United States Food and Drug Administration

Industry: Federal agency

Description

The 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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United States Food and Drug Administration Employees

Employee
Years
Job
Industry
Amanda Lauritzen Moher Amanda Lauritzen Moher Washington D.C. Metro Area Details
Amanda Lauritzen Moher's United States Food and Drug Administration Experience August 2004 - November 2004
Job Primary Patent Examiner at US Department of Commerce
Industry Medical Devices
Experience
United States Patent and Trademark Office  June 2006 - Present
United States Food and Drug Administration   August 2004 - November 2004
Marquette University  February 2004 - May 2004
Kimberly-Clark  2003 - 2004
Marquette University  2002 - 2004

Skills
Research, Medical Devices, Editing, Analytical Writing, Clinical Research, Patent Prosecution, Medical Imaging, Medical Writing, Technical Writing, Instruction Manuals, Tutoring, Patentability, Biomedical Engineering, Patent Applications

Education
The Johns Hopkins University   2008 — 2009
MS coursework in Applied Biomedical Engineering

Marquette University   2001 — 2006
BS, Biomedical Engineering (electrical instrumentation), Biological Sciences, Philosophy (minor), Cum Laude

Douglas Terry Douglas Terry Columbus, Ohio Area Details
Douglas Terry's United States Food and Drug Administration Experience August 2003 - August 2004
Job Certified Public Accountant (CPA)
Industry Accounting
Experience
Blue & Co., LLC   December 2012 - Present
JPMorgan Chase Bank  July 2010 - December 2012
Blue & Co.   October 2008 - June 2010
JPMorgan Chase  August 2006 - August 2008
JPMorgan Chase  August 2006 - August 2008
Reservoir Venture Partners   June 2005 - September 2005
United States Food and Drug Administration   August 2003 - August 2004
Thompson Hine LLP  August 2001 - May 2003
Kirkpatrick & Lockhart PLLC   June 2000 - September 2000
Jackson & Kelly PLLC   June 1999 - September 1999

Skills
Valuation, Litigation, Legal Writing, Legal Research, Investments, Financial Modeling, Finance, Civil Litigation, Business Valuation, CPA, Due Diligence, Mergers

Education
The Ohio State University Fisher College of Business   2004 — 2006
MBA, Finance, Investment Management, and Accounting

The Ohio State University Moritz College of Law   1998 — 2001
JD, Law

West Virginia University   1993 — 1997
BA, Biology

Meagan Freeman Meagan Freeman Springfield, Missouri Area Details
Meagan Freeman's United States Food and Drug Administration Experience May 2008 - August 2008
Job RN at Cox Health Systems
Industry Hospital & Health Care
Experience
Cox Health Systems  October 2014 - Present
Baptist Health Medical Center  July 2011 - September 2014
United States Food and Drug Administration   May 2008 - August 2008

Skills
Healthcare, Certified Medical..., Nursing, Patient Safety, BLS, EMR, Hospitals, Inpatient

Education
Baptist Health Schools Little Rock   2009 — 2011
Diploma, Registered Nursing/Registered Nurse

East Central University   2004 — 2008
Bachelors of Science, Biology, General

Paula Wilkerson, RAC, CRA Paula Wilkerson, RAC, CRA Gainesville, Florida Area Details
Paula Wilkerson, RAC, CRA's United States Food and Drug Administration Experience January 1990 - April 2002
Job Program Manager: Intertek Third Party Program; Sr. Reviewer; Sr. Staff Engineer at Intertek Testing Services
Industry Medical Devices
Experience
Intertek Testing Services  September 2009 - Present
College of Santa Fe  January 2009 - Present
Intertek  2009 - Present
Actualized Science LLC   October 2005 - September 2009
Nanotherapeutics, Inc.   2005 - September 2009
UF Sid Martin Biotechnology Incubation Program   2002 - 2009
Applied Genetic Technologies Corporation   2002 - 2005
United States Food and Drug Administration   January 1990 - April 2002

Skills
Clinical Research, Product Development, Lifesciences, Auditing, Validation, Quality Management, ISO 13485, Healthcare, New Business Development, Training, Business Development, Process Improvement, GMP, Clinical Development, Biomedical Engineering, FDA, Medical Devices, Life Sciences

Education
University of Washington   1983 — 1987
BS, Chemical Engineering

University of Oklahoma   1979 — 1981
MA, Mathmatics and Statistics

Hood College

Tyee HS

LCDR Melinda Ruiz, MPAS, RPA-C LCDR Melinda Ruiz, MPAS, RPA-C Greater New York City Area Details
LCDR Melinda Ruiz, MPAS, RPA-C's United States Food and Drug Administration Experience 2013 - Present
Job NY District Recall Coordinator at United States Food and Drug Administration
Industry Government Administration
Experience
United States Food and Drug Administration   2013 - Present
Montefiore Health System  May 2012 - August 2014
U.S. Food & Drug Administration   2010 - 2013
US Department of Homeland Security  2007 - 2010
U.S. Department of Justice   2005 - 2007

Skills
Public Health, Government, Policy Analysis, Public Policy, Emergency Management, Healthcare, Psychiatry, Correctional Medicine, Federal Law Enforcement, Law Enforcement..., Family Medicine, Medical Transcription, Regulatory Affairs, Policy, Research

Education
University of Nebraska Medical Center   2007 — 2008
MPAs, Physician Assistant

Sofie Davis School of Biomedical Education-CUNY   2002 — 2005
Bachelor's degree, Physician Assistant

CUNY Bronx Community College   1996 — 2000
Associate of Arts and Sciences (AAS), Clinical/Medical Laboratory Technician

Iona College   1994 — 1995
Law

Jeremy Mauldin Jeremy Mauldin Charlottesville, Virginia Details
Jeremy Mauldin's United States Food and Drug Administration Experience July 2002 - August 2003
Job Director of Business Development at HemoShear
Industry Biotechnology
Experience
HemoShear  September 2014 - Present
Baylor Scott & White Health  December 2007 - August 2014
United States Food and Drug Administration   July 2002 - August 2003
Department of Veterans Affairs  July 2001 - April 2002

Skills
Clinical Trials, GLP, Drug Development, Clinical Research, GMP, Data Analysis, Analysis, Biochemistry, Strategic Planning, Life Sciences, Microsoft Office, Lifesciences, Compliance, FDA GMP, Healthcare, Project Management, Business Development, Capital Budgeting, Department Budgeting, Department Budget..., Business Decision Making, Manage Client..., Contract Negotiation, Pharmacology, Executive Managment, Animal Models, Mammalian Cell Culture, Scientific Writing, IND, Toxicology, Lean Management, Strategic Financial..., Operations Management, Human Physiology

Education
University of Colorado at Colorado Springs   2010 — 2013
MBA, Innovation Management

University of Virginia   2003 — 2007
Ph.D., Pharmacology

Hampden-Sydney College   1997 — 2001
BS, Chemistry

Samuel Hamblin Samuel Hamblin Dallas, Texas Details
Samuel Hamblin's United States Food and Drug Administration Experience August 2009 - Present
Job Investigator at United States Food and Drug Administration
Industry Government Relations
Experience
United States Food and Drug Administration   August 2009 - Present
United States Food and Drug Administration   August 2009 - Present
VCA Animal Hospital  May 2009 - August 2009
Banfield, The Pet Hospital  June 2008 - January 2009

Skills
Agriculture, Quality Assurance, Veterinary, Veterinary Medicine, Policy, FDA, Surgery, Biochemistry, Microbiology, Vaccines, Lifesciences, Pharmaceutical Industry, GLP, ELISA, Medicine

Education
Morehead State University   2006 — 2009
Agriculture, Vetrinary Technology/Agriculture

Miami University   2003 — 2006
Studied, Biochemistry

David Jaworski David Jaworski Greater Chicago Area Details
David Jaworski's United States Food and Drug Administration Experience June 2014 - Present
Job Senior Policy Advisor at United States Food and Drug Administration
Industry Pharmaceuticals
Experience
United States Food and Drug Administration   June 2014 - Present

Skills
FDA, Pharmaceutical Industry, Biotechnology, Manufacturing, GMP, Regulatory Affairs, Validation, Regulatory Submissions, CAPA, Quality System, 21 CFR Part 11, Change Control, Regulatory Requirements, Technology Transfer, V&V, GLP, Biopharmaceuticals, Drug Development, Vaccines, Clinical Development, Pharmaceutics, Sop, Lifesciences, Quality Auditing, Clinical Trials, GCP, SOP, Life Sciences

Education
Syracuse University - Martin J. Whitman School of Management   1980 — 1985
MBA

Penn State University   1970 — 1973
BS

Darrell R. Hoffman, MBA, SPHR Darrell R. Hoffman, MBA, SPHR Washington D.C. Metro Area Details
Darrell R. Hoffman, MBA, SPHR's United States Food and Drug Administration Experience 2000 - 2002
Job Director, Workforce Management and Vitality
Industry Government Administration
Experience
U.S. Department of Health and Human Services   October 2014 - Present
U.S. Department of Health and Human Service   June 2013 - October 2014
the United States Department of the Interior   2009 - June 2013
U.S. Department of Education   2008 - 2009
Martinsburg VA Medical Center  2006 - 2008
Department of Defense  2003 - 2006
National Transportation Safety Board  2002 - 2003
United States Food and Drug Administration   2000 - 2002
U.S. General Services Administration   1998 - 2000

Skills
National Labor..., Government Contract..., Policy Writing, Policy Planning, Federal Labor Relations..., Labor Contract..., Federal Employment Law, Budgets, Strategic Finance, Consultative Services, Benefits Management, Retirement Planning, Workers Compensation, Analysis Services, Workforce Planning, Performance Management, Human Resources, Employee Relations, Organizational..., Succession Planning, Labor Relations, Personnel Management, Employment Law, Leadership, Program Management, Management, Employee Benefits, HR Policies, HRIS, Legal Compliance, Interviews, Policy, Federal Government, Leadership Development, Talent Management, Employee Engagement, Background Checks, Government, Federal Law, Training, Conflict Resolution, Talent Acquisition, EEO, Change Management, Coaching, SPHR, Benefits Administration, FMLA, Deferred Compensation, Business Process...

Education
Baker College Center for Graduate Studies
MBA

State University of New York Empire State College
BS

Travell Sawyer Travell Sawyer Orange County, California Area Details
Travell Sawyer's United States Food and Drug Administration Experience Customs and Border patrol OfficerUS Department of Homeland SecurityAugust 2005 - December 2007
Job Investigator at United States Food and Drug Administration
Industry Public Safety
Experience
United States Food and Drug Administration   Customs and Border patrol OfficerUS Department of Homeland SecurityAugust 2005 - December 2007
Los Angeles County  October 2000 - August 2005

Skills
Enforcement, Private Investigations, Public Safety, Criminal Investigations, Police, Emergency Management, Criminal Justice, Firearms, Surveillance, Evidence, Interrogation, Homeland Security, Investigation, Patrol, Emergency Services, Physical Security, Crime Prevention, CBRN

Education
CSUDH   1998 — 1999
Biology, Biology

Southern University and Agricultural and Mechanical College at Baton Rouge   1991 — 1997
Premed, Biology, General

James P. Stansbury James P. Stansbury Washington D.C. Metro Area Details
James P. Stansbury's United States Food and Drug Administration Experience July 2010 - Present
Job Social Scientist
Industry Government Administration
Experience
United States Food and Drug Administration   July 2010 - Present
Washington Association of Professional Anthropologists   2011 - 2012
EnCompass  June 2008 - July 2010
Office of Behavioral and Social Sciences Research, National Institutes of Health   2007 - 2008
University of Florida  1997 - 2005
Rehabilitation Outcomes Research Center   2002 - 2004
University of Kentucky  1988 - 1996

Skills
Public Health, Program Evaluation, Research, Qualitative Research, Capacity Building, Global Health, Policy Analysis, Grants, Program Development, Epidemiology, Grant Writing, Infectious Diseases, Report Writing, Public Policy, Health Communication, Community Outreach, Policy, Nonprofits, Clinical Research, International..., International Health, Health Policy, Human Rights, Government, Health Education, Non-profits, Fundraising

Education
The Johns Hopkins University   2005 — 2006
MPH, public health

University of Kentucky   1987 — 1996
PhD, medical anthropology

The University of New Mexico   1983 — 1986
MA, anthropology

Bibie Adesioye Bibie Adesioye Columbus, Ohio Area Details
Bibie Adesioye's United States Food and Drug Administration Experience October 2001 - August 2010
Job Attorney, Immigration and Naturalization Law
Industry Law Practice
Experience
Abiola Akinwunmi Adesioye Law Firm   August 2012 - Present
Flagship Ventures LLC   November 2003 - September 2011
United States Food and Drug Administration   October 2001 - August 2010

Skills
Research, Immigration Issues, Employment-based..., Immigration Policy, U.S. Immigration, Visas, Business Visas, Trials, Appeals, Hearings, Removals, Naturalization, Citizenship, Motions, Immigration Law, Deportation, Consular Processing, Removal Defense, Adjustment Of Status, VAWA, Waivers Of..., Asylum, Public Policy, Public Speaking, Community Outreach, Policy Analysis, Criminal Law, Legal Research

Education
University of Georgia School of Law   1998 — 2001
Juris Doctorate

Georgia State University   1995 — 1998
Bachelor of Arts, Political Science

Chrisland   1990 — 1992
High School, High School/Secondary Diplomas and Certificates

Lauren Berkowitz, JD Lauren Berkowitz, JD Washington D.C. Metro Area Details
Lauren Berkowitz, JD's United States Food and Drug Administration Experience August 2009 - August 2011
Job Regulatory Counsel at FDA
Industry Government Administration
Experience
FDA  June 2011 - Present
United States Food and Drug Administration   August 2009 - August 2011
Schulman, Treem, Kaminkow & Gilden   August 2008 - February 2009
Baltimore County Government  August 2007 - August 2008
Frank, Frank & Scherr, LLC   May 2006 - May 2007
Office of the Attorney General of Maryland, Medicaid Fraud Control Unit   January 2006 - May 2007
Bazelon Center   September 2003 - January 2004

Skills
Policy, Public Health, Legal Research, Policy Analysis, Writing, Research, Strategic Planning, Analysis, Healthcare, Legal Writing, Public Policy, Nonprofits, Legislation, Contract Negotiation, Program Management, Community Outreach, Politics, Administrative Law, Litigation, Appeals, Legislative Relations, Courts, Negotiation, Government, Hearings, Health Law, Mediation, Motions, Regulatory Analysis, Criminal Law, Westlaw, Legal Issues

Education
Georgetown University   2012 — 2013
Certificate in Marketing

University of Maryland Francis King Carey School of Law   2004 — 2007
Law, Health Care Law Certificate

University of Pennsylvania   2001 — 2004
BA, Political Science and Psychology

McDonogh   1988 — 2000

Eugene Chuang Eugene Chuang Washington D.C. Metro Area Details
Eugene Chuang's United States Food and Drug Administration Experience June 2014 - Present
Job Consumer Safety at FDA | USAF
Industry Government Administration
Experience
United States Food and Drug Administration   June 2014 - Present
United States Air Force Reserves  December 2008 - Present
Ambient Bamboo Products, Inc.   January 2014 - June 2014
United States Air Force  September 2012 - May 2013
UMBC Club Sports   February 2010 - May 2010
RnJ Sports  July 2009 - February 2010

Skills
Military, Security Clearance, Air Force, Team Leadership, Military Logistics, Weapons Handling, Leadership, DoD, Chinese, Teamwork, Logistics, Aviation, Operations Management, Customer Service, Transportation, Security, Firearms, Operational Planning, Team Building, First Aid, Military Operations, Followership, Defense, Joint Military..., Air Freight, Salesforce.com, QuickBooks, UPS Shipping

Education
University of Maryland Baltimore County   2010 — 2012
Emergency Medical Services

Community College of the Air Force   2008 — 2010
Associate of Science (AS), Air Transportation

University of Maryland College Park   2005 — 2008

Andrew Zawisza Andrew Zawisza Greater Chicago Area Details
Andrew Zawisza's United States Food and Drug Administration Experience May 2007 - August 2007
Job Quality at Phonak
Industry Medical Devices
Experience
Phonak  April 2015 - Present
Zimmer Orthopedics  September 2014 - April 2015
Stryker Corp  June 2013 - September 2014
AM Andrew Z, LLC   December 2012 - December 2013
Stryker Corp  January 2012 - June 2013
Stryker Corp  December 2010 - December 2011
Kraft Foods  July 2008 - October 2009
United States Food and Drug Administration   May 2007 - August 2007

Skills
Medical Devices, FDA, Quality System, Product Development, Cross-functional Team..., Six Sigma, Continuous Improvement, Manufacturing, Engineering, Design Control, Project Management, Process Improvement, Microsoft Office, Process Engineering, Quality Assurance, Root Cause Analysis, R&D

Education
Stevens Institute of Technology   2010 — 2010
Candidate, Master of Biomedical Engineering, Biomedical Engineering

Michigan State University   2004 — 2008
Bachelor of Science, Biosystems Engineering

Kaylee Mosher Kaylee Mosher Livermore, California Details
Kaylee Mosher's United States Food and Drug Administration Experience February 2009 - March 2013
Job Your Dream Job Find it here @ Blackhawk Network
Industry Human Resources
Experience
Blackhawk Network  June 2015 - Present
Stanford Law School  July 2013 - June 2015
MacDonald-Bedford LLC  April 2013 - July 2013
United States Food and Drug Administration   February 2009 - March 2013
Alpha Phi - Eta Delta Chapter   January 2010 - January 2011

Skills
Public Speaking, PowerPoint, Event Planning, Research, Microsoft Office, Data Entry, Social Media, Microsoft Word, Expense Reports, Employee Benefits, Payroll, Benefits Administration, Quality Assurance, Human Resources, Records Management, Microsoft Excel, Management, Outlook, Administrative..., Project Planning, Time Management, Customer Service, Software Documentation, Social Networking, Training, Access

Education
California State University-East Bay   2009 — 2013
B.S. Degree, Health Science; Administration Option

Bishop O'Dowd High School   2004 — 2008

Guy E. Skinner Guy E. Skinner United States Details
Guy E. Skinner's United States Food and Drug Administration Experience December 1990 - Present
Job Research Food Technologist at United States Food and Drug Administration
Industry
Experience
United States Food and Drug Administration   December 1990 - Present
ABC Research   1989 - 1990
Southern Belle Foods   1988 - 1989

Education
The University of Georgia   1983 — 1988
Doctor of Philosophy (Ph.D.), Food Engineering / Food Science

The University of Georgia   1980 — 1983
Master of Science (MS), Food Science and Engineering

The University of Georgia   1975 — 1980
Bachelor of Science (B.Sc.), Food Science and Technology

henderson high school

Mark Clanton, M.D.,M.P.H.,F.A.A.P. Mark Clanton, M.D.,M.P.H.,F.A.A.P. Austin, Texas Area Details
Mark Clanton, M.D.,M.P.H.,F.A.A.P.'s United States Food and Drug Administration Experience 2010 - Present
Job Medical Director TMF Health Quality Institute
Industry Hospital & Health Care
Experience
TMF Health Quality Institute  October 2014 - Present
KU Cancer Center   2011 - Present
The Transdisciplinary Research on Energetics and Cancer (TREC), Washington University in St. Louis   2011 - Present
United States Food and Drug Administration   2010 - Present
University of Hawaii Cancer Center  2009 - Present
National Council of the Institute of Public Health, Washington University in St. Louis   2009 - Present
Washington University in St. Louis, Siteman Cancer Center   2007 - Present
Baltimore City Health Department  April 2014 - July 2014
American Cancer Society  November 2006 - May 2013
National Cancer Institute  2004 - 2006

Skills
Pediatrics, Cancer, Prevention, Healthcare, Public Speaking, Strategic Planning, Non-profits, Fundraising, Public Health, Disaster response and..., Health care advocacy, Building strategic..., Clinical Research, Health Policy, Grants, Healthcare Management, Medicine, Health Advocacy, Community Outreach, Program Development, Oncology, Leadership, Hospitals, Program Management, Policy, Research, Nonprofits, Lifesciences, Program Evaluation, Science, Cancer Research, Infectious Diseases, Genetics, Epidemiology, Clinical Trials, Informatics, Biostatistics, Health Education, Public Policy, Community Engagement

Education
Harvard T.H. Chan School of Public Health   1989 — 1990
Master of Public Health, Health Policy and Management

Tulane University School of Medicine   1982 — 1985
M.D., Medicine

Southern Methodist University - Cox School of Business   1997 — 1998
Certificate in Finance, Corporate Finance

Howard University   1974 — 1978
B.S., Microbiology

Nicole Dockery Nicole Dockery Kansas City, Missouri Area Details
Nicole Dockery's United States Food and Drug Administration Experience May 2002 - July 2003
Job Associate RSU Manager at Quintiles
Industry Research
Experience
Quintiles  July 2006 - Present
Hickman Mills School District  August 2003 - July 2006
United States Food and Drug Administration   May 2002 - July 2003

Skills
Protocol, Pharmaceutical Industry, Leadership, Clinical Trials, CTMS, Strategy, EDC, Biotechnology, GCP, CRO, ICH-GCP, Regulatory Affairs

Education
University of Central Missouri   2005 — 2006
Masters, Eduacation

University of Missouri-Kansas City   1998 — 2002
Bachelors, Chemistry

Chris Vockley Chris Vockley Durham, North Carolina Details
Chris Vockley's United States Food and Drug Administration Experience 2003 - 2006
Job PhD Student at Duke University
Industry Research
Experience
Duke University  September 2011 - Present
Harvard University  January 2009 - July 2011
National Institutes of Health  2007 - 2008
US Food and Drug Administration  2007 - 2007
United States Food and Drug Administration   2003 - 2006
Genelogic  2000 - 2000

Skills
Molecular Biology, Genomics, Cell Biology, Molecular Cloning, Assay Development, DNA, Transfection, DNA sequencing, Confocal Microscopy, Sequencing, Microarray, Cancer, Stem Cells, Cancer Research, real-time PCR, Functional Genomics, Histology, Developmental Biology

Education
University of Maryland College Park   2003 — 2006

The Johns Hopkins University   2007 — 2009
bioinformatics

Duke University

Pecora Consulting LLC Pecora Consulting LLC Greater New York City Area Details
Pecora Consulting LLC's United States Food and Drug Administration Experience January 1977 - February 1988
Job Managing Director
Industry Government Relations
Experience
Pecora Consulting LLC   May 2005 - Present
Pecora Consulting LLC   May 2005 - Present
United States Food and Drug Administration   January 1977 - February 1988

Skills
GMP, FDA, Management, Manufacturing, Training, Pharmaceutical Industry, Medical Devices, Food, Project Planning, Insurance, Import, Strategic Planning, Business Strategy, Product Development, International Business, Inspection, Food Safety, International Trade, New Business Development, Negotiation

Education
City University of New York   1972 — 1976
BS, Biology/Chemistry

Sandra Kircus Sandra Kircus Greater Boston Area Details
Sandra Kircus's United States Food and Drug Administration Experience February 2002 - December 2005
Job Regulatory Affairs
Industry Biotechnology
Experience
Genzyme  July 2015 - Present
Genzyme  August 2013 - July 2015
Eurus Pharma   September 2011 - August 2013
Teleflex Medical  February 2011 - September 2011
Gorbec Pharmaceutical Services Inc.   July 2007 - December 2010
Durham Technical Community College  June 2006 - August 2007
Wyeth Vaccines  March 2006 - July 2007
United States Food and Drug Administration   February 2002 - December 2005

Skills
FDA, GMP, HPLC, Chemistry, Regulatory Affairs, Quality Assurance, Medical Devices, Sop, ISO, Biotechnology, Pharmaceutical Industry, Regulatory Submissions, Analytical Chemistry, Technology Transfer, Quality System, Quality Control, Change Control, CAPA, Laboratory, Validation, Pharmaceutics, Regulatory Requirements, GLP, ELISA, LC-MS, 21 CFR Part 11, V&V, LIMS, Drug Development, Biopharmaceuticals, SOP

Education
University of North Carolina at Chapel Hill   1997 — 2001
Ph.D., Chemistry

University of Montevallo   1993 — 1997
Bachelors, Chemistry

Erica Land Erica Land Washington D.C. Metro Area Details
Erica Land's United States Food and Drug Administration Experience 1993 - 2006
Job photographer owner at erica land photography
Industry Photography
Experience
erica land photography   AttorneyFood and Drug Administration1993 - 2006
United States Food and Drug Administration   1993 - 2006

Education
American University Washington College of Law   1989 — 1992
Doctor of Law (J.D.), Law

Ithaca College   1985 — 1989
Bachelor's degree, phsycology/Business

Rich Koller Rich Koller Sheboygan, Wisconsin Area Details
Rich Koller's United States Food and Drug Administration Experience 2010 - 2012
Job Shipping and Receiving Supervisor at The Toro Company
Industry Pharmaceuticals
Experience
The Toro Company  March 2013 - Present
Sheboygan Paint   February 2012 - October 2012
United States Food and Drug Administration   2010 - 2012
Cedarburg Hauser Pharmaceuticals, LLC   2007 - 2010
Cedarburg Hauser Pharmaceuticals, LLC   2001 - 2007
Sigma Aldrich  1995 - 1999

Skills
FDA, Pharmaceutical Industry, Regulated Product..., cGMP Training, Leadership, Quality Assurance, Quality System, GMP, Cross-functional Team..., CAPA, Management, Training, Medical Devices, Sop, Quality Control, Quality Auditing, Validation, Manufacturing, Regulatory Affairs, HPLC, V&V, Technology Transfer, GLP, Biotechnology, Chemistry, Change Control, 21 CFR Part 11, Regulatory Submissions, Analytical Chemistry, ISO 13485, Regulatory Requirements, Six Sigma, Team Building

Education
Lakeshore Technical College   2014 — 2014
Certificate, Six Sigma Green Belt

Lakeshore Technical College   2014 — 2014
Six Sigma Black Belt

University of Wisconsin-La Crosse   1989 — 1993
Bachelor's degree, Biology

Maureen Dreher Maureen Dreher Washington D.C. Metro Area Details
Maureen Dreher's United States Food and Drug Administration Experience December 2009 - Present
Job Biomedical Engineer at US Food and Drug Administration
Industry Medical Devices
Experience
United States Food and Drug Administration   December 2009 - Present
United States Food and Drug Administration   May 2007 - December 2009
GlaxoSmithKline  May 2003 - September 2003

Education
Duke University   2000 — 2007
PhD, Biomedical Engineering

Duke University   2000 — 2002
MS, Biomedical Engineering

Worcester Polytechnic Institute   1996 — 2000
BS, Biomedical Enginnering

JOHN COLERANGLE JOHN COLERANGLE Greater New York City Area Details
JOHN COLERANGLE's United States Food and Drug Administration Experience July 1999 - August 2007
Job Associate Director, Global Regulatory Affairs at Sanofi U. S. Inc.
Industry Pharmaceuticals
Experience
Sanofi U. S. Inc.   November 2014 - Present
Sanofi U. S. Inc.   May 2010 - October 2014
Sanofi-Aventis  September 2007 - April 2010
United States Food and Drug Administration   July 1999 - August 2007

Skills
Excellent Written and..., IND, Clinical Development, Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Oncology, Clinical Trials, Pharmacology, Biotechnology, Drug Discovery, Pharmacokinetics, Clinical Study Design, NDA, Drug Safety, GLP

Education
University of Alabama at Birmingham   1992 — 1997
Ph.D., Toxicology

Tuskegee University   1987 — 1991
DVM, Veterinary Medicine

Tara Alcazar Tara Alcazar Chicago, Illinois Details
Tara Alcazar's United States Food and Drug Administration Experience July 2010 - Present
Job Investigator at United States Food and Drug Administration
Industry Government Relations
Experience
United States Food and Drug Administration   July 2010 - Present
Pilsen Junior Tennis Camp   March 2009 - Present
University of Illinois at Chicago  October 2008 - August 2010
Burlington Atomic Energy Commission Plant Former Worker Program   August 2007 - August 2008

Skills
Leadership, Research, Entrepreneurship, Sustainability, Public Health, Recruiting, Genetics, Nonprofits, Fundraising, Public Speaking, Community Outreach, Grant Writing, Philanthropy, Community Development, Social Media, Non-profits

Education
University of Illinois at Chicago   2005 — 2007
MS, Environmental and Occupational Health Science, Industrial Hygiene

Cornell College   2001 — 2005
BA, Biology, Spanish

Eric Nitz Eric Nitz United States Details
Eric Nitz's United States Food and Drug Administration Experience May 2008 - April 2009
Job Associate Attorney at MoloLamken LLP
Industry
Experience
MoloLamken LLP  September 2013 - Present
U.S. Court of Appeals for the Seventh Circuit   September 2012 - August 2013
Winston & Strawn LLP  October 2011 - August 2012
DC Bar Pro Bono Program  September 2011 - October 2011
Winston & Strawn LLP  June 2010 - July 2010
United States Department of Justice, Antitrust Division, National Criminal Enforcement Section   June 2009 - August 2009
United States Food and Drug Administration   May 2008 - April 2009
Pope John Paul II High School  July 2005 - June 2007
Executive Office of the President - Office of Strategic Initiatives   August 2003 - December 2003

Education
Georgetown University   2008 — 2011
M.P.P., Public Policy

Georgetown University Law Center   2007 — 2011
J.D., Law

University of Notre Dame   2005 — 2007
M. Ed., Secondary Education

University of Notre Dame   2001 — 2005
B.S., Biological Sciences

Patrick Ayres Patrick Ayres Greater Denver Area Details
Patrick Ayres's United States Food and Drug Administration Experience March 2010 - Present
Job Supervisory Chemist at United States Food and Drug Administration
Industry Government Administration
Experience
United States Food and Drug Administration   March 2010 - Present
State of Colorado  April 1998 - March 2010
University of Colorado at Denver  January 1996 - May 1998

Skills
Research, Community Outreach, HPLC, Analytical Chemistry, Analysis, LC-MS, Mass Spectrometry, Public Speaking, Sustainability, Nonprofits, PowerPoint, Strategic Planning, Instrumental chemistry, GC-MS, Molecular Biology, Laboratory, FTIR, GC-FID, Instrumental Analysis, Microsoft Excel, Project Management, Supervisory Skills, Molecular Microbiology, UV/Vis, Chemistry, Organic Chemistry, Quality Assurance, Government, FDA, Leadership, Data Analysis, Program Management, Management, Customer Service, Policy

Education
University of Denver   2005 — 2008
Masters of Science, Chemistry and Biochemistry

University of Colorado at Denver   1999 — 2001
Bachelor of Science (B.S.), Chemistry

University of Colorado at Denver   1996 — 1998
Bachelor of Science (B.S.), Molecular Biology

Amanda Merkelson, MPH Amanda Merkelson, MPH Greater New York City Area Details
Amanda Merkelson, MPH's United States Food and Drug Administration Experience May 2005 - July 2005
Job BioMe Biobank Managing Director at The Mount Sinai Hospital
Industry Pharmaceuticals
Experience
The Mount Sinai Hospital  July 2013 - Present
New York University Langone Medical Center  February 2011 - July 2013
Mount Sinai School of Medicine  November 2006 - February 2011
United States Food and Drug Administration   May 2005 - July 2005
Novartis Pharma AG  June 2002 - August 2002
Lab of Professor Martin Kagnoff, MD   May 2001 - August 2001

Skills
Clinical Trials, Clinical Research, Infectious Diseases, Regulatory Submissions, Therapeutic Areas, IRB, Hematology, Gastroenterology, Endocrinology, Protocol, Medicine, Regulatory Affairs, Nephrology, GCP, Lifesciences, Life Sciences

Education
Yale University School of Medicine   2004 — 2006
MPH, Chronic Disease Epidemiology

Yale University School of Medicine   2004 — 2006
MPH, Epidemiology and Public Health (Chronic Disease Epidemiology)

Cornell University   2000 — 2004
BA, American Studies

Guillermo Cuevas Guillermo Cuevas Washington, District Of Columbia Details
Guillermo Cuevas's United States Food and Drug Administration Experience June 2011 - August 2011
Job Attorney at Consumer Financial Protection Bureau
Industry Legal Services
Experience
Consumer Financial Protection Bureau  February 2015 - Present
Alston & Bird LLP  August 2012 - December 2014
United States Food and Drug Administration   June 2011 - August 2011
Bristol Myers Squibb  June 2010 - August 2010

Skills
FDA regulatory law

Education
Columbia University Mailman School of Public Health   2009 — 2012
Master of Public Health (M.P.H.), Environmental Toxicology

Columbia Law School   2008 — 2012
Doctor of Law (J.D.)

Claremont McKenna College   2001 — 2005
Bachelor of Arts (B.A.), Environmental Science and History

Sarah Haugh Sarah Haugh Cincinnati Area Details
Sarah Haugh's United States Food and Drug Administration Experience May 2009 - September 2011
Job Molecular Genetic Technician I at Cincinnati Children's Hospital Medical Center
Industry Research
Experience
Cincinnati Children's Hospital Medical Center  November 2012 - Present
Genetica DNA Laboratories, Inc.   September 2011 - October 2012
United States Food and Drug Administration   May 2009 - September 2011

Skills
GC-MS, Mass Spectrometry, Analytical Chemistry, Microscopy, LC-MS, Laboratory, Chemistry, Chromatography, FTIR, PCR, HPLC, UV/Vis, Forensic Analysis, Gas Chromatography, Science, Wet Chemistry, Spectroscopy, Statistics, Molecular Genetics, Genetics, Cell

Education
University of Cincinnati   2009 — 2011
MS, Molecular Genetics, Microbiology and Biochemsitry

Eastern Kentucky University   2005 — 2009
BS, Forensic Science

Brooks McPhail Brooks McPhail Raleigh-Durham, North Carolina Area Details
Brooks McPhail's United States Food and Drug Administration Experience September 2009 - December 2009
Job Forensic Toxicologist at North Carolina State Crime Laboratory
Industry Research
Experience
North Carolina State Crime Laboratory  June 2014 - Present
Columbia Southern University  April 2013 - Present
Virginia College  January 2013 - June 2013
Centers for Disease Control & Prevention  July 2008 - July 2012
United States Food and Drug Administration   September 2009 - December 2009
USDA-ARS  June 2002 - February 2008

Skills
Mass Spectrometry, Toxicology, Chemistry, Gas Chromatography, Laboratory, Pharmacokinetics, ADME, Physiology, Research, Teaching, Cell Culture, Science

Education
The University of Georgia   2002 — 2008
PhD, Toxicology

South Carolina State University   1998 — 2002
BS, Biology

Aileen H. Ciampa Aileen H. Ciampa Greater Nashville Area Details
Aileen H. Ciampa's United States Food and Drug Administration Experience 2002 - 2005
Job Independent Consultant
Industry Legal Services
Experience
Self-Employed  2009 - Present
United States Food and Drug Administration   2002 - 2005
King and Spalding  2000 - 2002
Covington & Burling  1997 - 1999
Covington & Burling LLP  1995 - 1997

Skills
Writing, Editing, Policy, Research, Policy Analysis, Legal Research, Legal Writing, Nonprofits, Microsoft Office, Federal & State..., Negotiation, Communication, Strategy, Administrative Law, Discovery

Education
Georgetown University Law Center   1997 — 2000
Juris Doctor, Magna Cum Laude

Wake Forest University   1991 — 1995
B.A., Magna Cum Laude

Holly Wieland Holly Wieland Washington D.C. Metro Area Details
Holly Wieland's United States Food and Drug Administration Experience 2003 - Present
Job Regulatory Project Manager at United States Food and Drug Administration
Industry Research
Experience
United States Food and Drug Administration   2003 - Present
National Institutes of Health  October 1998 - October 2003

Skills
Public Speaking, Research, Microsoft Office, Social Media, Project Management

Education
The Johns Hopkins University
Master of Public Health (MPH), International Public Health/International Health

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