FDA Company
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
FDA List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at FDA. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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4,886 FDA employees in database. Find out everything there's to know about FDA employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
FDA Employees
Employee
Years
Job
Industry
Danielle Norman Danielle Norman's FDA Experience July 2014 - Present
Job Student at Fisk University
Industry Pharmaceuticals
Experience
FDA July 2014 - Present
TJ Maxx August 2011 - January 2014
The Leaders of Tennessee PAC October 2012 - November 2012
Skills
Retail Sales, Communication, Administrative..., Customer Service, Data Entry, Organizational..., Cashiering, merchandise presentation, Data Analysis, Creative Writing, Memorization
Education
Fisk University 2012 — 2016
Bachelor of Arts (BA), Biology, General, Senior
Gwendolyn Brooks College Prepatory Academy Highschool 2008 — 2012
General Studies
FDA July 2014 - Present
TJ Maxx August 2011 - January 2014
The Leaders of Tennessee PAC October 2012 - November 2012
Skills
Retail Sales, Communication, Administrative..., Customer Service, Data Entry, Organizational..., Cashiering, merchandise presentation, Data Analysis, Creative Writing, Memorization
Education
Fisk University 2012 — 2016
Bachelor of Arts (BA), Biology, General, Senior
Gwendolyn Brooks College Prepatory Academy Highschool 2008 — 2012
General Studies
Alexis Mosquera Alexis Mosquera's FDA Experience June 2007 - December 2012
Job Science Officer at Congresionally Directed Medical Research Programs
Industry Military
Experience
Congresionally Directed Medical Research Programs December 2012 - Present
FDA June 2007 - December 2012
National Institutes of Health January 1999 - June 2007
Skills
Public Health, Policy Analysis, Epidemiology, Statistics, Global Health, International Health, Program Evaluation, Health Policy, Biostatistics, Infectious Diseases, Prevention, Health Promotion, Environmental Health, Health Education, Clinical Research, Policy, Stata, SAS, Data Analysis, Research, Community Health, Medical Research, Public Health Emergency..., Vaccines, Health Communication
Education
George Mason University
Masters in Public Health, Global Health
Marymount University
Bachelor of Science, Nursing
Congresionally Directed Medical Research Programs December 2012 - Present
FDA June 2007 - December 2012
National Institutes of Health January 1999 - June 2007
Skills
Public Health, Policy Analysis, Epidemiology, Statistics, Global Health, International Health, Program Evaluation, Health Policy, Biostatistics, Infectious Diseases, Prevention, Health Promotion, Environmental Health, Health Education, Clinical Research, Policy, Stata, SAS, Data Analysis, Research, Community Health, Medical Research, Public Health Emergency..., Vaccines, Health Communication
Education
George Mason University
Masters in Public Health, Global Health
Marymount University
Bachelor of Science, Nursing
Pallavi Mishra-Kalyani Pallavi Mishra-Kalyani's FDA Experience April 2015 - Present
Job Mathematical Statistician at FDA
Industry
Experience
FDA April 2015 - Present
Department of Biostatistics and Bioinformatics, Emory University September 2011 - August 2014
Department of Biostatistics and Bioinformatics, Emory University August 2009 - August 2014
Department of Biostatistics and Bioinformatics, Emory University September 2010 - December 2013
Harvard School of Public Health February 2008 - May 2009
Putnam Associates September 2005 - April 2007
Globsyn Technologies June 2005 - August 2005
Putnam Associates June 2004 - August 2004
U.S. Census Bureau June 2003 - August 2003
Skills
Biostatistics, Causal Inference, Epidemiology, Clinical Research, Observational Studies, Clinical Trials, Statistical Modeling, Statistical Data..., Public Health, R, SAS, Statistics, Data Analysis, Immunology
Education
Emory University 2009 — 2014
Doctor of Philosophy (Ph.D.)
Harvard School of Public Health 2007 — 2009
Master of Science (M.S.)
Massachusetts Institute of Technology 2001 — 2005
Bachelor of Science (B.S.)
FDA April 2015 - Present
Department of Biostatistics and Bioinformatics, Emory University September 2011 - August 2014
Department of Biostatistics and Bioinformatics, Emory University August 2009 - August 2014
Department of Biostatistics and Bioinformatics, Emory University September 2010 - December 2013
Harvard School of Public Health February 2008 - May 2009
Putnam Associates September 2005 - April 2007
Globsyn Technologies June 2005 - August 2005
Putnam Associates June 2004 - August 2004
U.S. Census Bureau June 2003 - August 2003
Skills
Biostatistics, Causal Inference, Epidemiology, Clinical Research, Observational Studies, Clinical Trials, Statistical Modeling, Statistical Data..., Public Health, R, SAS, Statistics, Data Analysis, Immunology
Education
Emory University 2009 — 2014
Doctor of Philosophy (Ph.D.)
Harvard School of Public Health 2007 — 2009
Master of Science (M.S.)
Massachusetts Institute of Technology 2001 — 2005
Bachelor of Science (B.S.)
Jan Holladay Pierre, MPH, CMQ/OE Jan Holladay Pierre, MPH, CMQ/OE's FDA Experience December 1998 - September 2004
Job Sr QA Auditor at INC Research
Industry Research
Experience
INC Research July 2014 - Present
Translational Research Institute for Metabolism and Diabetes November 2012 - May 2014
DynPort Vaccine Company LLC, A CSC Company June 2011 - November 2012
SAIC August 2010 - June 2011
Quintiles July 2009 - July 2010
KAI Research, Inc October 2007 - July 2009
RxTrials September 2005 - September 2007
Association of Clinical Research Professionals September 2004 - September 2005
FDA December 1998 - September 2004
Skills
Clinical Trials, Regulatory Affairs, FDA, GCP, Clinical Research, Medical Devices, Biotechnology, Pharmaceutical Industry, CTMS, Lifesciences, Infectious Diseases, Vaccines, Regulatory Submissions, Clinical Development, Sop, Quality System, Quality Auditing, Quality Assurance, SOP, Life Sciences
Education
The George Washington University 1999 — 2002
Master of Public Health (M.P.H.), Health Policy
Florida State University 1987 — 1990
Bachelor's degree, Political Science and Government
Mainland Senior High
INC Research July 2014 - Present
Translational Research Institute for Metabolism and Diabetes November 2012 - May 2014
DynPort Vaccine Company LLC, A CSC Company June 2011 - November 2012
SAIC August 2010 - June 2011
Quintiles July 2009 - July 2010
KAI Research, Inc October 2007 - July 2009
RxTrials September 2005 - September 2007
Association of Clinical Research Professionals September 2004 - September 2005
FDA December 1998 - September 2004
Skills
Clinical Trials, Regulatory Affairs, FDA, GCP, Clinical Research, Medical Devices, Biotechnology, Pharmaceutical Industry, CTMS, Lifesciences, Infectious Diseases, Vaccines, Regulatory Submissions, Clinical Development, Sop, Quality System, Quality Auditing, Quality Assurance, SOP, Life Sciences
Education
The George Washington University 1999 — 2002
Master of Public Health (M.P.H.), Health Policy
Florida State University 1987 — 1990
Bachelor's degree, Political Science and Government
Mainland Senior High
Melanie Douez, RMP Melanie Douez, RMP's FDA Experience January 2002 - August 2002
Job Massage Therapist
Industry Health, Wellness and Fitness
Experience
Nuvo Salon and Spa January 2013 - Present
Healing Circles Wellness Center March 2012 - December 2012
GenSpring Family Offices (SunTrust Bank) January 2006 - February 2008
Elaj Aveda Day Spa August 2002 - August 2003
FDA January 2002 - August 2002
MedContrax, Inc. July 1999 - January 2002
McLean Racquet and Health Club December 1997 - July 1999
Skills
Neuromuscular Therapy, Connective Tissue..., Swedish Massage, Reflexology, Polarity Therapy, Chair Massage, Deep Tissue Massage, Therapeutic Massage, Stress Management, Microsoft Office Xp, PowerPoint development, Microsoft Excel, Executive..., Prenatal Care, Relaxation, Pain Management, Holistic Health, Fitness, Swedish, Stress, Healing, Trigger Point Therapy, Spa, Wellbeing
Education
Florida School of Massage 1997 — 1997
Certified, Massage Therapy/Therapeutic Massage
Nuvo Salon and Spa January 2013 - Present
Healing Circles Wellness Center March 2012 - December 2012
GenSpring Family Offices (SunTrust Bank) January 2006 - February 2008
Elaj Aveda Day Spa August 2002 - August 2003
FDA January 2002 - August 2002
MedContrax, Inc. July 1999 - January 2002
McLean Racquet and Health Club December 1997 - July 1999
Skills
Neuromuscular Therapy, Connective Tissue..., Swedish Massage, Reflexology, Polarity Therapy, Chair Massage, Deep Tissue Massage, Therapeutic Massage, Stress Management, Microsoft Office Xp, PowerPoint development, Microsoft Excel, Executive..., Prenatal Care, Relaxation, Pain Management, Holistic Health, Fitness, Swedish, Stress, Healing, Trigger Point Therapy, Spa, Wellbeing
Education
Florida School of Massage 1997 — 1997
Certified, Massage Therapy/Therapeutic Massage
Saumya Gurbani Saumya Gurbani's FDA Experience January 2012 - December 2012
Job MD/PhD Student, Emory University School of Medicine
Industry Medical Devices
Experience
FDA January 2012 - December 2012
Hopkins Consulting Agency March 2009 - December 2011
Hopkins Consulting Agency September 2010 - August 2011
FDA June 2010 - August 2011
Gracias Lab January 2009 - April 2011
Skills
LaTeX, Matlab, Mathematical Modeling, Biomedical Engineering
Education
Emory University School of Medicine 2013 — 2020
MD/PhD
The Johns Hopkins University 2011 — 2013
M.S.E., Biomedical Engineering
The Johns Hopkins University 2008 — 2011
B.S., Biomedical Engineering, Applied Math & Statistics, Entrepreneurship & Management
FDA January 2012 - December 2012
Hopkins Consulting Agency March 2009 - December 2011
Hopkins Consulting Agency September 2010 - August 2011
FDA June 2010 - August 2011
Gracias Lab January 2009 - April 2011
Skills
LaTeX, Matlab, Mathematical Modeling, Biomedical Engineering
Education
Emory University School of Medicine 2013 — 2020
MD/PhD
The Johns Hopkins University 2011 — 2013
M.S.E., Biomedical Engineering
The Johns Hopkins University 2008 — 2011
B.S., Biomedical Engineering, Applied Math & Statistics, Entrepreneurship & Management
Jason Contino Jason Contino's FDA Experience October 1998 - June 1999
Job Account Executive at Suncoast Business Technologies, LLC
Industry Information Technology and Services
Experience
Suncoast Business Technologies, LLC May 2015 - Present
Atlas Professional Services September 2014 - April 2015
Pentasys Corporation June 2011 - August 2014
Academy at the Lakes June 2008 - June 2011
Corbett Preparatory School of IDS June 2006 - June 2008
Best Buy August 2001 - August 2004
Dell January 2001 - May 2001
Florida Department of Transportation July 1999 - December 2000
FDA October 1998 - June 1999
Skills
Virtualization, Citrix, Cloud Computing, Integration, Troubleshooting, VoIP, Data Center, IT Service Management, VMware, Disaster Recovery, Business Development, Databases, Enterprise Software, IT Management, Information Technology, Infrastructure, Leadership, Managed Services, Network Security, Networking, Professional Services, Project Management, Project Planning, SaaS, Security, Servers, Solution Selling, Storage, Strategic Planning, Strategy, Team Building, Technical Support, Windows Server, Vendor Management, Business Alliances, Telecommunications, Operations Management, Management, IT Strategy, Product Management, Channel Partners, Unified Communications, Hardware, IT Operations, Pre-sales, System Deployment, Team Leadership, VDI, Cisco Technologies
Education
Coursera
University of Central Florida 1997 — 1999
Bachelor of Science (BS), Health Services Administration
Metropolitan State University of Denver 2003 — 2004
Certificate, Secondary Education, Social Studies
Florida State University 1994 — 1997
A.A., Liberal Arts and Sciences/Liberal Studies
Lake Mary High School 1989 — 1994
Suncoast Business Technologies, LLC May 2015 - Present
Atlas Professional Services September 2014 - April 2015
Pentasys Corporation June 2011 - August 2014
Academy at the Lakes June 2008 - June 2011
Corbett Preparatory School of IDS June 2006 - June 2008
Best Buy August 2001 - August 2004
Dell January 2001 - May 2001
Florida Department of Transportation July 1999 - December 2000
FDA October 1998 - June 1999
Skills
Virtualization, Citrix, Cloud Computing, Integration, Troubleshooting, VoIP, Data Center, IT Service Management, VMware, Disaster Recovery, Business Development, Databases, Enterprise Software, IT Management, Information Technology, Infrastructure, Leadership, Managed Services, Network Security, Networking, Professional Services, Project Management, Project Planning, SaaS, Security, Servers, Solution Selling, Storage, Strategic Planning, Strategy, Team Building, Technical Support, Windows Server, Vendor Management, Business Alliances, Telecommunications, Operations Management, Management, IT Strategy, Product Management, Channel Partners, Unified Communications, Hardware, IT Operations, Pre-sales, System Deployment, Team Leadership, VDI, Cisco Technologies
Education
Coursera
University of Central Florida 1997 — 1999
Bachelor of Science (BS), Health Services Administration
Metropolitan State University of Denver 2003 — 2004
Certificate, Secondary Education, Social Studies
Florida State University 1994 — 1997
A.A., Liberal Arts and Sciences/Liberal Studies
Lake Mary High School 1989 — 1994
John Sarmiento's FDA Experience March 2014 - Present
Job Sr. Technician at FDA
Industry Information Technology and Services
Experience
FDA March 2014 - Present
Best Buy December 2011 - April 2014
General Nutrition Center May 2009 - September 2011
Skills
Building Relationships, Customer Satisfaction, Management, Sales Management, Leadership, Customer Experience, Problem Solving, Strategic Leadership, Consulting, Business Analysis, Employee Training, Store Management, Telecommunications, Adobe Connect, Hiring, Teamwork, Marketing, Profit, Planograms, Merchandising, Communication, Multi Tasking, Strategy, Finance, Business Process..., Business Planning, Microsoft Excel, Microsoft Office, Inventory Management, Team-orientated
Education
George Mason University 2013 — 2015
Bachelor of Business Administration (BBA)
Northern Virginia Community College 2011 — 2013
Associate of Arts and Sciences (A.A.S.), Business Administration, Management and Operations, 3.3
FDA March 2014 - Present
Best Buy December 2011 - April 2014
General Nutrition Center May 2009 - September 2011
Skills
Building Relationships, Customer Satisfaction, Management, Sales Management, Leadership, Customer Experience, Problem Solving, Strategic Leadership, Consulting, Business Analysis, Employee Training, Store Management, Telecommunications, Adobe Connect, Hiring, Teamwork, Marketing, Profit, Planograms, Merchandising, Communication, Multi Tasking, Strategy, Finance, Business Process..., Business Planning, Microsoft Excel, Microsoft Office, Inventory Management, Team-orientated
Education
George Mason University 2013 — 2015
Bachelor of Business Administration (BBA)
Northern Virginia Community College 2011 — 2013
Associate of Arts and Sciences (A.A.S.), Business Administration, Management and Operations, 3.3
Paul Sheiman Paul Sheiman's FDA Experience January 2011 - April 2011
Job Public Policy Student at Rutgers University
Industry Public Policy
Experience
FDA January 2011 - April 2011
Estee Lauder March 2010 - June 2010
Farmingdale State University of New York September 2009 - December 2009
A. E. Feldman Associates, Inc. July 2002 - September 2009
Skills
Laboratory, Microbiology, Molecular Biology, Cell Biology, Databases, HTML, Operating Systems, Microsoft Exchange, Microsoft SQL Server, Cell, Networking, Network Administration, Photography, Computer Hardware, Troubleshooting, FTP, WordPress, Microsoft Excel, Microsoft Office, Laboratory Skills, Aseptic Technique, Cell Culture
Education
Rutgers University-New Brunswick
Public Health
Farmingdale State University of New York 2004 — 2009
B.S., Bioscience Research
Nassau Community College 1997 — 2001
A.A.S., Computer Information Systems
FDA January 2011 - April 2011
Estee Lauder March 2010 - June 2010
Farmingdale State University of New York September 2009 - December 2009
A. E. Feldman Associates, Inc. July 2002 - September 2009
Skills
Laboratory, Microbiology, Molecular Biology, Cell Biology, Databases, HTML, Operating Systems, Microsoft Exchange, Microsoft SQL Server, Cell, Networking, Network Administration, Photography, Computer Hardware, Troubleshooting, FTP, WordPress, Microsoft Excel, Microsoft Office, Laboratory Skills, Aseptic Technique, Cell Culture
Education
Rutgers University-New Brunswick
Public Health
Farmingdale State University of New York 2004 — 2009
B.S., Bioscience Research
Nassau Community College 1997 — 2001
A.A.S., Computer Information Systems
Hany S. Edward Hany S. Edward's FDA Experience May 2015 - Present
Job Branch Chief (acting) at FDA
Industry Pharmaceuticals
Experience
FDA May 2015 - Present
Inova Health System November 2013 - Present
FDA November 2013 - May 2015
Virginia Commonwealth University College of Pharmacy July 2012 - February 2015
Inova Health System July 2012 - November 2013
CVS Caremark Corporation May 2010 - August 2012
University of Pittsburgh Medical Center July 2010 - June 2012
CVS Caremark Corporation September 2006 - March 2010
Med-Care Pharmacy May 2005 - August 2006
Skills
Pharmacy Automation, Pharmacists, Medication Therapy..., Pharmacy, Hospital Pharmacy, Pharmacy Practice, Community Pharmacy, Immunization, Hospitals, Patient Safety, Medicine, Pharmacy Benefit..., Managed Care, Informatics, Clinical Research, Healthcare Management, Diabetes, Disease Management, Inpatient, Patient Education, Pharmacology, Healthcare, Healthcare Information..., CPOE, Cerner, Medicaid
Education
University of Pittsburgh 2010 — 2011
Master of Science, Health-System Pharmacy Administration
Florida A&M University 2004 — 2010
Doctor of Pharmacy
Florida State University 2004 — 2008
Business Administation, Minor, Business Administration, Management and Operations
FDA May 2015 - Present
Inova Health System November 2013 - Present
FDA November 2013 - May 2015
Virginia Commonwealth University College of Pharmacy July 2012 - February 2015
Inova Health System July 2012 - November 2013
CVS Caremark Corporation May 2010 - August 2012
University of Pittsburgh Medical Center July 2010 - June 2012
CVS Caremark Corporation September 2006 - March 2010
Med-Care Pharmacy May 2005 - August 2006
Skills
Pharmacy Automation, Pharmacists, Medication Therapy..., Pharmacy, Hospital Pharmacy, Pharmacy Practice, Community Pharmacy, Immunization, Hospitals, Patient Safety, Medicine, Pharmacy Benefit..., Managed Care, Informatics, Clinical Research, Healthcare Management, Diabetes, Disease Management, Inpatient, Patient Education, Pharmacology, Healthcare, Healthcare Information..., CPOE, Cerner, Medicaid
Education
University of Pittsburgh 2010 — 2011
Master of Science, Health-System Pharmacy Administration
Florida A&M University 2004 — 2010
Doctor of Pharmacy
Florida State University 2004 — 2008
Business Administation, Minor, Business Administration, Management and Operations
Konstantinos Makrodimitris,PhD Konstantinos Makrodimitris,PhD's FDA Experience August 2013 - Present
Job Biomedical Engineer, Reviewer at FDA
Industry Information Technology and Services
Experience
US Department of Health and Human Services August 2013 - Present
FDA August 2013 - Present
K Makrodimitris January 2010 - December 2013
ComplianceOnline July 2012 - August 2013
CAL2CAL Corporation January 2012 - August 2013
Food & Drug Law Institute March 2011 - August 2013
Maryland Department of Business and Economic Development November 2012 - March 2013
Syneren Technologies Corporation April 2012 - October 2012
FDA October 2009 - November 2011
MAKRO-nano-Kosmos, Inc. September 2007 - October 2009
Skills
Modeling, Informatics, Entrepreneurship, Strategic Thinking, Health, Science, Research, Data Analysis, Analysis, Writing, Biomedical Engineering, Bioinformatics, Cheminformatics, Medical Devices, Public Health, Statistics, Data Mining, Healthcare, Databases, Genomics, FDA, Strategic Planning, Data Management, Programming, HL7, UML, Business Development, International Standards, Lifesciences, Healthcare Information..., Business Analysis, Big Data, Analytics, Mobile Health, eHealth, EHR, Business Architecture, Program Management, Enterprise Architecture, Quality Assurance, Project Management, Clinical Trials, Life Sciences
Education
US Food and Drug Administration 2009 — 2011
CERTIFICATES
The Johns Hopkins University 2005 — 2007
PostDoctoral Fellowship
University of Virginia 2003 — 2005
Post-Doctoral
AVLONAS
AVLONAS
Ethnikon kai Kapodistriakon Panepistimion Athinon
B.Sc.
Ethnikon kai Kapodistriakon Panepistimion Athinon
National Technical University of Athens
PhD
US Department of Health and Human Services August 2013 - Present
FDA August 2013 - Present
K Makrodimitris January 2010 - December 2013
ComplianceOnline July 2012 - August 2013
CAL2CAL Corporation January 2012 - August 2013
Food & Drug Law Institute March 2011 - August 2013
Maryland Department of Business and Economic Development November 2012 - March 2013
Syneren Technologies Corporation April 2012 - October 2012
FDA October 2009 - November 2011
MAKRO-nano-Kosmos, Inc. September 2007 - October 2009
Skills
Modeling, Informatics, Entrepreneurship, Strategic Thinking, Health, Science, Research, Data Analysis, Analysis, Writing, Biomedical Engineering, Bioinformatics, Cheminformatics, Medical Devices, Public Health, Statistics, Data Mining, Healthcare, Databases, Genomics, FDA, Strategic Planning, Data Management, Programming, HL7, UML, Business Development, International Standards, Lifesciences, Healthcare Information..., Business Analysis, Big Data, Analytics, Mobile Health, eHealth, EHR, Business Architecture, Program Management, Enterprise Architecture, Quality Assurance, Project Management, Clinical Trials, Life Sciences
Education
US Food and Drug Administration 2009 — 2011
CERTIFICATES
The Johns Hopkins University 2005 — 2007
PostDoctoral Fellowship
University of Virginia 2003 — 2005
Post-Doctoral
AVLONAS
AVLONAS
Ethnikon kai Kapodistriakon Panepistimion Athinon
B.Sc.
Ethnikon kai Kapodistriakon Panepistimion Athinon
National Technical University of Athens
PhD
Tielin Qin Tielin Qin's FDA Experience February 2012 - Present
Job Mathematical Statistician at FDA
Industry Government Administration
Experience
FDA February 2012 - Present
CDC February 2008 - April 2010
UCB Pharma June 2007 - August 2007
Skills
Biostatistics, SAS, R, Statistical Modeling, Clinical Trials, Public Health, Clinical Development, Epidemiology, Statistics, Clinical Study Design, SAS programming, Statistical Programming, Statistical Consulting, Data Analysis, SAS Programming, Survival Analysis, Clinical Research
Education
Emory University 2005 — 2011
PhD, Biostatistics
Peking University
Bachelor in Medicine, Preventive Medicine
FDA February 2012 - Present
CDC February 2008 - April 2010
UCB Pharma June 2007 - August 2007
Skills
Biostatistics, SAS, R, Statistical Modeling, Clinical Trials, Public Health, Clinical Development, Epidemiology, Statistics, Clinical Study Design, SAS programming, Statistical Programming, Statistical Consulting, Data Analysis, SAS Programming, Survival Analysis, Clinical Research
Education
Emory University 2005 — 2011
PhD, Biostatistics
Peking University
Bachelor in Medicine, Preventive Medicine
Junyi (Chloe) Zhu Junyi (Chloe) Zhu's FDA Experience May 2011 - September 2011
Job Assistant Manager of Michigan Dining
Industry Health, Wellness and Fitness
Experience
University of Michigan October 2014 - Present
University of Michigan Health System May 2013 - May 2014
FDA May 2011 - September 2011
Skills
Public Health, Literature Reviews, SPSS, Community Health, Nutrition Education, Program Evaluation, Nutrition, Program Development, Clinical Research, Healthcare
Education
Unversity of Michigan, Ann Arbor 2012 — 2014
Master of Public Health (MPH), Environmental Health Science, Human Nutrition
Fudan University 2008 — 2012
Bachelor of Science (BS), Pharmaceutical Sciences
University of Michigan October 2014 - Present
University of Michigan Health System May 2013 - May 2014
FDA May 2011 - September 2011
Skills
Public Health, Literature Reviews, SPSS, Community Health, Nutrition Education, Program Evaluation, Nutrition, Program Development, Clinical Research, Healthcare
Education
Unversity of Michigan, Ann Arbor 2012 — 2014
Master of Public Health (MPH), Environmental Health Science, Human Nutrition
Fudan University 2008 — 2012
Bachelor of Science (BS), Pharmaceutical Sciences
Amir Shams Amir Shams's FDA Experience 2013 - 2014
Job Bioinformatics Research Associate
Industry Biotechnology
Experience
National Institutes of Health December 2014 - Present
FDA 2013 - 2014
George Washington University 2013 - 2014
George Mason University 2012 - 2013
Skills
Bioinformatics, Molecular Biology, Data Analysis, Research, Microsoft Word, PowerPoint, Statistics, Biochemistry, Cell Culture, Science, Microsoft Office, Microsoft Excel, PCR, C++, Customer Service, Teaching, Python, Perl, PHP, Cytoscape, BLAST, NextGen, JavaScript, Bowtie, Metagenomics, mothur, Qiime, Virome
Education
George Mason University 2012 — 2013
Master of Science (M.S.), Bioinformatics, and Computational Biology, 4.0
Harvard Medical School 2013 — 2013
Summer Internship, System biology
National Institutes of Health December 2014 - Present
FDA 2013 - 2014
George Washington University 2013 - 2014
George Mason University 2012 - 2013
Skills
Bioinformatics, Molecular Biology, Data Analysis, Research, Microsoft Word, PowerPoint, Statistics, Biochemistry, Cell Culture, Science, Microsoft Office, Microsoft Excel, PCR, C++, Customer Service, Teaching, Python, Perl, PHP, Cytoscape, BLAST, NextGen, JavaScript, Bowtie, Metagenomics, mothur, Qiime, Virome
Education
George Mason University 2012 — 2013
Master of Science (M.S.), Bioinformatics, and Computational Biology, 4.0
Harvard Medical School 2013 — 2013
Summer Internship, System biology
Joanne M. Lucas, J.D. Joanne M. Lucas, J.D.'s FDA Experience September 2014 - Present
Job Regulatory Counsel at FDA
Industry Hospital & Health Care
Experience
FDA September 2014 - Present
IMPAQ International July 2014 - September 2014
Center for Medicare and Medicaid Services (CMS) February 2014 - May 2014
University of Maryland Francis King Carey School of Law August 2013 - May 2014
The Network for Public Health Law May 2013 - August 2013
FDA January 2013 - May 2013
Office of the Attorney General: Department of Health and Mental Hygiene September 2012 - December 2012
Jacksonville Area Legal Aid, Inc. May 2012 - August 2012
Oliff & Berridge, PLC June 2011 - August 2011
Miller Center of Public Affairs at the University of Virginia July 2010 - June 2011
Skills
Strong verbal and..., ability to think..., Problem Solving, Timely Decision Making, Ability to read and..., Strong Persuasion Skills, Communication, Organization, Time Management, Legal Documents, Westlaw, Lexis, Critical Thinking
Education
University of Maryland School of Law 2012 — 2014
Juris Doctor, Health Law Certificate
Florida Coastal School of Law 2011 — 2012
Juris Doctor
University of Virginia 2007 — 2011
Bachelor of Arts, Foreign Affairs
FDA September 2014 - Present
IMPAQ International July 2014 - September 2014
Center for Medicare and Medicaid Services (CMS) February 2014 - May 2014
University of Maryland Francis King Carey School of Law August 2013 - May 2014
The Network for Public Health Law May 2013 - August 2013
FDA January 2013 - May 2013
Office of the Attorney General: Department of Health and Mental Hygiene September 2012 - December 2012
Jacksonville Area Legal Aid, Inc. May 2012 - August 2012
Oliff & Berridge, PLC June 2011 - August 2011
Miller Center of Public Affairs at the University of Virginia July 2010 - June 2011
Skills
Strong verbal and..., ability to think..., Problem Solving, Timely Decision Making, Ability to read and..., Strong Persuasion Skills, Communication, Organization, Time Management, Legal Documents, Westlaw, Lexis, Critical Thinking
Education
University of Maryland School of Law 2012 — 2014
Juris Doctor, Health Law Certificate
Florida Coastal School of Law 2011 — 2012
Juris Doctor
University of Virginia 2007 — 2011
Bachelor of Arts, Foreign Affairs
Angelina Albert Angelina Albert's FDA Experience October 2000 - 2012
Job Special Assistant Micro Branch Director at U.S. Public Health Service Commissioned Corps
Industry Hospital & Health Care
Experience
U.S. Public Health Service Commissioned Corps July 2011 - Present
FDA October 2000 - 2012
Indian Health Service December 1991 - October 2000
Education
Argosy University Orange 2008 — 2011
Master of Business Administration (MBA), Health/Health Care Administration/Management
The University of New Mexico 1989 — 1991
Bachelor's degree, Medical Technology
Fort Lewis College 1986 — 1988
Bachelor of Science (BS), Chemistry
U.S. Public Health Service Commissioned Corps July 2011 - Present
FDA October 2000 - 2012
Indian Health Service December 1991 - October 2000
Education
Argosy University Orange 2008 — 2011
Master of Business Administration (MBA), Health/Health Care Administration/Management
The University of New Mexico 1989 — 1991
Bachelor's degree, Medical Technology
Fort Lewis College 1986 — 1988
Bachelor of Science (BS), Chemistry
Sarah McMullen Sarah McMullen's FDA Experience February 2005 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA February 2005 - Present
Skills
Lifesciences, HPLC, Chemistry, UV/Vis, Validation, Policy, Technology Transfer, Research, Data Analysis, Technical Writing, Microsoft Office, Public Speaking, Quality Assurance, Project Management, Process Improvement
Education
Emory University 1997 — 2002
Ph.D., Chemistry
Emory University 1995 — 1997
B.S., Chemistry
FDA February 2005 - Present
Skills
Lifesciences, HPLC, Chemistry, UV/Vis, Validation, Policy, Technology Transfer, Research, Data Analysis, Technical Writing, Microsoft Office, Public Speaking, Quality Assurance, Project Management, Process Improvement
Education
Emory University 1997 — 2002
Ph.D., Chemistry
Emory University 1995 — 1997
B.S., Chemistry
Patrick Gavin R.Ph Patrick Gavin R.Ph's FDA Experience May 2011 - Present
Job Chair, Patient Advocate Committee at Alliance For Clinical Trials in Oncology
Industry Medical Practice
Experience
Cancer Research Consortium of West Michigan January 2012 - Present
Alliance For Clinical Trials in Oncology November 2011 - Present
FDA May 2011 - Present
Patrick Gavin R.Ph. Consulting July 2001 - Present
Meijer Inc November 1969 - February 2002
Michigan Board of Pharmacy June 1991 - June 1996
Skills
Public Speaking, Pharmacists, Health, Strategic Planning, Planning, Healthcare Management, Healthcare, Clinical Research, Pharmacy Automation, Pharmacy, Project Planning, Oncology, Medication Therapy..., Managed Care, Research, Retail, Pharmacy Benefit..., Informatics, Hospitals, Clinical Pharmacology, Diabetes, Management, Team Building, Leadership
Education
Ferris State University 1969 — 1973
Bachelor of Science (BS), Pharmacy
Ferris State University 1968 — 1973
Bachelor of Science (BS), Pharmacy
Cancer Research Consortium of West Michigan January 2012 - Present
Alliance For Clinical Trials in Oncology November 2011 - Present
FDA May 2011 - Present
Patrick Gavin R.Ph. Consulting July 2001 - Present
Meijer Inc November 1969 - February 2002
Michigan Board of Pharmacy June 1991 - June 1996
Skills
Public Speaking, Pharmacists, Health, Strategic Planning, Planning, Healthcare Management, Healthcare, Clinical Research, Pharmacy Automation, Pharmacy, Project Planning, Oncology, Medication Therapy..., Managed Care, Research, Retail, Pharmacy Benefit..., Informatics, Hospitals, Clinical Pharmacology, Diabetes, Management, Team Building, Leadership
Education
Ferris State University 1969 — 1973
Bachelor of Science (BS), Pharmacy
Ferris State University 1968 — 1973
Bachelor of Science (BS), Pharmacy
Motao (Marvin) Sun Motao (Marvin) Sun's FDA Experience September 2013 - January 2014
Job Intern at The Cooper Companies
Industry Pharmaceuticals
Experience
The Cooper Companies June 2015 - September 2015
IMS Consulting Group February 2014 - August 2014
FDA September 2013 - January 2014
UCLA July 2013 - September 2013
University of Queensland July 2012 - September 2012
Skills
Pharmacology, Neuroscience, Biology, Public Health, Statistics, Pharmaceutics, R, SAS programming, Clinical Trials, Medicine, Microsoft Word, Microsoft PowerPoint, PowerPoint, SAS Programming
Education
Yale University 2014 — 2016
Master's Degree, Public Health
Fudan University 2010 — 2014
Bachelor of Science (BS), Pharmaceutical Sciences
National Taiwan University 2012 — 2013
Exchange student, Pharmaceutical Sciences
The Cooper Companies June 2015 - September 2015
IMS Consulting Group February 2014 - August 2014
FDA September 2013 - January 2014
UCLA July 2013 - September 2013
University of Queensland July 2012 - September 2012
Skills
Pharmacology, Neuroscience, Biology, Public Health, Statistics, Pharmaceutics, R, SAS programming, Clinical Trials, Medicine, Microsoft Word, Microsoft PowerPoint, PowerPoint, SAS Programming
Education
Yale University 2014 — 2016
Master's Degree, Public Health
Fudan University 2010 — 2014
Bachelor of Science (BS), Pharmaceutical Sciences
National Taiwan University 2012 — 2013
Exchange student, Pharmaceutical Sciences
phil sayre's FDA Experience 1985 - 1987
Job Associate Director at US EPA
Industry Government Administration
Experience
US EPA 2000 - Present
University of Venice 2011 - 2013
The George Washington University May 2005 - September 2007
FDA 1985 - 1987
Skills
Policy Analysis, Environmental Policy, Policy, Government, Sustainability, Environmental Awareness, Community Outreach, Climate Change, Program Management, Program Evaluation, Grant Writing, Environmental Impact..., Research, Nonprofits, Grants, Stakeholder Engagement, Strategic Communications, Sustainable Development, Federal Government
Education
Georgetown University 1980 — 1984
Ph.D.
Emory University 1975 — 1980
B.S, M.S., Biology, General
US EPA 2000 - Present
University of Venice 2011 - 2013
The George Washington University May 2005 - September 2007
FDA 1985 - 1987
Skills
Policy Analysis, Environmental Policy, Policy, Government, Sustainability, Environmental Awareness, Community Outreach, Climate Change, Program Management, Program Evaluation, Grant Writing, Environmental Impact..., Research, Nonprofits, Grants, Stakeholder Engagement, Strategic Communications, Sustainable Development, Federal Government
Education
Georgetown University 1980 — 1984
Ph.D.
Emory University 1975 — 1980
B.S, M.S., Biology, General
Irene O. Aihie, MPH Irene O. Aihie, MPH's FDA Experience September 2013 - Present
Job Public Health Advisor at FDA
Industry Internet
Experience
FDA September 2013 - Present
HealthNHipHop.com July 2012 - Present
Circle Solutions, Inc. May 2013 - August 2013
JBS International, Inc. November 2011 - November 2012
Federal Business Services July 2010 - September 2011
American Cancer Society August 2008 - May 2009
Skills
Public speaking, Social media proficient, FEMA Emergency..., Social Media, Public Speaking, Program Management, Policy, Leadership, Research, Analysis, Negotiation, Qualitative Research, Public Health, Community Outreach, Program Development, Budgets, Training, Editing, Healthcare, Grants, Grant Writing, Marketing Communications, Fundraising, Facebook, Nonprofits
Education
Florida International University 2008 — 2010
Master of Public Health, Public Health
Florida A&M University 1999 — 2006
Health Information Management, Healthcare
FDA September 2013 - Present
HealthNHipHop.com July 2012 - Present
Circle Solutions, Inc. May 2013 - August 2013
JBS International, Inc. November 2011 - November 2012
Federal Business Services July 2010 - September 2011
American Cancer Society August 2008 - May 2009
Skills
Public speaking, Social media proficient, FEMA Emergency..., Social Media, Public Speaking, Program Management, Policy, Leadership, Research, Analysis, Negotiation, Qualitative Research, Public Health, Community Outreach, Program Development, Budgets, Training, Editing, Healthcare, Grants, Grant Writing, Marketing Communications, Fundraising, Facebook, Nonprofits
Education
Florida International University 2008 — 2010
Master of Public Health, Public Health
Florida A&M University 1999 — 2006
Health Information Management, Healthcare
Tim Merrill Tim Merrill's FDA Experience March 1973 - July 1974
Job Freelance Editor, Proofreader
Industry Libraries
Experience
Library of Congress May 1983 - February 1996
Searle June 1982 - May 1983
Library of Congress July 1975 - June 1982
Library of Congress July 1974 - July 1975
FDA March 1973 - July 1974
Skills
Editing, Technical Translation, Proofreading, Research
Education
Florida State University 1970 — 1972
Bachelor of Arts (B.A.), Chemistry, Spanish
Georgia Tech 1967 — 1970
Chemistry
Library of Congress May 1983 - February 1996
Searle June 1982 - May 1983
Library of Congress July 1975 - June 1982
Library of Congress July 1974 - July 1975
FDA March 1973 - July 1974
Skills
Editing, Technical Translation, Proofreading, Research
Education
Florida State University 1970 — 1972
Bachelor of Arts (B.A.), Chemistry, Spanish
Georgia Tech 1967 — 1970
Chemistry
Gary Slatko Gary Slatko's FDA Experience August 2014 - Present
Job Associate Office Director at FDA
Industry Government Administration
Experience
FDA August 2014 - Present
FDA September 2012 - August 2014
ParagonRx (An InVentiv Health Company) May 2001 - August 2012
GSK November 1996 - May 2001
Stuart Disease Management Services, An AstraZeneca Company November 1993 - November 1996
AstraZeneca (formerly Zeneca) November 1992 - November 1993
DuPont Merck Pharmaceuticals (formerly DuPont Pharmaceuticals) November 1987 - November 1992
Education
University of Pittsburgh School of Medicine 1982 — 1985
Internal Medicine Residency Program
University of Miami Leonard M. Miller School of Medicine 1978 — 1982
Doctor of Medicine (MD), Internal Medicine
The Johns Hopkins University School of Medicine 1985 — 1986
Radiation Oncology Research Fellowship
West Chester University of Pennsylvania 1990 — 1992
Master of Business Administration (MBA)
Emory University 1974 — 1978
BA, Chemistry, Psychology
FDA August 2014 - Present
FDA September 2012 - August 2014
ParagonRx (An InVentiv Health Company) May 2001 - August 2012
GSK November 1996 - May 2001
Stuart Disease Management Services, An AstraZeneca Company November 1993 - November 1996
AstraZeneca (formerly Zeneca) November 1992 - November 1993
DuPont Merck Pharmaceuticals (formerly DuPont Pharmaceuticals) November 1987 - November 1992
Education
University of Pittsburgh School of Medicine 1982 — 1985
Internal Medicine Residency Program
University of Miami Leonard M. Miller School of Medicine 1978 — 1982
Doctor of Medicine (MD), Internal Medicine
The Johns Hopkins University School of Medicine 1985 — 1986
Radiation Oncology Research Fellowship
West Chester University of Pennsylvania 1990 — 1992
Master of Business Administration (MBA)
Emory University 1974 — 1978
BA, Chemistry, Psychology
Shayla Hunter Shayla Hunter's FDA Experience 2011 - Present
Job Scientist
Industry Food & Beverages
Experience
FDA 2011 - Present
Skills
Microbiology, Food Science, Molecular Biology, PCR, Biotechnology, Lifesciences, Food Safety, Science, HACCP, Regulatory Affairs, Food Technology, Food Microbiology
Education
The University of Georgia 2005 — 2007
Master of Science (MS), Food Science and Technology
Florida A&M University 2000 — 2004
Bachelor's degree, Agriculture, Agriculture Operations, and Related Sciences
FDA 2011 - Present
Skills
Microbiology, Food Science, Molecular Biology, PCR, Biotechnology, Lifesciences, Food Safety, Science, HACCP, Regulatory Affairs, Food Technology, Food Microbiology
Education
The University of Georgia 2005 — 2007
Master of Science (MS), Food Science and Technology
Florida A&M University 2000 — 2004
Bachelor's degree, Agriculture, Agriculture Operations, and Related Sciences
David Soltysik's FDA Experience August 2009 - Present
Job Staff Fellow at FDA
Industry Medical Devices
Experience
FDA August 2009 - Present
Northstar Neuroscience May 2008 - January 2009
Northstar Neuroscience October 2007 - May 2008
Medical College of Wisconsin September 2003 - August 2007
Skills
Research, MRI, Matlab, Data Analysis, Physics, Biomedical Engineering, Neuroimaging, Life Sciences, Medical Devices, Biotechnology
Education
University of Florida 1998 — 2003
PhD, Medical Physics
Florida State University 1996 — 1998
MS, Physics
University of Illinois at Chicago 1992 — 1996
BS, Physics
FDA August 2009 - Present
Northstar Neuroscience May 2008 - January 2009
Northstar Neuroscience October 2007 - May 2008
Medical College of Wisconsin September 2003 - August 2007
Skills
Research, MRI, Matlab, Data Analysis, Physics, Biomedical Engineering, Neuroimaging, Life Sciences, Medical Devices, Biotechnology
Education
University of Florida 1998 — 2003
PhD, Medical Physics
Florida State University 1996 — 1998
MS, Physics
University of Illinois at Chicago 1992 — 1996
BS, Physics
Amber Marsh Amber Marsh's FDA Experience August 2012 - July 2013
Job Research Tracker at George Washington University
Industry Research
Experience
George Washington University October 2014 - Present
FDA August 2012 - July 2013
Christopher Unger, MD Private Practice October 2011 - June 2012
University of Maryland, College Park January 2011 - May 2011
Higher Achievement Program October 2009 - December 2010
Skills
clinical data collection, Research, PCR, Customer Service, Microsoft Office, Cell Biology, Data Analysis, Genetics, Biology, Molecular Biology, Qualitative Research, Social Media, Leadership, Public Speaking, PowerPoint, Microsoft Excel, Community Outreach, Microsoft Word
Education
Georgetown University 2014 — 2014
Master's Degree, Physiology, 3.799
George Mason University 2013 — 2014
Certificate, Advanced Biomedical Sciences, 3.68
University of Maryland College Park 2008 — 2012
Bachelor's Degree, Biological Sciences, Cell Biology and Molecular Genetics
George Washington University October 2014 - Present
FDA August 2012 - July 2013
Christopher Unger, MD Private Practice October 2011 - June 2012
University of Maryland, College Park January 2011 - May 2011
Higher Achievement Program October 2009 - December 2010
Skills
clinical data collection, Research, PCR, Customer Service, Microsoft Office, Cell Biology, Data Analysis, Genetics, Biology, Molecular Biology, Qualitative Research, Social Media, Leadership, Public Speaking, PowerPoint, Microsoft Excel, Community Outreach, Microsoft Word
Education
Georgetown University 2014 — 2014
Master's Degree, Physiology, 3.799
George Mason University 2013 — 2014
Certificate, Advanced Biomedical Sciences, 3.68
University of Maryland College Park 2008 — 2012
Bachelor's Degree, Biological Sciences, Cell Biology and Molecular Genetics
Matthew Poliner Matthew Poliner's FDA Experience October 2013 - July 2014
Job Associate Attorney at Venable LLP
Industry Legal Services
Experience
Venable LLP July 2014 - Present
FDA October 2013 - July 2014
FDA January 2013 - October 2013
Arnstein & Lehr LLP May 2011 - August 2011
FAA January 2011 - May 2011
Holland America Line July 2010 - August 2010
Foltz Martin, LLC May 2010 - June 2010
Education
Emory University 2009 — 2012
JD, Law
Emory University 2005 — 2009
BA, History & Political Science
Venable LLP July 2014 - Present
FDA October 2013 - July 2014
FDA January 2013 - October 2013
Arnstein & Lehr LLP May 2011 - August 2011
FAA January 2011 - May 2011
Holland America Line July 2010 - August 2010
Foltz Martin, LLC May 2010 - June 2010
Education
Emory University 2009 — 2012
JD, Law
Emory University 2005 — 2009
BA, History & Political Science
Vera Harris's FDA Experience December 2009 - Present
Job Consumer Safety Technician at FDA
Industry Government Relations
Experience
FDA December 2009 - Present
U.S. Army June 2001 - November 2005
Skills
Demonstrated Master..., Adju Instructor in Food..., Certified Professional..., Certified Teacher..., Government, Military, Security Clearance, Human Resources, Management, Analysis, Policy, Command, Training, Army, Leadership, DoD
Education
University of Phoenix 2006 — 2008
Master of Business Administration (MBA), Human Resources Management/Personnel Administration, General, 3.49
Excelsior College
Bachelor of Arts
FDA December 2009 - Present
U.S. Army June 2001 - November 2005
Skills
Demonstrated Master..., Adju Instructor in Food..., Certified Professional..., Certified Teacher..., Government, Military, Security Clearance, Human Resources, Management, Analysis, Policy, Command, Training, Army, Leadership, DoD
Education
University of Phoenix 2006 — 2008
Master of Business Administration (MBA), Human Resources Management/Personnel Administration, General, 3.49
Excelsior College
Bachelor of Arts
Gettie Audain, DHSc, MPH, BSN, RN Gettie Audain, DHSc, MPH, BSN, RN's FDA Experience May 2014 - Present
Job Director Health Promotion Officer/Senior Nurse Advisor Office of Women's Health at FDA
Industry
Experience
United States Public Health Service June 2002 - Present
FDA May 2014 - Present
US Department of Health and Human Services, Health Resources and Services Administration July 2012 - Present
Mercy Health Clinic August 2013 - Present
US Department of Health and Human Services, Health Resources and Services Administration March 2005 - July 2012
Adventist HealthCare, Washington Adventist Hospital July 2008 - July 2010
National Institutes of Health April 2001 - March 2005
Suburban Endoscopy Center April 1999 - April 2001
Alexandria Health Department September 1997 - September 1998
Florida Department of Health in Miami-Dade County August 1994 - August 1997
Skills
Project Management, Research, Strategic Planning, Financial Management..., Program Evaluation, Performance Improvement, Performance Metrics, Performance Analysis, Collaboration, Collaborative Problem..., Resource Allocation, Work Groups, Milestones, Service Delivery..., Project Tracking, Oral & Written..., Written & Oral..., Persuasive Presentations, Engaging Public Speaker, Contract Management, Grant Administration, Microsoft Excel, Policy, Health Promotion, Global Health, Health Policy
Education
Nova Southeastern University
DOCTOR OF HEALTH SCIENCE, Global Health Concentration, Honor Cord Recipient
Walden University
MASTER OF PUBLIC HEALTH, Community Public Health
Florida International University
BACHELOR OF SCIENCE IN NURSING
Jackson Memorial Hospital School of Nursing
REGISTERED NURSE, Nursing
United States Public Health Service June 2002 - Present
FDA May 2014 - Present
US Department of Health and Human Services, Health Resources and Services Administration July 2012 - Present
Mercy Health Clinic August 2013 - Present
US Department of Health and Human Services, Health Resources and Services Administration March 2005 - July 2012
Adventist HealthCare, Washington Adventist Hospital July 2008 - July 2010
National Institutes of Health April 2001 - March 2005
Suburban Endoscopy Center April 1999 - April 2001
Alexandria Health Department September 1997 - September 1998
Florida Department of Health in Miami-Dade County August 1994 - August 1997
Skills
Project Management, Research, Strategic Planning, Financial Management..., Program Evaluation, Performance Improvement, Performance Metrics, Performance Analysis, Collaboration, Collaborative Problem..., Resource Allocation, Work Groups, Milestones, Service Delivery..., Project Tracking, Oral & Written..., Written & Oral..., Persuasive Presentations, Engaging Public Speaker, Contract Management, Grant Administration, Microsoft Excel, Policy, Health Promotion, Global Health, Health Policy
Education
Nova Southeastern University
DOCTOR OF HEALTH SCIENCE, Global Health Concentration, Honor Cord Recipient
Walden University
MASTER OF PUBLIC HEALTH, Community Public Health
Florida International University
BACHELOR OF SCIENCE IN NURSING
Jackson Memorial Hospital School of Nursing
REGISTERED NURSE, Nursing
Owen Chaput's FDA Experience February 2014 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA February 2014 - Present
The Phillips Law Firm, PA October 2013 - January 2014
MailChimp January 2013 - May 2013
Emory University School of Law August 2010 - May 2013
Federal Trade Commission May 2012 - August 2012
Atlanta Legal Aid Society May 2011 - August 2011
University of Illinois at Chicago April 2010 - August 2010
The Crepe Escape, LLC January 2009 - January 2010
Connecticut Legal Services, Inc. September 2009 - December 2009
National Park Service May 2008 - December 2008
Education
Emory University School of Law 2010 — 2013
J.D.
The University of Connecticut 2005 — 2008
BA
St. John's College (MD) 2004 — 2005
FDA February 2014 - Present
The Phillips Law Firm, PA October 2013 - January 2014
MailChimp January 2013 - May 2013
Emory University School of Law August 2010 - May 2013
Federal Trade Commission May 2012 - August 2012
Atlanta Legal Aid Society May 2011 - August 2011
University of Illinois at Chicago April 2010 - August 2010
The Crepe Escape, LLC January 2009 - January 2010
Connecticut Legal Services, Inc. September 2009 - December 2009
National Park Service May 2008 - December 2008
Education
Emory University School of Law 2010 — 2013
J.D.
The University of Connecticut 2005 — 2008
BA
St. John's College (MD) 2004 — 2005
Peter Nemes Peter Nemes's FDA Experience February 2011 - August 2013
Job Assistant Professor of Chemistry, George Washington University
Industry Higher Education
Experience
George Washington University August 2013 - Present
FDA February 2011 - August 2013
University of Illinois at Urbana-Champaign September 2009 - February 2011
George Washington University January 2005 - August 2009
EGIS Pharmaceuticals PLC 2003 - 2004
Skills
Research, Chemistry, Analytical Chemistry, HPLC, Mass Spectrometry, Science, Molecular Biology, Biochemistry, Chromatography, Lifesciences, UV/Vis, LC-MS, Bioinformatics
Education
The George Washington University 2005 — 2009
PhD, Chemistry
Eötvös Loránd Tudományegyetem 1999 — 2004
Master of Science (MSc), Chemistry
George Washington University August 2013 - Present
FDA February 2011 - August 2013
University of Illinois at Urbana-Champaign September 2009 - February 2011
George Washington University January 2005 - August 2009
EGIS Pharmaceuticals PLC 2003 - 2004
Skills
Research, Chemistry, Analytical Chemistry, HPLC, Mass Spectrometry, Science, Molecular Biology, Biochemistry, Chromatography, Lifesciences, UV/Vis, LC-MS, Bioinformatics
Education
The George Washington University 2005 — 2009
PhD, Chemistry
Eötvös Loránd Tudományegyetem 1999 — 2004
Master of Science (MSc), Chemistry
Reasol Agustin Reasol Agustin's FDA Experience May 2011 - April 2014
Job Pharmacist
Industry Hospital & Health Care
Experience
U. S. Public Health Service Phoenix Indian Medical Center April 2014 - Present
FDA May 2011 - April 2014
Tuba City Regional Health Care Corporation March 2008 - May 2011
Tuba City Regional Health Care Corporation January 2007 - March 2008
Skills
Pharmacists, Healthcare, Public Health, Pharmacy Automation, Pharmacy, Pharmacokinetics, Healthcare Management, Patient Safety, Immunization, Inpatient, Clinical Pharmacy, Medication Therapy..., EMR, Medicine, Regulatory Affairs
Education
University of Maryland School of Pharmacy 2001 — 2005
Doctor of Pharmacy (PharmD)
Frostburg State University 1996 — 2000
Bachelor of Science (B.S.), Biochemistry
U. S. Public Health Service Phoenix Indian Medical Center April 2014 - Present
FDA May 2011 - April 2014
Tuba City Regional Health Care Corporation March 2008 - May 2011
Tuba City Regional Health Care Corporation January 2007 - March 2008
Skills
Pharmacists, Healthcare, Public Health, Pharmacy Automation, Pharmacy, Pharmacokinetics, Healthcare Management, Patient Safety, Immunization, Inpatient, Clinical Pharmacy, Medication Therapy..., EMR, Medicine, Regulatory Affairs
Education
University of Maryland School of Pharmacy 2001 — 2005
Doctor of Pharmacy (PharmD)
Frostburg State University 1996 — 2000
Bachelor of Science (B.S.), Biochemistry
Henry Allen's FDA Experience June 2010 - September 2014
Job Lieutenant Commander, U.S. Public Health Service Commissioned Corps
Industry Government Administration
Experience
US Department of Health and Human Services October 2014 - Present
U.S. Public Health Service Commissioned Corps 2012 - Present
Broward College July 2002 - Present
FDA June 2010 - September 2014
Broward College July 2002 - August 2010
Florida Atlantic University January 2007 - December 2008
Keiser University January 2003 - May 2003
Turner Construction Company 1999 - 2002
Skills
Health, Curriculum Development, Adult Education, Curriculum Design, E-learning, Staff Development, Classroom Instruction, Instructional Design, Teaching, Classroom, Research, Educational Technology, Program Evaluation, E-Learning, Health Promotion, Health Education, Technical Writing, Higher Education, Public Speaking, Government, Leadership, College Teaching, Program Management, Community Outreach, Program Development, Training, Distance Learning, Student Development
Education
Florida Atlantic University 2007 — 2009
MS, Exercise Science & Health Promotion
Troy University 1990 — 1991
MEd, Educational Leadership
University of New Hampshire 1980 — 1984
BA, Political Science
US Department of Health and Human Services October 2014 - Present
U.S. Public Health Service Commissioned Corps 2012 - Present
Broward College July 2002 - Present
FDA June 2010 - September 2014
Broward College July 2002 - August 2010
Florida Atlantic University January 2007 - December 2008
Keiser University January 2003 - May 2003
Turner Construction Company 1999 - 2002
Skills
Health, Curriculum Development, Adult Education, Curriculum Design, E-learning, Staff Development, Classroom Instruction, Instructional Design, Teaching, Classroom, Research, Educational Technology, Program Evaluation, E-Learning, Health Promotion, Health Education, Technical Writing, Higher Education, Public Speaking, Government, Leadership, College Teaching, Program Management, Community Outreach, Program Development, Training, Distance Learning, Student Development
Education
Florida Atlantic University 2007 — 2009
MS, Exercise Science & Health Promotion
Troy University 1990 — 1991
MEd, Educational Leadership
University of New Hampshire 1980 — 1984
BA, Political Science
Suzie Davis Suzie Davis's FDA Experience November 1988 - November 1993
Job Administrative Assistant at Pan American Screw, Inc.
Industry Building Materials
Experience
Pan American Screw, Inc. November 1999 - Present
Piedmont Healthcare October 1995 - November 1999
Davis Hospital November 1993 - October 1995
FDA November 1988 - November 1993
Skills
Microsoft Excel, Inventory Management, Microsoft Office, Microsoft Word, Pricing, Forecasting, Outlook, Administrative..., Customer Service, Strategic Planning, Data Entry, Process Scheduler, Management, Time Management, Purchasing, Higher Education
Education
Gardner-Webb University 2012 — 2014
Bachelor's Degree, Computer Information Systems, Graduated Suma Cum Laude
Montgomery College 1988 — 1992
Associate Arts, General Studies
Tahoma Alternative High School 1980 — 1984
HS Diploma, General Studies
Pan American Screw, Inc. November 1999 - Present
Piedmont Healthcare October 1995 - November 1999
Davis Hospital November 1993 - October 1995
FDA November 1988 - November 1993
Skills
Microsoft Excel, Inventory Management, Microsoft Office, Microsoft Word, Pricing, Forecasting, Outlook, Administrative..., Customer Service, Strategic Planning, Data Entry, Process Scheduler, Management, Time Management, Purchasing, Higher Education
Education
Gardner-Webb University 2012 — 2014
Bachelor's Degree, Computer Information Systems, Graduated Suma Cum Laude
Montgomery College 1988 — 1992
Associate Arts, General Studies
Tahoma Alternative High School 1980 — 1984
HS Diploma, General Studies
Jim Shugars Jim Shugars's FDA Experience September 2004 - October 2014
Job Consultant/Retired at Calabash, NC
Industry Information Technology and Services
Experience
Calabash, NC October 2014 - Present
FDA September 2004 - October 2014
FBI 1982 - 2004
Skills
Enterprise Architecture, Federal Government, Program Management, Government, IT Strategy, Data Center, SDLC, Strategy, Management, Information Technology, Integration, Security, Data Warehousing, PMP, Requirements Analysis, Business Intelligence, Mergers & Acquisitions, Risk Management, Government Contracting, Project Planning, Human Resources, Governance, Project Management, PMO, Project Portfolio..., IT Management, Business Process..., Analysis
Education
Frostburg State University 1976 — 1980
Bachelor of Science (BS), Mathematics
Westminster High School
Westminster High School
Calabash, NC October 2014 - Present
FDA September 2004 - October 2014
FBI 1982 - 2004
Skills
Enterprise Architecture, Federal Government, Program Management, Government, IT Strategy, Data Center, SDLC, Strategy, Management, Information Technology, Integration, Security, Data Warehousing, PMP, Requirements Analysis, Business Intelligence, Mergers & Acquisitions, Risk Management, Government Contracting, Project Planning, Human Resources, Governance, Project Management, PMO, Project Portfolio..., IT Management, Business Process..., Analysis
Education
Frostburg State University 1976 — 1980
Bachelor of Science (BS), Mathematics
Westminster High School
Westminster High School
Rachelle M. Lubin Pharm.D. Rachelle M. Lubin Pharm.D.'s FDA Experience August 2010 - Present
Job Pharmacologist at FDA
Industry Pharmaceuticals
Experience
FDA August 2010 - Present
Novartis Pharmaceuticals July 2009 - July 2010
State University of New York at Buffalo July 2007 - July 2010
Baptist Health South Florida 2002 - 2004
Florida International University Department of Biology 2000 - 2002
Skills
Patient Recruitment, Translational Research, Pharmacokinetics, Pharmacodynamics, Clinical Pharmacology, Clinical Development, Drug Development, Clinical Trials, Regulatory Affairs, Pharmaceuticals, Oncology, HIV Research, Hematology, Infectious Diseases, DMPK, ADME, IND, IRB, ANDA, FDA, GCP, eCTD, WinNonlin, ADAPT, Pheonix, GastroPlus, NONMEM, SAS, MATLAB, SYSTAT, GraphPad Prism, Pharmaceutical Industry
Education
University at Buffalo 2007 — 2010
Post-Doctoral Fellowship:, Clinical Research, Drug Development, PK/PD
Palm Beach Atlantic University 2003 — 2007
Pharm.D., Interest: Clinical Pharmacology and Therapeutics
Florida International University 2000 — 2002
Pre-Pharmacy, Chemistry
FDA August 2010 - Present
Novartis Pharmaceuticals July 2009 - July 2010
State University of New York at Buffalo July 2007 - July 2010
Baptist Health South Florida 2002 - 2004
Florida International University Department of Biology 2000 - 2002
Skills
Patient Recruitment, Translational Research, Pharmacokinetics, Pharmacodynamics, Clinical Pharmacology, Clinical Development, Drug Development, Clinical Trials, Regulatory Affairs, Pharmaceuticals, Oncology, HIV Research, Hematology, Infectious Diseases, DMPK, ADME, IND, IRB, ANDA, FDA, GCP, eCTD, WinNonlin, ADAPT, Pheonix, GastroPlus, NONMEM, SAS, MATLAB, SYSTAT, GraphPad Prism, Pharmaceutical Industry
Education
University at Buffalo 2007 — 2010
Post-Doctoral Fellowship:, Clinical Research, Drug Development, PK/PD
Palm Beach Atlantic University 2003 — 2007
Pharm.D., Interest: Clinical Pharmacology and Therapeutics
Florida International University 2000 — 2002
Pre-Pharmacy, Chemistry
Yue John Zhang Yue John Zhang's FDA Experience April 2014 - Present
Job Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA April 2014 - Present
Nektar Therapeutics January 2009 - March 2014
Novo Nordisk November 2005 - October 2008
Enzon Pharmaceuticals 2004 - 2005
Weill Cornell Medical College January 2000 - April 2004
Skills
Drug Discovery, Drug Development, Pharmacokinetics, Assay Development, Biotechnology, Pharmacology, Purification, Inflammation, In Vitro, Drug Metabolism
Education
University of Kentucky 1993 — 1999
Ph.D., Pharmaceutical Sciences
Fudan University 1986 — 1991
B.S., Pharmacology
FDA April 2014 - Present
Nektar Therapeutics January 2009 - March 2014
Novo Nordisk November 2005 - October 2008
Enzon Pharmaceuticals 2004 - 2005
Weill Cornell Medical College January 2000 - April 2004
Skills
Drug Discovery, Drug Development, Pharmacokinetics, Assay Development, Biotechnology, Pharmacology, Purification, Inflammation, In Vitro, Drug Metabolism
Education
University of Kentucky 1993 — 1999
Ph.D., Pharmaceutical Sciences
Fudan University 1986 — 1991
B.S., Pharmacology
Jonathan Norton's FDA Experience March 2008 - November 2013
Job Senior Principal Statistician at MedImmune
Industry Pharmaceuticals
Experience
MedImmune November 2013 - Present
FDA March 2008 - November 2013
University of Arkansas for Medical Sciences November 2002 - August 2005
Skills
Epidemiology, Statistics, Biostatistics, R, Public Health, Statistical Modeling, Clinical Trials, SAS programming, Data Analysis, Data Collection, Government, Public Policy, Oncology, Cancer Immunotherapy, Clinical Development, Pharmaceutical Industry, SAS, Biotechnology, Clinical Research, Drug Development, Clinical Study Design, Life Sciences, Regulatory Submissions, Research, FDA, Clinical Data Management, Survival Analysis, Protocol, Regulatory Affairs, Analysis, Science
Education
Florida State University 2005 — 2008
Doctor of Philosophy (Ph.D.), Statistics
The University of Chicago
Master of Science, Statistics
MedImmune November 2013 - Present
FDA March 2008 - November 2013
University of Arkansas for Medical Sciences November 2002 - August 2005
Skills
Epidemiology, Statistics, Biostatistics, R, Public Health, Statistical Modeling, Clinical Trials, SAS programming, Data Analysis, Data Collection, Government, Public Policy, Oncology, Cancer Immunotherapy, Clinical Development, Pharmaceutical Industry, SAS, Biotechnology, Clinical Research, Drug Development, Clinical Study Design, Life Sciences, Regulatory Submissions, Research, FDA, Clinical Data Management, Survival Analysis, Protocol, Regulatory Affairs, Analysis, Science
Education
Florida State University 2005 — 2008
Doctor of Philosophy (Ph.D.), Statistics
The University of Chicago
Master of Science, Statistics
Richard Awdeh, M.D. Richard Awdeh, M.D.'s FDA Experience March 2015 - Present
Job Chairman, Dermatologic and Ophthalmic Drugs Advisory Committee at FDA
Industry Hospital & Health Care
Experience
FDA March 2015 - Present
FDA April 2014 - Present
Miami Marlins, L.P. January 2012 - Present
CheckedUp January 2012 - Present
Cirle November 2010 - Present
University of Miami January 2010 - Present
Bascom Palmer Eye Institute July 2008 - Present
Bascom Palmer Eye Institute June 2008 - October 2012
Duke University Medical Center July 2005 - June 2008
US Food and Drug Administration - Center for Drug Evaluation and Research May 2007 - August 2007
Skills
Surgeon, Innovator, Entrepreneur, Ophthalmology, Clinical Trials, Surgery, Medicine, Hospitals, Hardware Diagnostics, FDA, Glaucoma, Cataract Surgery, Cornea, Digital Imaging, Public Speaking, Entrepreneurship, Clinical Research, Medical Education, Technology Transfer, Medical Devices, Business Development, Healthcare, Medical Imaging, Industrial Sector, Business Strategy
Education
Yale University School of Medicine 2000 — 2004
MD, Medicine
Emory University - Goizueta Business School 1995 — 1999
BBA, Finance, Computer Science
FDA March 2015 - Present
FDA April 2014 - Present
Miami Marlins, L.P. January 2012 - Present
CheckedUp January 2012 - Present
Cirle November 2010 - Present
University of Miami January 2010 - Present
Bascom Palmer Eye Institute July 2008 - Present
Bascom Palmer Eye Institute June 2008 - October 2012
Duke University Medical Center July 2005 - June 2008
US Food and Drug Administration - Center for Drug Evaluation and Research May 2007 - August 2007
Skills
Surgeon, Innovator, Entrepreneur, Ophthalmology, Clinical Trials, Surgery, Medicine, Hospitals, Hardware Diagnostics, FDA, Glaucoma, Cataract Surgery, Cornea, Digital Imaging, Public Speaking, Entrepreneurship, Clinical Research, Medical Education, Technology Transfer, Medical Devices, Business Development, Healthcare, Medical Imaging, Industrial Sector, Business Strategy
Education
Yale University School of Medicine 2000 — 2004
MD, Medicine
Emory University - Goizueta Business School 1995 — 1999
BBA, Finance, Computer Science
Catrina White Catrina White's FDA Experience January 2009 - March 2014
Job Regulatory Microbiologist at FDA
Industry Government Administration
Experience
Palmetto Health March 2014 - Present
FDA January 2009 - March 2014
Quest Diagnostics July 2007 - July 2011
Grady Memorial Hospital May 2003 - July 2007
Skills
Laboratory Medicine, Microbiology, PCR, Healthcare, PowerPoint, Microsoft Excel, Microsoft Word, Laboratory, Gel Electrophoresis, RT-PCR, DNA extraction, Phlebotomy, Immunoassays, Medical Technology, Public Health, Microsoft Office, Molecular Biology, Infectious Diseases, Immunology, Hematology, DNA Extraction, Quality Assurance
Education
Bellevue University 2005 — 2007
Master's degree, Health/Health Care Administration/Management
Medical College of Georgia 2002 — 2003
Bachelor's degree, Medical Technology
Fort Valley State University 1999 — 2002
Bachelor's degree, Biology, General
Palmetto Health March 2014 - Present
FDA January 2009 - March 2014
Quest Diagnostics July 2007 - July 2011
Grady Memorial Hospital May 2003 - July 2007
Skills
Laboratory Medicine, Microbiology, PCR, Healthcare, PowerPoint, Microsoft Excel, Microsoft Word, Laboratory, Gel Electrophoresis, RT-PCR, DNA extraction, Phlebotomy, Immunoassays, Medical Technology, Public Health, Microsoft Office, Molecular Biology, Infectious Diseases, Immunology, Hematology, DNA Extraction, Quality Assurance
Education
Bellevue University 2005 — 2007
Master's degree, Health/Health Care Administration/Management
Medical College of Georgia 2002 — 2003
Bachelor's degree, Medical Technology
Fort Valley State University 1999 — 2002
Bachelor's degree, Biology, General
Teresa Cain Teresa Cain's FDA Experience June 2003 - Present
Job Analytical Scientist at FDA
Industry Government Administration
Experience
FDA June 2003 - Present
Skills
Analytical Chemistry, HPLC, LC-MS, Chromatography, UV/Vis, Mass Spectrometry, GC-MS, IR, R&D, Science, GLP, Wet Chemistry, Gas Chromatography, Chemistry, FDA, GMP, Laboratory, Life Sciences
Education
Michigan State University
M.S., Pharmacology/Toxicology
The University of Michigan 1991 — 1997
Doctor of Philosophy (Ph.D.), Analytical Chemistry
The University of Michigan 1991 — 1996
Master's Degree, Environmental Engineering
Florida International University 1986 — 1990
Bachelor's Degree, Chemistry
FDA June 2003 - Present
Skills
Analytical Chemistry, HPLC, LC-MS, Chromatography, UV/Vis, Mass Spectrometry, GC-MS, IR, R&D, Science, GLP, Wet Chemistry, Gas Chromatography, Chemistry, FDA, GMP, Laboratory, Life Sciences
Education
Michigan State University
M.S., Pharmacology/Toxicology
The University of Michigan 1991 — 1997
Doctor of Philosophy (Ph.D.), Analytical Chemistry
The University of Michigan 1991 — 1996
Master's Degree, Environmental Engineering
Florida International University 1986 — 1990
Bachelor's Degree, Chemistry
Jennifer Newberger Jennifer Newberger's FDA Experience April 2010 - December 2010
Job Associate at Hyman, Phelps & McNamara, P.C.
Industry Law Practice
Experience
Hyman, Phelps & McNamara, P.C. 2011 - Present
FDA April 2010 - December 2010
Arnold & Porter September 2007 - April 2010
Skills
Policy, Medical Devices, Legal Research, Legal Writing, FDA, Westlaw, Administrative Law, Policy Analysis, Program Evaluation, Pharmaceutical Industry, Healthcare
Education
University of Miami School of Law 2004 — 2007
J.D.
Emory University 1999 — 2001
M.P.H, International Health
Washington University in St. Louis 1995 — 1999
B.A., Anthropology
Hyman, Phelps & McNamara, P.C. 2011 - Present
FDA April 2010 - December 2010
Arnold & Porter September 2007 - April 2010
Skills
Policy, Medical Devices, Legal Research, Legal Writing, FDA, Westlaw, Administrative Law, Policy Analysis, Program Evaluation, Pharmaceutical Industry, Healthcare
Education
University of Miami School of Law 2004 — 2007
J.D.
Emory University 1999 — 2001
M.P.H, International Health
Washington University in St. Louis 1995 — 1999
B.A., Anthropology
Ethan Stegman Ethan Stegman's FDA Experience August 2008 - Present
Job Bioresearch Investigator at FDA
Industry Government Administration
Experience
FDA August 2008 - Present
Skills
Regulatory Affairs, GCP, Pharmaceuticals, GMP, In Vivo, Biopharmaceuticals, CAPA, Biotechnology, Biochemistry, Clinical Research, Biomarkers, GLP, In Vitro, Clinical Development, Pharmacovigilance, Clinical Pharmacology, Clinical Trials, Public Health, Regulatory Submissions, IND, FDA, Pharmaceutical Industry, 21 CFR, 21 CFR Part 11, Infectious Diseases, Quality System, Regulatory Requirements, Technology Transfer
Education
Florida Atlantic University
BS, Biology
FDA August 2008 - Present
Skills
Regulatory Affairs, GCP, Pharmaceuticals, GMP, In Vivo, Biopharmaceuticals, CAPA, Biotechnology, Biochemistry, Clinical Research, Biomarkers, GLP, In Vitro, Clinical Development, Pharmacovigilance, Clinical Pharmacology, Clinical Trials, Public Health, Regulatory Submissions, IND, FDA, Pharmaceutical Industry, 21 CFR, 21 CFR Part 11, Infectious Diseases, Quality System, Regulatory Requirements, Technology Transfer
Education
Florida Atlantic University
BS, Biology
Timothy Watson's FDA Experience June 2002 - January 2005
Job Kitchen Division Assistant at Central Wholesalers, Inc.
Industry Wholesale
Experience
Central Wholesalers, Inc. April 2013 - Present
Bowles Fluidics Corporation May 2012 - February 2013
CARQUEST - B & D Auto Parts July 2005 - May 2012
FDA June 2002 - January 2005
Skills
Eagle Scout, •Works well under..., Team Leadership, Microsoft Office, Microsoft Dynamics, Multi Tasking, Multimedia, Research, Organization, Accounting, Presentations, Inventory Management, High Availability, Customer Service, Multi-line Phone, Efficiency, Networking, Receptionist Duties, Spreadsheets, Manuals, Employee Training, Databases, Data Entry, Filing, Management, Access, Lotus Notes, Outlook, Analysis, Leadership, Purchasing, Microsoft Excel, Sales, Account Management, Budgets
Education
Frostburg State University 2000 — 2005
Bachelor of Arts (BA), Liberal Arts and Sciences/Liberal Studies
Howard Community College 2010 — 2011
Accounting and Finance
Central Wholesalers, Inc. April 2013 - Present
Bowles Fluidics Corporation May 2012 - February 2013
CARQUEST - B & D Auto Parts July 2005 - May 2012
FDA June 2002 - January 2005
Skills
Eagle Scout, •Works well under..., Team Leadership, Microsoft Office, Microsoft Dynamics, Multi Tasking, Multimedia, Research, Organization, Accounting, Presentations, Inventory Management, High Availability, Customer Service, Multi-line Phone, Efficiency, Networking, Receptionist Duties, Spreadsheets, Manuals, Employee Training, Databases, Data Entry, Filing, Management, Access, Lotus Notes, Outlook, Analysis, Leadership, Purchasing, Microsoft Excel, Sales, Account Management, Budgets
Education
Frostburg State University 2000 — 2005
Bachelor of Arts (BA), Liberal Arts and Sciences/Liberal Studies
Howard Community College 2010 — 2011
Accounting and Finance
Patrick Weixel Patrick Weixel's FDA Experience March 2012 - Present
Job Postmarket Team Leader at FDA
Industry Government Administration
Experience
FDA March 2012 - Present
FDA Center for Devices and Radiological Health August 2010 - March 2012
FDA/Center for Devices and Radiological Health September 2002 - August 2010
FDA/ Philadelphia District Office 1992 - 1993
Skills
Sterilization, Quality System..., Standards Compliance, Quality System, Medical Devices, Regulatory Requirements, CAPA, FDA, Inspection, Healthcare, Quality Auditing, Regulatory Affairs, Environmental Monitoring, Microbiology, GMP, Regulatory Submissions, ISO 13485, Validation, Biotechnology, Life Sciences
Education
Frostburg State University 1984 — 1989
Bachelor of Science (BS), Wildlife, Fish and Wildlands Science and Management
FDA March 2012 - Present
FDA Center for Devices and Radiological Health August 2010 - March 2012
FDA/Center for Devices and Radiological Health September 2002 - August 2010
FDA/ Philadelphia District Office 1992 - 1993
Skills
Sterilization, Quality System..., Standards Compliance, Quality System, Medical Devices, Regulatory Requirements, CAPA, FDA, Inspection, Healthcare, Quality Auditing, Regulatory Affairs, Environmental Monitoring, Microbiology, GMP, Regulatory Submissions, ISO 13485, Validation, Biotechnology, Life Sciences
Education
Frostburg State University 1984 — 1989
Bachelor of Science (BS), Wildlife, Fish and Wildlands Science and Management
Andrej Petronijevic Andrej Petronijevic's FDA Experience May 2010 - Present
Job Medical Device Fellow at FDA
Industry Medical Devices
Experience
FDA May 2010 - Present
Great Falls Eye Care October 2012 - April 2013
Skills
Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Word, Customer Service, Research, Social Media, Teamwork, Public Speaking, English, Windows, Access
Education
George Mason University 2011 — 2013
Global and Community Health, Pre- Health Studies
FDA May 2010 - Present
Great Falls Eye Care October 2012 - April 2013
Skills
Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Word, Customer Service, Research, Social Media, Teamwork, Public Speaking, English, Windows, Access
Education
George Mason University 2011 — 2013
Global and Community Health, Pre- Health Studies
Lillian Xiang Li Lillian Xiang Li's FDA Experience May 2009 - August 2009
Job Scientist II at The Clorox Company
Industry Research
Experience
The Clorox Company October 2014 - Present
Contract Pharmacal Corp May 2013 - June 2014
Brookhaven National Laboratory March 2011 - March 2013
Penn State University September 2005 - January 2011
FDA May 2009 - August 2009
Skills
Spectroscopy, Fluorescence..., Fluorescence, Mass Spectrometry, Physical Chemistry, Characterization, Analytical Chemistry, Chemistry, HPLC, Chromatography, Science, Chemometrics, Polymers, Microscopy, Purification, NMR, X-ray, UV-Vis, IR, NIR, cGMP practices, ANDAs, ICP
Education
Pennsylvania State University 2005 — 2010
Ph.D, Physical/Analytical Chemistry
Fudan University 2001 — 2005
Bachelor of Science (BS), Chemistry
The Clorox Company October 2014 - Present
Contract Pharmacal Corp May 2013 - June 2014
Brookhaven National Laboratory March 2011 - March 2013
Penn State University September 2005 - January 2011
FDA May 2009 - August 2009
Skills
Spectroscopy, Fluorescence..., Fluorescence, Mass Spectrometry, Physical Chemistry, Characterization, Analytical Chemistry, Chemistry, HPLC, Chromatography, Science, Chemometrics, Polymers, Microscopy, Purification, NMR, X-ray, UV-Vis, IR, NIR, cGMP practices, ANDAs, ICP
Education
Pennsylvania State University 2005 — 2010
Ph.D, Physical/Analytical Chemistry
Fudan University 2001 — 2005
Bachelor of Science (BS), Chemistry
Gregg Doyle Gregg Doyle's FDA Experience November 2003 - June 2011
Job Management & Government Consulting at Gregg Doyle Enterprises
Industry Government Administration
Experience
Gregg Doyle Enterprises January 2014 - Present
no company July 2011 - January 2014
FDA November 2003 - June 2011
Internal Revenue Service November 2001 - October 2003
US Customs Service October 2000 - October 2001
US Department of the Army June 1998 - October 2000
US Army Medical Research and Materiel Command November 1993 - May 1998
US Army Special Operations Command June 1990 - October 1993
US Army Communications-Electronics Command September 1977 - May 1990
Skills
Federal Government, Government, Strategic Planning, Program Management, Policy, Change Management, Process Improvement, Business Process..., Contract Management, Management Consulting, Analysis, Business Process..., Leadership, Risk Management, Organizational..., Project Management, Budgets, Policy Analysis, Public Speaking, Organizational..., Project Planning, Leadership Development, Operations Management, Government Procurement, Management, Strategy, Procurement, Cross-functional Team..., Contract Negotiation, Governance, Government Contracting, Proposal Writing, Performance Management, Training
Education
National Defense University 1997 — 1998
National Resources Strategies, Acquisition
Fairleigh Dickinson University 1985 — 1988
MBA, Management
University of North Carolina at Chapel Hill 1973 — 1977
BA, Political Science
Gregg Doyle Enterprises January 2014 - Present
no company July 2011 - January 2014
FDA November 2003 - June 2011
Internal Revenue Service November 2001 - October 2003
US Customs Service October 2000 - October 2001
US Department of the Army June 1998 - October 2000
US Army Medical Research and Materiel Command November 1993 - May 1998
US Army Special Operations Command June 1990 - October 1993
US Army Communications-Electronics Command September 1977 - May 1990
Skills
Federal Government, Government, Strategic Planning, Program Management, Policy, Change Management, Process Improvement, Business Process..., Contract Management, Management Consulting, Analysis, Business Process..., Leadership, Risk Management, Organizational..., Project Management, Budgets, Policy Analysis, Public Speaking, Organizational..., Project Planning, Leadership Development, Operations Management, Government Procurement, Management, Strategy, Procurement, Cross-functional Team..., Contract Negotiation, Governance, Government Contracting, Proposal Writing, Performance Management, Training
Education
National Defense University 1997 — 1998
National Resources Strategies, Acquisition
Fairleigh Dickinson University 1985 — 1988
MBA, Management
University of North Carolina at Chapel Hill 1973 — 1977
BA, Political Science
Rebecca Torene Rebecca Torene's FDA Experience September 2003 - June 2004
Job Clinical Genomics Analyst at Novartis
Industry Research
Experience
Novartis July 2013 - Present
Brigham and Women's Hospital December 2009 - June 2013
Harvard Medical School December 2009 - June 2013
Emory University 2004 - 2009
FDA September 2003 - June 2004
Skills
PCR, qPCR, Cloning, array comparative..., Sequencing, R, Genetics, Genomics, Bioinformatics
Education
Harvard Medical School 2011 — 2013
MMSc, Biomedical Informatics
Emory University 2004 — 2009
Ph.D., Genetics and Molecular Biology
University of Maryland College Park 1999 — 2003
B.S., Cellular, Molecular Biology, and Genetics
Novartis July 2013 - Present
Brigham and Women's Hospital December 2009 - June 2013
Harvard Medical School December 2009 - June 2013
Emory University 2004 - 2009
FDA September 2003 - June 2004
Skills
PCR, qPCR, Cloning, array comparative..., Sequencing, R, Genetics, Genomics, Bioinformatics
Education
Harvard Medical School 2011 — 2013
MMSc, Biomedical Informatics
Emory University 2004 — 2009
Ph.D., Genetics and Molecular Biology
University of Maryland College Park 1999 — 2003
B.S., Cellular, Molecular Biology, and Genetics
Constance Y. Fears, J.D., Ph.D.'s FDA Experience December 2014 - Present
Job Drug Investigator, FDA
Industry Pharmaceuticals
Experience
FDA December 2014 - Present
Middle Georgia State University August 2012 - December 2014
Yasheen Fears Media, LLC February 2011 - February 2012
California State Universtity August 2010 - December 2011
Cal State San Marcos August 2010 - August 2011
Morrison & Foerster LLP November 2009 - April 2010
Foley & Lardner LLP 2007 - 2007
Jefferson State Community College January 2006 - August 2006
University of Alabama at Birmingham September 2005 - August 2006
Skills
Molecular Biology, Biotechnology, Cell Biology, Cell, Protein Chemistry, Genetics, Microbiology, Science, Scientific Writing, Chemistry, Cancer, Research, Medical Devices, Editing, Biology, Teaching, Lifesciences, Biochemistry, Cell Culture, Western Blotting, Microsoft Office, Microsoft Excel, ELISA, DNA, Social Media, Psychotherapy, Protein Purification, PCR, Immunology, Chromatography, Assay Development
Education
The University of Texas at Austin 2006 — 2009
J.D., Law
Université Jean Moulin (Lyon III) 2008 — 2008
Diploma, International and European Law
University of Alabama at Birmingham 2001 — 2005
Ph.D., Cellular and Molecular Biology
Florida State University 1997 — 2001
B.S., Biological Sciences
Huffman High School
FDA December 2014 - Present
Middle Georgia State University August 2012 - December 2014
Yasheen Fears Media, LLC February 2011 - February 2012
California State Universtity August 2010 - December 2011
Cal State San Marcos August 2010 - August 2011
Morrison & Foerster LLP November 2009 - April 2010
Foley & Lardner LLP 2007 - 2007
Jefferson State Community College January 2006 - August 2006
University of Alabama at Birmingham September 2005 - August 2006
Skills
Molecular Biology, Biotechnology, Cell Biology, Cell, Protein Chemistry, Genetics, Microbiology, Science, Scientific Writing, Chemistry, Cancer, Research, Medical Devices, Editing, Biology, Teaching, Lifesciences, Biochemistry, Cell Culture, Western Blotting, Microsoft Office, Microsoft Excel, ELISA, DNA, Social Media, Psychotherapy, Protein Purification, PCR, Immunology, Chromatography, Assay Development
Education
The University of Texas at Austin 2006 — 2009
J.D., Law
Université Jean Moulin (Lyon III) 2008 — 2008
Diploma, International and European Law
University of Alabama at Birmingham 2001 — 2005
Ph.D., Cellular and Molecular Biology
Florida State University 1997 — 2001
B.S., Biological Sciences
Huffman High School
Lipscomb Donna Lipscomb Donna's FDA Experience May 2011 - Present
Job Director, Division of Manufacturers Assistance and Training at US Department of Health and Human Services
Industry Government Administration
Experience
FDA May 2011 - Present
Skills
Data Analysis, Government, Organizational..., Program Management, Policy, Training
Education
Frostburg State University
Bachelor of Science (B.S.), Secondary Education and Teaching
FDA May 2011 - Present
Skills
Data Analysis, Government, Organizational..., Program Management, Policy, Training
Education
Frostburg State University
Bachelor of Science (B.S.), Secondary Education and Teaching
Alsean R. Bryant, Pharm.D. Alsean R. Bryant, Pharm.D.'s FDA Experience January 2010 - February 2010
Job Subject Matter Expert AIDS Education and Training Center/Pharmacist AHF Pharmacy
Industry Health, Wellness and Fitness
Experience
AIDS Healthcare Foundation July 2012 - Present
AIDS Education and Training Center January 2011 - Present
United Medical Center August 2013 - December 2013
CMS Health Initiatives July 2011 - June 2012
CMS Health Initiatives December 2010 - June 2011
Washington DC Veterans Affairs Hospital July 2010 - June 2011
ASHP 2011 - 2011
FDA January 2010 - February 2010
Bristol-Myers Squibb September 2009 - October 2009
The Washington Center January 2009 - January 2009
Skills
Medication Therapy..., Pharmacists, Pharmacy Benefit..., Clinical Research, Clinical Pharmacology, Pharmacy, Patient Counseling, Community Outreach, Healthcare, Managed Care, Public Speaking, Pharmacy Automation, Customer Service, Pharmacy Practice, Pharmaceutical Industry, Hospitals, Immunization, Clinical Pharmacy, Healthcare Information...
Education
Florida Agricultural and Mechanical University 2004 — 2010
Pharm.D., Pharmacy
Florida Agricultural and Mechanical University 2004 — 2010
Doctor of Pharmacy (Pharm.D.), Pharmacy
AIDS Healthcare Foundation July 2012 - Present
AIDS Education and Training Center January 2011 - Present
United Medical Center August 2013 - December 2013
CMS Health Initiatives July 2011 - June 2012
CMS Health Initiatives December 2010 - June 2011
Washington DC Veterans Affairs Hospital July 2010 - June 2011
ASHP 2011 - 2011
FDA January 2010 - February 2010
Bristol-Myers Squibb September 2009 - October 2009
The Washington Center January 2009 - January 2009
Skills
Medication Therapy..., Pharmacists, Pharmacy Benefit..., Clinical Research, Clinical Pharmacology, Pharmacy, Patient Counseling, Community Outreach, Healthcare, Managed Care, Public Speaking, Pharmacy Automation, Customer Service, Pharmacy Practice, Pharmaceutical Industry, Hospitals, Immunization, Clinical Pharmacy, Healthcare Information...
Education
Florida Agricultural and Mechanical University 2004 — 2010
Pharm.D., Pharmacy
Florida Agricultural and Mechanical University 2004 — 2010
Doctor of Pharmacy (Pharm.D.), Pharmacy
Garrett Davis's FDA Experience June 2008 - July 2011
Job Procurement Specialist at Floorco
Industry Pharmaceuticals
Experience
Floorco September 2015 - Present
Floorco July 2015 - September 2015
Best Practices, LLC February 2015 - July 2015
Plates Neighborhood Kitchen October 2013 - June 2015
Busy Bee Cafe August 2014 - February 2015
Red Bowl Asian Bistro July 2011 - March 2014
Tilted Kilt Pub & Eatery April 2012 - September 2012
FDA June 2008 - July 2011
Holly Hills Country Club May 2005 - May 2009
Skills
Bartending, Customer Service, Restaurants, Biostatistics, Beer, Management, Time Management, Bar Management, Sales, FDA, Fine Dining, Wine, Food, Menu Development, Microsoft Excel, Microsoft Office, Social Media, Microsoft Word, Teamwork, Pharmaceutical Industry, Mathematics, Marketing, Research, Sales Logix
Education
North Carolina State University 2011 — 2014
Bachelor of Applied Science (BASc), Mathematics
Frederick Community College 2009 — 2010
Associate of Science (AS), Mathematics
North Carolina State University 2007 — 2009
Bachelor of Applied Science (BASc), Mathematics
Floorco September 2015 - Present
Floorco July 2015 - September 2015
Best Practices, LLC February 2015 - July 2015
Plates Neighborhood Kitchen October 2013 - June 2015
Busy Bee Cafe August 2014 - February 2015
Red Bowl Asian Bistro July 2011 - March 2014
Tilted Kilt Pub & Eatery April 2012 - September 2012
FDA June 2008 - July 2011
Holly Hills Country Club May 2005 - May 2009
Skills
Bartending, Customer Service, Restaurants, Biostatistics, Beer, Management, Time Management, Bar Management, Sales, FDA, Fine Dining, Wine, Food, Menu Development, Microsoft Excel, Microsoft Office, Social Media, Microsoft Word, Teamwork, Pharmaceutical Industry, Mathematics, Marketing, Research, Sales Logix
Education
North Carolina State University 2011 — 2014
Bachelor of Applied Science (BASc), Mathematics
Frederick Community College 2009 — 2010
Associate of Science (AS), Mathematics
North Carolina State University 2007 — 2009
Bachelor of Applied Science (BASc), Mathematics
Katherine Reiss Katherine Reiss's FDA Experience May 2010 - July 2010
Job Business and marketing student
Industry Marketing and Advertising
Experience
The Disney Store August 2015 - Present
Life Uniform April 2015 - Present
Bed Bath & Beyond March 2012 - February 2015
Bath & Body Works September 2014 - January 2015
FDA May 2010 - July 2010
Baxter Healthcare August 2008 - May 2010
Marquette University June 2007 - August 2008
Skills
Sales, Customer Service, Data Analysis
Education
Franklin University 2015 — 2016
Bachelor of Business Administration (BBA), Minor: Marketing
Marquette University
B.S., Biomedical Engineering - Mechanical
Catholic Memorial High School
The Disney Store August 2015 - Present
Life Uniform April 2015 - Present
Bed Bath & Beyond March 2012 - February 2015
Bath & Body Works September 2014 - January 2015
FDA May 2010 - July 2010
Baxter Healthcare August 2008 - May 2010
Marquette University June 2007 - August 2008
Skills
Sales, Customer Service, Data Analysis
Education
Franklin University 2015 — 2016
Bachelor of Business Administration (BBA), Minor: Marketing
Marquette University
B.S., Biomedical Engineering - Mechanical
Catholic Memorial High School
Nina Mezu-Nwaba, PharmD., MPH, MSC. Nina Mezu-Nwaba, PharmD., MPH, MSC.'s FDA Experience November 2003 - Present
Job Director, Regulatory Affairs USFDA
Industry Government Administration
Experience
NAPPSA September 2009 - Present
FDA November 2003 - Present
U.S. Public Health Service Commissioned Corps November 2000 - Present
Mezu International Foundation January 1992 - Present
Rite Aid January 1992 - November 2011
FDA September 2000 - November 2003
FDA November 2000 - August 2003
Baltimore Washington Medical Center April 1997 - November 2002
University of Maryland School of Pharmacy 1992 - 1996
Skills
Medical Devices, Drug Development, Regulatory Affairs, Hospital Pharmacy, Consulting, Standards Compliance, Quality Assurance, Pharmacovigilance, Public Health, Written & Oral..., Immunization, Post Market Surveillance, HIV prevention, Malaria, Sickle Cell Disease, Nonprofits, Pharmacy Practice, Clinical Pharmacology, Pharmacy, Research, Medicine, Hospitals, Epidemiology, GMP, Infectious Diseases, FDA, Clinical Research, Drug Safety, Pharmaceutics, Drug Discovery, Pharmacists, Drug Testing, Pharmacology
Education
Johns Hopkins University Bloomberg School of Public Health 2009 — 2011
Master of Public Health (MPH), International Public Health/HIV AIDS/REFUGEE Health
Georgetown University 2006 — 2008
Masters in Biomedical Technology, Biomedical/Medical Engineering
University of Maryland School of Pharmacy 1992 — 1996
Doctor of Pharmacy (Pharm.D.), Pharmacy
Essex Community College 1991 — 1992
Associate of Arts and Sciences (AAS), Chemistry/Biology
Federal Government Girls College Abuloma
NAPPSA September 2009 - Present
FDA November 2003 - Present
U.S. Public Health Service Commissioned Corps November 2000 - Present
Mezu International Foundation January 1992 - Present
Rite Aid January 1992 - November 2011
FDA September 2000 - November 2003
FDA November 2000 - August 2003
Baltimore Washington Medical Center April 1997 - November 2002
University of Maryland School of Pharmacy 1992 - 1996
Skills
Medical Devices, Drug Development, Regulatory Affairs, Hospital Pharmacy, Consulting, Standards Compliance, Quality Assurance, Pharmacovigilance, Public Health, Written & Oral..., Immunization, Post Market Surveillance, HIV prevention, Malaria, Sickle Cell Disease, Nonprofits, Pharmacy Practice, Clinical Pharmacology, Pharmacy, Research, Medicine, Hospitals, Epidemiology, GMP, Infectious Diseases, FDA, Clinical Research, Drug Safety, Pharmaceutics, Drug Discovery, Pharmacists, Drug Testing, Pharmacology
Education
Johns Hopkins University Bloomberg School of Public Health 2009 — 2011
Master of Public Health (MPH), International Public Health/HIV AIDS/REFUGEE Health
Georgetown University 2006 — 2008
Masters in Biomedical Technology, Biomedical/Medical Engineering
University of Maryland School of Pharmacy 1992 — 1996
Doctor of Pharmacy (Pharm.D.), Pharmacy
Essex Community College 1991 — 1992
Associate of Arts and Sciences (AAS), Chemistry/Biology
Federal Government Girls College Abuloma
Anya Coleman Anya Coleman's FDA Experience January 2014 - June 2014
Job Project Coordinator IPT Associates
Industry Government Administration
Experience
IPT Associates June 2014 - Present
CDNB Inc. January 2014 - Present
FDA January 2014 - June 2014
College of Health and Human Services - GMU June 2013 - April 2014
George Mason University August 2010 - September 2013
AcademyHealth August 2012 - June 2013
Welless, Alcohol and Violence Education and Services (WAVES) August 2012 - May 2013
Skills
Public Health, Nutrition Education, Nutrition, Microsoft Office, Health Program Planning, Biostatistics, Program Evaluation, SPSS, NVivo, Customer Service, Organization, Leadership, Research, Event Planning, Community Outreach, Health Education, Public Speaking, Leadership Development, Health Equity, Data Analysis, Nonprofits, Program Management, Program Development, Training, Microsoft Word, Grants, PowerPoint, Proposal Writing, Qualitative Research, Grant Writing, Microsoft Excel
Education
University of Virginia 2015 — 2016
Graduate Certificate, Purchasing, Procurement/Acquisitions and Contracts Management
George Mason University 2009 — 2014
Bachelor of Science (B.S.), Global and Community Health
IPT Associates June 2014 - Present
CDNB Inc. January 2014 - Present
FDA January 2014 - June 2014
College of Health and Human Services - GMU June 2013 - April 2014
George Mason University August 2010 - September 2013
AcademyHealth August 2012 - June 2013
Welless, Alcohol and Violence Education and Services (WAVES) August 2012 - May 2013
Skills
Public Health, Nutrition Education, Nutrition, Microsoft Office, Health Program Planning, Biostatistics, Program Evaluation, SPSS, NVivo, Customer Service, Organization, Leadership, Research, Event Planning, Community Outreach, Health Education, Public Speaking, Leadership Development, Health Equity, Data Analysis, Nonprofits, Program Management, Program Development, Training, Microsoft Word, Grants, PowerPoint, Proposal Writing, Qualitative Research, Grant Writing, Microsoft Excel
Education
University of Virginia 2015 — 2016
Graduate Certificate, Purchasing, Procurement/Acquisitions and Contracts Management
George Mason University 2009 — 2014
Bachelor of Science (B.S.), Global and Community Health
Patrice Brooks-Gelling Patrice Brooks-Gelling's FDA Experience August 2015 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA August 2015 - Present
Skills
Legal Research, Legal Writing, Research, Litigation, Civil Litigation, FDA, Product Liability, Administrative Law
Education
Howard University School of Law 2008 — 2011
Juris Doctor, Law
Emory University 2004 — 2006
MPH, Health Education
University of Arizona 2002 — 2004
BS, Physiology
FDA August 2015 - Present
Skills
Legal Research, Legal Writing, Research, Litigation, Civil Litigation, FDA, Product Liability, Administrative Law
Education
Howard University School of Law 2008 — 2011
Juris Doctor, Law
Emory University 2004 — 2006
MPH, Health Education
University of Arizona 2002 — 2004
BS, Physiology
Christopher Freebairn Christopher Freebairn's FDA Experience 2002 - 2012
Job Government Administration Professional
Industry Government Administration
Experience
FDA 2002 - 2012
Immigration & Naturalization Service December 1997 - September 2002
Albuquerque Public Schools October 1991 - November 1996
Skills
Food Safety & Security, Computer Technology, Public Health, Complaint Investigations, Public Administration, Regulatory Affairs, Customer Service, Legal Compliance
Education
The University of New Mexico 1994 — 1996
Biology/Biological Sciences, Chemistry
Fordham University 1978 — 1982
Bachelor of Arts (B.A.), Economics
FDA 2002 - 2012
Immigration & Naturalization Service December 1997 - September 2002
Albuquerque Public Schools October 1991 - November 1996
Skills
Food Safety & Security, Computer Technology, Public Health, Complaint Investigations, Public Administration, Regulatory Affairs, Customer Service, Legal Compliance
Education
The University of New Mexico 1994 — 1996
Biology/Biological Sciences, Chemistry
Fordham University 1978 — 1982
Bachelor of Arts (B.A.), Economics
Francine Davis Francine Davis's FDA Experience June 2010 - August 2010
Job Product Transfer Specialist at Ben Venue Laboratories
Industry Environmental Services
Experience
Boehringer Ingelheim April 2013 - December 2013
Boehringer Ingelheim February 2012 - April 2013
Earth Sciences and Resource Institute August 2010 - June 2011
FDA June 2010 - August 2010
The Student Conservation Association June 2001 - October 2002
Skills
Biology, PowerPoint, Microsoft Office, Organization, Microsoft Excel, Microsoft Word, Customer Service, Data Analysis, Research, Statistics, Environmental Awareness, Time Management, Environmental Compliance, Leadership, Sustainability, Community Outreach, Chemistry, Training
Education
University of South Carolina-Columbia 2009 — 2011
MS, Environmental Health Sciences
John Carroll University 2004 — 2007
Bachelor of Science (BS) Degree, Biology
Fordham University
Boehringer Ingelheim April 2013 - December 2013
Boehringer Ingelheim February 2012 - April 2013
Earth Sciences and Resource Institute August 2010 - June 2011
FDA June 2010 - August 2010
The Student Conservation Association June 2001 - October 2002
Skills
Biology, PowerPoint, Microsoft Office, Organization, Microsoft Excel, Microsoft Word, Customer Service, Data Analysis, Research, Statistics, Environmental Awareness, Time Management, Environmental Compliance, Leadership, Sustainability, Community Outreach, Chemistry, Training
Education
University of South Carolina-Columbia 2009 — 2011
MS, Environmental Health Sciences
John Carroll University 2004 — 2007
Bachelor of Science (BS) Degree, Biology
Fordham University
James Bowling James Bowling's FDA Experience January 2014 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA January 2014 - Present
Charles B. Roberts & Associates, P.C. July 2012 - October 2013
Ayuda May 2012 - July 2012
Right Size Law PLLC June 2011 - August 2011
DCI Group August 2008 - December 2008
AmeriCorps September 2007 - January 2008
Skills
Spanish, Legal Research, Legal Writing, International Law, Policy Analysis, Research, Political Science, Immigration Law, Family Law, Appellate Practice, Civil Litigation, Torts, Criminal Law, Public Policy, Hearings
Education
Florida Coastal School of Law 2009 — 2011
Doctor of Law (JD)
Virginia Commonwealth University 2004 — 2008
Bachelor's degree, Political Science and Government
FDA January 2014 - Present
Charles B. Roberts & Associates, P.C. July 2012 - October 2013
Ayuda May 2012 - July 2012
Right Size Law PLLC June 2011 - August 2011
DCI Group August 2008 - December 2008
AmeriCorps September 2007 - January 2008
Skills
Spanish, Legal Research, Legal Writing, International Law, Policy Analysis, Research, Political Science, Immigration Law, Family Law, Appellate Practice, Civil Litigation, Torts, Criminal Law, Public Policy, Hearings
Education
Florida Coastal School of Law 2009 — 2011
Doctor of Law (JD)
Virginia Commonwealth University 2004 — 2008
Bachelor's degree, Political Science and Government
James Kenimer James Kenimer's FDA Experience 1980 - 1993
Job Consultant Emeritus & Chairman
Industry Pharmaceuticals
Experience
Biologics Consulting Group, Inc 2011 - Present
US Coast Guard Auxiliary 2012 - Present
Biologics Consulting Group 1993 - 2011
FDA 1980 - 1993
Education
Emory University 1962 — 1972
PhD, Biochemistry
Biologics Consulting Group, Inc 2011 - Present
US Coast Guard Auxiliary 2012 - Present
Biologics Consulting Group 1993 - 2011
FDA 1980 - 1993
Education
Emory University 1962 — 1972
PhD, Biochemistry
Susan Meadows's FDA Experience May 1987 - March 2012
Job Senior Policy Analyst at U.S. Food & Drug Administration
Industry Public Policy
Experience
Food and Drug Administration, Center for Devices and Radiological Health March 2012 - Present
FDA May 1987 - March 2012
FDA May 1987 - May 2005
National Academy of Sciences September 1985 - September 1986
U.S. Consumer Product Safety Commission November 1979 - April 1984
Skills
Global Regulation, Medical Devices, Consumer Products, International Standards, Human Factors Analysis, Policy Analysis, Public Health Emergency..., Project Management, Constituent Relations, Strategic Communications, Occupational Health and..., Human Performance, Human Physiology, Myofascial Release..., Sports Medicine, Public Health
Education
The George Washington University 2007 — 2007
Master's Certificate in Project Management, Project Management
West Virginia University 1979 — 1979
Additional Graduate Studies, Environmental and Occupational Health and Safety
Marshall University 1973 — 1975
Master's Degree, Human Biology, Work Physiology
Fairmont State University 1969 — 1973
Bachelor's Degree, Education, Biology, Physical Education
Food and Drug Administration, Center for Devices and Radiological Health March 2012 - Present
FDA May 1987 - March 2012
FDA May 1987 - May 2005
National Academy of Sciences September 1985 - September 1986
U.S. Consumer Product Safety Commission November 1979 - April 1984
Skills
Global Regulation, Medical Devices, Consumer Products, International Standards, Human Factors Analysis, Policy Analysis, Public Health Emergency..., Project Management, Constituent Relations, Strategic Communications, Occupational Health and..., Human Performance, Human Physiology, Myofascial Release..., Sports Medicine, Public Health
Education
The George Washington University 2007 — 2007
Master's Certificate in Project Management, Project Management
West Virginia University 1979 — 1979
Additional Graduate Studies, Environmental and Occupational Health and Safety
Marshall University 1973 — 1975
Master's Degree, Human Biology, Work Physiology
Fairmont State University 1969 — 1973
Bachelor's Degree, Education, Biology, Physical Education
Frank DeDominicis Frank DeDominicis's FDA Experience May 1901 - Present
Job Owner, FD&A
Industry Consumer Goods
Experience
FD&A May 1901 - Present
Skills
Organizational..., Business Mangement, E-commerce Consulting
Education
Front Range Community College 2007 — 2011
AAS - Business with a concentration in management, Management, Human resources, E-commerce
LaSalle College/University -- Philadelphia. PA 1969 — 1971
FD&A May 1901 - Present
Skills
Organizational..., Business Mangement, E-commerce Consulting
Education
Front Range Community College 2007 — 2011
AAS - Business with a concentration in management, Management, Human resources, E-commerce
LaSalle College/University -- Philadelphia. PA 1969 — 1971
Adrienne Rothstein Adrienne Rothstein's FDA Experience 2004 - 2014
Job Senior Safety Scientist at AbbVie
Industry Pharmaceuticals
Experience
AbbVie 2014 - Present
FDA 2004 - 2014
Elan Pharmaceuticals 1998 - 2004
Stanford Health Care 1997 - 1998
University of Cincinnati Academic Health Center 1995 - 1997
Skills
Pharmacovigilance, FDA, Pharmaceutical Industry, Drug Safety, Oncology, Regulatory Submissions, Drug Development, Clinical Development
Education
Georgetown University 2009 — 2010
Certificate Program in Public Health
Stanford University 1997 — 1998
Pharmacy Practice Residency at Stanford Health Care
University of Cincinnati 1995 — 1997
Doctorate in Pharmacy
St. John's University 1992 — 1995
Bachelor's Degree
Fordham University 1986 — 1990
Bachelor's Degree
AbbVie 2014 - Present
FDA 2004 - 2014
Elan Pharmaceuticals 1998 - 2004
Stanford Health Care 1997 - 1998
University of Cincinnati Academic Health Center 1995 - 1997
Skills
Pharmacovigilance, FDA, Pharmaceutical Industry, Drug Safety, Oncology, Regulatory Submissions, Drug Development, Clinical Development
Education
Georgetown University 2009 — 2010
Certificate Program in Public Health
Stanford University 1997 — 1998
Pharmacy Practice Residency at Stanford Health Care
University of Cincinnati 1995 — 1997
Doctorate in Pharmacy
St. John's University 1992 — 1995
Bachelor's Degree
Fordham University 1986 — 1990
Bachelor's Degree
Behnaz Minaei's FDA Experience January 2012 - Present
Job Policy Analyst at FDA
Industry Computer Software
Experience
FDA January 2012 - Present
Center for Medicare and Medicaid Services February 2009 - Present
Kaiser permanente September 2001 - April 2010
Education
George Mason University 1993 — 1996
Master of Science, Information Management/Software Engineering
University of Maryland College Park 1986 — 1989
FDA January 2012 - Present
Center for Medicare and Medicaid Services February 2009 - Present
Kaiser permanente September 2001 - April 2010
Education
George Mason University 1993 — 1996
Master of Science, Information Management/Software Engineering
University of Maryland College Park 1986 — 1989
Kevin Shine's FDA Experience February 2015 - Present
Job Associate Deputy CIO for the Office of the Commissioner/Operations at FDA
Industry Information Technology and Services
Experience
FDA February 2015 - Present
Pension Benefit Guaranty Corporation (PBGC) February 2013 - February 2015
DoD Navy Bureau of Medicine and Surgery July 2007 - February 2013
US Department of Labor May 2004 - July 2007
DHS - Transportation Security Administration December 2002 - May 2004
Booz Allen Hamilton 1992 - 2002
Loudoun County Health Dept/BDM International 1988 - 1992
Skills
Strategic Planning, Project Management, Change Management, Program Management, Team Building, Microsoft Office, Budget, Process Improvement, Team Leadership, Earned Value Management, IT Portfolio Management, Capital Planning..., Budgets, SDLC, Leadership, PMO, Project Planning, IT Portfolio, Governance, Management, Analysis, Policy, Government, Enterprise Architecture, Business Analysis, DoD, Risk Management, Software Documentation, Management Consulting, PMP, Training, Requirements Analysis, Information Technology, Software Project..., Project Portfolio..., MS Project, Security, Proposal Writing, SharePoint, Information Security, IT Strategy, IT Management, Integration, ITIL, Disaster Recovery, Business Process..., Business Intelligence, Executive Management, Information Assurance, IT Operations
Education
Virginia Polytechnic Institute and State University 1989 — 1996
M.S. Environmental Engineering, Environmental Engineering Technology/Environmental Technology
Syracuse University - College of Environmental Science and Forestry 1981 — 1983
Bachelor of Science (B.S.), Environmental Biology
Erie Community College 1978 — 1980
Associate of Arts and Sciences (A.A.S.), Liberal Arts and Sciences/Liberal Studies
FDA February 2015 - Present
Pension Benefit Guaranty Corporation (PBGC) February 2013 - February 2015
DoD Navy Bureau of Medicine and Surgery July 2007 - February 2013
US Department of Labor May 2004 - July 2007
DHS - Transportation Security Administration December 2002 - May 2004
Booz Allen Hamilton 1992 - 2002
Loudoun County Health Dept/BDM International 1988 - 1992
Skills
Strategic Planning, Project Management, Change Management, Program Management, Team Building, Microsoft Office, Budget, Process Improvement, Team Leadership, Earned Value Management, IT Portfolio Management, Capital Planning..., Budgets, SDLC, Leadership, PMO, Project Planning, IT Portfolio, Governance, Management, Analysis, Policy, Government, Enterprise Architecture, Business Analysis, DoD, Risk Management, Software Documentation, Management Consulting, PMP, Training, Requirements Analysis, Information Technology, Software Project..., Project Portfolio..., MS Project, Security, Proposal Writing, SharePoint, Information Security, IT Strategy, IT Management, Integration, ITIL, Disaster Recovery, Business Process..., Business Intelligence, Executive Management, Information Assurance, IT Operations
Education
Virginia Polytechnic Institute and State University 1989 — 1996
M.S. Environmental Engineering, Environmental Engineering Technology/Environmental Technology
Syracuse University - College of Environmental Science and Forestry 1981 — 1983
Bachelor of Science (B.S.), Environmental Biology
Erie Community College 1978 — 1980
Associate of Arts and Sciences (A.A.S.), Liberal Arts and Sciences/Liberal Studies
Kevin Swiss's FDA Experience April 1999 - June 2001
Job Private Consultant in CMC Regulatory
Industry Pharmaceuticals
Experience
Nautilus Neurosciences, Inc. February 2013 - January 2014
CMC GMP LLC 2013 - 2014
BIOTRONIK September 2012 - February 2013
Kowa Research Institute, Inc. June 2008 - October 2012
Proethic Pharmaceuticals January 2006 - June 2008
PharmaNet July 2003 - January 2006
Inex Pharmaceuticals 2001 - 2003
FDA April 1999 - June 2001
Boehringer Ingelheim Pharmaceuticals 1996 - 1999
University of Illinois at Urbana-Champaign 1991 - 1995
Skills
Pharmaceutical Industry, Regulatory Affairs, FDA, Quality Assurance, IND, GMP, Clinical Trials, Drug Development, Regulatory Submissions, CRO, Regulatory Requirements, CMC, NDA, CAPA, Validation, Biotechnology, Sop, Technology Transfer
Education
Emory University 1987 — 1991
Ph.D., Organic Chemistry
Princeton University 1985 — 1987
MA, Chemistry
University of North Carolina at Greensboro 1982 — 1985
Bachelor of Science (BS), Chemistry
Nautilus Neurosciences, Inc. February 2013 - January 2014
CMC GMP LLC 2013 - 2014
BIOTRONIK September 2012 - February 2013
Kowa Research Institute, Inc. June 2008 - October 2012
Proethic Pharmaceuticals January 2006 - June 2008
PharmaNet July 2003 - January 2006
Inex Pharmaceuticals 2001 - 2003
FDA April 1999 - June 2001
Boehringer Ingelheim Pharmaceuticals 1996 - 1999
University of Illinois at Urbana-Champaign 1991 - 1995
Skills
Pharmaceutical Industry, Regulatory Affairs, FDA, Quality Assurance, IND, GMP, Clinical Trials, Drug Development, Regulatory Submissions, CRO, Regulatory Requirements, CMC, NDA, CAPA, Validation, Biotechnology, Sop, Technology Transfer
Education
Emory University 1987 — 1991
Ph.D., Organic Chemistry
Princeton University 1985 — 1987
MA, Chemistry
University of North Carolina at Greensboro 1982 — 1985
Bachelor of Science (BS), Chemistry
Katrina Damiani's FDA Experience September 2014 - Present
Job Supervisory Administrative Management Specialist at FDA
Industry Government Administration
Experience
FDA September 2014 - Present
Kat Damiani Designs 2009 - Present
Air Force Space Command June 2009 - September 2014
The Outdoor Recreation Group February 2009 - June 2009
Sienna Rose October 2008 - February 2009
United States Air Force July 2006 - September 2007
United States Air Force January 2007 - June 2007
United States Air Force August 2005 - July 2006
United States Air Force August 2004 - August 2005
United States Air Force September 2003 - August 2004
Skills
Organizational..., Leadership, Team Leadership, Inventory Management, Supervisory Experience, Operations Management, Management, Microsoft Office, Government, Project Planning, Training, Team Building, Photoshop, Military, Program Management
Education
Fashion Institute of Design & Merchandising 2007 — 2008
Associate of Arts (A.A.), Fashion Design
Webster University 2002 — 2004
MBA, Business Administration
Prairie View A&M University 1997 — 2001
Bachelor of Science (B.S.), Liberal Arts and Sciences, General Studies and Humanities
FDA September 2014 - Present
Kat Damiani Designs 2009 - Present
Air Force Space Command June 2009 - September 2014
The Outdoor Recreation Group February 2009 - June 2009
Sienna Rose October 2008 - February 2009
United States Air Force July 2006 - September 2007
United States Air Force January 2007 - June 2007
United States Air Force August 2005 - July 2006
United States Air Force August 2004 - August 2005
United States Air Force September 2003 - August 2004
Skills
Organizational..., Leadership, Team Leadership, Inventory Management, Supervisory Experience, Operations Management, Management, Microsoft Office, Government, Project Planning, Training, Team Building, Photoshop, Military, Program Management
Education
Fashion Institute of Design & Merchandising 2007 — 2008
Associate of Arts (A.A.), Fashion Design
Webster University 2002 — 2004
MBA, Business Administration
Prairie View A&M University 1997 — 2001
Bachelor of Science (B.S.), Liberal Arts and Sciences, General Studies and Humanities
Alison Cotterell's FDA Experience January 2004 - Present
Job Microbiologist at the US Food and Drug Administration
Industry Medical Devices
Experience
FDA January 2004 - Present
University of Maryland University College 2009 - Present
Thermo Fisher Scientific 2006 - 2006
Diabetes Research Institute, University of Miami 2000 - 2003
National Institutes of Health 1996 - 1999
Skills
Immunology, PCR, Microbiology, Molecular Biology, Research, qPCR, DNA, Lifesciences, Cell Culture, Biochemistry, GLP, RT-PCR, Microsoft Office, Biotechnology, Tissue Culture, Life Sciences, cGMP manufacturing, cGMP practices, Higher Education, Secondary Education, Curriculum Design, Distance Learning
Education
Howard University
Ph.D., Microbiology and Immunology
Florida International University 1991 — 1993
M.S., Biology/Science Education
University of Miami 1985 — 1989
B.S, Major: Microbiology and Immunology, Minor: Chenistry
FDA January 2004 - Present
University of Maryland University College 2009 - Present
Thermo Fisher Scientific 2006 - 2006
Diabetes Research Institute, University of Miami 2000 - 2003
National Institutes of Health 1996 - 1999
Skills
Immunology, PCR, Microbiology, Molecular Biology, Research, qPCR, DNA, Lifesciences, Cell Culture, Biochemistry, GLP, RT-PCR, Microsoft Office, Biotechnology, Tissue Culture, Life Sciences, cGMP manufacturing, cGMP practices, Higher Education, Secondary Education, Curriculum Design, Distance Learning
Education
Howard University
Ph.D., Microbiology and Immunology
Florida International University 1991 — 1993
M.S., Biology/Science Education
University of Miami 1985 — 1989
B.S, Major: Microbiology and Immunology, Minor: Chenistry
Julie Bringger's FDA Experience 1988 - Present
Job Compliance Officer at US Food and Drug Administration
Industry Government Administration
Experience
US Food and Drug Administration April 2006 - Present
FDA 1988 - Present
U.S. Food and Drug Administration August 1988 - April 2006
US Food and Drug Adminstration July 1988 - April 2006
Skills
Quality Auditing, GMP, Regulatory Submissions, Regulatory Affairs, Quality System, Regulations, Government, Regulatory Analysis, FDA, Risk Assessment, Regulatory Requirements, Personnel Management, Policy, Regulatory Policy
Education
Florida Coastal School of Law 2013 — 2017
Juris Doctrate
University of Tennessee-Knoxville 1987 — 1988
Bachelor Of Science, Food Technology and Science
University of Tennessee-Knoxville 1977 — 1987
Bachelor of Science, Pre-Vet/Animal Science
Florida Coastal
US Food and Drug Administration April 2006 - Present
FDA 1988 - Present
U.S. Food and Drug Administration August 1988 - April 2006
US Food and Drug Adminstration July 1988 - April 2006
Skills
Quality Auditing, GMP, Regulatory Submissions, Regulatory Affairs, Quality System, Regulations, Government, Regulatory Analysis, FDA, Risk Assessment, Regulatory Requirements, Personnel Management, Policy, Regulatory Policy
Education
Florida Coastal School of Law 2013 — 2017
Juris Doctrate
University of Tennessee-Knoxville 1987 — 1988
Bachelor Of Science, Food Technology and Science
University of Tennessee-Knoxville 1977 — 1987
Bachelor of Science, Pre-Vet/Animal Science
Florida Coastal
Brett Podoski's FDA Experience 1998 - Present
Job SME (Subject Matter Expert) / FDA / Center for Food Safety and Applied Nutrition (CFSAN)
Industry Government Administration
Experience
FDA 1998 - Present
Skills
Food Safety, HACCP, FDA, Food Science, Food Microbiology, Analysis, Government, Food Technology, Policy, Food Processing, Public Health, Public Health Emergency..., Outbreak Investigation, SSOP, Thermal Processing, Food Manufacturing, Food Chemistry, Allergens, Pasteurization, Retort, Flexibles, Pouches, Food Labelling, Sensory Evaluation, Shelf Life, Sanitary Design, Plant Products and..., FSMA, Regulatory Compliance, Regulatory Affairs, Environmental Assessment, Environmental Sampling, Wine & Spirits Industry, Fruit, Vegetables, Juice, Food & Beverage, Preventative Controls
Education
Florida State University
Bachelor's Degree
University of Florida
Master's Degree
FDA 1998 - Present
Skills
Food Safety, HACCP, FDA, Food Science, Food Microbiology, Analysis, Government, Food Technology, Policy, Food Processing, Public Health, Public Health Emergency..., Outbreak Investigation, SSOP, Thermal Processing, Food Manufacturing, Food Chemistry, Allergens, Pasteurization, Retort, Flexibles, Pouches, Food Labelling, Sensory Evaluation, Shelf Life, Sanitary Design, Plant Products and..., FSMA, Regulatory Compliance, Regulatory Affairs, Environmental Assessment, Environmental Sampling, Wine & Spirits Industry, Fruit, Vegetables, Juice, Food & Beverage, Preventative Controls
Education
Florida State University
Bachelor's Degree
University of Florida
Master's Degree
Wendy Carr's FDA Experience July 2002 - February 2007
Job Ebola vaccine trial team at Centers for Disease Control and Prevention
Industry Research
Experience
Centers for Disease Control and Prevention November 2014 - Present
Centers for Disease Control and Prevention August 2009 - August 2015
Centers for Disease Control September 2008 - April 2010
NIH March 2007 - September 2008
FDA July 2002 - February 2007
Skills
Infectious Diseases, Microbiology, Biochemistry, Virology, Public Health, Molecular Biology, Epidemiology, Lifesciences, Pharmacology, Regulatory Affairs, Biotechnology, Research, Science, Life Sciences, Cell Biology, Immunology, Western Blotting
Education
Emory University 1996 — 2002
PhD, Microbiology and Molecular Genetics
Florida State University 1992 — 1996
B.S., Biochemistry
Centers for Disease Control and Prevention November 2014 - Present
Centers for Disease Control and Prevention August 2009 - August 2015
Centers for Disease Control September 2008 - April 2010
NIH March 2007 - September 2008
FDA July 2002 - February 2007
Skills
Infectious Diseases, Microbiology, Biochemistry, Virology, Public Health, Molecular Biology, Epidemiology, Lifesciences, Pharmacology, Regulatory Affairs, Biotechnology, Research, Science, Life Sciences, Cell Biology, Immunology, Western Blotting
Education
Emory University 1996 — 2002
PhD, Microbiology and Molecular Genetics
Florida State University 1992 — 1996
B.S., Biochemistry
Rhona Shanker's FDA Experience 1984 - 1989
Job Medical Device Regulatory Consulting at Z & B Enterprises, Inc.
Industry Medical Devices
Experience
Z & B Enterprises, Inc. March 2001 - Present
CDRH May 1989 - March 2001
FDA 1984 - 1989
FDA 1979 - 1984
Skills
Medical Devices, FDA, Diagnostics, 510 K, PMA, IDE, Regulatory Affairs, Clinical Trials, Product Development, Clinical Research, Clinical Development, Design Control, Regulatory Requirements, Validation, Regulatory Submissions, Biotechnology, Hardware Diagnostics, Surgery, CAPA, ISO 13485, Lifesciences, Quality System, Start-ups, Compliance, FMEA, R&D, V&V, GMP, Commercialization, Life Sciences
Education
Emory University
Biology
High School 1970 — 1973
Z & B Enterprises, Inc. March 2001 - Present
CDRH May 1989 - March 2001
FDA 1984 - 1989
FDA 1979 - 1984
Skills
Medical Devices, FDA, Diagnostics, 510 K, PMA, IDE, Regulatory Affairs, Clinical Trials, Product Development, Clinical Research, Clinical Development, Design Control, Regulatory Requirements, Validation, Regulatory Submissions, Biotechnology, Hardware Diagnostics, Surgery, CAPA, ISO 13485, Lifesciences, Quality System, Start-ups, Compliance, FMEA, R&D, V&V, GMP, Commercialization, Life Sciences
Education
Emory University
Biology
High School 1970 — 1973
David Zorn's FDA Experience April 2008 - Present
Job Director, Division of Social Sciences at FDA, Center for Food Safety & Applied Nutrition
Industry Government Administration
Experience
FDA April 2008 - Present
FDA, Center for Food Safety & Applied Nutrition June 2006 - April 2008
FDA, Center for Food Safety & Applied Nutrition May 1992 - June 2006
Education
George Mason University 1985 — 1992
PhD, Economics
Trinity University 1981 — 1985
BA, Economics
FDA April 2008 - Present
FDA, Center for Food Safety & Applied Nutrition June 2006 - April 2008
FDA, Center for Food Safety & Applied Nutrition May 1992 - June 2006
Education
George Mason University 1985 — 1992
PhD, Economics
Trinity University 1981 — 1985
BA, Economics
Hakeem Graham's FDA Experience March 2010 - Present
Job It Specialist at FDA
Industry Commercial Real Estate
Experience
FDA March 2010 - Present
IT Solutions March 2008 - March 2010
CoStar Group May 2004 - March 2008
Atlantic Services Group, Inc. 2004 - 2005
America's community Bankers February 2000 - March 2004
Skills
Windows Server, Data Center, VMware, Active Directory, VPN, Troubleshooting, DNS, Microsoft Exchange, Contemporary Dance, Disaster Recovery, Firewalls, Help Desk Support, System Administration, Blackberry Enterprise..., System Deployment, Windows XP, Customer Service, Microsoft Office, Strategic Planning, Management
Education
Dover Business College 1999 — 2001
Computerized accounting
Rutgers, The State University of New Jersey-Newark 1992 — 1994
Essex County College 1990 — 1992
Electrical Engineering
FDA March 2010 - Present
IT Solutions March 2008 - March 2010
CoStar Group May 2004 - March 2008
Atlantic Services Group, Inc. 2004 - 2005
America's community Bankers February 2000 - March 2004
Skills
Windows Server, Data Center, VMware, Active Directory, VPN, Troubleshooting, DNS, Microsoft Exchange, Contemporary Dance, Disaster Recovery, Firewalls, Help Desk Support, System Administration, Blackberry Enterprise..., System Deployment, Windows XP, Customer Service, Microsoft Office, Strategic Planning, Management
Education
Dover Business College 1999 — 2001
Computerized accounting
Rutgers, The State University of New Jersey-Newark 1992 — 1994
Essex County College 1990 — 1992
Electrical Engineering
Edward DePaola's FDA Experience December 2008 - Present
Job Technical Information Specialist at FDA
Industry Government Administration
Experience
FDA December 2008 - Present
fda October 2002 - December 2008
Giant Food May 1986 - January 2005
CVS Caremark Corporation 1989 - 1991
Skills
Government, Customer Service, Microsoft Office, Program Management, Training, Research, Public Speaking, Nonprofits, Strategic Planning, Community Outreach, Data Analysis, Process Improvement, Team Building, Leadership, Project Management, Management
Education
Essex Community College 2003 — 2004
General Sciences
Towson University 1986 — 1988
BS, Business Management
FDA December 2008 - Present
fda October 2002 - December 2008
Giant Food May 1986 - January 2005
CVS Caremark Corporation 1989 - 1991
Skills
Government, Customer Service, Microsoft Office, Program Management, Training, Research, Public Speaking, Nonprofits, Strategic Planning, Community Outreach, Data Analysis, Process Improvement, Team Building, Leadership, Project Management, Management
Education
Essex Community College 2003 — 2004
General Sciences
Towson University 1986 — 1988
BS, Business Management
Ebony (Daniels) Sanon's FDA Experience May 2012 - September 2012
Job Business Development Manager and Quality Engineer at BioTeknica
Industry Medical Devices
Experience
BioTeknica January 2015 - Present
BioTeknica October 2012 - Present
FDA May 2012 - September 2012
Goode Consulting International May 2011 - May 2012
Florida International University June 2010 - May 2011
NASA Goddard Space Flight Center May 2009 - August 2009
Texas Instruments 2001 - 2002
Skills
Electrochemical..., X-Ray Diffraction, Cell Culture, Matlab, Contact Angle Meter, Medical Devices, Impedance Spectroscopy, Biomedical Engineering, Validation
Education
Florida International University 2008 — 2012
Master of Science, Biomedical Engineering
Howard University 1996 — 2001
Bachelor of Science, Mechanical Engineering
BioTeknica January 2015 - Present
BioTeknica October 2012 - Present
FDA May 2012 - September 2012
Goode Consulting International May 2011 - May 2012
Florida International University June 2010 - May 2011
NASA Goddard Space Flight Center May 2009 - August 2009
Texas Instruments 2001 - 2002
Skills
Electrochemical..., X-Ray Diffraction, Cell Culture, Matlab, Contact Angle Meter, Medical Devices, Impedance Spectroscopy, Biomedical Engineering, Validation
Education
Florida International University 2008 — 2012
Master of Science, Biomedical Engineering
Howard University 1996 — 2001
Bachelor of Science, Mechanical Engineering
Samantha Smith-Roberts's FDA Experience October 2007 - October 2010
Job Science Policy Analyst at Friends of Cancer Research
Industry Research
Experience
Friends of Cancer Research October 2010 - Present
FDA October 2007 - October 2010
Emory University School of Medicine July 2002 - October 2007
Wittenberg University January 2001 - May 2002
NIH October 2000 - December 2000
Hope College June 2000 - August 2000
Skills
Clinical Research, Policy Analysis, Biotechnology, Data Analysis, Microbiology, Molecular Biology, Genetics, Immunology, DNA, Research, Science
Education
Emory University School of Medicine 2002 — 2007
PhD, Microbiology and Molecular Genetics
Wittenberg University 1998 — 2002
BA, Biochemistry and Molecular Biology
Fairborn High School
Fairborn High School
Friends of Cancer Research October 2010 - Present
FDA October 2007 - October 2010
Emory University School of Medicine July 2002 - October 2007
Wittenberg University January 2001 - May 2002
NIH October 2000 - December 2000
Hope College June 2000 - August 2000
Skills
Clinical Research, Policy Analysis, Biotechnology, Data Analysis, Microbiology, Molecular Biology, Genetics, Immunology, DNA, Research, Science
Education
Emory University School of Medicine 2002 — 2007
PhD, Microbiology and Molecular Genetics
Wittenberg University 1998 — 2002
BA, Biochemistry and Molecular Biology
Fairborn High School
Fairborn High School
Karen A Morgante's FDA Experience InvestigatorFood & Drug AdministrationJanuary 1992 - Present
Job Investigator at Food & Drug Administration
Industry Government Administration
Experience
FDA InvestigatorFood & Drug AdministrationJanuary 1992 - Present
Internal Revenue Service January 1987 - January 1992
Education
Erie Community College
FDA InvestigatorFood & Drug AdministrationJanuary 1992 - Present
Internal Revenue Service January 1987 - January 1992
Education
Erie Community College
Robert Makowsky's FDA Experience August 2011 - October 2012
Job Biostatistics Manager at HTG Molecular Diagnostics
Industry Research
Experience
HTG Molecular Diagnostics December 2014 - Present
Gore November 2012 - December 2014
FDA August 2011 - October 2012
University of Alabama at Birmingham August 2009 - August 2011
Skills
Molecular Biology, PCR, Genetics, Statistics, Data Analysis, DNA sequencing, R, Science, Statistical Consulting, Scientific Writing, Biostatistics, Genomics, Experimental Design, Medical Devices, Bioinformatics, Population Genetics, DNA Sequencing, Clinical Research
Education
The University of Texas at Arlington 2007 — 2009
Doctor of Philosophy (Ph.D.), Quantitative biology
Marshall University 2002 — 2004
M.S., Biology
Emory University 1997 — 2001
B.S., Biology, neurobehavioral biology
HTG Molecular Diagnostics December 2014 - Present
Gore November 2012 - December 2014
FDA August 2011 - October 2012
University of Alabama at Birmingham August 2009 - August 2011
Skills
Molecular Biology, PCR, Genetics, Statistics, Data Analysis, DNA sequencing, R, Science, Statistical Consulting, Scientific Writing, Biostatistics, Genomics, Experimental Design, Medical Devices, Bioinformatics, Population Genetics, DNA Sequencing, Clinical Research
Education
The University of Texas at Arlington 2007 — 2009
Doctor of Philosophy (Ph.D.), Quantitative biology
Marshall University 2002 — 2004
M.S., Biology
Emory University 1997 — 2001
B.S., Biology, neurobehavioral biology
Martina Sahre's FDA Experience June 2012 - Present
Job Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA June 2012 - Present
FDA February 2011 - June 2012
University of Florida January 2007 - December 2010
GlaxoSmithKline May 2010 - August 2010
Marksburg Apotheke, Germany May 2006 - December 2006
University of Florida October 2005 - March 2006
Skills
Pharmacodynamics, Pharmacokinetics, Clinical Pharmacology, Drug Metabolism, Pharmaceutics, Pharmaceutical Industry, Drug Development, Pharmacology
Education
University of Florida 2007 — 2010
PhD Candidate, Pharmaceutical Sciences
Freie Universität Berlin 2000 — 2005
Bachelor of Science (B.S.), Pharmaceutics
FDA June 2012 - Present
FDA February 2011 - June 2012
University of Florida January 2007 - December 2010
GlaxoSmithKline May 2010 - August 2010
Marksburg Apotheke, Germany May 2006 - December 2006
University of Florida October 2005 - March 2006
Skills
Pharmacodynamics, Pharmacokinetics, Clinical Pharmacology, Drug Metabolism, Pharmaceutics, Pharmaceutical Industry, Drug Development, Pharmacology
Education
University of Florida 2007 — 2010
PhD Candidate, Pharmaceutical Sciences
Freie Universität Berlin 2000 — 2005
Bachelor of Science (B.S.), Pharmaceutics
Kimberly Wallace Thomas's FDA Experience May 2010 - Present
Job Lead Regulatory Project Manager at FDA
Industry Pharmaceuticals
Experience
FDA May 2010 - Present
ICON Development Solutions October 2007 - May 2010
MGI Pharma, Inc. (Formerly Guilford Pharmaceuticals) 2005 - 2007
Guilford Pharmaceuticals 1996 - 2005
Education
Emory University
Bachelors, Biology
Georgia Institute of Technology
Masters, Health Systems Management
FDA May 2010 - Present
ICON Development Solutions October 2007 - May 2010
MGI Pharma, Inc. (Formerly Guilford Pharmaceuticals) 2005 - 2007
Guilford Pharmaceuticals 1996 - 2005
Education
Emory University
Bachelors, Biology
Georgia Institute of Technology
Masters, Health Systems Management
Yolanda Branch's FDA Experience September 2009 - Present
Job Pharmacologist/Toxicologist at United States Food and Drug Administration
Industry Pharmaceuticals
Experience
FDA September 2009 - Present
Lockheed Martin September 2007 - September 2009
Education
Meharry Medical College 2002 — 2006
Fisk University 2000 — 2002
Master of Arts (M.A.)
FDA September 2009 - Present
Lockheed Martin September 2007 - September 2009
Education
Meharry Medical College 2002 — 2006
Fisk University 2000 — 2002
Master of Arts (M.A.)
Bing Cai's FDA Experience April 2013 - December 2014
Job DIVISION DIRECTOR (ACTING) at FDA/CDER/OPQ
Industry Pharmaceuticals
Experience
FDA/CDER/OPQ January 2015 - Present
FDA April 2013 - December 2014
FDA September 1997 - April 2013
Alteon Inc 1995 - 1997
Pharm-Eco 1993 - 1994
Skills
Analytical Chemistry, Biopharmaceuticals, Chemistry, Chromatography, Drug Development, Drug Discovery, FDA, GLP, GMP, HPLC, IND, LC-MS, Medicinal Chemistry, Organic Chemistry, Organic Synthesis, Pharmaceutical Industry, Regulatory Affairs, SOP, Sop, Technology Transfer, Validation, Regulatory Submissions, UV/Vis
Education
New York University 1988 — 1993
Ph. D., CHEMISTRY
Fudan University 1982 — 1986
BS, CHEMISTRY
FDA/CDER/OPQ January 2015 - Present
FDA April 2013 - December 2014
FDA September 1997 - April 2013
Alteon Inc 1995 - 1997
Pharm-Eco 1993 - 1994
Skills
Analytical Chemistry, Biopharmaceuticals, Chemistry, Chromatography, Drug Development, Drug Discovery, FDA, GLP, GMP, HPLC, IND, LC-MS, Medicinal Chemistry, Organic Chemistry, Organic Synthesis, Pharmaceutical Industry, Regulatory Affairs, SOP, Sop, Technology Transfer, Validation, Regulatory Submissions, UV/Vis
Education
New York University 1988 — 1993
Ph. D., CHEMISTRY
Fudan University 1982 — 1986
BS, CHEMISTRY
Yolanda Hawkins, Ph.D., M.B.A.'s FDA Experience January 2015 - Present
Job Technology Transfer Specialist at FDA
Industry Government Administration
Experience
FDA January 2015 - Present
Office of Technology Transfer, National Institutes of Health October 2012 - January 2015
National Institutes of Health January 2004 - September 2012
National Institute on Aging, National Institutes of Health 1994 - 1998
Skills
Molecular Biology, Animal Models, Western Blotting, Technology Transfer, Laboratory, Cell Culture, Entrepreneurship, Business Strategy, Cell Biology, Cell, Lifesciences, Patents, Intellectual Property, Life Sciences, Biotechnology, Research, Data Analysis, Public Health, Management, Science
Education
The Johns Hopkins University - Carey Business School 2011 — 2013
Master of Business Administration (MBA)
Foundation for Advanced Education in the Sciences, Inc. (FAES) Graduate School at the NIH 2009 — 2012
Certificate in Technology Transfer
Meharry Medical College 1988 — 1994
Ph.D., cell biology
Texas Southern University 1987 — 1988
M.S., Biology
Fisk University 1982 — 1986
B.S., Biology
FDA January 2015 - Present
Office of Technology Transfer, National Institutes of Health October 2012 - January 2015
National Institutes of Health January 2004 - September 2012
National Institute on Aging, National Institutes of Health 1994 - 1998
Skills
Molecular Biology, Animal Models, Western Blotting, Technology Transfer, Laboratory, Cell Culture, Entrepreneurship, Business Strategy, Cell Biology, Cell, Lifesciences, Patents, Intellectual Property, Life Sciences, Biotechnology, Research, Data Analysis, Public Health, Management, Science
Education
The Johns Hopkins University - Carey Business School 2011 — 2013
Master of Business Administration (MBA)
Foundation for Advanced Education in the Sciences, Inc. (FAES) Graduate School at the NIH 2009 — 2012
Certificate in Technology Transfer
Meharry Medical College 1988 — 1994
Ph.D., cell biology
Texas Southern University 1987 — 1988
M.S., Biology
Fisk University 1982 — 1986
B.S., Biology
EJ Park's FDA Experience January 2014 - Present
Job Reviewer at FDA
Industry Government Administration
Experience
FDA January 2014 - Present
FDA September 2009 - January 2014
EntreMed December 2005 - December 2008
Skills
Regulatory Science, Data Mining, Bacterial Culture, Cell Culture, Pharmaceutical Industry, Clinical Trials, Analytical Chemistry, Molecular Biology, Biotechnology
Education
Seoul National University 1990 — 1999
Doctor of Philosophy (Ph.D.), Pharmacy
Ewha Womans University 1986 — 1990
Bachelor's degree, Pharmacy
FDA January 2014 - Present
FDA September 2009 - January 2014
EntreMed December 2005 - December 2008
Skills
Regulatory Science, Data Mining, Bacterial Culture, Cell Culture, Pharmaceutical Industry, Clinical Trials, Analytical Chemistry, Molecular Biology, Biotechnology
Education
Seoul National University 1990 — 1999
Doctor of Philosophy (Ph.D.), Pharmacy
Ewha Womans University 1986 — 1990
Bachelor's degree, Pharmacy
Rachel Slone's FDA Experience June 2015 - Present
Job Regulatory Counsel at FDA
Industry Government Administration
Experience
FDA June 2015 - Present
Contract Attorney February 2015 - May 2015
ASRC Federal December 2013 - January 2015
Florida Advocates August 2012 - May 2013
Office of the State Attorney, 17th Judicial Circuit May 2012 - August 2012
Skills
Legal Research, Legal Issues, Civil Litigation, Outlook, Westlaw, Public Speaking, Litigation, Legal Writing, Government, Political Science, Research, Hearings, Lexis
Education
Nova Southeastern University—Shepard Broad Law Center 2010 — 2013
Law, Law
Florida State University 2006 — 2010
Bachelor's Degree, Political Science
FDA June 2015 - Present
Contract Attorney February 2015 - May 2015
ASRC Federal December 2013 - January 2015
Florida Advocates August 2012 - May 2013
Office of the State Attorney, 17th Judicial Circuit May 2012 - August 2012
Skills
Legal Research, Legal Issues, Civil Litigation, Outlook, Westlaw, Public Speaking, Litigation, Legal Writing, Government, Political Science, Research, Hearings, Lexis
Education
Nova Southeastern University—Shepard Broad Law Center 2010 — 2013
Law, Law
Florida State University 2006 — 2010
Bachelor's Degree, Political Science
Noelle Ojo's FDA Experience November 2013 - Present
Job Testimony Specialist at FDA
Industry Government Administration
Experience
FDA November 2013 - Present
U.S. Department of State August 2012 - October 2013
Howard University November 2010 - August 2012
Kedari Capital March 2009 - November 2009
U.S. Department of State November 2002 - February 2009
Skills
Non-profits, Legal Research, Community Outreach, Grant Writing, Research, Public Speaking, Policy Analysis, Legal Writing, Program Evaluation, Event Planning, Litigation, Public Policy, Strategic Planning, International Law, International Relations, Program Development, Nonprofits, Project Planning, Management, Proposal Writing, Politics, Policy, Leadership, Business Development, Training
Education
New York University School of Law 1999 — 2002
JD, Immigration, International Development
Florida Agricultural and Mechanical University 1994 — 1999
BS/MBA, Business Administration and Management, General
T.S. Wootton High School 1990 — 1994
Diploma
FDA November 2013 - Present
U.S. Department of State August 2012 - October 2013
Howard University November 2010 - August 2012
Kedari Capital March 2009 - November 2009
U.S. Department of State November 2002 - February 2009
Skills
Non-profits, Legal Research, Community Outreach, Grant Writing, Research, Public Speaking, Policy Analysis, Legal Writing, Program Evaluation, Event Planning, Litigation, Public Policy, Strategic Planning, International Law, International Relations, Program Development, Nonprofits, Project Planning, Management, Proposal Writing, Politics, Policy, Leadership, Business Development, Training
Education
New York University School of Law 1999 — 2002
JD, Immigration, International Development
Florida Agricultural and Mechanical University 1994 — 1999
BS/MBA, Business Administration and Management, General
T.S. Wootton High School 1990 — 1994
Diploma
Sutan Wu's FDA Experience October 2013 - September 2014
Job Principal Statistics Consultant at SutanStats
Industry Pharmaceuticals
Experience
SutanStats September 2014 - Present
FDA October 2013 - September 2014
Bristol-Myers Squibb May 2012 - October 2013
Roche Diagnostics December 2009 - February 2012
Florida State University October 2007 - December 2009
Johnson & Johnson June 2009 - September 2009
Medical College of Wisconsin June 2008 - August 2008
Skills
SAS, JMP, R, Multivariate Analysis, Design of Experiments, Biostatistics, Statistical Modeling, Statistics, Data Mining, Data Analysis, Time Series Analysis, Survival Analysis, Experimental Design, Minitab, Clinical Trials, SAS programming, Predictive Modeling
Education
Florida State University 2005 — 2010
Ph.D, Statistics
University of Science and Technology of China 2001 — 2005
B.S, Applied Mathematics
SutanStats September 2014 - Present
FDA October 2013 - September 2014
Bristol-Myers Squibb May 2012 - October 2013
Roche Diagnostics December 2009 - February 2012
Florida State University October 2007 - December 2009
Johnson & Johnson June 2009 - September 2009
Medical College of Wisconsin June 2008 - August 2008
Skills
SAS, JMP, R, Multivariate Analysis, Design of Experiments, Biostatistics, Statistical Modeling, Statistics, Data Mining, Data Analysis, Time Series Analysis, Survival Analysis, Experimental Design, Minitab, Clinical Trials, SAS programming, Predictive Modeling
Education
Florida State University 2005 — 2010
Ph.D, Statistics
University of Science and Technology of China 2001 — 2005
B.S, Applied Mathematics
Kallol Biswas's FDA Experience May 2011 - August 2013
Job
Industry Research
Experience
WIL Research September 2013 - Present
FDA May 2011 - August 2013
FDA October 2009 - August 2013
Eli Lilly January 2003 - October 2009
Indiana University-Purdue University Indianapolis January 2005 - May 2005
Skills
Analytical Chemistry, Pharmaceutical..., Chromatography, HPLC, Quality Systems, FDA, LC-MS, Pharmaceuticals, GMP, Chemistry, Mass Spectrometry, Validation, cGMP, R&D, GLP, Regulatory Affairs, Laboratory, Pharmaceutical Industry, Formulation, UV/Vis, CAPA, Quality System, Drug Development
Education
Florida State University 1998 — 2002
Doctorate, Chemistry
West Virginia University 1995 — 1998
M.S., Chemistry
West Virginia University 1991 — 1995
B.A., Chemistry
WIL Research September 2013 - Present
FDA May 2011 - August 2013
FDA October 2009 - August 2013
Eli Lilly January 2003 - October 2009
Indiana University-Purdue University Indianapolis January 2005 - May 2005
Skills
Analytical Chemistry, Pharmaceutical..., Chromatography, HPLC, Quality Systems, FDA, LC-MS, Pharmaceuticals, GMP, Chemistry, Mass Spectrometry, Validation, cGMP, R&D, GLP, Regulatory Affairs, Laboratory, Pharmaceutical Industry, Formulation, UV/Vis, CAPA, Quality System, Drug Development
Education
Florida State University 1998 — 2002
Doctorate, Chemistry
West Virginia University 1995 — 1998
M.S., Chemistry
West Virginia University 1991 — 1995
B.A., Chemistry
Daniel Vega Martinez's FDA Experience August 2014 - August 2015
Job Research Assistant at FDA
Industry Food Production
Experience
National Pasteurized Eggs September 2014 - Present
FDA August 2014 - August 2015
Corrosión y Protección Ingeniería February 2010 - June 2013
Procequipos S.A. de C.V. June 2012 - August 2012
Policables SA de CV January 2009 - April 2009
Skills
Food Processing, Chemical Engineering, Food, Eggs, Engineering, Oil/Gas, Petroleum, Energy, Project Management, Engineering Management, MS Project, Process Engineering, Project Planning, English, Microsoft Office, Microsoft Excel, Negotiation, Corrosion
Education
Illinois Institute of Technology 2013 — 2015
Master's Degree, Food Technology and Processing, 3.6
Fundación Universidad de las Américas Puebla 2004 — 2008
Chemical Process Engineer, Chemical Process Technology, 3.0
National Pasteurized Eggs September 2014 - Present
FDA August 2014 - August 2015
Corrosión y Protección Ingeniería February 2010 - June 2013
Procequipos S.A. de C.V. June 2012 - August 2012
Policables SA de CV January 2009 - April 2009
Skills
Food Processing, Chemical Engineering, Food, Eggs, Engineering, Oil/Gas, Petroleum, Energy, Project Management, Engineering Management, MS Project, Process Engineering, Project Planning, English, Microsoft Office, Microsoft Excel, Negotiation, Corrosion
Education
Illinois Institute of Technology 2013 — 2015
Master's Degree, Food Technology and Processing, 3.6
Fundación Universidad de las Américas Puebla 2004 — 2008
Chemical Process Engineer, Chemical Process Technology, 3.0
Garmendia Craig's FDA Experience February 2009 - Present
Job Investigator/ Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA February 2009 - Present
Vanderbilt University 2004 - 2008
Skills
FDA, Regulatory Guidelines, Investigations, Inspections, Sampling, Clinical Research, GCP, GLP, GMP, USP, Chemistry, Organic Chemistry, Bioorganic Chemistry, HPLC, HPLC-MS, NMR, UV/Vis, Mass Spectrometry, Inspection, Clinical Trials, Biotechnology, Medical Devices, IND, Microbiology, Regulatory Affairs, Regulatory Submissions
Education
Vanderbilt University 2004 — 2008
Master, Chemistry
Florida International University 2000 — 2004
B.S., Chemistry
FDA February 2009 - Present
Vanderbilt University 2004 - 2008
Skills
FDA, Regulatory Guidelines, Investigations, Inspections, Sampling, Clinical Research, GCP, GLP, GMP, USP, Chemistry, Organic Chemistry, Bioorganic Chemistry, HPLC, HPLC-MS, NMR, UV/Vis, Mass Spectrometry, Inspection, Clinical Trials, Biotechnology, Medical Devices, IND, Microbiology, Regulatory Affairs, Regulatory Submissions
Education
Vanderbilt University 2004 — 2008
Master, Chemistry
Florida International University 2000 — 2004
B.S., Chemistry
Jason N. Moore, Pharm.D.'s FDA Experience January 2014 - January 2014
Job Clinical Pharmacology Fellow at Thomas Jefferson University
Industry Pharmaceuticals
Experience
Thomas Jefferson University June 2014 - Present
FDA January 2014 - January 2014
American Society of Health System Pharmacy 2013 - 2014
Bristol-Myers Squibb August 2013 - August 2013
Skills
Pharmacy, Research, Statistics, Data Analysis, Leadership, Clinical Research, Clinical Pharmacology, R, NONMEM, Immunology, Pharmacodynamics, Pharmacokinetics, Clinical Trials
Education
Florida Agricultural and Mechanical University 2009 — 2014
Doctor of Pharmacy (Pharm.D.)
James S. Rickards High School
Thomas Jefferson University June 2014 - Present
FDA January 2014 - January 2014
American Society of Health System Pharmacy 2013 - 2014
Bristol-Myers Squibb August 2013 - August 2013
Skills
Pharmacy, Research, Statistics, Data Analysis, Leadership, Clinical Research, Clinical Pharmacology, R, NONMEM, Immunology, Pharmacodynamics, Pharmacokinetics, Clinical Trials
Education
Florida Agricultural and Mechanical University 2009 — 2014
Doctor of Pharmacy (Pharm.D.)
James S. Rickards High School
Susan Peacock's FDA Experience July 2002 - August 2004
Job Project Officer at NIH
Industry Research
Experience
CDC May 2010 - October 2010
NIH 2006 - 2010
Department of Health and Human Services August 2004 - May 2006
FDA July 2002 - August 2004
FDA/CDER/Div. of Special Pathogen and Immunologic Drug Products 2002 - 2004
Walter Reed Army Medical Center May 2000 - June 2002
Armed Forces Radiobiology Research Institute April 1997 - June 2000
Skills
Microbiology, Infectious Diseases, Molecular Biology, Lifesciences, Virology, Policy Analysis, Research, PCR, Biochemistry, Program Management, Biotechnology, Policy, Government, Public Health, Project Planning, Process Improvement, Public Speaking, Cell Culture, Public Policy, Project Management, Immunology, Cell Biology, Life Sciences
Education
The University of Georgia 1994 — 1997
Masters, Microbiology
Furman University 1990 — 1994
BS, Biology
CDC May 2010 - October 2010
NIH 2006 - 2010
Department of Health and Human Services August 2004 - May 2006
FDA July 2002 - August 2004
FDA/CDER/Div. of Special Pathogen and Immunologic Drug Products 2002 - 2004
Walter Reed Army Medical Center May 2000 - June 2002
Armed Forces Radiobiology Research Institute April 1997 - June 2000
Skills
Microbiology, Infectious Diseases, Molecular Biology, Lifesciences, Virology, Policy Analysis, Research, PCR, Biochemistry, Program Management, Biotechnology, Policy, Government, Public Health, Project Planning, Process Improvement, Public Speaking, Cell Culture, Public Policy, Project Management, Immunology, Cell Biology, Life Sciences
Education
The University of Georgia 1994 — 1997
Masters, Microbiology
Furman University 1990 — 1994
BS, Biology
Jackie Gil, PharmD's FDA Experience June 2012 - July 2012
Job Pharmacist
Industry Pharmaceuticals
Experience
CVS Pharmacy April 2015 - Present
Publix Super Markets October 2013 - September 2014
LECOM Lake Erie College of Osteopathic Medicine August 2009 - June 2013
Bayfront Medical Center April 2013 - April 2013
Consumer Health Information Corporation March 2013 - March 2013
Walgreens January 2013 - February 2013
Florida Hospital at Connerton, Long Term Acute Care (LTAC) November 2012 - December 2012
Bayfront Medical Center September 2012 - November 2012
Walgreens July 2012 - August 2012
FDA June 2012 - July 2012
Skills
Medication Therapy..., Pharmacy, Pharmacists, Pharmacy Automation, Clinical Pharmacology, Critical Care, Healthcare, Pharmacokinetics, Diabetes, Hospitals, Community Pharmacy, Clinical Research, Immunization, Clinical Pharmacy, Public Speaking, Patient Safety, Patient Counseling
Education
Lake Erie College of Osteopathic Medicine, LECOM 2009 — 2013
Doctor of Pharmacy (Pharm.D.), Pharmacy
Florida International University
Miami Dade College
Associate of Arts (A.A.), Pre-Pharmacy Studies
CVS Pharmacy April 2015 - Present
Publix Super Markets October 2013 - September 2014
LECOM Lake Erie College of Osteopathic Medicine August 2009 - June 2013
Bayfront Medical Center April 2013 - April 2013
Consumer Health Information Corporation March 2013 - March 2013
Walgreens January 2013 - February 2013
Florida Hospital at Connerton, Long Term Acute Care (LTAC) November 2012 - December 2012
Bayfront Medical Center September 2012 - November 2012
Walgreens July 2012 - August 2012
FDA June 2012 - July 2012
Skills
Medication Therapy..., Pharmacy, Pharmacists, Pharmacy Automation, Clinical Pharmacology, Critical Care, Healthcare, Pharmacokinetics, Diabetes, Hospitals, Community Pharmacy, Clinical Research, Immunization, Clinical Pharmacy, Public Speaking, Patient Safety, Patient Counseling
Education
Lake Erie College of Osteopathic Medicine, LECOM 2009 — 2013
Doctor of Pharmacy (Pharm.D.), Pharmacy
Florida International University
Miami Dade College
Associate of Arts (A.A.), Pre-Pharmacy Studies
Viral Dalal's FDA Experience May 2011 - Present
Job Hyperion Functional Leader at FDA
Industry Financial Services
Experience
FDA May 2011 - Present
Fannie Mae March 2010 - May 2011
GE Commercial Finance July 2008 - February 2010
Fannie Mae October 2006 - May 2008
HighPoint Solutions (Syszen) May 2003 - October 2006
Skills
Project Planning, Project Management, IT Solutions, Data Warehousing, Data Warehouse..., Functional..., Functional Analysis, Functional Requirements, Technical Leadership, Functional Leadership, Software Project..., Hyperion Financial..., Oracle SQL, Hyperion Planning, Mentoring, Project Coordination, Cross-functional..., FDM, Essbase, Financial Reporting, Business Analysis, Requirements Analysis, Smartview
Education
Fairleigh Dickinson University
Master's degree
FDA May 2011 - Present
Fannie Mae March 2010 - May 2011
GE Commercial Finance July 2008 - February 2010
Fannie Mae October 2006 - May 2008
HighPoint Solutions (Syszen) May 2003 - October 2006
Skills
Project Planning, Project Management, IT Solutions, Data Warehousing, Data Warehouse..., Functional..., Functional Analysis, Functional Requirements, Technical Leadership, Functional Leadership, Software Project..., Hyperion Financial..., Oracle SQL, Hyperion Planning, Mentoring, Project Coordination, Cross-functional..., FDM, Essbase, Financial Reporting, Business Analysis, Requirements Analysis, Smartview
Education
Fairleigh Dickinson University
Master's degree
Yoonyoung Park's FDA Experience September 2013 - September 2014
Job Harvard School of Public Health
Industry Research
Experience
Brigham and Women's Hospital July 2013 - Present
Harvard School of Public Health 2014 - 2015
FDA September 2013 - September 2014
Korea Food and Drug Administration 2010 - 2012
Ewha Medical Center April 2010 - October 2010
Korea Institute of Science and Technology February 2008 - August 2010
Retail pharmacy 2008 - 2008
Skills
Epidemiology, Biostatistics, SAS, R, LaTeX, Neuroscience
Education
Harvard University
Doctor of Science candidate, Epidemiology
Ewha Womans University
Bachelor, Pharmacy
Korea University
Master, Neuroscience
Brigham and Women's Hospital July 2013 - Present
Harvard School of Public Health 2014 - 2015
FDA September 2013 - September 2014
Korea Food and Drug Administration 2010 - 2012
Ewha Medical Center April 2010 - October 2010
Korea Institute of Science and Technology February 2008 - August 2010
Retail pharmacy 2008 - 2008
Skills
Epidemiology, Biostatistics, SAS, R, LaTeX, Neuroscience
Education
Harvard University
Doctor of Science candidate, Epidemiology
Ewha Womans University
Bachelor, Pharmacy
Korea University
Master, Neuroscience
Robert Hopkins's FDA Experience July 1994 - September 1996
Job Sr Director, Clinical Development US at Emergent BioSolutions
Industry Biotechnology
Experience
Emergent BioSolutions September 2004 - Present
Emergent BioSolutions September 2004 - January 2014
DynPort Vaccine Company LLC, A CSC Company September 2002 - August 2004
DynPort Vaccine Company LLC, A CSC Company September 2001 - September 2002
Merck September 1998 - September 2001
Food and Drug Administration September 1996 - September 1999
FDA July 1994 - September 1996
Skills
Biotechnology, Clinical Development, GLP, Medicine, FDA, Infectious Diseases, Clinical Research, Vaccines, GCP, Immunology, Drug Development, Biopharmaceuticals, Lifesciences, Clinical Trials, Internal Medicine, Pharmaceutical Industry
Education
University of Maryland School of Medicine 1992 — 1994
Residency, Internal Medicine, Fellowship, Infectious Disease and Geographic Medicine
University of Maryland School of Medicine 1989 — 1992
Internal Medicine Residency
Emory University School of Medicine 1988 — 1989
Internship, Internal Medicine
Tulane University School of Medicine 1984 — 1988
MD, MPH & TM, Medicine, Tropical Medicine
Emergent BioSolutions September 2004 - Present
Emergent BioSolutions September 2004 - January 2014
DynPort Vaccine Company LLC, A CSC Company September 2002 - August 2004
DynPort Vaccine Company LLC, A CSC Company September 2001 - September 2002
Merck September 1998 - September 2001
Food and Drug Administration September 1996 - September 1999
FDA July 1994 - September 1996
Skills
Biotechnology, Clinical Development, GLP, Medicine, FDA, Infectious Diseases, Clinical Research, Vaccines, GCP, Immunology, Drug Development, Biopharmaceuticals, Lifesciences, Clinical Trials, Internal Medicine, Pharmaceutical Industry
Education
University of Maryland School of Medicine 1992 — 1994
Residency, Internal Medicine, Fellowship, Infectious Disease and Geographic Medicine
University of Maryland School of Medicine 1989 — 1992
Internal Medicine Residency
Emory University School of Medicine 1988 — 1989
Internship, Internal Medicine
Tulane University School of Medicine 1984 — 1988
MD, MPH & TM, Medicine, Tropical Medicine
Stephanie Croskey's FDA Experience November 2006 - Present
Job IT Liaison at FDA
Industry
Experience
FDA November 2006 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Teaching, Photoshop, Public Speaking
Education
Florida State University
Bachelor's degree, Economics
FDA November 2006 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Teaching, Photoshop, Public Speaking
Education
Florida State University
Bachelor's degree, Economics
Christine Garnett's FDA Experience February 2015 - Present
Job FDA reviewer
Industry Government Administration
Experience
FDA February 2015 - Present
Certara April 2013 - February 2015
Certara September 2012 - March 2013
FDA March 2010 - July 2012
Division of Pharmacometrics, OCP, OTS, CDER, FDA October 2007 - July 2012
FDA January 2005 - October 2007
Skills
Pharmacokinetics, Clinical Pharmacology, Clinical Trials, Drug Development, Clinical Development, FDA, Pharmaceutical Industry, Pharmacology, Clinical Research, Regulatory Affairs, Pharmacometrics, Medical Devices, Cardiac safety, Pharmacodynamics
Education
Georgetown University 2002 — 2004
Clinical Pharmacology Fellowship
University of Maryland School of Pharmacy 1995 — 1999
Pharm.D., Clinical Pharmacy
Florida State University 1988 — 1991
B.S., Biological Sciences
FDA February 2015 - Present
Certara April 2013 - February 2015
Certara September 2012 - March 2013
FDA March 2010 - July 2012
Division of Pharmacometrics, OCP, OTS, CDER, FDA October 2007 - July 2012
FDA January 2005 - October 2007
Skills
Pharmacokinetics, Clinical Pharmacology, Clinical Trials, Drug Development, Clinical Development, FDA, Pharmaceutical Industry, Pharmacology, Clinical Research, Regulatory Affairs, Pharmacometrics, Medical Devices, Cardiac safety, Pharmacodynamics
Education
Georgetown University 2002 — 2004
Clinical Pharmacology Fellowship
University of Maryland School of Pharmacy 1995 — 1999
Pharm.D., Clinical Pharmacy
Florida State University 1988 — 1991
B.S., Biological Sciences
Jiajie Huang's FDA Experience May 2014 - August 2014
Job Bioinformatician/Applied Statistician looking for full time/intern opportunities
Industry Biotechnology
Experience
Purdue University August 2009 - Present
FDA May 2014 - August 2014
Purdue University August 2010 - May 2014
Fudan University October 2007 - June 2009
Skills
Bioinformatics, Statistics, Object Oriented Perl, SAS, R, Matlab, Next Gen, Molecular Biology, Cell Culture, PCR, Data Analysis, Python, Lifesciences, Western Blotting, Biochemistry, Protein Purification, Minitab, LaTeX, Vim, Emacs, CVS, Unix
Education
Purdue University 2009 — 2015
Doctor of Philosophy (Ph.D.), Bioinformatics and Computational Biology, 3.7/4.0
Purdue University 2013 — 2014
Master of Science (M.S.), Applied Statistics, 3.8/4.0
Fudan University 2005 — 2009
Bachelor of Science (B.S.), Biological and Biomedical Sciences
Zhuhai No.1 Middle School 2002 — 2005
High School Diploma, General Science
Purdue University August 2009 - Present
FDA May 2014 - August 2014
Purdue University August 2010 - May 2014
Fudan University October 2007 - June 2009
Skills
Bioinformatics, Statistics, Object Oriented Perl, SAS, R, Matlab, Next Gen, Molecular Biology, Cell Culture, PCR, Data Analysis, Python, Lifesciences, Western Blotting, Biochemistry, Protein Purification, Minitab, LaTeX, Vim, Emacs, CVS, Unix
Education
Purdue University 2009 — 2015
Doctor of Philosophy (Ph.D.), Bioinformatics and Computational Biology, 3.7/4.0
Purdue University 2013 — 2014
Master of Science (M.S.), Applied Statistics, 3.8/4.0
Fudan University 2005 — 2009
Bachelor of Science (B.S.), Biological and Biomedical Sciences
Zhuhai No.1 Middle School 2002 — 2005
High School Diploma, General Science
Toby Keaton's FDA Experience December 2010 - Present
Job Investigator/ Consumer Safety Officer at FDA
Industry Public Safety
Experience
FDA December 2010 - Present
Skills
Microsoft Word, Policy, Government, Data Analysis, Emergency Management, Research, Microsoft Office
Education
Franklin University
Management Information Sciences, Finance, Cum Laude 3.70
FDA December 2010 - Present
Skills
Microsoft Word, Policy, Government, Data Analysis, Emergency Management, Research, Microsoft Office
Education
Franklin University
Management Information Sciences, Finance, Cum Laude 3.70
Gregory Kilkus's FDA Experience September 2009 - August 2011
Job Purchasing Agent at The Henry M. Jackson Foundation for the Advancement of Military Medicine
Industry Government Administration
Experience
The Henry M. Jackson Foundation for the Advancement of Military Medicine February 2012 - Present
The Henry M. Jackson Foundation for the Advancement of Military Medicine August 2011 - February 2012
FDA September 2009 - August 2011
FDA June 2009 - September 2009
Skills
Procurement, Government Procurement, Databases, Business Analysis, Purchasing, Analysis, Contract Management, Microsoft Excel, Strategic Planning, Microsoft Office, Microsoft Word
Education
Frostburg State University 2005 — 2009
BS, Economics
The Henry M. Jackson Foundation for the Advancement of Military Medicine February 2012 - Present
The Henry M. Jackson Foundation for the Advancement of Military Medicine August 2011 - February 2012
FDA September 2009 - August 2011
FDA June 2009 - September 2009
Skills
Procurement, Government Procurement, Databases, Business Analysis, Purchasing, Analysis, Contract Management, Microsoft Excel, Strategic Planning, Microsoft Office, Microsoft Word
Education
Frostburg State University 2005 — 2009
BS, Economics
Ken Falci's FDA Experience September 1977 - September 2005
Job President at Ken Falci Consulting, LLC
Industry Consumer Goods
Experience
Ken Falci Consulting, LLC April 2013 - Present
Kellogg Company September 2005 - January 2013
FDA September 1977 - September 2005
Skills
Scientific Management, Scientific Writing, Materials Science, Chemistry, Management Consulting, Grant Monitoring, Scientific Review, Food Safety, Food, Food Manufacturing, Food Industry, Ingredients, FDA, Regulatory Affairs, Nutrition, R&D, Product Innovation, HACCP, Food Processing, GMP
Education
Fordham University 1972 — 1976
Doctor of Philosophy (Ph.D.), Organic Chemistry drug synthesis
Ken Falci Consulting, LLC April 2013 - Present
Kellogg Company September 2005 - January 2013
FDA September 1977 - September 2005
Skills
Scientific Management, Scientific Writing, Materials Science, Chemistry, Management Consulting, Grant Monitoring, Scientific Review, Food Safety, Food, Food Manufacturing, Food Industry, Ingredients, FDA, Regulatory Affairs, Nutrition, R&D, Product Innovation, HACCP, Food Processing, GMP
Education
Fordham University 1972 — 1976
Doctor of Philosophy (Ph.D.), Organic Chemistry drug synthesis
Jiang Shao's FDA Experience June 2012 - September 2012
Job Graduate Student at Florida State University
Industry Research
Experience
Department of Statistics September 2010 - Present
FSU College of Medicine January 2011 - Present
FDA June 2012 - September 2012
Skills
Statistics, Bioinformatics, Personalized Medicine, Machine Learning, SAS, R, Python, Matlab, SQL, Data Mining
Education
Florida State University
Master's degree, Biochemistry
Peking University
Bachelor's degree, Pharmaceutical Sciences
Department of Statistics September 2010 - Present
FSU College of Medicine January 2011 - Present
FDA June 2012 - September 2012
Skills
Statistics, Bioinformatics, Personalized Medicine, Machine Learning, SAS, R, Python, Matlab, SQL, Data Mining
Education
Florida State University
Master's degree, Biochemistry
Peking University
Bachelor's degree, Pharmaceutical Sciences
Nan Zheng's FDA Experience 2011 - Present
Job Pharmaceutical Professional, FDA
Industry Pharmaceuticals
Experience
FDA 2011 - Present
Roswell Park Cancer Institute 2011 - 2011
University of Michigan 2006 - 2011
Skills
Pharmaceutical Policy, Regulatory Affairs, PK/PD, MATLAB, NONMEM, WinNonlin, SAS programming, Clinical Pharmacology, DMPK, Biotechnology
Education
University of Michigan
Ph.D., Pharmaceutical Sciences
Fudan University
B.S., Biology
FDA 2011 - Present
Roswell Park Cancer Institute 2011 - 2011
University of Michigan 2006 - 2011
Skills
Pharmaceutical Policy, Regulatory Affairs, PK/PD, MATLAB, NONMEM, WinNonlin, SAS programming, Clinical Pharmacology, DMPK, Biotechnology
Education
University of Michigan
Ph.D., Pharmaceutical Sciences
Fudan University
B.S., Biology
Alysia Salonia's FDA Experience January 2009 - Present
Job Investigator at U.S. Food & Drug Administration
Industry Government Administration
Experience
United States Public Health Service July 2011 - Present
FDA January 2009 - Present
Massachusetts Department of Public Health, Food Protection Program December 2005 - January 2009
Fitz, Vogt & Associates October 2004 - December 2005
Skills
Regulatory Affairs, Healthcare, Risk Assessment, Food Safety, FDA, Food, Nutrition, Food Processing, Food Service, Auditing, Environmental Health, Sanitation, Inspection, Food Quality, Team Leadership, Food Science
Education
Northeastern University 2012 — 2015
Master's degree, Regulatory Affairs
Framingham State College 2000 — 2004
Bachelor of Science, Food & Nutrition
United States Public Health Service July 2011 - Present
FDA January 2009 - Present
Massachusetts Department of Public Health, Food Protection Program December 2005 - January 2009
Fitz, Vogt & Associates October 2004 - December 2005
Skills
Regulatory Affairs, Healthcare, Risk Assessment, Food Safety, FDA, Food, Nutrition, Food Processing, Food Service, Auditing, Environmental Health, Sanitation, Inspection, Food Quality, Team Leadership, Food Science
Education
Northeastern University 2012 — 2015
Master's degree, Regulatory Affairs
Framingham State College 2000 — 2004
Bachelor of Science, Food & Nutrition
Ticia Hopkins's FDA Experience September 2013 - Present
Job Writer/Editor at FDA
Industry Government Administration
Experience
FDA September 2013 - Present
WakeMed October 2012 - September 2013
Nash Health Care System February 2011 - October 2012
Skills
Medical Terminology, Healthcare Information..., Healthcare, Hospitals
Education
Florida Agricultural and Mechanical University
FDA September 2013 - Present
WakeMed October 2012 - September 2013
Nash Health Care System February 2011 - October 2012
Skills
Medical Terminology, Healthcare Information..., Healthcare, Hospitals
Education
Florida Agricultural and Mechanical University
Peter Nemes's FDA Experience Postdoctorate research associateUniversity of Illinois at Urbana-Champaign2009 - 2011
Job Staff member at FDA
Industry Biotechnology
Experience
FDA Postdoctorate research associateUniversity of Illinois at Urbana-Champaign2009 - 2011
George Washington University 2005 - 2009
Education
The George Washington University 2005 — 2009
PhD, Chemistry
Eötvös Loránd University 1999 — 2004
MS, Chemistry
FDA Postdoctorate research associateUniversity of Illinois at Urbana-Champaign2009 - 2011
George Washington University 2005 - 2009
Education
The George Washington University 2005 — 2009
PhD, Chemistry
Eötvös Loránd University 1999 — 2004
MS, Chemistry
Diqiong (Joan) Xie's FDA Experience February 2012 - Present
Job Mathematical statistician
Industry Government Administration
Experience
FDA February 2012 - Present
University of Iowa February 2010 - February 2012
University of Iowa August 2006 - February 2012
University of Iowa April 2009 - July 2010
Skills
R, SAS, Biostatistics, Statistics, Data Analysis, Clinical Trials, Observational Studies, Survival Analysis, SAS Programming, SPSS, Data Management
Education
University of Iowa 2008 — 2011
Ph.D, Biostatistics
University of Iowa 2006 — 2008
M.S, Biostatistics
Fudan University 2002 — 2006
B.S, Statistics
FDA February 2012 - Present
University of Iowa February 2010 - February 2012
University of Iowa August 2006 - February 2012
University of Iowa April 2009 - July 2010
Skills
R, SAS, Biostatistics, Statistics, Data Analysis, Clinical Trials, Observational Studies, Survival Analysis, SAS Programming, SPSS, Data Management
Education
University of Iowa 2008 — 2011
Ph.D, Biostatistics
University of Iowa 2006 — 2008
M.S, Biostatistics
Fudan University 2002 — 2006
B.S, Statistics
Michelle Marcarelli's FDA Experience November 2014 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA November 2014 - Present
FDA July 2012 - November 2014
FDA June 2010 - July 2012
Darnestown Swim and Racquet Club May 2005 - August 2010
Skills
Microsoft Office, Strategic Planning, Leadership, Government, PowerPoint, Microsoft Excel, Outlook, Microsoft Word, Customer Service, Public Speaking, Data Entry, Editing, Event Planning, Typing, Logo Design, Communication, FDA, Statistics, Social Media, Community Outreach, Leading Discussions, Public Health
Education
University of South Florida 2014 — 2015
Master’s Degree, Public Health
The George Washington University - School of Business 2013 — 2014
Masters Certificate, Project Management
The George Washington University - School of Business 2013 — 2013
Associate's Certificate, Project Management
University of Maryland College Park 2012 — 2013
Bachelor of Science (BS), Public Health Science
Montgomery College 2010 — 2013
Associate of Arts (A.A.), General Studies
Florida State University 2009 — 2010
FDA November 2014 - Present
FDA July 2012 - November 2014
FDA June 2010 - July 2012
Darnestown Swim and Racquet Club May 2005 - August 2010
Skills
Microsoft Office, Strategic Planning, Leadership, Government, PowerPoint, Microsoft Excel, Outlook, Microsoft Word, Customer Service, Public Speaking, Data Entry, Editing, Event Planning, Typing, Logo Design, Communication, FDA, Statistics, Social Media, Community Outreach, Leading Discussions, Public Health
Education
University of South Florida 2014 — 2015
Master’s Degree, Public Health
The George Washington University - School of Business 2013 — 2014
Masters Certificate, Project Management
The George Washington University - School of Business 2013 — 2013
Associate's Certificate, Project Management
University of Maryland College Park 2012 — 2013
Bachelor of Science (BS), Public Health Science
Montgomery College 2010 — 2013
Associate of Arts (A.A.), General Studies
Florida State University 2009 — 2010
Cary Greene's FDA Experience February 2011 - Present
Job Investigator at FDA
Industry Government Administration
Experience
FDA February 2011 - Present
FDA May 2002 - January 2011
FDA June 1994 - May 2002
Unilever 1983 - 1988
Kraft/General Foods 1978 - 1983
Buitoni Foods Company 1975 - 1978
Skills
FDA, Food Science, Ingredients, GMP, Food, Food Manufacturing, Food Industry, Food Microbiology, Food Quality, Quality Assurance, Auditing, Sanitation, Quality System, Microbiology, infant formula/medical..., Aseptic processing, Food HACCP Systems, Acidified/LACF
Education
Fairleigh Dickinson University
Bachelor's degree, Business, Management, Marketing, and Related Support Services
Farmingdale State College
Associate of Arts and Sciences (AAS), Food Processing Technology
FDA February 2011 - Present
FDA May 2002 - January 2011
FDA June 1994 - May 2002
Unilever 1983 - 1988
Kraft/General Foods 1978 - 1983
Buitoni Foods Company 1975 - 1978
Skills
FDA, Food Science, Ingredients, GMP, Food, Food Manufacturing, Food Industry, Food Microbiology, Food Quality, Quality Assurance, Auditing, Sanitation, Quality System, Microbiology, infant formula/medical..., Aseptic processing, Food HACCP Systems, Acidified/LACF
Education
Fairleigh Dickinson University
Bachelor's degree, Business, Management, Marketing, and Related Support Services
Farmingdale State College
Associate of Arts and Sciences (AAS), Food Processing Technology
Michael Divine's FDA Experience September 1977 - Present
Job retired FDA
Industry Government Administration
Experience
FDA September 1977 - Present
Skills
Mammography, Medical Devices, radiological health, Diagnostic x-ray...
Education
Emory University
Georgetown University
Master of Science (MS), Radiation Science
FDA September 1977 - Present
Skills
Mammography, Medical Devices, radiological health, Diagnostic x-ray...
Education
Emory University
Georgetown University
Master of Science (MS), Radiation Science
Jennifer Menendez's FDA Experience September 1996 - April 2007
Job PresidentJMM Consulting Inc.
Industry Research
Experience
JMM Consulting Inc. January 2012 - Present
Merck October 2010 - December 2011
Schering-Plough Research Institute April 2007 - October 2010
FDA September 1996 - April 2007
Skills
Clinical Research, FDA, Quality Assurance, Sop, GCP, Clinical Trials, Software Documentation, EDC, Policy, CAPA, Training, Auditing, Regulatory Affairs, Clinical Development, Regulatory Submissions, CRO, Drug Development, Biotechnology, Medical Devices, CTMS, Protocol, Pharmaceutical Industry
Education
Florida State University 1992 — 1996
Bachelor of Science (BS), Dietetics/Dietitian
JMM Consulting Inc. January 2012 - Present
Merck October 2010 - December 2011
Schering-Plough Research Institute April 2007 - October 2010
FDA September 1996 - April 2007
Skills
Clinical Research, FDA, Quality Assurance, Sop, GCP, Clinical Trials, Software Documentation, EDC, Policy, CAPA, Training, Auditing, Regulatory Affairs, Clinical Development, Regulatory Submissions, CRO, Drug Development, Biotechnology, Medical Devices, CTMS, Protocol, Pharmaceutical Industry
Education
Florida State University 1992 — 1996
Bachelor of Science (BS), Dietetics/Dietitian
Rita Scott's FDA Experience April 2010 - Present
Job Program Analyst at FDA
Industry Government Administration
Experience
FDA April 2010 - Present
Skills
Government Accounting, Budget Process, Auditing, Government Contracting, Government, Policy Analysis, Program Management, Policy, Analysis, Community Outreach, Project Management
Education
Fairmont State College 1979 — 1981
Associate of Science (A.S.), Legal Administrative Assistant/Secretary
FDA April 2010 - Present
Skills
Government Accounting, Budget Process, Auditing, Government Contracting, Government, Policy Analysis, Program Management, Policy, Analysis, Community Outreach, Project Management
Education
Fairmont State College 1979 — 1981
Associate of Science (A.S.), Legal Administrative Assistant/Secretary
Sandra Tallent's FDA Experience 2008 - Present
Job Microbiologist at FDA
Industry Government Administration
Experience
FDA 2008 - Present
State of Virginia 2004 - 2008
Virginia Commonwealth University 1998 - 2004
Skills
FDA, Food Microbiology, Bacterial Culture, PCR, Clinical Microbiology, Molecular Microbiology, Lifesciences, DNA, Genetics, Biochemistry, Biotechnology, Cell Culture, Food Science, Immunology, DNA sequencing, Gel Electrophoresis, Molecular Cloning, Bioinformatics, Immunoassays, Western Blotting, Protein Chemistry, Data Analysis
Education
Virginia Commonwealth University 2003 — 2007
Doctor of Philosophy (PhD), Microbiology and Immunology
Virginia Commonwealth University 1998 — 2003
Master of Science (MS), Microbiology and Immunology
Florida Southern College 1976 — 1980
BS, Biology, General
FDA 2008 - Present
State of Virginia 2004 - 2008
Virginia Commonwealth University 1998 - 2004
Skills
FDA, Food Microbiology, Bacterial Culture, PCR, Clinical Microbiology, Molecular Microbiology, Lifesciences, DNA, Genetics, Biochemistry, Biotechnology, Cell Culture, Food Science, Immunology, DNA sequencing, Gel Electrophoresis, Molecular Cloning, Bioinformatics, Immunoassays, Western Blotting, Protein Chemistry, Data Analysis
Education
Virginia Commonwealth University 2003 — 2007
Doctor of Philosophy (PhD), Microbiology and Immunology
Virginia Commonwealth University 1998 — 2003
Master of Science (MS), Microbiology and Immunology
Florida Southern College 1976 — 1980
BS, Biology, General
Yuanyuan (Sophie) Tang's FDA Experience June 2012 - August 2012
Job Sr. Research Statistician at AbbVie
Industry Pharmaceuticals
Experience
AbbVie December 2013 - Present
Eli Lilly and Company July 2013 - November 2013
Department of Statistics, Florida State University August 2009 - June 2013
Department of Statistics, Florida State University December 2011 - May 2013
FDA June 2012 - August 2012
The Dannon Company June 2011 - August 2011
College of Medicine, Florida State University January 2010 - June 2011
Department of Mathematics, Florida State University August 2006 - May 2009
Skills
Statistics, Research, Teaching, R, LaTeX, SAS, Matlab, Statistical Modeling, Stata, Data Analysis, SPSS, Fortran, Machine Learning, Mathematica, Mathematical Modeling, Time Series Analysis, Monte Carlo Simulation
Education
Florida State University 2009 — 2013
Doctor of Philosophy (Ph.D.), Statistics
Florida State University 2006 — 2009
Master's degree, Applied/Computational Mathematics
University of Science and Technology of China 2002 — 2006
Bachelor's degree, Mathematics/Applied Mathematics
AbbVie December 2013 - Present
Eli Lilly and Company July 2013 - November 2013
Department of Statistics, Florida State University August 2009 - June 2013
Department of Statistics, Florida State University December 2011 - May 2013
FDA June 2012 - August 2012
The Dannon Company June 2011 - August 2011
College of Medicine, Florida State University January 2010 - June 2011
Department of Mathematics, Florida State University August 2006 - May 2009
Skills
Statistics, Research, Teaching, R, LaTeX, SAS, Matlab, Statistical Modeling, Stata, Data Analysis, SPSS, Fortran, Machine Learning, Mathematica, Mathematical Modeling, Time Series Analysis, Monte Carlo Simulation
Education
Florida State University 2009 — 2013
Doctor of Philosophy (Ph.D.), Statistics
Florida State University 2006 — 2009
Master's degree, Applied/Computational Mathematics
University of Science and Technology of China 2002 — 2006
Bachelor's degree, Mathematics/Applied Mathematics
Michelle Noonan-Smith's FDA Experience June 2012 - April 2015
Job Public Health Advisor at CDC
Industry Government Administration
Experience
Centers for Disease Control and Prevention May 2015 - Present
FDA June 2012 - April 2015
FDA October 2011 - June 2012
FDA May 2006 - October 2011
FDA March 2005 - May 2006
Centers for Disease Control and Prevention December 2002 - March 2005
FDA January 2001 - December 2002
Skills
FDA, Public Health, Policy, Regulatory Affairs, Public Policy
Education
The University of Georgia 1997 — 1999
Bachelor of Science (BS), Environmental Health
Florida International University 2004 — 2004
Public Health
Centers for Disease Control and Prevention May 2015 - Present
FDA June 2012 - April 2015
FDA October 2011 - June 2012
FDA May 2006 - October 2011
FDA March 2005 - May 2006
Centers for Disease Control and Prevention December 2002 - March 2005
FDA January 2001 - December 2002
Skills
FDA, Public Health, Policy, Regulatory Affairs, Public Policy
Education
The University of Georgia 1997 — 1999
Bachelor of Science (BS), Environmental Health
Florida International University 2004 — 2004
Public Health
Kelly Doremus Hall's FDA Experience January 2009 - August 2014
Job VM Water Quality Coordinator
Industry Government Administration
Experience
Coastal Carolina University December 2014 - Present
FDA January 2009 - August 2014
Passaic County Health Dept September 2001 - December 2008
Skills
Regulatory Affairs, Environmental Health, Public Health, Environmental Law, Water Quality, Biology, Private Investigations, FDA, Criminal Justice, Customer Service, Emergency Management, Environmental Awareness, Environmental Monitoring, Environmental Policy, Evidence, Government, Microsoft Excel, Microsoft Office, Microsoft Word, Policy, PowerPoint, Public Speaking, Regulations, Regulatory Analysis, Research
Education
Fairleigh Dickinson University
Master's degree, Ad. Science
Montclair State University
Bachelor's degree, Geoscience
Coastal Carolina University December 2014 - Present
FDA January 2009 - August 2014
Passaic County Health Dept September 2001 - December 2008
Skills
Regulatory Affairs, Environmental Health, Public Health, Environmental Law, Water Quality, Biology, Private Investigations, FDA, Criminal Justice, Customer Service, Emergency Management, Environmental Awareness, Environmental Monitoring, Environmental Policy, Evidence, Government, Microsoft Excel, Microsoft Office, Microsoft Word, Policy, PowerPoint, Public Speaking, Regulations, Regulatory Analysis, Research
Education
Fairleigh Dickinson University
Master's degree, Ad. Science
Montclair State University
Bachelor's degree, Geoscience
Mary Callahan-Squire's FDA Experience September 1977 - April 1985
Job
Industry Pharmaceuticals
Experience
AstraZeneca March 2002 - Present
AstraZeneca July 1999 - March 2002
AstraZeneca April 1985 - July 1999
FDA September 1977 - April 1985
Skills
Project Portfolio..., Project Management, Line Management, Clinical Development, Clinical Research, FDA, Oncology
Education
Florida Institute of Technology
Bachelor of Science (B.S.), Oceanography, Chemical and Physical
AstraZeneca March 2002 - Present
AstraZeneca July 1999 - March 2002
AstraZeneca April 1985 - July 1999
FDA September 1977 - April 1985
Skills
Project Portfolio..., Project Management, Line Management, Clinical Development, Clinical Research, FDA, Oncology
Education
Florida Institute of Technology
Bachelor of Science (B.S.), Oceanography, Chemical and Physical
Chester Fisher's FDA Experience November 1993 - January 2002
Job Senior Human Resources Specialist at National Transportation Safety Board
Industry Public Safety
Experience
National Transportation Safety Board December 2004 - Present
FDIC July 2004 - December 2004
FDA November 1993 - January 2002
Education
Frostburg State University 1982 — 1985
Master of Business Administration (M.B.A.)
St. Augustine's University 1960 — 1964
Bachelor of Arts (B.A.), Political Science and Government
National Transportation Safety Board December 2004 - Present
FDIC July 2004 - December 2004
FDA November 1993 - January 2002
Education
Frostburg State University 1982 — 1985
Master of Business Administration (M.B.A.)
St. Augustine's University 1960 — 1964
Bachelor of Arts (B.A.), Political Science and Government
Talia Shirazi's FDA Experience May 2012 - August 2012
Job Postbac IRTA, NIH/NIMH
Industry Research
Experience
Office of the Clinical Director, NIH/NIMH August 2014 - Present
Behavioral Endocrinology Lab, Emory University September 2012 - June 2014
Children's National Health System May 2013 - August 2013
FDA May 2012 - August 2012
Lab of Personality and Psychopathology, Emory University January 2012 - May 2012
The Walden School at Emory Autism Center August 2011 - January 2012
Skills
SPSS, Quantitative Research, Eye Tracking, Analysis, Proposal Writing, Survey Research, Microsoft Office, Data Management, Qualitative Research, Neuropsychology
Education
Emory University 2010 — 2014
Bachelor of Arts (BA)
Walter Johnson High School 2006 — 2010
Office of the Clinical Director, NIH/NIMH August 2014 - Present
Behavioral Endocrinology Lab, Emory University September 2012 - June 2014
Children's National Health System May 2013 - August 2013
FDA May 2012 - August 2012
Lab of Personality and Psychopathology, Emory University January 2012 - May 2012
The Walden School at Emory Autism Center August 2011 - January 2012
Skills
SPSS, Quantitative Research, Eye Tracking, Analysis, Proposal Writing, Survey Research, Microsoft Office, Data Management, Qualitative Research, Neuropsychology
Education
Emory University 2010 — 2014
Bachelor of Arts (BA)
Walter Johnson High School 2006 — 2010
Yoonhee Kim's FDA Experience February 2013 - May 2014
Job Director of Bioinformatics at Macrogen Clinical Laboratory
Industry Biotechnology
Experience
Macrogen Clinical Laboratory June 2014 - Present
FDA February 2013 - May 2014
National Institutes of Health April 2008 - January 2013
Skills
Statistical Genetics, Genetic Epidemiology, Biostatistics, Bioinformatics, Pharmacogenomics, R, Next Generation..., DNA-seq, RNA-seq, Methyl-seq, Sanger sequencing, linkage analysis, Association studies, Genome wide association..., Clinical Trials, Biomarkers
Education
Seoul National University 2003 — 2008
Doctor of Philosophy (Ph.D.), Biostatistics and Epidemiology
Seoul National University 2001 — 2003
Master of Public Health (MPH), Biostatistics and Epidemiology
Ewha Womans University 1997 — 2001
Bachelor's Degree, Statistics
Macrogen Clinical Laboratory June 2014 - Present
FDA February 2013 - May 2014
National Institutes of Health April 2008 - January 2013
Skills
Statistical Genetics, Genetic Epidemiology, Biostatistics, Bioinformatics, Pharmacogenomics, R, Next Generation..., DNA-seq, RNA-seq, Methyl-seq, Sanger sequencing, linkage analysis, Association studies, Genome wide association..., Clinical Trials, Biomarkers
Education
Seoul National University 2003 — 2008
Doctor of Philosophy (Ph.D.), Biostatistics and Epidemiology
Seoul National University 2001 — 2003
Master of Public Health (MPH), Biostatistics and Epidemiology
Ewha Womans University 1997 — 2001
Bachelor's Degree, Statistics
Thomas Eads's FDA Experience 2011 - Present
Job Science Policy
Industry Government Administration
Experience
FDA 2011 - Present
Education
Florida State University
Doctor of Philosophy (Ph.D.), Molecular Biophysics
Harvard University, John F. Kennedy School of Government
Master in Public Administration, Science Policy
Penn State University
Bachelor of Science (B.S.), Biophysics
FDA 2011 - Present
Education
Florida State University
Doctor of Philosophy (Ph.D.), Molecular Biophysics
Harvard University, John F. Kennedy School of Government
Master in Public Administration, Science Policy
Penn State University
Bachelor of Science (B.S.), Biophysics
Department of Veterans Affairs
US Census Bureau
U.S. Department of Veterans Affairs
US Securities and Exchange Commission
USAID
US Fish and Wildlife Service
TSA
Defense Logistics Agency