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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FDA Employees
Employee
Years
Job
Industry
Michael Karfunkle Michael Karfunkle's FDA Experience September 2014 - Present
Job ORISE Fellow Analytical Chemistry at FDA
Industry Research
Experience
FDA September 2014 - Present
WordJet, LLC March 2014 - Present
University of Chicago September 2013 - August 2014
Textbroker.com July 2012 - June 2014
Museum of Science and Industry July 2013 - September 2013
University of Chicago March 2010 - July 2013
Elite Academy March 2010 - September 2010
Skills
Python, Fourier Analysis, Signal Processing, Physics, Astrophysics, Organic Chemistry, Spanish-speaking, Tutoring, NI LabVIEW, PCB design, Machining, Arduino, Brazilian Portuguese, Microsoft Excel, SQL, Java, Data Analysis, Fortran, R, Optics, Mathematica, Technical Writing, Statistics, Labview, Mathematical Modeling, Matlab, Experimentation
Education
University of Chicago 2009 — 2013
Bachelor of Arts, Physics and Chemistry
Universidad de Salamanca 2009 — 2009
Spanish Language and Literature
Texas State Technical College Harlingen 2006 — 2008
FDA September 2014 - Present
WordJet, LLC March 2014 - Present
University of Chicago September 2013 - August 2014
Textbroker.com July 2012 - June 2014
Museum of Science and Industry July 2013 - September 2013
University of Chicago March 2010 - July 2013
Elite Academy March 2010 - September 2010
Skills
Python, Fourier Analysis, Signal Processing, Physics, Astrophysics, Organic Chemistry, Spanish-speaking, Tutoring, NI LabVIEW, PCB design, Machining, Arduino, Brazilian Portuguese, Microsoft Excel, SQL, Java, Data Analysis, Fortran, R, Optics, Mathematica, Technical Writing, Statistics, Labview, Mathematical Modeling, Matlab, Experimentation
Education
University of Chicago 2009 — 2013
Bachelor of Arts, Physics and Chemistry
Universidad de Salamanca 2009 — 2009
Spanish Language and Literature
Texas State Technical College Harlingen 2006 — 2008
Bonnie Healy Bonnie Healy's FDA Experience 1996 - 1997
Job Manager, IT at Corning Incorporated
Industry Glass, Ceramics & Concrete
Experience
Corning Incorporated September 2000 - Present
Valley Health 1997 - 2000
FDA 1996 - 1997
United States Senate 1991 - 1996
LSW, Inc 1990 - 1991
United States Senator John Heinz 1988 - 1990
Skills
ERP, Process Improvement, SAP, SharePoint, Integration, IT Strategy, Business Strategy, IT Infrastructure..., ITIL v3 Foundations..., Yellow Belt, Executive Presentations, Mobility Strategy, Customer Engagement, Lean Thinking, Governance, Management, CRM, Enterprise Software, Telecommunications, Project Planning, Leadership
Education
Syracuse University
Bachelor of Science, Education
Corning Incorporated September 2000 - Present
Valley Health 1997 - 2000
FDA 1996 - 1997
United States Senate 1991 - 1996
LSW, Inc 1990 - 1991
United States Senator John Heinz 1988 - 1990
Skills
ERP, Process Improvement, SAP, SharePoint, Integration, IT Strategy, Business Strategy, IT Infrastructure..., ITIL v3 Foundations..., Yellow Belt, Executive Presentations, Mobility Strategy, Customer Engagement, Lean Thinking, Governance, Management, CRM, Enterprise Software, Telecommunications, Project Planning, Leadership
Education
Syracuse University
Bachelor of Science, Education
Derrell Williams Derrell Williams's FDA Experience January 2014 - September 2014
Job Student at Stevenson University
Industry Graphic Design
Experience
FDA January 2014 - September 2014
Gap Inc./Banana Republic September 2013 - April 2014
Writting Momma Publishing July 2013 - December 2013
Library of Congress June 2012 - August 2012
Library of Congress June 2011 - August 2011
Skills
Graphic Design, Web Design, Photography, Photoshop, Illustrator, Video, Illustration
Education
Stevenson University 2009 — 2014
Bachelor of Science (BS), Visual Communications Design
FDA January 2014 - September 2014
Gap Inc./Banana Republic September 2013 - April 2014
Writting Momma Publishing July 2013 - December 2013
Library of Congress June 2012 - August 2012
Library of Congress June 2011 - August 2011
Skills
Graphic Design, Web Design, Photography, Photoshop, Illustrator, Video, Illustration
Education
Stevenson University 2009 — 2014
Bachelor of Science (BS), Visual Communications Design
R. Derike Smiley R. Derike Smiley's FDA Experience December 2008 - Present
Job Microbiologist at FDA
Industry Government Administration
Experience
FDA December 2008 - Present
North Carolina State University June 2007 - December 2008
Duke University February 2004 - June 2007
University of Tennessee December 1998 - February 2004
Skills
Microbiology, PCR, Molecular Biology, ELISA, Lifesciences, Food Microbiology, Biochemistry, Western Blotting, Biotechnology, DNA Sequencing, real-time PCR, Gel Electrophoresis, Aseptic Technique
Education
University of Tennessee-Knoxvile 1993 — 1998
Doctor of Philosophy (Ph.D.), Food Science and Technology
Tennessee Technological University 1989 — 1993
Bachelor of Science (BS), Animal Sciences
FDA December 2008 - Present
North Carolina State University June 2007 - December 2008
Duke University February 2004 - June 2007
University of Tennessee December 1998 - February 2004
Skills
Microbiology, PCR, Molecular Biology, ELISA, Lifesciences, Food Microbiology, Biochemistry, Western Blotting, Biotechnology, DNA Sequencing, real-time PCR, Gel Electrophoresis, Aseptic Technique
Education
University of Tennessee-Knoxvile 1993 — 1998
Doctor of Philosophy (Ph.D.), Food Science and Technology
Tennessee Technological University 1989 — 1993
Bachelor of Science (BS), Animal Sciences
W. Jacob Cobb W. Jacob Cobb's FDA Experience June 2014 - June 2014
Job Medical School Student at Texas A&M Health Science Center College of Medicine
Industry Medical Practice
Experience
Texas A&M University January 2012 - August 2013
FDA June 2014 - June 2014
Texas A&M University January 2013 - May 2013
Blue Pelican Math August 2009 - August 2011
MD Anderson Cancer Center May 2009 - July 2009
Skills
Mammalian Cell Culture, Tissue Culture, Parasitology, DNA extraction, PCR, Vector Cloning, Molecular Diagnostics, Entomology, Cancer Research, Clinical Research, Immunofluorescence, Phylogenetics, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Research, Customer Service, Public Speaking, Healthcare, Cpr Certified, Teamwork, Social Media, Event Planning, Photoshop, NCBI, Gel Extraction, Gel Electrophoresis, Molecular Biology, Molecular Genetics, Molecular Cloning, Community Outreach, Spanish, Scientific Writing, Chemistry, Microbiology, PCR primer design, Infectious Diseases, Laboratory
Education
Texas A&M University System Health Science Center -College of Medicine 2013 — 2017
Doctor of Medicine (M.D.)
Texas A&M University 2009 — 2013
Bachelor of Science (BS), Biomedical Sciences, General
Texas A&M University January 2012 - August 2013
FDA June 2014 - June 2014
Texas A&M University January 2013 - May 2013
Blue Pelican Math August 2009 - August 2011
MD Anderson Cancer Center May 2009 - July 2009
Skills
Mammalian Cell Culture, Tissue Culture, Parasitology, DNA extraction, PCR, Vector Cloning, Molecular Diagnostics, Entomology, Cancer Research, Clinical Research, Immunofluorescence, Phylogenetics, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Research, Customer Service, Public Speaking, Healthcare, Cpr Certified, Teamwork, Social Media, Event Planning, Photoshop, NCBI, Gel Extraction, Gel Electrophoresis, Molecular Biology, Molecular Genetics, Molecular Cloning, Community Outreach, Spanish, Scientific Writing, Chemistry, Microbiology, PCR primer design, Infectious Diseases, Laboratory
Education
Texas A&M University System Health Science Center -College of Medicine 2013 — 2017
Doctor of Medicine (M.D.)
Texas A&M University 2009 — 2013
Bachelor of Science (BS), Biomedical Sciences, General
Jessica Lo Surdo Jessica Lo Surdo's FDA Experience September 2008 - Present
Job Staff Fellow/CMC reviewer and researcher at FDA
Industry Government Administration
Experience
FDA September 2008 - Present
Skills
Multi-color Flow..., Cell Sorting, real-time PCR, Immunofluorescence, Fluorescence Microscopy, Immunohistochemistry, Cell Culture
Education
University of Pittsburgh 2009 — 2013
Doctor of Philosophy (Ph.D.), Bioengineering
University of Pittsburgh 2005 — 2008
Master of Science (MS), Bioengineering
Syracuse University 2000 — 2005
Bachelor of Science (BS), Bioengineering
FDA September 2008 - Present
Skills
Multi-color Flow..., Cell Sorting, real-time PCR, Immunofluorescence, Fluorescence Microscopy, Immunohistochemistry, Cell Culture
Education
University of Pittsburgh 2009 — 2013
Doctor of Philosophy (Ph.D.), Bioengineering
University of Pittsburgh 2005 — 2008
Master of Science (MS), Bioengineering
Syracuse University 2000 — 2005
Bachelor of Science (BS), Bioengineering
Grace D. Appiah's FDA Experience July 2011 - June 2014
Job Epidemic Intelligence Service Officer at Centers for Disease Control and Prevention
Industry Hospital & Health Care
Experience
Centers for Disease Control and Prevention July 2014 - Present
Commissioned Corps of the U.S. Public Health Service July 2014 - Present
Children's National Medical Center July 2011 - June 2014
FDA July 2011 - June 2014
St. Christopher's Hospital for Children July 2008 - June 2011
Skills
Pediatrics, Infectious Diseases, Public Health, Clinical Research, Data Analysis, Research, Epidemiology, Healthcare, Community Outreach, Program Evaluation, Statistics, Lifesciences, Grant Writing, Global Health, Science, Medical Education, Medicine
Education
The George Washington University School of Medicine and Health Sciences 2012 — 2014
Master of Science (M.S.), Clinical and Translational Research
University of Virginia School of Medicine 2004 — 2008
Doctor of Medicine (MD)
Swarthmore College 2000 — 2004
Bachelor's degree, History
Centers for Disease Control and Prevention July 2014 - Present
Commissioned Corps of the U.S. Public Health Service July 2014 - Present
Children's National Medical Center July 2011 - June 2014
FDA July 2011 - June 2014
St. Christopher's Hospital for Children July 2008 - June 2011
Skills
Pediatrics, Infectious Diseases, Public Health, Clinical Research, Data Analysis, Research, Epidemiology, Healthcare, Community Outreach, Program Evaluation, Statistics, Lifesciences, Grant Writing, Global Health, Science, Medical Education, Medicine
Education
The George Washington University School of Medicine and Health Sciences 2012 — 2014
Master of Science (M.S.), Clinical and Translational Research
University of Virginia School of Medicine 2004 — 2008
Doctor of Medicine (MD)
Swarthmore College 2000 — 2004
Bachelor's degree, History
Ellen Hart Ellen Hart's FDA Experience June 2010 - August 2010
Job Doctor of Veterinary Medicine at Angels Camp Veterinary Hospital
Industry Veterinary
Experience
Angels Camp Veterinary Hospital May 2013 - Present
Cornell Veterinary Leadership Program June 2011 - August 2011
FDA June 2010 - August 2010
University of Wyoming August 2008 - May 2009
University of Wyoming Residence Life and Dining Services August 2006 - May 2009
EPSCoR - Undergraduate Research Fellowship May 2008 - December 2008
Saint Louis Zoo May 2007 - August 2007
Family Video May 2005 - August 2007
Skills
Veterinary Medicine, Veterinary, Animal Welfare, Dogs, Pets, Animal Husbandry, Client Education, Soft Tissue Surgery, Horses, Cattle, Beef Cattle, Equine, Feline Medicine, Science, Herd Management, Production Medicine, Veterinary Public Health, Quantitative Research, University Teaching, Public Health, Public Speaking, Cell Culture, Cell Signaling, Laboratory, Medicine
Education
Texas A&M University 2009 — 2013
Doctor of Veterinary Medicine, Veterinary Medicine
University of Wyoming 2005 — 2009
Bachelor of Science (BS), Human Physiology, Honors
Pleasant Valley High School 2001 — 2005
Angels Camp Veterinary Hospital May 2013 - Present
Cornell Veterinary Leadership Program June 2011 - August 2011
FDA June 2010 - August 2010
University of Wyoming August 2008 - May 2009
University of Wyoming Residence Life and Dining Services August 2006 - May 2009
EPSCoR - Undergraduate Research Fellowship May 2008 - December 2008
Saint Louis Zoo May 2007 - August 2007
Family Video May 2005 - August 2007
Skills
Veterinary Medicine, Veterinary, Animal Welfare, Dogs, Pets, Animal Husbandry, Client Education, Soft Tissue Surgery, Horses, Cattle, Beef Cattle, Equine, Feline Medicine, Science, Herd Management, Production Medicine, Veterinary Public Health, Quantitative Research, University Teaching, Public Health, Public Speaking, Cell Culture, Cell Signaling, Laboratory, Medicine
Education
Texas A&M University 2009 — 2013
Doctor of Veterinary Medicine, Veterinary Medicine
University of Wyoming 2005 — 2009
Bachelor of Science (BS), Human Physiology, Honors
Pleasant Valley High School 2001 — 2005
Paloma Paultre Paloma Paultre's FDA Experience June 2009 - August 2010
Job Public Relations/Communications/Stylist and Makeup Artist
Industry Public Relations and Communications
Experience
UNIQLO August 2013 - March 2014
Shop Jeen June 2013 - June 2013
FDA June 2009 - August 2010
Skills
Video Editing, Video Production, News Writing, Blogging, Event Planning, Designs, Risk Management, Organizational..., Management, Proposal Writing, Social Media Marketing, Fashion, Retail
Education
State University of New York at Stony Brook 2008 — 2011
Bachelor of Arts (B.A.), Communication and Media Studies
UNIQLO August 2013 - March 2014
Shop Jeen June 2013 - June 2013
FDA June 2009 - August 2010
Skills
Video Editing, Video Production, News Writing, Blogging, Event Planning, Designs, Risk Management, Organizational..., Management, Proposal Writing, Social Media Marketing, Fashion, Retail
Education
State University of New York at Stony Brook 2008 — 2011
Bachelor of Arts (B.A.), Communication and Media Studies
Luis Chavarria Luis Chavarria's FDA Experience November 1983 - May 2012
Job www.supaso.com FDA Consultant
Industry Management Consulting
Experience
SUPASO INTERNATIONAL LLC FDA CONSULTANTS June 2012 - Present
FDA November 1983 - May 2012
U.S. Department of Justice November 1980 - June 1983
Texas State Teacher January 1979 - October 1980
Skills
HACCP, Food Safety, GMP, Quality Management, Quality Assurance, Quality Auditing, Food, Quality System, Spanish, English, Product Development, Regulatory Affairs, Pharmaceutical Industry, CAPA, Policy, GLP, V&V, GCP, Manufacturing, Clinical Research, Training, Regulatory Submissions, Sop, Regulatory Requirements, Validation, Lifesciences, 21 CFR Part 11, Biotechnology, Program Management, ISO 13485, Technology Transfer, R&D, Change Control, Clinical Trials, Clinical Development, Quality Control, Drug Development, Microbiology, Biopharmaceuticals, Regulations, Pharmaceutics, Vaccines, Government, Laboratory, Analytical Chemistry, CRO, HPLC
Education
Texas A&M Kingsville 1975 — 1979
Biology, General
Texas A&M University
University of California, Los Angeles 1981 — 1982
Computer Science
Federal Law Enforcement Training Center
Police Class
SUPASO INTERNATIONAL LLC FDA CONSULTANTS June 2012 - Present
FDA November 1983 - May 2012
U.S. Department of Justice November 1980 - June 1983
Texas State Teacher January 1979 - October 1980
Skills
HACCP, Food Safety, GMP, Quality Management, Quality Assurance, Quality Auditing, Food, Quality System, Spanish, English, Product Development, Regulatory Affairs, Pharmaceutical Industry, CAPA, Policy, GLP, V&V, GCP, Manufacturing, Clinical Research, Training, Regulatory Submissions, Sop, Regulatory Requirements, Validation, Lifesciences, 21 CFR Part 11, Biotechnology, Program Management, ISO 13485, Technology Transfer, R&D, Change Control, Clinical Trials, Clinical Development, Quality Control, Drug Development, Microbiology, Biopharmaceuticals, Regulations, Pharmaceutics, Vaccines, Government, Laboratory, Analytical Chemistry, CRO, HPLC
Education
Texas A&M Kingsville 1975 — 1979
Biology, General
Texas A&M University
University of California, Los Angeles 1981 — 1982
Computer Science
Federal Law Enforcement Training Center
Police Class
Bryce Durgin Bryce Durgin's FDA Experience June 2013 - August 2013
Job Teaching Assistant Consulting I and II at Texas A&M University
Industry
Experience
Texas A&M University January 2014 - Present
Texas A&M University January 2013 - Present
Texas A&M University August 2011 - Present
FDA June 2013 - August 2013
Skills
Statistics, Biostatistics, Bayesian statistics, Statistical Consulting, Statistical Modeling, R, SAS Base, SAS Stat, SAS Macro, SAS SQL, Organizational..., Research, Management, Data Mining
Education
Texas A&M University 2011 — 2015
Master's Degree, Statistics, 3.7
University of Notre Dame 2007 — 2011
Bachelor of Science (BS), Mathematics and Political Science, 3.2
Texas A&M University January 2014 - Present
Texas A&M University January 2013 - Present
Texas A&M University August 2011 - Present
FDA June 2013 - August 2013
Skills
Statistics, Biostatistics, Bayesian statistics, Statistical Consulting, Statistical Modeling, R, SAS Base, SAS Stat, SAS Macro, SAS SQL, Organizational..., Research, Management, Data Mining
Education
Texas A&M University 2011 — 2015
Master's Degree, Statistics, 3.7
University of Notre Dame 2007 — 2011
Bachelor of Science (BS), Mathematics and Political Science, 3.2
Deirdre K Garrett's FDA Experience 2011 - Present
Job Director, Administration
Industry Government Administration
Experience
FDA 2011 - Present
Dept of Veterans Affairs February 1989 - July 2011
Skills
Research, Public Speaking, Public Policy, Policy Analysis, Policy, Government, Data Analysis, Administration, Nonprofits, Program Development, Community Outreach, Report Writing, Budgets
Education
Sullivan University 1998 — 2003
Master of Business Administration (MBA), Organizational Leadership
Sullivan University
Master of Business Administration (MBA)
Sullivan University
Bachelor of Science Business Administration (BSBA), Marketing
FDA 2011 - Present
Dept of Veterans Affairs February 1989 - July 2011
Skills
Research, Public Speaking, Public Policy, Policy Analysis, Policy, Government, Data Analysis, Administration, Nonprofits, Program Development, Community Outreach, Report Writing, Budgets
Education
Sullivan University 1998 — 2003
Master of Business Administration (MBA), Organizational Leadership
Sullivan University
Master of Business Administration (MBA)
Sullivan University
Bachelor of Science Business Administration (BSBA), Marketing
Hanh Le Hanh Le's FDA Experience February 2012 - December 2014
Job Graduate Student Researcher
Industry Research
Experience
Biophotonics Lab, Johns Hopkins University September 2013 - Present
Children's National Health System May 2014 - Present
FDA February 2012 - December 2014
Biophotonics Lab August 2011 - January 2012
Electromagnetic Wave Propagation & Remote Sensing Lab May 2010 - July 2011
Skills
Signal Processing, Image Processing, Matlab, Biomedical Engineering, Labview, Science, LaTeX, Simulations, Research, Algorithms, Mathematical Modeling, Statistics, Physics, Programming, C++, Arduino, Hyperspectral Imaging, LabVIEW
Education
The Johns Hopkins University 2013 — 2017
Doctor of Philosophy (PhD), Electrical and Computer Engineering
The Catholic University of America 2013 — 2014
Bachelor of Science (B.S.), Electrical and Electronics Engineering
Biophotonics Lab, Johns Hopkins University September 2013 - Present
Children's National Health System May 2014 - Present
FDA February 2012 - December 2014
Biophotonics Lab August 2011 - January 2012
Electromagnetic Wave Propagation & Remote Sensing Lab May 2010 - July 2011
Skills
Signal Processing, Image Processing, Matlab, Biomedical Engineering, Labview, Science, LaTeX, Simulations, Research, Algorithms, Mathematical Modeling, Statistics, Physics, Programming, C++, Arduino, Hyperspectral Imaging, LabVIEW
Education
The Johns Hopkins University 2013 — 2017
Doctor of Philosophy (PhD), Electrical and Computer Engineering
The Catholic University of America 2013 — 2014
Bachelor of Science (B.S.), Electrical and Electronics Engineering
Wes Conn's FDA Experience August 2014 - Present
Job Biomedical Engineer
Industry Medical Practice
Experience
FDA August 2014 - Present
ForTec Medical, Inc. January 2014 - August 2014
The School of Engineering at The Catholic University of America August 2013 - December 2013
Children's Hospital May 2013 - August 2013
National Rehabilitation Hospital May 2013 - August 2013
BI-LO, LLC June 2010 - August 2011
Out of the Blue Cafe May 2009 - August 2009
The Water Garden LLC May 2008 - August 2008
Chattanooga Lookouts April 2006 - August 2008
Education
The Catholic University of America 2010 — 2014
BME-B.S., Biomedical Engineering
SOLO Southeast 2012 — 2012
Wilderness EMT, Wilderness Medicine
FDA August 2014 - Present
ForTec Medical, Inc. January 2014 - August 2014
The School of Engineering at The Catholic University of America August 2013 - December 2013
Children's Hospital May 2013 - August 2013
National Rehabilitation Hospital May 2013 - August 2013
BI-LO, LLC June 2010 - August 2011
Out of the Blue Cafe May 2009 - August 2009
The Water Garden LLC May 2008 - August 2008
Chattanooga Lookouts April 2006 - August 2008
Education
The Catholic University of America 2010 — 2014
BME-B.S., Biomedical Engineering
SOLO Southeast 2012 — 2012
Wilderness EMT, Wilderness Medicine
LaKeisha West LaKeisha West's FDA Experience May 2008 - February 2009
Job Experienced Executive /Administrative Assistantcurrently seeking employment
Industry Government Administration
Experience
Professional for Non Profits Inc May 2014 - August 2014
The Midtown Group September 2013 - November 2013
The MindFinders Inc. August 2009 - April 2013
FDA May 2008 - February 2009
National Institute of Health October 2004 - May 2008
Skills
Proficient in MS Office..., Microsoft Office, Government, Research, Microsoft Excel, Customer Service, Policy, Microsoft Word, PowerPoint, Public Speaking, Event Planning, Nonprofits, Community Outreach, Outlook, Social Media, Policy Analysis
Education
Strayer University 2014 — 2017
Bachelor of Business Administration (B.B.A.), Human Resources
Ballou High School 1993 — 1995
Dipolma, 12th
Professional for Non Profits Inc May 2014 - August 2014
The Midtown Group September 2013 - November 2013
The MindFinders Inc. August 2009 - April 2013
FDA May 2008 - February 2009
National Institute of Health October 2004 - May 2008
Skills
Proficient in MS Office..., Microsoft Office, Government, Research, Microsoft Excel, Customer Service, Policy, Microsoft Word, PowerPoint, Public Speaking, Event Planning, Nonprofits, Community Outreach, Outlook, Social Media, Policy Analysis
Education
Strayer University 2014 — 2017
Bachelor of Business Administration (B.B.A.), Human Resources
Ballou High School 1993 — 1995
Dipolma, 12th
Hsiaomin (Wendy) Huang's FDA Experience April 2013 - February 2014
Job Research Associate at University of Michigan Health System
Industry Research
Experience
University of Michigan Health System September 2012 - Present
FDA April 2013 - February 2014
Hospital Authority May 2009 - August 2010
Skills
Statistics, Risk Assessment, Data Managnent, Clinical Research, Biostatistics, Public Health, SPSS, Epidemiology, Analysis, Literature Reviews, SAS, Health Promotion, Microsoft Office, Research, Grant Writing, Global Health
Education
University of Michigan 2010 — 2012
Master of Public Health (MPH), School of Public Health
Taipei Medical University 2004 — 2008
BS, Public Health
Pui Ching Middle School
University of Michigan Health System September 2012 - Present
FDA April 2013 - February 2014
Hospital Authority May 2009 - August 2010
Skills
Statistics, Risk Assessment, Data Managnent, Clinical Research, Biostatistics, Public Health, SPSS, Epidemiology, Analysis, Literature Reviews, SAS, Health Promotion, Microsoft Office, Research, Grant Writing, Global Health
Education
University of Michigan 2010 — 2012
Master of Public Health (MPH), School of Public Health
Taipei Medical University 2004 — 2008
BS, Public Health
Pui Ching Middle School
Falyn D. Donaldson Falyn D. Donaldson's FDA Experience June 2012 - January 2014
Job Young professional who specializes in the art of multitasking and noteworthy interpersonal skills.
Industry Market Research
Experience
Bellevue Media Group July 2014 - June 2015
Philadelphia Flyers December 2013 - May 2014
FDA June 2012 - January 2014
Philadelphia Parks and Recreation June 2013 - October 2013
School of Tourism and Hospitality Management, Temple University May 2013 - July 2013
Temple University Athletic Communications Department January 2013 - May 2013
Philadelphia Parks and Recreation: Max Myers Recreation Center January 2013 - May 2013
2013 NCAA Division I Men's Basketball Tournament March 2013 - March 2013
Temple University August 2010 - March 2011
Skills
Microsoft Office, Teamwork, Microsoft Excel, PowerPoint, Customer Service, Research, Microsoft Word, Photoshop, Social Media Marketing, Creative Writing, Sports Management, Business Writing, Marketing, Public Relations, Leadership, Event Management
Education
Temple University 2010 — 2014
Bachelor of Science (BS), Sport and Recreation Management, Senior
North Point High School 2006 — 2010
Bellevue Media Group July 2014 - June 2015
Philadelphia Flyers December 2013 - May 2014
FDA June 2012 - January 2014
Philadelphia Parks and Recreation June 2013 - October 2013
School of Tourism and Hospitality Management, Temple University May 2013 - July 2013
Temple University Athletic Communications Department January 2013 - May 2013
Philadelphia Parks and Recreation: Max Myers Recreation Center January 2013 - May 2013
2013 NCAA Division I Men's Basketball Tournament March 2013 - March 2013
Temple University August 2010 - March 2011
Skills
Microsoft Office, Teamwork, Microsoft Excel, PowerPoint, Customer Service, Research, Microsoft Word, Photoshop, Social Media Marketing, Creative Writing, Sports Management, Business Writing, Marketing, Public Relations, Leadership, Event Management
Education
Temple University 2010 — 2014
Bachelor of Science (BS), Sport and Recreation Management, Senior
North Point High School 2006 — 2010
Jonathan Rappaport, PMP, MBA Jonathan Rappaport, PMP, MBA's FDA Experience April 2012 - Present
Job Technical Project Manager
Industry Information Technology and Services
Experience
FDA April 2012 - Present
North Star Group LLC April 2009 - April 2012
Technology Service Corporation April 2008 - March 2009
Technology Service Corporation June 2003 - March 2008
Skills
Program Management, Systems Engineering, Project Management, Requirements Management, Requirements Analysis, Process Improvement, Government, MS Project, PMP, Integration, Earned Value Management, SQL, Security Clearance, Enterprise Architecture, Analysis, Software Documentation, Change Management, IT Management, Business Intelligence, Project Portfolio..., Proposal Writing, Project Planning, Management, Cross-functional Team..., Process Engineering, Software Development, Testing, DoD, Business Analysis, Risk Management, Government Contracting, Telecommunications, Business Process..., Software Project..., SDLC, IT Strategy, Governance, Vendor Management, System Architecture, Strategic Planning, Budgets, Information Assurance, PMO, Visio
Education
University of Maryland - Robert H. Smith School of Business 2005 — 2008
MBA, Management and Organization
Syracuse University 1999 — 2003
B.S., Computer and Information Science
FDA April 2012 - Present
North Star Group LLC April 2009 - April 2012
Technology Service Corporation April 2008 - March 2009
Technology Service Corporation June 2003 - March 2008
Skills
Program Management, Systems Engineering, Project Management, Requirements Management, Requirements Analysis, Process Improvement, Government, MS Project, PMP, Integration, Earned Value Management, SQL, Security Clearance, Enterprise Architecture, Analysis, Software Documentation, Change Management, IT Management, Business Intelligence, Project Portfolio..., Proposal Writing, Project Planning, Management, Cross-functional Team..., Process Engineering, Software Development, Testing, DoD, Business Analysis, Risk Management, Government Contracting, Telecommunications, Business Process..., Software Project..., SDLC, IT Strategy, Governance, Vendor Management, System Architecture, Strategic Planning, Budgets, Information Assurance, PMO, Visio
Education
University of Maryland - Robert H. Smith School of Business 2005 — 2008
MBA, Management and Organization
Syracuse University 1999 — 2003
B.S., Computer and Information Science
Shivani Gandhi's FDA Experience October 2013 - November 2013
Job Postdoctoral Fellow at Bayer
Industry Pharmaceuticals
Experience
Bayer HealthCare July 2014 - Present
Department of Pharmaceutical Health Services Research, University of Maryland May 2013 - May 2014
FDA October 2013 - November 2013
Eli Lilly and Company September 2013 - October 2013
PosiHealth, Inc May 2013 - June 2013
Department of Pharmaceutical Sciences, University of Maryland July 2011 - May 2013
Skills
Medication Therapy..., Pharmacists, Pharmacokinetics, Clinical Pharmacy, Pharmacy Automation, Inpatient, Clinical Pharmacology, Healthcare, Pharmacy, Public Health, Compounding, Pharmacology, Clinical Research, Immunization, Patient Education, Critical Care, Oncology, Pharmaceutical Industry
Education
University of Maryland School of Pharmacy 2010 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy
Texas A&M University 2006 — 2010
Bachelor's degree, Nutrition Sciences
Bayer HealthCare July 2014 - Present
Department of Pharmaceutical Health Services Research, University of Maryland May 2013 - May 2014
FDA October 2013 - November 2013
Eli Lilly and Company September 2013 - October 2013
PosiHealth, Inc May 2013 - June 2013
Department of Pharmaceutical Sciences, University of Maryland July 2011 - May 2013
Skills
Medication Therapy..., Pharmacists, Pharmacokinetics, Clinical Pharmacy, Pharmacy Automation, Inpatient, Clinical Pharmacology, Healthcare, Pharmacy, Public Health, Compounding, Pharmacology, Clinical Research, Immunization, Patient Education, Critical Care, Oncology, Pharmaceutical Industry
Education
University of Maryland School of Pharmacy 2010 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy
Texas A&M University 2006 — 2010
Bachelor's degree, Nutrition Sciences
René Viñas, M.S., Ph.D. René Viñas, M.S., Ph.D.'s FDA Experience February 2014 - January 2015
Job Toxicologist, Consumer Product Safety at Grocery Manufacturers Association
Industry Consumer Goods
Experience
Grocery Manufacturers Association February 2015 - Present
FDA February 2014 - January 2015
Skills
Toxicology, Pharmacology, In Vitro, Cell Culture, Molecular Biology, Western Blotting, Animal Models, Biochemistry, Environmental Toxicology, Environmental Awareness, Statistics, Mixtures Toxicology, Pharmacokinetics, Cell Biology, In Vivo, FDA
Education
The University of Texas Medical Branch at Galveston 2007 — 2013
Ph.D, Pharmacology & Toxicology
Texas Tech University 2004 — 2007
M.S., Environmental Toxicology
Texas Tech University 2001 — 2004
B.S., Cell & Molecular Biology
Grocery Manufacturers Association February 2015 - Present
FDA February 2014 - January 2015
Skills
Toxicology, Pharmacology, In Vitro, Cell Culture, Molecular Biology, Western Blotting, Animal Models, Biochemistry, Environmental Toxicology, Environmental Awareness, Statistics, Mixtures Toxicology, Pharmacokinetics, Cell Biology, In Vivo, FDA
Education
The University of Texas Medical Branch at Galveston 2007 — 2013
Ph.D, Pharmacology & Toxicology
Texas Tech University 2004 — 2007
M.S., Environmental Toxicology
Texas Tech University 2001 — 2004
B.S., Cell & Molecular Biology
Christopher Scully's FDA Experience June 2015 - Present
Job Staff Fellow at FDA
Industry Research
Experience
FDA June 2015 - Present
FDA July 2013 - May 2015
Worcester Polytechnic Institute 2011 - 2013
National Institutes of Health 2010 - June 2011
Stony Brook University August 2008 - December 2009
Stony Brook University 2008 - 2009
Electric Boat May 2007 - August 2007
Symmetricom May 2006 - August 2006
Skills
Signal Processing, Statistical Signal..., Image Processing, Biomedical..., Physiological Monitoring, Data Acquisition, Multivariate Analysis, Biomedical Engineering, Clinical Research, Medical Devices, Algorithms, FDA, LabVIEW, Data Analysis, Matlab, Statistics
Education
Worcester Polytechnic Institute 2010 — 2013
PhD, Biomedical Engineering
Stony Brook University 2008 — 2009
MS, Biomedical Engineering
Wentworth Institute of Technology 2003 — 2008
BS, Electromechanical Engineering
FDA June 2015 - Present
FDA July 2013 - May 2015
Worcester Polytechnic Institute 2011 - 2013
National Institutes of Health 2010 - June 2011
Stony Brook University August 2008 - December 2009
Stony Brook University 2008 - 2009
Electric Boat May 2007 - August 2007
Symmetricom May 2006 - August 2006
Skills
Signal Processing, Statistical Signal..., Image Processing, Biomedical..., Physiological Monitoring, Data Acquisition, Multivariate Analysis, Biomedical Engineering, Clinical Research, Medical Devices, Algorithms, FDA, LabVIEW, Data Analysis, Matlab, Statistics
Education
Worcester Polytechnic Institute 2010 — 2013
PhD, Biomedical Engineering
Stony Brook University 2008 — 2009
MS, Biomedical Engineering
Wentworth Institute of Technology 2003 — 2008
BS, Electromechanical Engineering
Thelma Valdes, PhD Thelma Valdes, PhD's FDA Experience November 2010 - Present
Job Interdisciplinary Scientist at FDA
Industry Medical Devices
Experience
FDA November 2010 - Present
Skills
Biomedical Engineering, FDA, Medical Devices, Biomaterials, Tissue Engineering, Microscopy, Regulatory Affairs, Product Development, R&D, Design of Experiments, Materials Science, Cross-functional Team..., Design Control, Validation, Lifesciences, Commercialization, V&V, Minitab, Biotechnology, Cell Culture, Laboratory, Testing, Quality System, CAPA, Technology Transfer, FMEA, GMP, Cell, Drug Delivery
Education
University of Washington 2003 — 2005
PhD - visiting scholar, Bioengineering
University of Connecticut 1999 — 2005
PhD, Biomedical Engineering
The Catholic University of America
BBE, Biomedical Engineering
FDA November 2010 - Present
Skills
Biomedical Engineering, FDA, Medical Devices, Biomaterials, Tissue Engineering, Microscopy, Regulatory Affairs, Product Development, R&D, Design of Experiments, Materials Science, Cross-functional Team..., Design Control, Validation, Lifesciences, Commercialization, V&V, Minitab, Biotechnology, Cell Culture, Laboratory, Testing, Quality System, CAPA, Technology Transfer, FMEA, GMP, Cell, Drug Delivery
Education
University of Washington 2003 — 2005
PhD - visiting scholar, Bioengineering
University of Connecticut 1999 — 2005
PhD, Biomedical Engineering
The Catholic University of America
BBE, Biomedical Engineering
Philip Stafford Philip Stafford's FDA Experience January 2013 - Present
Job Chemist at FDA
Industry Chemicals
Experience
FDA January 2013 - Present
Portsmouth Naval Shipyard November 2010 - December 2012
ATK Launch Systems October 1997 - September 2008
Utah State University September 2002 - May 2005
Utah State University September 1996 - October 1997
Skills
Thermogravimetric..., Differential Scanning..., FT-IR Spectroscopy, ICP-OES, Ion Chromatography, Thermomechanical..., Analytical Chemistry, Environmental Chemistry, FTIR, NMR, Differential Scanning..., TGA, Deformulation, Chemistry, Laboratory, Wet Chemistry, Polymers, Mass Spectrometry, Characterization, Gas Chromatography, NMR spectroscopy, Science, IR, Scanning Electron..., Chromatography, Physical Chemistry, Design of Experiments, Inorganic Chemistry, Adhesives, Spectroscopy, Testing, Thermal Analysis, GPC, Chemical Engineering, Polymer Chemistry, Polymer Characterization, R&D, Method Development, GC-MS, Coatings, Composites, HPLC, Titration, Polymer Science, Analysis, Organic Chemistry, IR spectroscopy
Education
University of Illinois at Urbana-Champaign 1991 — 1996
PhD, Chemistry
Texas A&M University 1986 — 1990
BS, Chemistry
FDA January 2013 - Present
Portsmouth Naval Shipyard November 2010 - December 2012
ATK Launch Systems October 1997 - September 2008
Utah State University September 2002 - May 2005
Utah State University September 1996 - October 1997
Skills
Thermogravimetric..., Differential Scanning..., FT-IR Spectroscopy, ICP-OES, Ion Chromatography, Thermomechanical..., Analytical Chemistry, Environmental Chemistry, FTIR, NMR, Differential Scanning..., TGA, Deformulation, Chemistry, Laboratory, Wet Chemistry, Polymers, Mass Spectrometry, Characterization, Gas Chromatography, NMR spectroscopy, Science, IR, Scanning Electron..., Chromatography, Physical Chemistry, Design of Experiments, Inorganic Chemistry, Adhesives, Spectroscopy, Testing, Thermal Analysis, GPC, Chemical Engineering, Polymer Chemistry, Polymer Characterization, R&D, Method Development, GC-MS, Coatings, Composites, HPLC, Titration, Polymer Science, Analysis, Organic Chemistry, IR spectroscopy
Education
University of Illinois at Urbana-Champaign 1991 — 1996
PhD, Chemistry
Texas A&M University 1986 — 1990
BS, Chemistry
Gonzalo Mendoza Gonzalo Mendoza's FDA Experience October 2003 - Present
Job Biomedical Engineering at FDA
Industry Biotechnology
Experience
FDA October 2003 - Present
The Catholic University of America April 2002 - September 2003
Skills
Medical Devices, Biomedical Engineering, LabVIEW, FDA, Matlab, Soccer, Team Leadership, Microsoft Office, Biomechanics
Education
The Catholic University of America 1999 — 2002
Master of Science (M.Sc.), Bioengineering and Biomedical Engineering
Anglo American School
FDA October 2003 - Present
The Catholic University of America April 2002 - September 2003
Skills
Medical Devices, Biomedical Engineering, LabVIEW, FDA, Matlab, Soccer, Team Leadership, Microsoft Office, Biomechanics
Education
The Catholic University of America 1999 — 2002
Master of Science (M.Sc.), Bioengineering and Biomedical Engineering
Anglo American School
Robert F. Church Robert F. Church's FDA Experience September 1994 - July 1999
Job Partner, Hogan Lovells
Industry Law Practice
Experience
Hogan Lovells US LLP 2008 - Present
Amgen August 1999 - December 2007
FDA September 1994 - July 1999
Skills
Life Sciences, Biotechnology, FDA, Clinical Trials, R&D, Manufacturing, Lifesciences, Biopharmaceuticals, CRO, GMP, Regulatory Requirements, Drug Development, Trade Secrets, Regulatory Affairs, Patentability, Commercialization, Patents, Medical Devices, Clinical Development, Licensing, Intellectual Property, Patent Prosecution
Education
The College of William and Mary - Marshall Wythe Law School
JD
University of Virginia
BA
Hogan Lovells US LLP 2008 - Present
Amgen August 1999 - December 2007
FDA September 1994 - July 1999
Skills
Life Sciences, Biotechnology, FDA, Clinical Trials, R&D, Manufacturing, Lifesciences, Biopharmaceuticals, CRO, GMP, Regulatory Requirements, Drug Development, Trade Secrets, Regulatory Affairs, Patentability, Commercialization, Patents, Medical Devices, Clinical Development, Licensing, Intellectual Property, Patent Prosecution
Education
The College of William and Mary - Marshall Wythe Law School
JD
University of Virginia
BA
Francisco Javier Bueso Ucles's FDA Experience July 2010 - December 2010
Job Regulatory Food Scientist
Industry Food & Beverages
Experience
3E Company April 2015 - Present
EAP Zamorano University February 2004 - August 2014
FDA July 2010 - December 2010
Monsanto Company May 2003 - September 2003
Skills
Quality Systems: ISO..., Experimental Design and..., Nutritional Labeling:..., Database construction..., Analytical Chemistry:..., Wet analytical chemistry
Education
Texas A&M University 2000 — 2003
Doctor of Philosophy (Ph.D.), Food Science and Technology, Cereal Chemistry and Processing
Texas A&M University 1995 — 1997
Master of Science (MSc), Food Science and Technology, Sorghum breeding
EAP Zamorano University 1990 — 1994
Bachelor of Science (BS), Agronomy
3E Company April 2015 - Present
EAP Zamorano University February 2004 - August 2014
FDA July 2010 - December 2010
Monsanto Company May 2003 - September 2003
Skills
Quality Systems: ISO..., Experimental Design and..., Nutritional Labeling:..., Database construction..., Analytical Chemistry:..., Wet analytical chemistry
Education
Texas A&M University 2000 — 2003
Doctor of Philosophy (Ph.D.), Food Science and Technology, Cereal Chemistry and Processing
Texas A&M University 1995 — 1997
Master of Science (MSc), Food Science and Technology, Sorghum breeding
EAP Zamorano University 1990 — 1994
Bachelor of Science (BS), Agronomy
Marjan Nabili's FDA Experience July 2015 - Present
Job Biomedical Engineer/Medical Devices Reviewer at FDA
Industry Medical Devices
Experience
FDA July 2015 - Present
FDA February 2014 - July 2015
George Washington University August 2014 - December 2014
George Washington University January 2010 - December 2013
The Catholic University of America January 2008 - May 2009
University of Maryland /Bioprocess Scale-Up Facility February 2007 - May 2007
University of Maryland /Orthopaedic Mechanobiology Lab January 2007 - May 2007
Skills
Matlab, Labview, Image Processing, Signal Processing, Statistics, Mathematica, Scanning Electron..., Cell Culture, Biomechanics, Data Analysis, Physics, Science, Biomedical Engineering, Pspice, Spectroscopy, Teaching, Ultrasound
Education
The George Washington University 2010 — 2013
Doctor of Philosophy (Ph.D.), Electrical Engineering
The Catholic University of America 2007 — 2009
Master's degree, Biomedical/Medical Engineering
University of Maryland College Park 2005 — 2007
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
FDA July 2015 - Present
FDA February 2014 - July 2015
George Washington University August 2014 - December 2014
George Washington University January 2010 - December 2013
The Catholic University of America January 2008 - May 2009
University of Maryland /Bioprocess Scale-Up Facility February 2007 - May 2007
University of Maryland /Orthopaedic Mechanobiology Lab January 2007 - May 2007
Skills
Matlab, Labview, Image Processing, Signal Processing, Statistics, Mathematica, Scanning Electron..., Cell Culture, Biomechanics, Data Analysis, Physics, Science, Biomedical Engineering, Pspice, Spectroscopy, Teaching, Ultrasound
Education
The George Washington University 2010 — 2013
Doctor of Philosophy (Ph.D.), Electrical Engineering
The Catholic University of America 2007 — 2009
Master's degree, Biomedical/Medical Engineering
University of Maryland College Park 2005 — 2007
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Lal Thlengliani Lal Thlengliani's FDA Experience 2008 - November 2014
Job Analyst Logistics
Industry Government Administration
Experience
District of Columbia Public Schools (DCPS) DC Goverment November 2014 - Present
FDA 2008 - November 2014
Skills
Healthcare Information..., Strategic Planning, Program Management, Public Speaking, Project Management, Team Building, Leadership, Program Development, Informatics, EHR, HIPAA, Training, EMR, Research, Consulting, Data Analysis, Management
Education
Strayer University-Maryland
MBA, Health Services Administration
District of Columbia Public Schools (DCPS) DC Goverment November 2014 - Present
FDA 2008 - November 2014
Skills
Healthcare Information..., Strategic Planning, Program Management, Public Speaking, Project Management, Team Building, Leadership, Program Development, Informatics, EHR, HIPAA, Training, EMR, Research, Consulting, Data Analysis, Management
Education
Strayer University-Maryland
MBA, Health Services Administration
Edwin Soto Edwin Soto's FDA Experience September 2009 - August 2010
Job OEF/OIF Transition Patient Advocate at Veterans Health Administration
Industry Hospital & Health Care
Experience
Veterans Health Administration August 2010 - Present
FDA September 2009 - August 2010
US Navy September 1981 - June 2009
Skills
Case Managment, Mental Health, Medical/Surgical, First Aid, DoD, First Responder, Pharmacy Automation, Navy, Software Documentation, Government, Infectious Diseases, Laboratory, Data Analysis, Ultrasound, Cardiology, Public Speaking, Disaster Medicine, X-ray, Informatics, Home Care, Venipuncture, Patient Advocacy, CBRN, Medical Assisting, Nutrition, Military Experience, Wound Care, Photoshop, AED, Managed Care, Critical Thinking, Policy, ATLS, Psychology, Community Outreach, Radiation Safety, Vital Signs, Social Media, Direct Patient Care, Acute Care, Emergency Medical, Family Medicine, Security Clearance, Emergency Medicine, Data Entry, Sports Medicine, Medical Devices, Healthcare Management, Military, Homeland Security
Education
Strayer University 2014 — 2015
Master of Business Administration (M.B.A.), Master of Business Administration Concentration in Management, 3.9 G.P.A.
Strayer University-Florida
Bachelor of Arts (B.A.), Health Services Administration
Veterans Health Administration August 2010 - Present
FDA September 2009 - August 2010
US Navy September 1981 - June 2009
Skills
Case Managment, Mental Health, Medical/Surgical, First Aid, DoD, First Responder, Pharmacy Automation, Navy, Software Documentation, Government, Infectious Diseases, Laboratory, Data Analysis, Ultrasound, Cardiology, Public Speaking, Disaster Medicine, X-ray, Informatics, Home Care, Venipuncture, Patient Advocacy, CBRN, Medical Assisting, Nutrition, Military Experience, Wound Care, Photoshop, AED, Managed Care, Critical Thinking, Policy, ATLS, Psychology, Community Outreach, Radiation Safety, Vital Signs, Social Media, Direct Patient Care, Acute Care, Emergency Medical, Family Medicine, Security Clearance, Emergency Medicine, Data Entry, Sports Medicine, Medical Devices, Healthcare Management, Military, Homeland Security
Education
Strayer University 2014 — 2015
Master of Business Administration (M.B.A.), Master of Business Administration Concentration in Management, 3.9 G.P.A.
Strayer University-Florida
Bachelor of Arts (B.A.), Health Services Administration
Alexander Beylin Alexander Beylin's FDA Experience April 2007 - Present
Job Scientific Reviewer at FDA
Industry Medical Devices
Experience
FDA April 2007 - Present
Mount Sinai Medical Center 2005 - 2007
Image Enhancement Technologies, LLC July 2002 - June 2006
New York State Center for Advanced Technology in Sensor Systems and Diagnostic Tools February 2003 - November 2004
InstruTECH March 2000 - June 2002
Mount Sinai Medical Center April 1998 - March 2000
Noifield Heart Research Institute July 1996 - February 1998
Julius Silver Institute of Biomedical Engineering, Technion-I.I.T April 1991 - January 1998
Skills
Healthcare, Medical Devices, Regulatory Affairs, Biotechnology, Regulatory Submissions, FDA, Molecular Biology, ISO 13485, Lifesciences, Biomedical Engineering, V&V
Education
Technion-Machon Technologi Le' Israel 1994 — 1998
Ph.D., Biomedical/Medical Engineering
Moscow telecommunication institute 1983 — 1989
Master of Science (M.Sc.), Multichannel telecommunicaton
FDA April 2007 - Present
Mount Sinai Medical Center 2005 - 2007
Image Enhancement Technologies, LLC July 2002 - June 2006
New York State Center for Advanced Technology in Sensor Systems and Diagnostic Tools February 2003 - November 2004
InstruTECH March 2000 - June 2002
Mount Sinai Medical Center April 1998 - March 2000
Noifield Heart Research Institute July 1996 - February 1998
Julius Silver Institute of Biomedical Engineering, Technion-I.I.T April 1991 - January 1998
Skills
Healthcare, Medical Devices, Regulatory Affairs, Biotechnology, Regulatory Submissions, FDA, Molecular Biology, ISO 13485, Lifesciences, Biomedical Engineering, V&V
Education
Technion-Machon Technologi Le' Israel 1994 — 1998
Ph.D., Biomedical/Medical Engineering
Moscow telecommunication institute 1983 — 1989
Master of Science (M.Sc.), Multichannel telecommunicaton
Monique Frazier Monique Frazier's FDA Experience 2013 - February 2014
Job Director, Data Analysis Center at Howard University College of Medicine
Industry Information Technology and Services
Experience
Howard University College of Medicine April 2013 - Present
Frazier International Solutions November 2005 - Present
FDA 2013 - February 2014
ActioNet, Inc. May 2011 - January 2013
MSTI 2006 - 2007
Verizon Enterprise Solutions May 2000 - November 2004
Skills
Business Process..., Training, Professional Services, Requirements Gathering, Disaster Recovery, Vendor Management, Solution Architecture, Organizational..., Team Leadership, Business Process..., SharePoint, Project Management, IT Strategy, Government, System Deployment, Business Process, SDLC, PMO, IT Management, Infrastructure, Software Documentation, Integration, Knowledge Management, PMP, Project Portfolio..., Process Improvement, Program Management, Enterprise Architecture, Team Building, Data Center, Proposal Writing, Business Analysis, Business Intelligence, Requirements Analysis, Leadership, Microsoft SQL Server, Technical Writing, Networking, Management, Project Planning, ITIL, Management Consulting, MS Project, Visio, Data Warehousing, Change Management, Systems Analysis, Security, Databases, Cloud Computing
Education
Temple University 1988 — 1996
Bachelor's, Management Information Science
Temple University 1988 — 1992
Bachelor of Business Administration (B.B.A.), Management Information Systems
Overbrook High School 1986 — 1988
Robert E. Lamberton 1979 — 1985
Robert E. Mann School
Howard University College of Medicine April 2013 - Present
Frazier International Solutions November 2005 - Present
FDA 2013 - February 2014
ActioNet, Inc. May 2011 - January 2013
MSTI 2006 - 2007
Verizon Enterprise Solutions May 2000 - November 2004
Skills
Business Process..., Training, Professional Services, Requirements Gathering, Disaster Recovery, Vendor Management, Solution Architecture, Organizational..., Team Leadership, Business Process..., SharePoint, Project Management, IT Strategy, Government, System Deployment, Business Process, SDLC, PMO, IT Management, Infrastructure, Software Documentation, Integration, Knowledge Management, PMP, Project Portfolio..., Process Improvement, Program Management, Enterprise Architecture, Team Building, Data Center, Proposal Writing, Business Analysis, Business Intelligence, Requirements Analysis, Leadership, Microsoft SQL Server, Technical Writing, Networking, Management, Project Planning, ITIL, Management Consulting, MS Project, Visio, Data Warehousing, Change Management, Systems Analysis, Security, Databases, Cloud Computing
Education
Temple University 1988 — 1996
Bachelor's, Management Information Science
Temple University 1988 — 1992
Bachelor of Business Administration (B.B.A.), Management Information Systems
Overbrook High School 1986 — 1988
Robert E. Lamberton 1979 — 1985
Robert E. Mann School
Elyse Smith Elyse Smith's FDA Experience 1994 - 1997
Job Managing Director at Meridan Consulting, LLC
Industry Pharmaceuticals
Experience
Meridan Consulting, LLC March 2001 - Present
Watson Pharmaceuticals 1997 - 2000
Marsam Pharmaceuticals (became Watson) 1997 - 2000
FDA 1994 - 1997
Skills
Pharmaceutical Industry, Regulatory Affairs, GMP, FDA, Validation, Sop, CAPA, Change Control, Technology Transfer, V&V, Quality System, Biotechnology, Lifesciences, Biopharmaceuticals, Medical Devices, 21 CFR Part 11, Clinical Development, Clinical Trials, Regulatory Submissions, Quality Auditing, Pharmaceutics, Quality Assurance, Aseptic Processing, Vaccines, GCP, Drug Development, SOP
Education
Temple University
M.S., QA/RA
Richard Stockton College of New Jersey
B.S., Environmental Public Health
Meridan Consulting, LLC March 2001 - Present
Watson Pharmaceuticals 1997 - 2000
Marsam Pharmaceuticals (became Watson) 1997 - 2000
FDA 1994 - 1997
Skills
Pharmaceutical Industry, Regulatory Affairs, GMP, FDA, Validation, Sop, CAPA, Change Control, Technology Transfer, V&V, Quality System, Biotechnology, Lifesciences, Biopharmaceuticals, Medical Devices, 21 CFR Part 11, Clinical Development, Clinical Trials, Regulatory Submissions, Quality Auditing, Pharmaceutics, Quality Assurance, Aseptic Processing, Vaccines, GCP, Drug Development, SOP
Education
Temple University
M.S., QA/RA
Richard Stockton College of New Jersey
B.S., Environmental Public Health
Winston Howell Winston Howell's FDA Experience December 2014 - Present
Job Production Purification Supervisor
Industry Biotechnology
Experience
FDA December 2014 - Present
MedImmune November 2010 - Present
GlaxoSmithKline 2002 - 2008
Skills
Validation, Purification, Biopharmaceuticals, Biotechnology, Chromatography, Sop, Pharmaceutical Industry, GMP, Technology Transfer, Aseptic Processing, Change Control, FDA, CAPA, Vaccines, V&V, 21 CFR Part 11, Cleaning Validation
Education
Temple University
FDA December 2014 - Present
MedImmune November 2010 - Present
GlaxoSmithKline 2002 - 2008
Skills
Validation, Purification, Biopharmaceuticals, Biotechnology, Chromatography, Sop, Pharmaceutical Industry, GMP, Technology Transfer, Aseptic Processing, Change Control, FDA, CAPA, Vaccines, V&V, 21 CFR Part 11, Cleaning Validation
Education
Temple University
David Portnoy, Ph.D., MPH's FDA Experience June 2014 - Present
Job Social Scientist at FDA
Industry Research
Experience
FDA June 2014 - Present
FDA February 2013 - June 2014
FDA August 2013 - December 2013
MMG June 2012 - February 2013
National Cancer Institute June 2008 - June 2012
Center for Health, Intervention, & Prevention August 2003 - May 2008
Inflexxion August 2001 - June 2003
Skills
Public Health, Behavioral Science, Social Psychology, Cancer Research, Statistics, Study Design, Theory, Health Communication, Survey Design, Research Design, Tobacco, FDA, Epidemiology, Research, Literature Reviews, Grant Writing, Clinical Study Design, Data Analysis, Data Collection, Qualitative Research, Biostatistics, Program Evaluation, Survey Research, SPSS, Experimental Design, Scientific Writing, SAS, Quantitative Research
Education
The Johns Hopkins University 2008 — 2009
MPH, Public Health
University of Connecticut 2003 — 2008
Ph.D., Social Psychology
University of Connecticut 2003 — 2005
MA, Social Psychology
The George Washington University 1997 — 2001
BA, Psychology & Anthropology
William Penn Charter School 1990 — 1997
FDA June 2014 - Present
FDA February 2013 - June 2014
FDA August 2013 - December 2013
MMG June 2012 - February 2013
National Cancer Institute June 2008 - June 2012
Center for Health, Intervention, & Prevention August 2003 - May 2008
Inflexxion August 2001 - June 2003
Skills
Public Health, Behavioral Science, Social Psychology, Cancer Research, Statistics, Study Design, Theory, Health Communication, Survey Design, Research Design, Tobacco, FDA, Epidemiology, Research, Literature Reviews, Grant Writing, Clinical Study Design, Data Analysis, Data Collection, Qualitative Research, Biostatistics, Program Evaluation, Survey Research, SPSS, Experimental Design, Scientific Writing, SAS, Quantitative Research
Education
The Johns Hopkins University 2008 — 2009
MPH, Public Health
University of Connecticut 2003 — 2008
Ph.D., Social Psychology
University of Connecticut 2003 — 2005
MA, Social Psychology
The George Washington University 1997 — 2001
BA, Psychology & Anthropology
William Penn Charter School 1990 — 1997
Donald Ertel Donald Ertel's FDA Experience March 2010 - Present
Job Regulatory Officer / Lieutenant Commander, USPHS
Industry Public Safety
Experience
U.S. Public Health Service Commissioned Corps 2011 - Present
FDA March 2010 - Present
Shire Pharmaceuticals January 2009 - March 2010
Shire Pharmaceuticals September 2007 - January 2009
Shire Pharmaceuticals April 2003 - September 2007
Cell Works Inc. August 1999 - April 2003
The Johns Hopkins Hospital January 1999 - August 1999
Johns Hopkins Hospital July 1992 - January 1999
Skills
CAPA
Education
Temple University, School of Pharmacy
Master's degree, Qualioty Assurance / Regulatory Affairs, 3.89
Temple University 2007 — 2008
Certificate, School of Pharmacy, Quality Assurance / Regulatory Affairs
University of Maryland Baltimore 1987 — 1992
BS, Medical Technology
U.S. Public Health Service Commissioned Corps 2011 - Present
FDA March 2010 - Present
Shire Pharmaceuticals January 2009 - March 2010
Shire Pharmaceuticals September 2007 - January 2009
Shire Pharmaceuticals April 2003 - September 2007
Cell Works Inc. August 1999 - April 2003
The Johns Hopkins Hospital January 1999 - August 1999
Johns Hopkins Hospital July 1992 - January 1999
Skills
CAPA
Education
Temple University, School of Pharmacy
Master's degree, Qualioty Assurance / Regulatory Affairs, 3.89
Temple University 2007 — 2008
Certificate, School of Pharmacy, Quality Assurance / Regulatory Affairs
University of Maryland Baltimore 1987 — 1992
BS, Medical Technology
Olga Rass, Ph.D. Olga Rass, Ph.D.'s FDA Experience May 2015 - Present
Job Scientist at FDA
Industry Research
Experience
FDA May 2015 - Present
Johns Hopkins University School of Medicine September 2012 - May 2015
Indiana University Bloomington August 2007 - August 2012
The College of New Jersey 2004 - 2007
Rutgers Graduate School of Biomedical Sciences June 2005 - August 2005
CPC Behavioral Healthcare 2002 - 2003
Skills
Neuroscience, Cognitive Neuroscience, Cognition, EEG, Scientific Writing, Clinical Research, Statistics, Research, Electrophysiology, Experimental Design, Science, Research Design, Experimentation, Pharmacology, SPSS, Cognitive Psychology, Psychiatry, Psychology, Neuroimaging, Statistical Data..., Clinical Trials, Neuropsychological..., Data Analysis, Project Management, Stage Management, Project Coordination
Education
Indiana University Bloomington 2007 — 2012
Ph.D., Psychology, Neuroscience
The College of New Jersey 2003 — 2007
B.A., Psychology, Biopsychology concentration
FDA May 2015 - Present
Johns Hopkins University School of Medicine September 2012 - May 2015
Indiana University Bloomington August 2007 - August 2012
The College of New Jersey 2004 - 2007
Rutgers Graduate School of Biomedical Sciences June 2005 - August 2005
CPC Behavioral Healthcare 2002 - 2003
Skills
Neuroscience, Cognitive Neuroscience, Cognition, EEG, Scientific Writing, Clinical Research, Statistics, Research, Electrophysiology, Experimental Design, Science, Research Design, Experimentation, Pharmacology, SPSS, Cognitive Psychology, Psychiatry, Psychology, Neuroimaging, Statistical Data..., Clinical Trials, Neuropsychological..., Data Analysis, Project Management, Stage Management, Project Coordination
Education
Indiana University Bloomington 2007 — 2012
Ph.D., Psychology, Neuroscience
The College of New Jersey 2003 — 2007
B.A., Psychology, Biopsychology concentration
Yong Wu Yong Wu's FDA Experience April 2015 - Present
Job ORISE Research Fellow at FDA
Industry Research
Experience
FDA April 2015 - Present
Stevens Institute of Technology September 2008 - March 2015
University of Science and Technology of China September 2004 - July 2008
Institute of Chemistry, Chinese Academy of Sciences June 2007 - August 2007
Skills
AFM, TEM, Polymerization, Cryo-SEM, Confocal Microscopy, Research, FTIR, DLS, SEM, Polymers, Nanotechnology, Emulsion Polymerization, Biomaterials, Surface Modification, Spectrophotometry, Fluorescence Microscopy, Bacterial Culture, Matlab, Nanoparticles, Polymer Science, Microsoft Office, Powder X-ray Diffraction, Controlled Release, Dynamic Light Scattering, Neutron Scattering, Dip Pen Nanolithography, Cell Culture, Teaching, Statistics, Materials Science, Multi-color Cell Imaging, Characterization, UV/Vis, Spectroscopy, Fluorescence
Education
Stevens Institute of Technology 2008 — 2014
Doctor of Philosophy (PhD), Materials Engineering
Stevens Institute of Technology 2008 — 2010
Master's Degree, Materials Science
University of Science and Technology of China 2004 — 2008
Bachelor of Science (BS), Materials Chemistry
FDA April 2015 - Present
Stevens Institute of Technology September 2008 - March 2015
University of Science and Technology of China September 2004 - July 2008
Institute of Chemistry, Chinese Academy of Sciences June 2007 - August 2007
Skills
AFM, TEM, Polymerization, Cryo-SEM, Confocal Microscopy, Research, FTIR, DLS, SEM, Polymers, Nanotechnology, Emulsion Polymerization, Biomaterials, Surface Modification, Spectrophotometry, Fluorescence Microscopy, Bacterial Culture, Matlab, Nanoparticles, Polymer Science, Microsoft Office, Powder X-ray Diffraction, Controlled Release, Dynamic Light Scattering, Neutron Scattering, Dip Pen Nanolithography, Cell Culture, Teaching, Statistics, Materials Science, Multi-color Cell Imaging, Characterization, UV/Vis, Spectroscopy, Fluorescence
Education
Stevens Institute of Technology 2008 — 2014
Doctor of Philosophy (PhD), Materials Engineering
Stevens Institute of Technology 2008 — 2010
Master's Degree, Materials Science
University of Science and Technology of China 2004 — 2008
Bachelor of Science (BS), Materials Chemistry
Kanwal Jit Singh Kanwal Jit Singh's FDA Experience 2004 - 2004
Job Available Remote Only
Industry Computer Software
Experience
BAE Systems, L&A March 2010 - October 2012
Celgene May 2008 - March 2010
BAE Systems May 2006 - November 2007
BearingPoint March 1999 - April 2007
Unison Industires 2005 - 2006
Alcoa December 2002 - September 2004
FDA 2004 - 2004
Oracle Corporation 1997 - 1998
HCL Technologies February 1996 - April 1997
ITIL June 1994 - February 1996
Skills
Oracle Applications, Oracle E-Business Suite, Purchasing, Oracle, Procure-to-Pay, Accounts Payable, ERP, Solution Architecture, Oracle HR, Oracle Discoverer, PL/SQL, SQL, Supply Chain, SDLC, Business Transformation, Integration, Requirements Analysis, Business Process, Business Intelligence
Education
Thapar Institute of Engineering and Technology 1990 — 1994
Engineering, Electronics
BAE Systems, L&A March 2010 - October 2012
Celgene May 2008 - March 2010
BAE Systems May 2006 - November 2007
BearingPoint March 1999 - April 2007
Unison Industires 2005 - 2006
Alcoa December 2002 - September 2004
FDA 2004 - 2004
Oracle Corporation 1997 - 1998
HCL Technologies February 1996 - April 1997
ITIL June 1994 - February 1996
Skills
Oracle Applications, Oracle E-Business Suite, Purchasing, Oracle, Procure-to-Pay, Accounts Payable, ERP, Solution Architecture, Oracle HR, Oracle Discoverer, PL/SQL, SQL, Supply Chain, SDLC, Business Transformation, Integration, Requirements Analysis, Business Process, Business Intelligence
Education
Thapar Institute of Engineering and Technology 1990 — 1994
Engineering, Electronics
Brian Malkin Brian Malkin's FDA Experience 1991 - 2000
Job
Industry Law Practice
Experience
McGuireWoods LLP March 2014 - Present
Frommer Lawrence & Haug LLP 2004 - February 2014
Hyman, Phelps & McNamara, P.C. January 2001 - May 2002
FDA 1991 - 2000
Skills
Litigation, FDA, Patent Prosecution, Patent Litigation, Intellectual Property, Licensing, Patents, Pharmaceuticals, Biotechnology, Pharmaceutical Industry, Prosecution, Copyright Law, Unfair Competition, Due Diligence, Trademark Infringement, Patentability, Technology Transfer, Hatch-Waxman, Biosimilars, Pharmaceutics
Education
University of Maryland College Park 2002 — 2004
Bachelor's Degree, Biochemistry
The George Washington University Law School 1988 — 1991
J.D., Law
The George Washington University 1986 — 1988
B.A., Economics Political Science
The Johns Hopkins University 1983 — 1985
McGuireWoods LLP March 2014 - Present
Frommer Lawrence & Haug LLP 2004 - February 2014
Hyman, Phelps & McNamara, P.C. January 2001 - May 2002
FDA 1991 - 2000
Skills
Litigation, FDA, Patent Prosecution, Patent Litigation, Intellectual Property, Licensing, Patents, Pharmaceuticals, Biotechnology, Pharmaceutical Industry, Prosecution, Copyright Law, Unfair Competition, Due Diligence, Trademark Infringement, Patentability, Technology Transfer, Hatch-Waxman, Biosimilars, Pharmaceutics
Education
University of Maryland College Park 2002 — 2004
Bachelor's Degree, Biochemistry
The George Washington University Law School 1988 — 1991
J.D., Law
The George Washington University 1986 — 1988
B.A., Economics Political Science
The Johns Hopkins University 1983 — 1985
Catherine Sewell Catherine Sewell's FDA Experience August 2012 - Present
Job Medical Officer at FDA
Industry Government Administration
Experience
FDA August 2012 - Present
Johns Hopkins School of Medicine September 2007 - Present
Thomas Jefferson University Department of Obstetrics and Gynecology July 2001 - May 2007
Johns Hopkins School of Medicine July 1998 - May 2001
Skills
Hospitals, Clinical Research, Healthcare, Clinical Development, Clinical Trials, Medical Education, Public Health, Medicine, Epidemiology, Research
Education
The Johns Hopkins University 1998 — 2000
Master of Public Health (MPH) with Honors, Maternal Child Health (Population and Family Health Sciences)
The Johns Hopkins University School of Medicine 1994 — 1998
Obstetrics and Gynecology Residency Program
University of Pennsylvania 1989 — 1994
Doctor of Medicine (MD), Medicine
Swarthmore College 1985 — 1989
Bachelor of Arts (BA) with Honors, English Literature (British and Commonwealth)
National Cathedral School 1981 — 1985
HS diploma
FDA August 2012 - Present
Johns Hopkins School of Medicine September 2007 - Present
Thomas Jefferson University Department of Obstetrics and Gynecology July 2001 - May 2007
Johns Hopkins School of Medicine July 1998 - May 2001
Skills
Hospitals, Clinical Research, Healthcare, Clinical Development, Clinical Trials, Medical Education, Public Health, Medicine, Epidemiology, Research
Education
The Johns Hopkins University 1998 — 2000
Master of Public Health (MPH) with Honors, Maternal Child Health (Population and Family Health Sciences)
The Johns Hopkins University School of Medicine 1994 — 1998
Obstetrics and Gynecology Residency Program
University of Pennsylvania 1989 — 1994
Doctor of Medicine (MD), Medicine
Swarthmore College 1985 — 1989
Bachelor of Arts (BA) with Honors, English Literature (British and Commonwealth)
National Cathedral School 1981 — 1985
HS diploma
Kristi Muldoon Jacobs Kristi Muldoon Jacobs's FDA Experience June 2013 - Present
Job Regulatory toxicologist
Industry Public Safety
Experience
FDA June 2013 - Present
US FDA November 2008 - April 2013
National Cancer Institute June 2006 - October 2008
American University 2007 - 2008
Trinity University 2004 - 2006
Novartis 1999 - 2002
Skills
Cell Biology, Epigenetics, Molecular Biology, RNA biology, SDS-PAGE, Lifesciences, Protein Chemistry, Cell, Genetics, Pharmacology, Genomics, Laboratory, In Vitro, Animal Models, Cell Culture, Biochemistry, Molecular Genetics, Science, In Vivo, Toxicology, Management, PCR, Regulatory Submissions, qPCR
Education
University of Medicine and Dentistry of New Jersey 1999 — 2004
PhD, Biomedical Sciences
Stockton University 1995 — 1998
BS, Biochemisty
FDA June 2013 - Present
US FDA November 2008 - April 2013
National Cancer Institute June 2006 - October 2008
American University 2007 - 2008
Trinity University 2004 - 2006
Novartis 1999 - 2002
Skills
Cell Biology, Epigenetics, Molecular Biology, RNA biology, SDS-PAGE, Lifesciences, Protein Chemistry, Cell, Genetics, Pharmacology, Genomics, Laboratory, In Vitro, Animal Models, Cell Culture, Biochemistry, Molecular Genetics, Science, In Vivo, Toxicology, Management, PCR, Regulatory Submissions, qPCR
Education
University of Medicine and Dentistry of New Jersey 1999 — 2004
PhD, Biomedical Sciences
Stockton University 1995 — 1998
BS, Biochemisty
Tanesha Washington Tanesha Washington's FDA Experience January 2012 - Present
Job at Food and Drug Administration
Industry Human Resources
Experience
FDA January 2012 - Present
FDA August 2010 - December 2011
Education
University of Maryland Baltimore County 2008 — 2010
Masters in Professional Studies, Industrial/Organizational Psychology
Stevenson University 2004 — 2008
Bachelor of Science (BS), Psychology
FDA January 2012 - Present
FDA August 2010 - December 2011
Education
University of Maryland Baltimore County 2008 — 2010
Masters in Professional Studies, Industrial/Organizational Psychology
Stevenson University 2004 — 2008
Bachelor of Science (BS), Psychology
Davis Ancona's FDA Experience June 2010 - August 2010
Job Consultant (Technologist) at Booz Allen Hamilton
Industry Computer Software
Experience
Booz Allen Hamilton August 2014 - Present
Booz Allen Hamilton June 2013 - July 2013
Booz Allen Hamilton June 2012 - August 2012
FDA June 2010 - August 2010
Skills
Computer Science, Engineering, Python, Microsoft Office, Spanish (Basic), Research, Consulting
Education
Swarthmore College 2010 — 2014
Bachelor of Science (B.S.) and Bachelor of Arts (B.A.), Engineering and Computer Science
River Hill High School 2006 — 2010
Booz Allen Hamilton August 2014 - Present
Booz Allen Hamilton June 2013 - July 2013
Booz Allen Hamilton June 2012 - August 2012
FDA June 2010 - August 2010
Skills
Computer Science, Engineering, Python, Microsoft Office, Spanish (Basic), Research, Consulting
Education
Swarthmore College 2010 — 2014
Bachelor of Science (B.S.) and Bachelor of Arts (B.A.), Engineering and Computer Science
River Hill High School 2006 — 2010
Kristen McShane's FDA Experience May 2015 - Present
Job Health Communication Fellow at FDA
Industry Marketing and Advertising
Experience
FDA May 2015 - Present
Boston Children's Hospital June 2013 - April 2015
Massachusetts Department of Public Health January 2014 - July 2014
Boston Children's Hospital May 2011 - June 2013
EF Education First November 2010 - May 2011
American Cancer Society August 2010 - November 2010
Skills
Health Communication, Public Health, Community Outreach, Health Literacy, Social Marketing, Program Development, Non-profits, Facebook, Nonprofits, Social Media, Marketing, Healthcare, Event Planning, Editing, Hospitals, Research, Health Policy, Microsoft Office, Writing, Strategic Communications, Event Management, SPSS, PowerPoint, Customer Service, Health Education, Microsoft Word, Community Development, Fundraising, Health Promotion, Data Entry, Marketing Research, Communication Theory, Literature Reviews
Education
Emerson College 2011 — 2014
Master of Arts, Health Communication, 3.5 GPA
Tufts University School of Medicine 2011 — 2014
Master of Arts (MA), Health Communication
Stonehill College 2007 — 2010
Bachelor of Arts, Communication
University of Technology, Sydney 2009 — 2009
Bachelor's degree, Communication, General
FDA May 2015 - Present
Boston Children's Hospital June 2013 - April 2015
Massachusetts Department of Public Health January 2014 - July 2014
Boston Children's Hospital May 2011 - June 2013
EF Education First November 2010 - May 2011
American Cancer Society August 2010 - November 2010
Skills
Health Communication, Public Health, Community Outreach, Health Literacy, Social Marketing, Program Development, Non-profits, Facebook, Nonprofits, Social Media, Marketing, Healthcare, Event Planning, Editing, Hospitals, Research, Health Policy, Microsoft Office, Writing, Strategic Communications, Event Management, SPSS, PowerPoint, Customer Service, Health Education, Microsoft Word, Community Development, Fundraising, Health Promotion, Data Entry, Marketing Research, Communication Theory, Literature Reviews
Education
Emerson College 2011 — 2014
Master of Arts, Health Communication, 3.5 GPA
Tufts University School of Medicine 2011 — 2014
Master of Arts (MA), Health Communication
Stonehill College 2007 — 2010
Bachelor of Arts, Communication
University of Technology, Sydney 2009 — 2009
Bachelor's degree, Communication, General
Nissa Tasnim's FDA Experience May 2015 - June 2015
Job Doctor of Pharmacy Candidate at Temple University
Industry Pharmaceuticals
Experience
Penn State Milton S. Hershey Medical Center August 2015 - Present
Acme Markets November 2013 - Present
FDA May 2015 - June 2015
cGMP at Temple University School of Pharmacy December 2012 - April 2014
Walmart pharmacy June 2013 - June 2013
Department of Transfusion Medicine at Temple University Hospital January 2012 - May 2012
Department of Chemistry at Temple University May 2011 - May 2012
Skills
Microsoft Office, Agarose Gel..., Biochemistry, Molecular Biology, Clinical Trials, Protein Chemistry, DNA, Research, Pharmacology, Pharmacists, HPLC, Medication Therapy..., Pharmacy, Aseptic Technique, Bengali, PCR primer design, Time Management, Clinical Research, ELISA, PCR, Gel Electrophoresis, Pharmaceutics, SDS-PAGE, Compounding, Analytical Chemistry, Chromatography, Chemistry, Community Pharmacy, Infectious Diseases, Lifesciences, Protein Purification, Laboratory, UV/Vis, Patient Counseling, GMP, Medicinal Chemistry, Microbiology, Titration, Sop, PowerPoint, Microsoft Word, Healthcare, Microsoft Excel, CPR Certified, Teamwork, Life Sciences
Education
Temple University School of Pharmacy 2012 — 2016
Doctor of Pharmacy (Pharm.D.), Pharmacy
Temple University 2008 — 2012
Bachelor of Science (BS), Biochemistry
Penn State Milton S. Hershey Medical Center August 2015 - Present
Acme Markets November 2013 - Present
FDA May 2015 - June 2015
cGMP at Temple University School of Pharmacy December 2012 - April 2014
Walmart pharmacy June 2013 - June 2013
Department of Transfusion Medicine at Temple University Hospital January 2012 - May 2012
Department of Chemistry at Temple University May 2011 - May 2012
Skills
Microsoft Office, Agarose Gel..., Biochemistry, Molecular Biology, Clinical Trials, Protein Chemistry, DNA, Research, Pharmacology, Pharmacists, HPLC, Medication Therapy..., Pharmacy, Aseptic Technique, Bengali, PCR primer design, Time Management, Clinical Research, ELISA, PCR, Gel Electrophoresis, Pharmaceutics, SDS-PAGE, Compounding, Analytical Chemistry, Chromatography, Chemistry, Community Pharmacy, Infectious Diseases, Lifesciences, Protein Purification, Laboratory, UV/Vis, Patient Counseling, GMP, Medicinal Chemistry, Microbiology, Titration, Sop, PowerPoint, Microsoft Word, Healthcare, Microsoft Excel, CPR Certified, Teamwork, Life Sciences
Education
Temple University School of Pharmacy 2012 — 2016
Doctor of Pharmacy (Pharm.D.), Pharmacy
Temple University 2008 — 2012
Bachelor of Science (BS), Biochemistry
Edyta Pawelczyk, PhD Edyta Pawelczyk, PhD's FDA Experience September 2009 - September 2011
Job Manager, Regulatory Affairs CMC
Industry Biotechnology
Experience
Amgen November 2013 - Present
Baxter International Inc. October 2011 - October 2013
FDA September 2009 - September 2011
National Institutes of Health January 2005 - August 2009
Skills
FDA, Regulatory Affairs, Regulatory Submissions, Molecular Biology, CAPA, Oncology, SOP
Education
The University of Texas Medical Branch at Galveston 2000 — 2004
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Technical University of Wroclaw 1994 — 1998
Master’s Degree, Biotechnology & Biochemistry
Amgen November 2013 - Present
Baxter International Inc. October 2011 - October 2013
FDA September 2009 - September 2011
National Institutes of Health January 2005 - August 2009
Skills
FDA, Regulatory Affairs, Regulatory Submissions, Molecular Biology, CAPA, Oncology, SOP
Education
The University of Texas Medical Branch at Galveston 2000 — 2004
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Technical University of Wroclaw 1994 — 1998
Master’s Degree, Biotechnology & Biochemistry
Vondalea Glover, CISSP Vondalea Glover, CISSP's FDA Experience September 2012 - October 2015
Job Federal Compliance Manager at Virtustream
Industry Information Technology and Services
Experience
Virtustream\EMC October 2015 - Present
FDA September 2012 - October 2015
Lunarline, Inc. July 2007 - September 2012
CACI October 2006 - July 2007
Cox Communication January 2005 - August 2006
Sentinel Real Estate Corp. May 2000 - July 2004
Skills
Information Security, Computer Security, Security, Information Assurance, Network Security, NIST, FISMA, CISSP, Information Security..., Security Audits, C&A, Vulnerability Assessment, Application Security, Program Management, Vulnerability Management, Leadership, Nessus, Consulting, Penetration Testing, Computer Forensics, Security Architecture..., Incident Response, DIACAP, Security Policy, Vulnerability Scanning, Data Security, Intrusion Detection, PCI DSS, Business Continuity, Identity Management, Security Awareness, Security+, CompTIA Security+, PKI, IDS, Cloud Security
Education
Strayer University (VA) 2007 — 2010
BS Information Technology, Security, Information Security
University of Maryland University College
Masters Cyber Security
Virtustream\EMC October 2015 - Present
FDA September 2012 - October 2015
Lunarline, Inc. July 2007 - September 2012
CACI October 2006 - July 2007
Cox Communication January 2005 - August 2006
Sentinel Real Estate Corp. May 2000 - July 2004
Skills
Information Security, Computer Security, Security, Information Assurance, Network Security, NIST, FISMA, CISSP, Information Security..., Security Audits, C&A, Vulnerability Assessment, Application Security, Program Management, Vulnerability Management, Leadership, Nessus, Consulting, Penetration Testing, Computer Forensics, Security Architecture..., Incident Response, DIACAP, Security Policy, Vulnerability Scanning, Data Security, Intrusion Detection, PCI DSS, Business Continuity, Identity Management, Security Awareness, Security+, CompTIA Security+, PKI, IDS, Cloud Security
Education
Strayer University (VA) 2007 — 2010
BS Information Technology, Security, Information Security
University of Maryland University College
Masters Cyber Security
Casper Uldriks Casper Uldriks's FDA Experience 1978 - 2010
Job Encore Insight LLC
Industry Management Consulting
Experience
Encore Insight LLC August 2014 - Present
Olsson Frank Weeda Terman Bode Matz PC May 2010 - July 2014
Food & Drug Administration 1978 - 2010
FDA 1978 - 2010
Skills
Legal Writing, Policy, FDA, Regulatory Submissions, Legal Research, Litigation, Medical Devices, Public Policy, Regulatory Affairs, Regulatory Requirements, Government, Program Management, Public Speaking, Regulations, Legislative Relations, GMP, Federal Government, Food & Drug Law, Technology Transfer, Civil Litigation, Corporate Law, Intellectual Property, Lifesciences, Policy Analysis, Legislation, Arbitration, Health Policy, Health Law, Prosecution, Patent Litigation, Training, False Claims, Patent Prosecution, Life Sciences
Education
Suffolk University Law School 1982 — 1986
JD
Encore Insight LLC August 2014 - Present
Olsson Frank Weeda Terman Bode Matz PC May 2010 - July 2014
Food & Drug Administration 1978 - 2010
FDA 1978 - 2010
Skills
Legal Writing, Policy, FDA, Regulatory Submissions, Legal Research, Litigation, Medical Devices, Public Policy, Regulatory Affairs, Regulatory Requirements, Government, Program Management, Public Speaking, Regulations, Legislative Relations, GMP, Federal Government, Food & Drug Law, Technology Transfer, Civil Litigation, Corporate Law, Intellectual Property, Lifesciences, Policy Analysis, Legislation, Arbitration, Health Policy, Health Law, Prosecution, Patent Litigation, Training, False Claims, Patent Prosecution, Life Sciences
Education
Suffolk University Law School 1982 — 1986
JD
Elizabeth Blair Elizabeth Blair's FDA Experience June 2013 - July 2013
Job Clinical Development Manager at ViiV Healthcare
Industry Pharmaceuticals
Experience
ViiV Healthcare June 2015 - Present
GSK July 2014 - June 2015
Target January 2013 - January 2015
GlaxoSmithKline January 2013 - June 2014
FDA June 2013 - July 2013
University of North Carolina at Chapel Hill July 2012 - June 2013
J.B. Merrick Apothecary May 2009 - April 2012
Skills
Clinical Research, Clinical Trials, Cardiovascular Disease, Drug Development, Pharmacology, Pharmacists, Pharmaceutical Industry, Clinical Study Design, Pharmacy, Clinical Development, Pharmacovigilance, Biochemistry
Education
Thomas Jefferson University 2008 — 2012
Doctor of Pharmacy (Pharm.D.), Pharmacy
Syracuse University 2003 — 2007
Bachelor of Science (BS), Biochemistry, Spanish
ViiV Healthcare June 2015 - Present
GSK July 2014 - June 2015
Target January 2013 - January 2015
GlaxoSmithKline January 2013 - June 2014
FDA June 2013 - July 2013
University of North Carolina at Chapel Hill July 2012 - June 2013
J.B. Merrick Apothecary May 2009 - April 2012
Skills
Clinical Research, Clinical Trials, Cardiovascular Disease, Drug Development, Pharmacology, Pharmacists, Pharmaceutical Industry, Clinical Study Design, Pharmacy, Clinical Development, Pharmacovigilance, Biochemistry
Education
Thomas Jefferson University 2008 — 2012
Doctor of Pharmacy (Pharm.D.), Pharmacy
Syracuse University 2003 — 2007
Bachelor of Science (BS), Biochemistry, Spanish
Tamanna Rajpal Tamanna Rajpal's FDA Experience August 2014 - Present
Job Senior System Analyst at FDA
Industry Information Technology and Services
Experience
FDA August 2014 - Present
Express Scripts March 2014 - August 2014
Northrop Grumman Corporation December 2012 - March 2014
CA Technologies June 2008 - December 2012
USBeverageNet April 2007 - October 2007
Center for Development of Advanced Computing (CDAC), Mumbai, India June 2005 - June 2006
Skills
SDLC, Unix, Agile Methodologies, Requirements Analysis, SQL, SharePoint, Project Planning, Software Engineering, Software Development, Software Project..., Databases, Enterprise Architecture, Web Development, Web Services, XML, PL/SQL, Oracle, Perl
Education
Syracuse University 2006 — 2008
MS, Information Management
FDA August 2014 - Present
Express Scripts March 2014 - August 2014
Northrop Grumman Corporation December 2012 - March 2014
CA Technologies June 2008 - December 2012
USBeverageNet April 2007 - October 2007
Center for Development of Advanced Computing (CDAC), Mumbai, India June 2005 - June 2006
Skills
SDLC, Unix, Agile Methodologies, Requirements Analysis, SQL, SharePoint, Project Planning, Software Engineering, Software Development, Software Project..., Databases, Enterprise Architecture, Web Development, Web Services, XML, PL/SQL, Oracle, Perl
Education
Syracuse University 2006 — 2008
MS, Information Management
Kiwanda Robinson Kiwanda Robinson's FDA Experience June 2012 - August 2012
Job Student at Temple University
Industry Recreational Facilities and Services
Experience
FDA June 2012 - August 2012
Chop’t Salad Creation Company January 2011 - January 2012
U.S. House of Representatives January 2011 - May 2011
Skills
Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel, Customer Service, Public Speaking, Research, Social Media, Nutrition, Cpr Certified, Fitness, Photoshop
Education
Temple University 2012 — 2016
Bachelor of Science, Therapeutic Recreation
Potomac Senior High School 2008 — 2012
Volunteer, Redeem Christian Academy
Teacher’s Aid, Potomac High School
FDA June 2012 - August 2012
Chop’t Salad Creation Company January 2011 - January 2012
U.S. House of Representatives January 2011 - May 2011
Skills
Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel, Customer Service, Public Speaking, Research, Social Media, Nutrition, Cpr Certified, Fitness, Photoshop
Education
Temple University 2012 — 2016
Bachelor of Science, Therapeutic Recreation
Potomac Senior High School 2008 — 2012
Volunteer, Redeem Christian Academy
Teacher’s Aid, Potomac High School
Lilia Hinojosa's FDA Experience 2014 - Present
Job Consumer Safety Officer
Industry Government Administration
Experience
FDA 2014 - Present
Education
Texas A&M University-Kingsville
Bachelor's degree, Chemical Engineering
FDA 2014 - Present
Education
Texas A&M University-Kingsville
Bachelor's degree, Chemical Engineering
Suzanne Mahoney Suzanne Mahoney's FDA Experience May 2008 - July 2013
Job Architectural Intern at KieranTimberlake
Industry Architecture & Planning
Experience
KieranTimberlake January 2015 - Present
University of Pennsylvania September 2014 - December 2014
University of Pennsylvania September 2012 - December 2014
Turenscape June 2014 - August 2014
FDA May 2008 - July 2013
Skills
Revit, AutoCAD, SketchUp, Microsoft Office, Adobe Creative Suite, Photoshop, Illustrator, InDesign, Research, PowerPoint, Microsoft Word, Sketching, Sustainable Design, Architecture, Graphic Design, Public Speaking, Design Research
Education
University of Pennsylvania 2012 — 2014
Master of Landscape Architecture
University of Pennsylvania 2012 — 2014
Master of City Planning, Urban Design Concentration
Temple University 2007 — 2012
Bachelor of Architecture (BArch), Architecture
KieranTimberlake January 2015 - Present
University of Pennsylvania September 2014 - December 2014
University of Pennsylvania September 2012 - December 2014
Turenscape June 2014 - August 2014
FDA May 2008 - July 2013
Skills
Revit, AutoCAD, SketchUp, Microsoft Office, Adobe Creative Suite, Photoshop, Illustrator, InDesign, Research, PowerPoint, Microsoft Word, Sketching, Sustainable Design, Architecture, Graphic Design, Public Speaking, Design Research
Education
University of Pennsylvania 2012 — 2014
Master of Landscape Architecture
University of Pennsylvania 2012 — 2014
Master of City Planning, Urban Design Concentration
Temple University 2007 — 2012
Bachelor of Architecture (BArch), Architecture
Autumn Zack-Taylor's FDA Experience December 2011 - Present
Job ORISE Research Fellow at FDA
Industry Biotechnology
Experience
FDA December 2011 - Present
Skills
Molecular Biology, Cell Culture, Microbiology, Lifesciences, Biotechnology, Biochemistry, Western Blotting, ELISA, Cell Biology, Protein Purification, Transfection, Flow Cytometry, Gel Electrophoresis, Virus Culture, Regulatory Affairs, Assay Development, FDA, Laboratory, Tissue Culture, Life Sciences
Education
The Johns Hopkins University 2013 — 2014
Master of Science (MS), Biotechnology
Sweet Briar College 2007 — 2011
Bachelor of Science (BS), Biology, General
FDA December 2011 - Present
Skills
Molecular Biology, Cell Culture, Microbiology, Lifesciences, Biotechnology, Biochemistry, Western Blotting, ELISA, Cell Biology, Protein Purification, Transfection, Flow Cytometry, Gel Electrophoresis, Virus Culture, Regulatory Affairs, Assay Development, FDA, Laboratory, Tissue Culture, Life Sciences
Education
The Johns Hopkins University 2013 — 2014
Master of Science (MS), Biotechnology
Sweet Briar College 2007 — 2011
Bachelor of Science (BS), Biology, General
Paul Varki Paul Varki's FDA Experience September 2000 - 2002
Job Assistant General Counsel GlaxoSmithKline
Industry Biotechnology
Experience
GlaxoSmithKline January 2004 - Present
Reed Smith December 2002 - January 2004
FDA September 2000 - 2002
Covance 1995 - 1997
Skills
Corporate Governance, Corporate Law, Healthcare, Intellectual Property, Licensing, Pharmaceutical Industry, Regulatory Affairs, Technology Transfer, Clinical Development, Due Diligence
Education
Temple University - James E. Beasley School of Law 1997 — 2000
JD, law
The George Washington University 1994 — 1995
MPH
William & Mary 1990 — 1994
BA, English
GlaxoSmithKline January 2004 - Present
Reed Smith December 2002 - January 2004
FDA September 2000 - 2002
Covance 1995 - 1997
Skills
Corporate Governance, Corporate Law, Healthcare, Intellectual Property, Licensing, Pharmaceutical Industry, Regulatory Affairs, Technology Transfer, Clinical Development, Due Diligence
Education
Temple University - James E. Beasley School of Law 1997 — 2000
JD, law
The George Washington University 1994 — 1995
MPH
William & Mary 1990 — 1994
BA, English
Daniel Osei's FDA Experience May 2010 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA May 2010 - Present
First Convenience Bank December 2007 - May 2010
Skills
Public Health, Regulatory Affairs, Government, Policy, Policy Analysis, Data Analysis, Public Policy, Customer Service, Management, Emergency Management, Program Evaluation
Education
The University of Texas at Arlington 2007 — 2009
Bachelor of Science (B.S.), Biology, General
Tarrant County College 2004 — 2007
Associate of Arts and Sciences (A.A.S.), Pre-Pharmacy Studies
FDA May 2010 - Present
First Convenience Bank December 2007 - May 2010
Skills
Public Health, Regulatory Affairs, Government, Policy, Policy Analysis, Data Analysis, Public Policy, Customer Service, Management, Emergency Management, Program Evaluation
Education
The University of Texas at Arlington 2007 — 2009
Bachelor of Science (B.S.), Biology, General
Tarrant County College 2004 — 2007
Associate of Arts and Sciences (A.A.S.), Pre-Pharmacy Studies
Colin Tack Colin Tack's FDA Experience July 2014 - Present
Job Lead Reviewer at FDA
Industry Medical Devices
Experience
FDA July 2014 - Present
Orchid Design May 2013 - August 2013
Syracuse University January 2012 - May 2012
Skills
Matlab, Microsoft Office, Microsoft Excel, Solidworks, AutoCAD, Biomedical Engineering, Microsoft Word, Pro Engineer, Engineering, COMSOL, Multisim, NI LabVIEW, Autodesk Software, Minitab, FDA, Regulatory Affairs, Quality System...
Education
Syracuse University 2010 — 2014
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
FDA July 2014 - Present
Orchid Design May 2013 - August 2013
Syracuse University January 2012 - May 2012
Skills
Matlab, Microsoft Office, Microsoft Excel, Solidworks, AutoCAD, Biomedical Engineering, Microsoft Word, Pro Engineer, Engineering, COMSOL, Multisim, NI LabVIEW, Autodesk Software, Minitab, FDA, Regulatory Affairs, Quality System...
Education
Syracuse University 2010 — 2014
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Jaimee Friend Jaimee Friend's FDA Experience May 2011 - Present
Job Director, Employee Resource & Information Center at FDA
Industry Government Administration
Experience
FDA May 2011 - Present
FDA April 2004 - Present
Food & Drug Administration August 2008 - May 2011
FDA April 2004 - August 2008
Northwest Airlines February 2001 - April 2004
Northwest Airlines February 1998 - February 2001
Northwest Airlines October 1997 - February 1998
Northwest Airlines April 1988 - October 1997
USAF February 1985 - March 1988
USAF January 1983 - February 1985
Skills
Management, Change Management, Government, Process Improvement, Program Management, Project Management, Leadership, Policy, Project Planning, Team Leadership, Organizational..., Analysis, Policy Analysis, Training, Operations Management, Strategic Planning, Federal Government, Emergency Management, Budgets, Team Building, Microsoft Office, Contract Management, Government Contracting, Customer Service
Education
Project Management Institute 2008 — 2008
PMP, Project Management
The George Washington University - School of Business 2006 — 2007
Master's Certificate, Project Management
Webster University 2004 — 2006
Master of Arts, Computer Resources and Information Management
Syracuse University 1978 — 1982
Bachelor of Science, Rehabilitation/ Psychology
Yeadon High
FDA May 2011 - Present
FDA April 2004 - Present
Food & Drug Administration August 2008 - May 2011
FDA April 2004 - August 2008
Northwest Airlines February 2001 - April 2004
Northwest Airlines February 1998 - February 2001
Northwest Airlines October 1997 - February 1998
Northwest Airlines April 1988 - October 1997
USAF February 1985 - March 1988
USAF January 1983 - February 1985
Skills
Management, Change Management, Government, Process Improvement, Program Management, Project Management, Leadership, Policy, Project Planning, Team Leadership, Organizational..., Analysis, Policy Analysis, Training, Operations Management, Strategic Planning, Federal Government, Emergency Management, Budgets, Team Building, Microsoft Office, Contract Management, Government Contracting, Customer Service
Education
Project Management Institute 2008 — 2008
PMP, Project Management
The George Washington University - School of Business 2006 — 2007
Master's Certificate, Project Management
Webster University 2004 — 2006
Master of Arts, Computer Resources and Information Management
Syracuse University 1978 — 1982
Bachelor of Science, Rehabilitation/ Psychology
Yeadon High
Elisa Elliot Elisa Elliot's FDA Experience July 1989 - Present
Job Microbiologist at FDA
Industry Government Administration
Experience
FDA July 1989 - Present
University of Maryland University College August 1987 - December 1991
USDA Food Safety and Inspection Service 1987 - 1989
University of Alaska Fishery Industrial Technology Center 1984 - 1987
Skills
Microbiology, Epidemiology, Food Microbiology, Food Safety, Science, Lifesciences, Public Health, HACCP, Infectious Diseases, Biochemistry, Biostatistics, Data Analysis, Research, Food, FDA, Regulatory Affairs, Security Clearance, Laboratory, ELISA, Microsoft Office
Education
University of Maryland College Park 1978 — 1984
Ph.D.
Texas Tech University 1976 — 1977
B.S.
Texas A&M University 1974 — 1976
FDA July 1989 - Present
University of Maryland University College August 1987 - December 1991
USDA Food Safety and Inspection Service 1987 - 1989
University of Alaska Fishery Industrial Technology Center 1984 - 1987
Skills
Microbiology, Epidemiology, Food Microbiology, Food Safety, Science, Lifesciences, Public Health, HACCP, Infectious Diseases, Biochemistry, Biostatistics, Data Analysis, Research, Food, FDA, Regulatory Affairs, Security Clearance, Laboratory, ELISA, Microsoft Office
Education
University of Maryland College Park 1978 — 1984
Ph.D.
Texas Tech University 1976 — 1977
B.S.
Texas A&M University 1974 — 1976
maurille beheton's FDA Experience February 2012 - Present
Job Financial Advisor
Industry Government Administration
Experience
FDA February 2012 - Present
Food and drug administration May 2009 - January 2012
United Nations February 2006 - May 2009
Skills
Financial Analysis, Grants, Policy, Management, Managerial Finance, Budgets, Accounting, Team Leadership, Finance, Risk Management, Financial Reporting, Data Analysis, Leadership, Federal Government, Process Improvement, Human Resources, Program Management, Government, Project Planning, Access, Auditing, Management Consulting, Nonprofits, Procurement, Strategic Planning, Public Administration, Project Management, Analysis, Public Policy, Internal Controls, Microsoft Excel, Program Evaluation, Strategic Financial..., Business Analysis, Business Development, Program Development, Contract Negotiation, Financial Planning
Education
Strayer University 1999 — 2001
Master, Accounting, Business Administration
FDA February 2012 - Present
Food and drug administration May 2009 - January 2012
United Nations February 2006 - May 2009
Skills
Financial Analysis, Grants, Policy, Management, Managerial Finance, Budgets, Accounting, Team Leadership, Finance, Risk Management, Financial Reporting, Data Analysis, Leadership, Federal Government, Process Improvement, Human Resources, Program Management, Government, Project Planning, Access, Auditing, Management Consulting, Nonprofits, Procurement, Strategic Planning, Public Administration, Project Management, Analysis, Public Policy, Internal Controls, Microsoft Excel, Program Evaluation, Strategic Financial..., Business Analysis, Business Development, Program Development, Contract Negotiation, Financial Planning
Education
Strayer University 1999 — 2001
Master, Accounting, Business Administration
Edith Lang Edith Lang's FDA Experience August 2012 - Present
Job Nurse Consultant at FDA
Industry Government Administration
Experience
FDA August 2012 - Present
United States Department of Defense July 2010 - August 2012
United States Department of Defense July 2009 - July 2010
Skills
Critical Care, Clinical Workflow, Medical Devices, Patient Safety, Nursing Education, Project Management, Medical Information..., Public Health, Military Medicine
Education
Walden University 2008 — 2010
Master's degree, Public Health
Texas Christian University 1988 — 1992
Bachelor's degree, Registered Nursing/Registered Nurse
FDA August 2012 - Present
United States Department of Defense July 2010 - August 2012
United States Department of Defense July 2009 - July 2010
Skills
Critical Care, Clinical Workflow, Medical Devices, Patient Safety, Nursing Education, Project Management, Medical Information..., Public Health, Military Medicine
Education
Walden University 2008 — 2010
Master's degree, Public Health
Texas Christian University 1988 — 1992
Bachelor's degree, Registered Nursing/Registered Nurse
Larry Pilot Larry Pilot's FDA Experience December 1969 - June 1979
Job FDA Law Expert Witness at Expert Witness
Industry Law Practice
Experience
Attorney at Law January 2009 - Present
Expert Witness January 1983 - Present
McKenna Long & Aldridge LLP March 1983 - December 2008
FDA December 1969 - June 1979
PhRMA June 1966 - July 1969
Skills
Food & Drug Law, Pharmaceutical Industry, Medical Devices, Trade Associations, Regulatory Requirements, Litigation Support
Education
The Catholic University of America, Columbus School of Law 1964 — 1967
Doctor of Law (J.D.)
Wayne State University 1958 — 1962
Bachelor of Pharmacy (B.Pharm.), Pharmacy
Attorney at Law January 2009 - Present
Expert Witness January 1983 - Present
McKenna Long & Aldridge LLP March 1983 - December 2008
FDA December 1969 - June 1979
PhRMA June 1966 - July 1969
Skills
Food & Drug Law, Pharmaceutical Industry, Medical Devices, Trade Associations, Regulatory Requirements, Litigation Support
Education
The Catholic University of America, Columbus School of Law 1964 — 1967
Doctor of Law (J.D.)
Wayne State University 1958 — 1962
Bachelor of Pharmacy (B.Pharm.), Pharmacy
Colin O'Neill, MBE's FDA Experience 2008 - Present
Job Biomedical Engineer at FDA
Industry Government Administration
Experience
FDA 2008 - Present
Skills
Biomedical Engineering, Medical Devices, Analysis, Engineering, Biomechanics, Biomaterials, R&D, Finite Element Analysis, FDA
Education
The Catholic University of America 2007 — 2008
Master's degree, Biomedical Engineering
University of Delaware 2003 — 2007
Bachelor's Degree, Mechanical Engineering and Biomechanics
FDA 2008 - Present
Skills
Biomedical Engineering, Medical Devices, Analysis, Engineering, Biomechanics, Biomaterials, R&D, Finite Element Analysis, FDA
Education
The Catholic University of America 2007 — 2008
Master's degree, Biomedical Engineering
University of Delaware 2003 — 2007
Bachelor's Degree, Mechanical Engineering and Biomechanics
Stacy Sendrowski Zellers, PMP Stacy Sendrowski Zellers, PMP's FDA Experience September 2009 - September 2014
Job Project Manager at the Department of the Interior
Industry Government Administration
Experience
DOI - Department of the Interior September 2014 - Present
FDA September 2009 - September 2014
Engility Corporation formerly HPTi March 2009 - August 2009
PricewaterhouseCoopers November 2004 - March 2009
VarTec Telecom, Inc. January 2003 - November 2004
Evercom Systems, Inc. December 2001 - January 2003
Skills
Business Analysis, Process Improvement, Program Management, Business Process, Project Management, Business Process..., Risk Management, Strategic Planning, Change Management, Analysis, Business Intelligence, Financial Analysis, Quality Assurance, Team Leadership, Governance
Education
The George Washington University 2012 — 2013
Master's Certificate, Project Management
Texas A&M University 1997 — 2001
BBA, Management Information Systems (MIS)
DOI - Department of the Interior September 2014 - Present
FDA September 2009 - September 2014
Engility Corporation formerly HPTi March 2009 - August 2009
PricewaterhouseCoopers November 2004 - March 2009
VarTec Telecom, Inc. January 2003 - November 2004
Evercom Systems, Inc. December 2001 - January 2003
Skills
Business Analysis, Process Improvement, Program Management, Business Process, Project Management, Business Process..., Risk Management, Strategic Planning, Change Management, Analysis, Business Intelligence, Financial Analysis, Quality Assurance, Team Leadership, Governance
Education
The George Washington University 2012 — 2013
Master's Certificate, Project Management
Texas A&M University 1997 — 2001
BBA, Management Information Systems (MIS)
Jay Yuan Jay Yuan's FDA Experience 2003 - 2004
Job
Industry Medical Practice
Experience
Cedars-Sinai Medical Center 2014 - Present
UCLA Health 2014 - Present
Banner - University Medical Center 2012 - 2015
FDA 2003 - 2004
Skills
Medicine, Medical Education, Healthcare, Hospitals
Education
Banner - University Medical Center
Internal Medicine Residency Program - Hospital Medicine Track
Stony Brook University Health Sciences Center School of Medicine
Doctor of Medicine (M.D.)
The Johns Hopkins University
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Cedars-Sinai Medical Center 2014 - Present
UCLA Health 2014 - Present
Banner - University Medical Center 2012 - 2015
FDA 2003 - 2004
Skills
Medicine, Medical Education, Healthcare, Hospitals
Education
Banner - University Medical Center
Internal Medicine Residency Program - Hospital Medicine Track
Stony Brook University Health Sciences Center School of Medicine
Doctor of Medicine (M.D.)
The Johns Hopkins University
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Robert Bode's FDA Experience March 2014 - Present
Job Interactive Director
Industry Design
Experience
FÖDA March 2014 - Present
Skills
Adobe Creative Suite, Art Direction, Graphic Design, Typography, Web Design, Logo Design, Creative Direction, Interaction Design, User Experience, Wordpress, User Interface Design, Social Media, Advertising, Email Marketing, Information Architecture, Brand Development, Digital Strategy, SEO, Digital Marketing, Project Management, Corporate Identity, WordPress, Branding & Identity, InDesign, Social Media Marketing, Interactive Marketing
Education
Texas State University
FÖDA March 2014 - Present
Skills
Adobe Creative Suite, Art Direction, Graphic Design, Typography, Web Design, Logo Design, Creative Direction, Interaction Design, User Experience, Wordpress, User Interface Design, Social Media, Advertising, Email Marketing, Information Architecture, Brand Development, Digital Strategy, SEO, Digital Marketing, Project Management, Corporate Identity, WordPress, Branding & Identity, InDesign, Social Media Marketing, Interactive Marketing
Education
Texas State University
Zoya Wolff, MBA, PMP's FDA Experience November 2014 - Present
Job IT Project Manager at FDA
Industry Information Technology and Services
Experience
FDA November 2014 - Present
DRT Strategies November 2011 - October 2014
Celerity October 2010 - September 2011
Omnisolve September 2009 - October 2010
General Dynamics Information Technology and JPI (GDIT Subcontract) March 2008 - September 2009
ROH, Inc October 2002 - February 2008
American Management Systems, Inc. July 2000 - June 2001
Skills
Business Process..., Business Analysis, Program Management, Project Management, Process Improvement, Consulting, PMO, Analysis, CRM, Business Process, Software Documentation, SDLC, Management, Project Planning, Integration, Risk Management, Leadership, Enterprise Software, PMP
Education
University of Maryland - Robert H. Smith School of Business 2004 — 2007
MBA
Syracuse University 1996 — 2000
BS, Information Management and Technology
FDA November 2014 - Present
DRT Strategies November 2011 - October 2014
Celerity October 2010 - September 2011
Omnisolve September 2009 - October 2010
General Dynamics Information Technology and JPI (GDIT Subcontract) March 2008 - September 2009
ROH, Inc October 2002 - February 2008
American Management Systems, Inc. July 2000 - June 2001
Skills
Business Process..., Business Analysis, Program Management, Project Management, Process Improvement, Consulting, PMO, Analysis, CRM, Business Process, Software Documentation, SDLC, Management, Project Planning, Integration, Risk Management, Leadership, Enterprise Software, PMP
Education
University of Maryland - Robert H. Smith School of Business 2004 — 2007
MBA
Syracuse University 1996 — 2000
BS, Information Management and Technology
James L. Swiger's FDA Experience February 2010 - Present
Job
Industry Medical Devices
Experience
FDA February 2010 - Present
Skills
Medical Devices, FDA, Surgery, Spine, Biomedical Engineering, Lifesciences, Biotechnology, Patents, Intellectual Property, Data Analysis, Healthcare, Biomaterials, Biomechanics, Orthopedic, Medical Imaging, Microsoft Office
Education
The Catholic University of America 2001 — 2007
FDA February 2010 - Present
Skills
Medical Devices, FDA, Surgery, Spine, Biomedical Engineering, Lifesciences, Biotechnology, Patents, Intellectual Property, Data Analysis, Healthcare, Biomaterials, Biomechanics, Orthopedic, Medical Imaging, Microsoft Office
Education
The Catholic University of America 2001 — 2007
Audrey Uy's FDA Experience September 1996 - December 2003
Job quality manager at nv
Industry Pharmaceuticals
Experience
Novartis Pharmaceuticals September 2006 - Present
Schering-Plough Research Institute January 2004 - August 2006
FDA September 1996 - December 2003
Skills
Auditing, GMP, CAPA, Software Documentation, Sop, Manufacturing, Quality Assurance, Quality Auditing, Medical Devices
Education
Temple University 2000 — 2003
MS, Pharmaceutical QA/RA
University of California, Irvine 1991 — 1995
BS, Chemistry/Biology
Novartis Pharmaceuticals September 2006 - Present
Schering-Plough Research Institute January 2004 - August 2006
FDA September 1996 - December 2003
Skills
Auditing, GMP, CAPA, Software Documentation, Sop, Manufacturing, Quality Assurance, Quality Auditing, Medical Devices
Education
Temple University 2000 — 2003
MS, Pharmaceutical QA/RA
University of California, Irvine 1991 — 1995
BS, Chemistry/Biology
Christina Kichula's FDA Experience 1993 - 1999
Job Group Manager, Regulatory Affairs at Globus Medical
Industry Medical Devices
Experience
Therakos, Inc. May 2015 - Present
Globus Medical December 2011 - April 2015
Biomerix January 2006 - December 2011
FDA 1993 - 1999
Skills
Medical Devices, Design Control, ISO 13485
Education
The Catholic University of America 1988 — 1992
BBE, Biomedical Engineering
Therakos, Inc. May 2015 - Present
Globus Medical December 2011 - April 2015
Biomerix January 2006 - December 2011
FDA 1993 - 1999
Skills
Medical Devices, Design Control, ISO 13485
Education
The Catholic University of America 1988 — 1992
BBE, Biomedical Engineering
Ed Zimney, MD's FDA Experience 1991 - 1993
Job Retired
Industry Pharmaceuticals
Experience
Dendreon March 2011 - April 2014
Genentech April 2010 - March 2011
Genentech February 2009 - April 2010
HealthTalk May 2004 - October 2008
Amgen 2002 - 2004
Immunex 1994 - 2002
Immunex March 1994 - 2000
FDA 1991 - 1993
Zeneca 1986 - 1991
Wyeth March 1983 - 1986
Education
State University of New York Upstate Medical University 1971 — 1975
MD
Dendreon March 2011 - April 2014
Genentech April 2010 - March 2011
Genentech February 2009 - April 2010
HealthTalk May 2004 - October 2008
Amgen 2002 - 2004
Immunex 1994 - 2002
Immunex March 1994 - 2000
FDA 1991 - 1993
Zeneca 1986 - 1991
Wyeth March 1983 - 1986
Education
State University of New York Upstate Medical University 1971 — 1975
MD
Eric Thostesen's FDA Experience June 1991 - March 1995
Job Senior Director, Regulatory Compliance at Janssen, Pharmaceutical Companies of Johnson and Johnson
Industry Pharmaceuticals
Experience
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2012 - Present
Johnson & Johnson 2001 - Present
FDA June 1991 - March 1995
FDA June 1991 - March 1995
Skills
Pharmaceutical Industry, GMP, 21 CFR Part 11, Quality System, FDA, CAPA, Biotechnology, Regulatory Affairs, V&V, Sop, Regulatory Requirements, Root Cause Analysis, Quality Auditing, FDA GMP, Validation, Recalls, Strategic Business..., Compliance, GLP, Quality Assurance, Change Control, Cleaning Validation, Computer System..., Aseptic Processing, Regulatory Submissions, Biopharmaceuticals, IND, Technology Transfer, ISO 13485, Drug Development, ISO 14971, GCP, Medical Devices, Clinical Development, Clinical Trials, Lifesciences, Pharmacovigilance, Design Control, SOP, Life Sciences, Pharmaceutics, Cross-functional Team..., Management, GxP, HPLC
Education
The College of New Jersey 1986 — 1991
BS, Biology
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2012 - Present
Johnson & Johnson 2001 - Present
FDA June 1991 - March 1995
FDA June 1991 - March 1995
Skills
Pharmaceutical Industry, GMP, 21 CFR Part 11, Quality System, FDA, CAPA, Biotechnology, Regulatory Affairs, V&V, Sop, Regulatory Requirements, Root Cause Analysis, Quality Auditing, FDA GMP, Validation, Recalls, Strategic Business..., Compliance, GLP, Quality Assurance, Change Control, Cleaning Validation, Computer System..., Aseptic Processing, Regulatory Submissions, Biopharmaceuticals, IND, Technology Transfer, ISO 13485, Drug Development, ISO 14971, GCP, Medical Devices, Clinical Development, Clinical Trials, Lifesciences, Pharmacovigilance, Design Control, SOP, Life Sciences, Pharmaceutics, Cross-functional Team..., Management, GxP, HPLC
Education
The College of New Jersey 1986 — 1991
BS, Biology
Joe Grogan's FDA Experience November 2006 - August 2008
Job Government Affairs, Gilead
Industry Pharmaceuticals
Experience
Gilead Sciences November 2011 - Present
Amgen June 2009 - November 2011
The Marwood Group August 2008 - June 2009
FDA November 2006 - August 2008
Presidential Advisory Council on HIV and AIDS May 2004 - November 2006
Administration for Children and Families 2001 - 2004
Skills
Regulatory Affairs, FDA, Biotechnology, Healthcare, Strategic Planning, Pharmaceutical Industry, Policy Analysis, Government, Public Policy, Healthcare Information..., Due Diligence, Lifesciences, Policy, Health Policy, Regulations, Negotiation, Strategic Communications, Research, Cross-functional Team..., Public Health, Clinical Development, Clinical Trials, Leadership, Legislative Relations, Public Speaking, Strategy
Education
The College of William and Mary - Marshall Wythe Law School 1997 — 2000
JD, Law
State University of New York at Albany 1992 — 1994
Bachelor of Arts (B.A.), English Language and Literature, General
Gilead Sciences November 2011 - Present
Amgen June 2009 - November 2011
The Marwood Group August 2008 - June 2009
FDA November 2006 - August 2008
Presidential Advisory Council on HIV and AIDS May 2004 - November 2006
Administration for Children and Families 2001 - 2004
Skills
Regulatory Affairs, FDA, Biotechnology, Healthcare, Strategic Planning, Pharmaceutical Industry, Policy Analysis, Government, Public Policy, Healthcare Information..., Due Diligence, Lifesciences, Policy, Health Policy, Regulations, Negotiation, Strategic Communications, Research, Cross-functional Team..., Public Health, Clinical Development, Clinical Trials, Leadership, Legislative Relations, Public Speaking, Strategy
Education
The College of William and Mary - Marshall Wythe Law School 1997 — 2000
JD, Law
State University of New York at Albany 1992 — 1994
Bachelor of Arts (B.A.), English Language and Literature, General
Mikko Makarainen's FDA Experience March 2013 - May 2014
Job Budget Formulation and Reporting Branch Chief at National Institutes of Health
Industry Government Administration
Experience
National Institutes of Health May 2014 - Present
FDA March 2013 - May 2014
White House Office of Management and Budget February 2006 - March 2013
Skills
Government, Economics, Data Analysis, Policy, Program Evaluation, Analysis, Federal Government, Politics, Econometrics, Foreign Policy, Budgets
Education
Syracuse University - Maxwell School 1998 — 1999
Masters of Public Administration (M.P.A.), Public Administration
University at Buffalo 1990 — 1993
Master's degree, Geography with a concentration in International Trade
National Institutes of Health May 2014 - Present
FDA March 2013 - May 2014
White House Office of Management and Budget February 2006 - March 2013
Skills
Government, Economics, Data Analysis, Policy, Program Evaluation, Analysis, Federal Government, Politics, Econometrics, Foreign Policy, Budgets
Education
Syracuse University - Maxwell School 1998 — 1999
Masters of Public Administration (M.P.A.), Public Administration
University at Buffalo 1990 — 1993
Master's degree, Geography with a concentration in International Trade
ronda loyd-jones's FDA Experience March 2013 - Present
Job Compliance Officer at FDA
Industry Government Relations
Experience
FDA March 2013 - Present
Food and Drug Administration December 2009 - March 2013
food and drug administration June 1991 - December 2009
Skills
FDA, Regulatory Affairs, Medical Devices, Regulatory Requirements, Policy, Legal Research, Manufacturing, Policy Analysis, Training, Quality Auditing, Software Documentation, Government, Outlook
Education
Texas Woman's University 2011 — 2013
Master of Business Administration (M.B.A.), 3.7
Texas Woman's University 1988 — 1993
FDA March 2013 - Present
Food and Drug Administration December 2009 - March 2013
food and drug administration June 1991 - December 2009
Skills
FDA, Regulatory Affairs, Medical Devices, Regulatory Requirements, Policy, Legal Research, Manufacturing, Policy Analysis, Training, Quality Auditing, Software Documentation, Government, Outlook
Education
Texas Woman's University 2011 — 2013
Master of Business Administration (M.B.A.), 3.7
Texas Woman's University 1988 — 1993
Nancy Pressly's FDA Experience January 2011 - Present
Job Associate Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics at FDA
Industry Medical Devices
Experience
FDA January 2011 - Present
FDA June 2009 - January 2011
Food and Drug Administration September 2008 - November 2009
Food and Drug Administration September 1993 - September 2008
Skills
Biomedical Engineering, Medical Devices, Clinical Research, FDA, Healthcare, Healthcare Management, Hardware Diagnostics, Ultrasound, Leadership, Regulatory Affairs, Biomaterials, Risk Management, ISO 13485, Healthcare Information..., Informatics, Biomechanics, Lifesciences, Process Improvement, Radiology, Clinical Trials, Policy, Public Health, MRI, X-ray, Engineering, Medical Imaging, PACS, Hospitals, Design Control, Quality System, Management, Biotechnology, Digital Imaging, Cardiology, Validation, HL7, Regulatory Submissions, Medical Technology
Education
The Catholic University of America 1983 — 1987
Bachelor of Science (BS), Biomedical Engineering
Dartmouth HS
FDA January 2011 - Present
FDA June 2009 - January 2011
Food and Drug Administration September 2008 - November 2009
Food and Drug Administration September 1993 - September 2008
Skills
Biomedical Engineering, Medical Devices, Clinical Research, FDA, Healthcare, Healthcare Management, Hardware Diagnostics, Ultrasound, Leadership, Regulatory Affairs, Biomaterials, Risk Management, ISO 13485, Healthcare Information..., Informatics, Biomechanics, Lifesciences, Process Improvement, Radiology, Clinical Trials, Policy, Public Health, MRI, X-ray, Engineering, Medical Imaging, PACS, Hospitals, Design Control, Quality System, Management, Biotechnology, Digital Imaging, Cardiology, Validation, HL7, Regulatory Submissions, Medical Technology
Education
The Catholic University of America 1983 — 1987
Bachelor of Science (BS), Biomedical Engineering
Dartmouth HS
Mitra Ramson's FDA Experience October 2013 - Present
Job Program Analyst at FDA
Industry Accounting
Experience
FDA October 2013 - Present
Sodexo - (Entegra Finance Supply Chain Management Division) May 2012 - October 2013
Holy Cross Hospital - Trinity Health October 2010 - May 2012
The George Washington University Hospital - UHS February 2005 - October 2010
Skills
Financial Analysis, Financial Modeling, Process Improvement, Budgets, Risk Management, Microsoft Excel, Strategic Planning, Access, PowerPoint, Customer Service, Microsoft Office, Microsoft Word
Education
The George Washington University - School of Business
Master of Science (M.S.), Finance
SUNY Stony Brook
Economics
FDA October 2013 - Present
Sodexo - (Entegra Finance Supply Chain Management Division) May 2012 - October 2013
Holy Cross Hospital - Trinity Health October 2010 - May 2012
The George Washington University Hospital - UHS February 2005 - October 2010
Skills
Financial Analysis, Financial Modeling, Process Improvement, Budgets, Risk Management, Microsoft Excel, Strategic Planning, Access, PowerPoint, Customer Service, Microsoft Office, Microsoft Word
Education
The George Washington University - School of Business
Master of Science (M.S.), Finance
SUNY Stony Brook
Economics
Nancy Kavanaugh's FDA Experience 1995 - 1997
Job Vice President, Regulatory Affairs at MedImmune Vaccines
Industry Biotechnology
Experience
MedImmune December 2009 - Present
MedImmune 2005 - Present
Don Hill and Associates 1997 - 2005
FDA 1995 - 1997
FDA, CBER 1987 - 1997
FDA 1993 - 1995
FDA 1987 - 1993
Skills
Biopharmaceuticals, Clinical Development, FDA, Technology Transfer, Regulatory Affairs, Biotechnology, IND, Licensing, Regulatory Submissions, Sop, Pharmaceutical Industry, Life Sciences, Validation, Drug Development, GMP, Lifesciences, Clinical Trials, Biologics, Vaccines
Education
The Catholic University of America 1998 — 2002
Ph.D., Biology
The Catholic University of America 1986 — 1989
MS, Cell and Microbial Biology
The Catholic University of America 1982 — 1986
BS, Biology
The Catholic University of America 1982 — 1986
BS, Biology
MedImmune December 2009 - Present
MedImmune 2005 - Present
Don Hill and Associates 1997 - 2005
FDA 1995 - 1997
FDA, CBER 1987 - 1997
FDA 1993 - 1995
FDA 1987 - 1993
Skills
Biopharmaceuticals, Clinical Development, FDA, Technology Transfer, Regulatory Affairs, Biotechnology, IND, Licensing, Regulatory Submissions, Sop, Pharmaceutical Industry, Life Sciences, Validation, Drug Development, GMP, Lifesciences, Clinical Trials, Biologics, Vaccines
Education
The Catholic University of America 1998 — 2002
Ph.D., Biology
The Catholic University of America 1986 — 1989
MS, Cell and Microbial Biology
The Catholic University of America 1982 — 1986
BS, Biology
The Catholic University of America 1982 — 1986
BS, Biology
Ashley Groves's FDA Experience October 2008 - Present
Job Compliance Officer
Industry Government Administration
Experience
FDA October 2008 - Present
FDA August 2005 - October 2008
FDA August 2002 - August 2005
Southwest Research Institute 2000 - 2002
Skills
FDA, Research, Organic Chemistry, IACUC, Strategic Planning, GLP, Data Analysis, Regulations, Russian, Toxicology, Government, Policy, Chemistry, Science, IND, Analytical Chemistry, Federal Government, Molecular Biology, Biochemistry, Biotechnology, Management, Life Sciences
Education
Texas Tech University 1997 — 1999
Organic Chemistry
Texas Tech University 1995 — 1997
Chemistry
Texas Tech University 1993 — 1995
Russian Language and Area Studies
University of Oklahoma 1990 — 1993
FDA October 2008 - Present
FDA August 2005 - October 2008
FDA August 2002 - August 2005
Southwest Research Institute 2000 - 2002
Skills
FDA, Research, Organic Chemistry, IACUC, Strategic Planning, GLP, Data Analysis, Regulations, Russian, Toxicology, Government, Policy, Chemistry, Science, IND, Analytical Chemistry, Federal Government, Molecular Biology, Biochemistry, Biotechnology, Management, Life Sciences
Education
Texas Tech University 1997 — 1999
Organic Chemistry
Texas Tech University 1995 — 1997
Chemistry
Texas Tech University 1993 — 1995
Russian Language and Area Studies
University of Oklahoma 1990 — 1993
Colleen Matkowski's FDA Experience 1996 - 2000
Job Regulatory Affairs
Industry Pharmaceuticals
Experience
BioMarin Pharmaceutical Inc. January 2013 - Present
ViroPharma Incorporated January 2010 - 2012
Endo Pharmaceuticals October 2008 - 2010
Cephalon 2004 - June 2008
Wyeth 2000 - 2004
FDA 1996 - 2000
Skills
Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, GMP, Clinical Development, FDA, NDA, Sop, eCTD, Clinical Trials, IND, 21 CFR Part 11, Clinical Research, GCP, Biopharmaceuticals, Pharmacovigilance, Drug Development, Infectious Diseases, Regulatory Requirements, Regulations, CRO, CMC
Education
Temple University 1999 — 2003
MS, QA/RA
BioMarin Pharmaceutical Inc. January 2013 - Present
ViroPharma Incorporated January 2010 - 2012
Endo Pharmaceuticals October 2008 - 2010
Cephalon 2004 - June 2008
Wyeth 2000 - 2004
FDA 1996 - 2000
Skills
Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, GMP, Clinical Development, FDA, NDA, Sop, eCTD, Clinical Trials, IND, 21 CFR Part 11, Clinical Research, GCP, Biopharmaceuticals, Pharmacovigilance, Drug Development, Infectious Diseases, Regulatory Requirements, Regulations, CRO, CMC
Education
Temple University 1999 — 2003
MS, QA/RA
Alexandria Fujisaki's FDA Experience January 2013 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA January 2013 - Present
Alternative Dispute Resolution Society May 2011 - May 2012
Journal of Contemporary Health Law and Policy 2011 - 2012
United States Attorney's Office, District of Massachusetts June 2011 - August 2011
U.S. Department of Labor January 2011 - May 2011
Alternative Dispute Resolution Society September 2010 - May 2011
U.S. Court of Appeals for the First Circuit June 2010 - August 2010
Rhode Island Department of Attorney General April 2008 - June 2009
Blue Cross & Blue Shield July 2005 - May 2008
Skills
Legal Research, Litigation, Legal Writing, Westlaw, Arbitration, Lexis, Administrative Law, Legal Issues, Courts, Legislation, Appeals, Criminal Law
Education
The Catholic University of America, Columbus School of Law 2010 — 2012
Juris Doctor, Law
Suffolk University 2009 — 2010
Juris Doctor Program
York College of Pennsylvania 2000 — 2004
BA
FDA January 2013 - Present
Alternative Dispute Resolution Society May 2011 - May 2012
Journal of Contemporary Health Law and Policy 2011 - 2012
United States Attorney's Office, District of Massachusetts June 2011 - August 2011
U.S. Department of Labor January 2011 - May 2011
Alternative Dispute Resolution Society September 2010 - May 2011
U.S. Court of Appeals for the First Circuit June 2010 - August 2010
Rhode Island Department of Attorney General April 2008 - June 2009
Blue Cross & Blue Shield July 2005 - May 2008
Skills
Legal Research, Litigation, Legal Writing, Westlaw, Arbitration, Lexis, Administrative Law, Legal Issues, Courts, Legislation, Appeals, Criminal Law
Education
The Catholic University of America, Columbus School of Law 2010 — 2012
Juris Doctor, Law
Suffolk University 2009 — 2010
Juris Doctor Program
York College of Pennsylvania 2000 — 2004
BA
Ta-Chen Wu's FDA Experience
Job Clinical Pharmacologist at FDA
Industry Government Administration
Experience
FDA
Education
Taipei Medical University
The University of Illinois at Chicago
Ph.D., Pharmacokinetics, Pharmacodynamics (Biopharmaceutical Sciences)
FDA
Education
Taipei Medical University
The University of Illinois at Chicago
Ph.D., Pharmacokinetics, Pharmacodynamics (Biopharmaceutical Sciences)
Clara Chu's FDA Experience January 1999 - June 2003
Job Statistician
Industry Biotechnology
Experience
MD Consulting LLC November 2010 - Present
University of Maryland University College January 2010 - December 2010
Lifetech Research, Inc. July 2007 - December 2008
Clinical Trials and Surveys Corp. July 2003 - June 2007
FDA January 1999 - June 2003
Johns Hopkins University October 1994 - July 1997
Skills
SAS, R, S-Plus, Biostatistics, Clinical Trials, Biotechnology, Clinical Development, Statistics, Clinical Research, Vaccines, Epidemiology, FDA, Biomarkers, Oncology, Research, Protocol, Drug Development, Genetics
Education
Temple University - Fox School of Business and Management 1990 — 1998
PhD
The Johns Hopkins University 1986 — 1990
BA
MD Consulting LLC November 2010 - Present
University of Maryland University College January 2010 - December 2010
Lifetech Research, Inc. July 2007 - December 2008
Clinical Trials and Surveys Corp. July 2003 - June 2007
FDA January 1999 - June 2003
Johns Hopkins University October 1994 - July 1997
Skills
SAS, R, S-Plus, Biostatistics, Clinical Trials, Biotechnology, Clinical Development, Statistics, Clinical Research, Vaccines, Epidemiology, FDA, Biomarkers, Oncology, Research, Protocol, Drug Development, Genetics
Education
Temple University - Fox School of Business and Management 1990 — 1998
PhD
The Johns Hopkins University 1986 — 1990
BA
Letria Hall's FDA Experience May 2005 - Present
Job IT Specialist at FDA
Industry Information Technology and Services
Experience
FDA May 2005 - Present
CSC 2002 - 2004
Education
Strayer University 2013 — 2014
Master of Business Administration (MBA)
Strayer 2009 — 2011
MS, IT Systems/Database Mgmt.
University of Maryland University College 2002 — 2004
High School
FDA May 2005 - Present
CSC 2002 - 2004
Education
Strayer University 2013 — 2014
Master of Business Administration (MBA)
Strayer 2009 — 2011
MS, IT Systems/Database Mgmt.
University of Maryland University College 2002 — 2004
High School
Brian Niland's FDA Experience 2009 - Present
Job Biologist (Product/CMC Reviewer) at FDA
Industry Government Administration
Experience
FDA 2009 - Present
SUNY Upstate Medical University 2006 - 2009
SUNY Upstate Medical University 1997 - 2005
SUNY Upstate Medical University 2000 - 2002
Wyeth Pharmaceuticals 1993 - 1996
Skills
Immunology
Education
State University of New York Upstate Medical University 1997 — 2005
Ph.D., Microbiology & Immunology, Cell & Molecular Biology
University at Albany, SUNY
B.S., Biology/Chemistry
FDA 2009 - Present
SUNY Upstate Medical University 2006 - 2009
SUNY Upstate Medical University 1997 - 2005
SUNY Upstate Medical University 2000 - 2002
Wyeth Pharmaceuticals 1993 - 1996
Skills
Immunology
Education
State University of New York Upstate Medical University 1997 — 2005
Ph.D., Microbiology & Immunology, Cell & Molecular Biology
University at Albany, SUNY
B.S., Biology/Chemistry
Paul Preczewski's FDA Experience November 2010 - May 2013
Job Civil Servant
Industry Government Administration
Experience
Food and Drug Administration May 2013 - Present
FDA November 2010 - May 2013
Syracuse University Graduate Student Organization July 2010 - July 2011
Veterans Administration May 2009 - November 2010
Syracuse University August 2009 - May 2010
Syracuse University August 2007 - May 2009
Syracuse University August 2006 - May 2009
Syracuse University January 2000 - January 2006
Skills
Risk Assessment, Food Defense, Statistical Forecasting, Public Health, Statistics, Epidemiology, Biochemistry, Food Science, Data Analysis, Research, SPSS, Teaching, Government, Stata, Health, Higher Education, Database Management, Modeling, Public Policy, Psychology, Nonprofits, Grant Writing, Qualitative Research, Research Design, Policy Analysis, Policy, Data Collection, University Teaching, Program Development, Community Outreach
Education
Syracuse University 2002 — 2006
Master's Degree, Science Education
Saint Francis Borgia Regional High School 1992 — 2006
Syracuse University 1996 — 2001
Bachelor's Degree, Biochemistry
Food and Drug Administration May 2013 - Present
FDA November 2010 - May 2013
Syracuse University Graduate Student Organization July 2010 - July 2011
Veterans Administration May 2009 - November 2010
Syracuse University August 2009 - May 2010
Syracuse University August 2007 - May 2009
Syracuse University August 2006 - May 2009
Syracuse University January 2000 - January 2006
Skills
Risk Assessment, Food Defense, Statistical Forecasting, Public Health, Statistics, Epidemiology, Biochemistry, Food Science, Data Analysis, Research, SPSS, Teaching, Government, Stata, Health, Higher Education, Database Management, Modeling, Public Policy, Psychology, Nonprofits, Grant Writing, Qualitative Research, Research Design, Policy Analysis, Policy, Data Collection, University Teaching, Program Development, Community Outreach
Education
Syracuse University 2002 — 2006
Master's Degree, Science Education
Saint Francis Borgia Regional High School 1992 — 2006
Syracuse University 1996 — 2001
Bachelor's Degree, Biochemistry
Ju-Ping Lai's FDA Experience
Job Clinical Pharmacologist at FDA
Industry Pharmaceuticals
Experience
FDA
Skills
Pharmacokinetics
Education
The Ohio State University 2003 — 2008
Doctor of Philosophy (Ph.D.), Pharmacy, Pharmaceutics
Taipei Medical University 1996 — 1998
Master of Science (MS), Pharmaceutics
Taipei Medical University 1992 — 1996
Bachelor of Science (BS), Pharmacy
FDA
Skills
Pharmacokinetics
Education
The Ohio State University 2003 — 2008
Doctor of Philosophy (Ph.D.), Pharmacy, Pharmaceutics
Taipei Medical University 1996 — 1998
Master of Science (MS), Pharmaceutics
Taipei Medical University 1992 — 1996
Bachelor of Science (BS), Pharmacy
Ken Umberger's FDA Experience March 2008 - February 2011
Job EMI/EMC Engineer, RF & microwave test engineer, and RF Test equipment sales engineer
Industry Research
Experience
Home based office May 2012 - Present
FDA March 2008 - February 2011
Northrop Grumman Mission Systems January 2007 - February 2008
Windermere Essex February 2005 - January 2007
NoiseKen January 2001 - January 2005
LeCroy Corporation 2002 - 2003
Beta Lambda Instruments Inc 1993 - 2002
Tektronix 1972 - 1992
US Army February 1968 - January 1970
Boeing June 1967 - January 1968
Skills
Network Analyzer, Spectrum Analyzer, Power Meters, RF System measurements, Electrical Engineering, Electronics, Test Equipment, Oscilloscope, Antennas, Matlab, GPIB test equipment..., mm Wave system design..., MIL-STD-461E testing, Time Domain..., RF Signal generators, EMC Antennas, ESD testing..., Shielded enclosure..., Analog
Education
Tennessee Technological University 1970 — 1971
Master of Science (M.S.), Electrical Engineering
Tennessee Technological University 1962 — 1967
Bachelor of Science (BS), Electrical Engineering
Home based office May 2012 - Present
FDA March 2008 - February 2011
Northrop Grumman Mission Systems January 2007 - February 2008
Windermere Essex February 2005 - January 2007
NoiseKen January 2001 - January 2005
LeCroy Corporation 2002 - 2003
Beta Lambda Instruments Inc 1993 - 2002
Tektronix 1972 - 1992
US Army February 1968 - January 1970
Boeing June 1967 - January 1968
Skills
Network Analyzer, Spectrum Analyzer, Power Meters, RF System measurements, Electrical Engineering, Electronics, Test Equipment, Oscilloscope, Antennas, Matlab, GPIB test equipment..., mm Wave system design..., MIL-STD-461E testing, Time Domain..., RF Signal generators, EMC Antennas, ESD testing..., Shielded enclosure..., Analog
Education
Tennessee Technological University 1970 — 1971
Master of Science (M.S.), Electrical Engineering
Tennessee Technological University 1962 — 1967
Bachelor of Science (BS), Electrical Engineering
Ray Mangold's FDA Experience April 1980 - August 1980
Job Sadara Process Analytical Group Leader at Dow Chemical
Industry Chemicals
Experience
Dow Chemical August 2012 - Present
The Dow Chemical Company June 1986 - July 2012
DuPont Dow Elastomers 1997 - 2006
FDA April 1980 - August 1980
Skills
Polymer Chemistry, Polymer Characterization, Materials Science, Polymer Science, Chemistry, Polymers, Analytical Chemistry, R&D, Six Sigma, Organic Chemistry, GC-MS, UV/Vis, Spectroscopy, Chemical Engineering, Gas Chromatography, Process Simulation, NMR, Catalysis, HPLC
Education
Texas A&M University 1980 — 1986
PhD, Analytical Chemistry
Xavier University 1976 — 1980
BS, Chemistry
Dow Chemical August 2012 - Present
The Dow Chemical Company June 1986 - July 2012
DuPont Dow Elastomers 1997 - 2006
FDA April 1980 - August 1980
Skills
Polymer Chemistry, Polymer Characterization, Materials Science, Polymer Science, Chemistry, Polymers, Analytical Chemistry, R&D, Six Sigma, Organic Chemistry, GC-MS, UV/Vis, Spectroscopy, Chemical Engineering, Gas Chromatography, Process Simulation, NMR, Catalysis, HPLC
Education
Texas A&M University 1980 — 1986
PhD, Analytical Chemistry
Xavier University 1976 — 1980
BS, Chemistry
David Arvelo's FDA Experience March 2015 - Present
Job Health Communications Specialist
Industry Writing and Editing
Experience
FDA March 2015 - Present
FDA September 2012 - Present
FDA January 2001 - December 2012
FDA October 1994 - January 2001
FDA June 1990 - October 1994
Office of the Texas State Chemist May 1988 - June 1990
Texas A&M University September 1984 - May 1988
University of Puerto Rico September 1981 - May 1984
Skills
FDA, Medical Devices, Policy, Spanish, Quality Systems, Regulatory Affairs, Analytical Chemistry, GMP, Quality Assurance, Compliance, Public Speaking, Analysis, Chemistry, Analytical Skills, Food Law, Food & Drug Law, Food, Food Safety, Auditing, Federal Government, Government Ethics, Rulemaking, Public Relations, Communications Planning, Writing, Editing, Documentation, Technology, Microsoft Office, Social Media, LinkedIn, Facebook, Web Design, Thinking Outside The Box, Quality System, Regulations, Empathy, Public Health, Regulatory Requirements, Strategic Communications, Public Affairs, Infectious Diseases, Data Analysis, Speech Writing, Crisis Communications, Regulatory Submissions, Health Communication, Public Policy, Proposal Writing, Epidemiology
Education
University of Arkansas at Fayetteville 2012 — 2013
Texas A&M University 1984 — 1990
Universidad de Puerto Rico 1980 — 1984
B.S.
CROEM 1979 — 1980
FDA March 2015 - Present
FDA September 2012 - Present
FDA January 2001 - December 2012
FDA October 1994 - January 2001
FDA June 1990 - October 1994
Office of the Texas State Chemist May 1988 - June 1990
Texas A&M University September 1984 - May 1988
University of Puerto Rico September 1981 - May 1984
Skills
FDA, Medical Devices, Policy, Spanish, Quality Systems, Regulatory Affairs, Analytical Chemistry, GMP, Quality Assurance, Compliance, Public Speaking, Analysis, Chemistry, Analytical Skills, Food Law, Food & Drug Law, Food, Food Safety, Auditing, Federal Government, Government Ethics, Rulemaking, Public Relations, Communications Planning, Writing, Editing, Documentation, Technology, Microsoft Office, Social Media, LinkedIn, Facebook, Web Design, Thinking Outside The Box, Quality System, Regulations, Empathy, Public Health, Regulatory Requirements, Strategic Communications, Public Affairs, Infectious Diseases, Data Analysis, Speech Writing, Crisis Communications, Regulatory Submissions, Health Communication, Public Policy, Proposal Writing, Epidemiology
Education
University of Arkansas at Fayetteville 2012 — 2013
Texas A&M University 1984 — 1990
Universidad de Puerto Rico 1980 — 1984
B.S.
CROEM 1979 — 1980
Joyce Defibaugh's FDA Experience December 1984 - Present
Job Retired at FDA
Industry Information Services
Experience
FDA December 1984 - Present
Florida Dental Association December 1984 - January 2012
Florida Dental December 1984 - January 2012
Education
Tallahassee Community College 1993 — 1996
Associates
FDA December 1984 - Present
Florida Dental Association December 1984 - January 2012
Florida Dental December 1984 - January 2012
Education
Tallahassee Community College 1993 — 1996
Associates
Miller Stephen's FDA Experience Research ScientistNational Institutes of Health1984 - 1993
Job Chemist at FDA
Industry Pharmaceuticals
Experience
FDA Research ScientistNational Institutes of Health1984 - 1993
University of Wisconsin-Madison 1983 - 1984
Education
University of Wisconsin-Madison 1978 — 1983
Ph.D., Organic Chemistry
Stony Brook University 1974 — 1978
B.S., Chemistry
FDA Research ScientistNational Institutes of Health1984 - 1993
University of Wisconsin-Madison 1983 - 1984
Education
University of Wisconsin-Madison 1978 — 1983
Ph.D., Organic Chemistry
Stony Brook University 1974 — 1978
B.S., Chemistry
Mike Darj's FDA Experience 2003 - 2015
Job Quality Assessment Lead (acting) at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration May 2003 - Present
FDA 2003 - 2015
Skills
Chemistry, Pharmaceutical Sciences, CMC Regulatory Affairs, Quality by Design, Chemometrics, FDA
Education
Stevens Institute of Technology
Ph.D., Chemistry
Stevens Institute of Technology
Ph.D., Chemistry
Food and Drug Administration May 2003 - Present
FDA 2003 - 2015
Skills
Chemistry, Pharmaceutical Sciences, CMC Regulatory Affairs, Quality by Design, Chemometrics, FDA
Education
Stevens Institute of Technology
Ph.D., Chemistry
Stevens Institute of Technology
Ph.D., Chemistry
Ann Metayer's FDA Experience April 2012 - Present
Job Senior Regulatory Counsel at FDA
Industry Government Administration
Experience
FDA April 2012 - Present
Food and Drug Administration 2007 - 2012
State of Vermont 2003 - 2007
Vermont Technical College 2001 - 2003
Vermont Department of Banking, Insurance, Securities and Health Care Administration 1997 - 2001
Vermont Attorney General's Office 1993 - 1997
Windsor County State's Attorney 1989 - 1993
City of Worcester 1983 - 1989
Skills
FDA, Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Regulatory Requirements, CAPA, Drug Development, Clinical Trials, Policy, Biotechnology, GMP, Lifesciences, Sop, Technology Transfer, Medical Devices, IND
Education
Suffolk University Law School 1979 — 1982
Doctor of Law (J.D.)
University of Vermont
Biology and Chemistry
FDA April 2012 - Present
Food and Drug Administration 2007 - 2012
State of Vermont 2003 - 2007
Vermont Technical College 2001 - 2003
Vermont Department of Banking, Insurance, Securities and Health Care Administration 1997 - 2001
Vermont Attorney General's Office 1993 - 1997
Windsor County State's Attorney 1989 - 1993
City of Worcester 1983 - 1989
Skills
FDA, Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Regulatory Requirements, CAPA, Drug Development, Clinical Trials, Policy, Biotechnology, GMP, Lifesciences, Sop, Technology Transfer, Medical Devices, IND
Education
Suffolk University Law School 1979 — 1982
Doctor of Law (J.D.)
University of Vermont
Biology and Chemistry
Vinoth Thirugnanasambantham's FDA Experience February 2012 - Present
Job Research Fellow in FDA
Industry Research
Experience
FDA February 2012 - Present
Idaho Pacific Corporation June 2010 - May 2011
University of Idaho January 2007 - August 2010
SGR 777 Foods Pvt Ltd July 2006 - December 2006
Western India Cashew Company June 2004 - December 2005
MTR Foods Pvt Ltd October 2003 - May 2005
Skills
GMP, HACCP, Quality Assurance, Food Safety, Food Science, Food Microbiology, Ingredients, Food Processing, Product Development, Quality Control, Food, Sanitation, FDA, Microbiology, Food Industry, Regulatory Affairs, SQF
Education
University of Idaho 2007 — 2011
Masters, Food Science, 3.75/4.0
Tamil Nadu Agricultural University 1999 — 2003
B.Tech, Food Process Engineering, 8.74/10.0
FDA February 2012 - Present
Idaho Pacific Corporation June 2010 - May 2011
University of Idaho January 2007 - August 2010
SGR 777 Foods Pvt Ltd July 2006 - December 2006
Western India Cashew Company June 2004 - December 2005
MTR Foods Pvt Ltd October 2003 - May 2005
Skills
GMP, HACCP, Quality Assurance, Food Safety, Food Science, Food Microbiology, Ingredients, Food Processing, Product Development, Quality Control, Food, Sanitation, FDA, Microbiology, Food Industry, Regulatory Affairs, SQF
Education
University of Idaho 2007 — 2011
Masters, Food Science, 3.75/4.0
Tamil Nadu Agricultural University 1999 — 2003
B.Tech, Food Process Engineering, 8.74/10.0
Rebecca Kalman's FDA Experience September 2010 - August 2011
Job Assistant Professor of Chemistry and Biochemistry at Georgia Gwinnett College
Industry Higher Education
Experience
Georgia Gwinnett College July 2014 - Present
Kennesaw State University June 2012 - July 2014
FDA September 2010 - August 2011
University of Delaware August 2005 - July 2010
Centocor February 2005 - August 2005
Johns Hopkins University June 2004 - August 2004
Schering-Plough June 2003 - August 2003
Schering-Plough June 2002 - June 2003
Oak Ridge National Laboratory June 2001 - August 2001
Skills
Protein Chemistry, Spectroscopy, Chromatography, Cell Culture, Biochemistry, Chemistry, Characterization, R&D
Education
University of Delaware 2005 — 2010
PhD, Chemical Engineering
University of Delaware 2005 — 2008
MChE, Chemical Engineering
Tennessee Technological University 1999 — 2004
BS, Chemical Engineering
Georgia Gwinnett College July 2014 - Present
Kennesaw State University June 2012 - July 2014
FDA September 2010 - August 2011
University of Delaware August 2005 - July 2010
Centocor February 2005 - August 2005
Johns Hopkins University June 2004 - August 2004
Schering-Plough June 2003 - August 2003
Schering-Plough June 2002 - June 2003
Oak Ridge National Laboratory June 2001 - August 2001
Skills
Protein Chemistry, Spectroscopy, Chromatography, Cell Culture, Biochemistry, Chemistry, Characterization, R&D
Education
University of Delaware 2005 — 2010
PhD, Chemical Engineering
University of Delaware 2005 — 2008
MChE, Chemical Engineering
Tennessee Technological University 1999 — 2004
BS, Chemical Engineering
Kathryn (Gold) Meyer, PhD's FDA Experience 2011 - 2012
Job ORISE Postdoctoral Fellow at US EPA
Industry Research
Experience
US EPA 2012 - 2015
FDA 2011 - 2012
University of Maryland 2006 - 2011
Syracuse University 2004 - 2006
Skills
Molecular Cloning, Protein Expression, Protein Purification, Western Blotting, Gel Electrophoresis, DNA, PCR, Molecular Biology, Cell, Biochemistry, recombinant DNA..., Microbiology, Purification, Genetics, Molecular Genetics, Scientific Writing, Biology, Assay Development, qPCR, SDS-PAGE, GLP, Data Analysis
Education
University of Maryland College Park 2006 — 2011
PhD, Microbial Genetics
Syracuse University 2002 — 2006
BS, Biology, Magna Cum Laude
US EPA 2012 - 2015
FDA 2011 - 2012
University of Maryland 2006 - 2011
Syracuse University 2004 - 2006
Skills
Molecular Cloning, Protein Expression, Protein Purification, Western Blotting, Gel Electrophoresis, DNA, PCR, Molecular Biology, Cell, Biochemistry, recombinant DNA..., Microbiology, Purification, Genetics, Molecular Genetics, Scientific Writing, Biology, Assay Development, qPCR, SDS-PAGE, GLP, Data Analysis
Education
University of Maryland College Park 2006 — 2011
PhD, Microbial Genetics
Syracuse University 2002 — 2006
BS, Biology, Magna Cum Laude
Laurie Sternberg's FDA Experience June 2013 - Present
Job Senior Regulatory Counsel
Industry Legal Services
Experience
FDA June 2013 - Present
Epiq Systems August 2010 - June 2013
Kaye Scholer LLP August 2000 - August 2010
Brobeck, Phleger & Harrison 1997 - 2000
Skills
Trials, Litigation, Product Liability, Corporate Law, Torts, Motions, Government, Expert Witness, Commercial Litigation, Legal Research, Management, Legal Writing, Litigation Support, Civil Litigation, Courts, Appeals
Education
University of Michigan Law School 1993 — 1996
J.D., Law
Swarthmore College 1988 — 1992
B.A., Political Science
Pittsford Sutherland High School
FDA June 2013 - Present
Epiq Systems August 2010 - June 2013
Kaye Scholer LLP August 2000 - August 2010
Brobeck, Phleger & Harrison 1997 - 2000
Skills
Trials, Litigation, Product Liability, Corporate Law, Torts, Motions, Government, Expert Witness, Commercial Litigation, Legal Research, Management, Legal Writing, Litigation Support, Civil Litigation, Courts, Appeals
Education
University of Michigan Law School 1993 — 1996
J.D., Law
Swarthmore College 1988 — 1992
B.A., Political Science
Pittsford Sutherland High School
Rakhi Shah's FDA Experience 2004 - 2012
Job Chemist at US FDA
Industry Government Administration
Experience
Food and Drug Administration ChemistUS FDADecember 2012 - Present
FDA 2004 - 2012
Education
Texas Tech University Health Sciences Center 2000 — 2004
PhD, Pharmaceutical Sciences
UDCT 1998 — 2000
MS (Tech), Bioprocess Technology
ICT 1994 — 1998
BPharm, Pharmaceutical Sciences
Food and Drug Administration ChemistUS FDADecember 2012 - Present
FDA 2004 - 2012
Education
Texas Tech University Health Sciences Center 2000 — 2004
PhD, Pharmaceutical Sciences
UDCT 1998 — 2000
MS (Tech), Bioprocess Technology
ICT 1994 — 1998
BPharm, Pharmaceutical Sciences
Rachel Abaskharon's FDA Experience July 2010 - August 2010
Job Ph. D. Candidate in Chemistry
Industry Chemicals
Experience
University of Pennsylvania July 2012 - Present
University of Pennsylvania August 2012 - May 2013
The College of New Jersey September 2010 - May 2012
Princeton University June 2011 - August 2011
FDA July 2010 - August 2010
Skills
Spectroscopy, Fluorescence, Powder X-ray Diffraction, IR spectroscopy, Physical Chemistry, Circular Dichroism, Laboratory, Biomaterials, Peptides, Laser, Research, Chemistry, UV/Vis, Mathematica, Science
Education
University of Pennsylvania 2012 — 2017
Doctor of Philosophy (Ph.D.), Physical Chemistry
The College of New Jersey 2008 — 2012
Bachelor of Science and Bachelor of Arts, Chemistry and Mathematics
University of Pennsylvania July 2012 - Present
University of Pennsylvania August 2012 - May 2013
The College of New Jersey September 2010 - May 2012
Princeton University June 2011 - August 2011
FDA July 2010 - August 2010
Skills
Spectroscopy, Fluorescence, Powder X-ray Diffraction, IR spectroscopy, Physical Chemistry, Circular Dichroism, Laboratory, Biomaterials, Peptides, Laser, Research, Chemistry, UV/Vis, Mathematica, Science
Education
University of Pennsylvania 2012 — 2017
Doctor of Philosophy (Ph.D.), Physical Chemistry
The College of New Jersey 2008 — 2012
Bachelor of Science and Bachelor of Arts, Chemistry and Mathematics
Scott Dolan's FDA Experience December 2012 - September 2013
Job Director Health Solutions Group at Discover Technologies LLC
Industry Information Technology and Services
Experience
Discover Technologies LLC October 2013 - Present
FDA December 2012 - September 2013
FDA May 2008 - December 2012
FDA September 2004 - May 2008
FDA July 2001 - September 2004
FDA October 1989 - June 2001
U.S. Government Printing Office January 1989 - October 1989
National Institute of Standards and Technology March 1987 - December 1988
Skills
Integration, Process Improvement, Government, SharePoint, Program Management, Content Management, Information Architecture, Project Management, Enterprise Architecture, Web Content Management, Software Development, Strategic Planning, Business Process..., Strategic Policy..., Government Contracting, Requirements Analysis, Analytical Chemistry, Leadership, Analysis, Business Process, Management, Business Intelligence, Training, Proposal Writing, Governance, Federal Government, Enterprise Software, PMP, IT Strategy, Security, Software Documentation, SDLC, Business Strategy, Business Analysis
Education
The George Washington University 2005 — 2005
Master's Certificate, Information Technology Project Management
The George Washington University - School of Business 2004 — 2005
Master's Certificate, Information Technology Project Management
The Catholic University of America 1982 — 1986
BS, Chemistry
Discover Technologies LLC October 2013 - Present
FDA December 2012 - September 2013
FDA May 2008 - December 2012
FDA September 2004 - May 2008
FDA July 2001 - September 2004
FDA October 1989 - June 2001
U.S. Government Printing Office January 1989 - October 1989
National Institute of Standards and Technology March 1987 - December 1988
Skills
Integration, Process Improvement, Government, SharePoint, Program Management, Content Management, Information Architecture, Project Management, Enterprise Architecture, Web Content Management, Software Development, Strategic Planning, Business Process..., Strategic Policy..., Government Contracting, Requirements Analysis, Analytical Chemistry, Leadership, Analysis, Business Process, Management, Business Intelligence, Training, Proposal Writing, Governance, Federal Government, Enterprise Software, PMP, IT Strategy, Security, Software Documentation, SDLC, Business Strategy, Business Analysis
Education
The George Washington University 2005 — 2005
Master's Certificate, Information Technology Project Management
The George Washington University - School of Business 2004 — 2005
Master's Certificate, Information Technology Project Management
The Catholic University of America 1982 — 1986
BS, Chemistry
Clark Meyer's FDA Experience October 2011 - October 2013
Job Biomechanics (computational and experimental)
Industry Higher Education
Experience
University of Texas at Dallas October 2013 - Present
FDA October 2011 - October 2013
Texas A&M University January 2011 - July 2011
Institute of International Education January 2009 - December 2010
Equipe de Biomécanique Cardiovasculaire January 2009 - December 2010
Texas A&M University September 2003 - December 2008
Ethicon, Inc January 2003 - August 2003
Ethicon May 2001 - December 2001
Polyolefins R&D May 2000 - August 2000
Skills
Finite Element Analysis, Solid Mechanics, Research, Labview, Biomechanics, Abaqus, Fluid Mechanics, Mechanical Testing, Matlab, Experimentation, Biomaterials, Biomedical Engineering, Solidworks
Education
Texas A&M University 2003 — 2009
Ph.D, Biomedical Engineering
Texas A&M University 1998 — 2002
B.S, Biomedical Engineering
Bwood
University of Texas at Dallas October 2013 - Present
FDA October 2011 - October 2013
Texas A&M University January 2011 - July 2011
Institute of International Education January 2009 - December 2010
Equipe de Biomécanique Cardiovasculaire January 2009 - December 2010
Texas A&M University September 2003 - December 2008
Ethicon, Inc January 2003 - August 2003
Ethicon May 2001 - December 2001
Polyolefins R&D May 2000 - August 2000
Skills
Finite Element Analysis, Solid Mechanics, Research, Labview, Biomechanics, Abaqus, Fluid Mechanics, Mechanical Testing, Matlab, Experimentation, Biomaterials, Biomedical Engineering, Solidworks
Education
Texas A&M University 2003 — 2009
Ph.D, Biomedical Engineering
Texas A&M University 1998 — 2002
B.S, Biomedical Engineering
Bwood
Hilda Scharen's FDA Experience May 2009 - Present
Job Senior Science Health Advisor FDA
Industry Government Administration
Experience
FDA May 2009 - Present
Education
Saint Joseph College, Cusset, France
French Baccalauréate, Diploma Scientific Series C (Math and Physics)
The Catholic University of America
MS, School of Electrical Engineering
FDA May 2009 - Present
Education
Saint Joseph College, Cusset, France
French Baccalauréate, Diploma Scientific Series C (Math and Physics)
The Catholic University of America
MS, School of Electrical Engineering
John Teerlink's FDA Experience 2004 - 2009
Job Cardiologist, Heart Failure Specialist, Echocardiographer, Clinical Trialist, Clinical and Regulatory Consultant
Industry Medical Practice
Experience
San Francisco Veterans Affairs Medical Center 1998 - Present
San Francisco Veterans Affairs Medical Center 1998 - Present
University of California, San Francisco July 1988 - Present
FDA 2004 - 2009
Skills
Clinical, Heart Failure, Healthcare, Internal Medicine, Cardiology, Clinical Research, Medicine, FDA, Clinical Trials, Medical Education, Echocardiography, Pharmacology, Epidemiology, Medical Research, Clinical Development, Cancer
Education
Harvard Medical School 1983 — 1988
M.D., Medicine
Swarthmore College 1979 — 1983
BA with Highest Honors, 1983, Comparative Religious Studies/ Biology
San Francisco Veterans Affairs Medical Center 1998 - Present
San Francisco Veterans Affairs Medical Center 1998 - Present
University of California, San Francisco July 1988 - Present
FDA 2004 - 2009
Skills
Clinical, Heart Failure, Healthcare, Internal Medicine, Cardiology, Clinical Research, Medicine, FDA, Clinical Trials, Medical Education, Echocardiography, Pharmacology, Epidemiology, Medical Research, Clinical Development, Cancer
Education
Harvard Medical School 1983 — 1988
M.D., Medicine
Swarthmore College 1979 — 1983
BA with Highest Honors, 1983, Comparative Religious Studies/ Biology
Jennifer Hua's FDA Experience August 2008 - August 2010
Job Senior Quality Assurance Engineer at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical March 2015 - Present
St. Jude Medical April 2013 - Present
Orthofix October 2010 - February 2013
FDA August 2008 - August 2010
UT Southwestern Medical Center at Dallas March 2008 - August 2008
Nanomedicine & Tissue Engineering Laboratory February 2007 - December 2007
Extensible Formatting Systems Inc May 2006 - July 2006
B. Braun Group May 2005 - July 2005
Texas A&M University February 2005 - May 2005
B. Braun Group May 2004 - August 2004
Skills
Quality Assurance, Risk Management, FDA, CAPA, Medical Devices, Quality System, GMP, ISO 13485, Validation, Design Control, Six Sigma, Auditing, Documentation, Regulatory Affairs, Quality Auditing, Continuous Improvement, SPC, Manufacturing, Supplier Quality, Sop, Quality Management, Root Cause Analysis, Software Documentation
Education
The University of Texas at Arlington 2006 — 2007
MS, Biomedical Engineering
Texas A&M University 2001 — 2005
BS, Biomedical Engineering
St. Jude Medical March 2015 - Present
St. Jude Medical April 2013 - Present
Orthofix October 2010 - February 2013
FDA August 2008 - August 2010
UT Southwestern Medical Center at Dallas March 2008 - August 2008
Nanomedicine & Tissue Engineering Laboratory February 2007 - December 2007
Extensible Formatting Systems Inc May 2006 - July 2006
B. Braun Group May 2005 - July 2005
Texas A&M University February 2005 - May 2005
B. Braun Group May 2004 - August 2004
Skills
Quality Assurance, Risk Management, FDA, CAPA, Medical Devices, Quality System, GMP, ISO 13485, Validation, Design Control, Six Sigma, Auditing, Documentation, Regulatory Affairs, Quality Auditing, Continuous Improvement, SPC, Manufacturing, Supplier Quality, Sop, Quality Management, Root Cause Analysis, Software Documentation
Education
The University of Texas at Arlington 2006 — 2007
MS, Biomedical Engineering
Texas A&M University 2001 — 2005
BS, Biomedical Engineering
Crystal Ostrum's FDA Experience October 2011 - June 2014
Job Federal Trade Investigator at Federal Trade Commission
Industry Law Practice
Experience
Federal Trade Commission June 2014 - Present
FDA October 2011 - June 2014
Columbus Community Legal Services, Consumer Protection January 2011 - May 2011
U.S Department of Energy August 2010 - November 2010
Federal Communications Commission June 2010 - August 2010
U.S. Army May 2009 - May 2010
Webster, Chamberlain and Bean February 2005 - July 2008
Skills
Legal Research, Administrative Law, Legal Writing, Compliance, Government, Writing, Editing, Public Speaking, Non-profits, Westlaw, Regulatory Analysis, Legal Compliance, Regulations, Microsoft Office, Food & Drug Law, Lexis, Litigation, Legal Issues, Legislative Relations, Policy, Legal Assistance, LexisNexis, Litigation Support, Document Review, Legislative Research
Education
The Catholic University of America, Columbus School of Law 2008 — 2011
Juris Doctor
William & Mary 2000 — 2004
Bachelor of Arts, Middle Eastern Studies
Federal Trade Commission June 2014 - Present
FDA October 2011 - June 2014
Columbus Community Legal Services, Consumer Protection January 2011 - May 2011
U.S Department of Energy August 2010 - November 2010
Federal Communications Commission June 2010 - August 2010
U.S. Army May 2009 - May 2010
Webster, Chamberlain and Bean February 2005 - July 2008
Skills
Legal Research, Administrative Law, Legal Writing, Compliance, Government, Writing, Editing, Public Speaking, Non-profits, Westlaw, Regulatory Analysis, Legal Compliance, Regulations, Microsoft Office, Food & Drug Law, Lexis, Litigation, Legal Issues, Legislative Relations, Policy, Legal Assistance, LexisNexis, Litigation Support, Document Review, Legislative Research
Education
The Catholic University of America, Columbus School of Law 2008 — 2011
Juris Doctor
William & Mary 2000 — 2004
Bachelor of Arts, Middle Eastern Studies
Carmen Vick's FDA Experience June 2000 - July 2000
Job Bilingual LSSP/Diagnostician at Specialized Assessment and Consulting, LLC
Industry Individual & Family Services
Experience
Specialized Assessment and Consulting, LLC August 2012 - Present
“The Principal’s Office” Radio Show Guest June 2013 - June 2013
Leander Independent School District August 2008 - July 2012
Fort Worth Independent School District August 2007 - July 2008
McCallen Independent School District April 2008 - April 2008
Birdville Independent School District August 2006 - July 2007
Texas Woman’s University - Psychology and Sociology Department January 2006 - June 2006
(Former) JW Hamilton Jr. State School for Texas A&M Sociology Program September 2002 - December 2002
FDA June 2000 - July 2000
Skills
Psychology, Interventions, Special Education, Training, Autism Spectrum..., Psychological Assessment, Research, Interviews, Learning Disabilities, Spanish, Time Management, Elementary Education, Report Writing, Early Childhood..., Software Documentation
Education
Texas Woman's University 2004 — 2007
M.A./S.S.P., School Psychology
Texas A&M University 1998 — 2003
B.S., Psychology and Sociology
Specialized Assessment and Consulting, LLC August 2012 - Present
“The Principal’s Office” Radio Show Guest June 2013 - June 2013
Leander Independent School District August 2008 - July 2012
Fort Worth Independent School District August 2007 - July 2008
McCallen Independent School District April 2008 - April 2008
Birdville Independent School District August 2006 - July 2007
Texas Woman’s University - Psychology and Sociology Department January 2006 - June 2006
(Former) JW Hamilton Jr. State School for Texas A&M Sociology Program September 2002 - December 2002
FDA June 2000 - July 2000
Skills
Psychology, Interventions, Special Education, Training, Autism Spectrum..., Psychological Assessment, Research, Interviews, Learning Disabilities, Spanish, Time Management, Elementary Education, Report Writing, Early Childhood..., Software Documentation
Education
Texas Woman's University 2004 — 2007
M.A./S.S.P., School Psychology
Texas A&M University 1998 — 2003
B.S., Psychology and Sociology
Karolina Jaworska's FDA Experience October 2008 - September 2011
Job
Industry Research
Experience
Technical University of Berlin, Institute for Food Technology and Food Chemistry February 2012 - Present
FDA October 2008 - September 2011
Beiersdorf 2007 - 2008
Institute for Food Safety, Frankfurt 2004 - 2006
Skills
HPLC, Analytical Chemistry, Biochemistry, Chemistry, Microbiology, Research, Food, Quality Control, R&D, LC-MS, Laboratory, Validation, Mass Spectrometry, Molecular Biology, Gas Chromatography, UV/Vis, Western Blotting, Chromatography
Education
Universidad de Sevilla 2001 — 2002
Biochemistry, Food Chemistry, Spanish
Technische Universität Berlin
Master's degree, Food Chemistry
Technische Universität Berlin
Bachelor's degree, Chemistry
Technical University of Berlin, Institute for Food Technology and Food Chemistry February 2012 - Present
FDA October 2008 - September 2011
Beiersdorf 2007 - 2008
Institute for Food Safety, Frankfurt 2004 - 2006
Skills
HPLC, Analytical Chemistry, Biochemistry, Chemistry, Microbiology, Research, Food, Quality Control, R&D, LC-MS, Laboratory, Validation, Mass Spectrometry, Molecular Biology, Gas Chromatography, UV/Vis, Western Blotting, Chromatography
Education
Universidad de Sevilla 2001 — 2002
Biochemistry, Food Chemistry, Spanish
Technische Universität Berlin
Master's degree, Food Chemistry
Technische Universität Berlin
Bachelor's degree, Chemistry
Scott McFarland's FDA Experience June 2014 - Present
Job Associate Director, Regulatory Counsel at FDA
Industry Government Administration
Experience
FDA June 2014 - Present
FDA August 2011 - June 2014
FDA January 2009 - August 2011
Skills
Legal Research, Legal Writing, Administrative Law, Litigation, Government, Public Policy
Education
The College of William and Mary - Marshall Wythe Law School 2002 — 2005
Virginia Tech 1998 — 2002
Bachelor of Science (B.S.), Biology and Psychology
FDA June 2014 - Present
FDA August 2011 - June 2014
FDA January 2009 - August 2011
Skills
Legal Research, Legal Writing, Administrative Law, Litigation, Government, Public Policy
Education
The College of William and Mary - Marshall Wythe Law School 2002 — 2005
Virginia Tech 1998 — 2002
Bachelor of Science (B.S.), Biology and Psychology
Lisa Huggins's FDA Experience October 2011 - Present
Job Management Analyst at FDA
Industry Government Administration
Experience
FDA October 2011 - Present
Skills
Public Speaking, Strategic Communications, Strategic Planning, Customer Service, Microsoft Office, Public Relations, Government, Federal Government, Policy Analysis
Education
Strayer University 2004 — 2011
Bachelor of Business Administration (B.B.A.), Concentrating in Management
FDA October 2011 - Present
Skills
Public Speaking, Strategic Communications, Strategic Planning, Customer Service, Microsoft Office, Public Relations, Government, Federal Government, Policy Analysis
Education
Strayer University 2004 — 2011
Bachelor of Business Administration (B.B.A.), Concentrating in Management
Allan Bailey's FDA Experience March 1992 - June 2001
Job Supervisory chemist at FDA
Industry Government Relations
Experience
FDA/Center for Food Safety & Applied Nutrition/Office of Food Additive Safety June 2001 - Present
FDA March 1992 - June 2001
ARCO Chemical September 1990 - November 1991
Education
The Johns Hopkins University 1983 — 1989
Ph.D., Organic chemistry
Texas A&M University 1983 — 1983
Organic chemistry
The University of Texas at Dallas 1980 — 1982
BS, Chemistry
FDA/Center for Food Safety & Applied Nutrition/Office of Food Additive Safety June 2001 - Present
FDA March 1992 - June 2001
ARCO Chemical September 1990 - November 1991
Education
The Johns Hopkins University 1983 — 1989
Ph.D., Organic chemistry
Texas A&M University 1983 — 1983
Organic chemistry
The University of Texas at Dallas 1980 — 1982
BS, Chemistry
Ilan Geerlof-Vidavsky's FDA Experience August 2012 - Present
Job Chemist at FDA Division of Pharmaceutical Analysis
Industry Government Administration
Experience
FDA August 2012 - Present
Proteomics Core Laboratories, Washington University School of Medicine in St. Louis April 2012 - August 2012
Washington University in St. Louis August 1994 - January 2012
Skills
Mass Spectrometry, Bioinformatics, Proteomics, HPLC, LC-MS, Analytical Chemistry, Chromatography, GC-MS, Gas Chromatography, MALDI-TOF, GLP, Validation, Research, Method Development, Immunology, Data Analysis, Analysis, Peptides, Laboratory, Protein Chemistry, Chemistry, UV/Vis, Metabolomics
Education
Technion - Israel Institute of Technology 1987 — 1992
Ph.D., Mass Spectrometry
Technion - Israel Institute of Technology 1979 — 1982
BA, Chemistry
FDA August 2012 - Present
Proteomics Core Laboratories, Washington University School of Medicine in St. Louis April 2012 - August 2012
Washington University in St. Louis August 1994 - January 2012
Skills
Mass Spectrometry, Bioinformatics, Proteomics, HPLC, LC-MS, Analytical Chemistry, Chromatography, GC-MS, Gas Chromatography, MALDI-TOF, GLP, Validation, Research, Method Development, Immunology, Data Analysis, Analysis, Peptides, Laboratory, Protein Chemistry, Chemistry, UV/Vis, Metabolomics
Education
Technion - Israel Institute of Technology 1987 — 1992
Ph.D., Mass Spectrometry
Technion - Israel Institute of Technology 1979 — 1982
BA, Chemistry
Elisabeth Newcomb Sinha's FDA Experience September 2013 - Present
Job Ph.D.
Industry Research
Experience
FDA September 2013 - Present
USDA-ERS May 2008 - December 2008
Santa Catalina School 2003 - June 2005
King Low Heywood Thomas August 2001 - June 2003
Education
University of Maryland College Park 2005 — 2012
Ph.D., Agricultural and Resource Economics
University of Maryland, College Park 2005 — 2010
B.S., Agricultural and Resource Economics
Swarthmore College 1996 — 2000
B.A., Economics and Special Major: History & Education
Blacksburg High School
FDA September 2013 - Present
USDA-ERS May 2008 - December 2008
Santa Catalina School 2003 - June 2005
King Low Heywood Thomas August 2001 - June 2003
Education
University of Maryland College Park 2005 — 2012
Ph.D., Agricultural and Resource Economics
University of Maryland, College Park 2005 — 2010
B.S., Agricultural and Resource Economics
Swarthmore College 1996 — 2000
B.A., Economics and Special Major: History & Education
Blacksburg High School
Madeline Van Hoose's FDA Experience December 1991 - Present
Job Provide cross Center coordination of project management efforts & implementation of Microsoft Project & Server 2010
Industry
Experience
FDA December 1991 - Present
Skills
Strategic Planning, Project Management, Program Management, Public Speaking, Customer Service, Microsoft Office, Management, Team Building, Research, Microsoft Excel
Education
Texas Christian University 1961 — 1966
Master's Degree, Microbiology, 3.9
FDA December 1991 - Present
Skills
Strategic Planning, Project Management, Program Management, Public Speaking, Customer Service, Microsoft Office, Management, Team Building, Research, Microsoft Excel
Education
Texas Christian University 1961 — 1966
Master's Degree, Microbiology, 3.9
Angela DeMarco's FDA Experience August 2013 - Present
Job Biomedical Engineer
Industry Government Administration
Experience
FDA August 2013 - Present
FDA June 2012 - August 2013
FDA May 2011 - August 2011
The Catholic University of America September 2010 - May 2011
FDA May 2010 - August 2010
National Rehabilitation hospital June 2009 - July 2009
The Catholic University of America February 2009 - March 2009
Uncle Julio's Corporation June 2008 - November 2008
Skills
Microsoft Office, Matlab, AutoCAD, Zebris Motion Tracking..., Image 2000+, PubMed, Website Design, Web Design
Education
The Catholic University of America 2012 — 2014
Master of Engineering (M.Eng.), Biomedical Engineering
The Catholic University of America 2008 — 2012
Bachelor of Engineering (B.E.), Biomedical Engineering
FDA August 2013 - Present
FDA June 2012 - August 2013
FDA May 2011 - August 2011
The Catholic University of America September 2010 - May 2011
FDA May 2010 - August 2010
National Rehabilitation hospital June 2009 - July 2009
The Catholic University of America February 2009 - March 2009
Uncle Julio's Corporation June 2008 - November 2008
Skills
Microsoft Office, Matlab, AutoCAD, Zebris Motion Tracking..., Image 2000+, PubMed, Website Design, Web Design
Education
The Catholic University of America 2012 — 2014
Master of Engineering (M.Eng.), Biomedical Engineering
The Catholic University of America 2008 — 2012
Bachelor of Engineering (B.E.), Biomedical Engineering
Jane Broussard's FDA Experience
Job Emergency Response Coordinator at FDA
Industry Government Administration
Experience
FDA
Skills
Government, Emergency Management, Policy, Public Health, Public Policy, Disaster Response, Investigation, Policy Analysis, Program Management, Data Analysis, Environmental Health, Research, Program Evaluation, Strategic Planning, Preparedness, Risk Assessment, Public Speaking
Education
Texas A&M University
FDA
Skills
Government, Emergency Management, Policy, Public Health, Public Policy, Disaster Response, Investigation, Policy Analysis, Program Management, Data Analysis, Environmental Health, Research, Program Evaluation, Strategic Planning, Preparedness, Risk Assessment, Public Speaking
Education
Texas A&M University
Astrid Goldberg's FDA Experience 2006 - Present
Job Regulatory Counsel at FDA
Industry
Experience
FDA 2006 - Present
PHMSA - USDOT 1996 - 2006
USNRC 1989 - 1992
Skills
Regulations, FDA, Regulatory Affairs
Education
Suffolk University Law School 1992 — 1995
Doctor of Law (JD)
University of Maryland College Park 1983 — 1988
Bachelor of Science (BS), Mechanical Engineering
FDA 2006 - Present
PHMSA - USDOT 1996 - 2006
USNRC 1989 - 1992
Skills
Regulations, FDA, Regulatory Affairs
Education
Suffolk University Law School 1992 — 1995
Doctor of Law (JD)
University of Maryland College Park 1983 — 1988
Bachelor of Science (BS), Mechanical Engineering
Minho Chae's FDA Experience October 2009 - March 2011
Job Director of Green Center Computational Core Facility at UT Southwestern Medical Center
Industry Biotechnology
Experience
UT Southwestern Medical Center August 2012 - Present
UT Southwestern Medical Center April 2011 - Present
FDA October 2009 - March 2011
Samsung SDS February 1998 - January 2003
Education
University of Arkansas at Little Rock 2004 — 2009
Doctor of Philosophy (PhD), Bioinformatics
Texas A&M University 1995 — 1997
Master of Science (MS), Computer Science
University of Hawaii at Manoa 1991 — 1995
Bachelor of Arts (BA), Computer Science
UT Southwestern Medical Center August 2012 - Present
UT Southwestern Medical Center April 2011 - Present
FDA October 2009 - March 2011
Samsung SDS February 1998 - January 2003
Education
University of Arkansas at Little Rock 2004 — 2009
Doctor of Philosophy (PhD), Bioinformatics
Texas A&M University 1995 — 1997
Master of Science (MS), Computer Science
University of Hawaii at Manoa 1991 — 1995
Bachelor of Arts (BA), Computer Science
Shaye Nelson's FDA Experience October 2012 - September 2013
Job Financial Analyst
Industry Health, Wellness and Fitness
Experience
FDA October 2012 - September 2013
Lockheed Martin June 2005 - September 2009
Skills
Coaching, Healthcare, Strategic Planning, Public Speaking, Wellness, Team Building, Budgets, Customer Service, Data Analysis, Event Planning, Leadership, Leadership Development, Microsoft Excel, Microsoft Office, Nonprofits, Program Development, Training
Education
Strayer University 2013 — 2015
Bachelor of Business Administration (B.B.A.), Acquisition and Contract Management
FDA October 2012 - September 2013
Lockheed Martin June 2005 - September 2009
Skills
Coaching, Healthcare, Strategic Planning, Public Speaking, Wellness, Team Building, Budgets, Customer Service, Data Analysis, Event Planning, Leadership, Leadership Development, Microsoft Excel, Microsoft Office, Nonprofits, Program Development, Training
Education
Strayer University 2013 — 2015
Bachelor of Business Administration (B.B.A.), Acquisition and Contract Management
Anthony Tatum's FDA Experience January 2011 - Present
Job Program Support Specialist at FDA
Industry Government Administration
Experience
FDA January 2011 - Present
US Army May 1980 - June 2010
Education
Strayer University (VA) 2011 — 2013
Marketing
University of Phoenix 2005 — 2007
Accounting and Business/Management
FDA January 2011 - Present
US Army May 1980 - June 2010
Education
Strayer University (VA) 2011 — 2013
Marketing
University of Phoenix 2005 — 2007
Accounting and Business/Management
Dai J (Dave) Li's FDA Experience May 2004 - November 2010
Job Clinical Director at AIBiotech, LLC
Industry Medical Devices
Experience
AIBiotech, LLC January 2015 - Present
Health Diagnostic Laboratory, Inc. June 2013 - November 2014
Wako Life Science, inc. November 2010 - May 2013
FDA May 2004 - November 2010
Wako Chemicals USA May 2002 - April 2004
Wako Chemicals USA April 2000 - April 2004
Wako Chemicals USA May 1999 - March 2000
Johns Hopkins School of Medicine December 1998 - May 1999
Johns Hopkins School of Medicine 1996 - 1998
University of Texas Southwestern Medical Center at Dallas 1994 - 1996
Skills
Oncology, Clinical Development, Immunology, Cancer, Medical Devices, Hardware Diagnostics, Medicine, FDA, Regulatory Affairs, Laboratory, Informatics, In Vitro, Pathology, Laboratory Medicine, Pharmaceutics, Clinical Trials, Clinical Research, Lifesciences, Internal Medicine, Medical Education, Biotechnology, Life Sciences
Education
The Johns Hopkins University School of Medicine
Certificate, Clinical Informatics
The University of Texas M.D. Anderson Cancer Center
Doctor of Philosophy (PhD), Immunopathology
The University of Texas M.D. Anderson Cancer Center
Master of Science (MS), Molecular Pathology
Sun Yat-Sen University 1977 — 1982
Doctor of Medicine (MD), Medicine and Surgery
AIBiotech, LLC January 2015 - Present
Health Diagnostic Laboratory, Inc. June 2013 - November 2014
Wako Life Science, inc. November 2010 - May 2013
FDA May 2004 - November 2010
Wako Chemicals USA May 2002 - April 2004
Wako Chemicals USA April 2000 - April 2004
Wako Chemicals USA May 1999 - March 2000
Johns Hopkins School of Medicine December 1998 - May 1999
Johns Hopkins School of Medicine 1996 - 1998
University of Texas Southwestern Medical Center at Dallas 1994 - 1996
Skills
Oncology, Clinical Development, Immunology, Cancer, Medical Devices, Hardware Diagnostics, Medicine, FDA, Regulatory Affairs, Laboratory, Informatics, In Vitro, Pathology, Laboratory Medicine, Pharmaceutics, Clinical Trials, Clinical Research, Lifesciences, Internal Medicine, Medical Education, Biotechnology, Life Sciences
Education
The Johns Hopkins University School of Medicine
Certificate, Clinical Informatics
The University of Texas M.D. Anderson Cancer Center
Doctor of Philosophy (PhD), Immunopathology
The University of Texas M.D. Anderson Cancer Center
Master of Science (MS), Molecular Pathology
Sun Yat-Sen University 1977 — 1982
Doctor of Medicine (MD), Medicine and Surgery
Amber Nagy's FDA Experience January 2013 - November 2013
Job Research Toxicologist at The Henry M. Jackson Foundation for the Advancement of Military Medicine
Industry Military
Experience
The Henry M. Jackson Foundation for the Advancement of Military Medicine October 2013 - Present
FDA January 2013 - November 2013
Los Alamos National Laboratory January 2011 - December 2012
Battelle April 2005 - December 2010
Skills
Toxicology, Environmental Science, Nanobiotechnology, Immunohistochemistry, real-time PCR, Tissue Culture, in Vitro Toxicology, Western Blotting, Confocal Microscopy, ELISA, Toxin Neutralization..., Flow Cytometry, Risk Assessment, Medical Microbiology, Quality Assurance
Education
The Ohio State University 2006 — 2010
Doctor of Philosophy (Ph.D.), Integrated Biomedical Science
Texas Tech University 2002 — 2003
Master of Science (M.S.), Microbiology, General
The Henry M. Jackson Foundation for the Advancement of Military Medicine October 2013 - Present
FDA January 2013 - November 2013
Los Alamos National Laboratory January 2011 - December 2012
Battelle April 2005 - December 2010
Skills
Toxicology, Environmental Science, Nanobiotechnology, Immunohistochemistry, real-time PCR, Tissue Culture, in Vitro Toxicology, Western Blotting, Confocal Microscopy, ELISA, Toxin Neutralization..., Flow Cytometry, Risk Assessment, Medical Microbiology, Quality Assurance
Education
The Ohio State University 2006 — 2010
Doctor of Philosophy (Ph.D.), Integrated Biomedical Science
Texas Tech University 2002 — 2003
Master of Science (M.S.), Microbiology, General
Mollie Shea's FDA Experience 1978 - 1982
Job Grants and Contracts Specialist at National Institutes of Health
Industry Research
Experience
National Institutes of Health July 1996 - Present
National Institutes of Health August 1990 - December 1993
US Navy 1984 - 1989
FDA 1978 - 1982
Skills
Grants, Policy Analysis, Analysis, Research Administration, Government Contracting, Contract Negotiation, Contract Management, Federal Grant Management, Grantsmanship
Education
Stevenson University
National Institutes of Health July 1996 - Present
National Institutes of Health August 1990 - December 1993
US Navy 1984 - 1989
FDA 1978 - 1982
Skills
Grants, Policy Analysis, Analysis, Research Administration, Government Contracting, Contract Negotiation, Contract Management, Federal Grant Management, Grantsmanship
Education
Stevenson University
Annie Abraham's FDA Experience February 2014 - December 2014
Job Patent Examiner
Industry Government Administration
Experience
USPTO January 2015 - Present
FDA February 2014 - December 2014
Test America Inc September 2010 - June 2013
Skills
Scientific Review, Review 510(k)..., Regulatory Affairs, Customer Service, Microsoft Office, Technical Writing, Programming Languages, Laboratory Skills, Written & Oral..., Collaborative Problem..., Team Leadership, Analytics, Employee Training, People-oriented, Technical Discussions, Online Research, FDA, Analysis, Medical Devices, Statistics
Education
The Catholic University of America
Master of Science (M.S.), Biomedical/Medical Engineering
University of California, Los Angeles
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
USPTO January 2015 - Present
FDA February 2014 - December 2014
Test America Inc September 2010 - June 2013
Skills
Scientific Review, Review 510(k)..., Regulatory Affairs, Customer Service, Microsoft Office, Technical Writing, Programming Languages, Laboratory Skills, Written & Oral..., Collaborative Problem..., Team Leadership, Analytics, Employee Training, People-oriented, Technical Discussions, Online Research, FDA, Analysis, Medical Devices, Statistics
Education
The Catholic University of America
Master of Science (M.S.), Biomedical/Medical Engineering
University of California, Los Angeles
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
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