Food and Drug Administration
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Headquarters: Silver Spring, Maryland, United States Employees: 14,824 (2010) Jurisdiction: United States of America Founded: 30 June 1906 Subsidiaries: Center for Drug Evaluation and Research, Founders: Theodore Roosevelt, Harvey Washington Wiley
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Food and Drug Administration Employees
Employee
Years
Job
Industry
Alexander Chow Alexander Chow's Food and Drug Administration Experience June 2010 - August 2011
Job Doctor of Optometry Candidate at University of California, Berkeley
Industry Hospital & Health Care
Experience
Kaplan Test Prep October 2011 - September 2013
University of California, Berkeley June 2013 - August 2013
Food and Drug Administration June 2010 - August 2011
Education
University of California, Berkeley 2012 — 2016
Doctor of Optometry (O.D.), Optometry
University of Washington 2008 — 2012
Bachelor of Science (B.S.), Chemical Engineering
Kaplan Test Prep October 2011 - September 2013
University of California, Berkeley June 2013 - August 2013
Food and Drug Administration June 2010 - August 2011
Education
University of California, Berkeley 2012 — 2016
Doctor of Optometry (O.D.), Optometry
University of Washington 2008 — 2012
Bachelor of Science (B.S.), Chemical Engineering
Diana Dee Monaco Diana Dee Monaco's Food and Drug Administration Experience September 1992 - Present
Job Public Affairs SpecialistPublic Affairs and Editorial Staff at Food and Drug AdministrationDivision of Communications
Industry Government Relations
Experience
Food and Drug Administration-Division of Communications March 2014 - Present
Food and Drug Administration September 1992 - Present
Academy for Nutrition and Dietetics 2010 - 2014
Buffalo State College 1998 - 2010
Skills
Public Speaking, Community Outreach, Event Planning, Management, Leadership, Non-profits, Media Relations, Government, Public Health, Research, Training, Grant Writing, Fundraising, Program Development, Team Building, Project Planning, Microsoft Office, Program Evaluation, Teaching, Community Development, Public Relations, Program Management, Higher Education, Organizational..., Nonprofits, Healthcare, Event Management, Editing, Public Policy, Social Networking, Strategic Planning, Customer Service, Social Media, Press Releases, Facebook, Marketing, Policy, Strategic Communications, Nutrition, Social Media Marketing, Leadership Development, Coaching, Grants, Newsletters, Mentoring, Staff Development, Workshop Facilitation
Education
University at Buffalo 1979 — 1998
BA, BS, Public Relations, Dietetics
Food and Drug Administration-Division of Communications March 2014 - Present
Food and Drug Administration September 1992 - Present
Academy for Nutrition and Dietetics 2010 - 2014
Buffalo State College 1998 - 2010
Skills
Public Speaking, Community Outreach, Event Planning, Management, Leadership, Non-profits, Media Relations, Government, Public Health, Research, Training, Grant Writing, Fundraising, Program Development, Team Building, Project Planning, Microsoft Office, Program Evaluation, Teaching, Community Development, Public Relations, Program Management, Higher Education, Organizational..., Nonprofits, Healthcare, Event Management, Editing, Public Policy, Social Networking, Strategic Planning, Customer Service, Social Media, Press Releases, Facebook, Marketing, Policy, Strategic Communications, Nutrition, Social Media Marketing, Leadership Development, Coaching, Grants, Newsletters, Mentoring, Staff Development, Workshop Facilitation
Education
University at Buffalo 1979 — 1998
BA, BS, Public Relations, Dietetics
Lisa Adamiak Lisa Adamiak's Food and Drug Administration Experience June 2010 - June 2011
Job Graduate Student Researcher at University of California, San Diego
Industry Research
Experience
University of California, San Diego September 2011 - Present
Food and Drug Administration June 2010 - June 2011
University of California, Santa Cruz September 2009 - May 2010
Skills
NMR, Circular Dichroism, Mass Spectrometry, HPLC, UV/Vis, Organic Synthesis, Polymer Characterization, Enzyme Assays, MRI
Education
University of California, San Diego 2011 — 2016
Doctor of Philosophy (PhD), Chemistry
University of California, Santa Cruz 2006 — 2010
B.S. (Honors), Chemistry
University of California, San Diego September 2011 - Present
Food and Drug Administration June 2010 - June 2011
University of California, Santa Cruz September 2009 - May 2010
Skills
NMR, Circular Dichroism, Mass Spectrometry, HPLC, UV/Vis, Organic Synthesis, Polymer Characterization, Enzyme Assays, MRI
Education
University of California, San Diego 2011 — 2016
Doctor of Philosophy (PhD), Chemistry
University of California, Santa Cruz 2006 — 2010
B.S. (Honors), Chemistry
Brian Chou, Pharm.D. Brian Chou, Pharm.D.'s Food and Drug Administration Experience August 2013 - September 2013
Job Manager, Global Pricing Reimbursement and Access, Alzheimer's Platform at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company June 2015 - Present
Eli Lilly and Company June 2014 - June 2015
Butler University January 2015 - March 2015
Kaiser Permanente December 2010 - May 2014
Food and Drug Administration August 2013 - September 2013
Amgen June 2013 - August 2013
Pro Pharma Pharmaceutical Consultants, Inc May 2012 - July 2012
Los Angeles County-USC Medical Center April 2011 - May 2012
Skills
Managed Care, Diabetes, Healthcare, Inpatient, Oncology, Clinical Research, Patient Education, Pharmaceutical Industry, Hospitals, Clinical Development, Pharmaceutics, Clinical Trials
Education
University of Southern California 2010 — 2014
Doctor of Pharmacy (Pharm.D.)
University of California, San Diego 2006 — 2010
Bachelor of Science (B.S.), Pharmacology and Toxicology
Eli Lilly and Company June 2015 - Present
Eli Lilly and Company June 2014 - June 2015
Butler University January 2015 - March 2015
Kaiser Permanente December 2010 - May 2014
Food and Drug Administration August 2013 - September 2013
Amgen June 2013 - August 2013
Pro Pharma Pharmaceutical Consultants, Inc May 2012 - July 2012
Los Angeles County-USC Medical Center April 2011 - May 2012
Skills
Managed Care, Diabetes, Healthcare, Inpatient, Oncology, Clinical Research, Patient Education, Pharmaceutical Industry, Hospitals, Clinical Development, Pharmaceutics, Clinical Trials
Education
University of Southern California 2010 — 2014
Doctor of Pharmacy (Pharm.D.)
University of California, San Diego 2006 — 2010
Bachelor of Science (B.S.), Pharmacology and Toxicology
Patrick Hintz Patrick Hintz's Food and Drug Administration Experience September 2009 - Present
Job CAPT US Public Health Service | Health Promotion Officer at US Food and Drug Administration
Industry Public Safety
Experience
Food and Drug Administration September 2009 - Present
Centers for Disease Control and Prevention/ National Institute for Occupational Safety and Health August 1999 - September 2009
Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health July 1992 - August 1999
Education
Montana College of Mineral Science and Technology 1990 — 1992
Master of Science (MS), Industrial Hygiene
University of Montana 1986 — 1990
Bachelor of Science (B.S.), Microbiology and Biology
Food and Drug Administration September 2009 - Present
Centers for Disease Control and Prevention/ National Institute for Occupational Safety and Health August 1999 - September 2009
Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health July 1992 - August 1999
Education
Montana College of Mineral Science and Technology 1990 — 1992
Master of Science (MS), Industrial Hygiene
University of Montana 1986 — 1990
Bachelor of Science (B.S.), Microbiology and Biology
Leah Stitz Leah Stitz's Food and Drug Administration Experience March 2010 - February 2014
Job Public Affairs Specialist at FDA
Industry Government Administration
Experience
FDA April 2015 - Present
National Institutes of Health February 2014 - April 2015
Food and Drug Administration March 2010 - February 2014
Ken Hubbell & Associates July 2006 - November 2011
Brent & Sam's Cookies (part of Lance, Inc.) October 2008 - July 2009
City of North Little Rock Department of Community Planning June 2006 - October 2008
USDA Food & Nutrition Service, Child Nutrition Division February 2003 - September 2005
L-3 Communications / TMA Corporation June 2002 - February 2003
Coates & Jarratt, Inc. September 2000 - December 2001
The Arlington Institute May 1999 - August 2000
Skills
Strategic Thinking, Research, Project Collaboration, Strategic Planning, Analysis, Product Development, Food Technology, Food Science, Product R&D, Strategy, Program Management, Management, Leadership, Social Media, Project Management, Team Leadership, Team Building, Business Strategy, Government, Policy, Fundraising, Nonprofits, Organizational..., Data Analysis, Qualitative Research, Policy Analysis, Workshop Facilitation, Writing, Editing, Public Speaking, Proposal Writing, Leadership Development, Quality Assurance, Sustainability, Training, Community Outreach, Public Policy
Education
University of Houston-Clear Lake 1998 — 1999
M.S., Studies of the Future
University of Arkansas 1982 — 1984
Bachelor of Science, Agriculture - Food Technology
FDA April 2015 - Present
National Institutes of Health February 2014 - April 2015
Food and Drug Administration March 2010 - February 2014
Ken Hubbell & Associates July 2006 - November 2011
Brent & Sam's Cookies (part of Lance, Inc.) October 2008 - July 2009
City of North Little Rock Department of Community Planning June 2006 - October 2008
USDA Food & Nutrition Service, Child Nutrition Division February 2003 - September 2005
L-3 Communications / TMA Corporation June 2002 - February 2003
Coates & Jarratt, Inc. September 2000 - December 2001
The Arlington Institute May 1999 - August 2000
Skills
Strategic Thinking, Research, Project Collaboration, Strategic Planning, Analysis, Product Development, Food Technology, Food Science, Product R&D, Strategy, Program Management, Management, Leadership, Social Media, Project Management, Team Leadership, Team Building, Business Strategy, Government, Policy, Fundraising, Nonprofits, Organizational..., Data Analysis, Qualitative Research, Policy Analysis, Workshop Facilitation, Writing, Editing, Public Speaking, Proposal Writing, Leadership Development, Quality Assurance, Sustainability, Training, Community Outreach, Public Policy
Education
University of Houston-Clear Lake 1998 — 1999
M.S., Studies of the Future
University of Arkansas 1982 — 1984
Bachelor of Science, Agriculture - Food Technology
Greg Nieto Greg Nieto's Food and Drug Administration Experience November 1983 - August 2008
Job Owner at MoreData4u
Industry Security and Investigations
Experience
Moredata4u, LLC 2008 - Present
Food and Drug Administration November 1983 - August 2008
HTCIA Heartland Chapter 1998 - 1998
Skills
Private Investigations, Evidence, Internal Investigations, Investigation, Fraud, Emergency Management, Criminal Investigations, Homeland Security, Surveillance, Enforcement, Risk Assessment, Security, Executive Protection, Vulnerability Assessment, Background Checks, Counterterrorism, Physical Security
Education
University of Nebraska at Omaha
BS, Biology
Moredata4u, LLC 2008 - Present
Food and Drug Administration November 1983 - August 2008
HTCIA Heartland Chapter 1998 - 1998
Skills
Private Investigations, Evidence, Internal Investigations, Investigation, Fraud, Emergency Management, Criminal Investigations, Homeland Security, Surveillance, Enforcement, Risk Assessment, Security, Executive Protection, Vulnerability Assessment, Background Checks, Counterterrorism, Physical Security
Education
University of Nebraska at Omaha
BS, Biology
Rachel Oxman's Food and Drug Administration Experience July 2015 - Present
Job Program Analyst at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration July 2015 - Present
Food and Drug Administration September 2014 - Present
Food and Drug Administration June 2010 - Present
Food and Drug Administration November 2013 - March 2014
Sugar July 2009 - September 2009
Frills June 2009 - August 2009
Food and Drug Administration 2007 - 2008
Skills
Research, Microsoft Office, Government, Editing, Microsoft Excel, PowerPoint, Community Outreach, Data Analysis, Advertising, Sales, Policy, Policy Analysis, Public Policy, Program Evaluation, Records Management, Microsoft Word, Public Health, Graphic Design, Creative Writing, Leadership, Public Speaking, Federal Government, Interior Design, Online Advertising, Logo Design
Education
University of Baltimore 2013 — 2015
Master of Arts (M.A.), Publications Design
University of Rhode Island 2006 — 2010
Bachelor of Science (B.S.), Textiles, Fashion Merchandising and Design
Food and Drug Administration July 2015 - Present
Food and Drug Administration September 2014 - Present
Food and Drug Administration June 2010 - Present
Food and Drug Administration November 2013 - March 2014
Sugar July 2009 - September 2009
Frills June 2009 - August 2009
Food and Drug Administration 2007 - 2008
Skills
Research, Microsoft Office, Government, Editing, Microsoft Excel, PowerPoint, Community Outreach, Data Analysis, Advertising, Sales, Policy, Policy Analysis, Public Policy, Program Evaluation, Records Management, Microsoft Word, Public Health, Graphic Design, Creative Writing, Leadership, Public Speaking, Federal Government, Interior Design, Online Advertising, Logo Design
Education
University of Baltimore 2013 — 2015
Master of Arts (M.A.), Publications Design
University of Rhode Island 2006 — 2010
Bachelor of Science (B.S.), Textiles, Fashion Merchandising and Design
Moritz Reiter's Food and Drug Administration Experience June 2013 - October 2015
Job Program Analyst at FDA
Industry Government Administration
Experience
FDA October 2015 - Present
Food and Drug Administration June 2013 - October 2015
FDA February 2013 - June 2013
FDA February 2012 - February 2013
United States Air Force December 1993 - November 1997
Skills
Government, Federal Government, Policy, Editing, Program Management, Veterans, Government Procurement, Microsoft Office, Public Administration, Time Management, Public Policy, Project Planning, Research, Social Media, Technical Writing, Post Traumatic Stress, Volunteering, Team Leadership, SharePoint, Records Management, International Health, Training, Data Analysis, Visio, Knowledge Management, Smartboard, Military Logistics, Employee Training, Work Groups, Web Content, Literature Reviews, Disabilities, Sunflower, Oracle Applications, Microsoft SharePoint, Policy Writing, Conference Coordination, Technical Assistance, Blogging, Facebook, Twitter, Adobe Acrobat, Adobe LiveCycle, Technological Innovation
Education
University of Maryland University College 2013 — 2014
Bachelor of Arts (BA), English Language and Literature/Letters
FDA October 2015 - Present
Food and Drug Administration June 2013 - October 2015
FDA February 2013 - June 2013
FDA February 2012 - February 2013
United States Air Force December 1993 - November 1997
Skills
Government, Federal Government, Policy, Editing, Program Management, Veterans, Government Procurement, Microsoft Office, Public Administration, Time Management, Public Policy, Project Planning, Research, Social Media, Technical Writing, Post Traumatic Stress, Volunteering, Team Leadership, SharePoint, Records Management, International Health, Training, Data Analysis, Visio, Knowledge Management, Smartboard, Military Logistics, Employee Training, Work Groups, Web Content, Literature Reviews, Disabilities, Sunflower, Oracle Applications, Microsoft SharePoint, Policy Writing, Conference Coordination, Technical Assistance, Blogging, Facebook, Twitter, Adobe Acrobat, Adobe LiveCycle, Technological Innovation
Education
University of Maryland University College 2013 — 2014
Bachelor of Arts (BA), English Language and Literature/Letters
Veronica Carroll Veronica Carroll's Food and Drug Administration Experience 2013 - Present
Job Center for Food Safety and Nutrition
Industry Government Administration
Experience
Food and Drug Administration 2013 - Present
Chief, National Guard Bureau October 2012 - Present
US Department of Homeland Security July 2010 - October 2012
US Department of Health and Human Services September 2007 - July 2010
Skills
Travel Management, Office Administration, Employee Relations, Employee Training, Executive Writing, Communication Skills, Microsoft Office, Development Of Employees, Facilities Management, Organizational..., Event Planning, Resume Writing, Screening Resumes, E-Learning, Defense Travel System, Travel Arrangements, Digital Photography, Youth Ministry, Ministry Leadership, Social Networking, Social Skills, Apparel, Employee Benefits, Customer Service, Drawing, Food & Beverage, Hospitality Management, Interviews, Photojournalism
Education
Webster University 2012 — 2014
Pursuing Master's Degree, Human Resource Management
University of Maryland University College 2007 — 2011
Bachelor of Science (BS), Human Resources Management
Food and Drug Administration 2013 - Present
Chief, National Guard Bureau October 2012 - Present
US Department of Homeland Security July 2010 - October 2012
US Department of Health and Human Services September 2007 - July 2010
Skills
Travel Management, Office Administration, Employee Relations, Employee Training, Executive Writing, Communication Skills, Microsoft Office, Development Of Employees, Facilities Management, Organizational..., Event Planning, Resume Writing, Screening Resumes, E-Learning, Defense Travel System, Travel Arrangements, Digital Photography, Youth Ministry, Ministry Leadership, Social Networking, Social Skills, Apparel, Employee Benefits, Customer Service, Drawing, Food & Beverage, Hospitality Management, Interviews, Photojournalism
Education
Webster University 2012 — 2014
Pursuing Master's Degree, Human Resource Management
University of Maryland University College 2007 — 2011
Bachelor of Science (BS), Human Resources Management
Adrienne McDonald Adrienne McDonald's Food and Drug Administration Experience January 2007 - August 2010
Job Associate Accounts Receivables Supervisor at Coppin State University
Industry Higher Education
Experience
Coppin State University August 2014 - Present
Coppin State University June 2012 - August 2014
Maryland Institute College of Art August 2011 - June 2012
Maxim Healthcare Services February 2011 - June 2011
Good Samaritan Hospital of Maryland September 2010 - December 2010
Food and Drug Administration January 2007 - August 2010
Skills
Community Outreach, PeopleSoft, Training, Budgets, Public Speaking, Marketing, Recruiting, Human Resources, Policy, Payroll, Management, Time Management, Nonprofits, Event Planning, Leadership
Education
University of Maryland Baltimore County 2006 — 2010
B.A., Health Administration & Policy
Coppin State University August 2014 - Present
Coppin State University June 2012 - August 2014
Maryland Institute College of Art August 2011 - June 2012
Maxim Healthcare Services February 2011 - June 2011
Good Samaritan Hospital of Maryland September 2010 - December 2010
Food and Drug Administration January 2007 - August 2010
Skills
Community Outreach, PeopleSoft, Training, Budgets, Public Speaking, Marketing, Recruiting, Human Resources, Policy, Payroll, Management, Time Management, Nonprofits, Event Planning, Leadership
Education
University of Maryland Baltimore County 2006 — 2010
B.A., Health Administration & Policy
Bryan Ericksen Bryan Ericksen's Food and Drug Administration Experience December 2010 - June 2011
Job Scientific Liaison at United States Pharmacopoeia
Industry Biotechnology
Experience
United States Pharmacopoeia September 2015 - Present
United States Patent and Trademark Office March 2014 - April 2015
University of Maryland November 2011 - March 2014
Food and Drug Administration December 2010 - June 2011
Dow Pharmaceutical Sciences/Valeant Pharmaceuticals November 2005 - November 2009
Skills
Assay Development, Molecular Biology, HPLC, Microbiology, Genomics, Analytical Chemistry, PCR, Validation, GMP, Drug Development, Bioinformatics, Technical Writing, Chromatography, Method Development, Enzyme Kinetics, Computational Biology, Bacteriology, Stability Studies, Bacterial Cell Culture, Electrophoresis, Virtual Colony Count, Enzymology, Quality Control, Management, Bacterial Growth..., Dedication to..., Supervisory Experience
Education
University of California, Davis
Ph.D., Microbiology
University of Rochester
BS/BA, Environmental Sciences, Biology Track/Russian
United States Pharmacopoeia September 2015 - Present
United States Patent and Trademark Office March 2014 - April 2015
University of Maryland November 2011 - March 2014
Food and Drug Administration December 2010 - June 2011
Dow Pharmaceutical Sciences/Valeant Pharmaceuticals November 2005 - November 2009
Skills
Assay Development, Molecular Biology, HPLC, Microbiology, Genomics, Analytical Chemistry, PCR, Validation, GMP, Drug Development, Bioinformatics, Technical Writing, Chromatography, Method Development, Enzyme Kinetics, Computational Biology, Bacteriology, Stability Studies, Bacterial Cell Culture, Electrophoresis, Virtual Colony Count, Enzymology, Quality Control, Management, Bacterial Growth..., Dedication to..., Supervisory Experience
Education
University of California, Davis
Ph.D., Microbiology
University of Rochester
BS/BA, Environmental Sciences, Biology Track/Russian
Carole Jones Carole Jones's Food and Drug Administration Experience September 2008 - July 2010
Job
Industry Medical Devices
Experience
FDA October 2013 - Present
FDA December 2012 - May 2013
FDA July 2010 - March 2013
Food and Drug Administration September 2008 - July 2010
Food and Drug Administration September 2002 - September 2008
Guilford Pharmaceuticals March 1999 - September 2002
North American Vaccine January 1998 - February 1999
Skills
FDA, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Validation, GMP, Sop, GCP, Regulations, Regulatory Requirements, Microbiology, Medical Devices, Lifesciences, Quality Control, Technology Transfer, CAPA, Drug Development, Clinical Development, Cross-functional Team..., Biopharmaceuticals, IND, Quality Auditing, Process Simulation, R&D, Cell Culture, Change Control, Clinical Research, Vaccines, Document Management, Chromatography, Science, Manufacturing, Quality Management, Leadership, Pharmacovigilance, Quality Assurance, GLP, 21 CFR Part 11, Pharmaceutics, Regulatory Submissions, LIMS, SOP, Life Sciences
Education
University of Maryland University College 2001 — 2005
Masters, Biotechnology Sciences
University of Maryland Baltimore County 1993 — 1997
BS, Biological Sciences
FDA October 2013 - Present
FDA December 2012 - May 2013
FDA July 2010 - March 2013
Food and Drug Administration September 2008 - July 2010
Food and Drug Administration September 2002 - September 2008
Guilford Pharmaceuticals March 1999 - September 2002
North American Vaccine January 1998 - February 1999
Skills
FDA, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Validation, GMP, Sop, GCP, Regulations, Regulatory Requirements, Microbiology, Medical Devices, Lifesciences, Quality Control, Technology Transfer, CAPA, Drug Development, Clinical Development, Cross-functional Team..., Biopharmaceuticals, IND, Quality Auditing, Process Simulation, R&D, Cell Culture, Change Control, Clinical Research, Vaccines, Document Management, Chromatography, Science, Manufacturing, Quality Management, Leadership, Pharmacovigilance, Quality Assurance, GLP, 21 CFR Part 11, Pharmaceutics, Regulatory Submissions, LIMS, SOP, Life Sciences
Education
University of Maryland University College 2001 — 2005
Masters, Biotechnology Sciences
University of Maryland Baltimore County 1993 — 1997
BS, Biological Sciences
Peter Ashkenaz Peter Ashkenaz's Food and Drug Administration Experience March 2011 - April 2012
Job Director of Content and Media ONC
Industry Government Administration
Experience
Office of National Coordinator for Health IT April 2012 - Present
Food and Drug Administration March 2011 - April 2012
Centers for Medicare & Medicaid Services November 2007 - March 2011
United Healthcare 2006 - 2007
HCFA 1998 - 2006
Porter Novelli 1997 - 1998
AARP 1992 - 1996
Congressman Ronald Coleman (Tx-16) February 1991 - June 1992
Rio Grande Dispute Resolution Center 1985 - 1991
City of El Paso 1979 - 1983
Skills
Media Relations, Crisis Communications, Strategic Communications, Public Relations, Writing, Editing, Social Media, Internal Communications, Community Relations, Press Releases, Healthcare, Communications Planning, Storytelling, AP Style, Medicare, Community Development, Community Outreach, Politics, Reputation Management, Policy, Event Planning, Public Speaking, Newsletters, Leadership, Health Policy, Public Affairs, Grant Writing, Facebook, Message Development, Fundraising, Government, Copy Editing, Feature Articles, Medicaid, New Media, Journalism, Web Content Management, Proposal Writing, Corporate Communications, Policy Analysis, Speech Writing, Blogging, Content Development, Content Management, Nonprofits, News Writing, Publications, Political Campaigns, Marketing Communications, Content Strategy
Education
The University of Texas at El Paso 1970 — 1975
BS Journalism, Communication, Journalism, and Related Programs
The University of Texas at El Paso 1970 — 1974
BA, Communications
Office of National Coordinator for Health IT April 2012 - Present
Food and Drug Administration March 2011 - April 2012
Centers for Medicare & Medicaid Services November 2007 - March 2011
United Healthcare 2006 - 2007
HCFA 1998 - 2006
Porter Novelli 1997 - 1998
AARP 1992 - 1996
Congressman Ronald Coleman (Tx-16) February 1991 - June 1992
Rio Grande Dispute Resolution Center 1985 - 1991
City of El Paso 1979 - 1983
Skills
Media Relations, Crisis Communications, Strategic Communications, Public Relations, Writing, Editing, Social Media, Internal Communications, Community Relations, Press Releases, Healthcare, Communications Planning, Storytelling, AP Style, Medicare, Community Development, Community Outreach, Politics, Reputation Management, Policy, Event Planning, Public Speaking, Newsletters, Leadership, Health Policy, Public Affairs, Grant Writing, Facebook, Message Development, Fundraising, Government, Copy Editing, Feature Articles, Medicaid, New Media, Journalism, Web Content Management, Proposal Writing, Corporate Communications, Policy Analysis, Speech Writing, Blogging, Content Development, Content Management, Nonprofits, News Writing, Publications, Political Campaigns, Marketing Communications, Content Strategy
Education
The University of Texas at El Paso 1970 — 1975
BS Journalism, Communication, Journalism, and Related Programs
The University of Texas at El Paso 1970 — 1974
BA, Communications
Andreu Badal Andreu Badal's Food and Drug Administration Experience October 2008 - Present
Job Physicist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration October 2008 - Present
Skills
Monte Carlo Simulation, Medical Imaging, PENELOPE, Physics, Imaging Science, CUDA, X-ray, Computational Modeling, GPGPU, High Performance..., Fortran, Linux, Image Processing, Radiation, Dosimetry, Medical Physics, Biomedical Engineering
Education
Universitat Politècnica de Catalunya 2003 — 2008
Doctor of Philosophy (Ph.D.), Physics (Nuclear Engineering program)
Universitat de Barcelona 1997 — 2002
Bachelor's degree, Physics
Food and Drug Administration October 2008 - Present
Skills
Monte Carlo Simulation, Medical Imaging, PENELOPE, Physics, Imaging Science, CUDA, X-ray, Computational Modeling, GPGPU, High Performance..., Fortran, Linux, Image Processing, Radiation, Dosimetry, Medical Physics, Biomedical Engineering
Education
Universitat Politècnica de Catalunya 2003 — 2008
Doctor of Philosophy (Ph.D.), Physics (Nuclear Engineering program)
Universitat de Barcelona 1997 — 2002
Bachelor's degree, Physics
Sharon Gundersen Sharon Gundersen's Food and Drug Administration Experience August 2010 - Present
Job Consumer Safety Officer at Food and Drug Administration
Industry Biotechnology
Experience
Food and Drug Administration August 2010 - Present
The Ohio State University October 2007 - October 2009
University of Notre Dame August 2003 - September 2007
University of Notre Dame September 2003 - May 2005
Foster Wheeler Environmental Corporation (now part of Tetra Tech, Inc) June 2001 - September 2002
Skills
Cell Culture, ELISA, Flow Cytometry, Tissue Culture, Protein Chemistry, Experimentation, Microbiology, Lifesciences, Gel Electrophoresis, Western Blotting, HPLC, In Vitro, Immunology, Biotechnology, Protein Purification, Life Sciences
Education
University of Notre Dame 2003 — 2007
PhD, Chemical and Biomolecular Engineering
University of Notre Dame 2003 — 2006
M.S, Chemical and Biomolecular Engineering
University of Washington 1999 — 2003
B.S., Chemical Engineering
NKHS 1996 — 1999
Food and Drug Administration August 2010 - Present
The Ohio State University October 2007 - October 2009
University of Notre Dame August 2003 - September 2007
University of Notre Dame September 2003 - May 2005
Foster Wheeler Environmental Corporation (now part of Tetra Tech, Inc) June 2001 - September 2002
Skills
Cell Culture, ELISA, Flow Cytometry, Tissue Culture, Protein Chemistry, Experimentation, Microbiology, Lifesciences, Gel Electrophoresis, Western Blotting, HPLC, In Vitro, Immunology, Biotechnology, Protein Purification, Life Sciences
Education
University of Notre Dame 2003 — 2007
PhD, Chemical and Biomolecular Engineering
University of Notre Dame 2003 — 2006
M.S, Chemical and Biomolecular Engineering
University of Washington 1999 — 2003
B.S., Chemical Engineering
NKHS 1996 — 1999
Kelli Sikorski Simon Kelli Sikorski Simon's Food and Drug Administration Experience May 2014 - Present
Job Postdoctoral Research Fellow at Food and Drug Administration
Industry Research
Experience
Food and Drug Administration May 2014 - Present
University of Maryland Department of Chemistry August 2008 - May 2014
Northrop Grumman Space Technology June 2005 - June 2008
Bureau of Alcohol, Tobacco and Firearms May 2004 - August 2004
Skills
FTIR, UV/Vis, Gas Chromatography, HPLC, GC-MS, Fluorescence, Chemistry, Organic Chemistry, Microscopy, IR, Spectroscopy, Research, Wet Chemistry, AFM, Analytical Chemistry, Inorganic Chemistry
Education
University of Maryland College Park 2008 — 2013
Doctor of Philosophy (PhD), Chemistry
West Virginia University 2001 — 2005
Dual BS, Chemistry and Forensic Chemistry
South Allegheny High School 1998 — 2001
Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
Food and Drug Administration May 2014 - Present
University of Maryland Department of Chemistry August 2008 - May 2014
Northrop Grumman Space Technology June 2005 - June 2008
Bureau of Alcohol, Tobacco and Firearms May 2004 - August 2004
Skills
FTIR, UV/Vis, Gas Chromatography, HPLC, GC-MS, Fluorescence, Chemistry, Organic Chemistry, Microscopy, IR, Spectroscopy, Research, Wet Chemistry, AFM, Analytical Chemistry, Inorganic Chemistry
Education
University of Maryland College Park 2008 — 2013
Doctor of Philosophy (PhD), Chemistry
West Virginia University 2001 — 2005
Dual BS, Chemistry and Forensic Chemistry
South Allegheny High School 1998 — 2001
Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
Karin Ricker Karin Ricker's Food and Drug Administration Experience 2001 - 2008
Job Senior Consultant at Senior Consultant EAS Consulting Group
Industry Chemicals
Experience
EAS Consulting Group November 2009 - Present
OEHHA October 2009 - Present
Food and Drug Administration 2001 - 2008
Skills
Regulatory Affairs, Public Health, FDA, Food Safety
Education
Universität Konstanz 1978 — 1984
Masters, Biology
University of California, Davis
Ph.D., Plant Pathology/Phytopathology
EAS Consulting Group November 2009 - Present
OEHHA October 2009 - Present
Food and Drug Administration 2001 - 2008
Skills
Regulatory Affairs, Public Health, FDA, Food Safety
Education
Universität Konstanz 1978 — 1984
Masters, Biology
University of California, Davis
Ph.D., Plant Pathology/Phytopathology
Emily Wearne's Food and Drug Administration Experience June 2013 - Present
Job Pharmacologist at FDA
Industry Government Administration
Experience
Food and Drug Administration June 2013 - Present
Vanderbilt University August 2008 - June 2013
Skills
Life Sciences, Research, Cell Culture, In Vivo, Cell Based Assays, Animal Models, Molecular Biology, Immunohistochemistry, Transfection, Biochemistry, Cell, Western Blotting, Lifesciences
Education
University of Virginia 2003 — 2008
Ph.D., Pharmacology
Unviersity of Virginia 2003 — 2006
M.S., Biological and Physical Sciences
University of Kentucky 1999 — 2003
B.S., Biology
Food and Drug Administration June 2013 - Present
Vanderbilt University August 2008 - June 2013
Skills
Life Sciences, Research, Cell Culture, In Vivo, Cell Based Assays, Animal Models, Molecular Biology, Immunohistochemistry, Transfection, Biochemistry, Cell, Western Blotting, Lifesciences
Education
University of Virginia 2003 — 2008
Ph.D., Pharmacology
Unviersity of Virginia 2003 — 2006
M.S., Biological and Physical Sciences
University of Kentucky 1999 — 2003
B.S., Biology
Linda Joy Linda Joy's Food and Drug Administration Experience June 2015 - Present
Job WriterEditor at Food and Drug Administration
Industry Research
Experience
Food and Drug Administration June 2015 - Present
National Institute of Standards and Technology April 2013 - Present
NOAA: National Oceanic & Atmospheric Administration November 2008 - April 2013
National Institutes of Health 2002 - 2008
National Institute of Standards and Technology 1991 - 2002
The Frederick Post 1986 - 1991
Skills
Press Releases, Newsletters, Editing, Social Media, Community Outreach, Publications, New Media, Storytelling, Public Affairs, Management, Brochures, Strategic Communications, Media Relations, Photography, Feature Articles, Program Management
Education
University of Maryland College Park
Bachelor of Science (B.S.), Journalism
Food and Drug Administration June 2015 - Present
National Institute of Standards and Technology April 2013 - Present
NOAA: National Oceanic & Atmospheric Administration November 2008 - April 2013
National Institutes of Health 2002 - 2008
National Institute of Standards and Technology 1991 - 2002
The Frederick Post 1986 - 1991
Skills
Press Releases, Newsletters, Editing, Social Media, Community Outreach, Publications, New Media, Storytelling, Public Affairs, Management, Brochures, Strategic Communications, Media Relations, Photography, Feature Articles, Program Management
Education
University of Maryland College Park
Bachelor of Science (B.S.), Journalism
Charles Chiang Charles Chiang's Food and Drug Administration Experience August 2011 - July 2014
Job Examiner (Mechanical/Biomedical) at USPTO
Industry Government Administration
Experience
USPTO July 2014 - Present
Food and Drug Administration August 2011 - July 2014
Food and Drug Administration June 2010 - June 2011
Igene Biotechnology Inc May 2009 - February 2011
Skills
Technical Writing, Technical Analysis, Technical Documentation, Medical Devices, Validation, Labview, Matlab, Biomedical Engineering, Data Analysis, Research, Technical Presentations, Microsoft Excel, Biomaterials, Laboratory, Cell Culture, FDA
Education
University of Maryland College Park 2007 — 2011
BS, Bioengineering
University of Maryland - A. James Clark School of Engineering
USPTO July 2014 - Present
Food and Drug Administration August 2011 - July 2014
Food and Drug Administration June 2010 - June 2011
Igene Biotechnology Inc May 2009 - February 2011
Skills
Technical Writing, Technical Analysis, Technical Documentation, Medical Devices, Validation, Labview, Matlab, Biomedical Engineering, Data Analysis, Research, Technical Presentations, Microsoft Excel, Biomaterials, Laboratory, Cell Culture, FDA
Education
University of Maryland College Park 2007 — 2011
BS, Bioengineering
University of Maryland - A. James Clark School of Engineering
Stephen Hsia Stephen Hsia's Food and Drug Administration Experience 1991 - 1992
Job Toxicology Consulting, Senior Science Advisor
Industry Research
Experience
Self-employed 2011 - Present
Noblis, Inc. (formerly Mitretek Systems) 1996 - 2011
The MITRE Corporation 1987 - 1996
Food and Drug Administration 1991 - 1992
University of Wisconsin-Madison 1974 - 1987
Skills
Toxicology, Risk Assessment, Biochemistry, Biomarkers, Bionanotechnology, Chemical Carcinogenesis, Molecular Biology, Molecular Diagnostics, Molecular Epidemiology, New Technology..., Organic Chemistry, Biotechnology, FDA, Life Sciences
Education
University of California, San Diego 1969 — 1974
Ph.D., Organic Chemistry
Self-employed 2011 - Present
Noblis, Inc. (formerly Mitretek Systems) 1996 - 2011
The MITRE Corporation 1987 - 1996
Food and Drug Administration 1991 - 1992
University of Wisconsin-Madison 1974 - 1987
Skills
Toxicology, Risk Assessment, Biochemistry, Biomarkers, Bionanotechnology, Chemical Carcinogenesis, Molecular Biology, Molecular Diagnostics, Molecular Epidemiology, New Technology..., Organic Chemistry, Biotechnology, FDA, Life Sciences
Education
University of California, San Diego 1969 — 1974
Ph.D., Organic Chemistry
Adalberto Rivera Zapata's Food and Drug Administration Experience September 2014 - March 2015
Job SECERTARY (OA) at Department Of Veterans Affairs, Veterans Health Administration
Industry Military
Experience
Department Of Veterans Affairs, Veterans Health Administration March 2015 - Present
United States Army Reserve January 2005 - Present
Food and Drug Administration September 2014 - March 2015
DEPARTMENT OF VETERANS AFFAIRS REGIONAL OFFICE October 2012 - March 2014
Mowers Consulting, LLC August 2010 - July 2011
KBR September 2007 - July 2011
Cingular Wireless 2002 - 2004
Skills
Government, Military, Logistics, Transportation, Security Clearance, Process Scheduler, Transportation..., Analysis, Microsoft Word, Warehouse Management, DoD, Process Improvement, Networking, Microsoft Excel, Management, Military Operations, Technical Support, Military Experience, Logistics Management, Microsoft Office, Government Contracting, Military Logistics, Supervisory Skills, Army
Education
Universidad Del Este 2012 — 2014
Master's degree, Human Resources Management/Personnel Administration, General
Universidad Del Este 1999 — 2004
2004B.A, Business Administration
Francisco Gaztambide Vega 1997 — 1999
High School Diploma, High School/Secondary Diplomas and Certificates
Department Of Veterans Affairs, Veterans Health Administration March 2015 - Present
United States Army Reserve January 2005 - Present
Food and Drug Administration September 2014 - March 2015
DEPARTMENT OF VETERANS AFFAIRS REGIONAL OFFICE October 2012 - March 2014
Mowers Consulting, LLC August 2010 - July 2011
KBR September 2007 - July 2011
Cingular Wireless 2002 - 2004
Skills
Government, Military, Logistics, Transportation, Security Clearance, Process Scheduler, Transportation..., Analysis, Microsoft Word, Warehouse Management, DoD, Process Improvement, Networking, Microsoft Excel, Management, Military Operations, Technical Support, Military Experience, Logistics Management, Microsoft Office, Government Contracting, Military Logistics, Supervisory Skills, Army
Education
Universidad Del Este 2012 — 2014
Master's degree, Human Resources Management/Personnel Administration, General
Universidad Del Este 1999 — 2004
2004B.A, Business Administration
Francisco Gaztambide Vega 1997 — 1999
High School Diploma, High School/Secondary Diplomas and Certificates
Ramona Ruble Ramona Ruble's Food and Drug Administration Experience June 1997 - August 1999
Job Manager, Clinical Research Associates at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical November 2013 - Present
St. Jude Medical March 2013 - November 2013
St. Jude Medical November 2009 - March 2013
AGA Medical November 2007 - November 2009
Medtronic November 2006 - November 2007
Boston Scientific July 2005 - November 2006
Guidant Corporation August 2000 - April 2005
Food and Drug Administration June 1997 - August 1999
Skills
Clinical Research, Microbiology, FDA, Medical Devices, Clinical Trials, CTMS, Clinical Development, Clinical Monitoring, GCP, Regulatory Affairs, SOP, Laboratory, Cardiology
Education
University of Minnesota-Twin Cities 1996 — 1999
BS, Food Science
St. Jude Medical November 2013 - Present
St. Jude Medical March 2013 - November 2013
St. Jude Medical November 2009 - March 2013
AGA Medical November 2007 - November 2009
Medtronic November 2006 - November 2007
Boston Scientific July 2005 - November 2006
Guidant Corporation August 2000 - April 2005
Food and Drug Administration June 1997 - August 1999
Skills
Clinical Research, Microbiology, FDA, Medical Devices, Clinical Trials, CTMS, Clinical Development, Clinical Monitoring, GCP, Regulatory Affairs, SOP, Laboratory, Cardiology
Education
University of Minnesota-Twin Cities 1996 — 1999
BS, Food Science
Emmanuel Kerry Emmanuel Kerry's Food and Drug Administration Experience 2010 - Present
Job Consumer Safety Officer at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration 2010 - Present
Food and Drug Administration December 2009 - February 2011
National Archives II College Park MD July 2008 - November 2009
Education
University of Maryland College Park 2005 — 2010
Public and Community Health, Epidemiology
Food and Drug Administration 2010 - Present
Food and Drug Administration December 2009 - February 2011
National Archives II College Park MD July 2008 - November 2009
Education
University of Maryland College Park 2005 — 2010
Public and Community Health, Epidemiology
Caitlin Hickey's Food and Drug Administration Experience May 2008 - August 2008
Job ORISE Fellow, CFSAN Food Defense Team at FDA
Industry Food & Beverages
Experience
FDA September 2014 - Present
Deloitte August 2014 - September 2014
Deloitte & Touche, LLP November 2012 - August 2014
The Institute of Food Technologists (IFT) September 2011 - November 2012
Prime Label Consultants, Inc. May 2006 - August 2009
International Food Information Council Foundation June 2009 - July 2009
Food and Drug Administration May 2008 - August 2008
Skills
Food Safety, Food Science, Research, Food Industry, Food Processing, Regulatory Affairs, Traceability, Product Tracing, Labeling, Food Defense
Education
University of California, Davis 2009 — 2011
MS, Food Science, Consumer Studies
University of Maryland College Park 2005 — 2009
BS, Food Science
FDA September 2014 - Present
Deloitte August 2014 - September 2014
Deloitte & Touche, LLP November 2012 - August 2014
The Institute of Food Technologists (IFT) September 2011 - November 2012
Prime Label Consultants, Inc. May 2006 - August 2009
International Food Information Council Foundation June 2009 - July 2009
Food and Drug Administration May 2008 - August 2008
Skills
Food Safety, Food Science, Research, Food Industry, Food Processing, Regulatory Affairs, Traceability, Product Tracing, Labeling, Food Defense
Education
University of California, Davis 2009 — 2011
MS, Food Science, Consumer Studies
University of Maryland College Park 2005 — 2009
BS, Food Science
Richard Neill Richard Neill's Food and Drug Administration Experience 1999 - 2003
Job Vice Chair, Dept of Family Medicine and Community Health
Industry Higher Education
Experience
University of Pennsylvania Department of Family Medicine and Community Health July 1997 - Present
FDA 2011 - 2014
ACGME September 2005 - June 2012
Society of Teachers of Family Medicine 2008 - 2010
American Academy of Family Physicians 2006 - 2010
University of Pennsylvania Department of Family Medicine 2001 - 2010
Food and Drug Administration 1999 - 2003
University of Kentucky 1991 - 1997
University City Family Medicine 1987 - 1991
Education
The University of British Columbia 1998 — 1998
Family Medicine Obstetrics
University of Pennsylvania 1997 — 1998
Epidemiology, Business
Thomas Jefferson University 1986 — 1990
Family Medicine
University of Kentucky College of Medicine 1982 — 1986
MD, Medicine
University of Kentucky 1978 — 1982
BA, Chemistry
University of Pennsylvania Department of Family Medicine and Community Health July 1997 - Present
FDA 2011 - 2014
ACGME September 2005 - June 2012
Society of Teachers of Family Medicine 2008 - 2010
American Academy of Family Physicians 2006 - 2010
University of Pennsylvania Department of Family Medicine 2001 - 2010
Food and Drug Administration 1999 - 2003
University of Kentucky 1991 - 1997
University City Family Medicine 1987 - 1991
Education
The University of British Columbia 1998 — 1998
Family Medicine Obstetrics
University of Pennsylvania 1997 — 1998
Epidemiology, Business
Thomas Jefferson University 1986 — 1990
Family Medicine
University of Kentucky College of Medicine 1982 — 1986
MD, Medicine
University of Kentucky 1978 — 1982
BA, Chemistry
prajakta varadkar prajakta varadkar's Food and Drug Administration Experience January 2006 - December 2008
Job CMC Reviewer at Food & Drug Administration [FDA]
Industry Research
Experience
Food and Drug Administration (FDA) October 2009 - Present
Food and Drug Administration January 2006 - December 2008
NIH, NCI January 2004 - December 2005
Bhabha Atomic Research Center (BARC) 2000 - 2003
Skills
Molecular Biology, Cell Culture, Stem Cells, Biochemistry, Cell Biology, PCR, Protein Chemistry, Western Blotting, Cell, Flow Cytometry, Animal Models, ELISA, RT-PCR, Protein Purification, Fluorescence Microscopy, Tissue Culture, Microscopy, Confocal Microscopy, Cancer Research, Molecular Cloning, Immunohistochemistry, Transfection, In Vitro, qPCR, In Vivo, Immunofluorescence, Protein Expression, SDS-PAGE, Genetics, Immunology
Education
University of Mumbai 2000 — 2003
Ph.D., Biochemistry, Radiation Biology
University of Mumbai 1996 — 1998
Masters, Life Sciences
Food and Drug Administration (FDA) October 2009 - Present
Food and Drug Administration January 2006 - December 2008
NIH, NCI January 2004 - December 2005
Bhabha Atomic Research Center (BARC) 2000 - 2003
Skills
Molecular Biology, Cell Culture, Stem Cells, Biochemistry, Cell Biology, PCR, Protein Chemistry, Western Blotting, Cell, Flow Cytometry, Animal Models, ELISA, RT-PCR, Protein Purification, Fluorescence Microscopy, Tissue Culture, Microscopy, Confocal Microscopy, Cancer Research, Molecular Cloning, Immunohistochemistry, Transfection, In Vitro, qPCR, In Vivo, Immunofluorescence, Protein Expression, SDS-PAGE, Genetics, Immunology
Education
University of Mumbai 2000 — 2003
Ph.D., Biochemistry, Radiation Biology
University of Mumbai 1996 — 1998
Masters, Life Sciences
reyes candau reyes candau's Food and Drug Administration Experience February 2011 - Present
Job Biologist at Food and Drug Administration
Industry Biotechnology
Experience
Food and Drug Administration February 2011 - Present
Transgenomic August 2006 - February 2011
Edge BioSystems March 1997 - March 2006
University of Pennsylviania, The Wistar Institute August 1993 - December 1996
IMT Phillips Universitaet, Marburg, Germany July 1991 - July 1993
Education
Universidad de Sevilla 1986 — 1991
PhD, Biology
Food and Drug Administration February 2011 - Present
Transgenomic August 2006 - February 2011
Edge BioSystems March 1997 - March 2006
University of Pennsylviania, The Wistar Institute August 1993 - December 1996
IMT Phillips Universitaet, Marburg, Germany July 1991 - July 1993
Education
Universidad de Sevilla 1986 — 1991
PhD, Biology
Monica Fiszman Monica Fiszman's Food and Drug Administration Experience December 2005 - Present
Job Clinical Reviewer at FDA
Industry Government Administration
Experience
Food and Drug Administration December 2005 - Present
Georgetown University 2003 - 2005
Argentina 1991 - 2002
ANMAT 1992 - 1993
National Institutes of Health January 1987 - March 1990
Consejo Nacional de Investigaciones Cientificas y Tecnicas-Argentina 1982 - 1986
Skills
Pharmacology, Neuroscience, Molecular Biology, Lifesciences, Clinical Research, Animal Models, Toxicology, Regulatory Affairs, Drug Development, Science, Medicine, Clinical Development, FDA, Medical Writing, Clinical Trials, Life Sciences, Cell Biology
Education
University of Buenos Aires, School of Medicine 1982 — 1986
Doctor of Philosophy (PhD), Pharmacology
University of Buenos Aires 1974 — 1979
Doctor of Medicine (M.D.), Internal Medicine
University of Buenos Aires 1974 — 1979
Doctor of Medicine (M.D.), Internal Medicine
Food and Drug Administration December 2005 - Present
Georgetown University 2003 - 2005
Argentina 1991 - 2002
ANMAT 1992 - 1993
National Institutes of Health January 1987 - March 1990
Consejo Nacional de Investigaciones Cientificas y Tecnicas-Argentina 1982 - 1986
Skills
Pharmacology, Neuroscience, Molecular Biology, Lifesciences, Clinical Research, Animal Models, Toxicology, Regulatory Affairs, Drug Development, Science, Medicine, Clinical Development, FDA, Medical Writing, Clinical Trials, Life Sciences, Cell Biology
Education
University of Buenos Aires, School of Medicine 1982 — 1986
Doctor of Philosophy (PhD), Pharmacology
University of Buenos Aires 1974 — 1979
Doctor of Medicine (M.D.), Internal Medicine
University of Buenos Aires 1974 — 1979
Doctor of Medicine (M.D.), Internal Medicine
Isadora Stehlin Isadora Stehlin's Food and Drug Administration Experience
Job Web and Social Media manager at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration
Skills
Web Design, Government, Web Content Management, Social Media Marketing, Strategic Communications, Technical Writing, Internal Communications, Web Project Management, Web Content, Public Relations, Crisis Communications, Social Media, Content Management, Media Relations, Editing
Education
University of Maryland College Park
Bacehlor of Science, Horticultural Science
Food and Drug Administration
Skills
Web Design, Government, Web Content Management, Social Media Marketing, Strategic Communications, Technical Writing, Internal Communications, Web Project Management, Web Content, Public Relations, Crisis Communications, Social Media, Content Management, Media Relations, Editing
Education
University of Maryland College Park
Bacehlor of Science, Horticultural Science
Kathryn Phy Kathryn Phy's Food and Drug Administration Experience June 2011 - Present
Job Microbiologist at Food and Drug Administration
Industry Research
Experience
Food and Drug Administration June 2011 - Present
Carothers Parkway Veterinary Clinic May 2010 - December 2010
AMC Theatres June 2009 - May 2010
Skills
Cell Culture, Microsoft Office, Microsoft Excel, Microbiology, PCR, Gel Electrophoresis, DNA extraction, Microscopy, Laboratory, Biotechnology, Cell, Infectious Diseases, Molecular Biology
Education
The University of Georgia 2006 — 2009
BS in Agriculture, Animal Science
University of Colorado at Boulder 2005 — 2006
Food and Drug Administration June 2011 - Present
Carothers Parkway Veterinary Clinic May 2010 - December 2010
AMC Theatres June 2009 - May 2010
Skills
Cell Culture, Microsoft Office, Microsoft Excel, Microbiology, PCR, Gel Electrophoresis, DNA extraction, Microscopy, Laboratory, Biotechnology, Cell, Infectious Diseases, Molecular Biology
Education
The University of Georgia 2006 — 2009
BS in Agriculture, Animal Science
University of Colorado at Boulder 2005 — 2006
Deborah Castillo's Food and Drug Administration Experience December 2012 - Present
Job Biomedical Engineer / Lead Scientific Reviewer at FDA
Industry Medical Devices
Experience
Food and Drug Administration December 2012 - Present
Johns Hopkins University September 2005 - December 2012
Tam-Lee-Castillo (TLC) Business Advisors January 2011 - November 2012
NeuroEngineering Training Initiative (NETI) August 2005 - August 2007
Johns Hopkins University September 2006 - May 2007
University of Miami September 2003 - May 2004
UC San Diego June 2003 - August 2003
University of Miami June 2002 - August 2002
Skills
Biomedical Engineering, Neuroscience, Confocal Microscopy, Life Sciences, Cell Culture, Medical Devices, Immunohistochemistry, Fluorescence Microscopy, Market Research, Histology, Spinal Cord Injury, Regulatory Submissions, FDA, Clinical Trials, Statistics, Cancer, Cell, Fluent Spanish, Tissue Engineering, Lifesciences, R&D, CAD, AutoCAD, Probability, Strategic Consulting, Healthcare Consulting, Regulatory Affairs, Stem Cells, Matlab
Education
The Johns Hopkins University School of Medicine 2004 — 2012
Doctor of Philosophy (PhD), Biomedical Engineering
University of Miami 2000 — 2004
B.S., Biomedical Engineering/ Electrical Engineering
Food and Drug Administration December 2012 - Present
Johns Hopkins University September 2005 - December 2012
Tam-Lee-Castillo (TLC) Business Advisors January 2011 - November 2012
NeuroEngineering Training Initiative (NETI) August 2005 - August 2007
Johns Hopkins University September 2006 - May 2007
University of Miami September 2003 - May 2004
UC San Diego June 2003 - August 2003
University of Miami June 2002 - August 2002
Skills
Biomedical Engineering, Neuroscience, Confocal Microscopy, Life Sciences, Cell Culture, Medical Devices, Immunohistochemistry, Fluorescence Microscopy, Market Research, Histology, Spinal Cord Injury, Regulatory Submissions, FDA, Clinical Trials, Statistics, Cancer, Cell, Fluent Spanish, Tissue Engineering, Lifesciences, R&D, CAD, AutoCAD, Probability, Strategic Consulting, Healthcare Consulting, Regulatory Affairs, Stem Cells, Matlab
Education
The Johns Hopkins University School of Medicine 2004 — 2012
Doctor of Philosophy (PhD), Biomedical Engineering
University of Miami 2000 — 2004
B.S., Biomedical Engineering/ Electrical Engineering
Hilary Wanke's Food and Drug Administration Experience January 2013 - Present
Job eDiscovery Manager at the U.S. Food and Drug Administration
Industry Legal Services
Experience
Food and Drug Administration January 2013 - Present
eGlobalTech August 2012 - January 2013
Special Counsel March 2011 - August 2012
Management Resources Group, LLC 2009 - August 2010
Kansas Organization of State Employees May 2007 - September 2007
T.A.C. Americas January 2003 - December 2004
Skills
Legal Research, Legal Writing, Litigation, Westlaw, Civil Litigation, Mediation, Litigation Support, Legal Assistance, Policy, Corporate Law, Policy Analysis, Intellectual Property, Trials, Courts, Criminal Law
Education
Washburn University School of Law 2005 — 2007
J.D., Law
The University of Kansas 1998 — 2003
B.S., Business, Finance
Food and Drug Administration January 2013 - Present
eGlobalTech August 2012 - January 2013
Special Counsel March 2011 - August 2012
Management Resources Group, LLC 2009 - August 2010
Kansas Organization of State Employees May 2007 - September 2007
T.A.C. Americas January 2003 - December 2004
Skills
Legal Research, Legal Writing, Litigation, Westlaw, Civil Litigation, Mediation, Litigation Support, Legal Assistance, Policy, Corporate Law, Policy Analysis, Intellectual Property, Trials, Courts, Criminal Law
Education
Washburn University School of Law 2005 — 2007
J.D., Law
The University of Kansas 1998 — 2003
B.S., Business, Finance
Vikram Arya's Food and Drug Administration Experience March 2013 - Present
Job Senior Staff Fellow at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration March 2013 - Present
Food and Drug Administration October 2003 - March 2013
Aventis Pharmaceuticals May 2001 - August 2001
Skills
Drug Metabolism, Pharmacokinetics, Pharmacodynamics, Clinical Development, Drug-Drug interactions, Clinical pharmacology..., Drug Development, Clinical Pharmacology, Regulatory Affairs, Bioanalysis, DMPK, Drug Discovery, Clinical Trials, Clinical pharmacology...
Education
University of Florida 1998 — 2003
Doctor of Philosophy (Ph.D.), Pharmaceutics
Birla Institute of Technology, Ranchi, India 1993 — 1997
Bachelor of Pharmacy (B.Pharm.)
Food and Drug Administration March 2013 - Present
Food and Drug Administration October 2003 - March 2013
Aventis Pharmaceuticals May 2001 - August 2001
Skills
Drug Metabolism, Pharmacokinetics, Pharmacodynamics, Clinical Development, Drug-Drug interactions, Clinical pharmacology..., Drug Development, Clinical Pharmacology, Regulatory Affairs, Bioanalysis, DMPK, Drug Discovery, Clinical Trials, Clinical pharmacology...
Education
University of Florida 1998 — 2003
Doctor of Philosophy (Ph.D.), Pharmaceutics
Birla Institute of Technology, Ranchi, India 1993 — 1997
Bachelor of Pharmacy (B.Pharm.)
Robert Merker Robert Merker's Food and Drug Administration Experience July 1991 - Present
Job Supervisory Consumer Safety Officer at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration July 1991 - Present
Food and Drug Administration July 2007 - July 2010
Skills
FDA, Microbiology, Food Safety, Science, Food Microbiology, Lifesciences, Biotechnology, Public Health, Regulatory Affairs, PCR, Molecular Biology, Cell Culture, Biochemistry, Life Sciences, Policy, Research
Education
University of California, Davis 1980 — 1987
Ph.D., Microbiology
University of Illinois at Urbana-Champaign 1969 — 1973
B.S., Microbiology
Food and Drug Administration July 1991 - Present
Food and Drug Administration July 2007 - July 2010
Skills
FDA, Microbiology, Food Safety, Science, Food Microbiology, Lifesciences, Biotechnology, Public Health, Regulatory Affairs, PCR, Molecular Biology, Cell Culture, Biochemistry, Life Sciences, Policy, Research
Education
University of California, Davis 1980 — 1987
Ph.D., Microbiology
University of Illinois at Urbana-Champaign 1969 — 1973
B.S., Microbiology
Viky Gilles Daniel Verna's Food and Drug Administration Experience February 2010 - November 2011
Job Compliance Officer at CDRH Center for Devices and Radialogical Health FDA
Industry Biotechnology
Experience
FDA November 2011 - Present
Food and Drug Administration February 2010 - November 2011
JAS Diagnostics November 2009 - February 2010
Diabetes Research Institute August 2008 - July 2009
Information Technology University of Miami May 2007 - June 2009
Skills
Medical Devices, FDA, Biotechnology, Biomedical Engineering, Cell Culture, GMP
Education
University of Florida 2010 — 2012
Master's, Pharmacology, Drug Regulatory Affair
University of Miami 2005 — 2009
Dual Program Bachelor/Master of Science, Biomedical Engineering
University of Miami 2004 — 2009
Bachelor, Biomedical Engineering
St Louis
FDA November 2011 - Present
Food and Drug Administration February 2010 - November 2011
JAS Diagnostics November 2009 - February 2010
Diabetes Research Institute August 2008 - July 2009
Information Technology University of Miami May 2007 - June 2009
Skills
Medical Devices, FDA, Biotechnology, Biomedical Engineering, Cell Culture, GMP
Education
University of Florida 2010 — 2012
Master's, Pharmacology, Drug Regulatory Affair
University of Miami 2005 — 2009
Dual Program Bachelor/Master of Science, Biomedical Engineering
University of Miami 2004 — 2009
Bachelor, Biomedical Engineering
St Louis
Elise Eney Elise Eney's Food and Drug Administration Experience December 2009 - January 2013
Job Special Assistant at Centers for Medicare and Medicaid
Industry Government Administration
Experience
Centers for Medicare and Medicaid October 2012 - Present
Food and Drug Administration December 2009 - January 2013
Democratic National Committee August 2009 - December 2009
Education
University of Maryland Baltimore County 2007 — 2011
BA, Political Science
Centers for Medicare and Medicaid October 2012 - Present
Food and Drug Administration December 2009 - January 2013
Democratic National Committee August 2009 - December 2009
Education
University of Maryland Baltimore County 2007 — 2011
BA, Political Science
James P Swink James P Swink's Food and Drug Administration Experience July 2003 - September 2006
Job Director, Advisory Panel Program, CDRH, FDA
Industry Medical Devices
Experience
FDA September 2011 - Present
FDA July 2006 - August 2011
Food and Drug Administration July 2003 - September 2006
Skills
Medical Devices, Government, Policy, FDA, Administration, Health, Clinical Trials, Clinical Research, Sop, Training, Healthcare, Regulatory Submissions, Management, Budgets, Product Development, Regulatory Affairs, Lifesciences, SOP, Life Sciences, Program Management
Education
University of Maryland College Park 2000 — 2004
Neurobiology and Physiology
The University of Dallas 1997 — 1999
Biology, Philosophy, English, Economics, Art History
The Heights School
The Heights School
FDA September 2011 - Present
FDA July 2006 - August 2011
Food and Drug Administration July 2003 - September 2006
Skills
Medical Devices, Government, Policy, FDA, Administration, Health, Clinical Trials, Clinical Research, Sop, Training, Healthcare, Regulatory Submissions, Management, Budgets, Product Development, Regulatory Affairs, Lifesciences, SOP, Life Sciences, Program Management
Education
University of Maryland College Park 2000 — 2004
Neurobiology and Physiology
The University of Dallas 1997 — 1999
Biology, Philosophy, English, Economics, Art History
The Heights School
The Heights School
Jennifer Tenuto Jennifer Tenuto's Food and Drug Administration Experience 1991 - 1992
Job Manager Quality Systems at Hollister Incorporated
Industry Medical Devices
Experience
Hollister Incorporated June 2013 - Present
Hollister Incorporated February 2002 - June 2013
Sterigenics 1997 - 2002
SoloPak Pharmaceuticals 1996 - 1997
Wesley-Jensen Corporation 1994 - 1996
Pennex Pharamceuticals 1992 - 1994
Food and Drug Administration 1991 - 1992
Skills
Six Sigma, V&V, ISO 13485, FDA, Quality Assurance, Medical Devices, Testing, Validation, Quality System, ISO, Biotechnology, Calibration, R&D, Design Control, Sterilization, Product Development, CAPA, GMP, Management, 21 CFR Part 11, Change Control, Sop, Quality Auditing, Computer System..., SOP
Education
University of Illinois at Urbana-Champaign 1986 — 1991
Bachelor of Science, Agricultural Sciences
University of Illinois at Urbana-Champaign
Masters of Science, Food science and Human Nutrition
University of Illinois at Urbana-Champaign
Bachelor of Science, Engineering
Hollister Incorporated June 2013 - Present
Hollister Incorporated February 2002 - June 2013
Sterigenics 1997 - 2002
SoloPak Pharmaceuticals 1996 - 1997
Wesley-Jensen Corporation 1994 - 1996
Pennex Pharamceuticals 1992 - 1994
Food and Drug Administration 1991 - 1992
Skills
Six Sigma, V&V, ISO 13485, FDA, Quality Assurance, Medical Devices, Testing, Validation, Quality System, ISO, Biotechnology, Calibration, R&D, Design Control, Sterilization, Product Development, CAPA, GMP, Management, 21 CFR Part 11, Change Control, Sop, Quality Auditing, Computer System..., SOP
Education
University of Illinois at Urbana-Champaign 1986 — 1991
Bachelor of Science, Agricultural Sciences
University of Illinois at Urbana-Champaign
Masters of Science, Food science and Human Nutrition
University of Illinois at Urbana-Champaign
Bachelor of Science, Engineering
Manel Djeffal Manel Djeffal's Food and Drug Administration Experience January 2013 - August 2013
Job Research Intern at JHU School of Medicine
Industry Biotechnology
Experience
Johns Hopkins School of Medicine June 2014 - August 2014
Food and Drug Administration January 2013 - August 2013
P&E Microcomputer Systems June 2010 - July 2010
Skills
Matlab, Java, C, AFM, SEM, Digital Microscopy, Profilometry, Pro/ENGINEER, Brightfield Microscopy, Infrared Spectroscopy, SDS-PAGE, Western Blotting, Spectrophotometry, Column Chromatography
Education
University of Maryland - A. James Clark School of Engineering 2011 — 2016
Bioengineering/Computer Science
Johns Hopkins School of Medicine June 2014 - August 2014
Food and Drug Administration January 2013 - August 2013
P&E Microcomputer Systems June 2010 - July 2010
Skills
Matlab, Java, C, AFM, SEM, Digital Microscopy, Profilometry, Pro/ENGINEER, Brightfield Microscopy, Infrared Spectroscopy, SDS-PAGE, Western Blotting, Spectrophotometry, Column Chromatography
Education
University of Maryland - A. James Clark School of Engineering 2011 — 2016
Bioengineering/Computer Science
Solis Daniel Solis Daniel's Food and Drug Administration Experience November 2009 - Present
Job Director of Import Operations Los Angeles at US FDA
Industry Government Administration
Experience
Food and Drug Administration November 2009 - Present
Skills
FDA, Import, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Lifesciences, Sop, Clinical Development, GMP, Clinical Trials, GLP, Biotechnology, Leadership, Quality Assurance, Food outbreak..., Complaint Investigations, Special Investigations, Government, Policy, Program Management, Life Sciences, SOP, Public Health, Research
Education
University of La Verne 1994 — 1998
MHA, Health/Health Care Administration/Management
University of California, Irvine 1986 — 1990
Bachelor's degree, Microbiology, General
Food and Drug Administration November 2009 - Present
Skills
FDA, Import, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Lifesciences, Sop, Clinical Development, GMP, Clinical Trials, GLP, Biotechnology, Leadership, Quality Assurance, Food outbreak..., Complaint Investigations, Special Investigations, Government, Policy, Program Management, Life Sciences, SOP, Public Health, Research
Education
University of La Verne 1994 — 1998
MHA, Health/Health Care Administration/Management
University of California, Irvine 1986 — 1990
Bachelor's degree, Microbiology, General
Crystal Ford Crystal Ford's Food and Drug Administration Experience March 2015 - Present
Job Laboratory Support Technician FDA
Industry Research
Experience
Food and Drug Administration March 2015 - Present
Leidos July 2009 - March 2015
Skills
Government Contracting, Government, Program Management, Technical Writing, DoD, Analysis, Earned Value Management, National Security
Education
University of Arkansas at Little Rock
Graduate Certificate, Information Science/Studies
University of Arkansas at Pine Bluff
Bachelor of Science (BS), Business/Commerce, General
Food and Drug Administration March 2015 - Present
Leidos July 2009 - March 2015
Skills
Government Contracting, Government, Program Management, Technical Writing, DoD, Analysis, Earned Value Management, National Security
Education
University of Arkansas at Little Rock
Graduate Certificate, Information Science/Studies
University of Arkansas at Pine Bluff
Bachelor of Science (BS), Business/Commerce, General
Athena Starlard-Davenport Athena Starlard-Davenport's Food and Drug Administration Experience October 2010 - 2011
Job Molecular Biologist
Industry Research
Experience
University of Arkansas for Medical Sciences November 2011 - Present
Food and Drug Administration October 2010 - 2011
FDA October 2008 - September 2010
ORISE/FDA/National Center for Toxicological Research June 2007 - September 2008
UAMS August 2002 - May 2007
ULM January 2001 - July 2002
Skills
Western Blotting, qPCR, Assay Development, Clinical Research, Protein Chemistry, FDA, Tissue Culture, Cancer, DNA sequencing, Cell Culture, Biochemistry, PCR, Science, Molecular Biology, Immunology, DNA Sequencing
Education
University of Arkansas for Medical Sciences, College of Medicine 2002 — 2007
PhD, Biochemistry and Molecular Biology
University of Louisiana at Monroe 2001 — 2002
MS, Biology (emphasis in Microbiology)
University of Louisiana at Monroe 1996 — 2000
BS, Biology
University of Arkansas for Medical Sciences November 2011 - Present
Food and Drug Administration October 2010 - 2011
FDA October 2008 - September 2010
ORISE/FDA/National Center for Toxicological Research June 2007 - September 2008
UAMS August 2002 - May 2007
ULM January 2001 - July 2002
Skills
Western Blotting, qPCR, Assay Development, Clinical Research, Protein Chemistry, FDA, Tissue Culture, Cancer, DNA sequencing, Cell Culture, Biochemistry, PCR, Science, Molecular Biology, Immunology, DNA Sequencing
Education
University of Arkansas for Medical Sciences, College of Medicine 2002 — 2007
PhD, Biochemistry and Molecular Biology
University of Louisiana at Monroe 2001 — 2002
MS, Biology (emphasis in Microbiology)
University of Louisiana at Monroe 1996 — 2000
BS, Biology
Lydia Rump Lydia Rump's Food and Drug Administration Experience November 2007 - May 2011
Job Director Quality Assurance, Lidl US, LLC.
Industry Retail
Experience
Lidl US July 2015 - Present
MGP Retail Consulting LLC., (Lidl US, LLC.) January 2015 - July 2015
University of Maryland May 2011 - December 2014
Food and Drug Administration November 2007 - May 2011
KROHN Rechtsanwälte April 2007 - May 2007
Institut fuer Umwelt und Hygiene November 2006 - April 2007
Food and Drug Administration April 2006 - November 2006
Skills
Analytical Chemistry, Microbiology, Molecular Biology, Food Chemistry, Lifesciences, Food Microbiology, Food Science, Science, Chemistry, Food & Drug Law, Life Sciences, Genetics
Education
University of Hamburg 2007 — 2011
Ph.D., Food Chemistry, Microbiology (magna cum laude)
University of Hamburg 2006 — 2007
2. Staatsexamen, Food Chemistry, Food Law
University of Hamburg 2004 — 2006
1. Staatsexamen and Diploma, Food Chemistry, Food Microbiology, Analytical Chemistry
University of Hamburg 2001 — 2004
Bachelor, Chemistry
University of Maryland College Park
University of Maryland College Park
University of Maryland College Park
Lidl US July 2015 - Present
MGP Retail Consulting LLC., (Lidl US, LLC.) January 2015 - July 2015
University of Maryland May 2011 - December 2014
Food and Drug Administration November 2007 - May 2011
KROHN Rechtsanwälte April 2007 - May 2007
Institut fuer Umwelt und Hygiene November 2006 - April 2007
Food and Drug Administration April 2006 - November 2006
Skills
Analytical Chemistry, Microbiology, Molecular Biology, Food Chemistry, Lifesciences, Food Microbiology, Food Science, Science, Chemistry, Food & Drug Law, Life Sciences, Genetics
Education
University of Hamburg 2007 — 2011
Ph.D., Food Chemistry, Microbiology (magna cum laude)
University of Hamburg 2006 — 2007
2. Staatsexamen, Food Chemistry, Food Law
University of Hamburg 2004 — 2006
1. Staatsexamen and Diploma, Food Chemistry, Food Microbiology, Analytical Chemistry
University of Hamburg 2001 — 2004
Bachelor, Chemistry
University of Maryland College Park
University of Maryland College Park
University of Maryland College Park
Angela Hoague's Food and Drug Administration Experience March 2012 - March 2015
Job Legal Assistant at Private Biotechnology Company
Industry Biotechnology
Experience
Private Biotechnology Company August 2015 - Present
Venn Strategies, LLC March 2015 - August 2015
Food and Drug Administration March 2012 - March 2015
FDA June 2008 - March 2012
Lockheed Martin 2007 - 2008
Skills
Government, Data Analysis, Analysis, Program Management, Research, Microsoft Office, Microsoft Excel, Process Improvement, PowerPoint, Leadership
Education
University of Maryland College Park
Private Biotechnology Company August 2015 - Present
Venn Strategies, LLC March 2015 - August 2015
Food and Drug Administration March 2012 - March 2015
FDA June 2008 - March 2012
Lockheed Martin 2007 - 2008
Skills
Government, Data Analysis, Analysis, Program Management, Research, Microsoft Office, Microsoft Excel, Process Improvement, PowerPoint, Leadership
Education
University of Maryland College Park
Alice Tu Alice Tu's Food and Drug Administration Experience June 2010 - December 2013
Job Team Leader
Industry Government Administration
Experience
FDA December 2013 - Present
Food and Drug Administration June 2010 - December 2013
FDA July 2009 - June 2010
Medco July 2008 - June 2009
Skills
FDA, Pharmacy, Pharmacists, Pharmacovigilance, Public Health, Regulatory Affairs, Pharmacoepidemiology, Informatics
Education
UNC Eshelman School of Pharmacy 2004 — 2008
PharmD, Pharmacy
University of North Carolina at Chapel Hill 2002 — 2004
BS in Pharmaceutical Science, Pharmaceutical Science
FDA December 2013 - Present
Food and Drug Administration June 2010 - December 2013
FDA July 2009 - June 2010
Medco July 2008 - June 2009
Skills
FDA, Pharmacy, Pharmacists, Pharmacovigilance, Public Health, Regulatory Affairs, Pharmacoepidemiology, Informatics
Education
UNC Eshelman School of Pharmacy 2004 — 2008
PharmD, Pharmacy
University of North Carolina at Chapel Hill 2002 — 2004
BS in Pharmaceutical Science, Pharmaceutical Science
Kristen Bibeau, PhD, MSPH Kristen Bibeau, PhD, MSPH's Food and Drug Administration Experience May 2009 - September 2010
Job Director, Epidemiology and Outcomes Research at Quintiles
Industry Pharmaceuticals
Experience
Quintiles May 2015 - Present
GSK November 2014 - May 2015
GlaxoSmithKline September 2010 - November 2014
Food and Drug Administration May 2009 - September 2010
GlaxoSmithKline December 2004 - May 2009
University of North Carolina August 2004 - May 2009
University of New Hampshire January 2002 - May 2004
Skills
Pharmacoepidemiology, Real World Evidence..., Epidemiology, SAEfetyWorks, Risk Management, Comparative..., Public Health, SAS, Statistics, SPSS, Biotechnology, Data Analysis
Education
University of North Carolina at Chapel Hill 2006 — 2009
PhD, Epidemiology
University of North Carolina at Chapel Hill 2004 — 2006
MSPH, Epidemiology
University of New Hampshire 2000 — 2004
BS, Health Management and Policy
Quintiles May 2015 - Present
GSK November 2014 - May 2015
GlaxoSmithKline September 2010 - November 2014
Food and Drug Administration May 2009 - September 2010
GlaxoSmithKline December 2004 - May 2009
University of North Carolina August 2004 - May 2009
University of New Hampshire January 2002 - May 2004
Skills
Pharmacoepidemiology, Real World Evidence..., Epidemiology, SAEfetyWorks, Risk Management, Comparative..., Public Health, SAS, Statistics, SPSS, Biotechnology, Data Analysis
Education
University of North Carolina at Chapel Hill 2006 — 2009
PhD, Epidemiology
University of North Carolina at Chapel Hill 2004 — 2006
MSPH, Epidemiology
University of New Hampshire 2000 — 2004
BS, Health Management and Policy
Farzana Ansari's Food and Drug Administration Experience May 2011 - August 2011
Job Materials Engineering Associate, Exponent
Industry Mechanical or Industrial Engineering
Experience
Exponent Failure Analysis Associates September 2015 - Present
UC Berkeley January 2011 - May 2015
UC Berkeley August 2010 - December 2013
Food and Drug Administration May 2011 - August 2011
Baxter Healthcare June 2009 - July 2010
Skills
Biomedical Engineering, Materials Science, Mechanical Engineering, Data Analysis, Experimentation, Fatigue Testing, Characterization, Bioengineering, Biotechnology, Orthopaedic Implants, Metal Damage Analysis, Medical Devices, Matlab, LabVIEW, Microsoft Office
Education
University of California, Berkeley 2012 — 2015
PhD, Mechanical Engineering
University of California, Berkeley 2010 — 2012
MS, Mechanical Engineering
University of Southern California 2005 — 2009
BS, Biomedical Engineering
Exponent Failure Analysis Associates September 2015 - Present
UC Berkeley January 2011 - May 2015
UC Berkeley August 2010 - December 2013
Food and Drug Administration May 2011 - August 2011
Baxter Healthcare June 2009 - July 2010
Skills
Biomedical Engineering, Materials Science, Mechanical Engineering, Data Analysis, Experimentation, Fatigue Testing, Characterization, Bioengineering, Biotechnology, Orthopaedic Implants, Metal Damage Analysis, Medical Devices, Matlab, LabVIEW, Microsoft Office
Education
University of California, Berkeley 2012 — 2015
PhD, Mechanical Engineering
University of California, Berkeley 2010 — 2012
MS, Mechanical Engineering
University of Southern California 2005 — 2009
BS, Biomedical Engineering
Jeffrey M. Gilbert, PhD's Food and Drug Administration Experience May 2002 - Present
Job Supervisory Microbiologist & Team Leader, FDA/CVM
Industry Government Administration
Experience
Food and Drug Administration May 2002 - Present
Food and Drug Administration May 2001 - May 2002
Food and Drug Administration January 1994 - May 2001
The University of Georgia June 1987 - December 1993
Skills
Microbiology, Parasitology, Marketing, Management, Recruiting, Food Safety, Regulatory Affairs, FDA, Cell Culture, Food Microbiology, Lifesciences, Science, PCR, Molecular Biology, Research, Public Health, Data Analysis, GLP, Biotechnology, Infectious Diseases, Epidemiology, Pharmaceutical Industry, Policy
Education
The University of Georgia 1990 — 1993
Ph.D., Poultry Science (Parasitology)
The University of Georgia 1987 — 1989
M.S., Poultry Science (Parasitology)
The University of Georgia 1986 — 1987
B.S.A., Poultry Science
University of North Georgia 1984 — 1986
A.S., Agriculture
Food and Drug Administration May 2002 - Present
Food and Drug Administration May 2001 - May 2002
Food and Drug Administration January 1994 - May 2001
The University of Georgia June 1987 - December 1993
Skills
Microbiology, Parasitology, Marketing, Management, Recruiting, Food Safety, Regulatory Affairs, FDA, Cell Culture, Food Microbiology, Lifesciences, Science, PCR, Molecular Biology, Research, Public Health, Data Analysis, GLP, Biotechnology, Infectious Diseases, Epidemiology, Pharmaceutical Industry, Policy
Education
The University of Georgia 1990 — 1993
Ph.D., Poultry Science (Parasitology)
The University of Georgia 1987 — 1989
M.S., Poultry Science (Parasitology)
The University of Georgia 1986 — 1987
B.S.A., Poultry Science
University of North Georgia 1984 — 1986
A.S., Agriculture
Reyda Gonzalez Nieves Reyda Gonzalez Nieves's Food and Drug Administration Experience January 2003 - December 2003
Job Biologist at the National Science Foundation
Industry Program Development
Experience
National Science Foundation April 2014 - Present
Uniformed Services University of the Health Sciences August 2012 - April 2013
Uniformed Services University of the Health Sciences August 2005 - August 2012
MedImmune March 2004 - August 2005
Baxter Bioscience December 2003 - February 2004
Food and Drug Administration January 2003 - December 2003
Skills
Microsoft Excel, Microsoft Word, PowerPoint, Research, Windows, Public Speaking, Strategic Planning, Editing, Tissue Culture, Microbiology, Immunofluorescence, Confocal Microscopy, Western Blotting, DNA extraction, DNA quantification, RNA isolation, Miniprep, siRNA, Transfection, Aseptic Technique, Cell Migration, Cell Adhesion, Cell Signaling, Data Analysis, Analytical Reasoning, DNA electrophoresis, Bacterial Culture, Molecular & Cellular..., Multi Tasking, Bilingual-English/Spanis..., Deadline Oriented, Grant Writing, RT-PCR, Protein Purification, ELISA, Restriction Digestion, Analysis, Cancer, Public Health, Quantitative Research, Qualitative Research, Quantative Analysis, Breast Cancer, Cell, Cell Culture, Cell Biology, Laboratory
Education
Uniformed Services University of the Health Sciences 2005 — 2012
Doctor of Philosophy (Ph.D.), Molecular and Cell Biology
University of Puerto Rico-Bayamon 1998 — 2002
Bachelor's degree, Biology, General
National Science Foundation April 2014 - Present
Uniformed Services University of the Health Sciences August 2012 - April 2013
Uniformed Services University of the Health Sciences August 2005 - August 2012
MedImmune March 2004 - August 2005
Baxter Bioscience December 2003 - February 2004
Food and Drug Administration January 2003 - December 2003
Skills
Microsoft Excel, Microsoft Word, PowerPoint, Research, Windows, Public Speaking, Strategic Planning, Editing, Tissue Culture, Microbiology, Immunofluorescence, Confocal Microscopy, Western Blotting, DNA extraction, DNA quantification, RNA isolation, Miniprep, siRNA, Transfection, Aseptic Technique, Cell Migration, Cell Adhesion, Cell Signaling, Data Analysis, Analytical Reasoning, DNA electrophoresis, Bacterial Culture, Molecular & Cellular..., Multi Tasking, Bilingual-English/Spanis..., Deadline Oriented, Grant Writing, RT-PCR, Protein Purification, ELISA, Restriction Digestion, Analysis, Cancer, Public Health, Quantitative Research, Qualitative Research, Quantative Analysis, Breast Cancer, Cell, Cell Culture, Cell Biology, Laboratory
Education
Uniformed Services University of the Health Sciences 2005 — 2012
Doctor of Philosophy (Ph.D.), Molecular and Cell Biology
University of Puerto Rico-Bayamon 1998 — 2002
Bachelor's degree, Biology, General
Timothy Fouts's Food and Drug Administration Experience June 1987 - July 1989
Job Senior Director, Virology at Profectus BioSciences
Industry Biotechnology
Experience
RelMD September 2012 - Present
Profectus BioSciences, Inc January 2008 - Present
Profectus BioSciences, Inc March 2005 - January 2008
Institute of Human Virology, University of Maryland School of Medicine September 2002 - March 2005
Institute of Human Virology, University of Maryland School of Medicine September 1997 - September 2002
Aaron Diamond AIDS Research Center October 1994 - September 1997
Food and Drug Administration June 1987 - July 1989
Skills
Vaccinology, Virology, Immunology, Molecular Biology, Infectious Diseases, Emerging Infectious..., Microbicides, Biodefense
Education
University of Maryland Baltimore 1989 — 1994
Ph.D., Immunology, Microbiology, Vaccinology
Virginia Polytechnic Institute and State University 1982 — 1987
BS, Biochemistry
Henrico High School 1978 — 1982
High School
RelMD September 2012 - Present
Profectus BioSciences, Inc January 2008 - Present
Profectus BioSciences, Inc March 2005 - January 2008
Institute of Human Virology, University of Maryland School of Medicine September 2002 - March 2005
Institute of Human Virology, University of Maryland School of Medicine September 1997 - September 2002
Aaron Diamond AIDS Research Center October 1994 - September 1997
Food and Drug Administration June 1987 - July 1989
Skills
Vaccinology, Virology, Immunology, Molecular Biology, Infectious Diseases, Emerging Infectious..., Microbicides, Biodefense
Education
University of Maryland Baltimore 1989 — 1994
Ph.D., Immunology, Microbiology, Vaccinology
Virginia Polytechnic Institute and State University 1982 — 1987
BS, Biochemistry
Henrico High School 1978 — 1982
High School
Andrew Rybczynski Andrew Rybczynski's Food and Drug Administration Experience June 2011 - August 2012
Job Real Estate Analyst at CoStar Group
Industry Commercial Real Estate
Experience
CoStar Group Portfolio Strategy June 2014 - Present
CoStar Group February 2013 - May 2014
Revolution Prep January 2013 - July 2013
Quadel Consulting Corporation October 2012 - January 2013
Food and Drug Administration June 2011 - August 2012
University of Maryland October 2011 - May 2012
Baltimore County Sailing Center May 2008 - August 2010
Skills
ArcGIS, GIS, Data Analysis, Commercial Real Estate, Research, CoStar, Python, Microsoft Excel, Microsoft Word, Commercial Real Estate..., Statistics, Analysis, Report Writing, PowerPoint, Outlook, Cartography, Databases, Access, Microsoft Office, SQL
Education
University of Maryland College Park 2008 — 2012
B.S., Geographical Sciences
CoStar Group Portfolio Strategy June 2014 - Present
CoStar Group February 2013 - May 2014
Revolution Prep January 2013 - July 2013
Quadel Consulting Corporation October 2012 - January 2013
Food and Drug Administration June 2011 - August 2012
University of Maryland October 2011 - May 2012
Baltimore County Sailing Center May 2008 - August 2010
Skills
ArcGIS, GIS, Data Analysis, Commercial Real Estate, Research, CoStar, Python, Microsoft Excel, Microsoft Word, Commercial Real Estate..., Statistics, Analysis, Report Writing, PowerPoint, Outlook, Cartography, Databases, Access, Microsoft Office, SQL
Education
University of Maryland College Park 2008 — 2012
B.S., Geographical Sciences
Kari Schraf, PMP Kari Schraf, PMP's Food and Drug Administration Experience November 2009 - Present
Job Operations Research Analyst at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration November 2009 - Present
PricewaterhouseCoopers July 2007 - November 2009
Skills
Government Contracting, Program Management, Analysis, Project Planning, Business Process..., Process Improvement, Management Consulting, Government, Risk Management, Project Management, Leadership
Education
University of Maryland College Park
Bachelor of Science, Finance
Food and Drug Administration November 2009 - Present
PricewaterhouseCoopers July 2007 - November 2009
Skills
Government Contracting, Program Management, Analysis, Project Planning, Business Process..., Process Improvement, Management Consulting, Government, Risk Management, Project Management, Leadership
Education
University of Maryland College Park
Bachelor of Science, Finance
Paula Searle Paula Searle's Food and Drug Administration Experience April 1984 - January 2010
Job REALTOR, Berkshire Hathaway, Gallo Realty, Bethany Beach, DE
Industry Real Estate
Experience
Berkshire Hathaway Gallo - Bethany Beach, Delaware February 2012 - Present
Food and Drug Administration April 1984 - January 2010
FDA 2002 - 2009
Skills
Listings, Government, Buyer Representation, First Time Home Buyers, Relocation, New Home Sales, Sellers, Condos, Short Sales, Single Family Homes, Social Media Marketing, Strategic Planning, Management, Marketing Strategy, Program Management, Consulting, Investment Properties, Management Consulting, Strategic Communications, Strategy, Real Estate, Residential Homes, Contract Negotiation, Referrals
Education
George Mason University - School of Management
Management Information Systems, General
University of Maryland College Park
B.S. Business, Marketing
Berkshire Hathaway Gallo - Bethany Beach, Delaware February 2012 - Present
Food and Drug Administration April 1984 - January 2010
FDA 2002 - 2009
Skills
Listings, Government, Buyer Representation, First Time Home Buyers, Relocation, New Home Sales, Sellers, Condos, Short Sales, Single Family Homes, Social Media Marketing, Strategic Planning, Management, Marketing Strategy, Program Management, Consulting, Investment Properties, Management Consulting, Strategic Communications, Strategy, Real Estate, Residential Homes, Contract Negotiation, Referrals
Education
George Mason University - School of Management
Management Information Systems, General
University of Maryland College Park
B.S. Business, Marketing
Luke Ralston's Food and Drug Administration Experience July 2006 - Present
Job Biomedical Engineer, US Food and Drug Administration
Industry Government Administration
Experience
United States Army National Guard April 2014 - Present
Food and Drug Administration July 2006 - Present
DC Army National Guard September 2005 - April 2014
273rd Military Police Company, DCARNG January 2008 - February 2011
Skills
Medical Devices, Research, Biomedical Engineering, Microsoft Office, Program Management, Leadership, Data Analysis, Government, FDA, Project Management, Management, Security Clearance, Clinical Research, Military
Education
Tulane University 2001 — 2005
BSE, Biomedical Engineering
United States Army National Guard April 2014 - Present
Food and Drug Administration July 2006 - Present
DC Army National Guard September 2005 - April 2014
273rd Military Police Company, DCARNG January 2008 - February 2011
Skills
Medical Devices, Research, Biomedical Engineering, Microsoft Office, Program Management, Leadership, Data Analysis, Government, FDA, Project Management, Management, Security Clearance, Clinical Research, Military
Education
Tulane University 2001 — 2005
BSE, Biomedical Engineering
Jordyn Stubblefield Jordyn Stubblefield's Food and Drug Administration Experience June 2008 - September 2010
Job Premium Operations Analyst at BAE Systems
Industry Financial Services
Experience
BAE Systems March 2011 - January 2015
Food and Drug Administration June 2008 - September 2010
Skills
Microsoft Excel, Government, Data Analysis, Financial Analysis, Microsoft Office, Databases, PowerPoint, Public Speaking, Adobe Creative Suite, Research, Office Administration, Program Management, Leadership, Microsoft Word, Customer Service, Process Improvement, Analysis, Executive..., Budget Reconciliation
Education
University of Maryland Baltimore County 2005 — 2010
Bachelors of Science, Financial Economics
BAE Systems March 2011 - January 2015
Food and Drug Administration June 2008 - September 2010
Skills
Microsoft Excel, Government, Data Analysis, Financial Analysis, Microsoft Office, Databases, PowerPoint, Public Speaking, Adobe Creative Suite, Research, Office Administration, Program Management, Leadership, Microsoft Word, Customer Service, Process Improvement, Analysis, Executive..., Budget Reconciliation
Education
University of Maryland Baltimore County 2005 — 2010
Bachelors of Science, Financial Economics
Aaron Sachs Aaron Sachs's Food and Drug Administration Experience May 2009 - August 2009
Job General Surgery Resident at WellSpan Health
Industry Medical Practice
Experience
WellSpan York Hospital July 2014 - Present
Detroit Medical Center July 2013 - June 2014
University of Maryland Medical Center May 2010 - August 2010
Food and Drug Administration May 2009 - August 2009
National Institutes of Health May 2008 - August 2008
Skills
Surgery, Medicine, Research, Clinical Research, Healthcare, Medical Education, Data Analysis, Medical Research, Hospitals, Microsoft Office
Education
University of Maryland Baltimore 2009 — 2013
Doctor of Medicine (M.D.), Medicine
University of Michigan 2005 — 2009
Bachelor of Science in Engineering, Biomedical Engineering
WellSpan York Hospital July 2014 - Present
Detroit Medical Center July 2013 - June 2014
University of Maryland Medical Center May 2010 - August 2010
Food and Drug Administration May 2009 - August 2009
National Institutes of Health May 2008 - August 2008
Skills
Surgery, Medicine, Research, Clinical Research, Healthcare, Medical Education, Data Analysis, Medical Research, Hospitals, Microsoft Office
Education
University of Maryland Baltimore 2009 — 2013
Doctor of Medicine (M.D.), Medicine
University of Michigan 2005 — 2009
Bachelor of Science in Engineering, Biomedical Engineering
Colleen Kane Rogers's Food and Drug Administration Experience May 2004 - June 2009
Job Team Leader Antimicrobial and Oral Healthcare Team at FDA
Industry Government Administration
Experience
FDA February 2012 - Present
FDA July 2009 - February 2012
Food and Drug Administration May 2004 - June 2009
Uniformed Services University October 1998 - April 2004
Skills
Molecular Biology, Microbiology, Biotechnology, Lifesciences, Government, Pharmaceutical Industry, PCR, Regulatory Affairs, Immunology, Cell Culture, FDA, HPLC, Life Sciences
Education
University of Wisconsin-Madison 1990 — 1998
PhD, Medical Microbiology and Immunology
University of Illinois at Urbana-Champaign 1986 — 1990
BS, Microbiology
FDA February 2012 - Present
FDA July 2009 - February 2012
Food and Drug Administration May 2004 - June 2009
Uniformed Services University October 1998 - April 2004
Skills
Molecular Biology, Microbiology, Biotechnology, Lifesciences, Government, Pharmaceutical Industry, PCR, Regulatory Affairs, Immunology, Cell Culture, FDA, HPLC, Life Sciences
Education
University of Wisconsin-Madison 1990 — 1998
PhD, Medical Microbiology and Immunology
University of Illinois at Urbana-Champaign 1986 — 1990
BS, Microbiology
Trang Gisler's Food and Drug Administration Experience June 2010 - February 2013
Job SVP, Client Services
Industry Research
Experience
GMM Health, LLC May 2013 - Present
MyOwnMed, Inc March 2013 - Present
Food and Drug Administration June 2010 - February 2013
Department of Health and Human Services/BARDA September 2008 - June 2010
Immune Tolerance Network May 2002 - 2008
Johns Hopkins University 2001 - 2002
Biological Defense Research Directorate-Immunochemistry May 1999 - May 2001
Skills
Leadership, Fundraising, Clinical Development, Regulatory Affairs, Drug Development, Strategic Planning, Process Improvement, Government, Healthcare, Validation, Biochemistry, GMP, R&D, Drug Discovery, Technology Transfer, Sop, Immunology, Project Portfolio..., Policy, Public Health, Vaccines, Clinical Trials, Biotechnology, Microbiology, Lifesciences, FDA, Pharmaceutical Industry, Cell Culture, Infectious Diseases, CTMS, Molecular Biology
Education
University of Kansas 1995 — 1999
Microbiology
The Johns Hopkins University
MS
GMM Health, LLC May 2013 - Present
MyOwnMed, Inc March 2013 - Present
Food and Drug Administration June 2010 - February 2013
Department of Health and Human Services/BARDA September 2008 - June 2010
Immune Tolerance Network May 2002 - 2008
Johns Hopkins University 2001 - 2002
Biological Defense Research Directorate-Immunochemistry May 1999 - May 2001
Skills
Leadership, Fundraising, Clinical Development, Regulatory Affairs, Drug Development, Strategic Planning, Process Improvement, Government, Healthcare, Validation, Biochemistry, GMP, R&D, Drug Discovery, Technology Transfer, Sop, Immunology, Project Portfolio..., Policy, Public Health, Vaccines, Clinical Trials, Biotechnology, Microbiology, Lifesciences, FDA, Pharmaceutical Industry, Cell Culture, Infectious Diseases, CTMS, Molecular Biology
Education
University of Kansas 1995 — 1999
Microbiology
The Johns Hopkins University
MS
Virginia Hussong's Food and Drug Administration Experience 2004 - January 2015
Job Director, FDA/CDER/OBI, Division of Data Management Services & Solutions
Industry Government Administration
Experience
FDA January 2015 - Present
Food and Drug Administration 2004 - January 2015
Parenteral Drug Association (PDA) 1994 - 2003
Skills
GLP, Technical Writing, Technology Transfer, Regulatory Requirements, Training, Regulatory Affairs, Regulatory Submissions, FDA, CRO, Clinical Research, Lifesciences, Quality Assurance, Data Management, Document Management, Sop, Pharmaceutical Industry, Program Management, Public Speaking, 21 CFR Part 11, Validation, Team Leadership, Biotechnology, Quality System, GMP, Data Analysis, Clinical Trials, Process Improvement, Business Analysis, Biopharmaceuticals, Strategic Planning, Medical Devices, Project Management, GCP, Change Control, Strategy, Analysis, CAPA, Clinical Development, Software Documentation, Protocol, Pharmacovigilance, Drug Development, LIMS, Life Sciences, SOP
Education
University of Maryland College Park
B.A.
FDA January 2015 - Present
Food and Drug Administration 2004 - January 2015
Parenteral Drug Association (PDA) 1994 - 2003
Skills
GLP, Technical Writing, Technology Transfer, Regulatory Requirements, Training, Regulatory Affairs, Regulatory Submissions, FDA, CRO, Clinical Research, Lifesciences, Quality Assurance, Data Management, Document Management, Sop, Pharmaceutical Industry, Program Management, Public Speaking, 21 CFR Part 11, Validation, Team Leadership, Biotechnology, Quality System, GMP, Data Analysis, Clinical Trials, Process Improvement, Business Analysis, Biopharmaceuticals, Strategic Planning, Medical Devices, Project Management, GCP, Change Control, Strategy, Analysis, CAPA, Clinical Development, Software Documentation, Protocol, Pharmacovigilance, Drug Development, LIMS, Life Sciences, SOP
Education
University of Maryland College Park
B.A.
Autumn Ashby's Food and Drug Administration Experience September 2001 - September 2004
Job Account Supervisor at Ogilvy CommonHealth Worldwide
Industry Pharmaceuticals
Experience
Ogilvy CommonHealth Worldwide August 2015 - Present
BGB Group September 2014 - August 2015
BGB Group July 2013 - September 2014
Clinical CONNEXION March 2010 - July 2013
Synergy Medical Education November 2005 - March 2010
Kenwood Animal Hospital September 2004 - October 2005
Food and Drug Administration September 2001 - September 2004
Skills
Pharmaceutical Industry, Medical Education, Healthcare, Oncology, Infectious Diseases, Project Management, Medicine, Cross-functional Team..., Clinical Research, Strategic Planning, Proposal Writing, Marketing Communications, Medical Devices, Biotechnology, Marketing Strategy, PowerPoint, Program Management, Microsoft Office, CME, Clinical Trials, Marketing
Education
University of Maryland College Park 1997 — 2001
Bachelor of Science (BS), Animal Sciences
Ogilvy CommonHealth Worldwide August 2015 - Present
BGB Group September 2014 - August 2015
BGB Group July 2013 - September 2014
Clinical CONNEXION March 2010 - July 2013
Synergy Medical Education November 2005 - March 2010
Kenwood Animal Hospital September 2004 - October 2005
Food and Drug Administration September 2001 - September 2004
Skills
Pharmaceutical Industry, Medical Education, Healthcare, Oncology, Infectious Diseases, Project Management, Medicine, Cross-functional Team..., Clinical Research, Strategic Planning, Proposal Writing, Marketing Communications, Medical Devices, Biotechnology, Marketing Strategy, PowerPoint, Program Management, Microsoft Office, CME, Clinical Trials, Marketing
Education
University of Maryland College Park 1997 — 2001
Bachelor of Science (BS), Animal Sciences
Carol Rados's Food and Drug Administration Experience 2007 - 2008
Job Supervisory Congressional Analyst in the Office of Legislation, Food and Drug Administration
Industry Health, Wellness and Fitness
Experience
Office of Legislation, Food and Drug Administration June 2008 - Present
Food and Drug Administration 2007 - 2008
FDA 1997 - 2007
Education
University of Maryland University College 1990 — 2005
Journalism (incomplete), Communications; writing; public speaking
Office of Legislation, Food and Drug Administration June 2008 - Present
Food and Drug Administration 2007 - 2008
FDA 1997 - 2007
Education
University of Maryland University College 1990 — 2005
Journalism (incomplete), Communications; writing; public speaking
Bobby Gill's Food and Drug Administration Experience March 2007 - September 2013
Job CoFounder & Chief Operating Officer of Cupid's Undie Run
Industry Nonprofit Organization Management
Experience
Cupid Charities January 2010 - Present
Food and Drug Administration March 2007 - September 2013
Skydive Delmarva May 2007 - May 2009
Under Armour Performance Apparel May 2006 - February 2007
National Institutes of Health May 2005 - August 2005
Skills
Research, Public Speaking, Microsoft Office, Social Media, Entrepreneurship, Event Planning, Strategic Planning, Marketing, Project Management, Proposal Writing, PowerPoint, Non-profits, Program Management, Public Relations, Data Analysis, Social Networking, Product Development, Microsoft Excel, Business Development, Analysis, Medical Devices, Social Media Marketing, Leadership, Biomedical Engineering, Fundraising
Education
University of Maryland College Park 2002 — 2006
B.S., Biomedical Engineering
Cupid Charities January 2010 - Present
Food and Drug Administration March 2007 - September 2013
Skydive Delmarva May 2007 - May 2009
Under Armour Performance Apparel May 2006 - February 2007
National Institutes of Health May 2005 - August 2005
Skills
Research, Public Speaking, Microsoft Office, Social Media, Entrepreneurship, Event Planning, Strategic Planning, Marketing, Project Management, Proposal Writing, PowerPoint, Non-profits, Program Management, Public Relations, Data Analysis, Social Networking, Product Development, Microsoft Excel, Business Development, Analysis, Medical Devices, Social Media Marketing, Leadership, Biomedical Engineering, Fundraising
Education
University of Maryland College Park 2002 — 2006
B.S., Biomedical Engineering
Pauline Petitclerc (McFadden)'s Food and Drug Administration Experience August 2010 - Present
Job Sr. Program Analyst at Food and Drug Administration
Industry Information Technology and Services
Experience
Food and Drug Administration August 2010 - Present
U.S. Department of Energy March 2008 - November 2010
BearingPoint March 2005 - February 2008
Delta Solutions 2002 - 2004
CGI (American Management Systems) 2000 - 2002
Your Choice TV 1994 - 1998
Earle Palmer Brown 1993 - 1994
Education
University of Maryland College Park
Food and Drug Administration August 2010 - Present
U.S. Department of Energy March 2008 - November 2010
BearingPoint March 2005 - February 2008
Delta Solutions 2002 - 2004
CGI (American Management Systems) 2000 - 2002
Your Choice TV 1994 - 1998
Earle Palmer Brown 1993 - 1994
Education
University of Maryland College Park
Chuck Bonapace's Food and Drug Administration Experience June 2011 - December 2011
Job Good Laboratory Practice Branch Chief (Acting) at FDA
Industry Pharmaceuticals
Experience
Food and Drug Admnistration December 2011 - Present
Food and Drug Administration June 2011 - December 2011
Food and Drug Administration December 2010 - June 2011
Food And Drug Administration November 2006 - December 2010
Food and Drug Administration April 2004 - November 2006
Food and Drug Administration July 2000 - April 2004
Medical University of South Carolina July 1997 - June 2000
Education
University of Maryland Baltimore 1993 — 1997
Pharm.D., Pharmacy
University of Rochester 1986 — 1990
BA, Biology
Food and Drug Admnistration December 2011 - Present
Food and Drug Administration June 2011 - December 2011
Food and Drug Administration December 2010 - June 2011
Food And Drug Administration November 2006 - December 2010
Food and Drug Administration April 2004 - November 2006
Food and Drug Administration July 2000 - April 2004
Medical University of South Carolina July 1997 - June 2000
Education
University of Maryland Baltimore 1993 — 1997
Pharm.D., Pharmacy
University of Rochester 1986 — 1990
BA, Biology
Marla Stevens-Riley's Food and Drug Administration Experience January 2015 - Present
Job Senior Microbiologist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration January 2015 - Present
Food and Drug Administration 2000 - Present
Skills
Regulatory Affairs, FDA, Biotechnology, Microbiology, GMP
Education
The University of Georgia
Doctor of Philosophy (Ph.D.), Microbiology
The University of Texas Southwestern Medical Center at Dallas
Post-doctoral Fellow, Microbiology
William and Mary
Bachelor of Science (B.S.), Biology
Food and Drug Administration January 2015 - Present
Food and Drug Administration 2000 - Present
Skills
Regulatory Affairs, FDA, Biotechnology, Microbiology, GMP
Education
The University of Georgia
Doctor of Philosophy (Ph.D.), Microbiology
The University of Texas Southwestern Medical Center at Dallas
Post-doctoral Fellow, Microbiology
William and Mary
Bachelor of Science (B.S.), Biology
Victor Spanioli's Food and Drug Administration Experience September 1977 - November 2007
Job President at Spanioli Medical Device Auditing,Inc.
Industry Medical Devices
Experience
Spanioli Medical Device Auditing,Inc. December 2007 - Present
Food and Drug Administration September 1977 - November 2007
Skills
FDA, Medical Devices, CAPA, Quality System, V&V, GMP, Regulatory Submissions, Clinical Trials, Validation, Design Control, 21 CFR Part 11, ISO 13485, Biotechnology
Education
University of Miami 1972 — 1974
Bachelor's degree, Chemistry
Spanioli Medical Device Auditing,Inc. December 2007 - Present
Food and Drug Administration September 1977 - November 2007
Skills
FDA, Medical Devices, CAPA, Quality System, V&V, GMP, Regulatory Submissions, Clinical Trials, Validation, Design Control, 21 CFR Part 11, ISO 13485, Biotechnology
Education
University of Miami 1972 — 1974
Bachelor's degree, Chemistry
Michael D. Petty's Food and Drug Administration Experience 1987 - 1992
Job Partner at King & Spalding LLP
Industry Biotechnology
Experience
King & Spalding LLP July 2012 - Present
Amgen June 2006 - May 2012
Ropes & Gray LLP 1993 - 2006
Food and Drug Administration 1987 - 1992
Skills
Biotechnology, Pharmaceutical Industry, Research, Product Development, Regulatory Approvals, Safety, Manufacturing Operations, Marketing, Compliance, Crisis Management, Presenting to Senior..., Team Building, Team Leadership, Legal Advice, Strategic Planning, Business Strategy, Negotiation, Problem Solving, Drug Development, Clinical Development, Drug Discovery, Biopharmaceuticals, Oncology, Lifesciences, Clinical Trials, Regulatory Submissions, Commercialization, IND, Regulatory Requirements, FDA, R&D, Licensing, Due Diligence, Intellectual Property, Pharmacovigilance, Patents, Trade Secrets, Patent Prosecution, Corporate Law, Regulations, Patent Litigation, Trademarks, CRO, Privacy Law
Education
University of North Carolina at Chapel Hill 1983 — 1987
Doctor of Law (J.D.), Health Care; Adminstrative Agencies; Public Policy
University of North Carolina at Chapel Hill 1983 — 1987
Masters in Public Health, Health Policy (joint with Health Law focus)
University of North Carolina at Chapel Hill 1972 — 1977
BA, Interdisciplinary Studies (with Honors), Society and Medicine
King & Spalding LLP July 2012 - Present
Amgen June 2006 - May 2012
Ropes & Gray LLP 1993 - 2006
Food and Drug Administration 1987 - 1992
Skills
Biotechnology, Pharmaceutical Industry, Research, Product Development, Regulatory Approvals, Safety, Manufacturing Operations, Marketing, Compliance, Crisis Management, Presenting to Senior..., Team Building, Team Leadership, Legal Advice, Strategic Planning, Business Strategy, Negotiation, Problem Solving, Drug Development, Clinical Development, Drug Discovery, Biopharmaceuticals, Oncology, Lifesciences, Clinical Trials, Regulatory Submissions, Commercialization, IND, Regulatory Requirements, FDA, R&D, Licensing, Due Diligence, Intellectual Property, Pharmacovigilance, Patents, Trade Secrets, Patent Prosecution, Corporate Law, Regulations, Patent Litigation, Trademarks, CRO, Privacy Law
Education
University of North Carolina at Chapel Hill 1983 — 1987
Doctor of Law (J.D.), Health Care; Adminstrative Agencies; Public Policy
University of North Carolina at Chapel Hill 1983 — 1987
Masters in Public Health, Health Policy (joint with Health Law focus)
University of North Carolina at Chapel Hill 1972 — 1977
BA, Interdisciplinary Studies (with Honors), Society and Medicine
Jeanne Anson's Food and Drug Administration Experience 2007 - Present
Job Executive Officer at National Center for Toxicological Research (NCTR)
Industry Research
Experience
National Center for Toxicological Research (NCTR) November 2007 - Present
Food and Drug Administration 2007 - Present
Education
University of Arkansas at Little Rock 1985 — 1989
National Center for Toxicological Research (NCTR) November 2007 - Present
Food and Drug Administration 2007 - Present
Education
University of Arkansas at Little Rock 1985 — 1989
James M Saunders's Food and Drug Administration Experience February 2004 - September 2007
Job Senior Regulatory Management Officer at Food and Drug Administartion
Industry Government Administration
Experience
Food and Drug Administartion September 2007 - Present
Big Brothers Big Sisters 2006 - 2009
Food and Drug Administration February 2004 - September 2007
Education
University of Maryland University College 2004 — 2008
MS/MBA, Health Care Administration/Business Administration
University of Maryland Baltimore 1977 — 1980
BS Pharmacy, Pharmacy
University of Maryland College Park 1973 — 1977
Biological Sciences
Food and Drug Administartion September 2007 - Present
Big Brothers Big Sisters 2006 - 2009
Food and Drug Administration February 2004 - September 2007
Education
University of Maryland University College 2004 — 2008
MS/MBA, Health Care Administration/Business Administration
University of Maryland Baltimore 1977 — 1980
BS Pharmacy, Pharmacy
University of Maryland College Park 1973 — 1977
Biological Sciences
Catherine Chew's Food and Drug Administration Experience November 2000 - December 2011
Job Acting Director, FDA Division of Drug Information
Industry Pharmaceuticals
Experience
FDA Division of Drug Information December 2013 - Present
FDA January 2012 - Present
Food and Drug Administration November 2000 - December 2011
Johns Hopkins Hospital 1999 - 2000
Skills
Social Media Outreach, Division Management, Cross-functional Team..., Healthcare, Data Analysis, Program Management, Regulatory Affairs, FDA, Team Leadership, Analysis, Project Management, Strategy, Process Improvement, Clinical Trials, Leadership
Education
University of Maryland School of Pharmacy 1995 — 1999
PharmD
University of Maryland College Park 1992 — 1995
FDA Division of Drug Information December 2013 - Present
FDA January 2012 - Present
Food and Drug Administration November 2000 - December 2011
Johns Hopkins Hospital 1999 - 2000
Skills
Social Media Outreach, Division Management, Cross-functional Team..., Healthcare, Data Analysis, Program Management, Regulatory Affairs, FDA, Team Leadership, Analysis, Project Management, Strategy, Process Improvement, Clinical Trials, Leadership
Education
University of Maryland School of Pharmacy 1995 — 1999
PharmD
University of Maryland College Park 1992 — 1995
Shirley Murphy's Food and Drug Administration Experience 2005 - 2007
Job Physician, Pharmaceutical consultant, and Ukulele player
Industry Medical Practice
Experience
UNM Health Sciences Center March 2011 - Present
self-employed 2008 - Present
University of New Mexico School of Medicine January 1998 - Present
Food and Drug Administration 2005 - 2007
US Food and Drug Administration 2002 - 2007
GSK 1998 - 2002
Education
University of Kansas Medical Center 1966 — 1970
UNM Health Sciences Center March 2011 - Present
self-employed 2008 - Present
University of New Mexico School of Medicine January 1998 - Present
Food and Drug Administration 2005 - 2007
US Food and Drug Administration 2002 - 2007
GSK 1998 - 2002
Education
University of Kansas Medical Center 1966 — 1970
Cherice Holloway's Food and Drug Administration Experience February 2012 - Present
Job Public Health Analyst at FDA
Industry Health, Wellness and Fitness
Experience
Food and Drug Administration February 2012 - Present
Food and Drug Administration May 2009 - January 2012
NIH June 1999 - May 2009
Skills
Microsoft Office, Public Speaking, Writing, Editing, Administrative Support, Community Outreach, Microsoft Excel, Customer Service, Government, Nonprofits, Program Evaluation, Administrative..., Policy, PowerPoint, Research, Data Analysis, Event Planning, Program Development, Public Health
Education
University of Maryland University College 2000 — 2004
BA, Business Management
Food and Drug Administration February 2012 - Present
Food and Drug Administration May 2009 - January 2012
NIH June 1999 - May 2009
Skills
Microsoft Office, Public Speaking, Writing, Editing, Administrative Support, Community Outreach, Microsoft Excel, Customer Service, Government, Nonprofits, Program Evaluation, Administrative..., Policy, PowerPoint, Research, Data Analysis, Event Planning, Program Development, Public Health
Education
University of Maryland University College 2000 — 2004
BA, Business Management
Christie-Sue Cheely's Food and Drug Administration Experience March 2005 - May 2007
Job Writer
Industry Writing and Editing
Experience
self-employed January 2011 - Present
North Carolina State University October 2007 - January 2011
NC DOT Natural Environment Unit June 2007 - September 2007
Food and Drug Administration March 2005 - May 2007
USDA-ARS August 2002 - August 2004
Education
University of Maryland College Park 1999 — 2002
MS, Marine and Estuarine Environmental Sciences
University of North Carolina at Wilmington 1995 — 1999
BS, Marine Biology
self-employed January 2011 - Present
North Carolina State University October 2007 - January 2011
NC DOT Natural Environment Unit June 2007 - September 2007
Food and Drug Administration March 2005 - May 2007
USDA-ARS August 2002 - August 2004
Education
University of Maryland College Park 1999 — 2002
MS, Marine and Estuarine Environmental Sciences
University of North Carolina at Wilmington 1995 — 1999
BS, Marine Biology
Stephanie Slater's Food and Drug Administration Experience July 2010 - Present
Job at Food and Drug Administration
Industry Biotechnology
Experience
Food and Drug Administration July 2010 - Present
University of Washington September 2009 - June 2011
SNBL USA November 2008 - April 2009
SNBL USA September 2008 - November 2008
Meridian Valley Laboratory July 2007 - August 2008
University of Washington September 2006 - June 2007
University of Arizona January 2005 - August 2006
University of Arizona June 2003 - December 2004
University of Arizona May 2001 - May 2003
Skills
Microscopy, Protein Purification, In Vivo, Fluorescence Microscopy, Infectious Diseases, Cell, Protein Expression, RT-PCR, SDS-PAGE, Protein Chemistry, Transfection, Biomarkers, Clinical Trials, Laboratory, Pharmacology, GLP, Regulatory Affairs, Molecular Cloning, Clinical Development, Sop, In Vitro, Protocol, Regulatory Submissions, Chemistry, Gel Electrophoresis, Quality Control, Drug Development, Quality System, DNA sequencing, Genetics, Purification, GMP, Immunoassays, Validation, Biopharmaceuticals, SOP, DNA Sequencing
Education
University of Washington 2009 — 2011
Master of Science
University of Arizona 2003 — 2004
Master of Science
University of Arizona 1999 — 2003
Bachelor of Science
Food and Drug Administration July 2010 - Present
University of Washington September 2009 - June 2011
SNBL USA November 2008 - April 2009
SNBL USA September 2008 - November 2008
Meridian Valley Laboratory July 2007 - August 2008
University of Washington September 2006 - June 2007
University of Arizona January 2005 - August 2006
University of Arizona June 2003 - December 2004
University of Arizona May 2001 - May 2003
Skills
Microscopy, Protein Purification, In Vivo, Fluorescence Microscopy, Infectious Diseases, Cell, Protein Expression, RT-PCR, SDS-PAGE, Protein Chemistry, Transfection, Biomarkers, Clinical Trials, Laboratory, Pharmacology, GLP, Regulatory Affairs, Molecular Cloning, Clinical Development, Sop, In Vitro, Protocol, Regulatory Submissions, Chemistry, Gel Electrophoresis, Quality Control, Drug Development, Quality System, DNA sequencing, Genetics, Purification, GMP, Immunoassays, Validation, Biopharmaceuticals, SOP, DNA Sequencing
Education
University of Washington 2009 — 2011
Master of Science
University of Arizona 2003 — 2004
Master of Science
University of Arizona 1999 — 2003
Bachelor of Science
Carol J. Braun, M.D.'s Food and Drug Administration Experience 1987 - 1998
Job Owner, SAJE Consulting LLC
Industry Pharmaceuticals
Experience
SAJE Consulting LLC January 2008 - Present
AkaRx, Inc. 2006 - 2008
GloboMax/ICON 1998 - 2006
Food and Drug Administration 1987 - 1998
Skills
Clinical Development, Clinical Trials
Education
The Ohio State University College of Medicine 1980 — 1984
Medical Doctor, Medicine
The Ohio State University 1977 — 1980
B.S.Pharm., Pharmacy
SAJE Consulting LLC January 2008 - Present
AkaRx, Inc. 2006 - 2008
GloboMax/ICON 1998 - 2006
Food and Drug Administration 1987 - 1998
Skills
Clinical Development, Clinical Trials
Education
The Ohio State University College of Medicine 1980 — 1984
Medical Doctor, Medicine
The Ohio State University 1977 — 1980
B.S.Pharm., Pharmacy
Unger Julie's Food and Drug Administration Experience
Job Project Manager at FDA
Industry Public Safety
Experience
Food and Drug Administration
Skills
Policy, Project Management, Government, Program Management, Regulatory Affairs, Public Health, FDA, Public Policy, Policy Analysis, Software Documentation, Proposal Writing, Program Evaluation
Education
Hagerstown Community College
Health Education
University of Maryland University College
Food and Drug Administration
Skills
Policy, Project Management, Government, Program Management, Regulatory Affairs, Public Health, FDA, Public Policy, Policy Analysis, Software Documentation, Proposal Writing, Program Evaluation
Education
Hagerstown Community College
Health Education
University of Maryland University College
Rial Christensen's Food and Drug Administration Experience December 2003 - Present
Job Animal Scientist at Food and Drug Administration
Industry Dairy
Experience
Food and Drug Administration December 2003 - Present
FDA 2003 - Present
Caritas St. Elizabeth's Medical Center December 1996 - December 2003
Rutgers University September 1993 - December 1996
Skills
Dairy nutrition, Molecular Biology, Biology, Signal Transduction, Dairy Products, Research, Regulatory Affairs, Animal Nutrition, Biotechnology, Biochemistry, Cell Culture, Cell Signaling, Microbiology
Education
University of Illinois at Urbana-Champaign 1988 — 1993
Ph.D., Dairy Nutrition
University of Alberta 1985 — 1988
M.Sc., Animal physiology
University of Alberta 1975 — 1979
B.Sc., Animal Science
Food and Drug Administration December 2003 - Present
FDA 2003 - Present
Caritas St. Elizabeth's Medical Center December 1996 - December 2003
Rutgers University September 1993 - December 1996
Skills
Dairy nutrition, Molecular Biology, Biology, Signal Transduction, Dairy Products, Research, Regulatory Affairs, Animal Nutrition, Biotechnology, Biochemistry, Cell Culture, Cell Signaling, Microbiology
Education
University of Illinois at Urbana-Champaign 1988 — 1993
Ph.D., Dairy Nutrition
University of Alberta 1985 — 1988
M.Sc., Animal physiology
University of Alberta 1975 — 1979
B.Sc., Animal Science
Gideon Blumenthal's Food and Drug Administration Experience February 2013 - Present
Job Clinical Team Leader, Thoracic and Head/Neck Oncology, FDA
Industry Hospital & Health Care
Experience
Food and Drug Administration February 2013 - Present
National Cancer Institute July 2009 - Present
MedStar Montgomery Medical Center 2012 - Present
FDA July 2009 - February 2013
National Cancer Institute July 2006 - July 2009
University of Maryland July 2003 - June 2006
Skills
Oncology, Hematology, FDA, Clinical Research, Clinical Trials, Translational Research, Cancer, Internal Medicine, Cancer Research, Cell, Lifesciences, IND, Clinical Development, Immunology, Healthcare, Epidemiology, Medicine, Infectious Diseases
Education
University of Maryland School of Medicine 1999 — 2003
MD
Washington University in St. Louis 1997 — 2002
BA, Psychology, History
Food and Drug Administration February 2013 - Present
National Cancer Institute July 2009 - Present
MedStar Montgomery Medical Center 2012 - Present
FDA July 2009 - February 2013
National Cancer Institute July 2006 - July 2009
University of Maryland July 2003 - June 2006
Skills
Oncology, Hematology, FDA, Clinical Research, Clinical Trials, Translational Research, Cancer, Internal Medicine, Cancer Research, Cell, Lifesciences, IND, Clinical Development, Immunology, Healthcare, Epidemiology, Medicine, Infectious Diseases
Education
University of Maryland School of Medicine 1999 — 2003
MD
Washington University in St. Louis 1997 — 2002
BA, Psychology, History
Stephanie Hawk's Food and Drug Administration Experience April 2004 - April 2010
Job Division Director at FDA
Industry Government Administration
Experience
FDA June 2013 - Present
Food and Drug Adminstration April 2010 - June 2013
Food and Drug Administration April 2004 - April 2010
Skills
Federal Government, Program Management, Management, Research, Government, Policy, Project Management
Education
University of Maryland University College 1996 — 2001
M.S., Business Management/Marketing
University of Maryland Baltimore County 1988 — 1992
B.A., Philosophy
FDA June 2013 - Present
Food and Drug Adminstration April 2010 - June 2013
Food and Drug Administration April 2004 - April 2010
Skills
Federal Government, Program Management, Management, Research, Government, Policy, Project Management
Education
University of Maryland University College 1996 — 2001
M.S., Business Management/Marketing
University of Maryland Baltimore County 1988 — 1992
B.A., Philosophy
Erika Armani's Food and Drug Administration Experience November 2004 - June 2012
Job Deputy Ethics Counselor at Bureau of Reclamation
Industry Government Administration
Experience
Bureau of Reclamation March 2013 - Present
FDA June 2012 - February 2013
ImagineDesign August 2011 - July 2012
Food and Drug Administration November 2004 - June 2012
Food and Drug Administration August 2003 - May 2005
Skills
Process Improvement, Customer Service, Ethics, Problem Solving, Marketing Research, Web Development, Strategy, Strategic Advice, Competitive Analysis, HTML, Government..., Learning Management..., Organizational..., Technical Writing, CSS, Market Research, Public Speaking, Liasoning, Social Media, Marketing Strategy, Medical Devices, FDA, Marketing Communications, Industry Analysis, Diabetes, Regulatory Analysis
Education
University of Maryland - Robert H. Smith School of Business 2009 — 2012
MBA, Business
Tulane University 1999 — 2003
BSE, Biomedical Engineering
Bureau of Reclamation March 2013 - Present
FDA June 2012 - February 2013
ImagineDesign August 2011 - July 2012
Food and Drug Administration November 2004 - June 2012
Food and Drug Administration August 2003 - May 2005
Skills
Process Improvement, Customer Service, Ethics, Problem Solving, Marketing Research, Web Development, Strategy, Strategic Advice, Competitive Analysis, HTML, Government..., Learning Management..., Organizational..., Technical Writing, CSS, Market Research, Public Speaking, Liasoning, Social Media, Marketing Strategy, Medical Devices, FDA, Marketing Communications, Industry Analysis, Diabetes, Regulatory Analysis
Education
University of Maryland - Robert H. Smith School of Business 2009 — 2012
MBA, Business
Tulane University 1999 — 2003
BSE, Biomedical Engineering
Elizabeth Gordon's Food and Drug Administration Experience 1991 - 1996
Job Vice President Regulatory Affairs at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
EG Consulting, Inc. 2000 - Present
Shire Pharmaceuticals June 2014 - June 2015
Lumena Pharmaceuticals, Inc. August 2011 - June 2014
Quintiles Transnational 1996 - 2000
Food and Drug Administration 1991 - 1996
Food and Drug Administration 1991 - 1996
American Association for the Advancement of Science 1990 - 1991
Skills
FDA
Education
University of Maryland University College 1994 — 1996
Executive M.S., Technology Management
Uniformed Services University of the Health Sciences 1987 — 1990
Postdoctoral Fellow, Microbiology; Infectious Disease
University of Rhode Island 1982 — 1987
Ph.D., Microbiology
University of New Hampshire 1979 — 1981
B.A., Microbiology
EG Consulting, Inc. 2000 - Present
Shire Pharmaceuticals June 2014 - June 2015
Lumena Pharmaceuticals, Inc. August 2011 - June 2014
Quintiles Transnational 1996 - 2000
Food and Drug Administration 1991 - 1996
Food and Drug Administration 1991 - 1996
American Association for the Advancement of Science 1990 - 1991
Skills
FDA
Education
University of Maryland University College 1994 — 1996
Executive M.S., Technology Management
Uniformed Services University of the Health Sciences 1987 — 1990
Postdoctoral Fellow, Microbiology; Infectious Disease
University of Rhode Island 1982 — 1987
Ph.D., Microbiology
University of New Hampshire 1979 — 1981
B.A., Microbiology
Russ Felkey's Food and Drug Administration Experience 1972 - 1977
Job RA/QA Clinical Professional
Industry Medical Devices
Experience
Medtronic, Inc. 2011 - Present
Experien Group 2008 - 2011
EnteroMedics 2005 - 2008
Boston Scientific 2003 - 2005
Medtronic 2002 - 2003
ATS Medical, Inc. 1991 - 2002
Cardiovascular Imaging Systems 1989 - 1991
GV Medical 1984 - 1989
Medtronic 1977 - 1984
Food and Drug Administration 1972 - 1977
Skills
FDA, Regulatory Affairs, Clinical Development, R&D, Clinical Research, PMA, Regulatory Submissions, Medical Devices, Quality Assurance, ISO 13485, Design Control, Biomedical Engineering, CAPA, GLP, Cross-functional Team..., Quality Management, Start-ups, Quality System, Clinical Trials, Clinical Study Design, Neurology
Education
University of Iowa 1970 — 1972
B.S., Chemistry
Medtronic, Inc. 2011 - Present
Experien Group 2008 - 2011
EnteroMedics 2005 - 2008
Boston Scientific 2003 - 2005
Medtronic 2002 - 2003
ATS Medical, Inc. 1991 - 2002
Cardiovascular Imaging Systems 1989 - 1991
GV Medical 1984 - 1989
Medtronic 1977 - 1984
Food and Drug Administration 1972 - 1977
Skills
FDA, Regulatory Affairs, Clinical Development, R&D, Clinical Research, PMA, Regulatory Submissions, Medical Devices, Quality Assurance, ISO 13485, Design Control, Biomedical Engineering, CAPA, GLP, Cross-functional Team..., Quality Management, Start-ups, Quality System, Clinical Trials, Clinical Study Design, Neurology
Education
University of Iowa 1970 — 1972
B.S., Chemistry
Katherine Szestypalow's Food and Drug Administration Experience January 1985 - Present
Job Chemist/Investigator at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration January 1985 - Present
Skills
Research, Microsoft Office, Policy, Program Management, Microsoft Excel, Strategic Planning, Customer Service, Management, Leadership
Education
University of Cincinnati 1980 — 1984
Bachelor of Science (BS), Chemistry
Food and Drug Administration January 1985 - Present
Skills
Research, Microsoft Office, Policy, Program Management, Microsoft Excel, Strategic Planning, Customer Service, Management, Leadership
Education
University of Cincinnati 1980 — 1984
Bachelor of Science (BS), Chemistry
Martin Rose's Food and Drug Administration Experience March 2010 - Present
Job at FDA
Industry Pharmaceuticals
Experience
Food and Drug Administration March 2010 - Present
Otsuka America Pharmaceutical, Inc. April 2006 - May 2010
InKine Pharmaceutical Company, Inc. 1999 - 2006
Biometric Research Institute 1993 - 1997
NIH 1985 - 1986
Skills
Pharmaceutical Industry, Drug Development, Clinical Development, Clinical Trials, Medical Devices, Clinical Research, FDA, Regulatory Affairs
Education
University of California, Berkeley - School of Law 1979 — 1980
JD
University of California, San Francisco - School of Medicine 1967 — 1971
MD
Shaker Heights High School
Food and Drug Administration March 2010 - Present
Otsuka America Pharmaceutical, Inc. April 2006 - May 2010
InKine Pharmaceutical Company, Inc. 1999 - 2006
Biometric Research Institute 1993 - 1997
NIH 1985 - 1986
Skills
Pharmaceutical Industry, Drug Development, Clinical Development, Clinical Trials, Medical Devices, Clinical Research, FDA, Regulatory Affairs
Education
University of California, Berkeley - School of Law 1979 — 1980
JD
University of California, San Francisco - School of Medicine 1967 — 1971
MD
Shaker Heights High School
Ron Steigerwalt's Food and Drug Administration Experience 1996 - 2000
Job Research Fellow at Takeda California, Inc.
Industry Pharmaceuticals
Experience
Takeda California September 2012 - Present
Amgen, Inc. February 2011 - August 2012
Takeda San Diego, Inc July 2009 - February 2011
Amylin July 2008 - June 2009
GENENTECH INC., SOUTH SAN FRANCISCO, CA 94080, USA 2004 - 2008
Chiron Corp 2000 - 2004
Food and Drug Administration 1996 - 2000
Food and Drug Administration 1993 - 1996
Skills
Toxicology, Drug Discovery, IND, Drug Development, GLP, Pharmacology, Biotechnology, In Vitro, Oncology, Biopharmaceuticals, FDA, Pharmaceutical Industry, Endocrinology, Metabolism, In Vivo, Biomarkers, Clinical Development
Education
University of California, San Francisco 1978 — 1984
Ph.D., Endocrinology
Takeda California September 2012 - Present
Amgen, Inc. February 2011 - August 2012
Takeda San Diego, Inc July 2009 - February 2011
Amylin July 2008 - June 2009
GENENTECH INC., SOUTH SAN FRANCISCO, CA 94080, USA 2004 - 2008
Chiron Corp 2000 - 2004
Food and Drug Administration 1996 - 2000
Food and Drug Administration 1993 - 1996
Skills
Toxicology, Drug Discovery, IND, Drug Development, GLP, Pharmacology, Biotechnology, In Vitro, Oncology, Biopharmaceuticals, FDA, Pharmaceutical Industry, Endocrinology, Metabolism, In Vivo, Biomarkers, Clinical Development
Education
University of California, San Francisco 1978 — 1984
Ph.D., Endocrinology
Morgan Walker's Food and Drug Administration Experience April 2011 - October 2013
Job Patient Labeling Reviewer at FDA
Industry Hospital & Health Care
Experience
FDA January 2014 - Present
United States Public Health Service September 2013 - Present
FDA October 2013 - January 2014
Food and Drug Administration April 2011 - October 2013
The Johns Hopkins Hospital August 2009 - April 2011
Johns Hopkins Hospital June 2007 - August 2009
VA Medical Center October 2005 - May 2007
Howard University School of Pharmacy 2003 - 2007
Hospira 2005 - 2005
Washington hospital center 2004 - 2005
Skills
Pharmacy, Inpatient, Pharmacists, Patient Safety, Oncology, Pharmacy Automation, Clinical Trials, Clinical Research, Managed Care, Informatics, Hospitals, Clinical Pharmacology, Public Health, Healthcare
Education
The Johns Hopkins University - Carey Business School 2007 — 2009
MBA, Medical Services Management
Howard University School Of Pharmacy 2003 — 2007
PharmD, Pharmacy
University of Maryland Eastern Shore 1998 — 2002
B.S., Chemistry
Paul Laurence Dunbar High School 1994 — 1998
High School Diploma, Biotechnology
FDA January 2014 - Present
United States Public Health Service September 2013 - Present
FDA October 2013 - January 2014
Food and Drug Administration April 2011 - October 2013
The Johns Hopkins Hospital August 2009 - April 2011
Johns Hopkins Hospital June 2007 - August 2009
VA Medical Center October 2005 - May 2007
Howard University School of Pharmacy 2003 - 2007
Hospira 2005 - 2005
Washington hospital center 2004 - 2005
Skills
Pharmacy, Inpatient, Pharmacists, Patient Safety, Oncology, Pharmacy Automation, Clinical Trials, Clinical Research, Managed Care, Informatics, Hospitals, Clinical Pharmacology, Public Health, Healthcare
Education
The Johns Hopkins University - Carey Business School 2007 — 2009
MBA, Medical Services Management
Howard University School Of Pharmacy 2003 — 2007
PharmD, Pharmacy
University of Maryland Eastern Shore 1998 — 2002
B.S., Chemistry
Paul Laurence Dunbar High School 1994 — 1998
High School Diploma, Biotechnology
Nancy Ostrove's Food and Drug Administration Experience July 2003 - May 2011
Job Principle Consultant at A Honu You
Industry Public Relations and Communications
Experience
A Honu You June 2011 - Present
Food and Drug Administration July 2003 - May 2011
Education
University of Maryland College Park 1972 — 1976
PhD, Experimental Social Psychology
A Honu You June 2011 - Present
Food and Drug Administration July 2003 - May 2011
Education
University of Maryland College Park 1972 — 1976
PhD, Experimental Social Psychology
Caroline Strasinger's Food and Drug Administration Experience July 2009 - Present
Job Branch Chief Chemistry, Manufacturing and Controls at FDA
Industry Pharmaceuticals
Experience
FDA January 2015 - Present
Food and Drug Administration July 2009 - Present
American Association of Pharmaceutical Scientists (AAPS) 2005 - Present
University of Kentucky January 2009 - May 2009
Pfizer May 2005 - August 2005
Skills
FDA, Transdermal Drug..., Pharmaceutical Industry, CMC, Chemistry, Regulatory Affairs, Transdermal, R&D, In Vitro, Drug Discovery, Life Sciences, Pharmaceutics, Pharmacology, Drug Development, Drug Delivery, Formulation, IND, HPLC
Education
University of Kentucky 2004 — 2009
PhD, Pharmaceutical Sciences
University of Kentucky 1999 — 2004
Bachelor of Science (B.S.), Chemical Engineering
FDA January 2015 - Present
Food and Drug Administration July 2009 - Present
American Association of Pharmaceutical Scientists (AAPS) 2005 - Present
University of Kentucky January 2009 - May 2009
Pfizer May 2005 - August 2005
Skills
FDA, Transdermal Drug..., Pharmaceutical Industry, CMC, Chemistry, Regulatory Affairs, Transdermal, R&D, In Vitro, Drug Discovery, Life Sciences, Pharmaceutics, Pharmacology, Drug Development, Drug Delivery, Formulation, IND, HPLC
Education
University of Kentucky 2004 — 2009
PhD, Pharmaceutical Sciences
University of Kentucky 1999 — 2004
Bachelor of Science (B.S.), Chemical Engineering
Sally Winthrop's Food and Drug Administration Experience Web ManagerFDA1999 - Present
Job Web Manager at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration Web ManagerFDA1999 - Present
Education
University of California, Los Angeles
MLS
University of California, Santa Barbara
BA, Experimental Psychology
Food and Drug Administration Web ManagerFDA1999 - Present
Education
University of California, Los Angeles
MLS
University of California, Santa Barbara
BA, Experimental Psychology
David Villalpando's Food and Drug Administration Experience June 2007 - August 2007
Job Sales Manager at The Scotts MiracleGro Company
Industry Retail
Experience
The Scotts Miracle-Gro Company June 2014 - Present
The Scotts Miracle-Gro Company December 2012 - May 2014
The Scotts Miracle-Gro Company March 2011 - December 2012
Deutsche Bank August 2009 - August 2010
American Campus Communities September 2007 - May 2008
Food and Drug Administration June 2007 - August 2007
Bayer CropScience February 2007 - May 2007
The Scotts Miracle-Gro Company March 2005 - February 2007
Department of Treasury June 2006 - August 2006
Department of Treasury June 2005 - August 2005
Skills
Project Management, Sales Process, International Relations, Contingency Planning, Customer Service, Marketing, Sales, Microsoft Office, Financial Analysis, Data Analysis, Microsoft Excel, PowerPoint, Outlook, Analysis, Spanish, Event Planning, Competitive Analysis, Strategic Planning, Event Management, Marketing Strategy, Time Management, Retail, Training, Inventory Management
Education
Naresuan University 2010 — 2010
MBA, International Business
St. Mary's University College - Twickenham 2009 — 2010
MBA, International Business
University of Houston, C.T. Bauer College of Business 2006 — 2008
BBA, Management
The Scotts Miracle-Gro Company June 2014 - Present
The Scotts Miracle-Gro Company December 2012 - May 2014
The Scotts Miracle-Gro Company March 2011 - December 2012
Deutsche Bank August 2009 - August 2010
American Campus Communities September 2007 - May 2008
Food and Drug Administration June 2007 - August 2007
Bayer CropScience February 2007 - May 2007
The Scotts Miracle-Gro Company March 2005 - February 2007
Department of Treasury June 2006 - August 2006
Department of Treasury June 2005 - August 2005
Skills
Project Management, Sales Process, International Relations, Contingency Planning, Customer Service, Marketing, Sales, Microsoft Office, Financial Analysis, Data Analysis, Microsoft Excel, PowerPoint, Outlook, Analysis, Spanish, Event Planning, Competitive Analysis, Strategic Planning, Event Management, Marketing Strategy, Time Management, Retail, Training, Inventory Management
Education
Naresuan University 2010 — 2010
MBA, International Business
St. Mary's University College - Twickenham 2009 — 2010
MBA, International Business
University of Houston, C.T. Bauer College of Business 2006 — 2008
BBA, Management
Rob Berlin, JD, MPH's Food and Drug Administration Experience December 2013 - Present
Job Senior Policy Advisor, Office of the Commissioner, Food and Drug Administration
Industry Legal Services
Experience
Food and Drug Administration December 2013 - Present
Food and Drug Administration June 2010 - December 2013
Hogan & Hartson September 2007 - June 2010
The National Academies June 2005 - August 2005
Antigenics October 2000 - July 2003
University of Connecticut Health Center, Center for Immunotherapy May 2000 - October 2000
Skills
Legal Research, Litigation, Policy, Legal Writing, Research, FDA, Administrative Law, Regulatory Affairs, Civil Litigation
Education
University of Minnesota School of Public Health 2003 — 2007
Master of Public Health (MPH), Epidemiology
University of Minnesota Law School 2003 — 2006
Doctor of Law (JD), Law
University of Oregon 1996 — 1999
Bachelor of Arts (B.A.), Anthropology
Food and Drug Administration December 2013 - Present
Food and Drug Administration June 2010 - December 2013
Hogan & Hartson September 2007 - June 2010
The National Academies June 2005 - August 2005
Antigenics October 2000 - July 2003
University of Connecticut Health Center, Center for Immunotherapy May 2000 - October 2000
Skills
Legal Research, Litigation, Policy, Legal Writing, Research, FDA, Administrative Law, Regulatory Affairs, Civil Litigation
Education
University of Minnesota School of Public Health 2003 — 2007
Master of Public Health (MPH), Epidemiology
University of Minnesota Law School 2003 — 2006
Doctor of Law (JD), Law
University of Oregon 1996 — 1999
Bachelor of Arts (B.A.), Anthropology
Sean Hilscher's Food and Drug Administration Experience 1990 - 1998
Job Principal Consultant
Industry Medical Devices
Experience
Strategic Compliance Services September 2009 - Present
Kimberly-Clark 2008 - 2009
Pharmatech Associates, Inc 2007 - 2008
Baxter 2004 - 2005
PAREXEL 1998 - 2004
FDA 1990 - 1998
Food And Drug Administration 1990 - 1998
Skills
Quality Systems, CAPA, FDA, Medical Devices, ISO 13485, Process Validation, Quality Assurance, Change Control, cGMP, GMP, Validation, SOP, Quality Management, Compliance, 21 CFR Part 11, Process Improvement, Computer System..., Design Control, Quality Auditing, Auditing, Pharmaceuticals, Risk Management, Documentation, LIMS, ISO, Due Diligence, Continuous Improvement, Regulatory Affairs, Document Management, Manufacturing, Supplier Management, Strategic Planning, Risk Assessment, SDLC, Internal Audit, QSR, Software Validation, GxP, 510 K, Validations, Cleaning Validation, GAMP, Aseptic Processing, Root Cause Analysis, Supplier Audits, Complaint Handling, FMEA, Supplier Quality, Compliance Audits, PMA
Education
The University of Georgia 1986 — 1990
BS, Microbiology
Strategic Compliance Services September 2009 - Present
Kimberly-Clark 2008 - 2009
Pharmatech Associates, Inc 2007 - 2008
Baxter 2004 - 2005
PAREXEL 1998 - 2004
FDA 1990 - 1998
Food And Drug Administration 1990 - 1998
Skills
Quality Systems, CAPA, FDA, Medical Devices, ISO 13485, Process Validation, Quality Assurance, Change Control, cGMP, GMP, Validation, SOP, Quality Management, Compliance, 21 CFR Part 11, Process Improvement, Computer System..., Design Control, Quality Auditing, Auditing, Pharmaceuticals, Risk Management, Documentation, LIMS, ISO, Due Diligence, Continuous Improvement, Regulatory Affairs, Document Management, Manufacturing, Supplier Management, Strategic Planning, Risk Assessment, SDLC, Internal Audit, QSR, Software Validation, GxP, 510 K, Validations, Cleaning Validation, GAMP, Aseptic Processing, Root Cause Analysis, Supplier Audits, Complaint Handling, FMEA, Supplier Quality, Compliance Audits, PMA
Education
The University of Georgia 1986 — 1990
BS, Microbiology
Nancy Ostrove's Food and Drug Administration Experience January 1989 - March 2002
Job Experienced Social Science Researcher
Industry Research
Aman Bimbra, RN's Food and Drug Administration Experience March 2010 - Present
Job Regulatory Health Education Specialist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration March 2010 - Present
Food and Drug Administration May 2009 - August 2009
Education
University of Maryland Baltimore 2007 — 2009
Bachelor of Science, Nursing
Food and Drug Administration March 2010 - Present
Food and Drug Administration May 2009 - August 2009
Education
University of Maryland Baltimore 2007 — 2009
Bachelor of Science, Nursing
Carol Rehkopf's Food and Drug Administration Experience September 2009 - Present
Job Quality/Regulatory Expert
Industry Pharmaceuticals
Experience
Food and Drug Administration September 2009 - Present
Philips/Respironics January 2008 - September 2009
FDA 1991 - 2008
Skills
Compliance, Quality Systems, Biotechnology, SOP, Validation, Medical Devices, Quality Auditing, Regulatory Affairs, FDA, QSR, GMP, Risk Management, ISO, IND, Regulatory Requirements, Regulatory Submissions, Documentation, Process Improvement, Pharmaceuticals, Manufacturing, Vaccines, Microbiology, Program Management, Quality Management, Quality System
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business
Masters Certificate, Project Management
University of Maryland University College
Bachelor, Biology/Legal Studies
Food and Drug Administration September 2009 - Present
Philips/Respironics January 2008 - September 2009
FDA 1991 - 2008
Skills
Compliance, Quality Systems, Biotechnology, SOP, Validation, Medical Devices, Quality Auditing, Regulatory Affairs, FDA, QSR, GMP, Risk Management, ISO, IND, Regulatory Requirements, Regulatory Submissions, Documentation, Process Improvement, Pharmaceuticals, Manufacturing, Vaccines, Microbiology, Program Management, Quality Management, Quality System
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business
Masters Certificate, Project Management
University of Maryland University College
Bachelor, Biology/Legal Studies
Vinayak Pawar's Food and Drug Administration Experience January 2000 - Present
Job Senior Review Microbiologist at Food And Drug Administration
Industry Government Administration
Experience
Food And Drug Administration January 2000 - Present
Parkedale Pharmaceuticals & BioReliance Inc. June 1992 - January 2000
University of Nevada 1988 - 1992
University of Maryland School of Medicine 1977 - 1988
Skills
FDA, Microbiology, GMP, Research, Lifesciences, Molecular Biology, Life Sciences
Education
University of Kentucky 1974 — 1977
Ph.D., Microbiology
Food And Drug Administration January 2000 - Present
Parkedale Pharmaceuticals & BioReliance Inc. June 1992 - January 2000
University of Nevada 1988 - 1992
University of Maryland School of Medicine 1977 - 1988
Skills
FDA, Microbiology, GMP, Research, Lifesciences, Molecular Biology, Life Sciences
Education
University of Kentucky 1974 — 1977
Ph.D., Microbiology
Jamie Waterhouse's Food and Drug Administration Experience October 2010 - November 2011
Job Designated Federal Officer at FDA
Industry Medical Devices
Experience
FDA October 2011 - Present
Food and Drug Administration October 2010 - November 2011
Angel Medical Systems September 2008 - September 2010
Skills
FDA, Medical Devices, Clinical Trials, Biomedical Engineering, Research, Clinical Research, Cardiology, GMP, Hospitals, Biotechnology, ISO 13485, Product Development, Protocol, Training, Medicine, Validation, Clinical Development, Medical Imaging, Regulatory Affairs
Education
University of Maryland 2010 — 2013
Masters of Business Administration (MBA)
University of Maryland College Park 2005 — 2008
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
FDA October 2011 - Present
Food and Drug Administration October 2010 - November 2011
Angel Medical Systems September 2008 - September 2010
Skills
FDA, Medical Devices, Clinical Trials, Biomedical Engineering, Research, Clinical Research, Cardiology, GMP, Hospitals, Biotechnology, ISO 13485, Product Development, Protocol, Training, Medicine, Validation, Clinical Development, Medical Imaging, Regulatory Affairs
Education
University of Maryland 2010 — 2013
Masters of Business Administration (MBA)
University of Maryland College Park 2005 — 2008
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Charlene Baksh's Food and Drug Administration Experience September 2010 - April 2011
Job Pharmacokineticist/Pharmacist
Industry Medical Practice
Experience
St. Agnes Hospital October 2004 - Present
Food and Drug Administration September 2010 - April 2011
Greater Baltimore Medical Center January 2010 - August 2010
University of Maryland, Baltimore (UMB) August 2004 - May 2009
Skills
Clinical Research, Clinical Pharmacology, Pharmacokinetics, Pharmacists, Pharmacology, Pharmacy
Education
University of Maryland Baltimore 2004 — 2009
Ph.D, Pharmaceutical Sciences
University of Maryland Baltimore 2000 — 2004
Doctor of Pharmacy (Pharm.D.)
St. Agnes Hospital October 2004 - Present
Food and Drug Administration September 2010 - April 2011
Greater Baltimore Medical Center January 2010 - August 2010
University of Maryland, Baltimore (UMB) August 2004 - May 2009
Skills
Clinical Research, Clinical Pharmacology, Pharmacokinetics, Pharmacists, Pharmacology, Pharmacy
Education
University of Maryland Baltimore 2004 — 2009
Ph.D, Pharmaceutical Sciences
University of Maryland Baltimore 2000 — 2004
Doctor of Pharmacy (Pharm.D.)
Shannan Beisser's Food and Drug Administration Experience January 2010 - Present
Job Biologist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration January 2010 - Present
Missouri Master Naturalist November 2011 - November 2012
Midwest AOAC April 2010 - June 2012
Sosland Publishing June 2008 - January 2010
Skills
Project Coordination, Copy Editing, Proofreading, Magazine Editing, Report Editing, Regulatory Analysis, Chemical Instrumentation, Analytical Chemistry, Quality Assurance, Writing, Interviewing Skills, Editing, Laboratory
Education
University of Missouri-Columbia 2003 — 2008
Bachelor of Arts in Biology; Bachelor of Journalism
Food and Drug Administration January 2010 - Present
Missouri Master Naturalist November 2011 - November 2012
Midwest AOAC April 2010 - June 2012
Sosland Publishing June 2008 - January 2010
Skills
Project Coordination, Copy Editing, Proofreading, Magazine Editing, Report Editing, Regulatory Analysis, Chemical Instrumentation, Analytical Chemistry, Quality Assurance, Writing, Interviewing Skills, Editing, Laboratory
Education
University of Missouri-Columbia 2003 — 2008
Bachelor of Arts in Biology; Bachelor of Journalism
Cynthia Kleppinger's Food and Drug Administration Experience 2008 - Present
Job Medical Officer at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration 2008 - Present
Science Applications International Corporation-Frederick January 2005 - September 2008
National Institute on Drug Abuse/National Institutes of Health September 2002 - December 2004
FDA October 1998 - September 2002
Skills
GCP, Vaccines, Clinical Trials, Regulatory Affairs, Pharmacovigilance, Clinical Research, Clinical Development, FDA, Regulatory Submissions, Medicine, Public Health, Quality Assurance, Protocol, Medical Devices, Sop, Immunology, SOP
Education
University of Missouri-Kansas City School of Medicine 1973 — 1979
B.A./M.D., Biology/Medicine
Food and Drug Administration 2008 - Present
Science Applications International Corporation-Frederick January 2005 - September 2008
National Institute on Drug Abuse/National Institutes of Health September 2002 - December 2004
FDA October 1998 - September 2002
Skills
GCP, Vaccines, Clinical Trials, Regulatory Affairs, Pharmacovigilance, Clinical Research, Clinical Development, FDA, Regulatory Submissions, Medicine, Public Health, Quality Assurance, Protocol, Medical Devices, Sop, Immunology, SOP
Education
University of Missouri-Kansas City School of Medicine 1973 — 1979
B.A./M.D., Biology/Medicine
Navin Goyal's Food and Drug Administration Experience May 2009 - July 2009
Job Director, Clinical Pharmacology, Modeling and Simulation at GSK
Industry Pharmaceuticals
Experience
GSK November 2014 - Present
University of Florida February 2014 - Present
GlaxoSmithKline October 2009 - October 2014
Food and Drug Administration May 2009 - July 2009
University of Florida 2004 - 2009
GlaxoSmithKline May 2008 - August 2008
Skills
Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics, Clinical Research, NONMEM, WinNonlin, Pharmacometrics, PK/PD, Pharmacology, Clinical Development, Clinical Study Design, Clinical Trials, Pharmaceutical Research, Drug Discovery, Drug Delivery, Oncology, Pharmaceutical Industry, Drug Development, Biotechnology, Life Sciences, Pharmaceutics
Education
University of Florida 2004 — 2009
Ph. D., Pharmaceutics
GSK November 2014 - Present
University of Florida February 2014 - Present
GlaxoSmithKline October 2009 - October 2014
Food and Drug Administration May 2009 - July 2009
University of Florida 2004 - 2009
GlaxoSmithKline May 2008 - August 2008
Skills
Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics, Clinical Research, NONMEM, WinNonlin, Pharmacometrics, PK/PD, Pharmacology, Clinical Development, Clinical Study Design, Clinical Trials, Pharmaceutical Research, Drug Discovery, Drug Delivery, Oncology, Pharmaceutical Industry, Drug Development, Biotechnology, Life Sciences, Pharmaceutics
Education
University of Florida 2004 — 2009
Ph. D., Pharmaceutics
Stacy Powers Newalu, MPH, CCRC's Food and Drug Administration Experience June 2008 - March 2010
Job Associate Director, Compliance and Quality at Advanced Clinical
Industry Research
Experience
Advanced Clinical September 2015 - Present
Advanced Clinical September 2014 - Present
Powers-Newalu Clinical Research Consulting July 2012 - Present
University of South Florida March 2010 - July 2012
Food and Drug Administration June 2008 - March 2010
University of South Florida November 2000 - June 2008
All Children's Hospital March 1998 - November 2000
Skills
Clinical Research, Public Health, Clinical Trials, Clinical Development, GCP, FDA, Oncology, Regulatory Affairs, Infectious Diseases, Drug Development, IRB, Microbiology, Immunology, PCR, ICH-GCP, Protocol, Clinical Study Design, Medical Writing, Cancer, Project Management, Research, Science, Pharmaceutical Industry, Medical Devices, Global Health, Sop, CRO, SOP
Education
University of Massachusetts, Amherst
BS, Medical Technology
University of Massachusetts, Amherst
BS, Microbiology
University of South Florida
MPH, Public Health/Infectious Disease
Advanced Clinical September 2015 - Present
Advanced Clinical September 2014 - Present
Powers-Newalu Clinical Research Consulting July 2012 - Present
University of South Florida March 2010 - July 2012
Food and Drug Administration June 2008 - March 2010
University of South Florida November 2000 - June 2008
All Children's Hospital March 1998 - November 2000
Skills
Clinical Research, Public Health, Clinical Trials, Clinical Development, GCP, FDA, Oncology, Regulatory Affairs, Infectious Diseases, Drug Development, IRB, Microbiology, Immunology, PCR, ICH-GCP, Protocol, Clinical Study Design, Medical Writing, Cancer, Project Management, Research, Science, Pharmaceutical Industry, Medical Devices, Global Health, Sop, CRO, SOP
Education
University of Massachusetts, Amherst
BS, Medical Technology
University of Massachusetts, Amherst
BS, Microbiology
University of South Florida
MPH, Public Health/Infectious Disease
Salina Kwong's Food and Drug Administration Experience February 2010 - Present
Job Accountant at Food and Drug Administration
Industry Accounting
Experience
Food and Drug Administration February 2010 - Present
William adley & Co August 2007 - February 2010
University of Maryland, University College 2001 - 2007
Skills
Internal Controls, Federal Government, Accounting, Government, QuickBooks, Internal Audit, Financial Reporting, Enterprise Risk..., Managerial Finance, Policy, Project Management
Education
University of Maryland College Park
Bachelor's degree, Accounting
University of Maryland University College
Certificate, Project Management
Food and Drug Administration February 2010 - Present
William adley & Co August 2007 - February 2010
University of Maryland, University College 2001 - 2007
Skills
Internal Controls, Federal Government, Accounting, Government, QuickBooks, Internal Audit, Financial Reporting, Enterprise Risk..., Managerial Finance, Policy, Project Management
Education
University of Maryland College Park
Bachelor's degree, Accounting
University of Maryland University College
Certificate, Project Management
Michael Merchlinsky's Food and Drug Administration Experience 1995 - 2008
Job Subject matter Expert at Tunnell Government Services
Industry Biotechnology
Experience
Tunnell Government Services January 2009 - Present
Department of Health and Human Services 2009 - Present
Tunnell for BARDA 2009 - Present
United States Department of Health & Human Services 2009 - Present
Department of Heath and Human Services 2009 - Present
BARDA 2009 - Present
Food and Drug Administration 1995 - 2008
National Institutes of Health 1987 - 1994
Skills
FDA, Lifesciences, GLP, Regulatory Affairs, Biotechnology, GMP, Molecular Biology, Pharmaceutical Industry, Cell Biology, Science, Technology Transfer, Validation, Program Management
Education
Yale University 1977 — 1984
Doctor of Philosophy (Ph.D.), Molecular Biophysics and Biochemistry
University of Maryland College Park 1973 — 1977
Bachelor of Science (BS), General Sciences
Tunnell Government Services January 2009 - Present
Department of Health and Human Services 2009 - Present
Tunnell for BARDA 2009 - Present
United States Department of Health & Human Services 2009 - Present
Department of Heath and Human Services 2009 - Present
BARDA 2009 - Present
Food and Drug Administration 1995 - 2008
National Institutes of Health 1987 - 1994
Skills
FDA, Lifesciences, GLP, Regulatory Affairs, Biotechnology, GMP, Molecular Biology, Pharmaceutical Industry, Cell Biology, Science, Technology Transfer, Validation, Program Management
Education
Yale University 1977 — 1984
Doctor of Philosophy (Ph.D.), Molecular Biophysics and Biochemistry
University of Maryland College Park 1973 — 1977
Bachelor of Science (BS), General Sciences
Peter Salsbury's Food and Drug Administration Experience March 1987 - Present
Job Project Manager at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration March 1987 - Present
Skills
Public Health, Program Evaluation, Policy, Government, Project Management, Food Safety, Guitar Playing, Public Speaking, Event Planning
Education
University of Maryland College Park 1975 — 1977
B.S., Biological Sciences
Food and Drug Administration March 1987 - Present
Skills
Public Health, Program Evaluation, Policy, Government, Project Management, Food Safety, Guitar Playing, Public Speaking, Event Planning
Education
University of Maryland College Park 1975 — 1977
B.S., Biological Sciences
Lisa Creason's Food and Drug Administration Experience 2010 - Present
Job Director, Information Systems
Industry Information Technology and Services
Experience
FDA/Office of Regulatory Affairs October 2014 - Present
Food and Drug Administration 2010 - Present
Tracen Inc. June 2008 - May 2010
Northrop Grumman Corporation 1994 - 2004
Skills
Government, PMO, Data Analysis, Enterprise Architecture, Management, SDLC, Analysis, Business Analysis, Integration, PMP, Program Management, Leadership, SharePoint, Strategic Planning, Government Contracting, Software Project..., Requirements Analysis, Software Development, Federal Government, Project Management, Quality Assurance, Business Process..., Visio, Proposal Writing, Policy, Process Improvement, Project Planning, Business Process, Change Management, Business Intelligence, Requirements Gathering, MS Project, Policy Analysis, Project Portfolio..., Knowledge Management
Education
University of North Carolina at Chapel Hill 1989 — 2002
Bachelor of Arts (B.A.), Economics
University of Maryland - Robert H. Smith School of Business 1997 — 2000
Master of Business Administration (M.B.A.), Informations Systems and Supply Chain Management
FDA/Office of Regulatory Affairs October 2014 - Present
Food and Drug Administration 2010 - Present
Tracen Inc. June 2008 - May 2010
Northrop Grumman Corporation 1994 - 2004
Skills
Government, PMO, Data Analysis, Enterprise Architecture, Management, SDLC, Analysis, Business Analysis, Integration, PMP, Program Management, Leadership, SharePoint, Strategic Planning, Government Contracting, Software Project..., Requirements Analysis, Software Development, Federal Government, Project Management, Quality Assurance, Business Process..., Visio, Proposal Writing, Policy, Process Improvement, Project Planning, Business Process, Change Management, Business Intelligence, Requirements Gathering, MS Project, Policy Analysis, Project Portfolio..., Knowledge Management
Education
University of North Carolina at Chapel Hill 1989 — 2002
Bachelor of Arts (B.A.), Economics
University of Maryland - Robert H. Smith School of Business 1997 — 2000
Master of Business Administration (M.B.A.), Informations Systems and Supply Chain Management
Andreas Keller's Food and Drug Administration Experience 2000 - 2004
Job Director of International Equivalence at USDAFSIS
Industry Government Administration
Experience
USDA-FSIS August 2004 - Present
Food and Drug Administration 2000 - 2004
Skills
Infectious Diseases, Public Health, Policy, Microbiology, Epidemiology, Regulatory Affairs, Food Science, Program Management, GMP, Food Microbiology, Policy Analysis, HACCP, Government, Food Safety, Environmental Health, Federal Government, Meat, Public Policy
Education
U of Florida 1990 — 1997
University of Florida 1990 — 1997
Ph.D., Food Science and Human Nutrition
Humboldt Schule
USDA-FSIS August 2004 - Present
Food and Drug Administration 2000 - 2004
Skills
Infectious Diseases, Public Health, Policy, Microbiology, Epidemiology, Regulatory Affairs, Food Science, Program Management, GMP, Food Microbiology, Policy Analysis, HACCP, Government, Food Safety, Environmental Health, Federal Government, Meat, Public Policy
Education
U of Florida 1990 — 1997
University of Florida 1990 — 1997
Ph.D., Food Science and Human Nutrition
Humboldt Schule
Cruzan (Samhsa)'s Food and Drug Administration Experience November 1980 - August 2009
Job Public Affairs Specialist at Department of Health and Human Services
Industry Government Administration
Experience
Department of Health and Human Services August 2009 - Present
Food and Drug Administration November 1980 - August 2009
Education
University of Maryland College Park
BA, Radio, TV and Film
Department of Health and Human Services August 2009 - Present
Food and Drug Administration November 1980 - August 2009
Education
University of Maryland College Park
BA, Radio, TV and Film
Adrian Senderowicz's Food and Drug Administration Experience January 2005 - July 2008
Job Vice President, Clinical Development, and Chief Medical Officer at Tokai Pharmaceuticals
Industry
Experience
Tokai Pharmaceuticals July 2012 - Present
AstraZeneca Pharmaceuticals 2008 - July 2012
Food and Drug Administration January 2005 - July 2008
National Institutes of Health April 2000 - December 2004
National Cancer Institute July 1995 - March 2000
Education
University of Buenos Aires 1982 — 1987
md, School of Medicine
Tokai Pharmaceuticals July 2012 - Present
AstraZeneca Pharmaceuticals 2008 - July 2012
Food and Drug Administration January 2005 - July 2008
National Institutes of Health April 2000 - December 2004
National Cancer Institute July 1995 - March 2000
Education
University of Buenos Aires 1982 — 1987
md, School of Medicine
Bina Dharia's Food and Drug Administration Experience March 2007 - June 2007
Job Pharmacy Technician at Giant Food
Industry Retail
Experience
Giant Food April 2008 - Present
Washington Center for Diabetes and Endocrinology January 2006 - August 2007
Food and Drug Administration March 2007 - June 2007
Education
University of Maryland College Park 2002 — 2006
Bachelor of Science, Neurobiology & Physiology
Giant Food April 2008 - Present
Washington Center for Diabetes and Endocrinology January 2006 - August 2007
Food and Drug Administration March 2007 - June 2007
Education
University of Maryland College Park 2002 — 2006
Bachelor of Science, Neurobiology & Physiology
Cathy Condon's Food and Drug Administration Experience February 1993 - Present
Job Consumer Safety Officer at Food and Drug Administration
Industry Medical Devices
Experience
Food and Drug Administration February 1993 - Present
Education
Maryland Drafting Institute 1982 — 1984
University of Maryland College Park 1976 — 1980
Food and Drug Administration February 1993 - Present
Education
Maryland Drafting Institute 1982 — 1984
University of Maryland College Park 1976 — 1980
Virginia P. Hight's Food and Drug Administration Experience April 1991 - November 1991
Job Experienced research expert with doctoral degree in epidemiology and experience in global studies.
Industry Pharmaceuticals
Experience
University Research Company/Center for Human Services December 2010 - June 2012
IntraHealth International, Inc January 2008 - November 2010
Elizabethtown College August 2001 - December 2007
Shenandoah University, Program in Occupational Therapy July 1997 - July 2001
John Snow Incorporated April 1996 - July 1997
Georgetown Univ., Inst. Reprod. Health November 1991 - April 1996
Food and Drug Administration April 1991 - November 1991
Saint George's University School of Medicine August 1988 - December 1990
Population Council January 1990 - October 1990
National Research Council May 1984 - July 1988
Skills
Developing research..., Managing research..., Writing for peer..., Quality control of..., Ethics and IRBs, Global research: Asia,..., Management and..., Management of..., Applying epidemiology...
Education
School of Public Health, University of California Los Angeles 1973 — 1978
Master of Public Health, Division of Population Family and International Health
University of California, Los Angeles - Fielding School of Public Health 1973 — 1978
Doctor of Public Health, Division of Epidemiology
Tufts University 1966 — 1970
Bachelor of Science, Occupational Therapy
University Research Company/Center for Human Services December 2010 - June 2012
IntraHealth International, Inc January 2008 - November 2010
Elizabethtown College August 2001 - December 2007
Shenandoah University, Program in Occupational Therapy July 1997 - July 2001
John Snow Incorporated April 1996 - July 1997
Georgetown Univ., Inst. Reprod. Health November 1991 - April 1996
Food and Drug Administration April 1991 - November 1991
Saint George's University School of Medicine August 1988 - December 1990
Population Council January 1990 - October 1990
National Research Council May 1984 - July 1988
Skills
Developing research..., Managing research..., Writing for peer..., Quality control of..., Ethics and IRBs, Global research: Asia,..., Management and..., Management of..., Applying epidemiology...
Education
School of Public Health, University of California Los Angeles 1973 — 1978
Master of Public Health, Division of Population Family and International Health
University of California, Los Angeles - Fielding School of Public Health 1973 — 1978
Doctor of Public Health, Division of Epidemiology
Tufts University 1966 — 1970
Bachelor of Science, Occupational Therapy
Olga Claudio's Food and Drug Administration Experience March 2010 - Present
Job Regulatory Scientist
Industry Government Administration
Experience
Food and Drug Administration March 2010 - Present
San Juan Bautista School of Medicine 2008 - 2010
Amgen Manufacturing Limited 2005 - 2007
Abbott Laboratories 2002 - 2005
Skills
Pharmacology, In Vitro, FDA, Toxicology, Laboratory, Neuroscience, Medical Devices, Regulatory Affairs, Quality Control, Chemistry, Validation, Assay Development, CAPA, Electrophysiology, Biotechnology, Biochemistry, Project Management, Infectious Diseases, Inspection, Complaint Investigations, Product Complaints, Recalls, Regulatory Submissions, Regulatory Compliance
Education
University of Puerto Rico School of Medicine
Ph.D., Pharmacology and Toxicology
Universidad de Puerto Rico
BS, General Sciences
Food and Drug Administration March 2010 - Present
San Juan Bautista School of Medicine 2008 - 2010
Amgen Manufacturing Limited 2005 - 2007
Abbott Laboratories 2002 - 2005
Skills
Pharmacology, In Vitro, FDA, Toxicology, Laboratory, Neuroscience, Medical Devices, Regulatory Affairs, Quality Control, Chemistry, Validation, Assay Development, CAPA, Electrophysiology, Biotechnology, Biochemistry, Project Management, Infectious Diseases, Inspection, Complaint Investigations, Product Complaints, Recalls, Regulatory Submissions, Regulatory Compliance
Education
University of Puerto Rico School of Medicine
Ph.D., Pharmacology and Toxicology
Universidad de Puerto Rico
BS, General Sciences
Marina Irony's Food and Drug Administration Experience June 2009 - January 2010
Job Consultant at Accenture
Industry Management Consulting
Experience
Accenture February 2012 - Present
ORISE Fellowship August 2011 - February 2012
University of Maryland, College Park January 2010 - May 2011
University of Maryland, College Park August 2010 - December 2010
Food and Drug Administration June 2009 - January 2010
University of Maryland, College Park August 2009 - December 2009
University of Maryland, College Park January 2009 - May 2009
Kappa Alpha Theta Gamma mu chapter September 2008 - May 2009
Idea TV June 2008 - August 2008
Skills
AP Style, Microsoft Office, Traction, Brazilian Portuguese, Spanish, Hebrew, Strategic Planning, Community Outreach, Ap Style
Education
University of Maryland College Park 2007 — 2011
B.A., Communication - Public Relations
Charles E. Smith Jewish Day School 1995 — 2007
High School
Universitat de Barcelona
Spanish Language
Accenture February 2012 - Present
ORISE Fellowship August 2011 - February 2012
University of Maryland, College Park January 2010 - May 2011
University of Maryland, College Park August 2010 - December 2010
Food and Drug Administration June 2009 - January 2010
University of Maryland, College Park August 2009 - December 2009
University of Maryland, College Park January 2009 - May 2009
Kappa Alpha Theta Gamma mu chapter September 2008 - May 2009
Idea TV June 2008 - August 2008
Skills
AP Style, Microsoft Office, Traction, Brazilian Portuguese, Spanish, Hebrew, Strategic Planning, Community Outreach, Ap Style
Education
University of Maryland College Park 2007 — 2011
B.A., Communication - Public Relations
Charles E. Smith Jewish Day School 1995 — 2007
High School
Universitat de Barcelona
Spanish Language
Jee Eun Lee's Food and Drug Administration Experience July 2009 - Present
Job Pharmacometrics Reviewer at FDA
Industry Government Administration
Experience
Food and Drug Administration July 2009 - Present
Vertex Pharmaceuticals June 2007 - June 2009
Skills
Oncology, Pharmacokinetics, Clinical Pharmacology, R
Education
University of Minnesota-Twin Cities 2000 — 2007
Ph.D, Pharmacokinetics and Pharmacodynamics
Food and Drug Administration July 2009 - Present
Vertex Pharmaceuticals June 2007 - June 2009
Skills
Oncology, Pharmacokinetics, Clinical Pharmacology, R
Education
University of Minnesota-Twin Cities 2000 — 2007
Ph.D, Pharmacokinetics and Pharmacodynamics
Todd Phillips, PharmD, RAC's Food and Drug Administration Experience January 2009 - March 2011
Job Director, Executive Consultant at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences June 2014 - Present
Beckloff Associates (a Cardinal Health company) March 2011 - June 2014
Food and Drug Administration January 2009 - March 2011
Quintiles January 2008 - December 2008
Quintiles December 2006 - December 2007
Quintiles July 2005 - December 2006
Novartis Pharmaceuticals/Rutgers University Fellowship (Clnical Research and Marketing) June 2003 - June 2005
Skills
Regulatory Affairs, Project Management, Clinical Development, Clinical Pharmacology, Clinical Trials, Pharmaceutical Industry, Oncology, Regulatory Submissions, FDA, Clinical Research, SOP, Biotechnology
Education
University of Missouri-Kansas City 1998 — 2003
Pharm.D., Pharmacy
Cardinal Health Regulatory Sciences June 2014 - Present
Beckloff Associates (a Cardinal Health company) March 2011 - June 2014
Food and Drug Administration January 2009 - March 2011
Quintiles January 2008 - December 2008
Quintiles December 2006 - December 2007
Quintiles July 2005 - December 2006
Novartis Pharmaceuticals/Rutgers University Fellowship (Clnical Research and Marketing) June 2003 - June 2005
Skills
Regulatory Affairs, Project Management, Clinical Development, Clinical Pharmacology, Clinical Trials, Pharmaceutical Industry, Oncology, Regulatory Submissions, FDA, Clinical Research, SOP, Biotechnology
Education
University of Missouri-Kansas City 1998 — 2003
Pharm.D., Pharmacy
Anya McLin's Food and Drug Administration Experience October 2000 - October 2002
Job Information Technology and Services Professional
Industry Information Technology and Services
Experience
AOL April 2004 - February 2005
Spirent Communications October 2002 - March 2004
Food and Drug Administration October 2000 - October 2002
Network Associates July 2000 - October 2000
Arbros Technologies, Bethesda, Maryland May 1999 - June 2000
Huges Network 2000 - 2000
CSC September 1998 - May 1999
MCI 1999 - 1999
NASA Goddard Space Flight Center June 1998 - September 1998
M2Limited, Gaithersburg, MD April 1997 - June 1998
Education
University of Maryland College Park
B. A., Linguistics
AOL April 2004 - February 2005
Spirent Communications October 2002 - March 2004
Food and Drug Administration October 2000 - October 2002
Network Associates July 2000 - October 2000
Arbros Technologies, Bethesda, Maryland May 1999 - June 2000
Huges Network 2000 - 2000
CSC September 1998 - May 1999
MCI 1999 - 1999
NASA Goddard Space Flight Center June 1998 - September 1998
M2Limited, Gaithersburg, MD April 1997 - June 1998
Education
University of Maryland College Park
B. A., Linguistics
Linda Tukenmez's Food and Drug Administration Experience January 1976 - January 2007
Job Independent Consumer Services Professional
Industry Consumer Services
Experience
Food and Drug Administration January 1976 - January 2007
Skills
Government, Public Health, Community Outreach, Media Relations, Policy, Policy Analysis, Public Policy, Strategic Communications, Legislative Relations, Public Relations, Research, Program Evaluation
Education
University of Maryland College Park 1964 — 1973
M.A., B.A., Criminology, History
Food and Drug Administration January 1976 - January 2007
Skills
Government, Public Health, Community Outreach, Media Relations, Policy, Policy Analysis, Public Policy, Strategic Communications, Legislative Relations, Public Relations, Research, Program Evaluation
Education
University of Maryland College Park 1964 — 1973
M.A., B.A., Criminology, History
David Earles's Food and Drug Administration Experience April 2010 - January 2014
Job Developer at Discover Technologies
Industry Government Administration
Experience
Discover Technologies January 2014 - Present
Food and Drug Administration April 2010 - January 2014
Education
University of Maryland Baltimore County
Discover Technologies January 2014 - Present
Food and Drug Administration April 2010 - January 2014
Education
University of Maryland Baltimore County
Cheryl (Sherry) van der Zwet, Project Manager/AO's Food and Drug Administration Experience January 2013 - Present
Job Food and Drug Administration, Office of Human Resources, Bethesda, MD
Industry Government Administration
Experience
Food and Drug Administration January 2013 - Present
Education
University of Maryland College Park 1984 — 1985
Bachelor of Science (B.S.), Counseling Psychology
Food and Drug Administration January 2013 - Present
Education
University of Maryland College Park 1984 — 1985
Bachelor of Science (B.S.), Counseling Psychology
Sabena (Uddowla) Blakeney's Food and Drug Administration Experience February 2000 - May 2001
Job Biological Safety Coordinator/Biosafety Officer
Industry Research
Experience
University of Central Florida February 2015 - Present
National Institutes of Health January 2013 - December 2014
Plum Island Animal Disease Center, ARS, USDA November 2008 - October 2012
Tulane University School of Medicine January 2008 - August 2008
Tulane University School of Medicine August 2003 - December 2007
Johns Hopkins University June 2001 - June 2003
Food and Drug Administration February 2000 - May 2001
Education
Tulane University School of Medicine 2003 — 2007
Doctor of Philosophy (Ph.D.), Molecular and Cellular Biology
University of Maryland College Park 1997 — 2001
B.S, Microbiology
University of Central Florida February 2015 - Present
National Institutes of Health January 2013 - December 2014
Plum Island Animal Disease Center, ARS, USDA November 2008 - October 2012
Tulane University School of Medicine January 2008 - August 2008
Tulane University School of Medicine August 2003 - December 2007
Johns Hopkins University June 2001 - June 2003
Food and Drug Administration February 2000 - May 2001
Education
Tulane University School of Medicine 2003 — 2007
Doctor of Philosophy (Ph.D.), Molecular and Cellular Biology
University of Maryland College Park 1997 — 2001
B.S, Microbiology
Rongping Zeng's Food and Drug Administration Experience Research ScientistFood and Drug Administration$
Job Research Scientist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration Research ScientistFood and Drug Administration$
Education
University of Michigan 2002 — 2007
Doctor of Philosophy (PhD), Electrical Engineering and Computer Science
Tongji University
Food and Drug Administration Research ScientistFood and Drug Administration$
Education
University of Michigan 2002 — 2007
Doctor of Philosophy (PhD), Electrical Engineering and Computer Science
Tongji University
Nneka Onwudiwe, PharmD PhD MBA's Food and Drug Administration Experience 2012 - Present
Job PRO/PE Regulatory Review Officer at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration 2012 - Present
The Food and Drug Law Institute (FDLI) 2012 - 2015
University of Maryland 2005 - 2012
Skills
Regulatory Requirements, SAS, Data Analysis, Regulatory Affairs, Public Health, FDA, Infectious Diseases, Epidemiology, Pharmaceutical Industry, Clinical Trials, Lifesciences, Regulatory Submissions, Pharmacology, Health Economics, Outcomes Research, Clinical Research, Life Sciences, Healthcare
Education
University of Maryland Baltimore
Doctor of Pharmacy (PharmD), Pharmacy
University of Maryland Baltimore
Doctor of Philosophy (PhD), Pharmacoeconomics/Pharmaceutical Economics
University of Baltimore
Master of Business Administration (MBA)
Food and Drug Administration 2012 - Present
The Food and Drug Law Institute (FDLI) 2012 - 2015
University of Maryland 2005 - 2012
Skills
Regulatory Requirements, SAS, Data Analysis, Regulatory Affairs, Public Health, FDA, Infectious Diseases, Epidemiology, Pharmaceutical Industry, Clinical Trials, Lifesciences, Regulatory Submissions, Pharmacology, Health Economics, Outcomes Research, Clinical Research, Life Sciences, Healthcare
Education
University of Maryland Baltimore
Doctor of Pharmacy (PharmD), Pharmacy
University of Maryland Baltimore
Doctor of Philosophy (PhD), Pharmacoeconomics/Pharmaceutical Economics
University of Baltimore
Master of Business Administration (MBA)
Joe Neubauer's Food and Drug Administration Experience May 2005 - Present
Job Solutions Architect at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration May 2005 - Present
Education
University of Maryland College Park
Masters, Systems Engineering
University of Maryland Baltimore County
Batchelors, Computer Science
Food and Drug Administration May 2005 - Present
Education
University of Maryland College Park
Masters, Systems Engineering
University of Maryland Baltimore County
Batchelors, Computer Science
Erica I-Fang Lee's Food and Drug Administration Experience 1996 - 1999
Job Scientist II at ViroGin Biotech
Industry Pharmaceuticals
Experience
ViroGin Biotech Inc. July 2015 - Present
SignalChem Pharmaceuticals Inc. October 2014 - July 2015
SignalChem Pharmaceuticals Inc. November 2012 - October 2014
Department of Surgery, the University of British Columbia 2010 - 2012
Department of Molecular Immunology, National Kochi University 2004 - 2005
Food and Drug Administration 1996 - 1999
Skills
Immunology, Molecular & Cellular..., Assay Development, Drug Discovery, Gene Cloning, DNA Sequencing, RT-PCR, Western Blotting, siRNA transfection, Multi-color Flow..., Animal Models, Cell Isolation from..., Cytotoxicity Assay, Apoptosis Assay, in vitro T cells..., ELISA, ELISPOT, Colony formation assay, Cell Invasion Assay, Tumorsphere assay, Kinase / Enzyme..., Data Analysis, Mammalian Cell Culture, Bacterial Cell Culture
Education
The University of British Columbia 2005 — 2010
Doctor of Philosophy (Ph.D.)
ViroGin Biotech Inc. July 2015 - Present
SignalChem Pharmaceuticals Inc. October 2014 - July 2015
SignalChem Pharmaceuticals Inc. November 2012 - October 2014
Department of Surgery, the University of British Columbia 2010 - 2012
Department of Molecular Immunology, National Kochi University 2004 - 2005
Food and Drug Administration 1996 - 1999
Skills
Immunology, Molecular & Cellular..., Assay Development, Drug Discovery, Gene Cloning, DNA Sequencing, RT-PCR, Western Blotting, siRNA transfection, Multi-color Flow..., Animal Models, Cell Isolation from..., Cytotoxicity Assay, Apoptosis Assay, in vitro T cells..., ELISA, ELISPOT, Colony formation assay, Cell Invasion Assay, Tumorsphere assay, Kinase / Enzyme..., Data Analysis, Mammalian Cell Culture, Bacterial Cell Culture
Education
The University of British Columbia 2005 — 2010
Doctor of Philosophy (Ph.D.)
Department of Veterans Affairs
US Census Bureau
U.S. Department of Veterans Affairs
FDA
US Securities and Exchange Commission
USAID
US Fish and Wildlife Service
TSA