Experience October 2012 - Present
Job Social Scientist
Industry Research
Experience
U.S. Food and Drug Administration October 2012 - Present
North Dakota State University August 2007 - August 2012
Pine Rest Mental Health Services September 2004 - August 2007
Skills
Experimental Design, Psychology, Scientific Writing, Research Design, University Teaching, Social Psychology, Survey Design, Survey Research, Literature Reviews, Cognitive Psychology, Data Collection, Health Psychology, Healthcare, Negotiation, Clinical Research, Mental Health, Consulting, Statistics
Education
North Dakota State University 2007 — 2012
Ph.D., Social and Health Psychology
Grand Valley State University 2003 — 2007
B.S., Psychology, Sociology, Applied Statistics
U.S. Food and Drug Administration October 2012 - Present
North Dakota State University August 2007 - August 2012
Pine Rest Mental Health Services September 2004 - August 2007
Skills
Experimental Design, Psychology, Scientific Writing, Research Design, University Teaching, Social Psychology, Survey Design, Survey Research, Literature Reviews, Cognitive Psychology, Data Collection, Health Psychology, Healthcare, Negotiation, Clinical Research, Mental Health, Consulting, Statistics
Education
North Dakota State University 2007 — 2012
Ph.D., Social and Health Psychology
Grand Valley State University 2003 — 2007
B.S., Psychology, Sociology, Applied Statistics
Suzanne Treviño's U.S. Food and Drug Administration Experience March 2005 - October 2005
Job Media Relations and Crisis Communications
Industry Writing and Editing
Experience
Self-employed 2011 - Present
TSA August 2009 - October 2010
The Hutchinson Group October 2007 - November 2008
U.S. Customs and Border Protection October 2005 - May 2007
U.S. Food and Drug Administration March 2005 - October 2005
U.S. Department of Homeland Security December 2003 - March 2005
TSA November 2002 - December 2003
City of Phoenix April 1999 - November 2002
American Red Cross March 1997 - April 1999
KSAZ-TV Fox Phoenix May 1994 - March 1997
Skills
Strategic Communications, Microsoft Office, Strategic Planning, Program Management, Research, Social Media, Media Relations, Project Management, Public Relations, Leadership, Proposal Writing
Education
Arizona State University 1991 — 1995
Bachelor's degree, Broadcast Journalism
Self-employed 2011 - Present
TSA August 2009 - October 2010
The Hutchinson Group October 2007 - November 2008
U.S. Customs and Border Protection October 2005 - May 2007
U.S. Food and Drug Administration March 2005 - October 2005
U.S. Department of Homeland Security December 2003 - March 2005
TSA November 2002 - December 2003
City of Phoenix April 1999 - November 2002
American Red Cross March 1997 - April 1999
KSAZ-TV Fox Phoenix May 1994 - March 1997
Skills
Strategic Communications, Microsoft Office, Strategic Planning, Program Management, Research, Social Media, Media Relations, Project Management, Public Relations, Leadership, Proposal Writing
Education
Arizona State University 1991 — 1995
Bachelor's degree, Broadcast Journalism
Blake Scates Blake Scates's U.S. Food and Drug Administration Experience February 2010 - January 2011
Job Program Analyst at GSA
Industry Government Administration
Experience
GSA August 2014 - Present
US Department of Health and Human Services April 2014 - August 2014
U.S. Office of Personnel Management January 2011 - March 2014
U.S. Food and Drug Administration February 2010 - January 2011
U.S. Food and Drug Administration June 2008 - August 2008
U.S. Department of Health and Human Services May 2006 - August 2006
Skills
Public Speaking, Leadership, Organizational Structure, Government, Policy Analysis, Public Policy, Policy, Community Outreach, Strategic Communications, Research, Program Evaluation, Public Administration, Program Management, Non-profits, Editing, Qualitative Research, Program Development, Social Media, Strategy, Event Planning, Usability, Information Architecture, Section 508, Marketing, Business Development, Communication, Dialogue, Speech Writing, Government Contracting, Creative Writing, Leadership Development, Project Management
Education
University of South Florida 2007 — 2009
Master of Arts, Health and Organizational Communication
The Washington Center for Internships and Academic Seminars 2008 — 2008
Certificate, Post-graduate Professional Development Program
Florida Gulf Coast University 2003 — 2007
Bachelor of Arts, Political Communication
The Washington Center for Internships and Academic Seminars 2006 — 2006
Certificate, Mass Communications Program
American Council for Technology (ACT) – Industry Advisory Council (IAC) 2014 Voyagers Program
Leadership Development, Completed
GSA August 2014 - Present
US Department of Health and Human Services April 2014 - August 2014
U.S. Office of Personnel Management January 2011 - March 2014
U.S. Food and Drug Administration February 2010 - January 2011
U.S. Food and Drug Administration June 2008 - August 2008
U.S. Department of Health and Human Services May 2006 - August 2006
Skills
Public Speaking, Leadership, Organizational Structure, Government, Policy Analysis, Public Policy, Policy, Community Outreach, Strategic Communications, Research, Program Evaluation, Public Administration, Program Management, Non-profits, Editing, Qualitative Research, Program Development, Social Media, Strategy, Event Planning, Usability, Information Architecture, Section 508, Marketing, Business Development, Communication, Dialogue, Speech Writing, Government Contracting, Creative Writing, Leadership Development, Project Management
Education
University of South Florida 2007 — 2009
Master of Arts, Health and Organizational Communication
The Washington Center for Internships and Academic Seminars 2008 — 2008
Certificate, Post-graduate Professional Development Program
Florida Gulf Coast University 2003 — 2007
Bachelor of Arts, Political Communication
The Washington Center for Internships and Academic Seminars 2006 — 2006
Certificate, Mass Communications Program
American Council for Technology (ACT) – Industry Advisory Council (IAC) 2014 Voyagers Program
Leadership Development, Completed
Wayne Cimons Wayne Cimons's U.S. Food and Drug Administration Experience January 1991 - January 1995
Job Counsel at State Farm Insurance
Industry Legal Services
Experience
State Farm Insurance October 2010 - Present
Wayne Cimons March 2010 - October 2010
American International Group February 2000 - 2009
New York State Office of Federal Affairs, Governor George E. Pataki January 1995 - January 1998
U.S. Food and Drug Administration January 1991 - January 1995
U.S. House Committee on Government Operations January 1989 - January 1991
Joe DioGuardi 1986 - 1988
Skills
Legislative Relations, Insurance, Government, Financial Services, Privacy Law, Policy, Legal Research
Education
George Mason University School of Law 1989 — 1993
JD
The George Washington University 1980 — 1984
BA
State Farm Insurance October 2010 - Present
Wayne Cimons March 2010 - October 2010
American International Group February 2000 - 2009
New York State Office of Federal Affairs, Governor George E. Pataki January 1995 - January 1998
U.S. Food and Drug Administration January 1991 - January 1995
U.S. House Committee on Government Operations January 1989 - January 1991
Joe DioGuardi 1986 - 1988
Skills
Legislative Relations, Insurance, Government, Financial Services, Privacy Law, Policy, Legal Research
Education
George Mason University School of Law 1989 — 1993
JD
The George Washington University 1980 — 1984
BA
Arun Le, MSN-BL, BSN, RN's U.S. Food and Drug Administration Experience 2015 - Present
Job Senior Standards Advisor at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration 2015 - Present
Education
Columbia Union College
Bachelor of Science, Nursing/ Healthcare Administration
Washington Adventist University
Master of Science, Nursing/ Business Leadership, Nursing Administration
U.S. Food and Drug Administration 2015 - Present
Education
Columbia Union College
Bachelor of Science, Nursing/ Healthcare Administration
Washington Adventist University
Master of Science, Nursing/ Business Leadership, Nursing Administration
Patric Klotzbuecher-Cruz Patric Klotzbuecher-Cruz's U.S. Food and Drug Administration Experience November 2007 - Present
Job Senior Regulatory Operations Officer (Drug Specialist) at US Department of Health and Human Services
Industry Pharmaceuticals
Experience
Department of Health and Human Services February 2008 - Present
U.S. Food and Drug Administration November 2007 - Present
United States Air Force June 2002 - November 2007
Rutgers University Tissue Engineering Lab August 2006 - May 2007
Skills
Project Management, Analysis, Leadership, Data Analysis, Engineering, Troubleshooting, Program Management, Testing, Defense, Research, Microsoft Office, Software Documentation, Aseptic Processing, Deviation Management, Quality Investigations, Quality System..., Stability Programs, Method Transfer, Analytical Method..., cGMP practices, cGMP manufacturing, Pharmaceutical process..., Pharmaceutical..., Pharmaceutical..., Process Analytical..., Quality by Design, Biopharmaceutics, Cleaning Validation, Source Analysis, Operational Intelligence, Source Operations, Intelligence Collection, Weapons Handling, Quality Assurance, Medical Devices, Process Improvement, Risk Assessment, Public Health, Regulatory Affairs, Military Liaison, Joint Military..., Interagency Coordination, Joint Planning, Reconnaissance, Biodefense, Bioterrorism, Public Health Emergency..., Force Protection, Rescue Diver, Tactical Planning
Education
Drexel University - LeBow College of Business 2010 — 2011
MBA, Engineering Managment
Rutgers, The State University of New Jersey-Camden 2007 — 2008
MBA
Rutgers University-New Brunswick 2001 — 2007
BS, Biomedical Engineering & Biomathematics
Community College of the US Air Force 2002 — 2005
Associate of Arts and Sciences (A.A.S.), Aircraft Armament Systems Technology
Egg Harbor Township High School
Department of Health and Human Services February 2008 - Present
U.S. Food and Drug Administration November 2007 - Present
United States Air Force June 2002 - November 2007
Rutgers University Tissue Engineering Lab August 2006 - May 2007
Skills
Project Management, Analysis, Leadership, Data Analysis, Engineering, Troubleshooting, Program Management, Testing, Defense, Research, Microsoft Office, Software Documentation, Aseptic Processing, Deviation Management, Quality Investigations, Quality System..., Stability Programs, Method Transfer, Analytical Method..., cGMP practices, cGMP manufacturing, Pharmaceutical process..., Pharmaceutical..., Pharmaceutical..., Process Analytical..., Quality by Design, Biopharmaceutics, Cleaning Validation, Source Analysis, Operational Intelligence, Source Operations, Intelligence Collection, Weapons Handling, Quality Assurance, Medical Devices, Process Improvement, Risk Assessment, Public Health, Regulatory Affairs, Military Liaison, Joint Military..., Interagency Coordination, Joint Planning, Reconnaissance, Biodefense, Bioterrorism, Public Health Emergency..., Force Protection, Rescue Diver, Tactical Planning
Education
Drexel University - LeBow College of Business 2010 — 2011
MBA, Engineering Managment
Rutgers, The State University of New Jersey-Camden 2007 — 2008
MBA
Rutgers University-New Brunswick 2001 — 2007
BS, Biomedical Engineering & Biomathematics
Community College of the US Air Force 2002 — 2005
Associate of Arts and Sciences (A.A.S.), Aircraft Armament Systems Technology
Egg Harbor Township High School
Catherine Santai's U.S. Food and Drug Administration Experience February 2002 - January 2003
Job Assoc Professor of Chemistry and Biochemistry
Industry Higher Education
Experience
Harrisburg University August 2015 - Present
Harrisburg University July 2013 - April 2015
Wilson College August 2006 - June 2013
U.S. Food and Drug Administration February 2002 - January 2003
Poly One, Inc September 2001 - February 2002
Skills
Higher Education, University Teaching, Academic Advising, College Teaching, Teaching, Academic Administration, Grant Writing, Distance Learning, Curriculum Design, Tutoring, Western Blotting, Curriculum Development, Research, PCR, General Chemistry, Statistics, Undergraduate Teaching, Public Speaking, NMR spectroscopy, Molecular Biology, DNA, Biochemistry, UV/Vis, Protein Chemistry, HPLC, Spectroscopy, Fluorescence, Chemistry, Fluorescence..., Purification, Protein Expression, Assay Development, SDS-PAGE, Column Chromatography, AFM, Laboratory, FTIR, TEM, Science, Agarose Gel..., Bacterial Transformation, Protein Assays, Cell Culture, Microscopy, Gel Electrophoresis, Protein Purification, Technical Writing, Data Analysis, Student Affairs
Education
Georgia Institute of Technology 2003 — 2006
Ph.D., Chemistry, emphasis Biochemistry (nucleic acid Biochemistry)
Georgetown University 1996 — 2001
M.S., Chemistry, emphasis Protein Biochemistry
College of Notre Dame of Maryland 1992 — 1996
B.A., Chemistry, minors Biology and Physics, GPA 3.9
Harrisburg University August 2015 - Present
Harrisburg University July 2013 - April 2015
Wilson College August 2006 - June 2013
U.S. Food and Drug Administration February 2002 - January 2003
Poly One, Inc September 2001 - February 2002
Skills
Higher Education, University Teaching, Academic Advising, College Teaching, Teaching, Academic Administration, Grant Writing, Distance Learning, Curriculum Design, Tutoring, Western Blotting, Curriculum Development, Research, PCR, General Chemistry, Statistics, Undergraduate Teaching, Public Speaking, NMR spectroscopy, Molecular Biology, DNA, Biochemistry, UV/Vis, Protein Chemistry, HPLC, Spectroscopy, Fluorescence, Chemistry, Fluorescence..., Purification, Protein Expression, Assay Development, SDS-PAGE, Column Chromatography, AFM, Laboratory, FTIR, TEM, Science, Agarose Gel..., Bacterial Transformation, Protein Assays, Cell Culture, Microscopy, Gel Electrophoresis, Protein Purification, Technical Writing, Data Analysis, Student Affairs
Education
Georgia Institute of Technology 2003 — 2006
Ph.D., Chemistry, emphasis Biochemistry (nucleic acid Biochemistry)
Georgetown University 1996 — 2001
M.S., Chemistry, emphasis Protein Biochemistry
College of Notre Dame of Maryland 1992 — 1996
B.A., Chemistry, minors Biology and Physics, GPA 3.9
Kathleen Yu Kathleen Yu's U.S. Food and Drug Administration Experience February 2014 - Present
Job ORISE Fellow, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
Industry Research
Experience
U.S. Food and Drug Administration February 2014 - Present
Columbia University Mailman School of Public Health August 2012 - May 2013
Columbia University Mailman School of Public Health July 2012 - May 2013
UCLA Fielding School of Public Health June 2009 - August 2011
Los Angeles Unified School District August 2007 - June 2009
Skills
Project Management, Presentations, Public Speaking, Public Health, Highly detail oriented, Teamwork, Team Management, Teaching, Peer Mentoring, Research, Policy, SPSS, Grants, Literature Reviews, Community Outreach, Program Evaluation, Qualitative Research
Education
Columbia University Mailman School of Public Health 2011 — 2013
Master of Public Health (M.P.H.), Sociomedical Sciences - Urbanism & The Built Environment
UC Berkeley 2002 — 2006
Bachelor's Degree, Public Health (minor in Anthropology)
Bravo High School 1998 — 2002
High School
U.S. Food and Drug Administration February 2014 - Present
Columbia University Mailman School of Public Health August 2012 - May 2013
Columbia University Mailman School of Public Health July 2012 - May 2013
UCLA Fielding School of Public Health June 2009 - August 2011
Los Angeles Unified School District August 2007 - June 2009
Skills
Project Management, Presentations, Public Speaking, Public Health, Highly detail oriented, Teamwork, Team Management, Teaching, Peer Mentoring, Research, Policy, SPSS, Grants, Literature Reviews, Community Outreach, Program Evaluation, Qualitative Research
Education
Columbia University Mailman School of Public Health 2011 — 2013
Master of Public Health (M.P.H.), Sociomedical Sciences - Urbanism & The Built Environment
UC Berkeley 2002 — 2006
Bachelor's Degree, Public Health (minor in Anthropology)
Bravo High School 1998 — 2002
High School
Heather J Hopkins's U.S. Food and Drug Administration Experience August 2008 - May 2009
Job Circulation Volunteer at Pikes Peak Library District
Industry Libraries
Experience
Pikes Peak Library District February 2015 - Present
Self employed March 2013 - Present
Huntsville-Madison County Public Library October 2009 - February 2010
U.S. Food and Drug Administration August 2008 - May 2009
Literacy Council of Northern Virginia 2007 - 2008
Episcopal High School February 2007 - October 2007
National Library of Medicine 2004 - 2004
Centerscope 2003 - 2004
University of Central Florida 2002 - 2003
Tribune Interactive 1998 - 2001
Skills
Virtual Reference, Cataloging, Database Design, Online Research, Reference, Library Research, Library Management, Library Instruction, Information Literacy, Legal Research, Literature Reviews, Proposal Writing, Technical Writing, Intranet, Collection Development, Library 2.0, Integrated Library..., Web Applications, Webmaster Services, Online Marketing..., Academic Tutoring, SEO, Branding & Identity, Competitive Intelligence, Database Searching, Instructional Design, Library, Library Science, Interlibrary Loan, Digital Libraries, Electronic Resources, Academic Libraries, Metadata, Library Reference, Information Retrieval, Reader's Advisory, Circulation, Digitization, Bibliographic..., Digital Preservation
Education
University of South Florida 2003 — 2008
MLS, Library and Information Science
Rollins College 2000 — 2002
Liberal Studies
University of Alabama 1989 — 1993
B.A, English
Boston University 1988 — 1989
English Literature
Virgil I Grissom High School 1985 — 1988
Pikes Peak Library District February 2015 - Present
Self employed March 2013 - Present
Huntsville-Madison County Public Library October 2009 - February 2010
U.S. Food and Drug Administration August 2008 - May 2009
Literacy Council of Northern Virginia 2007 - 2008
Episcopal High School February 2007 - October 2007
National Library of Medicine 2004 - 2004
Centerscope 2003 - 2004
University of Central Florida 2002 - 2003
Tribune Interactive 1998 - 2001
Skills
Virtual Reference, Cataloging, Database Design, Online Research, Reference, Library Research, Library Management, Library Instruction, Information Literacy, Legal Research, Literature Reviews, Proposal Writing, Technical Writing, Intranet, Collection Development, Library 2.0, Integrated Library..., Web Applications, Webmaster Services, Online Marketing..., Academic Tutoring, SEO, Branding & Identity, Competitive Intelligence, Database Searching, Instructional Design, Library, Library Science, Interlibrary Loan, Digital Libraries, Electronic Resources, Academic Libraries, Metadata, Library Reference, Information Retrieval, Reader's Advisory, Circulation, Digitization, Bibliographic..., Digital Preservation
Education
University of South Florida 2003 — 2008
MLS, Library and Information Science
Rollins College 2000 — 2002
Liberal Studies
University of Alabama 1989 — 1993
B.A, English
Boston University 1988 — 1989
English Literature
Virgil I Grissom High School 1985 — 1988
Julianna Perrella Julianna Perrella's U.S. Food and Drug Administration Experience June 2011 - August 2011
Job Student Nurse at Wheeling Hospital
Industry Hospital & Health Care
Experience
Wheeling Hospital August 2012 - December 2012
East Liverpool City Hospital August 2012 - December 2012
Lifeline Hospital January 2012 - May 2012
UPMC Mercy August 2011 - December 2011
East Liverpool City Hospital August 2011 - December 2011
U.S. Food and Drug Administration June 2011 - August 2011
Weirton Medical Center January 2011 - May 2011
Skills
Nursing Care, Nursing, Patient Safety, Patient Advocacy, Direct Patient Care, Quality Patient Care, Patient Support, Healthcare, Therapeutic..., Cpr Certified, LNA
Education
Franciscan University of Steubenville 2009 — 2014
Bachelor of Science (BS), Nursing
Wheeling Hospital August 2012 - December 2012
East Liverpool City Hospital August 2012 - December 2012
Lifeline Hospital January 2012 - May 2012
UPMC Mercy August 2011 - December 2011
East Liverpool City Hospital August 2011 - December 2011
U.S. Food and Drug Administration June 2011 - August 2011
Weirton Medical Center January 2011 - May 2011
Skills
Nursing Care, Nursing, Patient Safety, Patient Advocacy, Direct Patient Care, Quality Patient Care, Patient Support, Healthcare, Therapeutic..., Cpr Certified, LNA
Education
Franciscan University of Steubenville 2009 — 2014
Bachelor of Science (BS), Nursing
Chris DeMers Chris DeMers's U.S. Food and Drug Administration Experience August 2004 - November 2004
Job
Industry Law Practice
Experience
Nichols Zauzig Sandler PC May 2012 - Present
Watt, Tieder, Hoffar & Fitzgerald, LLP August 2007 - May 2012
Rees Broome, PC November 2004 - August 2007
U.S. Food and Drug Administration August 2004 - November 2004
Thompson & Waldron April 2003 - April 2004
The Catholic University of America October 2000 - August 2001
Fingerhut, Powers, Smith and Associates June 1999 - August 1999
Skills
Real Estate, Contract Negotiation, Legal Research, Negotiation, Non-profits, Legal Writing, Commercial Lending, Commercial Banking, Mortgage Lending, Commercial Mortgages, Loans, Corporate Law
Education
George Mason University School of Law 2001 — 2004
J.D.
Xavier University 1996 — 2000
B.A.
Nichols Zauzig Sandler PC May 2012 - Present
Watt, Tieder, Hoffar & Fitzgerald, LLP August 2007 - May 2012
Rees Broome, PC November 2004 - August 2007
U.S. Food and Drug Administration August 2004 - November 2004
Thompson & Waldron April 2003 - April 2004
The Catholic University of America October 2000 - August 2001
Fingerhut, Powers, Smith and Associates June 1999 - August 1999
Skills
Real Estate, Contract Negotiation, Legal Research, Negotiation, Non-profits, Legal Writing, Commercial Lending, Commercial Banking, Mortgage Lending, Commercial Mortgages, Loans, Corporate Law
Education
George Mason University School of Law 2001 — 2004
J.D.
Xavier University 1996 — 2000
B.A.
Scott Danzis Scott Danzis's U.S. Food and Drug Administration Experience November 2006 - June 2008
Job Partner at Covington & Burling
Industry Law Practice
Experience
Covington & Burling June 2008 - Present
U.S. Food and Drug Administration November 2006 - June 2008
Skills
Litigation, Legal Writing, Intellectual Property, Competition Law, Civil Litigation, Appeals, Commercial Litigation, Administrative Law, Regulatory Affairs, Biotechnology, Corporate Governance, Legal Research
Education
University of Virginia School of Law 1997 — 2000
JD, Law
The George Washington University 1994 — 1997
MHSA, Health care public policy
Cornell University 1989 — 1993
B.S.
Covington & Burling June 2008 - Present
U.S. Food and Drug Administration November 2006 - June 2008
Skills
Litigation, Legal Writing, Intellectual Property, Competition Law, Civil Litigation, Appeals, Commercial Litigation, Administrative Law, Regulatory Affairs, Biotechnology, Corporate Governance, Legal Research
Education
University of Virginia School of Law 1997 — 2000
JD, Law
The George Washington University 1994 — 1997
MHSA, Health care public policy
Cornell University 1989 — 1993
B.S.
Andrea Kerrigan Andrea Kerrigan's U.S. Food and Drug Administration Experience May 2009 - Present
Job Chemist at FDA
Industry Government Administration
Experience
U.S. Food and Drug Administration May 2009 - Present
GlaxoSmithKline June 2006 - April 2009
Skills
Organic Synthesis, Chemistry, NMR, Organic Chemistry, Lifesciences, Drug Discovery, Mass Spectrometry, LC-MS, UV/Vis, HPLC, Chromatography
Education
University of Pennsylvania 2004 — 2006
M.S., Organic Chemistry
Butler University 2000 — 2004
B.S., Chemistry
U.S. Food and Drug Administration May 2009 - Present
GlaxoSmithKline June 2006 - April 2009
Skills
Organic Synthesis, Chemistry, NMR, Organic Chemistry, Lifesciences, Drug Discovery, Mass Spectrometry, LC-MS, UV/Vis, HPLC, Chromatography
Education
University of Pennsylvania 2004 — 2006
M.S., Organic Chemistry
Butler University 2000 — 2004
B.S., Chemistry
Jim McCormack Jim McCormack's U.S. Food and Drug Administration Experience January 1997 - June 2005
Job Vice President, Life Sciences Compliance, Global Regulatory & Cyber Security Management at IBM
Industry Information Technology and Services
Experience
IBM March 2011 - Present
Charles River Laboratories International, Inc. 2005 - 2011
U.S. Food and Drug Administration January 1997 - June 2005
U.S. Food and Drug Administration September 1987 - December 1996
Skills
Regulatory Requirements, FDA, 21 CFR Part 11, GLP, Regulatory Affairs, GCP, Electronic recordkeeping, Computer system..., International..., Validation, CAPA, Change Control, Lifesciences, Quality Auditing, CRO, Quality System, Biotechnology, Pharmaceutical Industry, Quality Assurance, Computer System..., Sop, GMP, Medical Devices, Technology Transfer, Regulatory Submissions, Clinical Development, Quality Control, R&D, Quality Management, Laboratory, Clinical Trials, V&V, Drug Discovery, Hardware Diagnostics
Education
Virginia Polytechnic Institute and State University 1984 — 1987
PhD, Neuroendcrinology
Iowa State University 1977 — 1980
MS, Animal Nutrition
Purdue University 1973 — 1977
BS, Animal Science
IBM March 2011 - Present
Charles River Laboratories International, Inc. 2005 - 2011
U.S. Food and Drug Administration January 1997 - June 2005
U.S. Food and Drug Administration September 1987 - December 1996
Skills
Regulatory Requirements, FDA, 21 CFR Part 11, GLP, Regulatory Affairs, GCP, Electronic recordkeeping, Computer system..., International..., Validation, CAPA, Change Control, Lifesciences, Quality Auditing, CRO, Quality System, Biotechnology, Pharmaceutical Industry, Quality Assurance, Computer System..., Sop, GMP, Medical Devices, Technology Transfer, Regulatory Submissions, Clinical Development, Quality Control, R&D, Quality Management, Laboratory, Clinical Trials, V&V, Drug Discovery, Hardware Diagnostics
Education
Virginia Polytechnic Institute and State University 1984 — 1987
PhD, Neuroendcrinology
Iowa State University 1977 — 1980
MS, Animal Nutrition
Purdue University 1973 — 1977
BS, Animal Science
Jeremiah J. Kelly Jeremiah J. Kelly's U.S. Food and Drug Administration Experience September 2006 - January 2007
Job Attorney, JAG, U.S. Army Medical Research and Material Command
Industry Law Practice
Experience
Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Material Command January 2011 - Present
Whiteford, Taylor & Preston September 2008 - January 2011
Office of Legislation, U.S. Food and Drug Administration October 2001 - September 2008
U.S. Food and Drug Administration September 2006 - January 2007
U.S. Army Center for Environmental Research, Ft. Detrick, Md. January 1997 - October 2001
Chesapeake Bay Foundation January 2001 - May 2001
Skills
Policy Analysis, Legislative Relations, Policy, Due Diligence, Litigation, Commercial Litigation, Biotechnology, Civil Litigation, Public Speaking, Public Policy, Legal Research, Food & Drug Law, Legal Advice, Intellectual Property, Health Law, Westlaw, Legislation, Research, Congressional Affairs, Administrative Law, Corporate Law, Government, Legal Writing, Mergers & Acquisitions
Education
University of Maryland Francis King Carey School of Law 2004 — 2008
The George Washington University - School of Business 2001 — 2003
Master of Public Policy, Public Policy
McDaniel College 1997 — 2001
Bachelor of Arts, Political Science, International Affairs (minor), Biology (minor)
Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Material Command January 2011 - Present
Whiteford, Taylor & Preston September 2008 - January 2011
Office of Legislation, U.S. Food and Drug Administration October 2001 - September 2008
U.S. Food and Drug Administration September 2006 - January 2007
U.S. Army Center for Environmental Research, Ft. Detrick, Md. January 1997 - October 2001
Chesapeake Bay Foundation January 2001 - May 2001
Skills
Policy Analysis, Legislative Relations, Policy, Due Diligence, Litigation, Commercial Litigation, Biotechnology, Civil Litigation, Public Speaking, Public Policy, Legal Research, Food & Drug Law, Legal Advice, Intellectual Property, Health Law, Westlaw, Legislation, Research, Congressional Affairs, Administrative Law, Corporate Law, Government, Legal Writing, Mergers & Acquisitions
Education
University of Maryland Francis King Carey School of Law 2004 — 2008
The George Washington University - School of Business 2001 — 2003
Master of Public Policy, Public Policy
McDaniel College 1997 — 2001
Bachelor of Arts, Political Science, International Affairs (minor), Biology (minor)
Christina Capacci-Daniel Christina Capacci-Daniel's U.S. Food and Drug Administration Experience May 2013 - Present
Job Consumer Safety Officer
Industry Pharmaceuticals
Experience
U.S. Food and Drug Administration May 2013 - Present
Novartis July 2009 - May 2013
Skills
Pharmacokinetics, Biopharmaceuticals, Toxicology, Pharmaceutics, Formulation, Crystallization, Analytical Chemistry, Drug Development, Project Management, Pharmaceutical Industry, Process Simulation, HPLC, Clinical Trials, Technology Transfer, LC-MS
Education
Georgetown University 2003 — 2009
PhD, Chemistry
Seattle University 1999 — 2003
BS, Chemistry
U.S. Food and Drug Administration May 2013 - Present
Novartis July 2009 - May 2013
Skills
Pharmacokinetics, Biopharmaceuticals, Toxicology, Pharmaceutics, Formulation, Crystallization, Analytical Chemistry, Drug Development, Project Management, Pharmaceutical Industry, Process Simulation, HPLC, Clinical Trials, Technology Transfer, LC-MS
Education
Georgetown University 2003 — 2009
PhD, Chemistry
Seattle University 1999 — 2003
BS, Chemistry
Shalisha Dapaa's U.S. Food and Drug Administration Experience February 2013 - Present
Job Director, Client Services at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration February 2013 - Present
U.S. Department of Energy, National Nuclear Security Administration 2009 - Present
Federal Aviation Administration 2007 - 2009
Federal Aviation Administraton 2003 - 2007
Education
Dillard University 1986 — 1990
BA, Accounting
U.S. Food and Drug Administration February 2013 - Present
U.S. Department of Energy, National Nuclear Security Administration 2009 - Present
Federal Aviation Administration 2007 - 2009
Federal Aviation Administraton 2003 - 2007
Education
Dillard University 1986 — 1990
BA, Accounting
Joan Rothenberg's U.S. Food and Drug Administration Experience October 2010 - Present
Job Regulatory Counsel, Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration October 2010 - Present
Center for Infrastructure Protection and Homelant Security September 2009 - October 2010
International Food Information Council January 2002 - March 2007
Starbucks September 1993 - August 1999
Slim Fast Foods May 1990 - April 1992
Campbell Soup Company October 1989 - May 1990
Kraft Foods September 1979 - October 1989
General Foods September 1979 - October 1989
Skills
Regulatory Affairs, Legislation, FDA, Product Development, Science, Public Policy, Government, Lifesciences, Regulations, Intellectual Property, Biotechnology, Federal Government, Food Safety, Quality System, Regulatory Analysis, Food Science
Education
George Mason University School of Law 2004 — 2009
Juris Doctor, Law
Central Michigan University 1990 — 1991
M.A., Business Management
Rutgers University 1983 — 1990
M.S., Food Science
University of Florida 1976 — 1979
B.S. Ag., Food Science
U.S. Food and Drug Administration October 2010 - Present
Center for Infrastructure Protection and Homelant Security September 2009 - October 2010
International Food Information Council January 2002 - March 2007
Starbucks September 1993 - August 1999
Slim Fast Foods May 1990 - April 1992
Campbell Soup Company October 1989 - May 1990
Kraft Foods September 1979 - October 1989
General Foods September 1979 - October 1989
Skills
Regulatory Affairs, Legislation, FDA, Product Development, Science, Public Policy, Government, Lifesciences, Regulations, Intellectual Property, Biotechnology, Federal Government, Food Safety, Quality System, Regulatory Analysis, Food Science
Education
George Mason University School of Law 2004 — 2009
Juris Doctor, Law
Central Michigan University 1990 — 1991
M.A., Business Management
Rutgers University 1983 — 1990
M.S., Food Science
University of Florida 1976 — 1979
B.S. Ag., Food Science
Bob Hastings's U.S. Food and Drug Administration Experience 1987 - 1991
Job Research Director at DePuy Synthes Joint Reconstruction
Industry Medical Devices
Experience
DePuy Synthes Joint Reconstruction January 2011 - Present
DePuy Orthopaedics March 2008 - January 2011
DePuy, a Johnson & Johnson Co. March 2006 - March 2008
DePuy, a Johnson & Johnson Co. September 2005 - March 2006
DePuy, a Johnson & Johnson Co. October 1998 - September 2005
DePuy February 1991 - 1998
U.S. Food and Drug Administration 1987 - 1991
Skills
Medical Devices, Biomechanics, project management, Failure Analysis, Orthopedic, Portfolio Management, Strategic Planning, People Development, R&D, Technology Evaluation, Biomedical Engineering, V&V, Project Management, Materials, Biomaterials, FDA, Regulatory Affairs, Product Development, ISO 13485, Commercialization, Design Control, CAPA, Polymers, Design of Experiments, Tissue Engineering, Validation, ISO 14971, Biotechnology, Quality System, Minitab, Lifesciences, Technology Transfer, Life Sciences, Orthopedics
Education
Case Western Reserve University 1985 — 1987
M.S., Biomedical Engineering
Bucknell University 1977 — 1982
B.A., Biology
Bucknell University 1977 — 1981
B.S., Mechanical Engineering
Lake Ridge Academy 1971 — 1977
College Prep
DePuy Synthes Joint Reconstruction January 2011 - Present
DePuy Orthopaedics March 2008 - January 2011
DePuy, a Johnson & Johnson Co. March 2006 - March 2008
DePuy, a Johnson & Johnson Co. September 2005 - March 2006
DePuy, a Johnson & Johnson Co. October 1998 - September 2005
DePuy February 1991 - 1998
U.S. Food and Drug Administration 1987 - 1991
Skills
Medical Devices, Biomechanics, project management, Failure Analysis, Orthopedic, Portfolio Management, Strategic Planning, People Development, R&D, Technology Evaluation, Biomedical Engineering, V&V, Project Management, Materials, Biomaterials, FDA, Regulatory Affairs, Product Development, ISO 13485, Commercialization, Design Control, CAPA, Polymers, Design of Experiments, Tissue Engineering, Validation, ISO 14971, Biotechnology, Quality System, Minitab, Lifesciences, Technology Transfer, Life Sciences, Orthopedics
Education
Case Western Reserve University 1985 — 1987
M.S., Biomedical Engineering
Bucknell University 1977 — 1982
B.A., Biology
Bucknell University 1977 — 1981
B.S., Mechanical Engineering
Lake Ridge Academy 1971 — 1977
College Prep
Nisha Shah Nisha Shah's U.S. Food and Drug Administration Experience September 2012 - Present
Job Regulatory Counsel at U.S. Food and Drug Administration
Industry Law Practice
Experience
U.S. Food and Drug Administration September 2012 - Present
Hyman, Phelps & McNamara, P.C. November 2009 - August 2012
Epstein Becker & Green, P.C. May 2006 - October 2009
AARP Foundation October 2005 - April 2006
U.S. Department of Justice May 2005 - August 2005
Abt Associates October 2001 - September 2004
European Generic medicines Association June 2000 - September 2001
Skills
Pharmaceutical Law, Due Diligence, Health Law, Administrative Law, FDA, Legal Research, Legal Writing, Medical Devices, Policy, Licensing, International Law, Patent Litigation, Patents, Government, Westlaw, Trials, Corporate Governance, Public Policy, Hearings, Intellectual Property, Securities Regulation
Education
The George Washington University Law School 2004 — 2007
J.D.
The London School of Economics and Political Science (LSE) 1999 — 2000
M.Sc., International Health Policy
Cornell University 1994 — 1998
Bachelor of Arts (B.A.), Economics
U.S. Food and Drug Administration September 2012 - Present
Hyman, Phelps & McNamara, P.C. November 2009 - August 2012
Epstein Becker & Green, P.C. May 2006 - October 2009
AARP Foundation October 2005 - April 2006
U.S. Department of Justice May 2005 - August 2005
Abt Associates October 2001 - September 2004
European Generic medicines Association June 2000 - September 2001
Skills
Pharmaceutical Law, Due Diligence, Health Law, Administrative Law, FDA, Legal Research, Legal Writing, Medical Devices, Policy, Licensing, International Law, Patent Litigation, Patents, Government, Westlaw, Trials, Corporate Governance, Public Policy, Hearings, Intellectual Property, Securities Regulation
Education
The George Washington University Law School 2004 — 2007
J.D.
The London School of Economics and Political Science (LSE) 1999 — 2000
M.Sc., International Health Policy
Cornell University 1994 — 1998
Bachelor of Arts (B.A.), Economics
Gregory Busse Gregory Busse's U.S. Food and Drug Administration Experience February 2008 - July 2012
Job Medical Science Liaison at Takeda
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals January 2015 - Present
Gershon Creative August 2012 - January 2015
Global Prairie August 2012 - December 2014
American University August 2012 - 2014
U.S. Food and Drug Administration February 2008 - July 2012
Skills
SPSS, Psychology, Research, Strategic Communications, Research Design, Higher Education, Program Management, Editing, Crisis Communications, Grant Writing, Grants, Qualitative Research, Community Outreach, Program Evaluation, Statistics
Education
American University 1999 — 2004
Doctor of Philosophy (Ph.D.), Psychology
Tulane University 1993 — 1997
Bachelor's degree, Psychology
Takeda Pharmaceuticals January 2015 - Present
Gershon Creative August 2012 - January 2015
Global Prairie August 2012 - December 2014
American University August 2012 - 2014
U.S. Food and Drug Administration February 2008 - July 2012
Skills
SPSS, Psychology, Research, Strategic Communications, Research Design, Higher Education, Program Management, Editing, Crisis Communications, Grant Writing, Grants, Qualitative Research, Community Outreach, Program Evaluation, Statistics
Education
American University 1999 — 2004
Doctor of Philosophy (Ph.D.), Psychology
Tulane University 1993 — 1997
Bachelor's degree, Psychology
Dia Hill's U.S. Food and Drug Administration Experience June 1994 - March 1999
Job Regulatory Affairs at MiMedx
Industry Biotechnology
Experience
MiMedx May 2014 - Present
Immucor, Inc. February 2012 - May 2014
Arbor Pharmaceuticals February 2011 - February 2012
Shionogi Pharma (formerly Sciele Pharma) November 2007 - January 2011
Xanodyne Pharmaceuticals March 2006 - October 2007
Pfizer June 2001 - March 2005
Eurand March 2001 - June 2001
Phoenix International Life Sciences March 1999 - September 2000
U.S. Food and Drug Administration June 1994 - March 1999
Skills
Medical Devices, CMC, Clinical Research, Quality Assurance, NDA, Electronic Submissions, DMF, Cosmetics, Food, FDA, Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry, CAPA, Sop, GMP, Change Control, Regulatory Requirements, eCTD, Regulations, IND, Pharmaceutics, Biotechnology, Medical Writing, SOP, Lifesciences, GLP, Life Sciences
Education
Kentucky State University 1989 — 1994
BS, Biology, Minors - Chemistry and Spanish
MiMedx May 2014 - Present
Immucor, Inc. February 2012 - May 2014
Arbor Pharmaceuticals February 2011 - February 2012
Shionogi Pharma (formerly Sciele Pharma) November 2007 - January 2011
Xanodyne Pharmaceuticals March 2006 - October 2007
Pfizer June 2001 - March 2005
Eurand March 2001 - June 2001
Phoenix International Life Sciences March 1999 - September 2000
U.S. Food and Drug Administration June 1994 - March 1999
Skills
Medical Devices, CMC, Clinical Research, Quality Assurance, NDA, Electronic Submissions, DMF, Cosmetics, Food, FDA, Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry, CAPA, Sop, GMP, Change Control, Regulatory Requirements, eCTD, Regulations, IND, Pharmaceutics, Biotechnology, Medical Writing, SOP, Lifesciences, GLP, Life Sciences
Education
Kentucky State University 1989 — 1994
BS, Biology, Minors - Chemistry and Spanish
Michael McGrane's U.S. Food and Drug Administration Experience September 1975 - August 1984
Job General Counsel to NASDAQ Listed Pharmaceutical Companies
Industry Pharmaceuticals
Experience
Columbia Laboratories, Inc. January 2002 - January 2013
The Liposome Company, Inc. January 1999 - October 2001
Novartis Consumer Health January 1997 - December 1998
Novartis Pharmaceuticals Corporation January 1993 - December 1996
Novartis Pharmaceuticals Corporation May 1988 - December 1992
Novartis Pharmaceuticals Corporation September 1987 - April 1988
Novartis Pharmaceuticals Corporation September 1984 - August 1987
U.S. Food and Drug Administration September 1975 - August 1984
Skills
Commercial Litigation, Intellectual Property, Regulatory Affairs, Pharmaceutical Industry, Corporate Governance, Healthcare, Mergers & Acquisitions
Education
Cornell College
Bachelor of Arts (B.A.), History and German
Georgetown University Law Center
Doctor of Law (J.D.)
Columbia Laboratories, Inc. January 2002 - January 2013
The Liposome Company, Inc. January 1999 - October 2001
Novartis Consumer Health January 1997 - December 1998
Novartis Pharmaceuticals Corporation January 1993 - December 1996
Novartis Pharmaceuticals Corporation May 1988 - December 1992
Novartis Pharmaceuticals Corporation September 1987 - April 1988
Novartis Pharmaceuticals Corporation September 1984 - August 1987
U.S. Food and Drug Administration September 1975 - August 1984
Skills
Commercial Litigation, Intellectual Property, Regulatory Affairs, Pharmaceutical Industry, Corporate Governance, Healthcare, Mergers & Acquisitions
Education
Cornell College
Bachelor of Arts (B.A.), History and German
Georgetown University Law Center
Doctor of Law (J.D.)
Andrea Broad's U.S. Food and Drug Administration Experience 1990 - 1998
Job Software Engineer at Young Consulting, Inc.
Industry Computer Software
Experience
Young Consulting, Inc. May 2000 - Present
Infocure, Inc. September 1999 - May 2000
CareLinc Corporation June 1998 - July 1999
U.S. Food & Drug Administration May 1990 - June 1998
U.S. Food and Drug Administration 1990 - 1998
Education
Georgia State University 1993 — 1999
University of Arizona 1986 — 1989
B.S., Major: Psychology Minor: Chemistry
Young Consulting, Inc. May 2000 - Present
Infocure, Inc. September 1999 - May 2000
CareLinc Corporation June 1998 - July 1999
U.S. Food & Drug Administration May 1990 - June 1998
U.S. Food and Drug Administration 1990 - 1998
Education
Georgia State University 1993 — 1999
University of Arizona 1986 — 1989
B.S., Major: Psychology Minor: Chemistry
Joseph Haynes's U.S. Food and Drug Administration Experience September 2009 - September 2011
Job Supervisory Consumer Safety Officer at FDA
Industry Pharmaceuticals
Experience
FDA August 2011 - Present
U.S. Food and Drug Administration September 2009 - September 2011
United Health, i3 Drug Safety 2007 - September 2009
i3 Drug Safety 2007 - 2009
Pfizer August 1998 - September 2007
Genzyme Transgenics 1997 - 1998
MPI Research 1993 - 1997
US Army 1989 - 1993
Skills
Pharmacovigilance, Pharmaceutical Industry, FDA, Regulatory Affairs, Clinical Trials, Clinical Development, Drug Development, Sop, GLP, Regulatory Submissions, Lifesciences, Biotechnology, GCP, Pharmacology, CRO
Education
Eastern Michigan University 2001 — 2006
B.S., Health Administration
FDA August 2011 - Present
U.S. Food and Drug Administration September 2009 - September 2011
United Health, i3 Drug Safety 2007 - September 2009
i3 Drug Safety 2007 - 2009
Pfizer August 1998 - September 2007
Genzyme Transgenics 1997 - 1998
MPI Research 1993 - 1997
US Army 1989 - 1993
Skills
Pharmacovigilance, Pharmaceutical Industry, FDA, Regulatory Affairs, Clinical Trials, Clinical Development, Drug Development, Sop, GLP, Regulatory Submissions, Lifesciences, Biotechnology, GCP, Pharmacology, CRO
Education
Eastern Michigan University 2001 — 2006
B.S., Health Administration
Meghan H. Scott's U.S. Food and Drug Administration Experience January 2012 - November 2013
Job Senior Advisor for Oversight at FDA
Industry Government Administration
Experience
FDA October 2014 - Present
US Department of Health and Human Services November 2013 - October 2014
U.S. Food and Drug Administration January 2012 - November 2013
U.S. Food and Drug Administration September 2009 - February 2012
WakeUpWalMart.com August 2007 - September 2009
American Association for Justice (formerly Association of Trial Lawyers of America) November 2005 - August 2007
Public Campaign Action Fund April 2005 - November 2005
Floridians for All June 2004 - November 2004
John Edwards for President August 2002 - April 2004
NH Democratic Party 2002 - 2003
Skills
Politics, Blogging, Strategic Communications, Government, Editing, Community Outreach, Press Releases, Public Relations, Policy, Strategy, Grassroots Organizing, Public Affairs, Fundraising, Media Relations, Public Policy, Grassroots, Policy Analysis
Education
Harvard University, John F. Kennedy School of Government 2012 — 2012
Strategic Management of Regulatory and Enforcement Agencies
Susquehanna University 1998 — 2001
B.A, Journalism
Emmaus High School 1994 — 1997
FDA October 2014 - Present
US Department of Health and Human Services November 2013 - October 2014
U.S. Food and Drug Administration January 2012 - November 2013
U.S. Food and Drug Administration September 2009 - February 2012
WakeUpWalMart.com August 2007 - September 2009
American Association for Justice (formerly Association of Trial Lawyers of America) November 2005 - August 2007
Public Campaign Action Fund April 2005 - November 2005
Floridians for All June 2004 - November 2004
John Edwards for President August 2002 - April 2004
NH Democratic Party 2002 - 2003
Skills
Politics, Blogging, Strategic Communications, Government, Editing, Community Outreach, Press Releases, Public Relations, Policy, Strategy, Grassroots Organizing, Public Affairs, Fundraising, Media Relations, Public Policy, Grassroots, Policy Analysis
Education
Harvard University, John F. Kennedy School of Government 2012 — 2012
Strategic Management of Regulatory and Enforcement Agencies
Susquehanna University 1998 — 2001
B.A, Journalism
Emmaus High School 1994 — 1997
Elaine Tseng's U.S. Food and Drug Administration Experience 2002 - 2006
Job Partner, King & Spalding LLP
Industry Law Practice
Experience
King & Spalding LLP January 2009 - Present
U.S. Food and Drug Administration 2002 - 2006
Skills
Intellectual Property
Education
Cornell University
B.A.
Harvard Law School
King & Spalding LLP January 2009 - Present
U.S. Food and Drug Administration 2002 - 2006
Skills
Intellectual Property
Education
Cornell University
B.A.
Harvard Law School
S. Fred Figa's U.S. Food and Drug Administration Experience 1986 - 1988
Job Associate Senior Counsel at Eisai Inc.
Industry Pharmaceuticals
Experience
Eisai Inc. November 2013 - Present
Shionogi Inc. May 2011 - November 2013
Eisai Inc. March 2010 - April 2011
Schering-Plough 2007 - March 2010
Organon USA Inc./Akzo Nobel 1991 - 2007
State and Federal Associates Inc 1988 - 1991
U.S. Food and Drug Administration 1986 - 1988
Skills
Pharmaceutical Industry, Clinical Trials, Regulatory Affairs, Oncology, Clinical Development, Biotechnology, Cross-functional Team..., Pharmaceutical Sales, FDA, Life Sciences
Education
George Mason University School of Law
JD, Law
Northeastern University
BS, Pharmacy
Eisai Inc. November 2013 - Present
Shionogi Inc. May 2011 - November 2013
Eisai Inc. March 2010 - April 2011
Schering-Plough 2007 - March 2010
Organon USA Inc./Akzo Nobel 1991 - 2007
State and Federal Associates Inc 1988 - 1991
U.S. Food and Drug Administration 1986 - 1988
Skills
Pharmaceutical Industry, Clinical Trials, Regulatory Affairs, Oncology, Clinical Development, Biotechnology, Cross-functional Team..., Pharmaceutical Sales, FDA, Life Sciences
Education
George Mason University School of Law
JD, Law
Northeastern University
BS, Pharmacy
David Perkins, J.D.'s U.S. Food and Drug Administration Experience December 1998 - May 2003
Job Director Quality & Compliance, AbbVie
Industry Pharmaceuticals
Experience
AbbVie November 2013 - Present
AbbVie January 2013 - Present
Abbott Laboratories October 2011 - January 2013
Abbott Laboratories July 2009 - October 2011
Sagent Pharmaceuticals January 2007 - May 2009
Cardinal Health January 2006 - December 2006
American Pharmaceutical Partners October 2003 - January 2006
U.S. Food and Drug Administration December 1998 - May 2003
U.S. Food and Drug Administration May 1993 - December 1998
Skills
Biotechnology, CAPA, Change Control, Continuous Improvement, Cross-functional Team..., FDA, GMP, Medical Devices, Pharmaceutical Industry, Quality Auditing, Quality Management, Quality System, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Sop, Strategic Planning, Technology Transfer, V&V, Validation, Quality Assurance
Education
Chicago-Kent College of Law, Illinois Institute of Technology 2001 — 2005
J.D., Law
University of Illinois at Chicago
B.S., Chemistry
AbbVie November 2013 - Present
AbbVie January 2013 - Present
Abbott Laboratories October 2011 - January 2013
Abbott Laboratories July 2009 - October 2011
Sagent Pharmaceuticals January 2007 - May 2009
Cardinal Health January 2006 - December 2006
American Pharmaceutical Partners October 2003 - January 2006
U.S. Food and Drug Administration December 1998 - May 2003
U.S. Food and Drug Administration May 1993 - December 1998
Skills
Biotechnology, CAPA, Change Control, Continuous Improvement, Cross-functional Team..., FDA, GMP, Medical Devices, Pharmaceutical Industry, Quality Auditing, Quality Management, Quality System, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Sop, Strategic Planning, Technology Transfer, V&V, Validation, Quality Assurance
Education
Chicago-Kent College of Law, Illinois Institute of Technology 2001 — 2005
J.D., Law
University of Illinois at Chicago
B.S., Chemistry
Ronald Moy's U.S. Food and Drug Administration Experience 1991 - 1997
Job Principal Life Sciences Consultant at Quintiles Consulting
Industry Medical Devices
Experience
Quintiles Consulting 2001 - Present
Baxter Healthcare 1998 - 2001
U.S. Food and Drug Administration 1991 - 1997
Skills
FDA, Medical Devices, CAPA, Pharmaceutical Industry, Regulatory Affairs, Quality System, Quality Management, Validation, 21 CFR Part 11, Quality Control, Quality Assurance, Lifesciences, ISO 13485, GLP, Six Sigma, V&V, GxP, Testing, GMP, Sop, Change Control, Quality Auditing, Computer System..., ISO 14971, Design Control, Regulatory Requirements, SOP, Aseptic Processing, Clinical Trials, FDA GMP, Life Sciences
Education
California State University-Long Beach 1988 — 1991
BSEE, Electrical Engineering, Software, Computer and ASIC design
Quintiles Consulting 2001 - Present
Baxter Healthcare 1998 - 2001
U.S. Food and Drug Administration 1991 - 1997
Skills
FDA, Medical Devices, CAPA, Pharmaceutical Industry, Regulatory Affairs, Quality System, Quality Management, Validation, 21 CFR Part 11, Quality Control, Quality Assurance, Lifesciences, ISO 13485, GLP, Six Sigma, V&V, GxP, Testing, GMP, Sop, Change Control, Quality Auditing, Computer System..., ISO 14971, Design Control, Regulatory Requirements, SOP, Aseptic Processing, Clinical Trials, FDA GMP, Life Sciences
Education
California State University-Long Beach 1988 — 1991
BSEE, Electrical Engineering, Software, Computer and ASIC design
Caroline Herron's U.S. Food and Drug Administration Experience December 1989 - July 1990
Job Project and Program Management Executive
Industry Management Consulting
Experience
Strategic Digital Signage September 2013 - Present
Herron Consulting LLC 2009 - Present
Fannie Mae June 2009 - January 2010
Fannie Mae August 2000 - October 2007
AppNet November 1998 - June 2000
Hoffmann-La Roche March 1996 - May 1998
Pharmaceutical Research and Manufacturers of America June 1993 - March 1996
George Washington University September 1991 - May 1994
U.S. Health Care Financing Administration August 1990 - August 1991
U.S. Food and Drug Administration December 1989 - July 1990
Skills
Program Management, Project Management, Product Management, Business Planning, Software Development, Strategic Policy..., Cross-functional Team..., Strategic Planning, Strategy, Leadership, Business Development, Project Planning, Product Development, Budgets, Market Research
Education
The George Washington University 1998 — 1998
Certificate, Dynamic Web Site Development and 3D Animation
The George Washington University 1990 — 1994
Masters of Philosophy, Economics -- Industrial Organization and Health Economics
Brown University 1986 — 1988
Bachelor of Arts, Applied Mathematics and Economics
Strategic Digital Signage September 2013 - Present
Herron Consulting LLC 2009 - Present
Fannie Mae June 2009 - January 2010
Fannie Mae August 2000 - October 2007
AppNet November 1998 - June 2000
Hoffmann-La Roche March 1996 - May 1998
Pharmaceutical Research and Manufacturers of America June 1993 - March 1996
George Washington University September 1991 - May 1994
U.S. Health Care Financing Administration August 1990 - August 1991
U.S. Food and Drug Administration December 1989 - July 1990
Skills
Program Management, Project Management, Product Management, Business Planning, Software Development, Strategic Policy..., Cross-functional Team..., Strategic Planning, Strategy, Leadership, Business Development, Project Planning, Product Development, Budgets, Market Research
Education
The George Washington University 1998 — 1998
Certificate, Dynamic Web Site Development and 3D Animation
The George Washington University 1990 — 1994
Masters of Philosophy, Economics -- Industrial Organization and Health Economics
Brown University 1986 — 1988
Bachelor of Arts, Applied Mathematics and Economics
Heather (Green) Tate's U.S. Food and Drug Administration Experience 2008 - Present
Job Epidemiologist, FDA Center for Veterinary Medicine
Industry Research
Experience
U.S. Food and Drug Administration 2008 - Present
FDA October 2008 - September 2010
Association of Public Health Laboratories May 2006 - October 2008
University of Maryland Baltimore June 2005 - May 2006
Skills
Epidemiology, Molecular Biology, Microbiology, Lifesciences, Infectious Diseases, Science, Biochemistry, Public Health, Global Health
Education
Harvard T.H. Chan School of Public Health 2004 — 2005
MS
New York University 1999 — 2004
PhD
University of Maryland Baltimore County 1995 — 1999
BS
U.S. Food and Drug Administration 2008 - Present
FDA October 2008 - September 2010
Association of Public Health Laboratories May 2006 - October 2008
University of Maryland Baltimore June 2005 - May 2006
Skills
Epidemiology, Molecular Biology, Microbiology, Lifesciences, Infectious Diseases, Science, Biochemistry, Public Health, Global Health
Education
Harvard T.H. Chan School of Public Health 2004 — 2005
MS
New York University 1999 — 2004
PhD
University of Maryland Baltimore County 1995 — 1999
BS
Julie Bringger's U.S. Food and Drug Administration Experience April 2006 - Present
Job Compliance Officer at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration April 2006 - Present
FDA 1988 - Present
U.S. Food and Drug Administration August 1988 - April 2006
US Food and Drug Adminstration July 1988 - April 2006
Skills
Quality Auditing, GMP, Regulatory Submissions, Regulatory Affairs, Quality System, Regulations, Government, Regulatory Analysis, FDA, Risk Assessment, Regulatory Requirements, Personnel Management, Policy, Regulatory Policy
Education
Florida Coastal School of Law 2013 — 2017
Juris Doctrate
University of Tennessee-Knoxville 1987 — 1988
Bachelor Of Science, Food Technology and Science
University of Tennessee-Knoxville 1977 — 1987
Bachelor of Science, Pre-Vet/Animal Science
Florida Coastal
US Food and Drug Administration April 2006 - Present
FDA 1988 - Present
U.S. Food and Drug Administration August 1988 - April 2006
US Food and Drug Adminstration July 1988 - April 2006
Skills
Quality Auditing, GMP, Regulatory Submissions, Regulatory Affairs, Quality System, Regulations, Government, Regulatory Analysis, FDA, Risk Assessment, Regulatory Requirements, Personnel Management, Policy, Regulatory Policy
Education
Florida Coastal School of Law 2013 — 2017
Juris Doctrate
University of Tennessee-Knoxville 1987 — 1988
Bachelor Of Science, Food Technology and Science
University of Tennessee-Knoxville 1977 — 1987
Bachelor of Science, Pre-Vet/Animal Science
Florida Coastal
Edward Parr's U.S. Food and Drug Administration Experience April 1994 - September 1996
Job Partner at Ury & Moskow
Industry Law Practice
Experience
Ury & Moskow September 2004 - Present
Ashcraft & Gerel, LLP January 2002 - August 2004
U.S. Food and Drug Administration April 1994 - September 1996
Skills
Product Liability, Torts, Appeals, Personal Injury, Trials, Civil Litigation, Wrongful Death, Litigation, Courts, Legal Research, Pleadings, Toxic Tort, Legal Writing, Automobile Accidents
Education
Georgetown University Law Center 1990 — 1993
Doctor of Law (JD)
New York University 1983 — 1986
Bachelor of Fine Arts (BFA), DRAMA
Ury & Moskow September 2004 - Present
Ashcraft & Gerel, LLP January 2002 - August 2004
U.S. Food and Drug Administration April 1994 - September 1996
Skills
Product Liability, Torts, Appeals, Personal Injury, Trials, Civil Litigation, Wrongful Death, Litigation, Courts, Legal Research, Pleadings, Toxic Tort, Legal Writing, Automobile Accidents
Education
Georgetown University Law Center 1990 — 1993
Doctor of Law (JD)
New York University 1983 — 1986
Bachelor of Fine Arts (BFA), DRAMA
Jerome Cordts, Ed.D.'s U.S. Food and Drug Administration Experience 1997 - 2003
Job Principal Systems Engineer
Industry Defense & Space
Experience
MITRE April 2008 - Present
Global Secure Systems 2005 - 2007
Appalachian College Association 2004 - 2005
U.S. Food and Drug Administration 1997 - 2003
Association of Public Health Laboratories 1990 - 1996
American Society for Microbiology 1986 - 1989
Skills
Systems Engineering, Program Management, Government, Strategic Partnerships, Technology Transfer, Non-profit Management, Non-profits, Management Consulting, Nonprofits, Defense, Information Assurance, Integration, Proposal Writing, DoD, Security, Enterprise Architecture, System Architecture, Requirements Analysis, Security Clearance, Strategy
Education
Frostburg State University
B.A.
North Carolina State University
M.Ed.
The George Washington University
Ed.D.
MITRE April 2008 - Present
Global Secure Systems 2005 - 2007
Appalachian College Association 2004 - 2005
U.S. Food and Drug Administration 1997 - 2003
Association of Public Health Laboratories 1990 - 1996
American Society for Microbiology 1986 - 1989
Skills
Systems Engineering, Program Management, Government, Strategic Partnerships, Technology Transfer, Non-profit Management, Non-profits, Management Consulting, Nonprofits, Defense, Information Assurance, Integration, Proposal Writing, DoD, Security, Enterprise Architecture, System Architecture, Requirements Analysis, Security Clearance, Strategy
Education
Frostburg State University
B.A.
North Carolina State University
M.Ed.
The George Washington University
Ed.D.
TJ Christl's U.S. Food and Drug Administration Experience August 2011 - January 2012
Job Director, Office of Drug Security, Integrity & Recalls at FDA
Industry Government Administration
Experience
FDA August 2013 - Present
Monrovia Medical Unit Team 2 December 2014 - February 2015
FDA January 2012 - August 2013
US Food and Drug Administration August 2011 - January 2012
U.S. Food and Drug Administration 2003 - August 2011
Medical University of South Carolina 1995 - 2005
Skills
Policy, Regulatory Submissions, Research, Lifesciences, Government, FDA, Biotechnology, Clinical Research, Molecular Biology, Pharmaceutical Industry, Public Health, Regulatory Affairs
Education
Medical University of South Carolina 1995 — 2004
MS, Biomedical Technology
University of Miami 1991 — 1995
BS, Biology, Marine Science
FDA August 2013 - Present
Monrovia Medical Unit Team 2 December 2014 - February 2015
FDA January 2012 - August 2013
US Food and Drug Administration August 2011 - January 2012
U.S. Food and Drug Administration 2003 - August 2011
Medical University of South Carolina 1995 - 2005
Skills
Policy, Regulatory Submissions, Research, Lifesciences, Government, FDA, Biotechnology, Clinical Research, Molecular Biology, Pharmaceutical Industry, Public Health, Regulatory Affairs
Education
Medical University of South Carolina 1995 — 2004
MS, Biomedical Technology
University of Miami 1991 — 1995
BS, Biology, Marine Science
Parag Aggarwal's U.S. Food and Drug Administration Experience February 2009 - December 2011
Job Specialist Master/Manager at Deloitte Consulting
Industry Biotechnology
Experience
Deloitte Consulting December 2011 - Present
U.S. Food and Drug Administration February 2009 - December 2011
SAIC January 2007 - February 2009
University of Michigan September 2001 - December 2006
Skills
FDA, Regulatory Affairs, Medical Devices, Strategy, Life Sciences, Translational Medicine, Comparative..., Patient-Centered..., Outcomes Research, Data Analysis, In Vitro, Immunology, GMP, Analysis, Clinical Development, Nanotechnology, Assay Development, ISO 13485, Research, Biotechnology, Laboratory, Molecular Biology, Patient Outcomes
Education
University of Michigan 2001 — 2006
Ph.D., Medicinal Chemistry
Case Western Reserve University 1997 — 2001
B.S., Chemistry
Deloitte Consulting December 2011 - Present
U.S. Food and Drug Administration February 2009 - December 2011
SAIC January 2007 - February 2009
University of Michigan September 2001 - December 2006
Skills
FDA, Regulatory Affairs, Medical Devices, Strategy, Life Sciences, Translational Medicine, Comparative..., Patient-Centered..., Outcomes Research, Data Analysis, In Vitro, Immunology, GMP, Analysis, Clinical Development, Nanotechnology, Assay Development, ISO 13485, Research, Biotechnology, Laboratory, Molecular Biology, Patient Outcomes
Education
University of Michigan 2001 — 2006
Ph.D., Medicinal Chemistry
Case Western Reserve University 1997 — 2001
B.S., Chemistry
Sarah Clark-Lynn's U.S. Food and Drug Administration Experience February 2012 - Present
Job Public Affairs Specialist at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration February 2012 - Present
FDA Center for Tobacco Products December 2010 - February 2012
Strategic Communications Group February 2008 - January 2011
APS Healthcare January 2006 - November 2007
Humana Inc. February 2005 - January 2006
Livewire Media Relations September 2004 - March 2005
Northlich February 2000 - September 2004
YMCA of Greater Cincinnati August 1998 - February 2000
Jack Horner Communications June 1996 - July 1998
Skills
Strategic Communications, Public Relations, Crisis Communications, Media Relations, Internal Communications, Leadership, Corporate Communications
Education
Bethany College 2002 — 2006
Bachelor of Arts in Communication, Public relations
U.S. Food and Drug Administration February 2012 - Present
FDA Center for Tobacco Products December 2010 - February 2012
Strategic Communications Group February 2008 - January 2011
APS Healthcare January 2006 - November 2007
Humana Inc. February 2005 - January 2006
Livewire Media Relations September 2004 - March 2005
Northlich February 2000 - September 2004
YMCA of Greater Cincinnati August 1998 - February 2000
Jack Horner Communications June 1996 - July 1998
Skills
Strategic Communications, Public Relations, Crisis Communications, Media Relations, Internal Communications, Leadership, Corporate Communications
Education
Bethany College 2002 — 2006
Bachelor of Arts in Communication, Public relations
Louis Novak's U.S. Food and Drug Administration Experience August 2013 - Present
Job Industrial Hygienist at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration August 2013 - Present
VA Roseburg Healthcare System December 2007 - August 2013
Dugway Proving Ground May 2003 - November 2007
ATC Associates 1999 - 2003
Skills
Project Management, Industrial Hygiene, Environmental Compliance, Hazardous Waste..., Asbestos, Environmental Awareness, Abatement, Risk Assessment
Education
The Ohio State University 1992 — 1995
Bachelor of Science (BS), Environmental Science
Cleveland State University 1989 — 1992
U.S. Food and Drug Administration August 2013 - Present
VA Roseburg Healthcare System December 2007 - August 2013
Dugway Proving Ground May 2003 - November 2007
ATC Associates 1999 - 2003
Skills
Project Management, Industrial Hygiene, Environmental Compliance, Hazardous Waste..., Asbestos, Environmental Awareness, Abatement, Risk Assessment
Education
The Ohio State University 1992 — 1995
Bachelor of Science (BS), Environmental Science
Cleveland State University 1989 — 1992
Mary Falvey's U.S. Food and Drug Administration Experience September 2008 - Present
Job Regulatory Policy Analyst at U.S. Food and Drug Administration
Industry Writing and Editing
Experience
U.S. Food and Drug Administration September 2008 - Present
Education
Columbia University in the City of New York 1981 — 1983
U.S. Food and Drug Administration September 2008 - Present
Education
Columbia University in the City of New York 1981 — 1983
Daniella Taveau's U.S. Food and Drug Administration Experience July 2005 - March 2008
Job Trade Negotiator
Industry International Trade and Development
Experience
U.S. Environmental Protection Agency March 2008 - Present
The Embassy Series March 2008 - Present
U.S. Food and Drug Administration July 2005 - March 2008
Darphin November 1999 - February 2004
Skills
Policy Analysis, Government, International Relations, Diplomacy, Public Policy, Policy, Economics, International..., Foreign Policy, Public Health, International Trade, Environmental Policy, Program Management, Agriculture, Environmental Health, Strategic Planning, Research, Analysis, Economic Development, Data Analysis, Program Evaluation, Community Outreach, Politics, Capacity Building, Sustainability, Legislative Relations, Strategic Communications, Proposal Writing, Federal Government, Legislation, Grants, Public Affairs, Political Science, Nonprofits, Corporate Social..., Energy Policy, Climate Change, Sustainable Development, Coalitions, Community Development, Political Campaigns, NGOs, Public/private..., Environmental Awareness, Regulations, International Law, Governance, Grassroots Organizing, Speech Writing, Crisis Management
Education
University of Maryland College Park
Master of Business Administration (EMBA)
Brandeis University
University of Maryland College Park
U.S. Environmental Protection Agency March 2008 - Present
The Embassy Series March 2008 - Present
U.S. Food and Drug Administration July 2005 - March 2008
Darphin November 1999 - February 2004
Skills
Policy Analysis, Government, International Relations, Diplomacy, Public Policy, Policy, Economics, International..., Foreign Policy, Public Health, International Trade, Environmental Policy, Program Management, Agriculture, Environmental Health, Strategic Planning, Research, Analysis, Economic Development, Data Analysis, Program Evaluation, Community Outreach, Politics, Capacity Building, Sustainability, Legislative Relations, Strategic Communications, Proposal Writing, Federal Government, Legislation, Grants, Public Affairs, Political Science, Nonprofits, Corporate Social..., Energy Policy, Climate Change, Sustainable Development, Coalitions, Community Development, Political Campaigns, NGOs, Public/private..., Environmental Awareness, Regulations, International Law, Governance, Grassroots Organizing, Speech Writing, Crisis Management
Education
University of Maryland College Park
Master of Business Administration (EMBA)
Brandeis University
University of Maryland College Park
Leah Proffitt's U.S. Food and Drug Administration Experience October 2009 - Present
Job Biologist at U.S. Food and Drug Administration
Industry Renewables & Environment
Experience
U.S. Food and Drug Administration October 2009 - Present
Millennium Challenge Corporation August 2008 - July 2009
Florida Department of Environmental Protection June 1997 - July 2007
Skills
Environmental, Public Administration, Food, Ecology, Environmental Policy, Environmental Awareness, RCRA, Policy, Environmental Science, Hazardous Waste..., Environmental Impact..., Wetlands, NEPA, Training, Policy Analysis, Environmental Compliance, International..., Sustainability
Education
Harvard University 2007 — 2008
MPA, Public Administration
Harvard University Kennedy School of Government 2007 — 2008
MPA
University of Central Florida 1994 — 1995
BS, Biology
Friedrich-Schiller-Universität Jena 1991 — 1993
Vordiplom, Biology
Landschulheim Kempfenhausen 1985 — 1987
Abitur/Baccaluareate
U.S. Food and Drug Administration October 2009 - Present
Millennium Challenge Corporation August 2008 - July 2009
Florida Department of Environmental Protection June 1997 - July 2007
Skills
Environmental, Public Administration, Food, Ecology, Environmental Policy, Environmental Awareness, RCRA, Policy, Environmental Science, Hazardous Waste..., Environmental Impact..., Wetlands, NEPA, Training, Policy Analysis, Environmental Compliance, International..., Sustainability
Education
Harvard University 2007 — 2008
MPA, Public Administration
Harvard University Kennedy School of Government 2007 — 2008
MPA
University of Central Florida 1994 — 1995
BS, Biology
Friedrich-Schiller-Universität Jena 1991 — 1993
Vordiplom, Biology
Landschulheim Kempfenhausen 1985 — 1987
Abitur/Baccaluareate
Paul Bellamy's U.S. Food and Drug Administration Experience June 1994 - Present
Job Drug Investigator at U.S. Food and Drug Administration
Industry Pharmaceuticals
Experience
U.S. Food and Drug Administration June 1994 - Present
Skills
Pharmaceutical Industry, Drug Discovery, Sop, CAPA, Research, 21 CFR Part 11, FDA
Education
Hampton University 1986 — 1990
U.S. Food and Drug Administration June 1994 - Present
Skills
Pharmaceutical Industry, Drug Discovery, Sop, CAPA, Research, 21 CFR Part 11, FDA
Education
Hampton University 1986 — 1990
Debra Chew's U.S. Food and Drug Administration Experience April 2009 - June 2009
Job Director, Office of Equity, Diversity and Inclusion at National Institutes of Health
Industry Legal Services
Experience
National Institutes of Health July 2012 - Present
Internal Revenue Service April 2011 - July 2012
Internal Revenue Service July 2009 - April 2011
U.S. Food and Drug Administration April 2009 - June 2009
U. S. Food and Drug Administration September 2003 - April 2009
U.S. Department of Health and Human Services, Office of the General Counsel November 1998 - December 2003
Fulton County Courts 1994 - 1997
Skills
Diversity, Inclusion, Employment..., Medical Malpractice..., Trial Litigation, Title VII of the Civil..., Americans with..., Senior Executive..., Diversity & Inclusion, Change Management, Mentoring, Strategic Leadership, Defense, Medical Malpractice, Employment..., Trials, Alternative Dispute..., Federal Government, Legal Writing, Leadership Development, Government, Administrative Law, Employment Law, Labor Relations, Mediation, Policy, Policy Analysis, Executive Management, Conflict Resolution, Government Contracting, Litigation, Intellectual Property, Legislation, Corporate Governance, Licensing, Civil Litigation, Corporate Law, Government Procurement, Legislative Relations, Arbitration, Appeals, Human Capital, Mergers & Acquisitions, Due Diligence, Governance, Commercial Litigation, Public Policy, Program Management, Public Speaking, Leadership
Education
American University Washington College of Law 1990 — 1993
J.D., Law
University of Virginia 1986 — 1990
Bachelor of Arts, Spanish and Sociology
Georgetown Visitation High School 1982 — 1986
High School Diploma
National Institutes of Health July 2012 - Present
Internal Revenue Service April 2011 - July 2012
Internal Revenue Service July 2009 - April 2011
U.S. Food and Drug Administration April 2009 - June 2009
U. S. Food and Drug Administration September 2003 - April 2009
U.S. Department of Health and Human Services, Office of the General Counsel November 1998 - December 2003
Fulton County Courts 1994 - 1997
Skills
Diversity, Inclusion, Employment..., Medical Malpractice..., Trial Litigation, Title VII of the Civil..., Americans with..., Senior Executive..., Diversity & Inclusion, Change Management, Mentoring, Strategic Leadership, Defense, Medical Malpractice, Employment..., Trials, Alternative Dispute..., Federal Government, Legal Writing, Leadership Development, Government, Administrative Law, Employment Law, Labor Relations, Mediation, Policy, Policy Analysis, Executive Management, Conflict Resolution, Government Contracting, Litigation, Intellectual Property, Legislation, Corporate Governance, Licensing, Civil Litigation, Corporate Law, Government Procurement, Legislative Relations, Arbitration, Appeals, Human Capital, Mergers & Acquisitions, Due Diligence, Governance, Commercial Litigation, Public Policy, Program Management, Public Speaking, Leadership
Education
American University Washington College of Law 1990 — 1993
J.D., Law
University of Virginia 1986 — 1990
Bachelor of Arts, Spanish and Sociology
Georgetown Visitation High School 1982 — 1986
High School Diploma
Robert Guidos's U.S. Food and Drug Administration Experience June 2013 - Present
Job Senior Advisor to the Director, Center for Drug Evaluation and Research at FDA
Industry Government Relations
Experience
U.S. Food and Drug Administration June 2013 - Present
Infectious Diseases Society of America March 2000 - June 2013
Department of Health and Human Services January 1999 - March 2000
The Brookings Institution May 1998 - December 1998
US Food and Drug Administration (FDA) July 1993 - December 1998
U.S Peace Corps May 1992 - December 1992
Skills
Infectious Diseases, Public Policy, Public Health, Health Policy, Program Evaluation, Epidemiology, FDA, Coalitions, Policy, Nonprofits, Clinical Research, Government, Media Relations, Vaccines, Healthcare, Public Relations, Research, Strategic Planning, Lifesciences, Medicine, Biotechnology, Legislative Relations, Policy Analysis, Leadership, Strategic Communications, Public Affairs, Federal Government, Program Development, Life Sciences
Education
University of Pittsburgh School of Law 1987 — 1990
Doctor of Law (JD)
Gannon University 1984 — 1987
BS, Chemistry/Business
U.S. Food and Drug Administration June 2013 - Present
Infectious Diseases Society of America March 2000 - June 2013
Department of Health and Human Services January 1999 - March 2000
The Brookings Institution May 1998 - December 1998
US Food and Drug Administration (FDA) July 1993 - December 1998
U.S Peace Corps May 1992 - December 1992
Skills
Infectious Diseases, Public Policy, Public Health, Health Policy, Program Evaluation, Epidemiology, FDA, Coalitions, Policy, Nonprofits, Clinical Research, Government, Media Relations, Vaccines, Healthcare, Public Relations, Research, Strategic Planning, Lifesciences, Medicine, Biotechnology, Legislative Relations, Policy Analysis, Leadership, Strategic Communications, Public Affairs, Federal Government, Program Development, Life Sciences
Education
University of Pittsburgh School of Law 1987 — 1990
Doctor of Law (JD)
Gannon University 1984 — 1987
BS, Chemistry/Business
Karl Kammann's U.S. Food and Drug Administration Experience 2001 - 2007
Job CFO at U.S. Office of Special Counsel
Industry Government Administration
Experience
U.S. Office of Special Counsel May 2010 - Present
Department of the Interior, National Business Center November 2006 - April 2010
U.S. Food and Drug Administration 2001 - 2007
Education
George Mason University - School of Business 1998 — 1999
Master of Business Administration, George Mason University
Louisiana State University
U.S. Office of Special Counsel May 2010 - Present
Department of the Interior, National Business Center November 2006 - April 2010
U.S. Food and Drug Administration 2001 - 2007
Education
George Mason University - School of Business 1998 — 1999
Master of Business Administration, George Mason University
Louisiana State University
Rose Goff's U.S. Food and Drug Administration Experience September 1983 - July 1990
Job Principal at Rose E. Goff, Attorney at Law
Industry Law Practice
Experience
Rose E. Goff, Attorney at Law January 2002 - Present
Greene, Buckley, Jones & McQueen January 1996 - January 2002
Greene, Buckley, Jones & McQueen 1996 - 2002
Greene, Buckley, Jones & McQueen September 1990 - December 1995
U.S. Food and Drug Administration September 1983 - July 1990
Education
Georgia State University College of Law 1986 — 1990
J.D., Law
Duke University 1979 — 1983
BS, ACS, Chemistry
Other
Rose E. Goff, Attorney at Law January 2002 - Present
Greene, Buckley, Jones & McQueen January 1996 - January 2002
Greene, Buckley, Jones & McQueen 1996 - 2002
Greene, Buckley, Jones & McQueen September 1990 - December 1995
U.S. Food and Drug Administration September 1983 - July 1990
Education
Georgia State University College of Law 1986 — 1990
J.D., Law
Duke University 1979 — 1983
BS, ACS, Chemistry
Other
Beth Keshishian's U.S. Food and Drug Administration Experience December 1991 - October 1995
Job Lead, US Media Practice inVentiv Health PR Group
Industry Public Relations and Communications
Experience
inVentiv Health Public Relations Group September 2014 - Present
Weber Shandwick July 2012 - August 2014
Independent Consultant February 2009 - June 2012
Hill & Knowlton October 2007 - February 2009
Biosector2 November 2002 - September 2007
Chandler Chicco Agency July 2001 - November 2002
BK Communications June 1998 - July 2001
Burson-Marsteller November 1995 - June 1997
U.S. Food and Drug Administration December 1991 - October 1995
Skills
Crisis Communications, Strategic Communications, Media Relations, Communication Training, Advertising, Leadership, Public Relations, Reputation Management, Corporate Communications, Press Releases, Integrated Marketing, Message Development, Publicity, Public Affairs
Education
Boston University 1987 — 1991
BA, Art History
inVentiv Health Public Relations Group September 2014 - Present
Weber Shandwick July 2012 - August 2014
Independent Consultant February 2009 - June 2012
Hill & Knowlton October 2007 - February 2009
Biosector2 November 2002 - September 2007
Chandler Chicco Agency July 2001 - November 2002
BK Communications June 1998 - July 2001
Burson-Marsteller November 1995 - June 1997
U.S. Food and Drug Administration December 1991 - October 1995
Skills
Crisis Communications, Strategic Communications, Media Relations, Communication Training, Advertising, Leadership, Public Relations, Reputation Management, Corporate Communications, Press Releases, Integrated Marketing, Message Development, Publicity, Public Affairs
Education
Boston University 1987 — 1991
BA, Art History
Gloria Sanchez-Contreras's U.S. Food and Drug Administration Experience February 2012 - Present
Job International Public Affairs Specialist / SpanishLanguage Communications Lead at U.S. Food and Drug Administration
Industry Government Relations
Experience
U.S. Food and Drug Administration February 2012 - Present
US Department of Health and Human Services October 2011 - February 2012
Centers for Medicare & Medicaid Services April 2010 - October 2011
NC Department of Health and Human Services April 2008 - March 2010
North Carolina Healthy Start Foundation January 2003 - March 2008
The Herald-Sun Durham January 1999 - December 2005
Vientos Tropicales / Mexico Norte September 1995 - December 2003
Presencia Latina 2000 - 2003
La Voz de Carolina January 1993 - December 1997
NBC Canal de Norticias 1994 - 1994
Skills
Spanish, Writing, Editing, Press Releases, Newsletters, Public Relations, Interactive Media, Social Media Outreach, Blogging, Radio Producing, Final Cut Pro, Journalism, Media Relations, Community Outreach, Grant Writing, Broadcast, Nonprofits, Storytelling, Public Speaking, Publications, Research, New Media, Fundraising
Education
American University 2010 — 2012
Masters, Interactive Journalism
University of North Carolina at Chapel Hill 1990 — 1993
Radio, TV and Motion Pictures, Communications and French
Universidad Nacional Autónoma de México 1987 — 1988
Humanidades, Ciencias de la Comunicación
U.S. Food and Drug Administration February 2012 - Present
US Department of Health and Human Services October 2011 - February 2012
Centers for Medicare & Medicaid Services April 2010 - October 2011
NC Department of Health and Human Services April 2008 - March 2010
North Carolina Healthy Start Foundation January 2003 - March 2008
The Herald-Sun Durham January 1999 - December 2005
Vientos Tropicales / Mexico Norte September 1995 - December 2003
Presencia Latina 2000 - 2003
La Voz de Carolina January 1993 - December 1997
NBC Canal de Norticias 1994 - 1994
Skills
Spanish, Writing, Editing, Press Releases, Newsletters, Public Relations, Interactive Media, Social Media Outreach, Blogging, Radio Producing, Final Cut Pro, Journalism, Media Relations, Community Outreach, Grant Writing, Broadcast, Nonprofits, Storytelling, Public Speaking, Publications, Research, New Media, Fundraising
Education
American University 2010 — 2012
Masters, Interactive Journalism
University of North Carolina at Chapel Hill 1990 — 1993
Radio, TV and Motion Pictures, Communications and French
Universidad Nacional Autónoma de México 1987 — 1988
Humanidades, Ciencias de la Comunicación
Ariel D. Weber's U.S. Food and Drug Administration Experience November 2014 - May 2015
Job Summer Associate at JONES DAY®; 2016 J.D./M.S. Candidate
Industry Law Practice
Experience
The Auragraph Institute, LLC October 2012 - Present
JONES DAY® May 2015 - August 2015
U.S. Food and Drug Administration November 2014 - May 2015
Gilead Sciences August 2014 - March 2015
U.S. Securities and Exchange Commission May 2014 - August 2014
Atlantic Tele-Network, Inc. July 2012 - August 2013
Shearman & Sterling LLP 2010 - 2012
PhRMA May 2009 - July 2010
FedEx North Pacific June 2008 - September 2008
IUCN (Nature Conservation Society of Japan) May 2007 - October 2007
Skills
Legal Research, Intellectual Property, Commercial Litigation, Legal Writing, Mergers & Acquisitions, Securities Law, Legal Japanese, Corporation Law of Japan, Asia Pacific, Japanese market, Japanese to English..., Medical Translation, Legal Translation, Financial Translation, Linguistic Validation, Language Services, Securities Regulation, Research, Public Policy, Policy
Education
American University, Washington College of Law 2013 — 2016
Juris Doctor (J.D.), Corporate Law, Food and Drug Law, Regulatory Interaction
The Ohio State University 2014 — 2016
The Ohio State University College of Medicine
Tufts University School of Medicine
Tufts Center for the Study of Drug Development
Dartmouth College 2005 — 2009
Bachelor of Arts (B.A.), Neurolinguistics and Asian Studies
The Linsly School 2001 — 2005
High School Diploma
The Auragraph Institute, LLC October 2012 - Present
JONES DAY® May 2015 - August 2015
U.S. Food and Drug Administration November 2014 - May 2015
Gilead Sciences August 2014 - March 2015
U.S. Securities and Exchange Commission May 2014 - August 2014
Atlantic Tele-Network, Inc. July 2012 - August 2013
Shearman & Sterling LLP 2010 - 2012
PhRMA May 2009 - July 2010
FedEx North Pacific June 2008 - September 2008
IUCN (Nature Conservation Society of Japan) May 2007 - October 2007
Skills
Legal Research, Intellectual Property, Commercial Litigation, Legal Writing, Mergers & Acquisitions, Securities Law, Legal Japanese, Corporation Law of Japan, Asia Pacific, Japanese market, Japanese to English..., Medical Translation, Legal Translation, Financial Translation, Linguistic Validation, Language Services, Securities Regulation, Research, Public Policy, Policy
Education
American University, Washington College of Law 2013 — 2016
Juris Doctor (J.D.), Corporate Law, Food and Drug Law, Regulatory Interaction
The Ohio State University 2014 — 2016
The Ohio State University College of Medicine
Tufts University School of Medicine
Tufts Center for the Study of Drug Development
Dartmouth College 2005 — 2009
Bachelor of Arts (B.A.), Neurolinguistics and Asian Studies
The Linsly School 2001 — 2005
High School Diploma
Jarrod Collier, M.Sc.'s U.S. Food and Drug Administration Experience 2006 - January 2010
Job Research Associate at Department of Veterans Affairs
Industry Pharmaceuticals
Experience
Department of Veterans Affairs August 2011 - Present
Technical Resources International, Inc July 2010 - August 2011
U.S. Food and Drug Administration 2006 - January 2010
Novartis August 2003 - May 2004
Skills
HPLC, FDA, IND, Lifesciences, Clinical Research, Pharmacovigilance, Regulatory Affairs, Regulatory Requirements, Clinical Trials, Clinical Development, Small Molecules, GCP, Data Management, Pharmaceutical Industry, Medical Writing, ICH-GCP, Molecular Biology, Validation, Infectious Diseases, Clinical Pharmacology, Formulation
Education
The University of Georgia 2001 — 2003
M.Sc., Pharmacy
Fort Valley State University 1996 — 2001
B.Sc., Chemistry
Department of Veterans Affairs August 2011 - Present
Technical Resources International, Inc July 2010 - August 2011
U.S. Food and Drug Administration 2006 - January 2010
Novartis August 2003 - May 2004
Skills
HPLC, FDA, IND, Lifesciences, Clinical Research, Pharmacovigilance, Regulatory Affairs, Regulatory Requirements, Clinical Trials, Clinical Development, Small Molecules, GCP, Data Management, Pharmaceutical Industry, Medical Writing, ICH-GCP, Molecular Biology, Validation, Infectious Diseases, Clinical Pharmacology, Formulation
Education
The University of Georgia 2001 — 2003
M.Sc., Pharmacy
Fort Valley State University 1996 — 2001
B.Sc., Chemistry
Lawrence Bachorik's U.S. Food and Drug Administration Experience March 2013 - Present
Job Assistant Commissioner for External Relations at U.S. Food and Drug Administration
Industry Government Relations
Experience
U.S. Food and Drug Administration March 2013 - Present
FDA 2013 - Present
Education
Cornell University 1967 — 1971
B.A., English Literature
U.S. Food and Drug Administration March 2013 - Present
FDA 2013 - Present
Education
Cornell University 1967 — 1971
B.A., English Literature
Claudine Kabera's U.S. Food and Drug Administration Experience July 2011 - Present
Job Epidemiologist
Industry Government Administration
Experience
FDA July 2013 - Present
U.S. FOOD AND DRUG ADMINISTRATION July 2011 - Present
FDA April 2009 - July 2011
US Food and Drug Administration April 2009 - July 2011
Loma Linda University Medical Center September 2008 - March 2009
LOMA LINDA UNVERSITY HEALTH CARE September 2008 - March 2009
Skills
Epidemiology, Statistics, Public Health, Healthcare, Program Evaluation, SAS, Grant Writing, Data Analysis, Global Health, Analysis, Research, Biostatistics, Health Equity, Literature Reviews, International Health, SPSS
Education
LOMA LINDA UNIVERSITY, SCHOOL OF PUBLIC HEALTH 2006 — 2008
Masters, Public Health
Loma Linda University 2006 — 2008
MPH, Epidemiology
UNIVERSITY OF SOUTHER CALIFORNIA 2002 — 2006
Bachelor of Arts, Health and Humanity, Pre-medicine
University of Southern California 2002 — 2006
BA, Health and Humanity
FDA July 2013 - Present
U.S. FOOD AND DRUG ADMINISTRATION July 2011 - Present
FDA April 2009 - July 2011
US Food and Drug Administration April 2009 - July 2011
Loma Linda University Medical Center September 2008 - March 2009
LOMA LINDA UNVERSITY HEALTH CARE September 2008 - March 2009
Skills
Epidemiology, Statistics, Public Health, Healthcare, Program Evaluation, SAS, Grant Writing, Data Analysis, Global Health, Analysis, Research, Biostatistics, Health Equity, Literature Reviews, International Health, SPSS
Education
LOMA LINDA UNIVERSITY, SCHOOL OF PUBLIC HEALTH 2006 — 2008
Masters, Public Health
Loma Linda University 2006 — 2008
MPH, Epidemiology
UNIVERSITY OF SOUTHER CALIFORNIA 2002 — 2006
Bachelor of Arts, Health and Humanity, Pre-medicine
University of Southern California 2002 — 2006
BA, Health and Humanity
John Jessop, Ph.D., M.P.H.'s U.S. Food and Drug Administration Experience 1977 - 1997
Job Nonclinical PharmacologyToxicology and Regulatory Consultant
Industry Pharmaceuticals
Experience
JJJESSOP LLC January 2015 - Present
Biologics Consulting Group, Inc. March 1999 - December 2014
Purdue Pharma 1997 - 1999
U.S. Food and Drug Administration 1977 - 1997
Skills
Ph.D. Pharmacology..., FDA experience - 20..., Pharmaceutical Industry..., Biologics Consulting..., Plans nonclinical..., Interface with..., Nonclinical pharm/tox..., FDA meetings (pre-IND,..., Author regulatory..., Resolve clinical hold..., Immunogenicity issues, Comparability issues, Biosimilar development, Animal rule and..., Monoclonal antibodies,..., Vaccines, blood..., combination product..., Due Diligence, Peptides, synthetic peptides and..., Pharmacokinetics, Regulatory Affairs, Review and assess..., Drug (small molecule)..., Neurological drug..., Cancer indications, Ophthalmological..., Toxicology, Pharmacology, Autoimmune Diseases, Rheumatoid Arthritis, GLPs, Study Monitoring, Study Reports, GLP, Biopharmaceuticals, Pharmaceutical Industry, FDA, Clinical Development, Biologics, IND, Regulatory Requirements, Vaccines, Regulatory Submissions, CRO, Pharmaceutics, Protein Chemistry
Education
Georgetown University School of Medicine 1981 — 1986
Ph.D., Pharmacology
JJJESSOP LLC January 2015 - Present
Biologics Consulting Group, Inc. March 1999 - December 2014
Purdue Pharma 1997 - 1999
U.S. Food and Drug Administration 1977 - 1997
Skills
Ph.D. Pharmacology..., FDA experience - 20..., Pharmaceutical Industry..., Biologics Consulting..., Plans nonclinical..., Interface with..., Nonclinical pharm/tox..., FDA meetings (pre-IND,..., Author regulatory..., Resolve clinical hold..., Immunogenicity issues, Comparability issues, Biosimilar development, Animal rule and..., Monoclonal antibodies,..., Vaccines, blood..., combination product..., Due Diligence, Peptides, synthetic peptides and..., Pharmacokinetics, Regulatory Affairs, Review and assess..., Drug (small molecule)..., Neurological drug..., Cancer indications, Ophthalmological..., Toxicology, Pharmacology, Autoimmune Diseases, Rheumatoid Arthritis, GLPs, Study Monitoring, Study Reports, GLP, Biopharmaceuticals, Pharmaceutical Industry, FDA, Clinical Development, Biologics, IND, Regulatory Requirements, Vaccines, Regulatory Submissions, CRO, Pharmaceutics, Protein Chemistry
Education
Georgetown University School of Medicine 1981 — 1986
Ph.D., Pharmacology
Neil Wilcox's U.S. Food and Drug Administration Experience January 1994 - September 1999
Job Senior Vice President & Chief Compliance Officer
Industry Tobacco
Experience
ITG Brands June 2015 - Present
Lorillard Tobacco Company May 2011 - Present
Kimberly-Clark Corporation August 2004 - August 2008
The Gillette Company September 1999 - July 2004
U.S. Food and Drug Administration January 1994 - September 1999
Small Animal Veterinary Medicine June 1974 - February 1999
U.S. Food and Drug Administration March 1990 - December 1993
Skills
FDA, Veterinary Medicine, Regulatory Compliance..., Regulatory Affairs, Quality Assurance, Cross-functional Team..., Risk Assessment, Consumer Products, Strategic Planning, Change Management, Business Strategy, Team Leadership, Project Management, Team Building, Strategy, Biotechnology, Lifesciences, Leadership, Pharmaceutical Industry, GLP, Drug Development
Education
University of Michigan 1988 — 1990
MPH, Public Health Policy & Administration
Michigan State University 1963 — 1971
DVM, Veterinary Medicine
ITG Brands June 2015 - Present
Lorillard Tobacco Company May 2011 - Present
Kimberly-Clark Corporation August 2004 - August 2008
The Gillette Company September 1999 - July 2004
U.S. Food and Drug Administration January 1994 - September 1999
Small Animal Veterinary Medicine June 1974 - February 1999
U.S. Food and Drug Administration March 1990 - December 1993
Skills
FDA, Veterinary Medicine, Regulatory Compliance..., Regulatory Affairs, Quality Assurance, Cross-functional Team..., Risk Assessment, Consumer Products, Strategic Planning, Change Management, Business Strategy, Team Leadership, Project Management, Team Building, Strategy, Biotechnology, Lifesciences, Leadership, Pharmaceutical Industry, GLP, Drug Development
Education
University of Michigan 1988 — 1990
MPH, Public Health Policy & Administration
Michigan State University 1963 — 1971
DVM, Veterinary Medicine
Huiquan Wu's U.S. Food and Drug Administration Experience 2002 - Present
Job Chemical Engineer at FDA
Industry Government Administration
Experience
FDA August 2002 - Present
U.S. Food and Drug Administration 2002 - Present
ACM Research, Inc. October 2001 - August 2002
LSI logic 2001 - 2001
Skills
R&D, Chemical Engineering, Process Simulation, Drug Development, Chemistry, Technology Transfer, HPLC, Analytical Chemistry, UV/Vis, Validation, Chromatography, Organic Chemistry, Formulation, Spectroscopy, GMP
Education
Iowa State University 1996 — 2001
Ph.D., Chemical Engineering
Tianjin University 1994 — 1995
Ph.D. candidate, Chemical Engineering
Sichuan University (Former Chengdu University of Science & Technology) 1985 — 1988
MSc, Chemical Engineering
Wuhan Institute of Technology (Former Wuhan Institute of Chemical Technology) 1981 — 1985
BSc, Chemical Engineering
FDA August 2002 - Present
U.S. Food and Drug Administration 2002 - Present
ACM Research, Inc. October 2001 - August 2002
LSI logic 2001 - 2001
Skills
R&D, Chemical Engineering, Process Simulation, Drug Development, Chemistry, Technology Transfer, HPLC, Analytical Chemistry, UV/Vis, Validation, Chromatography, Organic Chemistry, Formulation, Spectroscopy, GMP
Education
Iowa State University 1996 — 2001
Ph.D., Chemical Engineering
Tianjin University 1994 — 1995
Ph.D. candidate, Chemical Engineering
Sichuan University (Former Chengdu University of Science & Technology) 1985 — 1988
MSc, Chemical Engineering
Wuhan Institute of Technology (Former Wuhan Institute of Chemical Technology) 1981 — 1985
BSc, Chemical Engineering
Lyle Jaffe's U.S. Food and Drug Administration Experience November 1978 - March 2010
Job Customer Service
Industry Performing Arts
Experience
Rhino Sports and Entertainment Services November 2013 - Present
Music Center at Strathmore July 2010 - March 2011
U.S. Food and Drug Administration November 1978 - March 2010
Skills
Public Speaking, Fundraising, Government, Microsoft Office, Research, Policy, Program Management, PowerPoint, File Management, Outlook, Theatre, Tessitura, QLab, Cockney, Contemporary Dance, Non-profits, Physical Theatre, Dramaturgy, Shakespeare
Education
University of Maryland University College 1977 — 1990
Paralegal Studies, Business Management, Technical Writing
Montgomery College 1973 — 1976
Associate of Arts (A.A.), Music Education/General Education
Northwood High School 1970 — 1973
Forsyth Technical Community College
Rhino Sports and Entertainment Services November 2013 - Present
Music Center at Strathmore July 2010 - March 2011
U.S. Food and Drug Administration November 1978 - March 2010
Skills
Public Speaking, Fundraising, Government, Microsoft Office, Research, Policy, Program Management, PowerPoint, File Management, Outlook, Theatre, Tessitura, QLab, Cockney, Contemporary Dance, Non-profits, Physical Theatre, Dramaturgy, Shakespeare
Education
University of Maryland University College 1977 — 1990
Paralegal Studies, Business Management, Technical Writing
Montgomery College 1973 — 1976
Associate of Arts (A.A.), Music Education/General Education
Northwood High School 1970 — 1973
Forsyth Technical Community College
Brent Showalter's U.S. Food and Drug Administration Experience August 2015 - Present
Job Biomedical Engineer at U.S. Food and Drug Administration
Industry Medical Devices
Experience
U.S. Food and Drug Administration August 2015 - Present
University of Pennsylvania September 2009 - August 2015
University of Delaware August 2013 - December 2013
Brigham Young University 2007 - 2009
Skills
Biomedical Engineering, Biomechanics, Image Processing, Spine, Matlab, Data Analysis, Mechanical Testing of..., MRI, LabVIEW, Statistics, Numerical Analysis, Orthopaedics, Biocompatibility, CAD, SolidWorks, Presentations, Labview, Science
Education
University of Pennsylvania 2009 — 2015
Doctor of Philosophy (Ph.D.), Bioengineering
Brigham Young University 2005 — 2009
Bachelor of Science, Mechanical Engineering
U.S. Food and Drug Administration August 2015 - Present
University of Pennsylvania September 2009 - August 2015
University of Delaware August 2013 - December 2013
Brigham Young University 2007 - 2009
Skills
Biomedical Engineering, Biomechanics, Image Processing, Spine, Matlab, Data Analysis, Mechanical Testing of..., MRI, LabVIEW, Statistics, Numerical Analysis, Orthopaedics, Biocompatibility, CAD, SolidWorks, Presentations, Labview, Science
Education
University of Pennsylvania 2009 — 2015
Doctor of Philosophy (Ph.D.), Bioengineering
Brigham Young University 2005 — 2009
Bachelor of Science, Mechanical Engineering
Frederick Sweet's U.S. Food and Drug Administration Experience May 1962 - September 1962
Job Professor, Reproductive Biology in Obstetrics & Gynecology at Washington University School of Medicine
Industry Research
Experience
Washington University School of Medicine June 1971 - Present
Memorial Sloan-Kettering Cancer Center March 1968 - May 1970
Bronx Community College, City University of New York September 1962 - May 1964
U.S. Food and Drug Administration May 1962 - September 1962
New York State Psychiatric Institute May 1958 - September 1958
Education
University of Alberta 1964 — 1968
Ph.D., Organic Chemistry
Stevens Institute of Technology 1962 — 1964
ABD (Ph.D.), Organic Chemistry
City University of New York-Brooklyn College 1960 — 1962
ABD (M.A.), Oganic Chemistry
City University of New York-Brooklyn College 1956 — 1960
B.S., Chemistry/Mathematics premed
Washington University School of Medicine June 1971 - Present
Memorial Sloan-Kettering Cancer Center March 1968 - May 1970
Bronx Community College, City University of New York September 1962 - May 1964
U.S. Food and Drug Administration May 1962 - September 1962
New York State Psychiatric Institute May 1958 - September 1958
Education
University of Alberta 1964 — 1968
Ph.D., Organic Chemistry
Stevens Institute of Technology 1962 — 1964
ABD (Ph.D.), Organic Chemistry
City University of New York-Brooklyn College 1960 — 1962
ABD (M.A.), Oganic Chemistry
City University of New York-Brooklyn College 1956 — 1960
B.S., Chemistry/Mathematics premed
Maryam April Pugh's U.S. Food and Drug Administration Experience June 2000 - August 2001
Job Senior Quality Assurance Engineer at Oracle
Industry Computer Software
Experience
Oracle November 2013 - Present
Oracle January 2009 - November 2013
Primavera Systems January 2007 - January 2009
U.S. Environmental Protection Agency June 2002 - August 2002
U.S. Food and Drug Administration June 2000 - August 2001
Skills
Agile Methodologies, Test Automation, Software Project..., Test Cases, SQL, Java, Requirements Analysis, Quality Center, Software Quality..., Weblogic, Agile, Cucumber, Mobile Testing, Web Services, iOS development, Automation, Test Development, Ruby, Fitnesse, Scrum, Enterprise Architecture, Selenium, JIRA
Education
Keller Graduate School of Management of DeVry University 2005 — 2007
Masters, Information Systems Management
Cheyney University of Pennsylvania 1999 — 2003
Bachelors, Computer Science
Oracle November 2013 - Present
Oracle January 2009 - November 2013
Primavera Systems January 2007 - January 2009
U.S. Environmental Protection Agency June 2002 - August 2002
U.S. Food and Drug Administration June 2000 - August 2001
Skills
Agile Methodologies, Test Automation, Software Project..., Test Cases, SQL, Java, Requirements Analysis, Quality Center, Software Quality..., Weblogic, Agile, Cucumber, Mobile Testing, Web Services, iOS development, Automation, Test Development, Ruby, Fitnesse, Scrum, Enterprise Architecture, Selenium, JIRA
Education
Keller Graduate School of Management of DeVry University 2005 — 2007
Masters, Information Systems Management
Cheyney University of Pennsylvania 1999 — 2003
Bachelors, Computer Science
Doug Sporn's U.S. Food and Drug Administration Experience 1990 - 1996
Job President at D. Sporn Consulting LLC
Industry Pharmaceuticals
Experience
D. Sporn Consulting LLC August 2007 - Present
Abbott 2000 - 2007
FDA 1996 - 2000
U.S. Food and Drug Administration 1990 - 1996
Skills
Pharmaceuticals, Regulatory Affairs, Regulatory Strategy, ANDA, Generics, Regulatory Requirements, Generic Programming, Strategy, Pharmaceutical Industry, FDA, CAPA, Regulatory Submissions, Sop, Clinical Development
Education
Harvard Kennedy School of Government
Senior Fellow, Public Policy
Texas Christian University
MBA
The University of Texas at Austin
Bachelor's degree, Mathematics
D. Sporn Consulting LLC August 2007 - Present
Abbott 2000 - 2007
FDA 1996 - 2000
U.S. Food and Drug Administration 1990 - 1996
Skills
Pharmaceuticals, Regulatory Affairs, Regulatory Strategy, ANDA, Generics, Regulatory Requirements, Generic Programming, Strategy, Pharmaceutical Industry, FDA, CAPA, Regulatory Submissions, Sop, Clinical Development
Education
Harvard Kennedy School of Government
Senior Fellow, Public Policy
Texas Christian University
MBA
The University of Texas at Austin
Bachelor's degree, Mathematics
Elena N. Cohen's U.S. Food and Drug Administration Experience 2007 - 2009
Job Independent Consultant
Industry Hospital & Health Care
Experience
Elena N. Cohen Consulting 2015 - Present
Planned Parenthood Mar Monte November 2011 - December 2014
Elena N. Cohen Consulting 2009 - 2011
U.S. Food and Drug Administration 2007 - 2009
Elena N. Cohen Consulting 2005 - 2007
National Women's Law Center 1999 - 2004
New York Presbyterian Hospital 1996 - 1998
Maimonides Medical Center 1993 - 1996
Kalkines Arky Zall & Bernstein (now Manatt Phelps & Phillips) November 1988 - January 1993
Society for the Right to Die (no longer in existence) January 1986 - October 1988
Skills
Research, Healthcare, Public Speaking, Policy Analysis, Fundraising, Program Development, Public Policy, Nonprofits, Non-profits, Policy, Community Outreach, Grant Writing, Legal Writing, Public Health, Strategic Planning, Legal Research
Education
New York University School of Law 1981 — 1984
JD
Harvard University 1975 — 1979
BA, Philosophy
Elena N. Cohen Consulting 2015 - Present
Planned Parenthood Mar Monte November 2011 - December 2014
Elena N. Cohen Consulting 2009 - 2011
U.S. Food and Drug Administration 2007 - 2009
Elena N. Cohen Consulting 2005 - 2007
National Women's Law Center 1999 - 2004
New York Presbyterian Hospital 1996 - 1998
Maimonides Medical Center 1993 - 1996
Kalkines Arky Zall & Bernstein (now Manatt Phelps & Phillips) November 1988 - January 1993
Society for the Right to Die (no longer in existence) January 1986 - October 1988
Skills
Research, Healthcare, Public Speaking, Policy Analysis, Fundraising, Program Development, Public Policy, Nonprofits, Non-profits, Policy, Community Outreach, Grant Writing, Legal Writing, Public Health, Strategic Planning, Legal Research
Education
New York University School of Law 1981 — 1984
JD
Harvard University 1975 — 1979
BA, Philosophy
Mirena Lilley's U.S. Food and Drug Administration Experience March 2012 - June 2014
Job University of Maryland School of Medicine
Industry Hospital & Health Care
Experience
University of Maryland School of Medicine June 2014 - Present
U.S. Food and Drug Administration March 2012 - June 2014
American Medical Informatics Association May 2010 - March 2011
Washington Hospital January 2000 - March 2010
Skills
Accreditation, CME, Continuing Education, Staff Development, Public Health, Healthcare, Nonprofits, Nursing, Public Speaking, Strategic Planning, Research, Program Management, Fundraising, Medical Education, Event Planning, Program Development, Management, Healthcare Information..., Team Building, Clinical Research
Education
American University
Master's in Public Administration (MPA), Executive Leadership
Trinity University-Washington
Bachelor of Science, Business Administration, Marketing Management
University of Maryland School of Medicine June 2014 - Present
U.S. Food and Drug Administration March 2012 - June 2014
American Medical Informatics Association May 2010 - March 2011
Washington Hospital January 2000 - March 2010
Skills
Accreditation, CME, Continuing Education, Staff Development, Public Health, Healthcare, Nonprofits, Nursing, Public Speaking, Strategic Planning, Research, Program Management, Fundraising, Medical Education, Event Planning, Program Development, Management, Healthcare Information..., Team Building, Clinical Research
Education
American University
Master's in Public Administration (MPA), Executive Leadership
Trinity University-Washington
Bachelor of Science, Business Administration, Marketing Management
Scott MacIntire's U.S. Food and Drug Administration Experience November 2014 - Present
Job Division Director at U.S. Food & Drug Administration, Division of Enforcement, Office of Enforcement & Import Operations
Industry Government Administration
Experience
U.S. Food and Drug Administration November 2014 - Present
U.S. Food and Drug Administraton, Chicago District June 2004 - November 2014
U.S. Food and Drug Administration March 2010 - October 2014
U.S. Food and Drug Administration, Office of Regulatory Affairs, Office of Enforcement July 2001 - May 2004
U.S. Food and Drug Administration, Baltimore District June 1990 - June 2001
Virginia Department of Health and the Virginia Department of Agriculture 1983 - 1990
Skills
Legislation, Policy Analysis, Public Policy, Government, Quality Assurance, Federal Government, Legislative Relations, FDA, Policy, Regulatory Affairs, Grant Writing, GMP, Community Outreach, Microsoft Office, Nonprofits, Public Relations, Program Management, Healthcare, Program Evaluation, Quality System, Grants, Medical Devices, Public Health
Education
East Tennessee State University 1980 — 1982
Bachelor of Applied Science (BASc), Environmental Health
U.S. Food and Drug Administration November 2014 - Present
U.S. Food and Drug Administraton, Chicago District June 2004 - November 2014
U.S. Food and Drug Administration March 2010 - October 2014
U.S. Food and Drug Administration, Office of Regulatory Affairs, Office of Enforcement July 2001 - May 2004
U.S. Food and Drug Administration, Baltimore District June 1990 - June 2001
Virginia Department of Health and the Virginia Department of Agriculture 1983 - 1990
Skills
Legislation, Policy Analysis, Public Policy, Government, Quality Assurance, Federal Government, Legislative Relations, FDA, Policy, Regulatory Affairs, Grant Writing, GMP, Community Outreach, Microsoft Office, Nonprofits, Public Relations, Program Management, Healthcare, Program Evaluation, Quality System, Grants, Medical Devices, Public Health
Education
East Tennessee State University 1980 — 1982
Bachelor of Applied Science (BASc), Environmental Health
Katherine Przystup's U.S. Food and Drug Administration Experience January 2011 - July 2012
Job MBA Candidate at MIT Sloan, Class of 2016
Industry Hospital & Health Care
Experience
athenahealth June 2015 - August 2015
Massachusetts General Hospital January 2015 - January 2015
athenahealth September 2012 - August 2014
U.S. Food and Drug Administration January 2011 - July 2012
U.S. Peace Corps September 2008 - November 2010
Education
Massachusetts Institute of Technology - Sloan School of Management 2014 — 2016
Master of Business Administration (MBA)
University of Virginia 2004 — 2008
Bachelor of Arts (B.A.)
athenahealth June 2015 - August 2015
Massachusetts General Hospital January 2015 - January 2015
athenahealth September 2012 - August 2014
U.S. Food and Drug Administration January 2011 - July 2012
U.S. Peace Corps September 2008 - November 2010
Education
Massachusetts Institute of Technology - Sloan School of Management 2014 — 2016
Master of Business Administration (MBA)
University of Virginia 2004 — 2008
Bachelor of Arts (B.A.)
Christina Megalis's U.S. Food and Drug Administration Experience July 2009 - September 2012
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA September 2014 - Present
FDA March 2013 - Present
Nestlé S.A. September 2012 - March 2013
U.S. Food and Drug Administration July 2009 - September 2012
the Institute for Food Safety and Health August 2010 - December 2010
Deibel Laboratories October 2008 - July 2009
Deibel Laboratories October 2007 - July 2009
Skills
Food Microbiology, Process Validation, Microbiology, Thermal Processing, HACCP, Allergens, GMP, Molecular Biology, FDA, Quality Control, PCR, qPCR, Research, RT-PCR, Gel Electrophoresis, HPLC, Scanning Electron..., Laboratory, DNA extraction, RNA isolation, Poster Presentations, Microscopy, Biochemistry, Lifesciences, Cell Culture, University Teaching, Virus, Management, Safety Auditing, Scientific Writing, Chemistry, Biotechnology, Gas Chromatography, ELISA, Experimental Design, Chromatography, Mass Spectrometry, Analytical Chemistry, Food Safety, Science, Environmental Monitoring, Food Processing
Education
Illinois Institute of Technology 2010 — 2013
Master of Science (M.S.), Food Science and Technology, 3.65
University of Illinois at Chicago 2002 — 2007
B.S., Biology
DePaul University
FDA September 2014 - Present
FDA March 2013 - Present
Nestlé S.A. September 2012 - March 2013
U.S. Food and Drug Administration July 2009 - September 2012
the Institute for Food Safety and Health August 2010 - December 2010
Deibel Laboratories October 2008 - July 2009
Deibel Laboratories October 2007 - July 2009
Skills
Food Microbiology, Process Validation, Microbiology, Thermal Processing, HACCP, Allergens, GMP, Molecular Biology, FDA, Quality Control, PCR, qPCR, Research, RT-PCR, Gel Electrophoresis, HPLC, Scanning Electron..., Laboratory, DNA extraction, RNA isolation, Poster Presentations, Microscopy, Biochemistry, Lifesciences, Cell Culture, University Teaching, Virus, Management, Safety Auditing, Scientific Writing, Chemistry, Biotechnology, Gas Chromatography, ELISA, Experimental Design, Chromatography, Mass Spectrometry, Analytical Chemistry, Food Safety, Science, Environmental Monitoring, Food Processing
Education
Illinois Institute of Technology 2010 — 2013
Master of Science (M.S.), Food Science and Technology, 3.65
University of Illinois at Chicago 2002 — 2007
B.S., Biology
DePaul University
Cassie McGurk's U.S. Food and Drug Administration Experience 1995 - 1999
Job owner at Soul Stew Gift Baskets
Industry Health, Wellness and Fitness
Experience
Soul Stew Health Coaching ownerSoul Stew Gift Baskets2014 - Present
U.S. Food and Drug Administration 1995 - 1999
Skills
Public Speaking, Lifestyle, Fitness, Wellness, Wellness Coaching, Health Education, Weight, Healing, Nutritional Counseling, Personal Training, Nutrition, Lifestyle Coaching, Nutrition Education, Supplements, Sports Nutrition, Entrepreneurship, Small Business
Education
The George Washington University Law School 1992 — 1995
J.D.
Cornell University 1987 — 1991
B.A., government
Soul Stew Health Coaching ownerSoul Stew Gift Baskets2014 - Present
U.S. Food and Drug Administration 1995 - 1999
Skills
Public Speaking, Lifestyle, Fitness, Wellness, Wellness Coaching, Health Education, Weight, Healing, Nutritional Counseling, Personal Training, Nutrition, Lifestyle Coaching, Nutrition Education, Supplements, Sports Nutrition, Entrepreneurship, Small Business
Education
The George Washington University Law School 1992 — 1995
J.D.
Cornell University 1987 — 1991
B.A., government
Hank Pykosh, PMP, ITIL's U.S. Food and Drug Administration Experience September 1970 - August 1991
Job Program Manager at OnPoint Consulting, Inc.
Industry Information Technology and Services
Experience
OnPoint Consulting, Inc. January 2006 - Present
M-Cubed Information Systems, Inc. September 1997 - January 2006
US Navy August 1963 - October 1991
U.S. Food and Drug Administration September 1970 - August 1991
Skills
Integration, Information Assurance, Process Improvement, Security, IT Strategy, DoD, ITIL, Project Management, SDLC, Project Portfolio..., Enterprise Architecture, SharePoint, Management, IT Management, Governance
Education
American University 1967 — 1969
MA, Technology of Management
California University of Pennsylvania 1959 — 1963
Bachelor of Science (BS), Education/Math
Donora High School
Donora High School
Donora High School
Donora High School
Donora High School
Donora High School
Donora High School
OnPoint Consulting, Inc. January 2006 - Present
M-Cubed Information Systems, Inc. September 1997 - January 2006
US Navy August 1963 - October 1991
U.S. Food and Drug Administration September 1970 - August 1991
Skills
Integration, Information Assurance, Process Improvement, Security, IT Strategy, DoD, ITIL, Project Management, SDLC, Project Portfolio..., Enterprise Architecture, SharePoint, Management, IT Management, Governance
Education
American University 1967 — 1969
MA, Technology of Management
California University of Pennsylvania 1959 — 1963
Bachelor of Science (BS), Education/Math
Donora High School
Donora High School
Donora High School
Donora High School
Donora High School
Donora High School
Donora High School
Mr. Adrian M. Gonzalez's U.S. Food and Drug Administration Experience February 2012 - January 2013
Job Graduate Research Assistant (Ph.D. level) at University of Tennessee
Industry Environmental Services
Experience
University of Tennessee January 2013 - Present
Independent Research Program January 2000 - Present
U.S. Food and Drug Administration February 2012 - January 2013
Black and Veatch Special Projects Corp January 2003 - June 2011
Jacobs Engineering Group May 2001 - December 2002
Shaw Environmental Inc. (formerly IT Corporation) August 1996 - April 2001
Oak Ridge National Laboratory August 1993 - July 1996
Manhattan College January 1990 - April 1993
Skills
Environmental, Environmental Science, Water Quality, Feasibility Studies, Water, Environmental Impact..., Ecology, Water Resources, Risk Assessment, Sediment, Geochemistry, Research, Environmental Consulting, CERCLA, Environmental..., Groundwater Remediation
Education
University of Tennessee-Knoxville 2012 — 2015
Civil Engineering
Manhattan College 1990 — 1992
M.S.
Pomona College 1983 — 1987
B.A.
University of Tennessee January 2013 - Present
Independent Research Program January 2000 - Present
U.S. Food and Drug Administration February 2012 - January 2013
Black and Veatch Special Projects Corp January 2003 - June 2011
Jacobs Engineering Group May 2001 - December 2002
Shaw Environmental Inc. (formerly IT Corporation) August 1996 - April 2001
Oak Ridge National Laboratory August 1993 - July 1996
Manhattan College January 1990 - April 1993
Skills
Environmental, Environmental Science, Water Quality, Feasibility Studies, Water, Environmental Impact..., Ecology, Water Resources, Risk Assessment, Sediment, Geochemistry, Research, Environmental Consulting, CERCLA, Environmental..., Groundwater Remediation
Education
University of Tennessee-Knoxville 2012 — 2015
Civil Engineering
Manhattan College 1990 — 1992
M.S.
Pomona College 1983 — 1987
B.A.
York Lu's U.S. Food and Drug Administration Experience June 2008 - August 2010
Job Associate at American Capital Energy & Infrastructure
Industry Venture Capital & Private Equity
Experience
American Capital August 2015 - Present
Citigroup Global Markets Inc. Corporate & Investment Banking June 2013 - August 2015
Citigroup Global Markets Inc. Corporate & Investment Banking June 2012 - August 2012
U.S. Food and Drug Administration June 2008 - August 2010
Music and Arts Center May 2005 - August 2007
Education
Washington University in St. Louis 2010 — 2013
BSBA, Finance, Mathematics
Fudan University 2011 — 2011
Summer Study Abroad, Chinese
Winston Churchill High School 2006 — 2010
High School Diploma
American Capital August 2015 - Present
Citigroup Global Markets Inc. Corporate & Investment Banking June 2013 - August 2015
Citigroup Global Markets Inc. Corporate & Investment Banking June 2012 - August 2012
U.S. Food and Drug Administration June 2008 - August 2010
Music and Arts Center May 2005 - August 2007
Education
Washington University in St. Louis 2010 — 2013
BSBA, Finance, Mathematics
Fudan University 2011 — 2011
Summer Study Abroad, Chinese
Winston Churchill High School 2006 — 2010
High School Diploma
Karen Feibus, MD's U.S. Food and Drug Administration Experience December 2003 - November 2006
Job Medical Officer at the Food and Drug Administration/US Department of Health and Human Services
Industry Government Administration
Experience
Office of Generic Drugs, Food and Drug Administration, US Department of Health and Human Services October 2014 - Present
Women's Health Services, Department of Veterans Affairs January 2012 - September 2014
Food and Drug Administration October 2011 - January 2012
Office of New Drugs, Food and Drug Administration November 2006 - October 2011
U.S. Food and Drug Administration December 2003 - November 2006
Capital Women's Care December 1998 - December 2003
Skills
Public Health, Reproductive Health, Obstetrics and..., Drug Regulatory Science
Education
Georgetown University School of Medicine 1986 — 1990
MD, Medicine
Cornell University, College of Arts and Sciences 1982 — 1986
Bachelor of Arts (B.A.), Biology, Neurobiology and Behavior
Office of Generic Drugs, Food and Drug Administration, US Department of Health and Human Services October 2014 - Present
Women's Health Services, Department of Veterans Affairs January 2012 - September 2014
Food and Drug Administration October 2011 - January 2012
Office of New Drugs, Food and Drug Administration November 2006 - October 2011
U.S. Food and Drug Administration December 2003 - November 2006
Capital Women's Care December 1998 - December 2003
Skills
Public Health, Reproductive Health, Obstetrics and..., Drug Regulatory Science
Education
Georgetown University School of Medicine 1986 — 1990
MD, Medicine
Cornell University, College of Arts and Sciences 1982 — 1986
Bachelor of Arts (B.A.), Biology, Neurobiology and Behavior
Patricia Hoover, JD's U.S. Food and Drug Administration Experience June 2011 - August 2011
Job Experienced attorney with extensive legal research, writing, and title abstracting background.
Industry Legal Services
Experience
Member, Pennsylvania Lawyers and Attorneys 2013 - Present
Holland Services March 2013 - Present
U.S. Food and Drug Administration June 2011 - August 2011
Diocese of Pittsburgh December 1998 - February 2004
Diocese of Pittsburgh June 1996 - June 1997
University of Pittsburgh September 1986 - May 1987
Bensenville High School September 1985 - June 1986
Skills
Research, Health Care Law, Health Law, Higher Education, Mediation, Presentations, Legal Writing, Legal Research, Westlaw, Litigation, Public Speaking, Courts, Writing, Civil Litigation, Nonprofits, Policy, Healthcare, Leadership, Alternative Dispute..., Instructional Design, Adult Education, Legal Compliance, Analysis, Compliance
Education
Duquesne University School of Law 2008 — 2008
J.D., M.A., Law, Healthcare Ethics
Northwestern University 1983 — 1984
M.S., Education
University of Notre Dame 1979 — 1983
B.S., Biology
Member, Pennsylvania Lawyers and Attorneys 2013 - Present
Holland Services March 2013 - Present
U.S. Food and Drug Administration June 2011 - August 2011
Diocese of Pittsburgh December 1998 - February 2004
Diocese of Pittsburgh June 1996 - June 1997
University of Pittsburgh September 1986 - May 1987
Bensenville High School September 1985 - June 1986
Skills
Research, Health Care Law, Health Law, Higher Education, Mediation, Presentations, Legal Writing, Legal Research, Westlaw, Litigation, Public Speaking, Courts, Writing, Civil Litigation, Nonprofits, Policy, Healthcare, Leadership, Alternative Dispute..., Instructional Design, Adult Education, Legal Compliance, Analysis, Compliance
Education
Duquesne University School of Law 2008 — 2008
J.D., M.A., Law, Healthcare Ethics
Northwestern University 1983 — 1984
M.S., Education
University of Notre Dame 1979 — 1983
B.S., Biology
Carolyn Deming's U.S. Food and Drug Administration Experience July 2010 - June 2011
Job
Industry Public Relations and Communications
Experience
Hilton Worldwide September 2015 - Present
FEMA January 2012 - February 2015
U.S. Food and Drug Administration July 2010 - June 2011
TheManRegistry.com January 2009 - January 2011
Kim-from-L.A. Literary & Media Services June 2006 - July 2009
Borders Group Inc. August 2004 - June 2006
Skills
AP Style Editing, Microsoft Office, Writing, Change Management..., Social Media Development, Social Media Relations, Press Release..., LexisNexis, Executive Media Training, Presentation Coaching, Printed Materials, Presentation Development, Change Leadership, Executive Communications, Communication Training, Social Media, Ap Style, Training, Social Media Marketing, Media Relations, Nonprofits, Community Development, Public Relations, Community Outreach, Government, Leadership, Publicity, Crisis Communications, Strategic Communications, Public Affairs, Press Releases, Speech Writing, Internal Communications, Message Development, Corporate Communications, AP Style, Integrated Marketing, Editing, Crisis Management, Communications Planning, Copywriting, Reputation Management, Facebook, Copy Editing, Change Management, Event Planning, Public Speaking, Marketing Communications, Event Management
Education
DePaul University
MA
Regent's University London
Webster University
BFA
Hilton Worldwide September 2015 - Present
FEMA January 2012 - February 2015
U.S. Food and Drug Administration July 2010 - June 2011
TheManRegistry.com January 2009 - January 2011
Kim-from-L.A. Literary & Media Services June 2006 - July 2009
Borders Group Inc. August 2004 - June 2006
Skills
AP Style Editing, Microsoft Office, Writing, Change Management..., Social Media Development, Social Media Relations, Press Release..., LexisNexis, Executive Media Training, Presentation Coaching, Printed Materials, Presentation Development, Change Leadership, Executive Communications, Communication Training, Social Media, Ap Style, Training, Social Media Marketing, Media Relations, Nonprofits, Community Development, Public Relations, Community Outreach, Government, Leadership, Publicity, Crisis Communications, Strategic Communications, Public Affairs, Press Releases, Speech Writing, Internal Communications, Message Development, Corporate Communications, AP Style, Integrated Marketing, Editing, Crisis Management, Communications Planning, Copywriting, Reputation Management, Facebook, Copy Editing, Change Management, Event Planning, Public Speaking, Marketing Communications, Event Management
Education
DePaul University
MA
Regent's University London
Webster University
BFA
Bob Fetters's U.S. Food and Drug Administration Experience June 1962 - May 1982
Job Owner, MPIC
Industry Food Production
Experience
MPIC September 1979 - Present
U.S. Food and Drug Administration June 1962 - May 1982
Skills
Federal agency dog..., Project Management, Strategic Planning, Team Building, Management, Public Speaking, Budgets, Microsoft Office, Sales Management, Engineering, Marketing Strategy, Public Relations, Sales, Social Networking, Marketing, Business Development, Business Strategy, Construction, Negotiation, Leadership, New Business Development, Contract Negotiation, Research, Event Planning, Training
Education
Colorado State University 1957 — 1961
B.S. in Physical Science, Chemistry, Botany, Zoology, Geology
MPIC September 1979 - Present
U.S. Food and Drug Administration June 1962 - May 1982
Skills
Federal agency dog..., Project Management, Strategic Planning, Team Building, Management, Public Speaking, Budgets, Microsoft Office, Sales Management, Engineering, Marketing Strategy, Public Relations, Sales, Social Networking, Marketing, Business Development, Business Strategy, Construction, Negotiation, Leadership, New Business Development, Contract Negotiation, Research, Event Planning, Training
Education
Colorado State University 1957 — 1961
B.S. in Physical Science, Chemistry, Botany, Zoology, Geology
Belinda Acuña Mohr's U.S. Food and Drug Administration Experience August 2009 - February 2012
Job Health Economist at Gore
Industry Medical Devices
Experience
Gore February 2012 - Present
U.S. Food and Drug Administration August 2009 - February 2012
UC Santa Barbara September 2005 - June 2009
Education
University of California, Santa Barbara 2004 — 2009
Ph.D., Economics
Arizona State University 2000 — 2004
B.A., French
Arizona State University, W. P. Carey School of Business 2000 — 2004
B.S., Economics
Gore February 2012 - Present
U.S. Food and Drug Administration August 2009 - February 2012
UC Santa Barbara September 2005 - June 2009
Education
University of California, Santa Barbara 2004 — 2009
Ph.D., Economics
Arizona State University 2000 — 2004
B.A., French
Arizona State University, W. P. Carey School of Business 2000 — 2004
B.S., Economics
Elizabeth Riegel's U.S. Food and Drug Administration Experience October 1978 - August 2011
Job Retired FDA Consumer Safety Officer
Industry Government Administration
Experience
U.S. Food and Drug Administration October 1978 - August 2011
Education
University of Wisconsin-Madison 1974 — 1978
Master of Science (M.S.), Pharmacy
Bucknell University 1969 — 1973
Bachelor of Science (B.S.), Biology, General
U.S. Food and Drug Administration October 1978 - August 2011
Education
University of Wisconsin-Madison 1974 — 1978
Master of Science (M.S.), Pharmacy
Bucknell University 1969 — 1973
Bachelor of Science (B.S.), Biology, General
Lawrence Grylack's U.S. Food and Drug Administration Experience January 2003 - June 2006
Job Drug Development Regulatory Consultant
Industry Pharmaceuticals
Experience
Self-employed February 2011 - Present
PAREXEL February 2007 - January 2011
Self Employed 2011 - 2011
U.S. Food and Drug Administration January 2003 - June 2006
Skills
Drug Development..., Clinical Drug..., Pharmaceutical Due..., Clinical Trials, Clinical Development, Drug Development, FDA, Clinical Research, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Regulatory Submissions, Life Sciences
Education
Tufts University School of Medicine 1966 — 1970
M.D., Medicine
Brandeis University 1962 — 1966
BA, Political Science/Pre-Med
Self-employed February 2011 - Present
PAREXEL February 2007 - January 2011
Self Employed 2011 - 2011
U.S. Food and Drug Administration January 2003 - June 2006
Skills
Drug Development..., Clinical Drug..., Pharmaceutical Due..., Clinical Trials, Clinical Development, Drug Development, FDA, Clinical Research, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Regulatory Submissions, Life Sciences
Education
Tufts University School of Medicine 1966 — 1970
M.D., Medicine
Brandeis University 1962 — 1966
BA, Political Science/Pre-Med
Felicia Brayboy's U.S. Food and Drug Administration Experience February 2012 - Present
Job Consumer Safety Officer
Industry Public Safety
Experience
U.S. Food and Drug Administration February 2012 - Present
Eurofins Medinet July 2010 - December 2011
MICROBAC (formerly MICROBIOTEST) June 2007 - September 2009
SciReg, Inc. December 2005 - June 2007
MICROBAC (formerly MICROBIOTEST) March 2001 - September 2005
Education
James Madison University
Biology
U.S. Food and Drug Administration February 2012 - Present
Eurofins Medinet July 2010 - December 2011
MICROBAC (formerly MICROBIOTEST) June 2007 - September 2009
SciReg, Inc. December 2005 - June 2007
MICROBAC (formerly MICROBIOTEST) March 2001 - September 2005
Education
James Madison University
Biology
Yitong Liu's U.S. Food and Drug Administration Experience 2013 - Present
Job Research Pharmacologist at U.S. Food and Drug Administration
Industry Research
Experience
U.S. Food and Drug Administration 2013 - Present
Skills
In Vitro, DMPK, Pharmacokinetics, Drug Metabolism, Hepatotoxicity, In vitro liver disease..., LC-MS
Education
China Pharmaceutical University
Doctor of Philosophy (Ph.D.)
U.S. Food and Drug Administration 2013 - Present
Skills
In Vitro, DMPK, Pharmacokinetics, Drug Metabolism, Hepatotoxicity, In vitro liver disease..., LC-MS
Education
China Pharmaceutical University
Doctor of Philosophy (Ph.D.)
Dianne Hirsch's U.S. Food and Drug Administration Experience December 2004 - October 2014
Job Senior Staff Fellow at U.S. food and Drug Administration
Industry Research
Experience
U.S. food and Drug Administration December 2004 - October 2014
Fairfax4Horses 2003 - 2005
National Cancer Institute May 2001 - November 2004
Skills
Breast cancer research, Scientific Writing and...
Education
Georgetown University 1996 — 2000
Ph.D, Tumor Biology
University of Virginia 1988 — 1991
B.A., Biology
U.S. food and Drug Administration December 2004 - October 2014
Fairfax4Horses 2003 - 2005
National Cancer Institute May 2001 - November 2004
Skills
Breast cancer research, Scientific Writing and...
Education
Georgetown University 1996 — 2000
Ph.D, Tumor Biology
University of Virginia 1988 — 1991
B.A., Biology
Andrew McWilliam's U.S. Food and Drug Administration Experience July 2004 - September 2007
Job Senior Research Economist at New York City Office of the Comptroller
Industry Financial Services
Experience
New York City Office of the Comptroller April 2012 - Present
Internal Revenue Service September 2007 - May 2012
U.S. Food and Drug Administration July 2004 - September 2007
Skills
SAS, Matlab, Stata, Compustat, Spanish, Danish, Japanese, Monte Carlo Simulation, Applied Econometrics, Perl, Economics, Statistical Modeling, Data Analysis, Valuation, Excel, Quantitative Analysis, Financial Analysis, PowerPoint, Econometrics, Policy Analysis, Public Policy, Analysis, Microeconomics, Research, Economic Development
Education
University of Washington 1998 — 2003
Ph.D., Economics
London School of Economics and Political Science, U. of London 1991 — 1992
Postgraduate Diploma, Economics
Georgetown University 1986 — 1990
B.S., Foreign Service
New York City Office of the Comptroller April 2012 - Present
Internal Revenue Service September 2007 - May 2012
U.S. Food and Drug Administration July 2004 - September 2007
Skills
SAS, Matlab, Stata, Compustat, Spanish, Danish, Japanese, Monte Carlo Simulation, Applied Econometrics, Perl, Economics, Statistical Modeling, Data Analysis, Valuation, Excel, Quantitative Analysis, Financial Analysis, PowerPoint, Econometrics, Policy Analysis, Public Policy, Analysis, Microeconomics, Research, Economic Development
Education
University of Washington 1998 — 2003
Ph.D., Economics
London School of Economics and Political Science, U. of London 1991 — 1992
Postgraduate Diploma, Economics
Georgetown University 1986 — 1990
B.S., Foreign Service
Toni Shann's U.S. Food and Drug Administration Experience June 1980 - February 2000
Job Educational Administrator and Science Teacher
Industry Education Management
Experience
Lakewood Board Of Education September 2006 - Present
Educate, Inc September 2005 - June 2006
Keansburg Board of Education September 2004 - June 2005
Freehold Boro Board of Education September 2003 - February 2004
Dollar Discount February 2000 - August 2003
U.S. Food and Drug Administration June 1980 - February 2000
Skills
Curriculum Development, Lesson Planning, Teaching, Training, Biology, Research, Microbiology, Quality Assurance, Water Quality, Environmental Awareness, FDA, K-12
Education
Georgian Court University 2009 — 2012
Master of Arts (M.A.), Education Administration and Leadership
Long Island University, Brooklyn Campus
Bachelor of Science (B.S.), Biology, General
Lakewood Board Of Education September 2006 - Present
Educate, Inc September 2005 - June 2006
Keansburg Board of Education September 2004 - June 2005
Freehold Boro Board of Education September 2003 - February 2004
Dollar Discount February 2000 - August 2003
U.S. Food and Drug Administration June 1980 - February 2000
Skills
Curriculum Development, Lesson Planning, Teaching, Training, Biology, Research, Microbiology, Quality Assurance, Water Quality, Environmental Awareness, FDA, K-12
Education
Georgian Court University 2009 — 2012
Master of Arts (M.A.), Education Administration and Leadership
Long Island University, Brooklyn Campus
Bachelor of Science (B.S.), Biology, General
Mark Czarnolewski's U.S. Food and Drug Administration Experience January 1989 - July 1991
Job Statistics, Research Design, Psychometrics; Program Evaluation; Cognitive, NeuroPsychological/Psychiatric studies
Industry Research
Experience
SRA International February 2015 - June 2015
DRC (now part of Engility) October 2013 - December 2014
Altarum Institute August 2012 - October 2013
Manila Consulting November 2010 - March 2012
ORM/Exec Dir Off Mgnt Analy/ NIMH/NIH July 2002 - November 2010
Child Psychiatry Branch/NIMH/NIH July 2000 - July 2002
U.S. Department of Education September 1991 - July 2000
U.S. Food and Drug Administration January 1989 - July 1991
U.S. Army Research Institute December 1985 - January 1989
American Institutes for Research February 1984 - July 1985
Skills
Statistics, Research, Research Design, Psychology, Life Sciences
Education
Hofstra University 1977 — 1983
M.A./Ph.D., Applied Research Psychology and Program Evaluation, 3.3
The University of Akron 1975 — 1976
Industrial/Organizational Psychology
City University of New York City College 1971 — 1975
B.S., Psychoogy, 3.3
SRA International February 2015 - June 2015
DRC (now part of Engility) October 2013 - December 2014
Altarum Institute August 2012 - October 2013
Manila Consulting November 2010 - March 2012
ORM/Exec Dir Off Mgnt Analy/ NIMH/NIH July 2002 - November 2010
Child Psychiatry Branch/NIMH/NIH July 2000 - July 2002
U.S. Department of Education September 1991 - July 2000
U.S. Food and Drug Administration January 1989 - July 1991
U.S. Army Research Institute December 1985 - January 1989
American Institutes for Research February 1984 - July 1985
Skills
Statistics, Research, Research Design, Psychology, Life Sciences
Education
Hofstra University 1977 — 1983
M.A./Ph.D., Applied Research Psychology and Program Evaluation, 3.3
The University of Akron 1975 — 1976
Industrial/Organizational Psychology
City University of New York City College 1971 — 1975
B.S., Psychoogy, 3.3
Bruce S. Schneider's U.S. Food and Drug Administration Experience 1997 - Present
Job Medical Officer at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration 1997 - Present
U.S. Food and Drug Administration 1997 - Present
Albert Einstein College of Medicine 1989 - 1997
Long Island Jewish Medical Center 1983 - 1997
Rockefeller University 1975 - 1983
Skills
Medicine, FDA, Epidemiology, Public Health, Global Health, International Health, Infectious Diseases, Health Services Research, Pharmacoepidemiology, Evidence-based Medicine, Clinical Research, Medical Research, Biostatistics, Community Health, Prevention, Internal Medicine, Health Policy, Preventive Medicine, Environmental Health, Health Communication
Education
Harvard Medical School 1964 — 1968
Doctor of Medicine (MD), Medicine
Harvard University 1960 — 1964
AB, Biology
Food and Drug Administration 1997 - Present
U.S. Food and Drug Administration 1997 - Present
Albert Einstein College of Medicine 1989 - 1997
Long Island Jewish Medical Center 1983 - 1997
Rockefeller University 1975 - 1983
Skills
Medicine, FDA, Epidemiology, Public Health, Global Health, International Health, Infectious Diseases, Health Services Research, Pharmacoepidemiology, Evidence-based Medicine, Clinical Research, Medical Research, Biostatistics, Community Health, Prevention, Internal Medicine, Health Policy, Preventive Medicine, Environmental Health, Health Communication
Education
Harvard Medical School 1964 — 1968
Doctor of Medicine (MD), Medicine
Harvard University 1960 — 1964
AB, Biology
LeeAnn Branch's U.S. Food and Drug Administration Experience May 2002 - Present
Job Controlled Substance Officer and Risk Assessment Management Analyst at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration May 2002 - Present
Skills
Policy Analysis, Public Administration, Policy, Public Policy, Local Government, Program Management, Economic Development, Research, Community Outreach, Federal Government, Analysis
Education
John Brown University 2006 — 2008
Bachelor of Science (BS), Organizational Management, 3.9
U.S. Food and Drug Administration May 2002 - Present
Skills
Policy Analysis, Public Administration, Policy, Public Policy, Local Government, Program Management, Economic Development, Research, Community Outreach, Federal Government, Analysis
Education
John Brown University 2006 — 2008
Bachelor of Science (BS), Organizational Management, 3.9
Don Jantzen's U.S. Food and Drug Administration Experience September 1976 - May 1983
Job Senior Regulatory Affairs Professional
Industry Pharmaceuticals
Experience
Johnson & Johnson Consumer Companies December 2006 - November 2012
Pfizer Consumer Healthcare June 2000 - December 2006
Warner-Lambert Co. May 1983 - June 2000
U.S. Food and Drug Administration September 1976 - May 1983
Education
Fairleigh Dickinson University 1985 — 1989
Master of Business Administration (MBA), Finance, General
Cornell University 1972 — 1976
Bachelor of Applied Science (BASc), Animal Sciences
Johnson & Johnson Consumer Companies December 2006 - November 2012
Pfizer Consumer Healthcare June 2000 - December 2006
Warner-Lambert Co. May 1983 - June 2000
U.S. Food and Drug Administration September 1976 - May 1983
Education
Fairleigh Dickinson University 1985 — 1989
Master of Business Administration (MBA), Finance, General
Cornell University 1972 — 1976
Bachelor of Applied Science (BASc), Animal Sciences
Andre S. Lamontagne's U.S. Food and Drug Administration Experience 2003 - Present
Job Mechanical Engineer at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration 2003 - Present
Simpson Gumpertz & Heger Inc. 1989 - 2001
United States Air Force 1985 - 1989
Education
Cornell University 1984 — 1985
Master of Engineering (M.Eng.), Structural Engineering
Cornell University 1980 — 1984
Bachelor of Science (B.S.), Civil Engineering
U.S. Food and Drug Administration 2003 - Present
Simpson Gumpertz & Heger Inc. 1989 - 2001
United States Air Force 1985 - 1989
Education
Cornell University 1984 — 1985
Master of Engineering (M.Eng.), Structural Engineering
Cornell University 1980 — 1984
Bachelor of Science (B.S.), Civil Engineering
Department of Veterans Affairs
US Census Bureau
U.S. Department of Veterans Affairs
FDA
US Securities and Exchange Commission
USAID
US Fish and Wildlife Service
TSA