U.S. Food & Drug Administration
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Customer service: 1 (888) 463-6332 Emergency: 1 (866) 300-4374 Headquarters: Silver Spring, MD Jurisdiction: United States of America Founded: June 30, 1906 Founders: Theodore Roosevelt, Harvey Washington Wiley
U.S. Food & Drug Administration List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at U.S. Food & Drug Administration. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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U.S. Food & Drug Administration Employees
Employee
Years
Job
Industry
Phyllis Marquitz Phyllis Marquitz's U.S. Food & Drug Administration Experience June 2008 - October 2013
Job
Industry Consumer Goods
Experience
Mars October 2013 - Present
U.S. Food & Drug Administration June 2008 - October 2013
National Cattlemen's Beef Association 2007 - 2008
Penn State University's Agricultural Law Center 2005 - 2007
Carlise Borough Council 2003 - 2005
Department of Veterans Affairs 2000 - 2001
Skills
International Trade..., Food Safety, Regulatory Affairs, International Relations, Public Health, Public Policy, Agribusiness, Policy Analysis, Food Science, International Trade Law, Policy, Food, International..., Agriculture, Research, Lifesciences, Government, Food Industry, Science, Statistics, Microbiology, Program Evaluation, Biotechnology, Epidemiology, Public Affairs, Additives
Education
Pennsylvania State University, The Dickinson School of Law
JD, Certificate in International, Foreign and Comparative Law
James Madison University
MS, RD, Human Nutrition
Penn State University
BS, Nutrition
Mars October 2013 - Present
U.S. Food & Drug Administration June 2008 - October 2013
National Cattlemen's Beef Association 2007 - 2008
Penn State University's Agricultural Law Center 2005 - 2007
Carlise Borough Council 2003 - 2005
Department of Veterans Affairs 2000 - 2001
Skills
International Trade..., Food Safety, Regulatory Affairs, International Relations, Public Health, Public Policy, Agribusiness, Policy Analysis, Food Science, International Trade Law, Policy, Food, International..., Agriculture, Research, Lifesciences, Government, Food Industry, Science, Statistics, Microbiology, Program Evaluation, Biotechnology, Epidemiology, Public Affairs, Additives
Education
Pennsylvania State University, The Dickinson School of Law
JD, Certificate in International, Foreign and Comparative Law
James Madison University
MS, RD, Human Nutrition
Penn State University
BS, Nutrition
Lacey Olufsen Lacey Olufsen's U.S. Food & Drug Administration Experience June 2009 - October 2009
Job Biology Student At Northwest University
Industry Biotechnology
Experience
Dendreon April 2013 - April 2015
Dendreon-Lab Temps July 2012 - April 2013
Puget Sound Blood Center January 2011 - February 2012
U.S. Food & Drug Administration June 2009 - October 2009
Skills
Biotechnology, ELISA, DNA sequencing, Molecular Biology, DNA, Laboratory, PCR, Immunoassays, Cell and tissue culture, DNA extraction, Blood Bank, Bioinformatics, Media and Solution Prep, Gel Electrophoresis, Protein Purification, qPCR, SDS-PAGE, LIMS, Microbiology, Tissue Culture, Sop, In Vitro, Antibodies, Cell Culture, Recombinant DNA..., Protein analysis, Bacterial culture, DNA analysis, HPLC, Molecular Immunology, Amplification, OriginLab, real-time PCR, Quantitative PCR, Entomology, Spotfire, insect coulture, GraphPad Prism, Cancer Research, Prostate cancer research, Freezerworks, ICH Guidelines, ISO 9001, Cell Based Assays, Cellular Assays, FDA Guidelines, Fuctional assays, ELISPOT, Clinical Research, Quality Control and...
Education
Northwest University 2015 — 2018
Bachelor’s Degree, Biology, General
Shoreline Community College 2006 — 2010
Associate’s Degree, Biotechnology Lab Specialist
Dendreon April 2013 - April 2015
Dendreon-Lab Temps July 2012 - April 2013
Puget Sound Blood Center January 2011 - February 2012
U.S. Food & Drug Administration June 2009 - October 2009
Skills
Biotechnology, ELISA, DNA sequencing, Molecular Biology, DNA, Laboratory, PCR, Immunoassays, Cell and tissue culture, DNA extraction, Blood Bank, Bioinformatics, Media and Solution Prep, Gel Electrophoresis, Protein Purification, qPCR, SDS-PAGE, LIMS, Microbiology, Tissue Culture, Sop, In Vitro, Antibodies, Cell Culture, Recombinant DNA..., Protein analysis, Bacterial culture, DNA analysis, HPLC, Molecular Immunology, Amplification, OriginLab, real-time PCR, Quantitative PCR, Entomology, Spotfire, insect coulture, GraphPad Prism, Cancer Research, Prostate cancer research, Freezerworks, ICH Guidelines, ISO 9001, Cell Based Assays, Cellular Assays, FDA Guidelines, Fuctional assays, ELISPOT, Clinical Research, Quality Control and...
Education
Northwest University 2015 — 2018
Bachelor’s Degree, Biology, General
Shoreline Community College 2006 — 2010
Associate’s Degree, Biotechnology Lab Specialist
Maira P. Brading (Rios)'s U.S. Food & Drug Administration Experience July 1989 - Present
Job Investigator at U.S. Food & Drug Administration
Industry Law Enforcement
Experience
U.S. Food & Drug Administration July 1989 - Present
Skills
Regulatory Submissions, Regulations, Toxicology, Microsoft Office, Regulatory Affairs, Microsoft Word, Investigation, Evidence, Customer Service, Private Investigations, FDA, Microsoft Excel, English, PowerPoint, Regulatory Analysis, Pharmacokinetics, Regulatory Requirements, Health Law, Regulatory Agencies, Pharmacology, GLP, Environmental Health, Federal Law, Biostatistics, Internal Investigations, Federal Government, In Vitro, Immunology, Assay Development, In Vivo, Pharmacovigilance, Drug Discovery, Drug Development, IND, Administrative Law, Infectious Diseases, LC-MS, Validation, Government, GMP, Policy, Biotechnology, Quality System, Life Sciences, Team Building, Quality Assurance
Education
University of Texas at Pan American 1984 — 1989
Bachelor of Science (BS), Biology, General
The University of Texas at Austin 1985 — 1988
Biology, General
U.S. Food & Drug Administration July 1989 - Present
Skills
Regulatory Submissions, Regulations, Toxicology, Microsoft Office, Regulatory Affairs, Microsoft Word, Investigation, Evidence, Customer Service, Private Investigations, FDA, Microsoft Excel, English, PowerPoint, Regulatory Analysis, Pharmacokinetics, Regulatory Requirements, Health Law, Regulatory Agencies, Pharmacology, GLP, Environmental Health, Federal Law, Biostatistics, Internal Investigations, Federal Government, In Vitro, Immunology, Assay Development, In Vivo, Pharmacovigilance, Drug Discovery, Drug Development, IND, Administrative Law, Infectious Diseases, LC-MS, Validation, Government, GMP, Policy, Biotechnology, Quality System, Life Sciences, Team Building, Quality Assurance
Education
University of Texas at Pan American 1984 — 1989
Bachelor of Science (BS), Biology, General
The University of Texas at Austin 1985 — 1988
Biology, General
Barbara (Basha) Moss's U.S. Food & Drug Administration Experience September 1996 - January 2012
Job Tupperware Consultant
Industry Packaging and Containers
Experience
U.S. Food & Drug administration September 1996 - January 2012
U.S. Dept of Agriculture, Animal and Plant Health Inspection Service, Plant Protection & Quarantine September 1981 - October 1996
Skills
Customer Service
Education
University of Delaware 1972 — 1976
Bachelor of Science (BS), Ag, Plant Science
Martin Van Buren High School 1969 — 1972
U.S. Food & Drug administration September 1996 - January 2012
U.S. Dept of Agriculture, Animal and Plant Health Inspection Service, Plant Protection & Quarantine September 1981 - October 1996
Skills
Customer Service
Education
University of Delaware 1972 — 1976
Bachelor of Science (BS), Ag, Plant Science
Martin Van Buren High School 1969 — 1972
Rick Rutherford Rick Rutherford's U.S. Food & Drug Administration Experience July 1988 - July 2013
Job President/Principal at Rutherford MEDDEV Consulting
Industry Medical Devices
Experience
Rutherford MEDDEV Consulting Inc. August 2013 - Present
RCA Inc 2014 - 2014
U.S. Food & Drug Administration July 1988 - July 2013
Oklahoma State Department of Health December 1985 - July 1988
US Naval Reserves January 1984 - July 1988
US Navy March 1975 - March 1980
Skills
Quality systems/auditing, Medical Devices - Pre-..., Blood Bank and Plasma..., Medical Devices, Regulatory Submissions, Lifesciences, Biotechnology, Regulatory Requirements, GLP, Pharmaceutical Industry, Clinical Development, Quality System, Design Control, V&V, ISO 13485, Healthcare, Quality Assurance, R&D, 21 CFR Part 11, Sop, SOP, Life Sciences, FDA, Validation, CAPA, GMP, Change Control
Education
Northwestern Oklahoma State University 1982 — 1985
Bachelor of Science (B.S.), Biology, General
Merritt College 1976 — 1997
Environmental Health Technician Diploma, Environmental Health
Rutherford MEDDEV Consulting Inc. August 2013 - Present
RCA Inc 2014 - 2014
U.S. Food & Drug Administration July 1988 - July 2013
Oklahoma State Department of Health December 1985 - July 1988
US Naval Reserves January 1984 - July 1988
US Navy March 1975 - March 1980
Skills
Quality systems/auditing, Medical Devices - Pre-..., Blood Bank and Plasma..., Medical Devices, Regulatory Submissions, Lifesciences, Biotechnology, Regulatory Requirements, GLP, Pharmaceutical Industry, Clinical Development, Quality System, Design Control, V&V, ISO 13485, Healthcare, Quality Assurance, R&D, 21 CFR Part 11, Sop, SOP, Life Sciences, FDA, Validation, CAPA, GMP, Change Control
Education
Northwestern Oklahoma State University 1982 — 1985
Bachelor of Science (B.S.), Biology, General
Merritt College 1976 — 1997
Environmental Health Technician Diploma, Environmental Health
Robert Nusser Robert Nusser's U.S. Food & Drug Administration Experience July 1972 - August 1985
Job Real Estate AppraiserRETIRED
Industry Real Estate
Experience
Independent Fee Appraiser January 2014 - Present
Self-employed August 1985 - Present
US Food & Drug Administration July 1972 - August 1985
FDA 1972 - 1985
Skills
Residential Real Estate..., Investment Properties, Appraisals, REO, Residential Homes, Real Estate
Education
Rutgers, The State University of New Jersey-Newark 1968 — 1972
Bachelor's degree
Independent Fee Appraiser January 2014 - Present
Self-employed August 1985 - Present
US Food & Drug Administration July 1972 - August 1985
FDA 1972 - 1985
Skills
Residential Real Estate..., Investment Properties, Appraisals, REO, Residential Homes, Real Estate
Education
Rutgers, The State University of New Jersey-Newark 1968 — 1972
Bachelor's degree
Daniel Brenners's U.S. Food & Drug Administration Experience June 2013 - September 2013
Job Student at School of Information, UC Berkeley
Industry Information Technology and Services
Experience
Siemens Web of Things Research Group May 2015 - September 2015
US Food & Drug Administration June 2013 - September 2013
National Science Foundation September 2012 - June 2013
Education
University of California, Berkeley - School of Information 2014 — 2016
Master’s Degree, Information Management and Systems
University of California, Los Angeles 2008 — 2013
Bachelor’s Degree, Bioengineering
Siemens Web of Things Research Group May 2015 - September 2015
US Food & Drug Administration June 2013 - September 2013
National Science Foundation September 2012 - June 2013
Education
University of California, Berkeley - School of Information 2014 — 2016
Master’s Degree, Information Management and Systems
University of California, Los Angeles 2008 — 2013
Bachelor’s Degree, Bioengineering
Tina Crosby's U.S. Food & Drug Administration Experience August 2010 - Present
Job Biologist at U.S. Food & Drug Administration
Industry Research
Experience
U.S. Food & Drug Administration August 2010 - Present
University of Florida August 2005 - February 2010
University of Florida January 2003 - August 2005
Skills
Microbiology, PCR, Aquaculture, Laboratory, Science, Molecular Biology, Histology, Fish, Microscopy, Biochemistry, Biology, Scientific Writing, Experimental Design, Research, Lifesciences, Ecology, Fish Health Diagnostics, Fish Health, Water Quality, Life Sciences
Education
University of Florida 2005 — 2008
Master of Science (M.S.), Fisheries and Aquatic Sciences
Hillsborough Community College 2002 — 2004
Associate of Science (AS), Aquaculture
University of South Florida
Bachelor of Science (B.S.), Biology/Biological Sciences, General
U.S. Food & Drug Administration August 2010 - Present
University of Florida August 2005 - February 2010
University of Florida January 2003 - August 2005
Skills
Microbiology, PCR, Aquaculture, Laboratory, Science, Molecular Biology, Histology, Fish, Microscopy, Biochemistry, Biology, Scientific Writing, Experimental Design, Research, Lifesciences, Ecology, Fish Health Diagnostics, Fish Health, Water Quality, Life Sciences
Education
University of Florida 2005 — 2008
Master of Science (M.S.), Fisheries and Aquatic Sciences
Hillsborough Community College 2002 — 2004
Associate of Science (AS), Aquaculture
University of South Florida
Bachelor of Science (B.S.), Biology/Biological Sciences, General
LCDR Melinda Ruiz, MPAS, RPA-C LCDR Melinda Ruiz, MPAS, RPA-C's U.S. Food & Drug Administration Experience 2010 - 2013
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
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
Kevin Klommhaus Kevin Klommhaus's U.S. Food & Drug Administration Experience July 2012 - May 2014
Job Consumer Safety Officer Division of Compliance at Center for Veterinary Medicine US FDA
Industry Government Administration
Experience
Center for Veterinary Medicine US FDA May 2014 - Present
Ringgold County Hospital December 2009 - Present
US FOOD & DRUG ADMINISTRATION July 2012 - May 2014
Iowa Department of Agriculture & Land Stewardship June 2010 - July 2012
Iowa Department Of Agriculture & Land Stewardship December 2005 - July 2012
Mount Ayr Fire Department August 1996 - April 2011
US Bank October 2004 - December 2005
Skills
Agriculture, Emergency Management, Emergency Services, Homeland Security, Public Relations, NIMS, Disaster Response, Public Speaking, Research, Firefighting, Teaching, Grant Writing, Event Planning, Sustainable Agriculture, Hazardous Materials
Education
Northwest Missouri State University 1990 — 1992
BS, Agriculture
Des Moines Area Community College 1986 — 1988
AAS, Ag Business
Center for Veterinary Medicine US FDA May 2014 - Present
Ringgold County Hospital December 2009 - Present
US FOOD & DRUG ADMINISTRATION July 2012 - May 2014
Iowa Department of Agriculture & Land Stewardship June 2010 - July 2012
Iowa Department Of Agriculture & Land Stewardship December 2005 - July 2012
Mount Ayr Fire Department August 1996 - April 2011
US Bank October 2004 - December 2005
Skills
Agriculture, Emergency Management, Emergency Services, Homeland Security, Public Relations, NIMS, Disaster Response, Public Speaking, Research, Firefighting, Teaching, Grant Writing, Event Planning, Sustainable Agriculture, Hazardous Materials
Education
Northwest Missouri State University 1990 — 1992
BS, Agriculture
Des Moines Area Community College 1986 — 1988
AAS, Ag Business
Jennifer Hoffbauer Jennifer Hoffbauer's U.S. Food & Drug Administration Experience June 2012 - September 2012
Job Consultant at Deloitte
Industry Management Consulting
Experience
Deloitte January 2015 - Present
Lynch Consultants, LLC November 2013 - December 2014
Catapult Consultants May 2013 - September 2013
Civitas Group September 2012 - May 2013
George Washington University Medical School August 2010 - April 2013
U.S. Food & Drug Administration June 2012 - September 2012
Dorset Management June 2011 - August 2011
Julius Roehrs Company May 2010 - August 2010
Amdur, Maggs & Shor Law Firm May 2009 - August 2009
Jersey Shore Medical Center May 2009 - June 2009
Skills
Gel Electrophoresis, Biotechnology, Cell Culture, PCR, Microbiology, Medical Devices, Microscopy, Laboratory, Biomedical Engineering, Bioinformatics, Immunology, Science, Molecular Biology, Biochemistry, Lifesciences, ELISA, Protein Purification, Cell, Statistics, Chemistry, Microsoft Word, Data Analysis
Education
The George Washington University 2009 — 2013
BS, Biomedical Engineering, English
Biotechnology High School 2005 — 2009
International Baccalaureate Diploma Recipient, Biotechnology
Deloitte January 2015 - Present
Lynch Consultants, LLC November 2013 - December 2014
Catapult Consultants May 2013 - September 2013
Civitas Group September 2012 - May 2013
George Washington University Medical School August 2010 - April 2013
U.S. Food & Drug Administration June 2012 - September 2012
Dorset Management June 2011 - August 2011
Julius Roehrs Company May 2010 - August 2010
Amdur, Maggs & Shor Law Firm May 2009 - August 2009
Jersey Shore Medical Center May 2009 - June 2009
Skills
Gel Electrophoresis, Biotechnology, Cell Culture, PCR, Microbiology, Medical Devices, Microscopy, Laboratory, Biomedical Engineering, Bioinformatics, Immunology, Science, Molecular Biology, Biochemistry, Lifesciences, ELISA, Protein Purification, Cell, Statistics, Chemistry, Microsoft Word, Data Analysis
Education
The George Washington University 2009 — 2013
BS, Biomedical Engineering, English
Biotechnology High School 2005 — 2009
International Baccalaureate Diploma Recipient, Biotechnology
Jimmy D. Threet, M.S. Jimmy D. Threet, M.S.'s U.S. Food & Drug Administration Experience October 2001 - January 2011
Job
Industry Biotechnology
Experience
Arkanasas Genomics August 2006 - Present
Arkansas Genomics August 2006 - Present
U.S. Food & Drug Administration October 2001 - January 2011
Arkansas Department of Health October 1996 - October 2001
Skills
DNA, Genetics, Biotechnology, Life Sciences, Data Analysis, Lifesciences, Genomics, Molecular Biology, DNA extraction, Cell Culture, Cancer, DNA fingerprinting, Protein Chemistry, Hardware Diagnostics, Forensic Analysis, Genetic Analysis, Expert Witness, Genetic Testing, Laboratory, Molecular Diagnostics, real-time PCR, DNA sequencing, Flow Cytometry, PCR, Molecular Genetics, Microbiology, Personalized Medicine, qPCR, ELISA, Cell Biology, Immunology, Microscopy
Education
University of Florida 2006 — 2008
MS Forensic Science, DNA / Serology / Forensics
Texas Tech University 1991 — 1996
BA Science, Chemisty
Arkanasas Genomics August 2006 - Present
Arkansas Genomics August 2006 - Present
U.S. Food & Drug Administration October 2001 - January 2011
Arkansas Department of Health October 1996 - October 2001
Skills
DNA, Genetics, Biotechnology, Life Sciences, Data Analysis, Lifesciences, Genomics, Molecular Biology, DNA extraction, Cell Culture, Cancer, DNA fingerprinting, Protein Chemistry, Hardware Diagnostics, Forensic Analysis, Genetic Analysis, Expert Witness, Genetic Testing, Laboratory, Molecular Diagnostics, real-time PCR, DNA sequencing, Flow Cytometry, PCR, Molecular Genetics, Microbiology, Personalized Medicine, qPCR, ELISA, Cell Biology, Immunology, Microscopy
Education
University of Florida 2006 — 2008
MS Forensic Science, DNA / Serology / Forensics
Texas Tech University 1991 — 1996
BA Science, Chemisty
Don Segal's U.S. Food & Drug Administration Experience 1979 - 1991
Job Attorney FDA Regulatory Law at Alston & Bird LLP
Industry Legal Services
Experience
Alston & Bird LLP 2005 - Present
Buchanan Ingersoll 2000 - 2005
Akin Gump Strauss Hauer & Feld LLP 1993 - 2000
U.S. Food & Drug Administration 1979 - 1991
Skills
Commercial Litigation, Intellectual Property, Litigation, FDA, Due Diligence, Licensing
Education
Boston College Law School 1969 — 1972
Doctor of Law (J.D.)
Brandeis University 1965 — 1969
B.A., Political Science
Roxbury Latin School 1959 — 1965
Alston & Bird LLP 2005 - Present
Buchanan Ingersoll 2000 - 2005
Akin Gump Strauss Hauer & Feld LLP 1993 - 2000
U.S. Food & Drug Administration 1979 - 1991
Skills
Commercial Litigation, Intellectual Property, Litigation, FDA, Due Diligence, Licensing
Education
Boston College Law School 1969 — 1972
Doctor of Law (J.D.)
Brandeis University 1965 — 1969
B.A., Political Science
Roxbury Latin School 1959 — 1965
Gary E. Fendler Gary E. Fendler's U.S. Food & Drug Administration Experience 1992 - 1993
Job Senior Strategic Communications Advisor
Industry Hospital & Health Care
Experience
Manatt Health Solutions July 2014 - Present
TruLogix Analytics, Inc. April 2013 - Present
Ascension June 2013 - July 2014
DiscoveryTel International 2005 - May 2013
The Rendon Group 2001 - 2005
FundsXpress 1998 - 2001
Logical Design Solutions 1997 - 1998
Aetna Health Plans 1993 - 1996
U.S. Food & Drug Administration 1992 - 1993
U.S. Securities & Exchange Commission 1991 - 1992
Skills
Strategic Communications, Public Affairs, Media Relations, Message Development, Event Management, Corporate Communications, Leadership, Crisis Management, Community Development, Political Communication, Reputation Management, Policy, Strategic Partnerships, Government, Start-ups, Digital Media, Marketing Strategy, Management, Strategy, Communication Training, Spokesperson, Campaigns, Communications Planning, International Relations, Crisis Communications, Public Relations, Event Planning, Marketing Communications, Politics
Education
The University of Texas at Austin 1976 — 1980
BJ, Communications
Manatt Health Solutions July 2014 - Present
TruLogix Analytics, Inc. April 2013 - Present
Ascension June 2013 - July 2014
DiscoveryTel International 2005 - May 2013
The Rendon Group 2001 - 2005
FundsXpress 1998 - 2001
Logical Design Solutions 1997 - 1998
Aetna Health Plans 1993 - 1996
U.S. Food & Drug Administration 1992 - 1993
U.S. Securities & Exchange Commission 1991 - 1992
Skills
Strategic Communications, Public Affairs, Media Relations, Message Development, Event Management, Corporate Communications, Leadership, Crisis Management, Community Development, Political Communication, Reputation Management, Policy, Strategic Partnerships, Government, Start-ups, Digital Media, Marketing Strategy, Management, Strategy, Communication Training, Spokesperson, Campaigns, Communications Planning, International Relations, Crisis Communications, Public Relations, Event Planning, Marketing Communications, Politics
Education
The University of Texas at Austin 1976 — 1980
BJ, Communications
Jim DiNovo Jim DiNovo's U.S. Food & Drug Administration Experience February 1999 - February 2004
Job Medical Device QSR Consultant
Industry Medical Devices
Experience
Self-Employed August 2004 - Present
U.S. Department of Justice, Health Care Fraud Unit March 2004 - August 2004
U.S. Food & Drug Administration February 1999 - February 2004
U.S. Food & Drug Administration September 1977 - January 1999
Skills
Medical Devices, CAPA, V&V, Quality System, Quality Assurance, Design Control, FDA, Validation, Certified FDA Level I..., Regulatory Requirements, Quality Auditing, Technology Transfer, Biomedical Engineering, Testing, ISO 14971, Pharmaceutical Industry, Regulatory Affairs
Education
University of Massachusetts Lowell 1989 — 1992
Master of Management Science, Reliability Engineering, Statistical Process Control, Microelectronics, GPA: 3.8/4.0
Rensselaer Polytechnic Institute 1976 — 1977
Master of Engineering (M.Eng.), Biomedical Engineering
Rensselaer Polytechnic Institute 1974 — 1976
Bachelor of Science (B.Sc.), Biomedical Engineering
Self-Employed August 2004 - Present
U.S. Department of Justice, Health Care Fraud Unit March 2004 - August 2004
U.S. Food & Drug Administration February 1999 - February 2004
U.S. Food & Drug Administration September 1977 - January 1999
Skills
Medical Devices, CAPA, V&V, Quality System, Quality Assurance, Design Control, FDA, Validation, Certified FDA Level I..., Regulatory Requirements, Quality Auditing, Technology Transfer, Biomedical Engineering, Testing, ISO 14971, Pharmaceutical Industry, Regulatory Affairs
Education
University of Massachusetts Lowell 1989 — 1992
Master of Management Science, Reliability Engineering, Statistical Process Control, Microelectronics, GPA: 3.8/4.0
Rensselaer Polytechnic Institute 1976 — 1977
Master of Engineering (M.Eng.), Biomedical Engineering
Rensselaer Polytechnic Institute 1974 — 1976
Bachelor of Science (B.Sc.), Biomedical Engineering
Harris Eisenstein Harris Eisenstein's U.S. Food & Drug Administration Experience November 2010 - July 2011
Job Creditors' Rights and Litigation Attorney Rosenberg Martin Greenberg, LLP
Industry Law Practice
Experience
Rosenberg Martin Greenberg, LLP August 2011 - Present
U.S. Food & Drug Administration November 2010 - July 2011
Rosenberg Martin Greenberg, LLP December 2009 - October 2010
Ward Pratz & Associates, P.A. February 2009 - November 2009
Skills
Litigation, Appeals, Legal Research, Civil Litigation, Commercial Litigation, Legal Writing, Bankruptcy, Courts, Intellectual Property, Mediation, Trials, Personal Injury, Creditors' Rights
Education
University of Baltimore School of Law 2007 — 2010
Juris Doctor, cum laude
University of Maryland College Park 2003 — 2007
B.S., Finance
Rosenberg Martin Greenberg, LLP August 2011 - Present
U.S. Food & Drug Administration November 2010 - July 2011
Rosenberg Martin Greenberg, LLP December 2009 - October 2010
Ward Pratz & Associates, P.A. February 2009 - November 2009
Skills
Litigation, Appeals, Legal Research, Civil Litigation, Commercial Litigation, Legal Writing, Bankruptcy, Courts, Intellectual Property, Mediation, Trials, Personal Injury, Creditors' Rights
Education
University of Baltimore School of Law 2007 — 2010
Juris Doctor, cum laude
University of Maryland College Park 2003 — 2007
B.S., Finance
Wally Pellerite Wally Pellerite's U.S. Food & Drug Administration Experience 1984 - 2005
Job Medical Device Consultant
Industry Medical Devices
Experience
Pellerite Medical Device Consulting Chairman, Medical Device Compliance CommitteeBecker & AssociatesApril 2011 - November 2012
Quintiles Consulting 2005 - 2007
U.S. Food & Drug Administration 1984 - 2005
FDA 1984 - 2005
Skills
CAPA, Complaint Handling, Investigations, Management Review, QSR, FDA, Medical Devices, Quality Systems, Surveillance, Quality System, Regulatory Affairs, Pharmaceutical Industry, Quality Assurance, ISO 13485, Quality Auditing, V&V, Lifesciences, Complaint Management, Technology Transfer, Regulations, 21 CFR Part 11, Change Control, GMP, Biotechnology, Quality Control, Clinical Research, Regulatory Submissions, Regulatory Requirements, Pharmaceutics, Validation, ISO 14971, GxP, Design Control, PMA, Quality Management, Private Investigations, Sop, Clinical Trials, Strategy, Oncology, Clinical Development, R&D, GLP, ISO, Hardware Diagnostics, Biopharmaceuticals, Drug Development, Computer System..., GCP, Life Sciences
Education
Penn State 1966 — 1970
Pellerite Medical Device Consulting Chairman, Medical Device Compliance CommitteeBecker & AssociatesApril 2011 - November 2012
Quintiles Consulting 2005 - 2007
U.S. Food & Drug Administration 1984 - 2005
FDA 1984 - 2005
Skills
CAPA, Complaint Handling, Investigations, Management Review, QSR, FDA, Medical Devices, Quality Systems, Surveillance, Quality System, Regulatory Affairs, Pharmaceutical Industry, Quality Assurance, ISO 13485, Quality Auditing, V&V, Lifesciences, Complaint Management, Technology Transfer, Regulations, 21 CFR Part 11, Change Control, GMP, Biotechnology, Quality Control, Clinical Research, Regulatory Submissions, Regulatory Requirements, Pharmaceutics, Validation, ISO 14971, GxP, Design Control, PMA, Quality Management, Private Investigations, Sop, Clinical Trials, Strategy, Oncology, Clinical Development, R&D, GLP, ISO, Hardware Diagnostics, Biopharmaceuticals, Drug Development, Computer System..., GCP, Life Sciences
Education
Penn State 1966 — 1970
Patrisa Keys's U.S. Food & Drug Administration Experience August 2005 - February 2011
Job Middle School Teacher
Industry Education Management
Experience
School August 2012 - Present
Charter School January 2011 - June 2011
Lionel Hampton Elementary School January 2011 - May 2011
Marsh Elementary School February 2011 - April 2011
US Food & Drug Administration August 2005 - February 2011
C & T Afterschool Tutoring January 2009 - May 2009
St. Mark M. B. Church September 1998 - August 2005
Presidnet's Office of Employment Training (POET) July 1998 - August 1998
ARAMARK August 1996 - August 1998
Applebee's Grill and Bar June 1997 - June 1998
Skills
PowerPoint, Outlook, Microsoft Office, Access, Administrative Support, Database Administration, Typing, Office Equipment, Microsoft Money, Tutoring, Word, Excel, Teaching, Data Entry, Customer Service, Microsoft Excel, Fundraising, Event Management, Microsoft Word, Editing, Administration, Government, Program Management
Education
Saint Xavier University 2006 — 2011
Bachelor of Science, Elementary Education; Elementary Education
Robert Morris University - Illinois 1997 — 1998
Associate of Applied Science, Business Administration-Paralegal
School August 2012 - Present
Charter School January 2011 - June 2011
Lionel Hampton Elementary School January 2011 - May 2011
Marsh Elementary School February 2011 - April 2011
US Food & Drug Administration August 2005 - February 2011
C & T Afterschool Tutoring January 2009 - May 2009
St. Mark M. B. Church September 1998 - August 2005
Presidnet's Office of Employment Training (POET) July 1998 - August 1998
ARAMARK August 1996 - August 1998
Applebee's Grill and Bar June 1997 - June 1998
Skills
PowerPoint, Outlook, Microsoft Office, Access, Administrative Support, Database Administration, Typing, Office Equipment, Microsoft Money, Tutoring, Word, Excel, Teaching, Data Entry, Customer Service, Microsoft Excel, Fundraising, Event Management, Microsoft Word, Editing, Administration, Government, Program Management
Education
Saint Xavier University 2006 — 2011
Bachelor of Science, Elementary Education; Elementary Education
Robert Morris University - Illinois 1997 — 1998
Associate of Applied Science, Business Administration-Paralegal
Mike Dubinsky Mike Dubinsky's U.S. Food & Drug Administration Experience 1991 - 1998
Job Consultant & Instructor at UC Berkeley, Clinical Trial Topics
Industry Biotechnology
Experience
University of California, Berkeley May 2007 - Present
PM Dubinsky January 2007 - Present
Chiron(formerly) 2006 - Present
UC Berkeley Extension April 2009 - August 2013
Chiron 2003 - 2006
Wyeth Pharmaceuticals 2002 - 2003
SangStat Medical Corporation 2000 - 2001
Alpha Therapeutics Corporation (Now Grifols Biologicals) 1998 - 2000
Alpha Therapeutic Corp. 1998 - 2000
US Food & Drug Administration 1991 - 1998
Skills
Biotechnology, DNA sequencing, FDA, Lifesciences, Clinical Trials, GCP, Regulatory Affairs, Regulatory Submissions, 21 CFR Part 11, Quality Assurance, GLP, GxP, GMP, Biopharmaceuticals, Immunology, Sop, Drug Development, Clinical Research, Validation, Clinical Development, Drug Discovery, CAPA, Technology Transfer, Infectious Diseases, Vaccines, Microbiology, Protocol, Life Sciences
Education
University of Maryland College Park 1964 — 1969
BS, Microbiology
University of California, Berkeley May 2007 - Present
PM Dubinsky January 2007 - Present
Chiron(formerly) 2006 - Present
UC Berkeley Extension April 2009 - August 2013
Chiron 2003 - 2006
Wyeth Pharmaceuticals 2002 - 2003
SangStat Medical Corporation 2000 - 2001
Alpha Therapeutics Corporation (Now Grifols Biologicals) 1998 - 2000
Alpha Therapeutic Corp. 1998 - 2000
US Food & Drug Administration 1991 - 1998
Skills
Biotechnology, DNA sequencing, FDA, Lifesciences, Clinical Trials, GCP, Regulatory Affairs, Regulatory Submissions, 21 CFR Part 11, Quality Assurance, GLP, GxP, GMP, Biopharmaceuticals, Immunology, Sop, Drug Development, Clinical Research, Validation, Clinical Development, Drug Discovery, CAPA, Technology Transfer, Infectious Diseases, Vaccines, Microbiology, Protocol, Life Sciences
Education
University of Maryland College Park 1964 — 1969
BS, Microbiology
Rishi Thakur, Ph.D. Rishi Thakur, Ph.D.'s U.S. Food & Drug Administration Experience July 2014 - Present
Job Staff Fellow at US Food & Drug Administration
Industry Pharmaceuticals
Experience
US Food & Drug Administration July 2014 - Present
Banner Life Sciences, Division of Patheon November 2011 - July 2014
Capsugel, A Division of Pfizer December 2010 - November 2011
Forest Laboratories, Inc. May 2005 - September 2005
Unichem Laboratories Limited January 2003 - August 2003
Skills
Solid State..., Drug Delivery, Formulation, Nanoparticles, Characterization, Dissolution, Pharmaceutical Research, HPLC, GLP, TGA, UV/Vis, Technology Transfer, LC-MS, Analytical Chemistry, Pharmaceutics, GMP, Chromatography, Pharmaceutical Industry, UV, Sop, R&D, Spectroscopy, Design of Experiments, Differential Scanning..., Quality by Design, Validation, Clinical Development, FTIR, Polymers, Quality Control, Drug Development
Education
LIU Brooklyn 2005 — 2010
PhD., Pharmaceutics
Long Island University 2003 — 2005
Master, Industrial Pharmacy
Panjab University 1998 — 2002
B. Pharm, Pharmaceutics
US Food & Drug Administration July 2014 - Present
Banner Life Sciences, Division of Patheon November 2011 - July 2014
Capsugel, A Division of Pfizer December 2010 - November 2011
Forest Laboratories, Inc. May 2005 - September 2005
Unichem Laboratories Limited January 2003 - August 2003
Skills
Solid State..., Drug Delivery, Formulation, Nanoparticles, Characterization, Dissolution, Pharmaceutical Research, HPLC, GLP, TGA, UV/Vis, Technology Transfer, LC-MS, Analytical Chemistry, Pharmaceutics, GMP, Chromatography, Pharmaceutical Industry, UV, Sop, R&D, Spectroscopy, Design of Experiments, Differential Scanning..., Quality by Design, Validation, Clinical Development, FTIR, Polymers, Quality Control, Drug Development
Education
LIU Brooklyn 2005 — 2010
PhD., Pharmaceutics
Long Island University 2003 — 2005
Master, Industrial Pharmacy
Panjab University 1998 — 2002
B. Pharm, Pharmaceutics
Christina Karas's U.S. Food & Drug Administration Experience January 2005 - January 2006
Job Researcher | Writer | Knowledge Development
Industry Research
Experience
Greenleaf Health, LLC May 2012 - Present
Marian Court College September 2012 - May 2013
Boston College September 2011 - May 2012
Boston College June 2011 - August 2011
Boston College September 2010 - May 2011
BIO January 2006 - July 2010
U.S. Food & Drug Administration January 2005 - January 2006
Skills
Education Policy, Academic Advising, Research, Health Policy, Board Governance, Analysis, Curriculum Development, Community Outreach, Program Development, Policy, Volunteer Management, Tutoring, Staff Development, Higher Education, Proofreading, Strategy, Writing, Editing, Teaching, Mentoring, Public Policy, Non-profits, Nonprofits
Education
University of Michigan 2000 — 2002
Master of Public Policy
Boston College 2010 — 2012
Master of Arts (M.A.), English
University of Michigan 1997 — 2001
Bachelor of Arts (A.B.), with distinction, Political Science
The George Washington University 2008 — 2009
Semester at Sea International Study Program 2000 — 2000
Greenleaf Health, LLC May 2012 - Present
Marian Court College September 2012 - May 2013
Boston College September 2011 - May 2012
Boston College June 2011 - August 2011
Boston College September 2010 - May 2011
BIO January 2006 - July 2010
U.S. Food & Drug Administration January 2005 - January 2006
Skills
Education Policy, Academic Advising, Research, Health Policy, Board Governance, Analysis, Curriculum Development, Community Outreach, Program Development, Policy, Volunteer Management, Tutoring, Staff Development, Higher Education, Proofreading, Strategy, Writing, Editing, Teaching, Mentoring, Public Policy, Non-profits, Nonprofits
Education
University of Michigan 2000 — 2002
Master of Public Policy
Boston College 2010 — 2012
Master of Arts (M.A.), English
University of Michigan 1997 — 2001
Bachelor of Arts (A.B.), with distinction, Political Science
The George Washington University 2008 — 2009
Semester at Sea International Study Program 2000 — 2000
Jill Horowitz Jill Horowitz's U.S. Food & Drug Administration Experience January 1993 - March 1997
Job Head of Licensing, CEO at BBS Nanotechnology
Industry Pharmaceuticals
Experience
BBS Nanotechnology February 2013 - Present
Prescient Life Sciences January 2011 - September 2012
Pfizer November 2008 - November 2010
Novartis January 2007 - October 2008
Novartis June 2004 - December 2006
Wyeth Pharmaceuticals June 1999 - May 2004
Private consulting firm September 1998 - May 1999
National Institutes of Health April 1997 - August 1998
US Food & Drug Administration January 1993 - March 1997
National Institutes of Health January 1990 - December 1992
Skills
Deal Sourcing, Deal Structuring, Deal Closing, Infectious Diseases, Oncology, Vaccines, Due Diligence, Mergers, Product Development, Commerce, Animal Health, Technology Transfer, Pharmaceuticals, Biotechnology, Life Sciences, Immunology, Commercialization, Drug Discovery, Biopharmaceuticals, Clinical Trials, Competitive Analysis, Strategy Development, Clinical Development, Medical Devices, Licensing, Competitive Intelligence, Corporate Development, R&D, Market Research, Start-ups, Cross-functional Team..., Business Strategy, Marketing Strategy, Strategic Planning, Clinical Research, Molecular Biology, Regulatory Affairs, Healthcare, Clinical, Contract Negotiation, Portfolio Management, Business Planning, Negotiation, Alliances, Management Consulting, New Business Development, Diagnostics, Respiratory Products, Project Management, Lifesciences
Education
Albert Einstein College of Medicine of Yeshiva University 1980 — 1986
PhD, Molecular Pharmacology
Barnard College of Columbia University 1976 — 1980
BA, Biochemistry
BBS Nanotechnology February 2013 - Present
Prescient Life Sciences January 2011 - September 2012
Pfizer November 2008 - November 2010
Novartis January 2007 - October 2008
Novartis June 2004 - December 2006
Wyeth Pharmaceuticals June 1999 - May 2004
Private consulting firm September 1998 - May 1999
National Institutes of Health April 1997 - August 1998
US Food & Drug Administration January 1993 - March 1997
National Institutes of Health January 1990 - December 1992
Skills
Deal Sourcing, Deal Structuring, Deal Closing, Infectious Diseases, Oncology, Vaccines, Due Diligence, Mergers, Product Development, Commerce, Animal Health, Technology Transfer, Pharmaceuticals, Biotechnology, Life Sciences, Immunology, Commercialization, Drug Discovery, Biopharmaceuticals, Clinical Trials, Competitive Analysis, Strategy Development, Clinical Development, Medical Devices, Licensing, Competitive Intelligence, Corporate Development, R&D, Market Research, Start-ups, Cross-functional Team..., Business Strategy, Marketing Strategy, Strategic Planning, Clinical Research, Molecular Biology, Regulatory Affairs, Healthcare, Clinical, Contract Negotiation, Portfolio Management, Business Planning, Negotiation, Alliances, Management Consulting, New Business Development, Diagnostics, Respiratory Products, Project Management, Lifesciences
Education
Albert Einstein College of Medicine of Yeshiva University 1980 — 1986
PhD, Molecular Pharmacology
Barnard College of Columbia University 1976 — 1980
BA, Biochemistry
Jim Fleckenstein's U.S. Food & Drug Administration Experience 1977 - Present
Job Investigator at U.S. Food & Drug Administration
Industry Public Safety
Experience
U.S. Food & Drug Administration 1977 - Present
Skills
Regulatory Submissions, Regulatory Affairs, Regulatory Requirements, Clinical Trials, FDA, Infectious Diseases, Clinical Research, Medical Devices, Biotechnology, GCP, Clinical Development, Quality Assurance, Validation, GMP, 21 CFR Part 11, GLP
Education
Indiana University—Purdue University Fort Wayne 1970 — 1975
BS, Biology
U.S. Food & Drug Administration 1977 - Present
Skills
Regulatory Submissions, Regulatory Affairs, Regulatory Requirements, Clinical Trials, FDA, Infectious Diseases, Clinical Research, Medical Devices, Biotechnology, GCP, Clinical Development, Quality Assurance, Validation, GMP, 21 CFR Part 11, GLP
Education
Indiana University—Purdue University Fort Wayne 1970 — 1975
BS, Biology
Rohn Brown Rohn Brown's U.S. Food & Drug Administration Experience 2001 - 2003
Job Sr. Employee and Labor Relations Specialist at U.S. Nuclear Regulatory Commission
Industry Government Administration
Experience
U.S. Nuclear Regulatory Commission, Office of the CHCO April 2012 - Present
U.S. Nuclear Regulatory Commission, Office of NRR, Human Capital Branch December 2009 - April 2012
U.S. Nuclear Regulatory Commission December 2005 - December 2009
Office of the IG, US Small Business Administration September 2003 - December 2005
U.S. Food & Drug Administration 2001 - 2003
Skills
Employee Relations, Performance Management, Policy, Labor Relations, Benefits, Employee Benefits, Coaching, Team Building, Workforce Planning, Recruiting, Management, Human Resources, Organizational..., Management Consulting, Leadership, Government, Personnel Management, Analysis, Organizational..., Employee Training, Succession Planning, Employment Law, Program Management, Leadership Development, Strategic Planning, Career Development, Training, Talent Management, Change Management, HR Policies, Process Improvement, Workforce Development, Federal Government, Resume Writing, FMLA, Onboarding, EEO, Policy Analysis, Conflict Resolution, Deferred Compensation, Administration, Security Clearance, Nonprofits, Public Policy, Program Development, Community Outreach, Public Speaking, Project Planning, Public Administration
Education
University of Maryland University College
B.S., Business Management [Personnel and Labor Relations]
U.S. Nuclear Regulatory Commission, Office of the CHCO April 2012 - Present
U.S. Nuclear Regulatory Commission, Office of NRR, Human Capital Branch December 2009 - April 2012
U.S. Nuclear Regulatory Commission December 2005 - December 2009
Office of the IG, US Small Business Administration September 2003 - December 2005
U.S. Food & Drug Administration 2001 - 2003
Skills
Employee Relations, Performance Management, Policy, Labor Relations, Benefits, Employee Benefits, Coaching, Team Building, Workforce Planning, Recruiting, Management, Human Resources, Organizational..., Management Consulting, Leadership, Government, Personnel Management, Analysis, Organizational..., Employee Training, Succession Planning, Employment Law, Program Management, Leadership Development, Strategic Planning, Career Development, Training, Talent Management, Change Management, HR Policies, Process Improvement, Workforce Development, Federal Government, Resume Writing, FMLA, Onboarding, EEO, Policy Analysis, Conflict Resolution, Deferred Compensation, Administration, Security Clearance, Nonprofits, Public Policy, Program Development, Community Outreach, Public Speaking, Project Planning, Public Administration
Education
University of Maryland University College
B.S., Business Management [Personnel and Labor Relations]
Neil Sheller Neil Sheller's U.S. Food & Drug Administration Experience 1990 - 1999
Job Sr. Regulatory Engineer
Industry Medical Devices
Experience
Cardiac Science Corporation January 2010 - Present
Philips, Respironcis, Pro-Tech Services January 2008 - January 2010
Pro-Tech Services January 2004 - January 2008
Pro-Tech Services September 1999 - January 2003
U.S. Food & Drug Administration 1990 - 1999
Skills
Product Development, Auditing, ISO 13485, Medical Devices, Project Management, Risk Management, Quality Management, Regulatory Affairs, Regulatory Submissions, Quality Assurance, Design Control, Risk Assessment, FDA GMP, Continuous Improvement, Manufacturing, Six Sigma, Lean Manufacturing, ISO 14971, Quality System
Education
Old Dominion University 1985 — 1987
B.Sc., Electrical Engineering Technology
Tidewater Community College 1983 — 1985
A.A.S, Electrical Engineering Technology
Cardiac Science Corporation January 2010 - Present
Philips, Respironcis, Pro-Tech Services January 2008 - January 2010
Pro-Tech Services January 2004 - January 2008
Pro-Tech Services September 1999 - January 2003
U.S. Food & Drug Administration 1990 - 1999
Skills
Product Development, Auditing, ISO 13485, Medical Devices, Project Management, Risk Management, Quality Management, Regulatory Affairs, Regulatory Submissions, Quality Assurance, Design Control, Risk Assessment, FDA GMP, Continuous Improvement, Manufacturing, Six Sigma, Lean Manufacturing, ISO 14971, Quality System
Education
Old Dominion University 1985 — 1987
B.Sc., Electrical Engineering Technology
Tidewater Community College 1983 — 1985
A.A.S, Electrical Engineering Technology
Richard Lev Richard Lev's U.S. Food & Drug Administration Experience June 1991 - December 1998
Job Regulatory Counsel at Celgene
Industry Pharmaceuticals
Experience
Celgene February 2011 - Present
Publicis Touchpoint Solutions, Inc. April 2009 - January 2011
Hoffmann-La Roche May 2006 - April 2009
Biovail Pharmaceuticals, Inc. August 2004 - May 2006
Organon Pharmaceuticals July 2003 - August 2004
Pharmacia December 1998 - July 2003
US Food & Drug Administration June 1991 - December 1998
Skills
Compliance, FDA, Life Sciences, Pharmaceuticals, Healthcare, Biotechnology, Regulatory Affairs, Pharmaceutical Industry, Lifesciences, Cross-functional Team..., Regulatory Requirements, Auditing, Medical Devices, Oncology, Pharmaceutics, Infectious Diseases, Biopharmaceuticals, Managed Care, Clinical Trials, Diabetes, Risk Management
Education
Benjamin N. Cardozo School of Law, Yeshiva University 1987 — 1990
JD, Law
Union College 1983 — 1987
BS, Biology
Celgene February 2011 - Present
Publicis Touchpoint Solutions, Inc. April 2009 - January 2011
Hoffmann-La Roche May 2006 - April 2009
Biovail Pharmaceuticals, Inc. August 2004 - May 2006
Organon Pharmaceuticals July 2003 - August 2004
Pharmacia December 1998 - July 2003
US Food & Drug Administration June 1991 - December 1998
Skills
Compliance, FDA, Life Sciences, Pharmaceuticals, Healthcare, Biotechnology, Regulatory Affairs, Pharmaceutical Industry, Lifesciences, Cross-functional Team..., Regulatory Requirements, Auditing, Medical Devices, Oncology, Pharmaceutics, Infectious Diseases, Biopharmaceuticals, Managed Care, Clinical Trials, Diabetes, Risk Management
Education
Benjamin N. Cardozo School of Law, Yeshiva University 1987 — 1990
JD, Law
Union College 1983 — 1987
BS, Biology
Larry Schumaker Larry Schumaker's U.S. Food & Drug Administration Experience November 2006 - Present
Job Senior Realty Specialist with US FDA
Industry Government Administration
Experience
U.S. Food & Drug Administration November 2006 - Present
Florida Agency for Workforce Innovation September 2000 - August 2005
Florida Dept of Labor and Employment Security January 2000 - August 2000
Pensacola Junior College November 1994 - April 1995
Escambia County School District, Pensacola FL October 1994 - April 1995
US Navy November 1968 - June 1994
Skills
Project Management, Project Planning, Management, Facilities Management, Policy, Program Management, Human Resources, Security, Training
Education
Webster University 1988 — 1989
MA, Management
Webster University 1988 — 1989
MA, Business
Penn State University 1970 — 1973
BS, CmpSci
U.S. Food & Drug Administration November 2006 - Present
Florida Agency for Workforce Innovation September 2000 - August 2005
Florida Dept of Labor and Employment Security January 2000 - August 2000
Pensacola Junior College November 1994 - April 1995
Escambia County School District, Pensacola FL October 1994 - April 1995
US Navy November 1968 - June 1994
Skills
Project Management, Project Planning, Management, Facilities Management, Policy, Program Management, Human Resources, Security, Training
Education
Webster University 1988 — 1989
MA, Management
Webster University 1988 — 1989
MA, Business
Penn State University 1970 — 1973
BS, CmpSci
Achal Deo Achal Deo's U.S. Food & Drug Administration Experience October 2008 - April 2013
Job Quality System Manager
Industry Public Safety
Experience
FDA May 2013 - Present
US Food & Drug Administration October 2008 - April 2013
Libby Laboratories June 2008 - September 2008
Skills
Gel Electrophoresis, qPCR, Validation, Laboratory, Quality System, Quality Control, Medical Devices, Environmental..., ISO 17025, Sterility, PFGE, FDA, Quality Assurance, Aseptic Technique, Sop, GMP, Lifesciences, Microscopy, Quality Auditing, Food Safety, DNA, DNA extraction, real-time PCR, Agarose Gel..., Life Sciences, SOP
Education
San Francisco State University 2003 — 2008
Bachelor of Science (B.S.), Microbiology
FDA May 2013 - Present
US Food & Drug Administration October 2008 - April 2013
Libby Laboratories June 2008 - September 2008
Skills
Gel Electrophoresis, qPCR, Validation, Laboratory, Quality System, Quality Control, Medical Devices, Environmental..., ISO 17025, Sterility, PFGE, FDA, Quality Assurance, Aseptic Technique, Sop, GMP, Lifesciences, Microscopy, Quality Auditing, Food Safety, DNA, DNA extraction, real-time PCR, Agarose Gel..., Life Sciences, SOP
Education
San Francisco State University 2003 — 2008
Bachelor of Science (B.S.), Microbiology
Joedy Tracey Joedy Tracey's U.S. Food & Drug Administration Experience September 2008 - September 2009
Job International Research Analyst at U.S. Food and Drug Administration
Industry Government Administration
Experience
U.S. Food and Drug Administration January 2015 - Present
US Govt - FDA 2009 - Present
US Food & Drug Administration September 2008 - September 2009
U.S. Food & Drug Administration 1990 - August 2008
Skills
Government, Emergency Management, Disaster Recovery, Business Process..., Risk Assessment, Leadership Development, Training, Project Management, Policy, Management, Incident Management, Leadership, Criminal Justice, Program Management, System Administration, Public Safety, Change Management, Analysis, Process Improvement, Private Investigations
Education
Loyola Marymount University 1972 — 1975
Biology, General
U.S. Food and Drug Administration January 2015 - Present
US Govt - FDA 2009 - Present
US Food & Drug Administration September 2008 - September 2009
U.S. Food & Drug Administration 1990 - August 2008
Skills
Government, Emergency Management, Disaster Recovery, Business Process..., Risk Assessment, Leadership Development, Training, Project Management, Policy, Management, Incident Management, Leadership, Criminal Justice, Program Management, System Administration, Public Safety, Change Management, Analysis, Process Improvement, Private Investigations
Education
Loyola Marymount University 1972 — 1975
Biology, General
Martha Starr Martha Starr's U.S. Food & Drug Administration Experience July 2014 - Present
Job Associate professor of economics at American University
Industry Higher Education
Experience
U.S. Food & Drug Administration July 2014 - Present
American University August 2002 - Present
Greylock McKinnon Associates January 2013 - December 2013
Federal Reserve Board of Governors 1992 - 2001
Skills
healthcare antitrust, economics of..., healthcare spending, household surveys, consumption, savings &..., Federal Reserve, applied econometrics
Education
Boston University
PhD, Economics
McGill University
BA with First Class Honours
U.S. Food & Drug Administration July 2014 - Present
American University August 2002 - Present
Greylock McKinnon Associates January 2013 - December 2013
Federal Reserve Board of Governors 1992 - 2001
Skills
healthcare antitrust, economics of..., healthcare spending, household surveys, consumption, savings &..., Federal Reserve, applied econometrics
Education
Boston University
PhD, Economics
McGill University
BA with First Class Honours
James L. Casterline, Jr., PhD James L. Casterline, Jr., PhD's U.S. Food & Drug Administration Experience January 1961 - July 1998
Job Senior Research Biochemist Emeritus
Industry Research
Experience
U.S. Food & Drug Administration January 1961 - July 1998
Gallaudet University 1983 - 1991
University of Maryland 1959 - 1962
Skills
Biochemistry, Enzymology, Toxicology, Chemical Metabolism, Pharmacology, Methods Development, Human Metabolism
Education
University of Maryland 1974 — 1976
PhD, Biochemistry
Gallaudet University
BA, Chemistry
Cornell University
Post-doc, Human Metabolism
University of California, Berkeley
Pre-doc, Human Physiology
University of Wisconsin-Madison
Pre-doc, Pharmacology
U.S. Food & Drug Administration January 1961 - July 1998
Gallaudet University 1983 - 1991
University of Maryland 1959 - 1962
Skills
Biochemistry, Enzymology, Toxicology, Chemical Metabolism, Pharmacology, Methods Development, Human Metabolism
Education
University of Maryland 1974 — 1976
PhD, Biochemistry
Gallaudet University
BA, Chemistry
Cornell University
Post-doc, Human Metabolism
University of California, Berkeley
Pre-doc, Human Physiology
University of Wisconsin-Madison
Pre-doc, Pharmacology
Eileen Carpinella Eileen Carpinella's U.S. Food & Drug Administration Experience 1976 - 1986
Job Executive Director at Arts for Learning Connecticut, an affiliate of Young Audiences and of VSA
Industry Education Management
Experience
Arts for Learning Connecticut February 1995 - Present
North Haven Adult Education 1985 - 2011
AfterSchool Arts 1988 - 1992
US Food & Drug Administration 1976 - 1986
Skills
Program Development, Grant Writing, Non-profits, Community Outreach, Stewardship, Donor Relations, Fundraising, Public Speaking, Event Planning, Nonprofits, Teaching, Volunteer Management, Grants, Community Development, Program Evaluation, Staff Development, Art, Board Development, Curriculum Design, Youth Development, Workshop Facilitation, Curriculum Development, Leadership Development, Teacher Training, Educational Leadership, Higher Education, Adult Education, Organizational..., Philanthropy, Social Services, Career Counseling, Non-profit...
Education
University of Hartford
MPA, Management
University of Saint Joseph
BS, Education
Arts for Learning Connecticut February 1995 - Present
North Haven Adult Education 1985 - 2011
AfterSchool Arts 1988 - 1992
US Food & Drug Administration 1976 - 1986
Skills
Program Development, Grant Writing, Non-profits, Community Outreach, Stewardship, Donor Relations, Fundraising, Public Speaking, Event Planning, Nonprofits, Teaching, Volunteer Management, Grants, Community Development, Program Evaluation, Staff Development, Art, Board Development, Curriculum Design, Youth Development, Workshop Facilitation, Curriculum Development, Leadership Development, Teacher Training, Educational Leadership, Higher Education, Adult Education, Organizational..., Philanthropy, Social Services, Career Counseling, Non-profit...
Education
University of Hartford
MPA, Management
University of Saint Joseph
BS, Education
Don Zink Don Zink's U.S. Food & Drug Administration Experience March 2009 - Present
Job Sr. Science Advisor at CFSAN/FDA
Industry Government Administration
Experience
US Food & Drug Administration March 2009 - Present
US Food & Drug Administration July 2002 - March 2009
Future Beef, LLC 2000 - 2002
Nestlé USA 1991 - 2000
Carnation Foods Refrigerated Food Division (A Nestle Company) 1990 - 1991
Campbell Soup Company 1983 - 1990
The University of Arizona 1980 - 1983
Texas A&M University 1978 - 1980
Skills
Food Safety, HACCP, Biopharmaceuticals, Food Science, Microbiology, Food Microbiology, GMP, FDA, Regulatory Affairs, Food Processing, Public Health, Food Industry, Lifesciences, Food, Toxicology, Molecular Biology, R&D, Quality Assurance, Infectious Diseases, Biochemistry, Environmental Health, Food Technology, Immunology, Dairy, Sanitation, Quality System, Global Health, Genomics, Vaccines, Quality Control, Laboratory, Protein Chemistry, Ingredients, Chemistry, Scientific Writing, HPLC, Analytical Chemistry, Virology, GLP, Cell Biology, LIMS, Quality Auditing, Agriculture, Sop, Cell Culture, Commercialization, ELISA, Genetics, ISO 22000, Technology Transfer
Education
Texas A&M University 1976 — 1978
Ph.D., Biochemistry & Biophysics
Texas A&M University 1973 — 1976
M.S., Microbiology
Abilene Christian University 1970 — 1973
B.S., Biology, Chemistry
US Food & Drug Administration March 2009 - Present
US Food & Drug Administration July 2002 - March 2009
Future Beef, LLC 2000 - 2002
Nestlé USA 1991 - 2000
Carnation Foods Refrigerated Food Division (A Nestle Company) 1990 - 1991
Campbell Soup Company 1983 - 1990
The University of Arizona 1980 - 1983
Texas A&M University 1978 - 1980
Skills
Food Safety, HACCP, Biopharmaceuticals, Food Science, Microbiology, Food Microbiology, GMP, FDA, Regulatory Affairs, Food Processing, Public Health, Food Industry, Lifesciences, Food, Toxicology, Molecular Biology, R&D, Quality Assurance, Infectious Diseases, Biochemistry, Environmental Health, Food Technology, Immunology, Dairy, Sanitation, Quality System, Global Health, Genomics, Vaccines, Quality Control, Laboratory, Protein Chemistry, Ingredients, Chemistry, Scientific Writing, HPLC, Analytical Chemistry, Virology, GLP, Cell Biology, LIMS, Quality Auditing, Agriculture, Sop, Cell Culture, Commercialization, ELISA, Genetics, ISO 22000, Technology Transfer
Education
Texas A&M University 1976 — 1978
Ph.D., Biochemistry & Biophysics
Texas A&M University 1973 — 1976
M.S., Microbiology
Abilene Christian University 1970 — 1973
B.S., Biology, Chemistry
Jerry Mulnick Jerry Mulnick's U.S. Food & Drug Administration Experience January 1963 - January 2005
Job Membership Chairman at Staten Island Ballroom Dancers, Inc.
Industry Civic & Social Organization
Experience
Staten Island Ballroom Dancers, Inc. February 2006 - Present
U.S. Food & Drug Administration January 1963 - January 2005
U.S. FDA 1963 - 2005
Skills
Medical Devices, Training, GMP, Federal Government, Quality Assurance, Community Outreach, Quality System, Biotechnology, Statistics, Policy, Program Development, Microsoft Excel, Pharmaceutical Industry, Strategic Communications, Sop, Research, Validation, Cell Culture, Project Management, GCP, Regulatory Requirements, Public Relations, Epidemiology, Public Speaking, Public Policy, Infectious Diseases, Health Education, Emergency Management, Science, Risk Assessment, Public Health, Molecular Biology, V&V, Quality Auditing, Legal Research, Microsoft Office, Clinical Trials, FDA, Healthcare, Nonprofits, Data Analysis, Food Safety, Regulations, Regulatory Affairs, Lifesciences, Family Therapy, Government, Clinical Research, Microsoft Word, CAPA
Education
Delaware Valley College 1956 — 1961
B.S., Food Industry
Delaware Valley University 1956 — 1961
BS, Food Industry
Staten Island Ballroom Dancers, Inc. February 2006 - Present
U.S. Food & Drug Administration January 1963 - January 2005
U.S. FDA 1963 - 2005
Skills
Medical Devices, Training, GMP, Federal Government, Quality Assurance, Community Outreach, Quality System, Biotechnology, Statistics, Policy, Program Development, Microsoft Excel, Pharmaceutical Industry, Strategic Communications, Sop, Research, Validation, Cell Culture, Project Management, GCP, Regulatory Requirements, Public Relations, Epidemiology, Public Speaking, Public Policy, Infectious Diseases, Health Education, Emergency Management, Science, Risk Assessment, Public Health, Molecular Biology, V&V, Quality Auditing, Legal Research, Microsoft Office, Clinical Trials, FDA, Healthcare, Nonprofits, Data Analysis, Food Safety, Regulations, Regulatory Affairs, Lifesciences, Family Therapy, Government, Clinical Research, Microsoft Word, CAPA
Education
Delaware Valley College 1956 — 1961
B.S., Food Industry
Delaware Valley University 1956 — 1961
BS, Food Industry
Dheen Veerabadran Dheen Veerabadran's U.S. Food & Drug Administration Experience May 2001 - January 2006
Job Director Quality Control & Assay Development at IDT Biologika
Industry Biotechnology
Experience
IDT Biologika June 2015 - Present
Aeras January 2011 - June 2015
Aeras Global TB Vaccine Foundation January 2005 - January 2011
US FOOD & drug Administration May 2001 - January 2006
Skills
GLP, Assay Development, Vaccines, Molecular Biology, Protein Purification, Immunology, Cell Culture, DNA, Cell, PCR, Tissue Culture, Flow Cytometry, ELISA, Protein Expression, Biotechnology, Mentoring, Purification, qPCR, Lifesciences, Infectious Diseases, Animal Models, Microbiology, Biochemistry, In Vitro, Protein Chemistry, Immunoassays, RT-PCR, Western Blotting, Drug Discovery, Cell Biology, Virology, Life Sciences
Education
Cornell University 2000 — 2001
post-Doc, college of veterinary medicine, Ithaca
Madurai Kamaraj University 1994 — 2000
Ph.D, Immunology
Madurai Kamaraj University 1991 — 1993
Msc, Biology
Vivekananda College, Thiruvedakam west 1988 — 1991
B.Sc.,, Zoology
IDT Biologika June 2015 - Present
Aeras January 2011 - June 2015
Aeras Global TB Vaccine Foundation January 2005 - January 2011
US FOOD & drug Administration May 2001 - January 2006
Skills
GLP, Assay Development, Vaccines, Molecular Biology, Protein Purification, Immunology, Cell Culture, DNA, Cell, PCR, Tissue Culture, Flow Cytometry, ELISA, Protein Expression, Biotechnology, Mentoring, Purification, qPCR, Lifesciences, Infectious Diseases, Animal Models, Microbiology, Biochemistry, In Vitro, Protein Chemistry, Immunoassays, RT-PCR, Western Blotting, Drug Discovery, Cell Biology, Virology, Life Sciences
Education
Cornell University 2000 — 2001
post-Doc, college of veterinary medicine, Ithaca
Madurai Kamaraj University 1994 — 2000
Ph.D, Immunology
Madurai Kamaraj University 1991 — 1993
Msc, Biology
Vivekananda College, Thiruvedakam west 1988 — 1991
B.Sc.,, Zoology
Steven Wolfgang Steven Wolfgang's U.S. Food & Drug Administration Experience January 2005 - Present
Job Consumer Safety Officer at FDA
Industry Pharmaceuticals
Experience
US Food & Drug Administration January 2005 - Present
USP council of experts 2005 - December 2014
Skills
Quality Assurance, Pharmaceutical Industry, Regulatory Affairs, FDA, GMP, Quality System, Pharmaceutics, Validation, Manufacturing, Sop, Lifesciences, R&D, HPLC, Chemistry, Technology Transfer, GLP, CAPA, Drug Development, Change Control, Chromatography, IND, V&V, Regulatory Submissions, Biopharmaceuticals, Regulatory Requirements, Quality by Design, Biotechnology, Drug Delivery, Formulation, Analytical Chemistry, UV/Vis, Organic Chemistry, GxP, SOP, Life Sciences
Education
The Graduate Center, City University of New York 1979 — 1983
Ph.D., Chemistry
US Food & Drug Administration January 2005 - Present
USP council of experts 2005 - December 2014
Skills
Quality Assurance, Pharmaceutical Industry, Regulatory Affairs, FDA, GMP, Quality System, Pharmaceutics, Validation, Manufacturing, Sop, Lifesciences, R&D, HPLC, Chemistry, Technology Transfer, GLP, CAPA, Drug Development, Change Control, Chromatography, IND, V&V, Regulatory Submissions, Biopharmaceuticals, Regulatory Requirements, Quality by Design, Biotechnology, Drug Delivery, Formulation, Analytical Chemistry, UV/Vis, Organic Chemistry, GxP, SOP, Life Sciences
Education
The Graduate Center, City University of New York 1979 — 1983
Ph.D., Chemistry
Vijay Tammara Vijay Tammara's U.S. Food & Drug Administration Experience 1993 - 2000
Job Nuron Biotech Inc.
Industry Pharmaceuticals
Experience
Nuron Biotech Inc. October 2010 - Present
AAPS 1988 - Present
Merck Research Laboratories April 2004 - September 2010
Merck 2004 - 2009
Wyeth Pharmaceuticals 2002 - 2004
sanofi-aventis 2000 - 2002
US Food & Drug Administration 1993 - 2000
Skills
Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Clinical Development, Technology Transfer, FDA, Clinical Trials, GMP, Biotechnology, Pharmaceutics, Sop, Drug Discovery, Validation, Biopharmaceuticals
Education
University of Louisiana at Monroe 1988 — 1993
Ph.D., Pharmaceutics
Nagpur University 1983 — 1985
M.Pharm, Pharmacokinetics
Kakatiya University 1978 — 1982
B. Pharm, Pharmaceutical Sciences
Nuron Biotech Inc. October 2010 - Present
AAPS 1988 - Present
Merck Research Laboratories April 2004 - September 2010
Merck 2004 - 2009
Wyeth Pharmaceuticals 2002 - 2004
sanofi-aventis 2000 - 2002
US Food & Drug Administration 1993 - 2000
Skills
Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Clinical Development, Technology Transfer, FDA, Clinical Trials, GMP, Biotechnology, Pharmaceutics, Sop, Drug Discovery, Validation, Biopharmaceuticals
Education
University of Louisiana at Monroe 1988 — 1993
Ph.D., Pharmaceutics
Nagpur University 1983 — 1985
M.Pharm, Pharmacokinetics
Kakatiya University 1978 — 1982
B. Pharm, Pharmaceutical Sciences
Tim Kapsala Tim Kapsala's U.S. Food & Drug Administration Experience January 2014 - Present
Job Investigator Foreign Drug Cadre at U.S. Food & Drug Administration
Industry Government Administration
Experience
U.S. Food & Drug Administration January 2014 - Present
Department of Health and Human Services March 2000 - Present
Department of Health and Human Services March 2000 - December 2013
ScheIn/Steris Laboratories October 1992 - February 2000
Schein/Steris Laboratories May 1990 - October 1992
Schein/Steris Laboratories August 1989 - May 1990
Skills
Community Outreach, Public Health, Private Investigations, Leadership Development, Research, FDA, Public Speaking, Validation, Social Media, Team Building, Public Policy, Pharmaceutical..., GMP, Leadership, Project Management, Sop, Training, Microsoft Office, Program Management, Integrity, Lifesciences, Policy, Regulatory Requirements, Organizational..., Fundraising, Life Sciences, SOP
Education
Arizona State University
Bachelor of Science, Microbiology
U.S. Food & Drug Administration January 2014 - Present
Department of Health and Human Services March 2000 - Present
Department of Health and Human Services March 2000 - December 2013
ScheIn/Steris Laboratories October 1992 - February 2000
Schein/Steris Laboratories May 1990 - October 1992
Schein/Steris Laboratories August 1989 - May 1990
Skills
Community Outreach, Public Health, Private Investigations, Leadership Development, Research, FDA, Public Speaking, Validation, Social Media, Team Building, Public Policy, Pharmaceutical..., GMP, Leadership, Project Management, Sop, Training, Microsoft Office, Program Management, Integrity, Lifesciences, Policy, Regulatory Requirements, Organizational..., Fundraising, Life Sciences, SOP
Education
Arizona State University
Bachelor of Science, Microbiology
Aimee (Aimee Babcock-Ellis) Mui, MLS's U.S. Food & Drug Administration Experience April 2015 - Present
Job
Industry Libraries
Experience
U.S. Food & Drug Administration April 2015 - Present
National Institutes of Health March 2012 - April 2015
Drug Enforcement Administration November 2010 - November 2011
Nonprint Media Services Library- University of Maryland, College Park August 2008 - October 2010
National Library of Medicine June 2010 - July 2010
Johns Hopkins Bayview Medical Center January 2010 - May 2010
University of Maryland July 2009 - April 2010
ARL Leadership Institute 2010 2009 - 2010
Internet Public Library 2009 - 2010
Health Sciences Human Services Library, University of Maryland Baltimore July 2009 - September 2009
Skills
Reference Services, Community Outreach, Interlibrary Loan, Technical Services, Cataloging, Toastmasters, Library Instruction, Digital Libraries, Library Research, Metadata, Library, Library Science, Public Speaking, Online Research, Teaching, Information Literacy, Information Management, Research, Information Retrieval, Editing, Library Reference, Digital Preservation, Knowledge Management, Blogging, OCLC Connexion, Library Management, Virtual Reference, Program Development, Archives, Electronic Resources, Grants, Library 2.0, Project Management, Reference, Circulation, Web 2.0, Dublin Core, Collection Development, Leadership, Libraries, Grant Writing, Social Media Outreach, History, Indexing, Higher Education, Integrated Library..., LibGuides, Academic Libraries, Special Collections, Museum Collections
Education
University of Maryland College Park 2007 — 2009
Masters
Yonsei University 2007 — 2007
State University of New York at New Paltz 2004 — 2007
Bachelors of Arts
U.S. Food & Drug Administration April 2015 - Present
National Institutes of Health March 2012 - April 2015
Drug Enforcement Administration November 2010 - November 2011
Nonprint Media Services Library- University of Maryland, College Park August 2008 - October 2010
National Library of Medicine June 2010 - July 2010
Johns Hopkins Bayview Medical Center January 2010 - May 2010
University of Maryland July 2009 - April 2010
ARL Leadership Institute 2010 2009 - 2010
Internet Public Library 2009 - 2010
Health Sciences Human Services Library, University of Maryland Baltimore July 2009 - September 2009
Skills
Reference Services, Community Outreach, Interlibrary Loan, Technical Services, Cataloging, Toastmasters, Library Instruction, Digital Libraries, Library Research, Metadata, Library, Library Science, Public Speaking, Online Research, Teaching, Information Literacy, Information Management, Research, Information Retrieval, Editing, Library Reference, Digital Preservation, Knowledge Management, Blogging, OCLC Connexion, Library Management, Virtual Reference, Program Development, Archives, Electronic Resources, Grants, Library 2.0, Project Management, Reference, Circulation, Web 2.0, Dublin Core, Collection Development, Leadership, Libraries, Grant Writing, Social Media Outreach, History, Indexing, Higher Education, Integrated Library..., LibGuides, Academic Libraries, Special Collections, Museum Collections
Education
University of Maryland College Park 2007 — 2009
Masters
Yonsei University 2007 — 2007
State University of New York at New Paltz 2004 — 2007
Bachelors of Arts
Leanne Cusumano Roque, P.C.C. Leanne Cusumano Roque, P.C.C.'s U.S. Food & Drug Administration Experience March 1997 - December 2000
Job President & Executive Coach, CRC Consulting, Inc.
Industry Management Consulting
Experience
CRC Consulting, Inc. March 2004 - Present
Office of Inspector General, National Science Foundation December 2000 - March 2004
U.S. Food & Drug Administration March 1997 - December 2000
Leftwich & Douglas (now Leftwich & Ludaway) 1995 - 1997
Skills
Skilled Facilitator, Executive Coach, Inspiring Writer, Kinesthetic Leadership..., Coaching, Public Speaking, Strategic Planning, Organizational..., Leadership Development, Team Building, Writing, Change Management, Inspiration, Leadership, Training, Executive Coaching, Personal Development, Government, Entrepreneurship, Human Resources, Employee Engagement, Negotiation, Policy, Nonprofits, Workshop Facilitation, Facilitation, Conflict Resolution, Strategy, Management Consulting, Public Policy, Career Development, Executive Development, Consulting, Mediation, Program Management, Staff Development, Organizational..., Policy Analysis, Emotional Intelligence
Education
Success Unlimited Network® L.L.C. (SUN) 2004 — 2006
Graduate & Certified Success Unlimited Network® Coach
Federal Executive Institute 2002 — 2003
Leadership for a Democratic Society
The College of William and Mary - Marshall Wythe Law School 1991 — 1994
JD
The George Washington University 1987 — 1991
BA
Iyengar Yoga Teacher Training
Certified Iyengar Yoga Teacher
CRC Consulting, Inc. March 2004 - Present
Office of Inspector General, National Science Foundation December 2000 - March 2004
U.S. Food & Drug Administration March 1997 - December 2000
Leftwich & Douglas (now Leftwich & Ludaway) 1995 - 1997
Skills
Skilled Facilitator, Executive Coach, Inspiring Writer, Kinesthetic Leadership..., Coaching, Public Speaking, Strategic Planning, Organizational..., Leadership Development, Team Building, Writing, Change Management, Inspiration, Leadership, Training, Executive Coaching, Personal Development, Government, Entrepreneurship, Human Resources, Employee Engagement, Negotiation, Policy, Nonprofits, Workshop Facilitation, Facilitation, Conflict Resolution, Strategy, Management Consulting, Public Policy, Career Development, Executive Development, Consulting, Mediation, Program Management, Staff Development, Organizational..., Policy Analysis, Emotional Intelligence
Education
Success Unlimited Network® L.L.C. (SUN) 2004 — 2006
Graduate & Certified Success Unlimited Network® Coach
Federal Executive Institute 2002 — 2003
Leadership for a Democratic Society
The College of William and Mary - Marshall Wythe Law School 1991 — 1994
JD
The George Washington University 1987 — 1991
BA
Iyengar Yoga Teacher Training
Certified Iyengar Yoga Teacher
James Gorny James Gorny's U.S. Food & Drug Administration Experience July 2009 - May 2013
Job VP Food Safety & Technology at Produce Marketing Association
Industry Food & Beverages
Experience
Produce Marketing Association May 2013 - Present
U.S. Food & Drug Administration July 2009 - May 2013
University of California Davis - Postharvest Center August 2007 - June 2009
Skills
Product Development, Food Industry, Strategic Planning, Food, Food Safety, Leadership, Food Processing, Policy
Education
University of California, Davis 1990 — 1995
Doctor of Philosophy (Ph.D.), Botany/Plant Biology
Louisiana State University 1984 — 1986
Master's degree, Food Science and Technology
Louisiana State University 1980 — 1984
Bachelor's degree, Food Science and Technology
Produce Marketing Association May 2013 - Present
U.S. Food & Drug Administration July 2009 - May 2013
University of California Davis - Postharvest Center August 2007 - June 2009
Skills
Product Development, Food Industry, Strategic Planning, Food, Food Safety, Leadership, Food Processing, Policy
Education
University of California, Davis 1990 — 1995
Doctor of Philosophy (Ph.D.), Botany/Plant Biology
Louisiana State University 1984 — 1986
Master's degree, Food Science and Technology
Louisiana State University 1980 — 1984
Bachelor's degree, Food Science and Technology
Steven Brooks Steven Brooks's U.S. Food & Drug Administration Experience November 2007 - January 2014
Job VP of Regulatory Affairs and Health Economics at Ablative Solutions, Inc., Senior Advisor at Popper & Company
Industry Hospital & Health Care
Experience
Popper and Company August 2015 - Present
Ablative Solutions, Inc. August 2015 - Present
Health Investment & Financing July 2015 - Present
Sage Growth Partners, LLC January 2014 - July 2015
Sarnoff Foundation 1994 - 2015
US Food & Drug Administration November 2007 - January 2014
Midatlantic Cardiovascular Associates January 2005 - November 2007
University of Maryland Medical Center August 2003 - December 2004
Skills
Public Health, Clinical Research, Epidemiology, Healthcare, Internal Medicine, Healthcare Information..., Medicine, Medical Education, Board Certified, Healthcare Management, Medical Devices, Clinical Trials, Global Health, Cardiology, Medical Research, Hospitals, Surgery, Emergency Medicine, Molecular Biology, Cancer, Informatics, Infectious Diseases, Critical Care, PACS, Health Policy, EMRs, Interventional...
Education
The Johns Hopkins University - Carey Business School 2007 — 2011
MBA, Business of Medicine
University of Pittsburgh School of Medicine 2002 — 2003
Interventional Fellow, Interventional Cardiology
University of Pittsburgh School of Medicine 1999 — 2002
Fellow, General Cardiology
University of Pittsburgh School of Medicine 1996 — 1999
Resident, Internal Medicine
University of Pittsburgh School of Medicine 1991 — 1996
MD, Medicine
Duke University 1987 — 1991
BA, History
McDonogh School 1979 — 1987
Popper and Company August 2015 - Present
Ablative Solutions, Inc. August 2015 - Present
Health Investment & Financing July 2015 - Present
Sage Growth Partners, LLC January 2014 - July 2015
Sarnoff Foundation 1994 - 2015
US Food & Drug Administration November 2007 - January 2014
Midatlantic Cardiovascular Associates January 2005 - November 2007
University of Maryland Medical Center August 2003 - December 2004
Skills
Public Health, Clinical Research, Epidemiology, Healthcare, Internal Medicine, Healthcare Information..., Medicine, Medical Education, Board Certified, Healthcare Management, Medical Devices, Clinical Trials, Global Health, Cardiology, Medical Research, Hospitals, Surgery, Emergency Medicine, Molecular Biology, Cancer, Informatics, Infectious Diseases, Critical Care, PACS, Health Policy, EMRs, Interventional...
Education
The Johns Hopkins University - Carey Business School 2007 — 2011
MBA, Business of Medicine
University of Pittsburgh School of Medicine 2002 — 2003
Interventional Fellow, Interventional Cardiology
University of Pittsburgh School of Medicine 1999 — 2002
Fellow, General Cardiology
University of Pittsburgh School of Medicine 1996 — 1999
Resident, Internal Medicine
University of Pittsburgh School of Medicine 1991 — 1996
MD, Medicine
Duke University 1987 — 1991
BA, History
McDonogh School 1979 — 1987
Joseph (Jay) Cormier Joseph (Jay) Cormier's U.S. Food & Drug Administration Experience July 2005 - January 2011
Job Associate at Hyman, Phelps & McNamara, P.C.
Industry Pharmaceuticals
Experience
Hyman, Phelps & McNamara, P.C. April 2013 - Present
Arnold & Porter January 2011 - April 2013
US Food & Drug Administration July 2005 - January 2011
Columbia University July 2000 - June 2005
Procter & Gamble Pharmaceuticals 1999 - 1999
Skills
Biotechnology, Molecular Biology, Medical Devices, Healthcare, Policy, FDA, FDA GMP, Genetic Engineering, Biochemistry, Lifesciences, Regulatory Affairs, Pharmaceutical Industry, Technology Transfer, Strategy, Pharmaceutics, Life Sciences
Education
Georgetown University Law Center 2007 — 2010
J.D., Law
Columbia University in the City of New York 2000 — 2005
Ph.D., Pharmacology
Dartmouth College 1996 — 2000
A.B., Biochemistry and Computer Science
Hyman, Phelps & McNamara, P.C. April 2013 - Present
Arnold & Porter January 2011 - April 2013
US Food & Drug Administration July 2005 - January 2011
Columbia University July 2000 - June 2005
Procter & Gamble Pharmaceuticals 1999 - 1999
Skills
Biotechnology, Molecular Biology, Medical Devices, Healthcare, Policy, FDA, FDA GMP, Genetic Engineering, Biochemistry, Lifesciences, Regulatory Affairs, Pharmaceutical Industry, Technology Transfer, Strategy, Pharmaceutics, Life Sciences
Education
Georgetown University Law Center 2007 — 2010
J.D., Law
Columbia University in the City of New York 2000 — 2005
Ph.D., Pharmacology
Dartmouth College 1996 — 2000
A.B., Biochemistry and Computer Science
Kris Monagle Kris Monagle's U.S. Food & Drug Administration Experience July 1965 - May 1967
Job President, Mishawaka Penn Harris Friends of Library, . Secretary at National Alliance for the Mentally Ill
Industry Research
Experience
National Alliance for the Mentally Ill January 2013 - Present
retired microbiologist April 1992 - Present
Tri Kappa June 1983 - October 2011
Wall Street Wonders January 2001 - January 2002
GDS Technology, 1986 - 1992
Eli Lilly and Company May 1967 - September 1971
U.S. Food & Drug Administration July 1965 - May 1967
Skills
Research, Teaching, Writing, Non-profits, Public Speaking, trained Family to..., Lifesciences, PowerPoint, Volunteer Management, Higher Education, Microsoft Office, Customer Service, Budgets, Science, Event Management, Community Outreach, Instructional Design, SPSS, Event Planning, Fundraising, Program Evaluation, Program Development, Curriculum Design, Data Analysis, Curriculum Development, Strategic Planning, English, Healthcare, Coaching, Team Leadership, Organizational..., Leadership Development, Leadership, Nonprofits, Staff Development, Community Development, Editing, Public Relations, Tutoring, Grants, Social Media, Supervisory Skills, Team Building, Microsoft Word, Microsoft Excel, Marketing
Education
The Ohio State University 1961 — 1965
BS, microbiology
Ashland High School, class of '61 1957 — 1961
National Alliance for the Mentally Ill January 2013 - Present
retired microbiologist April 1992 - Present
Tri Kappa June 1983 - October 2011
Wall Street Wonders January 2001 - January 2002
GDS Technology, 1986 - 1992
Eli Lilly and Company May 1967 - September 1971
U.S. Food & Drug Administration July 1965 - May 1967
Skills
Research, Teaching, Writing, Non-profits, Public Speaking, trained Family to..., Lifesciences, PowerPoint, Volunteer Management, Higher Education, Microsoft Office, Customer Service, Budgets, Science, Event Management, Community Outreach, Instructional Design, SPSS, Event Planning, Fundraising, Program Evaluation, Program Development, Curriculum Design, Data Analysis, Curriculum Development, Strategic Planning, English, Healthcare, Coaching, Team Leadership, Organizational..., Leadership Development, Leadership, Nonprofits, Staff Development, Community Development, Editing, Public Relations, Tutoring, Grants, Social Media, Supervisory Skills, Team Building, Microsoft Word, Microsoft Excel, Marketing
Education
The Ohio State University 1961 — 1965
BS, microbiology
Ashland High School, class of '61 1957 — 1961
Deb Kleinfeld Deb Kleinfeld's U.S. Food & Drug Administration Experience 1991 - 2007
Job Kleinfeld Consulting, LLC
Industry Government Administration
Experience
Kleinfeld Consulting, LLC 2008 - Present
US Food & Drug Administration 1991 - 2007
food and Drug Administration 1991 - 2007
Skills
GTP, GMP, GCP, Compliance, Quality Auditing, Quality Management, Quality Assurance, Regulatory Requirements, Regulatory Affairs, Corrective Actions, Training, FDA, Quality System, Sop, CAPA, Quality Control, Risk Assessment, 21 CFR Part 11, Regulations, Validation, Change Control, Clinical Trials, GLP, Biotechnology, ISO 13485, Regulatory Submissions, SOP
Education
Loretto Heights University 1979 — 1983
BS, Nursing
University of Phoenix
MBA, Business Administration
Kleinfeld Consulting, LLC 2008 - Present
US Food & Drug Administration 1991 - 2007
food and Drug Administration 1991 - 2007
Skills
GTP, GMP, GCP, Compliance, Quality Auditing, Quality Management, Quality Assurance, Regulatory Requirements, Regulatory Affairs, Corrective Actions, Training, FDA, Quality System, Sop, CAPA, Quality Control, Risk Assessment, 21 CFR Part 11, Regulations, Validation, Change Control, Clinical Trials, GLP, Biotechnology, ISO 13485, Regulatory Submissions, SOP
Education
Loretto Heights University 1979 — 1983
BS, Nursing
University of Phoenix
MBA, Business Administration
E. Glenn Rogers Sr.'s U.S. Food & Drug Administration Experience January 1997 - October 2007
Job Vice President Health Solutions at L3 STRATIS
Industry Information Technology and Services
Experience
L-3 STRATIS January 2012 - Present
L-3 STRATIS August 2011 - January 2012
Unisys 2007 - 2011
US Food & Drug Administration January 1997 - October 2007
Skills
Program Management, PMP, Government, Enterprise Architecture, ITIL, Business Development, IT Strategy, Integration, Process Improvement, Security, Management Consulting, Strategic Planning, Requirements Analysis, Data Center, Management, Proposal Writing, Business Process..., Cloud Computing, Vendor Management, Software Project..., Strategy, Project Management, IT Service Management, Professional Services, Government Contracting, DoD, SDLC, Governance, PMO, Team Leadership, Change Management, IT Management, Business Intelligence, Disaster Recovery, Project Portfolio..., Enterprise Software, Information Technology, Leadership, Cross-functional Team..., Business Process, Consulting, SharePoint, Software Documentation, Business Analysis, Outsourcing, Risk Management, Analysis, Information Assurance, Resource Management
Education
Florida Agricultural and Mechanical University 1982 — 1987
BS, AA, Computer Information Systems, Mathematics
L-3 STRATIS January 2012 - Present
L-3 STRATIS August 2011 - January 2012
Unisys 2007 - 2011
US Food & Drug Administration January 1997 - October 2007
Skills
Program Management, PMP, Government, Enterprise Architecture, ITIL, Business Development, IT Strategy, Integration, Process Improvement, Security, Management Consulting, Strategic Planning, Requirements Analysis, Data Center, Management, Proposal Writing, Business Process..., Cloud Computing, Vendor Management, Software Project..., Strategy, Project Management, IT Service Management, Professional Services, Government Contracting, DoD, SDLC, Governance, PMO, Team Leadership, Change Management, IT Management, Business Intelligence, Disaster Recovery, Project Portfolio..., Enterprise Software, Information Technology, Leadership, Cross-functional Team..., Business Process, Consulting, SharePoint, Software Documentation, Business Analysis, Outsourcing, Risk Management, Analysis, Information Assurance, Resource Management
Education
Florida Agricultural and Mechanical University 1982 — 1987
BS, AA, Computer Information Systems, Mathematics
Matthew Yep's U.S. Food & Drug Administration Experience June 2002 - August 2002
Job Senior Compensation Analyst at Pharmacyclics
Industry Computer Software
Experience
Pharmacyclics September 2014 - Present
The Clorox Company January 2013 - August 2014
Blue Shield of California March 2009 - December 2012
Spansion June 2007 - March 2009
Hyperion Solutions July 2006 - March 2007
Hyperion Solutions January 2006 - June 2006
Hyperion Solutions June 2005 - December 2005
U.S. Food & Drug Administration June 2002 - August 2002
Kaiser Permanente Medical Center June 1997 - August 1998
Skills
HRIS, Human Resources, Performance Management, New Hire Orientations, Recruiting, Microsoft Excel, Personnel Management, Management, Interviews, Employee Benefits, Deferred Compensation, Training, Applicant Tracking..., Talent Management, Talent Acquisition, College Recruiting, Onboarding, Compensation, Workday
Education
San Jose State University 2003 — 2007
Business Administration, Human Resources Management
Pharmacyclics September 2014 - Present
The Clorox Company January 2013 - August 2014
Blue Shield of California March 2009 - December 2012
Spansion June 2007 - March 2009
Hyperion Solutions July 2006 - March 2007
Hyperion Solutions January 2006 - June 2006
Hyperion Solutions June 2005 - December 2005
U.S. Food & Drug Administration June 2002 - August 2002
Kaiser Permanente Medical Center June 1997 - August 1998
Skills
HRIS, Human Resources, Performance Management, New Hire Orientations, Recruiting, Microsoft Excel, Personnel Management, Management, Interviews, Employee Benefits, Deferred Compensation, Training, Applicant Tracking..., Talent Management, Talent Acquisition, College Recruiting, Onboarding, Compensation, Workday
Education
San Jose State University 2003 — 2007
Business Administration, Human Resources Management
Andrea Broad's U.S. Food & Drug Administration Experience May 1990 - June 1998
Job Software Engineer at Young Consulting, Inc.
Industry Computer Software
Experience
Young Consulting, Inc. May 2000 - Present
Infocure, Inc. September 1999 - May 2000
CareLinc Corporation June 1998 - July 1999
U.S. Food & Drug Administration May 1990 - June 1998
U.S. Food and Drug Administration 1990 - 1998
Education
Georgia State University 1993 — 1999
University of Arizona 1986 — 1989
B.S., Major: Psychology Minor: Chemistry
Young Consulting, Inc. May 2000 - Present
Infocure, Inc. September 1999 - May 2000
CareLinc Corporation June 1998 - July 1999
U.S. Food & Drug Administration May 1990 - June 1998
U.S. Food and Drug Administration 1990 - 1998
Education
Georgia State University 1993 — 1999
University of Arizona 1986 — 1989
B.S., Major: Psychology Minor: Chemistry
Bradley Killenbeck's U.S. Food & Drug Administration Experience October 2001 - October 2002
Job Associate Director, Public Health Services at Naval Medical Center Portsmouth, VA
Industry Hospital & Health Care
Experience
USNS COMFORT March 2015 - Present
Naval Medical Center Portsmouth, VA February 2013 - Present
U.S. Fleet Forces Command December 2009 - February 2013
U.S. Naval Central Command, 5th Fleet, Combined Maritime Forces December 2008 - December 2009
USNH GTMO Cuba & Joint Task Force GTMO Cuba July 2008 - October 2008
Commander Naval Air Forces March 2005 - June 2008
Combined Joint Task Foce Horn of Africa August 2004 - February 2005
Navy Environmental Health Center, Portsmouth, VA November 2002 - February 2005
U.S. Food & Drug Administration October 2001 - October 2002
National Naval Medical Center Bethesda, MD March 1999 - September 2001
Skills
Microsoft Office, Excel, PowerPoint, Word, Outlook, Public Health, Food Safety, Military, Health, Coaching, Environmental Health, Public Health Policy, Food Policy, Health Sciences, Coaching Staff, Security Clearance, Defense Support to..., Homeland Defense, International Health, Refugee Health, Disaster Response, Operational Risk..., Water Quality, SharePoint, Microsoft Word, Microsoft Excel, Program Management, DoD, Top Secret, Preventive Medicine, Policy, Navy, Healthcare, Emergency Management, Health Policy, Military Experience, Government, Training, National Security, Epidemiology, Military Operations, Command, Defense, Health Promotion, Homeland Security
Education
The George Washington University School of Medicine and Health Sciences 1999 — 2002
pursuing MPH, International Health
State University of New York College at Cortland 1989 — 1993
B.S., Health Science
Spencerport 1986 — 1989
USNS COMFORT March 2015 - Present
Naval Medical Center Portsmouth, VA February 2013 - Present
U.S. Fleet Forces Command December 2009 - February 2013
U.S. Naval Central Command, 5th Fleet, Combined Maritime Forces December 2008 - December 2009
USNH GTMO Cuba & Joint Task Force GTMO Cuba July 2008 - October 2008
Commander Naval Air Forces March 2005 - June 2008
Combined Joint Task Foce Horn of Africa August 2004 - February 2005
Navy Environmental Health Center, Portsmouth, VA November 2002 - February 2005
U.S. Food & Drug Administration October 2001 - October 2002
National Naval Medical Center Bethesda, MD March 1999 - September 2001
Skills
Microsoft Office, Excel, PowerPoint, Word, Outlook, Public Health, Food Safety, Military, Health, Coaching, Environmental Health, Public Health Policy, Food Policy, Health Sciences, Coaching Staff, Security Clearance, Defense Support to..., Homeland Defense, International Health, Refugee Health, Disaster Response, Operational Risk..., Water Quality, SharePoint, Microsoft Word, Microsoft Excel, Program Management, DoD, Top Secret, Preventive Medicine, Policy, Navy, Healthcare, Emergency Management, Health Policy, Military Experience, Government, Training, National Security, Epidemiology, Military Operations, Command, Defense, Health Promotion, Homeland Security
Education
The George Washington University School of Medicine and Health Sciences 1999 — 2002
pursuing MPH, International Health
State University of New York College at Cortland 1989 — 1993
B.S., Health Science
Spencerport 1986 — 1989
Susan Bond's U.S. Food & Drug Administration Experience 1988 - 2005
Job Director, Abbott Nutrition Regulatory Affairs U.S./Canada/Puerto Rico at Abbott
Industry Health, Wellness and Fitness
Experience
Abbott November 2012 - Present
GRACE Strategies, LLCwww. October 2010 - May 2014
ConAgra Foods February 2007 - July 2010
International Food Information Council November 2005 - February 2007
U.S. Food & Drug Administration 1988 - 2005
Skills
Policy, Science, Regulatory Affairs, Food Safety, Food Industry, Strategic Planning, Food Processing, GMP, Lifesciences, Strategic Communications, Biotechnology, FDA, Food Science, Food, Quality System, Nutrition, Microbiology, Public Health, R&D, Laboratory, Infectious Diseases
Education
University of Maryland University College 1993 — 1996
M.S., Technology, Biotechnology
West Virginia Wesleyan College 1984 — 1988
B.A., Biology, Government Affairs, Economics
Abbott November 2012 - Present
GRACE Strategies, LLCwww. October 2010 - May 2014
ConAgra Foods February 2007 - July 2010
International Food Information Council November 2005 - February 2007
U.S. Food & Drug Administration 1988 - 2005
Skills
Policy, Science, Regulatory Affairs, Food Safety, Food Industry, Strategic Planning, Food Processing, GMP, Lifesciences, Strategic Communications, Biotechnology, FDA, Food Science, Food, Quality System, Nutrition, Microbiology, Public Health, R&D, Laboratory, Infectious Diseases
Education
University of Maryland University College 1993 — 1996
M.S., Technology, Biotechnology
West Virginia Wesleyan College 1984 — 1988
B.A., Biology, Government Affairs, Economics
Brenda Uratani's U.S. Food & Drug Administration Experience July 2009 - July 2011
Job Associate Director, Regulatory Sciences, FDA
Industry Pharmaceuticals
Experience
FDA July 2011 - Present
FDA 2000 - Present
US Food & Drug Administration July 2009 - July 2011
Skills
FDA, Regulatory Submissions, Regulatory Affairs, Regulatory Requirements, GMP, Pharmaceutical Industry, Validation, CAPA, Quality Auditing, Sop, Biotechnology, Change Control, Quality System, Biopharmaceuticals, 21 CFR Part 11
Education
Brown University 1995 — 1999
FDA July 2011 - Present
FDA 2000 - Present
US Food & Drug Administration July 2009 - July 2011
Skills
FDA, Regulatory Submissions, Regulatory Affairs, Regulatory Requirements, GMP, Pharmaceutical Industry, Validation, CAPA, Quality Auditing, Sop, Biotechnology, Change Control, Quality System, Biopharmaceuticals, 21 CFR Part 11
Education
Brown University 1995 — 1999
Abi D'Sa's U.S. Food & Drug Administration Experience May 2001 - November 2008
Job Deputy Director US FDA (India)
Industry Government Administration
Experience
FDA August 2014 - Present
U.S. Food and Drug Administration January 2009 - Present
US Food & Drug Administration May 2001 - November 2008
U.S. Food and Drug Administration April 1996 - May 2001
NIH 1989 - 1992
Skills
Regulatory Requirements, Regulatory Affairs, FDA, Regulatory Submissions, GMP, Clinical Trials, Sop, Pharmaceutical Industry, GLP, Validation, CAPA, Vaccines, Technology Transfer, Quality Auditing, 21 CFR Part 11, Biopharmaceuticals, Change Control, Clinical Development, Lifesciences, V&V, Biotechnology, GCP, Chemistry, Drug Discovery, Pharmaceutics, IND, SOP, Life Sciences
Education
University of Missouri-Columbia 1984 — 1989
Ph. D, Organic and Bio-organic Chemistry
FDA August 2014 - Present
U.S. Food and Drug Administration January 2009 - Present
US Food & Drug Administration May 2001 - November 2008
U.S. Food and Drug Administration April 1996 - May 2001
NIH 1989 - 1992
Skills
Regulatory Requirements, Regulatory Affairs, FDA, Regulatory Submissions, GMP, Clinical Trials, Sop, Pharmaceutical Industry, GLP, Validation, CAPA, Vaccines, Technology Transfer, Quality Auditing, 21 CFR Part 11, Biopharmaceuticals, Change Control, Clinical Development, Lifesciences, V&V, Biotechnology, GCP, Chemistry, Drug Discovery, Pharmaceutics, IND, SOP, Life Sciences
Education
University of Missouri-Columbia 1984 — 1989
Ph. D, Organic and Bio-organic Chemistry
Shrikant Dighe's U.S. Food & 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 & Drug Administration Experience November 2011 - Present
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
Marva Moxey-Mims's U.S. Food & Drug Administration Experience 1999 - 2002
Job Director, Pediatric Nephrology Program, NIH
Industry Research
Experience
National Institutes of Health May 2002 - Present
US Food & Drug Administration 1999 - 2002
Children's National Medical Center 1994 - 1999
Skills
Medical Research, Pediatrics, Translational Research, Clinical Research, Clinical Trials, Protocol Development, Epidemiology, Protocol, Nephrology
Education
Howard University College of Medicine
M.D., Medicine
McGill University
B. Sc., Biology
St. Anne's
National Institutes of Health May 2002 - Present
US Food & Drug Administration 1999 - 2002
Children's National Medical Center 1994 - 1999
Skills
Medical Research, Pediatrics, Translational Research, Clinical Research, Clinical Trials, Protocol Development, Epidemiology, Protocol, Nephrology
Education
Howard University College of Medicine
M.D., Medicine
McGill University
B. Sc., Biology
St. Anne's
Lynn Bonner's U.S. Food & Drug Administration Experience July 1997 - Present
Job Compliance Officer at US Food & Drug Administration
Industry Government Relations
Experience
US Food & Drug Administration July 1997 - Present
Skills
Regulatory Affairs, Food Safety, Government, FDA, Quality System, Food Industry, Policy, Risk Assessment, Quality Assurance, HACCP, GMP, Sop
Education
Barton College 1972 — 1974
Southwood Jr. College 1970 — 1972
US Food & Drug Administration July 1997 - Present
Skills
Regulatory Affairs, Food Safety, Government, FDA, Quality System, Food Industry, Policy, Risk Assessment, Quality Assurance, HACCP, GMP, Sop
Education
Barton College 1972 — 1974
Southwood Jr. College 1970 — 1972
Karen A. Frank, M.D.'s U.S. Food & Drug Administration Experience 1993 - 1997
Job President/Principal Consultant
Industry Pharmaceuticals
Experience
K.A. Frank & Associates, LLC February 2003 - Present
Noven/Novogyne Pharmaceuticals 2002 - 2003
Novartis Pharmaceuticals 2001 - 2002
F. Hoffmann - La Roche, Ltd. (Switzerland) 1999 - 2001
Monsanto Pharma 1997 - 1999
U.S. Food & Drug Administration 1993 - 1997
Skills
Clinical Development, Oncology, Clinical Trials, Biotechnology, Drug Development, GCP, CRO, Regulatory Affairs, Regulatory Submissions, Infectious Diseases, Clinical Research, FDA, Diabetes, IND, Therapeutic Areas, Biomarkers, Cardiovascular Disease, Diabetes & Metabolism, Drug Metabolism
Education
The Johns Hopkins University School of Medicine
Doctor of Medicine (M.D.), Medicine
Washington University in St. Louis
Internship/Residency, Internal medicine
K.A. Frank & Associates, LLC February 2003 - Present
Noven/Novogyne Pharmaceuticals 2002 - 2003
Novartis Pharmaceuticals 2001 - 2002
F. Hoffmann - La Roche, Ltd. (Switzerland) 1999 - 2001
Monsanto Pharma 1997 - 1999
U.S. Food & Drug Administration 1993 - 1997
Skills
Clinical Development, Oncology, Clinical Trials, Biotechnology, Drug Development, GCP, CRO, Regulatory Affairs, Regulatory Submissions, Infectious Diseases, Clinical Research, FDA, Diabetes, IND, Therapeutic Areas, Biomarkers, Cardiovascular Disease, Diabetes & Metabolism, Drug Metabolism
Education
The Johns Hopkins University School of Medicine
Doctor of Medicine (M.D.), Medicine
Washington University in St. Louis
Internship/Residency, Internal medicine
Bill Schwemer's U.S. Food & Drug Administration Experience June 1962 - July 1993
Job Regulatory Consultant Specializing in FDA Enforcement Matters
Industry Pharmaceuticals
Experience
William L. Schwemer, Consultant December 2007 - Present
Tri Tech Laboratories, Inc. January 2004 - December 2007
AAC/Kendle Consulting Group, Inc July 1993 - December 2003
US Food & Drug Administration June 1962 - July 1993
Skills
Quality Assurance, Change Management, Regulatory Affairs, Validation, Change Control, CAPA, V&V, GxP, Pharmaceutical Industry, FDA, GMP, Sop, Clinical Trials, Quality System, Medical Devices, Quality Auditing, Quality Control, Regulatory Submissions, 21 CFR Part 11, Pharmaceutics, Technology Transfer, GLP, Regulatory Requirements, Microbiology, Clinical Development
Education
Bowling Green State University 1958 — 1962
BS, Chemistry, Math, Psychology
In-service courses at 7 major universities
William L. Schwemer, Consultant December 2007 - Present
Tri Tech Laboratories, Inc. January 2004 - December 2007
AAC/Kendle Consulting Group, Inc July 1993 - December 2003
US Food & Drug Administration June 1962 - July 1993
Skills
Quality Assurance, Change Management, Regulatory Affairs, Validation, Change Control, CAPA, V&V, GxP, Pharmaceutical Industry, FDA, GMP, Sop, Clinical Trials, Quality System, Medical Devices, Quality Auditing, Quality Control, Regulatory Submissions, 21 CFR Part 11, Pharmaceutics, Technology Transfer, GLP, Regulatory Requirements, Microbiology, Clinical Development
Education
Bowling Green State University 1958 — 1962
BS, Chemistry, Math, Psychology
In-service courses at 7 major universities
Kevin J. Ruff, Ph.D., MBA, CCRP's U.S. Food & Drug Administration Experience June 1994 - July 1995
Job Director of Scientific & Regulatory Affairs at ESM Technologies, LLC.
Industry Biotechnology
Experience
ESM Technologies, LLC March 2008 - Present
Ricerca Biosciences October 2005 - February 2008
Clariant March 2003 - December 2004
ChemSyn Science Labs September 2000 - March 2003
U.S. Food & Drug Administration June 1994 - July 1995
Skills
GMP, FDA, Regulatory Affairs, R&D, Quality System, Clinical Trials, Process Simulation, Product Development, Laboratory, GLP, Commercialization, Quality Assurance, Technology Transfer, Analytical Chemistry, GCP, HPLC, Pharmaceuticals, Manufacturing, Quality Systems, Biotechnology, Process Improvement, Process Development, organic chemistry, Process Validation, Pharmaceutical..., Clinical Development, Pharmaceutical Industry, Chromatography, Validation
Education
The University of Kansas 1995 — 2000
PhD, Organic Chemistry
University of Phoenix 2002 — 2007
MBA, Business Administration
Southern Illinois University, Edwardsville 1989 — 1993
BA, Chemistry - Medical Sciences
ESM Technologies, LLC March 2008 - Present
Ricerca Biosciences October 2005 - February 2008
Clariant March 2003 - December 2004
ChemSyn Science Labs September 2000 - March 2003
U.S. Food & Drug Administration June 1994 - July 1995
Skills
GMP, FDA, Regulatory Affairs, R&D, Quality System, Clinical Trials, Process Simulation, Product Development, Laboratory, GLP, Commercialization, Quality Assurance, Technology Transfer, Analytical Chemistry, GCP, HPLC, Pharmaceuticals, Manufacturing, Quality Systems, Biotechnology, Process Improvement, Process Development, organic chemistry, Process Validation, Pharmaceutical..., Clinical Development, Pharmaceutical Industry, Chromatography, Validation
Education
The University of Kansas 1995 — 2000
PhD, Organic Chemistry
University of Phoenix 2002 — 2007
MBA, Business Administration
Southern Illinois University, Edwardsville 1989 — 1993
BA, Chemistry - Medical Sciences
Nathan Treinish's U.S. Food & Drug Administration Experience 1977 - 1980
Job Experienced pharmaceutical professional, expert in regulatory law
Industry Pharmaceuticals
Experience
independent consultant January 2010 - Present
sanofi-aventis U.S. March 1984 - January 2010
Aventis Pharmaceuticals 2000 - 2005
Hoechst Marion Roussel & Marion Merrell Dow 1990 - 2000
Merrell Dow Pharmaceuticals March 1984 - 1990
Abbott Laboratories 1980 - 1984
US Food & Drug Administration 1977 - 1980
Skills
FDA, Compliance, Pharmaceuticals, Regulatory Affairs, Policy, Regulatory Strategy, DEA, Pharmaceutical Industry, Regulations, Corporate Law, Strategy, Regulatory Submissions, Intellectual Property, Biotechnology, Licensing, Medical Devices, Corporate Governance, Regulatory Requirements, Technology Transfer, Clinical Trials
Education
American University, Washington College of Law 1973 — 1976
JD
American University 1969 — 1972
B.A., political science
Walter Johnson High School
independent consultant January 2010 - Present
sanofi-aventis U.S. March 1984 - January 2010
Aventis Pharmaceuticals 2000 - 2005
Hoechst Marion Roussel & Marion Merrell Dow 1990 - 2000
Merrell Dow Pharmaceuticals March 1984 - 1990
Abbott Laboratories 1980 - 1984
US Food & Drug Administration 1977 - 1980
Skills
FDA, Compliance, Pharmaceuticals, Regulatory Affairs, Policy, Regulatory Strategy, DEA, Pharmaceutical Industry, Regulations, Corporate Law, Strategy, Regulatory Submissions, Intellectual Property, Biotechnology, Licensing, Medical Devices, Corporate Governance, Regulatory Requirements, Technology Transfer, Clinical Trials
Education
American University, Washington College of Law 1973 — 1976
JD
American University 1969 — 1972
B.A., political science
Walter Johnson High School
Anne Reid's U.S. Food & Drug Administration Experience 1990 - April 2010
Job Deputy Regional Food and Drug Director
Industry Government Administration
Experience
Food and Drug Administration August 1990 - Present
US Food & Drug Administration 1990 - April 2010
Skills
Policy, Government, Microsoft Office, Public Speaking, Customer Service, FDA, Research, Leadership, Strategic Planning, Biotechnology, Pharmaceutical Industry, Quality Assurance, Event Planning, Fundraising, Social Media, PowerPoint, Microsoft Excel, Quality Auditing, Clinical Trials, Medical Devices, Regulatory Requirements, Policy Analysis, Regulatory Affairs, Business Development
Education
Mississippi State University 1984 — 1990
Food and Drug Administration August 1990 - Present
US Food & Drug Administration 1990 - April 2010
Skills
Policy, Government, Microsoft Office, Public Speaking, Customer Service, FDA, Research, Leadership, Strategic Planning, Biotechnology, Pharmaceutical Industry, Quality Assurance, Event Planning, Fundraising, Social Media, PowerPoint, Microsoft Excel, Quality Auditing, Clinical Trials, Medical Devices, Regulatory Requirements, Policy Analysis, Regulatory Affairs, Business Development
Education
Mississippi State University 1984 — 1990
Travis Falconer's U.S. Food & Drug Administration Experience August 2010 - Present
Job Chemist at U.S. FDA Forensic Chemistry Center
Industry Research
Experience
U.S. Food & Drug Administration August 2010 - Present
University of North Carolina at Chapel Hill July 2008 - June 2010
University of North Carolina at Chapel Hill August 2002 - June 2008
Los Alamos National Laboratory May 2002 - August 2002
University of North Dakota January 1999 - May 2002
Skills
Mass Spectrometry, Spectroscopy, LC-MS, Chemistry, Analytical Chemistry, Chromatography, Physical Chemistry, Characterization, Science, Nanotechnology, Gas Chromatography, HPLC, Instrumentation, Vacuum, Experimentation, Research
Education
University of North Carolina at Chapel Hill 2002 — 2008
Ph. D.
The University of North Dakota 1998 — 2002
B. S.
U.S. Food & Drug Administration August 2010 - Present
University of North Carolina at Chapel Hill July 2008 - June 2010
University of North Carolina at Chapel Hill August 2002 - June 2008
Los Alamos National Laboratory May 2002 - August 2002
University of North Dakota January 1999 - May 2002
Skills
Mass Spectrometry, Spectroscopy, LC-MS, Chemistry, Analytical Chemistry, Chromatography, Physical Chemistry, Characterization, Science, Nanotechnology, Gas Chromatography, HPLC, Instrumentation, Vacuum, Experimentation, Research
Education
University of North Carolina at Chapel Hill 2002 — 2008
Ph. D.
The University of North Dakota 1998 — 2002
B. S.
Robert Shibuya's U.S. Food & Drug Administration Experience October 2011 - September 2012
Job Medical Director at Biogen Idec
Industry Government Administration
Experience
Biogen Idec July 2014 - Present
Cubist Pharmaceuticals September 2012 - July 2014
US Food & Drug Administration October 2011 - September 2012
US Food and Drug Administration March 2011 - October 2011
US Food & Drug Administration May 2008 - March 2011
US Food & Drug Administration October 2004 - May 2008
US Food & Drug Administration January 2002 - October 2004
US Food & Drug Administration September 2000 - January 2002
ISTA Pharmaceuticals April 1997 - May 2000
Metrika Laboratories June 1996 - April 1997
Skills
Clinical Development, Pain/Analgesia, Regulatory Affairs, Good Clinical Practice, REMS, Drug Safety, Pharmacokinetics, Infectious Diseases, FDA, CRO, Pharmacology, IND, Life Sciences, Protocol, Oncology, Clinical Trials, Drug Development, Clinical Research, Biotechnology
Education
Washington University in St. Louis School of Medicine 1988 — 1992
M.D.
University of California, Berkeley 1983 — 1987
AB, Physiology
Biogen Idec July 2014 - Present
Cubist Pharmaceuticals September 2012 - July 2014
US Food & Drug Administration October 2011 - September 2012
US Food and Drug Administration March 2011 - October 2011
US Food & Drug Administration May 2008 - March 2011
US Food & Drug Administration October 2004 - May 2008
US Food & Drug Administration January 2002 - October 2004
US Food & Drug Administration September 2000 - January 2002
ISTA Pharmaceuticals April 1997 - May 2000
Metrika Laboratories June 1996 - April 1997
Skills
Clinical Development, Pain/Analgesia, Regulatory Affairs, Good Clinical Practice, REMS, Drug Safety, Pharmacokinetics, Infectious Diseases, FDA, CRO, Pharmacology, IND, Life Sciences, Protocol, Oncology, Clinical Trials, Drug Development, Clinical Research, Biotechnology
Education
Washington University in St. Louis School of Medicine 1988 — 1992
M.D.
University of California, Berkeley 1983 — 1987
AB, Physiology
Richard Dent's U.S. Food & Drug Administration Experience 1982 - 2001
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
US Food & Drug Administration 1982 - 2001
U.S. and Puerto Rico June 1959 - December 1965
Education
Inter-American University of Puerto Rico-San Germán Campus 1966 — 1969
US Food & Drug Administration 1982 - 2001
U.S. and Puerto Rico June 1959 - December 1965
Education
Inter-American University of Puerto Rico-San Germán Campus 1966 — 1969
Joseph Mazurek's U.S. Food & Drug Administration Experience 1985 - 1990
Job President at JM2 Consulting LLC
Industry Pharmaceuticals
Experience
JM2 Consulting LLC Vice-President, QA/RAEmergent BioSolutions2001 - 2004
American Red Cross National Testing Lab 1994 - 1999
nellcor 1993 - 1994
BioPort Corporation, Lansing, MI. 1991 - 1994
U.S. Food & Drug Administration 1985 - 1990
Skills
CAPA, Project Management, Validation, Cross-functional Team..., Regulatory Affairs, FDA, Quality Assurance, Change Control, 21 CFR Part 11, V&V, Process Simulation, Medical Devices, GMP, Chemistry, Lifesciences, GLP, Sop, Clinical Trials, Pharmaceutics, Biotechnology, R&D, Quality Auditing, Biopharmaceuticals, Quality System, Pharmaceutical Industry, Technology Transfer, Regulatory Submissions, ISO 13485, Computer System..., Regulatory Requirements, Vaccines, Clinical Development, CRO, Drug Development, GxP, Analytical Chemistry, Aseptic Processing, HPLC, GCP
Education
Thomas M. Cooley Law School 1988 — 1991
J.D., Food & Drug Law
University of Oklahoma 1978 — 1979
M.S., Environmental Science
JM2 Consulting LLC Vice-President, QA/RAEmergent BioSolutions2001 - 2004
American Red Cross National Testing Lab 1994 - 1999
nellcor 1993 - 1994
BioPort Corporation, Lansing, MI. 1991 - 1994
U.S. Food & Drug Administration 1985 - 1990
Skills
CAPA, Project Management, Validation, Cross-functional Team..., Regulatory Affairs, FDA, Quality Assurance, Change Control, 21 CFR Part 11, V&V, Process Simulation, Medical Devices, GMP, Chemistry, Lifesciences, GLP, Sop, Clinical Trials, Pharmaceutics, Biotechnology, R&D, Quality Auditing, Biopharmaceuticals, Quality System, Pharmaceutical Industry, Technology Transfer, Regulatory Submissions, ISO 13485, Computer System..., Regulatory Requirements, Vaccines, Clinical Development, CRO, Drug Development, GxP, Analytical Chemistry, Aseptic Processing, HPLC, GCP
Education
Thomas M. Cooley Law School 1988 — 1991
J.D., Food & Drug Law
University of Oklahoma 1978 — 1979
M.S., Environmental Science
Aaron Adler's U.S. Food & Drug Administration Experience July 2014 - Present
Job Senior Program Analyst at U.S. Food & Drug Administration
Industry Research
Experience
U.S. Food & Drug Administration July 2014 - Present
US Food & Drug Administration July 2008 - July 2014
FDA 2008 - July 2014
Maxdem Inc. 1996 - 2002
Roche Bioscience 1999 - 2000
Skills
Data Analysis, UV/Vis, Science, Chemistry, Spectroscopy, Research, Program Management
Education
Harvey Mudd College 1992 — 1996
BS, Chemistry
U.S. Food & Drug Administration July 2014 - Present
US Food & Drug Administration July 2008 - July 2014
FDA 2008 - July 2014
Maxdem Inc. 1996 - 2002
Roche Bioscience 1999 - 2000
Skills
Data Analysis, UV/Vis, Science, Chemistry, Spectroscopy, Research, Program Management
Education
Harvey Mudd College 1992 — 1996
BS, Chemistry
Bernice Friedlander's U.S. Food & Drug Administration Experience January 1998 - February 2012
Job Senior Public Relations Director at US Food & Drug Administration
Industry Government Administration
Experience
Friedlander Family Scholarship July 2012 - Present
US Food & Drug Administration January 1998 - February 2012
HHS, FDA, Center for Food Safety Applied Nutrition 2004 - October 2010
Education
Harvard University, John F. Kennedy School of Government 1982 — 1983
MPA, Public Administration
Monmouth University 1962 — 1965
Bachelor's Degree, History and Political Science
Friedlander Family Scholarship July 2012 - Present
US Food & Drug Administration January 1998 - February 2012
HHS, FDA, Center for Food Safety Applied Nutrition 2004 - October 2010
Education
Harvard University, John F. Kennedy School of Government 1982 — 1983
MPA, Public Administration
Monmouth University 1962 — 1965
Bachelor's Degree, History and Political Science
Juli Putnam's U.S. Food & Drug Administration Experience September 2013 - Present
Job Press Officer, U.S. Food & Drug Administration
Industry Public Relations and Communications
Experience
U.S. Food & Drug Administration September 2013 - Present
The Pew Charitable Trusts August 2012 - September 2013
Hill+Knowlton Strategies January 2011 - August 2012
Hill & Knowlton April 2010 - January 2011
Chlopak, Leonard, Schechter & Associates August 2008 - April 2010
Ohio University Campus Recreation Marketing Dept January 2008 - June 2008
Athens MidDay, PBS, WOUB II January 2008 - March 2008
Cox Broadcasting September 2007 - December 2007
Grupo Sipse January 2007 - March 2007
Skills
Public Affairs, Public Relations, Media Relations, Strategic Communications, Communications Planning, Message Development, Reputation Management, Corporate Communications, Crisis Communications, Social Media, Account Management, News Writing, AP Style, WordPress, Nonprofits, Vocus, Cision, Avid, Critical Mention, Spokesperson, Speech Writing
Education
Ohio University 2004 — 2008
Bachelor of Science in Journalism, public relations, broadcast journalism, Spanish
Universidad Pública de Navarra 2007 — 2007
Spanish
Centro de Idiomas del Sureste 2006 — 2007
Spanish
Franklin Regional Senior High School 2000 — 2004
U.S. Food & Drug Administration September 2013 - Present
The Pew Charitable Trusts August 2012 - September 2013
Hill+Knowlton Strategies January 2011 - August 2012
Hill & Knowlton April 2010 - January 2011
Chlopak, Leonard, Schechter & Associates August 2008 - April 2010
Ohio University Campus Recreation Marketing Dept January 2008 - June 2008
Athens MidDay, PBS, WOUB II January 2008 - March 2008
Cox Broadcasting September 2007 - December 2007
Grupo Sipse January 2007 - March 2007
Skills
Public Affairs, Public Relations, Media Relations, Strategic Communications, Communications Planning, Message Development, Reputation Management, Corporate Communications, Crisis Communications, Social Media, Account Management, News Writing, AP Style, WordPress, Nonprofits, Vocus, Cision, Avid, Critical Mention, Spokesperson, Speech Writing
Education
Ohio University 2004 — 2008
Bachelor of Science in Journalism, public relations, broadcast journalism, Spanish
Universidad Pública de Navarra 2007 — 2007
Spanish
Centro de Idiomas del Sureste 2006 — 2007
Spanish
Franklin Regional Senior High School 2000 — 2004
Jeff Sincek's U.S. Food & Drug Administration Experience September 2012 - Present
Job Regional Radiological Health Representative at U.S. Food & Drug Administration
Industry Medical Devices
Experience
U.S. Food & Drug Administration September 2012 - Present
U.S. Food & Drug Administration March 2004 - September 2012
Skills
Team Leadership, Public Speaking, Radiology, Customer Service, Medical Devices, Team Building, Program Management, Cross-functional Team..., Leadership, Strategic Planning
Education
The Ohio State University
U.S. Food & Drug Administration September 2012 - Present
U.S. Food & Drug Administration March 2004 - September 2012
Skills
Team Leadership, Public Speaking, Radiology, Customer Service, Medical Devices, Team Building, Program Management, Cross-functional Team..., Leadership, Strategic Planning
Education
The Ohio State University
GABRIELLE PIRES's U.S. Food & Drug Administration Experience August 2002 - Present
Job Biologist at U.S. Food & Drug Administration
Industry Biotechnology
Experience
U.S. Food & Drug Administration August 2002 - Present
NOAA / National Marine Fisheries Service 1998 - 2002
Shark Reef, Mandalay Bay Resort 1999 - 2000
Western Washington University, Huxley College of Environmental Science September 1996 - June 1998
Coral Reef Research Foundation July 1995 - February 1996
Waikiki Aquarium September 1994 - May 1995
Skills
Marine Biology, Lifesciences, Environmental Awareness, Science, Research, Public Speaking, Teaching, Analysis, Sustainability, Data Analysis, Technical Writing, DNA sequencing, Underwater Photography, real-time PCR, Scuba Diving, Experimental Design, Life Sciences, Statistics, DNA, Laboratory, Conservation Issues, Molecular Biology, Aquaculture, Fish, Microscopy, Ecology, Biology, Scientific Writing, Microsoft Office
Education
Western Washington University 1996 — 1998
MSc, Marine and Estuarine Science
University of Hawaii at Manoa 1994 — 1995
Marine Biology
Oregon State University 1990 — 1994
BS, Biology w/ a Marine Biology concentration
U.S. Food & Drug Administration August 2002 - Present
NOAA / National Marine Fisheries Service 1998 - 2002
Shark Reef, Mandalay Bay Resort 1999 - 2000
Western Washington University, Huxley College of Environmental Science September 1996 - June 1998
Coral Reef Research Foundation July 1995 - February 1996
Waikiki Aquarium September 1994 - May 1995
Skills
Marine Biology, Lifesciences, Environmental Awareness, Science, Research, Public Speaking, Teaching, Analysis, Sustainability, Data Analysis, Technical Writing, DNA sequencing, Underwater Photography, real-time PCR, Scuba Diving, Experimental Design, Life Sciences, Statistics, DNA, Laboratory, Conservation Issues, Molecular Biology, Aquaculture, Fish, Microscopy, Ecology, Biology, Scientific Writing, Microsoft Office
Education
Western Washington University 1996 — 1998
MSc, Marine and Estuarine Science
University of Hawaii at Manoa 1994 — 1995
Marine Biology
Oregon State University 1990 — 1994
BS, Biology w/ a Marine Biology concentration
Ravi Juluru's U.S. Food & Drug Administration Experience October 2010 - Present
Job US Food & Drug Administration
Industry Pharmaceuticals
Experience
US Food & Drug Administration October 2010 - Present
Long Island University August 2008 - July 2009
Forest Laboratories May 2008 - August 2008
Long Island University August 2005 - May 2008
Skills
Pharmacokinetics, HPLC, Pharmacology, Drug Delivery, Clinical Trials, Bioavailability, Mathematical Modeling, WinNonlin, Drug Development, GLP, In Vitro
Education
LIU Brooklyn 2004 — 2009
Ph.D, Pharmaceutics
Acharya Nagarjuna University
B.Pharm, Pharmacy
US Food & Drug Administration October 2010 - Present
Long Island University August 2008 - July 2009
Forest Laboratories May 2008 - August 2008
Long Island University August 2005 - May 2008
Skills
Pharmacokinetics, HPLC, Pharmacology, Drug Delivery, Clinical Trials, Bioavailability, Mathematical Modeling, WinNonlin, Drug Development, GLP, In Vitro
Education
LIU Brooklyn 2004 — 2009
Ph.D, Pharmaceutics
Acharya Nagarjuna University
B.Pharm, Pharmacy
Tom Paino's U.S. Food & Drug Administration Experience July 2009 - Present
Job Review Chemist at U.S. Food & Drug Administration
Industry Pharmaceuticals
Experience
U.S. Food & Drug Administration July 2009 - Present
ProPharma Group November 2006 - June 2009
Monsanto August 2005 - October 2006
Tyco Healthcare/Mallinckrodt January 1994 - August 2005
Bausch & Lomb September 1990 - December 1993
Petrolite December 1986 - September 1990
Sigma Aldrich Chemcal Company August 1983 - December 1986
Missouri Baptist College August 1982 - August 1983
Skills
Quality Assurance, Quality Auditing, Quality Management, FDA, R&D, Root Cause Analysis, Lifesciences, Validation, CAPA, GMP, Six Sigma, Process Improvement, Quality Control, Manufacturing, Continuous Improvement
Education
Webster University 1987 — 1994
Master’s Degree, Management
University of Notre Dame 1978 — 1981
M.S., Chemistry
Saint Louis University 1974 — 1978
B.A., Chemistry
St. Louis U. High
St. Louis U. High
St. Louis U. High
St. Louis U. High
St. Louis U. High
U.S. Food & Drug Administration July 2009 - Present
ProPharma Group November 2006 - June 2009
Monsanto August 2005 - October 2006
Tyco Healthcare/Mallinckrodt January 1994 - August 2005
Bausch & Lomb September 1990 - December 1993
Petrolite December 1986 - September 1990
Sigma Aldrich Chemcal Company August 1983 - December 1986
Missouri Baptist College August 1982 - August 1983
Skills
Quality Assurance, Quality Auditing, Quality Management, FDA, R&D, Root Cause Analysis, Lifesciences, Validation, CAPA, GMP, Six Sigma, Process Improvement, Quality Control, Manufacturing, Continuous Improvement
Education
Webster University 1987 — 1994
Master’s Degree, Management
University of Notre Dame 1978 — 1981
M.S., Chemistry
Saint Louis University 1974 — 1978
B.A., Chemistry
St. Louis U. High
St. Louis U. High
St. Louis U. High
St. Louis U. High
St. Louis U. High
Halley Espy Kropa's U.S. Food & Drug Administration Experience December 2014 - Present
Job Attorney, U.S. Food & Drug Administration
Industry Law Practice
Experience
U.S. Food & Drug Administration December 2014 - Present
U.S. Food & Drug Administration September 2012 - December 2014
University of Georgia 2009 - 2012
Freie Universität Berlin August 2008 - November 2009
Georgia Tech Research Institute 2007 - 2007
Skills
Legal Writing, Legal Research, International Relations, Westlaw
Education
University of Georgia School of Law 2009 — 2012
International Law
Georgia Institute of Technology 2004 — 2008
BS, International Affairs
U.S. Food & Drug Administration December 2014 - Present
U.S. Food & Drug Administration September 2012 - December 2014
University of Georgia 2009 - 2012
Freie Universität Berlin August 2008 - November 2009
Georgia Tech Research Institute 2007 - 2007
Skills
Legal Writing, Legal Research, International Relations, Westlaw
Education
University of Georgia School of Law 2009 — 2012
International Law
Georgia Institute of Technology 2004 — 2008
BS, International Affairs
Mark Walderhaug's U.S. Food & Drug Administration Experience September 2006 - Present
Job Associate Office Director for Risk Assessment at U.S. Food & Drug Administration
Industry Government Administration
Experience
U.S. Food & Drug Administration September 2006 - Present
Food & Drug Administration 1991 - 2013
U.S. Food & Drug Administration March 1991 - September 2006
Skills
Risk Assessment, Microsoft Office, Vaccines, FDA, Microbiology, Biotechnology, Public Health, Risk Management, Statistics, Policy Analysis, Food Safety, Policy, Data Analysis, Lifesciences, Regulatory Affairs, Training, Epidemiology, Science, Infectious Diseases, Molecular Biology, Laboratory, Food Microbiology, Biochemistry, Biostatistics, PCR, Environmental Health, GMP, Technology Transfer, Toxicology, GLP, Chromatography, Clinical Trials, Validation, Pharmaceutical Industry, Drug Development, Scientific Writing, Regulations, Chemistry, Immunology, Sop, Bioinformatics, Federal Government, Clinical Research, Food Science, Global Health, Biopharmaceuticals, Genomics, Life Sciences
Education
University of Chicago 1984 — 1988
post doctoral appointment, molecular genetics and cell biology
Vanderbilt University 1978 — 1984
Ph.D., Physiology
Grinnell College 1970 — 1974
A.B., General Science
Northwood High School
The Hong Kong Polytechnic University
U.S. Food & Drug Administration September 2006 - Present
Food & Drug Administration 1991 - 2013
U.S. Food & Drug Administration March 1991 - September 2006
Skills
Risk Assessment, Microsoft Office, Vaccines, FDA, Microbiology, Biotechnology, Public Health, Risk Management, Statistics, Policy Analysis, Food Safety, Policy, Data Analysis, Lifesciences, Regulatory Affairs, Training, Epidemiology, Science, Infectious Diseases, Molecular Biology, Laboratory, Food Microbiology, Biochemistry, Biostatistics, PCR, Environmental Health, GMP, Technology Transfer, Toxicology, GLP, Chromatography, Clinical Trials, Validation, Pharmaceutical Industry, Drug Development, Scientific Writing, Regulations, Chemistry, Immunology, Sop, Bioinformatics, Federal Government, Clinical Research, Food Science, Global Health, Biopharmaceuticals, Genomics, Life Sciences
Education
University of Chicago 1984 — 1988
post doctoral appointment, molecular genetics and cell biology
Vanderbilt University 1978 — 1984
Ph.D., Physiology
Grinnell College 1970 — 1974
A.B., General Science
Northwood High School
The Hong Kong Polytechnic University
Siobhan DeLancey's U.S. Food & Drug Administration Experience December 2012 - Present
Job Team Leader, Strategic Communication and Public Engagement at FDA Center for Veterinary Medicine
Industry Government Administration
Experience
U.S Food & Drug Administration December 2012 - Present
US Food & Drug Administration May 2012 - November 2012
US Food & Drug Administration November 2010 - April 2012
US Food & Drug Administration January 2008 - November 2010
US Food & Drug Administration November 2004 - January 2008
Skills
Public Relations, Writing, Marketing Communications, Media Relations, Strategic Communications, Strategic Planning, Crisis Communications, Editing, Press Releases, Speech Writing, Leadership, Government, Public Speaking
Education
The Johns Hopkins University 2007 — 2009
Master of Public Health (MPH), Health Communication
Northern Virginia Community College 1995 — 1997
Associate of Science (AS), Veterinary Technology
American University 1987 — 1991
Bachelor of Arts (BA), Journalism
U.S Food & Drug Administration December 2012 - Present
US Food & Drug Administration May 2012 - November 2012
US Food & Drug Administration November 2010 - April 2012
US Food & Drug Administration January 2008 - November 2010
US Food & Drug Administration November 2004 - January 2008
Skills
Public Relations, Writing, Marketing Communications, Media Relations, Strategic Communications, Strategic Planning, Crisis Communications, Editing, Press Releases, Speech Writing, Leadership, Government, Public Speaking
Education
The Johns Hopkins University 2007 — 2009
Master of Public Health (MPH), Health Communication
Northern Virginia Community College 1995 — 1997
Associate of Science (AS), Veterinary Technology
American University 1987 — 1991
Bachelor of Arts (BA), Journalism
Diane Kelley's U.S. Food & Drug Administration Experience 1975 - July 2006
Job Vocalist, Vocal Coach
Industry Performing Arts
Experience
Sweet Adelines International 2007 - Present
Songboid Enterprises 2007 - Present
self-employed 1975 - Present
Curves November 2007 - 2009
U.S. Food & Drug Administration 1975 - July 2006
Skills
Leadership, Singing, Vocalist, Vocal, Band, Social Media, Public Speaking, Teaching, Piano, Event Planning, Jazz, Vocal Coaching, Music, Concerts, Music Education, Choral, Microsoft Office
Education
University of Rhode Island 1988 — 1995
B.S., Microbiology, Chemistry, Aquaculture
Woburn High School, Woburn, MA 1969 — 1973
Sweet Adelines International 2007 - Present
Songboid Enterprises 2007 - Present
self-employed 1975 - Present
Curves November 2007 - 2009
U.S. Food & Drug Administration 1975 - July 2006
Skills
Leadership, Singing, Vocalist, Vocal, Band, Social Media, Public Speaking, Teaching, Piano, Event Planning, Jazz, Vocal Coaching, Music, Concerts, Music Education, Choral, Microsoft Office
Education
University of Rhode Island 1988 — 1995
B.S., Microbiology, Chemistry, Aquaculture
Woburn High School, Woburn, MA 1969 — 1973
Frank Sedzielarz's U.S. Food & Drug Administration Experience February 1985 - March 2010
Job Independent Food Safety Professional at Semi Retired
Industry Food Production
Experience
Semi Retired March 2010 - Present
US Food & Drug Administration February 1985 - March 2010
Skills
Food, HACCP, Food Safety, Sanitation, Food Industry, Environmental Health
Education
Roosevelt University 1970 — 1973
Bachelor of Science (BS), Biology/Chemistry
Semi Retired March 2010 - Present
US Food & Drug Administration February 1985 - March 2010
Skills
Food, HACCP, Food Safety, Sanitation, Food Industry, Environmental Health
Education
Roosevelt University 1970 — 1973
Bachelor of Science (BS), Biology/Chemistry
Andrea Kirk's U.S. Food & Drug Administration Experience 2014 - Present
Job Regulatory Counsel, Conflict of Interest Analyst at U.S. Food & Drug Administration
Industry Government Administration
Experience
U.S. Food & Drug Administration 2014 - Present
U.S. Food & Drug Administration January 2012 - April 2014
Food & Drug Administration July 2009 - July 2011
U.S. Fish & Wildlife Service July 2006 - July 2009
U.S. Army Corps of Engineers May 2005 - August 2005
lucas law firm 2002 - 2005
JP Morgan Chase September 2001 - May 2003
Bank of America January 2001 - December 2001
Skills
Legal Writing, Legal Research, Policy, Government, Research, Policy Analysis, Editing, Litigation, Public Speaking, Non-profits, Analysis, Public Policy, Mediation, Microsoft Office, Risk Management, PowerPoint, Federal Law, Legal Issues, Project Management, Program Management
Education
Capital University Law School 2002 — 2006
J.D., 2006, Environmental Law/Government Affairs
Ohio University 1994 — 1997
B.A., 1997, English Literature
U.S. Food & Drug Administration 2014 - Present
U.S. Food & Drug Administration January 2012 - April 2014
Food & Drug Administration July 2009 - July 2011
U.S. Fish & Wildlife Service July 2006 - July 2009
U.S. Army Corps of Engineers May 2005 - August 2005
lucas law firm 2002 - 2005
JP Morgan Chase September 2001 - May 2003
Bank of America January 2001 - December 2001
Skills
Legal Writing, Legal Research, Policy, Government, Research, Policy Analysis, Editing, Litigation, Public Speaking, Non-profits, Analysis, Public Policy, Mediation, Microsoft Office, Risk Management, PowerPoint, Federal Law, Legal Issues, Project Management, Program Management
Education
Capital University Law School 2002 — 2006
J.D., 2006, Environmental Law/Government Affairs
Ohio University 1994 — 1997
B.A., 1997, English Literature
N. Brent Conatser's U.S. Food & Drug Administration Experience 1985 - 1991
Job Senior Consultant Regulatory Surveillance and External Engagement at Elanco
Industry Pharmaceuticals
Experience
Elanco March 2015 - Present
Eli Lilly and Company October 2014 - Present
Eli Lilly and Company April 2012 - October 2014
Eli Lilly and Company 2007 - 2012
Eli Lilly and Company 2002 - 2007
Pfizer, Inc 1993 - 2002
Johnson & Johnson (Janssen Research Foundation - Beerse, Belgium) 1991 - 1993
U.S. Food & Drug Administration 1985 - 1991
Skills
FDA, GMP, Pharmaceutical Industry, Validation, Regulatory Affairs, Quality System, GxP, Quality Assurance, GLP, Quality Auditing, Sop, Change Control, 21 CFR Part 11, Biotechnology, Clinical Development, Quality Control, Pharmaceutics, Cleaning Validation, CAPA, Aseptic Processing, Regulatory Requirements, Regulatory Submissions, V&V, Leadership, Pharmacovigilance, Quality Management, Inspection, Auditing, Internal Audit, Complaint Investigations, Annual Reports, Vaccines, Mentoring, Regulatory Surveillance, SOP
Education
Baker University 1993 — 1994
Executive MBA Program, 3.9
University of Tennessee-Knoxville 1976 — 1979
B.S., Biology
Elanco March 2015 - Present
Eli Lilly and Company October 2014 - Present
Eli Lilly and Company April 2012 - October 2014
Eli Lilly and Company 2007 - 2012
Eli Lilly and Company 2002 - 2007
Pfizer, Inc 1993 - 2002
Johnson & Johnson (Janssen Research Foundation - Beerse, Belgium) 1991 - 1993
U.S. Food & Drug Administration 1985 - 1991
Skills
FDA, GMP, Pharmaceutical Industry, Validation, Regulatory Affairs, Quality System, GxP, Quality Assurance, GLP, Quality Auditing, Sop, Change Control, 21 CFR Part 11, Biotechnology, Clinical Development, Quality Control, Pharmaceutics, Cleaning Validation, CAPA, Aseptic Processing, Regulatory Requirements, Regulatory Submissions, V&V, Leadership, Pharmacovigilance, Quality Management, Inspection, Auditing, Internal Audit, Complaint Investigations, Annual Reports, Vaccines, Mentoring, Regulatory Surveillance, SOP
Education
Baker University 1993 — 1994
Executive MBA Program, 3.9
University of Tennessee-Knoxville 1976 — 1979
B.S., Biology
Pamela Sopczyk's U.S. Food & Drug Administration Experience October 1977 - October 1986
Job HR Administrator at NH Dept of Environmental Services
Industry Government Administration
Experience
NH Dept of Environmental Services November 2005 - Present
Northeast Cooperatives 1998 - 2004
Vermont Medical July 1990 - February 1998
US Food & Drug Administration October 1977 - October 1986
Skills
Public Speaking, Community Outreach, Nonprofits, System Administration, Strategic Planning, Research, Policy Analysis, Grant Writing, Microsoft Office, Customer Service, PowerPoint, Event Planning, Sustainability, Editing, Program Management
Education
Antioch University New England 1993 — 1995
MS, Organization& Management
State University of New York College at Plattsburgh 1972 — 1976
BA, Biology
NH Dept of Environmental Services November 2005 - Present
Northeast Cooperatives 1998 - 2004
Vermont Medical July 1990 - February 1998
US Food & Drug Administration October 1977 - October 1986
Skills
Public Speaking, Community Outreach, Nonprofits, System Administration, Strategic Planning, Research, Policy Analysis, Grant Writing, Microsoft Office, Customer Service, PowerPoint, Event Planning, Sustainability, Editing, Program Management
Education
Antioch University New England 1993 — 1995
MS, Organization& Management
State University of New York College at Plattsburgh 1972 — 1976
BA, Biology
Palmer Orlandi's U.S. Food & Drug Administration Experience February 2013 - Present
Job Senior Science Advisor, Office of Food and Veterinary Medicine at U.S. Food & Drug Administration
Industry Research
Experience
U.S. Food & Drug Administration February 2013 - Present
U.S. Food & Drug Administration September 1997 - February 2013
National Institutes of Health February 1991 - September 1997
Walter Reed Army Institute of Research February 1987 - February 1991
Skills
Biology, Science, Public Health, PCR, Lifesciences, Scientific Writing, Molecular Biology, Genetics, Cell Culture, Microbiology, Biochemistry, Western Blotting, Laboratory, Cell Biology, Immunology, Statistics, Biotechnology, R, Science Communication, Epidemiology, Medicine, Chemistry, qPCR
Education
University of Kentucky College of Medicine 1981 — 1987
Ph.D., Biochemistry
Lafayette College 1977 — 1981
AB, Chemistry
U.S. Food & Drug Administration February 2013 - Present
U.S. Food & Drug Administration September 1997 - February 2013
National Institutes of Health February 1991 - September 1997
Walter Reed Army Institute of Research February 1987 - February 1991
Skills
Biology, Science, Public Health, PCR, Lifesciences, Scientific Writing, Molecular Biology, Genetics, Cell Culture, Microbiology, Biochemistry, Western Blotting, Laboratory, Cell Biology, Immunology, Statistics, Biotechnology, R, Science Communication, Epidemiology, Medicine, Chemistry, qPCR
Education
University of Kentucky College of Medicine 1981 — 1987
Ph.D., Biochemistry
Lafayette College 1977 — 1981
AB, Chemistry
Gordon Wales's U.S. Food & Drug Administration Experience June 1990 - Present
Job Investigative Engineer at U.S. Food & Drug Administration
Industry Import and Export
Experience
U.S. Food & Drug Administration June 1990 - Present
Education
McGill University
Business
United States Military Academy at West Point
Engineering
U.S. Food & Drug Administration June 1990 - Present
Education
McGill University
Business
United States Military Academy at West Point
Engineering
Paul Dietze's U.S. Food & Drug Administration Experience 1993 - 1998
Job Attorney at Haynes & Boone LLP
Industry Law Practice
Experience
Haynes and Boone LLP May 2011 - Present
Townsend, Townsend & Crew April 2008 - January 2011
Kenyon & Kenyon 2005 - 2008
Morgan Lewis Bockius LLP 2004 - 2005
Pennie & Edmonds LLP 1998 - 2003
U.S. Food & Drug Administration 1993 - 1998
University of Maryland Baltimore County 1987 - 1993
Earlham College 1982 - 1984
Skills
Patent Prosecution, Courts, Client Counseling, Patents, Appeals, Licensing, Patent Litigation, Legal Opinions, Trade Secrets, Prosecution
Education
University of Maryland School of Law 1994 — 1998
Juris Doctor, Law
Brandeis University 1984 — 1987
Post Doctoral Associate, Chemistry
New York University 1979 — 1983
Ph.D. and M.S., Chemistry
Queens College City University of New York 1972 — 1976
BS, Chemistry
Haynes and Boone LLP May 2011 - Present
Townsend, Townsend & Crew April 2008 - January 2011
Kenyon & Kenyon 2005 - 2008
Morgan Lewis Bockius LLP 2004 - 2005
Pennie & Edmonds LLP 1998 - 2003
U.S. Food & Drug Administration 1993 - 1998
University of Maryland Baltimore County 1987 - 1993
Earlham College 1982 - 1984
Skills
Patent Prosecution, Courts, Client Counseling, Patents, Appeals, Licensing, Patent Litigation, Legal Opinions, Trade Secrets, Prosecution
Education
University of Maryland School of Law 1994 — 1998
Juris Doctor, Law
Brandeis University 1984 — 1987
Post Doctoral Associate, Chemistry
New York University 1979 — 1983
Ph.D. and M.S., Chemistry
Queens College City University of New York 1972 — 1976
BS, Chemistry
Isaac J. Miller's U.S. Food & Drug Administration Experience June 2015 - Present
Job Education Program Specialist at Armed Forces Medical Examiner System
Industry Government Administration
Experience
U.S. Food & Drug administration June 2015 - Present
Armed Forces Medical Examiner System August 2011 - June 2015
Armed Forces Institute of Pathology April 2005 - July 2011
U. S. Air Force May 1985 - April 2005
Skills
Project Management, Brochures, Advertising, Marketing, Office Administration, DoD, E-Learning, Graphic Design, HIPAA, Health, Military, Networking, PowerPoint, Fitness Training, Microsoft Word, Writing, Customer Service, Government, Policy, Training
Education
Community College of the Air Force
University of Phoenix
Program Management
U.S. Food & Drug administration June 2015 - Present
Armed Forces Medical Examiner System August 2011 - June 2015
Armed Forces Institute of Pathology April 2005 - July 2011
U. S. Air Force May 1985 - April 2005
Skills
Project Management, Brochures, Advertising, Marketing, Office Administration, DoD, E-Learning, Graphic Design, HIPAA, Health, Military, Networking, PowerPoint, Fitness Training, Microsoft Word, Writing, Customer Service, Government, Policy, Training
Education
Community College of the Air Force
University of Phoenix
Program Management
L. Mary Kuehborn's U.S. Food & Drug Administration Experience September 2013 - Present
Job Public Health Professional with the US Food and Drug Administration
Industry Government Administration
Experience
US Food & Drug Administration September 2013 - Present
US Food & Drug Administration August 2010 - September 2013
Northwest / Delta Airlines, Inc. May 2000 - February 2010
Education
University of Minnesota-Twin Cities 1977 — 1981
B.S., Business Administration - Carlson School of Management
US Food & Drug Administration September 2013 - Present
US Food & Drug Administration August 2010 - September 2013
Northwest / Delta Airlines, Inc. May 2000 - February 2010
Education
University of Minnesota-Twin Cities 1977 — 1981
B.S., Business Administration - Carlson School of Management
D. Charles Thompson's U.S. Food & Drug Administration Experience 2007 - Present
Job Toxicologist at U.S. Food & Drug Administration
Industry Pharmaceuticals
Experience
U.S. Food & Drug Administration 2007 - Present
US EPA 2005 - 2007
Burdock Group Consultants 2003 - 2005
U.S. Food & Drug Administration 2000 - 2003
Procter & Gamble 1995 - 2000
Skills
Diplomate, American...
Education
University of North Carolina at Chapel Hill 1989 — 1995
Doctor of Philosophy (Ph.D.), Toxicology
University of North Carolina at Chapel Hill 1983 — 1986
Bachelor of Science (B.S.), Pharmacy
University of North Carolina at Chapel Hill 1979 — 1982
Bachelor of Arts (B.A.), English
U.S. Food & Drug Administration 2007 - Present
US EPA 2005 - 2007
Burdock Group Consultants 2003 - 2005
U.S. Food & Drug Administration 2000 - 2003
Procter & Gamble 1995 - 2000
Skills
Diplomate, American...
Education
University of North Carolina at Chapel Hill 1989 — 1995
Doctor of Philosophy (Ph.D.), Toxicology
University of North Carolina at Chapel Hill 1983 — 1986
Bachelor of Science (B.S.), Pharmacy
University of North Carolina at Chapel Hill 1979 — 1982
Bachelor of Arts (B.A.), English
Kristopher Bough's U.S. Food & Drug Administration Experience October 2005 - February 2008
Job Program Director at NIH / NIDA
Industry Pharmaceuticals
Experience
NIH / NIDA May 2013 - Present
NIH / NIDA December 2012 - May 2013
NIH / NIDA February 2008 - November 2012
US Food & Drug Administration October 2005 - February 2008
Emory University 2001 - 2005
University of Washington 1999 - 2001
Skills
Translational Medicine, Clinical Trials, Neuroscience, Translational Research, Cell Biology, Neuropharmacology, Research, Drug Development, Clinical Development, Lifesciences, Grants, Public Health, Biochemistry, Statistics, Microscopy, Biotechnology, Pharmaceutical Industry, Clinical Research, Genetics, Molecular Biology, Protocol, Animal Models, Grant Writing, Science, Public Speaking, Program Management, Drug Discovery, Pharmacology, Biomarkers, Positron Emission..., Data Analysis, Life Sciences
Education
Georgetown University 1998 — 1999
PhD, Biology / Neuroscience
Georgetown University 1994 — 1998
MSc, Biology / Neuroscience
Gettysburg College 1988 — 1992
BS, Biology
NIH / NIDA May 2013 - Present
NIH / NIDA December 2012 - May 2013
NIH / NIDA February 2008 - November 2012
US Food & Drug Administration October 2005 - February 2008
Emory University 2001 - 2005
University of Washington 1999 - 2001
Skills
Translational Medicine, Clinical Trials, Neuroscience, Translational Research, Cell Biology, Neuropharmacology, Research, Drug Development, Clinical Development, Lifesciences, Grants, Public Health, Biochemistry, Statistics, Microscopy, Biotechnology, Pharmaceutical Industry, Clinical Research, Genetics, Molecular Biology, Protocol, Animal Models, Grant Writing, Science, Public Speaking, Program Management, Drug Discovery, Pharmacology, Biomarkers, Positron Emission..., Data Analysis, Life Sciences
Education
Georgetown University 1998 — 1999
PhD, Biology / Neuroscience
Georgetown University 1994 — 1998
MSc, Biology / Neuroscience
Gettysburg College 1988 — 1992
BS, Biology
Patrick Ricucci, PMP's U.S. Food & Drug Administration Experience May 2014 - Present
Job Project Manager & Business Operations at U.S. Food & Drug Administration
Industry Information Technology and Services
Experience
U.S. Food & Drug Administration May 2014 - Present
Acclaro Research Solutions, Inc. May 2013 - February 2014
Alexton, Inc June 2012 - March 2013
Business Operations Consultant March 2011 - May 2012
Udig Technologies June 2009 - February 2011
Stratix Corporation October 2008 - May 2009
Hewlett-Packard / Compaq / Digital Equipment Corp December 1994 - July 2008
Corporate Trainer February 1993 - December 1994
Digital Equipment Corporation 1986 - February 1993
Skills
Forecasting, Budgeting, Pricing, Financial Reporting, Project Finance, Certified Project..., Training & Development, Budgets, Process Improvement, Program Management, Employee Training, Project Management, Software Project..., Strategic Planning, Strategy, Vendor Management, Leadership, Integration, Business Intelligence, Analysis, Management, PMP, Resource Management, Consulting
Education
University of Maryland University College 1993 — 1997
BS, Business Management
U.S. Food & Drug Administration May 2014 - Present
Acclaro Research Solutions, Inc. May 2013 - February 2014
Alexton, Inc June 2012 - March 2013
Business Operations Consultant March 2011 - May 2012
Udig Technologies June 2009 - February 2011
Stratix Corporation October 2008 - May 2009
Hewlett-Packard / Compaq / Digital Equipment Corp December 1994 - July 2008
Corporate Trainer February 1993 - December 1994
Digital Equipment Corporation 1986 - February 1993
Skills
Forecasting, Budgeting, Pricing, Financial Reporting, Project Finance, Certified Project..., Training & Development, Budgets, Process Improvement, Program Management, Employee Training, Project Management, Software Project..., Strategic Planning, Strategy, Vendor Management, Leadership, Integration, Business Intelligence, Analysis, Management, PMP, Resource Management, Consulting
Education
University of Maryland University College 1993 — 1997
BS, Business Management
Nicole Stevenson's U.S. Food & Drug Administration Experience June 2011 - Present
Job Procurement, U.S. Food & Drug Administration
Industry Government Administration
Experience
U.S. Food & Drug Administration June 2011 - Present
Alliances for Quality Education, Inc. January 2009 - June 2011
The MayaTech Corporation May 2004 - November 2008
Greater Washington Urban League 2000 - 2003
Greater Washington Urban League 2000 - 2003
Skills
Business Development, Government Contracting, Management, Program Management, Project Management, Proposal Writing, Strategic Planning, Business Strategy, Policy, Policy Analysis
Education
University of Maryland School of Law 1995 — 1998
J.D., Health Care Law
Northwestern University 1988 — 1992
B.A., Economics
U.S. Food & Drug Administration June 2011 - Present
Alliances for Quality Education, Inc. January 2009 - June 2011
The MayaTech Corporation May 2004 - November 2008
Greater Washington Urban League 2000 - 2003
Greater Washington Urban League 2000 - 2003
Skills
Business Development, Government Contracting, Management, Program Management, Project Management, Proposal Writing, Strategic Planning, Business Strategy, Policy, Policy Analysis
Education
University of Maryland School of Law 1995 — 1998
J.D., Health Care Law
Northwestern University 1988 — 1992
B.A., Economics
Richard Needham's U.S. Food & Drug Administration Experience July 1973 - September 2005
Job President at RFL Associates
Industry Pharmaceuticals
Experience
RFL Associates October 2006 - Present
US Food & Drug Administration July 1973 - September 2005
Skills
FDA GMP, GMP, FDA, CAPA, GLP, Validation, Sop, Pharmaceutical Industry, HPLC, Regulatory Affairs, Analytical Chemistry
Education
Yale University 1971 — 1973
MS, Chemistry
Northeastern University 1976 — 1978
MS, Pharmacology
Oberlin College 1963 — 1967
BA, Chemistry
RFL Associates October 2006 - Present
US Food & Drug Administration July 1973 - September 2005
Skills
FDA GMP, GMP, FDA, CAPA, GLP, Validation, Sop, Pharmaceutical Industry, HPLC, Regulatory Affairs, Analytical Chemistry
Education
Yale University 1971 — 1973
MS, Chemistry
Northeastern University 1976 — 1978
MS, Pharmacology
Oberlin College 1963 — 1967
BA, Chemistry
John Rubright's U.S. Food & Drug Administration Experience October 1985 - March 1994
Job Project Specialist III / Consultant at Kinsale Holdings, dba Validant
Industry Medical Devices
Experience
Bayer HealthCare Diabetes Care January 2007 - November 2010
Bayer HealthCare Product Supply January 2003 - December 2006
Bayer Corporation April 2000 - December 2002
Respironics April 1994 - April 2000
U.S. Food & Drug Administration October 1985 - March 1994
Skills
FDA, Pharmaceutical Industry, Leadership, CAPA, Quality Auditing, Quality System, Clinical Research, Process Improvement, Quality Assurance, CRO, ISO 13485, GMP, Medical Devices, Quality Control, Training, Regulatory Requirements, Change Management, Due Diligence, Strategy, Auditing, Software Documentation, Risk Management, Quality Management, 21 CFR Part 11, Business Development, Internal Audit, Product Development, Regulatory Affairs, Clinical Trials, Root Cause Analysis, V&V, Continuous Improvement, Six Sigma, ISO 14971, Program Management, Technical Writing
Education
Penn State University
B.S., Biology
Texas A&M University
M.S., Oceanography
University of Pittsburgh - Joseph M. Katz Graduate School of Business
MBA, General Business
Bayer HealthCare Diabetes Care January 2007 - November 2010
Bayer HealthCare Product Supply January 2003 - December 2006
Bayer Corporation April 2000 - December 2002
Respironics April 1994 - April 2000
U.S. Food & Drug Administration October 1985 - March 1994
Skills
FDA, Pharmaceutical Industry, Leadership, CAPA, Quality Auditing, Quality System, Clinical Research, Process Improvement, Quality Assurance, CRO, ISO 13485, GMP, Medical Devices, Quality Control, Training, Regulatory Requirements, Change Management, Due Diligence, Strategy, Auditing, Software Documentation, Risk Management, Quality Management, 21 CFR Part 11, Business Development, Internal Audit, Product Development, Regulatory Affairs, Clinical Trials, Root Cause Analysis, V&V, Continuous Improvement, Six Sigma, ISO 14971, Program Management, Technical Writing
Education
Penn State University
B.S., Biology
Texas A&M University
M.S., Oceanography
University of Pittsburgh - Joseph M. Katz Graduate School of Business
MBA, General Business
Jarred Reiling's U.S. Food & Drug Administration Experience August 2011 - September 2013
Job Associate at Gelber Schachter & Greenberg, P.A.
Industry Law Practice
Experience
Gelber Schachter & Greenberg, P.A. August 2015 - Present
Florida International University College of Law August 2014 - Present
United States District Court for the Southern District of Florida July 2014 - August 2015
United States Court of Appeals for the Eleventh Circuit September 2013 - July 2014
U.S. Food & Drug Administration August 2011 - September 2013
University of the District of Columbia - David A. Clarke School of Law August 2012 - June 2013
U.S. Department of Justice May 2012 - September 2012
Education
Florida International University - College of Law 2008 — 2011
J.D.
Harriet L. Wilkes Honors College of Florida Atlantic University
B.A.
Gelber Schachter & Greenberg, P.A. August 2015 - Present
Florida International University College of Law August 2014 - Present
United States District Court for the Southern District of Florida July 2014 - August 2015
United States Court of Appeals for the Eleventh Circuit September 2013 - July 2014
U.S. Food & Drug Administration August 2011 - September 2013
University of the District of Columbia - David A. Clarke School of Law August 2012 - June 2013
U.S. Department of Justice May 2012 - September 2012
Education
Florida International University - College of Law 2008 — 2011
J.D.
Harriet L. Wilkes Honors College of Florida Atlantic University
B.A.
Joan Loreng's U.S. Food & Drug Administration Experience 1970 - 2010
Job GMP, QSR Consultant/Biologics, Pharmaceuticals, Medical Devices, Former FDA National Expert, Biologics
Industry Pharmaceuticals
Experience
Self-employed 2010 - 2012
U.S. Food & Drug Administration 1970 - 2010
Skills
Medical Devices, Pharmaceuticals, Regulatory Affairs, CAPA, QSR, Quality Auditing, GMP, Quality Systems, Life Sciences, Quality System, Pharmaceutical Industry, Regulatory Requirements, Validation, FDA, Regulatory Submissions, Lifesciences, Vaccines, IND, 21 CFR Part 11, Sop, V&V, Change Control, Clinical Development, Computer System..., GCP, GLP, Biopharmaceuticals, GxP, Technology Transfer, ISO 13485, Clinical Trials, LIMS, Pharmaceutics, Biotechnology, Quality Assurance, SOP
Education
Chestnut Hill College
B.S., Chemistry
Gwynedd-Mercy College
B.S., Computer and Information Systems
Self-employed 2010 - 2012
U.S. Food & Drug Administration 1970 - 2010
Skills
Medical Devices, Pharmaceuticals, Regulatory Affairs, CAPA, QSR, Quality Auditing, GMP, Quality Systems, Life Sciences, Quality System, Pharmaceutical Industry, Regulatory Requirements, Validation, FDA, Regulatory Submissions, Lifesciences, Vaccines, IND, 21 CFR Part 11, Sop, V&V, Change Control, Clinical Development, Computer System..., GCP, GLP, Biopharmaceuticals, GxP, Technology Transfer, ISO 13485, Clinical Trials, LIMS, Pharmaceutics, Biotechnology, Quality Assurance, SOP
Education
Chestnut Hill College
B.S., Chemistry
Gwynedd-Mercy College
B.S., Computer and Information Systems
Maria Chaput's U.S. Food & Drug Administration Experience September 1972 - Present
Job BioInvestgative Analyst at U.S. Food & Drug Administration
Industry Government Administration
Experience
U.S. Food & Drug Administration September 1972 - Present
Education
Harvard University
Regis College
Bachelor of Arts (B.A.), Biology, General
U.S. Food & Drug Administration September 1972 - Present
Education
Harvard University
Regis College
Bachelor of Arts (B.A.), Biology, General
Eve Jefferson's U.S. Food & Drug Administration Experience August 1990 - Present
Job Financial Management Specialist at U.S. Food & Drug Administration
Industry Accounting
Experience
U.S. Food & Drug Administration August 1990 - Present
Skills
Regulations, Data Analysis, Federal Government, Accounts Payable, Finance, Accounting, Data Entry
Education
Webster Career College 1988 — 1989
Data Processing Certificate, Computer Programming, A
University of Southern California 1979 — 1983
None, Business Administration and Management, General, N/A
St. Michael's High School 1975 — 1979
High School Diploma, N/A, 2nd Highest GPA out of 58 graduates
U.S. Food & Drug Administration August 1990 - Present
Skills
Regulations, Data Analysis, Federal Government, Accounts Payable, Finance, Accounting, Data Entry
Education
Webster Career College 1988 — 1989
Data Processing Certificate, Computer Programming, A
University of Southern California 1979 — 1983
None, Business Administration and Management, General, N/A
St. Michael's High School 1975 — 1979
High School Diploma, N/A, 2nd Highest GPA out of 58 graduates
Ann T. Kelley's U.S. Food & Drug Administration Experience July 1964 - August 1965
Job Student Tutor at Houston Community College
Industry Professional Training & Coaching
Experience
Houston Community College January 2014 - Present
Self-employed June 2003 - Present
Bilingual Education Institute 2012 - 2013
Bilingual Education Institute 2012 - 2013
Houston ISD 1989 - 2003
Catholic University of Peru December 1968 - December 1969
Chemical Abstracts Service June 1966 - June 1968
FDA July 1964 - August 1965
U.S. Food & Drug Administration July 1964 - August 1965
Skills
Protein Chemistry, Research, FDA, Analysis, ESL, Teaching, Instructional Design, E-Learning, Public Speaking, Curriculum Development, Adult Education, Curriculum Design, Tutoring, Higher Education, Career Counseling, Personal Development, Classroom, Coaching, Staff Development, Training
Education
University of Houston 1995 — 2001
Master's degree, Science Curriculum and Instruction
Central Connecticut State University 1986 — 1989
Coursework for teacher certification
College of Our Lady of the Elms 1959 — 1964
Bachelor of Arts (B.A.), Chemistry
College of Our Lady of the Elms 1959 — 1964
Bachelor of Arts (B.A.), Chemistry
Houston Community College January 2014 - Present
Self-employed June 2003 - Present
Bilingual Education Institute 2012 - 2013
Bilingual Education Institute 2012 - 2013
Houston ISD 1989 - 2003
Catholic University of Peru December 1968 - December 1969
Chemical Abstracts Service June 1966 - June 1968
FDA July 1964 - August 1965
U.S. Food & Drug Administration July 1964 - August 1965
Skills
Protein Chemistry, Research, FDA, Analysis, ESL, Teaching, Instructional Design, E-Learning, Public Speaking, Curriculum Development, Adult Education, Curriculum Design, Tutoring, Higher Education, Career Counseling, Personal Development, Classroom, Coaching, Staff Development, Training
Education
University of Houston 1995 — 2001
Master's degree, Science Curriculum and Instruction
Central Connecticut State University 1986 — 1989
Coursework for teacher certification
College of Our Lady of the Elms 1959 — 1964
Bachelor of Arts (B.A.), Chemistry
College of Our Lady of the Elms 1959 — 1964
Bachelor of Arts (B.A.), Chemistry
Kristen Goh's U.S. Food & Drug Administration Experience January 2015 - March 2015
Job Healthy Communities Intern at Orange County Health Care Agency
Industry
Experience
Orange County Health Care Agency July 2015 - Present
U.S. Food & Drug Administration January 2015 - March 2015
Skills
Microsoft Office, Customer Service, Management, Research, Microsoft Excel
Education
University of California, Irvine 2012 — 2015
Bachelor’s Degree, Public Health Policy
Orange County Health Care Agency July 2015 - Present
U.S. Food & Drug Administration January 2015 - March 2015
Skills
Microsoft Office, Customer Service, Management, Research, Microsoft Excel
Education
University of California, Irvine 2012 — 2015
Bachelor’s Degree, Public Health Policy
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