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
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U.S. Food and Drug Administration Employees
Employee
Years
Job
Industry
Aryun (Eileen) Kim Aryun (Eileen) Kim's U.S. Food and Drug Administration Experience September 2008 - October 2011
Job Clinical Pharmacologist at Genentech
Industry Pharmaceuticals
Experience
Genentech September 2015 - Present
Clinical and Laboratory Standards Institute 2013 - Present
AstraZeneca October 2011 - May 2015
US Food and Drug Administration September 2008 - October 2011
Hartford Hospital July 2006 - July 2008
The Brooklyn Hospital Center July 2005 - June 2006
Education
Rutgers University 1999 — 2005
Doctor of Pharmacy (Pharm.D.), Pharmacy
Genentech September 2015 - Present
Clinical and Laboratory Standards Institute 2013 - Present
AstraZeneca October 2011 - May 2015
US Food and Drug Administration September 2008 - October 2011
Hartford Hospital July 2006 - July 2008
The Brooklyn Hospital Center July 2005 - June 2006
Education
Rutgers University 1999 — 2005
Doctor of Pharmacy (Pharm.D.), Pharmacy
Emily Hague Emily Hague's U.S. Food and Drug Administration Experience September 2010 - January 2011
Job Senior Consultant at Navigant
Industry Management Consulting
Experience
Navigant January 2015 - Present
Ministerio del Trabajo del Colombia, Servicio Nacional de Aprendizaje (SENA) January 2014 - January 2015
Pace Harmon September 2012 - July 2013
The Advisory Board Company June 2011 - September 2012
US Food and Drug Administration September 2010 - January 2011
The Benter Foundation June 2010 - September 2010
Hospital Council of Western Pennsylvania January 2010 - May 2010
Jewish Healthcare Foundation/University of Pittsburgh Center for Bioethics and Health Law September 2009 - May 2010
Michigan State University Departments of Surgery and Epidemiology October 2006 - May 2009
Skills
Policy Analysis, Cross-functional Team..., International..., Research, Non-profits, Program Development, Program Evaluation, Program Coordination, Volunteer Management, Strategic Planning, Business Strategy, Operations Management, Communication, Strategic Communications, Health Education, Health Policy, Public Policy, Public Management, Non-profit..., Non-profit Consulting, Non-profit Leadership, Healthcare Management, Healthcare Consulting, US Healthcare, Healthcare Industry, Healthcare Information..., Healthcare Analytics, Public Health, Public Administration, Health Care Reform, Health Care Systems, Data Analysis, Leadership, Healthcare, Program Management, Stata, Management Consulting, Nonprofits, Strategy, Quantitative Analytics, Policy, Qualitative Research, Statistics, Analysis, Analytics, Latin American culture, Time Management
Education
Colegio de Estudios Superiores de Administración 2014 — 2014
Carnegie Mellon University 2009 — 2011
MS, Health Care Policy and Management
Michigan State University 2005 — 2009
BS, Human Biology, Bioethics and Philosophy
University College London, U. of London 2008 — 2008
Ethics summer program
Navigant January 2015 - Present
Ministerio del Trabajo del Colombia, Servicio Nacional de Aprendizaje (SENA) January 2014 - January 2015
Pace Harmon September 2012 - July 2013
The Advisory Board Company June 2011 - September 2012
US Food and Drug Administration September 2010 - January 2011
The Benter Foundation June 2010 - September 2010
Hospital Council of Western Pennsylvania January 2010 - May 2010
Jewish Healthcare Foundation/University of Pittsburgh Center for Bioethics and Health Law September 2009 - May 2010
Michigan State University Departments of Surgery and Epidemiology October 2006 - May 2009
Skills
Policy Analysis, Cross-functional Team..., International..., Research, Non-profits, Program Development, Program Evaluation, Program Coordination, Volunteer Management, Strategic Planning, Business Strategy, Operations Management, Communication, Strategic Communications, Health Education, Health Policy, Public Policy, Public Management, Non-profit..., Non-profit Consulting, Non-profit Leadership, Healthcare Management, Healthcare Consulting, US Healthcare, Healthcare Industry, Healthcare Information..., Healthcare Analytics, Public Health, Public Administration, Health Care Reform, Health Care Systems, Data Analysis, Leadership, Healthcare, Program Management, Stata, Management Consulting, Nonprofits, Strategy, Quantitative Analytics, Policy, Qualitative Research, Statistics, Analysis, Analytics, Latin American culture, Time Management
Education
Colegio de Estudios Superiores de Administración 2014 — 2014
Carnegie Mellon University 2009 — 2011
MS, Health Care Policy and Management
Michigan State University 2005 — 2009
BS, Human Biology, Bioethics and Philosophy
University College London, U. of London 2008 — 2008
Ethics summer program
Joseph L. (Joe) Quimby, Sr., APR Joseph L. (Joe) Quimby, Sr., APR's U.S. Food and Drug Administration Experience September 2014 - Present
Job Team Lead, Health Communications Specialist, Office of Regulatory Affairs at U.S Food and Drug Administration
Industry Public Relations and Communications
Experience
U.S Food and Drug Administration September 2014 - Present
Georgia State Department of Defense October 2013 - September 2014
Redwood Global Communications, Inc. August 2011 - October 2013
Kennesaw State University August 2011 - May 2012
Emory University December 2010 - June 2011
Centers for Disease Control and Prevention May 2009 - November 2010
Lockheed Martin Aeronautics October 2004 - July 2007
US Navy October 1984 - November 2000
Skills
Crisis Communications, Crisis Management, Media Relations, Strategic Communications, Strategic Planning, Executive Media Training, Corporate Branding, Message Development, Advertising, Graphic Design, Social Media, Internal Communications, Investor Relations, Corporate Communications, commuincations audits, Speech Writing, Community Relations, radio, television and..., Risk Management..., Video Production, Security Clearance, Press Releases, Public Relations, Strategy, Leadership, Public Affairs, Spokesperson, Government, Communications Planning, Program Management, Communication Training, Publications, Reputation Management, Editing, Public Speaking, Newsletters, International Relations, Military, Management, Community Development, Community Outreach, Copywriting, Event Management, Integrated Marketing, Interviews, Journalism, Marketing Communications, Media Studies, Messaging, Nonprofits
Education
U.S. Naval War College 1997 — 1998
MA, Strategic Studies & National Security
Brigham Young University 1980 — 1983
BA, Communictions (Public Relations)
U.S Food and Drug Administration September 2014 - Present
Georgia State Department of Defense October 2013 - September 2014
Redwood Global Communications, Inc. August 2011 - October 2013
Kennesaw State University August 2011 - May 2012
Emory University December 2010 - June 2011
Centers for Disease Control and Prevention May 2009 - November 2010
Lockheed Martin Aeronautics October 2004 - July 2007
US Navy October 1984 - November 2000
Skills
Crisis Communications, Crisis Management, Media Relations, Strategic Communications, Strategic Planning, Executive Media Training, Corporate Branding, Message Development, Advertising, Graphic Design, Social Media, Internal Communications, Investor Relations, Corporate Communications, commuincations audits, Speech Writing, Community Relations, radio, television and..., Risk Management..., Video Production, Security Clearance, Press Releases, Public Relations, Strategy, Leadership, Public Affairs, Spokesperson, Government, Communications Planning, Program Management, Communication Training, Publications, Reputation Management, Editing, Public Speaking, Newsletters, International Relations, Military, Management, Community Development, Community Outreach, Copywriting, Event Management, Integrated Marketing, Interviews, Journalism, Marketing Communications, Media Studies, Messaging, Nonprofits
Education
U.S. Naval War College 1997 — 1998
MA, Strategic Studies & National Security
Brigham Young University 1980 — 1983
BA, Communictions (Public Relations)
Brian Galbraith Brian Galbraith's U.S. Food and Drug Administration Experience December 2011 - January 2012
Job Manager at Deloitte
Industry Management Consulting
Experience
Deloitte August 2015 - Present
Deloitte July 2013 - August 2015
Deloitte June 2012 - August 2012
US Food and Drug Administration December 2011 - January 2012
DRS Technologies, Inc. June 2009 - July 2011
Johns Hopkins University Applied Physics Laboratory May 2008 - August 2008
Catania Engineering Associates May 2007 - August 2007
Skills
Proposal Writing, Cost Benefit, Program Management, Analysis, Financial Modeling, Requirements Analysis, Procurement, Project Engineering, Cash Flow, Macroeconomics, Microeconomics, Subcontracts Management, Design Documents, Investment Valuation, Diversification, Cross-functional Team..., Project Management, Data Mining, Process Improvement, Business Process..., Strategy, Systems Engineering, Business Strategy, Management, Corporate Finance, Earned Value Management, Financial Analysis, DoD, Management Consulting, Change Management
Education
University of Notre Dame - Mendoza College of Business 2011 — 2013
MBA, Corporate Finance, Consulting
The Johns Hopkins University 2005 — 2009
BS, Electrical Engineering
Deloitte August 2015 - Present
Deloitte July 2013 - August 2015
Deloitte June 2012 - August 2012
US Food and Drug Administration December 2011 - January 2012
DRS Technologies, Inc. June 2009 - July 2011
Johns Hopkins University Applied Physics Laboratory May 2008 - August 2008
Catania Engineering Associates May 2007 - August 2007
Skills
Proposal Writing, Cost Benefit, Program Management, Analysis, Financial Modeling, Requirements Analysis, Procurement, Project Engineering, Cash Flow, Macroeconomics, Microeconomics, Subcontracts Management, Design Documents, Investment Valuation, Diversification, Cross-functional Team..., Project Management, Data Mining, Process Improvement, Business Process..., Strategy, Systems Engineering, Business Strategy, Management, Corporate Finance, Earned Value Management, Financial Analysis, DoD, Management Consulting, Change Management
Education
University of Notre Dame - Mendoza College of Business 2011 — 2013
MBA, Corporate Finance, Consulting
The Johns Hopkins University 2005 — 2009
BS, Electrical Engineering
Katherine Kiernan Katherine Kiernan's U.S. Food and Drug Administration Experience July 2014 - August 2014
Job Student at Brown University
Industry
Experience
Center for Science in the Public Interest June 2015 - August 2015
Brown Daily Herald Inc. January 2015 - May 2015
Change Magazine September 2014 - December 2014
Brown University School of Public Health September 2014 - December 2014
The Brown Daily Herald January 2014 - December 2014
U.S Food and Drug Administration July 2014 - August 2014
U.S. House of Representatives June 2014 - July 2014
Children's Hospital Foundation June 2013 - August 2013
Office of U.S Senator Al Franken June 2011 - August 2011
Skills
Public Health, Political Science, SPSS, Qualitative Research, Microsoft Office, Research, Editing, Public Speaking, Social Media, PowerPoint, Microsoft Excel, Blogging, Teaching, Writing, Program Evaluation, Policy Analysis, Quantitative Research
Education
Brown University 2012 — 2016
Bachelor's Degree, Public Health, Junior
Stone Ridge School of the Sacred Heart 1999 — 2012
High School
Center for Science in the Public Interest June 2015 - August 2015
Brown Daily Herald Inc. January 2015 - May 2015
Change Magazine September 2014 - December 2014
Brown University School of Public Health September 2014 - December 2014
The Brown Daily Herald January 2014 - December 2014
U.S Food and Drug Administration July 2014 - August 2014
U.S. House of Representatives June 2014 - July 2014
Children's Hospital Foundation June 2013 - August 2013
Office of U.S Senator Al Franken June 2011 - August 2011
Skills
Public Health, Political Science, SPSS, Qualitative Research, Microsoft Office, Research, Editing, Public Speaking, Social Media, PowerPoint, Microsoft Excel, Blogging, Teaching, Writing, Program Evaluation, Policy Analysis, Quantitative Research
Education
Brown University 2012 — 2016
Bachelor's Degree, Public Health, Junior
Stone Ridge School of the Sacred Heart 1999 — 2012
High School
Aurin Chakravarty's U.S. Food and Drug Administration Experience June 2012 - August 2014
Job Account Executive at Aflac
Industry Research
Experience
Johns Hopkins University October 2014 - Present
Aflac May 2015 - August 2015
U.S Food and Drug Administration June 2012 - August 2014
ShapeU, LLC September 2013 - March 2014
George Washington University July 2010 - October 2010
Novell June 2010 - August 2010
Skills
Research, Matlab, C++, Statistics, PowerPoint, Microsoft Office, Data Analysis, SPSS, Microsoft Excel, Nanophotonics, Java, English, Labview, C, Microsoft Word, Molecular Biology, Medical Lasers, Teamwork, Programming, Web Design, PHP, HTML 5, JDK, JavaScript, LabVIEW, Data Science, Data Analytics, Sales
Education
The Johns Hopkins University 2013 — 2017
Electrical Engineering, Signal Processing
Walt Whitman High School 2009 — 2013
High School Diploma
Johns Hopkins University October 2014 - Present
Aflac May 2015 - August 2015
U.S Food and Drug Administration June 2012 - August 2014
ShapeU, LLC September 2013 - March 2014
George Washington University July 2010 - October 2010
Novell June 2010 - August 2010
Skills
Research, Matlab, C++, Statistics, PowerPoint, Microsoft Office, Data Analysis, SPSS, Microsoft Excel, Nanophotonics, Java, English, Labview, C, Microsoft Word, Molecular Biology, Medical Lasers, Teamwork, Programming, Web Design, PHP, HTML 5, JDK, JavaScript, LabVIEW, Data Science, Data Analytics, Sales
Education
The Johns Hopkins University 2013 — 2017
Electrical Engineering, Signal Processing
Walt Whitman High School 2009 — 2013
High School Diploma
Pooja Dharia, Pharm.D., RAC's U.S. Food and Drug Administration Experience November 2014 - April 2015
Job Associate/Regulatory Scientist at Booz Allen Hamilton
Industry Government Administration
Experience
Booz Allen Hamilton April 2015 - Present
US Food and Drug Administration November 2014 - April 2015
US Food and Drug Administration October 2009 - November 2014
Pathmark Stores, Inc. June 2006 - September 2009
Bayer HealthCare June 2007 - August 2007
Skills
Regulatory Affairs, FDA, Pharmacists, Pharmacy, Pharmaceutical Industry, Clinical Trials, Clinical Development, Medical Writing, Regulatory Submissions, Medical Affairs, Pharmacology
Education
Rutgers, The State University of New Jersey-New Brunswick 2003 — 2009
Pharm.D., Pharmacy
Booz Allen Hamilton April 2015 - Present
US Food and Drug Administration November 2014 - April 2015
US Food and Drug Administration October 2009 - November 2014
Pathmark Stores, Inc. June 2006 - September 2009
Bayer HealthCare June 2007 - August 2007
Skills
Regulatory Affairs, FDA, Pharmacists, Pharmacy, Pharmaceutical Industry, Clinical Trials, Clinical Development, Medical Writing, Regulatory Submissions, Medical Affairs, Pharmacology
Education
Rutgers, The State University of New Jersey-New Brunswick 2003 — 2009
Pharm.D., Pharmacy
David Awotwe-Otoo, Ph.D.'s U.S. Food and Drug Administration Experience July 2012 - January 2014
Job Quality Assessment Lead at Office of Pharmaceutical Quality, FDA
Industry Government Administration
Experience
FDA January 2015 - Present
FDA January 2014 - Present
US Food and Drug Administration July 2012 - January 2014
US Food and Drug Administration November 2011 - July 2012
FDA May 2010 - September 2011
Howard University College of Pharmacy January 2007 - May 2011
Laboratory Corporation of America February 2005 - November 2008
Skills
Quality by Design, Process Analytical..., Near IR Spectroscopy,..., Lyophilization (Lyostar..., UPLC-MS (Q-TOF and..., Raman Spectroscopy, Lasentec Focused Beam..., Particle Vision Analysis, Colloidal drug Delivery..., Cell culturing and RAW..., Lyophilization, Reflectance, Cell Culture, HPLC, ELISA, UV/Vis, Validation, Spectroscopy, Cell, Biotechnology, Protein Chemistry, Differential Scanning..., Lifesciences, Technology Transfer, Science, UV, Clinical Research, Pharmaceutics, Chemistry, Microscopy, In Vitro, Assay Development, Formulation, IR, Sop, FTIR, Pharmacokinetics, Laboratory, LC-MS, Drug Discovery, Chromatography, Scientific Writing, Biochemistry, Mass Spectrometry, Analytical Chemistry, Pharmacology, Purification, Western Blotting, NMR, TGA
Education
Howard University 2006 — 2011
Ph.D., Pharmaceutical Sciences (Pharmaceutics and Drug Delivery), Graduated with distinction
Kwame Nkrumah University of Science and Technology, Kumasi 1996 — 2000
BSc(Hons), Biochemistry, Graduated Cum Laude (Top 1%)
Mfantsipim School
FDA January 2015 - Present
FDA January 2014 - Present
US Food and Drug Administration July 2012 - January 2014
US Food and Drug Administration November 2011 - July 2012
FDA May 2010 - September 2011
Howard University College of Pharmacy January 2007 - May 2011
Laboratory Corporation of America February 2005 - November 2008
Skills
Quality by Design, Process Analytical..., Near IR Spectroscopy,..., Lyophilization (Lyostar..., UPLC-MS (Q-TOF and..., Raman Spectroscopy, Lasentec Focused Beam..., Particle Vision Analysis, Colloidal drug Delivery..., Cell culturing and RAW..., Lyophilization, Reflectance, Cell Culture, HPLC, ELISA, UV/Vis, Validation, Spectroscopy, Cell, Biotechnology, Protein Chemistry, Differential Scanning..., Lifesciences, Technology Transfer, Science, UV, Clinical Research, Pharmaceutics, Chemistry, Microscopy, In Vitro, Assay Development, Formulation, IR, Sop, FTIR, Pharmacokinetics, Laboratory, LC-MS, Drug Discovery, Chromatography, Scientific Writing, Biochemistry, Mass Spectrometry, Analytical Chemistry, Pharmacology, Purification, Western Blotting, NMR, TGA
Education
Howard University 2006 — 2011
Ph.D., Pharmaceutical Sciences (Pharmaceutics and Drug Delivery), Graduated with distinction
Kwame Nkrumah University of Science and Technology, Kumasi 1996 — 2000
BSc(Hons), Biochemistry, Graduated Cum Laude (Top 1%)
Mfantsipim School
Barun Maskara Barun Maskara's U.S. Food and Drug Administration Experience 2004 - 2005
Job Business Consultant at ZS Associates
Industry Medical Devices
Experience
ZS Associates 2014 - Present
Boston Scientific Corporation 2005 - 2014
Guidant Corporation 2005 - 2006
US Food and Drug Administration 2004 - 2005
Education
University of Pennsylvania - The Wharton School 2012 — 2014
Master of Business Administration (MBA), Finance
The Johns Hopkins University 2002 — 2004
MS, Biomedical Engineering
Indian Institute of Technology, Kharagpur 1998 — 2002
B.Tech(H), Electrical Engineering
ZS Associates 2014 - Present
Boston Scientific Corporation 2005 - 2014
Guidant Corporation 2005 - 2006
US Food and Drug Administration 2004 - 2005
Education
University of Pennsylvania - The Wharton School 2012 — 2014
Master of Business Administration (MBA), Finance
The Johns Hopkins University 2002 — 2004
MS, Biomedical Engineering
Indian Institute of Technology, Kharagpur 1998 — 2002
B.Tech(H), Electrical Engineering
Kathryn Aikin Kathryn Aikin's U.S. Food and Drug Administration Experience November 2012 - Present
Job
Industry Pharmaceuticals
Experience
US Food and Drug Administration November 2012 - Present
US Food and Drug Administration September 1996 - Present
Skills
Research, FDA, Advertising, Direct to Consumer, Research Design, Policy Analysis, Public Health, Qualitative Research, Public Policy, Experimental Research, Program Management, Statistics, Market Research, Leadership, Public Speaking, Psychology, Social Psychology, Program Evaluation, SPSS, Contracting Officer..., Pharmaceutical...
Education
Penn State University
Ph.D.
Oberlin College
A.B.
Paint Branch High School
Penn State University
M.A.
US Food and Drug Administration November 2012 - Present
US Food and Drug Administration September 1996 - Present
Skills
Research, FDA, Advertising, Direct to Consumer, Research Design, Policy Analysis, Public Health, Qualitative Research, Public Policy, Experimental Research, Program Management, Statistics, Market Research, Leadership, Public Speaking, Psychology, Social Psychology, Program Evaluation, SPSS, Contracting Officer..., Pharmaceutical...
Education
Penn State University
Ph.D.
Oberlin College
A.B.
Paint Branch High School
Penn State University
M.A.
Ray Kent Ray Kent's U.S. Food and Drug Administration Experience October 1989 - July 2009
Job Ray Kent Photography
Industry Photography
Experience
Ray Kent Photography January 2002 - Present
U.S Food and Drug Administration October 1989 - July 2009
Skills
Team Building, Agriculture, Food, Policy, Project Management, Small Business, Social Media, Government, Public Speaking, Program Management, Strategic Planning, Image Editing, FDA, Biotechnology, Digital Photography, Photography, Customer Service, Microsoft Office, Landscape Photography, Marketing Strategy, Policy Analysis, Research, Regulatory Affairs, Photoshop, Portrait Photography, Lifesciences, Public Policy
Education
Cornell University 1967 — 1971
BS, Agriculture
Ray Kent Photography January 2002 - Present
U.S Food and Drug Administration October 1989 - July 2009
Skills
Team Building, Agriculture, Food, Policy, Project Management, Small Business, Social Media, Government, Public Speaking, Program Management, Strategic Planning, Image Editing, FDA, Biotechnology, Digital Photography, Photography, Customer Service, Microsoft Office, Landscape Photography, Marketing Strategy, Policy Analysis, Research, Regulatory Affairs, Photoshop, Portrait Photography, Lifesciences, Public Policy
Education
Cornell University 1967 — 1971
BS, Agriculture
Mike Falkow Mike Falkow's U.S. Food and Drug Administration Experience 1972 - 1986
Job Independent Consultant
Industry Pharmaceuticals
Experience
The Lancer Group June 2013 - Present
Program Lead December 2014 - December 2014
Program Lead September 2014 - September 2014
PAREXEL Consulting January 2008 - May 2013
Tunnell Consulting 2003 - 2008
American Red Cross December 2001 - May 2003
Aventis Pharmaceuticals April 1996 - December 2001
US Food and Drug Administration 1972 - 1986
Skills
FDA, Pharmaceutical Industry, Validation, Biotechnology, Quality Systems, FDA Inspection Readiness, Compliance Remediation, Quality Assurance, Training, Quality System, 21 CFR Part 11, GxP, Medical Devices, GCP, Clinical Development, Aseptic Processing, GMP, Pharmaceutics, Clinical Trials, Regulatory Submissions, Regulatory Requirements, Biopharmaceuticals, Computer System..., Strategy, CAPA, Cleaning Validation, Cross-functional Team..., Change Control, Technology Transfer, GAMP, Pharmacovigilance, Regulatory Affairs, Sop, R&D, Lifesciences, Quality Control, Quality Auditing, Quality Management, V&V, GLP, Drug Development, IND, CRO, Medical Writing, Vaccines, ISO 13485, Oncology, CTMS, Commercialization, Protocol
Education
Temple University
Bachelor's degree, Biochemistry and Molecular Biology
The Lancer Group June 2013 - Present
Program Lead December 2014 - December 2014
Program Lead September 2014 - September 2014
PAREXEL Consulting January 2008 - May 2013
Tunnell Consulting 2003 - 2008
American Red Cross December 2001 - May 2003
Aventis Pharmaceuticals April 1996 - December 2001
US Food and Drug Administration 1972 - 1986
Skills
FDA, Pharmaceutical Industry, Validation, Biotechnology, Quality Systems, FDA Inspection Readiness, Compliance Remediation, Quality Assurance, Training, Quality System, 21 CFR Part 11, GxP, Medical Devices, GCP, Clinical Development, Aseptic Processing, GMP, Pharmaceutics, Clinical Trials, Regulatory Submissions, Regulatory Requirements, Biopharmaceuticals, Computer System..., Strategy, CAPA, Cleaning Validation, Cross-functional Team..., Change Control, Technology Transfer, GAMP, Pharmacovigilance, Regulatory Affairs, Sop, R&D, Lifesciences, Quality Control, Quality Auditing, Quality Management, V&V, GLP, Drug Development, IND, CRO, Medical Writing, Vaccines, ISO 13485, Oncology, CTMS, Commercialization, Protocol
Education
Temple University
Bachelor's degree, Biochemistry and Molecular Biology
Suzanne Junod's U.S. Food and Drug Administration Experience 1984 - Present
Job FDA Historian at US Department of Health & Human Services
Industry Government Administration
Experience
US Department of Health & Human Services August 1984 - Present
US Food and Drug Administration 1984 - Present
Emory University September 1981 - August 1984
Skills
Public Policy, Research, Policy Analysis, Program Evaluation, Grant Writing, Government, Qualitative Research, FDA, Policy, Science, American History, Oral History, Clinical Research, Politics, Data Analysis, Community Outreach, Biotechnology, Project Management, Grants, Nonprofits, Life Sciences, History, Public Speaking
Education
Emory University 1981 — 1984
M.A.; Ph.D., 20th Century American History/History of Medicine/Science
US Department of Health & Human Services August 1984 - Present
US Food and Drug Administration 1984 - Present
Emory University September 1981 - August 1984
Skills
Public Policy, Research, Policy Analysis, Program Evaluation, Grant Writing, Government, Qualitative Research, FDA, Policy, Science, American History, Oral History, Clinical Research, Politics, Data Analysis, Community Outreach, Biotechnology, Project Management, Grants, Nonprofits, Life Sciences, History, Public Speaking
Education
Emory University 1981 — 1984
M.A.; Ph.D., 20th Century American History/History of Medicine/Science
David Kreutzer David Kreutzer's U.S. Food and Drug Administration Experience 1994 - 1994
Job Senior Research Fellow at The Heritage Foundation
Industry Research
Experience
The Heritage Foundation March 2015 - Present
The Heritage Foundation January 2010 - March 2015
The Heritage Foundation February 2008 - March 2010
Berman and Company July 2007 - February 2008
James Madison University September 1984 - August 2007
US Food and Drug Administration 1994 - 1994
Ohio University September 1981 - June 1984
Skills
Policy Analysis, Climate Change, Energy Economics, Economics, Public Policy, Analysis, Econometrics, Energy Policy, Quantitative Analytics, Energy, Policy, Public Speaking, Economic Research, Economic Policy, International Economics, Political Science, Foreign Policy, Politics
Education
George Mason University 1983 — 1984
Ph.D., Economics
Virginia Polytechnic Institute and State University 1974 — 1981
MA, Economics
Eckerd College 1972 — 1973
The Heritage Foundation March 2015 - Present
The Heritage Foundation January 2010 - March 2015
The Heritage Foundation February 2008 - March 2010
Berman and Company July 2007 - February 2008
James Madison University September 1984 - August 2007
US Food and Drug Administration 1994 - 1994
Ohio University September 1981 - June 1984
Skills
Policy Analysis, Climate Change, Energy Economics, Economics, Public Policy, Analysis, Econometrics, Energy Policy, Quantitative Analytics, Energy, Policy, Public Speaking, Economic Research, Economic Policy, International Economics, Political Science, Foreign Policy, Politics
Education
George Mason University 1983 — 1984
Ph.D., Economics
Virginia Polytechnic Institute and State University 1974 — 1981
MA, Economics
Eckerd College 1972 — 1973
Carrie (Hendrickson) McMahon's U.S. Food and Drug Administration Experience July 2004 - Present
Job Consumer Safety Officer at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration July 2004 - Present
Department of Health and Human Services July 2002 - July 2004
Skills
Regulatory Affairs, Lifesciences, Public Health, Molecular Biology, Regulatory Requirements, FDA, Biotechnology, Public Speaking, Food Safety, Life Sciences, Cell Biology
Education
University of Pennsylvania School of Medicine 1994 — 2002
Doctor of Philosophy (Ph.D.), Cell/Cellular and Molecular Biology
Drew University 1990 — 1994
Bachelor of Arts (B.A.), Biology, General
US Food and Drug Administration July 2004 - Present
Department of Health and Human Services July 2002 - July 2004
Skills
Regulatory Affairs, Lifesciences, Public Health, Molecular Biology, Regulatory Requirements, FDA, Biotechnology, Public Speaking, Food Safety, Life Sciences, Cell Biology
Education
University of Pennsylvania School of Medicine 1994 — 2002
Doctor of Philosophy (Ph.D.), Cell/Cellular and Molecular Biology
Drew University 1990 — 1994
Bachelor of Arts (B.A.), Biology, General
Suf Alkhaldi Ph.D. Suf Alkhaldi Ph.D.'s U.S. Food and Drug Administration Experience June 2009 - September 2013
Job Supervisory PM, Director of Operation, Senior Science Advisor at the Office of the Chief Scientist US FDA
Industry Biotechnology
Experience
FDA September 2013 - Present
US- Food and Drug Administration June 2009 - September 2013
US Food and Drug Administration November 2000 - September 2013
Emory University April 2000 - September 2000
Skills
Microbiology, Food Microbiology, HACCP, Food Safety, FDA, Regulatory Affairs, Lifesciences, Food Industry
Education
Oklahoma State University 1993 — 1998
Ph.D., Microbiology and Cell Molecular Biology
Oklahoma State University 1990 — 1992
MS, Microbiology
FDA September 2013 - Present
US- Food and Drug Administration June 2009 - September 2013
US Food and Drug Administration November 2000 - September 2013
Emory University April 2000 - September 2000
Skills
Microbiology, Food Microbiology, HACCP, Food Safety, FDA, Regulatory Affairs, Lifesciences, Food Industry
Education
Oklahoma State University 1993 — 1998
Ph.D., Microbiology and Cell Molecular Biology
Oklahoma State University 1990 — 1992
MS, Microbiology
Mark R. Russo Mark R. Russo's U.S. Food and Drug Administration Experience December 2010 - December 2012
Job Acting Director, Office of Crisis Management at U.S. Department of Health & Human Services, Food and Drug Administration
Industry Government Administration
Experience
U.S. Department of Health & Human Services, Food and Drug Administration October 2012 - Present
College Park Volunteer Fire Department July 1989 - Present
U.S. Food and Drug Administration December 2010 - December 2012
U.S. Department of Health and Human Services, National Disaster Medical System January 2007 - December 2010
U.S. Department of Homeland Security, Office of Emergency Response April 2006 - January 2007
U.S. General Services Administration November 2004 - April 2006
U.S. Department of Homeland Security, Office of Emergency Response March 2003 - November 2004
U.S. Department of Health and Human Services, National Disaster Medical System November 2001 - March 2003
DHHS, Office of Emergency Preparedness July 2001 - November 2001
Federal Emergency Management Agency October 1994 - July 2001
Skills
Policy Analysis, Government, Emergency Management, Policy, Crisis Management, Preparedness, Incident Command, Public Health, Public Safety, NIMS, Public Policy, Homeland Security
Education
University of Rochester 1985 — 1987
M.S., Public Policy Analysis
University of Rochester 1981 — 1985
B.S., Geomechanics
U.S. Department of Health & Human Services, Food and Drug Administration October 2012 - Present
College Park Volunteer Fire Department July 1989 - Present
U.S. Food and Drug Administration December 2010 - December 2012
U.S. Department of Health and Human Services, National Disaster Medical System January 2007 - December 2010
U.S. Department of Homeland Security, Office of Emergency Response April 2006 - January 2007
U.S. General Services Administration November 2004 - April 2006
U.S. Department of Homeland Security, Office of Emergency Response March 2003 - November 2004
U.S. Department of Health and Human Services, National Disaster Medical System November 2001 - March 2003
DHHS, Office of Emergency Preparedness July 2001 - November 2001
Federal Emergency Management Agency October 1994 - July 2001
Skills
Policy Analysis, Government, Emergency Management, Policy, Crisis Management, Preparedness, Incident Command, Public Health, Public Safety, NIMS, Public Policy, Homeland Security
Education
University of Rochester 1985 — 1987
M.S., Public Policy Analysis
University of Rochester 1981 — 1985
B.S., Geomechanics
Becky Robinson's U.S. Food and Drug Administration Experience June 2012 - January 2015
Job Biomedical Engineer / Team Leader at US Food and Drug Adminstration
Industry Biotechnology
Experience
US Food and Drug Adminstration January 2015 - Present
US Food and Drug Administration June 2012 - January 2015
US Food and Drug Administration October 2010 - May 2012
Yale University June 2007 - October 2010
Yale University September 2005 - June 2009
SouthTrust Bank (dba Wachovia Bank) July 2003 - June 2005
Skills
Regulatory Affairs, Polymer Chemistry, Tissue Engineering, Ophthalmic Drug Delivery, Hydrogel Fabrication, Nanotechnology, Surgical Mesh, Cell Culture, Biomedical Engineering, Drug Delivery, Microscopy, Confocal Microscopy, Biomaterials, Western Blotting, In Vitro, Life Sciences, FDA
Education
Yale University 2007 — 2010
Doctor of Philosophy (PhD), Biomedical Engineering
Yale University 2007 — 2008
Master of Philosophy (MPhil), Biomedical Engineering
Yale University 2005 — 2007
Master of Science (MS), Biomedical Engineering, Neuroengineering
Columbia University - Fu Foundation School of Engineering and Applied Science 1999 — 2003
Bachelor of Science (BS), Biomedical Engineering
US Food and Drug Adminstration January 2015 - Present
US Food and Drug Administration June 2012 - January 2015
US Food and Drug Administration October 2010 - May 2012
Yale University June 2007 - October 2010
Yale University September 2005 - June 2009
SouthTrust Bank (dba Wachovia Bank) July 2003 - June 2005
Skills
Regulatory Affairs, Polymer Chemistry, Tissue Engineering, Ophthalmic Drug Delivery, Hydrogel Fabrication, Nanotechnology, Surgical Mesh, Cell Culture, Biomedical Engineering, Drug Delivery, Microscopy, Confocal Microscopy, Biomaterials, Western Blotting, In Vitro, Life Sciences, FDA
Education
Yale University 2007 — 2010
Doctor of Philosophy (PhD), Biomedical Engineering
Yale University 2007 — 2008
Master of Philosophy (MPhil), Biomedical Engineering
Yale University 2005 — 2007
Master of Science (MS), Biomedical Engineering, Neuroengineering
Columbia University - Fu Foundation School of Engineering and Applied Science 1999 — 2003
Bachelor of Science (BS), Biomedical Engineering
Justin Eggleton's U.S. Food and Drug Administration Experience June 2004 - June 2006
Job Director, Spine Regulatory Affairs at Musculoskeletal Clinical Regulatory Advisers, LLC
Industry Medical Devices
Experience
Musculoskeletal Clinical Regulatory Advisers July 2006 - Present
US Food and Drug Administration June 2004 - June 2006
Skills
Medical Devices, Biomaterials, FDA, Regulatory Affairs, Orthopedic, Biomedical Engineering, Biomechanics, Spine, PMA, Design Control, Clinical Research, Tissue Engineering, Healthcare, ISO 14971, ISO 13485, Product Launch, Orthopedics, Biotechnology, Clinical Development
Education
Drexel University 1999 — 2004
BS, Biomedical Engineering
Musculoskeletal Clinical Regulatory Advisers July 2006 - Present
US Food and Drug Administration June 2004 - June 2006
Skills
Medical Devices, Biomaterials, FDA, Regulatory Affairs, Orthopedic, Biomedical Engineering, Biomechanics, Spine, PMA, Design Control, Clinical Research, Tissue Engineering, Healthcare, ISO 14971, ISO 13485, Product Launch, Orthopedics, Biotechnology, Clinical Development
Education
Drexel University 1999 — 2004
BS, Biomedical Engineering
Chris Frazar Chris Frazar's U.S. Food and Drug Administration Experience September 2002 - October 2007
Job Research Molecular Biologist
Industry Research
Experience
University of Washington November 2012 - Present
University of Washington December 2011 - November 2012
University of Washington November 2007 - July 2011
US Food and Drug Administration September 2002 - October 2007
Skills
Molecular Biology, Microbiology, PCR, Microscopy, DNA sequencing, DNA extraction, Science, Research, Laboratory, Genomics, automation, Laboratory Automation, Genetics, Biochemistry, Cell Culture, Automation
Education
The University of Montana 1999 — 2002
MS, Microbiology
Colby College 1995 — 1999
BA, Biology
University of Washington November 2012 - Present
University of Washington December 2011 - November 2012
University of Washington November 2007 - July 2011
US Food and Drug Administration September 2002 - October 2007
Skills
Molecular Biology, Microbiology, PCR, Microscopy, DNA sequencing, DNA extraction, Science, Research, Laboratory, Genomics, automation, Laboratory Automation, Genetics, Biochemistry, Cell Culture, Automation
Education
The University of Montana 1999 — 2002
MS, Microbiology
Colby College 1995 — 1999
BA, Biology
Peter Gothro Peter Gothro's U.S. Food and Drug Administration Experience September 2002 - Present
Job Entomologist/ Sensory Analyst at US FDA, PRLNW
Industry Public Safety
Experience
US Food and Drug Administration September 2002 - Present
Oregon State University December 1998 - September 2002
Sun Pacific Biological, Santa Cruz, CA September 1997 - August 1998
Elliot Glacier Public House, Parkdale, OR February 1997 - August 1997
Marine Systems Laboratory, Smithsonian Institution 1988 - 1989
Full Sail Brewing Co., Hood River OR October 1987 - March 1988
Oregon State University 1987 - 1988
Skills
Insect Identification, Sensory Evaluation, Regulatory Analysis, Optical Microscopy, Entomology, Microscopy, Laboratory, Experimental Design, DNA sequencing, In Vitro, Agriculture, Lifesciences, Insect, Sensory Analysis, Feed Microscopy, Light Microscopy, FDA, Food Microbiology, Regulatory Affairs, GMP, Life Sciences, Data Analysis, Microbiology, Molecular Biology, Science
Education
University of Idaho 1992 — 1996
Plant, Soil and Entomological Sciences
University of Delaware 1989 — 1992
MSc, Entomology and Applied Ecology
Oregon State University 1983 — 1987
BS, Zoology
US Food and Drug Administration September 2002 - Present
Oregon State University December 1998 - September 2002
Sun Pacific Biological, Santa Cruz, CA September 1997 - August 1998
Elliot Glacier Public House, Parkdale, OR February 1997 - August 1997
Marine Systems Laboratory, Smithsonian Institution 1988 - 1989
Full Sail Brewing Co., Hood River OR October 1987 - March 1988
Oregon State University 1987 - 1988
Skills
Insect Identification, Sensory Evaluation, Regulatory Analysis, Optical Microscopy, Entomology, Microscopy, Laboratory, Experimental Design, DNA sequencing, In Vitro, Agriculture, Lifesciences, Insect, Sensory Analysis, Feed Microscopy, Light Microscopy, FDA, Food Microbiology, Regulatory Affairs, GMP, Life Sciences, Data Analysis, Microbiology, Molecular Biology, Science
Education
University of Idaho 1992 — 1996
Plant, Soil and Entomological Sciences
University of Delaware 1989 — 1992
MSc, Entomology and Applied Ecology
Oregon State University 1983 — 1987
BS, Zoology
Dwayne Scott Dwayne Scott's U.S. Food and Drug Administration Experience January 1990 - June 1996
Job Cisco VoIP Engineer at MVCSD BOCES
Industry Information Technology and Services
Experience
MVCSD BOCES December 2014 - Present
Winter Wyman for New York University September 2014 - December 2014
Allen Technologies February 2014 - August 2014
Juvenile Diabetes Research Foundation June 2011 - November 2013
Ropes & Gray, LLP July 2007 - March 2011
LexisNexis, Inc April 2001 - June 2007
Organic Inc February 1997 - March 2001
US Food and Drug Administration January 1990 - June 1996
NYC Department of Probation/CSSP January 1984 - August 1989
Skills
VoIP, Switches, Troubleshooting, Firewalls, Avaya, Wireless, Routers, IP, Telephony, VPN, Routing, Hardware, Networking, Video Conferencing, SIP Trunking, Help Desk Support, Voice Mail, Call Center, Security, Cisco Routers, Active Directory, Network Design, Cisco Technologies, Cloud Computing, Unified Communications, Cisco Call Manager, Call Centers, Avaya Technologies
Education
Long Island University 1990 — 1993
Biology/Philosophy
University of Pittsburgh 1981 — 1982
Electrical Engineering
Brooklyn Technical High School 1976 — 1980
MVCSD BOCES December 2014 - Present
Winter Wyman for New York University September 2014 - December 2014
Allen Technologies February 2014 - August 2014
Juvenile Diabetes Research Foundation June 2011 - November 2013
Ropes & Gray, LLP July 2007 - March 2011
LexisNexis, Inc April 2001 - June 2007
Organic Inc February 1997 - March 2001
US Food and Drug Administration January 1990 - June 1996
NYC Department of Probation/CSSP January 1984 - August 1989
Skills
VoIP, Switches, Troubleshooting, Firewalls, Avaya, Wireless, Routers, IP, Telephony, VPN, Routing, Hardware, Networking, Video Conferencing, SIP Trunking, Help Desk Support, Voice Mail, Call Center, Security, Cisco Routers, Active Directory, Network Design, Cisco Technologies, Cloud Computing, Unified Communications, Cisco Call Manager, Call Centers, Avaya Technologies
Education
Long Island University 1990 — 1993
Biology/Philosophy
University of Pittsburgh 1981 — 1982
Electrical Engineering
Brooklyn Technical High School 1976 — 1980
Monica Pagan Motta, MPH Monica Pagan Motta, MPH's U.S. Food and Drug Administration Experience September 2013 - Present
Job Public Health Advisor at FDA
Industry Public Relations and Communications
Experience
US Food and Drug Administration September 2013 - Present
US Department of Health and Human Services July 2010 - September 2013
National Alliance for Hispanic Health January 2008 - June 2010
Forum for Collaborative HIV Research - The George Washington University September 2007 - January 2008
Food and Drug Administration July 2007 - September 2007
Food and Drug Administration August 2006 - July 2007
Adult Health and Development Program - University of Maryland College Park August 2004 - August 2006
University of Maryland - Student Association August 2004 - June 2006
Skills
Program Evaluation, Program Management, Data Analysis, Epidemiology, Teaching, Proposal Writing, Research, Public Health, Health Communication, Government, SAS, Policy Analysis, Analysis, Prevention, Global Health, Clinical Trials, Policy
Education
The George Washington University 2007 — 2009
Master of Public Health (MPH), Maternal & Child Health
University of Maryland College Park 2002 — 2006
Bachelor of Science (BS), Biological and Biomedical Sciences
US Food and Drug Administration September 2013 - Present
US Department of Health and Human Services July 2010 - September 2013
National Alliance for Hispanic Health January 2008 - June 2010
Forum for Collaborative HIV Research - The George Washington University September 2007 - January 2008
Food and Drug Administration July 2007 - September 2007
Food and Drug Administration August 2006 - July 2007
Adult Health and Development Program - University of Maryland College Park August 2004 - August 2006
University of Maryland - Student Association August 2004 - June 2006
Skills
Program Evaluation, Program Management, Data Analysis, Epidemiology, Teaching, Proposal Writing, Research, Public Health, Health Communication, Government, SAS, Policy Analysis, Analysis, Prevention, Global Health, Clinical Trials, Policy
Education
The George Washington University 2007 — 2009
Master of Public Health (MPH), Maternal & Child Health
University of Maryland College Park 2002 — 2006
Bachelor of Science (BS), Biological and Biomedical Sciences
Eugenio Andraca-Carrera Eugenio Andraca-Carrera's U.S. Food and Drug Administration Experience October 2008 - Present
Job Mathematical Statistician at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration October 2008 - Present
Skills
Biostatistics, SAS, Clinical Trials, Epidemiology, Data Analysis, FDA, R
Education
University of North Carolina at Chapel Hill 2002 — 2008
Doctor of Philosophy (PhD), Biostatistics
Fundación Universidad de las Américas, Puebla, A.C. 1997 — 2002
Bachelor's degree, Actuarial Science
US Food and Drug Administration October 2008 - Present
Skills
Biostatistics, SAS, Clinical Trials, Epidemiology, Data Analysis, FDA, R
Education
University of North Carolina at Chapel Hill 2002 — 2008
Doctor of Philosophy (PhD), Biostatistics
Fundación Universidad de las Américas, Puebla, A.C. 1997 — 2002
Bachelor's degree, Actuarial Science
Sonali Gunawardhana Sonali Gunawardhana's U.S. Food and Drug Administration Experience January 2011 - August 2012
Job Of Counsel at Wiley Rein LLP
Industry Law Practice
Experience
Wiley Rein LLP September 2012 - Present
US Food and Drug Administration January 2011 - August 2012
US Food and Drug Administration July 2003 - December 2010
US Patent and Trademark Office 2000 - 2002
Skills
Intellectual Property, FDA, Litigation, Legal Writing, Policy, Medical Devices, Public Policy, Government, Legislative Relations, Legal Research, Research, Regulatory Submissions, Regulations, Legislation, Federal Government, Policy Analysis, Regulatory Affairs, Administrative Law, Regulatory Analysis, Licensing, Patents
Education
Georgetown University 2010 — 2011
Certificate, Business Administration
American University Washington College of Law 2001 — 2003
LLM, Intellectual Property
UNH School of Law 1996 — 1999
JD, Health Law
Boston University 1995 — 1996
MPH, Health Law & Health Services
Webster University 1994 — 1995
MA
Syracuse University 1990 — 1994
BA, English & History
Wiley Rein LLP September 2012 - Present
US Food and Drug Administration January 2011 - August 2012
US Food and Drug Administration July 2003 - December 2010
US Patent and Trademark Office 2000 - 2002
Skills
Intellectual Property, FDA, Litigation, Legal Writing, Policy, Medical Devices, Public Policy, Government, Legislative Relations, Legal Research, Research, Regulatory Submissions, Regulations, Legislation, Federal Government, Policy Analysis, Regulatory Affairs, Administrative Law, Regulatory Analysis, Licensing, Patents
Education
Georgetown University 2010 — 2011
Certificate, Business Administration
American University Washington College of Law 2001 — 2003
LLM, Intellectual Property
UNH School of Law 1996 — 1999
JD, Health Law
Boston University 1995 — 1996
MPH, Health Law & Health Services
Webster University 1994 — 1995
MA
Syracuse University 1990 — 1994
BA, English & History
Marie Melzer Marie Melzer's U.S. Food and Drug Administration Experience June 2009 - May 2010
Job Chemistry Lecturer at Old Dominion University
Industry Chemicals
Experience
Old Dominion University June 2010 - Present
US Food and Drug Administration June 2009 - May 2010
2004-2009 August 2004 - May 2009
UNC-Charlotte January 2002 - May 2004
Skills
UV/Vis, HPLC, NMR
Education
Georgetown University 2004 — 2009
PhD, Inorganic Chemistry
University of North Carolina 2000 — 2004
BS; BA, Chemistry; Biology; Inorganic, General Chemistry Lecturer
Old Dominion University June 2010 - Present
US Food and Drug Administration June 2009 - May 2010
2004-2009 August 2004 - May 2009
UNC-Charlotte January 2002 - May 2004
Skills
UV/Vis, HPLC, NMR
Education
Georgetown University 2004 — 2009
PhD, Inorganic Chemistry
University of North Carolina 2000 — 2004
BS; BA, Chemistry; Biology; Inorganic, General Chemistry Lecturer
Joan E. Adamo Joan E. Adamo's U.S. Food and Drug Administration Experience March 2004 - November 2008
Job Associate Director, Regulatory Support Services at University of Rochester
Industry Biotechnology
Experience
University of Rochester May 2011 - Present
University of Rochester December 2008 - May 2011
US Food and Drug Administration March 2004 - November 2008
Education
Princeton University 2001 — 2004
Post Doctoral Research
Weill Medical College of Cornell University 1996 — 2001
PhD, Molecular Genetics
Cornell University 1992 — 1996
BS, Biochemistry
University of Rochester May 2011 - Present
University of Rochester December 2008 - May 2011
US Food and Drug Administration March 2004 - November 2008
Education
Princeton University 2001 — 2004
Post Doctoral Research
Weill Medical College of Cornell University 1996 — 2001
PhD, Molecular Genetics
Cornell University 1992 — 1996
BS, Biochemistry
Dmitri Kozlovski, PMP Dmitri Kozlovski, PMP's U.S. Food and Drug Administration Experience September 2012 - Present
Job Project Manager at FDA
Industry Government Administration
Experience
US Food and Drug Administration September 2012 - Present
U.S. General Services Administration February 2009 - September 2012
U.S. General Services Administration February 2003 - February 2009
Fleet Boston Financial February 1999 - February 2002
Summit Bancorp 1999 - 2001
Skills
PMP, Project Management, Vendor Management, Program Management, Project Planning, Process Improvement, Business Analysis, Government, Risk Management, Emotional Intelligence, Procurement, Strategic Planning, Policy, PMO, Project Portfolio..., Government Contracting, Governance, Business Process..., Budgets, Resource Management, Training, MS Project, Contract Management, Change Management, IT Management, Federal Government, Proposal Writing, Negotiation, SharePoint, Contract Negotiation, Information Technology, Requirements Analysis, Content Management, Certified Project..., Project Delivery, Critical Thinking, Problem Solving, Records Management, FAC/PPM, COR, Planning, Leadership Development, Cross-functional Team..., IT & Business Strategy...
Education
The George Washington University - School of Business 2004 — 2005
Masters, Project Management
Tbilisis 'Ilia ?av?avadzis' Sakhelobis Enata da Kulturata Sakhelmtsipo Universiteti 1981 — 1986
MA, English, German
US Food and Drug Administration September 2012 - Present
U.S. General Services Administration February 2009 - September 2012
U.S. General Services Administration February 2003 - February 2009
Fleet Boston Financial February 1999 - February 2002
Summit Bancorp 1999 - 2001
Skills
PMP, Project Management, Vendor Management, Program Management, Project Planning, Process Improvement, Business Analysis, Government, Risk Management, Emotional Intelligence, Procurement, Strategic Planning, Policy, PMO, Project Portfolio..., Government Contracting, Governance, Business Process..., Budgets, Resource Management, Training, MS Project, Contract Management, Change Management, IT Management, Federal Government, Proposal Writing, Negotiation, SharePoint, Contract Negotiation, Information Technology, Requirements Analysis, Content Management, Certified Project..., Project Delivery, Critical Thinking, Problem Solving, Records Management, FAC/PPM, COR, Planning, Leadership Development, Cross-functional Team..., IT & Business Strategy...
Education
The George Washington University - School of Business 2004 — 2005
Masters, Project Management
Tbilisis 'Ilia ?av?avadzis' Sakhelobis Enata da Kulturata Sakhelmtsipo Universiteti 1981 — 1986
MA, English, German
Timothy A Anderson, MS, MBA Timothy A Anderson, MS, MBA's U.S. Food and Drug Administration Experience February 1992 - March 1994
Job Principal at The AquaMarine Group, Inc. and Owner, The AquaMarine Group, Inc.
Industry Pharmaceuticals
Experience
The AquaMarine Group, Inc. February 1996 - Present
AlgoRx, Inc. January 2002 - January 2005
Sandoz Pharmaceuticals Corporation March 1994 - February 1996
US Food and Drug Administration February 1992 - March 1994
Bayer February 1987 - February 1992
Purdue Pharma March 1984 - February 1987
Skills
FDA, Regulatory Affairs, GMP, CAPA, Quality Assurance, Pharmaceutical Industry, V&V, 21 CFR Part 11, Clinical Development, Validation, Chemistry, Biotechnology, Change Control, Medical Devices, Clinical Trials, Quality System, Technology Transfer, Biopharmaceuticals, IND, Regulatory Submissions, Clinical Research, Sop, GLP, Life Sciences, Generic Programming, CRO, ANDA, Due Diligence, Pharmaceuticals, GxP, Quality Auditing, Vaccines, eCTD, IDE, cGMP, 510 K, Regulatory Strategy, PMA, Formulation Development, Validations, Business Analysis, Pharmaceutical..., Generics, Quality Systems, Drug Delivery, QSR, Process Validation, GCP, Clinical Trial..., ISO 13485
Education
University of Bridgeport 1989 — 1992
MBA, International Business
New York Medical College 1985 — 1988
MS, Biochemistry
Virginia Commonwealth University 1980 — 1982
BS, Chemistry
Virginia Commonwealth University 1978 — 1980
BS, Biology
North Greenville University 1976 — 1978
Associate of Arts and Sciences (AAS), Applied Science
North Middlesex Regional High School 1972 — 1976
Shelton College 1969 — 1971
Piano
Barrington College 1966 — 1969
Piano
The AquaMarine Group, Inc. February 1996 - Present
AlgoRx, Inc. January 2002 - January 2005
Sandoz Pharmaceuticals Corporation March 1994 - February 1996
US Food and Drug Administration February 1992 - March 1994
Bayer February 1987 - February 1992
Purdue Pharma March 1984 - February 1987
Skills
FDA, Regulatory Affairs, GMP, CAPA, Quality Assurance, Pharmaceutical Industry, V&V, 21 CFR Part 11, Clinical Development, Validation, Chemistry, Biotechnology, Change Control, Medical Devices, Clinical Trials, Quality System, Technology Transfer, Biopharmaceuticals, IND, Regulatory Submissions, Clinical Research, Sop, GLP, Life Sciences, Generic Programming, CRO, ANDA, Due Diligence, Pharmaceuticals, GxP, Quality Auditing, Vaccines, eCTD, IDE, cGMP, 510 K, Regulatory Strategy, PMA, Formulation Development, Validations, Business Analysis, Pharmaceutical..., Generics, Quality Systems, Drug Delivery, QSR, Process Validation, GCP, Clinical Trial..., ISO 13485
Education
University of Bridgeport 1989 — 1992
MBA, International Business
New York Medical College 1985 — 1988
MS, Biochemistry
Virginia Commonwealth University 1980 — 1982
BS, Chemistry
Virginia Commonwealth University 1978 — 1980
BS, Biology
North Greenville University 1976 — 1978
Associate of Arts and Sciences (AAS), Applied Science
North Middlesex Regional High School 1972 — 1976
Shelton College 1969 — 1971
Piano
Barrington College 1966 — 1969
Piano
Brian L. Baker P.E.'s U.S. Food and Drug Administration Experience June 2008 - Present
Job Director, Winchester Engineering and Analytical Center at FDA
Industry Government Administration
Experience
US Food and Drug Administration June 2008 - Present
FDA August 2014 - March 2015
Federal Executive Institute August 2013 - September 2013
Northeast Engineers and Consultants Inc. 2006 - 2008
General Services Administration 2005 - 2006
MIT 2000 - 2005
Skills
Government, Policy, Analysis, DoD, Strategic Planning, Project Planning, Leadership, Project Management, Management, Regulatory Affairs, Training, FDA, Human Resources, Medical Devices, Engineering, Program Management, Leadership Development, Policy Analysis, Federal Government, Military, Research, Construction, Public Speaking, Data Analysis, Team Building, Community Outreach, Risk Assessment
Education
Massachusetts Institute of Technology 1990 — 1992
Master of Science (MS), Engineering
Massachusetts Institute of Technology 1990 — 1992
Master of Science (MS), Political Science
University of Rhode Island 1980 — 1984
BS, Civil and Environmental Engineering
US Food and Drug Administration June 2008 - Present
FDA August 2014 - March 2015
Federal Executive Institute August 2013 - September 2013
Northeast Engineers and Consultants Inc. 2006 - 2008
General Services Administration 2005 - 2006
MIT 2000 - 2005
Skills
Government, Policy, Analysis, DoD, Strategic Planning, Project Planning, Leadership, Project Management, Management, Regulatory Affairs, Training, FDA, Human Resources, Medical Devices, Engineering, Program Management, Leadership Development, Policy Analysis, Federal Government, Military, Research, Construction, Public Speaking, Data Analysis, Team Building, Community Outreach, Risk Assessment
Education
Massachusetts Institute of Technology 1990 — 1992
Master of Science (MS), Engineering
Massachusetts Institute of Technology 1990 — 1992
Master of Science (MS), Political Science
University of Rhode Island 1980 — 1984
BS, Civil and Environmental Engineering
John W Gardner John W Gardner's U.S. Food and Drug Administration Experience 2005 - Present
Job Medical Officer at FDA
Industry Government Administration
Experience
US Food and Drug Administration 2005 - Present
US Army 1979 - 2004
Uniformed Services University of the Health Sciences 1984 - 2000
University of Utah School of Medicine 1980 - 1984
Church of Jesus Christ of Latter-day Saints 1967 - 1970
Skills
Epidemiology, Preventive Medicine, Informatics, Medicine, Public Health, Healthcare, Patient Safety, Policy, Medical Education, Pediatrics, Healthcare Management, Clinical Research, Prevention, Government, Research
Education
Harvard T.H. Chan School of Public Health 1978 — 1981
MPH, DrPH, Epidemiology, Biostatistics, General Preventive Medicine Residency
University of Arizona, College of Medicine 1976 — 1978
Pediatrics Residency, Pediatrics Residency Program
University of Utah School of Medicine 1972 — 1976
MD, Medicine
Brigham Young University 1966 — 1972
BA, MS, Physics, Chemistry
US Food and Drug Administration 2005 - Present
US Army 1979 - 2004
Uniformed Services University of the Health Sciences 1984 - 2000
University of Utah School of Medicine 1980 - 1984
Church of Jesus Christ of Latter-day Saints 1967 - 1970
Skills
Epidemiology, Preventive Medicine, Informatics, Medicine, Public Health, Healthcare, Patient Safety, Policy, Medical Education, Pediatrics, Healthcare Management, Clinical Research, Prevention, Government, Research
Education
Harvard T.H. Chan School of Public Health 1978 — 1981
MPH, DrPH, Epidemiology, Biostatistics, General Preventive Medicine Residency
University of Arizona, College of Medicine 1976 — 1978
Pediatrics Residency, Pediatrics Residency Program
University of Utah School of Medicine 1972 — 1976
MD, Medicine
Brigham Young University 1966 — 1972
BA, MS, Physics, Chemistry
Capt (Ret) Charles Higgins Capt (Ret) Charles Higgins's U.S. Food and Drug Administration Experience October 1990 - September 1996
Job Retired
Industry Government Administration
Experience
Exploring Life November 2014 - Present
National Park Service January 2004 - October 2014
National Park Service April 2001 - December 2003
Centers for Disease Control May 1999 - April 2001
Wyoming Department of Agriculture September 1996 - April 1999
US Food and Drug Administration October 1990 - September 1996
Denver Department of Health & Hospitals July 1987 - October 1990
Safeway March 1984 - July 1987
Converse County Wyoming August 1978 - March 1984
Skills
Systems Theory, Food Safety, Epidemiology, Environmental Awareness, Government, Policy, Environmental Health, Sustainability, Public Health, Occupational Health, Environmental Policy, Public Speaking, Environmental Science, Hazardous Waste..., Management, GIS, HACCP, Environmental Education, Program Management, Program Evaluation, Health Promotion, Leadership, Global Health, Report Writing, Health Policy, Environmental Compliance, Research, Community Development, Emergency Management, Policy Analysis
Education
Colorado State University 1989 — 1990
MS, Environmental Health
Colorado State University 1973 — 1978
BS, Environmental Health
Exploring Life November 2014 - Present
National Park Service January 2004 - October 2014
National Park Service April 2001 - December 2003
Centers for Disease Control May 1999 - April 2001
Wyoming Department of Agriculture September 1996 - April 1999
US Food and Drug Administration October 1990 - September 1996
Denver Department of Health & Hospitals July 1987 - October 1990
Safeway March 1984 - July 1987
Converse County Wyoming August 1978 - March 1984
Skills
Systems Theory, Food Safety, Epidemiology, Environmental Awareness, Government, Policy, Environmental Health, Sustainability, Public Health, Occupational Health, Environmental Policy, Public Speaking, Environmental Science, Hazardous Waste..., Management, GIS, HACCP, Environmental Education, Program Management, Program Evaluation, Health Promotion, Leadership, Global Health, Report Writing, Health Policy, Environmental Compliance, Research, Community Development, Emergency Management, Policy Analysis
Education
Colorado State University 1989 — 1990
MS, Environmental Health
Colorado State University 1973 — 1978
BS, Environmental Health
JoAnn Hittie's U.S. Food and Drug Administration Experience January 2013 - Present
Job Consumer Safety Officer
Industry Government Administration
Experience
US Food and Drug Administration January 2013 - Present
US Public Health Service - FCI Ft Dix July 2002 - January 2013
US Public Health Service - FMC Devens January 2000 - June 2002
US Public Health Service -FMC Devens May 1998 - December 1999
US Public Health Service - MCC Chicago March 1994 - May 1998
Baxter Healthcare 1989 - December 1993
Baxter Healthcare 1985 - 1988
Baxter Travenol March 1982 - December 1984
Hoechst A.G., Frankfurt, Germany August 1980 - February 1982
Dow Corning International, Brussels, Belgium 1974 - August 1977
Skills
Clinical Research, Regulatory Affairs, Pharmaceutics, Health Policy, Managed Care, Training, Program Evaluation, Pharmacy Automation, Public Health, Clinical Pharmacy, Healthcare, Medication Therapy..., Clinical Pharmacology, Regulatory Requirements, Health Education, Medical Writing, Pharmacology, Inventory Management, Informatics, Disease Management, Healthcare Management, Hospitals, Biotechnology, Research, Clinical Development, Patient Counseling, Pharmacy Benefit..., Lifesciences, Pharmacists, Policy Analysis, Outcomes Research, Patient Safety, Global Health, Epidemiology, Infectious Diseases, Immunization, Coaching, Regulations, Marketing, Program Development, Process Improvement, Clinical Trials, Medicine, FDA, Public Policy, Policy, Oncology, Microsoft Office, GCP, Pharmacokinetics
Education
Walden University 2009 — 2016
PhD, Epidemiology
Boston University Questrom School of Business 1980 — 1981
MS, Business Administration
University of Illinois at Chicago 1977 — 1980
BS, Pharmacy
University of Illinois at Chicago 1969 — 1973
BA, Chemistry
US Food and Drug Administration January 2013 - Present
US Public Health Service - FCI Ft Dix July 2002 - January 2013
US Public Health Service - FMC Devens January 2000 - June 2002
US Public Health Service -FMC Devens May 1998 - December 1999
US Public Health Service - MCC Chicago March 1994 - May 1998
Baxter Healthcare 1989 - December 1993
Baxter Healthcare 1985 - 1988
Baxter Travenol March 1982 - December 1984
Hoechst A.G., Frankfurt, Germany August 1980 - February 1982
Dow Corning International, Brussels, Belgium 1974 - August 1977
Skills
Clinical Research, Regulatory Affairs, Pharmaceutics, Health Policy, Managed Care, Training, Program Evaluation, Pharmacy Automation, Public Health, Clinical Pharmacy, Healthcare, Medication Therapy..., Clinical Pharmacology, Regulatory Requirements, Health Education, Medical Writing, Pharmacology, Inventory Management, Informatics, Disease Management, Healthcare Management, Hospitals, Biotechnology, Research, Clinical Development, Patient Counseling, Pharmacy Benefit..., Lifesciences, Pharmacists, Policy Analysis, Outcomes Research, Patient Safety, Global Health, Epidemiology, Infectious Diseases, Immunization, Coaching, Regulations, Marketing, Program Development, Process Improvement, Clinical Trials, Medicine, FDA, Public Policy, Policy, Oncology, Microsoft Office, GCP, Pharmacokinetics
Education
Walden University 2009 — 2016
PhD, Epidemiology
Boston University Questrom School of Business 1980 — 1981
MS, Business Administration
University of Illinois at Chicago 1977 — 1980
BS, Pharmacy
University of Illinois at Chicago 1969 — 1973
BA, Chemistry
Roselie Bright Roselie Bright's U.S. Food and Drug Administration Experience April 2008 - Present
Job Program Manager at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration April 2008 - Present
US Food and Drug Administration October 2006 - April 2008
US Food and Drug Administration July 1990 - October 2006
Beth Israel Hospital July 1989 - June 1990
Harvard Medical School March 1986 - June 1989
Skills
Business Process..., IT Governance, Epidemiology, Pharmacoepidemiology, Outcomes Research, Health Outcomes, Observational Research, Public Health Policy, Study Design, Public Health, Pharmacovigilance, Medical Devices, Systems Analysis, Risk Assessment, Risk Analysis, Risk Management, Program Management, Healthcare IT
Education
Harvard T.H. Chan School of Public Health 1979 — 1986
ScD, epidemiology, statistics
Harvard University School of Public Health 1979 — 1986
ScD, Epidemiology, statistics
Cornell University 1977 — 1979
MS, Food Science
Massachusetts Institute of Technology 1973 — 1977
SB, Applied Biology
US Food and Drug Administration April 2008 - Present
US Food and Drug Administration October 2006 - April 2008
US Food and Drug Administration July 1990 - October 2006
Beth Israel Hospital July 1989 - June 1990
Harvard Medical School March 1986 - June 1989
Skills
Business Process..., IT Governance, Epidemiology, Pharmacoepidemiology, Outcomes Research, Health Outcomes, Observational Research, Public Health Policy, Study Design, Public Health, Pharmacovigilance, Medical Devices, Systems Analysis, Risk Assessment, Risk Analysis, Risk Management, Program Management, Healthcare IT
Education
Harvard T.H. Chan School of Public Health 1979 — 1986
ScD, epidemiology, statistics
Harvard University School of Public Health 1979 — 1986
ScD, Epidemiology, statistics
Cornell University 1977 — 1979
MS, Food Science
Massachusetts Institute of Technology 1973 — 1977
SB, Applied Biology
Rachel Lange, PhD's U.S. Food and Drug Administration Experience June 2003 - Present
Job Acting Supervisory Economist at FDA
Industry Government Administration
Experience
FDA September 2013 - Present
US Food and Drug Administration June 2003 - Present
University of Kentucky August 1999 - May 2003
St. Joseph Hospital East September 1990 - May 1999
Skills
Research, Policy Analysis, Economics, Analysis, Teaching, Statistics, Editing, Writing, Leadership, Public Speaking, Data Analysis, Market Research, Nonprofits, Program Management, International Relations, Management, Public Relations, Proposal Writing, Strategic Planning, Government, Stata, Sustainability
Education
University of Kentucky 1999 — 2007
PhD, Economics
Eastern Kentucky University 1993 — 1998
BBA, Economics
FDA September 2013 - Present
US Food and Drug Administration June 2003 - Present
University of Kentucky August 1999 - May 2003
St. Joseph Hospital East September 1990 - May 1999
Skills
Research, Policy Analysis, Economics, Analysis, Teaching, Statistics, Editing, Writing, Leadership, Public Speaking, Data Analysis, Market Research, Nonprofits, Program Management, International Relations, Management, Public Relations, Proposal Writing, Strategic Planning, Government, Stata, Sustainability
Education
University of Kentucky 1999 — 2007
PhD, Economics
Eastern Kentucky University 1993 — 1998
BBA, Economics
Maria Reed Maria Reed's U.S. Food and Drug Administration Experience June 2011 - Present
Job Supervisory Chemist at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration June 2011 - Present
FDA May 2002 - June 2011
Most Holy Redeemer Church January 2008 - May 2009
Skills
Analytical Chemistry, Wet Chemistry, UV-Vis, LC-MS, Chemistry, GC-MS, Chromatography, Mass Spectrometry, GC/MS, HPLC, UV, Spectroscopy, Titration, Fluorescence, Regulatory Affairs, TLC
Education
Rutgers, The State University of New Jersey-Camden 2004 — 2008
MS, Chemistry
Bryn Mawr College 1998 — 2002
Bachelor of Arts (BA), chemistry
US Food and Drug Administration June 2011 - Present
FDA May 2002 - June 2011
Most Holy Redeemer Church January 2008 - May 2009
Skills
Analytical Chemistry, Wet Chemistry, UV-Vis, LC-MS, Chemistry, GC-MS, Chromatography, Mass Spectrometry, GC/MS, HPLC, UV, Spectroscopy, Titration, Fluorescence, Regulatory Affairs, TLC
Education
Rutgers, The State University of New Jersey-Camden 2004 — 2008
MS, Chemistry
Bryn Mawr College 1998 — 2002
Bachelor of Arts (BA), chemistry
Len Valenti Len Valenti's U.S. Food and Drug Administration Experience 2002 - 2004
Job Senior FDA Compliance Expert
Industry Pharmaceuticals
Experience
Valtech LLc July 2006 - Present
Guidepoint Global 2010 - 2015
Guidepoint Global 2010 - 2015
Guidepoint Global 2010 - 2015
Lachman Consulting Services, 2006 - 2008
U S Food and Drug Administration 2002 - 2006
US Food and Drug Admin 1997 - 2006
US Food and Drug Administration 2002 - 2004
FDA 1999 - 2002
FDA/CDRH 1995 - 1999
Skills
GMP, FDA, Regulatory Affairs, Quality System, Pharmaceutical Industry, Medical Devices, CAPA, Policy, 21 CFR Part 11, ISO 13485, Validation, Food, Auditing, Biotechnology, Due Diligence, Clinical Trials, Compliance, HACCP, Internal Audit, ISO 14971, Design Control, ISO, Risk Management, CE marking, PMA, Risk Assessment, Veterinary, Registration, Internal Controls, Menu Development, Accounting, Valuation, Food Industry, Wine, Food Safety, Cooking, OTC Drug Registration, cGMP, FD&C Labeling, Dietary Supplement..., Quality Systems, Audit, 510 K, Animal Health, SOX, QSR, Pharmaceuticals, Mergers, Process Validation, Culinary
Education
LIU CW Post 1974 — 1977
BS, CHEMISTRY
SUNY Farmingdale 1971 — 1972
Associate of Arts and Sciences (AAS), Liberal Arts and Sciences/Liberal Studies
Valtech LLc July 2006 - Present
Guidepoint Global 2010 - 2015
Guidepoint Global 2010 - 2015
Guidepoint Global 2010 - 2015
Lachman Consulting Services, 2006 - 2008
U S Food and Drug Administration 2002 - 2006
US Food and Drug Admin 1997 - 2006
US Food and Drug Administration 2002 - 2004
FDA 1999 - 2002
FDA/CDRH 1995 - 1999
Skills
GMP, FDA, Regulatory Affairs, Quality System, Pharmaceutical Industry, Medical Devices, CAPA, Policy, 21 CFR Part 11, ISO 13485, Validation, Food, Auditing, Biotechnology, Due Diligence, Clinical Trials, Compliance, HACCP, Internal Audit, ISO 14971, Design Control, ISO, Risk Management, CE marking, PMA, Risk Assessment, Veterinary, Registration, Internal Controls, Menu Development, Accounting, Valuation, Food Industry, Wine, Food Safety, Cooking, OTC Drug Registration, cGMP, FD&C Labeling, Dietary Supplement..., Quality Systems, Audit, 510 K, Animal Health, SOX, QSR, Pharmaceuticals, Mergers, Process Validation, Culinary
Education
LIU CW Post 1974 — 1977
BS, CHEMISTRY
SUNY Farmingdale 1971 — 1972
Associate of Arts and Sciences (AAS), Liberal Arts and Sciences/Liberal Studies
Denise Dion Denise Dion's U.S. Food and Drug Administration Experience February 1985 - November 2002
Job Vice President Regulatory and Quality Services at EduQuest, Inc.
Industry Medical Devices
Experience
EduQuest, Inc. 2011 - Present
U.S Food and Drug Administration February 1985 - November 2002
FDA 1985 - 2002
Food and Drug Administration (FDA) 1985 - 2002
Skills
Quality Systems..., Medical Device..., Pharmaceutical..., Biologics Regulations, FDA Regulatory Training, Computer System and..., Pharmaceutical Industry, Quality Auditing, FDA, 21 CFR Part 11, Medical Devices, Regulations, Compliance, Validation, Quality System, GMP, Regulatory Affairs, V&V, ISO 14971, ISO 13485, Clinical Trials, Design Control, CAPA, Biotechnology, Quality Management, Risk Management, PMA, Change Control, Computer System..., GxP, Regulatory Submissions, Regulatory Requirements, GLP, Sop, Quality Assurance, LIMS, FDA GMP, Aseptic Processing, IND, Cleaning Validation, Technology Transfer, Sterilization, CE marking, Medical Device Directive, Biologics, GCP, Trackwise, Biopharmaceuticals, Quality by Design, ICH guidelines
Education
Wayne State University 1984 — 1992
Aquatic Ecology, Microbial Ecology, Genetics
Western Michigan University 1979 — 1983
BS, Biology
Santa Rosa Community College 1979 — 1979
EMT, Emergency Medicine
Community College of the Air Force 1974 — 1979
Assoc, Emergency Medicine
EduQuest, Inc. 2011 - Present
U.S Food and Drug Administration February 1985 - November 2002
FDA 1985 - 2002
Food and Drug Administration (FDA) 1985 - 2002
Skills
Quality Systems..., Medical Device..., Pharmaceutical..., Biologics Regulations, FDA Regulatory Training, Computer System and..., Pharmaceutical Industry, Quality Auditing, FDA, 21 CFR Part 11, Medical Devices, Regulations, Compliance, Validation, Quality System, GMP, Regulatory Affairs, V&V, ISO 14971, ISO 13485, Clinical Trials, Design Control, CAPA, Biotechnology, Quality Management, Risk Management, PMA, Change Control, Computer System..., GxP, Regulatory Submissions, Regulatory Requirements, GLP, Sop, Quality Assurance, LIMS, FDA GMP, Aseptic Processing, IND, Cleaning Validation, Technology Transfer, Sterilization, CE marking, Medical Device Directive, Biologics, GCP, Trackwise, Biopharmaceuticals, Quality by Design, ICH guidelines
Education
Wayne State University 1984 — 1992
Aquatic Ecology, Microbial Ecology, Genetics
Western Michigan University 1979 — 1983
BS, Biology
Santa Rosa Community College 1979 — 1979
EMT, Emergency Medicine
Community College of the Air Force 1974 — 1979
Assoc, Emergency Medicine
Richard Canady Richard Canady's U.S. Food and Drug Administration Experience February 2003 - January 2009
Job Director at NeutralScience L3C
Industry Public Policy
Experience
NeutralScience L3C January 2015 - Present
ILSI Research Foundation May 2010 - December 2014
McKenna Long & Aldridge LLP January 2009 - May 2010
US Food and Drug Administration February 2003 - January 2009
Executive Office of the President, Office of Science and Technology Policy June 2004 - November 2005
Executive Office of the President, Office of Information and Regulatory Affairs 2004 - 2004
Food and Drug Administration, Center for Food Safety and Applied Nutrition March 2000 - June 2003
Rollins School of Public Health, Emory University January 1995 - March 2000
Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry (ATSDR) December 1991 - March 2000
Gradient September 1990 - November 1991
Skills
Policy Analysis, Policy, Public Health, Public Policy, Science, Research, Lifesciences, Government, Regulatory Affairs, Toxicology, Nanotechnology, R&D, FDA, Risk Assessment, Sustainability, Public Speaking, Chemistry, Technology Transfer, Environmental Policy, Environmental Health, Leadership, Environmental Awareness, Commercialization, Environmental Impact..., Ecology, Cancer, Health Policy, Statistics, Epidemiology, Molecular Biology, Infectious Diseases, Life Sciences
Education
Rockefeller University 1979 — 1985
PhD, Neurobiology
University of Michigan 1977 — 1979
Bachelor of Science, Psychology
NeutralScience L3C January 2015 - Present
ILSI Research Foundation May 2010 - December 2014
McKenna Long & Aldridge LLP January 2009 - May 2010
US Food and Drug Administration February 2003 - January 2009
Executive Office of the President, Office of Science and Technology Policy June 2004 - November 2005
Executive Office of the President, Office of Information and Regulatory Affairs 2004 - 2004
Food and Drug Administration, Center for Food Safety and Applied Nutrition March 2000 - June 2003
Rollins School of Public Health, Emory University January 1995 - March 2000
Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease Registry (ATSDR) December 1991 - March 2000
Gradient September 1990 - November 1991
Skills
Policy Analysis, Policy, Public Health, Public Policy, Science, Research, Lifesciences, Government, Regulatory Affairs, Toxicology, Nanotechnology, R&D, FDA, Risk Assessment, Sustainability, Public Speaking, Chemistry, Technology Transfer, Environmental Policy, Environmental Health, Leadership, Environmental Awareness, Commercialization, Environmental Impact..., Ecology, Cancer, Health Policy, Statistics, Epidemiology, Molecular Biology, Infectious Diseases, Life Sciences
Education
Rockefeller University 1979 — 1985
PhD, Neurobiology
University of Michigan 1977 — 1979
Bachelor of Science, Psychology
Banu Zolnik Banu Zolnik's U.S. Food and Drug Administration Experience February 2008 - Present
Job Pharmaceutical Scientist, U.S Food and Drug Administration
Industry Government Administration
Experience
U.S Food and Drug Administration February 2008 - Present
National Cancer Institute, Nanotechnology Characterization Lab November 2005 - February 2008
Boehringer Ingelheim 2001 - 2001
Skills
Regulatory Affairs, Drug Delivery, Pharmacokinetics, Drug Development, Pharmacology, HPLC, Pharmaceutical Industry, Drug Discovery, Clinical Development, Formulation, GLP, Regulatory Submissions, IND, R&D, In Vivo, Toxicology, In Vitro, LC-MS, Life Sciences, Pharmaceutics
Education
University of Connecticut 1999 — 2005
PhD, Pharmaceutical Sciences
Istanbul University 1992 — 1997
BSc, Pharmacy
U.S Food and Drug Administration February 2008 - Present
National Cancer Institute, Nanotechnology Characterization Lab November 2005 - February 2008
Boehringer Ingelheim 2001 - 2001
Skills
Regulatory Affairs, Drug Delivery, Pharmacokinetics, Drug Development, Pharmacology, HPLC, Pharmaceutical Industry, Drug Discovery, Clinical Development, Formulation, GLP, Regulatory Submissions, IND, R&D, In Vivo, Toxicology, In Vitro, LC-MS, Life Sciences, Pharmaceutics
Education
University of Connecticut 1999 — 2005
PhD, Pharmaceutical Sciences
Istanbul University 1992 — 1997
BSc, Pharmacy
Peyton Myers's U.S. Food and Drug Administration Experience August 2015 - Present
Job Team Leader (Detail) at FDA
Industry Pharmaceuticals
Experience
US Food and Drug Administration August 2015 - Present
US Food and Drug Administration May 2006 - Present
NIOSH January 2003 - May 2006
Skills
Toxicology, FDA, IND, GLP, In Vivo, Pharmacology, Microbiology, Drug Development, Pharmacokinetics, Drug Discovery, Immunology, Animal Models, In Vitro, Lifesciences
Education
Louisiana State University Health Sciences Center 1997 — 2002
PhD, Immunotoxicology
Mississippi State University 1993 — 1997
BS, Microbiology
Gallaudet University
American Sign Language (ASL)
US Food and Drug Administration August 2015 - Present
US Food and Drug Administration May 2006 - Present
NIOSH January 2003 - May 2006
Skills
Toxicology, FDA, IND, GLP, In Vivo, Pharmacology, Microbiology, Drug Development, Pharmacokinetics, Drug Discovery, Immunology, Animal Models, In Vitro, Lifesciences
Education
Louisiana State University Health Sciences Center 1997 — 2002
PhD, Immunotoxicology
Mississippi State University 1993 — 1997
BS, Microbiology
Gallaudet University
American Sign Language (ASL)
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
Deb Pagano, MT (ASCP) Deb Pagano, MT (ASCP)'s U.S. Food and Drug Administration Experience 1985 - 2002
Job President, DLP FDA Consultants, LLC
Industry Higher Education
Experience
DLP FDA Consultants, LLC October 2008 - Present
Debra Pagano Certification Board MemberInternational Pharmaceutical Excipient Auditing, Inc
Temple QA/RA September 2002 - Present
FDA 1985 - 2002
US Food and Drug Administration 1985 - 2002
U.S Food and Drug Administration 1985 - 2002
Skills
Regulatory Affairs, FDA, CAPA, GMP, Validation, Regulatory Submissions, Sop, Pharmaceutical Industry, 21 CFR Part 11, GLP, Change Control, V&V, Biotechnology, Regulatory Requirements, Quality System, Technology Transfer, Medical Devices, Quality Auditing, Drug Development, Quality Management, Lifesciences, Clinical Trials, Vaccines, Quality Assurance, Microbiology, Pharmaceutics, ISO 13485, Laboratory, Biopharmaceuticals, GCP, Analytical Chemistry, Clinical Development, HPLC, Chemistry, Quality Control, Chromatography, SOP, Life Sciences
Education
Arcadia University 1978 — 1982
BS, Medical Technology
DLP FDA Consultants, LLC October 2008 - Present
Debra Pagano Certification Board MemberInternational Pharmaceutical Excipient Auditing, Inc
Temple QA/RA September 2002 - Present
FDA 1985 - 2002
US Food and Drug Administration 1985 - 2002
U.S Food and Drug Administration 1985 - 2002
Skills
Regulatory Affairs, FDA, CAPA, GMP, Validation, Regulatory Submissions, Sop, Pharmaceutical Industry, 21 CFR Part 11, GLP, Change Control, V&V, Biotechnology, Regulatory Requirements, Quality System, Technology Transfer, Medical Devices, Quality Auditing, Drug Development, Quality Management, Lifesciences, Clinical Trials, Vaccines, Quality Assurance, Microbiology, Pharmaceutics, ISO 13485, Laboratory, Biopharmaceuticals, GCP, Analytical Chemistry, Clinical Development, HPLC, Chemistry, Quality Control, Chromatography, SOP, Life Sciences
Education
Arcadia University 1978 — 1982
BS, Medical Technology
Nicole M. Clapp Nicole M. Clapp's U.S. Food and Drug Administration Experience December 2010 - Present
Job Executive Assistant
Industry Government Administration
Experience
US Food and Drug Administration December 2010 - Present
KPMG 2008 - 2010
Skills
Strategy, Public Speaking, Government, Marketing, Management, Project Management, Microsoft Office, Project Planning, Program Management, Proposal Writing, Research, Leadership, Customer Service
Education
Hampton University 1991 — 1995
Bachelor of Arts, Mass Communications
US Food and Drug Administration December 2010 - Present
KPMG 2008 - 2010
Skills
Strategy, Public Speaking, Government, Marketing, Management, Project Management, Microsoft Office, Project Planning, Program Management, Proposal Writing, Research, Leadership, Customer Service
Education
Hampton University 1991 — 1995
Bachelor of Arts, Mass Communications
Michele Berger's U.S. Food and Drug Administration Experience June 2015 - Present
Job Senior Advisor at FDA
Industry Government Administration
Experience
US Food and Drug Administration June 2015 - Present
FDA October 2012 - Present
Food and Drug Administration March 2009 - October 2012
Food and Drug Administration (HHS) December 2004 - March 2009
Skills
Government, Operations Management, Policy, Risk Management, Program Management, Risk Assessment, Training, Leadership, Analysis, Business Process..., Federal Government, Security Clearance, Management, Process Improvement, Project Management, Professional Mentoring, Public Policy, Strategic Planning
Education
The Johns Hopkins University 1991 — 1993
Masters of Administrative Science, Management
Towson University 1982 — 1986
Bachelor's degree, Elementary Education and Teaching
US Food and Drug Administration June 2015 - Present
FDA October 2012 - Present
Food and Drug Administration March 2009 - October 2012
Food and Drug Administration (HHS) December 2004 - March 2009
Skills
Government, Operations Management, Policy, Risk Management, Program Management, Risk Assessment, Training, Leadership, Analysis, Business Process..., Federal Government, Security Clearance, Management, Process Improvement, Project Management, Professional Mentoring, Public Policy, Strategic Planning
Education
The Johns Hopkins University 1991 — 1993
Masters of Administrative Science, Management
Towson University 1982 — 1986
Bachelor's degree, Elementary Education and Teaching
Jur Strobos Jur Strobos's U.S. Food and Drug Administration Experience January 1991 - May 1995
Job Of Counsel at Olsson Frank Weeda Terman Matz PC
Industry Law Practice
Experience
Olsson Frank Weeda Terman Matz PC October 1997 - Present
UC Berkeley January 2010 - January 2015
Medicis Pharmaceuticals February 2004 - July 2007
R&D Laboratories October 1997 - July 2001
Greenberg Traurig, LLP May 1995 - October 1997
US Food and Drug Administration January 1991 - May 1995
US Court of Appeals for the Federal Circuit, Chambers of Judge Clevenger May 1989 - December 1991
US Court of Appeals for the Federal Circuit, Chambers of Judge Clevenger May 1989 - December 1990
Wilmer Cutler and Pickering, now WilmerHale July 1988 - May 1989
George Washington University Medical School January 1987 - May 1989
Skills
Food and Drug Law, Food and Drug Regulation, Drug Safety, Food Safety, Drug Development, Curriculum Development, Program Evaluation, Higher Education...
Education
University of Pennsylvania Law School 1983 — 1986
Doctor of Law (JD), Law
University of Chicago - The Pritzker School of Medicine 1974 — 1978
Doctor of Medicine (MD), Medicine
The Johns Hopkins University 1970 — 1974
Bachelor's degree, Biology/Biological Sciences, General
Olsson Frank Weeda Terman Matz PC October 1997 - Present
UC Berkeley January 2010 - January 2015
Medicis Pharmaceuticals February 2004 - July 2007
R&D Laboratories October 1997 - July 2001
Greenberg Traurig, LLP May 1995 - October 1997
US Food and Drug Administration January 1991 - May 1995
US Court of Appeals for the Federal Circuit, Chambers of Judge Clevenger May 1989 - December 1991
US Court of Appeals for the Federal Circuit, Chambers of Judge Clevenger May 1989 - December 1990
Wilmer Cutler and Pickering, now WilmerHale July 1988 - May 1989
George Washington University Medical School January 1987 - May 1989
Skills
Food and Drug Law, Food and Drug Regulation, Drug Safety, Food Safety, Drug Development, Curriculum Development, Program Evaluation, Higher Education...
Education
University of Pennsylvania Law School 1983 — 1986
Doctor of Law (JD), Law
University of Chicago - The Pritzker School of Medicine 1974 — 1978
Doctor of Medicine (MD), Medicine
The Johns Hopkins University 1970 — 1974
Bachelor's degree, Biology/Biological Sciences, General
Gary Bond, PhD, DABT's U.S. Food and Drug Administration Experience February 2003 - Present
Job Senior Pharmacologist/Toxicologist at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration February 2003 - Present
Chevron Phillips Chemical Company and Phillips Petroleum Company October 1997 - June 2002
Skills
Toxicology, Pharmacology, Regulatory Affairs, In Vivo, Drug Development, Drug Discovery, In Vitro, GLP, Lifesciences, Clinical Development, IND, Pharmacokinetics
Education
University of Kansas Medical Center
Doctor of Philosophy (PhD), Toxicology and Pharmacology
Harvard University
US Food and Drug Administration February 2003 - Present
Chevron Phillips Chemical Company and Phillips Petroleum Company October 1997 - June 2002
Skills
Toxicology, Pharmacology, Regulatory Affairs, In Vivo, Drug Development, Drug Discovery, In Vitro, GLP, Lifesciences, Clinical Development, IND, Pharmacokinetics
Education
University of Kansas Medical Center
Doctor of Philosophy (PhD), Toxicology and Pharmacology
Harvard University
William McGuinn William McGuinn's U.S. Food and Drug Administration Experience October 1993 - Present
Job Senior Toxicologist at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration October 1993 - Present
Columbia Scuba 2000 - 2014
Columbia Scuba 2000 - 2014
Columbia Scuba 2000 - 2014
American Board of Toxicology, Inc. 1995 - 2013
Society of Toxicology 1981 - 2013
Skills
Toxicology, Pharmacokinetics, Pharmacology, GLP, Regulatory Affairs, Clinical Study Design, Regulatory Submissions, In Vivo, In Vitro, Environmental Health, FDA, Animal Models, Life Sciences, Pharmaceutical Industry, Drug Discovery, Biotechnology, Drug Development, Oncology, Immunology, Molecular Biology, Biochemistry, Cancer
Education
North Carolina State University
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology
North Carolina State University
Master of Science (M.S.), Inorganic Chemistry
North Carolina State University
Bachelor of Science (B.S.), Physics
US Food and Drug Administration October 1993 - Present
Columbia Scuba 2000 - 2014
Columbia Scuba 2000 - 2014
Columbia Scuba 2000 - 2014
American Board of Toxicology, Inc. 1995 - 2013
Society of Toxicology 1981 - 2013
Skills
Toxicology, Pharmacokinetics, Pharmacology, GLP, Regulatory Affairs, Clinical Study Design, Regulatory Submissions, In Vivo, In Vitro, Environmental Health, FDA, Animal Models, Life Sciences, Pharmaceutical Industry, Drug Discovery, Biotechnology, Drug Development, Oncology, Immunology, Molecular Biology, Biochemistry, Cancer
Education
North Carolina State University
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology
North Carolina State University
Master of Science (M.S.), Inorganic Chemistry
North Carolina State University
Bachelor of Science (B.S.), Physics
Glenn Sherman Glenn Sherman's U.S. Food and Drug Administration Experience June 1993 - May 1998
Job Consultant, Sure Path Regulatory
Industry Pharmaceuticals
Experience
Sure Path Regulatory October 2009 - Present
Pacira Pharmaceuticals 2005 - 2009
Inex Pharmaceuticals 2004 - 2005
Vical Inc 2002 - 2003
Agouron/Pfizer 1998 - 2001
US Food and Drug Administration June 1993 - May 1998
National Institutes of Health October 1988 - June 1993
Education
Rutgers University-New Brunswick
B.A., German
University of North Carolina at Chapel Hill
PhD, Microbiology and Immunology
Sure Path Regulatory October 2009 - Present
Pacira Pharmaceuticals 2005 - 2009
Inex Pharmaceuticals 2004 - 2005
Vical Inc 2002 - 2003
Agouron/Pfizer 1998 - 2001
US Food and Drug Administration June 1993 - May 1998
National Institutes of Health October 1988 - June 1993
Education
Rutgers University-New Brunswick
B.A., German
University of North Carolina at Chapel Hill
PhD, Microbiology and Immunology
Carol Lytle's U.S. Food and Drug Administration Experience 1982 - 2006
Job Writer/Essayist at Formerly Feral Faye
Industry Writing and Editing
Experience
Formerly Feral Faye 2010 - Present
US Food and Drug Administration 1982 - 2006
University of Arkansas for Medical Sciences April 1979 - November 1982
Education
University of Maryland College Park 1970 — 1971
Master’s Degree, Library and Information Science
Purdue University 1959 — 1963
Bachelor’s Degree, Pharmacy
Formerly Feral Faye 2010 - Present
US Food and Drug Administration 1982 - 2006
University of Arkansas for Medical Sciences April 1979 - November 1982
Education
University of Maryland College Park 1970 — 1971
Master’s Degree, Library and Information Science
Purdue University 1959 — 1963
Bachelor’s Degree, Pharmacy
Devashish Shrivastava Devashish Shrivastava's U.S. Food and Drug Administration Experience July 2014 - Present
Job Senior Staff Fellow at US FDA
Industry Government Administration
Experience
US Food and Drug Administration July 2014 - Present
University of Minnesota August 2006 - July 2014
University of Minnesota October 2004 - August 2006
University of Utah May 1999 - October 2004
Skills
MRI Safety, Tissue Heating, Bioheat Thermal Modeling, Development of..., Mathematical Modeling, Heat Transfer, Thermodynamics, MRI, Research, Regulatory Science, Regulatory Submissions, Laser, Regulatory Affairs
Education
University of Minnesota-Twin Cities 2004 — 2006
Post-Doctorate, Radiology
University of Utah 2001 — 2004
Doctor of Philosophy (Ph.D.), Mechanical Engineering
University of Utah 1998 — 2001
Master's Degree, Mechanical Engineering
Indian Institute of Technology (Banaras Hindu University), Varanasi 1994 — 1998
Bachelor's Degree, Mechanical Engineering
US Food and Drug Administration July 2014 - Present
University of Minnesota August 2006 - July 2014
University of Minnesota October 2004 - August 2006
University of Utah May 1999 - October 2004
Skills
MRI Safety, Tissue Heating, Bioheat Thermal Modeling, Development of..., Mathematical Modeling, Heat Transfer, Thermodynamics, MRI, Research, Regulatory Science, Regulatory Submissions, Laser, Regulatory Affairs
Education
University of Minnesota-Twin Cities 2004 — 2006
Post-Doctorate, Radiology
University of Utah 2001 — 2004
Doctor of Philosophy (Ph.D.), Mechanical Engineering
University of Utah 1998 — 2001
Master's Degree, Mechanical Engineering
Indian Institute of Technology (Banaras Hindu University), Varanasi 1994 — 1998
Bachelor's Degree, Mechanical Engineering
Donal Parks Donal Parks's U.S. Food and Drug Administration Experience July 2008 - Present
Job Operations Research Analyst at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration July 2008 - Present
Policy Studies, Inc. January 2007 - June 2008
U.S. House of Representatives September 2001 - December 2007
Skills
Program Management, Policy Analysis, Business Process, Government, Data Analysis, Strategic Planning, Public Policy, Federal Government, Analysis, Process Improvement, Policy, Research, Management, Leadership, Nonprofits, Project Management, Pharmaceutical Industry, Change Management, Life Sciences, Business Process..., Project Planning, Strategy
Education
University of Maryland - Robert H. Smith School of Business 1993 — 1995
MBA, Finance
University of Maryland College Park 1993 — 1995
MPM, Public Finance
Georgetown University 1984 — 1988
BSFS, Foreign Service
US Food and Drug Administration July 2008 - Present
Policy Studies, Inc. January 2007 - June 2008
U.S. House of Representatives September 2001 - December 2007
Skills
Program Management, Policy Analysis, Business Process, Government, Data Analysis, Strategic Planning, Public Policy, Federal Government, Analysis, Process Improvement, Policy, Research, Management, Leadership, Nonprofits, Project Management, Pharmaceutical Industry, Change Management, Life Sciences, Business Process..., Project Planning, Strategy
Education
University of Maryland - Robert H. Smith School of Business 1993 — 1995
MBA, Finance
University of Maryland College Park 1993 — 1995
MPM, Public Finance
Georgetown University 1984 — 1988
BSFS, Foreign Service
Cheryl Boyce Cheryl Boyce's U.S. Food and Drug Administration Experience 1985 - November 1992
Job Founder & President, Boyce Consulting, Inc.
Industry Medical Devices
Experience
Self-employed March 1993 - Present
D'Amico, Griffin and Pettinicchi, LLC May 2013 - September 2013
Richard Hamer Associate, Inc. October 1992 - March 1994
U.S. Food and Drug Administration 1985 - November 1992
Skills
CAPA Programs..., FDA Mock Audits, Development and aid in..., Gap Analyses, Systemic Corrective..., Quality System Audits, Due Diligence Audits, On-site FDA audit..., FDA-483 responses, Assistance in any FDA..., GLP Audits, Development of GLP..., Personnel Training in..., Review of documentation..., Development of Process..., Development of Test..., Streamlining Production..., Developing Change..., Preparation for ISO..., 510(k) premarket..., FDA, Medical Devices, GLP, ISO, GMP, Process Improvement, Quality Auditing, Due Diligence, CAPA, Gap Analysis, Manufacturing, Design Control, Validation, ISO 13485, 21 CFR Part 11, Change Control, Quality System
Education
University of South Carolina
Bachelor of Science
University of South Carolina-Columbia
Bachelor of Science (BS), Chemical Engineering
Self-employed March 1993 - Present
D'Amico, Griffin and Pettinicchi, LLC May 2013 - September 2013
Richard Hamer Associate, Inc. October 1992 - March 1994
U.S. Food and Drug Administration 1985 - November 1992
Skills
CAPA Programs..., FDA Mock Audits, Development and aid in..., Gap Analyses, Systemic Corrective..., Quality System Audits, Due Diligence Audits, On-site FDA audit..., FDA-483 responses, Assistance in any FDA..., GLP Audits, Development of GLP..., Personnel Training in..., Review of documentation..., Development of Process..., Development of Test..., Streamlining Production..., Developing Change..., Preparation for ISO..., 510(k) premarket..., FDA, Medical Devices, GLP, ISO, GMP, Process Improvement, Quality Auditing, Due Diligence, CAPA, Gap Analysis, Manufacturing, Design Control, Validation, ISO 13485, 21 CFR Part 11, Change Control, Quality System
Education
University of South Carolina
Bachelor of Science
University of South Carolina-Columbia
Bachelor of Science (BS), Chemical Engineering
Kristin Marshall Kristin Marshall's U.S. Food and Drug Administration Experience
Job Research Microbiologist at US Food and Drug Administration
Industry Research
Experience
US Food and Drug Administration
Skills
Molecular Biology, Food Microbiology, Microbiology, Food Science, qPCR, Infectious Diseases
Education
University of Wisconsin-Madison 2004 — 2009
Doctor of Philosophy (Ph.D.), Food Science and Bacteriology
Iowa State University 2001 — 2004
Master's Degree, Food Science and Human Nutrition
Iowa State University 1997 — 2001
Bachelor's Degree, Microbiology
US Food and Drug Administration
Skills
Molecular Biology, Food Microbiology, Microbiology, Food Science, qPCR, Infectious Diseases
Education
University of Wisconsin-Madison 2004 — 2009
Doctor of Philosophy (Ph.D.), Food Science and Bacteriology
Iowa State University 2001 — 2004
Master's Degree, Food Science and Human Nutrition
Iowa State University 1997 — 2001
Bachelor's Degree, Microbiology
Eileen Girten Eileen Girten's U.S. Food and Drug Administration Experience July 1991 - May 1992
Job Adjunct Assistant Professor of Biomedical Writing at University of the Sciences in Philadelphia
Industry Writing and Editing
Experience
inVentiv Health Clinical August 2009 - Present
University of the Sciences in Philadelphia August 2011 - Present
Freelance Writer April 2009 - August 2009
School September 2002 - June 2009
New Jersey Department of Health and Senior Services November 1999 - June 2001
US Food and Drug Administration July 1991 - May 1992
Skills
Project Management, Customer Service, Presentations, Regulatory Writing, Mentoring
Education
University of the Sciences in Philadelphia 2008 — 2011
MS, Biomedical Writing
Saint Joseph's University 1994 — 1997
MS, Psychology (Biopsychology concentration)
Rosemont College 1987 — 1991
BA, Chemistry
Regulatory Affairs Professional Society
RAPS Regulatory Affairs Dual Certificate (Medical Devices and Pharmaceuticals)
inVentiv Health Clinical August 2009 - Present
University of the Sciences in Philadelphia August 2011 - Present
Freelance Writer April 2009 - August 2009
School September 2002 - June 2009
New Jersey Department of Health and Senior Services November 1999 - June 2001
US Food and Drug Administration July 1991 - May 1992
Skills
Project Management, Customer Service, Presentations, Regulatory Writing, Mentoring
Education
University of the Sciences in Philadelphia 2008 — 2011
MS, Biomedical Writing
Saint Joseph's University 1994 — 1997
MS, Psychology (Biopsychology concentration)
Rosemont College 1987 — 1991
BA, Chemistry
Regulatory Affairs Professional Society
RAPS Regulatory Affairs Dual Certificate (Medical Devices and Pharmaceuticals)
Mat Soukup Mat Soukup's U.S. Food and Drug Administration Experience March 2010 - Present
Job Team Lead at U.S. Food and Drug Administration
Industry Pharmaceuticals
Experience
U.S. Food and Drug Administration March 2010 - Present
U.S. Food and Drug Administration September 2004 - March 2010
University of Virginia 2002 - 2003
Merck May 2001 - August 2001
Skills
Teaching, Biostatistics, Clinical Trials, Data Analysis, FDA, Statistical Graphics, R, SAS
Education
University of Virginia 1999 — 2004
Ph.D., Biostatistics
University of Minnesota - Morris 1995 — 1999
B.A., Statistics
U.S. Food and Drug Administration March 2010 - Present
U.S. Food and Drug Administration September 2004 - March 2010
University of Virginia 2002 - 2003
Merck May 2001 - August 2001
Skills
Teaching, Biostatistics, Clinical Trials, Data Analysis, FDA, Statistical Graphics, R, SAS
Education
University of Virginia 1999 — 2004
Ph.D., Biostatistics
University of Minnesota - Morris 1995 — 1999
B.A., Statistics
Cristina Makela Cristina Makela's U.S. Food and Drug Administration Experience July 2012 - Present
Job Team Leader Regulatory Health Project Manager (CDER/OSE/PMS) at U.S Food and Drug Administration
Industry Government Administration
Experience
U.S Food and Drug Administration July 2012 - Present
MedImmune December 2003 - March 2012
MedImmune December 2004 - June 2008
MedImmune December 2003 - December 2004
Otsuka America Pharmaceutical, Inc. 1997 - 2003
Otsuka America Pharmaceutical, Inc. July 1999 - April 2001
Otsuka America Pharmaceutical, Inc. April 1998 - July 1999
Otsuka America Pharmaceutical, Inc. June 1997 - April 1998
Skills
Publishing, Microsoft Office, Document Management, People Management, Leading People, Employee Hiring, Staff Mentoring, Organizing, eCTD, Regulatory Submissions, Management, FDA, Leadership, Regulatory Affairs, IND, Clinical Development, Computer System..., GMP, Project Management, Sop, Recruiting, Validation, CAPA, CRM, GCP, SharePoint, Pharmacovigilance, GLP, Vaccines, SOP
Education
The Johns Hopkins University 2013 — 2016
Master's degree, Master of Science in Regulatory Science Program
University of Maryland College Park 1991 — 1996
BS, Biology, Psychology
Colegio San Antonio 1975 — 1989
U.S Food and Drug Administration July 2012 - Present
MedImmune December 2003 - March 2012
MedImmune December 2004 - June 2008
MedImmune December 2003 - December 2004
Otsuka America Pharmaceutical, Inc. 1997 - 2003
Otsuka America Pharmaceutical, Inc. July 1999 - April 2001
Otsuka America Pharmaceutical, Inc. April 1998 - July 1999
Otsuka America Pharmaceutical, Inc. June 1997 - April 1998
Skills
Publishing, Microsoft Office, Document Management, People Management, Leading People, Employee Hiring, Staff Mentoring, Organizing, eCTD, Regulatory Submissions, Management, FDA, Leadership, Regulatory Affairs, IND, Clinical Development, Computer System..., GMP, Project Management, Sop, Recruiting, Validation, CAPA, CRM, GCP, SharePoint, Pharmacovigilance, GLP, Vaccines, SOP
Education
The Johns Hopkins University 2013 — 2016
Master's degree, Master of Science in Regulatory Science Program
University of Maryland College Park 1991 — 1996
BS, Biology, Psychology
Colegio San Antonio 1975 — 1989
Mark Vogel Mark Vogel's U.S. Food and Drug Administration Experience 1995 - 1999
Job Nonclinical Drug Safety at Pfizer
Industry Pharmaceuticals
Experience
Pfizer June 2007 - Present
Pharmacia / Pfizer 1999 - 2007
US Food and Drug Administration 1995 - 1999
Hoffmann-La Roche 1991 - 1994
Boston University School of Medicine 1980 - 1991
Skills
Pharmacology, Toxicology, Drug Discovery, Drug Development, Cardiovascular, Inflammation, Autoimmune Diseases, Pulmonary Diseases, Pharmaceutical Industry, In Vivo, IND, NDA, GLP, Regulatory Submissions, Biopharmaceuticals, Lung, Regulatory Affairs, Immunology, Biotechnology
Education
Temple University
BA, Biology
University of Michigan
PhD, Cardiovascular Pharmacology
Pfizer June 2007 - Present
Pharmacia / Pfizer 1999 - 2007
US Food and Drug Administration 1995 - 1999
Hoffmann-La Roche 1991 - 1994
Boston University School of Medicine 1980 - 1991
Skills
Pharmacology, Toxicology, Drug Discovery, Drug Development, Cardiovascular, Inflammation, Autoimmune Diseases, Pulmonary Diseases, Pharmaceutical Industry, In Vivo, IND, NDA, GLP, Regulatory Submissions, Biopharmaceuticals, Lung, Regulatory Affairs, Immunology, Biotechnology
Education
Temple University
BA, Biology
University of Michigan
PhD, Cardiovascular Pharmacology
Lori Marie Gorski Lori Marie Gorski's U.S. Food and Drug Administration Experience 1994 - Present
Job Regulatory Health Project Manager at US Food and Drug Administration
Industry Research
Experience
US Food and Drug Administration 1994 - Present
FDA 1994 - Present
Pierce & Stevens 1987 - 1991
Education
Montgomery College 1997 — 2002
US Food and Drug Administration 1994 - Present
FDA 1994 - Present
Pierce & Stevens 1987 - 1991
Education
Montgomery College 1997 — 2002
Doug Poucher Doug Poucher's U.S. Food and Drug Administration Experience 1978 - 1994
Job Senior Quality Systems Consultant at King and Spalding
Industry Pharmaceuticals
Experience
King and Spalding Vice President - TechnicalPAREXEL1994 - 2007
U.S. Food and Drug Administration 1978 - 1994
Education
University of Michigan 1971 — 1975
BS, College of Engineering, Atmospheric and Oceanic Science
King and Spalding Vice President - TechnicalPAREXEL1994 - 2007
U.S. Food and Drug Administration 1978 - 1994
Education
University of Michigan 1971 — 1975
BS, College of Engineering, Atmospheric and Oceanic Science
Denise Esposito Denise Esposito's U.S. Food and Drug Administration Experience 2010 - 2015
Job Food and Drug Attorney
Industry Law Practice
Experience
US Food and Drug Administration 2010 - 2015
Emergent BioSolutions Inc. 2004 - 2010
WilmerHale 1992 - 2004
Skills
Life Sciences, Biotechnology, Pharmaceuticals, Intellectual Property, Regulatory Strategy, Risk Management, Complex Litigation, FDA, Pharmaceutical Industry, Vaccines, Public Policy, Biopharmaceuticals, Pharmaceutics, Technology Transfer, Administrative Law, Lifesciences, Strategy, Regulatory Affairs, Regulatory Requirements, Legal Writing, Licensing, Policy, Litigation, Commercial Litigation, Product Liability, Medical Devices, Legal Research, Government, Trade Secrets
Education
University of Michigan Law School 1989 — 1992
JD, Law
Rutgers University-New Brunswick 1984 — 1988
BA, Economics
US Food and Drug Administration 2010 - 2015
Emergent BioSolutions Inc. 2004 - 2010
WilmerHale 1992 - 2004
Skills
Life Sciences, Biotechnology, Pharmaceuticals, Intellectual Property, Regulatory Strategy, Risk Management, Complex Litigation, FDA, Pharmaceutical Industry, Vaccines, Public Policy, Biopharmaceuticals, Pharmaceutics, Technology Transfer, Administrative Law, Lifesciences, Strategy, Regulatory Affairs, Regulatory Requirements, Legal Writing, Licensing, Policy, Litigation, Commercial Litigation, Product Liability, Medical Devices, Legal Research, Government, Trade Secrets
Education
University of Michigan Law School 1989 — 1992
JD, Law
Rutgers University-New Brunswick 1984 — 1988
BA, Economics
Lauren Connelly Lauren Connelly's U.S. Food and Drug Administration Experience June 2008 - August 2010
Job Pharmacist at CVS
Industry Retail
Experience
CVS Caremark Corporation December 2013 - Present
The Medicine Shoppe August 2011 - Present
U.S. Food and Drug Administration June 2008 - August 2010
Skills
Pharmacists, Medication Therapy..., Pharmacy, Certified Immunizer, Community Pharmacy, Patient Counseling, Immunization, Pharmacy Practice, Pharmacology, Patient Education, Pharmacy Technicians, Cpr Certified, Compounding, Healthcare, Pharmacy Automation
Education
University of Pittsburgh School of Pharmacy 2010 — 2014
Doctor of Pharmacy (PharmD)
University of Pittsburgh 2008 — 2012
Bachelor of Pharmaceutical Sciences, Pharmacy
CVS Caremark Corporation December 2013 - Present
The Medicine Shoppe August 2011 - Present
U.S. Food and Drug Administration June 2008 - August 2010
Skills
Pharmacists, Medication Therapy..., Pharmacy, Certified Immunizer, Community Pharmacy, Patient Counseling, Immunization, Pharmacy Practice, Pharmacology, Patient Education, Pharmacy Technicians, Cpr Certified, Compounding, Healthcare, Pharmacy Automation
Education
University of Pittsburgh School of Pharmacy 2010 — 2014
Doctor of Pharmacy (PharmD)
University of Pittsburgh 2008 — 2012
Bachelor of Pharmaceutical Sciences, Pharmacy
Pamela Wertalik's U.S. Food and Drug Administration Experience August 1990 - May 1998
Job CEO / Founder ContractLaboratory.com and GlobalRegulatory.com
Industry Pharmaceuticals
Experience
ContractLaboratory.com May 2003 - Present
GlobalRegulatory.com January 2004 - Present
Global Regulatory Partners January 2000 - January 2005
Nabi Biopharmaceuticals 1999 - 2000
US Food and Drug Administration August 1990 - May 1998
Skills
Lifesciences, Biotechnology, Start-ups, Pharmaceutical Industry, FDA, Quality System, Clinical Trials, Product Development, Management, Laboratory, Medical Devices, Regulatory Affairs, Commercialization, Biopharmaceuticals, Technology Transfer
Education
Rutgers University-New Brunswick 1986 — 2000
BA, Biology
ContractLaboratory.com May 2003 - Present
GlobalRegulatory.com January 2004 - Present
Global Regulatory Partners January 2000 - January 2005
Nabi Biopharmaceuticals 1999 - 2000
US Food and Drug Administration August 1990 - May 1998
Skills
Lifesciences, Biotechnology, Start-ups, Pharmaceutical Industry, FDA, Quality System, Clinical Trials, Product Development, Management, Laboratory, Medical Devices, Regulatory Affairs, Commercialization, Biopharmaceuticals, Technology Transfer
Education
Rutgers University-New Brunswick 1986 — 2000
BA, Biology
Deborah Sholtes's U.S. Food and Drug Administration Experience September 2006 - November 2007
Job
Industry Government Administration
Experience
FDA Center for Tobacco Products March 2010 - Present
US FDA August 2008 - December 2009
U.S. FDA November 2007 - August 2008
US Food and Drug Administration September 2006 - November 2007
US FDA/Office of the Chief Information Officer March 1999 - August 2006
TRW 1992 - 2002
BDM 1992 - 1997
Skills
FDA, Epidemiology, Government, Program Management, Federal Government, Data Analysis, Policy, Project Management, Strategic Planning, Process Improvement, Change Management, Policy Analysis, Enterprise Architecture, Business Analysis, Public Policy, Requirements Analysis, Risk Management, Research, Management Consulting, Governance, Business Process..., Analysis, Technical Writing, Strategic Communications, Proposal Writing, Program Evaluation, PMP, Project Portfolio..., Strategy, Government Contracting, DoD, Public Health, PMO, Integration, Leadership, International Relations, SDLC, Information Assurance
Education
Partnership for Public Service - EIG 2013 — 2014
Harvard University Kennedy School of Government 2009 — 2009
Senior Executive Fellows
Washington University in St. Louis 1987 — 1989
M.S. Engineering and Public Policy
Beloit College 1982 — 1987
B.S. Environmental Geology
Partnership for Public Service - EIG
FDA Center for Tobacco Products March 2010 - Present
US FDA August 2008 - December 2009
U.S. FDA November 2007 - August 2008
US Food and Drug Administration September 2006 - November 2007
US FDA/Office of the Chief Information Officer March 1999 - August 2006
TRW 1992 - 2002
BDM 1992 - 1997
Skills
FDA, Epidemiology, Government, Program Management, Federal Government, Data Analysis, Policy, Project Management, Strategic Planning, Process Improvement, Change Management, Policy Analysis, Enterprise Architecture, Business Analysis, Public Policy, Requirements Analysis, Risk Management, Research, Management Consulting, Governance, Business Process..., Analysis, Technical Writing, Strategic Communications, Proposal Writing, Program Evaluation, PMP, Project Portfolio..., Strategy, Government Contracting, DoD, Public Health, PMO, Integration, Leadership, International Relations, SDLC, Information Assurance
Education
Partnership for Public Service - EIG 2013 — 2014
Harvard University Kennedy School of Government 2009 — 2009
Senior Executive Fellows
Washington University in St. Louis 1987 — 1989
M.S. Engineering and Public Policy
Beloit College 1982 — 1987
B.S. Environmental Geology
Partnership for Public Service - EIG
Chris Vockley's U.S. Food and Drug Administration Experience 2007 - 2007
Job PhD Student at Duke University
Industry Research
Experience
Duke University September 2011 - Present
Harvard University January 2009 - July 2011
National Institutes of Health 2007 - 2008
US Food and Drug Administration 2007 - 2007
United States Food and Drug Administration 2003 - 2006
Genelogic 2000 - 2000
Skills
Molecular Biology, Genomics, Cell Biology, Molecular Cloning, Assay Development, DNA, Transfection, DNA sequencing, Confocal Microscopy, Sequencing, Microarray, Cancer, Stem Cells, Cancer Research, real-time PCR, Functional Genomics, Histology, Developmental Biology
Education
University of Maryland College Park 2003 — 2006
The Johns Hopkins University 2007 — 2009
bioinformatics
Duke University
Duke University September 2011 - Present
Harvard University January 2009 - July 2011
National Institutes of Health 2007 - 2008
US Food and Drug Administration 2007 - 2007
United States Food and Drug Administration 2003 - 2006
Genelogic 2000 - 2000
Skills
Molecular Biology, Genomics, Cell Biology, Molecular Cloning, Assay Development, DNA, Transfection, DNA sequencing, Confocal Microscopy, Sequencing, Microarray, Cancer, Stem Cells, Cancer Research, real-time PCR, Functional Genomics, Histology, Developmental Biology
Education
University of Maryland College Park 2003 — 2006
The Johns Hopkins University 2007 — 2009
bioinformatics
Duke University
Jeff Yourick's U.S. Food and Drug Administration Experience February 2011 - Present
Job Chief, Toxicology Branch at US Food and Drug Administration
Industry Research
Experience
US Food and Drug Administration February 2011 - Present
Education
University of Kansas
Ph.D., Pharmacology and Toxicology
Western Michigan University
M.S., Biomedical Science
Kalamazoo College
B.S., Biology
US Food and Drug Administration February 2011 - Present
Education
University of Kansas
Ph.D., Pharmacology and Toxicology
Western Michigan University
M.S., Biomedical Science
Kalamazoo College
B.S., Biology
Katherine Bond's U.S. Food and Drug Administration Experience March 2010 - September 2012
Job Director, Strategy, Partnerships and Analytics at Office of International Programs, US Food and Drug Administration
Industry Health, Wellness and Fitness
Experience
Office of International Programs, US Food and Drug Administration September 2012 - Present
US Food and Drug Administration March 2010 - September 2012
Academy for Educational Development December 2009 - February 2010
Rockefeller Foundation November 2002 - October 2009
PATH 2000 - November 2002
Tulane University School of Public Health and Tropical Medicine 1997 - 2000
The Ford Foundation 1995 - 1997
The Johns Hopkins University/Chiang Mai University 1993 - 1995
Skills
Global Health, Public Health, Capacity Building, Program Evaluation, International..., Policy Analysis, Qualitative Research, Program Development, NGOs, Grants, Public Policy, Non-profits, Epidemiology, Grant Writing, Policy, Government, Community Development, Fundraising, Economic Development, Reproductive Health, Research, Technical Assistance, Foreign Policy, Data Analysis, Public Speaking, Nonprofits, Health Policy, Program Management, Proposal Writing, Report Writing, International Relations, Infectious Diseases, Community Outreach, Strategy, Human Rights, International Health, Research Design, Quantitative Research, Community Health, Health Economics, Strategic Communications, Strategic Planning, Leadership, Civil Society, Management, Philanthropy, HIV Prevention
Education
The Johns Hopkins University 1991 — 1995
Doctor of Science, Public Health
Swarthmore College 1982 — 1986
BA, Sociology and Anthropology
Office of International Programs, US Food and Drug Administration September 2012 - Present
US Food and Drug Administration March 2010 - September 2012
Academy for Educational Development December 2009 - February 2010
Rockefeller Foundation November 2002 - October 2009
PATH 2000 - November 2002
Tulane University School of Public Health and Tropical Medicine 1997 - 2000
The Ford Foundation 1995 - 1997
The Johns Hopkins University/Chiang Mai University 1993 - 1995
Skills
Global Health, Public Health, Capacity Building, Program Evaluation, International..., Policy Analysis, Qualitative Research, Program Development, NGOs, Grants, Public Policy, Non-profits, Epidemiology, Grant Writing, Policy, Government, Community Development, Fundraising, Economic Development, Reproductive Health, Research, Technical Assistance, Foreign Policy, Data Analysis, Public Speaking, Nonprofits, Health Policy, Program Management, Proposal Writing, Report Writing, International Relations, Infectious Diseases, Community Outreach, Strategy, Human Rights, International Health, Research Design, Quantitative Research, Community Health, Health Economics, Strategic Communications, Strategic Planning, Leadership, Civil Society, Management, Philanthropy, HIV Prevention
Education
The Johns Hopkins University 1991 — 1995
Doctor of Science, Public Health
Swarthmore College 1982 — 1986
BA, Sociology and Anthropology
Keary Dunn's U.S. Food and Drug Administration Experience 1998 - 1999
Job VP, Global Head, Legal and IP at Novartis Cell and Gene Therapies Unit
Industry Pharmaceuticals
Experience
St. Joseph's University - Erivan K. Haub School of Business June 2014 - Present
Novartis Cell and Gene Therapies Unit September 2014 - Present
Novartis Oncology May 2012 - September 2014
Novartis Oncology July 2010 - May 2012
sanofi-aventis US June 2008 - July 2010
Angiotech Pharmaceuticals Inc. June 2004 - June 2008
Otsuka America Pharmaceutical, Inc. 2000 - 2004
US Food and Drug Administration 1998 - 1999
Georgetown University Medical Center 1993 - 1998
Skills
Privacy Law, Product Development, Administrative Law, Pharmaceutical Industry, Intellectual Property, Commercialization, Regulatory Affairs, FDA, Biotechnology, Clinical Trials, Medical Devices, Clinical Development, GCP, Oncology, Lifesciences, Technology Transfer, Medical Affairs, Cardiology, Regulations, Clinical Research, Drug Development, Regulatory Submissions, Regulatory Requirements
Education
George Mason University School of Law 2000 — 2004
JD, Intellectual Property Track
State Uninversity of New York at Buffalo 1990 — 1993
BS, Biochemical Pharmacology
St. Joseph's University - Erivan K. Haub School of Business June 2014 - Present
Novartis Cell and Gene Therapies Unit September 2014 - Present
Novartis Oncology May 2012 - September 2014
Novartis Oncology July 2010 - May 2012
sanofi-aventis US June 2008 - July 2010
Angiotech Pharmaceuticals Inc. June 2004 - June 2008
Otsuka America Pharmaceutical, Inc. 2000 - 2004
US Food and Drug Administration 1998 - 1999
Georgetown University Medical Center 1993 - 1998
Skills
Privacy Law, Product Development, Administrative Law, Pharmaceutical Industry, Intellectual Property, Commercialization, Regulatory Affairs, FDA, Biotechnology, Clinical Trials, Medical Devices, Clinical Development, GCP, Oncology, Lifesciences, Technology Transfer, Medical Affairs, Cardiology, Regulations, Clinical Research, Drug Development, Regulatory Submissions, Regulatory Requirements
Education
George Mason University School of Law 2000 — 2004
JD, Intellectual Property Track
State Uninversity of New York at Buffalo 1990 — 1993
BS, Biochemical Pharmacology
Heupel, Chad's U.S. Food and Drug Administration Experience June 2008 - Present
Job Director, Division of Communication Media at US Food and Drug Administration
Industry Broadcast Media
Experience
US Food and Drug Administration June 2008 - Present
FDA 2008 - Present
Freelance Video Professional 1995 - 2010
US Dept of Health April 2004 - June 2008
Freelance Television Production 1995 - 2008
FEMA / National Emergency Training Center October 1992 - April 2004
US Department of Homeland Security 1992 - 2004
- 1990 - 1990
Skills
Government, Editing, Broadcast, Video, Production, Event Planning, Video Production, Broadcast Television, Event Management, Camera, Digital Media, Sound, Media Relations, Avid, Television, Video Editing, Non-linear Editing, Radio
Education
North Dakota State University 1987 — 1991
Bachelor of Applied Science (BASc), Broadcast Production
US Food and Drug Administration June 2008 - Present
FDA 2008 - Present
Freelance Video Professional 1995 - 2010
US Dept of Health April 2004 - June 2008
Freelance Television Production 1995 - 2008
FEMA / National Emergency Training Center October 1992 - April 2004
US Department of Homeland Security 1992 - 2004
- 1990 - 1990
Skills
Government, Editing, Broadcast, Video, Production, Event Planning, Video Production, Broadcast Television, Event Management, Camera, Digital Media, Sound, Media Relations, Avid, Television, Video Editing, Non-linear Editing, Radio
Education
North Dakota State University 1987 — 1991
Bachelor of Applied Science (BASc), Broadcast Production
Amy Fitzpatrick's U.S. Food and Drug Administration Experience 2011 - Present
Job Consumer Safety Officer/Regional Shellfish Specialist at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration 2011 - Present
Maine Department of Marine Resources January 2000 - February 2011
Skills
Government, Program Management, Public Health, Policy, Public Policy, Data Analysis, Public Speaking, Policy Analysis, Strategic Planning, Emergency Management, Project Management, Process Improvement, Team Leadership, Grants, Program Development, Community Outreach, Project Planning, Grant Writing, Analysis, Microsoft Excel, Cross-functional Team..., Environmental Awareness, Nonprofits, Research
Education
University of Rhode Island 1984 — 1986
U.S. Food and Drug Administration 2011 - Present
Maine Department of Marine Resources January 2000 - February 2011
Skills
Government, Program Management, Public Health, Policy, Public Policy, Data Analysis, Public Speaking, Policy Analysis, Strategic Planning, Emergency Management, Project Management, Process Improvement, Team Leadership, Grants, Program Development, Community Outreach, Project Planning, Grant Writing, Analysis, Microsoft Excel, Cross-functional Team..., Environmental Awareness, Nonprofits, Research
Education
University of Rhode Island 1984 — 1986
Darin Busch's U.S. Food and Drug Administration Experience 1990 - 1998
Job Director, Quality Assurance and Regulatory Affairs
Industry Medical Devices
Experience
AEIOMed November 2007 - Present
PDL BioPharma 2006 - 2007
St. Jude Medical 2001 - 2006
Nellcor Puritan Bennett / Mallinckrodt 1998 - 2001
US Food and Drug Administration 1990 - 1998
Education
University of Minnesota - Carlson School of Management 1999 — 2001
MS MOT
University of Minnesota-Twin Cities 1999 — 2001
North Dakota State University 1985 — 1989
BS EE, electrical engineering
AEIOMed November 2007 - Present
PDL BioPharma 2006 - 2007
St. Jude Medical 2001 - 2006
Nellcor Puritan Bennett / Mallinckrodt 1998 - 2001
US Food and Drug Administration 1990 - 1998
Education
University of Minnesota - Carlson School of Management 1999 — 2001
MS MOT
University of Minnesota-Twin Cities 1999 — 2001
North Dakota State University 1985 — 1989
BS EE, electrical engineering
Sylva Krizan, PhD RAC's U.S. Food and Drug Administration Experience October 2009 - February 2012
Job Senior Regulatory Affairs Manager at NanoString Technologies, Inc.
Industry Biotechnology
Experience
NanoString Technologies, Inc. March 2015 - Present
NanoString Technologies, Inc. March 2014 - March 2015
University of Washington February 2013 - March 2015
NanoString Technologies February 2012 - March 2014
US Food and Drug Administration October 2009 - February 2012
University of Pennsylvania January 2007 - May 2009
University of Michigan September 2002 - January 2007
Georgia Institute of Technology May 2002 - August 2002
Ford Motor Company May 2001 - September 2001
Allied Domecq (Hiram Walker & Sons Ltd.) May 1999 - September 2000
Skills
Biomedical Engineering, Research, Training, Medical Devices, Biotechnology, Cell Culture, Molecular Biology, FDA, Lifesciences, Science, Biochemistry, Biomaterials, Regenerative Medicine, Cell, Stem Cells, PCR, Tissue Engineering, Regulatory Affairs, Laboratory, Microscopy, Assay Development, In Vitro, Life Sciences
Education
University of Michigan 2002 — 2009
MS Eng, PhD Eng, Biomedical Engineering
McMaster University 1997 — 2002
B. Eng, Chemical Engineering & Society, Biology minor
NanoString Technologies, Inc. March 2015 - Present
NanoString Technologies, Inc. March 2014 - March 2015
University of Washington February 2013 - March 2015
NanoString Technologies February 2012 - March 2014
US Food and Drug Administration October 2009 - February 2012
University of Pennsylvania January 2007 - May 2009
University of Michigan September 2002 - January 2007
Georgia Institute of Technology May 2002 - August 2002
Ford Motor Company May 2001 - September 2001
Allied Domecq (Hiram Walker & Sons Ltd.) May 1999 - September 2000
Skills
Biomedical Engineering, Research, Training, Medical Devices, Biotechnology, Cell Culture, Molecular Biology, FDA, Lifesciences, Science, Biochemistry, Biomaterials, Regenerative Medicine, Cell, Stem Cells, PCR, Tissue Engineering, Regulatory Affairs, Laboratory, Microscopy, Assay Development, In Vitro, Life Sciences
Education
University of Michigan 2002 — 2009
MS Eng, PhD Eng, Biomedical Engineering
McMaster University 1997 — 2002
B. Eng, Chemical Engineering & Society, Biology minor
Laurie Farmer's U.S. Food and Drug Administration Experience 2008 - Present
Job FDA/ORA Dir. State Cooperative Programs SE
Industry Government Administration
Experience
U.S. Food and Drug Administration 2008 - Present
Skills
Food Safety, Public Health, HACCP, Food, FDA, Regulatory Affairs, Seafood, Policy, GMP, Veterinary, Environmental, Food Microbiology, Sanitation, Government
Education
University of North Carolina at Greensboro
U.S. Food and Drug Administration 2008 - Present
Skills
Food Safety, Public Health, HACCP, Food, FDA, Regulatory Affairs, Seafood, Policy, GMP, Veterinary, Environmental, Food Microbiology, Sanitation, Government
Education
University of North Carolina at Greensboro
Liza Virata-Theimer's U.S. Food and Drug Administration Experience July 2002 - Present
Job Regulatory Review Scientist at US Food and Drug Administration
Industry Biotechnology
Experience
US Food and Drug Administration July 2002 - Present
National Cancer Institute January 2000 - May 2002
Ateneo de Manila University January 1998 - April 1999
University of the Philippines June 1995 - March 1997
Skills
Molecular Biology, PCR, Cell Biology, Cell Culture, Protein Chemistry, ELISA, Biotechnology, Biochemistry, Science, Infectious Diseases, Virology, Neuroscience, Protein Purification, Clinical Development, Cancer Research, Laboratory, Cell, FDA, Chemistry
Education
Northwestern University 1987 — 1993
PhD, Tumor Cell Biology
University of the Philippines 1982 — 1986
BS, Biology
Philippine Science High School 1978 — 1982
Maryknoll College Grade School 1970 — 1978
Kindergarten, Grades 1-7
US Food and Drug Administration July 2002 - Present
National Cancer Institute January 2000 - May 2002
Ateneo de Manila University January 1998 - April 1999
University of the Philippines June 1995 - March 1997
Skills
Molecular Biology, PCR, Cell Biology, Cell Culture, Protein Chemistry, ELISA, Biotechnology, Biochemistry, Science, Infectious Diseases, Virology, Neuroscience, Protein Purification, Clinical Development, Cancer Research, Laboratory, Cell, FDA, Chemistry
Education
Northwestern University 1987 — 1993
PhD, Tumor Cell Biology
University of the Philippines 1982 — 1986
BS, Biology
Philippine Science High School 1978 — 1982
Maryknoll College Grade School 1970 — 1978
Kindergarten, Grades 1-7
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
Nancy Myers's U.S. Food and Drug Administration Experience 2003 - 2004
Job Strategic Regulatory and Health Policy Consultant; President Catalyst Healthcare Consulting
Industry Pharmaceuticals
Experience
Catalyst Healthcare Consulting, Inc. 2005 - Present
Pharmaceutical Research and Manufacturers of America 2005 - 2005
Food and Drug Administration 2004 - 2005
US Food and Drug Administration 2003 - 2004
Lehman Brothers 2000 - 2003
Biotechnology Industry Organization 1998 - 2000
Biotechnology Industry Organization 1998 - 2000
Blue Cross Blue Shield Association 1994 - 1997
Blue Cross Blue Shield of New Jersey 1993 - 1994
Congressman J. Alex McMillan May 1993 - July 1993
Skills
Lifesciences, Pharmaceutical Industry, Biotechnology, Public Policy, Regulatory Affairs, Policy Analysis, FDA, Health Policy, Non-profits, Policy, Nonprofits, Government, Healthcare, Politics, Public Affairs, Strategic Consulting, Networking, Leadership, Biopharmaceuticals, Medical Devices, Legislative Relations, Drug Development, Regulatory Requirements, Regulatory Submissions, Fundraising, Clinical Trials, Infectious Diseases, Clinical Development, Oncology, Strategy, Vaccines, Life Sciences
Education
Temple University School of Law 1990 — 1993
Doctor of Law (JD)
Duke University
Catalyst Healthcare Consulting, Inc. 2005 - Present
Pharmaceutical Research and Manufacturers of America 2005 - 2005
Food and Drug Administration 2004 - 2005
US Food and Drug Administration 2003 - 2004
Lehman Brothers 2000 - 2003
Biotechnology Industry Organization 1998 - 2000
Biotechnology Industry Organization 1998 - 2000
Blue Cross Blue Shield Association 1994 - 1997
Blue Cross Blue Shield of New Jersey 1993 - 1994
Congressman J. Alex McMillan May 1993 - July 1993
Skills
Lifesciences, Pharmaceutical Industry, Biotechnology, Public Policy, Regulatory Affairs, Policy Analysis, FDA, Health Policy, Non-profits, Policy, Nonprofits, Government, Healthcare, Politics, Public Affairs, Strategic Consulting, Networking, Leadership, Biopharmaceuticals, Medical Devices, Legislative Relations, Drug Development, Regulatory Requirements, Regulatory Submissions, Fundraising, Clinical Trials, Infectious Diseases, Clinical Development, Oncology, Strategy, Vaccines, Life Sciences
Education
Temple University School of Law 1990 — 1993
Doctor of Law (JD)
Duke University
David Essayan's U.S. Food and Drug Administration Experience April 1997 - August 2003
Job
Industry Pharmaceuticals
Experience
ONCORD, Inc. May 2007 - Present
Amgen August 2003 - May 2007
U.S. Food and Drug Administration April 1997 - August 2003
Johns Hopkins School of Medicine July 1994 - August 2003
Food and Drug Administration 1997 - 2003
Skills
Drug Development, Immunology, Clinical Development, Clinical Trials, Biotechnology, Regulatory Affairs, FDA, Infectious Diseases, Medical Writing, GMP, Vaccines, Clinical Research, Regulatory Submissions, Diabetes, Biopharmaceuticals, Cell Culture, Neurology, Healthcare, Pharmacology, Clinical Pharmacology, Oncology, Leadership, Lifesciences, Pharmaceutics, Pharmaceutical Industry, Medicine, Toxicology, Biochemistry, Cell Biology, Technology Transfer, Medical Devices, Drug Discovery, Therapeutic Areas, Biomarkers, Internal Medicine, Protocol, Validation, CRO, Commercialization, Sop, Molecular Biology, IND, Cancer, GLP, Pharmacovigilance, Medical Education, Medical Affairs, Protein Chemistry, GCP, Regulatory Requirements
Education
University of Pennsylvania School of Medicine 1982 — 1987
MD
Yale University 1978 — 1982
BS, Chemistry
ONCORD, Inc. May 2007 - Present
Amgen August 2003 - May 2007
U.S. Food and Drug Administration April 1997 - August 2003
Johns Hopkins School of Medicine July 1994 - August 2003
Food and Drug Administration 1997 - 2003
Skills
Drug Development, Immunology, Clinical Development, Clinical Trials, Biotechnology, Regulatory Affairs, FDA, Infectious Diseases, Medical Writing, GMP, Vaccines, Clinical Research, Regulatory Submissions, Diabetes, Biopharmaceuticals, Cell Culture, Neurology, Healthcare, Pharmacology, Clinical Pharmacology, Oncology, Leadership, Lifesciences, Pharmaceutics, Pharmaceutical Industry, Medicine, Toxicology, Biochemistry, Cell Biology, Technology Transfer, Medical Devices, Drug Discovery, Therapeutic Areas, Biomarkers, Internal Medicine, Protocol, Validation, CRO, Commercialization, Sop, Molecular Biology, IND, Cancer, GLP, Pharmacovigilance, Medical Education, Medical Affairs, Protein Chemistry, GCP, Regulatory Requirements
Education
University of Pennsylvania School of Medicine 1982 — 1987
MD
Yale University 1978 — 1982
BS, Chemistry
Dina Stolman's U.S. Food and Drug Administration Experience 1994 - 2001
Job President and Managing Director at Chelys Consulting, Inc.
Industry Research
Experience
Chelys Consulting, Inc. 2015 - Present
Amgen 2009 - 2014
Cedars Sinai Medical Center, Oschin Cancer Institute 2008 - 2009
Danya International 2004 - 2008
Rx Development, LLC 2002 - 2008
US Food and Drug Administration 1994 - 2001
Kaiser Permanente, Silver Spring, Maryland July 1991 - June 1994
California Pacific Medical Center July 1986 - June 1988
Kaiser Hospital San Francisco 1984 - 1985
Skills
Statistics, Clinical Trials, Clinical Research, Medicine, Healthcare, Life Sciences, Biotechnology, Pharmaceutical Industry, Oncology, Clinical Development, Research
Education
The George Washington University School of Medicine and Health Sciences 1980 — 1984
Doctor of Medicine (M.D.)
University of California Los Angeles 1977 — 1979
MSPH, Health Policy and Planning
Chelys Consulting, Inc. 2015 - Present
Amgen 2009 - 2014
Cedars Sinai Medical Center, Oschin Cancer Institute 2008 - 2009
Danya International 2004 - 2008
Rx Development, LLC 2002 - 2008
US Food and Drug Administration 1994 - 2001
Kaiser Permanente, Silver Spring, Maryland July 1991 - June 1994
California Pacific Medical Center July 1986 - June 1988
Kaiser Hospital San Francisco 1984 - 1985
Skills
Statistics, Clinical Trials, Clinical Research, Medicine, Healthcare, Life Sciences, Biotechnology, Pharmaceutical Industry, Oncology, Clinical Development, Research
Education
The George Washington University School of Medicine and Health Sciences 1980 — 1984
Doctor of Medicine (M.D.)
University of California Los Angeles 1977 — 1979
MSPH, Health Policy and Planning
Abi D'Sa's U.S. Food and Drug Administration Experience January 2009 - Present
Job Deputy Director US FDA (India)
Industry Government Administration
Experience
FDA August 2014 - Present
U.S. Food and Drug Administration January 2009 - Present
US Food & Drug Administration May 2001 - November 2008
U.S. Food and Drug Administration April 1996 - May 2001
NIH 1989 - 1992
Skills
Regulatory Requirements, Regulatory Affairs, FDA, Regulatory Submissions, GMP, Clinical Trials, Sop, Pharmaceutical Industry, GLP, Validation, CAPA, Vaccines, Technology Transfer, Quality Auditing, 21 CFR Part 11, Biopharmaceuticals, Change Control, Clinical Development, Lifesciences, V&V, Biotechnology, GCP, Chemistry, Drug Discovery, Pharmaceutics, IND, SOP, Life Sciences
Education
University of Missouri-Columbia 1984 — 1989
Ph. D, Organic and Bio-organic Chemistry
FDA August 2014 - Present
U.S. Food and Drug Administration January 2009 - Present
US Food & Drug Administration May 2001 - November 2008
U.S. Food and Drug Administration April 1996 - May 2001
NIH 1989 - 1992
Skills
Regulatory Requirements, Regulatory Affairs, FDA, Regulatory Submissions, GMP, Clinical Trials, Sop, Pharmaceutical Industry, GLP, Validation, CAPA, Vaccines, Technology Transfer, Quality Auditing, 21 CFR Part 11, Biopharmaceuticals, Change Control, Clinical Development, Lifesciences, V&V, Biotechnology, GCP, Chemistry, Drug Discovery, Pharmaceutics, IND, SOP, Life Sciences
Education
University of Missouri-Columbia 1984 — 1989
Ph. D, Organic and Bio-organic Chemistry
Andria Kuhlman's U.S. Food and Drug Administration Experience July 2008 - Present
Job Consumer Safety Officer FDA
Industry Hospital & Health Care
Experience
US Food and Drug Administration July 2008 - Present
American Red Cross October 2007 - March 2008
American Red Cross March 2003 - October 2007
Education
Ohio University 1992 — 1996
B.S., Biology
US Food and Drug Administration July 2008 - Present
American Red Cross October 2007 - March 2008
American Red Cross March 2003 - October 2007
Education
Ohio University 1992 — 1996
B.S., Biology
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
Kirk Prutzman's U.S. Food and Drug Administration Experience September 2010 - Present
Job Primary Reviewer/Regulatory Project Manager at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration September 2010 - Present
ASTAR June 2005 - Present
U.S. Food and Drug Administration October 2008 - September 2010
University of North Carolina at Chapel Hill June 2006 - October 2008
University of North Carolina at Chapel Hill August 1997 - May 2005
Bristol-Myers Squibb May 1997 - August 1997
Education
University of North Carolina at Chapel Hill 1997 — 2004
PhD, Biochemistry/Biophysics
State University of New York College of Environmental Sciences and Forestry 1995 — 1997
B.S., Chemistry
US Food and Drug Administration September 2010 - Present
ASTAR June 2005 - Present
U.S. Food and Drug Administration October 2008 - September 2010
University of North Carolina at Chapel Hill June 2006 - October 2008
University of North Carolina at Chapel Hill August 1997 - May 2005
Bristol-Myers Squibb May 1997 - August 1997
Education
University of North Carolina at Chapel Hill 1997 — 2004
PhD, Biochemistry/Biophysics
State University of New York College of Environmental Sciences and Forestry 1995 — 1997
B.S., Chemistry
Jennifer Grayson's U.S. Food and Drug Administration Experience 1972 - 1995
Job Independent Biotechnology Professional
Industry Biotechnology
Experience
U.S Food and Drug Administration 1972 - 1995
Education
South Carolina State University 1967 — 1972
U.S Food and Drug Administration 1972 - 1995
Education
South Carolina State University 1967 — 1972
Chryste Best's U.S. Food and Drug Administration Experience August 1990 - June 2003
Job Product Quality Assurance Manager/Microbiologist at Supply Chain Management Systems
Industry Pharmaceuticals
Experience
Supply Chain Management Systems (SCMS) April 2007 - Present
Eli Lilly and Company January 2005 - February 2007
Parexel July 2003 - October 2004
US Food and Drug Administration August 1990 - June 2003
Education
Howard University
BS
Supply Chain Management Systems (SCMS) April 2007 - Present
Eli Lilly and Company January 2005 - February 2007
Parexel July 2003 - October 2004
US Food and Drug Administration August 1990 - June 2003
Education
Howard University
BS
Anthony Ciavarella's U.S. Food and Drug Administration Experience ChemistFDA1995 - Present
Job Chemist at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration ChemistFDA1995 - Present
Skills
HPLC, Chromatography, Wet Chemistry, Analytical Chemistry, LC-MS, UV/Vis
Education
Pennsylvania State University 1987 — 1991
US Food and Drug Administration ChemistFDA1995 - Present
Skills
HPLC, Chromatography, Wet Chemistry, Analytical Chemistry, LC-MS, UV/Vis
Education
Pennsylvania State University 1987 — 1991
Tania Mercado, PMP's U.S. Food and Drug Administration Experience February 2002 - Present
Job Consumer Safety Officer at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration February 2002 - Present
Environmental Protection Agency 1998 - 2001
Skills
Regulatory Requirements, Infectious Diseases, Regulatory Affairs, Regulatory Submissions, FDA, GMP, Biotechnology, Federal Government, Project Management
Education
The George Washington University 2011 — 2012
Associate's Certificate, Project Management
Tufts University 1996 — 1998
Master of Science (M.S.), Environmental/Environmental Health Engineering
University of Massachusetts, Amherst 1991 — 1996
BS, Chemistry
US Food and Drug Administration February 2002 - Present
Environmental Protection Agency 1998 - 2001
Skills
Regulatory Requirements, Infectious Diseases, Regulatory Affairs, Regulatory Submissions, FDA, GMP, Biotechnology, Federal Government, Project Management
Education
The George Washington University 2011 — 2012
Associate's Certificate, Project Management
Tufts University 1996 — 1998
Master of Science (M.S.), Environmental/Environmental Health Engineering
University of Massachusetts, Amherst 1991 — 1996
BS, Chemistry
Massoud Motamed's U.S. Food and Drug Administration Experience November 2014 - Present
Job Generic Drug Investigator
Industry Pharmaceuticals
Experience
US Food and Drug Administration November 2014 - Present
Baylor College of Medicine 2012 - October 2014
UT Southwestern Medical Center at Dallas October 2008 - 2011
UC Berkeley May 2006 - August 2008
Southern Methodist University October 2004 - May 2006
UT Southwestern Medical Center at Dallas June 2003 - August 2003
Skills
Organic Chemistry, Chemistry, Mass Spectrometry, Biochemistry, Cell Culture, Protein Chemistry, NMR, Protein Expression, Protein Purification, Western Blotting, Organic Synthesis, Cell Biology, Molecular Biology, Fluorescence Microscopy, PCR, Purification, Cell
Education
UT Southwestern 2008 — 2011
Ph.D., Biochemistry
University of California, Berkeley 2006 — 2008
M.S., Chemistry
Southern Methodist University 2004 — 2006
B.S., Biochemistry
US Food and Drug Administration November 2014 - Present
Baylor College of Medicine 2012 - October 2014
UT Southwestern Medical Center at Dallas October 2008 - 2011
UC Berkeley May 2006 - August 2008
Southern Methodist University October 2004 - May 2006
UT Southwestern Medical Center at Dallas June 2003 - August 2003
Skills
Organic Chemistry, Chemistry, Mass Spectrometry, Biochemistry, Cell Culture, Protein Chemistry, NMR, Protein Expression, Protein Purification, Western Blotting, Organic Synthesis, Cell Biology, Molecular Biology, Fluorescence Microscopy, PCR, Purification, Cell
Education
UT Southwestern 2008 — 2011
Ph.D., Biochemistry
University of California, Berkeley 2006 — 2008
M.S., Chemistry
Southern Methodist University 2004 — 2006
B.S., Biochemistry
Oluchi Elekwachi, PharmD, MPH's U.S. Food and Drug Administration Experience August 2003 - August 2012
Job Director, Regulatory Review at US Food and Drug Administration, Center for Biologics Evaluationa and Research
Industry Government Administration
Experience
FDA, Center for Biologics Evaluation and Research, Advertising and Promotional Labeling August 2012 - Present
US Food and Drug Administration August 2003 - August 2012
EIG 2009 - 2010
FDA 2003 - 2010
American Pharmacists Association 1999 - 2000
Skills
FDA, Government, Policy, Leadership, Public Health, Management, Drug Development, Policy Analysis, Research, Biotechnology, Epidemiology, Life Sciences, Regulatory Affairs
Education
University of Maryland College Park 2011 — 2012
Graduate Fellowship, Global Health, School of Public Health
Howard University 1998 — 2002
PharmD, Pharmacy
The George Washington University 1997 — 1998
MPH, Epidemiology
University of North Carolina at Chapel Hill 1992 — 1996
Bachelors, Biology and Chemistry
FDA, Center for Biologics Evaluation and Research, Advertising and Promotional Labeling August 2012 - Present
US Food and Drug Administration August 2003 - August 2012
EIG 2009 - 2010
FDA 2003 - 2010
American Pharmacists Association 1999 - 2000
Skills
FDA, Government, Policy, Leadership, Public Health, Management, Drug Development, Policy Analysis, Research, Biotechnology, Epidemiology, Life Sciences, Regulatory Affairs
Education
University of Maryland College Park 2011 — 2012
Graduate Fellowship, Global Health, School of Public Health
Howard University 1998 — 2002
PharmD, Pharmacy
The George Washington University 1997 — 1998
MPH, Epidemiology
University of North Carolina at Chapel Hill 1992 — 1996
Bachelors, Biology and Chemistry
Larry Rodichok's U.S. Food and Drug Administration Experience April 2010 - Present
Job Medical Officer at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration April 2010 - Present
Solvay Pharmaceuticals May 2009 - August 2010
AstraZeneca October 2003 - May 2009
Lancaster Neuroscience Associates October 1995 - October 2003
Lancaster General Hospital October 1995 - October 2003
Penn State University October 1986 - October 1995
Albany Medical College July 1977 - October 1986
Education
Loyola University Chicago Stritch School of Medicine 1968 — 1972
MD, Medicine
Loyola University Chicago Stritch School of Medicine 1968 — 1972
MS, Neuropharmacology
University of Delaware 1965 — 1968
BA, Biology
US Food and Drug Administration April 2010 - Present
Solvay Pharmaceuticals May 2009 - August 2010
AstraZeneca October 2003 - May 2009
Lancaster Neuroscience Associates October 1995 - October 2003
Lancaster General Hospital October 1995 - October 2003
Penn State University October 1986 - October 1995
Albany Medical College July 1977 - October 1986
Education
Loyola University Chicago Stritch School of Medicine 1968 — 1972
MD, Medicine
Loyola University Chicago Stritch School of Medicine 1968 — 1972
MS, Neuropharmacology
University of Delaware 1965 — 1968
BA, Biology
Dewakar Sangaraju's U.S. Food and Drug Administration Experience November 2014 - March 2015
Job Associate Scientist at Genentech
Industry Biotechnology
Experience
Genentech March 2015 - Present
US Food and Drug Administration November 2014 - March 2015
University of Minnesota August 2009 - November 2014
Janssen Research and Development, LLC, June 2014 - September 2014
Promed Exports Pvt Ltd January 2008 - July 2009
GlaxoSmithKline Consumer Health care R&D, Gurgaon July 2007 - December 2007
Hetero Drugs Ltd May 2004 - July 2004
Skills
Quantitative Mass..., LC-MS method..., Bioanalytical chemistry, HPLC-MS, HPLC Method Development..., Environmental Toxicology, Mass Spectrometry, Drug Regulatory Affairs, Chemistry, Regulatory Affairs, Poster Presentations, Seminars, Pharmacology, Biochemistry, Medicinal Chemistry, Biotechnology, In Vitro, HPLC, LC-MS, Analytical Chemistry, Organic Synthesis
Education
University of Minnesota-Twin Cities 2009 — 2014
Doctor of Philosophy (PhD), Medicinal Chemsitry
Birla Institute of Technology and Science 2002 — 2007
B.Pharm and M.Pharm, Pharmacy
Genentech March 2015 - Present
US Food and Drug Administration November 2014 - March 2015
University of Minnesota August 2009 - November 2014
Janssen Research and Development, LLC, June 2014 - September 2014
Promed Exports Pvt Ltd January 2008 - July 2009
GlaxoSmithKline Consumer Health care R&D, Gurgaon July 2007 - December 2007
Hetero Drugs Ltd May 2004 - July 2004
Skills
Quantitative Mass..., LC-MS method..., Bioanalytical chemistry, HPLC-MS, HPLC Method Development..., Environmental Toxicology, Mass Spectrometry, Drug Regulatory Affairs, Chemistry, Regulatory Affairs, Poster Presentations, Seminars, Pharmacology, Biochemistry, Medicinal Chemistry, Biotechnology, In Vitro, HPLC, LC-MS, Analytical Chemistry, Organic Synthesis
Education
University of Minnesota-Twin Cities 2009 — 2014
Doctor of Philosophy (PhD), Medicinal Chemsitry
Birla Institute of Technology and Science 2002 — 2007
B.Pharm and M.Pharm, Pharmacy
Irma D. Ramirez's U.S. Food and Drug Administration Experience October 2009 - December 2010
Job Regulatory Specialist at Sharp Healthcare
Industry Research
Experience
Sharp HealthCare May 2014 - Present
Quintiles, Inc December 2013 - May 2014
Quintiles, Inc December 2010 - December 2013
US Food and Drug Administration October 2009 - December 2010
Synergy Clinical Research Center May 2008 - October 2009
CVS Pharmacy January 2008 - May 2008
Prescription Solutions United Healthcare Pharmacy January 2006 - October 2006
Rite Aid Pharmacy August 2004 - August 2005
Sav-On Drugs January 2004 - May 2004
The Salk Institute April 2003 - December 2003
Skills
Clinical Trials, Regulatory Affairs, GCP, Clinical Research, Lifesciences, Pharmaceutical Industry, Microbiology, Infectious Diseases, Regulatory Submissions, Oncology, GMP, Biotechnology, Pharmacovigilance, Molecular Biology, Study Maintenance, Study Start-Up, 21 CFR, Microsoft Office, Outlook, eClinical, FDA, ICH-GCP, Community Outreach, Community Service, CRO, CTMS, Sop, EDC, IRB, Clinical Data Management, Inform, Data Management, Regulatory Documentation, Oncology Clinical..., Project Management, Team-oriented, Clinical Monitoring, Friendly Personality, Protocol, Regulatory Requirements, Cell Culture, ELISA, Medical Devices, ICH guidelines, Cell Biology, Trial Management, PCR, Informed Consent, Genetics, Life Sciences
Education
2008 San Diego State University 2006 — 2008
B.S, Biology
2003 United Education InstitutePharmacy Technician Certification 2002 — 2003
Pharmacy Technician, Pharmacy
Southwestern College 1997 — 2000
A.A, General Studies (Biology emphasis)
Sharp HealthCare May 2014 - Present
Quintiles, Inc December 2013 - May 2014
Quintiles, Inc December 2010 - December 2013
US Food and Drug Administration October 2009 - December 2010
Synergy Clinical Research Center May 2008 - October 2009
CVS Pharmacy January 2008 - May 2008
Prescription Solutions United Healthcare Pharmacy January 2006 - October 2006
Rite Aid Pharmacy August 2004 - August 2005
Sav-On Drugs January 2004 - May 2004
The Salk Institute April 2003 - December 2003
Skills
Clinical Trials, Regulatory Affairs, GCP, Clinical Research, Lifesciences, Pharmaceutical Industry, Microbiology, Infectious Diseases, Regulatory Submissions, Oncology, GMP, Biotechnology, Pharmacovigilance, Molecular Biology, Study Maintenance, Study Start-Up, 21 CFR, Microsoft Office, Outlook, eClinical, FDA, ICH-GCP, Community Outreach, Community Service, CRO, CTMS, Sop, EDC, IRB, Clinical Data Management, Inform, Data Management, Regulatory Documentation, Oncology Clinical..., Project Management, Team-oriented, Clinical Monitoring, Friendly Personality, Protocol, Regulatory Requirements, Cell Culture, ELISA, Medical Devices, ICH guidelines, Cell Biology, Trial Management, PCR, Informed Consent, Genetics, Life Sciences
Education
2008 San Diego State University 2006 — 2008
B.S, Biology
2003 United Education InstitutePharmacy Technician Certification 2002 — 2003
Pharmacy Technician, Pharmacy
Southwestern College 1997 — 2000
A.A, General Studies (Biology emphasis)
Nada Hanafi's U.S. Food and Drug Administration Experience January 2008 - August 2010
Job Senior Science Health Advisor at Food and Drug Administration
Industry Medical Devices
Experience
Food and Drug Administration August 2010 - Present
US Food and Drug Administration January 2008 - August 2010
FDA September 2004 - December 2008
Skills
Biomedical Engineering, Biomaterials, Public Policy, Public Health, Medical Devices, Clinical Trials, Women's Health, Project Management, Program Development, Program Evaluation, FDA, Regulatory Requirements, Regulatory Submissions, Regulatory Affairs, Policy, Public Speaking, Change Management, Leadership, Program Management, Community Outreach, Research, Strategic Planning, Biotechnology, Data Analysis, Lifesciences, Clinical Research, Statistics, Life Sciences
Education
The Johns Hopkins University 2007 — 2009
Master of Public Health (MPH)
Queen Mary, U. of London 2001 — 2002
Master of Science (M.Sc.), Biomaterials, Honors
Queen Mary, U. of London 1998 — 2001
Bachelor of Engineering (BEng), Biomedical Materials Science and Engineering, Honors 2:1
Food and Drug Administration August 2010 - Present
US Food and Drug Administration January 2008 - August 2010
FDA September 2004 - December 2008
Skills
Biomedical Engineering, Biomaterials, Public Policy, Public Health, Medical Devices, Clinical Trials, Women's Health, Project Management, Program Development, Program Evaluation, FDA, Regulatory Requirements, Regulatory Submissions, Regulatory Affairs, Policy, Public Speaking, Change Management, Leadership, Program Management, Community Outreach, Research, Strategic Planning, Biotechnology, Data Analysis, Lifesciences, Clinical Research, Statistics, Life Sciences
Education
The Johns Hopkins University 2007 — 2009
Master of Public Health (MPH)
Queen Mary, U. of London 2001 — 2002
Master of Science (M.Sc.), Biomaterials, Honors
Queen Mary, U. of London 1998 — 2001
Bachelor of Engineering (BEng), Biomedical Materials Science and Engineering, Honors 2:1
Gary Dzidowski's U.S. Food and Drug Administration Experience May 1974 - August 2014
Job Retired Biologist, student of life. at Self employed hobby farmer
Industry Food & Beverages
Experience
Self employed hobby farmer August 2014 - Present
US Food and Drug Administration May 1974 - August 2014
FDA May 1974 - August 2014
FDA 1974 - 2014
Skills
FDA, Toxicology, Regulatory Affairs, Lifesciences, Food Safety, Food Additives, Cosmetic colors, Seafood HACCP, HACCP, Food Science, In Vitro, Protein Purification, Immunology, Pharmacology, Infectious Diseases, Vaccines, Protein Chemistry, GLP, Cell Biology, Life Sciences, Laboratory
Education
Wayne State University 1968 — 1977
Bachelor of Science (B.S.), Biology, General
Purdue University 1975 — 1975
Post. Grad., Cannery Technology
Self employed hobby farmer August 2014 - Present
US Food and Drug Administration May 1974 - August 2014
FDA May 1974 - August 2014
FDA 1974 - 2014
Skills
FDA, Toxicology, Regulatory Affairs, Lifesciences, Food Safety, Food Additives, Cosmetic colors, Seafood HACCP, HACCP, Food Science, In Vitro, Protein Purification, Immunology, Pharmacology, Infectious Diseases, Vaccines, Protein Chemistry, GLP, Cell Biology, Life Sciences, Laboratory
Education
Wayne State University 1968 — 1977
Bachelor of Science (B.S.), Biology, General
Purdue University 1975 — 1975
Post. Grad., Cannery Technology
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
Steven Melius's U.S. Food and Drug Administration Experience 1972 - 1973
Job Computer Software Professional, Project Manager, Quality Assurance System Tester
Industry Computer Software
Experience
IBM 2003 - 2009
IBM 1992 - 2003
IBM 1989 - 1992
IBM 1981 - 1989
General Electric Drive System Division 1978 - 1981
Vitro Labratories 1974 - 1978
Calspan Corporation 1973 - 1974
US Food and Drug Administration 1972 - 1973
Education
Florida Institute of Technology 1967 — 1971
Bachelor of Science, Computer Science
IBM 2003 - 2009
IBM 1992 - 2003
IBM 1989 - 1992
IBM 1981 - 1989
General Electric Drive System Division 1978 - 1981
Vitro Labratories 1974 - 1978
Calspan Corporation 1973 - 1974
US Food and Drug Administration 1972 - 1973
Education
Florida Institute of Technology 1967 — 1971
Bachelor of Science, Computer Science
Frank Schenck's U.S. Food and Drug Administration Experience January 1979 - April 2009
Job Flag Works: Florida Pesticide/North American Chemical Residue Workshop
Industry Research
Experience
Flag Works: Florida Pesticide Residue Workshop, North American Chemical Residue Workshop January 2007 - Present
U.S Food and Drug Administration January 1979 - April 2009
Skills
Food, Lifesciences, Science, Research, Molecular Biology, LC-MS, Analytical Chemistry, Biochemistry, Hazardous Waste..., Fruit, Chemistry, UV/Vis, Life Sciences, R&D
Education
Youngstown State University 1970 — 1974
M.S., biochemistry, clinical chemistry
Capital University 1961 — 1966
B.S., Biology, Chemistry
Flag Works: Florida Pesticide Residue Workshop, North American Chemical Residue Workshop January 2007 - Present
U.S Food and Drug Administration January 1979 - April 2009
Skills
Food, Lifesciences, Science, Research, Molecular Biology, LC-MS, Analytical Chemistry, Biochemistry, Hazardous Waste..., Fruit, Chemistry, UV/Vis, Life Sciences, R&D
Education
Youngstown State University 1970 — 1974
M.S., biochemistry, clinical chemistry
Capital University 1961 — 1966
B.S., Biology, Chemistry
Anthony Panzica's U.S. Food and Drug Administration Experience October 1966 - April 1990
Job President at Panzica Pharmaceutical Consulting, LLC
Industry Pharmaceuticals
Experience
Panzica Pharmaceutical Consulting, LLC April 2002 - Present
Pfizer Pharmaceuticals July 2000 - March 2002
Warner-Lambert Company May 1990 - June 2000
US Food and Drug Administration October 1966 - April 1990
Skills
GxP, cGMP, Process Validation, CAPA, FDA, GMP, SOP, Quality Systems, QC, Medical Devices, Quality Assurance, Pharmaceutical Industry, Sop, Quality System, Quality Auditing, Aseptic Processing, Cleaning Validation, Validation, Quality Management, Change Control, Microbiology, Contract Manufacturing, Manufacturing, Quality Control, Regulatory Requirements
Education
Long Island University, Brooklyn Campus 1964 — 1967
MS, Microbiology
St. John's University, New York 1960 — 1964
BS, Biology
Panzica Pharmaceutical Consulting, LLC April 2002 - Present
Pfizer Pharmaceuticals July 2000 - March 2002
Warner-Lambert Company May 1990 - June 2000
US Food and Drug Administration October 1966 - April 1990
Skills
GxP, cGMP, Process Validation, CAPA, FDA, GMP, SOP, Quality Systems, QC, Medical Devices, Quality Assurance, Pharmaceutical Industry, Sop, Quality System, Quality Auditing, Aseptic Processing, Cleaning Validation, Validation, Quality Management, Change Control, Microbiology, Contract Manufacturing, Manufacturing, Quality Control, Regulatory Requirements
Education
Long Island University, Brooklyn Campus 1964 — 1967
MS, Microbiology
St. John's University, New York 1960 — 1964
BS, Biology
Daniel Gordin's U.S. Food and Drug Administration Experience December 1988 - January 1994
Job Executive Director of Drug Regulatory Affairs
Industry Pharmaceuticals
Experience
Novartis January 2009 - Present
Novartis June 2002 - January 2009
Forest Laboratories May 1999 - June 2002
Synthelabo Research, Inc November 1997 - April 1999
Associate Director, Otsuka Pharmaceuticals April 1996 - October 1997
Leiras February 1994 - April 1996
U.S. Food and Drug Administration December 1988 - January 1994
Skills
Regulatory Affairs, FDA, Pharmaceutical Industry, Pharmacokinetics, Strategy, Product Development, Regulations, Regulatory Submissions, Clinical Development, Clinical Trials, Pharmacovigilance, Drug Development, GCP, eCTD, IND
Education
Medical University of South Carolina 1983 — 1989
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences (Pharmacokinetics)
University of South Carolina-Columbia
Bachelor of Science (BS), Biology, General
Novartis January 2009 - Present
Novartis June 2002 - January 2009
Forest Laboratories May 1999 - June 2002
Synthelabo Research, Inc November 1997 - April 1999
Associate Director, Otsuka Pharmaceuticals April 1996 - October 1997
Leiras February 1994 - April 1996
U.S. Food and Drug Administration December 1988 - January 1994
Skills
Regulatory Affairs, FDA, Pharmaceutical Industry, Pharmacokinetics, Strategy, Product Development, Regulations, Regulatory Submissions, Clinical Development, Clinical Trials, Pharmacovigilance, Drug Development, GCP, eCTD, IND
Education
Medical University of South Carolina 1983 — 1989
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences (Pharmacokinetics)
University of South Carolina-Columbia
Bachelor of Science (BS), Biology, General
Teena Aiken's U.S. Food and Drug Administration Experience 1985 - Present
Job Investigator at US Food and Drug Administration
Industry Law Enforcement
Experience
The United States Food and Drug Administration 2007 - Present
US Food and Drug Administration 1985 - Present
FDA 1978 - 1985
Skills
FDA, Regulatory Affairs, GLP, GMP, Medical Devices, Validation, Quality Auditing, Clinical Trials, Sop, IND, Regulatory Requirements, Clinical Research, GCP, ISO 13485, Biologics, Pharmacovigilance, 21 CFR Part 11, Clinical Development, Protocol, Regulations, Biopharmaceuticals, Technology Transfer, Analytical Chemistry, Drug Development, Oncology, Change Control, CRO, SOP
Education
Lubbock Christian University 1972 — 1976
B.S., Biology
The United States Food and Drug Administration 2007 - Present
US Food and Drug Administration 1985 - Present
FDA 1978 - 1985
Skills
FDA, Regulatory Affairs, GLP, GMP, Medical Devices, Validation, Quality Auditing, Clinical Trials, Sop, IND, Regulatory Requirements, Clinical Research, GCP, ISO 13485, Biologics, Pharmacovigilance, 21 CFR Part 11, Clinical Development, Protocol, Regulations, Biopharmaceuticals, Technology Transfer, Analytical Chemistry, Drug Development, Oncology, Change Control, CRO, SOP
Education
Lubbock Christian University 1972 — 1976
B.S., Biology
Nathan Lacy's U.S. Food and Drug Administration Experience January 2010 - Present
Job Supervisory Chemist at Food and Drug Administration
Industry Chemicals
Experience
US Food and Drug Administration January 2010 - Present
UC Davis July 2008 - July 2009
State of Washington August 2004 - June 2008
Naval Academy Preparatory School January 2004 - August 2004
Battelle November 2001 - January 2004
US Navy October 2000 - October 2001
US Navy June 1978 - February 2000
Skills
Chemistry, UV/Vis, Environmental Science, Analytical Chemistry, HPLC, Analysis, LC-MS, Research, Organic Chemistry, Mass Spectrometry, Leadership, Policy, Training, Environmental Awareness, Laboratory, Management, Public Speaking, Strategic Planning, Team Building, Data Analysis, Program Management
Education
University of Washington 1987 — 1990
Doctor of Philosophy (PhD), Analytical Chemistry
The Johns Hopkins University 1984 — 1987
MSTM, Technical Management
Eastern Washington University 1975 — 1977
Master's degree, Analytical Chemistry
Eastern Washington University 1973 — 1975
Bachelor of Science (BS), Chemistry
US Food and Drug Administration January 2010 - Present
UC Davis July 2008 - July 2009
State of Washington August 2004 - June 2008
Naval Academy Preparatory School January 2004 - August 2004
Battelle November 2001 - January 2004
US Navy October 2000 - October 2001
US Navy June 1978 - February 2000
Skills
Chemistry, UV/Vis, Environmental Science, Analytical Chemistry, HPLC, Analysis, LC-MS, Research, Organic Chemistry, Mass Spectrometry, Leadership, Policy, Training, Environmental Awareness, Laboratory, Management, Public Speaking, Strategic Planning, Team Building, Data Analysis, Program Management
Education
University of Washington 1987 — 1990
Doctor of Philosophy (PhD), Analytical Chemistry
The Johns Hopkins University 1984 — 1987
MSTM, Technical Management
Eastern Washington University 1975 — 1977
Master's degree, Analytical Chemistry
Eastern Washington University 1973 — 1975
Bachelor of Science (BS), Chemistry
Shasta McClenahan's U.S. Food and Drug Administration Experience July 2008 - May 2014
Job Staff Fellow at FDA
Industry Research
Experience
FDA May 2014 - Present
US Food and Drug Administration July 2008 - May 2014
University of Florida August 2004 - August 2008
Auburn University 2003 - 2004
Skills
Virology, Molecular Biology, Microbiology, Marine Biology, DNA sequencing, Immunology, PCR, Cell Culture, Marine Mammals, Bioinformatics, Assay Development, Protein Expression, Protein Chemistry, Biochemistry, Western Blotting, ELISA, Protein Purification, Tissue Culture, qPCR, RT-PCR, Cell
Education
University of Florida 2004 — 2008
PhD, Virology, marine mammals, Veterinary Medicine
Auburn University 2003 — 2004
M.S., Virology, Fisheries
Auburn University 1999 — 2003
B.S., Marine Biology
Dauphin Island Sea Lab
FDA May 2014 - Present
US Food and Drug Administration July 2008 - May 2014
University of Florida August 2004 - August 2008
Auburn University 2003 - 2004
Skills
Virology, Molecular Biology, Microbiology, Marine Biology, DNA sequencing, Immunology, PCR, Cell Culture, Marine Mammals, Bioinformatics, Assay Development, Protein Expression, Protein Chemistry, Biochemistry, Western Blotting, ELISA, Protein Purification, Tissue Culture, qPCR, RT-PCR, Cell
Education
University of Florida 2004 — 2008
PhD, Virology, marine mammals, Veterinary Medicine
Auburn University 2003 — 2004
M.S., Virology, Fisheries
Auburn University 1999 — 2003
B.S., Marine Biology
Dauphin Island Sea Lab
Kenneth Bergmann's U.S. Food and Drug Administration Experience October 2008 - Present
Job Senior Medical Officer at the US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration October 2008 - Present
Medical University of South Carolina 2001 - 2008
Mecklenburg Neurological Associates 1990 - 2000
Long Island Jewish - Hillside Medical Center 1987 - 1990
Boehringer Ingelheim 1986 - 1987
The Mount Sinai Hospital and Mount Sinai School of Medicine, City University of NY 1982 - 1986
Mount Sinai School of Medicine of the City University of New York 1981 - 1982
Mount Sinai Hopsital 1978 - 1981
US Public Health Service 1977 - 1978
Union Memorial Hspital 1976 - 1977
Skills
Regulatory Science, Drug Development, Degenerative..., Neuroscience, Clinical Trials, Clinical Research, Medicine, Clinical Development, Clinical Pharmacology, Healthcare
Education
Stony Brook University 1973 — 1976
MD, Medicine
The Johns Hopkins University 1969 — 1973
Bachelor’s Degree, Psychology
US Food and Drug Administration October 2008 - Present
Medical University of South Carolina 2001 - 2008
Mecklenburg Neurological Associates 1990 - 2000
Long Island Jewish - Hillside Medical Center 1987 - 1990
Boehringer Ingelheim 1986 - 1987
The Mount Sinai Hospital and Mount Sinai School of Medicine, City University of NY 1982 - 1986
Mount Sinai School of Medicine of the City University of New York 1981 - 1982
Mount Sinai Hopsital 1978 - 1981
US Public Health Service 1977 - 1978
Union Memorial Hspital 1976 - 1977
Skills
Regulatory Science, Drug Development, Degenerative..., Neuroscience, Clinical Trials, Clinical Research, Medicine, Clinical Development, Clinical Pharmacology, Healthcare
Education
Stony Brook University 1973 — 1976
MD, Medicine
The Johns Hopkins University 1969 — 1973
Bachelor’s Degree, Psychology
Elizabeth Ruenitz's U.S. Food and Drug Administration Experience April 1987 - December 2012
Job Retired Chemist, Industrial Hygienist at US Food and Drug Administration
Industry Government Relations
Experience
US Food and Drug Administration April 1987 - December 2012
Skills
Emergency Management, Environmental Compliance, Technical Writing, Environmental..., Laboratory, Ergonomics, Regulatory Requirements, GMP, Auditing, Research, Training, Security Clearance, Regulations, Protein Chemistry, HAZWOPER, Regulatory Affairs, FDA, EPA, DoD, Environmental Science, Environmental Policy, Chemistry, Social Media, RCRA, Pharmaceutical Industry, Industrial Hygiene, Environmental Consulting, Government, Analysis, Analytical Chemistry, Program Management, Hazardous Waste..., Regulatory Analysis, Investigation, Environmental Health, Industrial Safety, Public Speaking, Water, Environmental Awareness, Hazardous Materials, Environmental Monitoring, Hazardous Materials..., EHS, Chemical Safety, Asbestos
Education
University of Tennessee-Knoxville 1983 — 1986
Post MS in Geology (Left to enter job Market)
The Ohio State University 1979 — 1981
MS, Geology
University of South Alabama 1975 — 1979
BS, Geology, Minor Statistics
Stetson University 1970 — 1974
BS, Chemistry, Minor Education
St. Petersburg High School
US Food and Drug Administration April 1987 - December 2012
Skills
Emergency Management, Environmental Compliance, Technical Writing, Environmental..., Laboratory, Ergonomics, Regulatory Requirements, GMP, Auditing, Research, Training, Security Clearance, Regulations, Protein Chemistry, HAZWOPER, Regulatory Affairs, FDA, EPA, DoD, Environmental Science, Environmental Policy, Chemistry, Social Media, RCRA, Pharmaceutical Industry, Industrial Hygiene, Environmental Consulting, Government, Analysis, Analytical Chemistry, Program Management, Hazardous Waste..., Regulatory Analysis, Investigation, Environmental Health, Industrial Safety, Public Speaking, Water, Environmental Awareness, Hazardous Materials, Environmental Monitoring, Hazardous Materials..., EHS, Chemical Safety, Asbestos
Education
University of Tennessee-Knoxville 1983 — 1986
Post MS in Geology (Left to enter job Market)
The Ohio State University 1979 — 1981
MS, Geology
University of South Alabama 1975 — 1979
BS, Geology, Minor Statistics
Stetson University 1970 — 1974
BS, Chemistry, Minor Education
St. Petersburg High School
Emir Galevi's U.S. Food and Drug Administration Experience Engineer / Consumer Safety OfficeUS Food and Drug AdministrationMarch 2014 - May 2014
Job Sr. Electronics Engineer / ElectroOptics at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration Engineer / Consumer Safety OfficeUS Food and Drug AdministrationMarch 2014 - May 2014
Skills
CAPA, Medical Devices, Quality Control, Regulatory Affairs, Regulatory Requirements, R&D, FDA, GMP, Quality Auditing, Root Cause Analysis, Design Control, Project Management, Biomedical Engineering, Regulatory Submissions, Validation
Education
Northeastern University 1991 — 1992
Certificate, Quality Assurance Technology
Northeastern University 1978 — 1982
BSEE, Electronics Engineering
Oregon Ohio
US Food and Drug Administration Engineer / Consumer Safety OfficeUS Food and Drug AdministrationMarch 2014 - May 2014
Skills
CAPA, Medical Devices, Quality Control, Regulatory Affairs, Regulatory Requirements, R&D, FDA, GMP, Quality Auditing, Root Cause Analysis, Design Control, Project Management, Biomedical Engineering, Regulatory Submissions, Validation
Education
Northeastern University 1991 — 1992
Certificate, Quality Assurance Technology
Northeastern University 1978 — 1982
BSEE, Electronics Engineering
Oregon Ohio
Dipali Davé, MD, MHA's U.S. Food and Drug Administration Experience August 2010 - July 2012
Job Investigator Initiated Research Program Manager at Pfizer
Industry Medical Practice
Experience
Pfizer June 2015 - Present
SUNY College Of Optometry October 2013 - May 2015
Icahn School of Medicine at Mount Sinai July 2013 - October 2013
Mount Sinai Medical Center July 2012 - June 2013
US Food and Drug Administration August 2010 - July 2012
Skills
Public Health, Clinical Research, Clinical Trials, Healthcare, Research, Grant Writing, Medical Research, Data Analysis, Medical Education, Medicine, Healthcare Management, Management, Medical Affairs, Drug Development, RT-PCR, Contract Negotiation, Budget Development, Strategic Planning, Medical Writing, Regulatory Affairs, Policy Development, Medical Devices, Protocol, Policy, Pharmaceutical Industry, Science, Project Management
Education
University of Central Florida 2012 — 2014
Master of Science (MS), Health/Health Care Administration/Management
American University of Antigua College of Medicine 2006 — 2010
MD, Medicine
East Carolina University 2002 — 2006
BS, Biochemistry
Pfizer June 2015 - Present
SUNY College Of Optometry October 2013 - May 2015
Icahn School of Medicine at Mount Sinai July 2013 - October 2013
Mount Sinai Medical Center July 2012 - June 2013
US Food and Drug Administration August 2010 - July 2012
Skills
Public Health, Clinical Research, Clinical Trials, Healthcare, Research, Grant Writing, Medical Research, Data Analysis, Medical Education, Medicine, Healthcare Management, Management, Medical Affairs, Drug Development, RT-PCR, Contract Negotiation, Budget Development, Strategic Planning, Medical Writing, Regulatory Affairs, Policy Development, Medical Devices, Protocol, Policy, Pharmaceutical Industry, Science, Project Management
Education
University of Central Florida 2012 — 2014
Master of Science (MS), Health/Health Care Administration/Management
American University of Antigua College of Medicine 2006 — 2010
MD, Medicine
East Carolina University 2002 — 2006
BS, Biochemistry
Frank Fucile, JD, RAC's U.S. Food and Drug Administration Experience 1972 - 1983
Job Senior Director Regulatory Affairs at STERIS Corporation
Industry Medical Devices
Experience
STERIS Corporation 2003 - Present
ACMI 2001 - 2003
Covidien 1998 - 2000
Sherwood Medical Div of Wyeth Labs (American Home Products Corp) 1995 - 1998
Sherwood Medical Div of Wyeth Labs (American Home Products Corp) 1983 - 1995
US Food and Drug Administration 1972 - 1983
Skills
FDA, Medical Devices, Quality System, ISO 13485, CAPA, GMP, Validation, Project Management, CE marking, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions
Education
Chicago-Kent College of Law, Illinois Institute of Technology 1979 — 1983
Juris Doctor, Law
STERIS Corporation 2003 - Present
ACMI 2001 - 2003
Covidien 1998 - 2000
Sherwood Medical Div of Wyeth Labs (American Home Products Corp) 1995 - 1998
Sherwood Medical Div of Wyeth Labs (American Home Products Corp) 1983 - 1995
US Food and Drug Administration 1972 - 1983
Skills
FDA, Medical Devices, Quality System, ISO 13485, CAPA, GMP, Validation, Project Management, CE marking, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions
Education
Chicago-Kent College of Law, Illinois Institute of Technology 1979 — 1983
Juris Doctor, Law
James Bertram's U.S. Food and Drug Administration Experience October 2009 - September 2010
Job CDRH Product Jurisdictional Officer at FDA
Industry Biotechnology
Experience
FDA July 2014 - Present
FDA April 2014 - June 2014
US Food and Drug Administration (FDA) October 2010 - March 2014
US Food and Drug Administration October 2009 - September 2010
Skills
Biomedical Engineering, FDA, Biomaterials, Cell Culture, Medical Devices, Lifesciences, Biotechnology, Microscopy, Regulatory Affairs, Molecular Biology, Fluorescence Microscopy, Nanotechnology, Biochemistry, Science, Regulatory Affairs...
Education
Yale University 2005 — 2009
Doctor of Philosophy (PhD), Biomedical Engineering
Yale University 2003 — 2005
Master of Science (MS), Biomedical Engineering
Penn State University 1999 — 2003
Bachelor's degree, Mechanical Engineering
FDA July 2014 - Present
FDA April 2014 - June 2014
US Food and Drug Administration (FDA) October 2010 - March 2014
US Food and Drug Administration October 2009 - September 2010
Skills
Biomedical Engineering, FDA, Biomaterials, Cell Culture, Medical Devices, Lifesciences, Biotechnology, Microscopy, Regulatory Affairs, Molecular Biology, Fluorescence Microscopy, Nanotechnology, Biochemistry, Science, Regulatory Affairs...
Education
Yale University 2005 — 2009
Doctor of Philosophy (PhD), Biomedical Engineering
Yale University 2003 — 2005
Master of Science (MS), Biomedical Engineering
Penn State University 1999 — 2003
Bachelor's degree, Mechanical Engineering
Anne Pilaro's U.S. Food and Drug Administration Experience 2007 - 2012
Job Supervisory Toxicologist at US FDA
Industry Pharmaceuticals
Experience
US Food and Drug Administration, Center for Biologics Evaluation and Research June 2012 - Present
Olney-Sandy Spring Veterinary Hospital 2007 - 2014
US Food and Drug Administration 2007 - 2012
FDA 1993 - 2007
Gene Logic, Inc. 2003 - 2003
National Cancer Institute 1989 - 1993
Skills
Toxicology, Pharmacology, Regulatory Affairs, FDA, Regulatory Submissions, Immunology, IND, Drug Discovery, GLP, Biotechnology, Oncology, Pharmaceuticals, Monoclonal Antibodies, Biopharmaceuticals, Hematology, Risk Assessment, Cell Culture, Biochemistry, Clinical Development, Pharmaceutics, Clinical Pharmacology, Clinical Trials
Education
Rutgers University-New Brunswick 1983 — 1987
Ph.D., Toxicology
Albany Medical College 1980 — 1983
Experimental Pathology and Toxicology
US Food and Drug Administration, Center for Biologics Evaluation and Research June 2012 - Present
Olney-Sandy Spring Veterinary Hospital 2007 - 2014
US Food and Drug Administration 2007 - 2012
FDA 1993 - 2007
Gene Logic, Inc. 2003 - 2003
National Cancer Institute 1989 - 1993
Skills
Toxicology, Pharmacology, Regulatory Affairs, FDA, Regulatory Submissions, Immunology, IND, Drug Discovery, GLP, Biotechnology, Oncology, Pharmaceuticals, Monoclonal Antibodies, Biopharmaceuticals, Hematology, Risk Assessment, Cell Culture, Biochemistry, Clinical Development, Pharmaceutics, Clinical Pharmacology, Clinical Trials
Education
Rutgers University-New Brunswick 1983 — 1987
Ph.D., Toxicology
Albany Medical College 1980 — 1983
Experimental Pathology and Toxicology
Arnie Joseph's U.S. Food and Drug Administration Experience May 2015 - Present
Job Co Chairman, Communications subcommittee at U.S. Department of Health and Human Services
Industry Health, Wellness and Fitness
Experience
US Food and Drug Administration May 2015 - Present
American Diabetes Association March 2014 - Present
U.S. Department of Health and Human Services; Regional Health Equity Council October 2013 - Present
Chroma Health Solutions 2010 - Present
InContext Health; JL Shapiro Associates 2007 - 2010
Cline, Davis, Mann 2005 - 2007
PPS International Communications 2003 - 2005
Pfizer 1985 - 2001
Skills
Healthcare, Pharmaceutical Industry, Diabetes, Leadership Development, Oncology, Managed Care, Leadership, Clinical Research, Strategy, Product Launch, Sandwiches, Medical Devices, Marketing Strategy, Healthcare Management, Cross-functional Team..., Medicine, Hospitals, Strategic Planning, Integrated Marketing, Management, Marketing, Program Management, Training, Medical Education, Pharmaceutical Sales, Public Speaking, Neurology, Infectious Diseases, Dermatology, Cardiology, Medical Writing
Education
SUNY Binghamton
Biology, biochemistry
Wilkes University
Biology
US Food and Drug Administration May 2015 - Present
American Diabetes Association March 2014 - Present
U.S. Department of Health and Human Services; Regional Health Equity Council October 2013 - Present
Chroma Health Solutions 2010 - Present
InContext Health; JL Shapiro Associates 2007 - 2010
Cline, Davis, Mann 2005 - 2007
PPS International Communications 2003 - 2005
Pfizer 1985 - 2001
Skills
Healthcare, Pharmaceutical Industry, Diabetes, Leadership Development, Oncology, Managed Care, Leadership, Clinical Research, Strategy, Product Launch, Sandwiches, Medical Devices, Marketing Strategy, Healthcare Management, Cross-functional Team..., Medicine, Hospitals, Strategic Planning, Integrated Marketing, Management, Marketing, Program Management, Training, Medical Education, Pharmaceutical Sales, Public Speaking, Neurology, Infectious Diseases, Dermatology, Cardiology, Medical Writing
Education
SUNY Binghamton
Biology, biochemistry
Wilkes University
Biology
Nancy Sharts-Hopko's U.S. Food and Drug Administration Experience 1999 - 2003
Job Professor / Director, PhD Program at Villanova University College of Nursing
Industry Higher Education
Experience
Sigma Theta Tau International November 2011 - Present
Villanova University College of Nursing 1986 - Present
Sigma Theta Tau International 2003 - 2007
US Food and Drug Administration 1999 - 2003
US Food and Drug Administration 1992 - 1995
U. S. Army Reserve Nurse Corps 1987 - 1995
St. Luke's College of Nursing 1984 - 1986
University of Delaware 1980 - 1984
World Health Organization - Southeast Asia Regional Office May 1983 - September 1983
Herbert H. Lehman College CUNY 1978 - 1980
Skills
Healthcare, Microsoft Office, Non-profits, Microsoft Word, Curriculum Development, Microsoft Excel, Editing, Curriculum Design, Student Affairs, Student Development, Fundraising, Program Evaluation, Social Media, Data Analysis, Leadership Development, Hospitals, Nonprofits, Clinical Research, Program Development, Nursing Education, Team Building
Education
New York University 1977 — 1983
MA and PhD, Nursing Education, Nursing Research
Indiana University-Purdue University at Indianapolis 1971 — 1976
BSN, Nursing
Sigma Theta Tau International November 2011 - Present
Villanova University College of Nursing 1986 - Present
Sigma Theta Tau International 2003 - 2007
US Food and Drug Administration 1999 - 2003
US Food and Drug Administration 1992 - 1995
U. S. Army Reserve Nurse Corps 1987 - 1995
St. Luke's College of Nursing 1984 - 1986
University of Delaware 1980 - 1984
World Health Organization - Southeast Asia Regional Office May 1983 - September 1983
Herbert H. Lehman College CUNY 1978 - 1980
Skills
Healthcare, Microsoft Office, Non-profits, Microsoft Word, Curriculum Development, Microsoft Excel, Editing, Curriculum Design, Student Affairs, Student Development, Fundraising, Program Evaluation, Social Media, Data Analysis, Leadership Development, Hospitals, Nonprofits, Clinical Research, Program Development, Nursing Education, Team Building
Education
New York University 1977 — 1983
MA and PhD, Nursing Education, Nursing Research
Indiana University-Purdue University at Indianapolis 1971 — 1976
BSN, Nursing
Ronnie Djoukeng's U.S. Food and Drug Administration Experience April 2009 - November 2012
Job National Security at U.S. Federal Emergency Managment Agency (FEMA)
Industry International Trade and Development
Experience
U.S. Federal Emergency Managment Agency (FEMA) December 2012 - Present
US Food and Drug Administration April 2009 - November 2012
Skills
Policy Analysis, Government, Research, Public Policy, Public Health, National Security, Emergency Management, Project Management, Project Coordination, Cross-functional Team..., Diplomacy
Education
University of Maryland College Park 2000 — 2005
Bachelor of Arts (B.A.), American Government and Politics (United States)
The George Washington University
Project Management
University of Maryland College Park
Bachelor of Arts (B.A.), Psychology
U.S. Federal Emergency Managment Agency (FEMA) December 2012 - Present
US Food and Drug Administration April 2009 - November 2012
Skills
Policy Analysis, Government, Research, Public Policy, Public Health, National Security, Emergency Management, Project Management, Project Coordination, Cross-functional Team..., Diplomacy
Education
University of Maryland College Park 2000 — 2005
Bachelor of Arts (B.A.), American Government and Politics (United States)
The George Washington University
Project Management
University of Maryland College Park
Bachelor of Arts (B.A.), Psychology
Angela Wise's U.S. Food and Drug Administration Experience May 2002 - October 2008
Job Quality Supervisor at Naturesweet Ltd
Industry Consumer Goods
Experience
Nestlé Purina North America October 2014 - Present
NatureSweet May 2009 - Present
US Food and Drug Administration May 2002 - October 2008
US Food and Drug Administration May 2002 - October 2008
Skills
Food Safety, FDA, Quality System, HACCP, Auditing, GMP, Quality Auditing, Food Microbiology, Quality Assurance, Process Improvement, Sop, CAPA, Regulatory Affairs, Validation, Food Science, GLP, Quality Management, Data Analysis, V&V, ISO 13485, Microsoft Office, Microsoft Excel, Microsoft Word, SQF
Education
Texas A&M University 1996 — 2001
DASC, Science Option
Nestlé Purina North America October 2014 - Present
NatureSweet May 2009 - Present
US Food and Drug Administration May 2002 - October 2008
US Food and Drug Administration May 2002 - October 2008
Skills
Food Safety, FDA, Quality System, HACCP, Auditing, GMP, Quality Auditing, Food Microbiology, Quality Assurance, Process Improvement, Sop, CAPA, Regulatory Affairs, Validation, Food Science, GLP, Quality Management, Data Analysis, V&V, ISO 13485, Microsoft Office, Microsoft Excel, Microsoft Word, SQF
Education
Texas A&M University 1996 — 2001
DASC, Science Option
Christy John's U.S. Food and Drug Administration Experience Associate Professor of Radiology and BiochemistryThe George Washington University Medical Center1989 - 2000
Job Senior Clinical Pharmacologist at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration Associate Professor of Radiology and BiochemistryThe George Washington University Medical Center1989 - 2000
The George Washington University Medical Center 1989 - 2000
Education
Indian Institute of Technology, Roorkee
MSc, Chemistry
University of Missouri-Saint Louis
Ph.D., Chemistry
US Food and Drug Administration Associate Professor of Radiology and BiochemistryThe George Washington University Medical Center1989 - 2000
The George Washington University Medical Center 1989 - 2000
Education
Indian Institute of Technology, Roorkee
MSc, Chemistry
University of Missouri-Saint Louis
Ph.D., Chemistry
Tamara (McCann) Thies's U.S. Food and Drug Administration Experience 2001 - 2003
Job Founder, SkyLand Policy Group, LLC
Industry Government Relations
Experience
SkyLand Policy Group, LLC June 2013 - Present
National Cattlemen's Beef Association September 2003 - May 2013
US Food and Drug Administration 2001 - 2003
Vorys, Sater, Seymour and Pease LLP 1993 - 1994
US Senator Max Baucus (MT) 1987 - 1992
Winthrop. Stimson, Putnam and Roberts 1985 - 1987
US Senator Max Baucus 1983 - 1985
Beverage Management Resource Group 1982 - 1983
Div. for the Blind and Physically Handicapped, Library of Congress 1980 - 1982
Skills
Government Relations, Non-profits, Public Speaking, Policy Analysis, Food, Environmental, Public Policy, Policy, Sustainability, Agriculture, Politics, Legislative Relations, Nonprofits, Government, Environmental Awareness, Environmental Policy, Renewable Energy, Business Strategy, Public Affairs, Coalitions, Grassroots Organizing, Community Development
Education
The Catholic University of America, Columbus School of Law 1986 — 1990
Juris Doctorate
The Catholic University of America 1978 — 1982
BA, Economics
SkyLand Policy Group, LLC June 2013 - Present
National Cattlemen's Beef Association September 2003 - May 2013
US Food and Drug Administration 2001 - 2003
Vorys, Sater, Seymour and Pease LLP 1993 - 1994
US Senator Max Baucus (MT) 1987 - 1992
Winthrop. Stimson, Putnam and Roberts 1985 - 1987
US Senator Max Baucus 1983 - 1985
Beverage Management Resource Group 1982 - 1983
Div. for the Blind and Physically Handicapped, Library of Congress 1980 - 1982
Skills
Government Relations, Non-profits, Public Speaking, Policy Analysis, Food, Environmental, Public Policy, Policy, Sustainability, Agriculture, Politics, Legislative Relations, Nonprofits, Government, Environmental Awareness, Environmental Policy, Renewable Energy, Business Strategy, Public Affairs, Coalitions, Grassroots Organizing, Community Development
Education
The Catholic University of America, Columbus School of Law 1986 — 1990
Juris Doctorate
The Catholic University of America 1978 — 1982
BA, Economics
Joe Jablonski's U.S. Food and Drug Administration Experience
Job Research Chemist at US Food and Drug Administration
Industry Food & Beverages
Experience
US Food and Drug Administration
Skills
HPLC, Chemistry, Analytical Chemistry, Mass Spectrometry, Food Microbiology, Gel Electrophoresis, Science, Chromatography, R&D, GLP, UV/Vis, Food Science, Lifesciences, ELISA, Gas Chromatography, Microbiology, Biochemistry, Drug Discovery, Experimentation, Biotechnology, LC-MS, Cell Culture, GMP, PCR, Laboratory
Education
Ohio University 1981 — 1986
Ph.D., Analytical Chemistry
University of Notre Dame 1970 — 1974
Bachelor of Science (BS), Biology, General
Charles F Brush High School 1967 — 1970
High School Diploma, Sicence
US Food and Drug Administration
Skills
HPLC, Chemistry, Analytical Chemistry, Mass Spectrometry, Food Microbiology, Gel Electrophoresis, Science, Chromatography, R&D, GLP, UV/Vis, Food Science, Lifesciences, ELISA, Gas Chromatography, Microbiology, Biochemistry, Drug Discovery, Experimentation, Biotechnology, LC-MS, Cell Culture, GMP, PCR, Laboratory
Education
Ohio University 1981 — 1986
Ph.D., Analytical Chemistry
University of Notre Dame 1970 — 1974
Bachelor of Science (BS), Biology, General
Charles F Brush High School 1967 — 1970
High School Diploma, Sicence
Santanu Biswas's U.S. Food and Drug Administration Experience December 2012 - Present
Job ORISE Fellow at US Food and Drug Administration
Industry Biotechnology
Experience
US Food and Drug Administration December 2012 - Present
Bose Institute, India January 2012 - December 2012
Bose Institute, India June 2005 - December 2011
North Bengal University January 2001 - January 2003
Skills
Molecular Biology, RT-PCR, Genomics, PCR, Genetics, qPCR, Western Blotting, DNA, Tissue Culture, Bioinformatics, Cell Biology, Sequencing, Lifesciences, Molecular Cloning
Education
Jadavpur University 2005 — 2011
Doctor of Philosophy (Ph.D.), Life Sc. & Biotechnology
University of North Bengal 2001 — 2003
Master of Science (M.Sc.), Biotechnology, 66.70%
Vidyasagar University 1997 — 2000
Bachelor of Science (B.Sc.), Chemistry, Zoology, Industrial Fish & Fishery, 62.88%
US Food and Drug Administration December 2012 - Present
Bose Institute, India January 2012 - December 2012
Bose Institute, India June 2005 - December 2011
North Bengal University January 2001 - January 2003
Skills
Molecular Biology, RT-PCR, Genomics, PCR, Genetics, qPCR, Western Blotting, DNA, Tissue Culture, Bioinformatics, Cell Biology, Sequencing, Lifesciences, Molecular Cloning
Education
Jadavpur University 2005 — 2011
Doctor of Philosophy (Ph.D.), Life Sc. & Biotechnology
University of North Bengal 2001 — 2003
Master of Science (M.Sc.), Biotechnology, 66.70%
Vidyasagar University 1997 — 2000
Bachelor of Science (B.Sc.), Chemistry, Zoology, Industrial Fish & Fishery, 62.88%
Victor Montgomery, Ed.D.'s U.S. Food and Drug Administration Experience April 2013 - July 2015
Job Training Specialist at the Bureau of Engraving and Printing, U.S. Department of the Treasury
Industry Government Administration
Experience
Bureau of Engraving and Printing July 2015 - Present
US Food and Drug Administration April 2013 - July 2015
National Park Service January 2013 - April 2013
USPS Office of Inspector General March 2012 - January 2013
Joint Chiefs of Staff May 2010 - March 2012
National Institutes of Health February 2009 - May 2010
United States Marine Corps June 1987 - July 1990
Skills
Policy, Policy Analysis, International..., Community Outreach, Public Sector, Program Management, Public Policy, Capacity Building, Organizational..., Community Development, Command, Leadership, Leadership Development, Proposal Writing, Research, Teaching, Training
Education
Liberty University 2014 — 2015
Executive Leadership Certificate, Organizational Leadership
Liberty University 2008 — 2010
Doctor of Education (Ed.D.), Educational Leadership and Administration, General
Western Kentucky University 2004 — 2006
Rank 1 Ed.S., Educational Leadership and Administration, General
Bellarmine University 2000 — 2002
Master of Arts in Teaching, Elementary Education and Teaching
Morehouse College 1990 — 1994
Bachelor of Arts (B.A.), Marketing
East Carolina University
East Carolina University
Bureau of Engraving and Printing July 2015 - Present
US Food and Drug Administration April 2013 - July 2015
National Park Service January 2013 - April 2013
USPS Office of Inspector General March 2012 - January 2013
Joint Chiefs of Staff May 2010 - March 2012
National Institutes of Health February 2009 - May 2010
United States Marine Corps June 1987 - July 1990
Skills
Policy, Policy Analysis, International..., Community Outreach, Public Sector, Program Management, Public Policy, Capacity Building, Organizational..., Community Development, Command, Leadership, Leadership Development, Proposal Writing, Research, Teaching, Training
Education
Liberty University 2014 — 2015
Executive Leadership Certificate, Organizational Leadership
Liberty University 2008 — 2010
Doctor of Education (Ed.D.), Educational Leadership and Administration, General
Western Kentucky University 2004 — 2006
Rank 1 Ed.S., Educational Leadership and Administration, General
Bellarmine University 2000 — 2002
Master of Arts in Teaching, Elementary Education and Teaching
Morehouse College 1990 — 1994
Bachelor of Arts (B.A.), Marketing
East Carolina University
East Carolina University
Aparna Mohan's U.S. Food and Drug Administration Experience October 2001 - May 2004
Job Senior Director, Medical Surveillance and Pharmacovigilance at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals May 2012 - Present
Ikaria December 2010 - April 2012
Johnson & Johnson November 2007 - December 2010
Johnson & Johnson June 2004 - October 2007
US Food and Drug Administration October 2001 - May 2004
National Cancer Institute, August 1998 - September 2001
Johns Hopkins University School of Public Health June 1996 - July 1998
Skills
Pharmacoepidemiology, Pharmacovigilance, Epidemiology, drug safety, medical device safety, safety surveillance, Risk Management, Safety
Education
The Johns Hopkins University 1996 — 2001
Ph.D, Epidemiology
University of South Carolina-Columbia 1994 — 1996
MSPH, Occupational Health
University of Kerala
MBBS, Medicine
Shire Pharmaceuticals May 2012 - Present
Ikaria December 2010 - April 2012
Johnson & Johnson November 2007 - December 2010
Johnson & Johnson June 2004 - October 2007
US Food and Drug Administration October 2001 - May 2004
National Cancer Institute, August 1998 - September 2001
Johns Hopkins University School of Public Health June 1996 - July 1998
Skills
Pharmacoepidemiology, Pharmacovigilance, Epidemiology, drug safety, medical device safety, safety surveillance, Risk Management, Safety
Education
The Johns Hopkins University 1996 — 2001
Ph.D, Epidemiology
University of South Carolina-Columbia 1994 — 1996
MSPH, Occupational Health
University of Kerala
MBBS, Medicine
Betsy Taylor's U.S. Food and Drug Administration Experience September 2004 - December 2004
Job Medical Writer at Envision Pharma Group
Industry Writing and Editing
Experience
Envision Pharma Group Senior Medical WriterAegis CreativeMay 2014 - July 2015
Aegis Creative May 2012 - May 2014
American Journal Experts September 2010 - February 2012
University of Pennsylvania School of Medicine September 2005 - December 2009
Colorado State University May 2002 - July 2005
US Food and Drug Administration September 2004 - December 2004
Skills
Immunology, Medical Writing, Editing, Scientific Writing, Research, Microbiology, Cell Biology, Copy Editing, Grant Writing, Organization, Grants, Experimental Design, Science, Tissue Culture, Cell Culture, Biochemistry, Molecular Biology
Education
University of Pennsylvania 2005 — 2009
PhD, Immunology
Colorado State University 2001 — 2005
BS, Microbiology
Envision Pharma Group Senior Medical WriterAegis CreativeMay 2014 - July 2015
Aegis Creative May 2012 - May 2014
American Journal Experts September 2010 - February 2012
University of Pennsylvania School of Medicine September 2005 - December 2009
Colorado State University May 2002 - July 2005
US Food and Drug Administration September 2004 - December 2004
Skills
Immunology, Medical Writing, Editing, Scientific Writing, Research, Microbiology, Cell Biology, Copy Editing, Grant Writing, Organization, Grants, Experimental Design, Science, Tissue Culture, Cell Culture, Biochemistry, Molecular Biology
Education
University of Pennsylvania 2005 — 2009
PhD, Immunology
Colorado State University 2001 — 2005
BS, Microbiology
LaRee Tracy, MA, PhD's U.S. Food and Drug Administration Experience July 2014 - Present
Job Senior Mathematical Statistician at US Food and Drug Administration
Industry Research
Experience
US Food and Drug Administration July 2014 - Present
San Diego State University August 2013 - Present
CDC 2015 - 2015
TRICARE Management Activity January 2013 - July 2014
FDA August 2009 - January 2013
FDA October 2002 - August 2009
Walter Reed Army Institute of Research January 2000 - October 2002
US Army October 1998 - October 2002
Baxter Healthcare January 1997 - October 1998
Skills
Biostatistics, Epidemiology, S-Plus, SAS, Outcomes Research, R, Public Health, Statistical Modeling, Stata, Statistics, SAS programming, Multivariate Statistics
Education
University of Maryland Baltimore 2006 — 2010
PhD, Epidemiology
University of Maryland College Park 2000 — 2002
MA, Mathematical Statistics
Creighton University 1992 — 1996
BS, Mathematics
US Food and Drug Administration July 2014 - Present
San Diego State University August 2013 - Present
CDC 2015 - 2015
TRICARE Management Activity January 2013 - July 2014
FDA August 2009 - January 2013
FDA October 2002 - August 2009
Walter Reed Army Institute of Research January 2000 - October 2002
US Army October 1998 - October 2002
Baxter Healthcare January 1997 - October 1998
Skills
Biostatistics, Epidemiology, S-Plus, SAS, Outcomes Research, R, Public Health, Statistical Modeling, Stata, Statistics, SAS programming, Multivariate Statistics
Education
University of Maryland Baltimore 2006 — 2010
PhD, Epidemiology
University of Maryland College Park 2000 — 2002
MA, Mathematical Statistics
Creighton University 1992 — 1996
BS, Mathematics
Chao Liu's U.S. Food and Drug Administration Experience September 2015 - Present
Job Pharmacometrics Reviewer at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration September 2015 - Present
US Food and Drug Administration September 2014 - September 2015
University of Florida August 2008 - August 2014
University of Florida August 2012 - May 2014
People's Republic of China Tianjin entry-exit inspection and Quarantine Bureau June 2007 - September 2007
Skills
Immunology, Statistics, R, Genetics, SAS, Bioinformatics, Biomarkers, Pharmacokinetics, Pharmacodynamics, Survival Analysis, NONMEM, Oncology, Pharmacometrics, FDA, Clinical Pharmacology, Biomedical Sciences, Flow Cytometry
Education
University of Florida 2008 — 2014
Doctor of Philosophy (PhD), Immunology
University of Florida 2012 — 2014
Master of Science (MS), Statistics
Nankai University 2004 — 2008
Bachelor's degree, Biology/Biological Sciences, General
Tianjin No.1 High School
US Food and Drug Administration September 2015 - Present
US Food and Drug Administration September 2014 - September 2015
University of Florida August 2008 - August 2014
University of Florida August 2012 - May 2014
People's Republic of China Tianjin entry-exit inspection and Quarantine Bureau June 2007 - September 2007
Skills
Immunology, Statistics, R, Genetics, SAS, Bioinformatics, Biomarkers, Pharmacokinetics, Pharmacodynamics, Survival Analysis, NONMEM, Oncology, Pharmacometrics, FDA, Clinical Pharmacology, Biomedical Sciences, Flow Cytometry
Education
University of Florida 2008 — 2014
Doctor of Philosophy (PhD), Immunology
University of Florida 2012 — 2014
Master of Science (MS), Statistics
Nankai University 2004 — 2008
Bachelor's degree, Biology/Biological Sciences, General
Tianjin No.1 High School
Carolyn Hommel's U.S. Food and Drug Administration Experience December 1980 - July 2010
Job GCP Compliance Specialist
Industry Pharmaceuticals
Experience
Carolyn Hommel, GCP Compliance Specialist October 2010 - Present
. July 2010 - Present
US Food and Drug Administration December 1980 - July 2010
Skills
Clinical Trials, FDA, Health Policy, GCP, Regulatory Affairs, Clinical Research, Regulatory Requirements, Pharmaceutical Industry, 21 CFR Part 11, Clinical Development, Regulations, Public Health, Epidemiology, Life Sciences, Research, IRB, Regulatory Submissions, Policy
Education
Fordham University 1975 — 1978
M.A., American History
Concordia Teachers College, Seward, NE 1969 — 1973
BS, Education (Early Childhood)
Carolyn Hommel, GCP Compliance Specialist October 2010 - Present
. July 2010 - Present
US Food and Drug Administration December 1980 - July 2010
Skills
Clinical Trials, FDA, Health Policy, GCP, Regulatory Affairs, Clinical Research, Regulatory Requirements, Pharmaceutical Industry, 21 CFR Part 11, Clinical Development, Regulations, Public Health, Epidemiology, Life Sciences, Research, IRB, Regulatory Submissions, Policy
Education
Fordham University 1975 — 1978
M.A., American History
Concordia Teachers College, Seward, NE 1969 — 1973
BS, Education (Early Childhood)
Amy Babb's U.S. Food and Drug Administration Experience March 2011 - Present
Job Technical Writer/Editor at United States Food and Drug Administration
Industry
Experience
US FDA November 2012 - Present
US Food and Drug Administration March 2011 - Present
Toxicologic Pathology Associates March 2010 - March 2011
Charles River Laboratories August 1993 - December 2009
Skills
Toxicology, In Vivo, FDA, Lifesciences, Biotechnology, GLP, Pharmacology, Sop, Pharmaceutical Industry, IND, Regulatory Submissions, Regulatory Affairs, Animal Models, CRO, Life Sciences
Education
Arkansas State University 1989 — 1993
B.S., Zoology
US FDA November 2012 - Present
US Food and Drug Administration March 2011 - Present
Toxicologic Pathology Associates March 2010 - March 2011
Charles River Laboratories August 1993 - December 2009
Skills
Toxicology, In Vivo, FDA, Lifesciences, Biotechnology, GLP, Pharmacology, Sop, Pharmaceutical Industry, IND, Regulatory Submissions, Regulatory Affairs, Animal Models, CRO, Life Sciences
Education
Arkansas State University 1989 — 1993
B.S., Zoology
Jan Gardner's U.S. Food and Drug Administration Experience February 1999 - September 2010
Job President Food Safe Pacific LLC
Industry Food Production
Experience
Food Safe Pacific LLC September 2010 - Present
US Food and Drug Administration February 1999 - September 2010
Wisconsin Department of Health and Human Services August 1990 - February 1999
Skills
Food Safety, Team Building, Leadership, Product Development, Quality System, HACCP, Training, Food, Quality Management, Food Industry, GMP, Strategic Planning, Food Processing, Project Management, Quality Auditing, Management, Microsoft Office, Food Science, Quality Assurance, New Business Development, Food Technology, Coaching
Education
Moraine Park Technical College
Food Science Technology
Upper Iowa University
Business Management
Food Safe Pacific LLC September 2010 - Present
US Food and Drug Administration February 1999 - September 2010
Wisconsin Department of Health and Human Services August 1990 - February 1999
Skills
Food Safety, Team Building, Leadership, Product Development, Quality System, HACCP, Training, Food, Quality Management, Food Industry, GMP, Strategic Planning, Food Processing, Project Management, Quality Auditing, Management, Microsoft Office, Food Science, Quality Assurance, New Business Development, Food Technology, Coaching
Education
Moraine Park Technical College
Food Science Technology
Upper Iowa University
Business Management
John Reves's U.S. Food and Drug Administration Experience May 1976 - March 1999
Job Compliance Officer/Consultant
Industry Consumer Goods
Experience
self employed part-time March 1999 - Present
U.S Food and Drug Administration May 1976 - March 1999
FDA 1976 - 1991
Education
California State University-East Bay 1971 — 1976
MA, American Lit.
California State University-Sacramento 1970 — 1976
BA, U.S. History
self employed part-time March 1999 - Present
U.S Food and Drug Administration May 1976 - March 1999
FDA 1976 - 1991
Education
California State University-East Bay 1971 — 1976
MA, American Lit.
California State University-Sacramento 1970 — 1976
BA, U.S. History
William Burkhardt's U.S. Food and Drug Administration Experience November 2014 - Present
Job Director, Division of Seafood Science and Technology at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration November 2014 - Present
U.S. Food and Drug Administration/ U.S Public Health Service January 1997 - Present
Skills
Virology, Water Pollution..., Seafood Safety, Microbiology, Government, Regulatory Affairs, Lifesciences, FDA, Vaccines, GLP, Cell Culture, Infectious Diseases, Biotechnology, ELISA, Immunology
Education
University of Rhode Island 1985 — 1991
Ph.D., Microbiology, General
U.S. Food and Drug Administration November 2014 - Present
U.S. Food and Drug Administration/ U.S Public Health Service January 1997 - Present
Skills
Virology, Water Pollution..., Seafood Safety, Microbiology, Government, Regulatory Affairs, Lifesciences, FDA, Vaccines, GLP, Cell Culture, Infectious Diseases, Biotechnology, ELISA, Immunology
Education
University of Rhode Island 1985 — 1991
Ph.D., Microbiology, General
Zi-Qiang Gu's U.S. Food and Drug Administration Experience 2005 - 2011
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
US Food and Drug Administration 2005 - 2011
US Food and Drug Administration May 1998 - May 2005
Skills
Drug Discovery, FDA, Pharmaceutics, Chemistry, Drug Development, Regulatory Affairs, Laboratory, Regulatory Submissions, Sop, GLP, Validation, HPLC
Education
National Institute of Health 1990 — 1992
Post-doctoral Fellow, Medicinal Science and Nueroscience
Rutgers University 1985 — 1990
Doctor of Philosophy (Ph.D.), Oraginc Synthesis and Medicinal Chemistry
US Food and Drug Administration 2005 - 2011
US Food and Drug Administration May 1998 - May 2005
Skills
Drug Discovery, FDA, Pharmaceutics, Chemistry, Drug Development, Regulatory Affairs, Laboratory, Regulatory Submissions, Sop, GLP, Validation, HPLC
Education
National Institute of Health 1990 — 1992
Post-doctoral Fellow, Medicinal Science and Nueroscience
Rutgers University 1985 — 1990
Doctor of Philosophy (Ph.D.), Oraginc Synthesis and Medicinal Chemistry
Richard` Anderson's U.S. Food and Drug Administration Experience June 1988 - September 2007
Job Site Security Supervisor(Mgr.) at Housing Development Fund Corporation
Industry Security and Investigations
Experience
Housing Development Fund Corporation June 2001 - Present
FDA June 1988 - September 2007
U.S Food and Drug Administration June 1988 - September 2007
U.S. Air Force March Air March 1984 - March 1988
Skills
Microsoft Office 2010, Computer Repair, Microsoft Access, Training, Management, Human Resources, Employee Relations, Access, Security, Coaching, Auditing, Interviews, Healthcare, Private Investigations, Process Scheduler, Surveillance, Risk Management, Team Building, Policy, Research, Government, Public Speaking, Microsoft Excel, Investigation
Education
Lincoln University 1979 — 1983
BS, Political Science/Pre-Law
Housing Development Fund Corporation June 2001 - Present
FDA June 1988 - September 2007
U.S Food and Drug Administration June 1988 - September 2007
U.S. Air Force March Air March 1984 - March 1988
Skills
Microsoft Office 2010, Computer Repair, Microsoft Access, Training, Management, Human Resources, Employee Relations, Access, Security, Coaching, Auditing, Interviews, Healthcare, Private Investigations, Process Scheduler, Surveillance, Risk Management, Team Building, Policy, Research, Government, Public Speaking, Microsoft Excel, Investigation
Education
Lincoln University 1979 — 1983
BS, Political Science/Pre-Law
Trean Blumenthal's U.S. Food and Drug Administration Experience 1962 - 1975
Job Executive Vice President at Libra Laboratories, Inc.
Industry Research
Experience
Libra Laboratories, Inc. January 1985 - Present
Schering-Plough Corporation June 1981 - January 1985
Schering-Plough Corporation April 1978 - June 1981
U.S. Food and Drug Administration 1962 - 1975
Skills
FDA, R&D, Quality Assurance, Team Leadership, Public Speaking, Pharmaceutical Industry, Laboratory, Lifesciences, Analytical Chemistry, Regulatory Affairs, Leadership, Chemistry, Drug Development, Organic Chemistry, Validation, Strategic Planning, Science, Product Development, Project Management, Ethics, Research, Analysis, SOP development, Technology Transfer, Biotechnology, Pharmaceutics, Biopharmaceuticals, GLP, Drug Delivery, Staff Development, Interviewing Skills, Perseverance, Life Sciences, High Quality Standards, Management, Change Management, Food safety, Food Quality, Ingenuity, International Quality...
Education
University of Pennsylvania 1957 — 1961
B.A., Chemistry and Liberal Arts, Chemistry Major plus full liberal arts education
St. Joseph's University, Philadelphia, PA 1963 — 1967
M.S., Chemistry with Dissertation, Chemistry
Rutgers University, New Brunswick, NJ
post-M.S. graduate studies, Chemistry and Statistics
Libra Laboratories, Inc. January 1985 - Present
Schering-Plough Corporation June 1981 - January 1985
Schering-Plough Corporation April 1978 - June 1981
U.S. Food and Drug Administration 1962 - 1975
Skills
FDA, R&D, Quality Assurance, Team Leadership, Public Speaking, Pharmaceutical Industry, Laboratory, Lifesciences, Analytical Chemistry, Regulatory Affairs, Leadership, Chemistry, Drug Development, Organic Chemistry, Validation, Strategic Planning, Science, Product Development, Project Management, Ethics, Research, Analysis, SOP development, Technology Transfer, Biotechnology, Pharmaceutics, Biopharmaceuticals, GLP, Drug Delivery, Staff Development, Interviewing Skills, Perseverance, Life Sciences, High Quality Standards, Management, Change Management, Food safety, Food Quality, Ingenuity, International Quality...
Education
University of Pennsylvania 1957 — 1961
B.A., Chemistry and Liberal Arts, Chemistry Major plus full liberal arts education
St. Joseph's University, Philadelphia, PA 1963 — 1967
M.S., Chemistry with Dissertation, Chemistry
Rutgers University, New Brunswick, NJ
post-M.S. graduate studies, Chemistry and Statistics
Thomas A. Peter's U.S. Food and Drug Administration Experience June 2015 - Present
Job Medical Device Specialist at U.S. Food and Drug Administration
Industry Medical Devices
Experience
U.S. Food and Drug Administration June 2015 - Present
U.S. Food and Drug Administration January 2015 - June 2015
U.S. Food and Drug Administration September 2010 - January 2015
Education
University of Michigan 2009 — 2010
Master of Science in Engineering, Biomedical Engineering
University of Michigan 2005 — 2009
Bachelor of Science in Engineering, Biomedical Engineering
U.S. Food and Drug Administration June 2015 - Present
U.S. Food and Drug Administration January 2015 - June 2015
U.S. Food and Drug Administration September 2010 - January 2015
Education
University of Michigan 2009 — 2010
Master of Science in Engineering, Biomedical Engineering
University of Michigan 2005 — 2009
Bachelor of Science in Engineering, Biomedical Engineering
William Bassett Jr's U.S. Food and Drug Administration Experience August 1990 - December 2014
Job Retired Investigator for US Food and Drug Administration (24 + years of service)
Industry
Experience
US Food and Drug Administration August 1990 - December 2014
West Virginia Bureau of Public Health August 1988 - August 1990
Wyoming County Health Department 1977 - 1988
Skills
Policy, Government, Policy Analysis, Community Outreach, Program Management, Law Enforcement, Research, Public Speaking
Education
West Virginia Graduate College (now Marshall University) 1994 — 1996
Master's Degree, Environmental Studies
University of North Carolina at Chapel Hill 1975 — 1977
Bachelor's Degree, Human Biology
Charlotte Piedmont Community College 1973 — 1974
Human Biology
Florida State University 1971 — 1972
Music Performance, General
US Food and Drug Administration August 1990 - December 2014
West Virginia Bureau of Public Health August 1988 - August 1990
Wyoming County Health Department 1977 - 1988
Skills
Policy, Government, Policy Analysis, Community Outreach, Program Management, Law Enforcement, Research, Public Speaking
Education
West Virginia Graduate College (now Marshall University) 1994 — 1996
Master's Degree, Environmental Studies
University of North Carolina at Chapel Hill 1975 — 1977
Bachelor's Degree, Human Biology
Charlotte Piedmont Community College 1973 — 1974
Human Biology
Florida State University 1971 — 1972
Music Performance, General
Bryan Coleman's U.S. Food and Drug Administration Experience February 1992 - May 1997
Job Senior Manager Quality and Compliance
Industry Military
Experience
Altria Client Services December 2010 - Present
Virginia Army National Guard May 1990 - Present
Pfizer (formerly Wyeth Consumer Healthcare) May 1997 - November 2010
US Food and Drug Administration February 1992 - May 1997
Skills
FDA
Education
Syracuse University 1986 — 1990
Bachelor of Arts (B.A.), Chemistry / History
Altria Client Services December 2010 - Present
Virginia Army National Guard May 1990 - Present
Pfizer (formerly Wyeth Consumer Healthcare) May 1997 - November 2010
US Food and Drug Administration February 1992 - May 1997
Skills
FDA
Education
Syracuse University 1986 — 1990
Bachelor of Arts (B.A.), Chemistry / History
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