FDA Company
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Headquarters: Silver Spring, Maryland, United States Employees: 14,824 (2010) Jurisdiction: United States of America Founded: 30 June 1906 Subsidiaries: Center for Drug Evaluation and Research, Founders: Theodore Roosevelt, Harvey Washington Wiley
FDA List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at FDA. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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4,886 FDA employees in database. Find out everything there's to know about FDA employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
FDA Employees
Employee
Years
Job
Industry
Waverly Chao Waverly Chao's FDA Experience February 2015 - March 2015
Job Marketing Communications at GAIA
Industry Marketing and Advertising
Experience
GAIA (Global Alliance for Incinerator Alternatives) September 2015 - Present
One Reason Recordings February 2013 - Present
Macy's June 2015 - August 2015
Business Operations and Student Affairs August 2014 - May 2015
FDA February 2015 - March 2015
Undergraduate Marketing Associaton September 2012 - May 2014
UC Berkeley South/Southeast Asian Library April 2013 - August 2013
Skills
Student Leadership, PowerPoint, Microsoft Office, Social Media, Microsoft Word, Teaching, Photoshop, Public Relations, Facebook, Graphic Design, Marketing Strategy, Social Networking, Microsoft Excel
Education
UC Berkeley 2012 — 2016
Bachelor of Science (B.S.), Environmental Economics and Policy, Senior
GAIA (Global Alliance for Incinerator Alternatives) September 2015 - Present
One Reason Recordings February 2013 - Present
Macy's June 2015 - August 2015
Business Operations and Student Affairs August 2014 - May 2015
FDA February 2015 - March 2015
Undergraduate Marketing Associaton September 2012 - May 2014
UC Berkeley South/Southeast Asian Library April 2013 - August 2013
Skills
Student Leadership, PowerPoint, Microsoft Office, Social Media, Microsoft Word, Teaching, Photoshop, Public Relations, Facebook, Graphic Design, Marketing Strategy, Social Networking, Microsoft Excel
Education
UC Berkeley 2012 — 2016
Bachelor of Science (B.S.), Environmental Economics and Policy, Senior
Malik Qaiser Malik Qaiser's FDA Experience April 2009 - August 2012
Job Senior Design Quality Engineer at Medtronic
Industry Medical Devices
Experience
Medtronic Graduate Teaching AssistantUC DavisSeptember 2013 - July 2014
FDA April 2009 - August 2012
Hill-Rom April 2009 - September 2009
University of Cincinnati January 2005 - September 2009
AtriCure, Inc. October 2007 - March 2008
Cincinnati Sub-Zero September 2005 - March 2006
Skills
Quality Systems, FDA, R&D, Biomedical Engineering, Quality, Quality Assurance, Research Design, Sports Medicine, Weight Training, AV, Computer Repair, Computer Hardware, Auditing, Audit, Engineering, Medical, Medical Devices, Medical Device Product..., Product Development, Process Engineering, Investigations, Quality Inspection, Electronics, Quality System, CAPA, Quality Control, Solidworks, Data Analysis, Medicine, Validation, Testing, Biomechanics, Design of Experiments, Analysis, V&V, Manufacturing, SolidWorks
Education
University of California, Davis 2012 — 2014
Master of Science (MS), Biomechanics
University of Cincinnati 2003 — 2009
Biomedical Engineering, Medical Device Design
Saint Marys
Medtronic Graduate Teaching AssistantUC DavisSeptember 2013 - July 2014
FDA April 2009 - August 2012
Hill-Rom April 2009 - September 2009
University of Cincinnati January 2005 - September 2009
AtriCure, Inc. October 2007 - March 2008
Cincinnati Sub-Zero September 2005 - March 2006
Skills
Quality Systems, FDA, R&D, Biomedical Engineering, Quality, Quality Assurance, Research Design, Sports Medicine, Weight Training, AV, Computer Repair, Computer Hardware, Auditing, Audit, Engineering, Medical, Medical Devices, Medical Device Product..., Product Development, Process Engineering, Investigations, Quality Inspection, Electronics, Quality System, CAPA, Quality Control, Solidworks, Data Analysis, Medicine, Validation, Testing, Biomechanics, Design of Experiments, Analysis, V&V, Manufacturing, SolidWorks
Education
University of California, Davis 2012 — 2014
Master of Science (MS), Biomechanics
University of Cincinnati 2003 — 2009
Biomedical Engineering, Medical Device Design
Saint Marys
Elodie Tong-Lin Elodie Tong-Lin's FDA Experience August 2014 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA August 2014 - Present
FDA April 2013 - August 2014
FDA August 2012 - April 2013
UC Berkeley College of Natural Resources August 2010 - May 2012
Center for Environmental Research and Children's Health June 2011 - January 2012
Environmental Chemistry and Toxicology Laboratory October 2010 - May 2011
The Sul Lab June 2010 - August 2010
California State University, Fullerton June 2009 - August 2009
California State University, Fullerton June 2008 - August 2008
California State University, Fullerton June 2007 - August 2007
Skills
Site Inspections, Compliance, Regulations, Cell Culture, Leadership, Western Blotting, Data Analysis, Risk Assessment, Research, Molecular Biology, Electronic Newsletters, Toxicology, Proliferation, Biochemistry, PCR, Data Collection
Education
University of California, Berkeley 2008 — 2012
BS, Molecular Toxicology
FDA August 2014 - Present
FDA April 2013 - August 2014
FDA August 2012 - April 2013
UC Berkeley College of Natural Resources August 2010 - May 2012
Center for Environmental Research and Children's Health June 2011 - January 2012
Environmental Chemistry and Toxicology Laboratory October 2010 - May 2011
The Sul Lab June 2010 - August 2010
California State University, Fullerton June 2009 - August 2009
California State University, Fullerton June 2008 - August 2008
California State University, Fullerton June 2007 - August 2007
Skills
Site Inspections, Compliance, Regulations, Cell Culture, Leadership, Western Blotting, Data Analysis, Risk Assessment, Research, Molecular Biology, Electronic Newsletters, Toxicology, Proliferation, Biochemistry, PCR, Data Collection
Education
University of California, Berkeley 2008 — 2012
BS, Molecular Toxicology
Lara Ianov Lara Ianov's FDA Experience May 2011 - June 2011
Job Ph.D candidate at the University of Florida McKnight Brain Institute
Industry Biotechnology
Experience
University of Florida - McKnight Brain Institute January 2013 - Present
Center for Integrative Nanotechnology Sciences - University of Arkansas at Little Rock August 2010 - May 2012
FDA May 2011 - June 2011
Skills
NGS, Transcriptomics, Epigenetics, Bioinformatics, PCR, Biotechnology, Molecular Biology, Microbiology, qRT-PCR, Western Blotting, DNA, RNA and protein..., Gel Electrophoresis, Molecular Cloning, Cell Biology
Education
University of Florida 2012 — 2017
Doctor of Philosophy (Ph.D.), Genetics and Genomics
University of Arkansas at Little Rock 2008 — 2012
Bachelor of Science (BS), Molecular Biology
University of Florida - McKnight Brain Institute January 2013 - Present
Center for Integrative Nanotechnology Sciences - University of Arkansas at Little Rock August 2010 - May 2012
FDA May 2011 - June 2011
Skills
NGS, Transcriptomics, Epigenetics, Bioinformatics, PCR, Biotechnology, Molecular Biology, Microbiology, qRT-PCR, Western Blotting, DNA, RNA and protein..., Gel Electrophoresis, Molecular Cloning, Cell Biology
Education
University of Florida 2012 — 2017
Doctor of Philosophy (Ph.D.), Genetics and Genomics
University of Arkansas at Little Rock 2008 — 2012
Bachelor of Science (BS), Molecular Biology
Asis Lopez Asis Lopez's FDA Experience May 2015 - Present
Job Graduate Researcher at Tulane University
Industry Medical Devices
Experience
FDA May 2015 - Present
Tulane University August 2014 - Present
UCSC Genome Sequencing Center June 2013 - June 2014
SACNAS August 2011 - July 2013
UC San Francisco May 2011 - September 2011
UC Santa Cruz September 2008 - June 2011
Plantronics August 2010 - December 2010
Skills
C, LaTeX, Solidworks, R, Matlab, Research, Statistics, Grant Writing, Medical Devices, Embedded Systems, Sensors, Microcontrollers, Simulations, Teaching, Leadership, Data Analysis, Robotics, SolidWorks, Microsoft Office
Education
University of California, Santa Cruz
B.S., Biomedical Engineering
Southwestern College
Chemistry, Transfer Studies; Mathematics, Engineering
FDA May 2015 - Present
Tulane University August 2014 - Present
UCSC Genome Sequencing Center June 2013 - June 2014
SACNAS August 2011 - July 2013
UC San Francisco May 2011 - September 2011
UC Santa Cruz September 2008 - June 2011
Plantronics August 2010 - December 2010
Skills
C, LaTeX, Solidworks, R, Matlab, Research, Statistics, Grant Writing, Medical Devices, Embedded Systems, Sensors, Microcontrollers, Simulations, Teaching, Leadership, Data Analysis, Robotics, SolidWorks, Microsoft Office
Education
University of California, Santa Cruz
B.S., Biomedical Engineering
Southwestern College
Chemistry, Transfer Studies; Mathematics, Engineering
Jin-Hee Lim's FDA Experience September 2011 - September 2014
Job Staff Fellow at FDA
Industry Government Administration
Experience
FDA September 2011 - September 2014
University of New Orleans 2007 - 2011
Skills
UV/Vis, Microscopy, Confocal Microscopy, Nanotechnology, Spectroscopy, Nanoparticles, Scanning Electron..., Powder X-ray Diffraction, Characterization, Nanomaterials, Mass Spectrometry, FTIR
Education
University of Arkansas for Medical Sciences 2012 — 2013
Environmental and Occupational Health, Graduate Student
FDA September 2011 - September 2014
University of New Orleans 2007 - 2011
Skills
UV/Vis, Microscopy, Confocal Microscopy, Nanotechnology, Spectroscopy, Nanoparticles, Scanning Electron..., Powder X-ray Diffraction, Characterization, Nanomaterials, Mass Spectrometry, FTIR
Education
University of Arkansas for Medical Sciences 2012 — 2013
Environmental and Occupational Health, Graduate Student
Janice Maniwang Janice Maniwang's FDA Experience May 2012 - November 2014
Job Acting Deputy Director, FDA, Office of Program and Regulatory Operations
Industry Government Administration
Experience
FDA, Office of Program and Regulatory Operations November 2014 - Present
U.S. Public Health Service Commissioned Corps November 2009 - Present
FDA May 2012 - November 2014
FDA July 2008 - May 2012
NeighborCare January 2007 - July 2008
Skills
Pharmacists, Clinical Pharmacology, Pharmacy, Healthcare, Medication Therapy..., Immunization, Regulatory Affairs, Clinical Trials, Public Health, Hospitals, Medical Writing, Healthcare Management, Epidemiology
Education
Georgetown University 2008 — 2010
Certificate, Public Health
University of Baltimore 2001 — 2003
MBA
University of Maryland, Baltimore 1999 — 2003
Pharm.D., Pharmacy
FDA, Office of Program and Regulatory Operations November 2014 - Present
U.S. Public Health Service Commissioned Corps November 2009 - Present
FDA May 2012 - November 2014
FDA July 2008 - May 2012
NeighborCare January 2007 - July 2008
Skills
Pharmacists, Clinical Pharmacology, Pharmacy, Healthcare, Medication Therapy..., Immunization, Regulatory Affairs, Clinical Trials, Public Health, Hospitals, Medical Writing, Healthcare Management, Epidemiology
Education
Georgetown University 2008 — 2010
Certificate, Public Health
University of Baltimore 2001 — 2003
MBA
University of Maryland, Baltimore 1999 — 2003
Pharm.D., Pharmacy
Susan Hepp Susan Hepp's FDA Experience 2008 - 2011
Job PhD Student at University of California Berkeley
Industry Research
Experience
UC Berkeley June 2011 - Present
FDA 2008 - 2011
Skills
Virology, Virus Culture, Mutagenesis, Molecular Cloning, PCR, qPCR, Bioinformatics, Phylogenetics, Microscopy, Cell Culture, Plant Tissue Culture, Genetics, Python, Sequencing, Illumina library prep, Microbiology, Genomics, Cell Biology, Bacmid Technology, Protein Expression
Education
University of California, Berkeley 2011 — 2016
Ph.D., Microbiology
University of Maryland College Park 2007 — 2011
Bachelor of Science (BS), Microbiology, General
UC Berkeley June 2011 - Present
FDA 2008 - 2011
Skills
Virology, Virus Culture, Mutagenesis, Molecular Cloning, PCR, qPCR, Bioinformatics, Phylogenetics, Microscopy, Cell Culture, Plant Tissue Culture, Genetics, Python, Sequencing, Illumina library prep, Microbiology, Genomics, Cell Biology, Bacmid Technology, Protein Expression
Education
University of California, Berkeley 2011 — 2016
Ph.D., Microbiology
University of Maryland College Park 2007 — 2011
Bachelor of Science (BS), Microbiology, General
Leah Stitz Leah Stitz's FDA Experience April 2015 - Present
Job Public Affairs Specialist at FDA
Industry Government Administration
Experience
FDA April 2015 - Present
National Institutes of Health February 2014 - April 2015
Food and Drug Administration March 2010 - February 2014
Ken Hubbell & Associates July 2006 - November 2011
Brent & Sam's Cookies (part of Lance, Inc.) October 2008 - July 2009
City of North Little Rock Department of Community Planning June 2006 - October 2008
USDA Food & Nutrition Service, Child Nutrition Division February 2003 - September 2005
L-3 Communications / TMA Corporation June 2002 - February 2003
Coates & Jarratt, Inc. September 2000 - December 2001
The Arlington Institute May 1999 - August 2000
Skills
Strategic Thinking, Research, Project Collaboration, Strategic Planning, Analysis, Product Development, Food Technology, Food Science, Product R&D, Strategy, Program Management, Management, Leadership, Social Media, Project Management, Team Leadership, Team Building, Business Strategy, Government, Policy, Fundraising, Nonprofits, Organizational..., Data Analysis, Qualitative Research, Policy Analysis, Workshop Facilitation, Writing, Editing, Public Speaking, Proposal Writing, Leadership Development, Quality Assurance, Sustainability, Training, Community Outreach, Public Policy
Education
University of Houston-Clear Lake 1998 — 1999
M.S., Studies of the Future
University of Arkansas 1982 — 1984
Bachelor of Science, Agriculture - Food Technology
FDA April 2015 - Present
National Institutes of Health February 2014 - April 2015
Food and Drug Administration March 2010 - February 2014
Ken Hubbell & Associates July 2006 - November 2011
Brent & Sam's Cookies (part of Lance, Inc.) October 2008 - July 2009
City of North Little Rock Department of Community Planning June 2006 - October 2008
USDA Food & Nutrition Service, Child Nutrition Division February 2003 - September 2005
L-3 Communications / TMA Corporation June 2002 - February 2003
Coates & Jarratt, Inc. September 2000 - December 2001
The Arlington Institute May 1999 - August 2000
Skills
Strategic Thinking, Research, Project Collaboration, Strategic Planning, Analysis, Product Development, Food Technology, Food Science, Product R&D, Strategy, Program Management, Management, Leadership, Social Media, Project Management, Team Leadership, Team Building, Business Strategy, Government, Policy, Fundraising, Nonprofits, Organizational..., Data Analysis, Qualitative Research, Policy Analysis, Workshop Facilitation, Writing, Editing, Public Speaking, Proposal Writing, Leadership Development, Quality Assurance, Sustainability, Training, Community Outreach, Public Policy
Education
University of Houston-Clear Lake 1998 — 1999
M.S., Studies of the Future
University of Arkansas 1982 — 1984
Bachelor of Science, Agriculture - Food Technology
Aziza Yogore Aziza Yogore's FDA Experience January 2010 - March 2010
Job Receptionist at Astoria Nursing and Rehab Center
Industry Public Policy
Experience
Astoria Nursing and Rehab Center August 2014 - Present
Kaiser Permanente April 2014 - Present
Asian Pacific Community Fund 2014 - 2014
Aliso Viejo Kumon 2010 - 2013
FDA January 2010 - March 2010
Skills
Work Independently with..., Works well with a team, Learning Quickly, Highly responsible, Positive Can-do Attitude
Education
University of California, Irvine 2009 — 2012
Bachelor of Arts (B.A.), Public Health Policy
Astoria Nursing and Rehab Center August 2014 - Present
Kaiser Permanente April 2014 - Present
Asian Pacific Community Fund 2014 - 2014
Aliso Viejo Kumon 2010 - 2013
FDA January 2010 - March 2010
Skills
Work Independently with..., Works well with a team, Learning Quickly, Highly responsible, Positive Can-do Attitude
Education
University of California, Irvine 2009 — 2012
Bachelor of Arts (B.A.), Public Health Policy
Farukh Khambaty, Ph.D. Farukh Khambaty, Ph.D.'s FDA Experience May 2003 - October 2006
Job Consultant; formerly FDA & NIH
Industry Research
Experience
Farukh Khambaty, SP October 2012 - Present
NIH November 2006 - October 2012
FDA May 2003 - October 2006
FDA October 1989 - April 2003
Skills
Microbiology, Infectious Diseases, Molecular Biology, Vaccines, Antimicrobial food..., Clinical Trials, Diagnostics, Federal Grants..., Government Contract..., FDA, Food Microbiology, Immunology, Virology, Biotechnology, Global Health, Public Health, Epidemiology, Genetics, Biochemistry, PCR, DNA, Medical Diagnostics
Education
University of South Carolina-Columbia 1982 — 1989
PhD, Microbiology, 3.9
Virginia Tech 1981 — 1982
Post grad studies, Food Science and Technology
University Of Bombay 1979 — 1981
MSc, Biochemistry
Wilson College 1979 — 1981
Master of Science (M.Sc.), Biochemistry, First Class
Wilson College, Bombay 1975 — 1979
BSc (Honours), Chemistry & Microbiology, Honours with Distinction
Christ Church High School 1968 — 1973
Indian Certif. of Secondary Education, High School subjects
Farukh Khambaty, SP October 2012 - Present
NIH November 2006 - October 2012
FDA May 2003 - October 2006
FDA October 1989 - April 2003
Skills
Microbiology, Infectious Diseases, Molecular Biology, Vaccines, Antimicrobial food..., Clinical Trials, Diagnostics, Federal Grants..., Government Contract..., FDA, Food Microbiology, Immunology, Virology, Biotechnology, Global Health, Public Health, Epidemiology, Genetics, Biochemistry, PCR, DNA, Medical Diagnostics
Education
University of South Carolina-Columbia 1982 — 1989
PhD, Microbiology, 3.9
Virginia Tech 1981 — 1982
Post grad studies, Food Science and Technology
University Of Bombay 1979 — 1981
MSc, Biochemistry
Wilson College 1979 — 1981
Master of Science (M.Sc.), Biochemistry, First Class
Wilson College, Bombay 1975 — 1979
BSc (Honours), Chemistry & Microbiology, Honours with Distinction
Christ Church High School 1968 — 1973
Indian Certif. of Secondary Education, High School subjects
Andrew Tabarracci Andrew Tabarracci's FDA Experience September 2012 - January 2013
Job Strategic Analytics Associate at Alteryx, Inc.
Industry Information Technology and Services
Experience
Alteryx, Inc. January 2015 - Present
Booker Software July 2013 - January 2015
FDA September 2012 - January 2013
Skills
Sales, Cold Calling, Sales Operations, B2B, Salesforce.com, Customer Service, Teamwork, New Business Development, Microsoft Office, Data Analysis, Project Management, Program Management, Management, Social Networking
Education
University of California, Irvine 2009 — 2013
Bachelor's Degree, Public Health
Alteryx, Inc. January 2015 - Present
Booker Software July 2013 - January 2015
FDA September 2012 - January 2013
Skills
Sales, Cold Calling, Sales Operations, B2B, Salesforce.com, Customer Service, Teamwork, New Business Development, Microsoft Office, Data Analysis, Project Management, Program Management, Management, Social Networking
Education
University of California, Irvine 2009 — 2013
Bachelor's Degree, Public Health
Chad Hillman Chad Hillman's FDA Experience November 2009 - February 2010
Job Lab Assistant at UC Davis Veterinary Medical Teaching Hospital
Industry Hospital & Health Care
Experience
UC Davis Veterinary Medical Teaching Hospital March 2010 - Present
FDA November 2009 - February 2010
UC Davis June 2006 - October 2009
NIH Intramural Research Program (IRP) June 2008 - September 2008
Skills
PCR, Molecular Biology, Cell Culture, Western Blotting, Data Analysis, Research, Laboratory, Biochemistry, Lifesciences, Statistics, Cell Biology, ELISA, Microsoft Office, Flow Cytometry, RT-PCR, qPCR, Molecular Cloning, Nucleic Acid Extraction, Agarose Gel..., fePBMC, Feline Immunodeficiency..., Lentivirus, Lentiviral Vectors, Gene Therapy, Bacterial Transformation, Cryopreservation, Restriction Enzymes, PubMed, Sequence Alignment
Education
University of California, Davis 2004 — 2008
Bachelor of Science (BSc), Neurobiology, Physiology and Behavior
East Union High School 2000 — 2004
UC Davis Veterinary Medical Teaching Hospital March 2010 - Present
FDA November 2009 - February 2010
UC Davis June 2006 - October 2009
NIH Intramural Research Program (IRP) June 2008 - September 2008
Skills
PCR, Molecular Biology, Cell Culture, Western Blotting, Data Analysis, Research, Laboratory, Biochemistry, Lifesciences, Statistics, Cell Biology, ELISA, Microsoft Office, Flow Cytometry, RT-PCR, qPCR, Molecular Cloning, Nucleic Acid Extraction, Agarose Gel..., fePBMC, Feline Immunodeficiency..., Lentivirus, Lentiviral Vectors, Gene Therapy, Bacterial Transformation, Cryopreservation, Restriction Enzymes, PubMed, Sequence Alignment
Education
University of California, Davis 2004 — 2008
Bachelor of Science (BSc), Neurobiology, Physiology and Behavior
East Union High School 2000 — 2004
Shondelle Wilson Frederick Shondelle Wilson Frederick's FDA Experience November 2012 - January 2014
Job LT, US Public Health Service HHS, Office of Minority Health
Industry Research
Experience
Office of the Secretary, Office of Minority Health January 2014 - Present
FDA November 2012 - January 2014
Maryland Department of Health and Mental Hygiene November 2011 - November 2012
The Johns Hopkins Bloomberg School of Public Health, Department of Epidemiolgy August 2007 - September 2011
University of Wisconsin-Madison September 2000 - September 2005
Skills
Research, Epidemiology, Public Health, Program Evaluation, Qualitative Research, Stata, Literature Reviews, Grant Writing, Statistics, Policy Analysis, SAS, Health Equity, Biostatistics, Capacity Building, Data Analysis, Program Development, Data Collection
Education
University of Wisconsin-Madison 1997 — 2007
PhD, Bacteriology
University of California, Davis 1995 — 1997
BS, Microbiology
Office of the Secretary, Office of Minority Health January 2014 - Present
FDA November 2012 - January 2014
Maryland Department of Health and Mental Hygiene November 2011 - November 2012
The Johns Hopkins Bloomberg School of Public Health, Department of Epidemiolgy August 2007 - September 2011
University of Wisconsin-Madison September 2000 - September 2005
Skills
Research, Epidemiology, Public Health, Program Evaluation, Qualitative Research, Stata, Literature Reviews, Grant Writing, Statistics, Policy Analysis, SAS, Health Equity, Biostatistics, Capacity Building, Data Analysis, Program Development, Data Collection
Education
University of Wisconsin-Madison 1997 — 2007
PhD, Bacteriology
University of California, Davis 1995 — 1997
BS, Microbiology
Anna Frid's FDA Experience June 2007 - July 2008
Job Associate Project Manager at Cardiocore
Industry Research
Experience
BioTelemetry Research, formerly Cardiocore May 2014 - Present
UCLA September 2009 - July 2012
UCLA September 2009 - September 2011
FDA June 2007 - July 2008
Skills
Animal Models, Biostatistics, Clinical Research, Research, Experimental Design, DNA, Clinical Trials, Biotechnology, Protein Chemistry, Epidemiology, Science, Literature Reviews, Experimentation, Lifesciences, Mass Spectrometry, PowerPoint, Microsoft Office, Life Sciences, Data Analysis, Project Management
Education
University of California, Los Angeles 2009 — 2012
M.S., Physiological Science
University of California, Berkeley 2003 — 2007
B.S., Molecular Toxicology
BioTelemetry Research, formerly Cardiocore May 2014 - Present
UCLA September 2009 - July 2012
UCLA September 2009 - September 2011
FDA June 2007 - July 2008
Skills
Animal Models, Biostatistics, Clinical Research, Research, Experimental Design, DNA, Clinical Trials, Biotechnology, Protein Chemistry, Epidemiology, Science, Literature Reviews, Experimentation, Lifesciences, Mass Spectrometry, PowerPoint, Microsoft Office, Life Sciences, Data Analysis, Project Management
Education
University of California, Los Angeles 2009 — 2012
M.S., Physiological Science
University of California, Berkeley 2003 — 2007
B.S., Molecular Toxicology
Michael A William Michael A William's FDA Experience September 2012 - October 2012
Job Pharmacovigilance (PV) Scientist at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca September 2015 - Present
Pfizer November 2013 - September 2015
The University of Maryland Medical System January 2013 - May 2013
Walter Reed Army Medical Center March 2013 - April 2013
Safeway February 2013 - March 2013
Holy Cross Hospital January 2013 - February 2013
Blue Cross Blue Shield Association October 2012 - November 2012
FDA September 2012 - October 2012
Kaiser Permanente July 2012 - September 2012
University of Maryland School of Pharmacy September 2011 - August 2012
Skills
Pharmacy, Pharmacists, Pharmacovigilance, Drug Safety, MedDRA, Argus Safety, Pharmaceutical Industry, Adverse Event Reporting, Medical Terminology, Data Analysis, Presentation Skills, Public Speaking, Biotechnology, PowerPoint, Healthcare, Microsoft Excel, Microsoft Word, Microsoft Office, Public Policy, Presentations, Drug Policy, Report Writing, Reporting & Analysis, Managed Care, Research, Data Coding, Medical Communications
Education
University of Maryland School of Pharmacy 2009 — 2013
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of California, Riverside 2004 — 2008
Bachelor of Science (BS), Biology
AstraZeneca September 2015 - Present
Pfizer November 2013 - September 2015
The University of Maryland Medical System January 2013 - May 2013
Walter Reed Army Medical Center March 2013 - April 2013
Safeway February 2013 - March 2013
Holy Cross Hospital January 2013 - February 2013
Blue Cross Blue Shield Association October 2012 - November 2012
FDA September 2012 - October 2012
Kaiser Permanente July 2012 - September 2012
University of Maryland School of Pharmacy September 2011 - August 2012
Skills
Pharmacy, Pharmacists, Pharmacovigilance, Drug Safety, MedDRA, Argus Safety, Pharmaceutical Industry, Adverse Event Reporting, Medical Terminology, Data Analysis, Presentation Skills, Public Speaking, Biotechnology, PowerPoint, Healthcare, Microsoft Excel, Microsoft Word, Microsoft Office, Public Policy, Presentations, Drug Policy, Report Writing, Reporting & Analysis, Managed Care, Research, Data Coding, Medical Communications
Education
University of Maryland School of Pharmacy 2009 — 2013
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of California, Riverside 2004 — 2008
Bachelor of Science (BS), Biology
Patricia Ryan Patricia Ryan's FDA Experience June 2010 - August 2011
Job Senior Manager Regulatory Affairs at La Jolla Pharmaceutical Company
Industry Biotechnology
Experience
La Jolla Pharmaceutical Company July 2015 - Present
Halozyme Therapeutics, Inc. May 2013 - August 2015
MedImmune August 2011 - May 2013
FDA June 2010 - August 2011
The Salk Institute September 2003 - December 2009
University of Minnesota September 2002 - September 2003
Skills
Molecular Biology, Regulatory Affairs, Microbiology, Scientific Writing, Immunology, Science, CMC, Cell Biology, Cell Culture, Biochemistry, Protein Purification
Education
University of California, San Diego 2003 — 2009
Ph.D., Molecular Biology
University of Wisconsin-Madison 1998 — 2002
B.S., Biology
La Jolla Pharmaceutical Company July 2015 - Present
Halozyme Therapeutics, Inc. May 2013 - August 2015
MedImmune August 2011 - May 2013
FDA June 2010 - August 2011
The Salk Institute September 2003 - December 2009
University of Minnesota September 2002 - September 2003
Skills
Molecular Biology, Regulatory Affairs, Microbiology, Scientific Writing, Immunology, Science, CMC, Cell Biology, Cell Culture, Biochemistry, Protein Purification
Education
University of California, San Diego 2003 — 2009
Ph.D., Molecular Biology
University of Wisconsin-Madison 1998 — 2002
B.S., Biology
Christopher Stewart, PhD, DABT's FDA Experience 1989 - 1996
Job Your Advocate in Regulatory Toxicology at MPI Research
Industry Research
Experience
MPI Research January 2010 - Present
MPI Research July 2009 - Present
MPI Research June 2006 - December 2009
MPI Research January 2009 - July 2009
MPI Research June 2005 - December 2008
MPI Research 2004 - June 2006
Charles River Laboratories 1999 - 2003
University of Arkansas for Medical Sciences 1996 - 1999
FDA 1989 - 1996
Skills
Toxicology, Drug Discovery, Biotechnology, CRO, Management, IND, Business Development, GLP, Pharmaceutical Industry, Clinical Development, Clinical Trials, Budgets, Lifesciences, Medical Devices, Research, Project Management, Biopharmaceuticals, Regulatory Affairs, Pharmacology, In Vitro, HPLC, Drug Development, Infectious Diseases, GMP, FDA, PCR, Laboratory, Proteomics, Validation, Immunology, Cell, Life Sciences, Biochemistry, Sop, ELISA, Chemistry, In Vivo, Program Development, Molecular Biology, Animal Models, Oncology, Data Analysis, Analytical Chemistry, Bioanalysis, Microbiology, Pathology, Human Resources, Science, R&D, Pharmacokinetics
Education
University of Arkansas for Medical Sciences 1991 — 1996
Ph.D., Interdisciplinary Toxicology
Philander Smith College 1986 — 1991
B.S., Biology
MPI Research January 2010 - Present
MPI Research July 2009 - Present
MPI Research June 2006 - December 2009
MPI Research January 2009 - July 2009
MPI Research June 2005 - December 2008
MPI Research 2004 - June 2006
Charles River Laboratories 1999 - 2003
University of Arkansas for Medical Sciences 1996 - 1999
FDA 1989 - 1996
Skills
Toxicology, Drug Discovery, Biotechnology, CRO, Management, IND, Business Development, GLP, Pharmaceutical Industry, Clinical Development, Clinical Trials, Budgets, Lifesciences, Medical Devices, Research, Project Management, Biopharmaceuticals, Regulatory Affairs, Pharmacology, In Vitro, HPLC, Drug Development, Infectious Diseases, GMP, FDA, PCR, Laboratory, Proteomics, Validation, Immunology, Cell, Life Sciences, Biochemistry, Sop, ELISA, Chemistry, In Vivo, Program Development, Molecular Biology, Animal Models, Oncology, Data Analysis, Analytical Chemistry, Bioanalysis, Microbiology, Pathology, Human Resources, Science, R&D, Pharmacokinetics
Education
University of Arkansas for Medical Sciences 1991 — 1996
Ph.D., Interdisciplinary Toxicology
Philander Smith College 1986 — 1991
B.S., Biology
Noelani Chiu Noelani Chiu's FDA Experience May 2012 - Present
Job Biological Science Laboratory Intern at FDA
Industry Hospital & Health Care
Experience
FDA May 2012 - Present
UC Berkeley Workstation and Microcomputer Facilities August 2012 - January 2013
UC Berkeley Workstation and Microcomputer Facilities October 2011 - August 2012
Education
University of California, Berkeley 2009 — 2013
FDA May 2012 - Present
UC Berkeley Workstation and Microcomputer Facilities August 2012 - January 2013
UC Berkeley Workstation and Microcomputer Facilities October 2011 - August 2012
Education
University of California, Berkeley 2009 — 2013
Merelynn Rhoten Merelynn Rhoten's FDA Experience April 2002 - Present
Job Owner of Blessed Bath Products
Industry Cosmetics
Experience
Blessed Bath Products June 2012 - Present
FDA April 2002 - Present
Skills
The goat's milk soap is...
Education
University of Central Arkansas 1993 — 1997
Family and Consumer Science, Dietetics and Clinical Nutrition Services
Blessed Bath Products June 2012 - Present
FDA April 2002 - Present
Skills
The goat's milk soap is...
Education
University of Central Arkansas 1993 — 1997
Family and Consumer Science, Dietetics and Clinical Nutrition Services
Prakash Rath, Ph.D. Prakash Rath, Ph.D.'s FDA Experience September 2013 - Present
Job Policy Analyst FDA
Industry Government Administration
Experience
FDA September 2013 - Present
FDA November 2011 - September 2013
Johns Hopkins School of Medicine January 2010 - November 2011
Education
University of Missouri-Columbia 2004 — 2009
PhD, Biological Sciences
University of Arkansas at Fayetteville 2002 — 2004
MS, Cell and Molecular Biology
University of Arkansas at Fayetteville 1997 — 2002
BS, Zoology
FDA September 2013 - Present
FDA November 2011 - September 2013
Johns Hopkins School of Medicine January 2010 - November 2011
Education
University of Missouri-Columbia 2004 — 2009
PhD, Biological Sciences
University of Arkansas at Fayetteville 2002 — 2004
MS, Cell and Molecular Biology
University of Arkansas at Fayetteville 1997 — 2002
BS, Zoology
Deborah Hsu Deborah Hsu's FDA Experience 2008 - Present
Job Consumer Safety Officer at FDA
Industry
Experience
FDA 2008 - Present
Fuscoe Engineering 2005 - 2008
Skills
AutoCAD, Civil Engineering, GIS, ArcGIS, Surveying, Regulatory Affairs, Matlab, Water, Microsoft Excel, Regulatory Requirements, Environmental Compliance, Environmental Awareness, Environmental Consulting, Environmental Monitoring, Regulations, Environmental Science, Project Management
Education
California State University-Fullerton
Master of Arts (M.A.), Civil Engineering/environmental engineering
UC Irvine
Applied Ecology
FDA 2008 - Present
Fuscoe Engineering 2005 - 2008
Skills
AutoCAD, Civil Engineering, GIS, ArcGIS, Surveying, Regulatory Affairs, Matlab, Water, Microsoft Excel, Regulatory Requirements, Environmental Compliance, Environmental Awareness, Environmental Consulting, Environmental Monitoring, Regulations, Environmental Science, Project Management
Education
California State University-Fullerton
Master of Arts (M.A.), Civil Engineering/environmental engineering
UC Irvine
Applied Ecology
Ilona Bebenek's FDA Experience June 2013 - Present
Job Toxicologist at FDA
Industry Research
Experience
FDA June 2013 - Present
Cardno ChemRisk January 2011 - May 2013
California State University, Dominguez Hills January 2011 - May 2011
UCLA May 2005 - February 2011
Allergan, Inc June 2008 - August 2008
University of California January 2000 - January 2008
Skills
Toxicology, Regulatory Affairs
Education
University of California, Los Angeles 2005 — 2010
PhD, Molecular Toxicology
University of California, Los Angeles 2001 — 2003
MA, Organismic Biology, Ecology and Evolution and
BA University of California
FDA June 2013 - Present
Cardno ChemRisk January 2011 - May 2013
California State University, Dominguez Hills January 2011 - May 2011
UCLA May 2005 - February 2011
Allergan, Inc June 2008 - August 2008
University of California January 2000 - January 2008
Skills
Toxicology, Regulatory Affairs
Education
University of California, Los Angeles 2005 — 2010
PhD, Molecular Toxicology
University of California, Los Angeles 2001 — 2003
MA, Organismic Biology, Ecology and Evolution and
BA University of California
Melissa Kim Melissa Kim's FDA Experience December 2014 - Present
Job Regulatory Counsel at FDA CDER, Office of Drug Security, Integrity, and Response
Industry Health, Wellness and Fitness
Experience
FDA December 2014 - Present
FDA September 2013 - December 2014
FDA September 2012 - September 2013
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Public Speaking, Research, Customer Service, Cpr Certified, Social Media, Healthcare, Event Planning, Nutrition, Teamwork, Clinical Research, Fitness, Public Health, Wellness, Outlook, Social Networking, Organizational..., Pharmacy, Pharmacology, Pharmacokinetics, Pharmacists
Education
University of Maryland School of Law 2009 — 2013
JD
University of Maryland School of Pharmacy 2007 — 2012
Doctor of Pharmacy (Pharm.D.), Pharmacy, 3.6
University of California, San Diego 2001 — 2005
BS, Psychology, Human Biology
FDA December 2014 - Present
FDA September 2013 - December 2014
FDA September 2012 - September 2013
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Public Speaking, Research, Customer Service, Cpr Certified, Social Media, Healthcare, Event Planning, Nutrition, Teamwork, Clinical Research, Fitness, Public Health, Wellness, Outlook, Social Networking, Organizational..., Pharmacy, Pharmacology, Pharmacokinetics, Pharmacists
Education
University of Maryland School of Law 2009 — 2013
JD
University of Maryland School of Pharmacy 2007 — 2012
Doctor of Pharmacy (Pharm.D.), Pharmacy, 3.6
University of California, San Diego 2001 — 2005
BS, Psychology, Human Biology
Ronald Manning Ronald Manning's FDA Experience 1990 - 1995
Job Senior Technical Director, Model Development at Pharmaceutical Industry
Industry Pharmaceuticals
Experience
Pharmaceutical Industry March 2014 - Present
U.S. Dept. Health and Human Services July 2007 - February 2014
United States Pharmacopeia 2000 - 2007
National Institutes of Health 1997 - 2000
Vanderbilt University Medical Center January 1988 - November 1997
FDA 1990 - 1995
Mallinckrodt 1983 - 1988
National Institutes of Health 1979 - 1983
SRI International 1977 - 1979
NIST 1975 - 1977
Skills
Clinical Research, Chemistry, Molecular Biology, Vaccines, Biotechnology, Clinical Trials, Pharmaceutical Industry, Medical Devices, Analytical Chemistry, Lifesciences, Regulatory Submissions, FDA, Laboratory, Biomedical Engineering, Digital Imaging, Neuroscience, Drug Development, Nuclear, Clinical Development, GLP, LC-MS, Science, R&D, GMP, Medicine, UV/Vis, Biomarkers, HPLC, Radiation Safety, Radiology, Validation, Nuclear Medicine, Research, Microbiology, Regulatory Affairs, Chromatography, Program Management, Mass Spectrometry, IND, Organic Chemistry, Biopharmaceuticals, Medicinal Chemistry, Drug Discovery, Technology Transfer, Immunology, Quality Assurance, Protein Chemistry, Manufacturing, Positron Emission..., Cross-functional Team...
Education
UC Davis 1971 — 1975
Ph.D., Physical Chemistry
UC Davis 1967 — 1971
Bachelor of Science (B.S.), Chemistry
Wilson High School
Wilson High School
Pharmaceutical Industry March 2014 - Present
U.S. Dept. Health and Human Services July 2007 - February 2014
United States Pharmacopeia 2000 - 2007
National Institutes of Health 1997 - 2000
Vanderbilt University Medical Center January 1988 - November 1997
FDA 1990 - 1995
Mallinckrodt 1983 - 1988
National Institutes of Health 1979 - 1983
SRI International 1977 - 1979
NIST 1975 - 1977
Skills
Clinical Research, Chemistry, Molecular Biology, Vaccines, Biotechnology, Clinical Trials, Pharmaceutical Industry, Medical Devices, Analytical Chemistry, Lifesciences, Regulatory Submissions, FDA, Laboratory, Biomedical Engineering, Digital Imaging, Neuroscience, Drug Development, Nuclear, Clinical Development, GLP, LC-MS, Science, R&D, GMP, Medicine, UV/Vis, Biomarkers, HPLC, Radiation Safety, Radiology, Validation, Nuclear Medicine, Research, Microbiology, Regulatory Affairs, Chromatography, Program Management, Mass Spectrometry, IND, Organic Chemistry, Biopharmaceuticals, Medicinal Chemistry, Drug Discovery, Technology Transfer, Immunology, Quality Assurance, Protein Chemistry, Manufacturing, Positron Emission..., Cross-functional Team...
Education
UC Davis 1971 — 1975
Ph.D., Physical Chemistry
UC Davis 1967 — 1971
Bachelor of Science (B.S.), Chemistry
Wilson High School
Wilson High School
Vasudevan LAKSHMINARAYANAN's FDA Experience August 2012 - Present
Job Visiting Scholar at Physics Department, University of Michigan
Industry Higher Education
Experience
University of Michigan June 2013 - Present
FDA August 2012 - Present
Center for Bioengineering and Biotechology, University of Waterloo 2011 - Present
university of Waterloo August 2006 - Present
University of Michigan June 2013 - September 2014
University of Michigan June 2010 - June 2013
University of Missouri - St. Louis October 1993 - September 2006
University of California, Santa Barbara January 2001 - December 2003
National Board of Examiners in Optometry 1998 - 2003
Allergan Medical Optics June 1991 - September 1993
Skills
Optics, Physics, Photonics, Teaching, Mathematica, Research, Mathematical Modeling, Statistics, Applied Mathematics, Optical Engineering, Laser Physics, Simulations, Nanotechnology, Nonlinear Optics, Biomedical Engineering, Experimentation, Microscopy, University Teaching, Lecturing, Clinical Research, Numerical Analysis, Signal Processing, LaTeX, Chemistry, Image Processing, Materials Science, Characterization, Scientific Computing, Fortran, Theory, Biophysics, Science, Matlab, Data Analysis, R&D, Higher Education
Education
University of California, Berkeley 1979 — 1985
Ph.D., optics, vision science
University of Oregon 1978 — 1979
Physics
University of Madras 1976 — 1978
Master's degree, Theoretical and Mathematical Physics, biophysics
University of Madras 1973 — 1976
Bachelor of Science, Physics, Math and Chemistry
University of Michigan June 2013 - Present
FDA August 2012 - Present
Center for Bioengineering and Biotechology, University of Waterloo 2011 - Present
university of Waterloo August 2006 - Present
University of Michigan June 2013 - September 2014
University of Michigan June 2010 - June 2013
University of Missouri - St. Louis October 1993 - September 2006
University of California, Santa Barbara January 2001 - December 2003
National Board of Examiners in Optometry 1998 - 2003
Allergan Medical Optics June 1991 - September 1993
Skills
Optics, Physics, Photonics, Teaching, Mathematica, Research, Mathematical Modeling, Statistics, Applied Mathematics, Optical Engineering, Laser Physics, Simulations, Nanotechnology, Nonlinear Optics, Biomedical Engineering, Experimentation, Microscopy, University Teaching, Lecturing, Clinical Research, Numerical Analysis, Signal Processing, LaTeX, Chemistry, Image Processing, Materials Science, Characterization, Scientific Computing, Fortran, Theory, Biophysics, Science, Matlab, Data Analysis, R&D, Higher Education
Education
University of California, Berkeley 1979 — 1985
Ph.D., optics, vision science
University of Oregon 1978 — 1979
Physics
University of Madras 1976 — 1978
Master's degree, Theoretical and Mathematical Physics, biophysics
University of Madras 1973 — 1976
Bachelor of Science, Physics, Math and Chemistry
Sara Heydari Sara Heydari's FDA Experience July 2014 - December 2014
Job Public Health Analyst at Centers for Disease Control and Prevention
Industry Research
Experience
Centers for Disease Control and Prevention August 2015 - Present
U.S. Office of Personnel Management (OPM) December 2014 - Present
FDA July 2014 - December 2014
INTEGRATED REFUGEE & IMMIGRANT SERVICES (IRIS) January 2014 - May 2014
UNODC May 2013 - September 2013
Yale University September 2012 - December 2012
National Institutes of Health March 2009 - July 2012
The Scripps Research Institute May 2007 - March 2009
Salk Institute for Biological Studies 2006 - 2007
Children's Hospital Oakland Research Institute May 2005 - August 2005
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Photoshop, Social Media, Teamwork, Public Speaking, English
Education
Yale School of Public Health 2012 — 2014
Master of Public Health (M.P.H.), Epidemiology
University of California, San Diego 2005 — 2007
Bachelor of Science (B.S.), Biochemistry and Cell Biology
Centers for Disease Control and Prevention August 2015 - Present
U.S. Office of Personnel Management (OPM) December 2014 - Present
FDA July 2014 - December 2014
INTEGRATED REFUGEE & IMMIGRANT SERVICES (IRIS) January 2014 - May 2014
UNODC May 2013 - September 2013
Yale University September 2012 - December 2012
National Institutes of Health March 2009 - July 2012
The Scripps Research Institute May 2007 - March 2009
Salk Institute for Biological Studies 2006 - 2007
Children's Hospital Oakland Research Institute May 2005 - August 2005
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Photoshop, Social Media, Teamwork, Public Speaking, English
Education
Yale School of Public Health 2012 — 2014
Master of Public Health (M.P.H.), Epidemiology
University of California, San Diego 2005 — 2007
Bachelor of Science (B.S.), Biochemistry and Cell Biology
Thuy Vu Thuy Vu's FDA Experience May 2007 - September 2007
Job Senior Scientist at Amgen
Industry Biotechnology
Experience
Amgen March 2011 - Present
Amgen October 2008 - April 2011
The University of Auckland 2007 - 2008
FDA May 2007 - September 2007
fka Cor Therapeutics Inc. 2000 - 2001
UC Davis Medical Center 1999 - 2000
UC Davis Medical Center 1994 - 1997
Skills
Clinical Development, Clinical Pharmacology, Pharmacodynamics, Clinical Trials, Drug Development, Pharmacokinetics, Statistical Modeling, Modeling and Simulation, Mechanistic Modeling, Written & Oral..., Neuroscience, Clinical Research, Biomarkers, Drug Discovery, Neurology, Biotechnology, Pharmaceutical Industry, Pharmacology
Education
University of California, San Francisco 2005 — 2007
Postdoctoral, Clinical pharmacology & pharmacometrics
University of California, San Francisco 2001 — 2005
PharmD, Pharmacy
University of California, Davis 1993 — 1997
BS, Biochemistry
Amgen March 2011 - Present
Amgen October 2008 - April 2011
The University of Auckland 2007 - 2008
FDA May 2007 - September 2007
fka Cor Therapeutics Inc. 2000 - 2001
UC Davis Medical Center 1999 - 2000
UC Davis Medical Center 1994 - 1997
Skills
Clinical Development, Clinical Pharmacology, Pharmacodynamics, Clinical Trials, Drug Development, Pharmacokinetics, Statistical Modeling, Modeling and Simulation, Mechanistic Modeling, Written & Oral..., Neuroscience, Clinical Research, Biomarkers, Drug Discovery, Neurology, Biotechnology, Pharmaceutical Industry, Pharmacology
Education
University of California, San Francisco 2005 — 2007
Postdoctoral, Clinical pharmacology & pharmacometrics
University of California, San Francisco 2001 — 2005
PharmD, Pharmacy
University of California, Davis 1993 — 1997
BS, Biochemistry
Emily C Shin Emily C Shin's FDA Experience July 2007 - Present
Job Research
Industry Pharmaceuticals
Experience
FDA July 2007 - Present
Production One, Inc October 2012 - October 2012
Eli Lilly and Company January 2011 - June 2012
Eli Lilly and Company May 2007 - December 2010
RBC Life Sciences, Korea November 2005 - December 2006
UCLA School of Law November 2002 - March 2005
Creative Labs 2004 - 2005
American Computer Experience 2001 - 2002
Mobil Chemical Co June 1999 - September 1999
Arco Gas June 1998 - September 1998
Skills
Training, CRM, Strategic Planning, Research, Management, Project Management, Selling, Business Planning
Education
University of California, Los Angeles 2000 — 2004
Psychology
South
General
FDA July 2007 - Present
Production One, Inc October 2012 - October 2012
Eli Lilly and Company January 2011 - June 2012
Eli Lilly and Company May 2007 - December 2010
RBC Life Sciences, Korea November 2005 - December 2006
UCLA School of Law November 2002 - March 2005
Creative Labs 2004 - 2005
American Computer Experience 2001 - 2002
Mobil Chemical Co June 1999 - September 1999
Arco Gas June 1998 - September 1998
Skills
Training, CRM, Strategic Planning, Research, Management, Project Management, Selling, Business Planning
Education
University of California, Los Angeles 2000 — 2004
Psychology
South
General
Jaime Raben Jaime Raben's FDA Experience October 2013 - Present
Job Biomedical Engineer at FDA
Industry
Experience
FDA October 2013 - Present
Virginia Tech AEThER Laboratory July 2007 - August 2013
Virginia Tech - Department of Engineering Education August 2011 - December 2011
Virginia Tech August 2008 - May 2010
Skills
Experimental Fluid..., Particle Image..., micro-Particle Image..., Matlab, Solidworks, Labview, AutoCAD, Programming
Education
Virginia Tech 2007 — 2013
Doctor of Philosophy (Ph.D.), Biomedical Engineering
University of California, Irvine 2006 — 2007
Master's degree, Biomedical Engineering
Virginia Tech 2002 — 2006
Bachelor of Science, Mechanical Engineering
FDA October 2013 - Present
Virginia Tech AEThER Laboratory July 2007 - August 2013
Virginia Tech - Department of Engineering Education August 2011 - December 2011
Virginia Tech August 2008 - May 2010
Skills
Experimental Fluid..., Particle Image..., micro-Particle Image..., Matlab, Solidworks, Labview, AutoCAD, Programming
Education
Virginia Tech 2007 — 2013
Doctor of Philosophy (Ph.D.), Biomedical Engineering
University of California, Irvine 2006 — 2007
Master's degree, Biomedical Engineering
Virginia Tech 2002 — 2006
Bachelor of Science, Mechanical Engineering
Caitlin Hickey's FDA Experience September 2014 - Present
Job ORISE Fellow, CFSAN Food Defense Team at FDA
Industry Food & Beverages
Experience
FDA September 2014 - Present
Deloitte August 2014 - September 2014
Deloitte & Touche, LLP November 2012 - August 2014
The Institute of Food Technologists (IFT) September 2011 - November 2012
Prime Label Consultants, Inc. May 2006 - August 2009
International Food Information Council Foundation June 2009 - July 2009
Food and Drug Administration May 2008 - August 2008
Skills
Food Safety, Food Science, Research, Food Industry, Food Processing, Regulatory Affairs, Traceability, Product Tracing, Labeling, Food Defense
Education
University of California, Davis 2009 — 2011
MS, Food Science, Consumer Studies
University of Maryland College Park 2005 — 2009
BS, Food Science
FDA September 2014 - Present
Deloitte August 2014 - September 2014
Deloitte & Touche, LLP November 2012 - August 2014
The Institute of Food Technologists (IFT) September 2011 - November 2012
Prime Label Consultants, Inc. May 2006 - August 2009
International Food Information Council Foundation June 2009 - July 2009
Food and Drug Administration May 2008 - August 2008
Skills
Food Safety, Food Science, Research, Food Industry, Food Processing, Regulatory Affairs, Traceability, Product Tracing, Labeling, Food Defense
Education
University of California, Davis 2009 — 2011
MS, Food Science, Consumer Studies
University of Maryland College Park 2005 — 2009
BS, Food Science
Faruk Sheikh Faruk Sheikh's FDA Experience 2002 - Present
Job Scientist
Industry Government Administration
Experience
FDA 2002 - Present
Walter Reed Army Institute of Research 1999 - 2002
Medical University of South Carolina 1995 - 1999
Harvard Medical School 1993 - 1995
Bose Institute 1988 - 1993
Skills
Molecular Biology, Biochemistry, Cell Culture, PCR, Life Sciences, Cell Biology, Western Blotting, Biotechnology, ELISA, Protein Chemistry, Lifesciences, Cell, Purification, Immunology, Drug Development
Education
University of Calcutta
Ph.D., Biochemistry
University of Calcutta 1985 — 1987
Ph.D., Biochemistry
FDA 2002 - Present
Walter Reed Army Institute of Research 1999 - 2002
Medical University of South Carolina 1995 - 1999
Harvard Medical School 1993 - 1995
Bose Institute 1988 - 1993
Skills
Molecular Biology, Biochemistry, Cell Culture, PCR, Life Sciences, Cell Biology, Western Blotting, Biotechnology, ELISA, Protein Chemistry, Lifesciences, Cell, Purification, Immunology, Drug Development
Education
University of Calcutta
Ph.D., Biochemistry
University of Calcutta 1985 — 1987
Ph.D., Biochemistry
Laura Fontan Laura Fontan's FDA Experience July 2014 - Present
Job Consumer Safety Officer at FDA
Industry Biotechnology
Experience
FDA July 2014 - Present
Meridian BioGroup LLC April 2014 - July 2014
Wellstat Diagnostics February 2014 - April 2014
MedImmune November 2011 - December 2013
ProPharma Group August 2011 - November 2011
Private Consultant March 2011 - June 2011
Intercell USA September 2009 - March 2011
Alcon Laboratories, Inc. June 2009 - September 2009
Human Genome Sciences Inc May 2003 - April 2009
Genentech Inc April 1994 - May 2003
Skills
FDA, Validation, CAPA, GMP, Quality Assurance, Sop, Team Building, Quality System, Change Management, Change Control, Continuous Improvement, Cleaning Validation
Education
MBA University of Phoenix 2001 — 2003
MBA, Businesss
University of California, Santa Cruz 1979 — 1983
BS, Biology
Montgomery Works workshop
FDA July 2014 - Present
Meridian BioGroup LLC April 2014 - July 2014
Wellstat Diagnostics February 2014 - April 2014
MedImmune November 2011 - December 2013
ProPharma Group August 2011 - November 2011
Private Consultant March 2011 - June 2011
Intercell USA September 2009 - March 2011
Alcon Laboratories, Inc. June 2009 - September 2009
Human Genome Sciences Inc May 2003 - April 2009
Genentech Inc April 1994 - May 2003
Skills
FDA, Validation, CAPA, GMP, Quality Assurance, Sop, Team Building, Quality System, Change Management, Change Control, Continuous Improvement, Cleaning Validation
Education
MBA University of Phoenix 2001 — 2003
MBA, Businesss
University of California, Santa Cruz 1979 — 1983
BS, Biology
Montgomery Works workshop
Lorie Castleberry's FDA Experience July 2015 - Present
Job Lead Financial Management Specialist, Field Financial Services at FDA
Industry Government Administration
Experience
FDA July 2015 - Present
FDA February 2010 - July 2015
FDA July 1991 - February 2010
Skills
Government, Microsoft Word, Financial Reporting, Government Procurement, Security Clearance, Research, Enforcement, Federal Government, Financial Analysis, Program Management, Government Contracting, Policy Analysis, Data Analysis, Proposal Writing, Internal Audit, Data Entry, Strategic Planning, Non-profits, Policy, Access, Budgets, Project Management, Finance, Emergency Management, Microsoft Excel, Cost Benefit, Process Improvement, Microsoft Office, Community Outreach, Analysis, Project Planning, Change Management, Accounting, Management, PowerPoint, Supervisory Skills, Leadership, Regulations, Risk Management, Event Planning, Private Investigations, Employee Relations, Healthcare, Public Speaking, Public Policy, Public Relations, Auditing, Software Documentation, Managerial Finance, Outlook
Education
University of Arkanasas at Pine Bluff
Pending, Accounting
University of Arkansas at Pine Bluff
Accounting and Finance
FDA July 2015 - Present
FDA February 2010 - July 2015
FDA July 1991 - February 2010
Skills
Government, Microsoft Word, Financial Reporting, Government Procurement, Security Clearance, Research, Enforcement, Federal Government, Financial Analysis, Program Management, Government Contracting, Policy Analysis, Data Analysis, Proposal Writing, Internal Audit, Data Entry, Strategic Planning, Non-profits, Policy, Access, Budgets, Project Management, Finance, Emergency Management, Microsoft Excel, Cost Benefit, Process Improvement, Microsoft Office, Community Outreach, Analysis, Project Planning, Change Management, Accounting, Management, PowerPoint, Supervisory Skills, Leadership, Regulations, Risk Management, Event Planning, Private Investigations, Employee Relations, Healthcare, Public Speaking, Public Policy, Public Relations, Auditing, Software Documentation, Managerial Finance, Outlook
Education
University of Arkanasas at Pine Bluff
Pending, Accounting
University of Arkansas at Pine Bluff
Accounting and Finance
Emanuel Hignutt, Jr., MPH's FDA Experience September 2015 - Present
Job Chemist at FDA Center for Food Safety and Applied Nutrition
Industry Government Administration
Experience
FDA September 2015 - Present
US Army June 2014 - September 2015
University of North Carolina at Chapel Hill January 2014 - April 2014
University of North Carolina at Chapel Hill August 2013 - December 2013
Granville Vance District Health Department May 2013 - August 2013
State of Alaska June 2004 - April 2013
City of Palmer Department of Fire and Rescue September 2004 - January 2011
North Creek Analytical April 2003 - May 2004
Severn Trent Laboratories, Inc. April 1995 - January 2001
Quanterra Incorporated February 1991 - April 1995
Skills
Analytical Chemistry, Laboratory, Environmental Awareness, Environmental Science, Analysis, HPLC, Program Management, Policy, Water Quality, Environmental Compliance, Chemistry, Leadership, Proposal Writing, Gas Chromatography, Data Analysis, Public Health, Mass Spectrometry, Team Leadership, Quality Assurance, ELISA, Project Management, Analytical Skills, Business Strategy, Sustainability, Technical Writing, Fluorescence, Science
Education
University of North Carolina at Chapel Hill 2012 — 2014
Master of Public Health (M.P.H.), Public Health Leadership
University of California, Davis 1981 — 1985
Bachelor of Arts, Chemistry
FDA September 2015 - Present
US Army June 2014 - September 2015
University of North Carolina at Chapel Hill January 2014 - April 2014
University of North Carolina at Chapel Hill August 2013 - December 2013
Granville Vance District Health Department May 2013 - August 2013
State of Alaska June 2004 - April 2013
City of Palmer Department of Fire and Rescue September 2004 - January 2011
North Creek Analytical April 2003 - May 2004
Severn Trent Laboratories, Inc. April 1995 - January 2001
Quanterra Incorporated February 1991 - April 1995
Skills
Analytical Chemistry, Laboratory, Environmental Awareness, Environmental Science, Analysis, HPLC, Program Management, Policy, Water Quality, Environmental Compliance, Chemistry, Leadership, Proposal Writing, Gas Chromatography, Data Analysis, Public Health, Mass Spectrometry, Team Leadership, Quality Assurance, ELISA, Project Management, Analytical Skills, Business Strategy, Sustainability, Technical Writing, Fluorescence, Science
Education
University of North Carolina at Chapel Hill 2012 — 2014
Master of Public Health (M.P.H.), Public Health Leadership
University of California, Davis 1981 — 1985
Bachelor of Arts, Chemistry
Adrian Senderowicz's FDA Experience January 2005 - July 2008
Job Chief Medical Officer at Cerulean Pharma, Inc
Industry Pharmaceuticals
Experience
Cerulean Pharma, Inc September 2015 - Present
PUMA BIOTECHNOLOGY LTD August 2015 - Present
IGNYTA, Inc. August 2014 - April 2015
Sanofi July 2013 - August 2014
Tokai Pharmaceuticals July 2012 - April 2013
Astra Zeneca July 2009 - July 2012
AstraZeneca July 2008 - July 2009
FDA January 2005 - July 2008
National Cancer Institute June 2006 - June 2008
National Institutes of Health April 2000 - December 2004
Skills
Oncology, Clinical Trials, Cancer, Molecular Biology, Therapeutics, Clinical Research, Regulatory Affairs, Clinical Development, Hematology, Regulatory Submissions, R&D, Diagnostics, FDA, Cancer Research, Biomarkers, Translational Medicine, Pharmaceutical Industry, Medicine, Medical Writing, Infectious Diseases, Neurology, Drug Development, Pharmacovigilance, Drug Discovery, Medical Devices, Medical Education, Therapists, Cardiology, CTMS, GCP, Pharmacology, Lifesciences, Biostatistics, Biotechnology, Immunology, Translational Research, Clinical Pharmacology, Medical Affairs, Informatics, Internal Medicine, CRO, Therapeutic Areas, Vaccines, Life Sciences
Education
Universidad de Buenos Aires / UBA 1982 — 1987
Medical Doctor
Cerulean Pharma, Inc September 2015 - Present
PUMA BIOTECHNOLOGY LTD August 2015 - Present
IGNYTA, Inc. August 2014 - April 2015
Sanofi July 2013 - August 2014
Tokai Pharmaceuticals July 2012 - April 2013
Astra Zeneca July 2009 - July 2012
AstraZeneca July 2008 - July 2009
FDA January 2005 - July 2008
National Cancer Institute June 2006 - June 2008
National Institutes of Health April 2000 - December 2004
Skills
Oncology, Clinical Trials, Cancer, Molecular Biology, Therapeutics, Clinical Research, Regulatory Affairs, Clinical Development, Hematology, Regulatory Submissions, R&D, Diagnostics, FDA, Cancer Research, Biomarkers, Translational Medicine, Pharmaceutical Industry, Medicine, Medical Writing, Infectious Diseases, Neurology, Drug Development, Pharmacovigilance, Drug Discovery, Medical Devices, Medical Education, Therapists, Cardiology, CTMS, GCP, Pharmacology, Lifesciences, Biostatistics, Biotechnology, Immunology, Translational Research, Clinical Pharmacology, Medical Affairs, Informatics, Internal Medicine, CRO, Therapeutic Areas, Vaccines, Life Sciences
Education
Universidad de Buenos Aires / UBA 1982 — 1987
Medical Doctor
David Keire's FDA Experience October 2008 - Present
Job Research Chemist at FDA
Industry Research
Experience
FDA October 2008 - Present
UCLA Medical School January 1999 - September 2008
The Beckman Research Institute of the City of Hope January 1992 - January 1999
Skills
NMR spectroscopy, HPLC, Mass Spectrometry, NMR, Chromatography, Analytical Chemistry, Protein Chemistry, Organic Chemistry, LC-MS, UV/Vis, GLP, Biochemistry, Lifesciences, GC-MS, Spectroscopy, Organic Synthesis
Education
University of California, Riverside 1985 — 1990
PhD, Analytical Chemistry
University of Washington 1981 — 1985
BS, Chemistry
FDA October 2008 - Present
UCLA Medical School January 1999 - September 2008
The Beckman Research Institute of the City of Hope January 1992 - January 1999
Skills
NMR spectroscopy, HPLC, Mass Spectrometry, NMR, Chromatography, Analytical Chemistry, Protein Chemistry, Organic Chemistry, LC-MS, UV/Vis, GLP, Biochemistry, Lifesciences, GC-MS, Spectroscopy, Organic Synthesis
Education
University of California, Riverside 1985 — 1990
PhD, Analytical Chemistry
University of Washington 1981 — 1985
BS, Chemistry
Carly N. Daniels (Ferguson) Carly N. Daniels (Ferguson)'s FDA Experience August 2014 - Present
Job ORISE Postdoctoral Fellow at FDA
Industry Research
Experience
FDA August 2014 - Present
UCLA August 2009 - July 2014
University of Florida January 2007 - July 2009
AMOLF May 2008 - July 2008
Skills
Imaging Mass..., Mass Spectrometry, Biochemistry, Protein Chemistry, Molecular Genetics, Analytical Chemistry, Proteomics, Histology, Gel Electrophoresis, Agarose Gel..., Molecular Cloning, ICP-OES, LC-MS, MALDI-TOF, ESI-MS, Molecular Evolution, Protein Purification, GC-MS, HPLC, HPLC-MS, Pharmacokinetics, Drug Metabolism, Drug Development
Education
UCLA 2009 — 2014
PhD, Biochemistry & Molecular Biology
University of Florida 2005 — 2009
BS, Chemistry
FDA August 2014 - Present
UCLA August 2009 - July 2014
University of Florida January 2007 - July 2009
AMOLF May 2008 - July 2008
Skills
Imaging Mass..., Mass Spectrometry, Biochemistry, Protein Chemistry, Molecular Genetics, Analytical Chemistry, Proteomics, Histology, Gel Electrophoresis, Agarose Gel..., Molecular Cloning, ICP-OES, LC-MS, MALDI-TOF, ESI-MS, Molecular Evolution, Protein Purification, GC-MS, HPLC, HPLC-MS, Pharmacokinetics, Drug Metabolism, Drug Development
Education
UCLA 2009 — 2014
PhD, Biochemistry & Molecular Biology
University of Florida 2005 — 2009
BS, Chemistry
Nick Duckworth Nick Duckworth's FDA Experience June 2014 - Present
Job Project Manager at FDA
Industry International Affairs
Experience
FDA June 2014 - Present
Peace Corps February 2013 - February 2014
Peace Corps January 2012 - February 2014
World Affairs Institute August 2011 - December 2011
LNESC August 2011 - December 2011
University of Denver September 2010 - June 2011
GEICO January 2010 - July 2010
Enterprise Rent-A-Car September 2008 - July 2009
Skills
Community Outreach, Grant Writing, Non-profits, Fundraising, Nonprofits, Leadership, Program Management, Editing, Analysis, Social Media Marketing, Marketing, Management, Project Management, Training, Program Evaluation, Grants, Microsoft Office, Sales, Customer Service, Time Management, SAS, Statistics
Education
University of Denver 2010 — 2012
M.A., International Administration
University of California, San Diego 2004 — 2008
B.A., Linguistics, International Studies
FDA June 2014 - Present
Peace Corps February 2013 - February 2014
Peace Corps January 2012 - February 2014
World Affairs Institute August 2011 - December 2011
LNESC August 2011 - December 2011
University of Denver September 2010 - June 2011
GEICO January 2010 - July 2010
Enterprise Rent-A-Car September 2008 - July 2009
Skills
Community Outreach, Grant Writing, Non-profits, Fundraising, Nonprofits, Leadership, Program Management, Editing, Analysis, Social Media Marketing, Marketing, Management, Project Management, Training, Program Evaluation, Grants, Microsoft Office, Sales, Customer Service, Time Management, SAS, Statistics
Education
University of Denver 2010 — 2012
M.A., International Administration
University of California, San Diego 2004 — 2008
B.A., Linguistics, International Studies
Andrew Harmon Andrew Harmon's FDA Experience June 2014 - Present
Job ORISE Fellow at FDA
Industry Biotechnology
Experience
FDA June 2014 - Present
UCLA 2008 - 2014
Education
University of California, Los Angeles 2008 — 2014
Ph.D., Molecular, Cell and Developmental Biology
University of Delaware 2004 — 2008
B.S., Cell and Molecular Biology and Genetics
FDA June 2014 - Present
UCLA 2008 - 2014
Education
University of California, Los Angeles 2008 — 2014
Ph.D., Molecular, Cell and Developmental Biology
University of Delaware 2004 — 2008
B.S., Cell and Molecular Biology and Genetics
Joy Okonkwo Joy Okonkwo's FDA Experience December 2010 - Present
Job Program Specialist at FDA
Industry Public Safety
Experience
FDA December 2010 - Present
Skills
Government, Research, Event Planning, Microsoft Office, Public Speaking, Legal Research, Program Management, International Relations, Data Analysis, Community Outreach, Policy Analysis, MS Project, Analysis, Non-profits, Public Health, Project Management, Data Management, Grant Writing
Education
University of Baltimore 2011 — 2014
Masters of Science in Conflict Management and Conflict Negotiation
University of Massachusetts, Amherst 2002 — 2006
B.A., Legal Studies
FDA December 2010 - Present
Skills
Government, Research, Event Planning, Microsoft Office, Public Speaking, Legal Research, Program Management, International Relations, Data Analysis, Community Outreach, Policy Analysis, MS Project, Analysis, Non-profits, Public Health, Project Management, Data Management, Grant Writing
Education
University of Baltimore 2011 — 2014
Masters of Science in Conflict Management and Conflict Negotiation
University of Massachusetts, Amherst 2002 — 2006
B.A., Legal Studies
Lianna Tilton Lianna Tilton's FDA Experience June 2014 - Present
Job Pathways Student Intern at FDA, ORA WEAC
Industry Food & Beverages
Experience
FDA June 2014 - Present
University of Massachusetts Amherst January 2012 - Present
University of Massachusetts Amherst January 2014 - October 2014
University of Massachusetts Amherst January 2012 - Present
African Array Backpackers November 2013 - December 2013
Camp West Woods June 2009 - July 2013
Boston Pretzel May 2012 - August 2012
Skills
Food Science, Microbiology, Food Safety, Food, Food Technology, Laboratory, Science, Food Quality, Chemistry, Dairy, Nutrition, Food Processing, Food Industry, Fermentation, Food Chemistry, Food Microbiology, Sensory Evaluation, Biochemistry, AutoCAD, Inkjet Printing, Laser Cutting, BioTek analysis, Titration, pH meter, Distillation, Recrystallization, Gas Chromatography, MPN, Gram Staining, Streak Plating
Education
University of California, Davis 2015 — 2017
Master’s Degree, Food Science and Technology
University of Massachusetts, Amherst 2011 — 2015
Bachelor of Science (B.S.), Food Science and Technology, Sophmore
University of KwaZulu-Natal 2013 — 2013
Stoughton High School 2007 — 2011
High School Deploma
FDA June 2014 - Present
University of Massachusetts Amherst January 2012 - Present
University of Massachusetts Amherst January 2014 - October 2014
University of Massachusetts Amherst January 2012 - Present
African Array Backpackers November 2013 - December 2013
Camp West Woods June 2009 - July 2013
Boston Pretzel May 2012 - August 2012
Skills
Food Science, Microbiology, Food Safety, Food, Food Technology, Laboratory, Science, Food Quality, Chemistry, Dairy, Nutrition, Food Processing, Food Industry, Fermentation, Food Chemistry, Food Microbiology, Sensory Evaluation, Biochemistry, AutoCAD, Inkjet Printing, Laser Cutting, BioTek analysis, Titration, pH meter, Distillation, Recrystallization, Gas Chromatography, MPN, Gram Staining, Streak Plating
Education
University of California, Davis 2015 — 2017
Master’s Degree, Food Science and Technology
University of Massachusetts, Amherst 2011 — 2015
Bachelor of Science (B.S.), Food Science and Technology, Sophmore
University of KwaZulu-Natal 2013 — 2013
Stoughton High School 2007 — 2011
High School Deploma
Daniel Allgeier Daniel Allgeier's FDA Experience September 2010 - July 2012
Job Senior Disease Intervention Technician at Contra Costa County
Industry Health, Wellness and Fitness
Experience
Contra Costa County July 2015 - Present
Contra Costa County Health Services, Emergency Medical Services June 2014 - July 2015
Cardno ChemRisk June 2013 - June 2014
FDA September 2010 - July 2012
AmeriCorps VISTA September 2009 - September 2010
Virginia Department of Health, Peninsula Health District May 2008 - August 2008
Genetics Research Lab of Dr. Lizabeth Allison, College of William and Mary February 2007 - February 2008
Skills
Public Health, Statistics, Epidemiology, Biostatistics, SAS programming, Data Analysis, Microsoft Excel, Python, Infectious Diseases, Disease investigation, Access, Emergency Management, ICS, ESRI, ArcGIS, HIPAA, Microsoft Office, Community Assessment..., Community Outreach, Gel Electrophoresis, Research, Grant Writing, Grants, Nonprofits, FACS analysis, Western Blotting, Non-profits, Plasmid Preparation, Centrifugation, Silver Staining, Stata, SQL
Education
UC Berkeley 2012 — 2014
Master's Degree, Epidemiology, Biostatistics
The College of William and Mary 2005 — 2009
Bachelor of Science (B.S.), Biology, General
Contra Costa County July 2015 - Present
Contra Costa County Health Services, Emergency Medical Services June 2014 - July 2015
Cardno ChemRisk June 2013 - June 2014
FDA September 2010 - July 2012
AmeriCorps VISTA September 2009 - September 2010
Virginia Department of Health, Peninsula Health District May 2008 - August 2008
Genetics Research Lab of Dr. Lizabeth Allison, College of William and Mary February 2007 - February 2008
Skills
Public Health, Statistics, Epidemiology, Biostatistics, SAS programming, Data Analysis, Microsoft Excel, Python, Infectious Diseases, Disease investigation, Access, Emergency Management, ICS, ESRI, ArcGIS, HIPAA, Microsoft Office, Community Assessment..., Community Outreach, Gel Electrophoresis, Research, Grant Writing, Grants, Nonprofits, FACS analysis, Western Blotting, Non-profits, Plasmid Preparation, Centrifugation, Silver Staining, Stata, SQL
Education
UC Berkeley 2012 — 2014
Master's Degree, Epidemiology, Biostatistics
The College of William and Mary 2005 — 2009
Bachelor of Science (B.S.), Biology, General
Telba Irony Telba Irony's FDA Experience August 1998 - Present
Job Head, Quantitative Innovation Program at Center for Devices and Radiological Health, FDA
Industry Medical Devices
Experience
FDA August 1998 - Present
George Washington University June 1990 - August 1998
Skills
Statistics, FDA, Statistical Modeling, Biostatistics, Data Analysis, Analysis, Medical Devices, Clinical Trials, Public Health, Mathematical Modeling, Bayesian statistics, Operations Research, SAS, Regulatory Affairs, Clinical Study Design, Decision Analysis, Simulations
Education
University of California, Berkeley
PhD, Operations Research
FDA August 1998 - Present
George Washington University June 1990 - August 1998
Skills
Statistics, FDA, Statistical Modeling, Biostatistics, Data Analysis, Analysis, Medical Devices, Clinical Trials, Public Health, Mathematical Modeling, Bayesian statistics, Operations Research, SAS, Regulatory Affairs, Clinical Study Design, Decision Analysis, Simulations
Education
University of California, Berkeley
PhD, Operations Research
Alex Slizza Alex Slizza's FDA Experience September 1997 - May 2003
Job Owner at Aegis Regulatory Consulting, LLC
Industry Medical Devices
Experience
Aegis Regulatory Consulting, LLC January 2013 - Present
FAS Regulatory Consulting March 2007 - December 2012
Oculir, Inc. January 2006 - February 2007
Inova Diagnostics May 2003 - September 2005
FDA September 1997 - May 2003
Skills
FDA, Medical Devices, Quality Systems, Validation, CAPA, ISO 13485, Regulatory Affairs, GMP, Compliance, Quality Assurance, 510 K, PMA, ISO, Regulatory Strategy, QSR, Auditing, Documentation, FDA Response Preparation, Quality Auditing, Inspection, Quality System, Testing, Lifesciences, 21 CFR Part 11, Software Documentation, Sop, Technology Transfer, Quality Control, R&D, ISO 14971, Hardware Diagnostics, V&V, Strategy, Continuous Improvement, Design Control, Clinical Trials, Manufacturing, Biotechnology, Biomedical Engineering, Biopharmaceuticals, Regulatory Requirements, Microbiology, FDA GMP, Quality Management, Change Control, Regulatory Submissions, Clinical Research, GLP, Laboratory, Root Cause Analysis
Education
University of California, San Diego 1989 — 1993
BS, Bioengineering
Redondo Union High School 1985 — 1989
High School Diploma, College Prep
Aegis Regulatory Consulting, LLC January 2013 - Present
FAS Regulatory Consulting March 2007 - December 2012
Oculir, Inc. January 2006 - February 2007
Inova Diagnostics May 2003 - September 2005
FDA September 1997 - May 2003
Skills
FDA, Medical Devices, Quality Systems, Validation, CAPA, ISO 13485, Regulatory Affairs, GMP, Compliance, Quality Assurance, 510 K, PMA, ISO, Regulatory Strategy, QSR, Auditing, Documentation, FDA Response Preparation, Quality Auditing, Inspection, Quality System, Testing, Lifesciences, 21 CFR Part 11, Software Documentation, Sop, Technology Transfer, Quality Control, R&D, ISO 14971, Hardware Diagnostics, V&V, Strategy, Continuous Improvement, Design Control, Clinical Trials, Manufacturing, Biotechnology, Biomedical Engineering, Biopharmaceuticals, Regulatory Requirements, Microbiology, FDA GMP, Quality Management, Change Control, Regulatory Submissions, Clinical Research, GLP, Laboratory, Root Cause Analysis
Education
University of California, San Diego 1989 — 1993
BS, Bioengineering
Redondo Union High School 1985 — 1989
High School Diploma, College Prep
Leigh A Sawyer, DVM, MPH Leigh A Sawyer, DVM, MPH's FDA Experience 1987 - 1994
Job Clinical Research Manager at The Emmes Corporation
Industry Research
Experience
The Emmes Corporation June 2015 - Present
United States Public Health Service - Detail DoD February 2013 - June 2015
US Public Health Service - Deployment December 2014 - February 2015
US Public Health Service - Detail DHS December 2011 - February 2013
U.S. Department of Health and Human Services August 2007 - November 2011
US Department of Health and Human Services June 2006 - August 2007
U.S. Department of Health and Human Services June 2005 - June 2006
National Institutes of Health February 1994 - February 2005
FDA 1987 - 1994
Centers for Disease Control and Prevention 1985 - 1987
Skills
Epidemic Intelligence..., Diplomat American..., Veterinary..., Public Health, Science, Government, Policy, Program Management, National Security, Data Analysis, Research, Security Clearance, Infectious Diseases, Epidemiology, Global Health, Grants
Education
University of California, Berkeley
Master of Public Health (M.P.H.)
University of California, San Diego
Bachelor of Arts (B.A.), Microbiology, General
University of Florida College of Veterinary Medicine
Doctor of Veterinary Medicine (D.V.M.)
The Emmes Corporation June 2015 - Present
United States Public Health Service - Detail DoD February 2013 - June 2015
US Public Health Service - Deployment December 2014 - February 2015
US Public Health Service - Detail DHS December 2011 - February 2013
U.S. Department of Health and Human Services August 2007 - November 2011
US Department of Health and Human Services June 2006 - August 2007
U.S. Department of Health and Human Services June 2005 - June 2006
National Institutes of Health February 1994 - February 2005
FDA 1987 - 1994
Centers for Disease Control and Prevention 1985 - 1987
Skills
Epidemic Intelligence..., Diplomat American..., Veterinary..., Public Health, Science, Government, Policy, Program Management, National Security, Data Analysis, Research, Security Clearance, Infectious Diseases, Epidemiology, Global Health, Grants
Education
University of California, Berkeley
Master of Public Health (M.P.H.)
University of California, San Diego
Bachelor of Arts (B.A.), Microbiology, General
University of Florida College of Veterinary Medicine
Doctor of Veterinary Medicine (D.V.M.)
Hua Peng Hua Peng's FDA Experience June 2015 - August 2015
Job Ph.D Candidate at University of California, Riverside
Industry
Experience
University of California, Riverside January 2014 - Present
FDA June 2015 - August 2015
University of California, Riverside July 2014 - August 2014
Education
University of California, Riverside 2013 — 2017
Doctor of Philosophy (PhD), Statistics
University of California, Riverside 2011 — 2013
Master's degree, Statistics
University of California, Riverside January 2014 - Present
FDA June 2015 - August 2015
University of California, Riverside July 2014 - August 2014
Education
University of California, Riverside 2013 — 2017
Doctor of Philosophy (PhD), Statistics
University of California, Riverside 2011 — 2013
Master's degree, Statistics
Shanaz (Tata) Read Shanaz (Tata) Read's FDA Experience January 2015 - Present
Job Policy Reviewer at FDA
Industry Government Administration
Experience
FDA January 2015 - Present
FDA July 2003 - December 2014
Actavis May 1998 - July 2003
Mylan April 1995 - August 1997
Lederle Laboratories June 1991 - August 1991
Skills
Regulatory Affairs, Research, Chemistry, Pharmaceutical Industry, FDA, Public Health, Formulation, GMP, GLP, Analytical Chemistry, HPLC, Drug Development
Education
University of Michigan 1990 — 1995
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
University of Toledo 1988 — 1990
Master of Science (MS), Industrial Pharmacy
University Of Bombay 1984 — 1988
Bachelor of Pharmacy (B.Pharm.), Pharmacy
FDA January 2015 - Present
FDA July 2003 - December 2014
Actavis May 1998 - July 2003
Mylan April 1995 - August 1997
Lederle Laboratories June 1991 - August 1991
Skills
Regulatory Affairs, Research, Chemistry, Pharmaceutical Industry, FDA, Public Health, Formulation, GMP, GLP, Analytical Chemistry, HPLC, Drug Development
Education
University of Michigan 1990 — 1995
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
University of Toledo 1988 — 1990
Master of Science (MS), Industrial Pharmacy
University Of Bombay 1984 — 1988
Bachelor of Pharmacy (B.Pharm.), Pharmacy
Joseph Kotarek Joseph Kotarek's FDA Experience September 2012 - May 2015
Job President, Brand Management at Brand Institute
Industry Biotechnology
Experience
Brand Institute May 2015 - Present
FDA September 2012 - May 2015
NIST August 2010 - August 2012
Skills
Protein Aggregation, Protein Chemistry, Nanoparticles, Nanotechnology, Materials Science, IR spectroscopy, Scanning Electron..., Chemical Engineering, COMSOL, Chemistry, UV/Vis, Microscopy, Fluorescence Microscopy, AFM, Electrochemistry
Education
University of South Carolina-Columbia 2005 — 2010
Ph.D., Chemcial Engineering
University of Arkansas 2000 — 2004
B.S., Chemical Engineering
Brand Institute May 2015 - Present
FDA September 2012 - May 2015
NIST August 2010 - August 2012
Skills
Protein Aggregation, Protein Chemistry, Nanoparticles, Nanotechnology, Materials Science, IR spectroscopy, Scanning Electron..., Chemical Engineering, COMSOL, Chemistry, UV/Vis, Microscopy, Fluorescence Microscopy, AFM, Electrochemistry
Education
University of South Carolina-Columbia 2005 — 2010
Ph.D., Chemcial Engineering
University of Arkansas 2000 — 2004
B.S., Chemical Engineering
Athena Starlard-Davenport Athena Starlard-Davenport's FDA Experience October 2008 - September 2010
Job Molecular Biologist
Industry Research
Experience
University of Arkansas for Medical Sciences November 2011 - Present
Food and Drug Administration October 2010 - 2011
FDA October 2008 - September 2010
ORISE/FDA/National Center for Toxicological Research June 2007 - September 2008
UAMS August 2002 - May 2007
ULM January 2001 - July 2002
Skills
Western Blotting, qPCR, Assay Development, Clinical Research, Protein Chemistry, FDA, Tissue Culture, Cancer, DNA sequencing, Cell Culture, Biochemistry, PCR, Science, Molecular Biology, Immunology, DNA Sequencing
Education
University of Arkansas for Medical Sciences, College of Medicine 2002 — 2007
PhD, Biochemistry and Molecular Biology
University of Louisiana at Monroe 2001 — 2002
MS, Biology (emphasis in Microbiology)
University of Louisiana at Monroe 1996 — 2000
BS, Biology
University of Arkansas for Medical Sciences November 2011 - Present
Food and Drug Administration October 2010 - 2011
FDA October 2008 - September 2010
ORISE/FDA/National Center for Toxicological Research June 2007 - September 2008
UAMS August 2002 - May 2007
ULM January 2001 - July 2002
Skills
Western Blotting, qPCR, Assay Development, Clinical Research, Protein Chemistry, FDA, Tissue Culture, Cancer, DNA sequencing, Cell Culture, Biochemistry, PCR, Science, Molecular Biology, Immunology, DNA Sequencing
Education
University of Arkansas for Medical Sciences, College of Medicine 2002 — 2007
PhD, Biochemistry and Molecular Biology
University of Louisiana at Monroe 2001 — 2002
MS, Biology (emphasis in Microbiology)
University of Louisiana at Monroe 1996 — 2000
BS, Biology
Darby Kozak Darby Kozak's FDA Experience April 2015 - Present
Job Chemist
Industry Nanotechnology
Experience
FDA April 2015 - Present
Izon Science Ltd August 2012 - November 2014
University of Queensland April 2005 - August 2012
Nanomics Biosystems February 2008 - February 2010
Fred Hutchinson Cancer Research Center 2007 - 2008
Skills
Nanotechnology, Medical Diagnostics, NMR spectroscopy, Flow Cytometry, FTIR, Polymer Science, Immunoassays, Particle Size Analysis, Particle Physics, TRPS - Tunable..., XPS/ESCA (X-ray..., Physical Chemistry, NMR, Biotechnology, Science, Assay Development, Polymers, Nanoparticles, Chemistry, Characterization, Spectroscopy, R&D, Microscopy, Life Sciences, Materials Science
Education
University of Bristol 2001 — 2005
Doctor of Philosophy (PhD), Physical Chemistry
University of Washington 1996 — 2001
Bachelor of Science (BSc), Chemical Engineering
FDA April 2015 - Present
Izon Science Ltd August 2012 - November 2014
University of Queensland April 2005 - August 2012
Nanomics Biosystems February 2008 - February 2010
Fred Hutchinson Cancer Research Center 2007 - 2008
Skills
Nanotechnology, Medical Diagnostics, NMR spectroscopy, Flow Cytometry, FTIR, Polymer Science, Immunoassays, Particle Size Analysis, Particle Physics, TRPS - Tunable..., XPS/ESCA (X-ray..., Physical Chemistry, NMR, Biotechnology, Science, Assay Development, Polymers, Nanoparticles, Chemistry, Characterization, Spectroscopy, R&D, Microscopy, Life Sciences, Materials Science
Education
University of Bristol 2001 — 2005
Doctor of Philosophy (PhD), Physical Chemistry
University of Washington 1996 — 2001
Bachelor of Science (BSc), Chemical Engineering
Maryam Shirmohamadali, Pharm.D. Maryam Shirmohamadali, Pharm.D.'s FDA Experience August 2012 - September 2012
Job Clinical Trial Manager at Gilead Sciences
Industry Biotechnology
Experience
Gilead Sciences March 2015 - Present
Novartis April 2014 - March 2015
Rutgers University July 2013 - March 2015
Novartis July 2013 - April 2014
Kaiser Permanente December 2011 - June 2013
FDA August 2012 - September 2012
CVS Caremark Corporation June 2010 - February 2012
Touro University August 2010 - May 2011
Roche October 2007 - July 2009
Stanford University Medical Center July 2005 - September 2007
Skills
PCR, Molecular Biology, Lifesciences, Cell Culture, Biotechnology, Western Blotting, Pharmacology, ELISA, Biochemistry, Clinical Trials, Infectious Diseases, DNA extraction, DNA sequencing, DNA, Aseptic Technique, Gel Electrophoresis, Clinical Research, Genetics, Microbiology, Cell Biology, LC-MS, Medication Therapy..., Pharmacists, Clinical Development, Pharmacy, Medicine, Managed Care, Medical Writing, Clinical Pharmacology, Oncology, Pharmacokinetics, Immunology, Life Sciences
Education
Touro University 2009 — 2013
PharmD, Doctor of pharmacy
University of California, Davis 2001 — 2005
B.S., Neurobiology, Physiology, and Behavior
Gilead Sciences March 2015 - Present
Novartis April 2014 - March 2015
Rutgers University July 2013 - March 2015
Novartis July 2013 - April 2014
Kaiser Permanente December 2011 - June 2013
FDA August 2012 - September 2012
CVS Caremark Corporation June 2010 - February 2012
Touro University August 2010 - May 2011
Roche October 2007 - July 2009
Stanford University Medical Center July 2005 - September 2007
Skills
PCR, Molecular Biology, Lifesciences, Cell Culture, Biotechnology, Western Blotting, Pharmacology, ELISA, Biochemistry, Clinical Trials, Infectious Diseases, DNA extraction, DNA sequencing, DNA, Aseptic Technique, Gel Electrophoresis, Clinical Research, Genetics, Microbiology, Cell Biology, LC-MS, Medication Therapy..., Pharmacists, Clinical Development, Pharmacy, Medicine, Managed Care, Medical Writing, Clinical Pharmacology, Oncology, Pharmacokinetics, Immunology, Life Sciences
Education
Touro University 2009 — 2013
PharmD, Doctor of pharmacy
University of California, Davis 2001 — 2005
B.S., Neurobiology, Physiology, and Behavior
Amanda Sugay Amanda Sugay's FDA Experience June 2014 - July 2014
Job PharmD | CRDP Associate | Genentech
Industry Pharmaceuticals
Experience
Genentech June 2015 - Present
UCSF March 2015 - June 2015
UCSF February 2015 - March 2015
UCSF Medical Center January 2015 - February 2015
Walgreens at UCSF November 2014 - December 2014
U.S. Department of Veterans Affairs October 2014 - November 2014
CVS Caremark Corporation February 2012 - November 2014
UCSF Medical Center August 2014 - September 2014
FDA June 2014 - July 2014
UCSF Medical Center May 2014 - June 2014
Skills
Pharmacists, Pharmacokinetics, Compounding, Community Pharmacy, Outcomes Research, Health Economics, Health Policy, Pharmacy, Medical Affairs, Clinical Development, Clinical Pharmacology, Diabetes, Clinical Trials, Clinical Research, Pharmacology
Education
University of California, San Francisco 2011 — 2015
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of California, Santa Cruz 2008 — 2009
Bachelor of Science (BS), Molecular, Cellular & Developmental Biology, summa cum laude
Genentech June 2015 - Present
UCSF March 2015 - June 2015
UCSF February 2015 - March 2015
UCSF Medical Center January 2015 - February 2015
Walgreens at UCSF November 2014 - December 2014
U.S. Department of Veterans Affairs October 2014 - November 2014
CVS Caremark Corporation February 2012 - November 2014
UCSF Medical Center August 2014 - September 2014
FDA June 2014 - July 2014
UCSF Medical Center May 2014 - June 2014
Skills
Pharmacists, Pharmacokinetics, Compounding, Community Pharmacy, Outcomes Research, Health Economics, Health Policy, Pharmacy, Medical Affairs, Clinical Development, Clinical Pharmacology, Diabetes, Clinical Trials, Clinical Research, Pharmacology
Education
University of California, San Francisco 2011 — 2015
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of California, Santa Cruz 2008 — 2009
Bachelor of Science (BS), Molecular, Cellular & Developmental Biology, summa cum laude
Jonathan Jazayeri Jonathan Jazayeri's FDA Experience March 2011 - May 2011
Job Regulatory Affairs Director at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca June 2014 - Present
Vertex Pharmaceuticals October 2012 - June 2014
MedImmune July 2011 - October 2012
FDA March 2011 - May 2011
University of Southern California School of Pharmacy March 2008 - May 2011
Amgen May 2010 - August 2010
GeiserPharma June 2009 - August 2009
Skills
Clinical Research, Oncology, Regulatory Affairs, Clinical Trials, FDA, Pharmacology, Pharmaceutical Industry, Biotechnology, Lifesciences, Cell Culture, Clinical Development, Immunology, Cancer, Pharmacokinetics, Medical Writing, Pharmacists, Diabetes, Validation, Managed Care, In Vitro, IND, Clinical Pharmacology, Pharmacy
Education
University of Southern California 2007 — 2011
Doctorate, Pharmacy
University of Southern California School of Pharmacy 2007 — 2011
Masters of Science, Regulatory Science
University of California, Santa Barbara 2003 — 2007
Bachelor of Science, Pharmacology
AstraZeneca June 2014 - Present
Vertex Pharmaceuticals October 2012 - June 2014
MedImmune July 2011 - October 2012
FDA March 2011 - May 2011
University of Southern California School of Pharmacy March 2008 - May 2011
Amgen May 2010 - August 2010
GeiserPharma June 2009 - August 2009
Skills
Clinical Research, Oncology, Regulatory Affairs, Clinical Trials, FDA, Pharmacology, Pharmaceutical Industry, Biotechnology, Lifesciences, Cell Culture, Clinical Development, Immunology, Cancer, Pharmacokinetics, Medical Writing, Pharmacists, Diabetes, Validation, Managed Care, In Vitro, IND, Clinical Pharmacology, Pharmacy
Education
University of Southern California 2007 — 2011
Doctorate, Pharmacy
University of Southern California School of Pharmacy 2007 — 2011
Masters of Science, Regulatory Science
University of California, Santa Barbara 2003 — 2007
Bachelor of Science, Pharmacology
Alexandra Lynn Alexandra Lynn's FDA Experience July 2013 - Present
Job Toxicology Research Fellow at FDA
Industry Government Administration
Experience
FDA July 2013 - Present
Skills
Toxicology, Biology, Research, Microsoft Office, Government, Policy, Data Analysis, R, Matlab, Applied Mathematics
Education
University of California, Berkeley 2009 — 2013
Bachelor's Degree, Applied Mathematics
FDA July 2013 - Present
Skills
Toxicology, Biology, Research, Microsoft Office, Government, Policy, Data Analysis, R, Matlab, Applied Mathematics
Education
University of California, Berkeley 2009 — 2013
Bachelor's Degree, Applied Mathematics
Ryan Owen Ryan Owen's FDA Experience June 2008 - Present
Job Senior Scientist in Clinical Pharmacology at Genentech
Industry Government Administration
Experience
Genentech July 2015 - Present
FDA June 2008 - Present
Stanford University October 2006 - May 2008
Education
University of California, San Francisco 2000 — 2006
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences and Pharmacogenomics
University of Michigan 1996 — 2000
Bachelor of Science (B.S.), Biochemistry
Genentech July 2015 - Present
FDA June 2008 - Present
Stanford University October 2006 - May 2008
Education
University of California, San Francisco 2000 — 2006
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences and Pharmacogenomics
University of Michigan 1996 — 2000
Bachelor of Science (B.S.), Biochemistry
Liliana Yu Liliana Yu's FDA Experience May 2009 - January 2011
Job Google For Work, Deal Operations
Industry Internet
Experience
Google May 2012 - Present
Google June 2011 - May 2012
Work4 Labs January 2011 - May 2011
FDA May 2009 - January 2011
Skills
Adobe Creative Suite, Excel, SAS, JMP, Flash Animation, Microsoft Excel, Enterprise Software, Social Media, Microsoft Word, Microsoft Office, Data Analysis
Education
University of California, Berkeley 2007 — 2011
B.A, Economics
Google May 2012 - Present
Google June 2011 - May 2012
Work4 Labs January 2011 - May 2011
FDA May 2009 - January 2011
Skills
Adobe Creative Suite, Excel, SAS, JMP, Flash Animation, Microsoft Excel, Enterprise Software, Social Media, Microsoft Word, Microsoft Office, Data Analysis
Education
University of California, Berkeley 2007 — 2011
B.A, Economics
Lisa Pence Lisa Pence's FDA Experience September 2007 - October 2008
Job Research Chemist at National Center for Toxicological Research
Industry Research
Experience
National Center for Toxicological Research October 2008 - Present
FDA September 2007 - October 2008
FDA October 2001 - September 2007
Skills
Counterterrorism, Forensic Analysis, Mass Spectrometry, Laboratory, Biomarker Discovery, Spectroscopy, FDA, Biomarkers, Metabolomics, LC-MS, Analytical Chemistry, Chromatography, Protein Chemistry, Purification, UV/Vis, Chemistry
Education
University of Oklahoma College of Medicine 1998 — 2001
Post-doctroal fellowship, Infectious Disease Residency Program
University of Arkansas at Fayetteville 1992 — 1998
Doctor of Philosophy (Ph.D.), Theoretical Chemistry
University of Oklahoma 1987 — 1992
Bachelor of Science (B.S.), Chemistry
National Center for Toxicological Research October 2008 - Present
FDA September 2007 - October 2008
FDA October 2001 - September 2007
Skills
Counterterrorism, Forensic Analysis, Mass Spectrometry, Laboratory, Biomarker Discovery, Spectroscopy, FDA, Biomarkers, Metabolomics, LC-MS, Analytical Chemistry, Chromatography, Protein Chemistry, Purification, UV/Vis, Chemistry
Education
University of Oklahoma College of Medicine 1998 — 2001
Post-doctroal fellowship, Infectious Disease Residency Program
University of Arkansas at Fayetteville 1992 — 1998
Doctor of Philosophy (Ph.D.), Theoretical Chemistry
University of Oklahoma 1987 — 1992
Bachelor of Science (B.S.), Chemistry
Gregory Crimmins Gregory Crimmins's FDA Experience November 2012 - Present
Job CEO, Scientist at Remedy Plan
Industry Biotechnology
Experience
Remedy Plan July 2013 - Present
FDA November 2012 - Present
Tufts University February 2009 - November 2012
Skills
Entrepreneurship, Early-stage Startups, Lean Startup, Corporate Finance, Project Management, Elevator Pitch, Molecular Cloning, Molecular Biology, Cell Biology, Fluorescence Microscopy, Tissue Culture, Microbiology, Public Speaking, Next generation DNA..., Grant Writing, College Teaching
Education
University of California, Berkeley 2003 — 2008
Ph.D., Molecular and Cell Biology
University of Illinois at Urbana-Champaign 1998 — 2002
B.S., Cell and Structural Biology
Remedy Plan July 2013 - Present
FDA November 2012 - Present
Tufts University February 2009 - November 2012
Skills
Entrepreneurship, Early-stage Startups, Lean Startup, Corporate Finance, Project Management, Elevator Pitch, Molecular Cloning, Molecular Biology, Cell Biology, Fluorescence Microscopy, Tissue Culture, Microbiology, Public Speaking, Next generation DNA..., Grant Writing, College Teaching
Education
University of California, Berkeley 2003 — 2008
Ph.D., Molecular and Cell Biology
University of Illinois at Urbana-Champaign 1998 — 2002
B.S., Cell and Structural Biology
Dale Rimmer Dale Rimmer's FDA Experience July 2014 - Present
Job FDA Chemist
Industry Medical Devices
Experience
FDA July 2014 - Present
FDA November 2012 - July 2014
Brookhaven National Laboratory March 2010 - November 2012
UC Santa Barbara August 2004 - March 2010
UC Santa Barbara January 2005 - August 2007
University of Arkansas at Little Rock January 2002 - May 2004
Skills
UV-Vis, FTIR, Photochemistry, Time-Resolved..., Mass Spectrometry, Ionic Liquids, Pulse Radiolysis, Optics, Igor, Experienced in quickly..., UV/Vis, NMR, Inorganic Chemistry, Data Analysis, HPLC, Science, Characterization, Spectroscopy
Education
UC Santa Barbara 2004 — 2009
PhD, Physical-Inorganic Photochemistry
University of Arkansas at Little Rock 2000 — 2004
BS, Chemistry
FDA July 2014 - Present
FDA November 2012 - July 2014
Brookhaven National Laboratory March 2010 - November 2012
UC Santa Barbara August 2004 - March 2010
UC Santa Barbara January 2005 - August 2007
University of Arkansas at Little Rock January 2002 - May 2004
Skills
UV-Vis, FTIR, Photochemistry, Time-Resolved..., Mass Spectrometry, Ionic Liquids, Pulse Radiolysis, Optics, Igor, Experienced in quickly..., UV/Vis, NMR, Inorganic Chemistry, Data Analysis, HPLC, Science, Characterization, Spectroscopy
Education
UC Santa Barbara 2004 — 2009
PhD, Physical-Inorganic Photochemistry
University of Arkansas at Little Rock 2000 — 2004
BS, Chemistry
Jerry Cott Jerry Cott's FDA Experience January 2003 - Present
Job Senior Pharmacologist at FDA
Industry Government Administration
Experience
FDA January 2003 - Present
NIMH 1991 - 2000
Skills
Pharmacology, Clinical Research, Toxicology, Clinical Trials, Treatment, Pharmacokinetics, Drug Development, Nutrition, Herbal Remedies, Natural Products, Psychopharmacology, Drug Discovery, Neuropharmacology, Psychiatry, Research, Clinical Development, Prevention, Neuroscience, Mental Health, Clinical Pharmacology, In Vivo, Medicinal Chemistry, Strategic Planning
Education
University of North Carolina at Chapel Hill 1970 — 1975
Ph.D, Pharmacology, Neuroscience
University of Central Oklahoma 1965 — 1969
B.S., Biology & Chemistry
FDA January 2003 - Present
NIMH 1991 - 2000
Skills
Pharmacology, Clinical Research, Toxicology, Clinical Trials, Treatment, Pharmacokinetics, Drug Development, Nutrition, Herbal Remedies, Natural Products, Psychopharmacology, Drug Discovery, Neuropharmacology, Psychiatry, Research, Clinical Development, Prevention, Neuroscience, Mental Health, Clinical Pharmacology, In Vivo, Medicinal Chemistry, Strategic Planning
Education
University of North Carolina at Chapel Hill 1970 — 1975
Ph.D, Pharmacology, Neuroscience
University of Central Oklahoma 1965 — 1969
B.S., Biology & Chemistry
Satjit Brar Satjit Brar's FDA Experience July 2013 - March 2015
Job Associate Director, Clinical Pharmacology, Immunooncology
Industry Research
Experience
Pfizer March 2015 - Present
FDA July 2013 - March 2015
FDA May 2011 - July 2013
FDA December 2008 - May 2011
Virginia Commonwealth University May 2008 - December 2008
Skills
Pharmacodynamics, Pharmacokinetics, Clinical Pharmacology, Biomarkers, Clinical Trials, Pharmacology, Clinical Research, Clinical Development, ADME, Drug Development, Clinical Study Design, Regulatory Affairs, Translational Research, Translational Medicine, Drug Discovery, Animal Models, Toxicology, Drug Metabolism, Neuroscience, Biotechnology, Science
Education
Virginia Commonwealth University 2000 — 2008
Ph.D., Pharmacokinetics/Pharmacodynamics
Virginia Commonwealth University 2000 — 2008
Pharm.D., Pharmacy
University of California, Santa Barbara 1995 — 1998
Pfizer March 2015 - Present
FDA July 2013 - March 2015
FDA May 2011 - July 2013
FDA December 2008 - May 2011
Virginia Commonwealth University May 2008 - December 2008
Skills
Pharmacodynamics, Pharmacokinetics, Clinical Pharmacology, Biomarkers, Clinical Trials, Pharmacology, Clinical Research, Clinical Development, ADME, Drug Development, Clinical Study Design, Regulatory Affairs, Translational Research, Translational Medicine, Drug Discovery, Animal Models, Toxicology, Drug Metabolism, Neuroscience, Biotechnology, Science
Education
Virginia Commonwealth University 2000 — 2008
Ph.D., Pharmacokinetics/Pharmacodynamics
Virginia Commonwealth University 2000 — 2008
Pharm.D., Pharmacy
University of California, Santa Barbara 1995 — 1998
Lea Patrice McDaniel Lea Patrice McDaniel's FDA Experience January 1991 - Present
Job Biologist at FDA
Industry Government Administration
Experience
FDA January 1991 - Present
Skills
Regulatory Science, Public Health, Scientific Writing, Project Management, Code of Federal..., FDA Regulations, Budgets, Protocol Design, Proofreading & editing, GLP, GCPs, GMPs, Tobacco Research, Regulatory Genetic..., WHO Regulatory..., ICH guidelines, Biotechnology, Drug Discovery, Biochemistry, Chemistry, IACUC, in Vitro Toxicology, Federal Budget..., Government Contracting, Government Procurement, Property Management, Cell, In Vivo, Global Drug Development, Clinical Research, Clinical Trials, Biologics, Medical Devices, Pharmacovigilance, FDA, GMP, Research, Assay Development
Education
University of Maryland School of Pharmacy 2014 — 2016
Master of Science (MS), Regulatory Science, 4.0
University of Arkansas for Medical Sciences 2013 — 2014
graduate certificate, regulatory science
University of Arkansas at Little Rock 1990 — 1994
Bachelor's Degree, Psychology, Biology, General Business
FDA January 1991 - Present
Skills
Regulatory Science, Public Health, Scientific Writing, Project Management, Code of Federal..., FDA Regulations, Budgets, Protocol Design, Proofreading & editing, GLP, GCPs, GMPs, Tobacco Research, Regulatory Genetic..., WHO Regulatory..., ICH guidelines, Biotechnology, Drug Discovery, Biochemistry, Chemistry, IACUC, in Vitro Toxicology, Federal Budget..., Government Contracting, Government Procurement, Property Management, Cell, In Vivo, Global Drug Development, Clinical Research, Clinical Trials, Biologics, Medical Devices, Pharmacovigilance, FDA, GMP, Research, Assay Development
Education
University of Maryland School of Pharmacy 2014 — 2016
Master of Science (MS), Regulatory Science, 4.0
University of Arkansas for Medical Sciences 2013 — 2014
graduate certificate, regulatory science
University of Arkansas at Little Rock 1990 — 1994
Bachelor's Degree, Psychology, Biology, General Business
Kellie Gelles Ward, PharmD MS Kellie Gelles Ward, PharmD MS's FDA Experience September 2007 - November 2007
Job Manager, Medical Science Liaisons at BTG
Industry Pharmaceuticals
Experience
BTG April 2015 - Present
BTG June 2014 - April 2015
AstraZeneca August 2013 - June 2014
Medtronic Vascular May 2010 - June 2013
Palm Drive Hospital November 2008 - March 2012
Direct Flow Medical Inc July 2008 - March 2010
University of Southern California June 2006 - June 2008
FDA September 2007 - November 2007
Kythera Biopharmaceuticals May 2007 - August 2007
Kaiser Permanente November 2004 - June 2006
Skills
Medical Writing, R&D, Clinical Trials, Medical Devices, Regulatory Submissions, Biotechnology, Clinical Research, Medical Affairs, Cardiology, Renal Denervation, Public Speaking, Dermatology, Vascular, Interventional..., Aesthetics, TAVR, Product Development, Salesforce Training, Physician Relations, KOL development, Neurology, Clinical Development, Medicine, Hypertension, Oncology, Regulatory Affairs, Clinical Study Design
Education
University of California, Berkeley
BS, Toxicology
University of Southern California
PharmD, MS Regulatory Science
BTG April 2015 - Present
BTG June 2014 - April 2015
AstraZeneca August 2013 - June 2014
Medtronic Vascular May 2010 - June 2013
Palm Drive Hospital November 2008 - March 2012
Direct Flow Medical Inc July 2008 - March 2010
University of Southern California June 2006 - June 2008
FDA September 2007 - November 2007
Kythera Biopharmaceuticals May 2007 - August 2007
Kaiser Permanente November 2004 - June 2006
Skills
Medical Writing, R&D, Clinical Trials, Medical Devices, Regulatory Submissions, Biotechnology, Clinical Research, Medical Affairs, Cardiology, Renal Denervation, Public Speaking, Dermatology, Vascular, Interventional..., Aesthetics, TAVR, Product Development, Salesforce Training, Physician Relations, KOL development, Neurology, Clinical Development, Medicine, Hypertension, Oncology, Regulatory Affairs, Clinical Study Design
Education
University of California, Berkeley
BS, Toxicology
University of Southern California
PharmD, MS Regulatory Science
Kris Roth Kris Roth's FDA Experience September 2011 - Present
Job Chemist FDA/CDRH
Industry Biotechnology
Experience
FDA September 2011 - Present
Meso Scale Discovery March 2008 - September 2011
CombiMatrix Corp. February 2005 - February 2008
Universtiy of California Santa Barbara January 2003 - February 2005
University of California Riverside August 1997 - December 2002
Kimberly-Clark 1996 - 1996
Skills
Immunoassays, Molecular Biology, Lifesciences, Biotechnology, Laboratory, Genomics, FDA, Immunology, Microbiology, Assay Development, Medical Devices, Materials Science, Vaccines, Validation, Biochemistry, PCR, Cell Culture, Genetics, R&D, Proteomics, Infectious Diseases, Technology Transfer, Purification, Protein Chemistry, Life Sciences
Education
University of California, Riverside 1997 — 2002
Ph.D., Analytical Chemistry
University of Minnesota 1993 — 1997
BA, Chemistry
FDA September 2011 - Present
Meso Scale Discovery March 2008 - September 2011
CombiMatrix Corp. February 2005 - February 2008
Universtiy of California Santa Barbara January 2003 - February 2005
University of California Riverside August 1997 - December 2002
Kimberly-Clark 1996 - 1996
Skills
Immunoassays, Molecular Biology, Lifesciences, Biotechnology, Laboratory, Genomics, FDA, Immunology, Microbiology, Assay Development, Medical Devices, Materials Science, Vaccines, Validation, Biochemistry, PCR, Cell Culture, Genetics, R&D, Proteomics, Infectious Diseases, Technology Transfer, Purification, Protein Chemistry, Life Sciences
Education
University of California, Riverside 1997 — 2002
Ph.D., Analytical Chemistry
University of Minnesota 1993 — 1997
BA, Chemistry
Eveline Arnold Eveline Arnold's FDA Experience December 2014 - Present
Job Staff Fellow at FDA
Industry Biotechnology
Experience
FDA December 2014 - Present
National Institutes of Health February 2013 - December 2014
UC San Diego 2006 - 2012
UC San Diego January 2007 - March 2007
University of Pennsylvania 2004 - 2006
University of Pennsylvania September 2005 - December 2005
Skills
Fluorescence Microscopy, Confocal Microscopy, Histology, Dissection, Animal Behavior, Animal Models, Molecular Biology, Molecular Cloning, Data Analysis, Life Sciences, Microsoft Office, GraphPad Prism, Adobe Creative Suite, HTML, Research, Teaching Experience, Immunofluorescence, Biochemistry, Lifesciences, Translational Research
Education
University of California, San Diego 2006 — 2011
Ph.D., Biomedical Sciences
University of Pennsylvania 2002 — 2006
B.A., Biology
FDA December 2014 - Present
National Institutes of Health February 2013 - December 2014
UC San Diego 2006 - 2012
UC San Diego January 2007 - March 2007
University of Pennsylvania 2004 - 2006
University of Pennsylvania September 2005 - December 2005
Skills
Fluorescence Microscopy, Confocal Microscopy, Histology, Dissection, Animal Behavior, Animal Models, Molecular Biology, Molecular Cloning, Data Analysis, Life Sciences, Microsoft Office, GraphPad Prism, Adobe Creative Suite, HTML, Research, Teaching Experience, Immunofluorescence, Biochemistry, Lifesciences, Translational Research
Education
University of California, San Diego 2006 — 2011
Ph.D., Biomedical Sciences
University of Pennsylvania 2002 — 2006
B.A., Biology
Sudi Jawahery's FDA Experience May 2013 - July 2014
Job Graduate Student at UC Berkeley
Industry Research
Experience
FDA May 2013 - July 2014
Matysiak Lab April 2011 - July 2014
Department of Chemical and Biomolecular Engineering August 2013 - May 2014
Skills
Matlab, Unix Shell Scripting, Linux, High Performance..., Technical Writing, Data Analysis, GROMACS, VMD, Python, Data Presentation, LAMMPS, Violin
Education
University of California, Berkeley 2014 — 2019
Doctor of Philosophy (Ph.D.), Chemical and Biomolecular Engineering
University of Maryland College Park 2010 — 2014
B.S., Chemical and Biomolecular Engineering
FDA May 2013 - July 2014
Matysiak Lab April 2011 - July 2014
Department of Chemical and Biomolecular Engineering August 2013 - May 2014
Skills
Matlab, Unix Shell Scripting, Linux, High Performance..., Technical Writing, Data Analysis, GROMACS, VMD, Python, Data Presentation, LAMMPS, Violin
Education
University of California, Berkeley 2014 — 2019
Doctor of Philosophy (Ph.D.), Chemical and Biomolecular Engineering
University of Maryland College Park 2010 — 2014
B.S., Chemical and Biomolecular Engineering
Richard (Rick) Farnsworth PhD, PMP Richard (Rick) Farnsworth PhD, PMP's FDA Experience 1999 - 2000
Job International Program Manager, Battelle
Industry Research
Experience
Battelle Memorial Institute October 2004 - Present
US Army (Reserve) February 1984 - Present
ATCC October 2001 - September 2004
Anthologies December 2003 - July 2004
FDA 1999 - 2000
Baylor College of Medicine April 1997 - April 1999
Skills
Aviation, Defence Sector, Research, Program Management, Leadership, Molecular Biology, Lifesciences, Science, Cell Culture, Biochemistry, Biotechnology, Command, Strategy, Data Analysis, Military, Proposal Writing, Public Health, Government
Education
US Army War College 2010 — 2011
MS, Strategy
University of California, Santa Cruz 1993 — 1997
Ph.D., Biology (MCD)
UC Davis 1989 — 1992
BS, Zoology
Battelle Memorial Institute October 2004 - Present
US Army (Reserve) February 1984 - Present
ATCC October 2001 - September 2004
Anthologies December 2003 - July 2004
FDA 1999 - 2000
Baylor College of Medicine April 1997 - April 1999
Skills
Aviation, Defence Sector, Research, Program Management, Leadership, Molecular Biology, Lifesciences, Science, Cell Culture, Biochemistry, Biotechnology, Command, Strategy, Data Analysis, Military, Proposal Writing, Public Health, Government
Education
US Army War College 2010 — 2011
MS, Strategy
University of California, Santa Cruz 1993 — 1997
Ph.D., Biology (MCD)
UC Davis 1989 — 1992
BS, Zoology
Raul Alicea's FDA Experience December 2013 - June 2014
Job Software Engineer at AVT Simulation
Industry Computer Hardware
Experience
AVT Simulation August 2014 - Present
FDA December 2013 - June 2014
NAVAIR December 2012 - November 2013
U.S. Southern Command March 2011 - December 2012
US Army Electronic Proving Ground September 2009 - October 2011
Freescale September 2006 - September 2009
Digital Infrared Imaging December 2005 - August 2006
Applied Research Associates April 2004 - December 2005
Avici Systems January 2000 - September 2002
Agere (formerly Lucent) January 1998 - December 1999
Skills
Perl, Vera, Embedded Systems, Labview, PIC, Debugging, FPGA, ASIC, Verilog, Firmware, VHDL, Xilinx, Digital Signal..., Embedded Software, SoC, Testing, Systems Engineering
Education
University of Central Florida
BSEE
AVT Simulation August 2014 - Present
FDA December 2013 - June 2014
NAVAIR December 2012 - November 2013
U.S. Southern Command March 2011 - December 2012
US Army Electronic Proving Ground September 2009 - October 2011
Freescale September 2006 - September 2009
Digital Infrared Imaging December 2005 - August 2006
Applied Research Associates April 2004 - December 2005
Avici Systems January 2000 - September 2002
Agere (formerly Lucent) January 1998 - December 1999
Skills
Perl, Vera, Embedded Systems, Labview, PIC, Debugging, FPGA, ASIC, Verilog, Firmware, VHDL, Xilinx, Digital Signal..., Embedded Software, SoC, Testing, Systems Engineering
Education
University of Central Florida
BSEE
Keroline Simmonds's FDA Experience July 1998 - Present
Job Food Chemistry Director at FDA
Industry Food & Beverages
Experience
FDA July 1998 - Present
Skills
Community Outreach, GMP, FDA, GLP, Federal Government, Quality Assurance, Engaging Public Speaker, Published Author, Strategic Planning, Strategic Leadership, Scientific Management, Problem Solving, Social Networking, Security, Leadership, Laboratory, Fundraising, Teaching
Education
University of California, Santa Cruz 1979 — 1984
FDA July 1998 - Present
Skills
Community Outreach, GMP, FDA, GLP, Federal Government, Quality Assurance, Engaging Public Speaker, Published Author, Strategic Planning, Strategic Leadership, Scientific Management, Problem Solving, Social Networking, Security, Leadership, Laboratory, Fundraising, Teaching
Education
University of California, Santa Cruz 1979 — 1984
Michael Hamrell's FDA Experience January 1985 - June 1990
Job President, MORIAH Consultants
Industry Pharmaceuticals
Experience
MORIAH Consultants 1994 - Present
The Center for Professional Innovation & Education (CfPIE) January 2004 - Present
Vestar January 1993 - December 1993
NIH - Division of AIDS June 1990 - December 1992
FDA January 1985 - June 1990
Anaquest 1982 - 1985
Skills
Regulatory Affairs, Pharmaceutical Industry, Clinical Trials, Clinical Development, FDA, GCP, Biotechnology, Regulatory Submissions, Clinical Research, CRO, CTMS, Lifesciences, Drug Development, Medical Devices, Oncology, Medical Writing, Sop, GMP, GLP, Biopharmaceuticals
Education
University of Southern California 1973 — 1977
Ph.D., Pharmacology
University of California, Los Angeles 1969 — 1973
B.S., Biochemistry
MORIAH Consultants 1994 - Present
The Center for Professional Innovation & Education (CfPIE) January 2004 - Present
Vestar January 1993 - December 1993
NIH - Division of AIDS June 1990 - December 1992
FDA January 1985 - June 1990
Anaquest 1982 - 1985
Skills
Regulatory Affairs, Pharmaceutical Industry, Clinical Trials, Clinical Development, FDA, GCP, Biotechnology, Regulatory Submissions, Clinical Research, CRO, CTMS, Lifesciences, Drug Development, Medical Devices, Oncology, Medical Writing, Sop, GMP, GLP, Biopharmaceuticals
Education
University of Southern California 1973 — 1977
Ph.D., Pharmacology
University of California, Los Angeles 1969 — 1973
B.S., Biochemistry
Bronwen Blass's FDA Experience November 2014 - Present
Job Deputy Chief of Staff at FDA
Industry Law Practice
Experience
FDA November 2014 - Present
FDA March 2014 - November 2014
WilmerHale October 2004 - March 2014
Legal Counsel for the Elderly April 2008 - October 2008
Chambers of the Honorable Martha Craig Daughtrey, U.S. Court of Appeals for the Sixth Circuit August 2003 - August 2004
Wilmer Cutler Pickering May 2002 - August 2002
Law Center for Families May 2001 - November 2001
National Organization for Women May 1998 - August 1998
Skills
Commercial Litigation, Civil Litigation, Litigation, Legal Research, FCPA, Mediation, Public Policy, Legal Writing, Government
Education
University of California, Berkeley - School of Law 2000 — 2003
JD
Vanderbilt University 1996 — 2000
B.A., Political Science major with double minor in Women's Studies and French
Spruce Creek High School 1991 — 1996
FDA November 2014 - Present
FDA March 2014 - November 2014
WilmerHale October 2004 - March 2014
Legal Counsel for the Elderly April 2008 - October 2008
Chambers of the Honorable Martha Craig Daughtrey, U.S. Court of Appeals for the Sixth Circuit August 2003 - August 2004
Wilmer Cutler Pickering May 2002 - August 2002
Law Center for Families May 2001 - November 2001
National Organization for Women May 1998 - August 1998
Skills
Commercial Litigation, Civil Litigation, Litigation, Legal Research, FCPA, Mediation, Public Policy, Legal Writing, Government
Education
University of California, Berkeley - School of Law 2000 — 2003
JD
Vanderbilt University 1996 — 2000
B.A., Political Science major with double minor in Women's Studies and French
Spruce Creek High School 1991 — 1996
Jay H. Chang's FDA Experience March 2015 - Present
Job Pharmacology Toxicology Team Lead at FDA Center for Drug Evaluation and Research
Industry Pharmaceuticals
Experience
FDA March 2015 - Present
FDA, Center for Drug Evaluation and Research, Office of New Drugs May 2008 - March 2015
NIH, National Institute of Mental Health January 2005 - April 2008
NIH, National Cancer Institute June 1995 - August 1998
Skills
Toxicology, Clinical Development, Drug Development, FDA, Pharmacology, Molecular Biology, Pharmacokinetics, Immunology, Drug Discovery, Assay Development, Lifesciences, IND, In Vivo
Education
University of California, Los Angeles
Ph.D., Cellular and Molecular Pathology
FDA March 2015 - Present
FDA, Center for Drug Evaluation and Research, Office of New Drugs May 2008 - March 2015
NIH, National Institute of Mental Health January 2005 - April 2008
NIH, National Cancer Institute June 1995 - August 1998
Skills
Toxicology, Clinical Development, Drug Development, FDA, Pharmacology, Molecular Biology, Pharmacokinetics, Immunology, Drug Discovery, Assay Development, Lifesciences, IND, In Vivo
Education
University of California, Los Angeles
Ph.D., Cellular and Molecular Pathology
Michael Shultz's FDA Experience July 2007 - December 2007
Job Director of Scientific Research at Grace BioLabs
Industry Biotechnology
Experience
Grace Bio-Labs August 2010 - Present
Arcxis Biotechnologies November 2006 - August 2010
FDA July 2007 - December 2007
UC Davis January 2003 - June 2007
Molecular Dynamics / Amersham January 2000 - December 2002
Education
University of California, Davis 1994 — 2000
PhD, Pharmacology and Toxicology
Grace Bio-Labs August 2010 - Present
Arcxis Biotechnologies November 2006 - August 2010
FDA July 2007 - December 2007
UC Davis January 2003 - June 2007
Molecular Dynamics / Amersham January 2000 - December 2002
Education
University of California, Davis 1994 — 2000
PhD, Pharmacology and Toxicology
Erin Katzelnick-Wise's FDA Experience May 2015 - Present
Job FDA
Industry Government Administration
Experience
FDA May 2015 - Present
U.S. House of Representatives, Rep. Anna G. Eshoo January 2013 - May 2015
U.S. House of Representatives, Rep. Anna G. Eshoo June 2010 - December 2012
U.S. House of Representatives, Anna G. Eshoo February 2007 - June 2010
U.S. House of Representatives, Anna G. Eshoo June 2006 - February 2007
U.S. House of Representatives, Rep. Jane Harman February 2005 - June 2006
Skills
Legislative Relations, Legislative Research, Legislation, Public Policy, Politics, Policy Analysis, Political Campaigns, Appropriations, Constituent Services, Political Science, Grassroots Organizing, Legislative Affairs
Education
University of California, Santa Cruz 2000 — 2004
B.A., Politics
FDA May 2015 - Present
U.S. House of Representatives, Rep. Anna G. Eshoo January 2013 - May 2015
U.S. House of Representatives, Rep. Anna G. Eshoo June 2010 - December 2012
U.S. House of Representatives, Anna G. Eshoo February 2007 - June 2010
U.S. House of Representatives, Anna G. Eshoo June 2006 - February 2007
U.S. House of Representatives, Rep. Jane Harman February 2005 - June 2006
Skills
Legislative Relations, Legislative Research, Legislation, Public Policy, Politics, Policy Analysis, Political Campaigns, Appropriations, Constituent Services, Political Science, Grassroots Organizing, Legislative Affairs
Education
University of California, Santa Cruz 2000 — 2004
B.A., Politics
Deborah Livornese's FDA Experience June 2010 - Present
Job Senior Regulatory Counsel FDA
Industry Government Administration
Experience
FDA June 2010 - Present
Buc & Beardsley, LLP 2004 - 2010
Wendel, Rosen, Black & Dean LLP 1997 - 2003
Education
University of California, Hastings College of the Law 1981 — 1984
JD
SIA
FDA June 2010 - Present
Buc & Beardsley, LLP 2004 - 2010
Wendel, Rosen, Black & Dean LLP 1997 - 2003
Education
University of California, Hastings College of the Law 1981 — 1984
JD
SIA
Randolph Kline's FDA Experience May 2012 - Present
Job Policy Analyst at FDA Center for Tobacco Products
Industry Public Policy
Experience
FDA May 2012 - Present
Public Health Law & Policy September 2001 - December 2008
Education
University of California, Hastings College of the Law 1994 — 1997
JD
UC Berkeley 1988 — 1990
BS, Genetics
FDA May 2012 - Present
Public Health Law & Policy September 2001 - December 2008
Education
University of California, Hastings College of the Law 1994 — 1997
JD
UC Berkeley 1988 — 1990
BS, Genetics
Brian Rostron's FDA Experience 2014 - Present
Job Epidemiologist at FDA
Industry Research
Experience
FDA 2014 - Present
FDA 2010 - 2014
Centers for Disease Control 2008 - 2010
Skills
Biostatistics, Survey Methodology, SAS, Statistical Modeling, Stata, Statistics, Qualitative Research, R, Epidemiology, Multivariate Statistics, Data Collection, Data Analysis
Education
Osbourn Park
Osbourn Park
Osbourn Park
University of California, Berkeley 2003 — 2008
Doctor of Philosophy (Ph.D.), Demography
University of California, Berkeley 2004 — 2005
Master of Public Health (M.P.H.), Epidemiology
University of Virginia
University of Virginia
FDA 2014 - Present
FDA 2010 - 2014
Centers for Disease Control 2008 - 2010
Skills
Biostatistics, Survey Methodology, SAS, Statistical Modeling, Stata, Statistics, Qualitative Research, R, Epidemiology, Multivariate Statistics, Data Collection, Data Analysis
Education
Osbourn Park
Osbourn Park
Osbourn Park
University of California, Berkeley 2003 — 2008
Doctor of Philosophy (Ph.D.), Demography
University of California, Berkeley 2004 — 2005
Master of Public Health (M.P.H.), Epidemiology
University of Virginia
University of Virginia
Darren Fegley's FDA Experience March 2008 - Present
Job Pharmacologist at FDA
Industry Biotechnology
Experience
FDA March 2008 - Present
National Institute of Mental Health October 2005 - March 2008
University of California, Irvine September 2000 - September 2005
Education
University of California, Irvine - College of Medicine 2000 — 2005
FDA March 2008 - Present
National Institute of Mental Health October 2005 - March 2008
University of California, Irvine September 2000 - September 2005
Education
University of California, Irvine - College of Medicine 2000 — 2005
Lillian Huang's FDA Experience October 2009 - Present
Job Chemist at FDA San Francisco District
Industry Renewables & Environment
Experience
FDA October 2009 - Present
Nano-Tex June 2001 - December 2009
Curtis & Tompkins May 2007 - May 2008
Skills
Chromatography, Experimental Design, Water, Data Analysis, Polymers, Environmental Compliance, Materials Science, Spectroscopy, GC-MS, R, Chemistry, Technology Transfer, Organic Chemistry
Education
University of California, Davis
B.S., Environmental Toxicology
FDA October 2009 - Present
Nano-Tex June 2001 - December 2009
Curtis & Tompkins May 2007 - May 2008
Skills
Chromatography, Experimental Design, Water, Data Analysis, Polymers, Environmental Compliance, Materials Science, Spectroscopy, GC-MS, R, Chemistry, Technology Transfer, Organic Chemistry
Education
University of California, Davis
B.S., Environmental Toxicology
Brien Fox's FDA Experience 2002 - 2005
Job Manager I, Quality Fill/Finish at Baxter Bioscience
Industry Biotechnology
Experience
Baxalta August 2013 - Present
Gilead Sciences 2005 - 2013
FDA 2002 - 2005
ALZA Corporation 1998 - 2001
Skills
FDA, Aseptic Processing, CAPA, GMP, Process Improvement, Quality Assurance, Contract Manufacturing, 21 CFR Part 11, Manufacturing, GLP, R&D
Education
University of California, Los Angeles 1993 — 1998
Bachelor of Science (BS), Chemistry
Baxalta August 2013 - Present
Gilead Sciences 2005 - 2013
FDA 2002 - 2005
ALZA Corporation 1998 - 2001
Skills
FDA, Aseptic Processing, CAPA, GMP, Process Improvement, Quality Assurance, Contract Manufacturing, 21 CFR Part 11, Manufacturing, GLP, R&D
Education
University of California, Los Angeles 1993 — 1998
Bachelor of Science (BS), Chemistry
Norm Drezin's FDA Experience 1999 - 2000
Job Owner, Drezin Consultants, LLC
Industry Pharmaceuticals
Experience
Drezin Consultants, LLC August 2003 - Present
PharmaNet February 2000 - August 2003
PharmaNet 2000 - 2003
FDA/CDER/DDMAC November 1991 - February 2000
FDA 1999 - 2000
FTC Bureau of Competition 1978 - 1991
US Patent & Trademark Office 1969 - 1978
US Public Health Service July 1966 - July 1968
Skills
Clinical Development, Oncology, Medical Devices, Pharmaceutics, Cardiology, Clinical Trials, Biotechnology, Regulatory Affairs, CRO, Diabetes, Drug Development, Regulatory Submissions, FDA, Clinical Research, GCP, Sop, Technology Transfer
Education
University of Baltimore School of Law 1971 — 1974
JD, Law
Columbia University College of Pharmaceutical Sciences 1960 — 1966
BS Pharmacy, Pharmacy
Drezin Consultants, LLC August 2003 - Present
PharmaNet February 2000 - August 2003
PharmaNet 2000 - 2003
FDA/CDER/DDMAC November 1991 - February 2000
FDA 1999 - 2000
FTC Bureau of Competition 1978 - 1991
US Patent & Trademark Office 1969 - 1978
US Public Health Service July 1966 - July 1968
Skills
Clinical Development, Oncology, Medical Devices, Pharmaceutics, Cardiology, Clinical Trials, Biotechnology, Regulatory Affairs, CRO, Diabetes, Drug Development, Regulatory Submissions, FDA, Clinical Research, GCP, Sop, Technology Transfer
Education
University of Baltimore School of Law 1971 — 1974
JD, Law
Columbia University College of Pharmaceutical Sciences 1960 — 1966
BS Pharmacy, Pharmacy
Marcus Yambot's FDA Experience October 2008 - Present
Job Consumer Safety Officer at FDA
Industry Biotechnology
Experience
FDA October 2008 - Present
UCLA Bioengineering Department April 2006 - August 2008
Education
University of California, Los Angeles 2007 — 2008
MS, Biomedical Engineering
University of California, Los Angeles 2003 — 2007
BS
FDA October 2008 - Present
UCLA Bioengineering Department April 2006 - August 2008
Education
University of California, Los Angeles 2007 — 2008
MS, Biomedical Engineering
University of California, Los Angeles 2003 — 2007
BS
Ruben Ayala's FDA Experience August 2010 - Present
Job Pharmacologist, FDA
Industry Pharmaceuticals
Experience
FDA August 2010 - Present
Roche July 2008 - June 2010
Amgen June 2003 - June 2004
Sugen, Inc June 2002 - June 2003
UC Santa Barbara July 1999 - June 2001
Skills
Pharmacokinetics, Pharmacodynamics, Clinical Pharmacology, Bioanalysis, Pharmacology, Clinical Trials, Oncology, Pharmaceutical Industry, Drug Development, Clinical Development, Biotechnology, Infectious Diseases, Drug Discovery
Education
Western University of Health Sciences 2004 — 2008
PharmD, Pharmacy
University of California, Santa Barbara 1997 — 2001
BS, Pharmacology
FDA August 2010 - Present
Roche July 2008 - June 2010
Amgen June 2003 - June 2004
Sugen, Inc June 2002 - June 2003
UC Santa Barbara July 1999 - June 2001
Skills
Pharmacokinetics, Pharmacodynamics, Clinical Pharmacology, Bioanalysis, Pharmacology, Clinical Trials, Oncology, Pharmaceutical Industry, Drug Development, Clinical Development, Biotechnology, Infectious Diseases, Drug Discovery
Education
Western University of Health Sciences 2004 — 2008
PharmD, Pharmacy
University of California, Santa Barbara 1997 — 2001
BS, Pharmacology
Mike Goerger's FDA Experience April 2009 - November 2011
Job Chemist at USDAFSIS
Industry Research
Experience
USDA-FSIS November 2011 - Present
FDA April 2009 - November 2011
Hexion 2006 - 2008
Dynea 2001 - 2005
Dynea 1997 - 2001
Neste Resins Corporation 1991 - 2001
Skills
Research, Analysis, Manufacturing, Cross-functional Team..., Analytical Chemistry, R&D, HPLC, NMR, IR, Adhesives, FTIR, LC-MS, Resin, Mass Spectrometry, Organic Chemistry, GMP, UV/Vis, Validation, Organic Synthesis, Quality System, Gas Chromatography, Product Development
Education
University of Oregon 1979 — 1985
Ph.D., Chemistry
University of California, Berkeley 1977 — 1979
BS, Chemistry
USDA-FSIS November 2011 - Present
FDA April 2009 - November 2011
Hexion 2006 - 2008
Dynea 2001 - 2005
Dynea 1997 - 2001
Neste Resins Corporation 1991 - 2001
Skills
Research, Analysis, Manufacturing, Cross-functional Team..., Analytical Chemistry, R&D, HPLC, NMR, IR, Adhesives, FTIR, LC-MS, Resin, Mass Spectrometry, Organic Chemistry, GMP, UV/Vis, Validation, Organic Synthesis, Quality System, Gas Chromatography, Product Development
Education
University of Oregon 1979 — 1985
Ph.D., Chemistry
University of California, Berkeley 1977 — 1979
BS, Chemistry
Owen Fields's FDA Experience July 1991 - January 1995
Job Vice President Regulatory Strategy at Pfizer
Industry Pharmaceuticals
Experience
Pfizer February 1995 - Present
FDA July 1991 - January 1995
Skills
Biologics, Early Development, Biosimilars, Regulatory Affairs, Regulatory Science, Clinical Development, Pharmaceutical Industry, Biopharmaceuticals, Drug Development, Clinical Trials, IND, Biotechnology, Regulatory Strategy..., Medical Affairs, Oncology, Vaccines, Regulatory Submissions, Biotherapeutics, Therapeutic Areas, CRO, Translational Medicine, GCP, Medical Writing, Pharmacovigilance, CTMS, Infectious Diseases, Regulatory Requirements, Technology Transfer, Pharmacology, FDA
Education
University of California, Berkeley 1986 — 1991
Ph.D., Molecular Biology
Pfizer February 1995 - Present
FDA July 1991 - January 1995
Skills
Biologics, Early Development, Biosimilars, Regulatory Affairs, Regulatory Science, Clinical Development, Pharmaceutical Industry, Biopharmaceuticals, Drug Development, Clinical Trials, IND, Biotechnology, Regulatory Strategy..., Medical Affairs, Oncology, Vaccines, Regulatory Submissions, Biotherapeutics, Therapeutic Areas, CRO, Translational Medicine, GCP, Medical Writing, Pharmacovigilance, CTMS, Infectious Diseases, Regulatory Requirements, Technology Transfer, Pharmacology, FDA
Education
University of California, Berkeley 1986 — 1991
Ph.D., Molecular Biology
Laurie Brokowski's FDA Experience June 2006 - July 2006
Job Drug Information Clinical Pharmacist at Department of Veterans Affairs
Industry Pharmaceuticals
Experience
Department of Veterans Affairs July 2009 - Present
Walgreens Pharmacy November 2008 - June 2009
Purdue University July 2008 - June 2009
Eli Lilly July 2008 - June 2009
Clarian Health Partners July 2008 - June 2009
Sarasota Memorial Hospital July 2007 - June 2008
CVS Pharmacy May 2000 - June 2008
FDA June 2006 - July 2006
Education
University of Florida 2003 — 2007
PharmD, Pharmacy
University Of Central Florida 1997 — 2002
BS, Biology
Department of Veterans Affairs July 2009 - Present
Walgreens Pharmacy November 2008 - June 2009
Purdue University July 2008 - June 2009
Eli Lilly July 2008 - June 2009
Clarian Health Partners July 2008 - June 2009
Sarasota Memorial Hospital July 2007 - June 2008
CVS Pharmacy May 2000 - June 2008
FDA June 2006 - July 2006
Education
University of Florida 2003 — 2007
PharmD, Pharmacy
University Of Central Florida 1997 — 2002
BS, Biology
Jonathan Boress's FDA Experience September 2010 - September 2010
Job Pharmacy Supervisor, Nahatá Dziil Health Center LT, United States Public Health Service
Industry Hospital & Health Care
Experience
Nahatá Dziil Health Center - Fort Defiance Indian Hospital Board, Inc. July 2014 - Present
Commissioned Corps of the U.S. Public Health Service October 2012 - Present
Tséhootsooí Medical Center - Fort Defiance Indian Hospital Board, Inc. July 2012 - June 2014
Tséhootsooí Medical Center - Fort Defiance Indian Hospital Board, Inc. November 2011 - July 2012
Premier, Inc. November 2010 - May 2012
Medication Therapy Management Call Center, University of Florida College of Pharmacy October 2010 - December 2010
FDA September 2010 - September 2010
Premier, Inc. August 2010 - August 2010
Department of Pharmaceutical Outcomes and Policy, University of Florida College of Pharmacy July 2010 - July 2010
Pharmacotherapy Clinic - Internal Medicine at Shands Medical Plaza May 2010 - June 2010
Skills
Data Analysis, Pharmaceutical Industry, Pharmacy, Healthcare, Medication Therapy..., Pharmacists, Clinical Research, Diabetes, Hospitals, Informatics, Inpatient, Patient Counseling, Management
Education
University of Florida - Hough Graduate School of Business - Warrington College of Business 2008 — 2011
MBA, Entrepreneurship, General Management
University of Florida 2006 — 2011
Pharm.D, Doctor of Pharmacy
University of Central Florida 2003 — 2006
B.S., Molecular Biology & Microbiology
Nahatá Dziil Health Center - Fort Defiance Indian Hospital Board, Inc. July 2014 - Present
Commissioned Corps of the U.S. Public Health Service October 2012 - Present
Tséhootsooí Medical Center - Fort Defiance Indian Hospital Board, Inc. July 2012 - June 2014
Tséhootsooí Medical Center - Fort Defiance Indian Hospital Board, Inc. November 2011 - July 2012
Premier, Inc. November 2010 - May 2012
Medication Therapy Management Call Center, University of Florida College of Pharmacy October 2010 - December 2010
FDA September 2010 - September 2010
Premier, Inc. August 2010 - August 2010
Department of Pharmaceutical Outcomes and Policy, University of Florida College of Pharmacy July 2010 - July 2010
Pharmacotherapy Clinic - Internal Medicine at Shands Medical Plaza May 2010 - June 2010
Skills
Data Analysis, Pharmaceutical Industry, Pharmacy, Healthcare, Medication Therapy..., Pharmacists, Clinical Research, Diabetes, Hospitals, Informatics, Inpatient, Patient Counseling, Management
Education
University of Florida - Hough Graduate School of Business - Warrington College of Business 2008 — 2011
MBA, Entrepreneurship, General Management
University of Florida 2006 — 2011
Pharm.D, Doctor of Pharmacy
University of Central Florida 2003 — 2006
B.S., Molecular Biology & Microbiology
Jeffrey Kraft's FDA Experience October 2011 - Present
Job Clinical Pharmacology Reviewer, Genomics at FDA
Industry Pharmaceuticals
Experience
FDA October 2011 - Present
Abbott Laboratories June 2008 - February 2011
University of California, San Francisco 2002 - 2008
Skills
Molecular Biology, Biotechnology, Genetics, Biochemistry, Drug Discovery, Cell Biology, Genomics, Lifesciences, Western Blotting, Cell, Cell Culture
Education
University of California, San Francisco 2001 — 2008
FDA October 2011 - Present
Abbott Laboratories June 2008 - February 2011
University of California, San Francisco 2002 - 2008
Skills
Molecular Biology, Biotechnology, Genetics, Biochemistry, Drug Discovery, Cell Biology, Genomics, Lifesciences, Western Blotting, Cell, Cell Culture
Education
University of California, San Francisco 2001 — 2008
Vi Au's FDA Experience November 2013 - August 2015
Job Student
Industry Food & Beverages
Experience
FDA November 2013 - August 2015
FDA January 2011 - September 2013
North Pacific Seafoods - Sitka Sound Seafoods June 2008 - November 2009
Andersen Bakery (Grain D'or) March 2008 - June 2008
Education
Michigan State University 2013 — 2017
Master of Science (M.S.), Food Safety
University of California, Davis 2003 — 2007
Bachelor of Science (B.S.), Food Science
FDA November 2013 - August 2015
FDA January 2011 - September 2013
North Pacific Seafoods - Sitka Sound Seafoods June 2008 - November 2009
Andersen Bakery (Grain D'or) March 2008 - June 2008
Education
Michigan State University 2013 — 2017
Master of Science (M.S.), Food Safety
University of California, Davis 2003 — 2007
Bachelor of Science (B.S.), Food Science
John Feeney, M.D.'s FDA Experience September 2013 - Present
Job Clinical Team Leader, FDA
Industry Pharmaceuticals
Experience
FDA September 2013 - Present
Feeney Consulting LLC October 2012 - September 2013
Vanda Pharmaceuticals January 2009 - September 2012
FDA November 2006 - October 2007
FDA January 1992 - November 2006
National Naval Medical Center April 1993 - July 2005
Skills
Pharmaceutical Industry, Biotechnology, Drug Development, Clinical Trials, Clinical Research, Clinical Development, Due Diligence, Licensing, Neuroscience
Education
Georgetown Medical School
University of California, San Diego
FDA September 2013 - Present
Feeney Consulting LLC October 2012 - September 2013
Vanda Pharmaceuticals January 2009 - September 2012
FDA November 2006 - October 2007
FDA January 1992 - November 2006
National Naval Medical Center April 1993 - July 2005
Skills
Pharmaceutical Industry, Biotechnology, Drug Development, Clinical Trials, Clinical Research, Clinical Development, Due Diligence, Licensing, Neuroscience
Education
Georgetown Medical School
University of California, San Diego
Sarah Horowitz's FDA Experience October 2014 - Present
Job Congressional Affairs Specialist, FDA
Industry Legislative Office
Experience
FDA October 2014 - Present
FDA September 2011 - Present
Howard County Circuit Court September 2010 - August 2011
Maryland Attorney General, Maryland Department of the Environment May 2009 - August 2009
Andalman & Flynn June 2008 - August 2008
BBYO January 2006 - August 2007
Maryland Court of Special Appeals 2007 - 2007
United States House of Representatives September 2005 - December 2005
Hadassah Washington Action Office May 2005 - August 2005
Skills
Legal Research, Courts, Criminal Law, Appeals, Policy, Hearings, Research, Legislation, Legal Writing, Analysis, Litigation, Westlaw, Civil Litigation, Mediation, Public Policy, Legislative Relations, Health Law, Administrative Law, Policy Analysis, Trials, Lexis
Education
University of Baltimore School of Law 2007 — 2010
J.D., Law
University of Maryland College Park 2002 — 2005
B.A., Communication
FDA October 2014 - Present
FDA September 2011 - Present
Howard County Circuit Court September 2010 - August 2011
Maryland Attorney General, Maryland Department of the Environment May 2009 - August 2009
Andalman & Flynn June 2008 - August 2008
BBYO January 2006 - August 2007
Maryland Court of Special Appeals 2007 - 2007
United States House of Representatives September 2005 - December 2005
Hadassah Washington Action Office May 2005 - August 2005
Skills
Legal Research, Courts, Criminal Law, Appeals, Policy, Hearings, Research, Legislation, Legal Writing, Analysis, Litigation, Westlaw, Civil Litigation, Mediation, Public Policy, Legislative Relations, Health Law, Administrative Law, Policy Analysis, Trials, Lexis
Education
University of Baltimore School of Law 2007 — 2010
J.D., Law
University of Maryland College Park 2002 — 2005
B.A., Communication
Debra Ryan, Pharm.D., MBA's FDA Experience November 2008 - Present
Job Safety Evaluator at FDA
Industry Government Administration
Experience
FDA November 2008 - Present
Skills
Epidemiology, Strategic Planning, Leadership, Healthcare, Pharmacovigilance, Change Management, Project Management, Pharmaceutical Industry, Process Improvement, Business Analysis, Customer Service, Business Development, Marketing, Program Management, Business Strategy, Research, Management, Quality Assurance
Education
University of California, Irvine - The Paul Merage School of Business
MBA, Health Care Administration
University of California, San Francisco
Pharm.D., Pharmacy
FDA November 2008 - Present
Skills
Epidemiology, Strategic Planning, Leadership, Healthcare, Pharmacovigilance, Change Management, Project Management, Pharmaceutical Industry, Process Improvement, Business Analysis, Customer Service, Business Development, Marketing, Program Management, Business Strategy, Research, Management, Quality Assurance
Education
University of California, Irvine - The Paul Merage School of Business
MBA, Health Care Administration
University of California, San Francisco
Pharm.D., Pharmacy
Arsen Karapetyan's FDA Experience May 2009 - Present
Job Consumer Safety Officer/Investigator at FDA
Industry Writing and Editing
Experience
FDA May 2009 - Present
Bank of America August 2004 - September 2007
Skills
Inspection Techniques..., System Based Drug..., Active Pharmaceutical..., Dietary Supplement GMP's, Inspection of Human..., Blood Banking and..., Tissue Residue..., AMDUCA/Compounding..., Bovine Spongiform..., Cornell University and..., Fluent in Eastern..., FDA, GMP, Medical Devices, Quality Assurance, Regulatory Affairs
Education
University of California, Los Angeles 2005 — 2008
Biology B.S., Ecology and Evolutionary Biology
FDA May 2009 - Present
Bank of America August 2004 - September 2007
Skills
Inspection Techniques..., System Based Drug..., Active Pharmaceutical..., Dietary Supplement GMP's, Inspection of Human..., Blood Banking and..., Tissue Residue..., AMDUCA/Compounding..., Bovine Spongiform..., Cornell University and..., Fluent in Eastern..., FDA, GMP, Medical Devices, Quality Assurance, Regulatory Affairs
Education
University of California, Los Angeles 2005 — 2008
Biology B.S., Ecology and Evolutionary Biology
Walter Wu's FDA Experience 1995 - 1995
Job Attorney/Physician at Morrison & Foerster LLP
Industry Law Practice
Experience
Morrison & Foerster LLP August 2007 - Present
Knobbe Martens Olson & Bear LLP September 2003 - August 2007
Knobbe Martens Olson & Bear LLP June 2002 - August 2002
UCLA Olive View Medical Center July 1999 - June 2000
UCLA Olive View Medical Center July 1996 - June 1999
National Governors Association 1995 - 1995
FDA 1995 - 1995
Skills
Intellectual Property, Licensing, Patents, Patent Prosecution, Legal Research, Legal Writing, Litigation, Courts, Trials, Litigation Support, Document Review, Employment Law, Life Sciences, Medical Devices, Medical Diagnostics
Education
UCLA School of Law 2000 — 2003
Doctor of Law (J.D.), Business Law Concentration
UC Davis School of Medicine 1991 — 1996
Doctor of Medicine (M.D.)
UCLA 1987 — 1991
Bachelor of Science (B.S.), Kinesiology
San Luis Obispo High School
Morrison & Foerster LLP August 2007 - Present
Knobbe Martens Olson & Bear LLP September 2003 - August 2007
Knobbe Martens Olson & Bear LLP June 2002 - August 2002
UCLA Olive View Medical Center July 1999 - June 2000
UCLA Olive View Medical Center July 1996 - June 1999
National Governors Association 1995 - 1995
FDA 1995 - 1995
Skills
Intellectual Property, Licensing, Patents, Patent Prosecution, Legal Research, Legal Writing, Litigation, Courts, Trials, Litigation Support, Document Review, Employment Law, Life Sciences, Medical Devices, Medical Diagnostics
Education
UCLA School of Law 2000 — 2003
Doctor of Law (J.D.), Business Law Concentration
UC Davis School of Medicine 1991 — 1996
Doctor of Medicine (M.D.)
UCLA 1987 — 1991
Bachelor of Science (B.S.), Kinesiology
San Luis Obispo High School
Joseph Bruns's FDA Experience 1974 - 1975
Job System Planning and Strategic Advisor at Corporation for Public Broadcasting
Industry Broadcast Media
Experience
Corporation for Public Broadcasting November 2014 - Present
WETA July 2001 - 2013
USIA May 1982 - December 1997
International Broadcasting Bureau 1995 - 1996
Voice of America 1986 - 1996
National Endowment for the Humanities February 1979 - March 1982
Department of the Navy February 1976 - February 1979
FDA 1974 - 1975
Skills
Broadcast, Video, Nonprofits, Television, Non-profits, Policy, Public Speaking, Digital Media, Radio, Social Media, Broadcast Television, Government, Video Production, Strategic Planning, New Media, Program Management, Media Relations, Media Production, HD Video, Broadcast Journalism, Journalism, Producing, Documentaries
Education
University of California, San Diego
George Washington University
Graduate School of Management
Corporation for Public Broadcasting November 2014 - Present
WETA July 2001 - 2013
USIA May 1982 - December 1997
International Broadcasting Bureau 1995 - 1996
Voice of America 1986 - 1996
National Endowment for the Humanities February 1979 - March 1982
Department of the Navy February 1976 - February 1979
FDA 1974 - 1975
Skills
Broadcast, Video, Nonprofits, Television, Non-profits, Policy, Public Speaking, Digital Media, Radio, Social Media, Broadcast Television, Government, Video Production, Strategic Planning, New Media, Program Management, Media Relations, Media Production, HD Video, Broadcast Journalism, Journalism, Producing, Documentaries
Education
University of California, San Diego
George Washington University
Graduate School of Management
Krishna Asundi's FDA Experience October 2010 - October 2013
Job Human Factors Engineer at Apple Inc.
Industry Research
Experience
Apple November 2013 - Present
FDA October 2010 - October 2013
Harvard School of Public Health September 2007 - October 2010
UC Berkeley July 2003 - July 2007
Skills
Biomechanics, Biomedical Engineering, Labview, Matlab, Statistics, Medical Devices, Ergonomics, Human Factors, Human Factors..., Experimental Design, FDA
Education
University of California, Berkeley 2000 — 2007
Ph.D., Bioengineering
University of California, San Francisco 2000 — 2007
Ph.D., Bioengineering
University of Puerto Rico 1994 — 2000
B.S., Mechanical Engineering
Apple November 2013 - Present
FDA October 2010 - October 2013
Harvard School of Public Health September 2007 - October 2010
UC Berkeley July 2003 - July 2007
Skills
Biomechanics, Biomedical Engineering, Labview, Matlab, Statistics, Medical Devices, Ergonomics, Human Factors, Human Factors..., Experimental Design, FDA
Education
University of California, Berkeley 2000 — 2007
Ph.D., Bioengineering
University of California, San Francisco 2000 — 2007
Ph.D., Bioengineering
University of Puerto Rico 1994 — 2000
B.S., Mechanical Engineering
Mary C Carson's FDA Experience ChemistFood and Drug Administration1990 - Present
Job Chemist at FDA
Industry Government Administration
Experience
FDA ChemistFood and Drug Administration1990 - Present
Skills
Analytical Chemistry, Laboratory, Chromatography, Chemistry
Education
UC Berkeley
Doctor of Philosophy (Ph.D.), Biochemistry
FDA ChemistFood and Drug Administration1990 - Present
Skills
Analytical Chemistry, Laboratory, Chromatography, Chemistry
Education
UC Berkeley
Doctor of Philosophy (Ph.D.), Biochemistry
Daniela Verthelyi's FDA Experience Chief, Laboratory of ImmunologyFDAMarch 2008 - Present
Job Chief, Laboratory of Immunology at FDA
Industry Pharmaceuticals
Experience
FDA Chief, Laboratory of ImmunologyFDAMarch 2008 - Present
Skills
Microbiology, Molecular Biology, Drug Discovery, Cell Culture, Immunology, Cell Biology, Lifesciences, Biotechnology, ELISA, Flow Cytometry, Cell
Education
Virginia Polytechnic Institute and State University 1990 — 1996
M.D. PhD, Immunology
University of Buenos Aires 1982 — 1988
MD, Medicina
FDA Chief, Laboratory of ImmunologyFDAMarch 2008 - Present
Skills
Microbiology, Molecular Biology, Drug Discovery, Cell Culture, Immunology, Cell Biology, Lifesciences, Biotechnology, ELISA, Flow Cytometry, Cell
Education
Virginia Polytechnic Institute and State University 1990 — 1996
M.D. PhD, Immunology
University of Buenos Aires 1982 — 1988
MD, Medicina
Victoria Kao's FDA Experience 2003 - 2005
Job Senior International Trade Specialist at Department of Commerce
Industry Government Administration
Experience
Department of Commerce 2010 - Present
U.S. Department of Commerce 2005 - 2010
FDA 2003 - 2005
U.S. Food and Drug Administration 1999 - 2003
University of California at San Francisco 1995 - 1999
Skills
International Trade, Export Controls, International Economics, International Relations, Trade Compliance, Economic Development, Foreign Policy, Export, International..., Policy Analysis, International Trade Law, International Marketing, Public Policy, Government, International Business, Latin America, Customs Regulations, International Business..., Economics, Diplomacy, Politics, Spanish, Policy, Research, Strategic Communications, Pharmaceutical Industry
Education
FCIB
FCIB
FCIB
UC Berkeley
Immunology
Department of Commerce 2010 - Present
U.S. Department of Commerce 2005 - 2010
FDA 2003 - 2005
U.S. Food and Drug Administration 1999 - 2003
University of California at San Francisco 1995 - 1999
Skills
International Trade, Export Controls, International Economics, International Relations, Trade Compliance, Economic Development, Foreign Policy, Export, International..., Policy Analysis, International Trade Law, International Marketing, Public Policy, Government, International Business, Latin America, Customs Regulations, International Business..., Economics, Diplomacy, Politics, Spanish, Policy, Research, Strategic Communications, Pharmaceutical Industry
Education
FCIB
FCIB
FCIB
UC Berkeley
Immunology
Deborah S Hammond, RAC, CQA's FDA Experience February 2002 - Present
Job Supervisory Investigator at FDA
Industry Government Administration
Experience
FDA February 2002 - Present
School of Biomedical Engineering, Colorado State University 2010 - June 2014
FDA July 1990 - February 2002
Skills
Regulatory Affairs, FDA, Regulatory Requirements, Regulatory Submissions, Biotechnology, CAPA, GMP, IND, Clinical Trials, GLP, Validation, Life Sciences, Change Control, Regulations, SOP, Quality Auditing, GCP, Clinical Development, Quality Assurance, 21 CFR Part 11, Microbiology, Medical Devices, Pharmaceutical Industry, Lifesciences, Quality System, Technology Transfer, Analytical Chemistry, cGMP practices, Cell Culture, V&V, ISO 13485, HPLC, Quality Management, GLPs, Biologics
Education
UC Davis
Bachelor of Science (BS)
FDA February 2002 - Present
School of Biomedical Engineering, Colorado State University 2010 - June 2014
FDA July 1990 - February 2002
Skills
Regulatory Affairs, FDA, Regulatory Requirements, Regulatory Submissions, Biotechnology, CAPA, GMP, IND, Clinical Trials, GLP, Validation, Life Sciences, Change Control, Regulations, SOP, Quality Auditing, GCP, Clinical Development, Quality Assurance, 21 CFR Part 11, Microbiology, Medical Devices, Pharmaceutical Industry, Lifesciences, Quality System, Technology Transfer, Analytical Chemistry, cGMP practices, Cell Culture, V&V, ISO 13485, HPLC, Quality Management, GLPs, Biologics
Education
UC Davis
Bachelor of Science (BS)
Jesse Ho's FDA Experience June 2014 - August 2014
Job Post Doctoral Fellow, Global Pharmaceutical Sciences at Allergan/USC
Industry Higher Education
Experience
Allergan July 2015 - Present
Kaiser Permanente September 2013 - Present
Emmaus Life Sciences September 2014 - May 2015
CVS Caremark Corporation March 2013 - March 2015
FDA June 2014 - August 2014
Key Pharmacy September 2012 - May 2014
University of California, Irvine June 2009 - July 2011
UC Irvine School of Medicine June 2007 - March 2009
University of California, Irvine November 2006 - March 2009
Skills
Laboratory, Research, Data Analysis, Neuroscience, Microsoft Office, Matlab, Pharmacy, Clinical Research, Pharmacology, Lifesciences, Pharmacists, Clinical Trials, Medication Therapy...
Education
University of Southern California 2011 — 2015
Doctorate, Pharmacy
University of California, Irvine 2005 — 2009
Bachelors of Science, Biology
University of Southern California
Master’s Degree, Regulatory Science
Allergan July 2015 - Present
Kaiser Permanente September 2013 - Present
Emmaus Life Sciences September 2014 - May 2015
CVS Caremark Corporation March 2013 - March 2015
FDA June 2014 - August 2014
Key Pharmacy September 2012 - May 2014
University of California, Irvine June 2009 - July 2011
UC Irvine School of Medicine June 2007 - March 2009
University of California, Irvine November 2006 - March 2009
Skills
Laboratory, Research, Data Analysis, Neuroscience, Microsoft Office, Matlab, Pharmacy, Clinical Research, Pharmacology, Lifesciences, Pharmacists, Clinical Trials, Medication Therapy...
Education
University of Southern California 2011 — 2015
Doctorate, Pharmacy
University of California, Irvine 2005 — 2009
Bachelors of Science, Biology
University of Southern California
Master’s Degree, Regulatory Science
Leslie Chinn's FDA Experience July 2011 - June 2015
Job Clinical Pharmacologist at Genentech
Industry Pharmaceuticals
Experience
Genentech July 2015 - Present
FDA July 2011 - June 2015
FDA November 2010 - July 2011
National Cancer Institute June 2008 - October 2010
Skills
Molecular Biology, Biochemistry, Genomics, Cell Culture, Genetics, PCR, Cell Biology, Drug Discovery, Science, Life Sciences, Cell, Lifesciences, Pharmacokinetics, Western Blotting, Cancer, Biotechnology, In Vivo
Education
University of California, San Francisco 2002 — 2008
PhD, Pharmaceutical Sciences & Pharmacogenomics
University of Michigan 1997 — 2001
BS, Biochemistry
Genentech July 2015 - Present
FDA July 2011 - June 2015
FDA November 2010 - July 2011
National Cancer Institute June 2008 - October 2010
Skills
Molecular Biology, Biochemistry, Genomics, Cell Culture, Genetics, PCR, Cell Biology, Drug Discovery, Science, Life Sciences, Cell, Lifesciences, Pharmacokinetics, Western Blotting, Cancer, Biotechnology, In Vivo
Education
University of California, San Francisco 2002 — 2008
PhD, Pharmaceutical Sciences & Pharmacogenomics
University of Michigan 1997 — 2001
BS, Biochemistry
Wil Sumner's FDA Experience January 1982 - January 1990
Job CEO/President at Sumner Analytical Svc
Industry Food Production
Experience
Sumner Analytical Svc January 1992 - Present
EMA/IEH Laboratories September 2013 - January 2015
Scientific Certification Systems, March 1990 - September 2013
FDA January 1982 - January 1990
USDA-ARS June 1976 - 1982
Skills
Food Safety, Agriculture, Microbiology, Food, Training, Food Processing, Laboratory, Chemistry, Environmental Awareness, FDA, Auditing, Validation, Program Management, Testing, Project Management, Community Outreach, Research, Ecology, Public Speaking, Strategic Planning
Education
University of Minnesota-Twin Cities 1980 — 1983
Master's degree, Toxicology
University of California, Davis 1974 — 1976
Bachelor's degree, Entomology & Chemistry
Sumner Analytical Svc January 1992 - Present
EMA/IEH Laboratories September 2013 - January 2015
Scientific Certification Systems, March 1990 - September 2013
FDA January 1982 - January 1990
USDA-ARS June 1976 - 1982
Skills
Food Safety, Agriculture, Microbiology, Food, Training, Food Processing, Laboratory, Chemistry, Environmental Awareness, FDA, Auditing, Validation, Program Management, Testing, Project Management, Community Outreach, Research, Ecology, Public Speaking, Strategic Planning
Education
University of Minnesota-Twin Cities 1980 — 1983
Master's degree, Toxicology
University of California, Davis 1974 — 1976
Bachelor's degree, Entomology & Chemistry
Holly Brevig, Ph.D.'s FDA Experience September 2015 - Present
Job
Industry Research
Experience
FDA September 2015 - Present
Avalere Health July 2015 - September 2015
CNA November 2010 - July 2015
US Marine Corps Headquarters June 2012 - March 2014
Scientists and Engineers for America (SEA) September 2010 - November 2010
Musiker Discovery Programs, Inc; Summer Discovery June 2010 - July 2010
University of Michigan March 2007 - May 2010
University of Michigan January 2009 - March 2009
American Society for Pharmacology and Experimental Therapeutics - ASPET 2006 - 2009
University of Michigan March 2004 - March 2007
Skills
Neuroscience, Science, Statistics, Data Analysis, Molecular Biology, Analysis, Scientific Writing, Research, Program Management, Pharmacology, Experimental Design, Program Evaluation, Operations Research, Protein Chemistry, Biochemistry, Proposal Writing, Cell Culture, Mathematical Modeling, Technical Writing, Defense, Strategy, Data Presentation, PowerPoint, Excel, Briefing, Access, Policy, Lifesciences, Chemistry, Microsoft Excel, Teaching, organizational redesign, Molecular Cloning, Genetics, Immunohistochemistry, Cell Biology, Western Blotting, Cell, qPCR, Grant Writing, Microscopy, Science Communication, Protein Purification, HPLC, SPSS, Animal Models, In Vivo, Assay Development, Grants, Laboratory
Education
University of Michigan 2003 — 2010
Ph.D. in Pharmacology, Areas of Research: Neuropharmacology, Sleep and Anesthesiology, Transcriptional Regulation
University of California, Irvine 1999 — 2003
B.S., Biological Sciences, Neuroscience
FDA September 2015 - Present
Avalere Health July 2015 - September 2015
CNA November 2010 - July 2015
US Marine Corps Headquarters June 2012 - March 2014
Scientists and Engineers for America (SEA) September 2010 - November 2010
Musiker Discovery Programs, Inc; Summer Discovery June 2010 - July 2010
University of Michigan March 2007 - May 2010
University of Michigan January 2009 - March 2009
American Society for Pharmacology and Experimental Therapeutics - ASPET 2006 - 2009
University of Michigan March 2004 - March 2007
Skills
Neuroscience, Science, Statistics, Data Analysis, Molecular Biology, Analysis, Scientific Writing, Research, Program Management, Pharmacology, Experimental Design, Program Evaluation, Operations Research, Protein Chemistry, Biochemistry, Proposal Writing, Cell Culture, Mathematical Modeling, Technical Writing, Defense, Strategy, Data Presentation, PowerPoint, Excel, Briefing, Access, Policy, Lifesciences, Chemistry, Microsoft Excel, Teaching, organizational redesign, Molecular Cloning, Genetics, Immunohistochemistry, Cell Biology, Western Blotting, Cell, qPCR, Grant Writing, Microscopy, Science Communication, Protein Purification, HPLC, SPSS, Animal Models, In Vivo, Assay Development, Grants, Laboratory
Education
University of Michigan 2003 — 2010
Ph.D. in Pharmacology, Areas of Research: Neuropharmacology, Sleep and Anesthesiology, Transcriptional Regulation
University of California, Irvine 1999 — 2003
B.S., Biological Sciences, Neuroscience
Sudipan Karmakar's FDA Experience March 2013 - Present
Job Biologist/Product Quality Reviewer (CMC) at Food & Drug Administration
Industry Government Administration
Experience
FDA March 2013 - Present
FDA 2010 - 2012
Baylor College of Medicine September 2009 - October 2010
Baylor College of Medicine June 2004 - August 2009
Indian Institute of Chemical Biology 1998 - 2003
Skills
Cell & Molecular Biology, Cancer Biology, Microbiology, phase-specific..., CMC regulatory..., Manufacturing,..., Reviewing regulatory..., FDA Inspection, Molecular Biology, Regulations, FDA, Biochemistry, Western Blotting, Cell Biology, Immunoprecipitation, Cell Culture, IND, Tissue Culture, Molecular Cloning, Protein Expression, Drug Development, Drug Discovery, Clinical Trials
Education
Indian Institute of Chemical Biology (http://www.iicb.res.in/) 1998 — 2003
Ph.D.
University of Calcutta 1995 — 1997
MS
FDA March 2013 - Present
FDA 2010 - 2012
Baylor College of Medicine September 2009 - October 2010
Baylor College of Medicine June 2004 - August 2009
Indian Institute of Chemical Biology 1998 - 2003
Skills
Cell & Molecular Biology, Cancer Biology, Microbiology, phase-specific..., CMC regulatory..., Manufacturing,..., Reviewing regulatory..., FDA Inspection, Molecular Biology, Regulations, FDA, Biochemistry, Western Blotting, Cell Biology, Immunoprecipitation, Cell Culture, IND, Tissue Culture, Molecular Cloning, Protein Expression, Drug Development, Drug Discovery, Clinical Trials
Education
Indian Institute of Chemical Biology (http://www.iicb.res.in/) 1998 — 2003
Ph.D.
University of Calcutta 1995 — 1997
MS
Hepei Chen's FDA Experience January 2015 - Present
Job Mathematical Statistician at FDA
Industry Pharmaceuticals
Experience
FDA January 2015 - Present
Covance April 2007 - October 2014
National Institutes of Health July 2004 - April 2007
Skills
Biostatistics, Clinical Trials, Drug Development, Clinical Development
Education
University of California, Berkeley
FDA January 2015 - Present
Covance April 2007 - October 2014
National Institutes of Health July 2004 - April 2007
Skills
Biostatistics, Clinical Trials, Drug Development, Clinical Development
Education
University of California, Berkeley
Thomas Mellor's FDA Experience October 2011 - Present
Job Program Support Assistant at FDA
Industry Government Administration
Experience
FDA October 2011 - Present
Hands On Technology Transfer, Inc. August 2008 - September 2011
Jet Aviation, Inc January 2007 - June 2008
US Navy September 2002 - August 2006
Skills
Security Clearance, Government, Troubleshooting, Military, DoD, Report Writing, Writing, Program Management, Program Development, Healthcare Management, Public Health, Health Care Regulation, Microsoft Office, Office Management
Education
University of Baltimore 2012 — 2015
Bachelor of Science, Health Systems Management
University of Massachusetts at Lowell 2008 — 2011
N/A, English, History
FDA October 2011 - Present
Hands On Technology Transfer, Inc. August 2008 - September 2011
Jet Aviation, Inc January 2007 - June 2008
US Navy September 2002 - August 2006
Skills
Security Clearance, Government, Troubleshooting, Military, DoD, Report Writing, Writing, Program Management, Program Development, Healthcare Management, Public Health, Health Care Regulation, Microsoft Office, Office Management
Education
University of Baltimore 2012 — 2015
Bachelor of Science, Health Systems Management
University of Massachusetts at Lowell 2008 — 2011
N/A, English, History
Dominique Christianson (French)'s FDA Experience January 2013 - September 2014
Job Regulations Specialist
Industry Law Practice
Experience
Alcohol and Tobacco Tax and Trade Bureau September 2014 - Present
FDA January 2013 - September 2014
Nuclear Information and Resource Service August 2011 - January 2013
US EPA August 2010 - May 2011
Donald Daneman and Associates May 2008 - August 2009
University of Baltimore School of Law April 2008 - June 2008
Skills
Legal Writing, Legal Research, Westlaw, Litigation, Civil Litigation, Criminal Law, Mediation, Environmental Law, Courts, Policy, Legal Issues, Lexis, Community Outreach, Trials, Appeals
Education
The George Washington University School of Law 2010 — 2011
LL.M, Energy and Environmental Law
University of Baltimore School of Law 2007 — 2010
J.D, Environmental Law
University of South Florida 2003 — 2007
B.A, English Literature and Communications
Alcohol and Tobacco Tax and Trade Bureau September 2014 - Present
FDA January 2013 - September 2014
Nuclear Information and Resource Service August 2011 - January 2013
US EPA August 2010 - May 2011
Donald Daneman and Associates May 2008 - August 2009
University of Baltimore School of Law April 2008 - June 2008
Skills
Legal Writing, Legal Research, Westlaw, Litigation, Civil Litigation, Criminal Law, Mediation, Environmental Law, Courts, Policy, Legal Issues, Lexis, Community Outreach, Trials, Appeals
Education
The George Washington University School of Law 2010 — 2011
LL.M, Energy and Environmental Law
University of Baltimore School of Law 2007 — 2010
J.D, Environmental Law
University of South Florida 2003 — 2007
B.A, English Literature and Communications
Bud Gerstman's FDA Experience 1985 - 1990
Job Professor at San Jose State University
Industry Higher Education
Experience
San Jose State University 1990 - Present
FDA 1985 - 1990
Education
UC Davis 1985 — 1989
Doctor of Philosophy (PhD), Epidemiology
UC Berkeley 1983 — 1984
Master of Public Health (MPH), Epidemiology
San Jose State University 1990 - Present
FDA 1985 - 1990
Education
UC Davis 1985 — 1989
Doctor of Philosophy (PhD), Epidemiology
UC Berkeley 1983 — 1984
Master of Public Health (MPH), Epidemiology
Terrance Nguyen's FDA Experience December 2008 - Present
Job
Industry
Experience
FDA December 2008 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Leadership
Education
University of California, San Diego 2002 — 2004
Bachelor of Science (BS), Biology, General
FDA December 2008 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Leadership
Education
University of California, San Diego 2002 — 2004
Bachelor of Science (BS), Biology, General
Boucher Phil's FDA Experience April 1994 - January 2006
Job Scientific Affairs Director at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences September 2014 - Present
Biologics Consulting Group March 2014 - September 2014
Novartis Vaccines and Diagnostics February 2006 - December 2013
FDA April 1994 - January 2006
Institut Pasteur 1990 - 1994
Skills
Biotechnology, Lifesciences, Biochemistry, Cell Culture, Pharmaceutical Industry, Molecular Biology, GMP, Sop, HPLC, Protein Purification, Clinical Trials, ELISA, Western Blotting, Validation, Chromatography, Immunology, PCR, Technology Transfer, Cell Biology, Microbiology
Education
University of California, Davis 1984 — 1989
Ph.D., Biochemistry
University of Oregon 1980 — 1984
Bachelor of Science (B.S.), Biology, General
International school manila
PRA Health Sciences September 2014 - Present
Biologics Consulting Group March 2014 - September 2014
Novartis Vaccines and Diagnostics February 2006 - December 2013
FDA April 1994 - January 2006
Institut Pasteur 1990 - 1994
Skills
Biotechnology, Lifesciences, Biochemistry, Cell Culture, Pharmaceutical Industry, Molecular Biology, GMP, Sop, HPLC, Protein Purification, Clinical Trials, ELISA, Western Blotting, Validation, Chromatography, Immunology, PCR, Technology Transfer, Cell Biology, Microbiology
Education
University of California, Davis 1984 — 1989
Ph.D., Biochemistry
University of Oregon 1980 — 1984
Bachelor of Science (B.S.), Biology, General
International school manila
Abhijit Raha's FDA Experience 2008 - Present
Job Pharmacologist at US Department of Health and Human Services
Industry Government Administration
Experience
FDA 2008 - Present
Goldbelt Raven LLC (at Chemical Biological Medical Systems [CBMS]) 2006 - 2008
Science Applications International Corporation 2004 - 2006
University of Maryland-Baltimore 2001 - 2004
Thomas Jefferson University and SUNY-Stony Brook (Synexin Mech. of Action, 2000-2001) 1997 - 2001
Fox Chase Cancer Center (affiliated with University of Pennsylvania) 1994 - 1997
Dartmouth Medical School (Dartmouth College) 1989 - 1994
University of Nebraska Medical Center - Eppley Institute for Research in Cancer 1987 - 1989
Michigan State University - Pesticide Research Center 1985 - 1987
University of California - Davis 1982 - 1985
Skills
GLP, FDA, Drug Development, Regulatory Affairs, Lifesciences, Clinical Development, Pharmacology, Infectious Diseases, IND, Bioanalysis, Toxicology, Cell Culture, Pharmaceutical Industry, Clinical Research, Life Sciences, Drug Discovery, Biotechnology, Biostatistics, Scientific Writing, biochemistry
Education
Dartmouth Medical School 1989 — 1994
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology (Regulation of AHH [CYP1A1] by Polycyclic Aromatic Hydrocarbons, Dioxin)
University of California, Davis 1982 — 1985
Master of Science, Pharmacology and Toxicology
University of Nebraska-Lincoln 1976 — 1981
Bachelor's Degree, Chemistry and Life Sciences (emphasis in physiology & biochemistry)
FDA 2008 - Present
Goldbelt Raven LLC (at Chemical Biological Medical Systems [CBMS]) 2006 - 2008
Science Applications International Corporation 2004 - 2006
University of Maryland-Baltimore 2001 - 2004
Thomas Jefferson University and SUNY-Stony Brook (Synexin Mech. of Action, 2000-2001) 1997 - 2001
Fox Chase Cancer Center (affiliated with University of Pennsylvania) 1994 - 1997
Dartmouth Medical School (Dartmouth College) 1989 - 1994
University of Nebraska Medical Center - Eppley Institute for Research in Cancer 1987 - 1989
Michigan State University - Pesticide Research Center 1985 - 1987
University of California - Davis 1982 - 1985
Skills
GLP, FDA, Drug Development, Regulatory Affairs, Lifesciences, Clinical Development, Pharmacology, Infectious Diseases, IND, Bioanalysis, Toxicology, Cell Culture, Pharmaceutical Industry, Clinical Research, Life Sciences, Drug Discovery, Biotechnology, Biostatistics, Scientific Writing, biochemistry
Education
Dartmouth Medical School 1989 — 1994
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology (Regulation of AHH [CYP1A1] by Polycyclic Aromatic Hydrocarbons, Dioxin)
University of California, Davis 1982 — 1985
Master of Science, Pharmacology and Toxicology
University of Nebraska-Lincoln 1976 — 1981
Bachelor's Degree, Chemistry and Life Sciences (emphasis in physiology & biochemistry)
Dikshya Shrestha's FDA Experience September 2012 - October 2012
Job Clinical Research Pharmacist at PAREXEL, PharmD/MBA
Industry Pharmaceuticals
Experience
PAREXEL September 2013 - Present
CVS Caremark Corporation July 2013 - Present
PAREXEL International Inc. January 2008 - Present
Johns Hopkins Hospital, Internal Medicine Clinic February 2013 - April 2013
FDA September 2012 - October 2012
Procter & Gamble June 2012 - July 2012
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Research, FDA, Pharmacovigilance, Analytical Chemistry, Research, Molecular Biology, CRO, ELISA, Regulatory Submissions, Healthcare, Biotechnology, Pharmaceutics, Hospitals, Pharmacology, Sop, Oncology, Infectious Diseases, Medication Therapy..., Diabetes, Clinical Pharmacology, Drug Development, Regulatory Affairs, Drug Discovery, Pharmacy, GMP, Biochemistry, Protocol, Pharmacokinetics, Purification, Chemistry, Pharmacists, Public Health, Clinical Development, Managed Care, GLP, Lifesciences, Validation, Immunology, Clinical Monitoring, Compounding, Laboratory, Medical Affairs, Biopharmaceuticals, Regulatory Requirements, Pharmaceutical Research, Patient Safety, Pharmacueticals, Hypertension
Education
University of Baltimore 2011 — 2014
Master of Business Administration (M.B.A.)
University of Maryland Baltimore 2009 — 2013
Doctor of Pharmacy (Pharm.D.)/MBA
PAREXEL September 2013 - Present
CVS Caremark Corporation July 2013 - Present
PAREXEL International Inc. January 2008 - Present
Johns Hopkins Hospital, Internal Medicine Clinic February 2013 - April 2013
FDA September 2012 - October 2012
Procter & Gamble June 2012 - July 2012
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Research, FDA, Pharmacovigilance, Analytical Chemistry, Research, Molecular Biology, CRO, ELISA, Regulatory Submissions, Healthcare, Biotechnology, Pharmaceutics, Hospitals, Pharmacology, Sop, Oncology, Infectious Diseases, Medication Therapy..., Diabetes, Clinical Pharmacology, Drug Development, Regulatory Affairs, Drug Discovery, Pharmacy, GMP, Biochemistry, Protocol, Pharmacokinetics, Purification, Chemistry, Pharmacists, Public Health, Clinical Development, Managed Care, GLP, Lifesciences, Validation, Immunology, Clinical Monitoring, Compounding, Laboratory, Medical Affairs, Biopharmaceuticals, Regulatory Requirements, Pharmaceutical Research, Patient Safety, Pharmacueticals, Hypertension
Education
University of Baltimore 2011 — 2014
Master of Business Administration (M.B.A.)
University of Maryland Baltimore 2009 — 2013
Doctor of Pharmacy (Pharm.D.)/MBA
Irvine Wellness Pharmacy's FDA Experience January 2001 - January 2002
Job Pharmacist Manager at Irvine Wellness Pharmacy
Industry Pharmaceuticals
Experience
Irvine Wellness Pharmacy August 2012 - Present
Rite Aid February 2010 - August 2012
FDA January 2001 - January 2002
Skills
Pharmaceutical Industry, Community Pharmacy, Pharmacoeconomics, Pharmaceutical..., Pharmacists
Education
USC 1994 — 1998
Doctor of Pharmacy (Pharm.D.), Pharmacy
UCI 1991 — 1994
Biological Sciences, Biology, General
Irvine Wellness Pharmacy August 2012 - Present
Rite Aid February 2010 - August 2012
FDA January 2001 - January 2002
Skills
Pharmaceutical Industry, Community Pharmacy, Pharmacoeconomics, Pharmaceutical..., Pharmacists
Education
USC 1994 — 1998
Doctor of Pharmacy (Pharm.D.), Pharmacy
UCI 1991 — 1994
Biological Sciences, Biology, General
Eleanor Dixon-Terry's FDA Experience July 2010 - Present
Job Regulatory Health Project Manager at FDA
Industry Government Administration
Experience
FDA July 2010 - Present
Society for Public Health Education August 1998 - July 2009
Skills
Health Communication
Education
UCLA
Bachelor of Arts (B.A.), Sociology & Psychology
UNC Chapel Hill
Master of Public Health (MPH), Health Behavior and Health Education
FDA July 2010 - Present
Society for Public Health Education August 1998 - July 2009
Skills
Health Communication
Education
UCLA
Bachelor of Arts (B.A.), Sociology & Psychology
UNC Chapel Hill
Master of Public Health (MPH), Health Behavior and Health Education
Ann Bost's FDA Experience September 2012 - Present
Job Information Management Specialist at FDA
Industry Government Administration
Experience
FDA September 2012 - Present
Education
Pine Bluff High School 1973 — 1976
diploma
University of Arkansas at Pine Bluff
FDA September 2012 - Present
Education
Pine Bluff High School 1973 — 1976
diploma
University of Arkansas at Pine Bluff
Rod Asmundson's FDA Experience Research MicrobiologistUS-FDA2010 - Present
Job Microbiologist at FDA
Industry Government Administration
Experience
FDA Research MicrobiologistUS-FDA2010 - Present
Education
USNR 1968 — 1969
Honorable Discharge
University of California, Berkeley 1964 — 1966
AB, Biochemistry
Massey U
Doctor of Philosophy (PhD), Biochemistry
FDA Research MicrobiologistUS-FDA2010 - Present
Education
USNR 1968 — 1969
Honorable Discharge
University of California, Berkeley 1964 — 1966
AB, Biochemistry
Massey U
Doctor of Philosophy (PhD), Biochemistry
Stacey Dial's FDA Experience April 1991 - Present
Job Biologist at FDA
Industry Government Administration
Experience
FDA April 1991 - Present
Skills
Molecular Biology, Microbiology, Cell Culture, PCR, Lifesciences, Science, ELISA, Biochemistry, Western Blotting, Ecology, Environmental Science, Cell Biology, Epidemiology, Public Health, Toxicology, Statistics, Environmental Policy, Data Analysis, Biotechnology, Genetics
Education
SEARK
Associate's degree, Biotechnology
University of Arkansas at Little Rock
Biology, General
FDA April 1991 - Present
Skills
Molecular Biology, Microbiology, Cell Culture, PCR, Lifesciences, Science, ELISA, Biochemistry, Western Blotting, Ecology, Environmental Science, Cell Biology, Epidemiology, Public Health, Toxicology, Statistics, Environmental Policy, Data Analysis, Biotechnology, Genetics
Education
SEARK
Associate's degree, Biotechnology
University of Arkansas at Little Rock
Biology, General
Lance De Souza's FDA Experience August 2010 - Present
Job FDA Pharmaceutical Inspectorate Member & Drug Specialist
Industry Pharmaceuticals
Experience
FDA August 2010 - Present
FDA May 2002 - Present
FDA January 2009 - December 2009
Incyte Pharmaceuticals, Inc. July 2000 - December 2001
Chiron Corporation April 1998 - July 2000
Skills
FDA, Quality Systems GMP..., Pre-Approval Inspections, Adverse Event Reporting, Clinical Research..., Industrial Sterilization, Non-Clinical..., Computer Aided..., Active Pharmaceutical..., Process Validation of..., Quality Systems..., Process Validation of..., Biological Therapeutic..., Bioprocessing, Downstream Bioprocessing, Quality Control, Aseptic Processing, 21 CFR Part 11, Chemistry Manufacturing..., Non-Clinical (GLP)..., Positron Emission..., REMS - Risk Evaluation..., Compounding Pharmacy..., Quality System..., Quality Assurance, SOP Development
Education
University of California, Berkeley
Bachelor's degree, Integrative Biology
University of Phoenix
Master of Business Administration (M.B.A.)
FDA August 2010 - Present
FDA May 2002 - Present
FDA January 2009 - December 2009
Incyte Pharmaceuticals, Inc. July 2000 - December 2001
Chiron Corporation April 1998 - July 2000
Skills
FDA, Quality Systems GMP..., Pre-Approval Inspections, Adverse Event Reporting, Clinical Research..., Industrial Sterilization, Non-Clinical..., Computer Aided..., Active Pharmaceutical..., Process Validation of..., Quality Systems..., Process Validation of..., Biological Therapeutic..., Bioprocessing, Downstream Bioprocessing, Quality Control, Aseptic Processing, 21 CFR Part 11, Chemistry Manufacturing..., Non-Clinical (GLP)..., Positron Emission..., REMS - Risk Evaluation..., Compounding Pharmacy..., Quality System..., Quality Assurance, SOP Development
Education
University of California, Berkeley
Bachelor's degree, Integrative Biology
University of Phoenix
Master of Business Administration (M.B.A.)
Jerome Lee's FDA Experience May 2012 - January 2015
Job Senior Health Insurance Specialist
Industry Government Administration
Experience
Centers for Medicare & Medicaid Services January 2015 - Present
Commissioned Corps of the U.S. Public Health Service November 2009 - Present
FDA May 2012 - January 2015
FDA November 2009 - May 2012
Walgreens March 2006 - November 2009
Neighborcare June 2004 - November 2005
University of Maryland, Baltimore (UMB) July 2003 - June 2004
Skills
Data Analysis, Pharmaceutical Industry, Healthcare Information..., Healthcare, Clinical Research, Medication Therapy..., Pharmacists, Pharmacy, Regulatory Affairs, Clinical Trials
Education
University of Maryland Baltimore 1999 — 2003
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of California, Berkeley 1994 — 1999
Bachelor's Degree, Chemistry
Centers for Medicare & Medicaid Services January 2015 - Present
Commissioned Corps of the U.S. Public Health Service November 2009 - Present
FDA May 2012 - January 2015
FDA November 2009 - May 2012
Walgreens March 2006 - November 2009
Neighborcare June 2004 - November 2005
University of Maryland, Baltimore (UMB) July 2003 - June 2004
Skills
Data Analysis, Pharmaceutical Industry, Healthcare Information..., Healthcare, Clinical Research, Medication Therapy..., Pharmacists, Pharmacy, Regulatory Affairs, Clinical Trials
Education
University of Maryland Baltimore 1999 — 2003
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of California, Berkeley 1994 — 1999
Bachelor's Degree, Chemistry
Bradley McEvoy's FDA Experience February 2009 - Present
Job Mathematical Statistician at FDA
Industry Government Administration
Experience
FDA February 2009 - Present
Skills
Statistics, Research, Data Analysis, Government
Education
University of California, Los Angeles
DrPH, Biostatistics
University of California, Los Angeles
Master of Science (M.S.), Biostatistics
University of California, Irvine
Bachelor of Arts (B.A.), Environmental Analysis and Design
FDA February 2009 - Present
Skills
Statistics, Research, Data Analysis, Government
Education
University of California, Los Angeles
DrPH, Biostatistics
University of California, Los Angeles
Master of Science (M.S.), Biostatistics
University of California, Irvine
Bachelor of Arts (B.A.), Environmental Analysis and Design
Kristina Chapman's FDA Experience December 1999 - Present
Job Information Specialist at FDA
Industry Government Administration
Experience
FDA December 1999 - Present
Education
University of Arkansas at Little Rock
Bachelor of Science (B.S.), Biology, Computer Science
FDA December 1999 - Present
Education
University of Arkansas at Little Rock
Bachelor of Science (B.S.), Biology, Computer Science
Jonathan Tung's FDA Experience June 2010 - Present
Job Consumer Safety Technician at FDA
Industry Government Administration
Experience
FDA June 2010 - Present
Education
University of California, Riverside 2010 — 2014
Bachelor of Arts (BA), Business/Managerial Economics
FDA June 2010 - Present
Education
University of California, Riverside 2010 — 2014
Bachelor of Arts (BA), Business/Managerial Economics
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