FDA Company
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Headquarters: Silver Spring, Maryland, United States Employees: 14,824 (2010) Jurisdiction: United States of America Founded: 30 June 1906 Subsidiaries: Center for Drug Evaluation and Research, Founders: Theodore Roosevelt, Harvey Washington Wiley
FDA List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at FDA. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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4,886 FDA employees in database. Find out everything there's to know about FDA employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
FDA Employees
Employee
Years
Job
Industry
Jason Mathew Jason Mathew's FDA Experience March 2015 - Present
Job
Industry Research
Experience
FDA March 2015 - Present
Quest Diagnostics Employer Solutions July 2014 - March 2015
Skills
Microsoft Word, Financial Analysis, Customer Service, Microsoft Office, Microsoft Excel, HPLC, GC-MS, Data collection and..., Analytical Biochemistry, SDS-PAGE, Outlook, Protein Expression, Research, PowerPoint, Biochemistry, Genetics, Molecular Biology, LC-MS, Laboratory, Aseptic Technique, Gas Chromatography, Gel Electrophoresis, PCR
Education
Georgia Gwinnett College
Bachelor of Science (BS), Biochemistry and Molecular Biology
FDA March 2015 - Present
Quest Diagnostics Employer Solutions July 2014 - March 2015
Skills
Microsoft Word, Financial Analysis, Customer Service, Microsoft Office, Microsoft Excel, HPLC, GC-MS, Data collection and..., Analytical Biochemistry, SDS-PAGE, Outlook, Protein Expression, Research, PowerPoint, Biochemistry, Genetics, Molecular Biology, LC-MS, Laboratory, Aseptic Technique, Gas Chromatography, Gel Electrophoresis, PCR
Education
Georgia Gwinnett College
Bachelor of Science (BS), Biochemistry and Molecular Biology
Rose Purcell Rose Purcell's FDA Experience February 2014 - Present
Job Regulatory Counsel at FDA
Industry Legal Services
Experience
FDA February 2014 - Present
Nash & Associates, Learn Capital August 2013 - January 2014
U. S. Attorney's Office for D. C. July 2012 - February 2013
Moscow Higher School of Economics August 2005 - July 2006
Naval Postgraduate School October 2004 - July 2005
Copper Mountain College, Sullivan College, McKendree College January 1998 - January 2002
Int'l Educational Development and Humanitarian Law Project, Geneva, Switz. March 1997 - May 1997
Georgetown University, Dr. Murray Feshbach January 1995 - March 1996
Human Rights Advocates, Geneva, Switz. July 1994 - August 1994
Skills
Research, English, Criminal Law, International Relations, Human Rights, Violence Against Women, Security Clearance, Public Policy, Legal Writing, Policy, National Security, Program Management, Defense, Litigation, Trials, Westlaw, Writing, Nonprofits
Education
University of Tulsa College of Law 2007 — 2010
Juris Doctor, International Law
Georgetown University 1995 — 1997
Master of Arts, Eurasian, Russian, and East European Studies
University of MD College Park
Bachelor of Arts, Political Science
FDA February 2014 - Present
Nash & Associates, Learn Capital August 2013 - January 2014
U. S. Attorney's Office for D. C. July 2012 - February 2013
Moscow Higher School of Economics August 2005 - July 2006
Naval Postgraduate School October 2004 - July 2005
Copper Mountain College, Sullivan College, McKendree College January 1998 - January 2002
Int'l Educational Development and Humanitarian Law Project, Geneva, Switz. March 1997 - May 1997
Georgetown University, Dr. Murray Feshbach January 1995 - March 1996
Human Rights Advocates, Geneva, Switz. July 1994 - August 1994
Skills
Research, English, Criminal Law, International Relations, Human Rights, Violence Against Women, Security Clearance, Public Policy, Legal Writing, Policy, National Security, Program Management, Defense, Litigation, Trials, Westlaw, Writing, Nonprofits
Education
University of Tulsa College of Law 2007 — 2010
Juris Doctor, International Law
Georgetown University 1995 — 1997
Master of Arts, Eurasian, Russian, and East European Studies
University of MD College Park
Bachelor of Arts, Political Science
Elizabeth Marek Elizabeth Marek's FDA Experience September 2014 - Present
Job Clinical Pharmacology Fellow at Thomas Jefferson University
Industry Pharmaceuticals
Experience
FDA September 2014 - Present
Thomas Jefferson University June 2013 - Present
Target September 2010 - June 2012
Walter Reed Army Institute of Research September 2007 - June 2009
Skills
Microsoft Office, PowerPoint, Healthcare, Microsoft Excel, Microsoft Word, Teamwork, Research, Clinical Research, Clinical Pharmacology, Pharmacy
Education
Ohio State University College of Pharmacy 2009 — 2013
Doctor of Pharmacy (PharmD)
Georgetown University 2006 — 2007
Master of Science (M.S.), Physiology
Mount Holyoke College 2002 — 2006
Bachelor of Arts (BA), Biochemistry
FDA September 2014 - Present
Thomas Jefferson University June 2013 - Present
Target September 2010 - June 2012
Walter Reed Army Institute of Research September 2007 - June 2009
Skills
Microsoft Office, PowerPoint, Healthcare, Microsoft Excel, Microsoft Word, Teamwork, Research, Clinical Research, Clinical Pharmacology, Pharmacy
Education
Ohio State University College of Pharmacy 2009 — 2013
Doctor of Pharmacy (PharmD)
Georgetown University 2006 — 2007
Master of Science (M.S.), Physiology
Mount Holyoke College 2002 — 2006
Bachelor of Arts (BA), Biochemistry
Massod Rahimi Massod Rahimi's FDA Experience December 2014 - Present
Job Senior Staff Fellow at FDA
Industry Government Administration
Experience
FDA December 2014 - Present
FDA October 2012 - December 2014
NCI December 2009 - October 2012
Institute for In Vitro Sciences, Inc. October 2001 - August 2004
Education
Georgetown University 2004 — 2009
Doctor of Philosophy (Ph.D.), Tumor Biology
FDA December 2014 - Present
FDA October 2012 - December 2014
NCI December 2009 - October 2012
Institute for In Vitro Sciences, Inc. October 2001 - August 2004
Education
Georgetown University 2004 — 2009
Doctor of Philosophy (Ph.D.), Tumor Biology
Glenn Rahmoeller Glenn Rahmoeller's FDA Experience 1972 - 1985
Job Lecturer, University of Maryland
Industry Higher Education
Experience
University of Maryland August 1998 - Present
Biometric Research Institute 1985 - 1997
FDA 1972 - 1985
Skills
Ethics, Bioethics, Biometrics, Academia, Lecturing, University Teaching, Public Speaking, Biotechnology, Teaching
Education
Georgetown University 1970 — 1972
Master's degree, Physiology
University of Missouri-Columbia 1964 — 1966
Master's degree, Electrical Engineering
University of Missouri-Rolla 1960 — 1964
BS, Electrical Engineering
University of Maryland August 1998 - Present
Biometric Research Institute 1985 - 1997
FDA 1972 - 1985
Skills
Ethics, Bioethics, Biometrics, Academia, Lecturing, University Teaching, Public Speaking, Biotechnology, Teaching
Education
Georgetown University 1970 — 1972
Master's degree, Physiology
University of Missouri-Columbia 1964 — 1966
Master's degree, Electrical Engineering
University of Missouri-Rolla 1960 — 1964
BS, Electrical Engineering
Sophia Sadiq Sophia Sadiq's FDA Experience October 2013 - Present
Job ORISE Fellow at FDA
Industry Health, Wellness and Fitness
Experience
FDA October 2013 - Present
Healthy Futures Program January 2013 - June 2013
FDA December 2012 - May 2013
SunTrust Bank July 2011 - December 2011
Skills
Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, SPSS, Data Analysis, Data Collection, Public Health, Analysis, Software Documentation, Healthcare
Education
George Mason University 2011 — 2013
Master of Public Health (MPH), Epidemiology
University of Maryland College Park 2007 — 2011
Bachelor of Science (B.S.), Psychology
FDA October 2013 - Present
Healthy Futures Program January 2013 - June 2013
FDA December 2012 - May 2013
SunTrust Bank July 2011 - December 2011
Skills
Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, SPSS, Data Analysis, Data Collection, Public Health, Analysis, Software Documentation, Healthcare
Education
George Mason University 2011 — 2013
Master of Public Health (MPH), Epidemiology
University of Maryland College Park 2007 — 2011
Bachelor of Science (B.S.), Psychology
Mahesh Kuruba Mahesh Kuruba's FDA Experience December 2011 - Present
Job Solution Architect at FDA
Industry Information Technology and Services
Experience
FDA December 2011 - Present
Booz Allen Hamilton October 2000 - December 2011
Saraf Software Solutions May 1999 - September 2000
Skills
SOA, IT Strategy, Project Management, Agile Methodologies, Enterprise Architecture, Business Analysis, XML, Hibernate, Leadership, Management, Web Services, PMP, Process Improvement, Management Consulting, Requirements Analysis, Security, Software Development, Struts, Java Enterprise Edition, Architecture, Integration, Business Development, SDLC, Program Management, XSLT, Solution Architecture, Software Project..., Cloud Computing, Databases, Scrum, SharePoint, Business Intelligence, Enterprise Software, System Architecture, Requirements Gathering, Architectures
Education
George Mason University 1998 — 2000
MS, Computer Science
Osmania University 1994 — 1998
BE, Computer Science
People's High School 1980 — 1993
FDA December 2011 - Present
Booz Allen Hamilton October 2000 - December 2011
Saraf Software Solutions May 1999 - September 2000
Skills
SOA, IT Strategy, Project Management, Agile Methodologies, Enterprise Architecture, Business Analysis, XML, Hibernate, Leadership, Management, Web Services, PMP, Process Improvement, Management Consulting, Requirements Analysis, Security, Software Development, Struts, Java Enterprise Edition, Architecture, Integration, Business Development, SDLC, Program Management, XSLT, Solution Architecture, Software Project..., Cloud Computing, Databases, Scrum, SharePoint, Business Intelligence, Enterprise Software, System Architecture, Requirements Gathering, Architectures
Education
George Mason University 1998 — 2000
MS, Computer Science
Osmania University 1994 — 1998
BE, Computer Science
People's High School 1980 — 1993
Martha (Mai) Nguyen Martha (Mai) Nguyen's FDA Experience 2014 - Present
Job Director of Generic Drug Policy Development at Food and Drug Administration
Industry Public Policy
Experience
FDA 2014 - Present
Food and Drug Administration 2005 - 2013
Powell Goldstein LLP 2003 - 2005
Powell Goldstein LLP 2000 - 2003
Center for Law and Social Policy 1999 - 2000
Skills
Drug Development, Public Policy, Food & Drug Law, Legislation, Regulatory Analysis, Administrative Law, Regulatory Policy, Drug Safety, Policy Analysis, Legal Research, Legal Writing, Legislative Relations, Westlaw, Health Law, Regulations
Education
Georgetown University Law Center 2000 — 2003
JD, Law
University of Pennsylvania 1995 — 1999
BA with Honors Distinction, Sociology of Health and Medicine
Connelly School of the Holy Child
FDA 2014 - Present
Food and Drug Administration 2005 - 2013
Powell Goldstein LLP 2003 - 2005
Powell Goldstein LLP 2000 - 2003
Center for Law and Social Policy 1999 - 2000
Skills
Drug Development, Public Policy, Food & Drug Law, Legislation, Regulatory Analysis, Administrative Law, Regulatory Policy, Drug Safety, Policy Analysis, Legal Research, Legal Writing, Legislative Relations, Westlaw, Health Law, Regulations
Education
Georgetown University Law Center 2000 — 2003
JD, Law
University of Pennsylvania 1995 — 1999
BA with Honors Distinction, Sociology of Health and Medicine
Connelly School of the Holy Child
Timothy Roy Stockdale Timothy Roy Stockdale's FDA Experience March 1995 - February 1997
Job Senior Health Policy Analyst: Military Healthcare System, Office of the Assistant Secretary of Defense/Health Affairs
Industry Military
Experience
Military Health System March 2013 - Present
TRICARE - Defense Health Agency March 2008 - February 2013
Joel Pomerene Memorial Hosp July 2005 - March 2008
U.S. Coast Guard June 2004 - July 2005
TRICARE Management Activity March 2001 - June 2004
U.S. Department of Justice February 1997 - March 2001
FDA March 1995 - February 1997
National Institutes of Health May 1983 - March 1995
US Army 1974 - 1977
Skills
Expertise in federal..., Ability to plan,..., Ability to develop..., Healthcare, Policy, Healthcare Management, Program Management, Healthcare Information..., Patient Safety, HIPAA, EHR, Risk Management, EMR, Medicaid, Managed Care, Hospitals, Leadership Development, Nursing, Quality Improvement, Clinical Research, Public Health, Government, Strategic Planning, Program Development, Health Policy, JCAHO
Education
Marymount University 1997 — 2000
Master of Science, Health Care Management
George Mason University 1980 — 1983
Bachelor of Science, Nursing Science
Military Health System March 2013 - Present
TRICARE - Defense Health Agency March 2008 - February 2013
Joel Pomerene Memorial Hosp July 2005 - March 2008
U.S. Coast Guard June 2004 - July 2005
TRICARE Management Activity March 2001 - June 2004
U.S. Department of Justice February 1997 - March 2001
FDA March 1995 - February 1997
National Institutes of Health May 1983 - March 1995
US Army 1974 - 1977
Skills
Expertise in federal..., Ability to plan,..., Ability to develop..., Healthcare, Policy, Healthcare Management, Program Management, Healthcare Information..., Patient Safety, HIPAA, EHR, Risk Management, EMR, Medicaid, Managed Care, Hospitals, Leadership Development, Nursing, Quality Improvement, Clinical Research, Public Health, Government, Strategic Planning, Program Development, Health Policy, JCAHO
Education
Marymount University 1997 — 2000
Master of Science, Health Care Management
George Mason University 1980 — 1983
Bachelor of Science, Nursing Science
Madhav Jai Paul's FDA Experience January 2012 - June 2012
Job Founder at Madhav Paul IT Consulting & Web Design
Industry
Experience
Georgetown Collegiate Investors, LLC September 2014 - Present
Madhav Paul IT Consulting & Web Design June 2010 - Present
MUFG in the Americas June 2015 - August 2015
Georgetown University Journal of Health Sciences September 2013 - May 2015
UBS June 2014 - November 2014
Georgetown University Student Investment Fund September 2013 - June 2014
Nevrivy Patent Law Group August 2013 - January 2014
GenProMarkers, Inc. June 2013 - August 2013
Integrated Life Sciences, UMD August 2012 - May 2013
FDA January 2012 - June 2012
Skills
Microsoft Office, Research, Photoshop, Social Media, HTML, Editing, Event Planning, Data Analysis, Website Development, Community Outreach, Spanish, Management, Facebook, Nonprofits, Analysis, Leadership, IT Consulting, Database Design and..., Tutoring, Microarray Analysis, Microsoft Excel, Agarose Gel..., Western Blotting, Fluorescence Microscopy, Microsoft Powerpoint, Public Speaking, Microsoft Word, PowerPoint
Education
Georgetown University 2013 — 2016
Bachelor of Science (B.S.), Human Science, Minor: Economics
University of Maryland College Park 2012 — 2013
Neurobiology & Physiology, Dean's List
Paint Branch High School 2008 — 2012
High School
Georgetown Collegiate Investors, LLC September 2014 - Present
Madhav Paul IT Consulting & Web Design June 2010 - Present
MUFG in the Americas June 2015 - August 2015
Georgetown University Journal of Health Sciences September 2013 - May 2015
UBS June 2014 - November 2014
Georgetown University Student Investment Fund September 2013 - June 2014
Nevrivy Patent Law Group August 2013 - January 2014
GenProMarkers, Inc. June 2013 - August 2013
Integrated Life Sciences, UMD August 2012 - May 2013
FDA January 2012 - June 2012
Skills
Microsoft Office, Research, Photoshop, Social Media, HTML, Editing, Event Planning, Data Analysis, Website Development, Community Outreach, Spanish, Management, Facebook, Nonprofits, Analysis, Leadership, IT Consulting, Database Design and..., Tutoring, Microarray Analysis, Microsoft Excel, Agarose Gel..., Western Blotting, Fluorescence Microscopy, Microsoft Powerpoint, Public Speaking, Microsoft Word, PowerPoint
Education
Georgetown University 2013 — 2016
Bachelor of Science (B.S.), Human Science, Minor: Economics
University of Maryland College Park 2012 — 2013
Neurobiology & Physiology, Dean's List
Paint Branch High School 2008 — 2012
High School
Constance Wilhelm-Miller Constance Wilhelm-Miller's FDA Experience February 2010 - Present
Job Director, CDRH Acquisitions & Grants Services Staff
Industry Legal Services
Experience
FDA February 2010 - Present
Food and Drug Administration 1979 - 2010
USAF July 1981 - July 1986
US Air Force Honor Guard January 1982 - January 1986
Skills
Facilities Management, Policy, Acquisitions, Grants, Management, Strategic Planning, Program Management, Proposal Writing, Government
Education
Georgetown University Law Center 2007 — 2011
Contract Law; Family Law
FDA February 2010 - Present
Food and Drug Administration 1979 - 2010
USAF July 1981 - July 1986
US Air Force Honor Guard January 1982 - January 1986
Skills
Facilities Management, Policy, Acquisitions, Grants, Management, Strategic Planning, Program Management, Proposal Writing, Government
Education
Georgetown University Law Center 2007 — 2011
Contract Law; Family Law
Steve Qin Steve Qin's FDA Experience 2014 - Present
Job FDA Consumer Safety Officer
Industry Biotechnology
Experience
FDA 2014 - Present
Veterans Affairs National Center for Patient Safety November 2013 - September 2014
EVMS September 2012 - November 2013
NIST January 2012 - May 2012
University of Michigan MNIMBS March 2007 - December 2009
Heat Inc. September 2008 - March 2009
Skills
Biomedical Engineering, Biotechnology, Biochemistry, Cell Culture, Experimental Design, Molecular Biology, Absorption Spectroscopy, Fluorescence..., Fluorescence Microscopy, Cytotoxicity, PowerPoint, Microsoft Word, Microsoft Excel, Serial Dilutions, Flow Cytometry, Gel Electrophoresis, PCR, Western Blotting, Confocal Microscopy, Matlab
Education
Georgetown University 2011 — 2012
Master of Science (M.S.), Biotechnology, 4.0
University of Michigan 2005 — 2009
Bachelor of Engineering (B.E.), Bioengineering and Biomedical Engineering, 3.5
FDA 2014 - Present
Veterans Affairs National Center for Patient Safety November 2013 - September 2014
EVMS September 2012 - November 2013
NIST January 2012 - May 2012
University of Michigan MNIMBS March 2007 - December 2009
Heat Inc. September 2008 - March 2009
Skills
Biomedical Engineering, Biotechnology, Biochemistry, Cell Culture, Experimental Design, Molecular Biology, Absorption Spectroscopy, Fluorescence..., Fluorescence Microscopy, Cytotoxicity, PowerPoint, Microsoft Word, Microsoft Excel, Serial Dilutions, Flow Cytometry, Gel Electrophoresis, PCR, Western Blotting, Confocal Microscopy, Matlab
Education
Georgetown University 2011 — 2012
Master of Science (M.S.), Biotechnology, 4.0
University of Michigan 2005 — 2009
Bachelor of Engineering (B.E.), Bioengineering and Biomedical Engineering, 3.5
Robert W. Fisher Robert W. Fisher's FDA Experience February 2015 - Present
Job Director, MCMi Regulatory Science at FDA OCET
Industry Government Administration
Experience
FDA February 2015 - Present
FDA December 2013 - January 2015
FDA February 2006 - December 2013
Goldbelt Raven 2005 - 2006
Centers for Disease Control 2003 - 2006
USAMRIID 2001 - 2005
US Army (USAMRIID) 2001 - 2004
Skills
BSL 3 and 4, GLP studies, Biologics manufacturing, cGMP practices, Virology, CBRN, Biodefense, CMC Regulatory Affairs, Biologics, FDA, Vaccines, Animal Models, Immunology, Infectious Diseases, GMP, Assay Development, Molecular Biology, Regulatory Affairs, GLP, Biochemistry, Biotechnology, Cell Culture, ELISA, Laboratory, Life Sciences, Microbiology, Toxicology
Education
Georgetown University 2011 — 2013
Graduate Certificate, Biohazardous Threat Agents & Emerging Infectious Diseases
University of North Carolina at Chapel Hill 1993 — 2001
Ph.D., Toxicology
University of North Carolina at Pembroke 1990 — 1993
B.S., Biology
FDA February 2015 - Present
FDA December 2013 - January 2015
FDA February 2006 - December 2013
Goldbelt Raven 2005 - 2006
Centers for Disease Control 2003 - 2006
USAMRIID 2001 - 2005
US Army (USAMRIID) 2001 - 2004
Skills
BSL 3 and 4, GLP studies, Biologics manufacturing, cGMP practices, Virology, CBRN, Biodefense, CMC Regulatory Affairs, Biologics, FDA, Vaccines, Animal Models, Immunology, Infectious Diseases, GMP, Assay Development, Molecular Biology, Regulatory Affairs, GLP, Biochemistry, Biotechnology, Cell Culture, ELISA, Laboratory, Life Sciences, Microbiology, Toxicology
Education
Georgetown University 2011 — 2013
Graduate Certificate, Biohazardous Threat Agents & Emerging Infectious Diseases
University of North Carolina at Chapel Hill 1993 — 2001
Ph.D., Toxicology
University of North Carolina at Pembroke 1990 — 1993
B.S., Biology
Marguerita Brunson Sims Marguerita Brunson Sims's FDA Experience July 2005 - August 2007
Job Senior Corporate Counsel at WellCare
Industry Legal Services
Experience
WellCare May 2013 - Present
K&L Gates 2010 - 2012
FirstCare Health Plans 2007 - 2010
FDA July 2005 - August 2007
Laboratory Corp of America 2001 - 2004
Morgan, Lewis & Bockius LLP January 1998 - December 2000
Skills
Corporate Governance, Corporate Law, Licensing, Intellectual Property, Mediation
Education
Georgetown University
BA, English/Pre-Med
University of Pennsylvania Law School
JD, Law
WellCare May 2013 - Present
K&L Gates 2010 - 2012
FirstCare Health Plans 2007 - 2010
FDA July 2005 - August 2007
Laboratory Corp of America 2001 - 2004
Morgan, Lewis & Bockius LLP January 1998 - December 2000
Skills
Corporate Governance, Corporate Law, Licensing, Intellectual Property, Mediation
Education
Georgetown University
BA, English/Pre-Med
University of Pennsylvania Law School
JD, Law
Kristina Lauritsen Kristina Lauritsen's FDA Experience June 2014 - Present
Job Deputy Ombudsman at Center for Drug Evaluation and Research, FDA
Industry Government Administration
Experience
FDA June 2014 - Present
FDA July 2003 - June 2014
US Army Medical Research Institute of Infectious Disease June 1997 - July 1998
Skills
Science Policy, Molecular Biology, Cell Biology, PCR, ELISA, Biochemistry
Education
Georgetown University 1998 — 2002
PhD, Tumor Biology
Shippensburg University of Pennsylvania 1995 — 1998
BS, Biology
FDA June 2014 - Present
FDA July 2003 - June 2014
US Army Medical Research Institute of Infectious Disease June 1997 - July 1998
Skills
Science Policy, Molecular Biology, Cell Biology, PCR, ELISA, Biochemistry
Education
Georgetown University 1998 — 2002
PhD, Tumor Biology
Shippensburg University of Pennsylvania 1995 — 1998
BS, Biology
Francis Godwin Francis Godwin's FDA Experience January 2015 - Present
Job Division Director at FDA
Industry Pharmaceuticals
Experience
FDA January 2015 - Present
FDA August 2012 - Present
FDA July 2011 - August 2012
FDA September 2009 - July 2011
MedAssurant June 2009 - September 2009
MCAM Financial June 2008 - August 2008
J.M. Huber Corporation July 2006 - July 2007
J.M. Huber Corporation March 2005 - July 2006
J.M. Huber Corporation June 2001 - March 2005
Monsanto June 2000 - August 2000
Skills
Lean Manufacturing, Six Sigma, Product Development, Process Improvement, Cross-functional Team..., Process Engineering, Project Management, Strategic Planning, Continuous Improvement, R&D, Manufacturing, Quality Assurance, Regulatory Affairs, GMP, Validation, FDA, Quality System, Operations Management, Medical Devices, Biotechnology, Quality Management, Technology Transfer, Pharmaceutical Industry, Sop, Management, Lifesciences, CAPA, Regulatory Submissions, Biopharmaceuticals, SOP, Life Sciences
Education
Georgetown University - The McDonough School of Business 2007 — 2009
MBA, Business Administration
Massachusetts Institute of Technology 1997 — 2001
BS, Chemical Engineering
FDA January 2015 - Present
FDA August 2012 - Present
FDA July 2011 - August 2012
FDA September 2009 - July 2011
MedAssurant June 2009 - September 2009
MCAM Financial June 2008 - August 2008
J.M. Huber Corporation July 2006 - July 2007
J.M. Huber Corporation March 2005 - July 2006
J.M. Huber Corporation June 2001 - March 2005
Monsanto June 2000 - August 2000
Skills
Lean Manufacturing, Six Sigma, Product Development, Process Improvement, Cross-functional Team..., Process Engineering, Project Management, Strategic Planning, Continuous Improvement, R&D, Manufacturing, Quality Assurance, Regulatory Affairs, GMP, Validation, FDA, Quality System, Operations Management, Medical Devices, Biotechnology, Quality Management, Technology Transfer, Pharmaceutical Industry, Sop, Management, Lifesciences, CAPA, Regulatory Submissions, Biopharmaceuticals, SOP, Life Sciences
Education
Georgetown University - The McDonough School of Business 2007 — 2009
MBA, Business Administration
Massachusetts Institute of Technology 1997 — 2001
BS, Chemical Engineering
Chris Holland Chris Holland's FDA Experience December 2005 - December 2008
Job Biostatistics Director at Amgen
Industry Pharmaceuticals
Experience
Amgen October 2011 - Present
Micromet October 2011 - August 2012
MacroGenics January 2009 - November 2011
FDA December 2005 - December 2008
Sucampo Pharmaceuticals February 2001 - December 2005
Quintiles 1997 - 2000
PRA International 1992 - 1997
Skills
Biostatistics, Oncology, CDISC, R, SAS, Clinical Trials, Biotechnology, Clinical Data Management, CRO, Data Management, Clinical Development, EDC, Drug Development, Pharmaceutical Industry, Lifesciences, SAS programming, Statistical Programming, Epidemiology, Clinical Research, Statistics, Regulatory Submissions, CTMS, GCP, SDTM, Protocol, Clinical Study Design, FDA, 21 CFR Part 11, Oracle Clinical, Life Sciences, SAS Programming
Education
University of Virginia 1994 — 1995
MS, Statistics
George Mason University 2001 — 2004
Graduate Certificate, Computational Sciences
Virginia Polytechnic Institute and State University 1988 — 1992
BS, Statistics
South Lakes High School 1983 — 1988
Amgen October 2011 - Present
Micromet October 2011 - August 2012
MacroGenics January 2009 - November 2011
FDA December 2005 - December 2008
Sucampo Pharmaceuticals February 2001 - December 2005
Quintiles 1997 - 2000
PRA International 1992 - 1997
Skills
Biostatistics, Oncology, CDISC, R, SAS, Clinical Trials, Biotechnology, Clinical Data Management, CRO, Data Management, Clinical Development, EDC, Drug Development, Pharmaceutical Industry, Lifesciences, SAS programming, Statistical Programming, Epidemiology, Clinical Research, Statistics, Regulatory Submissions, CTMS, GCP, SDTM, Protocol, Clinical Study Design, FDA, 21 CFR Part 11, Oracle Clinical, Life Sciences, SAS Programming
Education
University of Virginia 1994 — 1995
MS, Statistics
George Mason University 2001 — 2004
Graduate Certificate, Computational Sciences
Virginia Polytechnic Institute and State University 1988 — 1992
BS, Statistics
South Lakes High School 1983 — 1988
Maggie Fu Maggie Fu's FDA Experience June 2010 - July 2011
Job Program Specialist at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration August 2011 - Present
FDA June 2010 - July 2011
Skills
Mandarin, Microsoft Office, Administration, Database Administration, Website Management, Database Management, Data Analysis, Educational Outreach, Survey Development, Project Management, Social Networking, Management, Organization, Strategic Communications, Web-based Communication, Internal & External..., Policy, Policy Analysis, Public Health, Microsoft Excel, PowerPoint, Research, Leadership
Education
Georgetown University 2014 — 2016
Master's Degree, Biomedical Science Policy and Advocacy
University of Maryland College Park 2007 — 2011
Bachelor of Science (B.S.), Public Health
Connelly School of the Holy Child
Food and Drug Administration August 2011 - Present
FDA June 2010 - July 2011
Skills
Mandarin, Microsoft Office, Administration, Database Administration, Website Management, Database Management, Data Analysis, Educational Outreach, Survey Development, Project Management, Social Networking, Management, Organization, Strategic Communications, Web-based Communication, Internal & External..., Policy, Policy Analysis, Public Health, Microsoft Excel, PowerPoint, Research, Leadership
Education
Georgetown University 2014 — 2016
Master's Degree, Biomedical Science Policy and Advocacy
University of Maryland College Park 2007 — 2011
Bachelor of Science (B.S.), Public Health
Connelly School of the Holy Child
Annie Carlin Annie Carlin's FDA Experience May 2008 - January 2011
Job Yoga Teacher and Regulatory Policy Analyst (on hiatus)
Industry Health, Wellness and Fitness
Experience
Self employed August 2011 - Present
Association of Public Health Laboratories (APHL) January 2011 - March 2014
FDA May 2008 - January 2011
New York City Landmarks Preservation Commission June 2004 - August 2007
Skills
Research, Community Outreach, Public Policy, Policy, Policy Analysis, Hatha Yoga, Federal Government, City Government, Regulatory Affairs, Regulations, Public Health, Program Evaluation, Performance Measurement, Performance Metrics, Program Management, Editing
Education
Georgetown University 2007 — 2009
MPP, Regulatory Policy
New York University 2000 — 2004
BA, Metropolitan Studies
Self employed August 2011 - Present
Association of Public Health Laboratories (APHL) January 2011 - March 2014
FDA May 2008 - January 2011
New York City Landmarks Preservation Commission June 2004 - August 2007
Skills
Research, Community Outreach, Public Policy, Policy, Policy Analysis, Hatha Yoga, Federal Government, City Government, Regulatory Affairs, Regulations, Public Health, Program Evaluation, Performance Measurement, Performance Metrics, Program Management, Editing
Education
Georgetown University 2007 — 2009
MPP, Regulatory Policy
New York University 2000 — 2004
BA, Metropolitan Studies
Hector Beltran Hector Beltran's FDA Experience April 2015 - Present
Job Project Manager at FDA
Industry Information Technology and Services
Experience
FDA April 2015 - Present
Booz Allen Hamilton March 1996 - March 2015
Unisys July 1995 - March 1996
Ogden Corporation May 1989 - July 1995
Skills
Project Management, Software Project..., IT Strategy, IT Management, Requirements Analysis, Business Analysis, Cost Benefit, Process Improvement, Leadership, Information Technology, ERP, PMO, Management Consulting, Business Requirements, Program Management, Integration, Strategic Planning, Strategy
Education
George Mason University 1990 — 1994
Master of Science (M.S.), Software Systems Engineering
Mississippi State University 1984 — 1988
Bachelor of Science (B.S.), Computer Science and Computer Engineering double major
FDA April 2015 - Present
Booz Allen Hamilton March 1996 - March 2015
Unisys July 1995 - March 1996
Ogden Corporation May 1989 - July 1995
Skills
Project Management, Software Project..., IT Strategy, IT Management, Requirements Analysis, Business Analysis, Cost Benefit, Process Improvement, Leadership, Information Technology, ERP, PMO, Management Consulting, Business Requirements, Program Management, Integration, Strategic Planning, Strategy
Education
George Mason University 1990 — 1994
Master of Science (M.S.), Software Systems Engineering
Mississippi State University 1984 — 1988
Bachelor of Science (B.S.), Computer Science and Computer Engineering double major
Von Botteicher Von Botteicher's FDA Experience June 2011 - August 2011
Job Master's of Engineering Student at University of Virginia
Industry Biotechnology
Experience
Inova Health System May 2014 - August 2014
George Mason University February 2012 - May 2014
FDA June 2011 - August 2011
Skills
Matlab, Java, C, Python, Autodesk Software, Microsoft Office, Jsim Modeling Software, Signal Processing, Image Processing, Data Analysis
Education
University of Virginia 2014 — 2015
Master's Degree, Biomedical/Medical Engineering
George Mason University 2010 — 2014
Bachelor of Science (BS), Biomedical/Medical Engineering
Inova Health System May 2014 - August 2014
George Mason University February 2012 - May 2014
FDA June 2011 - August 2011
Skills
Matlab, Java, C, Python, Autodesk Software, Microsoft Office, Jsim Modeling Software, Signal Processing, Image Processing, Data Analysis
Education
University of Virginia 2014 — 2015
Master's Degree, Biomedical/Medical Engineering
George Mason University 2010 — 2014
Bachelor of Science (BS), Biomedical/Medical Engineering
Petar Georgiev's FDA Experience June 2012 - August 2012
Job Dental Student at Virginia Commonwealth University
Industry Medical Practice
Experience
Virginia Commonwealth University July 2013 - Present
Georgetown University Department of Pharmacology January 2011 - May 2013
Georgetown University Information Systems May 2009 - May 2013
Georgetown University August 2012 - December 2012
FDA June 2012 - August 2012
FDA Department of Office Managment May 2010 - August 2010
National Institutes of Health (NICHD) May 2008 - August 2009
Skills
Dental, Pharmacology, Science Policy, Global Health, Food Safety
Education
Virginia Commonwealth University - School of Dentistry 2013 — 2017
DDS
Georgetown University 2009 — 2013
BS, Human Science and Pre-Med
Virginia Commonwealth University July 2013 - Present
Georgetown University Department of Pharmacology January 2011 - May 2013
Georgetown University Information Systems May 2009 - May 2013
Georgetown University August 2012 - December 2012
FDA June 2012 - August 2012
FDA Department of Office Managment May 2010 - August 2010
National Institutes of Health (NICHD) May 2008 - August 2009
Skills
Dental, Pharmacology, Science Policy, Global Health, Food Safety
Education
Virginia Commonwealth University - School of Dentistry 2013 — 2017
DDS
Georgetown University 2009 — 2013
BS, Human Science and Pre-Med
Rada Puri's FDA Experience May 2009 - April 2011
Job Juris Doctor Candidate 2016, David A. Clarke School of Law
Industry Law Practice
Experience
The Diamond Law Group, LLC December 2013 - July 2014
The Kaiser Law Firm PLLC May 2013 - July 2013
Liberty Mutual Insurance May 2012 - May 2013
Radical Strategies, LLC 2011 - 2013
FDA May 2009 - April 2011
Skills
Online Marketing, Social Media, Marketing Strategy, New Business Development, Small Business, Insurance, Life Insurance, Property & Casualty..., Customer Service, Social Media Marketing, Marketing, Analysis, Strategic Planning, PowerPoint, Negotiation, Microsoft Excel, Business Development, Leadership, Microsoft Office, Legal, Legal Research, Legal Assistants, Legal Assistance, Small Business..., Web Design, Business Plan..., Business Plan Evaluation, Relationship Development, Auto, Fixed Annuities, Umbrella Insurance, Term Life Insurance, Biotechnology Industry, Legal Documents, Entrepreneurship, Social Networking, Public Relations, Start-ups, Consulting, Legal Writing
Education
University of DC David A Clarke School of Law 2013 — 2016
J.D., Law
Georgetown University 2006 — 2010
B.A., Government, Portuguese
The Diamond Law Group, LLC December 2013 - July 2014
The Kaiser Law Firm PLLC May 2013 - July 2013
Liberty Mutual Insurance May 2012 - May 2013
Radical Strategies, LLC 2011 - 2013
FDA May 2009 - April 2011
Skills
Online Marketing, Social Media, Marketing Strategy, New Business Development, Small Business, Insurance, Life Insurance, Property & Casualty..., Customer Service, Social Media Marketing, Marketing, Analysis, Strategic Planning, PowerPoint, Negotiation, Microsoft Excel, Business Development, Leadership, Microsoft Office, Legal, Legal Research, Legal Assistants, Legal Assistance, Small Business..., Web Design, Business Plan..., Business Plan Evaluation, Relationship Development, Auto, Fixed Annuities, Umbrella Insurance, Term Life Insurance, Biotechnology Industry, Legal Documents, Entrepreneurship, Social Networking, Public Relations, Start-ups, Consulting, Legal Writing
Education
University of DC David A Clarke School of Law 2013 — 2016
J.D., Law
Georgetown University 2006 — 2010
B.A., Government, Portuguese
Cathryn Lee Cathryn Lee's FDA Experience January 2013 - Present
Job Program Manager at FDA, CDER, Office of New Drugs
Industry Pharmaceuticals
Experience
FDA January 2013 - Present
FDA, CDER Office of Oncology an Hematology Products July 2012 - January 2013
FDA Center for Tobacco Products January 2011 - July 2012
Center for Drug Evaluation And Research, FDA September 2003 - December 2010
Skills
Regulatory Affairs, Regulatory Submissions, Public Health, FDA, Clinical Research, Program Development, Public Speaking, Management Consulting, Clinical Trials, Government, Healthcare, Strategic Planning, Program Management, Pharmaceutical Industry, GCP, Clinical Development, CTMS, Lifesciences
Education
George Mason University 1990 — 1992
MSN, Nursing
University fo Maryland School of Nursing
Bachelor of Science in Nursing (BSN), Registered Nursing/Registered Nurse
FDA January 2013 - Present
FDA, CDER Office of Oncology an Hematology Products July 2012 - January 2013
FDA Center for Tobacco Products January 2011 - July 2012
Center for Drug Evaluation And Research, FDA September 2003 - December 2010
Skills
Regulatory Affairs, Regulatory Submissions, Public Health, FDA, Clinical Research, Program Development, Public Speaking, Management Consulting, Clinical Trials, Government, Healthcare, Strategic Planning, Program Management, Pharmaceutical Industry, GCP, Clinical Development, CTMS, Lifesciences
Education
George Mason University 1990 — 1992
MSN, Nursing
University fo Maryland School of Nursing
Bachelor of Science in Nursing (BSN), Registered Nursing/Registered Nurse
Dustin Glasner Dustin Glasner's FDA Experience August 2011 - July 2013
Job Doctoral Candidate, University of California Berkeley, Infectious Diseases and Immunity
Industry Research
Experience
FDA August 2011 - July 2013
Earth Treks Climbing Centers June 2011 - July 2013
Georgetown University Biomedical Graduate School August 2010 - May 2011
Lab of Dr. Kurt E. Williamson September 2008 - August 2010
William & Mary Pep Band December 2007 - December 2008
Alpha Tau Omega - Kappa Kappa Chapter December 2007 - December 2008
Education
University of California, Berkeley 2013 — 2018
Doctor of Philosophy (PhD), Infectious Diseases & Immunity
Georgetown University 2010 — 2011
Masters of Science, Biohazardous Threat Agents & Emerging Infectious Diseases
William & Mary 2006 — 2010
B.S., Biology
FDA August 2011 - July 2013
Earth Treks Climbing Centers June 2011 - July 2013
Georgetown University Biomedical Graduate School August 2010 - May 2011
Lab of Dr. Kurt E. Williamson September 2008 - August 2010
William & Mary Pep Band December 2007 - December 2008
Alpha Tau Omega - Kappa Kappa Chapter December 2007 - December 2008
Education
University of California, Berkeley 2013 — 2018
Doctor of Philosophy (PhD), Infectious Diseases & Immunity
Georgetown University 2010 — 2011
Masters of Science, Biohazardous Threat Agents & Emerging Infectious Diseases
William & Mary 2006 — 2010
B.S., Biology
Kevin Laser's FDA Experience December 2014 - Present
Job Director, Budget Execution & Resource Management at FDA
Industry Government Administration
Experience
FDA December 2014 - Present
FDA February 2011 - December 2014
National Institutes of Health July 2010 - January 2011
National Institutes of Health March 2005 - July 2010
National Institutes of Health October 2004 - March 2005
National Institutes of Health October 2000 - October 2004
National Institutes of Health February 1994 - October 2000
Skills
Leadership, Management, Managing Multi-Million..., Operating Budgets, Public Speaking, Budget Monitoring, Budget Management, Customer Service, Training, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Research
Education
George Mason University 1986 — 1988
Master's Degree, Public Administration
Longwood University 1981 — 1985
Bachelor's Degree, Therapeutic Recreation/Recreational Therapy
FDA December 2014 - Present
FDA February 2011 - December 2014
National Institutes of Health July 2010 - January 2011
National Institutes of Health March 2005 - July 2010
National Institutes of Health October 2004 - March 2005
National Institutes of Health October 2000 - October 2004
National Institutes of Health February 1994 - October 2000
Skills
Leadership, Management, Managing Multi-Million..., Operating Budgets, Public Speaking, Budget Monitoring, Budget Management, Customer Service, Training, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Research
Education
George Mason University 1986 — 1988
Master's Degree, Public Administration
Longwood University 1981 — 1985
Bachelor's Degree, Therapeutic Recreation/Recreational Therapy
Syeda Khadija Zaidi Syeda Khadija Zaidi's FDA Experience July 2011 - December 2011
Job Ph.D. Student, Volgenau School of Engineering, Krasnow Institute for Advanced Studies
Industry Biotechnology
Experience
Microfluidics Lab - George Mason University December 2014 - Present
George Mason and Georgetown Universities August 2013 - October 2014
AMZ Center December 2011 - June 2014
University of Maryland August 2008 - June 2012
University of Maryland August 2011 - May 2012
National Institutes of Health December 2011 - February 2012
University of Maryland August 2011 - December 2011
FDA July 2011 - December 2011
George Mason University May 2011 - August 2011
George Mason University December 2009 - August 2011
Skills
Solidworks, Matlab, ProEngineer, Cell Culture, Cancer Genomics, PCR, Biomechanics, Neural Electrodes, Device Design, Biomedical Device Design, Fluoroscopy, Flow Cytometry, Patch-clamp, Biomedical Engineering, Mathematical Modeling, Reagents, Chemical Safety, College Teaching, Teaching, Event Management, Experience Working with..., Technical Writing, Proposal Writing, Accurate Record Keeping, Creative Writing, Visual Arts
Education
George Mason University 2015 — 2019
Doctor of Philosophy (PhD), Bioengineering
George Mason University 2013 — 2014
Graduate Studies, Advanced Biomedical Sciences
University of Maryland - A. James Clark School of Engineering 2008 — 2012
Bachelor's degree, Bioengineering and Biomedical Engineering
Microfluidics Lab - George Mason University December 2014 - Present
George Mason and Georgetown Universities August 2013 - October 2014
AMZ Center December 2011 - June 2014
University of Maryland August 2008 - June 2012
University of Maryland August 2011 - May 2012
National Institutes of Health December 2011 - February 2012
University of Maryland August 2011 - December 2011
FDA July 2011 - December 2011
George Mason University May 2011 - August 2011
George Mason University December 2009 - August 2011
Skills
Solidworks, Matlab, ProEngineer, Cell Culture, Cancer Genomics, PCR, Biomechanics, Neural Electrodes, Device Design, Biomedical Device Design, Fluoroscopy, Flow Cytometry, Patch-clamp, Biomedical Engineering, Mathematical Modeling, Reagents, Chemical Safety, College Teaching, Teaching, Event Management, Experience Working with..., Technical Writing, Proposal Writing, Accurate Record Keeping, Creative Writing, Visual Arts
Education
George Mason University 2015 — 2019
Doctor of Philosophy (PhD), Bioengineering
George Mason University 2013 — 2014
Graduate Studies, Advanced Biomedical Sciences
University of Maryland - A. James Clark School of Engineering 2008 — 2012
Bachelor's degree, Bioengineering and Biomedical Engineering
Olivia Novak Olivia Novak's FDA Experience May 2005 - August 2005
Job Epidemiologist/Public Health Specialist
Industry Research
Experience
Medical Reserve Corps April 2008 - Present
Department of Health and Human Services January 2012 - May 2012
CVS Pharmacy September 2009 - January 2012
Center for Biodefense at George Mason University January 2008 - May 2008
FDA May 2005 - August 2005
Skills
Research, SPSS, Public Health, Data Analysis, Microsoft Office, Public Speaking, PowerPoint, Microsoft Excel, Social Media, Microsoft Word, Public Policy, English, Epidemiology, SAS programming, Data Science, Infectious Diseases, Emerging Infectious..., Public Health Emergency..., Statistics
Education
George Mason University 2008 — 2012
Master of Public Health (MPH), Epidemiology
George Mason University 2004 — 2008
Bachelor's degree, Biology, General
Robinson Secondary
Medical Reserve Corps April 2008 - Present
Department of Health and Human Services January 2012 - May 2012
CVS Pharmacy September 2009 - January 2012
Center for Biodefense at George Mason University January 2008 - May 2008
FDA May 2005 - August 2005
Skills
Research, SPSS, Public Health, Data Analysis, Microsoft Office, Public Speaking, PowerPoint, Microsoft Excel, Social Media, Microsoft Word, Public Policy, English, Epidemiology, SAS programming, Data Science, Infectious Diseases, Emerging Infectious..., Public Health Emergency..., Statistics
Education
George Mason University 2008 — 2012
Master of Public Health (MPH), Epidemiology
George Mason University 2004 — 2008
Bachelor's degree, Biology, General
Robinson Secondary
Christina A. Marsh Christina A. Marsh's FDA Experience November 2011 - August 2012
Job Medical Student
Industry Medical Practice
Experience
FDA November 2011 - August 2012
National Institutes of Health January 2009 - November 2011
Skills
PCR, Cancer Research, Vaccines, Molecular Biology, Cell Culture, Western Blotting, Science, Biochemistry, Cell Biology, Genetics, Lifesciences, Neuroscience, Microscopy, Epidemiology, Immunohistochemistry, Bioinformatics, Fluorescence Microscopy, Statistics, Cancer, ELISA, Immunology
Education
Georgetown University School of Medicine 2012 — 2017
Doctor of Medicine (M.D.)
University of Washington 2005 — 2008
Bachelor of Arts (B.A.), Mathematics
FDA November 2011 - August 2012
National Institutes of Health January 2009 - November 2011
Skills
PCR, Cancer Research, Vaccines, Molecular Biology, Cell Culture, Western Blotting, Science, Biochemistry, Cell Biology, Genetics, Lifesciences, Neuroscience, Microscopy, Epidemiology, Immunohistochemistry, Bioinformatics, Fluorescence Microscopy, Statistics, Cancer, ELISA, Immunology
Education
Georgetown University School of Medicine 2012 — 2017
Doctor of Medicine (M.D.)
University of Washington 2005 — 2008
Bachelor of Arts (B.A.), Mathematics
Richard Baca's FDA Experience May 2013 - December 2014
Job J.D. Candidate at George Mason University School of Law | Summer Associate
Industry Law Practice
Experience
The Loudoun Lawyers. Biberaj Snow & Sinclair, PC January 2015 - Present
FDA May 2013 - December 2014
National Nuclear Security Administration August 2011 - May 2013
U.S. House of Representatives January 2011 - April 2011
National Nuclear Security Administration May 2010 - August 2010
Carlos J. Esparza, P.C. May 2006 - January 2009
Skills
Legal Writing, Government, Government Ethics, Operations Management, Public Speaking, Policy, Political Campaigns, Legal Research, Westlaw, Political Science, Lexis, Alternative Dispute..., Legislative Relations, Public Policy
Education
George Mason University School of Law 2013 — 2016
Juris Doctor, Law, 3L
The University of New Mexico 2008 — 2013
Bachelor of Arts (BA), Economics and Political Science, Suma Cum Laude, Honors in Economics
The Loudoun Lawyers. Biberaj Snow & Sinclair, PC January 2015 - Present
FDA May 2013 - December 2014
National Nuclear Security Administration August 2011 - May 2013
U.S. House of Representatives January 2011 - April 2011
National Nuclear Security Administration May 2010 - August 2010
Carlos J. Esparza, P.C. May 2006 - January 2009
Skills
Legal Writing, Government, Government Ethics, Operations Management, Public Speaking, Policy, Political Campaigns, Legal Research, Westlaw, Political Science, Lexis, Alternative Dispute..., Legislative Relations, Public Policy
Education
George Mason University School of Law 2013 — 2016
Juris Doctor, Law, 3L
The University of New Mexico 2008 — 2013
Bachelor of Arts (BA), Economics and Political Science, Suma Cum Laude, Honors in Economics
Leah R. Hart's FDA Experience July 2010 - August 2010
Job Associate Claims Counsel at Fidelity National Financial
Industry Legal Services
Experience
Fidelity National Financial August 2014 - Present
TRACE Fire Protection & Safety Consultants, Ltd. April 2014 - August 2014
Sword, Floyd & Moody, PLLC September 2012 - April 2014
Clariant February 2011 - May 2012
Professor Ariana Levinson, Univeristy of Louisville Brandeis School of Law May 2011 - April 2012
FDA July 2010 - August 2010
Skills
Legal Writing, Civil Litigation, Corporate Law, Legal Research, Litigation, Commercial Litigation, Appeals, Courts, Estate Planning, Drafting Agreements, Westlaw, Legal Assistance, Lexis, Legal Issues, Trials, Legal Advice, Real Estate Transactions, Land Use Planning and..., Probate, Title Insurance
Education
Louis D. Brandeis School of Law at the University of Louisville 2009 — 2012
Doctor of Law (J.D.)
Georgetown College 2005 — 2009
Bachelor of Arts (B.A.), Political Science and Government
Fidelity National Financial August 2014 - Present
TRACE Fire Protection & Safety Consultants, Ltd. April 2014 - August 2014
Sword, Floyd & Moody, PLLC September 2012 - April 2014
Clariant February 2011 - May 2012
Professor Ariana Levinson, Univeristy of Louisville Brandeis School of Law May 2011 - April 2012
FDA July 2010 - August 2010
Skills
Legal Writing, Civil Litigation, Corporate Law, Legal Research, Litigation, Commercial Litigation, Appeals, Courts, Estate Planning, Drafting Agreements, Westlaw, Legal Assistance, Lexis, Legal Issues, Trials, Legal Advice, Real Estate Transactions, Land Use Planning and..., Probate, Title Insurance
Education
Louis D. Brandeis School of Law at the University of Louisville 2009 — 2012
Doctor of Law (J.D.)
Georgetown College 2005 — 2009
Bachelor of Arts (B.A.), Political Science and Government
John Amazigo John Amazigo's FDA Experience August 1991 - April 1992
Job PMP, CISSP, ITIL Expert
Industry Information Technology and Services
Experience
IBM September 2013 - Present
Lockheed Martin July 2006 - September 2013
Unisys February 2006 - July 2006
FGM, Inc. 2000 - 2006
American Management Systems October 1998 - May 2000
Perot Systems December 1991 - October 1998
FDA August 1991 - April 1992
Monarch Food Services July 1991 - September 1991
United States Marine Corps April 1985 - April 1991
Skills
Program Management, Enterprise Architecture, Requirements Analysis, Integration, CMMI, Systems Engineering, PMP, Requirements Management, SDLC, Cloud Computing, Process Improvement, IT Strategy, Software Project..., Business Process..., Proposal Writing, ITIL Certified, Use Case, IT Infrastructure..., Knowledge Management, Enterprise Data Modeling, MS Project, DoDAF, Large Systems Design, Database Design, Data Modeling, Trade Studies
Education
The George Washington University - School of Business 2011 — 2012
Master's degree, Information Systems and Technology
George Mason University 1997 — 2002
Bachelor of Arts (B.A.), Economics
George Mason University 1997 — 2002
Bachelor of Arts (B.A.), Psychology
IBM September 2013 - Present
Lockheed Martin July 2006 - September 2013
Unisys February 2006 - July 2006
FGM, Inc. 2000 - 2006
American Management Systems October 1998 - May 2000
Perot Systems December 1991 - October 1998
FDA August 1991 - April 1992
Monarch Food Services July 1991 - September 1991
United States Marine Corps April 1985 - April 1991
Skills
Program Management, Enterprise Architecture, Requirements Analysis, Integration, CMMI, Systems Engineering, PMP, Requirements Management, SDLC, Cloud Computing, Process Improvement, IT Strategy, Software Project..., Business Process..., Proposal Writing, ITIL Certified, Use Case, IT Infrastructure..., Knowledge Management, Enterprise Data Modeling, MS Project, DoDAF, Large Systems Design, Database Design, Data Modeling, Trade Studies
Education
The George Washington University - School of Business 2011 — 2012
Master's degree, Information Systems and Technology
George Mason University 1997 — 2002
Bachelor of Arts (B.A.), Economics
George Mason University 1997 — 2002
Bachelor of Arts (B.A.), Psychology
Jennifer Cristofori Jennifer Cristofori's FDA Experience August 2006 - Present
Job Management and Program Analyst for US Food & Drug Administration
Industry Government Administration
Experience
FDA August 2006 - Present
FDA February 2004 - November 2006
Marriott International Corporate Headquarters August 2001 - November 2003
Skills
Government, Policy, Policy Analysis, Data Analysis, Analysis, Research, Federal Government, Government Contracting, Auditing, Public Policy, Access, Nonprofits, Grants, Program Management, Financial Analysis, Process Improvement, Strategic Planning, Change Management, Project Management
Education
Georgetown University - The McDonough School of Business
BS, Accounting
FDA August 2006 - Present
FDA February 2004 - November 2006
Marriott International Corporate Headquarters August 2001 - November 2003
Skills
Government, Policy, Policy Analysis, Data Analysis, Analysis, Research, Federal Government, Government Contracting, Auditing, Public Policy, Access, Nonprofits, Grants, Program Management, Financial Analysis, Process Improvement, Strategic Planning, Change Management, Project Management
Education
Georgetown University - The McDonough School of Business
BS, Accounting
Allison Chan Allison Chan's FDA Experience July 2011 - August 2011
Job Regulatory Affairs Specialist at Smith & Nephew Orthopaedics
Industry Medical Devices
Experience
Smith & Nephew June 2015 - Present
Smith & Nephew Orthopaedics March 2014 - June 2015
St. Jude Medical March 2012 - February 2014
Georgia Institute of Technology August 2010 - December 2011
Georgia Institute of Technology January 2008 - December 2011
FDA July 2011 - August 2011
HeartWare Inc 2010 - 2010
Skills
Solidworks, Simulink, PowerPoint, Excel, Matlab, Word, Statistics, FDA, Biomedical Engineering, Clinical Research, Regulatory Affairs, SolidWorks, Biomaterials, Microsoft Word, R
Education
Georgia Institute of Technology 2007 — 2011
B.S, Biomedical Engineering
Smith & Nephew June 2015 - Present
Smith & Nephew Orthopaedics March 2014 - June 2015
St. Jude Medical March 2012 - February 2014
Georgia Institute of Technology August 2010 - December 2011
Georgia Institute of Technology January 2008 - December 2011
FDA July 2011 - August 2011
HeartWare Inc 2010 - 2010
Skills
Solidworks, Simulink, PowerPoint, Excel, Matlab, Word, Statistics, FDA, Biomedical Engineering, Clinical Research, Regulatory Affairs, SolidWorks, Biomaterials, Microsoft Word, R
Education
Georgia Institute of Technology 2007 — 2011
B.S, Biomedical Engineering
Kim Newman Frey Kim Newman Frey's FDA Experience April 2012 - July 2013
Job Senior Design Engineer at Video Accessory Corporation
Industry Research
Experience
Video Accessory Corporation December 2013 - Present
University of Colorado Boulder September 2009 - Present
FDA April 2012 - July 2013
Innovative Life Technology June 2009 - August 2009
University of Denver January 2002 - June 2009
Rochester Institute of Technology September 2000 - June 2001
Georgia Tech Regional Engineering Program September 1999 - June 2000
Skills
biomedical monitoring, smart phone interfacing, assistive technology, FPGA, Biomedical Engineering, Embedded Systems, Research, Robotics, Medical Devices, VHDL, Assistive Technology, Microprocessors, Programming, C, Systems Engineering
Education
Georgia Institute of Technology 1988 — 1999
Ph.D., Electrical and Computer Engineering
Herschel V. Jenkins High School
Video Accessory Corporation December 2013 - Present
University of Colorado Boulder September 2009 - Present
FDA April 2012 - July 2013
Innovative Life Technology June 2009 - August 2009
University of Denver January 2002 - June 2009
Rochester Institute of Technology September 2000 - June 2001
Georgia Tech Regional Engineering Program September 1999 - June 2000
Skills
biomedical monitoring, smart phone interfacing, assistive technology, FPGA, Biomedical Engineering, Embedded Systems, Research, Robotics, Medical Devices, VHDL, Assistive Technology, Microprocessors, Programming, C, Systems Engineering
Education
Georgia Institute of Technology 1988 — 1999
Ph.D., Electrical and Computer Engineering
Herschel V. Jenkins High School
Brenda Pillari, Ph.D. Brenda Pillari, Ph.D.'s FDA Experience October 2003 - May 2013
Job Director, Regulatory Affairs at Teva Pharmaceuticals USA
Industry Pharmaceuticals
Experience
Teva Pharmaceuticals USA July 2013 - Present
FDA October 2003 - May 2013
March of Dimes 2010 - 2012
Skills
FDA, Aseptic Technique, Microbiology, Regulatory Affairs, Validation, CAPA, GMP, Biotechnology, Sop, Quality System, Lifesciences, Project Management, Research, Pharmaceutical Industry, ELISA, Environmental Monitoring, V&V, GLP, Technology Transfer, Biopharmaceuticals, Microsoft Office, Strategic Planning, Quality Management, Medical Devices, Quality Assurance, Regulatory Submissions, Regulatory Requirements, Quality Auditing, Vaccines, Change Control, Pharmaceutics, Drug Development
Education
George Mason University 1996 — 2002
Doctor of Philosophy (Ph.D.), Environmental Science & Public Policy
Fairleigh Dickinson University-Metropolitan Campus 1992 — 1996
Master of Science (MS), Microbiology & Pharmaceutical Marketing
Seton Hall University 1988 — 1992
Bachelor of Science (B.S.), Biology & Spanish
Teva Pharmaceuticals USA July 2013 - Present
FDA October 2003 - May 2013
March of Dimes 2010 - 2012
Skills
FDA, Aseptic Technique, Microbiology, Regulatory Affairs, Validation, CAPA, GMP, Biotechnology, Sop, Quality System, Lifesciences, Project Management, Research, Pharmaceutical Industry, ELISA, Environmental Monitoring, V&V, GLP, Technology Transfer, Biopharmaceuticals, Microsoft Office, Strategic Planning, Quality Management, Medical Devices, Quality Assurance, Regulatory Submissions, Regulatory Requirements, Quality Auditing, Vaccines, Change Control, Pharmaceutics, Drug Development
Education
George Mason University 1996 — 2002
Doctor of Philosophy (Ph.D.), Environmental Science & Public Policy
Fairleigh Dickinson University-Metropolitan Campus 1992 — 1996
Master of Science (MS), Microbiology & Pharmaceutical Marketing
Seton Hall University 1988 — 1992
Bachelor of Science (B.S.), Biology & Spanish
Timothy Ulatowski Timothy Ulatowski's FDA Experience January 2003 - January 2011
Job CEO at Ulatowski Consulting LLC
Industry Medical Devices
Experience
Ulatowski Consulting LLC April 2014 - Present
Becker & Associates September 2011 - April 2014
NDA Partners LLC January 2011 - August 2012
FDA January 2003 - January 2011
FDA 1980 - 2003
Skills
FDA law and regulations..., Knowledge of FDA..., Hands on experience..., Expert in quality..., Expert witness reports..., Executive and staff...
Education
Georgetown University School of Medicine 1984 — 1987
MS, Physiology/Biomedical Engineering
Penn State University 1971 — 1974
BS, Microbiology
Ulatowski Consulting LLC April 2014 - Present
Becker & Associates September 2011 - April 2014
NDA Partners LLC January 2011 - August 2012
FDA January 2003 - January 2011
FDA 1980 - 2003
Skills
FDA law and regulations..., Knowledge of FDA..., Hands on experience..., Expert in quality..., Expert witness reports..., Executive and staff...
Education
Georgetown University School of Medicine 1984 — 1987
MS, Physiology/Biomedical Engineering
Penn State University 1971 — 1974
BS, Microbiology
Jorge Rondon-Flores Jorge Rondon-Flores's FDA Experience May 2014 - Present
Job Organizational Excellence at FDA
Industry Management Consulting
Experience
FDA May 2014 - Present
FDIC 2012 - Present
FAA June 2011 - June 2012
Accenture Management Consulting April 2010 - June 2011
Lockheed Martin (Datrose) 2008 - 2010
Seaton Corp 2005 - 2008
Seaton Corp 2005 - 2008
Control Services Group January 2000 - January 2006
Skills
Six Sigma, Process Improvement, Organizational..., Process Engineering, Business Architecture, Performance Management, Continuous Improvement, Program Management, Change Management, Management, Leadership, Business Process..., Strategy, Business Process, Management Consulting, Business Transformation, IT Strategy, Business Process..., Business Process Mapping, Security Clearance, Process Management, Strategic Planning, Performance Improvement, Business Strategy, Training, Team Leadership, Project Planning, Lean Manufacturing, Human Resources, Quality Management, Procurement, Recruiting, Government, Operational Excellence, Resource Management, Risk Management, Training Facilitation, Workshop Facilitation, Lean Management, Stakeholder Engagement, Project Portfolio..., PMO, Governance, Analysis, Project Management, Organizational Design, Cross-functional Team..., Employee Relations, Operations Management, Business Analysis
Education
George Mason University
FDA May 2014 - Present
FDIC 2012 - Present
FAA June 2011 - June 2012
Accenture Management Consulting April 2010 - June 2011
Lockheed Martin (Datrose) 2008 - 2010
Seaton Corp 2005 - 2008
Seaton Corp 2005 - 2008
Control Services Group January 2000 - January 2006
Skills
Six Sigma, Process Improvement, Organizational..., Process Engineering, Business Architecture, Performance Management, Continuous Improvement, Program Management, Change Management, Management, Leadership, Business Process..., Strategy, Business Process, Management Consulting, Business Transformation, IT Strategy, Business Process..., Business Process Mapping, Security Clearance, Process Management, Strategic Planning, Performance Improvement, Business Strategy, Training, Team Leadership, Project Planning, Lean Manufacturing, Human Resources, Quality Management, Procurement, Recruiting, Government, Operational Excellence, Resource Management, Risk Management, Training Facilitation, Workshop Facilitation, Lean Management, Stakeholder Engagement, Project Portfolio..., PMO, Governance, Analysis, Project Management, Organizational Design, Cross-functional Team..., Employee Relations, Operations Management, Business Analysis
Education
George Mason University
Jason Warfel Jason Warfel's FDA Experience July 2005 - April 2010
Job Method Technical Transfer Lead at BristolMyers Squibb
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb August 2015 - Present
Food and Drug Administration April 2010 - August 2015
FDA July 2005 - April 2010
FDA December 2003 - July 2005
Skills
Neuroscience, Chemistry, Cell, Laboratory, Immunology, Animal Models, Microbiology, Cell Culture, Molecular Biology, Western Blotting, PCR, Biochemistry, Protein Expression, Cell Biology, Infectious Diseases
Education
Georgetown University 2005 — 2009
Ph.D., Immunology, Microbiology, 3.93 / 4.00
University of Kentucky 1998 — 2003
BS, Biology; BA, Chemistry, 3.80 / 4.00
duPont Manual High School 1994 — 1998
High School
Bristol-Myers Squibb August 2015 - Present
Food and Drug Administration April 2010 - August 2015
FDA July 2005 - April 2010
FDA December 2003 - July 2005
Skills
Neuroscience, Chemistry, Cell, Laboratory, Immunology, Animal Models, Microbiology, Cell Culture, Molecular Biology, Western Blotting, PCR, Biochemistry, Protein Expression, Cell Biology, Infectious Diseases
Education
Georgetown University 2005 — 2009
Ph.D., Immunology, Microbiology, 3.93 / 4.00
University of Kentucky 1998 — 2003
BS, Biology; BA, Chemistry, 3.80 / 4.00
duPont Manual High School 1994 — 1998
High School
Timothy Costales's FDA Experience June 2010 - July 2011
Job American Stroke Association Student Scholar in Cerebrovascular Disease at American Heart Association
Industry Medical Practice
Experience
University of Maryland R Adams Cowley Shock Trauma Center 2014 - Present
American Heart Association 2012 - 2013
University of Maryland School of Medicine May 2012 - August 2012
FDA June 2010 - July 2011
Sitel November 2009 - June 2011
Georgetown Emergency Response Medical Service January 2009 - May 2010
Georgetown University August 2008 - May 2010
Georgetown University August 2008 - May 2010
Georgetown University August 2009 - January 2010
INFANT FUNDACION May 2009 - July 2009
Skills
Cpr Certified, Research, Medical Education, Biochemistry, Microsoft Excel, Healthcare, Protein Chemistry, Teaching, Medicine, Community Outreach, CPR Certified
Education
University of Maryland School of Medicine 2011 — 2015
M.D.
Georgetown University 2008 — 2010
Bachelor of Science, Biochemistry
University of Cambridge 2007 — 2007
University of Maryland R Adams Cowley Shock Trauma Center 2014 - Present
American Heart Association 2012 - 2013
University of Maryland School of Medicine May 2012 - August 2012
FDA June 2010 - July 2011
Sitel November 2009 - June 2011
Georgetown Emergency Response Medical Service January 2009 - May 2010
Georgetown University August 2008 - May 2010
Georgetown University August 2008 - May 2010
Georgetown University August 2009 - January 2010
INFANT FUNDACION May 2009 - July 2009
Skills
Cpr Certified, Research, Medical Education, Biochemistry, Microsoft Excel, Healthcare, Protein Chemistry, Teaching, Medicine, Community Outreach, CPR Certified
Education
University of Maryland School of Medicine 2011 — 2015
M.D.
Georgetown University 2008 — 2010
Bachelor of Science, Biochemistry
University of Cambridge 2007 — 2007
Lauren Berkowitz, JD Lauren Berkowitz, JD's FDA Experience June 2011 - Present
Job Regulatory Counsel at FDA
Industry Government Administration
Experience
FDA June 2011 - Present
United States Food and Drug Administration August 2009 - August 2011
Schulman, Treem, Kaminkow & Gilden August 2008 - February 2009
Baltimore County Government August 2007 - August 2008
Frank, Frank & Scherr, LLC May 2006 - May 2007
Office of the Attorney General of Maryland, Medicaid Fraud Control Unit January 2006 - May 2007
Bazelon Center September 2003 - January 2004
Skills
Policy, Public Health, Legal Research, Policy Analysis, Writing, Research, Strategic Planning, Analysis, Healthcare, Legal Writing, Public Policy, Nonprofits, Legislation, Contract Negotiation, Program Management, Community Outreach, Politics, Administrative Law, Litigation, Appeals, Legislative Relations, Courts, Negotiation, Government, Hearings, Health Law, Mediation, Motions, Regulatory Analysis, Criminal Law, Westlaw, Legal Issues
Education
Georgetown University 2012 — 2013
Certificate in Marketing
University of Maryland Francis King Carey School of Law 2004 — 2007
Law, Health Care Law Certificate
University of Pennsylvania 2001 — 2004
BA, Political Science and Psychology
McDonogh 1988 — 2000
FDA June 2011 - Present
United States Food and Drug Administration August 2009 - August 2011
Schulman, Treem, Kaminkow & Gilden August 2008 - February 2009
Baltimore County Government August 2007 - August 2008
Frank, Frank & Scherr, LLC May 2006 - May 2007
Office of the Attorney General of Maryland, Medicaid Fraud Control Unit January 2006 - May 2007
Bazelon Center September 2003 - January 2004
Skills
Policy, Public Health, Legal Research, Policy Analysis, Writing, Research, Strategic Planning, Analysis, Healthcare, Legal Writing, Public Policy, Nonprofits, Legislation, Contract Negotiation, Program Management, Community Outreach, Politics, Administrative Law, Litigation, Appeals, Legislative Relations, Courts, Negotiation, Government, Hearings, Health Law, Mediation, Motions, Regulatory Analysis, Criminal Law, Westlaw, Legal Issues
Education
Georgetown University 2012 — 2013
Certificate in Marketing
University of Maryland Francis King Carey School of Law 2004 — 2007
Law, Health Care Law Certificate
University of Pennsylvania 2001 — 2004
BA, Political Science and Psychology
McDonogh 1988 — 2000
Margo Boster's FDA Experience August 2003 - June 2008
Job ImpaQ Solutions Developing Leaders, Organizations and Teams
Industry Management Consulting
Experience
ImpaQ Solutions, LLC February 2010 - Present
Misc 2009 - Present
AZ Transformational Leadership Program March 2015 - Present
CEO Network, Arizona Technology Council December 2012 - December 2014
Vangent, Inc. June 2008 - February 2010
FDA August 2003 - June 2008
State of Maryland January 2002 - June 2003
SAIC September 2000 - January 2002
Pinnacle Management Systems March 2000 - September 2000
Burnette Consulting Group, Inc. March 1992 - March 2000
Skills
Leadership Development, Executive Coaching, Organizational..., Strategic Planning, Strategic Planning..., Large Group Facilitation, Competency Mapping, Corporate Culture, MBTI, 360 Feedback, DISC, Healthcare IT, Healthcare Information..., Management Consulting, Coaching, Change Management, Program Management, Workshop Facilitation, Organizational..., Training, Strategy, Leadership, Government, Executive Management, Process Improvement, Executive Development, Employee Engagement, Personal Development, Consulting, Analysis, PMP, Management, Project Management, Performance Improvement, Project Planning, Emotional Intelligence, Career Development, Business Process..., Performance Management, Talent Management, Organizational Design, Culture Change, Team Building, Facilitation, Succession Planning, Public Speaking, Management Development, Conflict Resolution, Personnel Management
Education
Georgetown University 2010 — 2010
Masters Certificate, Leadership Coaching
University of Maryland University College
BS, Psychology
ImpaQ Solutions, LLC February 2010 - Present
Misc 2009 - Present
AZ Transformational Leadership Program March 2015 - Present
CEO Network, Arizona Technology Council December 2012 - December 2014
Vangent, Inc. June 2008 - February 2010
FDA August 2003 - June 2008
State of Maryland January 2002 - June 2003
SAIC September 2000 - January 2002
Pinnacle Management Systems March 2000 - September 2000
Burnette Consulting Group, Inc. March 1992 - March 2000
Skills
Leadership Development, Executive Coaching, Organizational..., Strategic Planning, Strategic Planning..., Large Group Facilitation, Competency Mapping, Corporate Culture, MBTI, 360 Feedback, DISC, Healthcare IT, Healthcare Information..., Management Consulting, Coaching, Change Management, Program Management, Workshop Facilitation, Organizational..., Training, Strategy, Leadership, Government, Executive Management, Process Improvement, Executive Development, Employee Engagement, Personal Development, Consulting, Analysis, PMP, Management, Project Management, Performance Improvement, Project Planning, Emotional Intelligence, Career Development, Business Process..., Performance Management, Talent Management, Organizational Design, Culture Change, Team Building, Facilitation, Succession Planning, Public Speaking, Management Development, Conflict Resolution, Personnel Management
Education
Georgetown University 2010 — 2010
Masters Certificate, Leadership Coaching
University of Maryland University College
BS, Psychology
Melissa Hogan Melissa Hogan's FDA Experience August 2014 - Present
Job Rare Disease Speaker/Advocate/Consultant
Industry Legal Services
Experience
FDA August 2014 - Present
Saving Case & Friends, Inc. January 2011 - Present
Melissa J Hogan LLC 2007 - 2013
Law Offices of Melissa J. Hogan 2005 - 2011
Nashville School of Law 2004 - 2005
Bass, Berry & Sims PLC 1999 - 2004
Nova Southeastern University; Shepherd Broad Law Center 2002 - 2003
US Court of Appeals - Sixth Circuit August 1998 - August 1999
Skills
Strategic Planning, Business Intelligence, Market Analysis, Special Education, Clinical Trials, Public Speaking, Writing, Social Media, Management Consulting, Blogging, Mergers, Contract Negotiation, Coaching, Rare Diseases, Hunter Syndrome, Wordpress, Mergers & Acquisitions, Legal Research, Legal Writing, Patient Advocacy
Education
University of Pittsburgh School of Law 1995 — 1998
JD, Health Law
Georgetown College 1991 — 1995
BA, Communications; Political Science
FDA August 2014 - Present
Saving Case & Friends, Inc. January 2011 - Present
Melissa J Hogan LLC 2007 - 2013
Law Offices of Melissa J. Hogan 2005 - 2011
Nashville School of Law 2004 - 2005
Bass, Berry & Sims PLC 1999 - 2004
Nova Southeastern University; Shepherd Broad Law Center 2002 - 2003
US Court of Appeals - Sixth Circuit August 1998 - August 1999
Skills
Strategic Planning, Business Intelligence, Market Analysis, Special Education, Clinical Trials, Public Speaking, Writing, Social Media, Management Consulting, Blogging, Mergers, Contract Negotiation, Coaching, Rare Diseases, Hunter Syndrome, Wordpress, Mergers & Acquisitions, Legal Research, Legal Writing, Patient Advocacy
Education
University of Pittsburgh School of Law 1995 — 1998
JD, Health Law
Georgetown College 1991 — 1995
BA, Communications; Political Science
Yusuf Mohamed, MBA Yusuf Mohamed, MBA's FDA Experience January 2014 - Present
Job Project Manager at FDA
Industry Information Technology and Services
Experience
FDA January 2014 - Present
IBM May 2011 - January 2014
Emaar, The Economic City March 2011 - May 2011
iDirect March 2008 - March 2011
Verizon September 2006 - March 2008
Sprint Nextel January 2006 - August 2006
Computer Associates, Inc April 2003 - January 2006
Skills
Management Consulting, Financial Analysis, Financial Reporting, Strategic Planning, Business Objects, OBIEE, Microsoft SQL Server, Oracle, Microsoft Reporting..., Rational Team Concert, Rational Quality Manager, Cognos, Crystal Reports, DB2, Data Integration, Integration, Business Intelligence, SDLC, Business Analysis, ERP, Solution Architecture, Enterprise Architecture, Data Warehousing, IT Strategy, Business Process, Requirements Analysis, Management, Program Management
Education
Argosy University Washington, DC 2010 — 2012
Master of Business Administration (M.B.A.), Managment
George Mason University 2001 — 2005
Bachelor of Engineering (B.E.), Systems Engineering
FDA January 2014 - Present
IBM May 2011 - January 2014
Emaar, The Economic City March 2011 - May 2011
iDirect March 2008 - March 2011
Verizon September 2006 - March 2008
Sprint Nextel January 2006 - August 2006
Computer Associates, Inc April 2003 - January 2006
Skills
Management Consulting, Financial Analysis, Financial Reporting, Strategic Planning, Business Objects, OBIEE, Microsoft SQL Server, Oracle, Microsoft Reporting..., Rational Team Concert, Rational Quality Manager, Cognos, Crystal Reports, DB2, Data Integration, Integration, Business Intelligence, SDLC, Business Analysis, ERP, Solution Architecture, Enterprise Architecture, Data Warehousing, IT Strategy, Business Process, Requirements Analysis, Management, Program Management
Education
Argosy University Washington, DC 2010 — 2012
Master of Business Administration (M.B.A.), Managment
George Mason University 2001 — 2005
Bachelor of Engineering (B.E.), Systems Engineering
Alec Studstill Alec Studstill's FDA Experience October 2014 - July 2015
Job Administrative Officer at U.S. Securities and Exchange Commission
Industry Government Administration
Experience
U.S. Securities and Exchange Commission July 2015 - Present
FDA October 2014 - July 2015
US Department of Homeland Security - Transportation Security Administration November 2013 - October 2014
United States Department of Defense - Army June 2011 - November 2013
United States Department of Defense - Army September 2010 - June 2011
Department of Veterans Affairs February 2009 - September 2010
Serco August 2008 - March 2009
US Army January 2004 - August 2008
Franklin Financial Group & Debt Collection March 2002 - January 2004
Skills
Leadership, Security Clearance, Government Contracting, DoD, Government, Military, Army, Defense, Policy, Homeland Security, Human Resources, Organizational..., Plannning, Counceling, Financial Planners, Budgets, Teaching Classes, Workshop Facilitation, Government Procurement, Program Management, Training, Project Planning, Management, Strategic Planning, Analysis, National Security, Military Experience, Personnel Management, Planning
Education
Georgetown University 2014 — 2016
Liberal Arts and Sciences/Liberal Studies
Army Management Staff College 2011 — 2012
Certification, Leadership
Army Logistics University 2011 — 2011
Certification, Mobilization and Deployment Planning
Harvard Business School 2011 — 2011
Certification, Finance
U.S. Securities and Exchange Commission July 2015 - Present
FDA October 2014 - July 2015
US Department of Homeland Security - Transportation Security Administration November 2013 - October 2014
United States Department of Defense - Army June 2011 - November 2013
United States Department of Defense - Army September 2010 - June 2011
Department of Veterans Affairs February 2009 - September 2010
Serco August 2008 - March 2009
US Army January 2004 - August 2008
Franklin Financial Group & Debt Collection March 2002 - January 2004
Skills
Leadership, Security Clearance, Government Contracting, DoD, Government, Military, Army, Defense, Policy, Homeland Security, Human Resources, Organizational..., Plannning, Counceling, Financial Planners, Budgets, Teaching Classes, Workshop Facilitation, Government Procurement, Program Management, Training, Project Planning, Management, Strategic Planning, Analysis, National Security, Military Experience, Personnel Management, Planning
Education
Georgetown University 2014 — 2016
Liberal Arts and Sciences/Liberal Studies
Army Management Staff College 2011 — 2012
Certification, Leadership
Army Logistics University 2011 — 2011
Certification, Mobilization and Deployment Planning
Harvard Business School 2011 — 2011
Certification, Finance
Mariel (Figueroa) Gindin, Ph.D.'s FDA Experience 2006 - 2007
Job Research Professional
Industry Research
Experience
Washington University in St. Louis April 2013 - June 2015
National Institutes of Health 2008 - 2012
The George Washington University Columbian College of Arts & Sciences 2008 - 2008
The NIH Graduate Partnership Program 2008 - 2008
The George Washington University Columbian College of Arts & Sciences 2008 - 2008
FDA 2006 - 2007
FDA 2005 - 2005
Regeneron Pharmaceuticals- pre-clinical dept. January 2003 - August 2004
Skills
Flow Cytometry, PCR, Western Blotting, Assay Development, Cell Culture, High Throughput..., Protein Chemistry, Mammalian Cell Culture, Antibodies, Molecular Biology, Sequencing, Genetics, Research, Laboratory, Metabolic flux analysis, Animal Models, Tumor Immunology, Molecular Virology, Phage library screening, Laser Capture..., Scientific...
Education
The George Washington University 2007 — 2012
Ph.D., Microbiology, Immunology, 3.72
Georgetown University 2004 — 2005
Master of Science (MS), Biochemistry, 3.81
Syracuse University 1998 — 2002
BS, Biochemistry, 3.34
Washington University in St. Louis April 2013 - June 2015
National Institutes of Health 2008 - 2012
The George Washington University Columbian College of Arts & Sciences 2008 - 2008
The NIH Graduate Partnership Program 2008 - 2008
The George Washington University Columbian College of Arts & Sciences 2008 - 2008
FDA 2006 - 2007
FDA 2005 - 2005
Regeneron Pharmaceuticals- pre-clinical dept. January 2003 - August 2004
Skills
Flow Cytometry, PCR, Western Blotting, Assay Development, Cell Culture, High Throughput..., Protein Chemistry, Mammalian Cell Culture, Antibodies, Molecular Biology, Sequencing, Genetics, Research, Laboratory, Metabolic flux analysis, Animal Models, Tumor Immunology, Molecular Virology, Phage library screening, Laser Capture..., Scientific...
Education
The George Washington University 2007 — 2012
Ph.D., Microbiology, Immunology, 3.72
Georgetown University 2004 — 2005
Master of Science (MS), Biochemistry, 3.81
Syracuse University 1998 — 2002
BS, Biochemistry, 3.34
Yaru Shi Yaru Shi's FDA Experience June 2014 - August 2014
Job Research Assistant at UIC, Health Media Collaboratory
Industry
Experience
University of Illinois at Chicago, Health Media Collaboratory September 2013 - Present
FDA June 2014 - August 2014
Georgetown University September 2011 - July 2013
Skills
Python, R, MySQL, Data Mining, Machine Learning, SAS Programming, Stata, Statistics, Matlab, SPSS, Data Analysis, LaTeX, Microsoft Office, Statistical Modeling
Education
University of Illinois at Chicago 2013 — 2017
Doctor of Philosophy (Ph.D.), Biostatistics, 4.0
Georgetown University 2011 — 2012
Master of Science (M.S.), Biostatistics, 3.97
University of Illinois at Chicago, Health Media Collaboratory September 2013 - Present
FDA June 2014 - August 2014
Georgetown University September 2011 - July 2013
Skills
Python, R, MySQL, Data Mining, Machine Learning, SAS Programming, Stata, Statistics, Matlab, SPSS, Data Analysis, LaTeX, Microsoft Office, Statistical Modeling
Education
University of Illinois at Chicago 2013 — 2017
Doctor of Philosophy (Ph.D.), Biostatistics, 4.0
Georgetown University 2011 — 2012
Master of Science (M.S.), Biostatistics, 3.97
Angela Aloi, LGSW Angela Aloi, LGSW's FDA Experience July 2009 - May 2013
Job Forensic Social Work Fellow with University of Maryland Clinical Law Office
Industry Mental Health Care
Experience
University of Maryland, Baltimore August 2015 - Present
Maryland Department of Public Safety and Correctional Services August 2014 - April 2015
Superior Court of the District of Columbia August 2013 - May 2014
FDA July 2009 - May 2013
Skills
Social Services, Behavioral Health, Mental Health, Treatment, Anger Management, Medical Social Work, Healthcare, Community Outreach, Corrections
Education
University of Maryland Baltimore 2014 — 2015
Master’s Degree, Clinical Social Work
George Mason University 2013 — 2014
Master's Degree, Clinical/Medical Social Work
University of Maryland, Baltimore August 2015 - Present
Maryland Department of Public Safety and Correctional Services August 2014 - April 2015
Superior Court of the District of Columbia August 2013 - May 2014
FDA July 2009 - May 2013
Skills
Social Services, Behavioral Health, Mental Health, Treatment, Anger Management, Medical Social Work, Healthcare, Community Outreach, Corrections
Education
University of Maryland Baltimore 2014 — 2015
Master’s Degree, Clinical Social Work
George Mason University 2013 — 2014
Master's Degree, Clinical/Medical Social Work
Grace (McElhenny) Stark's FDA Experience June 2014 - June 2015
Job MA Candidate in Bioethics & Health Policy at Loyola University Chicago
Industry Public Policy
Experience
FDA June 2014 - June 2015
Department of Veterans Affairs January 2014 - April 2014
Capital Educators September 2013 - April 2014
U.S. House of Representatives September 2013 - December 2013
The Heritage Foundation June 2013 - August 2013
Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center September 2010 - May 2013
United States Senate January 2013 - April 2013
DIS – Danish Institute for Study Abroad August 2012 - December 2012
Texas Public Policy Foundation May 2012 - July 2012
American Eagle Outfitters June 2008 - August 2010
Skills
Research, Health Policy, Bioethics, Policy Analysis, Microsoft Office, Editing, Public Speaking, Writing, Proposal Writing, Government, Public Health Policy, Economics, Health Economics, Policy Writing, Messaging Development, Meeting Scheduling, Volunteer Recruiting, Healthcare, Public Policy, Pharmaceutical Industry, Federal Government
Education
Loyola University Chicago 2015 — 2017
Master of Arts (M.A.), Bioethics & Health Policy
Georgetown University 2010 — 2014
Bachelor of Science (B.S.), Health Care Management & Policy (major), Economics (minor)
Danish Institute for Study Abroad 2012 — 2012
Public Health
St. Michael's Catholic Academy 2006 — 2010
High School Diploma, 4.05 / 4.0
FDA June 2014 - June 2015
Department of Veterans Affairs January 2014 - April 2014
Capital Educators September 2013 - April 2014
U.S. House of Representatives September 2013 - December 2013
The Heritage Foundation June 2013 - August 2013
Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center September 2010 - May 2013
United States Senate January 2013 - April 2013
DIS – Danish Institute for Study Abroad August 2012 - December 2012
Texas Public Policy Foundation May 2012 - July 2012
American Eagle Outfitters June 2008 - August 2010
Skills
Research, Health Policy, Bioethics, Policy Analysis, Microsoft Office, Editing, Public Speaking, Writing, Proposal Writing, Government, Public Health Policy, Economics, Health Economics, Policy Writing, Messaging Development, Meeting Scheduling, Volunteer Recruiting, Healthcare, Public Policy, Pharmaceutical Industry, Federal Government
Education
Loyola University Chicago 2015 — 2017
Master of Arts (M.A.), Bioethics & Health Policy
Georgetown University 2010 — 2014
Bachelor of Science (B.S.), Health Care Management & Policy (major), Economics (minor)
Danish Institute for Study Abroad 2012 — 2012
Public Health
St. Michael's Catholic Academy 2006 — 2010
High School Diploma, 4.05 / 4.0
Kalah Auchincloss's FDA Experience August 2011 - September 2013
Job at
Industry Government Administration
Experience
United States Senate March 2015 - Present
Office of Unapproved Drugs and Labeling Compliance, CDER, FDA June 2014 - March 2015
Division of Prescription Drugs, CDER, FDA October 2013 - May 2014
FDA August 2011 - September 2013
Foley Hoag LLP September 2006 - August 2010
Shannon O'Brien for Governor Campaign June 2001 - December 2002
Skills
Legal Research, Legislation, Public Policy, Legal Writing, Litigation, Administrative Law, Corporate Law, International Law, Appeals, Civil Litigation, Intellectual Property, Policy Analysis, Policy, Government
Education
Harvard University School of Public Health 2010 — 2011
MPH
Georgetown University Law Center 2003 — 2006
JD
Williams College 1997 — 2001
BA, History
United States Senate March 2015 - Present
Office of Unapproved Drugs and Labeling Compliance, CDER, FDA June 2014 - March 2015
Division of Prescription Drugs, CDER, FDA October 2013 - May 2014
FDA August 2011 - September 2013
Foley Hoag LLP September 2006 - August 2010
Shannon O'Brien for Governor Campaign June 2001 - December 2002
Skills
Legal Research, Legislation, Public Policy, Legal Writing, Litigation, Administrative Law, Corporate Law, International Law, Appeals, Civil Litigation, Intellectual Property, Policy Analysis, Policy, Government
Education
Harvard University School of Public Health 2010 — 2011
MPH
Georgetown University Law Center 2003 — 2006
JD
Williams College 1997 — 2001
BA, History
Ram K Bista Ram K Bista's FDA Experience 2011 - 2012
Job Network Security Engineer at Sotera Defense
Industry Computer & Network Security
Experience
Sotera Defense Solutions, Inc. January 2013 - Present
GeoEye Inc. (Digital Globe) October 2010 - December 2012
FDA 2011 - 2012
Skills
Network Security, Information Assurance, Vulnerability Assessment, CISSP, Computer Security, Information Security, Security, Security+, Information Security..., DIACAP, IDS, Firewalls, Intrusion Detection, Computer Forensics, Penetration Testing, CompTIA Security+, Network Administration, Windows Server, Security Clearance, Troubleshooting, VMware
Education
Training
University of Maryland University College
Master's degree, Cybersecurity
George Mason University 2008 — 2012
Bachelor of Science (B.S.), Information Security
Tribhuvan Vishwavidalaya 2000 — 2004
Bachelor's degree, Education
Sotera Defense Solutions, Inc. January 2013 - Present
GeoEye Inc. (Digital Globe) October 2010 - December 2012
FDA 2011 - 2012
Skills
Network Security, Information Assurance, Vulnerability Assessment, CISSP, Computer Security, Information Security, Security, Security+, Information Security..., DIACAP, IDS, Firewalls, Intrusion Detection, Computer Forensics, Penetration Testing, CompTIA Security+, Network Administration, Windows Server, Security Clearance, Troubleshooting, VMware
Education
Training
University of Maryland University College
Master's degree, Cybersecurity
George Mason University 2008 — 2012
Bachelor of Science (B.S.), Information Security
Tribhuvan Vishwavidalaya 2000 — 2004
Bachelor's degree, Education
Virginia Cox Virginia Cox's FDA Experience August 2011 - January 2014
Job 3D Communications, LLC Communications Strategists
Industry Pharmaceuticals
Experience
3D Communications, LLC January 2014 - Present
FDA August 2011 - January 2014
Education
Georgetown University Law Center
Doctor of Law (J.D.)
UCLA
Bachelor of Arts (B.A.)
3D Communications, LLC January 2014 - Present
FDA August 2011 - January 2014
Education
Georgetown University Law Center
Doctor of Law (J.D.)
UCLA
Bachelor of Arts (B.A.)
Kerry O'Dell Kerry O'Dell's FDA Experience 2014 - July 2014
Job Attorney at U.S. Customs and Border Protection
Industry Law Practice
Experience
U.S. Customs and Border Protection July 2014 - Present
FDA 2014 - July 2014
Schnader Harrison Segal & Lewis LLP June 2011 - 2013
Hollingsworth LLP March 2008 - June 2011
Hollingsworth LLP May 2007 - August 2007
The Employment Law Group, PC May 2006 - April 2007
D.C. Coalition Against Domestic Violence May 2005 - August 2005
The United States Army Field Band March 2000 - September 2004
Skills
Litigation, Legal Research, Commercial Litigation, Civil Litigation, Legal Writing, Mediation, Courts, Employment Law, Product Liability, Class Actions, Trials, Arbitration, Trial Practice, Depositions, Defense, International..., Administrative Law, Toxic Tort, Dispute Resolution, Construction Law, Insurance Law, Corporate Law, Appeals, Trade Secrets, Westlaw
Education
Georgetown University Law Center 2004 — 2008
J.D., Law
Temple University 1992 — 1996
B.M., Music
Lower Merion
U.S. Customs and Border Protection July 2014 - Present
FDA 2014 - July 2014
Schnader Harrison Segal & Lewis LLP June 2011 - 2013
Hollingsworth LLP March 2008 - June 2011
Hollingsworth LLP May 2007 - August 2007
The Employment Law Group, PC May 2006 - April 2007
D.C. Coalition Against Domestic Violence May 2005 - August 2005
The United States Army Field Band March 2000 - September 2004
Skills
Litigation, Legal Research, Commercial Litigation, Civil Litigation, Legal Writing, Mediation, Courts, Employment Law, Product Liability, Class Actions, Trials, Arbitration, Trial Practice, Depositions, Defense, International..., Administrative Law, Toxic Tort, Dispute Resolution, Construction Law, Insurance Law, Corporate Law, Appeals, Trade Secrets, Westlaw
Education
Georgetown University Law Center 2004 — 2008
J.D., Law
Temple University 1992 — 1996
B.M., Music
Lower Merion
David Warshawsky David Warshawsky's FDA Experience June 2004 - August 2004
Job Graduate Researcher at Georgia Institute of Technology
Industry Higher Education
Experience
Georgia Institute of Technology August 2010 - Present
University of Maryland June 2008 - May 2010
National Institute of Standards and Technology March 2006 - July 2006
FDA June 2004 - August 2004
Skills
Matlab, System of Systems..., Microsoft Office, Systems Engineering, Aerospace Engineering, Data Analysis, Statistics, Microsoft Excel, PowerPoint, Research, Microsoft Word, C++, Optimization, Engineering Design, Graph Theory, Network analsis, Genetic Algorithms, NetLogo, LabVIEW, JMP
Education
Georgia Institute of Technology 2010 — 2015
Doctor of Philosophy (Ph.D.), Aerospace Systems Engineering, 3.7
University of Maryland College Park 2006 — 2010
Bachelor's degree, Aerospace, Aeronautical and Astronautical Engineering, 3.63
Georgia Institute of Technology August 2010 - Present
University of Maryland June 2008 - May 2010
National Institute of Standards and Technology March 2006 - July 2006
FDA June 2004 - August 2004
Skills
Matlab, System of Systems..., Microsoft Office, Systems Engineering, Aerospace Engineering, Data Analysis, Statistics, Microsoft Excel, PowerPoint, Research, Microsoft Word, C++, Optimization, Engineering Design, Graph Theory, Network analsis, Genetic Algorithms, NetLogo, LabVIEW, JMP
Education
Georgia Institute of Technology 2010 — 2015
Doctor of Philosophy (Ph.D.), Aerospace Systems Engineering, 3.7
University of Maryland College Park 2006 — 2010
Bachelor's degree, Aerospace, Aeronautical and Astronautical Engineering, 3.63
David Grau David Grau's FDA Experience October 1996 - January 2007
Job Strategic Change Consultant, Ascent Advisor, Inc., "Mastering Change in 100 Days"
Industry Management Consulting
Experience
Ascent Advisor September 2010 - Present
DG Consulting November 2006 - Present
FDA October 1996 - January 2007
Skills
Organizational..., 360 Feedback, Management Consulting, Training, Strategic Planning, Coaching, Leadership Development, Leadership, Executive Coaching, Change Management, Performance Management, Recruiting, Conflict Resolution, Start-ups, Teaching, Culture Change, Workshop Facilitation, Personal Development, Public Speaking, Executive Development, Government
Education
Georgetown University 2001 — 2001
Certificate, Leadership (Executive) Coaching
Georgetown University 1999 — 1999
Certificate, Organization Development
San Diego State University-California State University 1993 — 1995
MA, Education, Specialty in Educational Technology
Harvard Medical School 1976 — 1980
DMD, Dentistry (School of Dental Medicine)
University at Buffalo 1972 — 1976
BA, Biology
Ascent Advisor September 2010 - Present
DG Consulting November 2006 - Present
FDA October 1996 - January 2007
Skills
Organizational..., 360 Feedback, Management Consulting, Training, Strategic Planning, Coaching, Leadership Development, Leadership, Executive Coaching, Change Management, Performance Management, Recruiting, Conflict Resolution, Start-ups, Teaching, Culture Change, Workshop Facilitation, Personal Development, Public Speaking, Executive Development, Government
Education
Georgetown University 2001 — 2001
Certificate, Leadership (Executive) Coaching
Georgetown University 1999 — 1999
Certificate, Organization Development
San Diego State University-California State University 1993 — 1995
MA, Education, Specialty in Educational Technology
Harvard Medical School 1976 — 1980
DMD, Dentistry (School of Dental Medicine)
University at Buffalo 1972 — 1976
BA, Biology
Xinyuan (Emily) Zhu Xinyuan (Emily) Zhu's FDA Experience May 2011 - August 2012
Job Estimating & Pricing Specialist at Boeing
Industry Financial Services
Experience
Boeing May 2015 - Present
Federal Aviation Administration - FAA (Via THANE Inc.) December 2014 - May 2015
The World Bank July 2013 - October 2013
FDA May 2011 - August 2012
Maryland State Highway Administration (Via University of Maryland) September 2009 - October 2010
Robert Bosch Engineering and Business Solutions Ltd. November 2008 - April 2009
The CID Group September 2006 - December 2007
Shanghai Electric Group Co., Ltd May 2007 - September 2007
Shanghai Jiao Tong University May 2005 - August 2006
Skills
Project Management, Data Analysis, Operations Management, Program Management, Sustainability, Industrial Engineering, Risk Analytics, MS Project, Renewable Energy, Climate Change, Wind, Energy Efficiency, SQL, Matlab, Environmental Policy, Energy, Energy Policy, Statistics, Environmental Awareness, Engineering, Environmental Science, Simulations, Stochastic Programming, SAS programming, C++, @Risk, GAMS, SAP, Analysis, Sustainable Energy, Strategy, Economics, Program M, Management, Research, Project Planning, Consulting
Education
University of Maryland College Park 2009 — 2014
Doctor of Philosophy (PhD), Project Management, Civil Engineering
Georgia Institute of Technology 2007 — 2009
Master of Engineering (M.Eng.), Industrial & System Engineering
Shanghai Jiao Tong University 2006 — 2009
Master of Science (M.S.) for Corporate Management, Logistics, and Supply Chain Management
Shanghai Jiao Tong University 2002 — 2006
Bachelor of Science (B.S.), Environmental Engineering Technology/Environmental Technology
Boeing May 2015 - Present
Federal Aviation Administration - FAA (Via THANE Inc.) December 2014 - May 2015
The World Bank July 2013 - October 2013
FDA May 2011 - August 2012
Maryland State Highway Administration (Via University of Maryland) September 2009 - October 2010
Robert Bosch Engineering and Business Solutions Ltd. November 2008 - April 2009
The CID Group September 2006 - December 2007
Shanghai Electric Group Co., Ltd May 2007 - September 2007
Shanghai Jiao Tong University May 2005 - August 2006
Skills
Project Management, Data Analysis, Operations Management, Program Management, Sustainability, Industrial Engineering, Risk Analytics, MS Project, Renewable Energy, Climate Change, Wind, Energy Efficiency, SQL, Matlab, Environmental Policy, Energy, Energy Policy, Statistics, Environmental Awareness, Engineering, Environmental Science, Simulations, Stochastic Programming, SAS programming, C++, @Risk, GAMS, SAP, Analysis, Sustainable Energy, Strategy, Economics, Program M, Management, Research, Project Planning, Consulting
Education
University of Maryland College Park 2009 — 2014
Doctor of Philosophy (PhD), Project Management, Civil Engineering
Georgia Institute of Technology 2007 — 2009
Master of Engineering (M.Eng.), Industrial & System Engineering
Shanghai Jiao Tong University 2006 — 2009
Master of Science (M.S.) for Corporate Management, Logistics, and Supply Chain Management
Shanghai Jiao Tong University 2002 — 2006
Bachelor of Science (B.S.), Environmental Engineering Technology/Environmental Technology
Bradford Hilson Bradford Hilson's FDA Experience May 2012 - Present
Job Candidate for Doctor of Medicine Degree, 2017
Industry Hospital & Health Care
Experience
FDA May 2012 - Present
Georgetown University Biology Department January 2010 - May 2012
Skills
Protein Chemistry, Microbiology, Research, Microsoft Office, Spanish, PCR, Data Analysis, Cell Culture, Gel Electrophoresis, Biochemistry, Molecular Biology, Laboratory, Statistics
Education
Georgetown University 2008 — 2012
Bachelor of Science (B.S.) Biology, Biology, Pre-Med Program
Xaverian Brothers High School 2004 — 2008
FDA May 2012 - Present
Georgetown University Biology Department January 2010 - May 2012
Skills
Protein Chemistry, Microbiology, Research, Microsoft Office, Spanish, PCR, Data Analysis, Cell Culture, Gel Electrophoresis, Biochemistry, Molecular Biology, Laboratory, Statistics
Education
Georgetown University 2008 — 2012
Bachelor of Science (B.S.) Biology, Biology, Pre-Med Program
Xaverian Brothers High School 2004 — 2008
Jane Hubbard's FDA Experience October 2012 - Present
Job Health Communication Specialist at FDA
Industry Public Relations and Communications
Experience
FDA October 2012 - Present
FDA January 2012 - September 2012
FDA January 2011 - December 2011
FDA September 2010 - December 2010
The Porter Gaud School August 2008 - April 2009
Skills
Public Health, Community Outreach, Public Relations, Health Communication, Government, Strategic Communications, Data Analysis, Crisis Communications, Media Relations, Press Releases
Education
Georgetown University 2015 — 2017
Master's Degree, Public Relations and Corporate Communication
UNC Gillings School of Global Public Health 2010 — 2011
Certificate, Public Health
University of North Carolina at Chapel Hill 2005 — 2007
BA, Psychology
Wofford College 2003 — 2005
Psychology/Spanish
FDA October 2012 - Present
FDA January 2012 - September 2012
FDA January 2011 - December 2011
FDA September 2010 - December 2010
The Porter Gaud School August 2008 - April 2009
Skills
Public Health, Community Outreach, Public Relations, Health Communication, Government, Strategic Communications, Data Analysis, Crisis Communications, Media Relations, Press Releases
Education
Georgetown University 2015 — 2017
Master's Degree, Public Relations and Corporate Communication
UNC Gillings School of Global Public Health 2010 — 2011
Certificate, Public Health
University of North Carolina at Chapel Hill 2005 — 2007
BA, Psychology
Wofford College 2003 — 2005
Psychology/Spanish
Edlira Stanisich Edlira Stanisich's FDA Experience 2002 - 2005
Job Associate Scientist at Macrogenics
Industry Biotechnology
Experience
MacroGenics December 2012 - Present
Human Genome Sciences October 2006 - December 2012
International Mission for Iraqi Elections 2005 - 2006
Georgetown University August 2004 - May 2005
FDA 2002 - 2005
University of the District 2000 - 2002
IOM 2000 - 2000
Skills
ELISA, R&D, Immunoassays, Assay Development, Validation, Clinical Trials, GLP, Biotechnology, Management Of Direct..., Pre-clinical Studies, SOP authoring, Technical Writing, MSD platform, Data Analysis, Research, Microsoft Office, FDA, Regulatory Affairs, Aseptic Technique, Tissue Culture, BSL 2, Troubleshooting, Bioanalytical Reports, Antibodies
Education
Georgetown University 2004 — 2005
"MS", Microbiology & Immunology
University of the District of Columbia 1999 — 2002
"BS", Chemistry
MacroGenics December 2012 - Present
Human Genome Sciences October 2006 - December 2012
International Mission for Iraqi Elections 2005 - 2006
Georgetown University August 2004 - May 2005
FDA 2002 - 2005
University of the District 2000 - 2002
IOM 2000 - 2000
Skills
ELISA, R&D, Immunoassays, Assay Development, Validation, Clinical Trials, GLP, Biotechnology, Management Of Direct..., Pre-clinical Studies, SOP authoring, Technical Writing, MSD platform, Data Analysis, Research, Microsoft Office, FDA, Regulatory Affairs, Aseptic Technique, Tissue Culture, BSL 2, Troubleshooting, Bioanalytical Reports, Antibodies
Education
Georgetown University 2004 — 2005
"MS", Microbiology & Immunology
University of the District of Columbia 1999 — 2002
"BS", Chemistry
James Norman's FDA Experience January 2015 - Present
Job FDA reviewer
Industry Pharmaceuticals
Experience
FDA January 2015 - Present
Massachusetts Institute of Technology (MIT) February 2014 - January 2015
Centers for Disease Control and Prevention October 2012 - February 2014
Georgia Institute of Technology August 2006 - October 2012
Intel Corporation May 2006 - August 2006
Education
Georgia Institute of Technology 2006 — 2011
Ph.D., Chemical Engineering
The University of Texas at Austin 2002 — 2006
B.S., Chemical Engineering
FDA January 2015 - Present
Massachusetts Institute of Technology (MIT) February 2014 - January 2015
Centers for Disease Control and Prevention October 2012 - February 2014
Georgia Institute of Technology August 2006 - October 2012
Intel Corporation May 2006 - August 2006
Education
Georgia Institute of Technology 2006 — 2011
Ph.D., Chemical Engineering
The University of Texas at Austin 2002 — 2006
B.S., Chemical Engineering
Joseph Majdi Joseph Majdi's FDA Experience February 2012 - December 2014
Job PhD Student in Electrical Engineering
Industry Medical Devices
Experience
George Mason University August 2014 - Present
FDA February 2012 - December 2014
Tulane University May 2009 - December 2011
Tulane University August 2007 - December 2011
Skills
Biomedical Engineering, Image Analysis, Matlab, Laboratory, Cell Culture, Abaqus, Labview, Fluorescence Microscopy, Data Analysis, Solidworks, Neuroscience, Patch-clamp, Animal Surgery, Electronics, Differential..., Bioengineering, Biotechnology, Science
Education
Tulane University 2010 — 2011
Master of Science (MS), Biomedical Engineering, 3.97
Tulane University 2006 — 2011
B.S.E., Biomedical Engineering
George Mason University
Electrical and Computer Engineering
George Mason University August 2014 - Present
FDA February 2012 - December 2014
Tulane University May 2009 - December 2011
Tulane University August 2007 - December 2011
Skills
Biomedical Engineering, Image Analysis, Matlab, Laboratory, Cell Culture, Abaqus, Labview, Fluorescence Microscopy, Data Analysis, Solidworks, Neuroscience, Patch-clamp, Animal Surgery, Electronics, Differential..., Bioengineering, Biotechnology, Science
Education
Tulane University 2010 — 2011
Master of Science (MS), Biomedical Engineering, 3.97
Tulane University 2006 — 2011
B.S.E., Biomedical Engineering
George Mason University
Electrical and Computer Engineering
Hieu Bui Hieu Bui's FDA Experience May 2012 - August 2012
Job Technology Research Analyst at IP2Biz LLC
Industry Biotechnology
Experience
Georgia Institute of Technology March 2013 - July 2014
IP2Biz LLC January 2013 - August 2013
Georgia Institute of Technology August 2011 - December 2012
FDA May 2012 - August 2012
Apluslearninglab January 2011 - May 2011
Georgia Institute of Technology January 2010 - December 2010
Skills
Bioengineering, Biomaterials, Tissue Engineering, Biomedical Engineering, Cell Culture, Matlab, ELISA, Solidworks, ANSYS, Abaqus, Simulink, NI LabVIEW, Instron, Statistics, ImageJ, Mechanical Testing, Tensile Testing, Materials Science, Polymer Characterization, Customer Service, Technical Presentations, AutoCAD, Calorimetry, Column Chromatography, Plasma Etching, PECVD, ICP, Lithography, AFM
Education
Georgia Institute of Technology 2008 — 2012
Bachelor's degree, Biomedical engineering
chapel hill high school
mount zion high school
Georgia Institute of Technology March 2013 - July 2014
IP2Biz LLC January 2013 - August 2013
Georgia Institute of Technology August 2011 - December 2012
FDA May 2012 - August 2012
Apluslearninglab January 2011 - May 2011
Georgia Institute of Technology January 2010 - December 2010
Skills
Bioengineering, Biomaterials, Tissue Engineering, Biomedical Engineering, Cell Culture, Matlab, ELISA, Solidworks, ANSYS, Abaqus, Simulink, NI LabVIEW, Instron, Statistics, ImageJ, Mechanical Testing, Tensile Testing, Materials Science, Polymer Characterization, Customer Service, Technical Presentations, AutoCAD, Calorimetry, Column Chromatography, Plasma Etching, PECVD, ICP, Lithography, AFM
Education
Georgia Institute of Technology 2008 — 2012
Bachelor's degree, Biomedical engineering
chapel hill high school
mount zion high school
Yolanda K. Jenkins Yolanda K. Jenkins's FDA Experience December 2011 - Present
Job Policy Analyst at FDA
Industry Public Policy
Experience
FDA December 2011 - Present
FDA July 2007 - December 2011
ASCAP April 2007 - May 2011
United States Pharmacopeia 2005 - 2007
Harvest Life Changers Church August 2002 - September 2006
National Institutes of Health/National Institute of Biomedical Imaging and Bioengineering 2004 - 2005
National Institutes of Health, Center for Scientific Review March 2004 - September 2004
INOVA Fairfax Hospital December 2001 - March 2004
Time-Life Customer Service Incorporated November 1997 - August 2001
Skills
Writing, Health Promotion, FDA, Healthcare, Non-profits, Organization Management, Media Relations, Strategic Communications, Communications and..., Communication, Public Policy, Leadership, Nonprofits, Customer Service, Management, Strategic Planning, Policy, Grants, Budgets, Public Health, Policy Analysis, Grant Writing, Government, Research, Proposal Writing, Program Evaluation, Federal Government, Editing, Crisis Communications, Program Development, Report Writing, Qualitative Research, Health Policy, Public Relations
Education
George Mason University 2001 — 2003
MPA, Public Administration/Health Policy
George Mason University 2001 — 2003
Master of Public Administration; MPA, Health Policy
Virginia Commonwealth University 1997 — 2001
Bachelor of Science (BS), Mass Communications
Virginia Commonwealth University 1995 — 2001
B.S., Mass-Communications/Electronic Media
FDA December 2011 - Present
FDA July 2007 - December 2011
ASCAP April 2007 - May 2011
United States Pharmacopeia 2005 - 2007
Harvest Life Changers Church August 2002 - September 2006
National Institutes of Health/National Institute of Biomedical Imaging and Bioengineering 2004 - 2005
National Institutes of Health, Center for Scientific Review March 2004 - September 2004
INOVA Fairfax Hospital December 2001 - March 2004
Time-Life Customer Service Incorporated November 1997 - August 2001
Skills
Writing, Health Promotion, FDA, Healthcare, Non-profits, Organization Management, Media Relations, Strategic Communications, Communications and..., Communication, Public Policy, Leadership, Nonprofits, Customer Service, Management, Strategic Planning, Policy, Grants, Budgets, Public Health, Policy Analysis, Grant Writing, Government, Research, Proposal Writing, Program Evaluation, Federal Government, Editing, Crisis Communications, Program Development, Report Writing, Qualitative Research, Health Policy, Public Relations
Education
George Mason University 2001 — 2003
MPA, Public Administration/Health Policy
George Mason University 2001 — 2003
Master of Public Administration; MPA, Health Policy
Virginia Commonwealth University 1997 — 2001
Bachelor of Science (BS), Mass Communications
Virginia Commonwealth University 1995 — 2001
B.S., Mass-Communications/Electronic Media
Rikin Mehta's FDA Experience April 2012 - January 2014
Job Healthcare and Medical Products Regulatory Executive
Industry Pharmaceuticals
Experience
DC Department of Health (DOH) January 2014 - Present
Rutgers University, School of Health Related Professions December 2011 - Present
FDA April 2012 - January 2014
Food and Drug Administration 2011 - 2012
FDA 2010 - 2011
FDA 2008 - 2010
Robert Wood Johnson University Hospital 2002 - 2008
Rite Aid Pharmacy 2001 - 2002
Skills
Policy, Healthcare, Public Health, Infectious Diseases, Managed Care, Pharmacology, Hospitals, Informatics, FDA, Pharmaceutical Industry, Pharmacy, Pharmacists, Clinical Pharmacy, Pharmacy Benefit..., Clinical Pharmacology, Regulatory Affairs, Pharmaceutics, Drug Development, Health Law, Global Health, Policy Analysis, Health Policy
Education
Georgetown University Law Center 2009 — 2011
LLM
Rutgers University School of Law - Newark
JD
University of Arkansas for Medical Sciences
Pharm.D
Rutgers University-New Brunswick
B.S.
Graduate Institute of International and Development Studies
Master of Laws (LL.M.)
DC Department of Health (DOH) January 2014 - Present
Rutgers University, School of Health Related Professions December 2011 - Present
FDA April 2012 - January 2014
Food and Drug Administration 2011 - 2012
FDA 2010 - 2011
FDA 2008 - 2010
Robert Wood Johnson University Hospital 2002 - 2008
Rite Aid Pharmacy 2001 - 2002
Skills
Policy, Healthcare, Public Health, Infectious Diseases, Managed Care, Pharmacology, Hospitals, Informatics, FDA, Pharmaceutical Industry, Pharmacy, Pharmacists, Clinical Pharmacy, Pharmacy Benefit..., Clinical Pharmacology, Regulatory Affairs, Pharmaceutics, Drug Development, Health Law, Global Health, Policy Analysis, Health Policy
Education
Georgetown University Law Center 2009 — 2011
LLM
Rutgers University School of Law - Newark
JD
University of Arkansas for Medical Sciences
Pharm.D
Rutgers University-New Brunswick
B.S.
Graduate Institute of International and Development Studies
Master of Laws (LL.M.)
Chad Burger,'s FDA Experience July 2012 - Present
Job Biologist at FDA
Industry Hospital & Health Care
Experience
FDA July 2012 - Present
Battelle December 2008 - July 2012
Walter Reed Army Medical Center February 2007 - February 2009
Walter Reed Army Medical Center November 2005 - February 2007
Johns Hopkins Hospital June 2002 - August 2006
Skills
Microbiology, Laboratory, Molecular Biology, PCR, Lifesciences, GMP, Quality Assurance, FDA, Infectious Diseases, Cell Culture, Clinical Trials, FDA GMP, Regulatory Submissions, Aseptic Processing, Environmental Monitoring, Regulatory Affairs, Validation, Sterilization, Clean Rooms, Pharmaceutical Industry, Clinical Research, DNA sequencing, Immunology, Microscopy, Healthcare, ELISA, Cleaning Validation, Inspection, Lyophilization, 21 CFR, Microsoft Office, Biologics, Compliance, Emerging Infectious..., Biodefense, Healthcare Information..., Purchasing, Management, CMC Regulatory Affairs, Point of Care, Sterility, Bioburden, Quality Management, Writing, Technical Writing, Risk Management, Risk Assessment, Site Inspections, Life Sciences
Education
Georgetown University 2013 — 2015
Biohazardous Threat Agents and Emerging Infectious Diseases
The Johns Hopkins University 2003 — 2005
Master's of Science; Master's Degree; a, Biotechnology; Biotechnology; Bio
University of Maryland Baltimore 2000 — 2002
BS, Medical Technology
University of Maryland Baltimore 2000 — 2002
Bachelor's of Science, Medical Technology
FDA July 2012 - Present
Battelle December 2008 - July 2012
Walter Reed Army Medical Center February 2007 - February 2009
Walter Reed Army Medical Center November 2005 - February 2007
Johns Hopkins Hospital June 2002 - August 2006
Skills
Microbiology, Laboratory, Molecular Biology, PCR, Lifesciences, GMP, Quality Assurance, FDA, Infectious Diseases, Cell Culture, Clinical Trials, FDA GMP, Regulatory Submissions, Aseptic Processing, Environmental Monitoring, Regulatory Affairs, Validation, Sterilization, Clean Rooms, Pharmaceutical Industry, Clinical Research, DNA sequencing, Immunology, Microscopy, Healthcare, ELISA, Cleaning Validation, Inspection, Lyophilization, 21 CFR, Microsoft Office, Biologics, Compliance, Emerging Infectious..., Biodefense, Healthcare Information..., Purchasing, Management, CMC Regulatory Affairs, Point of Care, Sterility, Bioburden, Quality Management, Writing, Technical Writing, Risk Management, Risk Assessment, Site Inspections, Life Sciences
Education
Georgetown University 2013 — 2015
Biohazardous Threat Agents and Emerging Infectious Diseases
The Johns Hopkins University 2003 — 2005
Master's of Science; Master's Degree; a, Biotechnology; Biotechnology; Bio
University of Maryland Baltimore 2000 — 2002
BS, Medical Technology
University of Maryland Baltimore 2000 — 2002
Bachelor's of Science, Medical Technology
Jennifer Morgan Gray's FDA Experience July 2015 - Present
Job Wordsmith and Communications Professional
Industry Writing and Editing
Experience
FDA July 2015 - Present
FDA Center for Tobacco Products April 2014 - July 2015
FDA Center for Tobacco Products January 2012 - April 2014
Elizabeth Glaser Pediatric AIDS Foundation August 2005 - January 2012
Elizabeth Glaser Pediatric AIDS Foundation 2004 - 2005
Woman's Day Special Interest Publications (Hachette Filipacchi Media) 2001 - 2004
Barnes & Noble.com 2000 - 2001
Hyperion Books (Disney) 1997 - 2000
Skills
Strategic Communications, Management, Team Leadership, Writing, Editing, Web Strategy, Web Content, Publication Strategy, Publication Planning, Publication Development, Speech Writing, Op-eds, Magazine Articles, Internal Communications, Publishing, Non-profits, Public Health, Nonprofits, Copywriting, Kindness, Copy Editing, Digital Media, Editorial, Press Releases, Leadership, Publicity, Publications, Proofreading, Proposal Writing, Media Relations, Journalism, Social Media
Education
Georgetown University 2012 — 2012
Certificate in Marketing, Marketing
Radcliffe Publishing Course 1997 — 1997
Publishing Certificate, All aspects of publishing
University of Virginia 1993 — 1997
B.A., Major: English; Minor: History
Ward Melville High School 1991 — 1993
FDA July 2015 - Present
FDA Center for Tobacco Products April 2014 - July 2015
FDA Center for Tobacco Products January 2012 - April 2014
Elizabeth Glaser Pediatric AIDS Foundation August 2005 - January 2012
Elizabeth Glaser Pediatric AIDS Foundation 2004 - 2005
Woman's Day Special Interest Publications (Hachette Filipacchi Media) 2001 - 2004
Barnes & Noble.com 2000 - 2001
Hyperion Books (Disney) 1997 - 2000
Skills
Strategic Communications, Management, Team Leadership, Writing, Editing, Web Strategy, Web Content, Publication Strategy, Publication Planning, Publication Development, Speech Writing, Op-eds, Magazine Articles, Internal Communications, Publishing, Non-profits, Public Health, Nonprofits, Copywriting, Kindness, Copy Editing, Digital Media, Editorial, Press Releases, Leadership, Publicity, Publications, Proofreading, Proposal Writing, Media Relations, Journalism, Social Media
Education
Georgetown University 2012 — 2012
Certificate in Marketing, Marketing
Radcliffe Publishing Course 1997 — 1997
Publishing Certificate, All aspects of publishing
University of Virginia 1993 — 1997
B.A., Major: English; Minor: History
Ward Melville High School 1991 — 1993
Jenny Haliski's FDA Experience February 2012 - February 2015
Job Chief, Media Relations Branch at National Cancer Institute (NCI)
Industry Health, Wellness and Fitness
Experience
National Cancer Institute (NCI) February 2015 - Present
FDA February 2012 - February 2015
National Institutes of Health July 2008 - February 2012
National Institutes of Health December 2006 - July 2009
massage therapist 2006 - 2009
The Advisory Board Company 2000 - 2006
Education
Georgetown University 1998 — 2000
University of Hamburg 1997 — 1998
Fulbright Scholar, Journalism, German and political science
University of Oregon 1994 — 1997
Bachelor of Arts, Journalism (magazine) and German Language and Literature
National Cancer Institute (NCI) February 2015 - Present
FDA February 2012 - February 2015
National Institutes of Health July 2008 - February 2012
National Institutes of Health December 2006 - July 2009
massage therapist 2006 - 2009
The Advisory Board Company 2000 - 2006
Education
Georgetown University 1998 — 2000
University of Hamburg 1997 — 1998
Fulbright Scholar, Journalism, German and political science
University of Oregon 1994 — 1997
Bachelor of Arts, Journalism (magazine) and German Language and Literature
Matt Scherer's FDA Experience January 2014 - Present
Job at
Industry Pharmaceuticals
Experience
FDA January 2014 - Present
FDA May 2007 - January 2014
Bassich & Associates 2004 - May 2007
Gene Logic, Inc. 2001 - 2002
Education
Georgetown University - The McDonough School of Business
Master of Business Administration (MBA)
University of Wisconsin-Madison
Bachelor of Science (B.S.), Molecular Biology
FDA January 2014 - Present
FDA May 2007 - January 2014
Bassich & Associates 2004 - May 2007
Gene Logic, Inc. 2001 - 2002
Education
Georgetown University - The McDonough School of Business
Master of Business Administration (MBA)
University of Wisconsin-Madison
Bachelor of Science (B.S.), Molecular Biology
Diane Cooke's FDA Experience November 2011 - November 2013
Job eLearning Developer at Insight Global
Industry Online Media
Experience
Insight Global October 2014 - Present
The Computer Merchant March 2014 - August 2014
FDA November 2011 - November 2013
Regent University November 2004 - June 2011
Virginia Beach Convention Center June 1988 - June 2011
Coastal Training Technologies May 1994 - May 2004
WABS Radio May 1985 - May 1995
NUS Training Corporation 1982 - 1987
Skills
Editing, Social Media, Photoshop, Technical Writing, Microsoft Office, Non-profits, PowerPoint, After Effects, E-Learning, Newsletters, Camtasia, Multimedia, Instructional Design, Research, Broadcast, Captivate, Strategic Communications, Adobe Acrobat, Teaching, Graphic Design, Final Cut Pro, Training, Graphics, Dreamweaver, Flash, Animation, Video, Video Production, Film, Television, Film Production, Web Design, Screenwriting, New Media, Video Editing, Marketing, Creative Writing, Voice Over, Content Management, Digital Media, Videography, Social Networking, Higher Education, Leadership, Adobe Creative Suite, Blogging, Social Media Marketing, Copywriting, Premiere, Copy Editing
Education
Old Dominion University 2007 — 2015
ABD, seeking Ph.D., English (New Media/Professional Writing track), 3.94
The Maryland Institute College of Art 2000 — 2006
Foundation Level Certificate, Online Web Design, 3.78
Regent University 1987 — 1989
M.A., Communication (Film), 4.0
George Mason University 1980 — 1983
B.A., Studio Art, 3.45
Insight Global October 2014 - Present
The Computer Merchant March 2014 - August 2014
FDA November 2011 - November 2013
Regent University November 2004 - June 2011
Virginia Beach Convention Center June 1988 - June 2011
Coastal Training Technologies May 1994 - May 2004
WABS Radio May 1985 - May 1995
NUS Training Corporation 1982 - 1987
Skills
Editing, Social Media, Photoshop, Technical Writing, Microsoft Office, Non-profits, PowerPoint, After Effects, E-Learning, Newsletters, Camtasia, Multimedia, Instructional Design, Research, Broadcast, Captivate, Strategic Communications, Adobe Acrobat, Teaching, Graphic Design, Final Cut Pro, Training, Graphics, Dreamweaver, Flash, Animation, Video, Video Production, Film, Television, Film Production, Web Design, Screenwriting, New Media, Video Editing, Marketing, Creative Writing, Voice Over, Content Management, Digital Media, Videography, Social Networking, Higher Education, Leadership, Adobe Creative Suite, Blogging, Social Media Marketing, Copywriting, Premiere, Copy Editing
Education
Old Dominion University 2007 — 2015
ABD, seeking Ph.D., English (New Media/Professional Writing track), 3.94
The Maryland Institute College of Art 2000 — 2006
Foundation Level Certificate, Online Web Design, 3.78
Regent University 1987 — 1989
M.A., Communication (Film), 4.0
George Mason University 1980 — 1983
B.A., Studio Art, 3.45
Mallory Duquesne's FDA Experience October 2007 - November 2009
Job Sr Product Development and Regulatory Affairs consultant at Novartis
Industry Pharmaceuticals
Experience
Novartis June 2015 - Present
Aurofinity Life Sciences February 2014 - May 2015
Biogen May 2013 - December 2013
Genzyme March 2011 - April 2012
Blue Torch Medical January 2010 - February 2011
FDA October 2007 - November 2009
Genentech June 2005 - August 2007
Eli Lilly and Company August 2003 - July 2004
Wyeth/Baxter International Inc. January 2002 - July 2003
Bayer HealthCare January 2001 - December 2001
Skills
FDA, Validation, GMP, CAPA, Pharmaceutical Industry, Biotechnology, V&V, GLP, Biopharmaceuticals, 21 CFR Part 11, Regulatory Affairs, Technology Transfer, Change Control, Quality System, Computer System..., SOP, Medical Devices, Regulatory Submissions
Education
Georgia Tech 1986 — 1989
Bachelor of Engineering (B.Eng.), Chemical Engineering, 3.5
Spring Hill College 1983 — 1986
Bachelor of Arts (B.A.), Biology, General, 3.4
Novartis June 2015 - Present
Aurofinity Life Sciences February 2014 - May 2015
Biogen May 2013 - December 2013
Genzyme March 2011 - April 2012
Blue Torch Medical January 2010 - February 2011
FDA October 2007 - November 2009
Genentech June 2005 - August 2007
Eli Lilly and Company August 2003 - July 2004
Wyeth/Baxter International Inc. January 2002 - July 2003
Bayer HealthCare January 2001 - December 2001
Skills
FDA, Validation, GMP, CAPA, Pharmaceutical Industry, Biotechnology, V&V, GLP, Biopharmaceuticals, 21 CFR Part 11, Regulatory Affairs, Technology Transfer, Change Control, Quality System, Computer System..., SOP, Medical Devices, Regulatory Submissions
Education
Georgia Tech 1986 — 1989
Bachelor of Engineering (B.Eng.), Chemical Engineering, 3.5
Spring Hill College 1983 — 1986
Bachelor of Arts (B.A.), Biology, General, 3.4
Sandra Park's FDA Experience August 2010 - April 2012
Job Corporate Counsel at Genentech
Industry Law Practice
Experience
Genentech May 2012 - Present
FDA August 2010 - April 2012
Morgan, Lewis & Bockius LLP April 2009 - August 2010
Sonnenschein Nath & Rosenthal LLP January 2008 - April 2009
Epstein Becker & Green, P.C. August 2005 - December 2007
CVS Caremark Corporation August 2000 - May 2005
ATP/PPDI August 1998 - July 1999
Skills
Health Law, Legal Research, Litigation, HIPAA, FDA, Healthcare, Regulations, Legal Writing, Policy, Internal Investigations, Pharmaceutical Industry, Regulatory Affairs, Fraud
Education
George Mason University School of Law 2002 — 2005
JD
University of North Carolina at Chapel Hill 1993 — 1998
B.S., Pharmacy
NC School of Science and Mathematics (NCSSM) 1991 — 1993
H.S. Diploma
University of Virginia
Genentech May 2012 - Present
FDA August 2010 - April 2012
Morgan, Lewis & Bockius LLP April 2009 - August 2010
Sonnenschein Nath & Rosenthal LLP January 2008 - April 2009
Epstein Becker & Green, P.C. August 2005 - December 2007
CVS Caremark Corporation August 2000 - May 2005
ATP/PPDI August 1998 - July 1999
Skills
Health Law, Legal Research, Litigation, HIPAA, FDA, Healthcare, Regulations, Legal Writing, Policy, Internal Investigations, Pharmaceutical Industry, Regulatory Affairs, Fraud
Education
George Mason University School of Law 2002 — 2005
JD
University of North Carolina at Chapel Hill 1993 — 1998
B.S., Pharmacy
NC School of Science and Mathematics (NCSSM) 1991 — 1993
H.S. Diploma
University of Virginia
Andrey Makeev's FDA Experience December 2014 - Present
Job Staff Fellow at FDA
Industry Research
Experience
FDA December 2014 - Present
UMass Medical School January 2011 - September 2014
Naval Research Laboratory 2003 - 2010
Skills
Monte Carlo Simulation, Programming, Research, Mathematics, Medical Imaging, Computed Tomography, Image Processing, Statistics, Science, Physics, Matlab, Simulations, Mathematica, X-ray, Mathematical Modeling, Algorithms
Education
George Mason University 2003 — 2010
Ph.D., Computational Sciences & Informatics
FDA December 2014 - Present
UMass Medical School January 2011 - September 2014
Naval Research Laboratory 2003 - 2010
Skills
Monte Carlo Simulation, Programming, Research, Mathematics, Medical Imaging, Computed Tomography, Image Processing, Statistics, Science, Physics, Matlab, Simulations, Mathematica, X-ray, Mathematical Modeling, Algorithms
Education
George Mason University 2003 — 2010
Ph.D., Computational Sciences & Informatics
Adrienne Walker's FDA Experience December 2013 - Present
Job Director, Program Effectiveness Office, Office of Operations at FDA
Industry Information Technology and Services
Experience
FDA December 2013 - Present
Program Manager - Information Sharing Environment April 2011 - December 2013
Office of Management and Budget September 2009 - June 2011
Department of Housing and Urban Development November 2007 - 2009
Department of Veterans Affairs 2004 - 2007
PricewaterhouseCoopers 2002 - 2004
Hammes Company 2000 - 2001
Skills
Government, Change Management, Program Management, Federal Government, Enterprise Architecture, Governance, Strategy, Leadership, Policy, Process Improvement, Integration, Business Process, Policy Analysis, Management, SDLC, Project Management, Information Sharing, Strategic Planning, Analysis, IT Management, Budgets, PMO, Information Technology, Executive Management, Performance Management
Education
University of Michigan 1998 — 2000
MHSA, Health Care Administration
Georgetown University 1994 — 1998
BA, Psychology
renaissance 1990 — 1994
High School Diploma
FDA December 2013 - Present
Program Manager - Information Sharing Environment April 2011 - December 2013
Office of Management and Budget September 2009 - June 2011
Department of Housing and Urban Development November 2007 - 2009
Department of Veterans Affairs 2004 - 2007
PricewaterhouseCoopers 2002 - 2004
Hammes Company 2000 - 2001
Skills
Government, Change Management, Program Management, Federal Government, Enterprise Architecture, Governance, Strategy, Leadership, Policy, Process Improvement, Integration, Business Process, Policy Analysis, Management, SDLC, Project Management, Information Sharing, Strategic Planning, Analysis, IT Management, Budgets, PMO, Information Technology, Executive Management, Performance Management
Education
University of Michigan 1998 — 2000
MHSA, Health Care Administration
Georgetown University 1994 — 1998
BA, Psychology
renaissance 1990 — 1994
High School Diploma
Allison Kumar's FDA Experience June 2011 - Present
Job MCM Sr. Program Manager at FDA
Industry Medical Devices
Experience
FDA June 2011 - Present
FDA October 2006 - June 2011
Seracare March 2005 - October 2006
Digene Corporation June 2001 - March 2005
Skills
FDA, Medical Devices, ISO 13485, Biomedical Engineering, Validation, Biotechnology, Lifesciences, R&D, GMP, Design Control, 21 CFR Part 11, Quality System, CAPA, Clinical Trials, Life Sciences, Sop
Education
Georgetown University 2011 — 2013
Graduate Certificate, Biohazardous Threat Agents & Emerging Infectious Diseases
Virginia Polytechnic Institute and State University 1996 — 2000
Engineering Science and Mechanics, Biomechanics
FDA June 2011 - Present
FDA October 2006 - June 2011
Seracare March 2005 - October 2006
Digene Corporation June 2001 - March 2005
Skills
FDA, Medical Devices, ISO 13485, Biomedical Engineering, Validation, Biotechnology, Lifesciences, R&D, GMP, Design Control, 21 CFR Part 11, Quality System, CAPA, Clinical Trials, Life Sciences, Sop
Education
Georgetown University 2011 — 2013
Graduate Certificate, Biohazardous Threat Agents & Emerging Infectious Diseases
Virginia Polytechnic Institute and State University 1996 — 2000
Engineering Science and Mechanics, Biomechanics
Rick Friedman's FDA Experience January 2015 - Present
Job
Industry Pharmaceuticals
Experience
FDA January 2015 - Present
FDA/ CDER Office of Manufacturing and Product Quality July 2011 - January 2015
FDA September 2006 - June 2011
FDA June 2002 - November 2006
FDA June 1995 - June 2002
FDA July 1990 - June 1995
Skills
FDA, GMP, Pharmaceutical Industry, Validation, Sop, Regulatory Affairs, Regulatory Submissions, Quality Assurance, Quality System
Education
Georgetown University School of Medicine
M.S., Microbiology
Montclair State University
Bachelor of Science (B.S.), Biology
FDA January 2015 - Present
FDA/ CDER Office of Manufacturing and Product Quality July 2011 - January 2015
FDA September 2006 - June 2011
FDA June 2002 - November 2006
FDA June 1995 - June 2002
FDA July 1990 - June 1995
Skills
FDA, GMP, Pharmaceutical Industry, Validation, Sop, Regulatory Affairs, Regulatory Submissions, Quality Assurance, Quality System
Education
Georgetown University School of Medicine
M.S., Microbiology
Montclair State University
Bachelor of Science (B.S.), Biology
Michelle (DiFilippo) Belinkie's FDA Experience October 2011 - April 2014
Job CoFounder, Coach at MoCo Track Club
Industry Government Administration
Experience
MoCo Track Club August 2014 - Present
FDA October 2011 - April 2014
FDA May 2010 - October 2011
Kuwait-America Foundation September 2005 - June 2010
Qorvis Communications January 2005 - September 2005
Skills
Public Policy, Government, Federal Government, Policy Analysis, Strategic Communications, Research, Non-profits, Public Administration, Media Relations, Program Evaluation, Public Relations, Nonprofits, Qualitative Research, Community Outreach, Grant Writing, International Relations, Leadership, Program Development, Data Analysis, Proposal Writing, Social Media, Policy, Politics, Community Development, Public Health
Education
George Mason University 2007 — 2010
M.P.A., Public Administration
Virginia Polytechnic Institute and State University 2001 — 2005
B.A., Communication and Sociology
West Springfield High School 1997 — 2001
MoCo Track Club August 2014 - Present
FDA October 2011 - April 2014
FDA May 2010 - October 2011
Kuwait-America Foundation September 2005 - June 2010
Qorvis Communications January 2005 - September 2005
Skills
Public Policy, Government, Federal Government, Policy Analysis, Strategic Communications, Research, Non-profits, Public Administration, Media Relations, Program Evaluation, Public Relations, Nonprofits, Qualitative Research, Community Outreach, Grant Writing, International Relations, Leadership, Program Development, Data Analysis, Proposal Writing, Social Media, Policy, Politics, Community Development, Public Health
Education
George Mason University 2007 — 2010
M.P.A., Public Administration
Virginia Polytechnic Institute and State University 2001 — 2005
B.A., Communication and Sociology
West Springfield High School 1997 — 2001
Elizabeth Godwin's FDA Experience June 2015 - Present
Job Regulatory Project Manager
Industry Hospital & Health Care
Experience
FDA June 2015 - Present
The EMMES Corporation June 2011 - June 2015
Data Networks Corporation December 2010 - May 2011
Cabezon Group, Inc. October 2009 - December 2010
Professional and Scientific Associates August 2008 - October 2009
Skills
Clinical Research, Clinical Trials, Data Management, Regulatory Submissions, GCP, Clinical Data Management, Life Sciences, Public Health
Education
The George Washington University School of Medicine and Health Sciences 2010 — 2014
M.S.H.S., Clinical Research Administration
George Mason University 2006 — 2008
B.A., Integrative Studies with a concentration in Liberal Arts for Elementary Education
FDA June 2015 - Present
The EMMES Corporation June 2011 - June 2015
Data Networks Corporation December 2010 - May 2011
Cabezon Group, Inc. October 2009 - December 2010
Professional and Scientific Associates August 2008 - October 2009
Skills
Clinical Research, Clinical Trials, Data Management, Regulatory Submissions, GCP, Clinical Data Management, Life Sciences, Public Health
Education
The George Washington University School of Medicine and Health Sciences 2010 — 2014
M.S.H.S., Clinical Research Administration
George Mason University 2006 — 2008
B.A., Integrative Studies with a concentration in Liberal Arts for Elementary Education
Tom Kraus's FDA Experience September 2015 - Present
Job Chief of Staff at FDA
Industry Government Administration
Experience
FDA September 2015 - Present
FDA August 2014 - September 2015
McKinsey & Company February 2011 - August 2014
United States Senate August 2006 - May 2011
Ernst & Young 2004 - 2006
Education
Georgetown University Law Center
Doctor of Law (J.D.)
The Johns Hopkins University
MHS, Health Policy
University of Michigan
BS, Biology
FDA September 2015 - Present
FDA August 2014 - September 2015
McKinsey & Company February 2011 - August 2014
United States Senate August 2006 - May 2011
Ernst & Young 2004 - 2006
Education
Georgetown University Law Center
Doctor of Law (J.D.)
The Johns Hopkins University
MHS, Health Policy
University of Michigan
BS, Biology
Shaila Shaheed's FDA Experience December 2013 - Present
Job FDA Project Manager, Office of the Chief Scientist/ Office of Regulatory Science and Innovation
Industry Biotechnology
Experience
FDA December 2013 - Present
FDA July 2010 - November 2013
Covance Inc. May 2007 - April 2010
Covance Inc. August 2002 - April 2007
Skills
FDA, Validation, Sop, GLP, GMP
Education
The George Washington University 2013 — 2014
Master's Certificate in Project Management, Project Management
The Johns Hopkins University 2005 — 2008
Master of Science, Biotechnology with Concentration in Regulatory Affairs
George Mason University 1998 — 2002
Bachelor of Science, Biology
FDA December 2013 - Present
FDA July 2010 - November 2013
Covance Inc. May 2007 - April 2010
Covance Inc. August 2002 - April 2007
Skills
FDA, Validation, Sop, GLP, GMP
Education
The George Washington University 2013 — 2014
Master's Certificate in Project Management, Project Management
The Johns Hopkins University 2005 — 2008
Master of Science, Biotechnology with Concentration in Regulatory Affairs
George Mason University 1998 — 2002
Bachelor of Science, Biology
Elisabeth Hanan's FDA Experience June 2013 - Present
Job Regulatory Project Manager at FDA
Industry Government Administration
Experience
FDA June 2013 - Present
AVANZA Laboratories July 2011 - May 2013
AVANZA Laboratories December 2009 - July 2011
Bridge Laboratories February 2008 - December 2009
Bridge Global Pharmaceutical Services, Inc. December 2006 - February 2008
Gene Logic July 2006 - December 2006
CoGenesys March 2005 - July 2006
Human Genome Sciences June 2003 - March 2005
Skills
CRO
Education
Georgetown University 2002 — 2003
MS
St. Mary's College of Maryland 1998 — 2002
BA
FDA June 2013 - Present
AVANZA Laboratories July 2011 - May 2013
AVANZA Laboratories December 2009 - July 2011
Bridge Laboratories February 2008 - December 2009
Bridge Global Pharmaceutical Services, Inc. December 2006 - February 2008
Gene Logic July 2006 - December 2006
CoGenesys March 2005 - July 2006
Human Genome Sciences June 2003 - March 2005
Skills
CRO
Education
Georgetown University 2002 — 2003
MS
St. Mary's College of Maryland 1998 — 2002
BA
Anne Marie Finley's FDA Experience 1989 - 1993
Job President at Biotech Policy Group LLC
Industry Pharmaceuticals
Experience
Biotech Policy Group LLC 2001 - Present
Celgene 2007 - 2014
US Department of Health and Human Services May 2007 - March 2011
GE Healthcare 2003 - 2004
Ketchum 1999 - 2001
U.S. House of Representatives 1995 - 1999
The Hershey Company 1993 - 1995
FDA 1989 - 1993
Skills
Public Policy, Public Affairs, Policy, Regulatory Affairs, Government, Legislative Relations, Biotechnology, Healthcare, Crisis Management, FDA, Crisis Communications, Public Relations, Speech Writing, Legislation, Drug Development, Strategic Communications, Community Outreach, Medical Devices, orphan drug development, Lobbying, Policy Analysis, Message Development, Program Management, Grassroots Organizing, Media Relations, Coalitions, food and nutrition..., International Relations, Political Campaigns, Health Policy, Governmental Affairs, Political Consulting, Political Communication, Reputation Management, Corporate Communications, Corporate Social..., Grants, Internal Communications, Spokesperson, Communication Training, Fundraising, Press Releases, Nonprofits, Communications Planning, Investment analysis..., Politics, Pharmaceutical Industry, Strategy, Grant Writing, Health Economics
Education
The University of Texas at Austin - Red McCombs School of Business 1996 — 1997
MS
Georgetown University
Bachelor's Degree
The George Washington University
Graduate Certificate
Biotech Policy Group LLC 2001 - Present
Celgene 2007 - 2014
US Department of Health and Human Services May 2007 - March 2011
GE Healthcare 2003 - 2004
Ketchum 1999 - 2001
U.S. House of Representatives 1995 - 1999
The Hershey Company 1993 - 1995
FDA 1989 - 1993
Skills
Public Policy, Public Affairs, Policy, Regulatory Affairs, Government, Legislative Relations, Biotechnology, Healthcare, Crisis Management, FDA, Crisis Communications, Public Relations, Speech Writing, Legislation, Drug Development, Strategic Communications, Community Outreach, Medical Devices, orphan drug development, Lobbying, Policy Analysis, Message Development, Program Management, Grassroots Organizing, Media Relations, Coalitions, food and nutrition..., International Relations, Political Campaigns, Health Policy, Governmental Affairs, Political Consulting, Political Communication, Reputation Management, Corporate Communications, Corporate Social..., Grants, Internal Communications, Spokesperson, Communication Training, Fundraising, Press Releases, Nonprofits, Communications Planning, Investment analysis..., Politics, Pharmaceutical Industry, Strategy, Grant Writing, Health Economics
Education
The University of Texas at Austin - Red McCombs School of Business 1996 — 1997
MS
Georgetown University
Bachelor's Degree
The George Washington University
Graduate Certificate
Peyton Hobson's FDA Experience November 2009 - Present
Job Regulatory Scientist
Industry Biotechnology
Experience
FDA November 2009 - Present
MSD April 2006 - November 2009
National Institutes of Health 2001 - 2005
Skills
Biochemistry, Immunoassays, Immunology, Molecular Biology, Cell Culture, Lifesciences, Cancer, Microbiology, Regulatory Submissions, Cell Biology, Validation, Drug Discovery, Protein Chemistry, Genomics, Small Molecules, ELISA, Toxicology, Drug Development, Immunohistochemistry, Nanotechnology
Education
Georgetown University 1997 — 2001
M.S./Ph.D., Biochemistry
Salisbury University 1993 — 1997
B.S., Biology
FDA November 2009 - Present
MSD April 2006 - November 2009
National Institutes of Health 2001 - 2005
Skills
Biochemistry, Immunoassays, Immunology, Molecular Biology, Cell Culture, Lifesciences, Cancer, Microbiology, Regulatory Submissions, Cell Biology, Validation, Drug Discovery, Protein Chemistry, Genomics, Small Molecules, ELISA, Toxicology, Drug Development, Immunohistochemistry, Nanotechnology
Education
Georgetown University 1997 — 2001
M.S./Ph.D., Biochemistry
Salisbury University 1993 — 1997
B.S., Biology
Phillip Johns's FDA Experience February 1977 - April 1985
Job Principal Consultant at Regulatory and Toxicology Consultant, LLC
Industry Pharmaceuticals
Experience
Regulatory and Toxicology Consultant, LLC April 1993 - Present
Battelle April 1992 - April 1993
Huntingdon Research Centre March 1985 - April 1992
FDA February 1977 - April 1985
Skills
Pharmaceutical Industry, FDA, Biotechnology, Lifesciences, Clinical Research, GCP, Sop, Regulatory Affairs, GMP, Drug Development, Dermatology, Medical Devices, Oncology, CRO, Drug Discovery, Regulatory Submissions, GLP, Pharmacokinetics, Pharmaceutics, Toxicology, Clinical Development, Clinical Trials, IND, Laboratory, Biopharmaceuticals, Protocol, Regulatory Requirements, Vaccines, Pharmacovigilance, Validation, Technology Transfer, 21 CFR Part 11
Education
Georgetown University School of Medicine 1976 — 1977
Post Doctoral Research, Biochemistry
University of Pittsburgh School of Medicine 1972 — 1977
Doctor of Philosophy (Ph.D.), Biochemistry
Potomac School of Law/ Antioch School of Law 1972 — 1974
Doctor of Law (J.D.)
Washington and Jefferson College 1968 — 1972
Bachelor of Arts (B.A.), Chemistry
Regulatory and Toxicology Consultant, LLC April 1993 - Present
Battelle April 1992 - April 1993
Huntingdon Research Centre March 1985 - April 1992
FDA February 1977 - April 1985
Skills
Pharmaceutical Industry, FDA, Biotechnology, Lifesciences, Clinical Research, GCP, Sop, Regulatory Affairs, GMP, Drug Development, Dermatology, Medical Devices, Oncology, CRO, Drug Discovery, Regulatory Submissions, GLP, Pharmacokinetics, Pharmaceutics, Toxicology, Clinical Development, Clinical Trials, IND, Laboratory, Biopharmaceuticals, Protocol, Regulatory Requirements, Vaccines, Pharmacovigilance, Validation, Technology Transfer, 21 CFR Part 11
Education
Georgetown University School of Medicine 1976 — 1977
Post Doctoral Research, Biochemistry
University of Pittsburgh School of Medicine 1972 — 1977
Doctor of Philosophy (Ph.D.), Biochemistry
Potomac School of Law/ Antioch School of Law 1972 — 1974
Doctor of Law (J.D.)
Washington and Jefferson College 1968 — 1972
Bachelor of Arts (B.A.), Chemistry
Eric Dubbin's FDA Experience February 2007 - Present
Job Executive Coach at FDA
Industry Veterinary
Experience
FDA February 2007 - Present
GTN OD program 2010 - 2010
FDA 2002 - 2007
Skills
Organizational..., Executive Coaching, Public Speaking, Leadership, Coaching, MBTI, Leadership Development, Training, Project Planning, Science, Management Consulting, Veterinary, Change Management, Public Health, Team Building, Veterinary Medicine, Teaching, Research
Education
Georgetown University 2008 — 2008
certificate, leadership coaching
University of Florida 1984 — 1988
DVM, veterinary medicine
FDA February 2007 - Present
GTN OD program 2010 - 2010
FDA 2002 - 2007
Skills
Organizational..., Executive Coaching, Public Speaking, Leadership, Coaching, MBTI, Leadership Development, Training, Project Planning, Science, Management Consulting, Veterinary, Change Management, Public Health, Team Building, Veterinary Medicine, Teaching, Research
Education
Georgetown University 2008 — 2008
certificate, leadership coaching
University of Florida 1984 — 1988
DVM, veterinary medicine
Alyssa (Ngangan) Kitchel's FDA Experience April 2015 - Present
Job Lead Reviewer Biomedical Engineer at FDA
Industry Medical Devices
Experience
FDA April 2015 - Present
Kimberly-Clark September 2014 - April 2015
Kimberly-Clark May 2012 - September 2014
Georgia Institute of Technology August 2011 - April 2012
Georgia Institute of Technology August 2005 - August 2011
Pfizer 2003 - 2005
Pfizer June 2003 - September 2003
Tufts University 2000 - 2003
Skills
developing cell-based..., embryonic stem cell..., gene targeting, Tissue Engineering, Cell Culture, Biomaterials, Stem Cells, Biomedical Engineering, Laboratory, Microscopy, Gene Targeting, Regenerative Medicine, Fluorescence Microscopy, Flow Cytometry, Confocal Microscopy, Biotechnology, PCR, Molecular Biology
Education
Georgia Institute of Technology 2005 — 2011
Ph.D., Biomedical Engineering
Tufts University 1999 — 2003
B.S., Chemical Engineering
FDA April 2015 - Present
Kimberly-Clark September 2014 - April 2015
Kimberly-Clark May 2012 - September 2014
Georgia Institute of Technology August 2011 - April 2012
Georgia Institute of Technology August 2005 - August 2011
Pfizer 2003 - 2005
Pfizer June 2003 - September 2003
Tufts University 2000 - 2003
Skills
developing cell-based..., embryonic stem cell..., gene targeting, Tissue Engineering, Cell Culture, Biomaterials, Stem Cells, Biomedical Engineering, Laboratory, Microscopy, Gene Targeting, Regenerative Medicine, Fluorescence Microscopy, Flow Cytometry, Confocal Microscopy, Biotechnology, PCR, Molecular Biology
Education
Georgia Institute of Technology 2005 — 2011
Ph.D., Biomedical Engineering
Tufts University 1999 — 2003
B.S., Chemical Engineering
Thomas Colatsky's FDA Experience February 2011 - September 2013
Job Director, Division of Applied Regulatory Science at FDA
Industry Pharmaceuticals
Experience
FDA/CDER/OTS/OCP September 2013 - Present
FDA February 2011 - September 2013
FDA July 2009 - February 2011
FDA July 2009 - February 2011
GainStage Biosciences January 2009 - July 2009
Alte Biosciences May 2006 - January 2009
PharmaDirections May 2006 - December 2008
Icoria (a Clinical Data company) August 2002 - May 2006
Argolyn Biosciences September 2001 - August 2002
Physiome Sciences February 1999 - August 2001
Skills
Drug Discovery, Pharmacology, Clinical Development, Toxicology, Biomarkers, Computational Biology, Systems Biology, Technology Development, Computational Modeling, Ion Channels, Cardiovascular Medicine, Metabolic Diseases, Biomarker Discovery, Drug Development, Pharmacogenomics, Electrophysiology, Regulatory Science, Technology Evaluation, Pharmaceutical Research, Pharmaceutical..., Lifesciences, Biotechnology, FDA, IND, Pharmaceutical Industry, R, Translational Medicine, Clinical Trials, Pharmacokinetics, Life Sciences, Oncology, In Vitro, Assay Development, Pharmaceutics, Product Development, CRO, Medicine, Immunology, Science, Genomics, Metabolism, In Vivo, GCP, ADME, Cell, Biopharmaceuticals, Clinical Research, R&D
Education
Yale University School of Medicine 1977 — 1979
Post-doctoral
State University of New York at Buffalo - School of Medicine & Biomedical Sciences 1972 — 1977
Ph.D.
Georgetown University 1967 — 1972
B.S.
FDA/CDER/OTS/OCP September 2013 - Present
FDA February 2011 - September 2013
FDA July 2009 - February 2011
FDA July 2009 - February 2011
GainStage Biosciences January 2009 - July 2009
Alte Biosciences May 2006 - January 2009
PharmaDirections May 2006 - December 2008
Icoria (a Clinical Data company) August 2002 - May 2006
Argolyn Biosciences September 2001 - August 2002
Physiome Sciences February 1999 - August 2001
Skills
Drug Discovery, Pharmacology, Clinical Development, Toxicology, Biomarkers, Computational Biology, Systems Biology, Technology Development, Computational Modeling, Ion Channels, Cardiovascular Medicine, Metabolic Diseases, Biomarker Discovery, Drug Development, Pharmacogenomics, Electrophysiology, Regulatory Science, Technology Evaluation, Pharmaceutical Research, Pharmaceutical..., Lifesciences, Biotechnology, FDA, IND, Pharmaceutical Industry, R, Translational Medicine, Clinical Trials, Pharmacokinetics, Life Sciences, Oncology, In Vitro, Assay Development, Pharmaceutics, Product Development, CRO, Medicine, Immunology, Science, Genomics, Metabolism, In Vivo, GCP, ADME, Cell, Biopharmaceuticals, Clinical Research, R&D
Education
Yale University School of Medicine 1977 — 1979
Post-doctoral
State University of New York at Buffalo - School of Medicine & Biomedical Sciences 1972 — 1977
Ph.D.
Georgetown University 1967 — 1972
B.S.
Lucas Kempf's FDA Experience 2012 - Present
Job Medical Officer at FDA
Industry Mental Health Care
Experience
FDA 2012 - Present
Lucas Kempf, MD PLLC 2005 - Present
Veterans Health Administration February 2012 - September 2012
Community Connections, Inc. 2011 - February 2012
National Institute of Mental Health 2005 - 2011
schizophrenia.com 1995 - 1998
Skills
Mental Health, Psychotherapy, Psychopharmacology, Adults, Genetics, Clinical, Neuroscience, Clinical Research, Research, Healthcare, Teaching, Psychology, Treatment, Board Certified, CBT, Behavioral Health, Neuroimaging, Statistics
Education
The Johns Hopkins University School of Medicine 2002 — 2005
Resident, psychiatry
Georgetown University School of Medicine 2001 — 2002
Intern, Psychiatry
University of Kansas Medical Center 1997 — 2001
MD, Medicine
University of California, Berkeley 1991 — 1995
BA, Molecular Cell Biology
SMS
FDA 2012 - Present
Lucas Kempf, MD PLLC 2005 - Present
Veterans Health Administration February 2012 - September 2012
Community Connections, Inc. 2011 - February 2012
National Institute of Mental Health 2005 - 2011
schizophrenia.com 1995 - 1998
Skills
Mental Health, Psychotherapy, Psychopharmacology, Adults, Genetics, Clinical, Neuroscience, Clinical Research, Research, Healthcare, Teaching, Psychology, Treatment, Board Certified, CBT, Behavioral Health, Neuroimaging, Statistics
Education
The Johns Hopkins University School of Medicine 2002 — 2005
Resident, psychiatry
Georgetown University School of Medicine 2001 — 2002
Intern, Psychiatry
University of Kansas Medical Center 1997 — 2001
MD, Medicine
University of California, Berkeley 1991 — 1995
BA, Molecular Cell Biology
SMS
Gretchen Knaack's FDA Experience September 2014 - Present
Job ORISE Post Doctorate Fellow at FDA
Industry Research
Experience
FDA September 2014 - Present
George Mason University July 2010 - August 2014
FDA February 2013 - August 2014
George Mason University August 2008 - July 2012
George Mason University August 2008 - July 2012
University of Central Florida August 2007 - July 2008
Skills
Electrophysiology, Immunohistochemistry, optogenetics, Primary Cell Isolation, Microelectrode arrays, Perfusion, Statistics, Fear Conditioning, SPSS
Education
George Mason University 2012 — 2014
Doctor of Philosophy (PhD), Neuroscience
George Mason University 2008 — 2012
Master of Arts (MA), Biopsychology
University of Central Florida 2004 — 2007
Bachelor of Science (BS), Psychology
FDA September 2014 - Present
George Mason University July 2010 - August 2014
FDA February 2013 - August 2014
George Mason University August 2008 - July 2012
George Mason University August 2008 - July 2012
University of Central Florida August 2007 - July 2008
Skills
Electrophysiology, Immunohistochemistry, optogenetics, Primary Cell Isolation, Microelectrode arrays, Perfusion, Statistics, Fear Conditioning, SPSS
Education
George Mason University 2012 — 2014
Doctor of Philosophy (PhD), Neuroscience
George Mason University 2008 — 2012
Master of Arts (MA), Biopsychology
University of Central Florida 2004 — 2007
Bachelor of Science (BS), Psychology
Julie Tierney's FDA Experience August 2008 - Present
Job Associate Chief Counsel for Drugs at Food and Drug Administration
Industry Government Administration
Experience
FDA August 2008 - Present
Arent Fox November 2003 - July 2008
Buc & Beardsley September 2000 - October 2003
Education
Georgetown University Law Center 1997 — 2000
J.D., Law
The Johns Hopkins University 1993 — 1997
B.A., Biology & History
FDA August 2008 - Present
Arent Fox November 2003 - July 2008
Buc & Beardsley September 2000 - October 2003
Education
Georgetown University Law Center 1997 — 2000
J.D., Law
The Johns Hopkins University 1993 — 1997
B.A., Biology & History
Lauren Silvis's FDA Experience May 2015 - Present
Job Deputy Center Director for Policy, CDRH at FDA
Industry Law Practice
Experience
FDA May 2015 - Present
Sidley Austin LLP January 2011 - April 2015
Sidley Austin June 2006 - December 2010
Covington & Burling 2003 - 2006
Law Clerk, The Honorable James L. Ryan, United States Court of Appeals for the Sixth Circuit 2002 - 2003
Skills
Litigation, Medical Devices
Education
Georgetown University Law Center
Duke University
FDA May 2015 - Present
Sidley Austin LLP January 2011 - April 2015
Sidley Austin June 2006 - December 2010
Covington & Burling 2003 - 2006
Law Clerk, The Honorable James L. Ryan, United States Court of Appeals for the Sixth Circuit 2002 - 2003
Skills
Litigation, Medical Devices
Education
Georgetown University Law Center
Duke University
Sean Shahparast ♠ Hiring Like Crazy's FDA Experience June 2009 - September 2009
Job Head of Programmatic
Industry Internet
Experience
Bounce Exchange December 2013 - Present
Unwritten January 2013 - Present
The Advisory Board Company June 2013 - November 2013
Dorchester Group September 2012 - June 2013
Fannie Mae/U.S. Dept of the Treasury February 2010 - September 2012
GoDo.com January 2009 - January 2010
FDA June 2009 - September 2009
Royal Investment Group 2006 - 2008
Skills
Business Development, Business Strategy, Negotiation, Online Advertising, Ad Exchanges, Social Media, New Business Development, Marketing, E-commerce, Market Research, Real Estate, Financial Modeling, Marketing Strategy, Account Management, Business Planning, Sales
Education
Georgetown University 2008 — 2010
Masters, RE-Finance
University of Maryland - Robert H. Smith School of Business 2004 — 2008
B.S., Business-Finance
Bounce Exchange December 2013 - Present
Unwritten January 2013 - Present
The Advisory Board Company June 2013 - November 2013
Dorchester Group September 2012 - June 2013
Fannie Mae/U.S. Dept of the Treasury February 2010 - September 2012
GoDo.com January 2009 - January 2010
FDA June 2009 - September 2009
Royal Investment Group 2006 - 2008
Skills
Business Development, Business Strategy, Negotiation, Online Advertising, Ad Exchanges, Social Media, New Business Development, Marketing, E-commerce, Market Research, Real Estate, Financial Modeling, Marketing Strategy, Account Management, Business Planning, Sales
Education
Georgetown University 2008 — 2010
Masters, RE-Finance
University of Maryland - Robert H. Smith School of Business 2004 — 2008
B.S., Business-Finance
Paul Balcer's FDA Experience July 2011 - August 2015
Job Training Officer/Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA/ORA/Office of Resource Management/Division of Human Resources and Development August 2015 - Present
FDA July 2011 - August 2015
Food and Drug Administration, CDER's Office of Compliance, Off. of Manufacturing and Product Quality November 2010 - July 2011
FDA, CDER's Office of Compliance, Division of Manufacturing and Product Quality June 2007 - November 2010
FDA, CDER, Office of New Drugs, Division of Anaesthesia, Analgesia and Rheumatology Products July 2003 - June 2007
Association for the Advancement of Medical Instrumentation March 1998 - December 2002
American Industrial Hygiene Association, Fairfax, VA November 1994 - March 1998
Skills
CAPA, Regulatory Affairs, FDA, Pharmaceutical Industry, Quality Assurance, GMP, Quality System, Drug Development, Policy, Process Improvement, Pharmaceutics, Training, Regulatory Submissions, Regulatory Requirements, IND, Sop, GLP, Validation, Clinical Trials
Education
George Mason University 1990 — 1994
B.A., Biology
Divine Mercy College, Henley-on-Thames, Oxon, RG9 3AE, United Kingdom 1980 — 1985
FDA/ORA/Office of Resource Management/Division of Human Resources and Development August 2015 - Present
FDA July 2011 - August 2015
Food and Drug Administration, CDER's Office of Compliance, Off. of Manufacturing and Product Quality November 2010 - July 2011
FDA, CDER's Office of Compliance, Division of Manufacturing and Product Quality June 2007 - November 2010
FDA, CDER, Office of New Drugs, Division of Anaesthesia, Analgesia and Rheumatology Products July 2003 - June 2007
Association for the Advancement of Medical Instrumentation March 1998 - December 2002
American Industrial Hygiene Association, Fairfax, VA November 1994 - March 1998
Skills
CAPA, Regulatory Affairs, FDA, Pharmaceutical Industry, Quality Assurance, GMP, Quality System, Drug Development, Policy, Process Improvement, Pharmaceutics, Training, Regulatory Submissions, Regulatory Requirements, IND, Sop, GLP, Validation, Clinical Trials
Education
George Mason University 1990 — 1994
B.A., Biology
Divine Mercy College, Henley-on-Thames, Oxon, RG9 3AE, United Kingdom 1980 — 1985
Amy Egan's FDA Experience September 2014 - December 2014
Job Deputy Director, Office of Drug Evaluation III, FDA
Industry Pharmaceuticals
Experience
FDA September 2014 - December 2014
FDA September 2008 - November 2013
FDA March 2006 - September 2008
'Self-Employed' September 1986 - August 2001
Education
Johns Hopkins Bloomberg School of Public Health 2002 — 2004
Master of Public Health (MPH), Epidemiology
Loyola University Chicago Stritch School of Medicine 1981 — 1983
Doctor of Medicine (M.D.)
Georgetown University School of Medicine 1979 — 1981
Medicine
Santa Clara University 1971 — 1975
Bachelor of Science (B.S.), Biology/Biological Sciences, General
FDA September 2014 - December 2014
FDA September 2008 - November 2013
FDA March 2006 - September 2008
'Self-Employed' September 1986 - August 2001
Education
Johns Hopkins Bloomberg School of Public Health 2002 — 2004
Master of Public Health (MPH), Epidemiology
Loyola University Chicago Stritch School of Medicine 1981 — 1983
Doctor of Medicine (M.D.)
Georgetown University School of Medicine 1979 — 1981
Medicine
Santa Clara University 1971 — 1975
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Erica Butler, MS's FDA Experience August 2015 - Present
Job Program Analyst at FDA
Industry Biotechnology
Experience
FDA August 2015 - Present
George Washington University February 2012 - Present
National Institues of Health, National Cancer Institute (NCI) February 2014 - July 2015
National Institutes of Health December 2011 - February 2014
National Institutes of Health March 2008 - February 2014
MedStar Health September 2006 - March 2013
Skills
Quality Assurance, Laboratory, Clinical Research, Medical Devices, Chemistry, Quality Control, Cell, Microbiology, Toxicology, Analytical Chemistry, FDA, GLP, Immunology, Clinical Trials, Biotechnology, Blood Bank, Clinical Chemistry, Transfusion Medicine, Hematology, Data Analysis
Education
The Johns Hopkins University 2011 — 2013
Master of Science (M.S.), Bioscience Regulatory Affairs
George Mason University 2002 — 2006
Bachelor of Science (B.S.), Medical Technology
FDA August 2015 - Present
George Washington University February 2012 - Present
National Institues of Health, National Cancer Institute (NCI) February 2014 - July 2015
National Institutes of Health December 2011 - February 2014
National Institutes of Health March 2008 - February 2014
MedStar Health September 2006 - March 2013
Skills
Quality Assurance, Laboratory, Clinical Research, Medical Devices, Chemistry, Quality Control, Cell, Microbiology, Toxicology, Analytical Chemistry, FDA, GLP, Immunology, Clinical Trials, Biotechnology, Blood Bank, Clinical Chemistry, Transfusion Medicine, Hematology, Data Analysis
Education
The Johns Hopkins University 2011 — 2013
Master of Science (M.S.), Bioscience Regulatory Affairs
George Mason University 2002 — 2006
Bachelor of Science (B.S.), Medical Technology
Cyrus Agarabi's FDA Experience March 2015 - Present
Job Senior Regulatory Research/Review Officer/LCDR USPHS at FDA
Industry Biotechnology
Experience
FDA March 2015 - Present
FDA December 2009 - February 2015
Cherokee Pharma LLC July 2007 - September 2008
Denison Pharmaceuticals January 2007 - May 2007
URI, College of Pharmacy September 2006 - May 2007
Pawtuxet Valley Pharmacy & Surgical Center September 2005 - October 2006
University of Rhode Island, College of Pharmacy September 2005 - May 2006
Wyeth BioPharma June 2004 - August 2004
Wyeth BioPharma June 2003 - August 2003
Skills
Pharmacokinetics, GMP, Biotechnology, HPLC, UV/Vis, Cell Culture, Pharmaceutics, Formulation, Biopharmaceuticals, CAPA, Clinical Trials, FTIR, Protein Chemistry, Laboratory, Drug Development, Data Analysis, Quality System, Design of Experiments, Protein Purification, Biochemistry, Lyophilization, Quality by Design, Chromatography, Analytical Chemistry, Lifesciences, Cell, Aseptic Technique, Pharmaceutical Industry, Scientific Writing, Dissolution, Pharmacy, Regulatory Requirements, Aseptic Processing, Cell Biology, Drug Discovery, Validation, Chemistry, Assay Development
Education
Georgetown University 2012 — 2015
Master of Business Administration (M.B.A.)
University of Rhode Island 2005 — 2008
Ph.D., Pharmaceutical Sciences
University of Rhode Island 2005 — 2007
M.S., Manufacturing Systems Engineering
University of Rhode Island 2004 — 2006
M.S., Pharmaceutical Sciences
University of Rhode Island 1999 — 2005
Pharm.D., Pharmacy
FDA March 2015 - Present
FDA December 2009 - February 2015
Cherokee Pharma LLC July 2007 - September 2008
Denison Pharmaceuticals January 2007 - May 2007
URI, College of Pharmacy September 2006 - May 2007
Pawtuxet Valley Pharmacy & Surgical Center September 2005 - October 2006
University of Rhode Island, College of Pharmacy September 2005 - May 2006
Wyeth BioPharma June 2004 - August 2004
Wyeth BioPharma June 2003 - August 2003
Skills
Pharmacokinetics, GMP, Biotechnology, HPLC, UV/Vis, Cell Culture, Pharmaceutics, Formulation, Biopharmaceuticals, CAPA, Clinical Trials, FTIR, Protein Chemistry, Laboratory, Drug Development, Data Analysis, Quality System, Design of Experiments, Protein Purification, Biochemistry, Lyophilization, Quality by Design, Chromatography, Analytical Chemistry, Lifesciences, Cell, Aseptic Technique, Pharmaceutical Industry, Scientific Writing, Dissolution, Pharmacy, Regulatory Requirements, Aseptic Processing, Cell Biology, Drug Discovery, Validation, Chemistry, Assay Development
Education
Georgetown University 2012 — 2015
Master of Business Administration (M.B.A.)
University of Rhode Island 2005 — 2008
Ph.D., Pharmaceutical Sciences
University of Rhode Island 2005 — 2007
M.S., Manufacturing Systems Engineering
University of Rhode Island 2004 — 2006
M.S., Pharmaceutical Sciences
University of Rhode Island 1999 — 2005
Pharm.D., Pharmacy
Dr. Norman Goodacre's FDA Experience April 2015 - Present
Job Postdoctoral Fellow at FDA
Industry Biotechnology
Experience
FDA April 2015 - Present
Academic Minds, UK May 2012 - Present
Virginia Commonwealth University February 2012 - Present
J. Craig Venter Institute May 2009 - September 2009
C2 Education December 2004 - July 2008
Skills
Bioinformatics, Structural..., Structural Dynamics, Machine Learning, Computational Biology, Programming, Foreign Languages, Genetics, PCR, Molecular Biology, Genomics, Science, Sequence Analysis, R, Biochemistry, Statistics, Research, Life Sciences
Education
Georgetown University 2008 — 2014
Doctor of Philosophy (PhD), Biochemistry, Bioinformatics Track
University of Cambridge 2005 — 2006
Master's degree, Computational Biology
George Mason University 2003 — 2005
Bachelor of Science (B.S.), Biotechnology
FDA April 2015 - Present
Academic Minds, UK May 2012 - Present
Virginia Commonwealth University February 2012 - Present
J. Craig Venter Institute May 2009 - September 2009
C2 Education December 2004 - July 2008
Skills
Bioinformatics, Structural..., Structural Dynamics, Machine Learning, Computational Biology, Programming, Foreign Languages, Genetics, PCR, Molecular Biology, Genomics, Science, Sequence Analysis, R, Biochemistry, Statistics, Research, Life Sciences
Education
Georgetown University 2008 — 2014
Doctor of Philosophy (PhD), Biochemistry, Bioinformatics Track
University of Cambridge 2005 — 2006
Master's degree, Computational Biology
George Mason University 2003 — 2005
Bachelor of Science (B.S.), Biotechnology
Anissa Ryan Ferguson, PharmD, MS's FDA Experience January 2011 - Present
Job Safety Evaluator at the Food and Drug Administration
Industry Pharmaceuticals
Experience
FDA January 2011 - Present
Skills
Pharmacists, Regulatory Affairs, Pharmacy, Public Health, Healthcare, Biotechnology, Medical Writing, Pharmacovigilance, Molecular Biology, Public Speaking, Government, Infectious Diseases, Microsoft Office, Pharmaceutical Industry, Clinical Research, Policy Analysis, Patient Safety
Education
Howard University 2006 — 2010
PharmD, Pharmacy
Georgetown University 2000 — 2001
MS, Biochemistry and Molecular Biology with specialization in Biotechnology
SC State University 1996 — 2000
BS, Professional Biology
FDA January 2011 - Present
Skills
Pharmacists, Regulatory Affairs, Pharmacy, Public Health, Healthcare, Biotechnology, Medical Writing, Pharmacovigilance, Molecular Biology, Public Speaking, Government, Infectious Diseases, Microsoft Office, Pharmaceutical Industry, Clinical Research, Policy Analysis, Patient Safety
Education
Howard University 2006 — 2010
PharmD, Pharmacy
Georgetown University 2000 — 2001
MS, Biochemistry and Molecular Biology with specialization in Biotechnology
SC State University 1996 — 2000
BS, Professional Biology
Karen Bijwaard's FDA Experience April 2005 - Present
Job Scientific Master Reviewer at FDA
Industry Medical Devices
Experience
FDA April 2005 - Present
NIH May 2003 - April 2005
Armed Forces Institute of Pathology May 1996 - May 2003
Georgetown University Medical Center November 1988 - May 1996
Georgetown University Medical Center March 1988 - November 1988
Skills
Immunology, Cancer, Laboratory, Medical Devices, Molecular Diagnostics, DNA, Genomics, Life Sciences, Clinical Research, Molecular Biology, Assay Development, In Vitro, Hematology, Pathology, Biotechnology, Genetics, Lifesciences, IVD, PCR, Hardware Diagnostics, Biochemistry, Medicine, Research, Molecular Pathology, Pediatrics, Molecular Genetics, Software Requirements, Software Documentation
Education
Georgetown University 1989 — 1993
MSc, Pathology
Virginia Polytechnic Institute and State University 1983 — 1987
BS/BS, Animal Science/Biology
FDA April 2005 - Present
NIH May 2003 - April 2005
Armed Forces Institute of Pathology May 1996 - May 2003
Georgetown University Medical Center November 1988 - May 1996
Georgetown University Medical Center March 1988 - November 1988
Skills
Immunology, Cancer, Laboratory, Medical Devices, Molecular Diagnostics, DNA, Genomics, Life Sciences, Clinical Research, Molecular Biology, Assay Development, In Vitro, Hematology, Pathology, Biotechnology, Genetics, Lifesciences, IVD, PCR, Hardware Diagnostics, Biochemistry, Medicine, Research, Molecular Pathology, Pediatrics, Molecular Genetics, Software Requirements, Software Documentation
Education
Georgetown University 1989 — 1993
MSc, Pathology
Virginia Polytechnic Institute and State University 1983 — 1987
BS/BS, Animal Science/Biology
Jim Melchiors's FDA Experience June 2012 - Present
Job Engineer at FDA
Industry Mechanical or Industrial Engineering
Experience
FDA June 2012 - Present
Aerotek December 2011 - September 2012
Industrial TurnAround Corp. (ITAC) August 2011 - May 2012
HP 2012 - 2012
The Shaw Group March 2010 - December 2010
Altria Client Services February 2001 - December 2009
Brown & Williamson Tobacco 1997 - 2001
Education
University of Virginia 2003 — 2004
Masters, Systems Engineering
Georgia Institute of Technology 1988 — 1993
Bachelors, Mechanical Engineering
FDA June 2012 - Present
Aerotek December 2011 - September 2012
Industrial TurnAround Corp. (ITAC) August 2011 - May 2012
HP 2012 - 2012
The Shaw Group March 2010 - December 2010
Altria Client Services February 2001 - December 2009
Brown & Williamson Tobacco 1997 - 2001
Education
University of Virginia 2003 — 2004
Masters, Systems Engineering
Georgia Institute of Technology 1988 — 1993
Bachelors, Mechanical Engineering
jane gilbert's FDA Experience 2007 - Present
Job Medical Officer at FDA
Industry
Experience
FDA 2007 - Present
Skills
Public Health, Clinical Trials, Intellectual Property, Medicine, Clinical Research, Policy Analysis, Policy, Global Health, Government, Nonprofits, Internal Medicine, Healthcare
Education
Georgetown University School of Medicine 1987 — 1992
MD
University of Rochester
PhD, Political Science
FDA 2007 - Present
Skills
Public Health, Clinical Trials, Intellectual Property, Medicine, Clinical Research, Policy Analysis, Policy, Global Health, Government, Nonprofits, Internal Medicine, Healthcare
Education
Georgetown University School of Medicine 1987 — 1992
MD
University of Rochester
PhD, Political Science
Krutanjali Shah's FDA Experience December 2013 - Present
Job Biomedical Engineer at FDA
Industry Medical Devices
Experience
FDA December 2013 - Present
USPTO April 2012 - November 2013
International Technidyne Corporation July 2011 - March 2012
Stryker Orthopaedics January 2010 - August 2010
NJIT January 2009 - January 2010
Skills
ANSYS, Matlab, PTC Pro/Engineer, Pro/Mechanica, CAPA, NCMR, Microsoft Office, FDA GMP, Intellectual Property, Code of Federal..., Medical Devices, Biomaterials
Education
Georgia Institute of Technology 2013 — 2015
M.S., Mechanical Engineering
New Jersey Institute of Technology 2007 — 2011
B.S., Biomedical Engineering
FDA December 2013 - Present
USPTO April 2012 - November 2013
International Technidyne Corporation July 2011 - March 2012
Stryker Orthopaedics January 2010 - August 2010
NJIT January 2009 - January 2010
Skills
ANSYS, Matlab, PTC Pro/Engineer, Pro/Mechanica, CAPA, NCMR, Microsoft Office, FDA GMP, Intellectual Property, Code of Federal..., Medical Devices, Biomaterials
Education
Georgia Institute of Technology 2013 — 2015
M.S., Mechanical Engineering
New Jersey Institute of Technology 2007 — 2011
B.S., Biomedical Engineering
Vanessa Topping's FDA Experience ORISE Research FellowFDAMay 2012 - August 2014
Job Biologist
Industry Research
Experience
FDA ORISE Research FellowFDAMay 2012 - August 2014
Perinatology Research Branch, NICHD August 2011 - May 2012
Samueli Institute June 2011 - August 2011
Wayne State University School of Medicine September 2008 - August 2010
Wayne State University School of Medicine June 2007 - September 2007
Walter Reed Army Institute of Research June 2006 - August 2006
Skills
Mental Health, Lifesciences, Research, Program Evaluation, Epidemiology, Healthcare, Data Analysis, Statistics, Pathology, Toxicology, Biology, Science, Qualitative Research, Community Outreach, Public Speaking
Education
Georgetown University 2010 — 2011
MS, Physiology and Biophysics, Complementary and Alternative Medicine
Kalamazoo College 2004 — 2008
BA, Biology, French
FDA ORISE Research FellowFDAMay 2012 - August 2014
Perinatology Research Branch, NICHD August 2011 - May 2012
Samueli Institute June 2011 - August 2011
Wayne State University School of Medicine September 2008 - August 2010
Wayne State University School of Medicine June 2007 - September 2007
Walter Reed Army Institute of Research June 2006 - August 2006
Skills
Mental Health, Lifesciences, Research, Program Evaluation, Epidemiology, Healthcare, Data Analysis, Statistics, Pathology, Toxicology, Biology, Science, Qualitative Research, Community Outreach, Public Speaking
Education
Georgetown University 2010 — 2011
MS, Physiology and Biophysics, Complementary and Alternative Medicine
Kalamazoo College 2004 — 2008
BA, Biology, French
Lara Mittereder's FDA Experience July 2012 - Present
Job Research Fellow at FDA
Industry Research
Experience
FDA July 2012 - Present
National Cancer Institute September 2010 - July 2012
Neurology Center of Fairfax August 2009 - August 2010
Smithsonian Institution, Museum of Natural History June 2009 - September 2009
Fairfax County Public Libraries June 2006 - July 2009
Skills
PCR, Cell Biology, qPCR, Western Blotting, Molecular Biology, Cell Culture, Gel Electrophoresis, Cancer, DNA extraction, Assay Development, Bioinformatics, DNA
Education
The Johns Hopkins University 2010 — 2012
M.S., Biotechnology, Concentration in Molecular Targets & Drug Discovery
George Mason University 2006 — 2010
B.S., Biology, Concentration in Biotechnology
FDA July 2012 - Present
National Cancer Institute September 2010 - July 2012
Neurology Center of Fairfax August 2009 - August 2010
Smithsonian Institution, Museum of Natural History June 2009 - September 2009
Fairfax County Public Libraries June 2006 - July 2009
Skills
PCR, Cell Biology, qPCR, Western Blotting, Molecular Biology, Cell Culture, Gel Electrophoresis, Cancer, DNA extraction, Assay Development, Bioinformatics, DNA
Education
The Johns Hopkins University 2010 — 2012
M.S., Biotechnology, Concentration in Molecular Targets & Drug Discovery
George Mason University 2006 — 2010
B.S., Biology, Concentration in Biotechnology
Brian Trent's FDA Experience September 2010 - Present
Job Associate Director for Management and Director, Office of Management at FDA
Industry Public Policy
Experience
FDA September 2010 - Present
Education
George Mason University 1995 — 1996
Masters of Public Administration, Public Finance
FDA September 2010 - Present
Education
George Mason University 1995 — 1996
Masters of Public Administration, Public Finance
Molly Flannery's FDA Experience August 2010 - Present
Job Regulatory Counsel, FDA
Industry Government Administration
Experience
FDA August 2010 - Present
WilmerHale October 2003 - July 2010
Education
Harvard Law School 2000 — 2003
JD
Georgetown University
BS, Spanish and Business
FDA August 2010 - Present
WilmerHale October 2003 - July 2010
Education
Harvard Law School 2000 — 2003
JD
Georgetown University
BS, Spanish and Business
Max Robinowitz's FDA Experience July 1990 - Present
Job Medical OfficerPathologist at US Department of Health and Human Services
Industry Government Administration
Experience
US Department of Health and Human Services July 1990 - Present
FDA July 1990 - Present
Skills
Public Health, Epidemiology, Healthcare, Clinical Research, Medicine, Medical Education, Cancer, Board Certified, Lifesciences, Clinical Trials
Education
Georgetown University School of Medicine 1957 — 1961
Doctor of Medicine (MD)
US Department of Health and Human Services July 1990 - Present
FDA July 1990 - Present
Skills
Public Health, Epidemiology, Healthcare, Clinical Research, Medicine, Medical Education, Cancer, Board Certified, Lifesciences, Clinical Trials
Education
Georgetown University School of Medicine 1957 — 1961
Doctor of Medicine (MD)
Krystal Lansdowne's FDA Experience September 2012 - Present
Job Experienced Analyst
Industry Research
Experience
FDA September 2012 - Present
The World Bank April 2012 - June 2012
Centurion Research Solutions July 2011 - April 2012
Fairfax County Government October 2008 - July 2011
IBM August 2008 - October 2008
Anacomp 2007 - 2008
Skills
Research, Data Analysis, Microsoft Excel, Data Collection, Microsoft Office, Project Management, Business Analysis, PowerPoint, Market Research, Analysis, Access, Data Entry, Microsoft Word, Salesforce.com, Customer Service
Education
George Mason University 2006 — 2011
Bachelor of Arts (B.A.), Psychology
FDA September 2012 - Present
The World Bank April 2012 - June 2012
Centurion Research Solutions July 2011 - April 2012
Fairfax County Government October 2008 - July 2011
IBM August 2008 - October 2008
Anacomp 2007 - 2008
Skills
Research, Data Analysis, Microsoft Excel, Data Collection, Microsoft Office, Project Management, Business Analysis, PowerPoint, Market Research, Analysis, Access, Data Entry, Microsoft Word, Salesforce.com, Customer Service
Education
George Mason University 2006 — 2011
Bachelor of Arts (B.A.), Psychology
Marisa Petruccelli's FDA Experience October 2014 - Present
Job Regulatory Project Manager at FDA
Industry Writing and Editing
Experience
FDA October 2014 - Present
U.S. Energy Information Administration August 2013 - October 2014
XLA, INC April 2012 - August 2013
The Advisory Board Company 2010 - 2012
Capital Educators 2007 - 2009
Education
Georgetown University 2003 — 2007
BA, Psychology
FDA October 2014 - Present
U.S. Energy Information Administration August 2013 - October 2014
XLA, INC April 2012 - August 2013
The Advisory Board Company 2010 - 2012
Capital Educators 2007 - 2009
Education
Georgetown University 2003 — 2007
BA, Psychology
Rasheed Rabbi's FDA Experience September 2010 - May 2011
Job Sr. Java Developer at CGI
Industry Government Administration
Experience
CGI June 2013 - Present
Department of Veterans Affairs August 2011 - Present
Fannie Mae June 2011 - August 2011
FDA September 2010 - May 2011
Dovel Technologies 2010 - 2011
Department of Veterans Affairs February 2008 - September 2010
George Mason University January 2009 - May 2010
Fannie Mae August 2004 - January 2008
Verizon March 2004 - August 2004
Minnesota State University, Mankato September 2000 - June 2003
Skills
Healthcare Information..., Information Management, Enterprise Software..., Requirements Analysis, Professional Research &..., Software Documentation, Java, SQL, Enterprise Architecture, Microsoft SQL Server
Education
George Mason University 2007 — 2015
Doctor of Philosophy (PhD), Computer Software Engineering
Hartford Seminary 2010 — 2012
Master of Arts (M.A.), Theology/Theological Studies
George Mason University 2005 — 2007
Master of Science (MS), Computer Software Engineering
Minnesota State University, Mankato 2000 — 2004
BS, Computer and Information Sciences, General
National University, Bangladesh 1996 — 1999
Bachelor of Commerce (B.Com.), Business/Commerce, General
CGI June 2013 - Present
Department of Veterans Affairs August 2011 - Present
Fannie Mae June 2011 - August 2011
FDA September 2010 - May 2011
Dovel Technologies 2010 - 2011
Department of Veterans Affairs February 2008 - September 2010
George Mason University January 2009 - May 2010
Fannie Mae August 2004 - January 2008
Verizon March 2004 - August 2004
Minnesota State University, Mankato September 2000 - June 2003
Skills
Healthcare Information..., Information Management, Enterprise Software..., Requirements Analysis, Professional Research &..., Software Documentation, Java, SQL, Enterprise Architecture, Microsoft SQL Server
Education
George Mason University 2007 — 2015
Doctor of Philosophy (PhD), Computer Software Engineering
Hartford Seminary 2010 — 2012
Master of Arts (M.A.), Theology/Theological Studies
George Mason University 2005 — 2007
Master of Science (MS), Computer Software Engineering
Minnesota State University, Mankato 2000 — 2004
BS, Computer and Information Sciences, General
National University, Bangladesh 1996 — 1999
Bachelor of Commerce (B.Com.), Business/Commerce, General
Chris Hooban's FDA Experience February 2015 - Present
Job Regulatory Project Manager at FDA
Industry Defense & Space
Experience
FDA February 2015 - Present
Naval Surface Warfare Center January 2008 - February 2015
US Department of Health and Human Services September 2014 - December 2014
UIC Technical Services / Bowhead 2006 - 2008
Skills
Technical Writing, Government, Statistics, Data Analysis, Validation, Analysis, Research, Biology, Experimental Design, Program Management, Biodefense
Education
The George Washington University 2013 — 2015
Master of Public Health (M.P.H.), Public Health
George Mason University 2007 — 2012
Master's degree, Biodefense, 3.7
George Mason University 2001 — 2006
Bachelor of Science (B.S.), Biology
FDA February 2015 - Present
Naval Surface Warfare Center January 2008 - February 2015
US Department of Health and Human Services September 2014 - December 2014
UIC Technical Services / Bowhead 2006 - 2008
Skills
Technical Writing, Government, Statistics, Data Analysis, Validation, Analysis, Research, Biology, Experimental Design, Program Management, Biodefense
Education
The George Washington University 2013 — 2015
Master of Public Health (M.P.H.), Public Health
George Mason University 2007 — 2012
Master's degree, Biodefense, 3.7
George Mason University 2001 — 2006
Bachelor of Science (B.S.), Biology
Howard Yablon's FDA Experience July 2011 - Present
Job Contract Specialist at FDA
Industry Government Administration
Experience
FDA July 2011 - Present
Rainbow Medical Adult Day Care, LLC June 2006 - June 2010
Skills
Microsoft Excel, Financial Analysis, Budgets, Customer Service, Federal Government, Business Strategy, Government Contracting, Government, Government Procurement, Business Development, FAR
Education
University of Maryland College Park 1978 — 1981
BS, Accounting
Georgia Tech 1976 — 1977
FDA July 2011 - Present
Rainbow Medical Adult Day Care, LLC June 2006 - June 2010
Skills
Microsoft Excel, Financial Analysis, Budgets, Customer Service, Federal Government, Business Strategy, Government Contracting, Government, Government Procurement, Business Development, FAR
Education
University of Maryland College Park 1978 — 1981
BS, Accounting
Georgia Tech 1976 — 1977
Cheri Lindberg's FDA Experience January 2009 - March 2012
Job Medical Science and Treatment Advisor at Reckitt Benckiser PharmaceuticalsIndivior
Industry Pharmaceuticals
Experience
Reckitt Benckiser Pharmaceuticals: Indivior December 2014 - Present
Medpace April 2012 - December 2014
FDA January 2009 - March 2012
Marshall University School of Medicine January 2007 - January 2009
Skills
Clinical Trials, Medicine, Clinical Research, Drug Development, FDA, Psychiatry, IND, Clinical Development, Medical Writing, Pharmacovigilance, Life Sciences, GCP
Education
Marshall University, Joan C. Edwards School of Medicine 1992 — 1996
Doctor of Medicine (MD), Medicine
Georgetown University 2010 — 2011
Certificate of Public Health
Reckitt Benckiser Pharmaceuticals: Indivior December 2014 - Present
Medpace April 2012 - December 2014
FDA January 2009 - March 2012
Marshall University School of Medicine January 2007 - January 2009
Skills
Clinical Trials, Medicine, Clinical Research, Drug Development, FDA, Psychiatry, IND, Clinical Development, Medical Writing, Pharmacovigilance, Life Sciences, GCP
Education
Marshall University, Joan C. Edwards School of Medicine 1992 — 1996
Doctor of Medicine (MD), Medicine
Georgetown University 2010 — 2011
Certificate of Public Health
Carly Starke's FDA Experience May 2013 - August 2013
Job PhD Candidate at Georgetown UniversityNational Institutes of Health Graduate Partnership Program
Industry Research
Experience
National Institutes of Health July 2014 - Present
James Madison University August 2011 - May 2014
James Madison University August 2010 - May 2014
FDA May 2013 - August 2013
James Madison University August 2012 - May 2013
VaxInnate Corporation May 2012 - August 2012
James Madison University August 2011 - May 2012
VaxInnate Corporation May 2011 - August 2011
Skills
Microsoft Office, PCR, Molecular Biology, Research, Biotechnology, Data Analysis, Immunology, Flow Cytometry, Microbiology
Education
Georgetown University
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
NIH Graduate Partnership Program
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
James Madison University 2010 — 2014
Bachelor of Science (B.S.), Biotechnology
Biotechnology High School 2006 — 2010
National Institutes of Health July 2014 - Present
James Madison University August 2011 - May 2014
James Madison University August 2010 - May 2014
FDA May 2013 - August 2013
James Madison University August 2012 - May 2013
VaxInnate Corporation May 2012 - August 2012
James Madison University August 2011 - May 2012
VaxInnate Corporation May 2011 - August 2011
Skills
Microsoft Office, PCR, Molecular Biology, Research, Biotechnology, Data Analysis, Immunology, Flow Cytometry, Microbiology
Education
Georgetown University
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
NIH Graduate Partnership Program
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
James Madison University 2010 — 2014
Bachelor of Science (B.S.), Biotechnology
Biotechnology High School 2006 — 2010
Rita Deng's FDA Experience December 2010 - May 2013
Job Communications Specialist at The Henry M. Jackson Foundation for the Advancement of Military Medicine
Industry Public Relations and Communications
Experience
The Henry M. Jackson Foundation for the Advancement of Military Medicine March 2014 - Present
Booz Allen Hamilton September 2013 - March 2014
FDA December 2010 - May 2013
Institute of Medicine, The National Academies October 2008 - August 2010
Avalere Health September 2006 - September 2008
Skills
Project Management, Team Facilitation, Healthcare Consulting, Strategic Communications, Writing, Editing, Project Coordination, Event Management, Office Administration, Records Management, FDA, Regulations, Public Health, Health Policy, Change Management
Education
Johns Hopkins University, Bloomberg School of Public Health 2005 — 2007
Master of Health Science
Georgetown University 2001 — 2005
Bachelor of Science, Health Studies
The Henry M. Jackson Foundation for the Advancement of Military Medicine March 2014 - Present
Booz Allen Hamilton September 2013 - March 2014
FDA December 2010 - May 2013
Institute of Medicine, The National Academies October 2008 - August 2010
Avalere Health September 2006 - September 2008
Skills
Project Management, Team Facilitation, Healthcare Consulting, Strategic Communications, Writing, Editing, Project Coordination, Event Management, Office Administration, Records Management, FDA, Regulations, Public Health, Health Policy, Change Management
Education
Johns Hopkins University, Bloomberg School of Public Health 2005 — 2007
Master of Health Science
Georgetown University 2001 — 2005
Bachelor of Science, Health Studies
Lois Gross's FDA Experience January 1990 - Present
Job Chemist at FDA
Industry Government Administration
Experience
FDA January 1990 - Present
Skills
Data Analysis, Microsoft Excel, PowerPoint, Microsoft Word, Policy, Customer Service
Education
Georgia Institute of Technology
Master's degree, Medicinal and Pharmaceutical Chemistry
FDA January 1990 - Present
Skills
Data Analysis, Microsoft Excel, PowerPoint, Microsoft Word, Policy, Customer Service
Education
Georgia Institute of Technology
Master's degree, Medicinal and Pharmaceutical Chemistry
Department of Veterans Affairs
US Census Bureau
U.S. Department of Veterans Affairs
US Securities and Exchange Commission
USAID
US Fish and Wildlife Service
TSA
Defense Logistics Agency