FDA Company

Industry: Federal agency

Description

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. 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
Denka Markova, PhD Denka Markova, PhD San Francisco, California Details
Denka Markova, PhD's FDA Experience September 2010 - February 2011
Job Senior Biostatistician at Medivation
Industry Pharmaceuticals
Experience
Medivation  May 2014 - Present
Axio Research  March 2013 - May 2014
Axio Research  July 2011 - February 2013
Baylor University  August 2006 - October 2011
FDA   September 2010 - February 2011
Department of Statistical Science, Social Work Dept, Dept of Psychology and Neuroscience   August 2008 - August 2010
Baylor University, Department of Mathematics   August 2006 - August 2010
Mind-Body Medicine Research Lab, Dept of Psychology and Neuroscience, Baylor University   June 2009 - June 2010
Baylor University, Dept of Health, Human Performance and Recreation   May 2008 - August 2008
Baylor University  August 2006 - July 2008

Skills
S-Plus, R, SAS, Stata, Mathematica, Statistical Modeling, Data Analysis, Biostatistics, SPSS, JMP, Logistic Regression, Statistics, Clinical Trials, SAS programming, Research, Data Mining, Multivariate Analysis, Time Series Analysis, LaTeX, Experimental Design, Survival Analysis, Quantitative Analytics, SAS Programming

Education
Baylor University   2006 — 2010
Ph.D., Statistical Science

Baylor University   2006 — 2008
M.S., Statistical Science

Henderson State University   2002 — 2006
B.S., Mathematics, Physics

OMG Akad. Kiril Popov   1997 — 2002
High School, Mathematics, Computer Science, English

Jennie K Jennie K Burley, Idaho Details
Jennie K's FDA Experience June 2013 - Present
Job Tobacco Sales Enforcement Team
Industry Law Enforcement
Experience
In Home Care  February 2015 - Present
FDA   June 2013 - Present
Healthy Lifestyles   May 2013 - Present
Idaho Department of Labor  2009 - 2011

Skills
Customer Service, Policy, Private Investigations, Security Clearance, Government, Public Speaking, Training, Microsoft Office, Organizational..., Community Outreach, Leadership, Recruiting

Education
Central Christian College of Kansas   2014 — 2015
Bachelor's Degree, Criminal Justice and Corrections

Boise State University
Criminal Justice/Law Enforcement Administration

Lokesh Jain Lokesh Jain Greater New York City Area Details
Lokesh Jain's FDA Experience January 2012 - Present
Job Principal Scientist at Merck
Industry Pharmaceuticals
Experience
Merck  October 2014 - Present
Virginia Commonwealth University  October 2013 - Present
FDA   January 2012 - Present
FDA   October 2012 - September 2014
FDA   December 2009 - February 2012
National Cancer Institute  June 2006 - June 2010
Virginia Commonwealth University  August 2005 - December 2009
Central Drug Research Institute, Lucknow  January 2005 - June 2005

Skills
Drug Development, Translational Research, Pharmacometrics, Clinical Pharmacology, Regulatory Policy, Biomarkers, Clinical Research, Pharmacokinetics, Pharmacodynamics, Pharmaceuticals, Clinical, Pharmacology, Pharmaceutical Industry, Assay Development, Team Leadership, In Vitro, Biotechnology, Pharmaceutics, Life Sciences, Drug Discovery, Cancer

Education
Virginia Commonwealth University   2005 — 2009
Ph.D., Clinical Pharmacology

Birla Institute of Technology and Science, Pilani   2003 — 2005
M.S., Pharmaceutical Sciences

L. M. College of Science and Technology, Jodhpur   1998 — 2003
B. Pharm, Pharmaceutical Sciences

Josue Gomez Josue Gomez Columbus, Ohio Details
Josue Gomez's FDA Experience June 2009 - August 2009
Job Graduate Teaching Assistant at The Ohio State University
Industry Higher Education
Experience
The Ohio State University  August 2013 - December 2014
Boise State University  August 2008 - May 2013
The Salvation Army  January 2011 - September 2012
Institute For Social Research University of Michigan  May 2012 - July 2012
Boise State University  July 2011 - October 2011
SL Start and Associates  June 2011 - August 2011
College of Western Idaho  August 2008 - May 2011
Boise State University  April 2009 - April 2010
FDA   June 2009 - August 2009
Thomas Real Estate Development   January 2008 - August 2008

Skills
English, Tutoring, Teaching, Research, Public Speaking, Event Planning, Spanish, Political Science, Public Relations, Fundraising, Customer Service, Microsoft Office, Higher Education, Community Outreach, Nonprofits, Grant Writing, International Relations, Politics

Education
The Ohio State University   2013 — 2018
Doctor of Philosophy (PhD), Political Science and Government

Boise State University   2007 — 2013
Bachelors of Arts, Political Science

Hu Jinjie Hu Jinjie Washington D.C. Metro Area Details
Hu Jinjie's FDA Experience July 2001 - November 2012
Job Senior Regulatory Consultant at BCG
Industry Medical Devices
Experience
Biologics Consulting Group, Inc.   November 2012 - Present
FDA   July 2001 - November 2012

Skills
FDA, Medical Devices, Regulatory Requirements, IVD, CMC, Regulatory Affairs, Regulatory Submissions, Clinical Trials, GLP, Drug Development, Infectious Diseases, Immunology, GMP, IVD Regulation, Molecular Diagnostics, Quality System, Design Control, PMA, 510(k), BLA, IDE, HDE, Clinical Development, IND, Biotechnology

Education
UC Davis   1995 — 1999
Ph. D., Comparative Pathology

Beijing Normal University
B.S., biology

John Martucci John Martucci Greater Philadelphia Area Details
John Martucci's FDA Experience June 2012 - June 2014
Job Student of Podiatric Medicine
Industry Hospital & Health Care
Experience
Children's Day Triathlon   January 2014 - January 2015
FDA   June 2012 - June 2014
Peer Health Exchange  October 2010 - April 2012
Boston College Annual Fund   August 2010 - November 2011
Boston College  February 2010 - August 2010
St. Luke's Health System   June 2010 - July 2010

Skills
Research, Leadership, Healthcare, Teaching, Data Analysis, Grant Writing, Microsoft Office, Molecular Biology, Community Outreach, Fundraising, Organization, Event Planning, Nonprofits, Health Policy, Social Networking

Education
Temple University, Pennsylvania College of Podiatric Medicine   2014 — 2018
Doctor of Podiatric Medicine

Boston College   2008 — 2012
B.S., Biology, Economics

Rockhurst High School   2004 — 2008

Philip Rinaldi Philip Rinaldi Whitestone, New York Details
Philip Rinaldi's FDA Experience December 2010 - Present
Job Consumer Safety Tech at FDA
Industry Government Administration
Experience
FDA   December 2010 - Present

Skills
Microsoft Word, PowerPoint, Microsoft Office, Leadership, Policy, Government, Outlook

Education
Nyu   2008 — 2009
Construction Estimating

Borough of Manhattan Community College   1994 — 1996

Queensborough Community College
Biology, General

Deb Autor Deb Autor Canonsburg, Pennsylvania Details
Deb Autor's FDA Experience 2011 - 2013
Job SVP, Strategic Global Quality & Regulatory Policy at Mylan
Industry Pharmaceuticals
Experience
Mylan  2013 - Present
FDA   2011 - 2013
FDA   2006 - 2011
FDA   2002 - 2006
U.S. Department of Justice   1995 - 2002
Weil,Gotshal & Manges and Buc Levitt & Beardsley   1992 - 1995

Skills
Crisis Management, Policy, FDA, Leadership, Strategy, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Regulations, Litigation, Government, Legislation, Risk Management, Policy Analysis, Drug Development, IND, Program Management, Data Analysis, Research, Public Policy

Education
Boston University School of Law   1989 — 1992
Doctor of Law (JD)

Columbia University, Barnard College   1984 — 1988
Bachelor of Arts (B.A.)

Barbara Abrams Barbara Abrams Tallahassee, Florida Details
Barbara Abrams's FDA Experience 2011 - 2013
Job Attorney at Law Office of David Abrams
Industry Law Practice
Experience
Law Office of David Abrams   2013 - Present
FDA   2011 - 2013
State of Florida  May 2005 - October 2011
Florida State University  September 2002 - October 2011

Skills
Public Health, Policy Analysis, Public Policy, Government, Policy, Regulatory Affairs, Lifesciences, Literature Reviews, Litigation, Teaching, Medical Devices, Clinical Research, FDA, Courts, Public Speaking

Education
Florida State University College of Law   2002 — 2005
Doctor of Law (J.D.), Law

Boston University School of Medicine   1979 — 1986
Doctor of Medicine (M.D.), Medicine

William (Bill) Coplin William (Bill) Coplin Denver, Colorado Details
William (Bill) Coplin's FDA Experience October 2010 - November 2010
Job Neurocritical Care
Industry Medical Practice
Experience
AANS/CNS Joint Section on Neurotrauma and Critical Care   2000 - Present
Neurocritical Care Society   1999 - Present
Society of Critical Care Medicine  1998 - Present
Centura Health  May 2013 - February 2015
Wayne State University School of Medicine  1996 - 2013
Michigan Stroke Network   2010 - November 2011
FDA   October 2010 - November 2010
USAMRICD , US Army Medical Research Institute of Chemical Defense   2006 - 2008
American Academy of Neurology  2005 - 2007
NIH BDCN-3/CDIN Study Section   1999 - 2005

Skills
Neurology, Medicine, Critical Care, Healthcare, Clinical Research, Neuroscience, Hospitals, Medical Education, Board Certified, Public Health, Clinical Trials, Emergency Medicine, Neurosurgery, Treatment, Physicians, Managed Care, Pediatrics, Neuromuscular Therapy, Neurocritical Care, Neurotrauma, Stroke Acute Care, Systems of Care, Population Health

Education
Baylor College of Medicine   1985 — 1989
Doctor of Medicine (MD), Medicine

The University of Chicago   1981 — 1985
Bachelor's Degree, Biological Sciences, Dean's List

Indian Springs School, Helena, AL   1976 — 1981
High School, High School/Secondary Diplomas and Certificates

Prakash Bhagav Prakash Bhagav Washington D.C. Metro Area Details
Prakash Bhagav's FDA Experience July 2015 - Present
Job Division of Bioequivalence, Office of Generic Drugs (CDER) FDA
Industry Pharmaceuticals
Experience
FDA   July 2015 - Present
University of Mississippi  June 2013 - June 2015
Panacea Biotec Ltd  January 2012 - May 2013
Nicholas Piramal India Limited   January 2011 - January 2012
Birla Institute of Technology and Science, Pilani  January 2006 - August 2010
Strides Arcolab Limited  September 2005 - January 2006

Education
Birla Institute of Technology and Science, Pilani   2006 — 2010
Ph.D, Pharmaceutics

Rajiv Gandhi University of Health Sciences   2003 — 2005
M.Pharm, Govt.College of Pharmacy, Bangalore

Rajiv Gandhi University of Health Sciences   1998 — 2002
Bachelor of Pharmacy (B.Pharm.), MCOPS, Manipal

Shuai Tang Shuai Tang College Park, Maryland Details
Shuai Tang's FDA Experience October 2013 - August 2014
Job Research Assistant and Master Student in Food Safety
Industry Food & Beverages
Experience
FDA   October 2013 - August 2014
Novozymes  August 2011 - June 2013

Skills
Food & Beverage, Food Science, Food Safety, Bioinformatics, Biochemistry, Molecular Biology, Data Analysis, Salmonella, E. coli, SPSS, Python, Perl, Microsoft Office, English, Chinese, DNA

Education
University of Maryland College Park   2013 — 2015
Master's Degree, Food Science, 3.745

Beijing Normal University   2007 — 2011
Bachelor's Degree, Biology/Biological Sciences, General, 3.896

Muntaha Burge Wali Muntaha Burge Wali Ashburn, Virginia Details
Muntaha Burge Wali's FDA Experience 2010 - 2013
Job Associate at Booz Allen Hamilton
Industry Management Consulting
Experience
Booz Allen Hamilton  August 2012 - Present
FDA   2010 - 2013
Booz Allen Hamilton  July 2010 - August 2012
PwC  January 2007 - July 2010

Skills
Enterprise Architecture, Project Management, Project Planning, MS Project, Software Project..., Project Coordination, Data Analysis, Data Modeling, Data Management, Software Documentation, Software Installation, SDLC, Testing, Requirements Analysis, Requirements Gathering, Business Analysis, Business Intelligence, IT Strategy, Management, Oracle, PMP

Education
Boston University   2010 — 2014
Master of Science (M.S.), Computer and Information Systems Security - IT Project Management

George Mason University   2003 — 2006
Bachelor of Science (B.S.), Information Technology

Sreedharan Sabarinath Sreedharan Sabarinath Washington D.C. Metro Area Details
Sreedharan Sabarinath's FDA Experience July 2013 - Present
Job Senior Staff Fellow at FDA
Industry Government Administration
Experience
FDA   July 2013 - Present
University of Florida  March 2013 - Present
American College of Clinical Pharmacology  2012 - Present
Food and Drug Administration  July 2010 - Present
University of Florida  December 2006 - June 2010
University of Gothenburg  December 2005 - August 2006

Skills
Pharmacokinetics, Pharmacodynamics, Pharmacometrics, Clinical Trials, Clinical Pharmacology, Pharmacology, Drug Development, Clinical Research, Clinical Development, NONMEM, WinNonlin, HPLC, Clinical Study Design, Drug Discovery, Pharmaceutical Industry, Infectious Diseases, In Vitro, Protein Chemistry, Lifesciences, In Vivo, Drug Metabolism, Toxicology, Medical Writing, Oncology

Education
University of Florida   2006 — 2010
Post Doctoral, Pharmaceutics - Pharmacometrics

University of Gothenburg   2005 — 2006
Post Doctoral Fellow, Pharmacology-Pharmacometrics

Jawaharlal Nehru Vishvavidyalaya   2002 — 2005
Ph. D., Pharmacy

Birla Institute of Technology and Science, Pilani   2000 — 2002
M. Pharm, Pharmacy

Coleen Klasmeier Coleen Klasmeier Washington, District Of Columbia Details
Coleen Klasmeier's FDA Experience May 2002 - November 2004
Job Partner and Global Coordinator, Food, Drug and Medical Device Regulatory Practice Area Team at Sidley Austin LLP
Industry Law Practice
Experience
Sidley Austin LLP  January 2005 - Present
FDA   May 2002 - November 2004
Covington & Burling  September 1996 - May 2002

Skills
Medical Devices, Policy Analysis, Public Policy, Policy, Government, Project Management, FDA, Lifesciences

Education
Boston University School of Law   1993 — 1996
Doctor of Law (J.D.)

Western Maryland College   1989 — 1993
Bachelor of Arts (B.A.)

Old Mill Middle School

Old Mill Middle School

Jennifer Goode Jennifer Goode Washington D.C. Metro Area Details
Jennifer Goode's FDA Experience 1994 - Present
Job Biomedical Engineer at FDA Office of Device Evaluation
Industry Medical Devices
Experience
FDA   1994 - Present

Skills
Biomedical Engineering, Strategic Planning, Biocompatibility, Cross-functional Team..., Medical Devices, Biomaterials, Product Development, FDA, ISO 13485, Program Management, Biomechanics, Quality System, Medical Imaging, R&D

Education
Clemson University   1991 — 1994
Bioengineering

Boston University   1986 — 1990
B.S., Biomedical Engineering, Cum Laude

Josh Rising Josh Rising Washington, District Of Columbia Details
Josh Rising's FDA Experience 2010 - 2012
Job Director, Healthcare at The Pew Charitable Trusts
Industry Philanthropy
Experience
The Pew Charitable Trusts  November 2014 - Present
The Pew Charitable Trusts  January 2012 - November 2014
FDA   2010 - 2012
State of Connecticut  2008 - 2010
Robert Wood Johnson Clinical Scholars Program   2007 - 2008

Education
Boston University School of Medicine   1997 — 2003
MD

Boston University School of Public Health   1997 — 2003
Master of Public Health (MPH), Health Services Research

Carleton College   1993 — 1997
BA, History

Jesse Muir Jesse Muir Washington D.C. Metro Area Details
Jesse Muir's FDA Experience September 2014 - Present
Job Biomedical Engineer at FDA
Industry Medical Devices
Experience
FDA   September 2014 - Present
Stony Brook University  2013 - September 2014
Stony Brook University  2004 - 2011
Stony Brook University  2004 - 2011
Boston University  June 2003 - May 2004
Pfizer  September 2002 - May 2003
Bayer Diagnostics  January 2002 - August 2002

Skills
Biomedical Engineering, Labview, Matlab, Biomechanics, Statistics, Medical Devices, Image Processing, Signal Processing, Bone, C++, Visual Basic, Visual C++, Computed Tomography (CT), MRI, Osteoporosis, Postural Control and..., Research Design, Clinical Trials, Animal Models, Musculoskeletal Health, SPSS, Aging, Spinal Cord Injury, Diabetic Neuropathy, Cerebral Palsy, Medical Sensors, Vibration, Musculoskeletal, Gait Analysis, Biomedical..., Motion Analysis, Medical Imaging, Ultrasound, X-ray, Design of Experiments, ANOVA, Diagnostic Ultrasound, Medical Ultrasound, Ultrasound Therapy, SolidWorks, CAD/CAM Software, Biomedical Device Design, Regulatory Affairs, Stereotaxic Instruments, Federal Government, Orthopedic Implants

Education
Stony Brook University   2004 — 2011
PhD, Biomedical Engineering

Boston University   1999 — 2004
BS, Biomedical Engineering

Shreya Shah, MS, MBA Shreya Shah, MS, MBA New York, New York Details
Shreya Shah, MS, MBA's FDA Experience September 2008 - July 2012
Job ECommerce Manager at Trish McEvoy
Industry Retail
Experience
Trish McEvoy  May 2015 - Present
Crabtree & Evelyn  June 2014 - May 2015
Quintiles  May 2013 - August 2013
FDA   September 2008 - July 2012

Skills
Digital Marketing, Online Marketing, Content Strategy, Email Strategy, Email Marketing, Google Analytics, Content Writing, Blog Marketing, Affiliate Marketing, SEM, Email Management, ExactTarget, Demandware, Social Media Marketing, Creative Briefs, Pinterest Marketing, Facebook Marketing, Market Research, Dashboard Metrics, KPI Dashboards, E-commerce SEO, SPSS, Corporate Finance, Financial Modeling, Marketing, Management, Social Media, Analytics, E-commerce

Education
Boston University   2012 — 2014
Master of Business Administration (MBA), Marketing

Long Island University, Brooklyn Campus   2010 — 2012
Master of Science (MS), Drug Regulatory Affairs

The College of New Jersey   2004 — 2008
BS, Biology, General

Cambria Cook Cambria Cook Greater Salt Lake City Area Details
Cambria Cook's FDA Experience September 1989 - September 1996
Job Owner and Sole Proprietor at Creations Relfection
Industry Photography
Experience
Creations Reflection   May 2012 - Present
FDA   September 1989 - September 1996
Baldwin Park Christian School   September 1986 - June 1988

Skills
Photography, Photoshop, Woodworking, Digital Photography, Photo Editing, PowerPoint, Image Editing, Illustration, Logo Design, Mac, Photos, Art

Education
Salt Lake Community College
Certificate, Media and Web Design, N.A

Biola University   1982 — 1985
B.S., Biological Science/Outdoor Education

Feather River College   1980 — 1982
A.S., Forestry

Los Angeles Lutheran High   1978 — 1980

Emily Shacter, Ph.D. Emily Shacter, Ph.D. Washington D.C. Metro Area Details
Emily Shacter, Ph.D.'s FDA Experience January 1994 - May 2012
Job Independent Consultant at ThinkFDA, LLC
Industry Government Administration
Experience
ThinkFDA, LLC   July 2012 - Present
FDA   January 1994 - May 2012
FDA   1994 - 2012
National Institutes of Health  1982 - 1994

Skills
Protein Biochemistry, FDA Regulatory..., Therapeutic proteins, Biotechnology, Regulatory Submissions, FDA, Protein Chemistry, Cell, Biochemistry, IND, Biopharmaceuticals, Regulatory Affairs, Lifesciences, Science, Clinical Research, Clinical Development, Cancer, Characterization, Laboratory, Drug Development

Education
The Johns Hopkins University   1976 — 1982
Ph.D., Biochemistry

University of Maryland College Park   1975 — 1975
B.Sc., Biology

Ben Gurion University   1972 — 1974

The Hebrew University   1971 — 1972
Science

Scott Rawls Scott Rawls North Little Rock, Arkansas Details
Scott Rawls's FDA Experience October 2011 - Present
Job Contract Specialist at FDA
Industry Government Administration
Experience
FDA   October 2011 - Present
Abacus Technology  June 1997 - September 2011
United States Air Force  December 1995 - May 1997

Skills
Program Management, Project Management, Leadership, Government, Contract Management, Business Process..., Human Resources, Management, Integration, SDLC, Six Sigma, Information Technology, Telecommunications, FAC-C (Contracting)..., Procurement, Business Development, FAC-C (Contracting)..., FAC-C (Contracting)..., DoD, Security Clearance

Education
Boston University   1993 — 1996
Master's degree, Computer Science

Texas A&M University-Commerce   1985 — 1987
Bachelor of Science (BSc), Computer Science

Bima Yige Bima Yige Chicago, Illinois Details
Bima Yige's FDA Experience September 2012 - December 2014
Job Student at Illinois Institute of Technology
Industry Food & Beverages
Experience
Mérieux NutriSciences - North America  June 2015 - Present
FDA   September 2012 - December 2014
FDA   January 2013 - August 2013
International Life Science Institute   November 2012 - December 2012
FDA   April 2012 - December 2012
新东方   February 2009 - July 2009

Skills
Microsoft Excel, Microbiology, Cell Biology, General Chemistry Lab..., General Biology Lab..., Food Safety, Food Science, 微生物学, 实验室, 细胞培养, Microsoft Office

Education
Illinois Institute of Technology   2011 — 2013
Master's degree, Food Safety and Technology

Beijing Normal University   2007 — 2011
Bachelor of Science (BS), Biotechnology

John Rex John Rex Greater Boston Area Details
John Rex's FDA Experience November 2007 - October 2011
Job Senior VP and Head of Infection, Global Medicines Development, AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca  June 2012 - Present
F2G, Ltd.   September 2012 - Present
Wellcome Trust  January 2011 - Present
The University of Texas Health Science Center at Houston  January 2003 - Present
Clinical and Laboratory Standards Institute  January 2013 - Present
Clinical and Laboratory Standards Institute  April 2013 - Present
Clinical and Laboratory Standards Institute  January 2009 - December 2012
AstraZeneca  January 2003 - May 2012
FDA   November 2007 - October 2011
American Society for Microbiology  July 2000 - June 2010

Skills
Clinical Research, Drug Discovery, Biochemistry, Microbiology, Infectious Diseases, Biotechnology, Healthcare, Clinical Trials, Oncology, Chemistry, Pharmaceutical Industry, Strategic Planning, Epidemiology, Drug Development, Medicine, Regulatory Submissions, Clinical Development, CRO, Molecular Biology, Science, Lifesciences, Medical Affairs, Cell Biology, Medical Writing, Immunology, Technology Transfer, Pharmacology, Life Sciences

Education
Baylor College of Medicine   1979 — 1982
MD

Rice University   1975 — 1979
BA, Biochemistry

William Bozza William Bozza Silver Spring, Maryland Details
William Bozza's FDA Experience June 2014 - Present
Job Staff Fellow, FDA
Industry Higher Education
Experience
FDA   June 2014 - Present
FDA   May 2013 - June 2014
University of Delaware  December 2006 - May 2013
Bristol-Myers Squibb  June 2006 - August 2006
Binghamton University  September 2004 - May 2006

Skills
UV/Vis, HPLC, Fluorescence..., Mass Spectrometry, Characterization, Spectroscopy, NMR, Protein Purification, Chemistry, IR spectroscopy, Protein Chemistry, Western Blotting, Biochemistry, Enzyme Kinetics, Flow Cytometry, Purification, LC-MS

Education
University of Delaware   2006 — 2013
Doctor of Philosophy (PhD), Biochemistry

Binghamton University   2002 — 2006
Bachelor of Arts (BA), Chemistry

Kelly Hair Kelly Hair Rockville, Maryland Details
Kelly Hair's FDA Experience February 2013 - January 2014
Job Senior Advisor at US Department of Health and Human Services
Industry Government Administration
Experience
US Department of Health and Human Services  January 2014 - Present
FDA   February 2013 - January 2014
U.S. Africa Command   April 2011 - February 2013
U.S. Africa Command   June 2008 - April 2011
U.S. European Command   June 2007 - June 2008
U.S. Army   May 1994 - September 2007
U.S. Army Training and Doctrine Command   October 2004 - June 2007
U.S. Army   1985 - 1992

Skills
HR Operations /..., Human Capital Management, Workforce Planning &..., Performance Management, Training and..., Staff Recruitment and..., Employee Recognition..., Compensation and..., Strategic Planning, Organizational..., Organizational Design, Business Process..., Business Process..., Qualitative/Quantitative..., Life Cycle Project..., Change Management, Management, Project Management, Leadership, Human Resources, Workforce Planning, Personnel Management, Analysis, Operational Planning, Training, Policy, Cross-functional Team..., DoD, Military Operations, Security Clearance, Defense, Program Management, Military, Government, National Security, Command

Education
University of Phoenix   2006 — 2008
Master of Business Administration (M.B.A.), Business Administration, 3.7

AG Officer Advanced Course   1997 — 1998

Bentley College   1991 — 1994
Bachelor of Science (B.S.), Accounting, 3.6

Teghpal Singh Teghpal Singh Boston, Massachusetts Details
Teghpal Singh's FDA Experience September 2012 - January 2013
Job Life Sciences Strategy Consultant
Industry Management Consulting
Experience
Navigant  October 2014 - Present
Covidien  April 2014 - October 2014
Covidien  February 2013 - May 2014
FDA   September 2012 - January 2013
FDA   April 2012 - September 2012
Brown University  April 2011 - April 2012

Skills
Project Management, Data Analysis, Scientific Writing, Scientific Review, Regulatory Affairs, Regulatory Policy, Neuroscience, Neurology, Neurological Disorders, Psychology, Neurophysiology, Neuropsychiatry, Management, Clinical Research, In Vivo, Science, Medical Devices, Cognition, FDA, Experimental Design, Histology, Electrophysiology, Biotechnology, Biomedical Engineering, Biostatistics, Neuropharmacology, Animal Models, Immunohistochemistry, Lifesciences, Molecular Biology, Cell Biology, Western Blotting, Pharmacology, In Vitro, Cell, Physiology, Biochemistry, Translational Research, Medical Writing, Experimentation, Laboratory, Confocal Microscopy, Microscopy, Behavioral Neuroscience, Neuroanatomy, Life Sciences, Strategy, Leadership, Research

Education
University of Maryland School of Medicine   2006 — 2011
Ph.D., Neuroscience

Boston University   2005 — 2006
M.A., Psychology

Washington University in St. Louis   2000 — 2004
B.A., Psychology

Gilman School   1988 — 2000

Anne Hammer Anne Hammer United States Details
Anne Hammer's FDA Experience 2015 - Present
Job External Expertise and Partnerships
Industry Government Administration
Experience
FDA   2015 - Present
Northeastern University College of Professional Studies  November 2014 - Present
Northeastern University Online   November 2012 - February 2015
Southern NH University  2001 - 2011
SNHU College of Online and Continuing Education   2003 - 2008

Skills
Higher Education, E-Learning, Strategy, Teaching, Curriculum Design, Research, Instructional Design, Distance Learning, University Teaching, Grant Writing, Leadership Development, Program Development, Editing

Education
Boston University   1993 — 1995
MA, Brain, Behavior and Cognition

The University of Texas Health Science Center at San Antonio   1996 — 1997
na, Neuropharmacology

Rensselaer Polytechnic Institute   1990 — 1993
Bachelor of Science (BS), Psychology & Neuroscience

CCHS

Vidhi Bhatt Vidhi Bhatt Greater Los Angeles Area Details
Vidhi Bhatt's FDA Experience April 2014 - March 2015
Job Regulatory Affairs Specialist at Immunalysis Corporation
Industry Pharmaceuticals
Experience
Immunalysis Corporation  July 2015 - Present
IcGXP, Inc.   May 2015 - Present
Regulatory Consulting Center, USC International Center for Regulatory Science   August 2014 - August 2015
USC Stevens Center for Innovation  April 2014 - August 2015
FDA   April 2014 - March 2015
Novartis  January 2013 - December 2013
Novartis  July 2012 - December 2012
Cadila Pharmaceuticals Limited  September 2008 - October 2008

Skills
Regulatory Affairs, Pharmacovigilance, Pharmaceutical Industry, Pharmaceutical Research, Drug Safety, Clinical Trials, FDA, PSUR, Drug Delivery, Pharmacokinetics, Pharmacology, Risk Management, Regulatory Submissions, Pharmaceutics, MedDRA, Quality Assurance, Global Regulatory..., Clinical Research, Risk Evaluation &..., Technology Transfer..., Medical Product..., SharePoint

Education
University of Southern California   2014 — 2015
Master of Science (MS), Regulatory Science, 4.0

Birla Institute of Technology and Science   2011 — 2012
Master of pharmacy, Pharmaceutical Sciences, 3.84

Dr. D. Y. Patil college of pharmacy   2006 — 2010
Bachelor of Pharmacy (B.Pharm.), Pharmacy, 3.94

Scott Mickey Scott Mickey Brookline, Massachusetts Details
Scott Mickey's FDA Experience June 2009 - August 2009
Job Digital Marketing Strategist at Unitrends
Industry Marketing and Advertising
Experience
Unitrends  August 2013 - Present
Bates College  August 2012 - May 2013
Ekotrope  July 2012 - August 2012
Bates College  August 2011 - December 2011
Steptoe & Johnson LLP  June 2011 - August 2011
Under Armor Outlet   June 2010 - August 2010
FDA   June 2009 - August 2009

Skills
Facebook, Social Media, Blogging, Editing, Marketing, Photoshop, Research, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Wordpress, Marketing Communications, Social Media Marketing, Advertising, Public Relations, Marketing Strategy, Business Strategy, Strategic Planning, Start-ups, Fundraising, Public Speaking, Business Development, Creative Writing, Press Releases, Sales, Copywriting, Data Analysis, Event Planning, Entrepreneurship, Social Networking, Newsletters, Salesforce.com, Email Marketing, Eloqua, CRM

Education
Bates College   2009 — 2013
Bachelor of Arts (BA) with Honors, Rhetoric

Gould Academy   2005 — 2009

Alvin Crosby MBA, RS Alvin Crosby MBA, RS Washington D.C. Metro Area Details
Alvin Crosby MBA, RS's FDA Experience September 2012 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA   September 2012 - Present
Center for Disease Control And Prevention  October 2010 - September 2012
Centers for Disease Control and Prevention  April 2010 - October 2010
Centers for Disease Control & Prevention  October 2009 - April 2010
Texas Department of State Health Services/HHS Region 2-3, Food and Drug Licensing Division   January 2009 - September 2009
City of Arlington  September 2001 - January 2009
City of Fort Worth  November 1999 - August 2001
Tarrant County Public Health Department  July 1995 - October 1999

Skills
Management, Program Evaluation, Project Management, Public Health, Policy, Training, Research, Program Management, Leadership, Grants, Emergency Management, Nonprofits, Prevention, Outbreak Investigations, Meeting Facilitation, Collaboration, Foodborne Illness, Problem Solving, Program Development, Workshop Facilitation

Education
The George Washington University   2013 — 2015
Master of Public Health (MPH), Global Health

University of Phoenix   2006 — 2008
MBA, Management

Baylor University   1987 — 1992
BA, Psychology

Jafar Sadik Bhasha Shaik Jafar Sadik Bhasha Shaik King Of Prussia, Pennsylvania Details
Jafar Sadik Bhasha Shaik's FDA Experience November 2013 - June 2014
Job UF GSK Postdoctoral Associate
Industry Pharmaceuticals
Experience
GSK  July 2014 - Present
FDA   November 2013 - June 2014
University of Pittsburgh  August 2007 - October 2013
Dr. Reddy's Laboratories Ltd, INDIA   2004 - 2007
AstraZeneca  January 2004 - May 2004
Central Drug Research Institute, Lucknow  January 2002 - May 2002

Skills
Pharmacokinetics, Drug Metabolism, Bioanalysis, Regulatory Affairs, DMPK, LC-MS, Validation, FDA, Pharmacometrics, Assay Development, Clinical Research, Clinical Trials, Chromatography, Mass Spectrometry, Animal Models, PK/PD, Pharmaceutics, Bioanalytical method..., Drug Development, PBPK Modeling, Clinical Pharmacology, PoP-PK

Education
University of Pittsburgh   2007 — 2013
Doctoral, Pharmaceutical Sciences, 3.91/4.0

Birla Institute of Technology and Science   2002 — 2004
M.Pharmacy, Pharmaceutics

Birla Institute of Technology and Science   1998 — 2002
B.Pharmacy, Pharmacy (Hons.)

S B Barone S B Barone San Francisco Bay Area Details
S B Barone's FDA Experience October 2009 - June 2014
Job Chief Medical Officer at Avalanche Biotechnologies, Inc.
Industry Biotechnology
Experience
Avalanche Biotechnologies, Inc.   June 2014 - Present
Retina Associates  October 2010 - July 2014
FDA   October 2009 - June 2014
USAF  2000 - 2004
Johns Hopkins School of Medicine  January 2002 - December 2003

Skills
Clinical Development, FDA, Cell, Treatment, Research, Science, Regulatory Affairs, Health, Board Certified, Ophthalmology, Tissue, IND, 21 CFR, Drug Development, Clinical Trials, Gene Therapy, Biologics, Biomedical Engineering, Cancer, Pharmacology, Drug Discovery, Epidemiology, Regulatory Submissions, Commercialization, Cardiology, GCP, Vaccines

Education
University of California, San Diego - School of Medicine   2007 — 2009
Vitreoretina Fellowship

The New York Eye & Ear Infirmary   2004 — 2007
Ophthalmology Residency

Pennsylvania State University College of Medicine   1995 — 1999
MD

Boston College   1991 — 1995
BS, Biology, General

Cathedral Prep

Cathedral Prep

Emily Shumsky Emily Shumsky Washington D.C. Metro Area Details
Emily Shumsky's FDA Experience February 2014 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA   February 2014 - Present
City of Cambridge/Consumer's Council   May 2012 - May 2013
Massachusetts Civil Service Commission   June 2011 - August 2011
Spring Partners   September 2009 - August 2010
Boston University  October 2006 - May 2010
LittmanKrooks LLP   May 2009 - August 2009
Brooklyn District Attorney  June 2007 - July 2007

Skills
Social Media, Research, Event Management, Mediation, Analysis, Courts, Interviews, Facebook, Event Planning, Hearings, Nonprofits, Community Outreach, WordPress, Microsoft Office, PowerPoint, Social Media Marketing

Education
New England Law Boston, formerly New England School of Law   2011 — 2013
Juris Doctor

Boston University   2006 — 2010
BA, BS, Public Relations, Sociology

Christopher Fanelli Christopher Fanelli Washington D.C. Metro Area Details
Christopher Fanelli's FDA Experience September 2011 - December 2014
Job Associate, FDA/Pharmaceutical and Biotechnology Practice Group at Hogan Lovells
Industry Law Practice
Experience
Hogan Lovells  January 2015 - Present
FDA   September 2011 - December 2014
Wells College  August 2006 - August 2008

Education
Boston University School of Law   2008 — 2011
JD

Juniata College   2002 — 2006
BA, Philosophy, Politics, and Economics

Kerri Snyder Kerri Snyder Washington D.C. Metro Area Details
Kerri Snyder's FDA Experience August 2013 - Present
Job Supervisory Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA   August 2013 - Present
FDA   January 2010 - July 2013

Skills
Epidemiology, Environmental Health, Microbiology, Compliance, Pharmaceutical Industry, Clinical Trials, FDA, Policy, Program Management, Public Health, Life Sciences, Healthcare, Strategic Planning

Education
Boston University   2001 — 2006
Masters of Public Health, Epidemiology and statistics

University of Maryland School of Pharmacy
Doctor of Pharmacy (Pharm.D.)

Christy Angell Nelson Christy Angell Nelson Washington D.C. Metro Area Details
Christy Angell Nelson's FDA Experience September 2010 - Present
Job Training Specialist at FDA
Industry Motion Pictures and Film
Experience
FDA   September 2010 - Present
Freelance  January 2009 - Present
Entity FX  March 2010 - August 2010
Trifecta Multimedia  July 2009 - August 2009
Secret Headquarters, Inc.   January 2009 - May 2009
Quake   January 2008 - April 2009
FDA   June 2008 - August 2008
Playback, Inc.   October 2007 - December 2007

Skills
After Effects, Final Cut Pro, Avid, Video Production, Video, Post Production, Film, Television, Film Production, Editing, Premiere, Digital Media, Mac, Illustrator, New Media

Education
University of Wisconsin-Stout   2011 — 2012
Graduate Certificate, Instructional Design

Boston University   2005 — 2009
B.S. & B.A., Film and Television, & Linguistics

Steve Hayleck Steve Hayleck Hampstead, North Carolina Details
Steve Hayleck's FDA Experience 1996 - 1999
Job Retired
Industry Government Administration
Experience
GBX Consultants, Inc.   January 2014 - Present
Topsail High School  October 2013 - Present
Self  August 2013 - Present
NOAA  September 2009 - June 2013
Architect of the Capitol  2003 - 2009
U.S. Government Printing Office   1999 - 2003
FDA   1996 - 1999
Internal Revenue Service  1994 - 1996
Department of Veterans Affairs  1992 - 1994
US Navy  1987 - 1992

Skills
Instructional Design, Training Management, Needs Analysis, Human Performance, Public Speaking, Organizational..., Leadership Development, Policy, Change Management, Performance Management, Coaching, Teaching, Strategic Planning, Customer Service, Team Leadership, Government, Training, Adult Education, Coastal Survey, Management Consulting

Education
University of Maryland College Park   1978 — 1983
BS, Kinesiological Sciences

Bowie State University   1987 — 1989
M.Ed., Education

University of Maryland University College   1975 — 1977

Deidre Cotton Deidre Cotton Montgomery Village, Maryland Details
Deidre Cotton's FDA Experience June 2011 - April 2015
Job Legal Secretary at U.S. Department of Justice
Industry Government Administration
Experience
U.S. Department of Justice   April 2015 - Present
FDA   June 2011 - April 2015
Internal Revenue Service  December 2010 - February 2011
National Institutes of Health  November 2008 - January 2010
Toyota Financial Services  October 2006 - October 2008
Verizon Wireless  April 2005 - August 2006
Comcast  December 2003 - April 2005

Skills
Program Management, Policy, Administrative..., Training, Time Management, Customer Service, Microsoft Office, Management, Research, Government, Microsoft Word, Event Planning, Leadership, Microsoft Excel, Nonprofits, Community Outreach, PowerPoint, Program Development

Education
Benedict College
Business Administration

Paint Branch High School

Michelle Carey Michelle Carey Washington D.C. Metro Area Details
Michelle Carey's FDA Experience September 2015 - Present
Job Medical Officer at FDA
Industry Government Administration
Experience
FDA   September 2015 - Present
Albert Einstein College of Medicine  July 2014 - July 2015
Albert Einstein College of Medicine  July 2011 - June 2014
Mount Sinai Health System  July 2008 - June 2011

Skills
Internal Medicine, Endocrinology, Diabetes, Hypoglycemia, Teaching, Medical Education

Education
Boston University School of Medicine   2004 — 2008
Doctor of Medicine (M.D.)

Boston University School of Public Health   2002 — 2004
Master of Public Health (M.P.H.)

University of Pennsylvania   1996 — 2000
Bachelor of Arts (B.A.), English Language and Literature/Letters

Stuyvesant High School   1992 — 1996

Adebola Ajao Adebola Ajao Washington D.C. Metro Area Details
Adebola Ajao's FDA Experience December 2014 - Present
Job Health Science Policy Analyst at FDA
Industry Hospital & Health Care
Experience
FDA   December 2014 - Present
US Department of Health and Human Services  July 2012 - November 2014
Tennessee Department of Health  August 2011 - July 2012
University of Maryland, Baltimore  November 2004 - August 2007

Skills
Clinical Research, Biostatistics, Monitoring and..., Project Management, Clinical Study Design, SAS programming, Pandemic Influenza..., Infectious Disease..., Healthcare Associated..., Policy Analysis, Public Health, Prevention, Epidemiology, Infectious Diseases, Data Analysis, Policy, Healthcare, Program Evaluation, Research, Analysis, Management, Program Management

Education
Univeristy of Maryland, Baltimore   2006 — 2011
Research Doctorate, Epidemiology

Boston University   2000 — 2001
Masters of Public Health, Epidemiology and Biostatistics

Monisha (Chakravarthy) Bhatia Monisha (Chakravarthy) Bhatia Nashville, Tennessee Details
Monisha (Chakravarthy) Bhatia's FDA Experience June 2013 - August 2013
Job Student at Vanderbilt University School of Medicine
Industry Medical Practice
Experience
FDA   June 2013 - August 2013
Boston Children's Hospital  2013 - 2013
United Technologies  June 2012 - August 2012
Mayer Brown  May 2012 - June 2012
Fulbright Scholarship  September 2010 - May 2011

Skills
Legal Research, Legal Writing, Litigation, Westlaw, Research, Legal Assistance, Public Speaking, Employment Law, Editing, Community Outreach, Non-profits, PowerPoint, Data Analysis, Public Policy, Corporate Law, Policy Analysis

Education
Vanderbilt University School of Medicine   2014 — 2018
Doctor of Medicine (M.D.)

Boston University School of Public Health   2012 — 2014
Master of Public Health (M.P.H.), Health Law, Bioethics, and Human Rights

Boston University School of Law   2011 — 2014
Doctor of Law (J.D.), Health Law

University of Pennsylvania   2006 — 2010
Bachelor of Arts (B.A.), Biological Basis of Behavior

Alex Aferiat Alex Aferiat Greater Boston Area Details
Alex Aferiat's FDA Experience May 2007 - January 2011
Job Commercial Contract Manager at BT Americas; Licensed MA Attorney
Industry Law Practice
Experience
BT Americas  October 2013 - Present
U.S. District Court: District of Massachusetts   May 2012 - July 2012
Massachusetts office of Consumer Affairs and Business Regulation  June 2011 - December 2011
FDA   May 2007 - January 2011
General Electric - GE Capital EMEA (United Kingdom)   January 2009 - April 2009

Skills
Legal Writing, Legal Research, Westlaw, Litigation, Civil Litigation, Lexis, Editing, Intellectual Property, Legal Issues, LexisNexis, Corporate Governance, Administrative Law, Corporate Law, Commercial Litigation, Employment Law, Contract Negotiation, Supplier Negotiation

Education
New England Law Boston   2010 — 2013
Juris Doctor, magna cum laude

Boston University - School of Management   2006 — 2010
B.S. Business Administration, magna cum laude, Business Law and Marketing

David Elder David Elder Gaithersburg, Maryland Details
David Elder's FDA Experience 2009 - 2012
Job VPTechnical at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL  January 2012 - Present
FDA   2009 - 2012
FDA   2003 - 2009
FDA   1988 - 2003

Skills
FDA, Medical Devices, Training, Regulatory Affairs, Regulatory Requirements, Validation, GMP, CAPA, Inspection, Pharmaceutical Industry, Regulatory Submissions, Sop

Education
Boston University   1984 — 1988
BS, Electrical and Electronics Engineering

FDA Sterilization School

FDA Sterilization School

George Miesegaes George Miesegaes Washington D.C. Metro Area Details
George Miesegaes's FDA Experience November 2014 - Present
Job CMC/ Product Quality Lead at FDA
Industry Pharmaceuticals
Experience
FDA   November 2014 - Present
FDA   January 2013 - November 2014
Food and Drug Administration  July 2009 - December 2012
FDA   July 2008 - June 2009
Rutgers University  October 1998 - July 2001
Center for Advanced Biotechnology and Medicine, University of Medicine and Dentistry of New Jersey   May 1998 - September 1998
Department of Psichiatry, University of Medicine and Dentistry of New Jersey   May 1997 - December 1997

Skills
Molecular Biology, Cell Culture, Chromatography, Purification, Chemistry, Regulatory Submissions, Biotechnology, Technical Presentations, Technical Writing

Education
Baylor College of Medicine   2001 — 2008
Ph.D., Cell and Molecular Biology

Rutgers University   1995 — 1998
B.A., Biology and Psychology (with honors)

Brookdale Community College   1993 — 1995
A.A.S., Psychology (with honors)

carol scheman carol scheman Greater Boston Area Details
carol scheman's FDA Experience 1991 - 1994
Job Independent NonProfit Organization Management Professional
Industry Nonprofit Organization Management
Experience
independent  Vice PresidentUniformed Services University of the Health Sciences2006 - 2008
University of Pennsylvania  1994 - 2005
FDA   1991 - 1994
Association of American Universities  1978 - 1991

Skills
Public Affairs, Grant Writing, Public Relations, Non-profits, Government, Higher Education, Public Policy, Program Management, Community Outreach, Public Speaking, Nonprofits, Program Development, Program Evaluation, Fundraising, Policy Analysis, Policy, Strategic Communications, Strategic Planning

Education
Boston University
BA

CWRU
MSSA

high school
HHS

Prasannan Krishnasharma Prasannan Krishnasharma Washington D.C. Metro Area Details
Prasannan Krishnasharma's FDA Experience July 2011 - Present
Job Senior Technical Manager at Centers for Medicare & Medicaid Services
Industry Information Technology and Services
Experience
Centers for Medicare & Medicaid Services  June 2014 - Present
FDA   July 2011 - Present
Federal Reserve Board of Governors  February 2010 - October 2011
WellPoint  October 2008 - January 2010
Lehman Brothers  June 2008 - September 2008
Chesapeake Energy  September 2007 - May 2008
Insurance House  June 2007 - August 2007
Sodexho  September 2006 - May 2007
Comerica  September 2005 - August 2006
Marketwell   May 2004 - August 2005

Skills
PL/SQL, Informatica, Requirements Analysis, Data Integration, Data Modeling, SDLC, Team Leadership, Software Project..., Analysis, ETL, Data Warehousing, Business Intelligence, Enterprise Architecture, Business Analysis, Requirements Gathering, Data Warehouse..., Oracle, Databases, Business Objects, Solution Architecture, SOA, Database Design, SQL, Integration, Agile Methodologies, Unix Shell Scripting, Microsoft SQL Server, IT Strategy, Visio, Unix, SharePoint, PMP, Systems Analysis, Web Services, OLAP

Education
Binghamton University   2002 — 2004
MS, Industrial Engineering

University of Madras   1995 — 1999
BS, Electronics and Communication Engineering

Balalok Matrick

Hsisuai Lee Hsisuai Lee Boston, Massachusetts Details
Hsisuai Lee's FDA Experience June 2014 - Present
Job MPH Candidate; Global Regulatory Affairs CMC Intern at Shire
Industry Pharmaceuticals
Experience
FDA   June 2014 - Present
Food Service Solutions   July 2011 - Present
Shire  May 2015 - August 2015
University of Massachusetts Amherst  October 2012 - May 2014
Pfizer  June 2012 - August 2012
Kimball Farms  April 2008 - August 2012

Skills
Teamwork, Public Speaking, Time Management, Microsoft Office, Research, Customer Service, Public Health, Regulatory Affairs, Clinical Trials, Teaching, Serve Safe Certified, Food Allergies, OSHA 10, Food Safety, Food Service Sanitation, Healthcare Improvement, Leadership, Event Organization, Technical Writing

Education
Boston University   2014 — 2016
Master of Public Health (MPH), Health Policy & Managment, Pharmaceutical Certificate, GPA 3.92

University of Massachusetts, Amherst   2010 — 2014
Bachelor of Science (BS), Biology, Cum Laude

Leena Chehab Leena Chehab Washington D.C. Metro Area Details
Leena Chehab's FDA Experience August 2011 - Present
Job Graduate Research Fellow at FDA
Industry Research
Experience
FDA   August 2011 - Present
University of Maryland  August 2009 - May 2010
University of Maryland  July 2007 - May 2010

Skills
Western Blotting, Flow Cytometry, Bacterial Cell Culture, Statistics, Microscopy, Data Analysis, Animal Models, Biochemistry, Fluorescence Microscopy, RT-PCR, Protein Chemistry, Cell Biology, Laboratory, PCR, Molecular Cloning, Gel Electrophoresis, Confocal Microscopy, Microbiology, Neuroscience, Public Health, Molecular Biology, Science, Cell Culture, Scientific Writing, Lifesciences, Research, Protein Purification, Epidemiology, R, Biostatistics, Teaching, Biology

Education
Virginia Commonwealth University School of Medicine   2012 — 2016
MD Candidate, Medicine

Boston University School of Medicine   2010 — 2012
Master of Arts (M.A.), Medical Sciences

University of Maryland College Park   2006 — 2010
Bachelor of Science (B.S.), Biology, Public and Community Health

Michael D. Robinson, MPH, MBA, JD, LLM Michael D. Robinson, MPH, MBA, JD, LLM Chicago, Illinois Details
Michael D. Robinson, MPH, MBA, JD, LLM's FDA Experience August 2013 - Present
Job Attorney at Law and Deputy Director, Investigations Branch at FDA Chicago District Office
Industry Government Administration
Experience
FDA   August 2013 - Present
Self-Employed  May 2015 - Present
FDA   January 2009 - August 2013

Skills
Health Law, Public Health Law, Business Administration, Health Sciences, Trial Advocacy, Dispute Resolution, Negotiation, Leadership, Management, Project Management, Strategic Planning, Microsoft Office, Customer Service, Public Speaking, Team Building, Government, Policy, Policy Analysis, Public Policy, Research, Public Health

Education
Loyola University Chicago School of Law   2015 — 2017
Master of Laws (LL.M.), Health Law and LL.M. Certificate in Compliance

The John Marshall Law School   2010 — 2014
Master of Laws (LL.M.), Trial Advocacy and Dispute Resolution, with honors

The John Marshall Law School   2010 — 2014
Juris Doctor, and J.D. Certificate in Health Law

Benedictine University   2008 — 2010
Master of Public Health (M.P.H.), Healthcare Administration

Benedictine University   2008 — 2010
Master of Business Administration (M.B.A.), Healthcare Administration

Benedictine University   2003 — 2008
Bachelor of Science (B.S.), Health Sciences

Frank A. Robey Frank A. Robey Gaithersburg, Maryland Details
Frank A. Robey's FDA Experience 1978 - 1987
Job CSO of KeraTein, LLC
Industry Biotechnology
Experience
KeraTein, LLC   July 2013 - Present
AriaVax, Inc.   April 2002 - July 2014
National Institutes of Health  April 1987 - April 2002
FDA   1978 - 1987

Skills
Biotech regulatory..., Extensive background in..., Conjugation chemistry..., Biotechnology, Vaccines, R&D, Chemistry, FDA, Monoclonal Antibodies, Life Sciences, GMP, Biopharmaceuticals, Technology Transfer, Biochemistry, Lifesciences, Protein Chemistry, Assay Development

Education
Boston College
BS, Chemistry

Gonzaga

HR

The Catholic University of America
PhD, Physical Chemistry

April Pradier April Pradier Washington, District Of Columbia Details
April Pradier's FDA Experience March 2012 - Present
Job Sr. Project Manager/Business Analyst at Food and Drug Administration (FDA)
Industry Biotechnology
Experience
FDA   March 2012 - Present
Viridian Energy  2014 - Present
PharmAthene  August 2009 - February 2012
Eurofins Medinet, Inc., Chantilly, VA   April 2008 - July 2009
Walter Reed Army Institute of Research  August 2001 - January 2007

Skills
Project Management, Procurement Management, SharePoint..., SharePoint, FDA, Clinical Trials, Analysis, Clinical Research, Regulatory Affairs, Procurement, Strategy, Clinical Development, Sop, R&D, Cross-functional Team..., Management, Pharmaceutical Industry, Change Control, Validation, Vaccines, Biotechnology, IND, Project Planning, Strategic Planning, Lifesciences, Leadership, GMP

Education
Bowie State University   1997 — 2001
Bachelor of Science, Biology

Webster University
Master of Business Administration (MBA)

Michelle Irwin Michelle Irwin Washington, District Of Columbia Details
Michelle Irwin's FDA Experience September 2013 - December 2013
Job J.D. Candidate at The George Washington University Law School
Industry
Experience
Frommer Lawrence & Haug LLP  June 2014 - July 2014
U.S. Department of Labor   January 2014 - April 2014
FDA   September 2013 - December 2013
U.S Senate Committee on Health, Education, Labor & Pensions   May 2013 - August 2013

Education
The George Washington University Law School   2012 — 2015
Juris Doctor (J.D.)

Boston College   2008 — 2012
Bachelor of Science (B.S.), Biochemistry

Masooma Razvi Masooma Razvi Greater Chicago Area Details
Masooma Razvi's FDA Experience 2014 - 2014
Job Regulatory Affairs Fellow at University of North Carolina at Chapel Hill GlaxoSmithKline
Industry Pharmaceuticals
Experience
University of North Carolina at Chapel Hill & GlaxoSmithKline   July 2015 - Present
Wheaton Franciscan - St. Joseph Campus   June 2014 - June 2015
Mark Drugs   August 2010 - May 2014
FDA   2014 - 2014
Abbott Laboratories  May 2012 - August 2012

Skills
Patient Counseling, Cell Culture, Pharmacists, Western Blotting, Confocal Microscopy, Pharmacology, Compounding, Molecular Biology, Cell Biology, Pharmacokinetics, PCR, ELISA, Biochemistry, FDA, qPCR, Clinical Research, Clinical Pharmacology, Clinical Trials, Molecular Cloning, Protein Purification, Flow Cytometry, Protein Expression, Pharmacy, Immunoprecipitation, Diabetes, Physiology, HPLC, RNA isolation, Immunohistochemistry, Transfection, RT-PCR, Mass Spectrometry, Fluorescence Microscopy, Pharmaceutical Industry, Pharmacy Automation, Cell, Drug Discovery, Medication Therapy...

Education
University of Illinois at Chicago   2010 — 2014
Doctor of Pharmacy, Pharmacy

University of Illinois at Chicago   2006 — 2014
Master's degree, Pharmacology

Benedictine University   2000 — 2004
Bachelor of Science (B.S.), Molecular Biology

Dow-Chung Chi Dow-Chung Chi Washington D.C. Metro Area Details
Dow-Chung Chi's FDA Experience August 2014 - Present
Job Medical Officer, FDA
Industry Government Administration
Experience
FDA   August 2014 - Present
Columbia University Medical Center  July 2011 - June 2014
National Cancer Institute (NCI)   April 2013 - May 2013
Boston Medical Center  June 2008 - June 2011
Massachusetts Medical Society  May 2005 - March 2009
Asterand  December 2001 - July 2002
Oxford Bioscience Partners  July 2000 - July 2002
Goldman Sachs  June 1998 - June 2000

Skills
Medical Education, Clinical Research, Internal Medicine, Medical Research, Epidemiology, Medicine, Public Health, Oncology Clinical..., Genomics, Systems Biology, Computational Biology, Bioinformatics, Corporate Finance, Venture Capital, Business Development, Cancer, Board Certified, Clinical Trials, Emergency Medicine, Oncology, Healthcare Information..., Clinical Development, Hematology, Global Health, Infectious Diseases, Molecular Biology, Biochemistry, Immunology, Quality Improvement, Diabetes, Healthcare, Hospitals, Neuroscience, Biotechnology, Drug Discovery, Lifesciences, Healthcare Management, Informatics

Education
Boston University School of Medicine   2004 — 2008
Doctor of Medicine (M.D.)

Massachusetts Institute of Technology   1994 — 1998
Bachelor of Science (B.S.), Biology, General

Carolina M. Wirth Carolina M. Wirth Washington D.C. Metro Area Details
Carolina M. Wirth's FDA Experience July 2012 - September 2014
Job FDA Regulatory Counsel at Kilpatrick Townsend & Stockton LLP
Industry Law Practice
Experience
Kilpatrick Townsend & Stockton LLP  June 2015 - Present
ReCellerate Inc.   September 2014 - May 2015
The Nobert Group LLC   September 2014 - May 2015
FDA   July 2012 - September 2014
K&L Gates, LLP   May 2007 - June 2012
Federal Railroad Administraton (FRA)   September 2003 - May 2007
US Department of Transportation (DOT)   September 2002 - September 2003

Skills
Medical Devices, Administrative Law, Clinical Research, Litigation, Legal Research, Intellectual Property, Civil Litigation

Education
Boston University School of Law   1999 — 2002
Doctor of Law (J.D.)

City University of New York-John Jay College of Criminal Justice   1995 — 1999
Bachelors of Science, Criminal Justice

Bilal Tariq Bilal Tariq Washington D.C. Metro Area Details
Bilal Tariq's FDA Experience July 2015 - August 2015
Job Pharmacy Student Intern
Industry Pharmaceuticals
Experience
University of Maryland School of Pharmacy  August 2015 - Present
University of Maryland Baltimore Washington Medical Center  August 2015 - Present
Kmart Corporation  July 2013 - Present
FDA   July 2015 - August 2015
PharMerica  December 2014 - January 2015
Costco Wholesale  July 2014 - August 2014
University of Maryland School of Pharmacy  May 2014 - August 2014
Dimensions Healthcare System  March 2013 - March 2013
Giant Food  October 2012 - October 2012

Skills
Pharmacy, Healthcare, Microsoft Office, Data Entry, Community Outreach, Teamwork, Cpr Certified, Diabetes, Leadership, Medication Therapy..., PowerPoint, Microsoft Excel, Pharmacueticals, Clinical Research, Pharmaceutical Industry

Education
University of Maryland School of Pharmacy   2015 — 2017
Master of Science (M.S.), Pharmacometrics

University of Maryland School of Pharmacy   2012 — 2016
Doctor of Pharmacy (PharmD)

University of Maryland College Park   2009 — 2012
Bachelor of Science (B.S.)

Belmont University   2007 — 2009

Wade Woolfolk, M.A. Wade Woolfolk, M.A. Washington D.C. Metro Area Details
Wade Woolfolk, M.A.'s FDA Experience December 2014 - Present
Job Program Analyst International Affairs at U.S. Food and Drug Administration
Industry Government Relations
Experience
FDA   December 2014 - Present

Education
Cornell University - Johnson Graduate School of Management   2012 — 2013
Master Certificate, Business Strategy

Bowie State University
MA, Organizational Communications

Bowie State University
BS, Business Administration - Marketing

Darlene Dudley Darlene Dudley Washington D.C. Metro Area Details
Darlene Dudley's FDA Experience July 2012 - August 2012
Job Examiner, Vocalist, Mentor
Industry Consumer Services
Experience
SEC  July 2012 - Present
Luke C Moore Academy Inc   August 2012 - May 2013
FDA   July 2012 - August 2012
Bowie State University  September 2009 - June 2012

Skills
Customer Service, Team Building, PowerPoint, Microsoft Office, Community Outreach, Leadership, Event Planning, Research, Microsoft Excel, Data Entry, Teamwork, Management, Teaching, Nonprofits, Strategic Planning, Time Management, Communication, Social Networking, Microsoft Word, Marketing, Event Management, Outlook, Training, Sales, Analysis, Coaching, Fundraising, Program Management, Policy, Leadership Development, Marketing Strategy, Data Analysis, Staff Development, Facebook, Social Media, Volunteer Management, Program Development, Marketing Communications, Public Speaking

Education
University of New England   2014 — 2016
Working towards Master's degree, Social Work

Bowie State University   2009 — 2013
Bachelor's degree, Social Work

Colleen (Stewart) Gill Colleen (Stewart) Gill Washington D.C. Metro Area Details
Colleen (Stewart) Gill's FDA Experience June 2007 - August 2007
Job Senior Associate at PwC
Industry Management Consulting
Experience
PwC Public Sector   August 2012 - Present
USAA  May 2011 - August 2011
Bazaarvoice  January 2010 - July 2010
Strathmore Music and Arts Center   September 2009 - December 2009
Center for Communications Management Information (CCMI)   August 2008 - June 2009
IQ Solutions  January 2008 - February 2008
FDA   June 2007 - August 2007

Skills
Social Media, Public Relations, Editing, Marketing, Facebook, Nonprofits, Press Releases, Newsletters, Leadership, Technical Writing, Human Resources, Social Media Marketing, Event Planning, Management Consulting, Journalism, Copy Editing, Project Management, Scheduling Management, Cost Model Development, Public Sector Marketing, Proposal Writing, Management

Education
Baylor University - Hankamer School of Business   2010 — 2012
MBA, Organizational Behavior, GPA: 3.9

University of Delaware   2005 — 2008
Honors BA, English: Business and Technical Writing / Vocal Music, GPA: 3.6

Richard Montgomery HS   2001 — 2005

Orlando Lopez, PhD, GWCPM Orlando Lopez, PhD, GWCPM Silver Spring, Maryland Details
Orlando Lopez, PhD, GWCPM's FDA Experience April 2015 - Present
Job Biomedical Engineer / Medical Device Professional
Industry Medical Devices
Experience
FDA   April 2015 - Present
FDA   October 2011 - Present
Toyzlove Colombia   May 2008 - Present
Division of Radiological Devices   April 2011 - October 2011
Cardiovascular and Interventional Therapeutics   October 2009 - October 2011
National Institutes of Health  March 2007 - September 2009
Mayo Clinic  1999 - 2007

Skills
Leadership, Biomedical Engineering, Medical Devices, FDA, Medical Imaging, Clinical Research, R&D, Image Processing, Lifesciences, Clinical Trials, Life Sciences, Research, Clinical Development, Data Analysis, Program Management, MRI, Strategic Planning, Regulatory Affairs, Project Management, Technology Transfer, Cross-functional Team..., Computational Modeling, Risk Analysis, Telemedicine, Innovation Development, Management

Education
The George Washington University   2010 — 2011
GWCPM, Master’s Certificate in Project Management with a Concentration in IT

Mayo School of Health Sciences   2000 — 2007
PhD, Biomedical Engineering - Medical Imaging & Biomechanics

Boston University
B.S., Biomedical Engineering

Kyle McCracken Kyle McCracken Greater Minneapolis-St. Paul Area Details
Kyle McCracken's FDA Experience September 2010 - Present
Job Consumer Safety Officer at FDA
Industry Medical Devices
Experience
FDA   September 2010 - Present
Bethel University  September 2006 - May 2010
Johnston Community School   June 2007 - September 2008

Skills
Customer Service, Leadership, Sales, Social Media, Public Speaking, Team Building, Microsoft Office, Microsoft Excel

Education
Bethel University   2006 — 2010
Bachelor of Science (B.S.), Biology, General

Bethel University   2006 — 2010
Bachelor's of Science, Biology, General

Alan Lee Myers, MA, PCC {LION} Alan Lee Myers, MA, PCC {LION} Washington D.C. Metro Area Details
Alan Lee Myers, MA, PCC {LION}'s FDA Experience April 2008 - October 2008
Job Executive & Leadership Coach Strategist and Thought Leader unleashing the greatness of each person & organization.
Industry Management Consulting
Experience
Department of Health and Human Services, Office of Human Resources, Talent and Organization Develop.   November 2014 - Present
ALM Group, Inc., doing business as Change by Design Coaching   September 2003 - Present
US Department of Health and Human Services  August 2013 - October 2014
US Department of Health and Human Services--Office of Human Resources   October 2008 - September 2013
FDA   April 2008 - October 2008
Centers for Medicare & Medicaid Services  1999 - 2008
Auction Brokers   2004 - 2007
Indian Health Service  December 1993 - October 1999
U.S. Office of Personnel Management   October 1992 - December 1993
Federal Communications Commission  February 1991 - October 1992

Skills
Executive Coaching, Leadership Development, Instructional Design, Organizational..., Coaching, Program Management, Training, Workshop Facilitation, Management Consulting, Team Building, Leadership, Succession Planning, Conflict Resolution, Career Counseling, Process Improvement, Policy, Organizational..., Management, Change Management, Government, Performance Management, Strategic Planning, Project Management, Personnel Management, Project Planning, Human Resources, Staff Development, Consulting, Recruiting, Fundraising, Performance Improvement, Career Development, Business Strategy, Strategic Communications, MBTI, Management Development, Organizational Design, Public Policy, Executive Development, Executive Management, Emotional Intelligence, Program Development, Employee Training, Strategy, Nonprofits, Budgets, Personal Development, E-Learning, Program Evaluation, Organizational...

Education
Trinity Theological Seminary   2008 — 2016
Doctor of Philosophy (Ph.D.), Leadership and Management

Master Coach University   2012 — 2014
Certificate, Accountability, Strategy, and Assessment Coaching

St. Stephens House of Studies   2010 — 2017
Certificate, Applied Theology in an Eastern Context

Georgetown University   2003 — 2004
Certificate, Leadership Coaching

Georgetown University   1995 — 1996
Certificate, Organization Development

University of Maryland Baltimore County   1991 — 1993
M.A., Instructional Systems Development

Bowie State University   1984 — 1987
M.A., Counseling Psychology

Liberty University   1980 — 1984
B.S., Religion

Laura Ting Laura Ting Washington D.C. Metro Area Details
Laura Ting's FDA Experience June 2009 - August 2009
Job Copywriter at Wunderman
Industry Marketing and Advertising
Experience
Wunderman  August 2015 - Present
Design Army  November 2014 - August 2015
Discovery Communications, Discovery Networks International   July 2012 - October 2014
LivingSocial  February 2012 - October 2014
Sweetgreen  June 2012 - July 2012
Alliance of Artists and Recording Companies  May 2010 - August 2010
FDA   June 2009 - August 2009
FDA   June 2008 - August 2008
Food & Drug Administration (FDA)   June 2007 - August 2007

Skills
Social Media, Editing, Press Releases, Research, Legal Writing, Media Relations, Intellectual Property, Publicity, Legal Research, Public Relations, Facebook, Event Planning, New Media, Commercial Litigation, Microsoft Office, Westlaw, Adobe Creative Suite, InDesign, Photoshop

Education
The Catholic University of America, Columbus School of Law   2008 — 2011
Juris Doctor (J.D.)

Boston College   2004 — 2008
Bachelor's Degree

Holton-Arms   1994 — 2004
High School Diploma

Andrew Rothman, M.S., E.I.T. Andrew Rothman, M.S., E.I.T. Greater Boston Area Details
Andrew Rothman, M.S., E.I.T.'s FDA Experience July 2013 - Present
Job Harvard University Doctoral candidate; Booz Allen University Scholar; FDA ORISE Research Fellow; MCPHS Adjunct Faculty
Industry Research
Experience
Booz Allen Hamilton  September 2015 - Present
Harvard Graduate Volunteer Consulting Group (HGVCG)   September 2015 - Present
FDA   July 2013 - Present
ORAU  July 2013 - Present
MCPHS University  October 2013 - Present
Harvard University  September 2014 - Present
Brigham and Women's Hospital  November 2012 - June 2013
Harvard Medical School  November 2012 - June 2013
Arcadia Healthcare Solutions  June 2012 - August 2012
Brigham and Women's Hospital  December 2009 - June 2012

Skills
Biostatistics, Public Health, Epidemiology, Research, SAS, Stata, Literature Reviews, Medical Research, Health Policy, IRB, Statistics, Data Analysis, Health Services Research, R, Pharmacoepidemiology, Matlab, Healthcare Consulting, Strategic Consulting, Data Science, Large-scale Data..., Supply Chain Management, Outcomes Research, Medical Devices, Medical Device R&D, Pharmaceutical Sciences, Engineering, Biomedical Engineering, Mechanical Engineering, Computational Modeling, Data Mining, Finite Element Analysis, SQL, SolidWorks, Database Design

Education
Harvard University   2013 — 2017
Doctor of Science (Sc.D.) candidate, Epidemiology, Pharmacoepidemiology

Massachusetts Institute of Technology
Cross-Registered Harvard University Student, Engineering

Harvard University   2015 — 2015
Harvard Mini-MBA Program

Harvard University   2011 — 2013
Master of Science (M.S.), Epidemiology, Pharmacoepidemiology

Boston University   2005 — 2009
Bachelor of Science (B.S.), Biomedical Engineering

Tecnológico de Monterrey
Biomedical Engineering

Bhargava Kandala Bhargava Kandala Gainesville, Florida Details
Bhargava Kandala's FDA Experience May 2011 - August 2011
Job Senior Scientist at Merck
Industry Higher Education
Experience
Merck  July 2014 - Present
University of Florida  August 2009 - May 2014
GlaxoSmithKline  May 2013 - August 2013
FDA   May 2011 - August 2011
Central Drug Research Institute, Lucknow  January 2008 - December 2008

Skills
Pharmacokinetics, Pharmacodynamics, Pharmacometrics, Statistical Modeling, Monte Carlo Simulation, Bioequivalence, NONMEM, SAS, R, PHOENIX, WinNonlin, Drug Delivery, Biostatistics, Clinical Study Design, Drug Metabolism, Clinical Pharmacology

Education
University of Florida   2009 — 2013
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences

University of Florida   2009 — 2012
Master of Statistics

Birla Institute of Technology and Science   2007 — 2009
Master of Pharmacy (M.Pharm.)

Dr. Steven Brass Dr. Steven Brass Greater Los Angeles Area Details
Dr. Steven Brass's FDA Experience October 2009 - Present
Job Director of Medical Affairs
Industry Hospital & Health Care
Experience
Providence Health & Services  March 2015 - Present
FDA   October 2009 - Present
UC Davis Medical Center  July 2009 - February 2015
Massachusetts General Hospital, Harvard University   July 2005 - June 2009

Skills
Neurology, Healthcare Management, Medicine, Hospitals, Board Certified, Accounting, Obstructive Sleep Apnea, Public Health, Financial Analysis, Consulting, EMR, Patient Safety, Internal Medicine, Healthcare, Leadership, Medical Education, Management, Quality Improvement, Utilization Management, Health Care..., Healthcare Information...

Education
University of California, Davis   2011 — 2014
MBA, Hospital and Health Care Facilities Administration/Management and Accounting

Boston University School of Medicine   2008 — 2009
Sleep Medicine, Sleep Medicine Fellowship

Harvard University School of Public Health   2005 — 2008
MPH, Clinical Effectiveness

Harvard University   2003 — 2005
Fellowship at Brigham and Women's Hospital, Multiple Sclerosis

McGill University   1998 — 2003
Neurology, Neurology Residency

McGill University   1993 — 1998
MD, Medicine

Lisa Benison Lisa Benison Valley Stream, New York Details
Lisa Benison's FDA Experience May 2012 - August 2012
Job President at Binghamton Bioengineers Club
Industry Biotechnology
Experience
HDEV 105 Practicum/Leadership and Community Service, Binghamton University   August 2011 - December 2013
Hinman College, Binghamton University   August 2011 - December 2013
FDA   May 2012 - August 2012
Binghamton Bioengineers Club, Binghamton University   August 2011 - May 2012

Skills
Mathematica, Research, Matlab, Statistics, R, Python, PowerPoint, Microsoft Office, Microsoft Word, Data Analysis, Microsoft Excel, chart5, ImageJ, Labview, Biomedical Engineering, Prezi, Teamwork, SolidWorks, Rapid Prototyping, Regulatory Affairs, Intellectual Property

Education
University of Rochester   2014 — 2015
Master's degree, Bioengineering and Biomedical Engineering

Binghamton University   2010 — 2014
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering

Valley Stream South High School   2004 — 2010

Hari Krishna Ananthula Hari Krishna Ananthula Cincinnati Area Details
Hari Krishna Ananthula's FDA Experience June 2012 - August 2012
Job Doctoral Candidate at University of Cincinnati
Industry Pharmaceuticals
Experience
University of Cincinnati  September 2010 - Present
FDA   June 2012 - August 2012
Dr. Reddy's Laboratories   January 2006 - August 2007
Dr. Reddy's Laboratories   June 2004 - December 2004

Skills
Pharmacokinetics, WinNonlin, R, Clinical Pharmacology, NONMEM, SimCYP, Drug Metabolism, Pharmaceutics, Pharmacology, HPLC, Quality Assurance

Education
University of Cincinnati   2010 — 2015
PhD, Pharmaceutical Sciences

University of Missouri-Kansas City   2008 — 2010
Pharmaceutical Sciences

Birla Institute of Technology and Science   2001 — 2005
B.Pharm. (Hons.)

Philip Hanno Philip Hanno United States Details
Philip Hanno's FDA Experience July 1998 - July 1999
Job Professor of Urology in Surgery at the Perelman School of Medicine of the University of Pennsylvania
Industry Medical Practice
Experience
University of Pennsylvania  1999 - Present
FDA   July 1998 - July 1999
Temple University Department of Urology   April 1990 - August 1998
University of Pennsylvania  September 1981 - April 1990

Skills
Medicine, Urology, Bladder Pain Syndrome, FDA Advisory Panelist, Clinical Research, Change Management, Public Health, Consulting, Medical Writing

Education
Medical College of Wisconsi
Master of Public Health (M.P.H.)

Baylor College of Medicine
Doctor of Medicine (M.D.)

University of Pennsylvania   1966 — 1970
Bachelor of Arts (BA)

Shalini Anand Shalini Anand Derwood, Maryland Details
Shalini Anand's FDA Experience October 2013 - Present
Job CMC Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA   October 2013 - Present
Novartis  July 2013 - September 2013
Hoffmann-La Roche  May 2009 - July 2013
Hoffmann-La-Roche  October 2006 - May 2009
Birla Institute of Technology and Science, Pilani  August 2003 - September 2006

Skills
Formulation, HPLC, Pharmaceutical Research, Drug Delivery, Pharmacokinetics, Strategy Formulation, Chemistry, In Vitro, Drug Discovery, Pharmaceutical Industry, Pharmacology, Pharmaceutics, GMP, Bioanalysis, Protein Chemistry, Regulatory Submissions, UV/Vis, CMC, Drug Development, Quality by Design, Differential Scanning..., NMR, FTIR, Spectroscopy, Gas Chromatography, Small Molecules, Characterization, TGA, Pharmacodynamics, Clinical Development, DMPK, UV, GLP, Organic Synthesis, Drug Metabolism, Medicinal Chemistry, LC-MS, NDA, Biopharmaceuticals, Molecular Modeling, Drug Design, Chromatography, ADME, Peptides, Dissolution, IND, Assay Development, Validation, Technology Transfer

Education
Birla Institute of Technology and Science, Pilani   2002 — 2006
MS,Phd, Pharmacy

Guru Jambeshwar University   1997 — 2001
Bachelor of Pharmacy (B.Pharm.)

Daniel Woloshen Daniel Woloshen Greater Boston Area Details
Daniel Woloshen's FDA Experience 1974 - 1979
Job Senior Vice President and General Counsel at LFB USA
Industry Biotechnology
Experience
LFB USA  1999 - Present
Philips  1989 - 1999
Baxter Healthcare  1984 - 1988
Merck  1979 - 1984
FDA   1974 - 1979
United States Air Force  1972 - 1974

Skills
Joint Ventures, Strategic Alliances, Biologics, FDA, Medical Devices, International Law, Employment Law, Pharmaceutical Industry, Licensing, Lifesciences, Corporate Law, Due Diligence, Litigation Management, Commercial Litigation, Legal Affairs, Business Transactions, Commercialization, Business Strategy, Contract Negotiation, Biotechnology, Technology Transfer, Biopharmaceuticals, Corporate Governance, Trade Secrets, Trademarks, Legal Writing, Pharmaceutics, Strategy, Regulatory Affairs, Intellectual Property, Patents, Litigation, Patent Prosecution, Venture Capital, Mergers & Acquisitions, Patent Litigation, Life Sciences

Education
Boston College Law School   1911 — 1914
JD, Law

Colby College   1902 — 1906
BA, Political Science

Pierre Milien Pierre Milien Washington D.C. Metro Area Details
Pierre Milien's FDA Experience December 2009 - Present
Job HelpDesk Supervisor @ FDA, System & Network Administrator in the DMV area
Industry Information Technology and Services
Experience
FDA   December 2009 - Present
RainKing  November 2006 - February 2008
Borough Of Manhattan Community College  August 2005 - November 2006

Skills
Active Directory, Data Analysis, Microsoft Office, Project Management, Software Documentation, HTML, Windows Server, Computer Hardware, SharePoint, Windows 7, Technical Support, Outlook, Microsoft Excel, PowerPoint, Editing, SQL, Windows, Government, Troubleshooting, System Administration, Databases, Team Leadership, Operating Systems, XP, Analysis

Education
Baruch College, City University of New York (CUNY)   2003 — 2006
BA, Operations Management

City University Of New York-Borough Of Manhattan Community College   2000 — 2003
Associate, Accounting

Rebecca Kurtzig Rebecca Kurtzig Washington D.C. Metro Area Details
Rebecca Kurtzig's FDA Experience February 2013 - Present
Job PHA Office of Surveillance and Epidemiology at FDA
Industry Think Tanks
Experience
FDA   February 2013 - Present
U.S. House of Representatives   June 2010 - October 2011
Corporate Executive Board  April 2003 - July 2009

Skills
Vendor Management, Staff Management, Strategic Planning, Business Process..., Business Process..., Data Analysis, Contract Management, Project Management, Training Delivery, Budget Monitoring, Budget Process, Business Development, Program Management, Government, Change Management, Strategy

Education
Boston University   1998 — 2002

Yuda Zong Yuda Zong Silver Spring, Maryland Details
Yuda Zong's FDA Experience May 2014 - Present
Job CMC reviewer
Industry Pharmaceuticals
Experience
FDA   May 2014 - Present
Ashland Inc  April 2008 - April 2014
J&J  May 2007 - December 2007

Skills
UV/Vis

Education
University of Utah   2001 — 2008
Ph.D., Pharmaceutics

Beijing Normal University

Kumara Vadivel Subramanian Kumara Vadivel Subramanian Washington D.C. Metro Area Details
Kumara Vadivel Subramanian's FDA Experience July 2014 - Present
Job CMC Reviewer at FDA
Industry Government Administration
Experience
FDA   July 2014 - Present
Center for Drug Discovery, Northeastern University  January 2010 - June 2014
Center for Drug Discovery, Northeastern University  2003 - 2010
Ecole Normale Superieure  2001 - 2002
Radboud University Nijmegen  1999 - 2001

Skills
HPLC, Drug Discovery, NMR, Organic Synthesis, Chemistry, UV/Vis, LC-MS, Organic Chemistry, Medicinal Chemistry, Chromatography, Mass Spectrometry, Spectroscopy, Purification, NMR spectroscopy, Analytical Chemistry

Education
Indian Institute of Chemical Technology, Hyderabad, India   1994 — 1999
Ph.D, Synthesis of Biologically Active Compounds

Bharathidasan University   1992 — 1994
M.Sc, Chemistry

Kathy Tormey Kathy Tormey Denver, Colorado Details
Kathy Tormey's FDA Experience 2009 - Present
Job Investigator at FDA
Industry Hospital & Health Care
Experience
FDA   2009 - Present
Northwestern University  March 2008 - January 2009
Boston University School of Medicine  March 2006 - March 2008
Lesotho-Boston Health Alliance  May 2007 - August 2007
Rush University Medical Center  2002 - 2005
Rush University Medical Center  2000 - 2002
Northwestern University Medical School  1998 - 2000

Education
Boston University   2005 — 2007
MPH, Social and Behavioral Sciences

University of Colorado Boulder   1994 — 1998
BA, Psychology

Jeannette Odonnell Jeannette Odonnell Washington D.C. Metro Area Details
Jeannette Odonnell's FDA Experience July 2014 - Present
Job Consumer Safety Officer at FDA
Industry Biotechnology
Experience
FDA   July 2014 - Present
U.S. Department of State   January 2013 - August 2013
BioReliance  March 2011 - November 2011
Covance  April 2007 - March 2011
SGS  February 2006 - April 2007

Skills
GLP, Lifesciences, Cell Culture, Sop, GMP, Biotechnology, Assay Development, FDA, Validation, Microbiology, Laboratory, Chemistry, Analytical Chemistry, SOP, Life Sciences, Cell

Education
Boston University   2001 — 2003
2 years graduate school, biomedical engineering

University Central Florida   1996 — 2001
BS., Chemistry and Molecular and Microbiology, 3.4

Chanda Taylor Anderson, CPA Chanda Taylor Anderson, CPA Washington D.C. Metro Area Details
Chanda Taylor Anderson, CPA's FDA Experience
Job Accountant at FDA
Industry Financial Services
Experience
FDA  

Skills
Auditing, Accounting, Financial Reporting, Internal Controls, Financial Analysis, Account Reconciliation, Internal Audit, Financial Accounting, Accounts Payable, Analysis, General Ledger, Accounts Receivable

Education
Bowie State University   1992 — 1997

William Neyer William Neyer Washington D.C. Metro Area Details
William Neyer's FDA Experience September 2011 - Present
Job Technical Information Specialist at Food and Drug Administration
Industry Information Technology and Services
Experience
FDA   September 2011 - Present
FDA   January 2011 - May 2011
FDA   April 2002 - January 2011

Skills
Instructional Design, Social Media, Content Management, Program Management, Strategic Communications, Government, Proposal Writing, Technical Writing, Data Analysis, Public Health, Blogging, Project Management, E-Learning, Knowledge Management, Analysis, Public Policy, Web Design

Education
Bloomsburg University of Pennsylvania   2000 — 2002
MS, Instructional Technology

Bloomsburg University of Pennsylvania   1996 — 2000
BS, Accounting, Management Information Systems

Jim Angel Jim Angel Derwood, Maryland Details
Jim Angel's FDA Experience May 2001 - Present
Job Music Director at Rockville Men's Chorus
Industry Music
Experience
Rockville Men's Chorus   September 2004 - Present
FDA   May 2001 - Present
Alderson Broaddus College  August 1993 - August 1999
John Wesley College  September 1987 - August 1990

Skills
Music Theory, Music, Ensemble, Composition, Conducting, Piano, Choral, Church Music, Chamber Music, Teaching, Singing, Music Education, Orchestral Music, Classical, Public Speaking, Curriculum Development, Higher Education

Education
State University of New York College at Potsdam   1983 — 1984
MM, Composition

Boston University   1979 — 1981
MSM, Sacred Music

Bowling Green State University   1973 — 1977
BA, Music Theory

Venkateswara Rao Simhadri Venkateswara Rao Simhadri Bethesda, Maryland Details
Venkateswara Rao Simhadri's FDA Experience November 2014 - Present
Job Post Doctoral Fellow at FDA
Industry Research
Experience
FDA   November 2014 - Present
FDA   July 2009 - Present
University Hospital of Cologne, Germany   July 2008 - May 2009
University Hospital of Cologne   July 2008 - May 2009

Skills
Molecular Biology, Cell Culture, Biochemistry, Western Blotting, Flow Cytometry, Tissue Culture, qPCR, Cell Biology, ELISA, Molecular Cloning, Immunology, Animal Models

Education
University Hospital of Cologne   2004 — 2008
Doctor of Philosophy (Ph.D.), Immunology, Sehr Gut

Tata Institute of Fundamental Research, Mumbai and India   2002 — 2004
Junior Research Fellow, Cell/Cellular and Molecular Biology

Bharathidasan University   2000 — 2002
Master's degree, Biotechnology, Distinction

Rajiv Institute of Technology and Management Studies, Andhra University, India.   1997 — 2000
Bachelor's of Science, Biotechnology, Biochemistry and Zoology, 1st

Charla Stevens-Tate Charla Stevens-Tate San Francisco Bay Area Details
Charla Stevens-Tate's FDA Experience November 1989 - July 2010
Job CNA
Industry Hospital & Health Care
Experience
Chaparral House  March 2013 - Present
Chaparral House  March 2013 - Present
Food & Drug Administration  December 1991 - July 2010
FDA   November 1989 - July 2010

Skills
Federal Government, Program Management, Research, Proposal Writing, Policy, Policy Analysis, Government, Healthcare, Cpr Certified, BLS, Microsoft Office, Microsoft Word, Microsoft Excel, PowerPoint, Teamwork, Social Media, HTML, Program Evaluation, Community Outreach, Data Analysis, Emergency Management, Public Speaking, Clinical Research, Medicine, Access, Public Health, Supervisory Skills

Education
Contra Costa College   2010 — 2012
Practical Nursing, Vocational Nursing and Nursing Assistants

Berkeley College   1989 — 1993
General Studies

Nancy Ostrove Nancy Ostrove Gaithersburg, Maryland Details
Nancy Ostrove's FDA Experience July 2003 - May 2011
Job Principal at EXPRE
Industry Public Relations and Communications
Experience
Georgetown University Medical Center  November 2013 - Present
EXPRE   January 2012 - Present
FDA   July 2003 - May 2011
Eli Lilly and Company  March 2002 - June 2003
FDA   January 1989 - March 2002
Porter Novelli  1983 - 1985

Skills
Social Science Research, Risk Communications, Public Health, Public Health Policy, Public Policy, Issues Management, Risk Management, Editing, Policy, Public Relations, FDA, Health Policy, Research, Social Sciences, Program Evaluation, Strategic Planning, Qualitative Research, Strategic Communications, Policy Analysis

Education
Uniformed Services University of the Health Sciences   1979 — 1980
Post Doc, Health Psychology

University of Maryland College Park   1972 — 1976
PhD, Social Psychology

SUNY Binghamton   1967 — 1971
BA, Psychology

Sarah Summer Sarah Summer San Francisco Bay Area Details
Sarah Summer's FDA Experience May 2008 - August 2009
Job Deputy Director, Public Policy at Blue Shield of California
Industry Law Practice
Experience
Blue Shield of California  March 2015 - Present
Blue Shield of California  January 2014 - March 2015
Centers for Medicare & Medicaid Services  April 2011 - January 2014
Physicians for Human Rights  October 2010 - 2011
FDA   May 2008 - August 2009
Joslin Diabetes Center  September 2007 - January 2009
World Health Organization  May 2007 - August 2007

Skills
Public Health, Project Management, Policy Analysis, Policy, Strategy, Research, Health Law, Health Care Reform, Public Health Law, Health Policy, Community Outreach, Government, Legal Writing

Education
Boston University   2007 — 2009
MPH, Public Health: Concentration in Health Law, Human RIghts and Bioethics

Boston University School of Law   2005 — 2008
JD, Concentration in Health Law

University of Washington   2001 — 2005
B.S., Cellular, Molecular and Developmental Biology, Minor, Chemistry

Kelly Wilkicki Kelly Wilkicki Washington D.C. Metro Area Details
Kelly Wilkicki's FDA Experience December 2010 - Present
Job Policy Analyst at FDA
Industry Government Administration
Experience
FDA   December 2010 - Present
FDA   July 2008 - December 2010
Library of Congress  November 2009 - June 2010
NCSL   April 2007 - July 2008
Backline  April 2005 - August 2006
XO Communications  November 2003 - January 2005
Boston Medical Center  September 1999 - May 2002

Skills
Medical Devices, Policy, Policy Analysis, Program Management, Public Health, Community Outreach, Grant Writing, Editing, Training, Proposal Writing, Analysis, Government, Public Policy, Healthcare, Legislative Relations, Program Evaluation, Data Analysis, Legislation

Education
The Johns Hopkins University   2006 — 2008
MPP, Health Policy, Health Finance and Management

Boston University   1998 — 2002
BA, Biology, Philosophy

Toll Gate

Daren Tolz Daren Tolz Greater New York City Area Details
Daren Tolz's FDA Experience September 2011 - Present
Job Math / Economics Teacher
Industry Primary/Secondary Education
Experience
FDA   September 2011 - Present
IBM Global Services  2001 - 2009
Gelband & Company   1995 - 2000

Skills
Entrepreneurship, Business Planning, Finance, Mergers, Change Management, Financial Analysis, IT Management, Project Portfolio..., Project Management, Strategic Planning, Sales Management, Management Consulting, Business Process..., Strategy, IT Strategy, Mergers & Acquisitions, Program Management, Sales, Start-ups, PMP, Teaching, Business Analysis, Budgets, Risk Management, Business Intelligence, Leadership, Project Planning, Team Leadership, Business Strategy, Consulting, Data Analysis, Leadership Development, Organizational...

Education
Boston University
MBA, Finance and Management

Drexel University
BS, Computer Science

Fordham University
Master of Education (MEd), Dual Degree, Math and Special Education

Jewell Martin Jewell Martin Washington D.C. Metro Area Details
Jewell Martin's FDA Experience September 2014 - Present
Job Sr. Regulatory Health Project Manager at FDA
Industry Government Administration
Experience
FDA   September 2014 - Present
Food and Drug Administration  February 2012 - September 2014
National Institutes of Health  July 2007 - February 2012
Food and Drug Administration  October 2003 - July 2007

Education
Howard University   2003 — 2006
MBA

Boston University   2002 — 2003
MA, Medical Science

Howard University   1996 — 2000
MA, Anthropology

Kirsten Paulson Kirsten Paulson Washington, District Of Columbia Details
Kirsten Paulson's FDA Experience 1986 - 1991
Job Sr. Director, Global CMCMedical Device Lead at Pfizer
Industry Medical Devices
Experience
Pfizer  June 2014 - Present
The Pew Charitable Trusts  April 2012 - May 2014
PPD Medical Device RA Group   April 2006 - April 2012
C.L.McIntosh   1991 - 2001
FDA   1986 - 1991

Education
Penn State University   1982 — 1985
MS, Bioengineering

Boston University   1978 — 1982
BS, Biomedical Engineering

Veronica Jae Veronica Jae Washington D.C. Metro Area Details
Veronica Jae's FDA Experience June 2014 - August 2014
Job Legal Editor at Bloomberg BNA
Industry Legal Services
Experience
Bloomberg BNA  September 2015 - Present
American University Washington College of Law  August 2012 - May 2015
FDA   June 2014 - August 2014
American University Washington College of Law  January 2014 - May 2014
U.S. Department of Health & Human Services   September 2013 - December 2013
Maurice A. Nernberg & Associates   September 2009 - July 2012
Bethany College  August 2005 - May 2009
Bethany College  September 2006 - December 2008

Skills
Editing, Microsoft Office, Microsoft Word, Facebook, French, International Relations, Teaching, Courts, Public Speaking, Fundraising, Microsoft Excel, Teamwork, Social Networking, Outlook, Nonprofits

Education
American University, Washington College of Law   2012 — 2015
Doctor of Law (J.D.)

Bethany College   2005 — 2009
BA, French, International Relations

Université Paris-Sorbonne   2007 — 2007
French Grammar, Civilization, and Literature

Kimberly S. Hill, PMP Kimberly S. Hill, PMP Rockville, Maryland Details
Kimberly S. Hill, PMP's FDA Experience November 2000 - February 2006
Job Deputy Director, Systems Division
Industry Government Administration
Experience
U.S. Government, Department of Health & Human Services, HRSA   July 2015 - Present
National Institutes of Health  May 2011 - July 2015
National Institutes of Health  December 2007 - May 2011
Department of Health and Human Services  February 2006 - December 2007
FDA   November 2000 - February 2006
US Army  May 2000 - November 2000
US Army  August 1997 - May 2000
Southern Building Code Congress International, Inc.   May 1996 - July 1997
Graphics Are In!   October 1993 - November 1996
Professional Convention Management Association  March 1995 - March 1996

Skills
Program Management, Training, Government, Project Management, Analysis, Change Management, Policy, Management, Leadership, Instructional Design, Process Improvement, Data Analysis, E-Learning, Organizational..., Leadership Development, Project Planning, Human Resources, Integration, PMP, Learning Management..., Training Delivery, Policy Analysis, Performance Management

Education
The George Washington University
Master's Certificate, IT Project Management

University of Massachusetts Lowell   1991 — 1992
M.Ed., Curriculum and Instruction

Binghamton University   1986 — 1990
B.A., Literature and Rhetoric

Melissa Hulett MSBA, MSN, FNP-BC, RN Melissa Hulett MSBA, MSN, FNP-BC, RN Washington D.C. Metro Area Details
Melissa Hulett MSBA, MSN, FNP-BC, RN's FDA Experience 2009 - 2014
Job CDR USPHS at Department of Health and Human Services
Industry Health, Wellness and Fitness
Experience
Department of Health and Human Services  April 2009 - Present
FDA   2009 - 2014

Skills
Public Policy, Policy Analysis, Community Outreach, Government, Nonprofits, Policy, Public Health, Strategic Communications, Public Speaking, Research, Editing, Public Relations

Education
Marymount University
Master's Degree, Family Nurse Practitioner

Georgetown University
Public Health Administration

Boston University
Master of Business Administration (M.B.A.)

East Carolina University
Bachelor's degree, Nursing Practice

Craven Community College   1992 — 1995
Associate's degree, Registered Nursing/Registered Nurse

Geetaram Sahu Geetaram Sahu Washington D.C. Metro Area Details
Geetaram Sahu's FDA Experience 2007 - 2009
Job Senior Research Scientist
Industry Biotechnology
Experience
George Washington University  2014 - Present
St. Jude Children's Research Hospital   2011 - 2014
Georgetown University  2009 - 2011
FDA   2007 - 2009

Skills
Chromatin..., ChIP-seq, CHIP-depletion, CHIP-CHIP, Gel Shift Assay, Nucleic Acid Pulldown..., DNA-Protein,..., RFLP, SNP genotyping, DNA methylation, Southern Blot, Immunocytochemistry, Immunohistochemistry, Western Blotting, ELISA, Co-immunoprecipitation, GST-pulldown Assay, Immunofluorescence, Gene Knockdown, Protein Purification, PCR-SSCP, PCR-CDGE,..., PCR, Gradient-PCR, RT-PCR, real-time PCR, Multiplex PCR, Soeing-PCR,..., Site directed..., recombinant DNA..., Gene Cloning, DNA sequencing Analysis, Tissue array, Fluorescent microscopy, Isolation and culture..., Isolation of Naïve CD4T..., Automax, Labelling of cells..., DNA and RNA labeling by..., Primer design for PCR,..., Graphpad Prism,..., Mammalian and Bacterial..., In Vitro Transcription..., Mouse and Rat Necropsy..., Biochemistry, Molecular Biology, Fluorescence Microscopy, Immunoprecipitation, Site-directed..., Biotechnology, Cancer, Transfection

Education
Utkal University   2001 — 2006
Doctor of Philosophy (Ph.D.), Molecular Cancer Research

Berhampur University   1994 — 1997
Master's Degree, Zoology/Animal Biology

Berhampur University   1990 — 1993
Bachelor's Degree, Zoology (Honors)

Jazmin Washington Jazmin Washington Greater Atlanta Area Details
Jazmin Washington's FDA Experience October 2006 - November 2013
Job Business Administration/Art&Style
Industry Insurance
Experience
Altisource  June 2015 - Present
Various  November 2011 - Present
Bay Area Credit Services   July 2014 - May 2015
FDA   October 2006 - November 2013
Word On The Streetz News   April 2013 - September 2013
BeautiiFLY   December 2010 - May 2013
Linda Underwood Showroom   December 2009 - January 2010
Jones Summer Camp   August 2004 - August 2006

Skills
Government, Research, Marketing Communications, Art, Creative Writing, Project Coordination, Team Coordination, Internal Communications, Promoting, Event Planning, Wardrobe Analysis, Team Building, Marketing Strategy, Budgets, Management, Marketing, Social Networking, Fashion, Social Media, Recruiting, Advertising, Editing, Blogging, PowerPoint, Microsoft Office, Brand Development, Microsoft Word, Styling, Organizational..., Microsoft Excel, Outlook, Teamwork, Customer Service, Time Management, Data Entry, Data Analysis

Education
Argosy University Atlanta   2011 — 2013
Masters of Science in Management, Marketing

Bauder College   2010 — 2011
Bachelors of Business, Business Admin, 3.0

Bauder College   2007 — 2010
AA, Fashion Merchandise/Business

Haiwen Shi Haiwen Shi Pittsburgh, Pennsylvania Details
Haiwen Shi's FDA Experience August 2012 - Present
Job Statistician
Industry Government Administration
Experience
FDA   August 2012 - Present
GPCL   March 2007 - August 2012
UPCI  February 2005 - February 2007
UPMC Magnetic Resonance Research Center   September 2002 - August 2004

Skills
Survival Analysis, Predictive Modeling, Time Series Analysis, ANOVA, SAS, SQL, R, Matlab, C++, Java, Perl, Microarray Analysis

Education
University of Pittsburgh   2009 — 2012
Doctor of Philosophy (PhD), Statistics

University of Pittsburgh   2007 — 2009
Master of Arts (M.A.), Statistics

University of Pittsburgh   2002 — 2004
Master of Science (M.S.), Computer Science

Beijing University of Technology   1988 — 1993
Bachelor of Engineering (B.E.), Metallic Materials Science and Engineering

Austin Hand, Ph.D. Austin Hand, Ph.D. Austin, Texas Details
Austin Hand, Ph.D.'s FDA Experience May 2010 - May 2011
Job Sr. Biostatistician at Quintiles
Industry Pharmaceuticals
Experience
Quintiles  January 2014 - Present
Las Manos de Christine   September 2008 - Present
PPD  June 2011 - January 2014
FDA   May 2010 - May 2011
Baylor University  August 2007 - May 2010
Oxford Language Centre   August 2006 - June 2007
University of New Mexico  August 2004 - May 2006
Starbucks/Aramark   January 2004 - July 2004
Asian Crown School   June 2003 - December 2003

Skills
SAS, R, Statistics, JMP, LaTeX, Bayesian statistics, SAS programming, Multivariate Statistics, Data Analysis, Statistical Modeling, Biostatistics, Program Management, CRO, Time Series Analysis, Survival Analysis, Clinical Trials, Clinical Research, Analysis, CDISC, SDTM, ADaM, Data Mining, SAS Programming

Education
Baylor University   2009 — 2011
PhD, Statistics

Baylor University   2007 — 2009
MS, Statistics

The University of New Mexico   2001 — 2006
BS, Applied Mathematics

Shayne Harrel Shayne Harrel Greater Boston Area Details
Shayne Harrel's FDA Experience November 2009 - Present
Job Application ScientistPhysical Chemistry
Industry Research
Experience
FDA   November 2009 - Present
Yale University  2001 - 2008
Parker Hannifin  2000 - 2001
Boston University  1996 - 1998
Genzyme  1996 - 1997

Skills
Chemistry, Analytical Chemistry

Education
Yale University   2001 — 2008
PhD, Physical Chemistry

Boston University   1994 — 1998
BA, Chemistry

Russell Fleischer Russell Fleischer Silver Spring, Maryland Details
Russell Fleischer's FDA Experience November 1993 - June 1997
Job Senior Clinical Analyst at Food and Drug Administration
Industry Pharmaceuticals
Experience
Food and Drug Administration  June 1997 - Present
FDA   November 1993 - June 1997
Medical Technology and Practice Patterns Institute   October 1992 - October 1993
Fred Hutchinson Cancer Research Center  1985 - 1988

Skills
Clinical Research, Public Health, Clinical Development, Infectious Diseases, Clinical Trials, Pharmaceutical Industry, FDA, Viral Hepatitis, HIV, Medicine, Regulatory Affairs, Healthcare, Epidemiology, Medical Writing, GCP, Oncology

Education
Boston University School of Medicine   1988 — 1990
MPH, Health Services

The George Washington University School of Medicine and Health Sciences   1981 — 1983
BS, PA-C, Medicine

sudha p sudha p Edison, New Jersey Details
sudha p's FDA Experience March 2014 - August 2014
Job Software programmer
Industry Program Development
Experience
Verizon Wireless  December 2014 - Present
Intuit  September 2013 - Present
FDA   March 2014 - August 2014
Master's Thesis Project   August 2009 - January 2012

Skills
Entrepreneurship, Business Planning, Business Development, Matlab, Linux, Integration, C, HTML

Education
Blekinge tekniska högskola
Master, Innovation

Java developer   2009 — 2011

Jawaharlal Nehru Technological University

Christine Falabella Christine Falabella Washington D.C. Metro Area Details
Christine Falabella's FDA Experience June 2014 - Present
Job Chemical Engineer
Industry Pharmaceuticals
Experience
FDA   June 2014 - Present
Stony Brook University  June 2012 - May 2014
Stony Brook University  September 2004 - June 2011
Stony Brook University  June 2004 - October 2004
Boston University, Biomedical Engineering Department   September 2003 - May 2004

Skills
Mammalian Cell Culture, ELISA, Histology, light microscopy, Animal Models, Small Animal Surgery, Technical Writing, Statistical Analysis, ImageJ, Western Blotting, Immunohistochemistry, New laboratory set up..., Fluorescence Microscopy, microsphere drug..., Hydrogel formulation, HTML + CSS, Medical Devices, Cell Culture, Statistics, Optical Microscopy, Biomedical Engineering, Biomechanics, Flow Cytometry, Assay Development, In Vitro, In Vivo, Cell Biology, Drug Delivery, Zeta Potential, Scanning Electron..., Biomaterials, Characterization

Education
State University of New York at Stony Brook   2004 — 2011
Ph.D., Biomedical Engineering

State University of New York at Stony Brook   2005 — 2005
Certificate of Completion, Fundamentals of the Biosciences Industry

Boston University   2000 — 2004
B.S., Biomedical Engineering

Winchester High School   1996 — 2000

Barry W. Miller Barry W. Miller Washington D.C. Metro Area Details
Barry W. Miller's FDA Experience January 2013 - Present
Job Senior Clinical Analyst at FDA
Industry Pharmaceuticals
Experience
FDA   January 2013 - Present
National Cancer Institute  2007 - 2013
Hospital of the University of Pennsylvania  2000 - 2007
University of Pennsylvania  2002 - 2004
Villanova University  2003 - 2003

Skills
Clinical Research, Healthcare, Public Health

Education
University of Pennsylvania

University of Massachusetts, Amherst

Bethel University

Kristin Webster Kristin Webster Washington D.C. Metro Area Details
Kristin Webster's FDA Experience July 2014 - Present
Job Regulatory Counsel at U.S. Food and Drug Administration
Industry Public Policy
Experience
FDA   July 2014 - Present
U.S. Department of Labor   August 2012 - July 2014
U.S. Department of Labor   August 2010 - August 2012
U.S. Department of Education, Office for Civil Rights   October 2011 - February 2012
Boston College Juvenile Rights Advocacy Project   January 2010 - May 2010
Harvard Legal Aid Bureau  May 2009 - August 2009
Boston College Immigration and Asylum Project  August 2008 - May 2009
Norfolk County District Attorney’s Office  June 2008 - August 2008
U.S. Department of Justice, Environmental Crimes Section   September 2005 - July 2007

Education
Boston College Law School   2007 — 2010
JD

University of Notre Dame   2001 — 2005
B.A., Political Science

Jason Rossi Jason Rossi Washington D.C. Metro Area Details
Jason Rossi's FDA Experience September 2011 - Present
Job Chemist at FDA
Industry Government Relations
Experience
FDA   September 2011 - Present
Cephalon  July 2011 - September 2011
GlaxoSmithKline  September 1999 - May 2011

Skills
SciFinder, ChemDraw, Column Chromatography, NMR spectroscopy, IR spectroscopy, Wet Chemistry, Medicinal Chemistry, Lead Optimization, Drug Design, Synthetic Chemistry, Organic Synthesis, HPLC, UV, TLC, Lead Change, NMR, Drug Discovery, Chemistry

Education
University of Virginia   1995 — 1999
MS, Chemistry

Bloomsburg University of Pennsylvania   1991 — 1995
BS, Chemistry

Rotimi Ogunbiyi Rotimi Ogunbiyi Greater Boston Area Details
Rotimi Ogunbiyi's FDA Experience September 2007 - August 2009
Job Global Supplier Quality Engineer QC/QA at Life Technologies
Industry Biotechnology
Experience
Thermo Fisher Scientific  May 2013 - Present
Cornell University  December 2012 - May 2013
Welch Allyn  September 2012 - May 2013
National Institutes of Health  May 2011 - September 2011
FDA   September 2007 - August 2009

Education
Cornell University   2012 — 2013
Master of Engineering (M.Eng.), Biomedical/Medical Engineering, 3.63/4.0

Boston University   2008 — 2012
Bachelor of Science (B.Sc.), Biomedical/Medical Engineering

.

Anne Pariser Anne Pariser Washington D.C. Metro Area Details
Anne Pariser's FDA Experience December 2014 - Present
Job Associate Director for Knowledge Management at FDA
Industry Government Administration
Experience
FDA   December 2014 - Present
FDA   February 2010 - December 2014
FDA   July 2006 - February 2010
US FDA  2000 - July 2006

Skills
Rare Diseases, Orphan Drugs, Regulatory Science, Regulatory Policy, Leadership, FDA, Clinical Research, Public Health, Medicine, Medical Education, Epidemiology, Clinical Development, Drug Development, Clinical Trials, Infectious Diseases, Regulatory Affairs, Immunology, Biotechnology, Life Sciences

Education
Georgetown University School of Medicine
Doctor of Medicine (MD)

Bates College
Bachelor of Science (B.Sc.), Chemistry

Diko kazandjian Diko kazandjian Washington D.C. Metro Area Details
Diko kazandjian's FDA Experience December 2012 - Present
Job Medical Officer at FDA
Industry Research
Experience
FDA   December 2012 - Present
NIH  December 2011 - Present
Wilford Hall Medical Center, USAF   June 2003 - June 2009

Skills
Neuroscience, Clinical Research, Immunohistochemistry, Molecular Biology, Cancer, Translational Research, Oncology, Molecular Oncology, Multiple Myeloma

Education
Boston University   1999 — 2003
MD, Medicine

Boston University   1995 — 1999
BS, Molecular Biology

Enver Holder-Hayes Enver Holder-Hayes Washington, District Of Columbia Details
Enver Holder-Hayes's FDA Experience October 2013 - Present
Job Epidemiologist at FDA
Industry Hospital & Health Care
Experience
FDA   October 2013 - Present
Mount Sinai Medical Center  November 2012 - October 2013
NYC Department of Health and Mental Hygiene  June 2010 - November 2012

Education
Boston University   2008 — 2010
MPH, Epidemiology

Morehouse College   2004 — 2008
BS, Psychology

Karen Marcus Karen Marcus Washington D.C. Metro Area Details
Karen Marcus's FDA Experience February 2013 - Present
Job Assistant Chief Counsel for Drugs and Biologics, Office of the Chief Counsel at FDA
Industry Law Practice
Experience
FDA   February 2013 - Present
Civil Litigation Clinic, Boston University School of Law   September 2011 - May 2012
FDA   May 2011 - July 2011
Health Care for All  February 2011 - May 2011
Volunteer Lawyers Project of the Boston Bar Association  February 2010 - August 2010
American Civil Liberties Union  March 2008 - July 2009

Skills
Legal Research, Legal Writing, Westlaw, Courts, Policy Analysis, Public Policy, Legal Issues, Health Law

Education
Boston University School of Public Health   2010 — 2012
MPH, Public Health

Boston University School of Law   2009 — 2012
Juris Doctor (J.D.), Cum Laude

Liang Li Liang Li San Francisco Bay Area Details
Liang Li's FDA Experience June 2010 - August 2010
Job Analytics Manager at Visa
Industry Research
Experience
Visa  June 2015 - Present
Acxiom Corp  2013 - May 2015
Gilead Sciences Inc  February 2012 - April 2013
Merkle  September 2011 - February 2012
FDA   June 2010 - August 2010
Genentech  June 2009 - August 2009
Statistics Collaborative Inc   May 2008 - December 2008
The AA   January 2006 - August 2006

Skills
SAS, SQL, Data Mining, Statistics, C, R, Modeling, Statistical Modeling, Regression, Predictive Modeling, Logistic Regression, Clinical Trials, Stata, Data Analysis, Biostatistics, Matlab, Machine Learning, Statistical Data...

Education
George Mason University   2006 — 2011
PhD, Statistics

The University of Manchester   2004 — 2005
MSc, Statistics

Beijing Forestry University   1999 — 2003
BS, Information Management and Information Systems

Big data class

Jessica Tierney Jessica Tierney Washington D.C. Metro Area Details
Jessica Tierney's FDA Experience 2011 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA   2011 - Present
WilmerHale  2006 - 2008
Patton Boggs LLP  2002 - 2005

Skills
Administrative Law, Legislation, Legislative Relations, Health Law, Regulatory Analysis, Federal Government, Policy Analysis, Legal Issues, Legal Research, Corporate Law, Civil Litigation

Education
Boston College
Bachelor of Arts (BA)

The Catholic University of America, Columbus School of Law
Doctor of Law (JD)

Jeremy Wally Jeremy Wally Washington D.C. Metro Area Details
Jeremy Wally's FDA Experience September 2013 - Present
Job Commander at Commissioned Corps of the U.S. Public Health Service
Industry Government Administration
Experience
Commissioned Corps of the U.S. Public Health Service   July 2014 - Present
FDA   September 2013 - Present
U.S. Public Health Service Commission Corps   July 2008 - July 2014
Food and Drug Administration  September 2007 - September 2013
National Institutes of Health  August 2004 - September 2007

Skills
Vaccines, Toxicology, Infectious Diseases, Regulatory Affairs, Public Health, Microbiology, Clinical Research, Epidemiology, Science, Data Analysis

Education
Boston University School of Medicine   2000 — 2005
PhD, Biophysics

Boston University School of Medicine   1998 — 2000
MA, Biochemistry

Brandeis University   1993 — 1996
BA, Biology

Tulane University   1992 — 1993

Socrates Boutsikaris Socrates Boutsikaris Washington D.C. Metro Area Details
Socrates Boutsikaris's FDA Experience August 2013 - June 2014
Job Patent Examiner at USPTO
Industry Medical Devices
Experience
USPTO  June 2014 - Present
FDA   August 2013 - June 2014
FDA   May 2012 - August 2012
FDA   May 2011 - August 2011
FDA   May 2010 - August 2010

Education
Boston University   2009 — 2013
Bachelor of Science (BS), Biomedical Engineering

Winston Churchill High School   2005 — 2009

Jamila Jones Jamila Jones Greater New York City Area Details
Jamila Jones's FDA Experience November 2013 - Present
Job Biological Sciences Laboratory Technician at FDA
Industry Biotechnology
Experience
FDA   November 2013 - Present
VCA Antech  July 2011 - November 2012
Bronx Lebanon Hospital Center  January 2010 - May 2011
Binghamton University  January 2010 - May 2010

Skills
Microbiology, Parasitology, Microscopy, Neuroscience, Analytical Chemistry, Hematology, Microsoft Office, IBM SPSS, Adobe Acrobat, Data Entry, HIPAA, OSHA, GLP, Clinical Trials

Education
State University of New York at Binghamton   2006 — 2010
Bachelor's degree, Biology/Biological Sciences, General

Nicholas Charest Nicholas Charest New Bedford, Massachusetts Details
Nicholas Charest's FDA Experience May 2012 - Present
Job Tobacco & Alcohol Prevention at City of New Bedford
Industry Government Administration
Experience
FDA   May 2012 - Present
City of New Bedford  December 2007 - March 2014
Stanley Street Treatment & Resources Inc.   2003 - 2007

Skills
Public Health, Grant Writing, Community Outreach, Grants, Nonprofits, Program Development, Health Equity, Health Education, Public Speaking, Prevention, Community Organizing, Community Development, Public Policy, Public Relations, Plannning

Education
Bridgewater State University   1999 — 2002
Bachelor of Science (BS), Communication Disorders Sciences and Services

Bates College   1997 — 1999

Daniel Steinberg Daniel Steinberg Washington, District Of Columbia Details
Daniel Steinberg's FDA Experience February 2014 - Present
Job Privacy Coordinator at FDA
Industry Government Administration
Experience
FDA   February 2014 - Present
US Department of Health & Human Services  May 2012 - Present
Booz Allen Hamilton  August 2002 - May 2012
National Conference of State Legislatures  January 1999 - November 2001

Skills
Policy Analysis, Privacy Issues, Program Management, Regulatory Analysis, Public Speaking, HIPAA

Education
Boston University School of Law   1995 — 1998
Doctor of Law (JD), Health Law

Brandeis University   1989 — 1993
Bachelor of Arts (B.A.), Biology, General

University College London, U. of London

DeJohn Davis DeJohn Davis Bowie, Maryland Details
DeJohn Davis's FDA Experience December 2012 - Present
Job IT Specialist at FDA
Industry Information Technology and Services
Experience
FDA   December 2012 - Present
DeJohn Davis Photography   March 2010 - Present
Chicasaw Nation Industries (FDA)   August 2011 - December 2012
Chickasaw Nations Industries  2011 - 2012

Education
Towson University   2007 — 2009
Bachelor of Business Administration (BBA); Computer Information Systems, Management Information Systems, General

Bowie State University   2004 — 2006

Elisabeth Drevet Elisabeth Drevet Alpharetta, Georgia Details
Elisabeth Drevet's FDA Experience January 2002 - December 2003
Job Licensed Pharmacist
Industry Pharmaceuticals
Experience
Walmart  July 2009 - July 2011
Walgreens  June 2007 - July 2009
FDA   January 2002 - December 2003

Skills
Active Pharmacist..., Pharmacy, Pharmacists, Medication Therapy..., Pharmaceutical Industry, Pharmacology, Pharmacueticals, Patient Education, Patient Counseling, Healthcare, Community Pharmacy

Education
Massachusetts College of Pharmacy and Health Sciences
Doctor of Pharmacy

Bates College
Bachelor of Science, Biology

Craig Hoover Craig Hoover Costa Mesa, California Details
Craig Hoover's FDA Experience August 1988 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA   August 1988 - Present
US Forest Service  1988 - 1988
Wasington State Department of Agriculture   January 1987 - December 1987
Idaho Fish and Game Department   February 1986 - October 1986
Idaho Department of Water Quality   January 1985 - December 1985
Streamside Restorations   May 1983 - October 1983
University of Washinton, Seattle WA   January 1983 - April 1983
Ada Veterinary Hospital   January 1980 - January 1982
Idaho Fish and Game Department   May 1978 - December 1980

Skills
Microbiology, Public Health, Epidemiology, Infectious Diseases, Lifesciences, ELISA, Regulatory Affairs, Food Microbiology, Cell Culture, Clinical Trials, Vaccines, FDA, Animal Husbandry, Toxicology, Immunology, Water Quality, Recalls of FDA..., FDA GMP, HACCP

Education
University of Idaho   1982 — 1983
Master's degree, Veterinary Preventive Medicine, Epidemiology, and Public Health

Boise State University   1975 — 1979
Bachelor's degree, Biology

Casi Alexander Casi Alexander Washington D.C. Metro Area Details
Casi Alexander's FDA Experience April 2014 - Present
Job Strategic Portfolio Management at FDA
Industry Management Consulting
Experience
FDA   April 2014 - Present
T. White Parker Associates, Inc   June 2010 - March 2014
Sevatec, Inc.   June 2007 - May 2010
BAE Systems  May 2003 - June 2007
Abacus Technology  November 1999 - June 2003

Skills
IT Governance, Project Management, IT Capital Planning, Governance, Project Portfolio..., Business Process..., Business Analysis, Program Management, PMP, Business Process..., PMO, Management, Management Consulting

Education
Webster University   1997 — 1999
Master of Arts (MA), Computer/Information Technology Management

Bennett College for Women   1993 — 1997
Bachelor of Arts (BA), Business Administration

Antonio Hood Antonio Hood Washington D.C. Metro Area Details
Antonio Hood's FDA Experience May 2006 - September 2010
Job Security Control Assessor at DoD
Industry Information Technology and Services
Experience
DoD  September 2013 - Present
DoD  January 2011 - August 2013
FDA   May 2006 - September 2010

Skills
Computer Security, Security, Information Assurance, Troubleshooting, Program Management, Information Security

Education
University of Maryland University College   2012 — 2014
Master's Degree, Technology Management: Information Systems & Services

Bowie State University   2005 — 2007
Bachelor's Degree, Business Information Systems

Norfolk State University   2002 — 2005
Bachelor's Degree, Business Information Systems

Lori Lawless Lori Lawless Finksburg, Maryland Details
Lori Lawless's FDA Experience June 1990 - Present
Job Investigator at FDA
Industry Government Administration
Experience
FDA   June 1990 - Present

Skills
Government, Policy, Research, Microsoft Office, Policy Analysis, Public Policy, Microsoft Excel, Customer Service, Program Management

Education
Binghamton University   1987 — 1990
Master of Arts (M.A.), Entomology

State University of New York at Albany   1983 — 1987
Biology, General

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