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
Jennifer Stevens Jennifer Stevens's U.S. Food and Drug Administration Experience July 2008 - December 2012
Job Head (Americas), Global Regulatory & Scientific Policy; US Lead, Global Regulatory Affairs
Industry Pharmaceuticals
Experience
EMD Serono R&D Institute, Inc. January 2013 - Present
U.S. Food and Drug Administration July 2008 - December 2012
Jennifer L. Stevens, Attorney at Law 2001 - 2008
Kirkland & Ellis LLP 1995 - 2000
Willkie Farr & Gallagher LLP 1990 - 1995
Skills
FDA, Strategy, Program Management, Drug Development, Litigation, Strategic Planning, Policy, Pharmaceutical Industry, Regulatory Requirements, Regulatory strategy, Regulatory diligence, Due diligence, Biopharmaceuticals, Regulatory Affairs, Leadership
Education
The George Washington University Law School
Juris Doctor, Cum Laude, Law
University of Illinois at Urbana-Champaign
Bachelor of Arts (B.A.), Cum Laude
EMD Serono R&D Institute, Inc. January 2013 - Present
U.S. Food and Drug Administration July 2008 - December 2012
Jennifer L. Stevens, Attorney at Law 2001 - 2008
Kirkland & Ellis LLP 1995 - 2000
Willkie Farr & Gallagher LLP 1990 - 1995
Skills
FDA, Strategy, Program Management, Drug Development, Litigation, Strategic Planning, Policy, Pharmaceutical Industry, Regulatory Requirements, Regulatory strategy, Regulatory diligence, Due diligence, Biopharmaceuticals, Regulatory Affairs, Leadership
Education
The George Washington University Law School
Juris Doctor, Cum Laude, Law
University of Illinois at Urbana-Champaign
Bachelor of Arts (B.A.), Cum Laude
Daniel Kassiday Daniel Kassiday's U.S. Food and Drug Administration Experience March 1990 - Present
Job Radiation Safety Engineer at U.S. Food and Drug Administration
Industry Public Safety
Experience
U.S. Food and Drug Administration March 1990 - Present
Skills
Nuclear Engineering, Nuclear, Systems Engineering, Engineering Management, Engineering, Project Management, Radiation Safety, Military, DoD, Radiation, Security Clearance, Technical Writing, Physics, Health Physics
Education
University of Illinois at Urbana-Champaign 1984 — 1988
Bachelor of Science (B.S.), Nuclear Engineering
U.S. Food and Drug Administration March 1990 - Present
Skills
Nuclear Engineering, Nuclear, Systems Engineering, Engineering Management, Engineering, Project Management, Radiation Safety, Military, DoD, Radiation, Security Clearance, Technical Writing, Physics, Health Physics
Education
University of Illinois at Urbana-Champaign 1984 — 1988
Bachelor of Science (B.S.), Nuclear Engineering
Keeshan Williams, Ph.D Keeshan Williams, Ph.D's U.S. Food and Drug Administration Experience January 2014 - Present
Job Scientist at U.S. Food and Drug Administration
Industry Nanotechnology
Experience
U.S. Food and Drug Administration January 2014 - Present
LaGuardia Community College March 2013 - Present
Polytechnic Institute of New York University January 2013 - March 2013
Polytechnic Institute of New York University September 2008 - January 2013
National Science Foundation September 2008 - September 2010
Port Authority of NY & NJ June 2007 - July 2008
Independent Testing Laboratories June 2005 - September 2006
Skills
Chemical Engineering, Affinity Chromatography, Ion Chromatography, Matlab, Biotechnology, Electrochemistry, Mathematical Modeling, UV/Vis, Biosensors, Genetic Testing, HPLC, Hardware Diagnostics, Protein Chemistry, Organic Chemistry, Diagnostics, DNA analysis, Protein-DNA interactions, Bacterial Culture, Bacterial Transformation, Cell Culture, Microsoft Office, Protein Purification, Purification, Conjugation, Cyclic Voltammetry, Alternating Current..., Nucleic Acid, Scale Up, FPLC
Education
The Polytechnic Institute of New York University 2008 — 2013
Doctor of Philosophy (PhD), Chemical and Biomolecular Engineering
Polytechnic University 2006 — 2008
MS, Chemical and Biological Engineering
Queens College 2000 — 2005
BS, Chemistry
U.S. Food and Drug Administration January 2014 - Present
LaGuardia Community College March 2013 - Present
Polytechnic Institute of New York University January 2013 - March 2013
Polytechnic Institute of New York University September 2008 - January 2013
National Science Foundation September 2008 - September 2010
Port Authority of NY & NJ June 2007 - July 2008
Independent Testing Laboratories June 2005 - September 2006
Skills
Chemical Engineering, Affinity Chromatography, Ion Chromatography, Matlab, Biotechnology, Electrochemistry, Mathematical Modeling, UV/Vis, Biosensors, Genetic Testing, HPLC, Hardware Diagnostics, Protein Chemistry, Organic Chemistry, Diagnostics, DNA analysis, Protein-DNA interactions, Bacterial Culture, Bacterial Transformation, Cell Culture, Microsoft Office, Protein Purification, Purification, Conjugation, Cyclic Voltammetry, Alternating Current..., Nucleic Acid, Scale Up, FPLC
Education
The Polytechnic Institute of New York University 2008 — 2013
Doctor of Philosophy (PhD), Chemical and Biomolecular Engineering
Polytechnic University 2006 — 2008
MS, Chemical and Biological Engineering
Queens College 2000 — 2005
BS, Chemistry
Melody Lyee Melody Lyee's U.S. Food and Drug Administration Experience June 2012 - March 2015
Job Data Analyst at EY
Industry Accounting
Experience
EY March 2015 - Present
QQ Spa March 2014 - June 2015
U.S. Food and Drug Administration June 2012 - March 2015
American Chinese School November 2012 - June 2013
U.S. Food and Drug Administration May 2009 - June 2012
CashCall March 2012 - May 2012
Consumer Action, San Francisco June 2006 - August 2007
Skills
Statistical Reporting, Oracle SQL, Quality Auditing, Control Charts, Microsoft Excel, Databases, Staff Development, Data Analysis, SPSS, Visio, Access, Program Management, Outlook, Business Analysis, Microsoft Office, SAS, SQL, Statistical Modeling, Research, R, Data Mining, Analytics, Analysis, Predictive Modeling, Minitab, Technical Writing, Predictive Analytics, Management, Training, PowerPoint, Quantitative Analytics, Linear Regression, SAS programming
Education
Northwestern University 2012 — 2014
Master of Science (M.S.), Predictive Analytics
University of California, Irvine 2007 — 2011
B.S., Mathematics, Statistics
EY March 2015 - Present
QQ Spa March 2014 - June 2015
U.S. Food and Drug Administration June 2012 - March 2015
American Chinese School November 2012 - June 2013
U.S. Food and Drug Administration May 2009 - June 2012
CashCall March 2012 - May 2012
Consumer Action, San Francisco June 2006 - August 2007
Skills
Statistical Reporting, Oracle SQL, Quality Auditing, Control Charts, Microsoft Excel, Databases, Staff Development, Data Analysis, SPSS, Visio, Access, Program Management, Outlook, Business Analysis, Microsoft Office, SAS, SQL, Statistical Modeling, Research, R, Data Mining, Analytics, Analysis, Predictive Modeling, Minitab, Technical Writing, Predictive Analytics, Management, Training, PowerPoint, Quantitative Analytics, Linear Regression, SAS programming
Education
Northwestern University 2012 — 2014
Master of Science (M.S.), Predictive Analytics
University of California, Irvine 2007 — 2011
B.S., Mathematics, Statistics
Norman Marks Norman Marks's U.S. Food and Drug Administration Experience January 2000 - December 2014
Job former Medical Director/Advisor, MedWatch, experienced in medical product safety, surveillance, and risk communication
Industry Hospital & Health Care
Experience
Medical Product Safety, LLC January 2015 - Present
US Food and Drug Administration January 2000 - December 2014
U.S. Food and Drug Administration August 1998 - January 2000
Humana Group Health Plan Inc., Chicago March 1992 - November 1997
Lafayette Clinic Of Urology July 1977 - March 1992
Skills
Clinical Trials, Medicine, Healthcare, Clinical Research, Public Health, Clinical Development, Health Communication, Drug Safety, Medical Devices, dietary supplement and..., Medical Product Safety, Risk Management, Healthcare Management
Education
University of Michigan School of Public Health 1990 — 1992
Dr.P.H ('a.b.d', or 'all but dissertation'), Health Services Administration and Policy
University of Colorado Denver 1988 — 1990
Masters of Health Administration (M.H.A.), Medical Care Organization
University of Wisconsin-Madison 1967 — 1970
Doctor of Medicine (M.D.), UW School of Medicine and Public Health
University of Wisconsin-Madison 1963 — 1967
B. Medical Science
Medical Product Safety, LLC January 2015 - Present
US Food and Drug Administration January 2000 - December 2014
U.S. Food and Drug Administration August 1998 - January 2000
Humana Group Health Plan Inc., Chicago March 1992 - November 1997
Lafayette Clinic Of Urology July 1977 - March 1992
Skills
Clinical Trials, Medicine, Healthcare, Clinical Research, Public Health, Clinical Development, Health Communication, Drug Safety, Medical Devices, dietary supplement and..., Medical Product Safety, Risk Management, Healthcare Management
Education
University of Michigan School of Public Health 1990 — 1992
Dr.P.H ('a.b.d', or 'all but dissertation'), Health Services Administration and Policy
University of Colorado Denver 1988 — 1990
Masters of Health Administration (M.H.A.), Medical Care Organization
University of Wisconsin-Madison 1967 — 1970
Doctor of Medicine (M.D.), UW School of Medicine and Public Health
University of Wisconsin-Madison 1963 — 1967
B. Medical Science
Jennifer (Croft) Gioffre Jennifer (Croft) Gioffre's U.S. Food and Drug Administration Experience 1995 - 2005
Job Strategic Diversity and Inclusion Branch Manager at National Institutes of Health
Industry Human Resources
Experience
National Institutes of Health April 2013 - Present
NOAA August 2010 - April 2013
NOAA May 2009 - August 2010
U.S. Department of Commerce March 2006 - May 2009
U.S. Food and Drug Administration 1995 - 2005
Various Universities in the D.C. Metropolitan Area August 1989 - October 2000
Skills
Diversity & Inclusion, Disability Employment, Recruiting, Program Management, Microsoft Word, Policy, Leadership, Fundraising, PowerPoint, Higher Education, Disabilities, Program Development, Human Resources, Government, Strategic Planning, Workshop Facilitation, Program Evaluation, Research, Nonprofits, Microsoft Office, American Sign Language, Non-profits, Community Outreach, Customer Service, Editing, Event Planning, Grant Writing, Public Policy, Teaching, Public Relations, Leadership Development, Project Management, Section 508, Policy Analysis, Social Media, Time Management, Volunteer Management, Access, Team Building, Social Networking, Public Speaking, Staff Development, Training
Education
The George Washington University - College of Professional Studies
Master’s Degree, Public Leadership- Multi Sector Leadership
University of Maryland College Park 1992 — 1994
B.A., Psychology
Western Maryland College 1989 — 1992
Bachelor's, Psychology
High Point High School
National Institutes of Health April 2013 - Present
NOAA August 2010 - April 2013
NOAA May 2009 - August 2010
U.S. Department of Commerce March 2006 - May 2009
U.S. Food and Drug Administration 1995 - 2005
Various Universities in the D.C. Metropolitan Area August 1989 - October 2000
Skills
Diversity & Inclusion, Disability Employment, Recruiting, Program Management, Microsoft Word, Policy, Leadership, Fundraising, PowerPoint, Higher Education, Disabilities, Program Development, Human Resources, Government, Strategic Planning, Workshop Facilitation, Program Evaluation, Research, Nonprofits, Microsoft Office, American Sign Language, Non-profits, Community Outreach, Customer Service, Editing, Event Planning, Grant Writing, Public Policy, Teaching, Public Relations, Leadership Development, Project Management, Section 508, Policy Analysis, Social Media, Time Management, Volunteer Management, Access, Team Building, Social Networking, Public Speaking, Staff Development, Training
Education
The George Washington University - College of Professional Studies
Master’s Degree, Public Leadership- Multi Sector Leadership
University of Maryland College Park 1992 — 1994
B.A., Psychology
Western Maryland College 1989 — 1992
Bachelor's, Psychology
High Point High School
Cheng Dong Cheng Dong's U.S. Food and Drug Administration Experience June 2015 - Present
Job Student at University of MissouriColumbia
Industry
Experience
U.S. Food and Drug Administration June 2015 - Present
University of Missouri September 2012 - Present
Boehringer Ingelheim May 2013 - August 2013
Tsinghua University September 2008 - June 2011
Skills
Statistics, Bayesian statistics, Mathematics, Monte Carlo Simulation, Matlab, R, SAS, WinBUGS, LaTeX, Mathematica, Microsoft Office, Drawing, Statistical Modeling
Education
University of Missouri-Columbia 2011 — 2016
Doctor of Philosophy (PhD), Statistics
Tsinghua University 2008 — 2011
Master's degree, Mathematics
Sun Yat-Sen University 2004 — 2008
Bachelor's degree, Statistics
U.S. Food and Drug Administration June 2015 - Present
University of Missouri September 2012 - Present
Boehringer Ingelheim May 2013 - August 2013
Tsinghua University September 2008 - June 2011
Skills
Statistics, Bayesian statistics, Mathematics, Monte Carlo Simulation, Matlab, R, SAS, WinBUGS, LaTeX, Mathematica, Microsoft Office, Drawing, Statistical Modeling
Education
University of Missouri-Columbia 2011 — 2016
Doctor of Philosophy (PhD), Statistics
Tsinghua University 2008 — 2011
Master's degree, Mathematics
Sun Yat-Sen University 2004 — 2008
Bachelor's degree, Statistics
Michael Wehr Michael Wehr's U.S. Food and Drug Administration Experience June 2014 - Present
Job International Policy Associate at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.s. Food and Drug Administration June 2014 - Present
U.S. Food and Drug Administration January 1998 - January 2014
TAS, Inc. and Novigen Sciences September 1992 - December 1996
Oregon Department of Agriculture September 1971 - May 1992
Skills
Policy Analysis, Policy, International..., Public Health, Public Policy, Project Planning, Government, Program Management, Strategic Planning, International Trade, Program Evaluation, Capacity Building, International Relations, Proposal Writing, Foreign Policy, Federal Government, Economic Development, Diplomacy, Global Health, Strategic Communications, Public Affairs, Epidemiology, Legislation, Health Policy
Education
Oregon State University 1968 — 1971
Doctor of Philosophy (Ph.D.), Biochemistry
Oregon State University 1966 — 1968
Master of Science (M.S.), Food Science and Technology
University of California, Berkeley 1963 — 1966
Bachelor of Science (B.S.), Food Science and Technology
University of California, Davis 1961 — 1963
Food Science and Technology
U.s. Food and Drug Administration June 2014 - Present
U.S. Food and Drug Administration January 1998 - January 2014
TAS, Inc. and Novigen Sciences September 1992 - December 1996
Oregon Department of Agriculture September 1971 - May 1992
Skills
Policy Analysis, Policy, International..., Public Health, Public Policy, Project Planning, Government, Program Management, Strategic Planning, International Trade, Program Evaluation, Capacity Building, International Relations, Proposal Writing, Foreign Policy, Federal Government, Economic Development, Diplomacy, Global Health, Strategic Communications, Public Affairs, Epidemiology, Legislation, Health Policy
Education
Oregon State University 1968 — 1971
Doctor of Philosophy (Ph.D.), Biochemistry
Oregon State University 1966 — 1968
Master of Science (M.S.), Food Science and Technology
University of California, Berkeley 1963 — 1966
Bachelor of Science (B.S.), Food Science and Technology
University of California, Davis 1961 — 1963
Food Science and Technology
Hugh M. McClure III Hugh M. McClure III's U.S. Food and Drug Administration Experience January 1987 - Present
Job National Expert/Bioresearch Monitoring at U.S. Food and Drug Administration
Industry Research
Experience
U.S. Food and Drug Administration January 1987 - Present
Skills
Clinical Trials, Biotechnology, Lifesciences, GLP, Regulatory Requirements, Clinical Development, GCP, Sop, Validation, Drug Development, Pharmaceutical Industry, IND, Clinical Research, Pharmacology, Analytical Chemistry, Regulations, Pharmacovigilance, Science, Quality Assurance, Policy, CRO, Public Health, GMP, Regulatory Affairs
Education
Old Dominion University
B.S., Biology
U.S. Food and Drug Administration January 1987 - Present
Skills
Clinical Trials, Biotechnology, Lifesciences, GLP, Regulatory Requirements, Clinical Development, GCP, Sop, Validation, Drug Development, Pharmaceutical Industry, IND, Clinical Research, Pharmacology, Analytical Chemistry, Regulations, Pharmacovigilance, Science, Quality Assurance, Policy, CRO, Public Health, GMP, Regulatory Affairs
Education
Old Dominion University
B.S., Biology
Donna Rogers Lochner Donna Rogers Lochner's U.S. Food and Drug Administration Experience 2011 - Present
Job U.S. Food and Drug Administration
Industry Medical Devices
Experience
U.S. Food and Drug Administration 2011 - Present
U.S. Food and Drug Administration 2004 - 2011
U.S. Food and Drug Administration 1991 - 2004
U.S. Food and Drug Administration 1987 - 1991
Cordis Corp 1983 - 1987
Skills
Quality System, FDA, CAPA, Medical Devices, Regulatory Affairs, Lifesciences, Biomedical Engineering, Innovation, Collaboration, Biomaterials, Regulatory Submissions, GMP, ISO 13485, Biotechnology, Life Sciences, Engineering, Validation, R&D, Regulatory Requirements, Design Control, Design of Experiments, V&V
Education
Penn State University 1979 — 1983
Bachelor’s Degree, Chemical Engineering
U.S. Food and Drug Administration 2011 - Present
U.S. Food and Drug Administration 2004 - 2011
U.S. Food and Drug Administration 1991 - 2004
U.S. Food and Drug Administration 1987 - 1991
Cordis Corp 1983 - 1987
Skills
Quality System, FDA, CAPA, Medical Devices, Regulatory Affairs, Lifesciences, Biomedical Engineering, Innovation, Collaboration, Biomaterials, Regulatory Submissions, GMP, ISO 13485, Biotechnology, Life Sciences, Engineering, Validation, R&D, Regulatory Requirements, Design Control, Design of Experiments, V&V
Education
Penn State University 1979 — 1983
Bachelor’s Degree, Chemical Engineering
Danielle Schor Danielle Schor's U.S. Food and Drug Administration Experience May 2015 - Present
Job Personal historian and consultant, U.S. Food and Drug Administration
Industry Writing and Editing
Experience
U.S. Food and Drug Administration May 2015 - Present
U.S. Food and Drug Administration November 2009 - March 2015
International Food Information Council 2007 - 2009
Skills
Public Speaking, Strategic Communications, Blogging, Public Health, Government, Public Policy, Crisis Communications, Media Relations, Newsletters, Nonprofits, Research, Copy Editing, Press Releases, Social Media, Community Outreach, Federal Government, Speech Writing
Education
University of Maryland
Bachelor of Science (B.S.), Nutrition Sciences
University of Maryland College Park
Bachelor's degree in dietetics
U.S. Food and Drug Administration May 2015 - Present
U.S. Food and Drug Administration November 2009 - March 2015
International Food Information Council 2007 - 2009
Skills
Public Speaking, Strategic Communications, Blogging, Public Health, Government, Public Policy, Crisis Communications, Media Relations, Newsletters, Nonprofits, Research, Copy Editing, Press Releases, Social Media, Community Outreach, Federal Government, Speech Writing
Education
University of Maryland
Bachelor of Science (B.S.), Nutrition Sciences
University of Maryland College Park
Bachelor's degree in dietetics
Chris Dugard's U.S. Food and Drug Administration Experience August 2013 - September 2014
Job Biologist/Lead Reviewer at FDA
Industry Research
Experience
FDA October 2014 - Present
U.S. Food and Drug Administration August 2013 - September 2014
Purdue University August 2011 - May 2013
Purdue University May 2010 - August 2011
Skills
Analytical Chemistry, HPLC, Chemistry, UV/Vis, Mass Spectrometry, Chromatography, LC-MS, Biochemistry, Science, Organic Chemistry, Microbiology, Laboratory, DNA sequencing, DNA Sequencing
Education
Purdue University 2011 — 2013
Master of Science (MS), Botany and Plant Pathology
Purdue University 2004 — 2008
Bachelor of Science (BS), Genetics
FDA October 2014 - Present
U.S. Food and Drug Administration August 2013 - September 2014
Purdue University August 2011 - May 2013
Purdue University May 2010 - August 2011
Skills
Analytical Chemistry, HPLC, Chemistry, UV/Vis, Mass Spectrometry, Chromatography, LC-MS, Biochemistry, Science, Organic Chemistry, Microbiology, Laboratory, DNA sequencing, DNA Sequencing
Education
Purdue University 2011 — 2013
Master of Science (MS), Botany and Plant Pathology
Purdue University 2004 — 2008
Bachelor of Science (BS), Genetics
Bobby J. Chun, Pharm. D. Bobby J. Chun, Pharm. D.'s U.S. Food and Drug Administration Experience August 2011 - May 2012
Job Senior Operations Research Analyst at FDA
Industry Pharmaceuticals
Experience
FDA May 2012 - Present
U.S. Food and Drug Administration August 2011 - May 2012
U.S. Food and Drug Administration August 2008 - August 2011
TheraCom, Inc March 2008 - August 2008
Ahold May 2000 - March 2008
Skills
Regulatory Affairs, Pharmaceuticals, Risk Analysis, Pharmacovigilance, Statistics, Pharmacists, Compliance, Regulatory Requirements, Risk Management, Decision Analysis, Reporting & Analysis, Project Management, Pharmaceutical Industry, FDA, CAPA, Quality Assurance
Education
University of Maryland Baltimore
Doctor of Pharmacy, Pharmacy
University of Maryland College Park
Pre-Pharmacy
FDA May 2012 - Present
U.S. Food and Drug Administration August 2011 - May 2012
U.S. Food and Drug Administration August 2008 - August 2011
TheraCom, Inc March 2008 - August 2008
Ahold May 2000 - March 2008
Skills
Regulatory Affairs, Pharmaceuticals, Risk Analysis, Pharmacovigilance, Statistics, Pharmacists, Compliance, Regulatory Requirements, Risk Management, Decision Analysis, Reporting & Analysis, Project Management, Pharmaceutical Industry, FDA, CAPA, Quality Assurance
Education
University of Maryland Baltimore
Doctor of Pharmacy, Pharmacy
University of Maryland College Park
Pre-Pharmacy
Dhaval Pathak Dhaval Pathak's U.S. Food and Drug Administration Experience October 2010 - Present
Job IT Specialist at U.S. Food and Drug Administration
Industry Information Technology and Services
Experience
U.S. Food and Drug Administration October 2010 - Present
Envision EMI September 2009 - December 2010
Envision EMI January 2007 - August 2009
Bilinguals Inc. June 2005 - December 2006
VNB Mortgage Services September 2004 - June 2005
Skills
Databases, SharePoint, Microsoft SQL Server, Visio, PL/SQL, Business Intelligence, Project Management, MS Project, SQL, Troubleshooting, Leadership, System Administration, Access, Database Administration, Management, Microsoft Office, Project Planning, T-SQL, JavaScript, Security, Oracle, Customer Service, Teamwork, Organization &..., Programming, HTML, Time Management, Organizational Structure, Oracle Application...
Education
Stevens Institute of Technology 2002 — 2003
MS, Computer Science
U.S. Food and Drug Administration October 2010 - Present
Envision EMI September 2009 - December 2010
Envision EMI January 2007 - August 2009
Bilinguals Inc. June 2005 - December 2006
VNB Mortgage Services September 2004 - June 2005
Skills
Databases, SharePoint, Microsoft SQL Server, Visio, PL/SQL, Business Intelligence, Project Management, MS Project, SQL, Troubleshooting, Leadership, System Administration, Access, Database Administration, Management, Microsoft Office, Project Planning, T-SQL, JavaScript, Security, Oracle, Customer Service, Teamwork, Organization &..., Programming, HTML, Time Management, Organizational Structure, Oracle Application...
Education
Stevens Institute of Technology 2002 — 2003
MS, Computer Science
Kathryn Cosentino Kathryn Cosentino's U.S. Food and Drug Administration Experience January 2012 - May 2012
Job Chemist, Research and Development at Alpha Associates, Inc
Industry Textiles
Experience
Alpha Associates, Inc March 2013 - Present
U.S. Food and Drug Administration January 2012 - May 2012
Skills
Research, Data Analysis, Microsoft Office, Technical Writing, Project Planning, Industrial Coatings, Product Design, Formulation Chemistry, Materials Science
Education
Richard Stockton College of New Jersey 2008 — 2012
Bachelor of Science (BS), Biochemistry and Molecular Biology
The Washington Center 2012 — 2012
Science, Technology and Society Program
Alpha Associates, Inc March 2013 - Present
U.S. Food and Drug Administration January 2012 - May 2012
Skills
Research, Data Analysis, Microsoft Office, Technical Writing, Project Planning, Industrial Coatings, Product Design, Formulation Chemistry, Materials Science
Education
Richard Stockton College of New Jersey 2008 — 2012
Bachelor of Science (BS), Biochemistry and Molecular Biology
The Washington Center 2012 — 2012
Science, Technology and Society Program
Darcie Gay Darcie Gay's U.S. Food and Drug Administration Experience 2000 - 2005
Job x
Industry Higher Education
Experience
Telesis Preparatory Academy 2012 - 2013
Lake Havasu High School 2008 - 2012
Lake Havasu Unified School District, AZ 2008 - 2012
U.S. Food and Drug Administration 2000 - 2005
Skills
Science, Instructional Design, Teaching, Public Speaking, Curriculum Design, Educational Leadership, E-Learning, Staff Development, Curriculum Development, Tutoring, Teacher Training, Adult Education, Secondary Education, Science Education, Lesson Planning, Instructional Technology
Education
Pima Community College 2005 — 2008
Secondary Education and Teaching
Northern Michigan University 1997 — 2000
Bachelor's degree, Biology, General
Telesis Preparatory Academy 2012 - 2013
Lake Havasu High School 2008 - 2012
Lake Havasu Unified School District, AZ 2008 - 2012
U.S. Food and Drug Administration 2000 - 2005
Skills
Science, Instructional Design, Teaching, Public Speaking, Curriculum Design, Educational Leadership, E-Learning, Staff Development, Curriculum Development, Tutoring, Teacher Training, Adult Education, Secondary Education, Science Education, Lesson Planning, Instructional Technology
Education
Pima Community College 2005 — 2008
Secondary Education and Teaching
Northern Michigan University 1997 — 2000
Bachelor's degree, Biology, General
Damon Sturniolo's U.S. Food and Drug Administration Experience June 1992 - February 2003
Job Senior Accounting Manager / Active CPA
Industry Accounting
Experience
Kofax - Lexmark Enterprise Software June 2014 - Present
Damon Sturniolo, CPA April 2010 - June 2014
Deloitte Consulting July 2007 - April 2010
McConnell, Jones, Lanier & Murphy, LLP July 2005 - June 2007
IBM February 2003 - June 2004
CGI formerly American Management Systems (AMS) February 2003 - June 2004
U.S. Food and Drug Administration June 1992 - February 2003
Skills
Accounting, US GAAP, Financial Reporting, Financial Analysis, Internal Controls, Strategy, Process Improvement, Strategic Planning, Finance, Financial Accounting, General Ledger, Budgets, Business Process..., IFRS, Program Management, Project Management, Tax, Financial Management, Change Management, Account Reconciliation, Business Analysis, Mergers & Acquisitions, Accounts Payable, Budgeting, Accounts Receivable, Operations Management, Compliance, Reconciliation, Sarbanes-Oxley Act, Analysis, ERP, Management Consulting, Auditing, Managerial Finance, Management
Education
Niagara University 1990 — 1992
BBA, Accounting, 3.91 / 4.0 GPA
Our Lady of Good Counsel High School 1979 — 1983
Kofax - Lexmark Enterprise Software June 2014 - Present
Damon Sturniolo, CPA April 2010 - June 2014
Deloitte Consulting July 2007 - April 2010
McConnell, Jones, Lanier & Murphy, LLP July 2005 - June 2007
IBM February 2003 - June 2004
CGI formerly American Management Systems (AMS) February 2003 - June 2004
U.S. Food and Drug Administration June 1992 - February 2003
Skills
Accounting, US GAAP, Financial Reporting, Financial Analysis, Internal Controls, Strategy, Process Improvement, Strategic Planning, Finance, Financial Accounting, General Ledger, Budgets, Business Process..., IFRS, Program Management, Project Management, Tax, Financial Management, Change Management, Account Reconciliation, Business Analysis, Mergers & Acquisitions, Accounts Payable, Budgeting, Accounts Receivable, Operations Management, Compliance, Reconciliation, Sarbanes-Oxley Act, Analysis, ERP, Management Consulting, Auditing, Managerial Finance, Management
Education
Niagara University 1990 — 1992
BBA, Accounting, 3.91 / 4.0 GPA
Our Lady of Good Counsel High School 1979 — 1983
AnnaMaria DeSalva AnnaMaria DeSalva's U.S. Food and Drug Administration Experience November 2007 - November 2009
Job Chief Communications Officer at DuPont
Industry Biotechnology
Experience
Argonne National Laboratory February 2015 - Present
DuPont March 2014 - Present
Pfizer 2009 - 2014
U.S. Food and Drug Administration November 2007 - November 2009
Hill+Knowlton Strategies 2006 - 2009
GCI Group 2002 - 2006
Bristol-Myers Squibb 1996 - 2002
Skills
Strategic Communications, Communication Training, Message Development, Crisis Communications, Reputation Management, Leadership, Public Affairs, Policy, Speech Writing, Communications Planning, Internal Communications, Strategy, Media Relations, Brand Management, Corporate Communications, Marketing Communications
Education
The College of William and Mary
Bachelor of Arts (BA), awarded with Honors
University of California, Berkeley
with Universitat Pompeu Fabra, Barcelona
Argonne National Laboratory February 2015 - Present
DuPont March 2014 - Present
Pfizer 2009 - 2014
U.S. Food and Drug Administration November 2007 - November 2009
Hill+Knowlton Strategies 2006 - 2009
GCI Group 2002 - 2006
Bristol-Myers Squibb 1996 - 2002
Skills
Strategic Communications, Communication Training, Message Development, Crisis Communications, Reputation Management, Leadership, Public Affairs, Policy, Speech Writing, Communications Planning, Internal Communications, Strategy, Media Relations, Brand Management, Corporate Communications, Marketing Communications
Education
The College of William and Mary
Bachelor of Arts (BA), awarded with Honors
University of California, Berkeley
with Universitat Pompeu Fabra, Barcelona
Don Bennett Don Bennett's U.S. Food and Drug Administration Experience January 2010 - Present
Job Quality Systems Manager at U.S. Food and Drug Administration
Industry Management Consulting
Experience
U.S. Food and Drug Administration January 2010 - Present
Big Fish Marketing January 2000 - January 2010
Quantum August 1998 - September 2001
Industrial Ceramics January 1996 - August 1998
International Quality Technologies October 1995 - October 1996
United States Air Force June 1990 - October 1995
United States Air Force January 1985 - June 1990
Skills
Program Management, Marketing, Project Management, Process Improvement, Six Sigma, Training, Web Development, Analysis, Business Process..., Business Strategy, Management, Project Planning, Quality Management, Management Consulting, Strategic Planning
Education
Troy State University 1989 — 1994
U.S. Food and Drug Administration January 2010 - Present
Big Fish Marketing January 2000 - January 2010
Quantum August 1998 - September 2001
Industrial Ceramics January 1996 - August 1998
International Quality Technologies October 1995 - October 1996
United States Air Force June 1990 - October 1995
United States Air Force January 1985 - June 1990
Skills
Program Management, Marketing, Project Management, Process Improvement, Six Sigma, Training, Web Development, Analysis, Business Process..., Business Strategy, Management, Project Planning, Quality Management, Management Consulting, Strategic Planning
Education
Troy State University 1989 — 1994
Robert Savage Robert Savage's U.S. Food and Drug Administration Experience September 1973 - May 1978
Job President at HACCP Consulting Group
Industry Food Production
Experience
HACCP Consulting Group July 1996 - Present
USDA, Food Safety and Inspection Service May 1978 - July 1996
U.S. Food and Drug Administration September 1973 - May 1978
The Great Atlantic & Pacific Tea Company 1969 - 1973
Skills
HACCP, Food Safety, Food Manufacturing, Food Science, Food Quality, Sensory Evaluation, Frozen Food, Ingredients, Dairy, Seafood, Food Service, Great Atlantic and..., Quality Auditing, FMCG, Microbiology, Laboratory, Food & Beverage, Grocery, R&D, Allergens, ISO 22000, Product Development, Quality Assurance, Food Chemistry, Consumer Products, Food Safety Management..., GFSI, Sop, TQM, Continuous Improvement, Quality System, BRC, Thermal Processing, Meat Processing, Food Labelling, Quality Management, SSOP, Quality Control, FDA, Validation, Pest Control, Hygiene, Bakery, Halal, Food Law, Catering, SOP
Education
University of Massachusetts, Amherst 1965 — 1969
MS, Food Science and Technology
HACCP Consulting Group July 1996 - Present
USDA, Food Safety and Inspection Service May 1978 - July 1996
U.S. Food and Drug Administration September 1973 - May 1978
The Great Atlantic & Pacific Tea Company 1969 - 1973
Skills
HACCP, Food Safety, Food Manufacturing, Food Science, Food Quality, Sensory Evaluation, Frozen Food, Ingredients, Dairy, Seafood, Food Service, Great Atlantic and..., Quality Auditing, FMCG, Microbiology, Laboratory, Food & Beverage, Grocery, R&D, Allergens, ISO 22000, Product Development, Quality Assurance, Food Chemistry, Consumer Products, Food Safety Management..., GFSI, Sop, TQM, Continuous Improvement, Quality System, BRC, Thermal Processing, Meat Processing, Food Labelling, Quality Management, SSOP, Quality Control, FDA, Validation, Pest Control, Hygiene, Bakery, Halal, Food Law, Catering, SOP
Education
University of Massachusetts, Amherst 1965 — 1969
MS, Food Science and Technology
Christian Hampp's U.S. Food and Drug Administration Experience April 2012 - Present
Job Senior Staff Fellow/Epidemiologist at FDA
Industry Government Administration
Experience
U.S. Food and Drug Administration April 2012 - Present
University of Florida January 2011 - Present
U.S. Food and Drug Administration August 2010 - April 2012
University of Florida August 2009 - July 2010
University of Florida September 2004 - August 2009
Skills
Outcomes Research, Pharmacoepidemiology, Pharmacoeconomics, Epidemiology, Clinical Pharmacology, Biostatistics, Infectious Diseases, Clinical Study Design, Pharmacology, Health Economics, Clinical Trials, Clinical Development, Drug Development, Clinical Research, Lifesciences, Research, Life Sciences, Public Health, Regulatory Affairs
Education
University of Florida 2004 — 2010
PhD, Pharmacoepidemiology
Universität des Saarlandes 1999 — 2003
BS, Pharmacy
U.S. Food and Drug Administration April 2012 - Present
University of Florida January 2011 - Present
U.S. Food and Drug Administration August 2010 - April 2012
University of Florida August 2009 - July 2010
University of Florida September 2004 - August 2009
Skills
Outcomes Research, Pharmacoepidemiology, Pharmacoeconomics, Epidemiology, Clinical Pharmacology, Biostatistics, Infectious Diseases, Clinical Study Design, Pharmacology, Health Economics, Clinical Trials, Clinical Development, Drug Development, Clinical Research, Lifesciences, Research, Life Sciences, Public Health, Regulatory Affairs
Education
University of Florida 2004 — 2010
PhD, Pharmacoepidemiology
Universität des Saarlandes 1999 — 2003
BS, Pharmacy
David Haggard David Haggard's U.S. Food and Drug Administration Experience June 1968 - June 2001
Job GMP Regulatory Consultant at David Haggard Associates, LLC
Industry Pharmaceuticals
Experience
David Haggard Associates, LLC January 2012 - Present
Merck Co., Inc. September 2003 - November 2011
Merck Co., Inc. June 2001 - September 2003
U.S. Food and Drug Administration June 1968 - June 2001
Skills
Pharmaceutical Industry, Aseptic Processing, Vaccines, Regulatory Requirements, 21 CFR Part 11, Regulatory Affairs, Computer System..., Regulatory Submissions, CAPA, Biopharmaceuticals, Process Improvement, Medical Devices, Quality System, Change Control, Clinical Trials, GMP, Quality Management, Validation, Cleaning Validation, R&D, V&V, Sop, Quality Auditing, Quality Assurance, Biotechnology, Pharmaceutics, GLP, GxP, LIMS, Technology Transfer, SOP
Education
University of Maryland College Park
B.S., Zoology
David Haggard Associates, LLC January 2012 - Present
Merck Co., Inc. September 2003 - November 2011
Merck Co., Inc. June 2001 - September 2003
U.S. Food and Drug Administration June 1968 - June 2001
Skills
Pharmaceutical Industry, Aseptic Processing, Vaccines, Regulatory Requirements, 21 CFR Part 11, Regulatory Affairs, Computer System..., Regulatory Submissions, CAPA, Biopharmaceuticals, Process Improvement, Medical Devices, Quality System, Change Control, Clinical Trials, GMP, Quality Management, Validation, Cleaning Validation, R&D, V&V, Sop, Quality Auditing, Quality Assurance, Biotechnology, Pharmaceutics, GLP, GxP, LIMS, Technology Transfer, SOP
Education
University of Maryland College Park
B.S., Zoology
William Rados William Rados's U.S. Food and Drug Administration Experience 1989 - 2006
Job Grand Poobah
Industry Photography
Experience
Self-employed April 2013 - Present
U.S. Food and Drug Administration 1989 - 2006
Skills
Photography, Digital Photography, Creative Direction, Editorial, Image Manipulation, Photos, Public Speaking, Strategic Planning
Education
The Ohio State University 1973 — 1974
Master of Arts (M.A.), Journalism
University of Notre Dame 1965 — 1969
Bachelor of Arts (B.A.), Political Science
Self-employed April 2013 - Present
U.S. Food and Drug Administration 1989 - 2006
Skills
Photography, Digital Photography, Creative Direction, Editorial, Image Manipulation, Photos, Public Speaking, Strategic Planning
Education
The Ohio State University 1973 — 1974
Master of Arts (M.A.), Journalism
University of Notre Dame 1965 — 1969
Bachelor of Arts (B.A.), Political Science
Mario Seminara Mario Seminara's U.S. Food and Drug Administration Experience April 2002 - Present
Job Regional Food Specialist at U.S. Food and Drug Administration
Industry Government Relations
Experience
U.S. Food and Drug Administration April 2002 - Present
Skills
Food Safety, HACCP, Sanitation, Environmental Health, Food Science, Food Processing, Food Microbiology, GMP, Food Safety Management..., Food Industry, Emergency Management, Policy, Quality System, Public Health, Food, Food Technology, Epidemiology, Food Quality, Government, Microbiology, ISO 22000, Quality Auditing, Regulatory Affairs, Hygiene, Quality Assurance, Meat, Dairy, Quality Management, Ingredients, SQF, FDA, BRC, Laboratory, Quality Control, Sop, Regulations, Regulatory Requirements
Education
Texas A&M University
BS + Post Grad Studies, Animal Science/Resource Development
U.S. Food and Drug Administration April 2002 - Present
Skills
Food Safety, HACCP, Sanitation, Environmental Health, Food Science, Food Processing, Food Microbiology, GMP, Food Safety Management..., Food Industry, Emergency Management, Policy, Quality System, Public Health, Food, Food Technology, Epidemiology, Food Quality, Government, Microbiology, ISO 22000, Quality Auditing, Regulatory Affairs, Hygiene, Quality Assurance, Meat, Dairy, Quality Management, Ingredients, SQF, FDA, BRC, Laboratory, Quality Control, Sop, Regulations, Regulatory Requirements
Education
Texas A&M University
BS + Post Grad Studies, Animal Science/Resource Development
Jo Ann Kurz Jo Ann Kurz's U.S. Food and Drug Administration Experience February 2011 - Present
Job Administration, Online Coach
Industry Human Resources
Experience
U.S. Food and Drug Administration February 2011 - Present
Meridian Tennis Association January 2009 - Present
Stevens Henager College August 2009 - August 2010
DIRECTV June 2009 - July 2009
Boise Racquet and Swim Club October 1994 - October 2008
Skills
Microsoft Office, United States..., Executive Reporting
Education
The University of Texas at Austin
B.A., Sociology with Special Honors
elementary
U.S. Food and Drug Administration February 2011 - Present
Meridian Tennis Association January 2009 - Present
Stevens Henager College August 2009 - August 2010
DIRECTV June 2009 - July 2009
Boise Racquet and Swim Club October 1994 - October 2008
Skills
Microsoft Office, United States..., Executive Reporting
Education
The University of Texas at Austin
B.A., Sociology with Special Honors
elementary
Chris Mark Chris Mark's U.S. Food and Drug Administration Experience 1999 - 2009
Job Senior Section 508 Accessibility Compliance Specialist at Aquilent
Industry Information Technology and Services
Experience
Aquilent May 2012 - Present
MILVETS Systems Technology, Inc. 2012 - May 2012
Montgomery College August 2011 - May 2012
Anne Arundel Community College August 2010 - May 2012
VersaTech Inc. October 2010 - July 2011
Towson University August 2010 - December 2010
Howard County Community College August 2010 - December 2010
US Census Bureau April 2010 - July 2010
Computer Technology Services October 1999 - November 2009
U.S. Food and Drug Administration 1999 - 2009
Skills
Accessibility, Section 508, WCAG 2.0, HTML, CSS, Web Development, JavaScript, Project Management, Dreamweaver, Usability, Teaching, Technical Training, Windows, CMS, XML, Web Design, Educational Technology, XHTML, Web Standards, W3C, Cross-browser..., Higher Education, Photoshop, DHTML, WCAG, Front-end Development, Microsoft Office, Access, Instructional Design, Content Management, Web Applications, Databases, User Experience, User Interface, Leadership, Public Speaking, Usability Testing, Management, Technical Writing, User Interface Design, E-Learning, Web Content Management, SEO, Advanced Mathematics
Education
University of Maryland College Park 1983 — 1990
MA, Mathematics
St. John's College 1978 — 1981
BA, Liberal Arts
Aquilent May 2012 - Present
MILVETS Systems Technology, Inc. 2012 - May 2012
Montgomery College August 2011 - May 2012
Anne Arundel Community College August 2010 - May 2012
VersaTech Inc. October 2010 - July 2011
Towson University August 2010 - December 2010
Howard County Community College August 2010 - December 2010
US Census Bureau April 2010 - July 2010
Computer Technology Services October 1999 - November 2009
U.S. Food and Drug Administration 1999 - 2009
Skills
Accessibility, Section 508, WCAG 2.0, HTML, CSS, Web Development, JavaScript, Project Management, Dreamweaver, Usability, Teaching, Technical Training, Windows, CMS, XML, Web Design, Educational Technology, XHTML, Web Standards, W3C, Cross-browser..., Higher Education, Photoshop, DHTML, WCAG, Front-end Development, Microsoft Office, Access, Instructional Design, Content Management, Web Applications, Databases, User Experience, User Interface, Leadership, Public Speaking, Usability Testing, Management, Technical Writing, User Interface Design, E-Learning, Web Content Management, SEO, Advanced Mathematics
Education
University of Maryland College Park 1983 — 1990
MA, Mathematics
St. John's College 1978 — 1981
BA, Liberal Arts
Paul Boccadoro Paul Boccadoro's U.S. Food and Drug Administration Experience January 2011 - Present
Job Web Content Manager at U.S. Food and Drug Administration
Industry Information Technology and Services
Experience
U.S. Food and Drug Administration January 2011 - Present
Department of Veterans Affairs May 2010 - January 2011
Reese, Lower, Patrick and Scott Architects May 2006 - April 2009
Pennsylvania State University August 2006 - May 2008
Department of Veterans Affairs May 2005 - August 2005
Hugh Moore Historical Park and Museum June 2001 - August 2004
Skills
Coordination, Web Design, Marketing, Organization, Management, Graphics, SketchUp, AutoCAD, Submittals, Design Research, Photoshop, Microsoft Office, InDesign, Sustainable Design, Adobe Creative Suite, Microsoft Word, Proposal Writing, Sketching, User Experience, PowerPoint, CAD, Graphic Design, 3D Studio Max, OS X, ArcGIS, Social Networking, Editing, Project Planning, Construction, Architecture, Project Management, Dreamweaver, Government, Microsoft Excel, Surveying, Flash, Social Media, Interior Design, SEO, Web Development, Mac, Photography, Advertising, Sustainability, HTML, Research, Analysis, Illustrator, CSS, WordPress
Education
Penn State University 2007 — 2008
Masters, Architecture, Community and Urban Design
Penn State University 2002 — 2007
Bachelor, Architecture
U.S. Food and Drug Administration January 2011 - Present
Department of Veterans Affairs May 2010 - January 2011
Reese, Lower, Patrick and Scott Architects May 2006 - April 2009
Pennsylvania State University August 2006 - May 2008
Department of Veterans Affairs May 2005 - August 2005
Hugh Moore Historical Park and Museum June 2001 - August 2004
Skills
Coordination, Web Design, Marketing, Organization, Management, Graphics, SketchUp, AutoCAD, Submittals, Design Research, Photoshop, Microsoft Office, InDesign, Sustainable Design, Adobe Creative Suite, Microsoft Word, Proposal Writing, Sketching, User Experience, PowerPoint, CAD, Graphic Design, 3D Studio Max, OS X, ArcGIS, Social Networking, Editing, Project Planning, Construction, Architecture, Project Management, Dreamweaver, Government, Microsoft Excel, Surveying, Flash, Social Media, Interior Design, SEO, Web Development, Mac, Photography, Advertising, Sustainability, HTML, Research, Analysis, Illustrator, CSS, WordPress
Education
Penn State University 2007 — 2008
Masters, Architecture, Community and Urban Design
Penn State University 2002 — 2007
Bachelor, Architecture
Alex Secora Alex Secora's U.S. Food and Drug Administration Experience 2013 - Present
Job Doctoral Student at The Johns Hopkins University / Epidemiologist at FDA
Industry Pharmaceuticals
Experience
U.S. Food and Drug Administration 2013 - Present
U.S. Food and Drug Administration 2012 - 2013
University of Pennsylvania 2010 - 2011
Columbia University Medical Center 2006 - 2010
Center on Addiction and Substance Abuse 2004 - 2006
Skills
Stata, Global Health, Program Evaluation, Public Health, Data Analysis, Social Media, Public Speaking, Program Development, Research, Qualitative Research, Community Outreach, Microsoft Office, SAS, Policy Analysis, Clinical Research, Statistics, SPSS, Grant Writing, Grants, Research Design, Quantitative Research, Epidemiology, Survey Design, Health Education, Public Policy, Biostatistics, Literature Reviews
Education
The Johns Hopkins University 2015 — 2019
Doctor of Philosophy (Ph.D.), Epidemiology
The Johns Hopkins University 2015 — 2017
Master’s Degree, Biostatistics
The Johns Hopkins University 2011 — 2012
Master of Public Health (MPH), Epidemiology/Biostatistics
New York University 2000 — 2004
Bachelor's degree, Psychology
U.S. Food and Drug Administration 2013 - Present
U.S. Food and Drug Administration 2012 - 2013
University of Pennsylvania 2010 - 2011
Columbia University Medical Center 2006 - 2010
Center on Addiction and Substance Abuse 2004 - 2006
Skills
Stata, Global Health, Program Evaluation, Public Health, Data Analysis, Social Media, Public Speaking, Program Development, Research, Qualitative Research, Community Outreach, Microsoft Office, SAS, Policy Analysis, Clinical Research, Statistics, SPSS, Grant Writing, Grants, Research Design, Quantitative Research, Epidemiology, Survey Design, Health Education, Public Policy, Biostatistics, Literature Reviews
Education
The Johns Hopkins University 2015 — 2019
Doctor of Philosophy (Ph.D.), Epidemiology
The Johns Hopkins University 2015 — 2017
Master’s Degree, Biostatistics
The Johns Hopkins University 2011 — 2012
Master of Public Health (MPH), Epidemiology/Biostatistics
New York University 2000 — 2004
Bachelor's degree, Psychology
Stephen Torosian Stephen Torosian's U.S. Food and Drug Administration Experience January 2003 - Present
Job Microbiologist at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration January 2003 - Present
Skills
qPCR, Gel Electrophoresis, Cell Culture, Microbiology, Western Blotting, Lifesciences, Molecular Biology, PCR, Biochemistry, ELISA, Immunology, Infectious Diseases, Virology, RT-PCR, DNA extraction, Life Sciences
Education
University of New Hampshire 1988 — 1993
Doctor of Philosophy (Ph.D.), Microbiology, General
University of Massachusetts, Amherst 1971 — 1977
Bachelor of Science (BS), Microbiology, General
U.S. Food and Drug Administration January 2003 - Present
Skills
qPCR, Gel Electrophoresis, Cell Culture, Microbiology, Western Blotting, Lifesciences, Molecular Biology, PCR, Biochemistry, ELISA, Immunology, Infectious Diseases, Virology, RT-PCR, DNA extraction, Life Sciences
Education
University of New Hampshire 1988 — 1993
Doctor of Philosophy (Ph.D.), Microbiology, General
University of Massachusetts, Amherst 1971 — 1977
Bachelor of Science (BS), Microbiology, General
Synim Rivers, MPH, CHES's U.S. Food and Drug Administration Experience April 2010 - November 2011
Job Vice President, Healthcare
Industry Public Relations and Communications
Experience
Edelman January 2015 - Present
FDA November 2013 - December 2014
FDA December 2012 - November 2013
FDA November 2011 - December 2012
U.S. Food and Drug Administration April 2010 - November 2011
CEPH February 2008 - April 2010
Skills
Public Health, Program Evaluation, Policy Analysis, Global Health, Grant Writing, Grants, Public Policy, Epidemiology, Nonprofits, Community Health, Research, Policy, Health Education, Community Outreach, Certified Health..., Program Development, Health Policy, Qualitative Research, Non-profits, Strategic Communications, Social Media Outreach, Media Relations
Education
The George Washington University 2011 — 2012
Masters Certificate in Project Management
Tulane University 2004 — 2006
MPH, Public Health - Health Education & Communications
Xavier University of Louisiana 1999 — 2003
BS, Biology
Edelman January 2015 - Present
FDA November 2013 - December 2014
FDA December 2012 - November 2013
FDA November 2011 - December 2012
U.S. Food and Drug Administration April 2010 - November 2011
CEPH February 2008 - April 2010
Skills
Public Health, Program Evaluation, Policy Analysis, Global Health, Grant Writing, Grants, Public Policy, Epidemiology, Nonprofits, Community Health, Research, Policy, Health Education, Community Outreach, Certified Health..., Program Development, Health Policy, Qualitative Research, Non-profits, Strategic Communications, Social Media Outreach, Media Relations
Education
The George Washington University 2011 — 2012
Masters Certificate in Project Management
Tulane University 2004 — 2006
MPH, Public Health - Health Education & Communications
Xavier University of Louisiana 1999 — 2003
BS, Biology
Candace Henson, M.B.A. Candace Henson, M.B.A.'s U.S. Food and Drug Administration Experience May 2012 - Present
Job Administrative Officer at U.S. Food and Drug Administration
Industry Human Resources
Experience
U.S. Food and Drug Administration May 2012 - Present
Eagle Jobs, LLC May 2013 - June 2014
Culinary Services Group February 2009 - February 2012
Northhampton Manor April 2008 - February 2009
Signature Companies April 2006 - April 2008
Skills
Human Resources, Budget Management, Marketing, New Business Development, Recruiting, Employee Training, Staff Development, Health Insurance, Payroll, Personnel Management, Coaching, Performance Management, Benefits Administration, Hiring, Job Descriptions, Performance Appraisal, Employee Relations, Talent Management, Management, Deferred Compensation, Workforce Planning, Succession Planning, College Recruiting, Career Development, Applicant Tracking..., Safety, Office Administration, Business Process..., Team Leadership, Resume Writing, Budgets, Interviews, Employee Benefits, Training, Workers Compensation, Entrepreneurship, Team Building, Leadership, Customer Service, Strategic Planning
Education
Mount Saint Mary's University 2003 — 2005
Master of Business Administration (M.B.A.), Business Administration and Management, General
Radford University 1997 — 2001
Bachelor of Science (B.S.), Sociology
U.S. Food and Drug Administration May 2012 - Present
Eagle Jobs, LLC May 2013 - June 2014
Culinary Services Group February 2009 - February 2012
Northhampton Manor April 2008 - February 2009
Signature Companies April 2006 - April 2008
Skills
Human Resources, Budget Management, Marketing, New Business Development, Recruiting, Employee Training, Staff Development, Health Insurance, Payroll, Personnel Management, Coaching, Performance Management, Benefits Administration, Hiring, Job Descriptions, Performance Appraisal, Employee Relations, Talent Management, Management, Deferred Compensation, Workforce Planning, Succession Planning, College Recruiting, Career Development, Applicant Tracking..., Safety, Office Administration, Business Process..., Team Leadership, Resume Writing, Budgets, Interviews, Employee Benefits, Training, Workers Compensation, Entrepreneurship, Team Building, Leadership, Customer Service, Strategic Planning
Education
Mount Saint Mary's University 2003 — 2005
Master of Business Administration (M.B.A.), Business Administration and Management, General
Radford University 1997 — 2001
Bachelor of Science (B.S.), Sociology
Alison Lieu's U.S. Food and Drug Administration Experience July 2009 - September 2009
Job Regulatory Compliance Analyst at RockIt Cargo USA LLC
Industry Internet
Experience
Rock-It Cargo USA LLC February 2011 - Present
Break.com September 2010 - February 2011
U.S. Food and Drug Administration July 2009 - September 2009
Sperry Van Ness October 2008 - December 2008
Skills
Social Media, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Event Planning, Logistics, Research, Operations Management, Customer Service, Social Media Marketing, Project Management, Transportation, Supply Chain, Leadership, Project Planning, Management, Editing, Policy, Marketing, Outlook, Data Analysis, Event Management, Team Leadership, Nonprofits, Community Outreach, Analysis, Time Management
Education
University of California, Riverside 2006 — 2010
Bachelor of Arts (BA), Interdisciplinary Studies: Business Administration and Political Science
Rock-It Cargo USA LLC February 2011 - Present
Break.com September 2010 - February 2011
U.S. Food and Drug Administration July 2009 - September 2009
Sperry Van Ness October 2008 - December 2008
Skills
Social Media, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Event Planning, Logistics, Research, Operations Management, Customer Service, Social Media Marketing, Project Management, Transportation, Supply Chain, Leadership, Project Planning, Management, Editing, Policy, Marketing, Outlook, Data Analysis, Event Management, Team Leadership, Nonprofits, Community Outreach, Analysis, Time Management
Education
University of California, Riverside 2006 — 2010
Bachelor of Arts (BA), Interdisciplinary Studies: Business Administration and Political Science
Samah Beg Samah Beg's U.S. Food and Drug Administration Experience June 2011 - August 2012
Job Patent Examiner at USPTO
Industry Research
Experience
USPTO January 2013 - Present
MSA National May 2012 - September 2013
George Washington University August 2012 - December 2012
U.S. Food and Drug Administration June 2011 - August 2012
George Washington University - SEAS Development & Alumni Relations October 2009 - May 2012
University of Maryland June 2010 - August 2010
DC Reads: Turning the Page September 2009 - January 2010
Education
The George Washington University 2012 — 2014
Master's Degree, Biomedical/Medical Engineering
The George Washington University 2008 — 2012
Bachelor's Degree, Biomedical/Medical Engineering
Marriotts Ridge High School 2005 — 2008
USPTO January 2013 - Present
MSA National May 2012 - September 2013
George Washington University August 2012 - December 2012
U.S. Food and Drug Administration June 2011 - August 2012
George Washington University - SEAS Development & Alumni Relations October 2009 - May 2012
University of Maryland June 2010 - August 2010
DC Reads: Turning the Page September 2009 - January 2010
Education
The George Washington University 2012 — 2014
Master's Degree, Biomedical/Medical Engineering
The George Washington University 2008 — 2012
Bachelor's Degree, Biomedical/Medical Engineering
Marriotts Ridge High School 2005 — 2008
Paul Vogel Paul Vogel's U.S. Food and Drug Administration Experience July 1991 - November 1993
Job Chairman of the Board, and Chief Executive Officer at Lachman Consultant Services Inc.
Industry Pharmaceuticals
Experience
Lachman Consultant Services Inc. July 2014 - Present
Lachman Consultant Services Inc. July 2011 - Present
Lachman Consultant Services Inc November 1993 - December 2007
U.S. Food and Drug Administration July 1991 - November 1993
US Food and Drug Administration 1993 - 1993
US Food and Drug Administration January 1991 - July 1991
U.S. Food and Drug Administration February 1988 - January 1991
US Food and Drug Administration August 1980 - February 1988
U.S. Food and Drug Administration (FDA) August 1972 - June 1976
Skills
Biotechnology, GxP, Quality System, Clinical Research, Medical Devices, Laboratory, Supplements, Change Control, Analytical Chemistry, CAPA, Start-ups, Aseptic Processing, CRO, Pharmacovigilance, Biopharmaceuticals, FDA, HPLC, ISO 13485, Testing, Chemistry, Validation, Quality Control, Computer System..., Regulatory Submissions, Regulatory Requirements, GLP, Oncology, Drug Delivery, Lifesciences, Vaccines, 21 CFR Part 11, Pharmaceutical Industry, Regulatory Affairs, R&D, V&V, Microbiology, Quality Assurance, GMP, Technology Transfer, Commercialization, GCP, Drug Development, CTMS, Sop, Pharmaceutics, Quality Auditing, Program Management, Manufacturing, Drug Discovery, Clinical Development
Education
Towson University 1969 — 1972
BS, Biological Sciences
Lachman Consultant Services Inc. July 2014 - Present
Lachman Consultant Services Inc. July 2011 - Present
Lachman Consultant Services Inc November 1993 - December 2007
U.S. Food and Drug Administration July 1991 - November 1993
US Food and Drug Administration 1993 - 1993
US Food and Drug Administration January 1991 - July 1991
U.S. Food and Drug Administration February 1988 - January 1991
US Food and Drug Administration August 1980 - February 1988
U.S. Food and Drug Administration (FDA) August 1972 - June 1976
Skills
Biotechnology, GxP, Quality System, Clinical Research, Medical Devices, Laboratory, Supplements, Change Control, Analytical Chemistry, CAPA, Start-ups, Aseptic Processing, CRO, Pharmacovigilance, Biopharmaceuticals, FDA, HPLC, ISO 13485, Testing, Chemistry, Validation, Quality Control, Computer System..., Regulatory Submissions, Regulatory Requirements, GLP, Oncology, Drug Delivery, Lifesciences, Vaccines, 21 CFR Part 11, Pharmaceutical Industry, Regulatory Affairs, R&D, V&V, Microbiology, Quality Assurance, GMP, Technology Transfer, Commercialization, GCP, Drug Development, CTMS, Sop, Pharmaceutics, Quality Auditing, Program Management, Manufacturing, Drug Discovery, Clinical Development
Education
Towson University 1969 — 1972
BS, Biological Sciences
Shelly Maifarth, RAC Shelly Maifarth, RAC's U.S. Food and Drug Administration Experience August 1982 - May 2006
Job Principal, FDA Compliance Group LLC
Industry Health, Wellness and Fitness
Experience
FDA Compliance Group LLC January 2008 - Present
U.S. Food and Drug Administration August 1982 - May 2006
FDA 1982 - 2006
Skills
FDA, GMP, Medical Devices, Quality Management, Quality Auditing, Supplements, Training, Inspection, Quality Assurance, Regulatory Affairs, CAPA, Quality System, Sop, Change Control, Pharmaceutics, Regulatory Requirements, Validation, Regulatory Submissions, Drug Development, Quality Control, GMP Audits, HACCP, Regulations, FDA GMP, PMA, GxP, GLP, 21 CFR Part 11, Gap Analysis, Pharmaceutical Industry, Supplier Evaluation, 483 and warning letter..., dietary Supplements, WL Remediation, Compliance Audits, Supplier Audits, Design Control, ISO 13485, 21 CFR, CE marking, V&V
Education
University of Michigan
BS
FDA Compliance Group LLC January 2008 - Present
U.S. Food and Drug Administration August 1982 - May 2006
FDA 1982 - 2006
Skills
FDA, GMP, Medical Devices, Quality Management, Quality Auditing, Supplements, Training, Inspection, Quality Assurance, Regulatory Affairs, CAPA, Quality System, Sop, Change Control, Pharmaceutics, Regulatory Requirements, Validation, Regulatory Submissions, Drug Development, Quality Control, GMP Audits, HACCP, Regulations, FDA GMP, PMA, GxP, GLP, 21 CFR Part 11, Gap Analysis, Pharmaceutical Industry, Supplier Evaluation, 483 and warning letter..., dietary Supplements, WL Remediation, Compliance Audits, Supplier Audits, Design Control, ISO 13485, 21 CFR, CE marking, V&V
Education
University of Michigan
BS
Loney Nunemaker, Jr. Loney Nunemaker, Jr.'s U.S. Food and Drug Administration Experience September 2014 - Present
Job Deputy Director Division of Human Resource Development at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration September 2014 - Present
Skills
Microsoft Office, Customer Service, Public Speaking, Teaching, Microsoft Excel, Research, Strategic Planning, Coaching, PowerPoint, Management, Microsoft Word, Team Building, Hazardous Materials, Fire Management, Team Leadership, English, Project Management, Training, Leadership Development, Program Management, Government, Policy
Education
Old Dominion University 1999 — 2001
Master of Science (MS), Educational/Instructional Technology
Virginia Commonwealth University 1981 — 1984
Bachelor of Science (BS), Mass Communication/Media Studies
Thomas Nelson Community College 1979 — 1981
Associate's Degree, Commercial Design
U.S. Food and Drug Administration September 2014 - Present
Skills
Microsoft Office, Customer Service, Public Speaking, Teaching, Microsoft Excel, Research, Strategic Planning, Coaching, PowerPoint, Management, Microsoft Word, Team Building, Hazardous Materials, Fire Management, Team Leadership, English, Project Management, Training, Leadership Development, Program Management, Government, Policy
Education
Old Dominion University 1999 — 2001
Master of Science (MS), Educational/Instructional Technology
Virginia Commonwealth University 1981 — 1984
Bachelor of Science (BS), Mass Communication/Media Studies
Thomas Nelson Community College 1979 — 1981
Associate's Degree, Commercial Design
Brian Hendrickson Brian Hendrickson's U.S. Food and Drug Administration Experience April 1996 - December 2011
Job Owner/Director BPHendrickson Consulting LLC/Retired FDA National Food Expert
Industry Food Production
Experience
Self-employed January 2012 - Present
BPHendrickson Consulting, LLC January 2012 - Present
Purdue University - Dept. of Food Science March 2011 - February 2014
U.S. Food and Drug Administration April 1996 - December 2011
U.S. Food and Drug Administration April 1991 - March 1996
U.S. Food and Drug Administration August 1972 - April 1991
Skills
Food packaging for high..., Management Consulting, ERP, Business Analysis, Change Management, Business Strategy, Manufacturing, FDA, HACCP, Training, Sop, GMP, Auditing, Food Safety, Technical Writing, Medical Devices, Food, Packaging, Food Science, Quality Assurance, Food Industry
Education
FDA Long Term Training - Food Technology 1989 — 1990
Food Processing and Packaging, A
Northern Illinois University 1974 — 1976
Master of Business Administration (MBA), Business Administration
Oregon State University 1967 — 1969
Bachelor's degree, Food Science and Technology
Self-employed January 2012 - Present
BPHendrickson Consulting, LLC January 2012 - Present
Purdue University - Dept. of Food Science March 2011 - February 2014
U.S. Food and Drug Administration April 1996 - December 2011
U.S. Food and Drug Administration April 1991 - March 1996
U.S. Food and Drug Administration August 1972 - April 1991
Skills
Food packaging for high..., Management Consulting, ERP, Business Analysis, Change Management, Business Strategy, Manufacturing, FDA, HACCP, Training, Sop, GMP, Auditing, Food Safety, Technical Writing, Medical Devices, Food, Packaging, Food Science, Quality Assurance, Food Industry
Education
FDA Long Term Training - Food Technology 1989 — 1990
Food Processing and Packaging, A
Northern Illinois University 1974 — 1976
Master of Business Administration (MBA), Business Administration
Oregon State University 1967 — 1969
Bachelor's degree, Food Science and Technology
Eileen Rhoads Eileen Rhoads's U.S. Food and Drug Administration Experience July 1989 - February 2008
Job
Industry Writing and Editing
Experience
Self-employed writer/author May 2008 - Present
Self-elployed 2008 - 2013
U.S. Food and Drug Administration July 1989 - February 2008
National Institutes of Health March 1983 - July 1989
Skills
Legal Research and..., Paralegal Studies
Education
University College, College Park, Maryland 1988 — 1991
Bachelor of Arts (BA), Paralegal Studies
University of Maryland College Park 1965 — 1972
Bachelor of Science (BS), Special Education and Teaching, 3.5
Self-employed writer/author May 2008 - Present
Self-elployed 2008 - 2013
U.S. Food and Drug Administration July 1989 - February 2008
National Institutes of Health March 1983 - July 1989
Skills
Legal Research and..., Paralegal Studies
Education
University College, College Park, Maryland 1988 — 1991
Bachelor of Arts (BA), Paralegal Studies
University of Maryland College Park 1965 — 1972
Bachelor of Science (BS), Special Education and Teaching, 3.5
Christopher Fiesel Christopher Fiesel's U.S. Food and Drug Administration Experience July 2010 - July 2015
Job Independent Contract Investigator
Industry Security and Investigations
Experience
Government Contractor August 2015 - Present
U.S. Food and Drug Administration July 2010 - July 2015
U.S. Navy Reserve September 1992 - September 2012
U.S. Food and Drug Administration October 2000 - July 2010
U.S. Customs Service (now part of DHS-ICE-HSI) October 1992 - October 2000
Naval Intelligence Operations Group Task Force 168 April 1991 - October 1992
Skills
Criminal Justice, Interrogation, Police, Enforcement, Criminal Investigations, Federal Law Enforcement, Evidence, Counterintelligence, Homeland Security, Counterterrorism, Intelligence Analysis, Internal Investigations, Investigation, National Security, Executive Protection, Private Investigations, Firearms, Intelligence, Law Enforcement..., Surveillance, Physical Security, Cybercrime, Security Operations, Emergency Management, Security Clearance, Tactics, Special Operations, Corporate Security, Crisis Management, Security Management, Force Protection, Criminal Intelligence, Government, Crime Prevention, Weapons, Team Management, Operations Management, Law Enforcement, Law Enforcement...
Education
U.S. Air Force Air Command and Staff College 2007 — 2008
Certificate - IDE-JPME, Remote Attendance:, Military Studies, Leadership, Nature of War and National Security Studies
San Diego State University-California State University 1988 — 1991
Graduate Studies - all coursework completed, did not finish thesis so no MA degree conferred, Russian Language and Literature
San Diego State University-California State University 1984 — 1988
Bachelor of Arts (B.A.), Russian Studies, Minors in English and Political Science
Government Contractor August 2015 - Present
U.S. Food and Drug Administration July 2010 - July 2015
U.S. Navy Reserve September 1992 - September 2012
U.S. Food and Drug Administration October 2000 - July 2010
U.S. Customs Service (now part of DHS-ICE-HSI) October 1992 - October 2000
Naval Intelligence Operations Group Task Force 168 April 1991 - October 1992
Skills
Criminal Justice, Interrogation, Police, Enforcement, Criminal Investigations, Federal Law Enforcement, Evidence, Counterintelligence, Homeland Security, Counterterrorism, Intelligence Analysis, Internal Investigations, Investigation, National Security, Executive Protection, Private Investigations, Firearms, Intelligence, Law Enforcement..., Surveillance, Physical Security, Cybercrime, Security Operations, Emergency Management, Security Clearance, Tactics, Special Operations, Corporate Security, Crisis Management, Security Management, Force Protection, Criminal Intelligence, Government, Crime Prevention, Weapons, Team Management, Operations Management, Law Enforcement, Law Enforcement...
Education
U.S. Air Force Air Command and Staff College 2007 — 2008
Certificate - IDE-JPME, Remote Attendance:, Military Studies, Leadership, Nature of War and National Security Studies
San Diego State University-California State University 1988 — 1991
Graduate Studies - all coursework completed, did not finish thesis so no MA degree conferred, Russian Language and Literature
San Diego State University-California State University 1984 — 1988
Bachelor of Arts (B.A.), Russian Studies, Minors in English and Political Science
Christopher DiFrancesco's U.S. Food and Drug Administration Experience September 2007 - November 2008
Job Associate Vice President for Communications at University of Rochester Medical Center
Industry Hospital & Health Care
Experience
University of Rochester Medical Center December 2014 - Present
University of Rochester Medical Center January 2013 - December 2014
National Cancer Institute June 2012 - January 2013
National Cancer Institute November 2008 - June 2012
U.S. Food and Drug Administration September 2007 - November 2008
Duke University Medical Center June 2006 - September 2007
Duke University Medical Center November 2004 - June 2006
University of Rochester Medical Center June 1997 - November 2004
Education
Rochester Institute of Technology
B.S., Communication
The Johns Hopkins University
M.A. expected 2015, Science and Medical Writing
University of Rochester Medical Center December 2014 - Present
University of Rochester Medical Center January 2013 - December 2014
National Cancer Institute June 2012 - January 2013
National Cancer Institute November 2008 - June 2012
U.S. Food and Drug Administration September 2007 - November 2008
Duke University Medical Center June 2006 - September 2007
Duke University Medical Center November 2004 - June 2006
University of Rochester Medical Center June 1997 - November 2004
Education
Rochester Institute of Technology
B.S., Communication
The Johns Hopkins University
M.A. expected 2015, Science and Medical Writing
James Milewski James Milewski's U.S. Food and Drug Administration Experience June 2011 - Present
Job Software Engineer, Medical Informatics
Industry Information Technology and Services
Experience
U.S. Food and Drug Administration June 2011 - Present
University of California, Irvine September 2010 - June 2012
California Institute for Telecommunications and Information Technology June 2009 - September 2009
Education
University of California, Irvine 2010 — 2012
Graduate Student, Software Engineering
University of California, Irvine 2007 — 2010
B.S., Informatics
Orange Coast College
A.S, Mathematics; Electronics Technology
U.S. Food and Drug Administration June 2011 - Present
University of California, Irvine September 2010 - June 2012
California Institute for Telecommunications and Information Technology June 2009 - September 2009
Education
University of California, Irvine 2010 — 2012
Graduate Student, Software Engineering
University of California, Irvine 2007 — 2010
B.S., Informatics
Orange Coast College
A.S, Mathematics; Electronics Technology
Ron Lahti's U.S. Food and Drug Administration Experience January 2009 - September 2009
Job Environmental, Safety, Occupational Health & Security Professional
Industry Public Safety
Experience
Pierce County/Pacific Coast Security September 2012 - Present
Pierce County Security, Inc. d.b.a. Pacific Coast Security August 2012 - February 2013
National Everclean Services [Currently d.b.a. Underwriter Laboratories Everclean] November 2009 - April 2010
U.S. Food and Drug Administration January 2009 - September 2009
Veterans of Foreign Wars January 2006 - July 2008
United States Air Force September 2003 - January 2006
U.S. Air Force July 1991 - September 2003
U.S. Army January 1989 - June 1991
U.S. Army, TRADOC Command Units October 1984 - December 1988
The Northstar June 1983 - September 1984
Skills
Auditing, Process Improvement, Food Safety, Government, HACCP, Risk Assessment, Policy, Strategic Planning, Regulations, Quality Auditing, Team Leadership, Microsoft Excel, Microsoft Office, PowerPoint, Microsoft Word, Project Planning, Emergency Management, Safety Management..., Security, Software Documentation, Security Clearance, Military, Program Management, Supervisory Skills, Enforcement, Occupational Health, Command, DoD, Training, Military Experience, Leadership, Tactics, Management, Security Management, Weapons, Military Operations, Private Investigations, Security Operations, Army, Physical Security, Air Force, Defense, Industrial Hygiene, Intelligence Analysis, Executive Protection, Surveillance, Firearms, Investigation, Homeland Security, Counterterrorism
Education
Tulane University 1989 — 1991
Master of Public Health (MPH), Environmental Science
College of Saint Scholastica 1978 — 1981
Bachelor of Arts (BA), Biology, General
Pierce County/Pacific Coast Security September 2012 - Present
Pierce County Security, Inc. d.b.a. Pacific Coast Security August 2012 - February 2013
National Everclean Services [Currently d.b.a. Underwriter Laboratories Everclean] November 2009 - April 2010
U.S. Food and Drug Administration January 2009 - September 2009
Veterans of Foreign Wars January 2006 - July 2008
United States Air Force September 2003 - January 2006
U.S. Air Force July 1991 - September 2003
U.S. Army January 1989 - June 1991
U.S. Army, TRADOC Command Units October 1984 - December 1988
The Northstar June 1983 - September 1984
Skills
Auditing, Process Improvement, Food Safety, Government, HACCP, Risk Assessment, Policy, Strategic Planning, Regulations, Quality Auditing, Team Leadership, Microsoft Excel, Microsoft Office, PowerPoint, Microsoft Word, Project Planning, Emergency Management, Safety Management..., Security, Software Documentation, Security Clearance, Military, Program Management, Supervisory Skills, Enforcement, Occupational Health, Command, DoD, Training, Military Experience, Leadership, Tactics, Management, Security Management, Weapons, Military Operations, Private Investigations, Security Operations, Army, Physical Security, Air Force, Defense, Industrial Hygiene, Intelligence Analysis, Executive Protection, Surveillance, Firearms, Investigation, Homeland Security, Counterterrorism
Education
Tulane University 1989 — 1991
Master of Public Health (MPH), Environmental Science
College of Saint Scholastica 1978 — 1981
Bachelor of Arts (BA), Biology, General
Teresa Rubio's U.S. Food and Drug Administration Experience April 2014 - Present
Job Health Programs Coordinator, Office of Health and Constituent Affairs, FDA
Industry Pharmaceuticals
Experience
U.S. Food and Drug Administration April 2014 - Present
Kangs Black Belt Academy 2010 - Present
FDA June 2009 - March 2014
ASHP February 2008 - March 2009
ASHP June 2003 - February 2008
Marymount Hospital June 1999 - June 2003
Skills
Pharmacy, Healthcare, Pharmacists, Research, Inpatient, Pharmacy Automation, Clinical Research, Pharmacovigilance, Diabetes, Healthcare Information..., Public Health
Education
University of Maryland University College 1993 — 1997
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of Virginia 1989 — 1993
BA, Chemistry
U.S. Food and Drug Administration April 2014 - Present
Kangs Black Belt Academy 2010 - Present
FDA June 2009 - March 2014
ASHP February 2008 - March 2009
ASHP June 2003 - February 2008
Marymount Hospital June 1999 - June 2003
Skills
Pharmacy, Healthcare, Pharmacists, Research, Inpatient, Pharmacy Automation, Clinical Research, Pharmacovigilance, Diabetes, Healthcare Information..., Public Health
Education
University of Maryland University College 1993 — 1997
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of Virginia 1989 — 1993
BA, Chemistry
Darlene Huang Darlene Huang's U.S. Food and Drug Administration Experience September 2014 - August 2015
Job Staff Attorney at Public Health Law Center
Industry Public Policy
Experience
Public Health Law Center September 2015 - Present
U.S. Food and Drug Administration September 2014 - August 2015
Skills
Legal Research, Legal Writing, Public Policy, Health Law, Policy Analysis, Public Health, Policy
Education
University of Minnesota-Twin Cities 2011 — 2014
Master of Public Health (MPH), Public Health Administration and Policy
William Mitchell College of Law 2010 — 2014
Doctor of Law (JD)
Public Health Law Center September 2015 - Present
U.S. Food and Drug Administration September 2014 - August 2015
Skills
Legal Research, Legal Writing, Public Policy, Health Law, Policy Analysis, Public Health, Policy
Education
University of Minnesota-Twin Cities 2011 — 2014
Master of Public Health (MPH), Public Health Administration and Policy
William Mitchell College of Law 2010 — 2014
Doctor of Law (JD)
Maegen Colehour Maegen Colehour's U.S. Food and Drug Administration Experience February 2009 - Present
Job Biomedical Engineer at FDA
Industry Medical Devices
Experience
U.S. Food and Drug Administration February 2009 - Present
Yale University May 2008 - September 2008
Draper Laboratory March 2006 - May 2007
Yale University June 2006 - August 2006
Tufts University January 2005 - May 2005
Skills
Medical Devices, Regulatory Submissions, Regulatory Requirements, Regenerative Medicine, FDA, Biomedical Engineering, Cell Culture, Tissue Culture, Aseptic Technique, Protein Purification, FACS, Tissue Engineering
Education
Yale University 2007 — 2008
MS, Biomedical Engineering
Tufts University 2003 — 2007
BS, Biomedical Engineering, Chemical Engineering
U.S. Food and Drug Administration February 2009 - Present
Yale University May 2008 - September 2008
Draper Laboratory March 2006 - May 2007
Yale University June 2006 - August 2006
Tufts University January 2005 - May 2005
Skills
Medical Devices, Regulatory Submissions, Regulatory Requirements, Regenerative Medicine, FDA, Biomedical Engineering, Cell Culture, Tissue Culture, Aseptic Technique, Protein Purification, FACS, Tissue Engineering
Education
Yale University 2007 — 2008
MS, Biomedical Engineering
Tufts University 2003 — 2007
BS, Biomedical Engineering, Chemical Engineering
Courtney Cruse Courtney Cruse's U.S. Food and Drug Administration Experience May 2015 - August 2015
Job Student at Western Kentucky University
Industry Chemicals
Experience
Western Kentucky University Chemistry Department February 2015 - Present
Western Kentucky University 2015 - Present
Independent 2014 - Present
U.S. Food and Drug Administration May 2015 - August 2015
Education
Western Kentucky University 2013 — 2017
Double Major in Chemistry and Criminology, 3.94
The Washington Center for Internships and Academic Seminars
Law and Criminal Justice Professional Track
Cooperative Center for Study Abroad
Rediscovering Chemistry’s British Roots
Western Kentucky University Chemistry Department February 2015 - Present
Western Kentucky University 2015 - Present
Independent 2014 - Present
U.S. Food and Drug Administration May 2015 - August 2015
Education
Western Kentucky University 2013 — 2017
Double Major in Chemistry and Criminology, 3.94
The Washington Center for Internships and Academic Seminars
Law and Criminal Justice Professional Track
Cooperative Center for Study Abroad
Rediscovering Chemistry’s British Roots
Arielle Gabarda's U.S. Food and Drug Administration Experience June 2015 - June 2015
Job Clinical Pharmacist Intern at Sarasota Memorial Health Care System
Industry Pharmaceuticals
Experience
Sarasota Memorial Health Care System July 2015 - Present
CVS Health February 2012 - Present
U.S. Food and Drug Administration June 2015 - June 2015
Southeastern Integrated Medical Health May 2015 - May 2015
University of Florida Medication Therapy Management Communication & Care Center March 2015 - April 2015
Skills
Pharmaceutical Industry, Managed Care, Leadership, Teamwork, Event Production, Newsletter Production, Public Speaking, Microsoft Excel, Time Management
Education
University of Florida College of Pharmacy 2012 — 2016
Doctor of Pharmacy (Pharm.D.)
University of Florida 2008 — 2011
Bachelor’s Degree, Human Nutrition
Sarasota Memorial Health Care System July 2015 - Present
CVS Health February 2012 - Present
U.S. Food and Drug Administration June 2015 - June 2015
Southeastern Integrated Medical Health May 2015 - May 2015
University of Florida Medication Therapy Management Communication & Care Center March 2015 - April 2015
Skills
Pharmaceutical Industry, Managed Care, Leadership, Teamwork, Event Production, Newsletter Production, Public Speaking, Microsoft Excel, Time Management
Education
University of Florida College of Pharmacy 2012 — 2016
Doctor of Pharmacy (Pharm.D.)
University of Florida 2008 — 2011
Bachelor’s Degree, Human Nutrition
Stacy Shord Stacy Shord's U.S. Food and Drug Administration Experience August 2009 - Present
Job Clinical Pharmacology Reviewer at U.S. Food and Drug Administration
Industry Health, Wellness and Fitness
Experience
U.S. Food and Drug Administration August 2009 - Present
University of Illinois at Chicago September 2001 - May 2009
University of North Carolina at Chapel Hill July 1999 - August 2001
UNC Hospitals July 1998 - June 1999
UPMC July 1997 - June 1998
Skills
Clinical Pharmacology, Oncology, Drug Metabolism, Drug Interactions, Pharmacokinetics, Clinical Research, Pharmacists, Pharmacy, Clinical Trials, Medical Writing, Clinical Development, Drug Development, Medical Education, Healthcare, Pharmaceutics, Cancer, Pharmacology
Education
University of Maryland Baltimore 1993 — 1997
Doctor of Pharmacy (Pharm.D.)
Western Maryland College 1991 — 1993
Pre-Pharmacy
U.S. Food and Drug Administration August 2009 - Present
University of Illinois at Chicago September 2001 - May 2009
University of North Carolina at Chapel Hill July 1999 - August 2001
UNC Hospitals July 1998 - June 1999
UPMC July 1997 - June 1998
Skills
Clinical Pharmacology, Oncology, Drug Metabolism, Drug Interactions, Pharmacokinetics, Clinical Research, Pharmacists, Pharmacy, Clinical Trials, Medical Writing, Clinical Development, Drug Development, Medical Education, Healthcare, Pharmaceutics, Cancer, Pharmacology
Education
University of Maryland Baltimore 1993 — 1997
Doctor of Pharmacy (Pharm.D.)
Western Maryland College 1991 — 1993
Pre-Pharmacy
Ayana Henry's U.S. Food and Drug Administration Experience April 2014 - August 2014
Job Ethics Program Advisor, National Institute of Health
Industry Government Administration
Experience
National Institutes of Health August 2014 - Present
U.S. Food and Drug Administration April 2014 - August 2014
Department of Veterans Affairs, Office of Policy and Planning April 2013 - April 2014
U.S. Department of Homeland Security May 2011 - April 2013
FEMA November 2010 - May 2011
Northrop Grumman Corporation, Contracted to the Federal Emergency Management Agency February 2010 - November 2010
BB&T Legal Department September 2007 - February 2010
Skills
Policy, Public Policy, Policy Analysis, Management, Government, Legal, Performance Auditing, Government Auditing, Emergency Management, Program Evaluation, Microsoft Office, Research
Education
Northwestern University 2010 — 2012
Masters of Arts, Public Policy and Administration
Norfolk State University 2002 — 2006
Bachelor of Arts, Political Science and Government, 3.11
National Institutes of Health August 2014 - Present
U.S. Food and Drug Administration April 2014 - August 2014
Department of Veterans Affairs, Office of Policy and Planning April 2013 - April 2014
U.S. Department of Homeland Security May 2011 - April 2013
FEMA November 2010 - May 2011
Northrop Grumman Corporation, Contracted to the Federal Emergency Management Agency February 2010 - November 2010
BB&T Legal Department September 2007 - February 2010
Skills
Policy, Public Policy, Policy Analysis, Management, Government, Legal, Performance Auditing, Government Auditing, Emergency Management, Program Evaluation, Microsoft Office, Research
Education
Northwestern University 2010 — 2012
Masters of Arts, Public Policy and Administration
Norfolk State University 2002 — 2006
Bachelor of Arts, Political Science and Government, 3.11
Elizabeth Lakota's U.S. Food and Drug Administration Experience May 2014 - June 2014
Job PGY1 Pharmacy Practice Resident at University of Illinois at Chicago
Industry Pharmaceuticals
Experience
University of Illinois at Chicago July 2015 - Present
Institute for Clinical Pharmacodynamics October 2012 - May 2015
Women and Children's Hospital of Buffalo July 2014 - August 2014
U.S. Food and Drug Administration May 2014 - June 2014
Hoffmann-La Roche May 2012 - August 2012
Newark-Wayne Community Hospital May 2011 - March 2012
Kinney Drugs May 2009 - August 2011
University at Buffalo August 2009 - May 2010
Education
State University of New York at Buffalo 2008 — 2015
Doctor of Pharmacy (PharmD) / Master of Science (MS), Pharmacometrics
University of Illinois at Chicago July 2015 - Present
Institute for Clinical Pharmacodynamics October 2012 - May 2015
Women and Children's Hospital of Buffalo July 2014 - August 2014
U.S. Food and Drug Administration May 2014 - June 2014
Hoffmann-La Roche May 2012 - August 2012
Newark-Wayne Community Hospital May 2011 - March 2012
Kinney Drugs May 2009 - August 2011
University at Buffalo August 2009 - May 2010
Education
State University of New York at Buffalo 2008 — 2015
Doctor of Pharmacy (PharmD) / Master of Science (MS), Pharmacometrics
Alexis Novoa, MP,GISP Alexis Novoa, MP,GISP's U.S. Food and Drug Administration Experience September 2014 - Present
Job Management and Program Analyst at U.S. Food and Drug Administration (FDA)
Industry Government Administration
Experience
U.S. Food and Drug Administration September 2014 - Present
U.S. Department of Veterans Affairs September 2012 - September 2014
U.S. Census Bureau June 2009 - September 2012
U.S. Department of Health and Human Services 2008 - 2009
Guaynabo Autonomous Municipality September 2005 - September 2008
Skills
Geography, GIS, GPS, ArcGIS, Demographic Analysis, Geoprocessing, Data Collection, GIS systems, Demography, Urban Planning, GIS Application, Enterprise GIS, Government Contracting, COTR, Demographics, Leadership, Project Planning, Strategic Planning, Policy, Statistical Data..., Data Analysis, Geospatial Data, Geostatistics, Program Evaluation, Project Management
Education
University of Puerto Rico
Master, Planning
Universidad de Puerto Rico
Bachelor's degree, Geography and Cartography
U.S. Food and Drug Administration September 2014 - Present
U.S. Department of Veterans Affairs September 2012 - September 2014
U.S. Census Bureau June 2009 - September 2012
U.S. Department of Health and Human Services 2008 - 2009
Guaynabo Autonomous Municipality September 2005 - September 2008
Skills
Geography, GIS, GPS, ArcGIS, Demographic Analysis, Geoprocessing, Data Collection, GIS systems, Demography, Urban Planning, GIS Application, Enterprise GIS, Government Contracting, COTR, Demographics, Leadership, Project Planning, Strategic Planning, Policy, Statistical Data..., Data Analysis, Geospatial Data, Geostatistics, Program Evaluation, Project Management
Education
University of Puerto Rico
Master, Planning
Universidad de Puerto Rico
Bachelor's degree, Geography and Cartography
Alexandra Martinez Faberlle Alexandra Martinez Faberlle's U.S. Food and Drug Administration Experience September 2008 - September 2011
Job English teacher, Translator, Interpreter and Editor Freelancer
Industry Translation and Localization
Experience
- Freelancer October 2013 - Present
Academia d’estudis L’Espiral October 2014 - August 2015
Hillsong Church July 2014 - August 2015
Language Meeting Point December 2013 - June 2014
TransPerfect February 2013 - July 2013
La Pedrera November 2012 - November 2012
U.S. Food and Drug Administration September 2008 - September 2011
Skills
Spanish-English, Translation, Editing, Foreign Languages, Spanish, Intercultural..., Teaching English as a..., Proofreading, Linguistics, Literature, English, Multilingual, Language Teaching, Italian, Technical Translation, Localization, ESL
Education
Universitat Autònoma de Barcelona 2011 — 2013
Master's degree, Audiovisual and Literary Translation and Intercultural Mediation
University of Puerto Rico-Rio Piedras 2006 — 2011
Bachelor's degree, Translation Studies
Centro Linguistico Italiano Dante Alighieri, Florence
Summer Program, Italian Language
- Freelancer October 2013 - Present
Academia d’estudis L’Espiral October 2014 - August 2015
Hillsong Church July 2014 - August 2015
Language Meeting Point December 2013 - June 2014
TransPerfect February 2013 - July 2013
La Pedrera November 2012 - November 2012
U.S. Food and Drug Administration September 2008 - September 2011
Skills
Spanish-English, Translation, Editing, Foreign Languages, Spanish, Intercultural..., Teaching English as a..., Proofreading, Linguistics, Literature, English, Multilingual, Language Teaching, Italian, Technical Translation, Localization, ESL
Education
Universitat Autònoma de Barcelona 2011 — 2013
Master's degree, Audiovisual and Literary Translation and Intercultural Mediation
University of Puerto Rico-Rio Piedras 2006 — 2011
Bachelor's degree, Translation Studies
Centro Linguistico Italiano Dante Alighieri, Florence
Summer Program, Italian Language
Pasha Hadidi Pasha Hadidi's U.S. Food and Drug Administration Experience June 2008 - August 2008
Job Postdoctoral researcher at University of California
Industry Biotechnology
Experience
University of California, Davis January 2015 - October 2015
PreScouter, Inc. February 2014 - April 2015
University of California, Davis September 2009 - December 2014
Johns Hopkins University September 2008 - May 2009
U.S. Food and Drug Administration June 2008 - August 2008
Johns Hopkins University, Build-A-Genome Project January 2008 - May 2008
Johns Hopkins University, Yarema Lab September 2007 - May 2008
U.S. Food and Drug Administration June 2007 - August 2007
Skills
Biomedical Engineering, Cell Culture, Data Analysis, Tissue Engineering, Matlab
Education
University of California, Davis - Graduate School of Management 2013 — 2014
Certificate in Business Development
University of California, Davis 2009 — 2014
Doctor of Philosophy (Ph.D.), Biomedical Engineering
The Johns Hopkins University 2005 — 2009
Bachelor of Science (B.S.), Biomedical Engineering
University of California, Davis January 2015 - October 2015
PreScouter, Inc. February 2014 - April 2015
University of California, Davis September 2009 - December 2014
Johns Hopkins University September 2008 - May 2009
U.S. Food and Drug Administration June 2008 - August 2008
Johns Hopkins University, Build-A-Genome Project January 2008 - May 2008
Johns Hopkins University, Yarema Lab September 2007 - May 2008
U.S. Food and Drug Administration June 2007 - August 2007
Skills
Biomedical Engineering, Cell Culture, Data Analysis, Tissue Engineering, Matlab
Education
University of California, Davis - Graduate School of Management 2013 — 2014
Certificate in Business Development
University of California, Davis 2009 — 2014
Doctor of Philosophy (Ph.D.), Biomedical Engineering
The Johns Hopkins University 2005 — 2009
Bachelor of Science (B.S.), Biomedical Engineering
Joanna (Joanna Parks) MacEwan Joanna (Joanna Parks) MacEwan's U.S. Food and Drug Administration Experience June 2012 - July 2013
Job Research Economist at Precision Health Economics, LLC
Industry Research
Experience
Precision Health Economics, LLC July 2013 - Present
U.S. Food and Drug Administration June 2012 - July 2013
UC Davis October 2011 - June 2012
UC Davis August 2011 - September 2011
UC Davis July 2007 - September 2011
Institute of Governmental Affairs, UC Davis June 2006 - September 2006
Skills
Stata, Econometrics, R, Economics, Policy Analysis, Public Policy, Research, Public Health, SAS, Statistics, Nonprofits, Science, Data Analysis, Sustainable Agriculture, Quantitative Analytics, Policy, Teaching, Microeconomics, Higher Education, Program Evaluation, Economic Development, Sustainability, Agriculture, SPSS, Qualitative Research, Fundraising, Statistical Modeling, Community Outreach, International..., Economic Research, Matlab, Grants
Education
University of California, Davis 2006 — 2011
Ph.D., Agricultural Economics, Health Economics, Applied Economics, Resource Economics
University of California, Davis 2003 — 2006
BA, Economics, Philosophy
Precision Health Economics, LLC July 2013 - Present
U.S. Food and Drug Administration June 2012 - July 2013
UC Davis October 2011 - June 2012
UC Davis August 2011 - September 2011
UC Davis July 2007 - September 2011
Institute of Governmental Affairs, UC Davis June 2006 - September 2006
Skills
Stata, Econometrics, R, Economics, Policy Analysis, Public Policy, Research, Public Health, SAS, Statistics, Nonprofits, Science, Data Analysis, Sustainable Agriculture, Quantitative Analytics, Policy, Teaching, Microeconomics, Higher Education, Program Evaluation, Economic Development, Sustainability, Agriculture, SPSS, Qualitative Research, Fundraising, Statistical Modeling, Community Outreach, International..., Economic Research, Matlab, Grants
Education
University of California, Davis 2006 — 2011
Ph.D., Agricultural Economics, Health Economics, Applied Economics, Resource Economics
University of California, Davis 2003 — 2006
BA, Economics, Philosophy
Mina Choi's U.S. Food and Drug Administration Experience May 2010 - August 2012
Job Fischell Fellow/PhD Candidate at University of Maryland
Industry Research
Experience
University of Maryland August 2012 - Present
KSEA 2015 - 2015
U.S. Food and Drug Administration May 2010 - August 2012
U.S. Food and Drug Administration January 2010 - May 2010
George Washington Univeristy May 2008 - May 2010
Iowa State University May 2009 - July 2009
Skills
Matlab, Biomedical Engineering, Statistics, C++, LaTeX, Science, Data Analysis, Research, Analysis, LabVIEW, Technical Writing, Cell Culture, C, Pspice, Verilog, Electronics, Signal Processing, Image Processing, Python, R
Education
University of Maryland College Park 2012 — 2016
Doctor of Philosophy (PhD), Bioengineering and Biomedical Engineering
The George Washington University 2006 — 2011
M.S./B.S., Electrical Engineering (Biomedical Engineering)
University of Maryland August 2012 - Present
KSEA 2015 - 2015
U.S. Food and Drug Administration May 2010 - August 2012
U.S. Food and Drug Administration January 2010 - May 2010
George Washington Univeristy May 2008 - May 2010
Iowa State University May 2009 - July 2009
Skills
Matlab, Biomedical Engineering, Statistics, C++, LaTeX, Science, Data Analysis, Research, Analysis, LabVIEW, Technical Writing, Cell Culture, C, Pspice, Verilog, Electronics, Signal Processing, Image Processing, Python, R
Education
University of Maryland College Park 2012 — 2016
Doctor of Philosophy (PhD), Bioengineering and Biomedical Engineering
The George Washington University 2006 — 2011
M.S./B.S., Electrical Engineering (Biomedical Engineering)
Tom Montville's U.S. Food and Drug Administration Experience 1999 - 2002
Job Distinguished Professor of Food Science
Industry Higher Education
Experience
Journal of industrial Microbiology and Biotechnology November 2014 - Present
Rutgers University 1998 - Present
Universidad Technológica de la Mixteca 2012 - Present
Various Firms 2006 - Present
Journal of Food Safety 1988 - 2003
U.S. Food and Drug Administration 1999 - 2002
Rutgers University 1997 - 2000
Rutgers University 1984 - 1998
Rutgers University 1991 - 1994
U.S. Department of Agriculture 1980 - 1984
Skills
Food Safety, Food Microbiology, Food Science, Expert Witness, Natural claims, Higher Education, Ingredients, Food, Food Industry, Laboratory, Leadership, Microbiology, Protein Chemistry, Research, Science, Teaching, Biotechnology, Biochemistry, R, Life Sciences, R&D
Education
Massachusetts Institute of Technology 1975 — 1979
Doctor of Philosophy (Ph.D.), Food Science
Rutgers University-New Brunswick 1971 — 1975
Bachelor's Degree, Food Science, cum laude
Journal of industrial Microbiology and Biotechnology November 2014 - Present
Rutgers University 1998 - Present
Universidad Technológica de la Mixteca 2012 - Present
Various Firms 2006 - Present
Journal of Food Safety 1988 - 2003
U.S. Food and Drug Administration 1999 - 2002
Rutgers University 1997 - 2000
Rutgers University 1984 - 1998
Rutgers University 1991 - 1994
U.S. Department of Agriculture 1980 - 1984
Skills
Food Safety, Food Microbiology, Food Science, Expert Witness, Natural claims, Higher Education, Ingredients, Food, Food Industry, Laboratory, Leadership, Microbiology, Protein Chemistry, Research, Science, Teaching, Biotechnology, Biochemistry, R, Life Sciences, R&D
Education
Massachusetts Institute of Technology 1975 — 1979
Doctor of Philosophy (Ph.D.), Food Science
Rutgers University-New Brunswick 1971 — 1975
Bachelor's Degree, Food Science, cum laude
Jason Sapsin Jason Sapsin's U.S. Food and Drug Administration Experience October 2007 - July 2010
Job Counsel at Faegre Baker Daniels LLP
Industry Law Practice
Experience
Faegre Baker Daniels LLP April 2015 - Present
Fox Rothschild LLP September 2013 - April 2015
Polsinelli Shughart PC July 2010 - September 2013
U.S. Food and Drug Administration October 2007 - July 2010
Maryland Office of the Attorney General May 2005 - October 2007
Johns Hopkins Bloomberg School of Public Health October 2001 - April 2005
Hirsch, Adams et al. September 1997 - July 2001
Patton Boggs LLP February 1995 - July 1996
Skills
FDA, Public Health, Administrative Law, Health Law, Litigation, Policy Analysis, Lifesciences, Clinical Trials, Start-ups, Health Policy, Biotechnology, Government, Nonprofits, CRO, Regulatory Affairs, Infectious Diseases, Policy, Civil Litigation, Patent Litigation, Legal Research, Mediation, Legal Writing, Licensing, Life Sciences
Education
The Johns Hopkins University 2001 — 2003
MPH, Public Health
University of Michigan Law School 1992 — 1994
JD, Law
Williams College 1987 — 1991
BA, English; History
Faegre Baker Daniels LLP April 2015 - Present
Fox Rothschild LLP September 2013 - April 2015
Polsinelli Shughart PC July 2010 - September 2013
U.S. Food and Drug Administration October 2007 - July 2010
Maryland Office of the Attorney General May 2005 - October 2007
Johns Hopkins Bloomberg School of Public Health October 2001 - April 2005
Hirsch, Adams et al. September 1997 - July 2001
Patton Boggs LLP February 1995 - July 1996
Skills
FDA, Public Health, Administrative Law, Health Law, Litigation, Policy Analysis, Lifesciences, Clinical Trials, Start-ups, Health Policy, Biotechnology, Government, Nonprofits, CRO, Regulatory Affairs, Infectious Diseases, Policy, Civil Litigation, Patent Litigation, Legal Research, Mediation, Legal Writing, Licensing, Life Sciences
Education
The Johns Hopkins University 2001 — 2003
MPH, Public Health
University of Michigan Law School 1992 — 1994
JD, Law
Williams College 1987 — 1991
BA, English; History
Jin (Connie) Yan Jin (Connie) Yan's U.S. Food and Drug Administration Experience May 2011 - May 2013
Job Quantitative Analyst at Capital One
Industry Financial Services
Experience
Capital One May 2015 - Present
Fannie Mae May 2013 - 2015
U.S. Food and Drug Administration May 2011 - May 2013
University of Maryland August 2008 - May 2013
University of Maryland August 2008 - June 2011
Skills
Statistics, Eye Tracking Data..., Marketing Research, Biostatistics, Meta-Analysis, Bayesian statistics, Hidden Markov Models, SAS Certified Base..., Group Fitness Instructor, R, Machine Learning, Time Series Analysis, Statistical Modeling, SPSS, Data Mining, SAS, Survival Analysis, Data Analysis, LaTeX, Matlab, Research, Multivariate Analysis, Economics, Analytics, Clinical Trials, Meta-analysis
Education
University of Maryland College Park 2008 — 2013
Doctor of Philosophy (Ph.D.), Mathematical Statistics
Tsinghua University 2004 — 2008
Bachelor of Science (B.S.), Mathematics
Capital One May 2015 - Present
Fannie Mae May 2013 - 2015
U.S. Food and Drug Administration May 2011 - May 2013
University of Maryland August 2008 - May 2013
University of Maryland August 2008 - June 2011
Skills
Statistics, Eye Tracking Data..., Marketing Research, Biostatistics, Meta-Analysis, Bayesian statistics, Hidden Markov Models, SAS Certified Base..., Group Fitness Instructor, R, Machine Learning, Time Series Analysis, Statistical Modeling, SPSS, Data Mining, SAS, Survival Analysis, Data Analysis, LaTeX, Matlab, Research, Multivariate Analysis, Economics, Analytics, Clinical Trials, Meta-analysis
Education
University of Maryland College Park 2008 — 2013
Doctor of Philosophy (Ph.D.), Mathematical Statistics
Tsinghua University 2004 — 2008
Bachelor of Science (B.S.), Mathematics
Monica Bali, PMP Monica Bali, PMP's U.S. Food and Drug Administration Experience January 2012 - Present
Job IT Program Manager at Food and Drug Administration
Industry Information Technology and Services
Experience
U.S. Food and Drug Administration January 2012 - Present
Deloitte Consulting May 2009 - January 2012
BearingPoint September 2007 - May 2009
Accenture March 2004 - September 2007
Skills
Business Process..., Management Consulting, Information Systems, Strategic Communications, Strategic Partnerships, Consulting, Communicaitons, Requirements Workshops, Requirements Gathering, Requirements Management, System Design, System Integration..., Training, Training Facilitation, Development & delivery..., Project Management, Program Management, Business Process Design, Business Transformation, Oracle E-Business Suite, Change Management, IT Strategy, Business Intelligence, Requirements Analysis, Enterprise Architecture, Business Process, PMO, SDLC, PMP, Governance, Integration, Information Technology, Software Project..., Project Portfolio...
Education
University of Maryland College Park 2000 — 2003
Bachelor of Science (B.S.), Dual Degree in Decision Information Systems and Marketing
University of Maryland Baltimore County 1999 — 2000
U.S. Food and Drug Administration January 2012 - Present
Deloitte Consulting May 2009 - January 2012
BearingPoint September 2007 - May 2009
Accenture March 2004 - September 2007
Skills
Business Process..., Management Consulting, Information Systems, Strategic Communications, Strategic Partnerships, Consulting, Communicaitons, Requirements Workshops, Requirements Gathering, Requirements Management, System Design, System Integration..., Training, Training Facilitation, Development & delivery..., Project Management, Program Management, Business Process Design, Business Transformation, Oracle E-Business Suite, Change Management, IT Strategy, Business Intelligence, Requirements Analysis, Enterprise Architecture, Business Process, PMO, SDLC, PMP, Governance, Integration, Information Technology, Software Project..., Project Portfolio...
Education
University of Maryland College Park 2000 — 2003
Bachelor of Science (B.S.), Dual Degree in Decision Information Systems and Marketing
University of Maryland Baltimore County 1999 — 2000
Michelle D. Johnson, CPC, CHES Michelle D. Johnson, CPC, CHES's U.S. Food and Drug Administration Experience December 2012 - Present
Job DrPH Graduate Student at Morgan State University
Industry Higher Education
Experience
U.S. Food and Drug Administration December 2012 - Present
Morgan State University August 2009 - Present
Skills
Grant Writing, Program Evaluation, Higher Education, Statistics, Program Development, Data Analysis, Teaching, Community Outreach, Non-profits, Health Education, Curriculum Development, Public Speaking, Microsoft Office, Health Promotion, Event Planning, PowerPoint, Policy, Staff Development, Healthcare, Microsoft Excel, Training, Policy Analysis, Public Health, SPSS, Nonprofits
Education
Morgan State University 2009 — 2016
Dr.P.H., Public Health, 3.5
Morgan State University 1988 — 1992
B.S. Psychology, Psychology
U.S. Food and Drug Administration December 2012 - Present
Morgan State University August 2009 - Present
Skills
Grant Writing, Program Evaluation, Higher Education, Statistics, Program Development, Data Analysis, Teaching, Community Outreach, Non-profits, Health Education, Curriculum Development, Public Speaking, Microsoft Office, Health Promotion, Event Planning, PowerPoint, Policy, Staff Development, Healthcare, Microsoft Excel, Training, Policy Analysis, Public Health, SPSS, Nonprofits
Education
Morgan State University 2009 — 2016
Dr.P.H., Public Health, 3.5
Morgan State University 1988 — 1992
B.S. Psychology, Psychology
Dr. Ali Mehrabi Dr. Ali Mehrabi's U.S. Food and Drug Administration Experience January 2008 - December 2012
Job Senior Regulatory Affairs Consultant at Validant
Industry Medical Devices
Experience
Validant November 2014 - Present
Johnson and Johnson, DuPuy Synthes July 2013 - November 2014
Johnson and Johnson, Ethicon Endo-Surgery 2013 - 2013
E4D Technologies, Inc. 2012 - 2013
Insight Consulting Services 2000 - 2013
U.S. Food and Drug Administration January 2008 - December 2012
DeVry University May 2004 - May 2008
Radiance Technologies, Inc. 2002 - 2004
InTank, Inc. 2001 - 2002
JDS Uniphase 2000 - 2001
Skills
Biomedical Engineering, Matlab, Program Management, Engineering, Software Development, Product Development, Quality Assurance, Requirements Analysis, C, Software Documentation, SDLC, Team Leadership
Education
University of Oklahoma
Ph.D., Electrical Engineering
Oklahoma State University 1985 — 1986
Master of Science, Electrical Engineering
Validant November 2014 - Present
Johnson and Johnson, DuPuy Synthes July 2013 - November 2014
Johnson and Johnson, Ethicon Endo-Surgery 2013 - 2013
E4D Technologies, Inc. 2012 - 2013
Insight Consulting Services 2000 - 2013
U.S. Food and Drug Administration January 2008 - December 2012
DeVry University May 2004 - May 2008
Radiance Technologies, Inc. 2002 - 2004
InTank, Inc. 2001 - 2002
JDS Uniphase 2000 - 2001
Skills
Biomedical Engineering, Matlab, Program Management, Engineering, Software Development, Product Development, Quality Assurance, Requirements Analysis, C, Software Documentation, SDLC, Team Leadership
Education
University of Oklahoma
Ph.D., Electrical Engineering
Oklahoma State University 1985 — 1986
Master of Science, Electrical Engineering
Hui-Shan Sandra King, Pharm.D. Hui-Shan Sandra King, Pharm.D.'s U.S. Food and Drug Administration Experience May 2006 - August 2006
Job Associate at Kramer & Amado, P.C.
Industry Law Practice
Experience
KRAMER & AMADO July 2008 - Present
Kramer & Amado, P.C. May 2007 - July 2008
CVS September 2005 - December 2007
U.S. FOOD AND DRUG ADMINISTRATION May 2006 - August 2006
Skills
Legal Research, Patentability, Patents, Pharmaceutical Industry, Licensing, Medical Devices, Patent Prosecution, FDA, Legal Writing, Pharmaceutics, Legal Opinions, Patent Litigation, Trademarks, Intellectual Property, Due Diligence
Education
The George Washington University Law School 2005 — 2008
Doctor of Law (JD), Law
Rutgers University-New Brunswick 1999 — 2005
Pharm.D., with High Honors, Pharmacy
KRAMER & AMADO July 2008 - Present
Kramer & Amado, P.C. May 2007 - July 2008
CVS September 2005 - December 2007
U.S. FOOD AND DRUG ADMINISTRATION May 2006 - August 2006
Skills
Legal Research, Patentability, Patents, Pharmaceutical Industry, Licensing, Medical Devices, Patent Prosecution, FDA, Legal Writing, Pharmaceutics, Legal Opinions, Patent Litigation, Trademarks, Intellectual Property, Due Diligence
Education
The George Washington University Law School 2005 — 2008
Doctor of Law (JD), Law
Rutgers University-New Brunswick 1999 — 2005
Pharm.D., with High Honors, Pharmacy
Stan Woollen Stan Woollen's U.S. Food and Drug Administration Experience 2001 - 2006
Job Senior Compliance Advisor at Stan Woollen and Associates
Industry Pharmaceuticals
Experience
Stan Woollen and Associates July 2006 - Present
U.S. Food and Drug Administration 2001 - 2006
U.S. Food and Drug Administration 1996 - 2001
U.S. Food and Drug Administration 1993 - 1996
U.S. Food and Drug Administration 1977 - 1993
Skills
GCP, Policy, GLP, Regulatory Affairs, Clinical Development, Pharmaceutical Industry, IND, Regulatory Submissions, CRO, IRB, Quality Auditing, FDA, Clinical Research, Biotechnology, Sop, Oncology, CAPA, Regulatory Requirements, Regulations, Drug Development, Clinical Trials, 21 CFR Part 11, GLPs, Pharmacovigilance, GxP, Toxicology, SOP
Education
University of Florida
BSA, Pre-Veternary Medicine, Lab Animal Science
Stan Woollen and Associates July 2006 - Present
U.S. Food and Drug Administration 2001 - 2006
U.S. Food and Drug Administration 1996 - 2001
U.S. Food and Drug Administration 1993 - 1996
U.S. Food and Drug Administration 1977 - 1993
Skills
GCP, Policy, GLP, Regulatory Affairs, Clinical Development, Pharmaceutical Industry, IND, Regulatory Submissions, CRO, IRB, Quality Auditing, FDA, Clinical Research, Biotechnology, Sop, Oncology, CAPA, Regulatory Requirements, Regulations, Drug Development, Clinical Trials, 21 CFR Part 11, GLPs, Pharmacovigilance, GxP, Toxicology, SOP
Education
University of Florida
BSA, Pre-Veternary Medicine, Lab Animal Science
TOMMY L MOSELY TOMMY L MOSELY's U.S. Food and Drug Administration Experience December 2000 - Present
Job RetireeinChief at Retired at home
Industry Medical Devices
Experience
Retired at home January 2014 - Present
U.S. Food and Drug Administration December 2000 - Present
Nucletron Corporation April 1997 - December 2000
Skills
FDA, Medical Devices, CAPA, Regulatory Requirements, Regulatory Affairs, Regulatory Submissions, ISO 13485, GMP, Quality System, Quality Auditing, Validation, R&D, Federal Government, Regulations, Quality Assurance, V&V, Hardware Diagnostics, GLP, Sop, Lifesciences, 21 CFR Part 11, Clinical Trials, Biopharmaceuticals, Change Control, PMA, Clinical Development, IND
Education
University of Arkansas at Fayetteville 1963 — 1965
Master of Science in Instrumental Sciences, Classical Physics
University of Central Arkansas 1959 — 1962
Bachelor of Science (BS), Physics & Mathematics
Retired at home January 2014 - Present
U.S. Food and Drug Administration December 2000 - Present
Nucletron Corporation April 1997 - December 2000
Skills
FDA, Medical Devices, CAPA, Regulatory Requirements, Regulatory Affairs, Regulatory Submissions, ISO 13485, GMP, Quality System, Quality Auditing, Validation, R&D, Federal Government, Regulations, Quality Assurance, V&V, Hardware Diagnostics, GLP, Sop, Lifesciences, 21 CFR Part 11, Clinical Trials, Biopharmaceuticals, Change Control, PMA, Clinical Development, IND
Education
University of Arkansas at Fayetteville 1963 — 1965
Master of Science in Instrumental Sciences, Classical Physics
University of Central Arkansas 1959 — 1962
Bachelor of Science (BS), Physics & Mathematics
Charles Brantley Jr Charles Brantley Jr's U.S. Food and Drug Administration Experience January 2011 - June 2012
Job Disabled American Veteran at US Federal Government (Retired)
Industry Military
Experience
US Federal Government (Retired) June 2012 - Present
U.S. Food and Drug Administration January 2011 - June 2012
Centers for Disease Control and Prevention January 2010 - January 2011
Defense Contract Audit Agency October 2007 - January 2010
Army Contracting Agency September 2006 - October 2007
US Army May 2002 - May 2006
Pentagon August 2001 - May 2002
Skills
Leadership, Software Documentation, Strategy, Human Resources, Contract Management, Microsoft Office, Databases, Editing, Auditing, Government, Military, Policy
Education
University of Phoenix 2009 — 2010
Associates, Business Administration
University of Maryland University College 2004 — 2005
Biology
Strayer University 2001 — 2002
Computer Information Systems
US Federal Government (Retired) June 2012 - Present
U.S. Food and Drug Administration January 2011 - June 2012
Centers for Disease Control and Prevention January 2010 - January 2011
Defense Contract Audit Agency October 2007 - January 2010
Army Contracting Agency September 2006 - October 2007
US Army May 2002 - May 2006
Pentagon August 2001 - May 2002
Skills
Leadership, Software Documentation, Strategy, Human Resources, Contract Management, Microsoft Office, Databases, Editing, Auditing, Government, Military, Policy
Education
University of Phoenix 2009 — 2010
Associates, Business Administration
University of Maryland University College 2004 — 2005
Biology
Strayer University 2001 — 2002
Computer Information Systems
Alan Heaton's U.S. Food and Drug Administration Experience 1991 - 1999
Job Market Research Excellence Practice Lead at Microsoft
Industry Information Technology and Services
Experience
Microsoft July 2015 - Present
Microsoft January 2013 - June 2015
Biogen Idec October 2011 - December 2012
Burning Sky Records, LLC April 2006 - December 2012
Bristol-Myers Squibb October 2010 - October 2011
Novo Nordisk A/S December 2007 - September 2010
GlaxoSmithKline 2004 - 2007
MERCK & CO., INC 1999 - 2004
U.S. FOOD AND DRUG ADMINISTRATION 1991 - 1999
THE AMERICAN UNIVERSITY 1990 - 1991
Skills
Product Launch, Analytics, Market Research, Segmentation, Diabetes, Pharmaceutical Industry, Oncology, Competitive Intelligence, Research, Marketing, Marketing Research, Analysis, Forecasting, Pricing, Management, Strategy, Competitive Analysis, Healthcare, Cross-functional Team..., Training, Marketing Strategy, Business Intelligence, Business Development, Market Analysis, Consulting, Business Strategy, Strategic Planning, Managed Care, Positioning, Portfolio Management, Customer Insight, Budgets
Education
University of Maryland, College
Ph.D, Social Psychology
University of Maryland, College
M.A, Social Psychology
The Johns Hopkins University
B.A, Psychology
Hopewell Valley Central High School
University of Maryland College Park
Doctor of Philosophy (Ph.D.), Social Psychology
Microsoft July 2015 - Present
Microsoft January 2013 - June 2015
Biogen Idec October 2011 - December 2012
Burning Sky Records, LLC April 2006 - December 2012
Bristol-Myers Squibb October 2010 - October 2011
Novo Nordisk A/S December 2007 - September 2010
GlaxoSmithKline 2004 - 2007
MERCK & CO., INC 1999 - 2004
U.S. FOOD AND DRUG ADMINISTRATION 1991 - 1999
THE AMERICAN UNIVERSITY 1990 - 1991
Skills
Product Launch, Analytics, Market Research, Segmentation, Diabetes, Pharmaceutical Industry, Oncology, Competitive Intelligence, Research, Marketing, Marketing Research, Analysis, Forecasting, Pricing, Management, Strategy, Competitive Analysis, Healthcare, Cross-functional Team..., Training, Marketing Strategy, Business Intelligence, Business Development, Market Analysis, Consulting, Business Strategy, Strategic Planning, Managed Care, Positioning, Portfolio Management, Customer Insight, Budgets
Education
University of Maryland, College
Ph.D, Social Psychology
University of Maryland, College
M.A, Social Psychology
The Johns Hopkins University
B.A, Psychology
Hopewell Valley Central High School
University of Maryland College Park
Doctor of Philosophy (Ph.D.), Social Psychology
Paula Trost's U.S. Food and Drug Administration Experience June 1991 - January 2015
Job Independent Consultant
Industry Pharmaceuticals
Experience
U.S. Food and Drug Administration June 1991 - January 2015
Abbott Laboratories May 1983 - June 1988
Skills
Regulatory Affairs, Policy, Government, Evidence, IND
Education
The University of Texas at Austin 1980 — 1982
Bachelor’s Degree, Biology (minor in Microbiology)
Texas A&M University at Galveston
Marine Biology
U.S. Food and Drug Administration June 1991 - January 2015
Abbott Laboratories May 1983 - June 1988
Skills
Regulatory Affairs, Policy, Government, Evidence, IND
Education
The University of Texas at Austin 1980 — 1982
Bachelor’s Degree, Biology (minor in Microbiology)
Texas A&M University at Galveston
Marine Biology
Briana McDowell Porter Briana McDowell Porter's U.S. Food and Drug Administration Experience May 2009 - April 2011
Job High School Life Science Teacher at Cecil County Public Schools
Industry Primary/Secondary Education
Experience
Cecil County Public Schools June 2014 - Present
Lighthouse Pool Management, Inc. May 2013 - Present
Cecil County Public Schools October 2012 - June 2014
The Center for Sleep and Wake Disorders June 2011 - August 2012
U.S. Food and Drug Administration May 2009 - April 2011
St. Mary's College of Maryland August 2008 - December 2008
Ridgefield Health Department May 2008 - September 2008
Skills
Cell Culture, PCR, Clinical Research, Medical Devices, FDA, Laboratory, Cpr Certified, Research, SPSS, Gel Electrophoresis, Protein Purification, Analysis, Aseptic Technique, Fundraising, Histology, Leadership, Microsoft Office, Western Blotting, Public Health, Microsoft Excel, Science, Statistics
Education
Wilmington University 2012 — 2014
Master of Arts, Secondary Teaching (Biology)
St. Mary's College of Maryland 2006 — 2009
B.A., Biology
Cecil County Public Schools June 2014 - Present
Lighthouse Pool Management, Inc. May 2013 - Present
Cecil County Public Schools October 2012 - June 2014
The Center for Sleep and Wake Disorders June 2011 - August 2012
U.S. Food and Drug Administration May 2009 - April 2011
St. Mary's College of Maryland August 2008 - December 2008
Ridgefield Health Department May 2008 - September 2008
Skills
Cell Culture, PCR, Clinical Research, Medical Devices, FDA, Laboratory, Cpr Certified, Research, SPSS, Gel Electrophoresis, Protein Purification, Analysis, Aseptic Technique, Fundraising, Histology, Leadership, Microsoft Office, Western Blotting, Public Health, Microsoft Excel, Science, Statistics
Education
Wilmington University 2012 — 2014
Master of Arts, Secondary Teaching (Biology)
St. Mary's College of Maryland 2006 — 2009
B.A., Biology
Esteban Alicea-Rivera, CSM's U.S. Food and Drug Administration Experience September 2013 - Present
Job U.S. Food and Drug Administration
Industry Internet
Experience
U.S. Food and Drug Administration September 2013 - Present
Cisco Systems July 2013 - September 2013
Beta Alpha Psi - AICPA February 2009 - June 2013
MetaMetrics, Inc. June 2006 - November 2008
Cascades Technologies, Inc. 2005 - 2005
Binary Information Technology, Inc. 2002 - 2005
Learnwright, Inc. 2000 - 2002
Tekamah Corp. 1998 - 2000
Skills
CSS, Dreamweaver, Photoshop, XHTML, HTML, ASP.NET, C#, JavaScript, Microsoft SQL Server, IIS, Visual Studio, Section 508, Adobe Fireworks, Accessibility, jQuery, PHP, Web Design, Web Applications, Web Development
Education
University of Maryland University College 1992 — 2001
U.S. Food and Drug Administration September 2013 - Present
Cisco Systems July 2013 - September 2013
Beta Alpha Psi - AICPA February 2009 - June 2013
MetaMetrics, Inc. June 2006 - November 2008
Cascades Technologies, Inc. 2005 - 2005
Binary Information Technology, Inc. 2002 - 2005
Learnwright, Inc. 2000 - 2002
Tekamah Corp. 1998 - 2000
Skills
CSS, Dreamweaver, Photoshop, XHTML, HTML, ASP.NET, C#, JavaScript, Microsoft SQL Server, IIS, Visual Studio, Section 508, Adobe Fireworks, Accessibility, jQuery, PHP, Web Design, Web Applications, Web Development
Education
University of Maryland University College 1992 — 2001
Shirley Seo's U.S. Food and Drug Administration Experience October 2012 - Present
Job Clinical Pharmacology Team Leader at U.S. FDA
Industry Government Administration
Experience
U.S. Food and Drug Administration October 2012 - Present
U.S. Food and Drug Administration August 2007 - October 2012
U.S. Food and Drug Administration August 2004 - August 2007
Education
The University of Texas at Austin 1999 — 2004
Ph.D., Pharmaceutics
The University of Texas at Austin 1995 — 1999
B.A., Biology
U.S. Food and Drug Administration October 2012 - Present
U.S. Food and Drug Administration August 2007 - October 2012
U.S. Food and Drug Administration August 2004 - August 2007
Education
The University of Texas at Austin 1999 — 2004
Ph.D., Pharmaceutics
The University of Texas at Austin 1995 — 1999
B.A., Biology
Jennifer Miller, Ph.D.'s U.S. Food and Drug Administration Experience October 2008 - Present
Job Acting Lead Pharmacologist
Industry Government Administration
Experience
Food and Drug Administration (FDA) April 2015 - Present
U.S. Food and Drug Administration October 2008 - Present
Skills
Pharmacology, Bioequivalence, Generic Drugs, Pharmacokinetics, Clinical Pharmacology, Regulatory Policy, FDA, Molecular Biology, Biochemistry, Cell Biology, HPLC, In Vivo, In Vitro, Cell, Science, GMP, Research, Laboratory, Genetics, Life Sciences
Education
Temple University School of Medicine 2003 — 2008
Ph.D.
Towson University 1998 — 2002
B.S.
Food and Drug Administration (FDA) April 2015 - Present
U.S. Food and Drug Administration October 2008 - Present
Skills
Pharmacology, Bioequivalence, Generic Drugs, Pharmacokinetics, Clinical Pharmacology, Regulatory Policy, FDA, Molecular Biology, Biochemistry, Cell Biology, HPLC, In Vivo, In Vitro, Cell, Science, GMP, Research, Laboratory, Genetics, Life Sciences
Education
Temple University School of Medicine 2003 — 2008
Ph.D.
Towson University 1998 — 2002
B.S.
Howard Philips's U.S. Food and Drug Administration Experience August 2003 - Present
Job Attorney at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration August 2003 - Present
Education
Rider University 1985 — 1989
U.S. Food and Drug Administration August 2003 - Present
Education
Rider University 1985 — 1989
Ene Ette's U.S. Food and Drug Administration Experience June 1992 - August 1997
Job President & CEO at Anoixis Corporation
Industry Pharmaceuticals
Experience
Anoixis Corporation October 2006 - Present
Vertex Pharmaceuticals August 1997 - October 2006
U.S. Food and Drug Administration June 1992 - August 1997
Skills
Pharmacometrics, Population PK, Exposure-Response..., Modeling and Simulation, Population PK/PD..., Clinical Pharmacology, Pharmacodynamics, Clinical Trials, Clinical Study Design, Pharmacokinetics, Exposure-QTc Analysis, Scenario Planning, Drug Development..., Drug Development, eCTD Clinical..., Strategic Consulting, PK/PD, Pharmaceutical Industry, Clinical Development, WinNonlin, Drug Discovery, Biopharmaceuticals, IND, GCP, Pharmacology, FDA, Cancer, Biomarkers, CRO, Translational Research, Toxicology, Drug Delivery, Translational Medicine, Regulatory Submissions, Medical Writing, Infectious Diseases, Oncology
Education
The University of Glasgow 1988 — 1991
Ph.D. (Clinical Pharmacology, Pharmacometrics
Northeastern University
Bachelor of Science (BS), Pharmacy
University of Ife (now Obafemi Awolowo University)
Master's Degree, Pharmacology
Anoixis Corporation October 2006 - Present
Vertex Pharmaceuticals August 1997 - October 2006
U.S. Food and Drug Administration June 1992 - August 1997
Skills
Pharmacometrics, Population PK, Exposure-Response..., Modeling and Simulation, Population PK/PD..., Clinical Pharmacology, Pharmacodynamics, Clinical Trials, Clinical Study Design, Pharmacokinetics, Exposure-QTc Analysis, Scenario Planning, Drug Development..., Drug Development, eCTD Clinical..., Strategic Consulting, PK/PD, Pharmaceutical Industry, Clinical Development, WinNonlin, Drug Discovery, Biopharmaceuticals, IND, GCP, Pharmacology, FDA, Cancer, Biomarkers, CRO, Translational Research, Toxicology, Drug Delivery, Translational Medicine, Regulatory Submissions, Medical Writing, Infectious Diseases, Oncology
Education
The University of Glasgow 1988 — 1991
Ph.D. (Clinical Pharmacology, Pharmacometrics
Northeastern University
Bachelor of Science (BS), Pharmacy
University of Ife (now Obafemi Awolowo University)
Master's Degree, Pharmacology
Paul Jung's U.S. Food and Drug Administration Experience 2002 - 2004
Job
Industry Government Administration
Experience
Peace Corps May 2014 - Present
Office of the Surgeon General, Commissioned Corps Headquarters (DCCPR) January 2013 - May 2014
Physicians Professional Advisory Committee (PPAC) January 2011 - December 2012
National Institute of Environmental Health Sciences 2010 - December 2012
University of Maryland University College 2008 - December 2011
University of Maryland, College Park 1997 - 2010
U.S. House of Representatives 2007 - 2009
Peace Corps 2004 - 2007
U.S. Food and Drug Administration 2002 - 2004
Johns Hopkins School of Medicine 2000 - 2002
Skills
Teaching, Research, Policy, Government, Public Health, Epidemiology, International Health, Policy Analysis, Program Evaluation, Hospitals, Statistics, Program Management, Infectious Diseases, Healthcare Management, Public Policy, Community Health, Health Policy, Health Promotion, Prevention, Biostatistics, Global Health, Public Speaking, Health Education, Medicine, Healthcare, Program Development, Grants, Grant Writing, Community Outreach, Emergency Management, Qualitative Research, Medical Education, Clinical Research, Preventive Medicine, Preparedness, Environmental Health, Health Services Research, Federal Government, Board Certified, Quality Improvement, Community Development, Environmental Policy, Mental Health, Literature Reviews, Disaster Response, Emergency Medicine, Medical Research, Training, Informatics
Education
University of Baltimore
MBA
The George Washington University
MA
The Johns Hopkins University
MPH
University of Maryland School of Medicine
MD
University of Maryland College Park 1987 — 1991
BA
Greensburg Central Catholic 1984 — 1987
Peace Corps May 2014 - Present
Office of the Surgeon General, Commissioned Corps Headquarters (DCCPR) January 2013 - May 2014
Physicians Professional Advisory Committee (PPAC) January 2011 - December 2012
National Institute of Environmental Health Sciences 2010 - December 2012
University of Maryland University College 2008 - December 2011
University of Maryland, College Park 1997 - 2010
U.S. House of Representatives 2007 - 2009
Peace Corps 2004 - 2007
U.S. Food and Drug Administration 2002 - 2004
Johns Hopkins School of Medicine 2000 - 2002
Skills
Teaching, Research, Policy, Government, Public Health, Epidemiology, International Health, Policy Analysis, Program Evaluation, Hospitals, Statistics, Program Management, Infectious Diseases, Healthcare Management, Public Policy, Community Health, Health Policy, Health Promotion, Prevention, Biostatistics, Global Health, Public Speaking, Health Education, Medicine, Healthcare, Program Development, Grants, Grant Writing, Community Outreach, Emergency Management, Qualitative Research, Medical Education, Clinical Research, Preventive Medicine, Preparedness, Environmental Health, Health Services Research, Federal Government, Board Certified, Quality Improvement, Community Development, Environmental Policy, Mental Health, Literature Reviews, Disaster Response, Emergency Medicine, Medical Research, Training, Informatics
Education
University of Baltimore
MBA
The George Washington University
MA
The Johns Hopkins University
MPH
University of Maryland School of Medicine
MD
University of Maryland College Park 1987 — 1991
BA
Greensburg Central Catholic 1984 — 1987
Dianne Weber, PMP's U.S. Food and Drug Administration Experience July 2008 - Present
Job Program Manager at U.S. Food and Drug Administration
Industry Information Technology and Services
Experience
U.S. Food and Drug Administration July 2008 - Present
Verizon Communications, Telecommunications April 2004 - July 2007
Skills
Project Management, Microsoft Office, Visio, EPLC, Microsoft Project, Microsoft Excel, Microsoft Word, MS Project, PMP, Project Planning, PMO, Program Management, IT Strategy, SDLC, Cross-functional Team..., Process Improvement, Integration, Management, Procurement, Change Management, Software Documentation, Business Analysis, Team Leadership, Technical Writing, Business Intelligence, Requirements Analysis, SharePoint, Enterprise Architecture, ITIL, Business Process, Analysis, Databases, Strategy, Requirements Gathering, IT Management, Vendor Management, Data Analysis, Risk Management, Agile Methodologies, Quality Assurance, Resource Management, Governance, Earned Value Management, Business Process..., Software Project..., Process Engineering, CMMI, Project Portfolio..., Requirements Management, Government
Education
The George Washington University 2010 — 2011
Master's Certificate, Project Management
University of Maryland University College 2003 — 2007
Bachelor's degree, Business Administration and Management, General
U.S. Food and Drug Administration July 2008 - Present
Verizon Communications, Telecommunications April 2004 - July 2007
Skills
Project Management, Microsoft Office, Visio, EPLC, Microsoft Project, Microsoft Excel, Microsoft Word, MS Project, PMP, Project Planning, PMO, Program Management, IT Strategy, SDLC, Cross-functional Team..., Process Improvement, Integration, Management, Procurement, Change Management, Software Documentation, Business Analysis, Team Leadership, Technical Writing, Business Intelligence, Requirements Analysis, SharePoint, Enterprise Architecture, ITIL, Business Process, Analysis, Databases, Strategy, Requirements Gathering, IT Management, Vendor Management, Data Analysis, Risk Management, Agile Methodologies, Quality Assurance, Resource Management, Governance, Earned Value Management, Business Process..., Software Project..., Process Engineering, CMMI, Project Portfolio..., Requirements Management, Government
Education
The George Washington University 2010 — 2011
Master's Certificate, Project Management
University of Maryland University College 2003 — 2007
Bachelor's degree, Business Administration and Management, General
Brian Kehoe's U.S. Food and Drug Administration Experience September 2007 - November 2013
Job Regulatory Counsel at FDA
Industry Pharmaceuticals
Experience
FDA November 2013 - Present
U.S. Food and Drug Administration September 2007 - November 2013
U.S. Department of Justice September 2008 - March 2009
MedImmune, Inc. November 2005 - May 2006
AstraZeneca, Inc. February 2004 - July 2004
Millennium Pharmaceuticals July 2002 - December 2003
Education
University of Maryland Baltimore 2004 — 2007
J.D.
University of Rochester 1998 — 2002
B.S., Microbiology
FDA November 2013 - Present
U.S. Food and Drug Administration September 2007 - November 2013
U.S. Department of Justice September 2008 - March 2009
MedImmune, Inc. November 2005 - May 2006
AstraZeneca, Inc. February 2004 - July 2004
Millennium Pharmaceuticals July 2002 - December 2003
Education
University of Maryland Baltimore 2004 — 2007
J.D.
University of Rochester 1998 — 2002
B.S., Microbiology
Sumit Sarkar's U.S. Food and Drug Administration Experience 2008 - Present
Job Research Scientist, FDA
Industry Research
Experience
Food and Drug Administration October 2008 - Present
U.S. Food and Drug Administration 2008 - Present
Harvard Medical School 2007 - 2008
Indiana University March 2004 - December 2006
Tufts-New England Medical Center September 2000 - March 2004
Skills
In Vivo, Cell Culture, Molecular Biology, Cell Biology, Pharmacology, Animal Models, In Vitro, Clinical Trials, Drug Development, Oncology, IND, Clinical Research, Toxicology, Western Blotting, Assay Development, GLP, ELISA
Education
Nagpur University 1996 — 2000
Ph.D, Neurobiology
University of Calcutta 1993 — 1996
M.Sc, Zoology
Food and Drug Administration October 2008 - Present
U.S. Food and Drug Administration 2008 - Present
Harvard Medical School 2007 - 2008
Indiana University March 2004 - December 2006
Tufts-New England Medical Center September 2000 - March 2004
Skills
In Vivo, Cell Culture, Molecular Biology, Cell Biology, Pharmacology, Animal Models, In Vitro, Clinical Trials, Drug Development, Oncology, IND, Clinical Research, Toxicology, Western Blotting, Assay Development, GLP, ELISA
Education
Nagpur University 1996 — 2000
Ph.D, Neurobiology
University of Calcutta 1993 — 1996
M.Sc, Zoology
Richard Forshee's U.S. Food and Drug Administration Experience March 2008 - January 2011
Job Associate Director for Research at U.S. Food and Drug Administration, CBER/OBE
Industry Research
Experience
U.S. Food and Drug Administration, CBER/OBE January 2011 - Present
U.S. Food and Drug Administration March 2008 - January 2011
University of Maryland 2005 - 2008
Virginia Tech, Northern Virginia Center 2001 - 2005
Georgetown University, Georgetown Public Policy Institute 1995 - 2001
Southeast Missouri State University 1982 - 1986
Skills
Risk Assessment, Statistics, Policy Analysis, Research, Public Health, Data Analysis, Policy, Administration, Writing, Microsoft Office, Public Speaking, Modeling, Teaching, Strategic Planning, Risk Analysis, Risk Management, Stata, Excel, Grant Writing, Lifesciences, FDA, Government, Regulatory Affairs, Public Policy, Biostatistics, Science, Infectious Diseases, Epidemiology, Program Evaluation, Statistical Modeling, Health Policy
Education
University of Michigan 1986 — 1994
PhD, Political Science
Southeast Missouri State University 1982 — 1986
BS, Political Science, Mathematics
U.S. Food and Drug Administration, CBER/OBE January 2011 - Present
U.S. Food and Drug Administration March 2008 - January 2011
University of Maryland 2005 - 2008
Virginia Tech, Northern Virginia Center 2001 - 2005
Georgetown University, Georgetown Public Policy Institute 1995 - 2001
Southeast Missouri State University 1982 - 1986
Skills
Risk Assessment, Statistics, Policy Analysis, Research, Public Health, Data Analysis, Policy, Administration, Writing, Microsoft Office, Public Speaking, Modeling, Teaching, Strategic Planning, Risk Analysis, Risk Management, Stata, Excel, Grant Writing, Lifesciences, FDA, Government, Regulatory Affairs, Public Policy, Biostatistics, Science, Infectious Diseases, Epidemiology, Program Evaluation, Statistical Modeling, Health Policy
Education
University of Michigan 1986 — 1994
PhD, Political Science
Southeast Missouri State University 1982 — 1986
BS, Political Science, Mathematics
Shrikant Dighe's U.S. Food and Drug Administration Experience 1984 - 1994
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Shrikant Dighe Associates 1995 - Present
FDA September 1984 - March 1994
US Food & Drug Administration 1984 - 1994
FDA CDER 1984 - 1994
U.S. Food and Drug Administration 1984 - 1994
Skills
Regulatory Strategy, Pharmaceutical Industry, Strategy, Bioequivalence, Regulatory Affairs
Education
University of Cincinnati 1959 — 1964
University of Mumbai and University of Cincinnati, USA
B. Sc. from U. of Bombay; Ph.D. from Univ. of Cincinnati (USA)
Shrikant Dighe Associates 1995 - Present
FDA September 1984 - March 1994
US Food & Drug Administration 1984 - 1994
FDA CDER 1984 - 1994
U.S. Food and Drug Administration 1984 - 1994
Skills
Regulatory Strategy, Pharmaceutical Industry, Strategy, Bioequivalence, Regulatory Affairs
Education
University of Cincinnati 1959 — 1964
University of Mumbai and University of Cincinnati, USA
B. Sc. from U. of Bombay; Ph.D. from Univ. of Cincinnati (USA)
Ebony Laster's U.S. Food and Drug Administration Experience March 2001 - November 2011
Job Quality Systems Specialist at U.S. Food & Drug Administration
Industry Government Administration
Experience
U.S. Food & Drug Administration November 2011 - Present
U.S. Food and Drug Administration March 2001 - November 2011
Education
University of Colorado Anschutz Medical Campus 1994 — 1998
U.S. Food & Drug Administration November 2011 - Present
U.S. Food and Drug Administration March 2001 - November 2011
Education
University of Colorado Anschutz Medical Campus 1994 — 1998
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
Elizabeth Reichl's U.S. Food and Drug Administration Experience March 2015 - Present
Job Staff Fellow, FDA
Industry Biotechnology
Experience
U.S. Food and Drug Administration March 2015 - Present
The Endocrine Society May 2012 - Present
Stevenson University January 2012 - May 2012
Human Genome Sciences, Inc. October 2007 - January 2012
Johns Hopkins University 2001 - 2007
Skills
Lifesciences, Molecular Biology, Cell Biology, Biochemistry, Cell Culture, Technology Transfer, Patent Prosecution, qPCR, Protein Expression, Biotechnology
Education
The Johns Hopkins University 2001 — 2007
PhD, Cell Biology
The Johns Hopkins University School of Medicine 2001 — 2007
U.S. Food and Drug Administration March 2015 - Present
The Endocrine Society May 2012 - Present
Stevenson University January 2012 - May 2012
Human Genome Sciences, Inc. October 2007 - January 2012
Johns Hopkins University 2001 - 2007
Skills
Lifesciences, Molecular Biology, Cell Biology, Biochemistry, Cell Culture, Technology Transfer, Patent Prosecution, qPCR, Protein Expression, Biotechnology
Education
The Johns Hopkins University 2001 — 2007
PhD, Cell Biology
The Johns Hopkins University School of Medicine 2001 — 2007
Seyoum Senay's U.S. Food and Drug Administration Experience November 2013 - Present
Job Lead Advanced Analytics
Industry Computer Software
Experience
U.S. Food and Drug Administration November 2013 - Present
Skills
SOA, Enterprise Architecture, ITIL, Integration, Web Services, DB2, WebSphere Application..., Design Patterns, Oracle, Requirements Analysis, SDLC, Six Sigma, Solution Architecture, Unix, Business Analysis, Enterprise Software, IT Strategy, Management, Program Management, WebSphere
Education
The Johns Hopkins University 2007 — 2010
Master of Information & Telcom Systems (MS)
Minnesota State University, Mankato 1995 — 1999
BS, Computer Information Systems
U.S. Food and Drug Administration November 2013 - Present
Skills
SOA, Enterprise Architecture, ITIL, Integration, Web Services, DB2, WebSphere Application..., Design Patterns, Oracle, Requirements Analysis, SDLC, Six Sigma, Solution Architecture, Unix, Business Analysis, Enterprise Software, IT Strategy, Management, Program Management, WebSphere
Education
The Johns Hopkins University 2007 — 2010
Master of Information & Telcom Systems (MS)
Minnesota State University, Mankato 1995 — 1999
BS, Computer Information Systems
Denise Johnson-Lyles's U.S. Food and Drug Administration Experience March 2010 - Present
Job Reviewer at U.S. FDA
Industry Government Relations
Experience
U.S. Food and Drug Administration March 2010 - Present
SAIC-Frederick, Inc. May 2008 - March 2010
Johns Hopkins University 2002 - 2008
Education
The Johns Hopkins University 2002 — 2008
PhD, Toxicology
Shaw University 1998 — 2002
B.S., Chemistry
U.S. Food and Drug Administration March 2010 - Present
SAIC-Frederick, Inc. May 2008 - March 2010
Johns Hopkins University 2002 - 2008
Education
The Johns Hopkins University 2002 — 2008
PhD, Toxicology
Shaw University 1998 — 2002
B.S., Chemistry
Nisha Bruce's U.S. Food and Drug Administration Experience 2009 - Present
Job at FDA
Industry Government Administration
Experience
U.S. Food and Drug Administration 2009 - Present
INNOVIA Education Institute July 2005 - December 2008
Education
Northwood University 1998 — 2002
Bachelor's, Business Administration and Management
U.S. Food and Drug Administration 2009 - Present
INNOVIA Education Institute July 2005 - December 2008
Education
Northwood University 1998 — 2002
Bachelor's, Business Administration and Management
Ronnie Djoukeng's U.S. Food and Drug Administration Experience 2009 - Present
Job International Policy Analyst at U.S. Food and Drug Administration
Industry International Affairs
Experience
U.S. Food and Drug Administration 2009 - Present
U.S. Federal Aviation Administration 2007 - 2009
Education
University of Maryland College Park 2000 — 2005
Bachelors, Government and Politics
U.S. Food and Drug Administration 2009 - Present
U.S. Federal Aviation Administration 2007 - 2009
Education
University of Maryland College Park 2000 — 2005
Bachelors, Government and Politics
Bret Koplow's U.S. Food and Drug Administration Experience Associate Chief CounselU.S. Food and Drug Administration, Office of Chief Counsel
Job Associate Chief Counsel at U.S. Food and Drug Administration, Office of Chief Counsel (Immediate Office)
Industry Law Practice
Experience
U.S. Food and Drug Administration Associate Chief CounselU.S. Food and Drug Administration, Office of Chief Counsel
U.S. Food and Drug Administration, Office of Regulatory Affairs, Office of Policy & Risk Management 2014 - 2015
U.S. Food and Drug Administration, Office of the Commissioner 2011 - 2014
Sonnenschein Nath & Rosenthal LLP February 2009 - 2010
Patton Boggs LLP September 2001 - January 2009
Case Western Reserve University School of Medicine May 1994 - April 1998
University Hospitals of Cleveland May 1994 - April 1998
Education
University of Chicago Law School 1998 — 2001
J.D., Law
Hawken School 1972 — 1977
U.S. Food and Drug Administration Associate Chief CounselU.S. Food and Drug Administration, Office of Chief Counsel
U.S. Food and Drug Administration, Office of Regulatory Affairs, Office of Policy & Risk Management 2014 - 2015
U.S. Food and Drug Administration, Office of the Commissioner 2011 - 2014
Sonnenschein Nath & Rosenthal LLP February 2009 - 2010
Patton Boggs LLP September 2001 - January 2009
Case Western Reserve University School of Medicine May 1994 - April 1998
University Hospitals of Cleveland May 1994 - April 1998
Education
University of Chicago Law School 1998 — 2001
J.D., Law
Hawken School 1972 — 1977
Clare Hingsbergen's U.S. Food and Drug Administration Experience February 2010 - November 2012
Job Administrative Management Specialist at U.S. Food and Drug Administration
Industry Public Relations and Communications
Experience
University of Cincinnati, Blue Ash August 2013 - Present
FDA July 2012 - Present
U.S. Food and Drug Administration February 2010 - November 2012
Skills
Internal Communications, Strategic Communications, Press Releases, Media Relations, Newsletters, Spokesperson, Public Affairs, Customer Service, Web Content Management, Community Outreach, Crisis Communications, Corporate Communications, Public Relations, Editing, Health Communication, College Teaching, Office Administration, Administrative Work, Purchase Requisitions, Purchasing, Fleet Management, Social Media, Public Speaking, Social Networking, Event Planning, Research, Microsoft Office
Education
Northern Kentucky University 2009 — 2011
M.A., Communication
Northern Kentucky University 2005 — 2008
Bachelor of Arts (B.A.), Public Relations
University of Cincinnati, Blue Ash August 2013 - Present
FDA July 2012 - Present
U.S. Food and Drug Administration February 2010 - November 2012
Skills
Internal Communications, Strategic Communications, Press Releases, Media Relations, Newsletters, Spokesperson, Public Affairs, Customer Service, Web Content Management, Community Outreach, Crisis Communications, Corporate Communications, Public Relations, Editing, Health Communication, College Teaching, Office Administration, Administrative Work, Purchase Requisitions, Purchasing, Fleet Management, Social Media, Public Speaking, Social Networking, Event Planning, Research, Microsoft Office
Education
Northern Kentucky University 2009 — 2011
M.A., Communication
Northern Kentucky University 2005 — 2008
Bachelor of Arts (B.A.), Public Relations
Rubina Madni's U.S. Food and Drug Administration Experience May 2014 - Present
Job Associate Chief Counsel for Biologics at U.S. Food and Drug Administration
Industry Law Practice
Experience
U.S. Food and Drug Administration May 2014 - Present
Arnold & Porter, LLP March 2010 - May 2014
Arnold & Porter, LLP May 2008 - August 2008
American Civil Liberties Union May 2007 - August 2007
Religions for Peace August 2005 - August 2006
Skills
Regulatory Analysis, Legislative Analysis, Administrative Law, Asylum Law, Civil Liberties, Environmental Compliance, Legislation, Government, Legal Writing
Education
Yale Law School 2006 — 2009
J.D.
State University of New York at Stony Brook
BA, summa cum laude
Sachem High School 1997 — 2001
U.S. Food and Drug Administration May 2014 - Present
Arnold & Porter, LLP March 2010 - May 2014
Arnold & Porter, LLP May 2008 - August 2008
American Civil Liberties Union May 2007 - August 2007
Religions for Peace August 2005 - August 2006
Skills
Regulatory Analysis, Legislative Analysis, Administrative Law, Asylum Law, Civil Liberties, Environmental Compliance, Legislation, Government, Legal Writing
Education
Yale Law School 2006 — 2009
J.D.
State University of New York at Stony Brook
BA, summa cum laude
Sachem High School 1997 — 2001
Kevin Lorick's U.S. Food and Drug Administration Experience May 2009 - Present
Job Regulatory Scientist
Industry Biotechnology
Experience
U.S. Food and Drug Administration May 2009 - Present
The Green Cell Inc October 2008 - May 2009
Intrexon Corporation June 2008 - October 2008
Intrexon Corporation May 2007 - June 2008
Intrexon December 2006 - May 2007
National Cancer Institute June 2003 - December 2006
Skills
Molecular Biology, Biochemistry, Cell Biology, Biotechnology, Immunology, Protein Chemistry, Chemistry, Regulatory Affairs, Life Sciences, Bioinformatics, Research, Cell Culture, Protein Purification, PCR, Western Blotting, Genetics, Cell Based Assays, DNA, R&D, GLP, ELISA, Patents, Oncology, PowerPoint, Data Analysis, Medical Devices, Protein Expression, Tissue Culture, Excel, GMP, Microsoft Office, Nanotechnology, Technical Writing, SDS-PAGE, Product Development, Cell, Science, In Vitro, FDA, Lifesciences, Laboratory
Education
Tulane University 1992 — 1997
PhD, Molecular and Cellular Biology
University of Chicago 1986 — 1990
SB, Biological Chemistry
U.S. Food and Drug Administration May 2009 - Present
The Green Cell Inc October 2008 - May 2009
Intrexon Corporation June 2008 - October 2008
Intrexon Corporation May 2007 - June 2008
Intrexon December 2006 - May 2007
National Cancer Institute June 2003 - December 2006
Skills
Molecular Biology, Biochemistry, Cell Biology, Biotechnology, Immunology, Protein Chemistry, Chemistry, Regulatory Affairs, Life Sciences, Bioinformatics, Research, Cell Culture, Protein Purification, PCR, Western Blotting, Genetics, Cell Based Assays, DNA, R&D, GLP, ELISA, Patents, Oncology, PowerPoint, Data Analysis, Medical Devices, Protein Expression, Tissue Culture, Excel, GMP, Microsoft Office, Nanotechnology, Technical Writing, SDS-PAGE, Product Development, Cell, Science, In Vitro, FDA, Lifesciences, Laboratory
Education
Tulane University 1992 — 1997
PhD, Molecular and Cellular Biology
University of Chicago 1986 — 1990
SB, Biological Chemistry
Beth Duvall's U.S. Food and Drug Administration Experience December 2011 - Present
Job Associate Director for Regulatory Affairs at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration December 2011 - Present
U.S. Food and Drug Administration 1996 - December 2011
U.S. Food and Drug Administration March 2003 - June 2006
Skills
Biotechnology, Drug Development, Clinical Development, Drug Discovery, FDA, Government, Leadership, Pharmaceutical Industry, Policy, Policy Analysis, Regulatory Submissions, Strategic Planning, Regulatory Requirements, Regulatory Affairs, Public Policy, Clinical Trials
Education
University of Delaware 1982 — 1986
B.S., Chemistry, minor in Mathematics
U.S. Food and Drug Administration December 2011 - Present
U.S. Food and Drug Administration 1996 - December 2011
U.S. Food and Drug Administration March 2003 - June 2006
Skills
Biotechnology, Drug Development, Clinical Development, Drug Discovery, FDA, Government, Leadership, Pharmaceutical Industry, Policy, Policy Analysis, Regulatory Submissions, Strategic Planning, Regulatory Requirements, Regulatory Affairs, Public Policy, Clinical Trials
Education
University of Delaware 1982 — 1986
B.S., Chemistry, minor in Mathematics
Yun Xu's U.S. Food and Drug Administration Experience 2008 - Present
Job Team leader at Office of Clinical Pharmacology, FDA
Industry Government Administration
Experience
U.S. Food and Drug Administration 2008 - Present
Novartis 2006 - 2008
GlaxoSmithKline 2004 - 2006
Skills
Clinical Research
Education
University of Washington 1999 — 2004
M.S., Ph.D., Biostatistics, Pharmaceutics
Peking University 1992 — 1997
Bachelor in Medicine, Medicine
U.S. Food and Drug Administration 2008 - Present
Novartis 2006 - 2008
GlaxoSmithKline 2004 - 2006
Skills
Clinical Research
Education
University of Washington 1999 — 2004
M.S., Ph.D., Biostatistics, Pharmaceutics
Peking University 1992 — 1997
Bachelor in Medicine, Medicine
Jeri Roth's U.S. Food and Drug Administration Experience 1979 - 1981
Job chemist at NIST
Industry Research
Experience
NIST 2004 - Present
National Institutes of Health 1982 - 2004
U.S. Food and Drug Administration 1979 - 1981
Skills
Mass Spectrometry, Proteomics, Peptides, Perl, Chromatography, Pharmacokinetics, Protein Chemistry
Education
Northeastern University 1976 — 1978
M.S., analytical chemistry
Washington University in St. Louis 1972 — 1976
A.B., chemistry
North Central High School
North Central High School
North Central High School
North Central High School
NIST 2004 - Present
National Institutes of Health 1982 - 2004
U.S. Food and Drug Administration 1979 - 1981
Skills
Mass Spectrometry, Proteomics, Peptides, Perl, Chromatography, Pharmacokinetics, Protein Chemistry
Education
Northeastern University 1976 — 1978
M.S., analytical chemistry
Washington University in St. Louis 1972 — 1976
A.B., chemistry
North Central High School
North Central High School
North Central High School
North Central High School
Lauren Soltani's U.S. Food and Drug Administration Experience June 2006 - August 2006
Job Legislative Counsel at U.S. House of Representatives
Industry Political Organization
Experience
U.S. House of Representatives January 2015 - Present
John Tierney for Congress May 2014 - September 2014
Pennsylvania for Allyson October 2013 - May 2014
U.S. House of Representatives August 2012 - April 2013
U.S. House of Representatives May 2012 - August 2012
Villanova University School of Law September 2011 - December 2011
Information Technology Industry Council June 2008 - June 2010
U.S. Food and Drug Administration June 2006 - August 2006
Skills
Public Policy, Policy Analysis, Legal Research, International Law, Research, Politics, Legislative Relations, Legislation, Policy
Education
Villanova University School of Law 2010 — 2013
JD, Law
The George Washington University 2004 — 2008
BA, International Affairs/International Politics
U.S. House of Representatives January 2015 - Present
John Tierney for Congress May 2014 - September 2014
Pennsylvania for Allyson October 2013 - May 2014
U.S. House of Representatives August 2012 - April 2013
U.S. House of Representatives May 2012 - August 2012
Villanova University School of Law September 2011 - December 2011
Information Technology Industry Council June 2008 - June 2010
U.S. Food and Drug Administration June 2006 - August 2006
Skills
Public Policy, Policy Analysis, Legal Research, International Law, Research, Politics, Legislative Relations, Legislation, Policy
Education
Villanova University School of Law 2010 — 2013
JD, Law
The George Washington University 2004 — 2008
BA, International Affairs/International Politics
Judith Dausch, Ph.D., R.D.'s U.S. Food and Drug Administration Experience August 2009 - Present
Job Consumer Safety Officer at U.S. Food and Drug Administration
Industry Public Safety
Experience
U.S. Food and Drug Administration August 2009 - Present
American Heart Association September 2006 - April 2009
American Dietetic Association April 2000 - February 2005
National Restaurant Association 1997 - 2000
Dairy Council 1993 - 1996
Skills
Public Health, Nutrition, Cancer, Food Safety, Nonprofits, Policy, Health Education, Health Promotion, Nutrition Education, Prevention, Non-profits, Epidemiology, FDA, Medical Nutrition..., Public Policy, Regulatory Affairs
Education
University of Maryland College Park 1984 — 1991
Ph.D., Health Education
University of Maryland College Park 1980 — 1982
MS, Nutrition
U.S. Food and Drug Administration August 2009 - Present
American Heart Association September 2006 - April 2009
American Dietetic Association April 2000 - February 2005
National Restaurant Association 1997 - 2000
Dairy Council 1993 - 1996
Skills
Public Health, Nutrition, Cancer, Food Safety, Nonprofits, Policy, Health Education, Health Promotion, Nutrition Education, Prevention, Non-profits, Epidemiology, FDA, Medical Nutrition..., Public Policy, Regulatory Affairs
Education
University of Maryland College Park 1984 — 1991
Ph.D., Health Education
University of Maryland College Park 1980 — 1982
MS, Nutrition
Cynthia J. Chang's U.S. Food and Drug Administration Experience October 2011 - August 2012
Job Biomedical Engineer at U.S. Food and Drug Administration, Center for Devices and Radiological Health
Industry Biotechnology
Experience
U.S. Food and Drug Administration, Center for Devices and Radiological Health August 2012 - Present
U.S. Food and Drug Administration, Center for Drug Evaluation and Research January 2015 - May 2015
U.S. Food and Drug Administration October 2011 - August 2012
University of Oxford October 2006 - September 2011
NIH August 2006 - September 2011
Education
University of Oxford 2006 — 2011
DPhil, Musculoskeletal Sciences
Rice University 2002 — 2006
BS, Bioengineering
U.S. Food and Drug Administration, Center for Devices and Radiological Health August 2012 - Present
U.S. Food and Drug Administration, Center for Drug Evaluation and Research January 2015 - May 2015
U.S. Food and Drug Administration October 2011 - August 2012
University of Oxford October 2006 - September 2011
NIH August 2006 - September 2011
Education
University of Oxford 2006 — 2011
DPhil, Musculoskeletal Sciences
Rice University 2002 — 2006
BS, Bioengineering
Matt Amann's U.S. Food and Drug Administration Experience March 1990 - Present
Job Safety and Occupational Health Manager at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration March 1990 - Present
American Society of Safety Engineers 1990 - Present
Education
University of Maryland College Park 1984 — 1990
DeMatha Catholic High School 1980 — 1984
U.S. Food and Drug Administration March 1990 - Present
American Society of Safety Engineers 1990 - Present
Education
University of Maryland College Park 1984 — 1990
DeMatha Catholic High School 1980 — 1984
Howard Rabinovitch's U.S. Food and Drug Administration Experience December 2000 - December 2009
Job Consultant on Food Safety and Food Defense
Industry Government Administration
Experience
Philadelphia InfraGard March 2014 - Present
U. S. Food and Drug Administration December 2000 - December 2011
U.S. Food and Drug Administration December 2000 - December 2009
U.S. Customs and Border Protection 1973 - 1978
Skills
Emergency Management, Incident Command, Food Safety, HACCP, Public Relations, Disaster Response, Food Science, Crisis Management, Counterterrorism, Program Evaluation, Team Building, Public Health, Government, Homeland Security, Security Clearance, Sanitation, Emergency Services, Enforcement, Public Safety, Policy, Security, Training, Private Investigations, Investigation, Criminal Investigations, Interrogation, Evidence, Criminal Justice, Police, Law Enforcement
Education
Rutgers, The State University of New Jersey-Camden 1968 — 1975
BA, Psychology, Public Administration, Criminal Justice
Philadelphia InfraGard March 2014 - Present
U. S. Food and Drug Administration December 2000 - December 2011
U.S. Food and Drug Administration December 2000 - December 2009
U.S. Customs and Border Protection 1973 - 1978
Skills
Emergency Management, Incident Command, Food Safety, HACCP, Public Relations, Disaster Response, Food Science, Crisis Management, Counterterrorism, Program Evaluation, Team Building, Public Health, Government, Homeland Security, Security Clearance, Sanitation, Emergency Services, Enforcement, Public Safety, Policy, Security, Training, Private Investigations, Investigation, Criminal Investigations, Interrogation, Evidence, Criminal Justice, Police, Law Enforcement
Education
Rutgers, The State University of New Jersey-Camden 1968 — 1975
BA, Psychology, Public Administration, Criminal Justice
Chanel Tissot's U.S. Food and Drug Administration Experience September 2014 - Present
Job ORISE Postdoctoral Fellow at U.S. Food and Drug Administration
Industry Higher Education
Experience
U.S. Food and Drug Administration September 2014 - Present
University of Maryland, College Park September 2010 - September 2014
Oregon State University - Department of Nuclear Engineering & Radiation Health Physics June 2009 - June 2010
Skills
German, Russian, Radiation Safety, Nuclear Engineering, Accelerated Testing, Gamma Irradiation, Electron Beam..., Government Proposals, Research Proposals, Reactor Design, Nuclear Materials, Polymer Engineering, Public Speaking, World History, Russian History, Geography, World Travel, U.S. foreign policy, Nanotechnology, Reactor, Simulations, Science, Radiation, Nanocomposites, Thermodynamics, Matlab, Nuclear
Education
University of Maryland College Park 2010 — 2014
Doctor of Philosophy, Nuclear Engineering
University of Maryland College Park 2010 — 2013
Master of Science (M.S.), Nuclear Engineering
Oregon State University 2007 — 2010
Bachelor of Science (B.S.), Nuclear Engineering
U.S. Food and Drug Administration September 2014 - Present
University of Maryland, College Park September 2010 - September 2014
Oregon State University - Department of Nuclear Engineering & Radiation Health Physics June 2009 - June 2010
Skills
German, Russian, Radiation Safety, Nuclear Engineering, Accelerated Testing, Gamma Irradiation, Electron Beam..., Government Proposals, Research Proposals, Reactor Design, Nuclear Materials, Polymer Engineering, Public Speaking, World History, Russian History, Geography, World Travel, U.S. foreign policy, Nanotechnology, Reactor, Simulations, Science, Radiation, Nanocomposites, Thermodynamics, Matlab, Nuclear
Education
University of Maryland College Park 2010 — 2014
Doctor of Philosophy, Nuclear Engineering
University of Maryland College Park 2010 — 2013
Master of Science (M.S.), Nuclear Engineering
Oregon State University 2007 — 2010
Bachelor of Science (B.S.), Nuclear Engineering
Merton Smith's U.S. Food and Drug Administration Experience January 2000 - Present
Job Director, International Programs and Product Standards, Center for Veterinary Medicine, FDA
Industry Government Administration
Experience
U.S. Food and Drug Administration January 2000 - Present
U.S. Food and Drug Administration April 1984 - December 1999
Office of the U.S. Trade Representative, Executive Office of the President January 1994 - October 1995
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition July 1975 - March 1984
Skills
Government, Microsoft Office, International Relations, Policy, Microsoft Excel, Public Administration, Strategic Planning, Customer Service, Research
Education
The Catholic University of America, Columbus School of Law 1978 — 1982
Doctor of Law (J.D.), Food and Drug Law, Environmental Law
Virginia Polytechnic Institute and State University 1973 — 1975
Doctor of Philosophy (Ph.D.), Food Science
Virginia Polytechnic Institute and State University 1971 — 1972
Master of Science (M.S.), Veterinary Microbiology and Immunobiology
University of Virginia 1964 — 1968
Bachelor of Arts (B.A.), Sociology and Anthropology
U.S. Food and Drug Administration January 2000 - Present
U.S. Food and Drug Administration April 1984 - December 1999
Office of the U.S. Trade Representative, Executive Office of the President January 1994 - October 1995
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition July 1975 - March 1984
Skills
Government, Microsoft Office, International Relations, Policy, Microsoft Excel, Public Administration, Strategic Planning, Customer Service, Research
Education
The Catholic University of America, Columbus School of Law 1978 — 1982
Doctor of Law (J.D.), Food and Drug Law, Environmental Law
Virginia Polytechnic Institute and State University 1973 — 1975
Doctor of Philosophy (Ph.D.), Food Science
Virginia Polytechnic Institute and State University 1971 — 1972
Master of Science (M.S.), Veterinary Microbiology and Immunobiology
University of Virginia 1964 — 1968
Bachelor of Arts (B.A.), Sociology and Anthropology
Bradley Schnackenberg's U.S. Food and Drug Administration Experience May 2013 - Present
Job Senior Regulatory Science Project Manager at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration May 2013 - Present
U.S. Food and Drug Administration January 2012 - Present
U.S. Food and Drug Administration February 2012 - May 2013
U.S. Food and Drug Administration March 2010 - February 2012
U.S. Food and Drug Administration October 2008 - February 2010
University of Arkansas for Medical Sciences January 2004 - September 2008
University of North Carolina at Chapel Hill January 1999 - December 2003
Skills
Molecular Biology, Lifesciences, Biotechnology, Animal Models, Cell Biology, Cell Culture, Toxicology, Biochemistry
Education
The University of Kansas 1992 — 1998
Ph.D., Cell Biology
The University of Kansas 1989 — 1991
B.S., Cell Biology
State Fair Community College 1986 — 1990
U.S. Food and Drug Administration May 2013 - Present
U.S. Food and Drug Administration January 2012 - Present
U.S. Food and Drug Administration February 2012 - May 2013
U.S. Food and Drug Administration March 2010 - February 2012
U.S. Food and Drug Administration October 2008 - February 2010
University of Arkansas for Medical Sciences January 2004 - September 2008
University of North Carolina at Chapel Hill January 1999 - December 2003
Skills
Molecular Biology, Lifesciences, Biotechnology, Animal Models, Cell Biology, Cell Culture, Toxicology, Biochemistry
Education
The University of Kansas 1992 — 1998
Ph.D., Cell Biology
The University of Kansas 1989 — 1991
B.S., Cell Biology
State Fair Community College 1986 — 1990
Celia Peacock's U.S. Food and Drug Administration Experience 2008 - Present
Job Senior Regulatory Project Manager
Industry Pharmaceuticals
Experience
U.S. Food and Drug Administration 2008 - Present
U.S. Public Health Service Commissioned Corps 1990 - Present
HIV/AIDS Bureau 1996 - 2008
National Institutes of Allergy and Infectious Disease 1990 - 1996
Education
St. Joseph's College, West Hartford, CT
B.S., Nutrition/Dietetics
University of Bridgeport
B.S., Biology
University of Connecticut School of Public Health
MPH, Epidemiology
U.S. Food and Drug Administration 2008 - Present
U.S. Public Health Service Commissioned Corps 1990 - Present
HIV/AIDS Bureau 1996 - 2008
National Institutes of Allergy and Infectious Disease 1990 - 1996
Education
St. Joseph's College, West Hartford, CT
B.S., Nutrition/Dietetics
University of Bridgeport
B.S., Biology
University of Connecticut School of Public Health
MPH, Epidemiology
Donald Demers's U.S. Food and Drug Administration Experience May 1988 - May 2007
Job Facilities Management Officer at U.S. Food and Drug Admin
Industry Government Administration
Experience
U.S. Food and Drug Admin June 2007 - Present
U.S. Food and Drug Administration May 1988 - May 2007
Skills
Government, Program Management, Policy, Policy Analysis, Government Contracting, Emergency Management, Analysis, Project Management, Facilities Management, Public Policy, Leadership, Project Planning, Sustainability, Risk Assessment, Change Management
Education
University of Maryland University College 1995 — 2001
Master of Science (MS), Management
University of Maryland College Park 1985 — 1989
Bachelor's degree, Industrial Safety
U.S. Food and Drug Admin June 2007 - Present
U.S. Food and Drug Administration May 1988 - May 2007
Skills
Government, Program Management, Policy, Policy Analysis, Government Contracting, Emergency Management, Analysis, Project Management, Facilities Management, Public Policy, Leadership, Project Planning, Sustainability, Risk Assessment, Change Management
Education
University of Maryland University College 1995 — 2001
Master of Science (MS), Management
University of Maryland College Park 1985 — 1989
Bachelor's degree, Industrial Safety
Victoria Kao's U.S. Food and Drug Administration Experience 1999 - 2003
Job Senior International Trade Specialist at Department of Commerce
Industry Government Administration
Experience
Department of Commerce 2010 - Present
U.S. Department of Commerce 2005 - 2010
FDA 2003 - 2005
U.S. Food and Drug Administration 1999 - 2003
University of California at San Francisco 1995 - 1999
Skills
International Trade, Export Controls, International Economics, International Relations, Trade Compliance, Economic Development, Foreign Policy, Export, International..., Policy Analysis, International Trade Law, International Marketing, Public Policy, Government, International Business, Latin America, Customs Regulations, International Business..., Economics, Diplomacy, Politics, Spanish, Policy, Research, Strategic Communications, Pharmaceutical Industry
Education
FCIB
FCIB
FCIB
UC Berkeley
Immunology
Department of Commerce 2010 - Present
U.S. Department of Commerce 2005 - 2010
FDA 2003 - 2005
U.S. Food and Drug Administration 1999 - 2003
University of California at San Francisco 1995 - 1999
Skills
International Trade, Export Controls, International Economics, International Relations, Trade Compliance, Economic Development, Foreign Policy, Export, International..., Policy Analysis, International Trade Law, International Marketing, Public Policy, Government, International Business, Latin America, Customs Regulations, International Business..., Economics, Diplomacy, Politics, Spanish, Policy, Research, Strategic Communications, Pharmaceutical Industry
Education
FCIB
FCIB
FCIB
UC Berkeley
Immunology
Chih-Ying (Natasha) Chen's U.S. Food and Drug Administration Experience March 2013 - Present
Job Visiting Scientist/Epidemiologist at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration March 2013 - Present
Brigham and Women's Hospital April 2010 - January 2013
Harvard Medical School April 2010 - January 2013
Skills
Outcomes Research, Pharmacoepidemiology, Epidemiology, SAS, Health Services Research, Scientific Writing
Education
University of Florida 2004 — 2010
Ph D, Pharmacoepidemiology
University of Pittsburgh 2002 — 2004
MHA, Health Administration
National Taiwan University 1997 — 2001
BS, Pharmacy
U.S. Food and Drug Administration March 2013 - Present
Brigham and Women's Hospital April 2010 - January 2013
Harvard Medical School April 2010 - January 2013
Skills
Outcomes Research, Pharmacoepidemiology, Epidemiology, SAS, Health Services Research, Scientific Writing
Education
University of Florida 2004 — 2010
Ph D, Pharmacoepidemiology
University of Pittsburgh 2002 — 2004
MHA, Health Administration
National Taiwan University 1997 — 2001
BS, Pharmacy
Edgar Grajo's U.S. Food and Drug Administration Experience December 1990 - May 1998
Job Hospital & Health Care Professional
Industry Hospital & Health Care
Experience
PacificEcoRisk March 2008 - April 2008
San Francisco Department of Public Health June 1998 - August 2005
U.S. Food and Drug Administration December 1990 - May 1998
Education
Solano Community College 1983 — 1985
General Studies
PacificEcoRisk March 2008 - April 2008
San Francisco Department of Public Health June 1998 - August 2005
U.S. Food and Drug Administration December 1990 - May 1998
Education
Solano Community College 1983 — 1985
General Studies
Janae Price's U.S. Food and Drug Administration Experience 2008 - Present
Job Consumer Safety Officer at U.S. Food and Drug Administration
Industry
Experience
U.S. Food and Drug Administration 2008 - Present
Education
Purdue University
B.S., Health Science
U.S. Food and Drug Administration 2008 - Present
Education
Purdue University
B.S., Health Science
Andrew Dempster, AICP's U.S. Food and Drug Administration Experience Senior Program ManagerU.S Food and Drug AdministrationNovember 2008 - January 2012
Job Branch Director, Logistics and Transportation Management FDA
Industry Government Administration
Experience
U.S. Food and Drug Administration Senior Program ManagerU.S Food and Drug AdministrationNovember 2008 - January 2012
U.S. Food and Drug Administration September 2005 - October 2008
Skills
Program Management, Logistics, Customer Service, Microsoft Office, Project Planning, Project Management, FDA, Governance, Strategy, Public Policy, PMP, Technical Writing, Cross-functional Team..., Procurement, Business Process..., Contract Management, Policy Analysis, Management, Federal Government, Research, Team Leadership, Proposal Writing, Government, Strategic Planning, Team Building, Budgets, Community Outreach, Strategic Communications, Policy, Leadership, Public Speaking, Operations Management, Change Management, Microsoft Excel, Process Improvement, Government Contracting
Education
University of Virginia 1989 — 1991
Masters of Planning, Urban and Environmental Planning
University of Maryland College Park 1980 — 1983
Bachelor of Science (B.S.), Behavioral and Social Sciences
U.S. Food and Drug Administration Senior Program ManagerU.S Food and Drug AdministrationNovember 2008 - January 2012
U.S. Food and Drug Administration September 2005 - October 2008
Skills
Program Management, Logistics, Customer Service, Microsoft Office, Project Planning, Project Management, FDA, Governance, Strategy, Public Policy, PMP, Technical Writing, Cross-functional Team..., Procurement, Business Process..., Contract Management, Policy Analysis, Management, Federal Government, Research, Team Leadership, Proposal Writing, Government, Strategic Planning, Team Building, Budgets, Community Outreach, Strategic Communications, Policy, Leadership, Public Speaking, Operations Management, Change Management, Microsoft Excel, Process Improvement, Government Contracting
Education
University of Virginia 1989 — 1991
Masters of Planning, Urban and Environmental Planning
University of Maryland College Park 1980 — 1983
Bachelor of Science (B.S.), Behavioral and Social Sciences
Terrence Gee's U.S. Food and Drug Administration Experience January 2009 - December 2012
Job Microbiologist at USDAFSIS
Industry Biotechnology
Experience
USDA-FSIS January 2013 - Present
U.S. Food and Drug Administration January 2009 - December 2012
Bayer Health September 2006 - December 2008
Campbell Soup Supply Co. LLC July 2003 - October 2003
Skills
Speacialized in..., cGMP, GMP, Quality Systems, Quality Assurance, QC, Auditing, HACCP, Documentation, Microsoft Office, Quality Auditing, Problem Solving, Excel, Testing, Data Analysis, Customer Service, Inventory Management, Healthcare, Microbiology, Biotechnology, Food, Team Building
Education
University of California, Davis 2002 — 2005
B.S., Food Science
USDA-FSIS January 2013 - Present
U.S. Food and Drug Administration January 2009 - December 2012
Bayer Health September 2006 - December 2008
Campbell Soup Supply Co. LLC July 2003 - October 2003
Skills
Speacialized in..., cGMP, GMP, Quality Systems, Quality Assurance, QC, Auditing, HACCP, Documentation, Microsoft Office, Quality Auditing, Problem Solving, Excel, Testing, Data Analysis, Customer Service, Inventory Management, Healthcare, Microbiology, Biotechnology, Food, Team Building
Education
University of California, Davis 2002 — 2005
B.S., Food Science
Stephanie Defibaugh-Chavez's U.S. Food and Drug Administration Experience October 2007 - November 2010
Job
Industry Government Administration
Experience
USDA-FSIS October 2014 - Present
USDA-FSIS November 2010 - October 2014
U.S. Food and Drug Administration October 2007 - November 2010
Skills
PCR, Analysis, Policy, qPCR, Biochemistry, Research, Assay Development, In Vitro, Molecular Genetics, Public Health
Education
University of Arkansas 2004 — 2008
Ph.D., Cell and Molecular Biology
University of Arkansas 1999 — 2004
M.S., Chemistry
University of Louisiana at Lafayette 1994 — 1999
B.S, Chemistry
USDA-FSIS October 2014 - Present
USDA-FSIS November 2010 - October 2014
U.S. Food and Drug Administration October 2007 - November 2010
Skills
PCR, Analysis, Policy, qPCR, Biochemistry, Research, Assay Development, In Vitro, Molecular Genetics, Public Health
Education
University of Arkansas 2004 — 2008
Ph.D., Cell and Molecular Biology
University of Arkansas 1999 — 2004
M.S., Chemistry
University of Louisiana at Lafayette 1994 — 1999
B.S, Chemistry
Jonathan Albay's U.S. Food and Drug Administration Experience March 2010 - June 2010
Job Research Associate at Illumina
Industry Biotechnology
Experience
Illumina December 2011 - Present
Urban Outfitters March 2010 - October 2013
Eton Bioscience, Inc. July 2011 - December 2011
ValueGene March 2011 - June 2011
U.S. Food and Drug Administration March 2010 - June 2010
GreenAnswers.com October 2009 - December 2009
University of California, Irvine August 2008 - June 2009
ASSOCIATED STUDENTS OF UCI September 2006 - April 2007
NORDAC MECHANICAL INC February 2003 - April 2005
Skills
Logistics, Microsoft Office, Research, Microsoft Excel, Molecular Biology
Education
University of California, Irvine 2005 — 2010
B.S, Public Health Sciences
Illumina December 2011 - Present
Urban Outfitters March 2010 - October 2013
Eton Bioscience, Inc. July 2011 - December 2011
ValueGene March 2011 - June 2011
U.S. Food and Drug Administration March 2010 - June 2010
GreenAnswers.com October 2009 - December 2009
University of California, Irvine August 2008 - June 2009
ASSOCIATED STUDENTS OF UCI September 2006 - April 2007
NORDAC MECHANICAL INC February 2003 - April 2005
Skills
Logistics, Microsoft Office, Research, Microsoft Excel, Molecular Biology
Education
University of California, Irvine 2005 — 2010
B.S, Public Health Sciences
Debra Frost's U.S. Food and Drug Administration Experience January 1990 - January 1999
Job Quality Assurance Manager at Abaxis, Incorporated
Industry Medical Devices
Experience
Abaxis, Incorporated August 2014 - Present
Intuitive Surgical March 2013 - August 2014
Accuray, Inc September 2007 - March 2013
IMPAX Laboratories, Inc February 2002 - September 2007
Kyphon, Inc January 1999 - February 2002
U.S. Food and Drug Administration January 1990 - January 1999
Envirotech Research, Inc January 1988 - January 1990
Country Crisp Foods January 1986 - January 1987
Carnation January 1984 - January 1985
Skills
Design Control, FDA, Quality System, CAPA, Quality Assurance, GMP, SOP, Medical Devices
Education
Oregon State University
B.S. Degree, Food Science and Technology
Southern Oregon State College
General Chemistry, Biology, and Calculus
Abaxis, Incorporated August 2014 - Present
Intuitive Surgical March 2013 - August 2014
Accuray, Inc September 2007 - March 2013
IMPAX Laboratories, Inc February 2002 - September 2007
Kyphon, Inc January 1999 - February 2002
U.S. Food and Drug Administration January 1990 - January 1999
Envirotech Research, Inc January 1988 - January 1990
Country Crisp Foods January 1986 - January 1987
Carnation January 1984 - January 1985
Skills
Design Control, FDA, Quality System, CAPA, Quality Assurance, GMP, SOP, Medical Devices
Education
Oregon State University
B.S. Degree, Food Science and Technology
Southern Oregon State College
General Chemistry, Biology, and Calculus
Surendra P Shrivastava's U.S. Food and Drug Administration Experience February 1990 - Present
Job Sr. Pharmacologist at U.S. Food and Drug Administration
Industry Research
Experience
U.S. Food and Drug Administration February 1990 - Present
Skills
Data Analysis, Cell Culture, Pharmacology, Molecular Biology, Toxicology
Education
University of California, Berkeley 1962 — 1967
Ph.D., Entomology (Toxicology)
U.S. Food and Drug Administration February 1990 - Present
Skills
Data Analysis, Cell Culture, Pharmacology, Molecular Biology, Toxicology
Education
University of California, Berkeley 1962 — 1967
Ph.D., Entomology (Toxicology)
Soo Jin Park's U.S. Food and Drug Administration Experience August 2008 - Present
Job Regulatory Officer at U.S. Public Health Service Commissioned Corps
Industry Government Administration
Experience
U.S. Food and Drug Administration August 2008 - Present
Ahold 2005 - Present
Skills
Pharmaceutical Industry, Regulatory Affairs, Pharmacists, Regulatory Requirements, Pharmacovigilance, FDA, Biotechnology, Healthcare, Medical Writing, GCP, Oncology, Pharmacology, Pharmacy, Hands-on Training, Presentations, Clinical Research, Medication Therapy..., Regulatory Submissions, Public Health, Patient Counseling, Medicare Part D, Pharmacy Automation
Education
University of Maryland School of Pharmacy 2014 — 2016
Masters in Regulatory Science
University of the Sciences in Philadelphia 2001 — 2005
PharmD, Pharmacy
University of Maryland Baltimore County 1997 — 2001
BS, Biology
U.S. Food and Drug Administration August 2008 - Present
Ahold 2005 - Present
Skills
Pharmaceutical Industry, Regulatory Affairs, Pharmacists, Regulatory Requirements, Pharmacovigilance, FDA, Biotechnology, Healthcare, Medical Writing, GCP, Oncology, Pharmacology, Pharmacy, Hands-on Training, Presentations, Clinical Research, Medication Therapy..., Regulatory Submissions, Public Health, Patient Counseling, Medicare Part D, Pharmacy Automation
Education
University of Maryland School of Pharmacy 2014 — 2016
Masters in Regulatory Science
University of the Sciences in Philadelphia 2001 — 2005
PharmD, Pharmacy
University of Maryland Baltimore County 1997 — 2001
BS, Biology
Mitchell Cheeseman's U.S. Food and Drug Administration Experience July 2009 - November 2011
Job Managing Director at Steptoe & Johnson LLP
Industry Law Practice
Experience
Steptoe & Johnson LLP November 2011 - Present
U.S. Food and Drug Administration July 2009 - November 2011
U.S. Food and Drug Administration April 2006 - November 2011
U.S. Food and Drug Administration September 2002 - April 2006
Skills
Regulatory Affairs, Risk Assessment, Food Safety, Cosmetics, Medical Devices, Supplements, Food Packaging, Food, Ingredients, Chemicals, FDA, GMP, Life Sciences, Compliance, Quality Assurance, Chemistry, Biotechnology, Food Industry, Problem Solving, Strategic Planning, Regulatory Strategy, HACCP, Quality Systems, Policy, Writing, Research, Science, Product Development, Packaging, Polymers, Organic Chemistry, Regulatory Submissions, Food Processing, Government, Analysis, Food Technology, Drug Discovery, Public Policy, Dairy, Biochemistry, Nanotechnology, Process Engineering, Sustainability, Environmental Policy, Toxicology, Regulatory Requirements, Food Microbiology, Regulations, Molecular Biology, Process Simulation
Education
University of Florida 1986 — 1990
Doctor of Philosophy, Chemistry
The University of Memphis 1980 — 1986
Bachelor of Science in Chemistry, Chemistry
Steptoe & Johnson LLP November 2011 - Present
U.S. Food and Drug Administration July 2009 - November 2011
U.S. Food and Drug Administration April 2006 - November 2011
U.S. Food and Drug Administration September 2002 - April 2006
Skills
Regulatory Affairs, Risk Assessment, Food Safety, Cosmetics, Medical Devices, Supplements, Food Packaging, Food, Ingredients, Chemicals, FDA, GMP, Life Sciences, Compliance, Quality Assurance, Chemistry, Biotechnology, Food Industry, Problem Solving, Strategic Planning, Regulatory Strategy, HACCP, Quality Systems, Policy, Writing, Research, Science, Product Development, Packaging, Polymers, Organic Chemistry, Regulatory Submissions, Food Processing, Government, Analysis, Food Technology, Drug Discovery, Public Policy, Dairy, Biochemistry, Nanotechnology, Process Engineering, Sustainability, Environmental Policy, Toxicology, Regulatory Requirements, Food Microbiology, Regulations, Molecular Biology, Process Simulation
Education
University of Florida 1986 — 1990
Doctor of Philosophy, Chemistry
The University of Memphis 1980 — 1986
Bachelor of Science in Chemistry, Chemistry
Gary Hagan's U.S. Food and Drug Administration Experience January 2006 - Present
Job Supervisory Investigator at U.S. Food and Drug Administration
Industry Law Enforcement
Experience
U.S. Food and Drug Administration January 2006 - Present
U.S.Food and Drug Administration September 1967 - September 1977
Skills
Investigator, Research microwave..., Research, FDA, Lifesciences, Regulatory Affairs, Private Investigations, Regulatory Submissions, GMP, Regulatory Requirements, Clinical Trials, Validation, Sop, Clinical Research
Education
University of Massachusetts at Lowell 1965 — 1967
Bachelor of Science (BS), Human Biology
Wentworth Institute of Technology 1963 — 1965
BS, Nuclear Engineering
U.S. Food and Drug Administration January 2006 - Present
U.S.Food and Drug Administration September 1967 - September 1977
Skills
Investigator, Research microwave..., Research, FDA, Lifesciences, Regulatory Affairs, Private Investigations, Regulatory Submissions, GMP, Regulatory Requirements, Clinical Trials, Validation, Sop, Clinical Research
Education
University of Massachusetts at Lowell 1965 — 1967
Bachelor of Science (BS), Human Biology
Wentworth Institute of Technology 1963 — 1965
BS, Nuclear Engineering
Bob Moro's U.S. Food and Drug Administration Experience January 1972 - February 1973
Job Captain Moro, LLC Marine Surveying and Engineering Services
Industry Maritime
Experience
Captain Moro, LLC - Marine Surveying and Engineering Services June 1985 - Present
U.S. Consumer Product Safety Commission January 1973 - September 2005
Crack-A-Dawn Charter Services, Inc. October 1978 - September 2004
U.S. Food and Drug Administration January 1972 - February 1973
Skills
Yachting, Negotiation, Maritime, Logistics, Shipping, Transportation, Strategic Planning, New Business Development, Customer Service, Boat, Sailing, Business Strategy, Freight, Project Management, Microsoft Office, Sales Management
Education
Newark College of Engineering 1967 — 1971
Diploma, Mechanical Engineering, B.S.
United States Merchant Marine Academy
Captain Moro, LLC - Marine Surveying and Engineering Services June 1985 - Present
U.S. Consumer Product Safety Commission January 1973 - September 2005
Crack-A-Dawn Charter Services, Inc. October 1978 - September 2004
U.S. Food and Drug Administration January 1972 - February 1973
Skills
Yachting, Negotiation, Maritime, Logistics, Shipping, Transportation, Strategic Planning, New Business Development, Customer Service, Boat, Sailing, Business Strategy, Freight, Project Management, Microsoft Office, Sales Management
Education
Newark College of Engineering 1967 — 1971
Diploma, Mechanical Engineering, B.S.
United States Merchant Marine Academy
Kathie McConnell's U.S. Food and Drug Administration Experience March 2011 - Present
Job Library Director at U.S. Food and Drug Administration
Industry Libraries
Experience
U.S. Food and Drug Administration March 2011 - Present
U.S. Food and Drug Administration April 1996 - March 2011
U.S. National Institutes of Health November 1991 - April 1996
Skills
Library Science, Library Instruction, Electronic Resources, Collection Development, Digital Libraries, Library, Cataloging, Library Reference, Virtual Reference, Integrated Library..., Reader's Advisory, Collection Maintenance, LibGuides, Library Management, Copy Cataloging, AACR2, Librarians, Records Management, Public Services, Archival Processing, Circulation, Library Programming, Special Libraries, Metadata Standards, Information Management, Library Research, Government Documents, MARC21, Interlibrary Loan, Young People, Online Databases, Serials Management, Special Collections, OCLC Connexion, PubMed, Library 2.0, Information Retrieval, Academic Libraries, Indexing, Digitization, Knowledge Management, Bibliographic...
Education
University of Illinois at Urbana-Champaign 1984 — 1986
Master's degree, Library and Information Science
University of Illinois at Urbana-Champaign 1982 — 1984
Bachelor of Science (BS), Business Administration / Information Management Systems
U.S. Food and Drug Administration March 2011 - Present
U.S. Food and Drug Administration April 1996 - March 2011
U.S. National Institutes of Health November 1991 - April 1996
Skills
Library Science, Library Instruction, Electronic Resources, Collection Development, Digital Libraries, Library, Cataloging, Library Reference, Virtual Reference, Integrated Library..., Reader's Advisory, Collection Maintenance, LibGuides, Library Management, Copy Cataloging, AACR2, Librarians, Records Management, Public Services, Archival Processing, Circulation, Library Programming, Special Libraries, Metadata Standards, Information Management, Library Research, Government Documents, MARC21, Interlibrary Loan, Young People, Online Databases, Serials Management, Special Collections, OCLC Connexion, PubMed, Library 2.0, Information Retrieval, Academic Libraries, Indexing, Digitization, Knowledge Management, Bibliographic...
Education
University of Illinois at Urbana-Champaign 1984 — 1986
Master's degree, Library and Information Science
University of Illinois at Urbana-Champaign 1982 — 1984
Bachelor of Science (BS), Business Administration / Information Management Systems
Amy Cramer's U.S. Food and Drug Administration Experience 2002 - Present
Job Medical Device Specialist at U.S. Food & Drug Administration
Industry Medical Devices
Experience
U.S. Food and Drug Administration 2002 - Present
Skills
Policy, Policy Analysis, Public Policy, Program Management, Homeland Security, Public Administration, National Security, Federal Government, Medical device..., Government, Environmental Science
Education
Rutgers University-New Brunswick
Doctor of Philosophy (PhD), Environmental Science
Rutgers University-New Brunswick
Master of Science (MS), Environmental Science
Western New England College School of Law
Doctor of Law (J.D.)
U.S. Food and Drug Administration 2002 - Present
Skills
Policy, Policy Analysis, Public Policy, Program Management, Homeland Security, Public Administration, National Security, Federal Government, Medical device..., Government, Environmental Science
Education
Rutgers University-New Brunswick
Doctor of Philosophy (PhD), Environmental Science
Rutgers University-New Brunswick
Master of Science (MS), Environmental Science
Western New England College School of Law
Doctor of Law (J.D.)
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