Food and Drug Administration (FDA)
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Customer service: 1 (888) 463-6332 Emergency: 1 (866) 300-4374 Headquarters: Silver Spring, MD Jurisdiction: United States of America Founded: June 30, 1906 Founders: Theodore Roosevelt, Harvey Washington Wiley
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Food and Drug Administration (FDA) Employees
Food and Drug Administration (FDA) September 2014 - Present
Independent Sector January 2013 - Present
Arctic Slope Regional Corporation Management Services August 2009 - January 2013
University of Florida August 2008 - July 2009
University of Illinois at Urbana-Champaign December 2006 - July 2008
University of Nebraska Medical Center January 2006 - August 2006
University of Edinburgh 2001 - 2005
Skills
Research, Leadership, Project Management, Software Engineering, Algorithms, Systems Engineering, Public Speaking, Matlab, Web Design, Software Design, Simulations, Python, Engineering, Image Analysis, Mobile Applications, Change Management, Data Analysis, Program Management, Regulatory Affairs, Team Leadership, Strategic Planning, Management, Social Media
Education
The University of Edinburgh 2000 — 2005
Doctor of Philosophy, Electrical Engineering
University of Arizona 1999 — 2000
Electrical and Computer Engineering
University of Nebraska-Lincoln 1994 — 1999
Bachelors of Science, Electrical Engineering
Catholic Charities August 2015 - Present
N Street Village August 2014 - July 2015
Saint Elizabeths Hospital September 2013 - April 2014
DC Department of Mental Health September 2012 - April 2013
Altarum 2003 - 2010
George Washington University 2005 - 2008
Northrop Grumman Corporation January 2002 - May 2003
Center for Women's Policy Studies 2000 - 2001
Food and Drug Administration (FDA) 1996 - 1999
American College of Rheumatology 1990 - 1995
Skills
Organizational..., Public Health, Proposal Writing, Program Evaluation, Training, Workshop Facilitation, Public Speaking, Program Management, Fundraising, Non-profits, Policy Analysis, Community Outreach, Nonprofits, Grants, Leadership Development, Policy, Program Development, Strategic Planning, Leadership, Social Services, Government, Volunteer Management, Grant Writing, Community Development, Coalitions, Community Organizing, Public Policy, Grassroots Organizing, Technical Assistance, Staff Development, Health Policy, Mental Health, Legislative Relations, Case Management, Health Communication, Trauma Survivors, Client Counseling, Substance Abuse...
Education
University of Maryland, School of Social Work
Masters of Social Work (MSW), Clinical/Mental Health, 4.02 GPA
Career Coach Academy
Certified Career Management Coach
The George Washington University
MPA
University of Michigan
BA
Food and Drug Administration (FDA) August 2015 - Present
Johns Hopkins School of Medicine March 2014 - August 2015
Maryland Institute for Applied Environmental Health , University of Maryland January 2013 - March 2014
Medical College of Wisconsin August 2006 - July 2012
Vector Gene Technology Company Limited March 2003 - March 2004
Institute of Microbiology, Chinese Academy of Sciences January 2002 - July 2002
Skills
Molecular Cloning, Western Blotting, Fluorescence Microscopy, Cell Culture, chromatin..., Protein Purification, nucleosome and..., Microarrays, lentivirus mediated..., Scientific Writing, recombinant DNA..., DNA extraction, Protein Expression, RNA isolation, Transfection, retroviral transduction, real-time PCR, RT-PCR, DNase footprinting and..., mentoring and training, Presentations, Intellectual Property, Teamwork, research project..., Microarray, Molecular Biology, Quantitative immuno-PCR, Immunoassay, ELISA, fully automated..., Cell Biology, Microscopy, Cancer, Protein Chemistry, In Vitro, HPLC, PCR, Research, Science, Genomics, qPCR
Education
Medical College of Wisconsin 2006 — 2012
Doctor of Philosophy (Ph.D.), Cell/Cellular and Molecular Biology
Beijing Technology and Business University 1998 — 2002
Bachelor of Science (B.S.), Biochemical Engineering
Food and Drug Administration (FDA) October 2009 - Present
Food and Drug Administration January 2006 - December 2008
NIH, NCI January 2004 - December 2005
Bhabha Atomic Research Center (BARC) 2000 - 2003
Skills
Molecular Biology, Cell Culture, Stem Cells, Biochemistry, Cell Biology, PCR, Protein Chemistry, Western Blotting, Cell, Flow Cytometry, Animal Models, ELISA, RT-PCR, Protein Purification, Fluorescence Microscopy, Tissue Culture, Microscopy, Confocal Microscopy, Cancer Research, Molecular Cloning, Immunohistochemistry, Transfection, In Vitro, qPCR, In Vivo, Immunofluorescence, Protein Expression, SDS-PAGE, Genetics, Immunology
Education
University of Mumbai 2000 — 2003
Ph.D., Biochemistry, Radiation Biology
University of Mumbai 1996 — 1998
Masters, Life Sciences
Bayer June 2014 - Present
Novartis January 2013 - June 2014
Hogan Lovells July 2010 - August 2011
Food and Drug Administration (FDA) September 2007 - July 2010
Leonard Carder May 2006 - July 2006
Georgetown University Law Center August 2005 - May 2006
AARP February 2006 - April 2006
Skills
FDA, Legal Writing, Regulatory Submissions, Medical Devices, Administrative Law, Legal Compliance, Due Diligence, Legal Research, Food, Spanish, Health Law, Regulatory Affairs, Management, Pharmaceutical Industry, Strategy, Intellectual Property, Supplements, Corporate Law, Regulatory Requirements, SOP, Litigation, Research, Public Speaking, Cosmetics, Personal Care, Product Labeling, Quality Auditing, Regulatory Compliance
Education
Georgetown University Law Center 2003 — 2007
Doctor of Law (J.D.)
University of California, Los Angeles 1999 — 2003
Bachelor of Arts (B.A.), Communication Studies, with honors
REI Success Center November 2013 - Present
Capital Estate Investments LLC December 2012 - Present
Global Marketing Concepts, Inc. 2013 - 2013
Food and Drug Administration (FDA) May 2009 - August 2011
Oakwood University January 2010 - August 2010
National Association June 2008 - August 2008
Vector Marketing Corporation June 2007 - August 2007
Preventive Care Network Services June 2006 - August 2006
Skills
Microsoft Office, PowerPoint, Excel, Word, Outlook, NMR spectroscopy, IR spectroscopy, Mass Spectrometry, Title Searches, Microsoft Word, Teaching, Real Estate, Public Speaking, Community Outreach, NMR, Microsoft Excel, Marketing, Time Management, Sales, Nonprofits, Social Networking, Leadership, Fundraising, Social Media, Event Planning
Education
Oakwood College 2007 — 2011
B.S., Biology
Greenleaf Health LLC July 2009 - Present
Food and Drug Administration (FDA) January 2006 - June 2009
US House of Representatives August 2000 - January 2006
U.S. Senate May 1998 - August 2000
Education
Southern Methodist University 1993 — 1997
BA Political Science; BA Communications
PBGC September 2012 - Present
N.E.W. Customer Service Companies, LLC. February 2012 - September 2012
Freddie Mac/ Celcom January 2011 - January 2012
Food and Drug Administration (FDA) February 2010 - December 2010
CelCom consultant Inc. June 2009 - January 2010
Texas Instruments April 2002 - May 2009
Qualcom Systems 2006 - 2007
Armillaire 1999 - 2002
TIP 1990 - 1993
Skills
PMP, Quality Assurance, Testing, ISO, SDLC, Enterprise Risk..., Program Management, Engineering, Integration, Telecommunications, Project Planning, Risk Management, Security, Software Development, Project Management, Software Documentation, Enterprise Architecture, PMO, Management, ITIL, Project Portfolio..., Process Improvement, System Testing, Requirements Analysis, Process Engineering, Resource Management, Software Project..., Information Technology, Operating Systems, Business Process, Vendor Management, Leadership, Agile Methodologies, Team Leadership, MS Project, Visio, SOA, Analysis, IT Strategy, SharePoint, Requirements Gathering, IT Management, Agile Project Management
Education
The Johns Hopkins University - Carey Business School 2006 — 2010
MBA, General
The Johns Hopkins University 2000 — 2005
MS, Computer Sciences
University of Maryland College Park 1994 — 1995
MS, Telecommunicatios
University of Azad Jammu and Kashmir 1983 — 1988
BEE, Telecom
University of Azad Jammu and Kashmir 1982 — 1988
BEE, Telecommunications
Food and Drug Administration (FDA) September 2013 - Present
USEPA April 1998 - September 2013
The Weinberg Group November 1994 - April 1998
ICF/Clement June 1988 - November 1994
Skills
Toxicology, Environmental Consulting, Remediation, CERCLA, Environmental Compliance, Exposure Assessment, Environmental Awareness, Food Safety, Risk Assessment
Education
University of Michigan 1986 — 1988
mph, toxicology
University of Massachusetts, Amherst 1982 — 1986
Environmental Science
EduQuest, Inc. 2011 - Present
U.S Food and Drug Administration February 1985 - November 2002
FDA 1985 - 2002
Food and Drug Administration (FDA) 1985 - 2002
Skills
Quality Systems..., Medical Device..., Pharmaceutical..., Biologics Regulations, FDA Regulatory Training, Computer System and..., Pharmaceutical Industry, Quality Auditing, FDA, 21 CFR Part 11, Medical Devices, Regulations, Compliance, Validation, Quality System, GMP, Regulatory Affairs, V&V, ISO 14971, ISO 13485, Clinical Trials, Design Control, CAPA, Biotechnology, Quality Management, Risk Management, PMA, Change Control, Computer System..., GxP, Regulatory Submissions, Regulatory Requirements, GLP, Sop, Quality Assurance, LIMS, FDA GMP, Aseptic Processing, IND, Cleaning Validation, Technology Transfer, Sterilization, CE marking, Medical Device Directive, Biologics, GCP, Trackwise, Biopharmaceuticals, Quality by Design, ICH guidelines
Education
Wayne State University 1984 — 1992
Aquatic Ecology, Microbial Ecology, Genetics
Western Michigan University 1979 — 1983
BS, Biology
Santa Rosa Community College 1979 — 1979
EMT, Emergency Medicine
Community College of the Air Force 1974 — 1979
Assoc, Emergency Medicine
Food and Drug Administration (FDA) December 2008 - Present
University of Texas at Arlington August 2007 - December 2008
UT Southwestern Medical Center at Dallas March 2006 - July 2007
Skills
Regulatory Affairs, Quality Assurance, Document Management, Process Validation, Design Control, 510 K, Medical Devices, FDA, PMA, CAPA, Cell Culture, Auditing, Microsoft Office, Matlab, Clinical Research, Quality Control, Quality System, Statistics, V, GMP, Biotechnology, V&V, Management, Research, Chromatography, Life Sciences
Education
The University of Texas Southwestern Medical Center at Dallas 2006 — 2008
Masters, Bioengineering and Biomedical Engineering
The University of Texas at Arlington 2002 — 2006
Bachelors, Biology, Mechanical Engineering, Chemistry
Lockheed Martin 2008 - Present
eNTEGRITI Inc. September 2005 - July 2008
Food and Drug Administration (FDA) September 2005 - October 2006
Interactive Technology Solutions (ITS) March 2005 - September 2005
American Red Cross January 2002 - March 2005
American Red Cross Biomedical Headquarters 2002 - 2005
Skills
Integration, PMP, Project Management, Project Planning, Consulting, SDLC, SharePoint, Requirements Analysis, Program Management, Business Analysis, PMO, Vendor Management, Visio, Change Management, Databases, Six Sigma, Quality Assurance, Strategy, Process Improvement, ITIL, Strategic Planning, Software Documentation, MS Project, CMMI, Microsoft Project, Management, Leadership, Analysis, Microsoft Office, Team Leadership, Public Speaking
Education
The George Washington University - School of Business 2002 — 2004
MASTERS, Project Management
American Society for Quality (ASQ) 2007 — 2008
Certification, Six Sigma Black Belt
University of Benin 1992 — 1997
Bachelors, Foundations of Educational Administration
Bilingual Grammar School Buea
Our Lady of Lourdes, Bamenda, Class of 86
Federal Retirement Thrift Investment Board August 2015 - Present
Food and Drug Administration (FDA) June 2014 - August 2015
T. Rowe Price November 2012 - May 2014
BrewKeep, LLC January 2012 - May 2014
T. Rowe Price April 2010 - November 2012
Skills
Microsoft Excel, Accounting, Leadership, Customer Service, Management, Data Analysis, Microsoft Office, PowerPoint, Outlook, Microsoft Word, Financial Reporting, Risk Management, Project Management, Social Media, Financial Analysis, Public Speaking, Finance, Investments, Analysis, Boy Scouts, Backpacking, Volleyball, Long Distance Running, Craft Beer, Camping
Education
University of Maryland College Park 2004 — 2008
Bachelor of Science (B.S.), Mathematics, 3.4
University of Maryland College Park 2004 — 2008
Germanic Studies, 3.4
Loyola Blakefield High School 2000 — 2004
I.Q. Auditing January 2006 - Present
Food and Drug Administration (FDA) 2002 - 2006
MedImmune November 1998 - May 2002
Wyeth July 1995 - November 1998
Skills
GMP, Quality Systems, Biotechnology, FDA, Quality Assurance, Validation, cGMP, Regulatory Affairs, Auditing, Compliance, Manufacturing, ISO, Medical Devices, Pharmaceuticals, CAPA, ISO 13485, Risk Management, Audit, Quality Auditing, GxP, SOP, Inspection, Process Validation, Internal Audit, 21 CFR Part 11, Risk Assessment, Quality Management, Computer System..., Sop, Pharmaceutical Industry, Quality System, V&V, Regulatory Submissions, GLP, Change Control, Regulatory Requirements, LIMS, Biopharmaceuticals
Education
Temple University 1996 — 1998
MS, Regulatory Affairs / Quality Assurance
Millersville University of Pennsylvania 1991 — 1995
BSE, Biology / Chemistry
Food and Drug Administration (FDA) June 2015 - Present
Office of Undergraduate Admissions and Relations with Schools 2014 - Present
Office of Undergraduate Admissions and Relations with Schools 2013 - Present
Skills
Separation,..., TLC, IR Spectroscopy, NMR Spectroscopy, Spectrophotometry, Basic Programming (C++), Cell Culture, SDS-PAGE, Agarose Gel..., Public presenter with..., •Proficient in..., Data Analysis, Social Networking, Event Planning, Microsoft Word, Microsoft Excel
Education
University of California, Los Angeles 2012 — 2016
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering, Senior
National Institute on Aging (NIA) June 2013 - June 2014
Food and Drug Administration (FDA) May 2012 - May 2013
University of Maryland Career Center September 2009 - May 2012
Cedar Beach's Sea Explorer's Marine Summer Camp June 2008 - August 2011
Skills
Science, Research, Microsoft Office, Flow Cytometry, ELISA, Western Blotting, Cell Culture, Luciferase Assay, Tissue Embedding, Microtome, Plasmid Isolation, Agarose Gel..., Data Mining, Academic Tutoring, Teaching, Genotyping, PCR, FACS, Primary Cell Isolation
Education
American University 2014 — 2015
MAT, Masters of the Arts in Teaching: Secondary Biology
University of Maryland College Park 2009 — 2013
Bachelor of Science, Microbiology, General
Food and Drug Administration (FDA) January 2015 - Present
Howard University Hospital July 2011 - December 2014
Skills
Program Development, Healthcare, Healthcare Management, Public Health, Community Outreach, Program Evaluation, Grant Writing, Nonprofits, Fundraising, Case Management, Health Education, Prevention, Community Health, Grants, Social Services
Education
Fort Valley State University 2008 — 2009
MPH
University of Maryland Eastern Shore
Food and Drug Administration (FDA) November 2010 - Present
CSL Plasma 2009 - 2010
Knoxville Plasma April 2008 - December 2008
Skills
Microbiology, Molecular Biology, Science, Public Health, Laboratory, Statistics, PCR, Cell Culture, Scientific Writing, Gel Electrophoresis, HPLC, Biology, Microscopy, ELISA, Biochemistry
Education
American Public University System 2011 — 2013
Masters, Public Health
University of Tennessee-Knoxville 2004 — 2008
BS, Biocellular, Chemistry, and Molecular Biology
Notre Dame High School 2000 — 2004
High School Diploma
Kessler Topaz Meltzer & Check, LLP October 2013 - Present
Hudson Legal January 2013 - April 2013
The Food and Drug Law Institute (FDLI) February 2012 - May 2012
Food and Drug Law Association August 2010 - May 2012
Delaware Department of Justice September 2011 - November 2011
Food and Drug Administration (FDA) May 2011 - August 2011
United States Army May 2005 - May 2011
Skills
Food and Drug Law, International Law, Administrative Law, Legal Writing, Legal Research, FDA, Regulatory Policy, Regulatory Compliance, Leadership, Team Leadership, Policy, Westlaw, Public Speaking, Research, Lexis, Analysis
Education
Widener University School of Law 2008 — 2012
J.D., Law
Penn State University 2004 — 2008
B.S., Marketing and International Business
Wyoming Seminary 2000 — 2004
Diploma, College Prep
Bear Creek Elementary School
Bear Creek Elementary School
Bear Creek Elementary School
Quest Diagnostics Nichols Institute May 2011 - Present
George Mason University January 2012 - Present
Food and Drug Administration (FDA) 2010 - 2011
George Mason University January 2006 - May 2010
Sentient Medical Systems January 2005 - January 2006
Education
George Mason University 2007 — 2010
Ph.D.
George Mason University 2006 — 2008
M.S.
Virginia Polytechnic Institute and State University
B.S.
William G. Johnson, M.D., P.C. April 2015 - June 2015
Premier Brands of America Inc. September 2014 - November 2014
Men's Center February 2011 - December 2013
Food and Drug Administration (FDA) August 2012 - September 2012
Skills
Microsoft Word, Microsoft Office, Tutoring, Customer Service, PowerPoint, Microsoft Excel
Education
TouroCOM 2015 — 2016
Master’s Degree, Biological and Physical Sciences
CUNY York College 2010 — 2014
Bachelor's Degree, Pharmaceutical Sciences/Pre-Med
Humanities and the Arts High School 2009 — 2010
High School
St Andrew High School for Girls 2004 — 2009
High School
HaloSource May 2013 - Present
CMC Biologics January 2010 - July 2012
CMC biologics January 2008 - June 2010
ICOS CORPORATION January 2003 - January 2008
ICOS Corporation January 2001 - January 2003
Food and Drug Administration (FDA) January 2000 - January 2001
ROCKER BAR & GRILL January 1996 - January 1998
HEARTHSTONE COTTAGE January 1994 - January 1996
Skills
GMP, Continuous Improvement, V&V, Technology Transfer, Validation, Biotechnology, Biopharmaceuticals, GLP, Sop, Lifesciences, Manufacturing, CAPA, FDA, Chromatography, Quality Assurance, HPLC, Protein Chemistry, Purification, Assay Development, Deviations, Life Sciences, SOP
Education
Shoreline Community College 1998 — 2000
Associates Degree, Biotechnology
Yakima Valley Community College 1993 — 1995
Associates Degree, Arts and Science
IBM June 2012 - Present
YNH Consulting LLC June 2010 - Present
College of American Pathologists (CAP) November 2011 - June 2012
Department of Health and Human Services August 2010 - October 2011
Oracle October 2008 - July 2010
Food and Drug Administration (FDA) March 2007 - October 2008
Centers for Medicare & Medicaid Services December 2004 - March 2007
National Institute of Child Health & Human Development, NIH 1991 - 2004
Skills
Analysis, Architecture, Architectures, Budgets, Business Analysis, Business Development, Business Intelligence, Business Planning, Business Process, Business Process..., Business Strategy, CRM, Change Management, Cloud Computing, Consulting, Customer Satisfaction, Customer Service, Data Center, Databases, Disaster Recovery, EHR, Enterprise Architecture, Enterprise Software, Governance, Government, Healthcare Information..., Hospitals, Human Resources, IT Management, IT Strategy, ITIL, Information Technology, Integration, Leadership, Management, Management Consulting, Negotiation, Networking, PMP, Process Improvement, Professional Services, Program Management, Project Management, Project Planning, Requirements Analysis, Research, Risk Management, SDLC, SaaS, Security
Education
University of Maryland University College 2001 — 2002
Masters, Information Technology
Food and Drug Administration (FDA) January 2010 - Present
Portfolio Management Consulting, LLC August 2009 - December 2009
IBM Global Business Services 1995 - 2009
PricewaterhouseCoopers 1992 - 1995
American Management Systems (AMS) 1989 - 1991
Skills
PMP, SDLC, Program Management, Requirements Analysis, Quality Assurance, Process Improvement, Project Management, Management, Leadership, Outsourcing, Analysis, Risk Management, Integration, Testing, Software Development, Proposal Writing
Education
The George Washington University - School of Business 2013 — 2014
Master Certificate, Project Management
University of Maryland College Park
Bachelor of Science (B.S.), Business Admin., Economics
University of Pittsburgh - Joseph M. Katz Graduate School of Business
Master of Business Administration (M.B.A.), Information Systems
Alpha & Omega Healthcare Management Consulting June 2009 - Present
March of Dimes July 2008 - April 2009
Food and Drug Administration (FDA) April 2006 - April 2008
Janssen, Johnson & Johnson Pharmaceuticals August 2005 - August 2005
Union Township Health Department February 2004 - November 2004
Delaware Health and Social Services, Office of Emergency Medical Services November 2001 - December 2003
West Virginia Department of Health and Human Resources September 2000 - October 2001
The U.S. Fund for UNICEF May 1999 - May 2000
Skills
Epidemiology, Drug Safety, Pharmacovigilance, Research, Management, Teaching, Public Health, Nonprofits, Healthcare Management, Social Media, Social Media Marketing, Marketing, Microsoft Office, Computer Proficiency, Leadership, Market Research, Policy, COMPUTER..., SAS, Adobe Creative Suite, Editing, Online Advertising, SEO, Email Marketing, Newsletters, Integrated Marketing, Digital Media, Public Relations, InDesign, Facebook, Social Networking, Event Planning, Advertising, Marketing Communications, Publishing, Blogging, Digital Marketing, Public Speaking, Budgets, Strategic Planning, Program Development, Organizational..., Marketing Strategy, Entrepreneurship, Executive Management, Business Development, Medical Terminology, Project Management, MS Project, Detail Oriented
Education
Ashwood University 2009 — 2012
Doctor of Philosophy (PhD) in Business Management with Distinction, Major: Business Management, GPA- 3.92
University of Warwick - Warwick Business School
MBA, Business Administration, GPA-3.51
Drexel University
MPH, Public Health with concentration in Epidemiology and Biostatisitics
Vitebski Dzjaržauny Medycynski Universitet
MD, General Medicine
Tbilisi State University
Certificate, Russian Language & Medical Prepatory Studies
Presentation Convent Senior Secondary School (St. Therese High School), Delhi
Senior Secondary School Certificate equivalent to High School Diploma, Science
Food and Drug Administration 2010 - Present
Food and Drug Administration (FDA) December 2009 - Present
Veterans Health Administration 2008 - May 2010
U.S. Department of Veterans Affairs 2007 - 2009
Georgia State University 2006 - 2008
Georgia Medical Care Foundation June 2006 - June 2007
UPS Supply Chain Solutions 2005 - 2006
UBG 2005 - 2006
Skills
Healthcare, Process Improvement, Budgets, Government, Business Development, Policy, Data Analysis
Education
Georgia State University - J. Mack Robinson College of Business 2004 — 2009
MBA, MHA, Healthcare administration
Emory University, Rollins School of Public Health 2002 — 2004
MPH, Health Policy and Management
Rutgers University-New Brunswick 1995 — 1999
B.Sc, Biological Sciences
Food and Drug Administration (FDA) April 2015 - Present
U.S. Food and Drug Administration October 2008 - Present
Skills
Pharmacology, Bioequivalence, Generic Drugs, Pharmacokinetics, Clinical Pharmacology, Regulatory Policy, FDA, Molecular Biology, Biochemistry, Cell Biology, HPLC, In Vivo, In Vitro, Cell, Science, GMP, Research, Laboratory, Genetics, Life Sciences
Education
Temple University School of Medicine 2003 — 2008
Ph.D.
Towson University 1998 — 2002
B.S.
Allegis Group March 2010 - Present
Tsource, LLC August 2008 - Present
Food and Drug Administration (FDA) March 2009 - March 2010
TSource, LLC August 2008 - January 2009
Kodiak Edge Consulting, LLC April 2008 - January 2009
IT Project Consultants, LLC January 2008 - January 2009
Allegis Group 2008 - 2009
Verizon, Inc. January 2003 - December 2007
Skills
Active Directory, Data Center, Cross-functional Team..., Business Process..., Virtualization, PMP, Integration, Vendor Management, Project Management, Unix, Servers, Business Intelligence, VMware, Information Technology, Security, SharePoint, Management, Strategy, Databases, System Deployment
Education
The Johns Hopkins University - Carey Business School 1989 — 1991
MS, Finance
University of Maryland College Park 1974 — 1979
BS, Finance
Food and Drug Administration (FDA) 2008 - Present
Bergeson & Campbell, PC 2006 - 2007
Keller and Heckman LLP 2000 - 2006
City of New York/Parks and Recreation 1998 - 2000
Kennedy School of Government/Harvard University August 1992 - July 1994
Skills
Intellectual Property, Litigation, Legal Research, Administrative Law, Litigation Support, Legal Writing, Health Law, Westlaw, Legal Assistance, Public Speaking, Public Policy, Legal Compliance, Regulatory Analysis, Supply Chain Security, Public Health, Government, Nonprofits, Policy, Legal Issues, Regulations, Regulatory Affairs, Licensing, Pharmaceutical Law, Regulatory Requirements, Enforcement, FDA, International Relations, Politics, Environmental Law, Health Policy, Lexis, Contract Negotiation, Legislative Relations, Policy Analysis, International Law, Legislation
Education
Partnership for Public Service 2013 — 2014
Senior Fellow, Excellence in Government
Georgetown University 2009 — 2011
Certificate, Public Health
Benjamin N. Cardozo School of Law, Yeshiva University 1994 — 1997
JD, Law
University of Oxford 1996 — 1996
Certificate, International Human Rights Law
Oberlin College 1982 — 1986
BA, Government
SRA International June 2013 - Present
SRA International August 2011 - June 2013
Food and Drug Administration (FDA) September 2009 - July 2011
Qwest Communications November 2008 - August 2009
Arbinet August 2008 - October 2008
Orange Business Services June 2006 - July 2008
Equant Inc. July 2004 - May 2006
US Census 2000 1999 - 2000
CRI India Ltd. 1996 - 1998
Skills
Capital, PMP, ITIL, SDLC, Project Management, Business Intelligence, Business Objects, Informatica, Software Project..., Agile Methodologies, SOA, Scrum, IT Management, Business Analysis, Integration
Education
D.G.Vaishnav College 1993 — 1996
M.C.A., Computer Science
Loyola College 1990 — 1993
B.Sc, Physics
Shrine Vailankanni HSS 1984 — 1990
High School
Food and Drug Administration (FDA) December 2007 - Present
Booz Allen Hamilton May 1996 - December 2007
Skills
Program Management, Project Management, PMP, Enterprise Architecture, SDLC, Business Process..., Requirements Analysis, Data Analysis, Management Consulting, Change Management, Government, Integration, Process Improvement, Business Analysis, Software Project..., IT Strategy, Analysis, Federal Government, SharePoint, Governance, ITIL, IT Management, Strategy, PMO, Strategic Planning
Education
University of Maryland College Park
BS, Biology
Principia Biopharma December 2012 - Present
Elan May 2011 - November 2012
Talima Therapeutics October 2010 - February 2011
Onyx Pharmaceuticals Inc November 2009 - October 2010
Proteolix (Acquired by Onyx Pharmaceuticals) September 2007 - November 2009
Ilypsa, Inc (Acquired by Amgen) January 2007 - August 2007
FibroGen January 2002 - December 2006
Food and Drug Administration (FDA) September 2000 - December 2001
Abbott Laboratories 1992 - 2000
Skills
Clinical Trials, Drug Development, Sop, R&D, Clinical Research, Oncology, Drug Discovery, Strategic Alliances, Project Management, Product Management, Immunology, IND, Clinical Development, Biopharmaceuticals, Pharmaceutical Industry, Regulatory Submissions, Biotechnology
Education
University of Missouri-Kansas City 1990 — 1992
Masters, Pharmaceutics
Kundnani college of Pharmacy 1985 — 1990
Bachelor of Pharmacy
Information Innovators Inc. (Triple-i) July 2015 - Present
SRA International August 2004 - April 2010
Food and Drug Administration (FDA) March 2008 - March 2010
Veterans Affairs (VA) September 2007 - March 2008
American Red Cross (ARC) March 2006 - September 2007
National Institute of Health (NIH) August 2004 - March 2006
Woodbourne Solutions, Inc November 2003 - August 2004
Objects Worldwide Inc October 2000 - April 2002
Durgabai Deshmukh Hospital August 1997 - July 1999
Skills
Requirements Analysis, Enterprise Architecture, SDLC, Integration, Program Management, Business Analysis, IT Strategy, Software Project..., Process Improvement, PMP, Agile Methodologies, Business Intelligence, Data Analysis
Education
University of Maryland University College
Master of Computer Systems Management, Database Management Systems track
wen nie
Food and Drug Administration (FDA) January 2015 - Present
University of Florida July 2008 - September 2014
University of Florida July 2008 - September 2014
Tulane University August 2007 - May 2008
UCLA June 2006 - August 2006
Skills
Regulatory Affairs, Medical Devices, Electrical Engineering, Biocompatibility, Cell Culture, Biomaterials, Electrophysiology, Aseptic Technique, Laboratory, Biomedical Engineering, Matlab, AFM, Immunostaining, Neural Networks, Fluorescence Microscopy, Nanotechnology, SEM, Carbon Nanotubes, Cell, Molecular Biology, Clean Rooms, Confocal Microscopy, Microscopy, Sterile Technique, Microcontact Printing, Laboratory Research, Lab Management, Multielectrode Arrays..., Multichannel Systems..., AutoCAD, ImageJ, Offline Sorter, Neuroexplorer, Statistica, Photolithography, Research, Data Analysis, Biotechnology, Science, Life Sciences, Statistics, Microsoft Office, In Vitro
Education
University of Florida 2008 — 2014
PhD in Biomedical Engineering, Neuroengineering, GPA - 3.87
Tulane University 2004 — 2008
B.S.E with Honors, Biomedical Engineering 2008, GPA - 3.32
University of South Florida 2005 — 2005
Bioengineering and Biomedical Engineering
Keck Graduate Institute December 2011 - Present
Anchen Pharmaceuticals (now Par Pharmaceutical) May 2011 - November 2011
Keck Graduate Institute August 2009 - May 2011
Food and Drug Administration (FDA) May 2009 - July 2009
Tata Memorial Hospital August 2006 - January 2007
TTK Healthcare TPA Pvt Ltd December 2003 - September 2004
Skills
Regulatory Affairs, Regulatory Submissions, Clinical Development, Clinical Research, Lifesciences, FDA, Drug Discovery, Pharmacovigilance, Biopharmaceuticals, Healthcare Management, Pharmaceutical Industry, GMP, Cancer, Orphan Drug Submissions, Medical Devices, Biotechnology, ICH-GCP, Drug Development, Drug Safety/Adverse..., Managed Care, Regulatory Intelligence, Hospitals, Drug Safety, Hospital Operations, Clinical and Surgical, Clinical Trials, Life Sciences
Education
Keck Graduate Institute 2008 — 2010
MBS (Master of Bioscience), Clinical and Regulatory Affairs, Drug Discovery and Development
Symbiosis institute of Management Studies 2006 — 2008
PGDHHM, Post Graduate Diploma in Hospital and Healthcare Management
University of Pune 1997 — 2001
MBBS, Medicine and Surgery
Food and Drug Administration (FDA) September 2009 - Present
AABB April 2006 - May 2009
BearingPoint June 2005 - April 2006
American Red Cross October 2002 - March 2005
US Air Force June 1988 - October 2002
Skills
Green Belt, Quality Assurance, FDA, Validation, Process Improvement, V&V, Auditing, Policy, Quality Management, CAPA, Quality System, 21 CFR Part 11, GLP, Medical Devices, Biotechnology, Quality Auditing, Continuous Improvement, Cross-functional Team..., Software Documentation, Six Sigma, Regulatory Requirements, Regulatory Affairs, Document Management, GMP, Laboratory, Sop, Integration, Program Management
Education
Bowling Green State University
MS
Thomas Jefferson University
BS
Princeton Theological Seminary September 2009 - Present
Mizo Society of America January 2009 - December 2009
Brown Advisory March 2009 - August 2009
Legg Mason Capital Management January 2007 - October 2008
Food and Drug Administration (FDA) June 2000 - January 2006
Skills
Securities, Financial Services, Valuation, Investment Management, Equity Trading, Small Business, Equity Valuation, Asset Allocation, Banking, Strategy
Education
University of Maryland College Park 2003 — 2006
BS, Finance
Food and Drug Administration Center for Tobacco Products October 2014 - Present
Food and Drug Administration (FDA) September 2009 - October 2013
Johns Hopkins Bayview Medical Center September 2006 - September 2009
University at Buffalo Department of Anatomy and Physiology 2005 - 2006
University at Buffalo School of Medicine and Biomedical Sciences 2001 - 2006
University at Buffalo Department of Pharmacology and Toxicology September 2001 - September 2001
Cornell University Department of Entomology June 1994 - June 2000
Skills
In Vitro, FDA, NDA, IND, Pharmacology, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Drug Development, Clinical Development, In Vivo, Animal Models, Animal Behavior, Translational Medicine, Clinical Research, Drug Delivery, Research, Drug Discovery, Drug Design, Drug Testing, Clinical Trials, Clinical Pharmacology, RNA isolation, Immunohistochemistry, Biochemistry, Confocal Microscopy, Toxicology, Pharmacokinetics
Education
The Johns Hopkins University School of Medicine 2006 — 2009
Postdoctoral Fellowship, Behavioral Pharmacology
State University of New York College at Buffalo 2001 — 2006
Ph.D., Pharmacology and Toxicology
State University of New York College at Cortland 1997 — 2001
B.S., Health Science
Geneva high school 1993 — 1997
EIG
McCormick & Company Inc. September 2009 - Present
Food and Drug Administration (FDA) June 2008 - December 2008
Walgreens February 2007 - May 2008
Illinois Institute of Technology August 2007 - January 2008
Swedish Covenant Hospital August 2003 - August 2006
Education
Illinois Institute of Technology 2007 — 2009
Masters, Food Safety and Technology
Northeastern Illinois University 2003 — 2006
Bachelors, Chemistry
Food and Drug Administration (FDA) January 2012 - Present
Bureau of Economic Analysis June 2003 - December 2011
Education
American University
BS, Applied Statistics and Economics
RevHealth October 2013 - Present
Food and Drug Administration (FDA) February 2013 - March 2013
CVS Caremark Corporation March 2009 - January 2013
Novartis November 2012 - December 2012
Rutgers University September 2011 - May 2012
RevHealth May 2011 - July 2011
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2013
Doctor of Pharmacy (PharmD), Pharmacy
Martha L. Chase, Ph.D., M.A. November 2010 - Present
Food and Drug Administration (FDA) May 2010 - November 2010
National Institutes of Health (NIH) December 2008 - January 2010
Second Chance Employment Services April 2006 - January 2008
Skills
Organizational..., Training, Coaching, Career Development, Career Counseling, Management, Talent Management, Executive Coaching, Policy, Conflict Resolution, MBTI, Succession Planning, Leadership, Emotional Intelligence, Workshop Facilitation, Executive Development
Education
Georgetown Visitation Preparatory School
Diploma
Hood College
B.A., Education
The Catholic University of America
Ph.D., Educational Psychology and Evaluation
The Catholic University of America
M.A., Curriculum and Instruction
US Food and Drug Administration (FDA) September 2014 - Present
Global Health Economics Consortium, University of California, San Francisco January 2014 - Present
University of California Haiti Initiative (UCHI) June 2010 - Present
Pan American Health Organization March 2014 - September 2014
University of California Haiti Initiative (UCHI) May 2010 - August 2014
Food and Drug Administration (FDA) April 2013 - March 2014
Guatemala Children’s Education Fund June 2010 - July 2013
San Francisco Community Behavioral Health Services (CBHS) September 2010 - April 2013
San Francisco General Hospital - Office of Formulary Management January 2013 - March 2013
World Health Organization October 2012 - January 2013
Skills
Microsoft Access..., Nonprofits, Project Management, Research, Policy, Program Evaluation, Grant Writing, Community Development, Healthcare, Non-profits, Clinical Research
Education
University of California, San Francisco 2013 — 2014
Master of Science (MSc), Global Health
University of California, San Francisco 2009 — 2013
PharmD, Doctor of Pharmacy
University of California, Davis 2001 — 2005
B.A.S, Political Science and Biological Sciences (Neurobiology, Physiology and Behavior)
Novartis July 2013 - Present
Food and Drug Administration (FDA) February 2010 - February 2013
North Caroina State University, USGS, and Purdue University June 2007 - November 2012
North Carolina State University and Virginia Institute of Marine Science August 2006 - June 2007
North Carolina State University and North Carolina Wildlife Resources Commission August 2005 - June 2007
Department of Applied Mathematics, Case Western Reserve University August 2004 - August 2005
Skills
Communications Audits, SAS, Statistics, Data Mining, R, Matlab, Data Analysis, Operations Research, SAS programming, Statistical Modeling, JMP, Mathematical Modeling, Clinical Trials
Education
Case Western Reserve University
Applied Mathematics
North Carolina State University
Ph.D., Co-major in Statistics and Operations Research
USDA July 2004 - Present
Food and Drug Administration (FDA) March 2003 - July 2004
Johns Hopkins University December 1999 - March 2003
Skills
Textile Chemistry, Flame Retardants, Microscale Combustion..., Thermogravimetric..., Bioinorganic Chemistry, Cotton, Microwave Reactror, Supercritical Carbon...
Education
Stony Brook University 1993 — 1999
Ph.D., Bioinorganic Chemistry
Food and Drug Administration (FDA) April 2010 - Present
Skills
Litigation, Public Policy, Policy Analysis, Policy, Administrative Law, Legal Research, Legal Writing, Regulatory Analysis, Privacy Law, Research, Federal Government, Health Law, Intellectual Property, Government, Corporate Governance, Westlaw, Program Management, Microsoft Office
Education
The Catholic University of America, Columbus School of Law 1998 — 2001
JD, Law
American University 1994 — 1998
BA, Literature and Communications
Rady Children's Hospital December 2012 - August 2015
Organized Change June 2012 - January 2014
BlueRio Strategies August 2012 - December 2012
Food and Drug Administration (FDA) February 2009 - November 2010
San Diego State University October 2005 - February 2009
San Diego State University Recreation Chapter September 2006 - June 2008
City of San Diego July 2007 - May 2008
Scripps Green Hospital March 2006 - August 2006
Surgical Associates October 2000 - December 2005
Skills
Product Marketing, Product Management, Performance Management, Organizational..., Marketing, Training, Organizational..., Project Management, Change Management, Strategic Planning, Team Building, Leadership Development, Coaching, Human Resources, Program Management, Management, Business Development, Organizational Behavior, Employee Training, Career Development, Leadership, Process Improvement, Event Management, Organizational Culture, Process Scheduler, Microsoft Office, Clinical Research, Public Relations, Investigation, Healthcare Management, Medical Terminology, Talent Management, Employee..., Microsoft Word, Microsoft Excel, PowerPoint, Medical Billing, Food & Drug Law, Veterans Transitional..., FDA GMP, Strategy, Workshop Facilitation, Employee Relations, Nonprofits, Customer Service, Policy, Conflict Resolution, Team Leadership, Analysis, Management Consulting
Education
Benedictine University 2012 — 2014
Master of Business Administration (MBA), Business/Management and Marketing, 4.0
BlueRio Strategies HawkEye Coaching 2012 — 2012
Certificate, Veteran Development Coach
Benedictine University 2009 — 2012
Master's of Science, Management and Organizational Behavior, 3.8
San Diego State University-California State University
Bachelors of Science, Criminal Justice/Psychology/Public Administration, 3.0
Moscow State University 2006 — 2006
Russian and United States Criminal Justice
San Diego Mesa College
A.A, Transfer Studies
Concorde Career Institute
Medical Assistant, Medical/Clinical Assistant
Food and Drug Administration (FDA) June 2013 - Present
U.S. Department of Housing and Urban Development August 2012 - May 2013
American University Washington College of Law August 2011 - November 2012
American Constitution Society for Law and Policy 2007 - 2011
Fair Labor Association 2006 - 2007
American Federation of Teachers 2001 - 2006
U.S. Department of Education 1993 - 2001
Supreme Court of the United States 1995 - 1996
Dickstein Shapiro LLP 1991 - 1993
Judge Ralph Guy, Jr., United States Court of Appeals for the Sixth Circuit 1990 - 1991
Skills
Strategic Communications, speechwriting, Writing, Public Speaking, New Media, Coalition Development, Policy Analysis, Public Policy, Publications, Public Relations, Editing, Scripting, Management, media training, Program Development, Communication, Legal, legal analysis, Legal Issues, Speech Writing, Press Releases, Political Campaigns
Education
American University, Washington College of Law
JD
Brandeis University
BA, History
Whitmer
Self-employed August 2011 - Present
Mountain View Whisman School District August 2011 - Present
Independent Contractor June 2010 - Present
Axial Biotech, Inc. 2009 - 2010
Food and Drug Administration (FDA) 2008 - 2009
diaDexus 1997 - 2008
Skills
Translation, Medical Translation, Technical Translation, Legal Translation, Interpretation, Simultaneous..., Consecutive..., Public Speaking, Molecular Biology, Genomics, Cancer Genomics, Molecular Genetics, Biochemistry
Education
The National Hispanic University 2011 — 2012
Professional Certificate in Translation & Interpretation Studies, Language Combination of English-Spanish
Universidad de Buenos Aires
PhD Degree in Molecular Biology
Universidad de Buenos Aires
Bachelor in Biological Sciences, Cytogenetics
University of California Extension, Santa Cruz, Cupertino, CA
Certificate in Bioinformatics
HackensackAlliance ACO (accountable care organization) January 2012 - Present
Rutgers University, New Jersey School of Medicine 1981 - 2014
Hackensack University Medical Center 2006 - 2011
Joint Commission on Accreditation of Healthcare Organizations (JCAHO) 2004 - 2006
Food and Drug Administration (FDA) 2003 - 2006
Infectious Diseases Society of America (IDSA) 2003 - 2006
The Robert Wood Johnson Foundation 2001 - 2006
Hackensack University Medical Center 1980 - 2006
Society for Healthcare Epidemiology of America 1994 - 1994
Skills
Hospitals, Healthcare, Healthcare Management, Clinical Research, Healthcare Information..., EMR, Patient Safety, EHR, Nursing, Critical Care, Informatics, Medicine, Managed Care, Medical Education, Inpatient, Board Certified, Internal Medicine, Physicians, Emergency Medicine, Healthcare Consulting, Pediatrics, Quality Improvement
Education
Yale University School of Medicine 1960 — 1964
Doctor of Medicine (MD), MD degree
Amherst College 1956 — 1960
BaA cum laude, Biology, General
Food and Drug Administration (FDA) July 2013 - Present
Food and Drug Administration (FDA) May 2009 - July 2013
FUJIFILM Corporation (R&D Management Headquarter, Japan) August 2012 - October 2012
Qualcomm (QCT) August 2007 - December 2007
Curtiss-Wright Controls, Embedded Computing January 2006 - December 2006
Skills
Medical Imaging, Monte Carlo Simulation, PENELOPE, X-ray Detector, Solid State Physics, Digital Radiography, Linux, Embedded Systems, RTOS, C, Matlab, R&D, Research, Scientific Writing, Biomedical Engineering, Image Processing, Semiconductors, FDA, Fortran, Regulatory Research, Regulations, Medical Devices, Characterization, Signal Processing, Sensors
Education
University of Waterloo 2008 — 2013
Doctor of Philosophy (PhD), Electrical Engineering
University of Maryland College Park 2010 — 2011
Visiting Graduate Student, Fischell Department of Bioengineering
University of Waterloo 2003 — 2008
Bachelor of Applied Science (BASc), Electrical Engineering (Honours)