FDA Company
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Headquarters: Silver Spring, Maryland, United States Employees: 14,824 (2010) Jurisdiction: United States of America Founded: 30 June 1906 Subsidiaries: Center for Drug Evaluation and Research, Founders: Theodore Roosevelt, Harvey Washington Wiley
FDA List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at FDA. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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FDA Employees
Employee
Years
Job
Industry
Emily Baughman Emily Baughman's FDA Experience June 2013 - June 2014
Job Public Health and Research Professional, MSPH, CHES, CPH
Industry Research
Experience
FDA June 2013 - June 2014
Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs January 2013 - March 2014
ICF International March 2011 - June 2012
ICF International April 2010 - February 2011
Agribank July 2009 - August 2009
FPT University September 2008 - August 2009
Vietnam Television September 2008 - May 2009
Skills
Health Communication, Report Writing, Teaching English as a..., Qualitative Research, SPSS, Literature Reviews, Public Health, Program Evaluation, Global Health, Data Collection, Editing, Program Development, Public Speaking, Data Analysis, Proposal Writing, Behavior Change..., Stata, Public Health..., Writing, International Relations, Nonprofits, Public Health Education, Social Media, Health Education, Research
Education
Johns Hopkins Bloomberg School of Public Health 2012 — 2013
MSPH, Health Communication and Health Education
Johns Hopkins Bloomberg School of Public Health 2012 — 2013
Certificate, Public Health Informatics
University of Michigan 2004 — 2008
BA, Psychology, International Studies
FDA June 2013 - June 2014
Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs January 2013 - March 2014
ICF International March 2011 - June 2012
ICF International April 2010 - February 2011
Agribank July 2009 - August 2009
FPT University September 2008 - August 2009
Vietnam Television September 2008 - May 2009
Skills
Health Communication, Report Writing, Teaching English as a..., Qualitative Research, SPSS, Literature Reviews, Public Health, Program Evaluation, Global Health, Data Collection, Editing, Program Development, Public Speaking, Data Analysis, Proposal Writing, Behavior Change..., Stata, Public Health..., Writing, International Relations, Nonprofits, Public Health Education, Social Media, Health Education, Research
Education
Johns Hopkins Bloomberg School of Public Health 2012 — 2013
MSPH, Health Communication and Health Education
Johns Hopkins Bloomberg School of Public Health 2012 — 2013
Certificate, Public Health Informatics
University of Michigan 2004 — 2008
BA, Psychology, International Studies
Jessica Wokovich's FDA Experience January 2011 - July 2012
Job Product Validation Associate at bioMerieux
Industry Biotechnology
Experience
bioMerieux August 2015 - Present
bioMerieux June 2014 - August 2015
bioMerieux November 2013 - June 2014
Donald Danforth Plant Science Center June 2013 - November 2013
Donald Danforth Plant Science Center September 2012 - June 2013
FDA January 2011 - July 2012
Skills
Gel Electrophoresis, DNA extraction, Aseptic Technique, Microbiology, Validation, Test Case Generation, Tissue Culture, Bacterial Culturing, Media Production, RNA extraction, VITEK 2, VITEK MS, Biotechnology, Laboratory, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Visio, GLP, GMP, Quality Control, DNA Extraction
Education
Washington University in St. Louis 2014 — 2016
Master's Degree, Biology, General
University of Missouri-Saint Louis 2009 — 2013
Bachelor of Arts (B.A.), Biology, General
bioMerieux August 2015 - Present
bioMerieux June 2014 - August 2015
bioMerieux November 2013 - June 2014
Donald Danforth Plant Science Center June 2013 - November 2013
Donald Danforth Plant Science Center September 2012 - June 2013
FDA January 2011 - July 2012
Skills
Gel Electrophoresis, DNA extraction, Aseptic Technique, Microbiology, Validation, Test Case Generation, Tissue Culture, Bacterial Culturing, Media Production, RNA extraction, VITEK 2, VITEK MS, Biotechnology, Laboratory, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Visio, GLP, GMP, Quality Control, DNA Extraction
Education
Washington University in St. Louis 2014 — 2016
Master's Degree, Biology, General
University of Missouri-Saint Louis 2009 — 2013
Bachelor of Arts (B.A.), Biology, General
Kent Jason Lowry, MD Kent Jason Lowry, MD's FDA Experience January 2014 - Present
Job Orthopedic Surgeon
Industry Medical Practice
Experience
FDA January 2014 - Present
American Academy of Orthopaedic Surgeons March 2015 - Present
Ministry Health Care January 2013 - Present
St. Mary's Hospital January 2006 - Present
Rhinelander High School August 2006 - Present
American Academy of Orthopaedic Surgeons March 2014 - March 2015
ASTM International January 2010 - March 2015
American Academy of Orthopaedic Surgeons February 2008 - March 2014
Northland Orthopedic Assoc August 2001 - December 2012
University of Missouri July 2000 - June 2001
Skills
Orthopedic, Surgery, Sports Medicine, Medicine, Healthcare, Hospitals, Quality Improvement, Healthcare Management, Medical Device Labeling, Spine, Clinical Research, Orthopedics, Patient Safety, Medical Devices, Musculoskeletal, Joint Replacement
Education
University of Missouri-Columbia 1992 — 1996
Doctor of Medicine (MD), Medicine
University of Missouri-Rolla 1987 — 1992
BS, Mechanical Engineering
FDA January 2014 - Present
American Academy of Orthopaedic Surgeons March 2015 - Present
Ministry Health Care January 2013 - Present
St. Mary's Hospital January 2006 - Present
Rhinelander High School August 2006 - Present
American Academy of Orthopaedic Surgeons March 2014 - March 2015
ASTM International January 2010 - March 2015
American Academy of Orthopaedic Surgeons February 2008 - March 2014
Northland Orthopedic Assoc August 2001 - December 2012
University of Missouri July 2000 - June 2001
Skills
Orthopedic, Surgery, Sports Medicine, Medicine, Healthcare, Hospitals, Quality Improvement, Healthcare Management, Medical Device Labeling, Spine, Clinical Research, Orthopedics, Patient Safety, Medical Devices, Musculoskeletal, Joint Replacement
Education
University of Missouri-Columbia 1992 — 1996
Doctor of Medicine (MD), Medicine
University of Missouri-Rolla 1987 — 1992
BS, Mechanical Engineering
Ji Guo Ji Guo's FDA Experience January 2008 - Present
Job Material Scientist at FDA
Industry Medical Devices
Experience
FDA January 2008 - Present
Skills
Biodegradable Polymers, polymers, Polymer Chemistry, Polymer Characterization, Nanomaterials, Controlled Release, Drug Delivery, Women's Health, Medical Device R&D, Polymer Physics, Polymer Science, Characterization, Nanoparticles, Polymers, Chemistry, Materials Science
Education
University of North Carolina at Chapel Hill 2002 — 2006
Doctor of Philosophy (PhD), Chemistry
Wuhan University
FDA January 2008 - Present
Skills
Biodegradable Polymers, polymers, Polymer Chemistry, Polymer Characterization, Nanomaterials, Controlled Release, Drug Delivery, Women's Health, Medical Device R&D, Polymer Physics, Polymer Science, Characterization, Nanoparticles, Polymers, Chemistry, Materials Science
Education
University of North Carolina at Chapel Hill 2002 — 2006
Doctor of Philosophy (PhD), Chemistry
Wuhan University
Laurie (Bollinger) Clotilde's FDA Experience November 2011 - May 2013
Job Assay Development Scientist at MagArray
Industry Research
Experience
MagArray, Inc. May 2013 - Present
FDA November 2011 - May 2013
USDA-ARS October 2008 - November 2011
University of Nevada-Reno May 2003 - August 2008
University of Nevada-Reno April 2002 - May 2003
Skills
Assay Development, Microbiology, Food Safety, Molecular Biology, PCR, qPCR, Cell Culture, ELISA, Cell Biology, Immunoassays, Tissue Culture, Microscopy, Protein Expression, Immunology, Antibodies, Gel Electrophoresis, Luminex, Beads, Molecular & Cellular..., Cytotoxicity, assay optimization, coupling to beads, Dynex, Probiotics, prebiotics, ADF, NDF, ADL, Sterilization, Sample Preparation, KingFisher, Smartcycler, Thermocycler, rep-PCR, Infectious Diseases, real-time PCR, Flow Cytometry, RNA isolation
Education
University of Nevada-Reno 2004 — 2008
Ph.D., Cellular and Molecular Biology
University of Nevada-Reno 2003 — 2004
M.S., Animal Science
University of Nevada-Reno 2002 — 2003
B.S., Biology
St Louis, Sclessin
MagArray, Inc. May 2013 - Present
FDA November 2011 - May 2013
USDA-ARS October 2008 - November 2011
University of Nevada-Reno May 2003 - August 2008
University of Nevada-Reno April 2002 - May 2003
Skills
Assay Development, Microbiology, Food Safety, Molecular Biology, PCR, qPCR, Cell Culture, ELISA, Cell Biology, Immunoassays, Tissue Culture, Microscopy, Protein Expression, Immunology, Antibodies, Gel Electrophoresis, Luminex, Beads, Molecular & Cellular..., Cytotoxicity, assay optimization, coupling to beads, Dynex, Probiotics, prebiotics, ADF, NDF, ADL, Sterilization, Sample Preparation, KingFisher, Smartcycler, Thermocycler, rep-PCR, Infectious Diseases, real-time PCR, Flow Cytometry, RNA isolation
Education
University of Nevada-Reno 2004 — 2008
Ph.D., Cellular and Molecular Biology
University of Nevada-Reno 2003 — 2004
M.S., Animal Science
University of Nevada-Reno 2002 — 2003
B.S., Biology
St Louis, Sclessin
Nikisha Joyner Nikisha Joyner's FDA Experience October 2013 - Present
Job Management Analyst at FDA
Industry Government Administration
Experience
FDA October 2013 - Present
FDA March 2003 - October 2013
Bowne October 2000 - March 2003
Bowne 2002 - 2003
Skills
Program Management, Research, Data Analysis, Public Speaking, Nonprofits, Project Planning, Customer Service, Government, Strategic Planning, Policy, Project Management, Analysis, Fundraising, Grant Writing, Community Outreach, Policy Analysis, Proposal Writing, Public Health, Grants, Program Development, Regulations, Government Contracting, FDA
Education
Villanova University 2012 — 2013
Master Certificate, Project Management
University of Phoenix
BS, Business Management
Suitland HS
FDA October 2013 - Present
FDA March 2003 - October 2013
Bowne October 2000 - March 2003
Bowne 2002 - 2003
Skills
Program Management, Research, Data Analysis, Public Speaking, Nonprofits, Project Planning, Customer Service, Government, Strategic Planning, Policy, Project Management, Analysis, Fundraising, Grant Writing, Community Outreach, Policy Analysis, Proposal Writing, Public Health, Grants, Program Development, Regulations, Government Contracting, FDA
Education
Villanova University 2012 — 2013
Master Certificate, Project Management
University of Phoenix
BS, Business Management
Suitland HS
Fatimah Omar, R-CPhT, MBA Fatimah Omar, R-CPhT, MBA's FDA Experience June 2015 - Present
Job Consumer Safety Technician at FDA
Industry Government Administration
Experience
FDA June 2015 - Present
Remington College - Memphis & Nashville Campuses March 2014 - June 2015
Methodist Healthcare December 2006 - December 2013
Methodist Healthcare April 2001 - December 2006
US Army October 1991 - January 1999
Skills
Public Speaking, Healthcare, Customer Service, PowerPoint, Team Building, Hospitals, Training, Microsoft Excel, Microsoft Word, Research, Inpatient, Patient Safety, Healthcare Management, Medical Terminology, HIPAA, Nursing, Pharmacy, Healthcare Information..., EMR
Education
University of Phoenix 2012 — 2014
Master of Business Administration (MBA), Business Administration, Management and Operations
University of Phoenix 2009 — 2012
Bachelor's degree, Health/Health Care Administration/Management
FDA June 2015 - Present
Remington College - Memphis & Nashville Campuses March 2014 - June 2015
Methodist Healthcare December 2006 - December 2013
Methodist Healthcare April 2001 - December 2006
US Army October 1991 - January 1999
Skills
Public Speaking, Healthcare, Customer Service, PowerPoint, Team Building, Hospitals, Training, Microsoft Excel, Microsoft Word, Research, Inpatient, Patient Safety, Healthcare Management, Medical Terminology, HIPAA, Nursing, Pharmacy, Healthcare Information..., EMR
Education
University of Phoenix 2012 — 2014
Master of Business Administration (MBA), Business Administration, Management and Operations
University of Phoenix 2009 — 2012
Bachelor's degree, Health/Health Care Administration/Management
Stewart Crumpler Stewart Crumpler's FDA Experience 1973 - 2001
Job Principal Life Sciences Consultant at Quintiles
Industry Medical Devices
Experience
Quintiles January 2015 - Present
Quintiles Consulting February 2007 - Present
Wyeth 2001 - 2006
FDA 1973 - 2001
Skills
GMP, Biotechnology, Validation, Change Control, Regulatory Affairs, Pharmaceutics, Pharmaceutical Industry, Lifesciences, Quality System, Medical Devices, Regulatory Requirements, Quality Control, Clinical Development, Regulatory Submissions, CAPA, Commercialization, Technology Transfer, V&V, 21 CFR Part 11, CRO, Clinical Trials, Sop, FDA, Biopharmaceuticals, Computer System..., GCP, Quality Assurance, Quality Auditing, Quality Management, R&D
Education
University of North Carolina at Chapel Hill 1971 — 1973
MSPH, Public Health, Radiological Hygiene
University of North Carolina at Chapel Hill 1967 — 1971
BS, Physics
Quintiles January 2015 - Present
Quintiles Consulting February 2007 - Present
Wyeth 2001 - 2006
FDA 1973 - 2001
Skills
GMP, Biotechnology, Validation, Change Control, Regulatory Affairs, Pharmaceutics, Pharmaceutical Industry, Lifesciences, Quality System, Medical Devices, Regulatory Requirements, Quality Control, Clinical Development, Regulatory Submissions, CAPA, Commercialization, Technology Transfer, V&V, 21 CFR Part 11, CRO, Clinical Trials, Sop, FDA, Biopharmaceuticals, Computer System..., GCP, Quality Assurance, Quality Auditing, Quality Management, R&D
Education
University of North Carolina at Chapel Hill 1971 — 1973
MSPH, Public Health, Radiological Hygiene
University of North Carolina at Chapel Hill 1967 — 1971
BS, Physics
Connie Cheng, PharmD, BCOP Connie Cheng, PharmD, BCOP's FDA Experience June 2009 - August 2009
Job Hematology/Oncology Clinical Pharmacist at Cleveland Clinic
Industry Hospital & Health Care
Experience
Cleveland Clinic July 2014 - Present
Cleveland Clinic July 2013 - June 2014
Cleveland Clinic July 2012 - June 2013
MedImmune May 2011 - July 2011
MedImmune June 2010 - August 2010
FDA June 2009 - August 2009
Education
University of Michigan 2008 — 2012
Doctor of Pharmacy (Pharm.D.)
University of Michigan 2005 — 2008
Bachelor of Science (B.S.), Biology, General
Cleveland Clinic July 2014 - Present
Cleveland Clinic July 2013 - June 2014
Cleveland Clinic July 2012 - June 2013
MedImmune May 2011 - July 2011
MedImmune June 2010 - August 2010
FDA June 2009 - August 2009
Education
University of Michigan 2008 — 2012
Doctor of Pharmacy (Pharm.D.)
University of Michigan 2005 — 2008
Bachelor of Science (B.S.), Biology, General
Kyle McMeekin's FDA Experience May 2010 - August 2010
Job Sales Engineer at QASymphony
Industry Information Technology and Services
Experience
QASymphony July 2015 - Present
Cognizant Technology Solutions June 2013 - June 2015
Orbital Sciences Corporation June 2012 - August 2012
University of Michigan Health System April 2011 - May 2012
FDA May 2010 - August 2010
Skills
.NET, Java, SQL, C++, Agile Testing, Agile Methodologies, JIRA, Version One, Rally
Education
University of Michigan 2009 — 2013
QASymphony July 2015 - Present
Cognizant Technology Solutions June 2013 - June 2015
Orbital Sciences Corporation June 2012 - August 2012
University of Michigan Health System April 2011 - May 2012
FDA May 2010 - August 2010
Skills
.NET, Java, SQL, C++, Agile Testing, Agile Methodologies, JIRA, Version One, Rally
Education
University of Michigan 2009 — 2013
Ryan Randall's FDA Experience August 2014 - Present
Job Biomedical Engineer / Scientific Reviewer at FDA
Industry Medical Devices
Experience
FDA August 2014 - Present
Medtronic CRDM - Heart Failure Research May 2013 - August 2013
Medtronic CRDM - Therapy Delivery Research May 2012 - August 2012
Advanced Human Modeling Lab - Wayne State University June 2011 - September 2011
Kongsberg Automotive June 2010 - September 2010
Skills
Matlab, Solidworks, Biomedical Engineering, Engineering, Finite Element Analysis, AutoCAD, Hypermesh, Research, ANSYS, Medical Devices, ISO 13485, FMEA, FDA, Project Management, Microsoft Office, Excel, Hazard Analysis, V&V, CAPA
Education
University of Michigan 2013 — 2014
M.S.E. Biomedical Engineering, Biomechanics
University of Michigan 2009 — 2013
B.S.E. Biomedical Engineering, Biomechanics
FDA August 2014 - Present
Medtronic CRDM - Heart Failure Research May 2013 - August 2013
Medtronic CRDM - Therapy Delivery Research May 2012 - August 2012
Advanced Human Modeling Lab - Wayne State University June 2011 - September 2011
Kongsberg Automotive June 2010 - September 2010
Skills
Matlab, Solidworks, Biomedical Engineering, Engineering, Finite Element Analysis, AutoCAD, Hypermesh, Research, ANSYS, Medical Devices, ISO 13485, FMEA, FDA, Project Management, Microsoft Office, Excel, Hazard Analysis, V&V, CAPA
Education
University of Michigan 2013 — 2014
M.S.E. Biomedical Engineering, Biomechanics
University of Michigan 2009 — 2013
B.S.E. Biomedical Engineering, Biomechanics
Claire (Perchonock) Myers Claire (Perchonock) Myers's FDA Experience November 2014 - Present
Job Regulatory Health Project Manager at FDA
Industry Government Administration
Experience
FDA November 2014 - Present
MedImmune July 2013 - October 2014
SRA International September 2010 - July 2013
Synchrogenix 2006 - August 2010
Skills
Project Management, PMP, Regulatory Affairs, Oncology, Immunology, Medical Writing, Medical Communications, Lifesciences, Clinical Trials, Clinical Development, Regulatory Submissions, Biotechnology, Clinical Research, Client Liaison, Commercialization, Government Contracting, CRO, Scientific Writing, Pharmaceutical Industry, Pharmacovigilance, IND/CTA Submissions, NDA/BLA Submissions, Peer Review Management, Agile Software..., Help Desk Management, Laboratory Research
Education
University of Pennsylvania 2001 — 2006
PhD, Immunology
Washington University in St. Louis 2000 — 2001
Immunology
University of Virginia 1996 — 2000
BA, Biology
Germantown Friends School 1990 — 1996
FDA November 2014 - Present
MedImmune July 2013 - October 2014
SRA International September 2010 - July 2013
Synchrogenix 2006 - August 2010
Skills
Project Management, PMP, Regulatory Affairs, Oncology, Immunology, Medical Writing, Medical Communications, Lifesciences, Clinical Trials, Clinical Development, Regulatory Submissions, Biotechnology, Clinical Research, Client Liaison, Commercialization, Government Contracting, CRO, Scientific Writing, Pharmaceutical Industry, Pharmacovigilance, IND/CTA Submissions, NDA/BLA Submissions, Peer Review Management, Agile Software..., Help Desk Management, Laboratory Research
Education
University of Pennsylvania 2001 — 2006
PhD, Immunology
Washington University in St. Louis 2000 — 2001
Immunology
University of Virginia 1996 — 2000
BA, Biology
Germantown Friends School 1990 — 1996
Aarthi Arab Aarthi Arab's FDA Experience September 2014 - Present
Job Regulatory Engineer at the Center for Tobacco Products, FDA
Industry Higher Education
Experience
FDA September 2014 - Present
Shikanov Biomaterials Lab August 2013 - Present
University of Michigan October 2010 - March 2013
University of Michigan Health System January 2012 - May 2012
Skills
Matlab, In Vivo, Labview, Autodesk Software, C++, PowerPoint, Microsoft Word, Microsoft Excel, Mammalian Cell Culture, Sterile Technique, Optical Microscopy, Dissection, Research, Cell Culture, Biomedical Engineering, Biochemistry, Animal Models, In Vitro, Biomaterials
Education
University of Michigan 2013 — 2014
Master's degree, Biomedical/Medical Engineering
University of Michigan 2009 — 2013
Bachelor of Science in Engineering, Bioengineering and Biomedical Engineering, Senior
FDA September 2014 - Present
Shikanov Biomaterials Lab August 2013 - Present
University of Michigan October 2010 - March 2013
University of Michigan Health System January 2012 - May 2012
Skills
Matlab, In Vivo, Labview, Autodesk Software, C++, PowerPoint, Microsoft Word, Microsoft Excel, Mammalian Cell Culture, Sterile Technique, Optical Microscopy, Dissection, Research, Cell Culture, Biomedical Engineering, Biochemistry, Animal Models, In Vitro, Biomaterials
Education
University of Michigan 2013 — 2014
Master's degree, Biomedical/Medical Engineering
University of Michigan 2009 — 2013
Bachelor of Science in Engineering, Bioengineering and Biomedical Engineering, Senior
aldo badano aldo badano's FDA Experience March 2001 - Present
Job Acting Deputy Director, DIDSR/OSEL/CDRH/FDA
Industry Government Administration
Experience
FDA March 2001 - Present
Skills
Medical Imaging, Biomedical Engineering, FDA, Medical Devices, Physics, Image Analysis, Science, Matlab, Teaching, Research, Digital Imaging, Data Analysis, Image Processing, Clinical Research, Analysis, Statistics, Healthcare
Education
University of Michigan
FDA March 2001 - Present
Skills
Medical Imaging, Biomedical Engineering, FDA, Medical Devices, Physics, Image Analysis, Science, Matlab, Teaching, Research, Digital Imaging, Data Analysis, Image Processing, Clinical Research, Analysis, Statistics, Healthcare
Education
University of Michigan
Laura Bach Laura Bach's FDA Experience May 2009 - August 2009
Job Research Manager at Campaign for TobaccoFree Kids
Industry Health, Wellness and Fitness
Experience
Campaign for Tobacco-Free Kids May 2015 - Present
University of North Carolina at Chapel Hill January 2014 - May 2015
CounterTobacco.Org May 2013 - May 2014
University of North Carolina at Chapel Hill August 2013 - December 2013
RTI International May 2013 - August 2013
University of North Carolina at Chapel Hill August 2012 - May 2013
Brown School at Washington University in St. Louis June 2010 - May 2012
FDA May 2009 - August 2009
Susan G. Komen for the Cure St. Louis Affiliate January 2009 - April 2009
Rush University Medical Center May 2008 - August 2008
Skills
Project Management, Program Evaluation, Process Evaluation, Survey Design, Clinical Trials, Stata, Qualitative Research, Qualtrics, Report Writing, Literature Reviews, Research, SPSS, InDesign, Atlas.ti, SAS, NVivo, ArcGIS, Wordpress, Key Informant Interviews, SharePoint, GeoDa, GWR, SaTScan, Health Program Planning, PowerPoint, Microsoft Excel, Toolkit development
Education
University of North Carolina at Chapel Hill 2012 — 2014
Master of Public Health (MPH), Health Behavior
Washington University in St. Louis 2006 — 2010
BA, Anthropology
Campaign for Tobacco-Free Kids May 2015 - Present
University of North Carolina at Chapel Hill January 2014 - May 2015
CounterTobacco.Org May 2013 - May 2014
University of North Carolina at Chapel Hill August 2013 - December 2013
RTI International May 2013 - August 2013
University of North Carolina at Chapel Hill August 2012 - May 2013
Brown School at Washington University in St. Louis June 2010 - May 2012
FDA May 2009 - August 2009
Susan G. Komen for the Cure St. Louis Affiliate January 2009 - April 2009
Rush University Medical Center May 2008 - August 2008
Skills
Project Management, Program Evaluation, Process Evaluation, Survey Design, Clinical Trials, Stata, Qualitative Research, Qualtrics, Report Writing, Literature Reviews, Research, SPSS, InDesign, Atlas.ti, SAS, NVivo, ArcGIS, Wordpress, Key Informant Interviews, SharePoint, GeoDa, GWR, SaTScan, Health Program Planning, PowerPoint, Microsoft Excel, Toolkit development
Education
University of North Carolina at Chapel Hill 2012 — 2014
Master of Public Health (MPH), Health Behavior
Washington University in St. Louis 2006 — 2010
BA, Anthropology
Matthew Psioda Matthew Psioda's FDA Experience August 2015 - Present
Job ORISE PreDoctoral Research Fellow at FDA
Industry Pharmaceuticals
Experience
FDA August 2015 - Present
University of North Carolina at Chapel Hill August 2011 - August 2015
INC Research April 2011 - August 2012
Kendle International August 2010 - April 2011
Kendle International June 2010 - August 2010
Kendle International March 2008 - June 2010
Kendle International June 2007 - March 2008
Skills
Biostatistics, CDISC, Clinical Trials, SAS programming, SDTM, SAS, Statistical Modeling, Statistical Consulting, CRO, Statistics, Statistical Programming, EDC, SAS Certified Base..., GCP, Survival Analysis, Clinical Study Design, Statistical Reporting, ADaM, Pharmacokinetics, Genomics, Advanced SAS Certified..., CTMS, FDA, Multivariate Statistics, SAS/SQL, Cancer Research, Oncology Clinical..., R, C++, C++ Language
Education
UNC Chapel Hill 2011 — 2015
PhD, Biostatistics
University of North Carolina at Wilmington 2008 — 2011
Graduate Certificate Program, Statistics
University of North Carolina at Wilmington 2004 — 2006
MS, Mathematics
University of North Carolina at Wilmington 2000 — 2004
BS, Mathematics
FDA August 2015 - Present
University of North Carolina at Chapel Hill August 2011 - August 2015
INC Research April 2011 - August 2012
Kendle International August 2010 - April 2011
Kendle International June 2010 - August 2010
Kendle International March 2008 - June 2010
Kendle International June 2007 - March 2008
Skills
Biostatistics, CDISC, Clinical Trials, SAS programming, SDTM, SAS, Statistical Modeling, Statistical Consulting, CRO, Statistics, Statistical Programming, EDC, SAS Certified Base..., GCP, Survival Analysis, Clinical Study Design, Statistical Reporting, ADaM, Pharmacokinetics, Genomics, Advanced SAS Certified..., CTMS, FDA, Multivariate Statistics, SAS/SQL, Cancer Research, Oncology Clinical..., R, C++, C++ Language
Education
UNC Chapel Hill 2011 — 2015
PhD, Biostatistics
University of North Carolina at Wilmington 2008 — 2011
Graduate Certificate Program, Statistics
University of North Carolina at Wilmington 2004 — 2006
MS, Mathematics
University of North Carolina at Wilmington 2000 — 2004
BS, Mathematics
Ariel Novick Ariel Novick's FDA Experience July 2007 - March 2008
Job Deputy Director, Transitional Reinsurance Program
Industry Public Policy
Experience
Centers for Medicare & Medicaid Services April 2010 - Present
Centers for Medicare and Medicaid Services, Office of Legislation April 2008 - March 2010
FDA July 2007 - March 2008
Skills
Public Health, Policy Analysis, Public Policy, Program Evaluation, Data Analysis, Government, Research, Statistics, Grants, Qualitative Research, Healthcare, Grant Writing, Program Development, Health Policy, Program Management, Public Speaking, International..., Strategic Planning, Nonprofits, Healthcare Information...
Education
University of Michigan 2005 — 2007
Master of Public Health (MPH), Public Health
Wellesley College 1998 — 2002
Bachelor of Arts (BA), Psychology, Magna Cum Laude
Centers for Medicare & Medicaid Services April 2010 - Present
Centers for Medicare and Medicaid Services, Office of Legislation April 2008 - March 2010
FDA July 2007 - March 2008
Skills
Public Health, Policy Analysis, Public Policy, Program Evaluation, Data Analysis, Government, Research, Statistics, Grants, Qualitative Research, Healthcare, Grant Writing, Program Development, Health Policy, Program Management, Public Speaking, International..., Strategic Planning, Nonprofits, Healthcare Information...
Education
University of Michigan 2005 — 2007
Master of Public Health (MPH), Public Health
Wellesley College 1998 — 2002
Bachelor of Arts (BA), Psychology, Magna Cum Laude
Ewan Plant Ewan Plant's FDA Experience August 2009 - Present
Job Staff Fellow, Food and Drug Administration
Industry Research
Experience
FDA August 2009 - Present
FDA March 2006 - August 2009
University of Maryland January 2002 - February 2006
UMDNJ January 2000 - December 2001
Skills
Manuscripts, Research, Molecular Biology, Life Sciences, Vaccines, Virology, Lifesciences, Cell Biology, Transfection, Cell Culture, PCR, Laboratory, Biochemistry, Manuscript, FDA, Genetics
Education
University of Otago
Bachelor of Science (B.Sc.), Biochemistry
FDA August 2009 - Present
FDA March 2006 - August 2009
University of Maryland January 2002 - February 2006
UMDNJ January 2000 - December 2001
Skills
Manuscripts, Research, Molecular Biology, Life Sciences, Vaccines, Virology, Lifesciences, Cell Biology, Transfection, Cell Culture, PCR, Laboratory, Biochemistry, Manuscript, FDA, Genetics
Education
University of Otago
Bachelor of Science (B.Sc.), Biochemistry
Eleni Anagnostiadis Eleni Anagnostiadis's FDA Experience July 2012 - Present
Job Director, Division of Supply Chain Integrity, U.S. Food and Drug Administration
Industry Government Administration
Experience
FDA July 2012 - Present
U.S. Public Health Service Commissioned Corps September 2011 - Present
FDA March 2010 - July 2012
National Association of Boards of Pharmacy January 2004 - February 2010
National Institute for Standards in Pharmacist Credentialing January 2001 - December 2003
Giant Pharmacy June 1989 - December 2000
Skills
Pharmacy, Pharmacists, Regulatory Affairs, Pharmaceutical Industry, Medication Therapy..., Pharmacy Automation, Patient Safety, Disease Management, Healthcare, Health Policy, Pharmaceutics, Medicare, Pharmacology, Pharmacy Benefit..., Public Health, Healthcare Management, Pharmacoeconomics, Healthcare Information..., Policy, Regulatory Requirements, Federal Government, Community Pharmacy, Certified Immunizer, Healthcare Industry, Global Health, Ambulatory Care, Patient Education, Supply Chain Management, Infectious Diseases, Medical Education
Education
University of North Carolina at Chapel Hill 1985 — 1990
Bachelor of Science, Pharmacy
FDA July 2012 - Present
U.S. Public Health Service Commissioned Corps September 2011 - Present
FDA March 2010 - July 2012
National Association of Boards of Pharmacy January 2004 - February 2010
National Institute for Standards in Pharmacist Credentialing January 2001 - December 2003
Giant Pharmacy June 1989 - December 2000
Skills
Pharmacy, Pharmacists, Regulatory Affairs, Pharmaceutical Industry, Medication Therapy..., Pharmacy Automation, Patient Safety, Disease Management, Healthcare, Health Policy, Pharmaceutics, Medicare, Pharmacology, Pharmacy Benefit..., Public Health, Healthcare Management, Pharmacoeconomics, Healthcare Information..., Policy, Regulatory Requirements, Federal Government, Community Pharmacy, Certified Immunizer, Healthcare Industry, Global Health, Ambulatory Care, Patient Education, Supply Chain Management, Infectious Diseases, Medical Education
Education
University of North Carolina at Chapel Hill 1985 — 1990
Bachelor of Science, Pharmacy
Nisarga Phatak Nisarga Phatak's FDA Experience July 2014 - Present
Job Postdoctoral Research Fellow at FDA
Industry Pharmaceuticals
Experience
FDA July 2014 - Present
University of Iowa August 2007 - May 2014
Covidien May 2011 - August 2011
University of Iowa, NMR Central Research Facility January 2010 - December 2010
University of Iowa August 2007 - May 2009
Pangea 3 June 2007 - July 2007
Skills
NMR spectroscopy, Mass Spectrometry, UV/Vis, HPLC, NMR, Chromatography, Spectroscopy, Chemistry, TGA, LC-MS, Organic Synthesis, FTIR, Gas Chromatography, Organic Chemistry, Characterization, GC-MS
Education
University of Iowa 2007 — 2014
PhD, Organic / Analytical Chemistry
University of Mumbai 2003 — 2007
B.Tech, Oils, Oleochemicals and Surfactant Technology
FDA July 2014 - Present
University of Iowa August 2007 - May 2014
Covidien May 2011 - August 2011
University of Iowa, NMR Central Research Facility January 2010 - December 2010
University of Iowa August 2007 - May 2009
Pangea 3 June 2007 - July 2007
Skills
NMR spectroscopy, Mass Spectrometry, UV/Vis, HPLC, NMR, Chromatography, Spectroscopy, Chemistry, TGA, LC-MS, Organic Synthesis, FTIR, Gas Chromatography, Organic Chemistry, Characterization, GC-MS
Education
University of Iowa 2007 — 2014
PhD, Organic / Analytical Chemistry
University of Mumbai 2003 — 2007
B.Tech, Oils, Oleochemicals and Surfactant Technology
Alyssa Milano Alyssa Milano's FDA Experience 2009 - 2010
Job QC Chemist at Johnson Matthey Pharma Services
Industry Chemicals
Experience
Johnson Matthey Pharma Services February 2014 - Present
PharmAssist, Inc. July 2011 - January 2014
FDA 2009 - 2010
Skills
HPLC, GLP, Laboratory, HPLC Qualification, HPLC Maintenance, UPLC, Dissolution Testing, Karl Fischer, GMP, Pharmaceutical Analysis, Analytical Chemistry, Analytical Methods..., Analytical Method..., Chemstation, Empower, Agilent EZ Chrome Elite, UV-Vis, FTIR, ATR-FTIR, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Powerpoint, ChemDraw, NMR spectroscopy, NMR, Dissolution, UV/Vis, NMR Spectroscopy
Education
University of New Hampshire 2007 — 2011
Bachelor of Science, Chemistry
Londonderry High School 2003 — 2007
Johnson Matthey Pharma Services February 2014 - Present
PharmAssist, Inc. July 2011 - January 2014
FDA 2009 - 2010
Skills
HPLC, GLP, Laboratory, HPLC Qualification, HPLC Maintenance, UPLC, Dissolution Testing, Karl Fischer, GMP, Pharmaceutical Analysis, Analytical Chemistry, Analytical Methods..., Analytical Method..., Chemstation, Empower, Agilent EZ Chrome Elite, UV-Vis, FTIR, ATR-FTIR, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Powerpoint, ChemDraw, NMR spectroscopy, NMR, Dissolution, UV/Vis, NMR Spectroscopy
Education
University of New Hampshire 2007 — 2011
Bachelor of Science, Chemistry
Londonderry High School 2003 — 2007
Phil Putter Phil Putter's FDA Experience June 2011 - January 2014
Job Legislative Affairs Specialist at National Aeronautics and Space Administration (NASA)
Industry Legislative Office
Experience
National Aeronautics and Space Administration (NASA) January 2014 - Present
FDA June 2011 - January 2014
Consultant January 2011 - June 2011
U.S. House of Representatives February 2008 - January 2011
U.S. House of Representatives February 2007 - February 2008
Penn, Schoen and Berland Associates August 2006 - February 2007
U.S. House of Representatives September 2003 - August 2006
Skills
Policy Analysis, Legislative Relations, Government, Public Policy, Legislation, Politics
Education
University of Pennsylvania 1999 — 2003
B.A., Political Science, Psychology
National Aeronautics and Space Administration (NASA) January 2014 - Present
FDA June 2011 - January 2014
Consultant January 2011 - June 2011
U.S. House of Representatives February 2008 - January 2011
U.S. House of Representatives February 2007 - February 2008
Penn, Schoen and Berland Associates August 2006 - February 2007
U.S. House of Representatives September 2003 - August 2006
Skills
Policy Analysis, Legislative Relations, Government, Public Policy, Legislation, Politics
Education
University of Pennsylvania 1999 — 2003
B.A., Political Science, Psychology
Panli Zheng's FDA Experience June 2015 - July 2015
Job Summer Intern at FDA
Industry Pharmaceuticals
Experience
Duke Translational Medicine Institute May 2015 - Present
Inmar December 2014 - Present
University of North Carolina at Chapel Hill July 2014 - Present
Division of Molecular Pharmaceutics, University of North Carolina at Chapel Hill January 2014 - Present
FDA June 2015 - July 2015
Duke Translational Medicine Institute January 2015 - March 2015
Howard Hughes Medical Institute 2012 - 2013
Skills
Molecular Biology, Western Blotting, Cell Culture, Molecular Cloning, PCR, Biochemistry, Protein Purification, Fluorescence Microscopy, Cell Biology, Genetics, Microscopy, Protein Expression, Neuroscience, Confocal Microscopy, Lifesciences, Transfection, Laboratory, Microsoft Excel, Matlab
Education
University of North Carolina at Chapel Hill 2013 — 2017
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of Washington 2009 — 2012
Bachelor of Science (B.S.), Biochemistry
Duke Translational Medicine Institute May 2015 - Present
Inmar December 2014 - Present
University of North Carolina at Chapel Hill July 2014 - Present
Division of Molecular Pharmaceutics, University of North Carolina at Chapel Hill January 2014 - Present
FDA June 2015 - July 2015
Duke Translational Medicine Institute January 2015 - March 2015
Howard Hughes Medical Institute 2012 - 2013
Skills
Molecular Biology, Western Blotting, Cell Culture, Molecular Cloning, PCR, Biochemistry, Protein Purification, Fluorescence Microscopy, Cell Biology, Genetics, Microscopy, Protein Expression, Neuroscience, Confocal Microscopy, Lifesciences, Transfection, Laboratory, Microsoft Excel, Matlab
Education
University of North Carolina at Chapel Hill 2013 — 2017
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of Washington 2009 — 2012
Bachelor of Science (B.S.), Biochemistry
Timothy Kropp Timothy Kropp's FDA Experience February 2011 - May 2013
Job Deputy Director at FDA/CDER/OTS/Office of Computational Science
Industry Public Safety
Experience
FDA/CDER/OTS/Office of Computational Science September 2015 - Present
FDA/CDER/OTS/Office of Computational Science June 2014 - Present
FDA/CDER/OTS/Office of Computational Science February 2014 - May 2014
FDA/CDER/OTS/Office of Computational Science May 2013 - February 2014
FDA February 2011 - May 2013
US FDA / CDER / Oncology Division July 2006 - February 2011
Environmental Working Group 2004 - 2006
Skills
FDA, Toxicology, Regulatory Submissions, Informatics, Biology, Research, Non-profits, Environmental Policy, Public Speaking, Program Management, Data Analysis, Project Management, Lifesciences, Science, Clinical Research, Regulatory Affairs, IND
Education
University of Michigan 2000 — 2004
Ph.D., Toxicology
University of Toledo 1995 — 1998
BS, Biology
FDA/CDER/OTS/Office of Computational Science September 2015 - Present
FDA/CDER/OTS/Office of Computational Science June 2014 - Present
FDA/CDER/OTS/Office of Computational Science February 2014 - May 2014
FDA/CDER/OTS/Office of Computational Science May 2013 - February 2014
FDA February 2011 - May 2013
US FDA / CDER / Oncology Division July 2006 - February 2011
Environmental Working Group 2004 - 2006
Skills
FDA, Toxicology, Regulatory Submissions, Informatics, Biology, Research, Non-profits, Environmental Policy, Public Speaking, Program Management, Data Analysis, Project Management, Lifesciences, Science, Clinical Research, Regulatory Affairs, IND
Education
University of Michigan 2000 — 2004
Ph.D., Toxicology
University of Toledo 1995 — 1998
BS, Biology
Lillian Hsu Lillian Hsu's FDA Experience February 2015 - Present
Job Microbiologist at FDA CFSAN
Industry Research
Experience
FDA February 2015 - Present
FDA January 2013 - Present
Cornell University August 2012 - December 2012
Cornell University August 2007 - September 2012
USDA-ARS July 2010 - August 2010
Skills
Microbiology, Food Science, Research, PCR, Western Blotting, Baking, Food Safety, Pulsed Light technology, Juice HACCP certified, Biochemistry, Food Chemistry, Nutrition, Food Microbiology, Life Sciences
Education
Cornell University 2007 — 2012
Doctor of Philosophy (Ph.D.), Food Science
University of Pennsylvania 2003 — 2007
BA & MS, Biochemistry & Chemistry
FDA February 2015 - Present
FDA January 2013 - Present
Cornell University August 2012 - December 2012
Cornell University August 2007 - September 2012
USDA-ARS July 2010 - August 2010
Skills
Microbiology, Food Science, Research, PCR, Western Blotting, Baking, Food Safety, Pulsed Light technology, Juice HACCP certified, Biochemistry, Food Chemistry, Nutrition, Food Microbiology, Life Sciences
Education
Cornell University 2007 — 2012
Doctor of Philosophy (Ph.D.), Food Science
University of Pennsylvania 2003 — 2007
BA & MS, Biochemistry & Chemistry
Leah Ford's FDA Experience September 2012 - May 2013
Job Student at University of North Carolina at Chapel Hill
Industry Public Policy
Experience
Earth Day Network June 2014 - August 2014
FDA September 2012 - May 2013
Skills
Cell
Education
University of North Carolina at Chapel Hill 2013 — 2017
Bachelor’s Degree, International/Global Studies and Public Policy
Earth Day Network June 2014 - August 2014
FDA September 2012 - May 2013
Skills
Cell
Education
University of North Carolina at Chapel Hill 2013 — 2017
Bachelor’s Degree, International/Global Studies and Public Policy
Antonia Curtin's FDA Experience June 2011 - August 2011
Job Graduate Research Assistant at University of Minnesota
Industry Biotechnology
Experience
University of Minnesota September 2013 - Present
UPMC September 2012 - April 2013
University of Pittsburgh September 2011 - September 2012
FDA June 2011 - August 2011
Skills
Biomedical Engineering, Mechanical Engineering, Matlab, SolidWorks, Biotechnology, Mechanical Testing, Biomechanics, Lifesciences, Labview, Cell Biology
Education
University of Minnesota-Twin Cities
Doctor of Philosophy (PhD), Bioengineering and Biomedical Engineering
University of Pittsburgh 2009 — 2013
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Walt Whitman High School, Bethesda, MD 2005 — 2009
University of Minnesota September 2013 - Present
UPMC September 2012 - April 2013
University of Pittsburgh September 2011 - September 2012
FDA June 2011 - August 2011
Skills
Biomedical Engineering, Mechanical Engineering, Matlab, SolidWorks, Biotechnology, Mechanical Testing, Biomechanics, Lifesciences, Labview, Cell Biology
Education
University of Minnesota-Twin Cities
Doctor of Philosophy (PhD), Bioengineering and Biomedical Engineering
University of Pittsburgh 2009 — 2013
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Walt Whitman High School, Bethesda, MD 2005 — 2009
Nisha Parikh's FDA Experience September 2015 - Present
Job Doctor of Pharmacy Candidate 2016
Industry Pharmaceuticals
Experience
FDA September 2015 - Present
Giant Pharmacy July 2013 - Present
McNeil Consumer Healthcare August 2015 - September 2015
Mercy Philadelphia Hospital July 2015 - August 2015
Indian Health Service May 2015 - June 2015
Acro Pharmaceutical Services January 2015 - May 2015
Drug Information Association August 2014 - August 2014
Walter Reed Army Medical Center May 2014 - May 2014
University of the Sciences in Philadelphia August 2013 - December 2013
Goodman Hall / University of the Sciences in Philadelphia August 2012 - May 2013
Skills
Microsoft Office, Public Speaking, Cpr Certified, Research, PowerPoint, Microsoft Word, Microsoft Excel, Teamwork, Social Media, HTML, Editing, Healthcare, Hospitals, Marketing, Pharmacueticals, CPR Certified, Pharmaceutical Industry, Pharmacy
Education
University of the Sciences in Philadelphia 2010 — 2016
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of the Sciences in Philadelphia 2010 — 2014
Bachelor of Science (B.S.) in Pharmaceutical and Healthcare Studies
University of New Haven 2013 — 2013
Pharmaceutical and Healthcare Business Minor, International Marketing
FDA September 2015 - Present
Giant Pharmacy July 2013 - Present
McNeil Consumer Healthcare August 2015 - September 2015
Mercy Philadelphia Hospital July 2015 - August 2015
Indian Health Service May 2015 - June 2015
Acro Pharmaceutical Services January 2015 - May 2015
Drug Information Association August 2014 - August 2014
Walter Reed Army Medical Center May 2014 - May 2014
University of the Sciences in Philadelphia August 2013 - December 2013
Goodman Hall / University of the Sciences in Philadelphia August 2012 - May 2013
Skills
Microsoft Office, Public Speaking, Cpr Certified, Research, PowerPoint, Microsoft Word, Microsoft Excel, Teamwork, Social Media, HTML, Editing, Healthcare, Hospitals, Marketing, Pharmacueticals, CPR Certified, Pharmaceutical Industry, Pharmacy
Education
University of the Sciences in Philadelphia 2010 — 2016
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of the Sciences in Philadelphia 2010 — 2014
Bachelor of Science (B.S.) in Pharmaceutical and Healthcare Studies
University of New Haven 2013 — 2013
Pharmaceutical and Healthcare Business Minor, International Marketing
Layla Batarseh's FDA Experience July 1993 - September 2009
Job FDA Middle East and North Africa Regional Office Director at The U.S. Food and Drug Administration
Industry Government Administration
Experience
The U.S. Food and Drug Administration July 2011 - Present
FDA July 1993 - September 2009
NCTR/FDA 1980 - 2007
Skills
FDA, Regulatory Affairs, Toxicology, Food Safety, HACCP, Food, Regulatory Submissions, Medical Devices, Microbiology, Public Health, Risk Assessment, Food Quality, Sop, GLP
Education
University of Michigan 1982 — 1986
PhD, Environmental Health Sciences
The U.S. Food and Drug Administration July 2011 - Present
FDA July 1993 - September 2009
NCTR/FDA 1980 - 2007
Skills
FDA, Regulatory Affairs, Toxicology, Food Safety, HACCP, Food, Regulatory Submissions, Medical Devices, Microbiology, Public Health, Risk Assessment, Food Quality, Sop, GLP
Education
University of Michigan 1982 — 1986
PhD, Environmental Health Sciences
Linh Lo's FDA Experience October 2011 - Present
Job Biomedical Engineer at FDA
Industry Medical Devices
Experience
FDA October 2011 - Present
FDA March 2015 - May 2015
TechStart - Office of Technology Transfer, University of Michigan May 2011 - July 2011
University of Michigan, Biomedical Engineering September 2002 - April 2011
University of Michigan, Department of Radiology 1999 - 2002
US Farathane June 1998 - August 1998
Skills
Tissue Engineering, Biomaterials, Cell Culture, Cell Based Assays, Microscopy, Fluorescence Microscopy, Biotechnology, FDA, Cell, Assay Development, ELISA, Confocal Microscopy, Medical Devices, Biomedical Engineering, Stem Cells, Characterization, Spectroscopy
Education
University of Michigan
M.S. and Ph.D., Biomedical Engineering
University of Michigan
B.S.E, Chemical Engineering
FDA October 2011 - Present
FDA March 2015 - May 2015
TechStart - Office of Technology Transfer, University of Michigan May 2011 - July 2011
University of Michigan, Biomedical Engineering September 2002 - April 2011
University of Michigan, Department of Radiology 1999 - 2002
US Farathane June 1998 - August 1998
Skills
Tissue Engineering, Biomaterials, Cell Culture, Cell Based Assays, Microscopy, Fluorescence Microscopy, Biotechnology, FDA, Cell, Assay Development, ELISA, Confocal Microscopy, Medical Devices, Biomedical Engineering, Stem Cells, Characterization, Spectroscopy
Education
University of Michigan
M.S. and Ph.D., Biomedical Engineering
University of Michigan
B.S.E, Chemical Engineering
Shelly Maifarth, RAC Shelly Maifarth, RAC's FDA Experience 1982 - 2006
Job Principal, FDA Compliance Group LLC
Industry Health, Wellness and Fitness
Experience
FDA Compliance Group LLC January 2008 - Present
U.S. Food and Drug Administration August 1982 - May 2006
FDA 1982 - 2006
Skills
FDA, GMP, Medical Devices, Quality Management, Quality Auditing, Supplements, Training, Inspection, Quality Assurance, Regulatory Affairs, CAPA, Quality System, Sop, Change Control, Pharmaceutics, Regulatory Requirements, Validation, Regulatory Submissions, Drug Development, Quality Control, GMP Audits, HACCP, Regulations, FDA GMP, PMA, GxP, GLP, 21 CFR Part 11, Gap Analysis, Pharmaceutical Industry, Supplier Evaluation, 483 and warning letter..., dietary Supplements, WL Remediation, Compliance Audits, Supplier Audits, Design Control, ISO 13485, 21 CFR, CE marking, V&V
Education
University of Michigan
BS
FDA Compliance Group LLC January 2008 - Present
U.S. Food and Drug Administration August 1982 - May 2006
FDA 1982 - 2006
Skills
FDA, GMP, Medical Devices, Quality Management, Quality Auditing, Supplements, Training, Inspection, Quality Assurance, Regulatory Affairs, CAPA, Quality System, Sop, Change Control, Pharmaceutics, Regulatory Requirements, Validation, Regulatory Submissions, Drug Development, Quality Control, GMP Audits, HACCP, Regulations, FDA GMP, PMA, GxP, GLP, 21 CFR Part 11, Gap Analysis, Pharmaceutical Industry, Supplier Evaluation, 483 and warning letter..., dietary Supplements, WL Remediation, Compliance Audits, Supplier Audits, Design Control, ISO 13485, 21 CFR, CE marking, V&V
Education
University of Michigan
BS
Angela Stark Angela Stark's FDA Experience June 2015 - Present
Job Press Officer at FDA
Industry Public Relations and Communications
Experience
FDA June 2015 - Present
Internet2 October 2014 - June 2015
The Optical Society January 2010 - October 2014
The Optical Society July 2008 - December 2009
The Optical Society August 2006 - June 2008
U.S. Newswire September 2004 - August 2006
Skills
Writing, Editing, Public Relations, Media Relations, Social Media, Strategic Communications, Social Media Strategy, Outreach Campaigns, Event Planning, Project Management, Personnel Management, Budgeting, Customer Relations, Government Relations, AP Style, Lobbying, Budgets, Social Media Marketing, Editorial, Customer Service, Journalism, Community Outreach, Web Content, Nonprofits, Press Releases, Public Speaking, Public Affairs, Research
Education
University of Northern Iowa 2000 — 2004
B.A.
FDA June 2015 - Present
Internet2 October 2014 - June 2015
The Optical Society January 2010 - October 2014
The Optical Society July 2008 - December 2009
The Optical Society August 2006 - June 2008
U.S. Newswire September 2004 - August 2006
Skills
Writing, Editing, Public Relations, Media Relations, Social Media, Strategic Communications, Social Media Strategy, Outreach Campaigns, Event Planning, Project Management, Personnel Management, Budgeting, Customer Relations, Government Relations, AP Style, Lobbying, Budgets, Social Media Marketing, Editorial, Customer Service, Journalism, Community Outreach, Web Content, Nonprofits, Press Releases, Public Speaking, Public Affairs, Research
Education
University of Northern Iowa 2000 — 2004
B.A.
Ashley Zborowsky Ashley Zborowsky's FDA Experience November 2013 - Present
Job Attorney at U.S. Food and Drug Administration
Industry Law Practice
Experience
FDA November 2013 - Present
Allina Hospitals & Clinics January 2006 - Present
Mayo Clinic June 2012 - April 2013
Public Health Law Center July 2011 - August 2011
Medtronic May 2010 - September 2010
Education
University of Minnesota Law School 2009 — 2013
Juris Doctor, Health Law and Bioethics
University of Minnesota School of Public Health 2009 — 2013
Masters of Public Health Administration, Public Health Administration and Policy
University of Minnesota-Twin Cities 2005 — 2009
Bachelor of Arts (B.A.), Psychology, summa cum laude
FDA November 2013 - Present
Allina Hospitals & Clinics January 2006 - Present
Mayo Clinic June 2012 - April 2013
Public Health Law Center July 2011 - August 2011
Medtronic May 2010 - September 2010
Education
University of Minnesota Law School 2009 — 2013
Juris Doctor, Health Law and Bioethics
University of Minnesota School of Public Health 2009 — 2013
Masters of Public Health Administration, Public Health Administration and Policy
University of Minnesota-Twin Cities 2005 — 2009
Bachelor of Arts (B.A.), Psychology, summa cum laude
Roshni Rao's FDA Experience November 2014 - Present
Job PostDoctoral Fellow at Center for Drug Evaluation and Research, US.FDA
Industry Research
Experience
FDA November 2014 - Present
University of South Carolina August 2009 - August 2014
University of South Carolina August 2009 - January 2010
University of Otago December 2006 - December 2008
University of Otago December 2007 - March 2008
Skills
Cell Culture, Western Blotting, Molecular Biology, PCR, Microsoft Office, RT-PCR, Research, Data Analysis, ELISA, Ingenuity Pathway..., Statistics, Leadership, Organizational..., Transient Transfection, Luciferase Assay, Gene Expression, Immunology, Toxicology, In Vivo, In Vitro, Natural Compounds, Lung, Mouse Models, Mouse Handling, Experimental Design, Oral & Written..., Team Leadership, Microbiology, Biochemistry
Education
University of South Carolina-Columbia 2009 — 2014
Doctor of Philosophy (PhD), Biological and Biomedical Sciences
University of Otago 2007 — 2009
BS (Hons), Microbiology and Immunology
St Joseph's College of Arts and Science, Bangalore, India 2003 — 2006
Bachelor of Science (BSc), Microbiology, Chemistry and Botany
Bishop Cotton Girls' High School 2001 — 2003
Physics, Chemistry, Biology, Mathematics
FDA November 2014 - Present
University of South Carolina August 2009 - August 2014
University of South Carolina August 2009 - January 2010
University of Otago December 2006 - December 2008
University of Otago December 2007 - March 2008
Skills
Cell Culture, Western Blotting, Molecular Biology, PCR, Microsoft Office, RT-PCR, Research, Data Analysis, ELISA, Ingenuity Pathway..., Statistics, Leadership, Organizational..., Transient Transfection, Luciferase Assay, Gene Expression, Immunology, Toxicology, In Vivo, In Vitro, Natural Compounds, Lung, Mouse Models, Mouse Handling, Experimental Design, Oral & Written..., Team Leadership, Microbiology, Biochemistry
Education
University of South Carolina-Columbia 2009 — 2014
Doctor of Philosophy (PhD), Biological and Biomedical Sciences
University of Otago 2007 — 2009
BS (Hons), Microbiology and Immunology
St Joseph's College of Arts and Science, Bangalore, India 2003 — 2006
Bachelor of Science (BSc), Microbiology, Chemistry and Botany
Bishop Cotton Girls' High School 2001 — 2003
Physics, Chemistry, Biology, Mathematics
Laura Trollinger Laura Trollinger's FDA Experience May 2012 - August 2012
Job M.D. Candidate at the University of North Carolina at Chapel Hill
Industry Hospital & Health Care
Experience
Deloitte July 2015 - August 2015
Deloitte August 2013 - June 2015
Wake 'N Shake Dance Marathon, Brian Piccolo Cancer Research Fund May 2012 - May 2013
FDA May 2012 - August 2012
Restore Study in the Department of Health and Exercise Science March 2011 - June 2012
Asheboro Dermatology and Skin Surgery Center July 2011 - August 2011
Hodges Family Practice November 2010 - January 2011
Skills
Research, Fundraising, PowerPoint, Social Media, SPSS, Google Docs, Facebook, Event Planning, Analysis, Leadership, Data Analysis, Microsoft Excel, Microsoft Word, Innovation Consulting, Digital Strategy
Education
University of North Carolina at Chapel Hill School of Medicine 2015 — 2019
Doctor of Medicine (M.D.)
Wake Forest University
Bachelor of Science, Health and Exercise Science, minors in Chemistry and Biology
Deloitte July 2015 - August 2015
Deloitte August 2013 - June 2015
Wake 'N Shake Dance Marathon, Brian Piccolo Cancer Research Fund May 2012 - May 2013
FDA May 2012 - August 2012
Restore Study in the Department of Health and Exercise Science March 2011 - June 2012
Asheboro Dermatology and Skin Surgery Center July 2011 - August 2011
Hodges Family Practice November 2010 - January 2011
Skills
Research, Fundraising, PowerPoint, Social Media, SPSS, Google Docs, Facebook, Event Planning, Analysis, Leadership, Data Analysis, Microsoft Excel, Microsoft Word, Innovation Consulting, Digital Strategy
Education
University of North Carolina at Chapel Hill School of Medicine 2015 — 2019
Doctor of Medicine (M.D.)
Wake Forest University
Bachelor of Science, Health and Exercise Science, minors in Chemistry and Biology
Man Luo's FDA Experience July 2011 - August 2012
Job Senior Research Investigator at BristolMyers Squibb
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb July 2013 - Present
The Hamner Institutes for Health Sciences August 2012 - July 2013
FDA July 2011 - August 2012
EU/US HPC Summer School August 2011 - August 2011
GlaxoSmithKline May 2010 - February 2011
SAMSI July 2010 - July 2010
GlaxoSmithKline May 2009 - October 2009
Skills
Clinical Pharmacology, Pharmacometrics, Pharmacokinetics..., Pharmacogenomics, Molecular Modeling, Cheminformatics, Data Mining, Text Mining, Drug Discovery, R, SAS, NONMEM, WinNonlin, Pharmacokinetics, Pharmacodynamics, Clinical Development, Bioinformatics
Education
University of North Carolina at Chapel Hill 2007 — 2011
Ph.D, Pharmaceutical Sciences
Wuhan University 2003 — 2007
BS, Biotechnology
Bristol-Myers Squibb July 2013 - Present
The Hamner Institutes for Health Sciences August 2012 - July 2013
FDA July 2011 - August 2012
EU/US HPC Summer School August 2011 - August 2011
GlaxoSmithKline May 2010 - February 2011
SAMSI July 2010 - July 2010
GlaxoSmithKline May 2009 - October 2009
Skills
Clinical Pharmacology, Pharmacometrics, Pharmacokinetics..., Pharmacogenomics, Molecular Modeling, Cheminformatics, Data Mining, Text Mining, Drug Discovery, R, SAS, NONMEM, WinNonlin, Pharmacokinetics, Pharmacodynamics, Clinical Development, Bioinformatics
Education
University of North Carolina at Chapel Hill 2007 — 2011
Ph.D, Pharmaceutical Sciences
Wuhan University 2003 — 2007
BS, Biotechnology
Holly Budlong (Epperly), PharmD, PhD Holly Budlong (Epperly), PharmD, PhD's FDA Experience October 2011 - December 2012
Job Medical Outcomes Specialist
Industry Pharmaceuticals
Experience
Pfizer May 2015 - Present
University of Minnesota College of Pharmacy May 2013 - Present
Target July 2013 - May 2015
Medtronic January 2013 - July 2013
FDA October 2011 - December 2012
FDA July 2011 - October 2011
Fairview Health Services August 2007 - June 2011
Prism Clinical Research July 2007 - June 2011
Chronic Disease Research Group February 2010 - May 2011
University of Minnesota August 2009 - May 2010
Skills
SAS, Xcel, Research, Analysis, Epidemiology, Teaching, Healthcare, Outcomes Research, Pharmaceuticals, Pharmaceutical Industry, Pharmacovigilance, Pharmacoepidemiology, Pharmacy, Medical Devices, Public Health, Health Policy, Pharmacy Automation, Clinical Research, Pharmacists, Pharmacoeconomics, Diabetes, Patient Safety, Medicine, Neuromodulation, Spinal Cord Stimulation, Deep Brain Stimulation, Oncology, Pharmacokinetics, Pharmacology, Clinical Trials, Clinical Pharmacy, Compounding, Clinical Pharmacology, Health Economics, Evidence-based Medicine, Medication Therapy..., Patient Counseling, Informatics, Medical Writing, Infectious Diseases, Disease Management, Immunization
Education
University of Minnesota-Twin Cities 2007 — 2011
Doctor of Philosophy (Ph.D.), Social and Administrative Pharmacy, Epidemiology
University of Nebraska Medical Center 2003 — 2007
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of Nebraska-Lincoln 2001 — 2003
N/A, Chemistry
Pfizer May 2015 - Present
University of Minnesota College of Pharmacy May 2013 - Present
Target July 2013 - May 2015
Medtronic January 2013 - July 2013
FDA October 2011 - December 2012
FDA July 2011 - October 2011
Fairview Health Services August 2007 - June 2011
Prism Clinical Research July 2007 - June 2011
Chronic Disease Research Group February 2010 - May 2011
University of Minnesota August 2009 - May 2010
Skills
SAS, Xcel, Research, Analysis, Epidemiology, Teaching, Healthcare, Outcomes Research, Pharmaceuticals, Pharmaceutical Industry, Pharmacovigilance, Pharmacoepidemiology, Pharmacy, Medical Devices, Public Health, Health Policy, Pharmacy Automation, Clinical Research, Pharmacists, Pharmacoeconomics, Diabetes, Patient Safety, Medicine, Neuromodulation, Spinal Cord Stimulation, Deep Brain Stimulation, Oncology, Pharmacokinetics, Pharmacology, Clinical Trials, Clinical Pharmacy, Compounding, Clinical Pharmacology, Health Economics, Evidence-based Medicine, Medication Therapy..., Patient Counseling, Informatics, Medical Writing, Infectious Diseases, Disease Management, Immunization
Education
University of Minnesota-Twin Cities 2007 — 2011
Doctor of Philosophy (Ph.D.), Social and Administrative Pharmacy, Epidemiology
University of Nebraska Medical Center 2003 — 2007
Doctor of Pharmacy (Pharm.D.), Pharmacy
University of Nebraska-Lincoln 2001 — 2003
N/A, Chemistry
Ethan Cohen Ethan Cohen's FDA Experience July 2003 - Present
Job Scientist at FDA
Industry Government Administration
Experience
FDA July 2003 - Present
Harvard University 1999 - 2003
Marine Biological Laboratory 2001 - 2001
Yale University School of Medicine 1992 - 1999
Skills
Neuroscience, Neuropharmacology, Neuroimaging, Medical Devices, Physiology, Immunohistochemistry, Electrophysiology, In Vivo, Animal Models, Microscopy, Fluorescence Microscopy, Pharmacology, Scientific Writing, Science, Histology, In Vitro, Cell Culture, Cell, Molecular Biology, Lifesciences, Drug Discovery, Biomedical Engineering, Confocal Microscopy, Retinal Prostheses, Optic Coherence..., Optogenetics
Education
University of Pennsylvania School of Medicine 1980 — 1987
Ph.D., Neuroanatomy
Washington University in St. Louis 1976 — 1980
Bachelor of Science, Biology
FDA July 2003 - Present
Harvard University 1999 - 2003
Marine Biological Laboratory 2001 - 2001
Yale University School of Medicine 1992 - 1999
Skills
Neuroscience, Neuropharmacology, Neuroimaging, Medical Devices, Physiology, Immunohistochemistry, Electrophysiology, In Vivo, Animal Models, Microscopy, Fluorescence Microscopy, Pharmacology, Scientific Writing, Science, Histology, In Vitro, Cell Culture, Cell, Molecular Biology, Lifesciences, Drug Discovery, Biomedical Engineering, Confocal Microscopy, Retinal Prostheses, Optic Coherence..., Optogenetics
Education
University of Pennsylvania School of Medicine 1980 — 1987
Ph.D., Neuroanatomy
Washington University in St. Louis 1976 — 1980
Bachelor of Science, Biology
Aimee Edwin Aimee Edwin's FDA Experience September 2008 - March 2011
Job Epic AnalystBeaker
Industry Information Technology and Services
Experience
Health Data Specialists, LLC August 2014 - Present
Medix Staffing Solutions February 2013 - August 2014
J & J Audit and Consulting April 2011 - May 2013
FDA September 2008 - March 2011
Education
University of Minnesota Medical School
MD
Health Data Specialists, LLC August 2014 - Present
Medix Staffing Solutions February 2013 - August 2014
J & J Audit and Consulting April 2011 - May 2013
FDA September 2008 - March 2011
Education
University of Minnesota Medical School
MD
Daniel Orr Daniel Orr's FDA Experience December 2013 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA December 2013 - Present
Morgan, Lewis & Bockius LLP October 2004 - October 2011
U.S. Department of Commerce May 2000 - August 2000
United States Senate February 1998 - October 1999
Skills
Commercial Litigation, Litigation, Civil Litigation, Intellectual Property, Legal Research, Class Actions, Legal Writing, Patents, Trade Secrets
Education
Vanderbilt University Law School 2001 — 2004
J.D., Law
Annenberg School, University of Pennsylvania 1999 — 2001
MA, Communication
University of Pennsylvania 1994 — 1998
BA, Communication with distinction
City University of New York 2011 — 2013
BS, Molecular Biology cum laude
Delbarton 1990 — 1994
FDA December 2013 - Present
Morgan, Lewis & Bockius LLP October 2004 - October 2011
U.S. Department of Commerce May 2000 - August 2000
United States Senate February 1998 - October 1999
Skills
Commercial Litigation, Litigation, Civil Litigation, Intellectual Property, Legal Research, Class Actions, Legal Writing, Patents, Trade Secrets
Education
Vanderbilt University Law School 2001 — 2004
J.D., Law
Annenberg School, University of Pennsylvania 1999 — 2001
MA, Communication
University of Pennsylvania 1994 — 1998
BA, Communication with distinction
City University of New York 2011 — 2013
BS, Molecular Biology cum laude
Delbarton 1990 — 1994
James Rinaldi's FDA Experience August 2002 - August 2005
Job CIO at Jet Propulsion Laboratory
Industry Aviation & Aerospace
Experience
Jet Propulsion Laboratory August 2005 - Present
FDA August 2002 - August 2005
Internal Revenue Service April 2001 - August 2002
Marriott International 1985 - 2001
Paradyne November 1982 - November 1985
SCM Organic Chemicals May 1977 - November 1982
Data Applications August 1973 - July 1977
Education
University of North Florida 1975 — 1980
Jet Propulsion Laboratory August 2005 - Present
FDA August 2002 - August 2005
Internal Revenue Service April 2001 - August 2002
Marriott International 1985 - 2001
Paradyne November 1982 - November 1985
SCM Organic Chemicals May 1977 - November 1982
Data Applications August 1973 - July 1977
Education
University of North Florida 1975 — 1980
Denise Hampton's FDA Experience 2013 - Present
Job Branch Chief at FDA
Industry Government Administration
Experience
FDA 2013 - Present
FDA 2006 - 2013
National Institutes of Health 2003 - 2006
Skills
Lifesciences, Microbiology, Infectious Diseases, Molecular Biology, Public Health, Government, Regulatory Affairs, FDA, Immunology, Policy, Data Analysis, Biotechnology, Biochemistry, Cell Biology, Research, Clinical Trials, Regulatory Submissions, Science, Cell, Life Sciences, Cell Culture
Education
University of North Carolina at Chapel Hill
BS, Biology
University of Virginia
Doctor of Philosophy (Ph.D.), Microbiology
FDA 2013 - Present
FDA 2006 - 2013
National Institutes of Health 2003 - 2006
Skills
Lifesciences, Microbiology, Infectious Diseases, Molecular Biology, Public Health, Government, Regulatory Affairs, FDA, Immunology, Policy, Data Analysis, Biotechnology, Biochemistry, Cell Biology, Research, Clinical Trials, Regulatory Submissions, Science, Cell, Life Sciences, Cell Culture
Education
University of North Carolina at Chapel Hill
BS, Biology
University of Virginia
Doctor of Philosophy (Ph.D.), Microbiology
Betsy Rosenblatt's FDA Experience June 2008 - August 2008
Job Detailee at U.S. Senate Committee on Energy & Natural Resources
Industry Oil & Energy
Experience
U.S. Senate Committee on Energy & Natural Resources July 2015 - Present
Federal Energy Regulatory Commission May 2011 - Present
Federal Energy Regulatory Commission January 2010 - May 2011
FDA June 2008 - August 2008
Skills
SAS programming, SQL, Energy, Access, Analysis, Statistics, Project Management, Financial Modeling, Energy Policy, SAS, Data Analysis, Economics, Quantitative Analytics, Renewable Energy, Public Policy, Policy Analysis, Policy, Research, Government, Microsoft Office, Management, Financial Analysis, Strategy, Business Strategy, Program Management, Social Media, Sustainability, Natural Gas
Education
University of Pennsylvania 2005 — 2009
Bachelors of Science in Engineering, Materials Science
Roosevelt High School 2001 — 2005
U.S. Senate Committee on Energy & Natural Resources July 2015 - Present
Federal Energy Regulatory Commission May 2011 - Present
Federal Energy Regulatory Commission January 2010 - May 2011
FDA June 2008 - August 2008
Skills
SAS programming, SQL, Energy, Access, Analysis, Statistics, Project Management, Financial Modeling, Energy Policy, SAS, Data Analysis, Economics, Quantitative Analytics, Renewable Energy, Public Policy, Policy Analysis, Policy, Research, Government, Microsoft Office, Management, Financial Analysis, Strategy, Business Strategy, Program Management, Social Media, Sustainability, Natural Gas
Education
University of Pennsylvania 2005 — 2009
Bachelors of Science in Engineering, Materials Science
Roosevelt High School 2001 — 2005
Alice Tu Alice Tu's FDA Experience December 2013 - Present
Job Team Leader
Industry Government Administration
Experience
FDA December 2013 - Present
Food and Drug Administration June 2010 - December 2013
FDA July 2009 - June 2010
Medco July 2008 - June 2009
Skills
FDA, Pharmacy, Pharmacists, Pharmacovigilance, Public Health, Regulatory Affairs, Pharmacoepidemiology, Informatics
Education
UNC Eshelman School of Pharmacy 2004 — 2008
PharmD, Pharmacy
University of North Carolina at Chapel Hill 2002 — 2004
BS in Pharmaceutical Science, Pharmaceutical Science
FDA December 2013 - Present
Food and Drug Administration June 2010 - December 2013
FDA July 2009 - June 2010
Medco July 2008 - June 2009
Skills
FDA, Pharmacy, Pharmacists, Pharmacovigilance, Public Health, Regulatory Affairs, Pharmacoepidemiology, Informatics
Education
UNC Eshelman School of Pharmacy 2004 — 2008
PharmD, Pharmacy
University of North Carolina at Chapel Hill 2002 — 2004
BS in Pharmaceutical Science, Pharmaceutical Science
Robert Glenn Stephens's FDA Experience December 2012 - August 2014
Job Student in Holistic Nutrition, and plan to enrol in ND program next year.
Industry Research
Experience
FDA December 2012 - August 2014
Ixpanpajul Resort and Park August 2011 - January 2013
ClubZ Tutoring December 2010 - May 2011
Strite's Garage November 2008 - September 2009
Las Vegas Valley Water District July 2006 - August 2008
Skills
Matlab, Microsoft Excel, Access, Energy Systems Analysis, Water Systems, Water Pumps, Equipment Maintenance, Acoustic Measurement, Spanish-English, Teamwork, Yamaha M7CL, Audio Engineering, Project Management, Public Speaking, CAD, AutoCAD
Education
Hawthorn University 2014 — 2017
MS - Holistic Nutrition
University of Nevada-Las Vegas 2004 — 2008
Bachelor of Science (BS), Mechanical Engineering
Hawthorn University
FDA December 2012 - August 2014
Ixpanpajul Resort and Park August 2011 - January 2013
ClubZ Tutoring December 2010 - May 2011
Strite's Garage November 2008 - September 2009
Las Vegas Valley Water District July 2006 - August 2008
Skills
Matlab, Microsoft Excel, Access, Energy Systems Analysis, Water Systems, Water Pumps, Equipment Maintenance, Acoustic Measurement, Spanish-English, Teamwork, Yamaha M7CL, Audio Engineering, Project Management, Public Speaking, CAD, AutoCAD
Education
Hawthorn University 2014 — 2017
MS - Holistic Nutrition
University of Nevada-Las Vegas 2004 — 2008
Bachelor of Science (BS), Mechanical Engineering
Hawthorn University
Noah Goodman's FDA Experience 2007 - 2007
Job MBA Candidate at The Wharton School
Industry Biotechnology
Experience
Spark Therapeutics, Inc. June 2015 - August 2015
Velano Vascular, Inc. September 2014 - 2015
Easton Associates (Navigant Consulting) 2010 - 2014
Jibo, Inc. 2010 - 2013
The State of the USA June 2009 - October 2010
Advanced Circulatory Systems Inc. May 2008 - August 2008
FDA 2007 - 2007
Skills
Biotechnology, Medical Devices, Business Development, Due Diligence, Lifesciences, Opportunity Assessment, Market Research, Venture Capital, Start-ups, Healthcare, Marketing Strategy, Management Consulting, Business Strategy, Strategic Planning, Pharmaceutics, Medical Diagnostics, Biosimilars, Pharmaceutical Industry, Product Launch, Commercialization, Strategy, Consulting, Cross-functional Team..., Project Management, Product Development
Education
University of Pennsylvania - The Wharton School 2014 — 2016
Master of Business Administration (MBA), Health Care Management
University of Michigan
B.S., Neuroscience
Spark Therapeutics, Inc. June 2015 - August 2015
Velano Vascular, Inc. September 2014 - 2015
Easton Associates (Navigant Consulting) 2010 - 2014
Jibo, Inc. 2010 - 2013
The State of the USA June 2009 - October 2010
Advanced Circulatory Systems Inc. May 2008 - August 2008
FDA 2007 - 2007
Skills
Biotechnology, Medical Devices, Business Development, Due Diligence, Lifesciences, Opportunity Assessment, Market Research, Venture Capital, Start-ups, Healthcare, Marketing Strategy, Management Consulting, Business Strategy, Strategic Planning, Pharmaceutics, Medical Diagnostics, Biosimilars, Pharmaceutical Industry, Product Launch, Commercialization, Strategy, Consulting, Cross-functional Team..., Project Management, Product Development
Education
University of Pennsylvania - The Wharton School 2014 — 2016
Master of Business Administration (MBA), Health Care Management
University of Michigan
B.S., Neuroscience
Nicolle Strand's FDA Experience May 2012 - July 2012
Job Research Analyst at Presidential Commission for the Study of Bioethical Issues
Industry Public Policy
Experience
Presidential Commission for the Study of Bioethical Issues ExternUniversity of Pennsylvania Office of General Counsel2013 - 2013
FDA May 2012 - July 2012
Legal Aid Society June 2011 - August 2011
Education
University of Pennsylvania 2010 — 2013
MBE, Masters of Bioethics
University of Pennsylvania Law School 2010 — 2013
Wellesley College 2006 — 2010
BA, Bioethics
Presidential Commission for the Study of Bioethical Issues ExternUniversity of Pennsylvania Office of General Counsel2013 - 2013
FDA May 2012 - July 2012
Legal Aid Society June 2011 - August 2011
Education
University of Pennsylvania 2010 — 2013
MBE, Masters of Bioethics
University of Pennsylvania Law School 2010 — 2013
Wellesley College 2006 — 2010
BA, Bioethics
Nikita Steward Nikita Steward's FDA Experience November 2014 - Present
Job Government Information Specialist at FDA
Industry Government Administration
Experience
FDA November 2014 - Present
Substance and Mental Health Services Admininstation August 2013 - November 2014
US Department of Health and Human Services March 2006 - August 2013
DHHS-SAMHSA-OPPI November 2012 - February 2013
DHHS-NIH / NIDA December 2006 - March 2009
Skills
Community Outreach, Public Speaking, Strategic Planning, Government, Policy, Budgets, Teamwork, Grants, Public Policy, Event Planning, Strategy, Management, Program Management, Fundraising, Administrative...
Education
University of the District of Columbia 2004 — 2004
Bachelor of Business Administration (B.B.A.), Business Management
University of Phoenix
Associate's degree, Associate of Arts with concentration in Communications
FDA November 2014 - Present
Substance and Mental Health Services Admininstation August 2013 - November 2014
US Department of Health and Human Services March 2006 - August 2013
DHHS-SAMHSA-OPPI November 2012 - February 2013
DHHS-NIH / NIDA December 2006 - March 2009
Skills
Community Outreach, Public Speaking, Strategic Planning, Government, Policy, Budgets, Teamwork, Grants, Public Policy, Event Planning, Strategy, Management, Program Management, Fundraising, Administrative...
Education
University of the District of Columbia 2004 — 2004
Bachelor of Business Administration (B.B.A.), Business Management
University of Phoenix
Associate's degree, Associate of Arts with concentration in Communications
Michael Axelson's FDA Experience August 2009 - August 2012
Job Oncology Development Medical Lead Joint Development Team
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb August 2015 - Present
Bristol-Myers Squibb August 2013 - August 2015
Oncology Specialist of Charlotte August 2012 - July 2013
PERI March 2013 - 2013
FDA August 2009 - August 2012
UT Southwestern Medical Center at Dallas July 2006 - June 2009
University of Texas Southwestern July 2003 - June 2006
Skills
Oncology, Drug Development, Regulatory Requirements, Drug Safety, Hematology, Clinical Trial Analysis, FDA, Cancer, Biologics, Medicine, Clinical Trials, IND
Education
University of Michigan Medical School 1999 — 2003
Doctor of Medicine (MD)
University of Michigan 1994 — 1998
Bachelor of Science (B.S.)
Bristol-Myers Squibb August 2015 - Present
Bristol-Myers Squibb August 2013 - August 2015
Oncology Specialist of Charlotte August 2012 - July 2013
PERI March 2013 - 2013
FDA August 2009 - August 2012
UT Southwestern Medical Center at Dallas July 2006 - June 2009
University of Texas Southwestern July 2003 - June 2006
Skills
Oncology, Drug Development, Regulatory Requirements, Drug Safety, Hematology, Clinical Trial Analysis, FDA, Cancer, Biologics, Medicine, Clinical Trials, IND
Education
University of Michigan Medical School 1999 — 2003
Doctor of Medicine (MD)
University of Michigan 1994 — 1998
Bachelor of Science (B.S.)
Purav Bhatt Purav Bhatt's FDA Experience June 2013 - July 2013
Job Medical Science Liaison at Fresenius Medical Care
Industry Pharmaceuticals
Experience
Fresenius Medical Care September 2014 - Present
GlaxoSmithKline August 2013 - July 2014
FDA June 2013 - July 2013
UNC Health Care July 2012 - May 2013
Rite Aid Pharmacy 2009 - July 2012
Skills
Pharmacology, Clinical Research, Drug Development, Medical Affairs, Regulatory Submissions, Project Management, Pharmacokinetics, Protocol, Clinical Trials, Pharmaceutical Industry, FDA, Healthcare, Oncology, Clinical Development, Medicine, Biotechnology, Hospitals, Regulatory Affairs
Education
UNC Eshelman School of Pharmacy 2008 — 2012
Doctor of Pharmacy (Pharm.D.), Pharmacy
UNC Chapel Hill 2006 — 2010
Bachelor of Science (BS), Pharmaceutical Sciences
Fresenius Medical Care September 2014 - Present
GlaxoSmithKline August 2013 - July 2014
FDA June 2013 - July 2013
UNC Health Care July 2012 - May 2013
Rite Aid Pharmacy 2009 - July 2012
Skills
Pharmacology, Clinical Research, Drug Development, Medical Affairs, Regulatory Submissions, Project Management, Pharmacokinetics, Protocol, Clinical Trials, Pharmaceutical Industry, FDA, Healthcare, Oncology, Clinical Development, Medicine, Biotechnology, Hospitals, Regulatory Affairs
Education
UNC Eshelman School of Pharmacy 2008 — 2012
Doctor of Pharmacy (Pharm.D.), Pharmacy
UNC Chapel Hill 2006 — 2010
Bachelor of Science (BS), Pharmaceutical Sciences
Lana Lake Lana Lake's FDA Experience October 2014 - Present
Job Quality Manager with FDA, Division of Pharmaceutical Analysis
Industry Pharmaceuticals
Experience
FDA October 2014 - Present
Mallinckrodt December 2012 - October 2014
Covidien July 2002 - December 2012
Tyco Healthcare/Mallinckrodt 2002 - 2006
American Red Cross August 2000 - July 2002
St. Louis County Department of Health 1998 - 2000
Chiron Corporation 1997 - 1998
Skills
CQA, Certified Manager of..., Change Control, Pharmaceutical Industry, Quality Auditing, Regulatory Affairs, Cleaning Validation, Quality Assurance, LIMS, GAMP, Document Management, Validation, Supervisory Skills, SOP development, APIs, Quality Management, Quality System..., Analytical Chemistry, Quality Control, HPLC, 21 CFR Part 11, Root Cause Analysis, Quality System, GMP, FDA, SOP, CAPA, Laboratory
Education
Webster University 2005 — 2007
Master of Arts (M.A.), Quality Management
University of Missouri-Columbia 1993 — 1997
Bachelor of Science (B.S.), Biochemistry
FDA October 2014 - Present
Mallinckrodt December 2012 - October 2014
Covidien July 2002 - December 2012
Tyco Healthcare/Mallinckrodt 2002 - 2006
American Red Cross August 2000 - July 2002
St. Louis County Department of Health 1998 - 2000
Chiron Corporation 1997 - 1998
Skills
CQA, Certified Manager of..., Change Control, Pharmaceutical Industry, Quality Auditing, Regulatory Affairs, Cleaning Validation, Quality Assurance, LIMS, GAMP, Document Management, Validation, Supervisory Skills, SOP development, APIs, Quality Management, Quality System..., Analytical Chemistry, Quality Control, HPLC, 21 CFR Part 11, Root Cause Analysis, Quality System, GMP, FDA, SOP, CAPA, Laboratory
Education
Webster University 2005 — 2007
Master of Arts (M.A.), Quality Management
University of Missouri-Columbia 1993 — 1997
Bachelor of Science (B.S.), Biochemistry
Patrick Raulerson Patrick Raulerson's FDA Experience May 2009 - Present
Job Regulatory Counsel at FDA
Industry Legal Services
Experience
FDA May 2009 - Present
Goodwin Procter LLP February 2005 - May 2008
Education
University of Michigan Law School 1998 — 2001
J.D.
FDA May 2009 - Present
Goodwin Procter LLP February 2005 - May 2008
Education
University of Michigan Law School 1998 — 2001
J.D.
Cassie Scherer Cassie Scherer's FDA Experience February 2013 - March 2014
Job Special Counsel at Covington & Burling
Industry Government Administration
Experience
Covington & Burling March 2014 - Present
FDA February 2013 - March 2014
FDA January 2012 - February 2013
FDA July 2009 - January 2012
US Department of Health and Human Services February 2011 - November 2011
Latham & Watkins 2006 - 2009
Skills
Legal Research, Legal Writing, Medical Devices, Policy, Public Policy, Policy Analysis, Government, Corporate Law, Appeals, Healthcare
Education
University of Virginia School of Law 2002 — 2005
JD
University of Pennsylvania 1996 — 2000
Bachelor of Arts, English
Covington & Burling March 2014 - Present
FDA February 2013 - March 2014
FDA January 2012 - February 2013
FDA July 2009 - January 2012
US Department of Health and Human Services February 2011 - November 2011
Latham & Watkins 2006 - 2009
Skills
Legal Research, Legal Writing, Medical Devices, Policy, Public Policy, Policy Analysis, Government, Corporate Law, Appeals, Healthcare
Education
University of Virginia School of Law 2002 — 2005
JD
University of Pennsylvania 1996 — 2000
Bachelor of Arts, English
Nahleen Lopez Nahleen Lopez's FDA Experience April 2015 - Present
Job Pharmacist at U.S. Public Health Service Commissioned Corps
Industry Government Administration
Experience
FDA April 2015 - Present
United States Government August 2009 - Present
U.S. Public Health Service Commissioned Corps August 2009 - Present
Commissioned Corps of the U.S. Public Health Service March 2013 - April 2015
U.S. Department of Justice August 2009 - March 2013
Skills
Healthcare, Public Health, Clinical Research
Education
University of Oklahoma Health Sciences Center 2005 — 2009
PharmD, Pharmacy
University of Oklahoma 1999 — 2003
BS in Chemistry, Chemistry
FDA April 2015 - Present
United States Government August 2009 - Present
U.S. Public Health Service Commissioned Corps August 2009 - Present
Commissioned Corps of the U.S. Public Health Service March 2013 - April 2015
U.S. Department of Justice August 2009 - March 2013
Skills
Healthcare, Public Health, Clinical Research
Education
University of Oklahoma Health Sciences Center 2005 — 2009
PharmD, Pharmacy
University of Oklahoma 1999 — 2003
BS in Chemistry, Chemistry
Karlene Garzone Karlene Garzone's FDA Experience 2010 - Present
Job IT Specialist, FDA
Industry Information Technology and Services
Experience
FDA 2010 - Present
IT Solutions 2007 - 2010
FedMed, Inc. 2002 - 2007
Education
University of Phoenix 2007 — 2009
MBA, Business Management
University of South Carolina Upstate 2001 — 2002
BS, Business Administration
Winthrop University 1998 — 2001
BS, Business Administration
FDA 2010 - Present
IT Solutions 2007 - 2010
FedMed, Inc. 2002 - 2007
Education
University of Phoenix 2007 — 2009
MBA, Business Management
University of South Carolina Upstate 2001 — 2002
BS, Business Administration
Winthrop University 1998 — 2001
BS, Business Administration
Heather Lombardi Heather Lombardi's FDA Experience July 2008 - Present
Job Chemist at FDA
Industry Government Administration
Experience
FDA July 2008 - Present
University of Pennsylvania 2003 - 2008
Banner Pharmacaps June 2000 - August 2003
Skills
Chemistry
Education
University of Pennsylvania 2003 — 2008
PhD, Chemistry
University of North Carolina at Chapel Hill 1995 — 1999
BS, Chemistry- Biochemistry Track
Robert B. Glenn High School 1991 — 1995
Wake Forest University
FDA July 2008 - Present
University of Pennsylvania 2003 - 2008
Banner Pharmacaps June 2000 - August 2003
Skills
Chemistry
Education
University of Pennsylvania 2003 — 2008
PhD, Chemistry
University of North Carolina at Chapel Hill 1995 — 1999
BS, Chemistry- Biochemistry Track
Robert B. Glenn High School 1991 — 1995
Wake Forest University
Kumar Janoria, PhD's FDA Experience January 2015 - Present
Job Staff Fellow, FDA
Industry Government Administration
Experience
FDA January 2015 - Present
FDA August 2014 - January 2015
West-Ward Pharmaceuticals July 2014 - August 2014
Boehringer Ingelheim Pharmaceuticals September 2010 - July 2014
Aptuit, Inc May 2008 - September 2010
Skills
Formulation Development, Project Management, Drug Delivery, Dry Granulation, Lyophilization, Pharmaceutics, Pharmacokinetics, Lifesciences, Chemistry, FDA, Bioanalysis, Pharmaceutical Industry, GMP, Pharmaceutical Research, HPLC, Drug Discovery, Technology Transfer, Dry, Validation, Granulation, Biopharmaceuticals, Formulation, Quality by Design, Pharmacology, Regulatory Affairs, Generic Programming, V&V, Dissolution, Clinical Development, Chromatography, CAPA, Sop, Cell, LC-MS, CRO, GLP, Drug Development, Six Sigma, Change Control, Analytical Chemistry, Cleaning Validation
Education
University of Missouri-Kansas City 2003 — 2008
Ph.D., Pharmaceutical Sciences
SGSITS 1999 — 2003
B.Pharm., Pharmaceutical Sciences
FDA January 2015 - Present
FDA August 2014 - January 2015
West-Ward Pharmaceuticals July 2014 - August 2014
Boehringer Ingelheim Pharmaceuticals September 2010 - July 2014
Aptuit, Inc May 2008 - September 2010
Skills
Formulation Development, Project Management, Drug Delivery, Dry Granulation, Lyophilization, Pharmaceutics, Pharmacokinetics, Lifesciences, Chemistry, FDA, Bioanalysis, Pharmaceutical Industry, GMP, Pharmaceutical Research, HPLC, Drug Discovery, Technology Transfer, Dry, Validation, Granulation, Biopharmaceuticals, Formulation, Quality by Design, Pharmacology, Regulatory Affairs, Generic Programming, V&V, Dissolution, Clinical Development, Chromatography, CAPA, Sop, Cell, LC-MS, CRO, GLP, Drug Development, Six Sigma, Change Control, Analytical Chemistry, Cleaning Validation
Education
University of Missouri-Kansas City 2003 — 2008
Ph.D., Pharmaceutical Sciences
SGSITS 1999 — 2003
B.Pharm., Pharmaceutical Sciences
Hassan Awada Hassan Awada's FDA Experience May 2010 - June 2011
Job Bioengineering PhD candidate at University of Pittsburgh
Industry Biotechnology
Experience
University of Pittsburgh October 2011 - Present
FDA May 2010 - June 2011
Cleveland Clinic January 2009 - August 2009
Skills
Biomaterials, Tissue Engineering, Drug Delivery, Biomedical Engineering, Biomechanics, Signal Processing, Data Analysis, Biotechnology, Angiogenesis, Fluorescence Microscopy, Histology, Microscopy, Vascular and cardiac..., Growth Factors, Urodynamics, Spine biomechanics, ELISA, Western Blotting, Radiolabeling, Minitab, GraphPad Prism, Matlab, Microsoft Office, ImageJ, EndNote, Echocardiography, Zymography, GPC, FTIR, Cell Culture, Rheometry, Scanning Electron..., Cryosectioning, Immunohistochemistry, Project Management, Presentation Skills, Mentoring
Education
University of Pittsburgh 2011 — 2016
Doctor of Philosophy (PhD), Bioengineering and Biomedical Engineering
University of Michigan 2005 — 2010
Bachelor of Science (BS), Biomedical/Medical Engineering
University of Pittsburgh October 2011 - Present
FDA May 2010 - June 2011
Cleveland Clinic January 2009 - August 2009
Skills
Biomaterials, Tissue Engineering, Drug Delivery, Biomedical Engineering, Biomechanics, Signal Processing, Data Analysis, Biotechnology, Angiogenesis, Fluorescence Microscopy, Histology, Microscopy, Vascular and cardiac..., Growth Factors, Urodynamics, Spine biomechanics, ELISA, Western Blotting, Radiolabeling, Minitab, GraphPad Prism, Matlab, Microsoft Office, ImageJ, EndNote, Echocardiography, Zymography, GPC, FTIR, Cell Culture, Rheometry, Scanning Electron..., Cryosectioning, Immunohistochemistry, Project Management, Presentation Skills, Mentoring
Education
University of Pittsburgh 2011 — 2016
Doctor of Philosophy (PhD), Bioengineering and Biomedical Engineering
University of Michigan 2005 — 2010
Bachelor of Science (BS), Biomedical/Medical Engineering
Sarah Ruth Hoffman's FDA Experience May 2013 - Present
Job
Industry Higher Education
Experience
University of North Carolina at Chapel Hill August 2015 - Present
FDA May 2013 - Present
FDA May 2015 - August 2015
University of North Carolina at Chapel Hill August 2014 - May 2015
Skills
Dietetics, Research, Writing, Leadership, Nutrition, Public Health, Public Speaking, SAS, Microsoft Excel, Epidemiology, Literature Reviews, Program Development, Grant Writing, Nutrition Education, Medical Nutrition..., Health Education, Teaching, Clinical Nutrition, Health Promotion, Program Evaluation, Healthcare, Clinical Research
Education
University of North Carolina at Chapel Hill 2014 — 2018
Doctor of Philosophy (PhD), Epidemiology
University of North Carolina at Chapel Hill 2012 — 2014
Master of Public Health (MPH), Public Health Leadership Program (PHLP)
Winthrop University 2010 — 2011
Master of Science, Human Nutrition
Winthrop University 2007 — 2009
Bachelor of Science, Human Nutrition
University of North Carolina at Chapel Hill August 2015 - Present
FDA May 2013 - Present
FDA May 2015 - August 2015
University of North Carolina at Chapel Hill August 2014 - May 2015
Skills
Dietetics, Research, Writing, Leadership, Nutrition, Public Health, Public Speaking, SAS, Microsoft Excel, Epidemiology, Literature Reviews, Program Development, Grant Writing, Nutrition Education, Medical Nutrition..., Health Education, Teaching, Clinical Nutrition, Health Promotion, Program Evaluation, Healthcare, Clinical Research
Education
University of North Carolina at Chapel Hill 2014 — 2018
Doctor of Philosophy (PhD), Epidemiology
University of North Carolina at Chapel Hill 2012 — 2014
Master of Public Health (MPH), Public Health Leadership Program (PHLP)
Winthrop University 2010 — 2011
Master of Science, Human Nutrition
Winthrop University 2007 — 2009
Bachelor of Science, Human Nutrition
Sally Choe's FDA Experience September 2006 - June 2011
Job Senior Director at PAREXEL
Industry Pharmaceuticals
Brad Glasscock's FDA Experience December 2002 - May 2005
Job Vice President, Regulatory Affairs at BioMarin Pharmaceutical Inc.
Industry Biotechnology
Experience
BioMarin Pharmaceutical Inc. April 2014 - Present
BioMarin Pharmaceutical Inc. September 2013 - April 2014
BioMarin Pharmaceutical Inc. February 2012 - September 2013
Amgen May 2005 - February 2012
FDA December 2002 - May 2005
FDA February 2000 - December 2002
Skills
FDA, Regulatory Affairs, Biotechnology, Clinical Development, Clinical Trials, IND, Drug Development, Regulatory Submissions, Pharmaceutical Industry, Lifesciences, Oncology, Biopharmaceuticals, Pharmacovigilance, GCP, Regulatory Requirements
Education
University of North Carolina at Chapel Hill 1993 — 1999
PharmD
BioMarin Pharmaceutical Inc. April 2014 - Present
BioMarin Pharmaceutical Inc. September 2013 - April 2014
BioMarin Pharmaceutical Inc. February 2012 - September 2013
Amgen May 2005 - February 2012
FDA December 2002 - May 2005
FDA February 2000 - December 2002
Skills
FDA, Regulatory Affairs, Biotechnology, Clinical Development, Clinical Trials, IND, Drug Development, Regulatory Submissions, Pharmaceutical Industry, Lifesciences, Oncology, Biopharmaceuticals, Pharmacovigilance, GCP, Regulatory Requirements
Education
University of North Carolina at Chapel Hill 1993 — 1999
PharmD
Jyotsna Mehta's FDA Experience February 2008 - November 2008
Job Director at EMD Serono
Industry Pharmaceuticals
Experience
EMD Serono, Inc. April 2015 - Present
sanofi-aventis September 2011 - April 2015
Medimmune (Astra Zeneca) November 2008 - September 2011
FDA February 2008 - November 2008
Brigham and Women's Hospital/Harvard Medical School January 2006 - January 2008
Harvard Pilgrim Health Care/Harvard Medical School January 2000 - December 2005
Skills
Pharmacoeconomics, Health, Oncology, Pharmacoepidemiology, Clinical Development, Clinical Trials, Health Economics, Epidemiology, Market Access, Biostatistics, Infectious Diseases
Education
University of Rhode Island 1998 — 2000
MS, Pharmacoepidemiology and Pharmacoeconomics
University of Mumbai 1992 — 1996
B.Pharm, Pharmacy
EMD Serono, Inc. April 2015 - Present
sanofi-aventis September 2011 - April 2015
Medimmune (Astra Zeneca) November 2008 - September 2011
FDA February 2008 - November 2008
Brigham and Women's Hospital/Harvard Medical School January 2006 - January 2008
Harvard Pilgrim Health Care/Harvard Medical School January 2000 - December 2005
Skills
Pharmacoeconomics, Health, Oncology, Pharmacoepidemiology, Clinical Development, Clinical Trials, Health Economics, Epidemiology, Market Access, Biostatistics, Infectious Diseases
Education
University of Rhode Island 1998 — 2000
MS, Pharmacoepidemiology and Pharmacoeconomics
University of Mumbai 1992 — 1996
B.Pharm, Pharmacy
Ian Joseph's FDA Experience March 2013 - Present
Job Quality Systems Specialist at FDA
Industry Research
Experience
FDA March 2013 - Present
FDA April 2009 - March 2013
Spelman College September 2008 - December 2008
Emory University 2005 - 2008
Georgia Institute of Technology June 2004 - June 2005
University of Michigan September 1999 - May 2000
Food, Chemistry and Technology Division, Ministry of Agriculture, Government of Antigua and Barbuda August 1992 - August 1993
Skills
Biochemistry, Bioinformatics, Cell Biology, Cell Culture, Laboratory, Life Sciences, Lifesciences, Microbiology, Molecular Biology, PCR, Research, Science, Teaching
Education
University of Michigan 1997 — 2003
PhD, Microbiology and Immunology
University of the Virgin Islands 1994 — 1997
BS, Biology
St. Joseph's Academy 1986 — 1989
FDA March 2013 - Present
FDA April 2009 - March 2013
Spelman College September 2008 - December 2008
Emory University 2005 - 2008
Georgia Institute of Technology June 2004 - June 2005
University of Michigan September 1999 - May 2000
Food, Chemistry and Technology Division, Ministry of Agriculture, Government of Antigua and Barbuda August 1992 - August 1993
Skills
Biochemistry, Bioinformatics, Cell Biology, Cell Culture, Laboratory, Life Sciences, Lifesciences, Microbiology, Molecular Biology, PCR, Research, Science, Teaching
Education
University of Michigan 1997 — 2003
PhD, Microbiology and Immunology
University of the Virgin Islands 1994 — 1997
BS, Biology
St. Joseph's Academy 1986 — 1989
Venu Boppana's FDA Experience December 2013 - Present
Job Solution/Technical Architect
Industry Information Technology and Services
Experience
FDA December 2013 - Present
Skills
Business Intelligence, Enterprise Architecture, Data Warehousing, Requirements Analysis, SDLC, Business Process, ETL, Requirements Gathering, Databases, Integration, Oracle E-Business Suite, Oracle, Business Analysis, SOA, Master Data Management, Architecture, Business Objects, IT Strategy, Agile Methodologies, Data Integration, PL/SQL, Technical Leadership, Architectures, Systems Analysis, Supply Chain Management, DoD, Datastage, Active DoD Secret..., Teradata Data Warehouse, Oracle Warehouse Builder, GoldenGate, Exadata, OBIEE, Informatica, Solr, Contracting Officer..., Exalytics, Geospatial Data
Education
University of Mysore
FDA December 2013 - Present
Skills
Business Intelligence, Enterprise Architecture, Data Warehousing, Requirements Analysis, SDLC, Business Process, ETL, Requirements Gathering, Databases, Integration, Oracle E-Business Suite, Oracle, Business Analysis, SOA, Master Data Management, Architecture, Business Objects, IT Strategy, Agile Methodologies, Data Integration, PL/SQL, Technical Leadership, Architectures, Systems Analysis, Supply Chain Management, DoD, Datastage, Active DoD Secret..., Teradata Data Warehouse, Oracle Warehouse Builder, GoldenGate, Exadata, OBIEE, Informatica, Solr, Contracting Officer..., Exalytics, Geospatial Data
Education
University of Mysore
Ross Filice's FDA Experience July 2010 - January 2014
Job Chief of Imaging Informatics, Assistant Professor at MedStar Georgetown University Hospital
Industry Hospital & Health Care
Experience
MedStar Georgetown University Hospital February 2014 - Present
MedStar Health May 2014 - Present
FDA July 2010 - January 2014
University of Maryland School of Medicine June 2009 - August 2010
Johns Hopkins Hospital July 2005 - June 2009
Greenwich Hospital June 2004 - June 2005
Skills
Public Health, Clinical Research, Radiology, Medical Imaging, Healthcare Information..., Hospitals, Healthcare, Informatics, Medicine, Board Certified, Medical Education, EHR, Medical Research, MRI, EMR, Medical Devices
Education
University of Minnesota Medical School 2000 — 2004
Doctor of Medicine (M.D.), Medicine
University of Wisconsin-Madison 1995 — 1999
Bachelor's Degree, Computer Science, Molecular Biology
MedStar Georgetown University Hospital February 2014 - Present
MedStar Health May 2014 - Present
FDA July 2010 - January 2014
University of Maryland School of Medicine June 2009 - August 2010
Johns Hopkins Hospital July 2005 - June 2009
Greenwich Hospital June 2004 - June 2005
Skills
Public Health, Clinical Research, Radiology, Medical Imaging, Healthcare Information..., Hospitals, Healthcare, Informatics, Medicine, Board Certified, Medical Education, EHR, Medical Research, MRI, EMR, Medical Devices
Education
University of Minnesota Medical School 2000 — 2004
Doctor of Medicine (M.D.), Medicine
University of Wisconsin-Madison 1995 — 1999
Bachelor's Degree, Computer Science, Molecular Biology
Hoi Leung's FDA Experience December 1979 - November 1997
Job Biopharmaceutical Statistics Consultant
Industry Pharmaceuticals
Experience
Self Employed May 2008 - Present
Hyperion Therapeutics September 2007 - April 2008
XOMA (US) LLC 2002 - 2007
XOMA 2002 - 2007
Quintiles Transnational 1997 - 2002
Quintiles, Inc. 1997 - 2002
FDA December 1979 - November 1997
Skills
IRB, Clinical Trials, Pharmaceutical Industry, Statistics, Clinical Development
Education
University of North Carolina at Chapel Hill 1969 — 1976
Ph.D., Statistics
Self Employed May 2008 - Present
Hyperion Therapeutics September 2007 - April 2008
XOMA (US) LLC 2002 - 2007
XOMA 2002 - 2007
Quintiles Transnational 1997 - 2002
Quintiles, Inc. 1997 - 2002
FDA December 1979 - November 1997
Skills
IRB, Clinical Trials, Pharmaceutical Industry, Statistics, Clinical Development
Education
University of North Carolina at Chapel Hill 1969 — 1976
Ph.D., Statistics
Jackie Ware's FDA Experience May 1996 - June 2008
Job Regulatory Project Manager at FDA/CDER
Industry Pharmaceuticals
Experience
FDA/CDER July 2008 - Present
FDA May 1996 - June 2008
Education
University of North Carolina at Chapel Hill 1985 — 1991
Pharm.D., pharmacy
FDA/CDER July 2008 - Present
FDA May 1996 - June 2008
Education
University of North Carolina at Chapel Hill 1985 — 1991
Pharm.D., pharmacy
Nancy Zou's FDA Experience April 2008 - April 2008
Job Global Medical Information Specialist Oncology
Industry Hospital & Health Care
Experience
Genentech April 2014 - Present
Ocean Breeze Healthcare March 2011 - June 2013
UNITE HERE Health Center July 2009 - March 2011
St. Luke's-Roosevelt Hospital July 2008 - June 2009
FDA April 2008 - April 2008
University of Michigan Health System January 2008 - February 2008
sanofi-aventis October 2007 - November 2007
VA Medical Center October 2007 - October 2007
Howard Brown Health Center September 2007 - September 2007
Michael Reese Hospital September 2007 - September 2007
Skills
Healthcare Management, Healthcare, Hospitals, Clinical Research, Pharmaceutical Industry, Pharmacy Automation, Managed Care, Pharmacy Benefit..., Inpatient, Internal Medicine, Ambulatory Care, Endocrinology, Clinical Pharmacy, Pharmaceutical Sales, Oncology, Pharmacists, Disease Management, ICU, Diabetes, Medication Therapy...
Education
Institute of Integrative Nutrition 2008 — 2009
Nutrition
University of Michigan 2004 — 2008
Doctor in Pharmacy, Pharmacy
University of Michigan 2001 — 2004
B.S., Cellular, Molecular Biology
Genentech April 2014 - Present
Ocean Breeze Healthcare March 2011 - June 2013
UNITE HERE Health Center July 2009 - March 2011
St. Luke's-Roosevelt Hospital July 2008 - June 2009
FDA April 2008 - April 2008
University of Michigan Health System January 2008 - February 2008
sanofi-aventis October 2007 - November 2007
VA Medical Center October 2007 - October 2007
Howard Brown Health Center September 2007 - September 2007
Michael Reese Hospital September 2007 - September 2007
Skills
Healthcare Management, Healthcare, Hospitals, Clinical Research, Pharmaceutical Industry, Pharmacy Automation, Managed Care, Pharmacy Benefit..., Inpatient, Internal Medicine, Ambulatory Care, Endocrinology, Clinical Pharmacy, Pharmaceutical Sales, Oncology, Pharmacists, Disease Management, ICU, Diabetes, Medication Therapy...
Education
Institute of Integrative Nutrition 2008 — 2009
Nutrition
University of Michigan 2004 — 2008
Doctor in Pharmacy, Pharmacy
University of Michigan 2001 — 2004
B.S., Cellular, Molecular Biology
Abi D'Sa's FDA Experience August 2014 - Present
Job Deputy Director US FDA (India)
Industry Government Administration
Experience
FDA August 2014 - Present
U.S. Food and Drug Administration January 2009 - Present
US Food & Drug Administration May 2001 - November 2008
U.S. Food and Drug Administration April 1996 - May 2001
NIH 1989 - 1992
Skills
Regulatory Requirements, Regulatory Affairs, FDA, Regulatory Submissions, GMP, Clinical Trials, Sop, Pharmaceutical Industry, GLP, Validation, CAPA, Vaccines, Technology Transfer, Quality Auditing, 21 CFR Part 11, Biopharmaceuticals, Change Control, Clinical Development, Lifesciences, V&V, Biotechnology, GCP, Chemistry, Drug Discovery, Pharmaceutics, IND, SOP, Life Sciences
Education
University of Missouri-Columbia 1984 — 1989
Ph. D, Organic and Bio-organic Chemistry
FDA August 2014 - Present
U.S. Food and Drug Administration January 2009 - Present
US Food & Drug Administration May 2001 - November 2008
U.S. Food and Drug Administration April 1996 - May 2001
NIH 1989 - 1992
Skills
Regulatory Requirements, Regulatory Affairs, FDA, Regulatory Submissions, GMP, Clinical Trials, Sop, Pharmaceutical Industry, GLP, Validation, CAPA, Vaccines, Technology Transfer, Quality Auditing, 21 CFR Part 11, Biopharmaceuticals, Change Control, Clinical Development, Lifesciences, V&V, Biotechnology, GCP, Chemistry, Drug Discovery, Pharmaceutics, IND, SOP, Life Sciences
Education
University of Missouri-Columbia 1984 — 1989
Ph. D, Organic and Bio-organic Chemistry
Nathan Rummel's FDA Experience November 1991 - Present
Job Chemist at FDA
Industry Pharmaceuticals
Experience
FDA November 1991 - Present
Wildlife International, LTD January 1991 - November 1991
Skills
Quality Assurance, Analysis, HPLC, Team Building, Quality System, FDA, Pharmacokinetics, Project Management, Research, Chemistry, Laboratory, Microsoft Excel, Testing, Validation, PMP, Data Analysis, CAPA, Microsoft Office, Program Management, Regulatory Affairs, Quality Auditing, Sop, GLP, Strategic Planning, Team Leadership, Analytical Chemistry, Microbiology, Pharmaceutical Industry, Process Improvement, Cross-functional Team..., Public Speaking, Technical Writing
Education
University of Missouri-Columbia 1985 — 1990
Fulton High School
FDA November 1991 - Present
Wildlife International, LTD January 1991 - November 1991
Skills
Quality Assurance, Analysis, HPLC, Team Building, Quality System, FDA, Pharmacokinetics, Project Management, Research, Chemistry, Laboratory, Microsoft Excel, Testing, Validation, PMP, Data Analysis, CAPA, Microsoft Office, Program Management, Regulatory Affairs, Quality Auditing, Sop, GLP, Strategic Planning, Team Leadership, Analytical Chemistry, Microbiology, Pharmaceutical Industry, Process Improvement, Cross-functional Team..., Public Speaking, Technical Writing
Education
University of Missouri-Columbia 1985 — 1990
Fulton High School
Carol H. Kasten, M.D.'s FDA Experience September 2013 - Present
Job FDA Medical Reviewer
Industry Pharmaceuticals
Experience
FDA September 2013 - Present
National Institutes of Health September 2008 - September 2013
National Cancer Institute January 2000 - September 2008
University of Michigan Medical Center July 1996 - December 1999
Education
University of Michigan Medical School
Medical Doctor, Medicine
University of Michigan, Ann Arbor, Michigan
B.A.
FDA September 2013 - Present
National Institutes of Health September 2008 - September 2013
National Cancer Institute January 2000 - September 2008
University of Michigan Medical Center July 1996 - December 1999
Education
University of Michigan Medical School
Medical Doctor, Medicine
University of Michigan, Ann Arbor, Michigan
B.A.
Laurel Burk's FDA Experience May 2014 - Present
Job Medical Device Lead Reviewer at FDA
Industry Medical Devices
Experience
FDA May 2014 - Present
University of North Carolina at Chapel Hill July 2013 - May 2014
University of North Carolina at Chapel Hill May 2008 - July 2013
University of North Carolina at Chapel Hill August 2007 - May 2008
Skills
Physics, Nanomaterials, LaTeX, Materials Science, Nanotechnology, Science, Matlab, Medical Imaging, Biomedical Engineering, NI LabVIEW, Computed Tomography, In vivo imaging, Condensed Matter Physics, Biological Physics, AFM, Scanning Tunneling..., TEM, Scanning Electron..., Experimentation, Solidworks, Grant Writing, Written & Oral..., Mentoring, Medical Devices, Research, Characterization, Regulatory Requirements, FDA, Regulatory Submissions
Education
University of North Carolina at Chapel Hill 2007 — 2013
PhD, Physics
University of Nebraska-Lincoln 2003 — 2007
Bachelor of Science, Physics, Mathematics, minor in English
FDA May 2014 - Present
University of North Carolina at Chapel Hill July 2013 - May 2014
University of North Carolina at Chapel Hill May 2008 - July 2013
University of North Carolina at Chapel Hill August 2007 - May 2008
Skills
Physics, Nanomaterials, LaTeX, Materials Science, Nanotechnology, Science, Matlab, Medical Imaging, Biomedical Engineering, NI LabVIEW, Computed Tomography, In vivo imaging, Condensed Matter Physics, Biological Physics, AFM, Scanning Tunneling..., TEM, Scanning Electron..., Experimentation, Solidworks, Grant Writing, Written & Oral..., Mentoring, Medical Devices, Research, Characterization, Regulatory Requirements, FDA, Regulatory Submissions
Education
University of North Carolina at Chapel Hill 2007 — 2013
PhD, Physics
University of Nebraska-Lincoln 2003 — 2007
Bachelor of Science, Physics, Mathematics, minor in English
Fangmiin Charlie Sheen's FDA Experience January 1995 - December 1997
Job Senior Field Applications Specialist at Promega
Industry Biotechnology
Experience
Promega May 2008 - Present
Promega May 2005 - May 2008
Taiwan Genome Sciences April 2003 - April 2005
Taiwan Genome Sciences May 2002 - November 2003
Promega November 2000 - April 2002
Promega January 1998 - October 2000
FDA January 1995 - December 1997
Fred Hutchinson Cancer Research Center January 1991 - December 1994
Skills
Genetics, Biotechnology, Technical Sales, Molecular Biology, Genotyping, Commercialization, Molecular Diagnostics, Genomics, Life Sciences, DNA Sequencing, DNA, PCR, Biochemistry, qPCR, Sequencing, Proteomics, Cell Culture, Laboratory Automation, Assay Development, Cell Biology, Protein Purification, ELISA, Cell, Product Development, Sales, DNA sequencing, Lifesciences
Education
University of Minnesota-Twin Cities 1984 — 2000
PhD, Genetics
Chin-Hsin Middle School
Promega May 2008 - Present
Promega May 2005 - May 2008
Taiwan Genome Sciences April 2003 - April 2005
Taiwan Genome Sciences May 2002 - November 2003
Promega November 2000 - April 2002
Promega January 1998 - October 2000
FDA January 1995 - December 1997
Fred Hutchinson Cancer Research Center January 1991 - December 1994
Skills
Genetics, Biotechnology, Technical Sales, Molecular Biology, Genotyping, Commercialization, Molecular Diagnostics, Genomics, Life Sciences, DNA Sequencing, DNA, PCR, Biochemistry, qPCR, Sequencing, Proteomics, Cell Culture, Laboratory Automation, Assay Development, Cell Biology, Protein Purification, ELISA, Cell, Product Development, Sales, DNA sequencing, Lifesciences
Education
University of Minnesota-Twin Cities 1984 — 2000
PhD, Genetics
Chin-Hsin Middle School
Jeffrey Meng's FDA Experience June 2009 - Present
Job Investigator at U.S. Food and Drug Administration
Industry Pharmaceuticals
Experience
FDA June 2009 - Present
MORE Program May 2008 - January 2009
ModuLine Technologies November 2007 - January 2009
University of Michigan Health System September 2005 - January 2008
University of Southern California June 2007 - August 2007
American Axle & Manufacturing May 2004 - August 2005
Education
University of Michigan 2007 — 2008
M.S.E., Biomedical Engineering
University of Michigan 2003 — 2007
B.S.E., Biomedical Engineering
FDA June 2009 - Present
MORE Program May 2008 - January 2009
ModuLine Technologies November 2007 - January 2009
University of Michigan Health System September 2005 - January 2008
University of Southern California June 2007 - August 2007
American Axle & Manufacturing May 2004 - August 2005
Education
University of Michigan 2007 — 2008
M.S.E., Biomedical Engineering
University of Michigan 2003 — 2007
B.S.E., Biomedical Engineering
Jim O'Hara's FDA Experience 1993 - 1997
Job Director, Health Promotion Policy at Center for Science in the Public Interest
Industry Public Policy
Experience
Center for Science in the Public Interest January 2014 - Present
JAO Consulting May 2013 - December 2013
US EPA July 2012 - May 2013
JAO Consulting 2010 - June 2012
The Pew Charitable Trusts 2006 - 2008
FDA 1993 - 1997
The Tennessean 1973 - 1990
Skills
Public Health, Public Relations, Public Policy, Campaign Strategy, Public Speaking, Political Campaigns, Policy, Grassroots Organizing, Nonprofits, Community Outreach, Policy Analysis, Copywriting, Politics, Grant Writing, Strategic Communications, Media Relations, Crisis Communications, Speech Writing
Education
The University of Chicago 1972 — 1973
MA, English
University of Notre Dame 1968 — 1972
BA, English
Center for Science in the Public Interest January 2014 - Present
JAO Consulting May 2013 - December 2013
US EPA July 2012 - May 2013
JAO Consulting 2010 - June 2012
The Pew Charitable Trusts 2006 - 2008
FDA 1993 - 1997
The Tennessean 1973 - 1990
Skills
Public Health, Public Relations, Public Policy, Campaign Strategy, Public Speaking, Political Campaigns, Policy, Grassroots Organizing, Nonprofits, Community Outreach, Policy Analysis, Copywriting, Politics, Grant Writing, Strategic Communications, Media Relations, Crisis Communications, Speech Writing
Education
The University of Chicago 1972 — 1973
MA, English
University of Notre Dame 1968 — 1972
BA, English
Ronald Lieberman's FDA Experience 1984 - 1996
Job Senior Director at Quintiles
Industry Biotechnology
Experience
Quintiles October 2006 - Present
Argos Therapeutics 2008 - 2010
National Cancer Institue June 1977 - June 2005
FDA 1984 - 1996
National Institutes of Health June 1979 - June 1981
Skills
Clinical Development, Clinical Trials, Oncology, CRO, CTMS, Biotechnology, Pharmaceutical Industry, Infectious Diseases, GCP, IND, Clinical Research, Immunology, Regulatory Submissions, Regulatory Affairs, Therapeutic Areas, Vaccines, Clinical Monitoring, Clinical Operations, Lifesciences, Sop, FDA
Education
University of Michigan
Doctor of Medicine (MD), Medicine
Quintiles October 2006 - Present
Argos Therapeutics 2008 - 2010
National Cancer Institue June 1977 - June 2005
FDA 1984 - 1996
National Institutes of Health June 1979 - June 1981
Skills
Clinical Development, Clinical Trials, Oncology, CRO, CTMS, Biotechnology, Pharmaceutical Industry, Infectious Diseases, GCP, IND, Clinical Research, Immunology, Regulatory Submissions, Regulatory Affairs, Therapeutic Areas, Vaccines, Clinical Monitoring, Clinical Operations, Lifesciences, Sop, FDA
Education
University of Michigan
Doctor of Medicine (MD), Medicine
Ferrin Jarrison's FDA Experience August 1990 - Present
Job Mathematical Statistician at FDA
Industry Government Administration
Experience
FDA August 1990 - Present
University of Missouri - Columbia August 1986 - December 1986
Education
University of Missouri-Columbia 1985 — 1990
PhD, Mathematical Statistics
University of Missouri-Columbia 1979 — 1986
BSc, Chemistry
FDA August 1990 - Present
University of Missouri - Columbia August 1986 - December 1986
Education
University of Missouri-Columbia 1985 — 1990
PhD, Mathematical Statistics
University of Missouri-Columbia 1979 — 1986
BSc, Chemistry
Anuja Patnaik's FDA Experience April 2011 - May 2014
Job Research Fellow at FDA
Industry Research
Experience
FDA April 2011 - May 2014
Education
University of Nebraska-Lincoln 2006 — 2008
FDA April 2011 - May 2014
Education
University of Nebraska-Lincoln 2006 — 2008
Kevin Gaido's FDA Experience January 2011 - June 2012
Job Director, Office of Applied Research and Safety Assessment/CFSAN/FDA
Industry Research
Experience
Office of Applied Research and Safety Assessment/CFSAN/FDA June 2012 - Present
FDA January 2011 - June 2012
FDA August 2009 - December 2010
The Hamner Institutes for health Sciences May 1986 - August 2009
The Hamner Institutes for Health Sciences 2003 - 2008
CIIT Centers for Health Research 1998 - 2003
The Chemical Industry Institute of Toxicology 1993 - 1998
The Chemical Industry Institute of Toxicology 1989 - 1992
The Chemical Industry Institute of Toxicology 1986 - 1989
Skills
Toxicology, Pharmacology, Lifesciences, In Vivo, GLP, Genomics, Molecular Biology, Biotechnology, Cell Culture
Education
West Virginia University 1982 — 1986
Ph.D., Pharmacology and Toxicology
University of Notre Dame 1978 — 1982
B.S., Biochemistry
Office of Applied Research and Safety Assessment/CFSAN/FDA June 2012 - Present
FDA January 2011 - June 2012
FDA August 2009 - December 2010
The Hamner Institutes for health Sciences May 1986 - August 2009
The Hamner Institutes for Health Sciences 2003 - 2008
CIIT Centers for Health Research 1998 - 2003
The Chemical Industry Institute of Toxicology 1993 - 1998
The Chemical Industry Institute of Toxicology 1989 - 1992
The Chemical Industry Institute of Toxicology 1986 - 1989
Skills
Toxicology, Pharmacology, Lifesciences, In Vivo, GLP, Genomics, Molecular Biology, Biotechnology, Cell Culture
Education
West Virginia University 1982 — 1986
Ph.D., Pharmacology and Toxicology
University of Notre Dame 1978 — 1982
B.S., Biochemistry
Chessa Huff-Woodard, Esq.'s FDA Experience September 2008 - March 2010
Job Agricultural Biotechnology Policy and Regulatory Analyst at USDAAPHIS
Industry Government Administration
Experience
USDA-APHIS March 2010 - Present
USDA-APHIS January 2015 - April 2015
USDA-APHIS December 2013 - July 2014
FDA September 2008 - March 2010
MAXIMUS Federal Services June 2008 - September 2008
Hudson Legal June 2007 - June 2008
Delaware Law-Related Education Center April 2006 - May 2007
Skills
Speech Writing, Program Management, Policy Analysis, Government, Legal Research, Policy, Public Policy, Research, Analysis, Legal Writing, Data Analysis, Public Speaking, Litigation, International Relations, Nonprofits, Administrative Law, Legislative Relations
Education
Widener University School of Law 2003 — 2006
Juris Doctor
University of North Carolina at Chapel Hill 1999 — 2003
BA
West Charlotte HIgh School
USDA-APHIS March 2010 - Present
USDA-APHIS January 2015 - April 2015
USDA-APHIS December 2013 - July 2014
FDA September 2008 - March 2010
MAXIMUS Federal Services June 2008 - September 2008
Hudson Legal June 2007 - June 2008
Delaware Law-Related Education Center April 2006 - May 2007
Skills
Speech Writing, Program Management, Policy Analysis, Government, Legal Research, Policy, Public Policy, Research, Analysis, Legal Writing, Data Analysis, Public Speaking, Litigation, International Relations, Nonprofits, Administrative Law, Legislative Relations
Education
Widener University School of Law 2003 — 2006
Juris Doctor
University of North Carolina at Chapel Hill 1999 — 2003
BA
West Charlotte HIgh School
Chathuri Daluwatte's FDA Experience January 2015 - Present
Job Research Fellow
Industry Medical Devices
Experience
FDA January 2015 - Present
bioMerieux July 2013 - December 2014
University of Missouri January 2009 - June 2013
Social Science Statistics Center (SSSC), University of Missouri September 2011 - December 2011
Mobitel (Pvt) Ltd November 2007 - December 2008
Airport and Aviation Services (SL) Ltd February 2006 - July 2006
Skills
Matlab, Signal Processing, Image Processing, Machine Learning, Computer Vision, Algorithms, C++, Mathematical Modeling, Biostatistics, Biomedical Engineering, Clinical Research, Java, Translational Research, SAS programming, Autism Spectrum..., Neurodevelopmental..., SPSS, ITK, OpenCV, GPU, R, Causal Inference, Bioinformatics, Statistics, Statistical Modeling, SAS, Data Analysis, Data Mining, High Performance..., Human Physiology, Predictive Analytics
Education
University of Missouri-Columbia 2009 — 2013
Doctor of Philosophy (PhD)
University of Missouri-Columbia 2010 — 2012
Master's degree
University of Moratuwa 2003 — 2007
Engineering
FDA January 2015 - Present
bioMerieux July 2013 - December 2014
University of Missouri January 2009 - June 2013
Social Science Statistics Center (SSSC), University of Missouri September 2011 - December 2011
Mobitel (Pvt) Ltd November 2007 - December 2008
Airport and Aviation Services (SL) Ltd February 2006 - July 2006
Skills
Matlab, Signal Processing, Image Processing, Machine Learning, Computer Vision, Algorithms, C++, Mathematical Modeling, Biostatistics, Biomedical Engineering, Clinical Research, Java, Translational Research, SAS programming, Autism Spectrum..., Neurodevelopmental..., SPSS, ITK, OpenCV, GPU, R, Causal Inference, Bioinformatics, Statistics, Statistical Modeling, SAS, Data Analysis, Data Mining, High Performance..., Human Physiology, Predictive Analytics
Education
University of Missouri-Columbia 2009 — 2013
Doctor of Philosophy (PhD)
University of Missouri-Columbia 2010 — 2012
Master's degree
University of Moratuwa 2003 — 2007
Engineering
Jiwei He's FDA Experience January 2015 - Present
Job Mathematical Statistician at FDA
Industry Government Administration
Experience
FDA January 2015 - Present
Merck September 2012 - September 2013
University of Pennsylvania School of Medicine September 2010 - June 2012
Skills
R, SAS, Statistical Modeling, Biostatistics, Causal Inference, Matlab, Survival Analysis, Epidemiology
Education
University of Pennsylvania 2010 — 2014
Doctor of Philosophy (PhD), Biostatistics
University of Pennsylvania 2007 — 2010
Master of Science (MS), Neuroscience
University of Toronto 2004 — 2007
Bachelor of Science (BS)
Hwa Chong Junior College
A Level
Suzhou Middle School
FDA January 2015 - Present
Merck September 2012 - September 2013
University of Pennsylvania School of Medicine September 2010 - June 2012
Skills
R, SAS, Statistical Modeling, Biostatistics, Causal Inference, Matlab, Survival Analysis, Epidemiology
Education
University of Pennsylvania 2010 — 2014
Doctor of Philosophy (PhD), Biostatistics
University of Pennsylvania 2007 — 2010
Master of Science (MS), Neuroscience
University of Toronto 2004 — 2007
Bachelor of Science (BS)
Hwa Chong Junior College
A Level
Suzhou Middle School
Martin Ho's FDA Experience August 2015 - Present
Job Acting Branch Chief
Industry Government Administration
Experience
FDA August 2015 - Present
FDA March 2014 - August 2015
FDA February 2009 - March 2014
The EMMES Corporation February 2005 - February 2009
Quintiles November 2003 - February 2005
The EMMES Corporation November 1999 - February 2003
Westat December 1998 - November 1999
Skills
Biostatistics, Statistics, Epidemiology, Medical Devices, SAS, Statistical Modeling, Clinical Trials, Public Health, Data Analysis, Infectious Diseases, Statistical Consulting, SAS programming, R, Clinical Study Design, FDA
Education
University of Wisconsin-Madison 1996 — 1998
Master of Science (M.S.), Statistics with emphasis in Biostatistics
Yale University 1991 — 1996
Ph.D. Program, Economics
University of Minnesota-Twin Cities 1990 — 1991
Bachelor of Science (B.S.), Mathematics and Economics
FDA August 2015 - Present
FDA March 2014 - August 2015
FDA February 2009 - March 2014
The EMMES Corporation February 2005 - February 2009
Quintiles November 2003 - February 2005
The EMMES Corporation November 1999 - February 2003
Westat December 1998 - November 1999
Skills
Biostatistics, Statistics, Epidemiology, Medical Devices, SAS, Statistical Modeling, Clinical Trials, Public Health, Data Analysis, Infectious Diseases, Statistical Consulting, SAS programming, R, Clinical Study Design, FDA
Education
University of Wisconsin-Madison 1996 — 1998
Master of Science (M.S.), Statistics with emphasis in Biostatistics
Yale University 1991 — 1996
Ph.D. Program, Economics
University of Minnesota-Twin Cities 1990 — 1991
Bachelor of Science (B.S.), Mathematics and Economics
Diaa Shakleya's FDA Experience October 2014 - Present
Job Mass Spec and Analytical Consultant at American Spine
Industry Research
Experience
FDA October 2014 - Present
American Spine May 2014 - Present
Intrexon Corporation March 2014 - Present
Intrexon Corporation 2010 - Present
National Institute of Health 2006 - 2010
West Virginia University 2003 - 2006
Skills
HPLC, Drug Discovery, Biotechnology, Molecular Biology, In Vitro, Analytical Chemistry, Chemistry, Protein Chemistry, Drug Delivery, Pharmacology, Toxicology, Pharmaceutical Research, Purification, NMR, Chromatography, GMP, Clinical Development, Validation, Drug Metabolism, Method Development, Cell Culture, Assay Development, SDS-PAGE, In Vivo, Biopharmaceuticals, LC-MS, DNA, Bioanalysis, Pharmacokinetics, Formulation, Lifesciences, UV/Vis, Mass Spectrometry, Drug Development, Laboratory
Education
West Virginia University 2003 — 2004
Postdcotoral Fellow, Forensic Toxicology
University of Mumbai 1999 — 2002
Ph.D, Pharmaceutics
FDA October 2014 - Present
American Spine May 2014 - Present
Intrexon Corporation March 2014 - Present
Intrexon Corporation 2010 - Present
National Institute of Health 2006 - 2010
West Virginia University 2003 - 2006
Skills
HPLC, Drug Discovery, Biotechnology, Molecular Biology, In Vitro, Analytical Chemistry, Chemistry, Protein Chemistry, Drug Delivery, Pharmacology, Toxicology, Pharmaceutical Research, Purification, NMR, Chromatography, GMP, Clinical Development, Validation, Drug Metabolism, Method Development, Cell Culture, Assay Development, SDS-PAGE, In Vivo, Biopharmaceuticals, LC-MS, DNA, Bioanalysis, Pharmacokinetics, Formulation, Lifesciences, UV/Vis, Mass Spectrometry, Drug Development, Laboratory
Education
West Virginia University 2003 — 2004
Postdcotoral Fellow, Forensic Toxicology
University of Mumbai 1999 — 2002
Ph.D, Pharmaceutics
George Spite's FDA Experience 1972 - 1985
Job Independent Management Consulting Professional
Industry Management Consulting
Kande Amarasinghe's FDA Experience 2010 - Present
Job Chemist at FDA
Industry Pharmaceuticals
Experience
FDA 2010 - Present
GE Global Research 2006 - 2009
Procter & Gamble 2002 - 2006
Education
Wayne State University 1997 — 2002
PhD, Organic Chemistry
University of Peradeniya 1990 — 1994
B.Sc., Chemistry
FDA 2010 - Present
GE Global Research 2006 - 2009
Procter & Gamble 2002 - 2006
Education
Wayne State University 1997 — 2002
PhD, Organic Chemistry
University of Peradeniya 1990 — 1994
B.Sc., Chemistry
See-Yan Lam's FDA Experience
Job Regulatory Health Education Specialist at FDA
Industry Government Administration
Experience
FDA
Skills
Clinical Research, Clinical Pharmacology, Regulatory Affairs, Pharmacology, Research, Clinical Trials, Pharmaceutical Industry, Clinical Development, Life Sciences, FDA, Regulatory Submissions, Drug Development, SOP
Education
University of Oregon
BA, MA
University of the Pacific
PharmD PhD
FDA
Skills
Clinical Research, Clinical Pharmacology, Regulatory Affairs, Pharmacology, Research, Clinical Trials, Pharmaceutical Industry, Clinical Development, Life Sciences, FDA, Regulatory Submissions, Drug Development, SOP
Education
University of Oregon
BA, MA
University of the Pacific
PharmD PhD
Andrew Lazerow's FDA Experience 1993 - 1995
Job Covington & Burling LLP
Industry Law Practice
Experience
Covington & Burling LLP March 2011 - Present
Howrey LLP July 2003 - March 2011
Mintz Levin 2000 - 2003
FDA 1993 - 1995
Skills
Class Actions, Litigation, Commercial Litigation, Patent Litigation, Securities Litigation, Competition Law, Civil Litigation, Unfair Competition, Antitrust Law, Depositions
Education
Georgetown University Law Center 1995 — 1998
Doctor of Law (J.D.)
University of Pennsylvania 1989 — 1993
Bachelor's degree, International Relations
Landon School 1979 — 1989
High School
Covington & Burling LLP March 2011 - Present
Howrey LLP July 2003 - March 2011
Mintz Levin 2000 - 2003
FDA 1993 - 1995
Skills
Class Actions, Litigation, Commercial Litigation, Patent Litigation, Securities Litigation, Competition Law, Civil Litigation, Unfair Competition, Antitrust Law, Depositions
Education
Georgetown University Law Center 1995 — 1998
Doctor of Law (J.D.)
University of Pennsylvania 1989 — 1993
Bachelor's degree, International Relations
Landon School 1979 — 1989
High School
Karl Lin's FDA Experience
Job Mathematical Statistician at FDA
Industry Government Administration
Experience
FDA
Skills
Data Analysis, Biostatistics, Statistics
Education
University of Michigan - Rackham Graduate School
Doctor of Philosophy (Ph.D.), Statistics
FDA
Skills
Data Analysis, Biostatistics, Statistics
Education
University of Michigan - Rackham Graduate School
Doctor of Philosophy (Ph.D.), Statistics
Marjorie Shapiro's FDA Experience 1993 - Present
Job Chief, Laboratory of Molecular and Developmental Immunology at FDA
Industry Biotechnology
Experience
FDA 1993 - Present
NIAID 1987 - 1993
Skills
Biochemistry, Immunology, Laboratory, Monoclonal Antibodies, Clinical Development, ELISA, Lifesciences, Molecular Biology, Cell Culture, IND, Protein Chemistry, Cell, Assay Development, Cell Biology, In Vitro, Protein Purification, Drug Discovery, Cancer, Cancer Research, Vaccines, Antibodies, Pharmacology, Biopharmaceuticals, Toxicology, Purification, Tissue Culture, Drug Development, DNA, Protein Expression, Western Blotting, Immunofluorescence
Education
University of Pennsylvania 1980 — 1987
Doctor of Philosophy (Ph.D.), Immunology
Univeristy of Maryland 1984 — 1986
Master's degree, Zoology/Animal Biology
FDA 1993 - Present
NIAID 1987 - 1993
Skills
Biochemistry, Immunology, Laboratory, Monoclonal Antibodies, Clinical Development, ELISA, Lifesciences, Molecular Biology, Cell Culture, IND, Protein Chemistry, Cell, Assay Development, Cell Biology, In Vitro, Protein Purification, Drug Discovery, Cancer, Cancer Research, Vaccines, Antibodies, Pharmacology, Biopharmaceuticals, Toxicology, Purification, Tissue Culture, Drug Development, DNA, Protein Expression, Western Blotting, Immunofluorescence
Education
University of Pennsylvania 1980 — 1987
Doctor of Philosophy (Ph.D.), Immunology
Univeristy of Maryland 1984 — 1986
Master's degree, Zoology/Animal Biology
Pamela Edwards-Leake's FDA Experience June 2015 - Present
Job Technical Information Specialist
Industry Government Administration
Experience
FDA June 2015 - Present
BarnAllen Technologies, Inc. June 2015 - Present
Skills
Policy, Research, Microsoft Office, Records Management, Customer Service, Conflict Management, Conflict Resolution, Time Management, OSHA Record Keeping
Education
University of Phoenix
Associate’s Degree, Business Administration and Management, General
FDA June 2015 - Present
BarnAllen Technologies, Inc. June 2015 - Present
Skills
Policy, Research, Microsoft Office, Records Management, Customer Service, Conflict Management, Conflict Resolution, Time Management, OSHA Record Keeping
Education
University of Phoenix
Associate’s Degree, Business Administration and Management, General
Cynthia Kleppinger's FDA Experience October 1998 - September 2002
Job Medical Officer at Food and Drug Administration
Industry Government Administration
Experience
Food and Drug Administration 2008 - Present
Science Applications International Corporation-Frederick January 2005 - September 2008
National Institute on Drug Abuse/National Institutes of Health September 2002 - December 2004
FDA October 1998 - September 2002
Skills
GCP, Vaccines, Clinical Trials, Regulatory Affairs, Pharmacovigilance, Clinical Research, Clinical Development, FDA, Regulatory Submissions, Medicine, Public Health, Quality Assurance, Protocol, Medical Devices, Sop, Immunology, SOP
Education
University of Missouri-Kansas City School of Medicine 1973 — 1979
B.A./M.D., Biology/Medicine
Food and Drug Administration 2008 - Present
Science Applications International Corporation-Frederick January 2005 - September 2008
National Institute on Drug Abuse/National Institutes of Health September 2002 - December 2004
FDA October 1998 - September 2002
Skills
GCP, Vaccines, Clinical Trials, Regulatory Affairs, Pharmacovigilance, Clinical Research, Clinical Development, FDA, Regulatory Submissions, Medicine, Public Health, Quality Assurance, Protocol, Medical Devices, Sop, Immunology, SOP
Education
University of Missouri-Kansas City School of Medicine 1973 — 1979
B.A./M.D., Biology/Medicine
Peter Beckerman's FDA Experience 2008 - February 2013
Job Deputy Associate General Counsel for Program Review (Foods and Veterinary Medicine) at US FDA/US Dept of HHS
Industry Public Policy
Experience
US FDA/US Dept of HHS February 2013 - Present
FDA 2008 - February 2013
Education
University of Michigan Law School 1992 — 1995
JD
US FDA/US Dept of HHS February 2013 - Present
FDA 2008 - February 2013
Education
University of Michigan Law School 1992 — 1995
JD
Deep Kwatra's FDA Experience January 2015 - Present
Job Clinical Pharmacology Reviewer at the FDA
Industry Research
Experience
FDA January 2015 - Present
University of Kansas Medical Center September 2011 - December 2014
UMKC August 2006 - September 2011
University of Missouri-Kansas City August 2006 - August 2011
Skills
Pharmacokinetics, Assay Development, Cell Culture, Cancer, HPLC, Western Blotting, Stem Cells, Confocal Microscopy, UV/Vis, RT-PCR, ELISA, Biochemistry, Biomarker Discovery, Protein Purification, Molecular Biology, Flow Cytometry, DMPK, Pharmacology
Education
Choithram School
University of Missouri-Kansas City 2006 — 2011
PhD, Pharmaceutical Sciences, Biochemistry and Molecular Biology
University of Missouri-Kansas City 2006 — 2010
MS, Cell and Molecular Biology
University of Missouri-Kansas City 2008 — 2010
Graduate Certificate in Teaching and Academic Carreer Preparation, Education
Smriti College of Pharmaceutical Educaton -Indore, MP, India 2002 — 2006
B. Pharm, Pharmacy
FDA January 2015 - Present
University of Kansas Medical Center September 2011 - December 2014
UMKC August 2006 - September 2011
University of Missouri-Kansas City August 2006 - August 2011
Skills
Pharmacokinetics, Assay Development, Cell Culture, Cancer, HPLC, Western Blotting, Stem Cells, Confocal Microscopy, UV/Vis, RT-PCR, ELISA, Biochemistry, Biomarker Discovery, Protein Purification, Molecular Biology, Flow Cytometry, DMPK, Pharmacology
Education
Choithram School
University of Missouri-Kansas City 2006 — 2011
PhD, Pharmaceutical Sciences, Biochemistry and Molecular Biology
University of Missouri-Kansas City 2006 — 2010
MS, Cell and Molecular Biology
University of Missouri-Kansas City 2008 — 2010
Graduate Certificate in Teaching and Academic Carreer Preparation, Education
Smriti College of Pharmaceutical Educaton -Indore, MP, India 2002 — 2006
B. Pharm, Pharmacy
Jing Zhang's FDA Experience July 2013 - September 2013
Job Assistant Professor at University of Maryland College Park
Industry Research
Experience
University of Maryland College Park August 2014 - Present
University of Minnesota, Department of Biostatistics September 2009 - June 2014
FDA July 2013 - September 2013
Boehringer Ingelheim May 2013 - July 2013
University of Minnesota, Department of Biostatistics September 2009 - January 2011
Skills
Biostatistics, R, SAS, Statistics, LaTeX, Statistical Modeling, Matlab, C++, C, SQL, Machine Learning, Data Mining, Experimental Design, Python, Mathematica, Time Series Analysis, Bioinformatics, Data Analysis, Mathematical Modeling, Bayesian statistics, Survival Analysis, Clinical Study Design, SAS programming, Statistical Consulting, Logistic Regression, Monte Carlo Simulation, Linear Regression, Epidemiology
Education
University of Minnesota-Twin Cities 2011 — 2014
PHD, Biostatistics
University of Minnesota-Twin Cities 2009 — 2011
MS, Biostatistics
University of Maryland College Park August 2014 - Present
University of Minnesota, Department of Biostatistics September 2009 - June 2014
FDA July 2013 - September 2013
Boehringer Ingelheim May 2013 - July 2013
University of Minnesota, Department of Biostatistics September 2009 - January 2011
Skills
Biostatistics, R, SAS, Statistics, LaTeX, Statistical Modeling, Matlab, C++, C, SQL, Machine Learning, Data Mining, Experimental Design, Python, Mathematica, Time Series Analysis, Bioinformatics, Data Analysis, Mathematical Modeling, Bayesian statistics, Survival Analysis, Clinical Study Design, SAS programming, Statistical Consulting, Logistic Regression, Monte Carlo Simulation, Linear Regression, Epidemiology
Education
University of Minnesota-Twin Cities 2011 — 2014
PHD, Biostatistics
University of Minnesota-Twin Cities 2009 — 2011
MS, Biostatistics
Larisa Wu's FDA Experience May 2014 - Present
Job Chemical engineer at FDA
Industry Higher Education
Experience
FDA May 2014 - Present
FDA July 2012 - May 2014
FDA December 2011 - June 2012
Pharmaceutical Sciences, School of Pharmacy, Univ of Maryland, Baltimore February 2011 - December 2011
Center for Controlled Chemical Release, University of Utah August 2006 - October 2010
Education
University of Utah 2006 — 2010
PhD, Bioengineering
University of New Orleans 2004 — 2006
M.S., Chemistry
FDA May 2014 - Present
FDA July 2012 - May 2014
FDA December 2011 - June 2012
Pharmaceutical Sciences, School of Pharmacy, Univ of Maryland, Baltimore February 2011 - December 2011
Center for Controlled Chemical Release, University of Utah August 2006 - October 2010
Education
University of Utah 2006 — 2010
PhD, Bioengineering
University of New Orleans 2004 — 2006
M.S., Chemistry
Murray Sheldon's FDA Experience December 2012 - Present
Job Associate Director of Technology and Innovation at FDA
Industry Medical Devices
Experience
FDA December 2012 - Present
BioVentrix March 2011 - December 2012
Solinas Medical 2010 - December 2012
Arbor Surgical Technologies 2003 - 2009
Arbor Surgical 2003 - 2009
Education
University of Michigan Medical School
FDA December 2012 - Present
BioVentrix March 2011 - December 2012
Solinas Medical 2010 - December 2012
Arbor Surgical Technologies 2003 - 2009
Arbor Surgical 2003 - 2009
Education
University of Michigan Medical School
Andre Markon's FDA Experience November 2014 - Present
Job General Health Scientist (Epidemiologist)/ Presidential Management Fellow at FDA
Industry Hospital & Health Care
Experience
FDA November 2014 - Present
University of Michigan School of Public Health September 2009 - September 2014
Skills
Epidemiology, Infectious Diseases, Public Health, Research, Global Health, Food Safety, Literature Reviews, International Health, Disease Surveillance, SAS, ArcGIS, Data Collection, Statistics, Data Analysis, SPSS, Qualitative Research
Education
University of Michigan 2009 — 2014
Doctor of Philosophy (PhD), Epidemiology
University of Michigan 2007 — 2009
Master of Public Health (MPH), Epidemiology- International Health
FDA November 2014 - Present
University of Michigan School of Public Health September 2009 - September 2014
Skills
Epidemiology, Infectious Diseases, Public Health, Research, Global Health, Food Safety, Literature Reviews, International Health, Disease Surveillance, SAS, ArcGIS, Data Collection, Statistics, Data Analysis, SPSS, Qualitative Research
Education
University of Michigan 2009 — 2014
Doctor of Philosophy (PhD), Epidemiology
University of Michigan 2007 — 2009
Master of Public Health (MPH), Epidemiology- International Health
Bradley Rowe, PhD's FDA Experience February 1995 - September 1995
Job Experienced Chemist
Industry Biotechnology
Experience
Desalination project December 2014 - Present
Independent Scientific Consultant June 2008 - Present
Bankers Life and Collonial Penn October 2014 - December 2014
Crown Benefits Solutions March 2014 - July 2014
Tyco Healthcare Mallinckrodt October 2003 - November 2006
Stereotaxis, Inc December 2001 - January 2003
Ralston Purina May 1997 - September 1997
Monsanto September 1995 - May 1997
FDA February 1995 - September 1995
Education
University of Missouri-Saint Louis 1997 — 2003
Ph.D., Organic Chemistry
University of Missouri-Saint Louis 1989 — 1995
B.S., Chemistry
Bishop Du Bourg High School 1986 — 1989
College prep.
Desalination project December 2014 - Present
Independent Scientific Consultant June 2008 - Present
Bankers Life and Collonial Penn October 2014 - December 2014
Crown Benefits Solutions March 2014 - July 2014
Tyco Healthcare Mallinckrodt October 2003 - November 2006
Stereotaxis, Inc December 2001 - January 2003
Ralston Purina May 1997 - September 1997
Monsanto September 1995 - May 1997
FDA February 1995 - September 1995
Education
University of Missouri-Saint Louis 1997 — 2003
Ph.D., Organic Chemistry
University of Missouri-Saint Louis 1989 — 1995
B.S., Chemistry
Bishop Du Bourg High School 1986 — 1989
College prep.
Karen Meysick's FDA Experience August 2006 - August 2009
Job Lecturer at University of Oklahoma
Industry Higher Education
Experience
University of Oklahoma August 2009 - Present
FDA August 2006 - August 2009
Skills
University Teaching
Education
University of Ottawa 1990 — 1996
PhD, Microbiology & Immunology
University of Oklahoma August 2009 - Present
FDA August 2006 - August 2009
Skills
University Teaching
Education
University of Ottawa 1990 — 1996
PhD, Microbiology & Immunology
Cristin Welle's FDA Experience 2010 - Present
Job Neurophysiologist
Industry Research
Experience
FDA 2010 - Present
Skills
Neurophysiology, Project Management, in Vivo..., Two-photon Microscopy, Data Analysis, In Vivo, Science, Animal Models, Immunohistochemistry, Confocal Microscopy, Neuroscience
Education
University of Pennsylvania 2004 — 2010
Doctor of Philosophy (Ph.D.), Neuroscience
FDA 2010 - Present
Skills
Neurophysiology, Project Management, in Vivo..., Two-photon Microscopy, Data Analysis, In Vivo, Science, Animal Models, Immunohistochemistry, Confocal Microscopy, Neuroscience
Education
University of Pennsylvania 2004 — 2010
Doctor of Philosophy (Ph.D.), Neuroscience
Nancy Parr's FDA Experience December 2006 - Present
Job Blackberry Program Manager at FDA
Industry Information Technology and Services
Emily Moses's FDA Experience June 2012 - September 2012
Job Project QA Engineer at Minnetronix, Inc.
Industry Medical Devices
Experience
Minnetronix, Inc. June 2013 - Present
FDA June 2012 - September 2012
Education
University of Michigan 2012 — 2013
MSE, Biomedical Engineering
University of Michigan 2008 — 2012
BSE, Biomedical Engineering/Mathematics
Minnetronix, Inc. June 2013 - Present
FDA June 2012 - September 2012
Education
University of Michigan 2012 — 2013
MSE, Biomedical Engineering
University of Michigan 2008 — 2012
BSE, Biomedical Engineering/Mathematics
Nora Ross's FDA Experience September 2014 - Present
Job Accountant at FDA
Industry Accounting
Experience
FDA September 2014 - Present
Cambridge Information Group March 2012 - September 2012
VPS convenience store July 2008 - May 2012
Boylan Development Company 2007 - 2008
House of Raeford 2005 - 2007
Skills
Accounts Receivable, Quickbooks, Accounting, Excel, Outlook, Word, Microsoft Office, Financial Reporting, Payroll, Data Entry, Auditing, QuickBooks
Education
University of North Carolina at Wilmington 2001 — 2005
Bachelor of Business Administration (B.B.A.), Accounting
FDA September 2014 - Present
Cambridge Information Group March 2012 - September 2012
VPS convenience store July 2008 - May 2012
Boylan Development Company 2007 - 2008
House of Raeford 2005 - 2007
Skills
Accounts Receivable, Quickbooks, Accounting, Excel, Outlook, Word, Microsoft Office, Financial Reporting, Payroll, Data Entry, Auditing, QuickBooks
Education
University of North Carolina at Wilmington 2001 — 2005
Bachelor of Business Administration (B.B.A.), Accounting
Jonathan B. Smith's FDA Experience June 1976 - November 1986
Job Legal Investigator at City of Kansas City, MO
Industry Government Administration
Experience
City of Kansas City, MO. January 1987 - Present
City of Kansas City, MO 1987 - Present
F.D.A. June 1976 - November 1986
FDA June 1976 - November 1986
Skills
Strategic Leadership
Education
University of Missouri-Columbia 1972 — 1976
B.S., Biology
City of Kansas City, MO. January 1987 - Present
City of Kansas City, MO 1987 - Present
F.D.A. June 1976 - November 1986
FDA June 1976 - November 1986
Skills
Strategic Leadership
Education
University of Missouri-Columbia 1972 — 1976
B.S., Biology
Rhonda Dash's FDA Experience 2008 - 2010
Job Research Compliance Auditor at University of North Texas Health Science Center
Industry Higher Education
Experience
UNT Health Science Center (UNTHSC) May 2012 - Present
UNT Health Science Center (UNTHSC) January 2010 - May 2012
FDA 2008 - 2010
Skills
FDA, Public Health, Life Sciences, Microbiology, Clinical Trials, Clinical Research, GCP, Molecular Biology, Regulatory Affairs, Western Blotting, PCR, Lifesciences, Pharmaceutical Industry, Medical Devices, GLP, Regulatory Submissions, Sop, Quality Assurance, Validation, Statistics, Biotechnology
Education
UNT Health Science Center 2001 — 2004
MPH, Evironmental Health
University of North Texas 1993 — 1998
Bachelor of Science (B.S.), Biology, General
UNT Health Science Center (UNTHSC) May 2012 - Present
UNT Health Science Center (UNTHSC) January 2010 - May 2012
FDA 2008 - 2010
Skills
FDA, Public Health, Life Sciences, Microbiology, Clinical Trials, Clinical Research, GCP, Molecular Biology, Regulatory Affairs, Western Blotting, PCR, Lifesciences, Pharmaceutical Industry, Medical Devices, GLP, Regulatory Submissions, Sop, Quality Assurance, Validation, Statistics, Biotechnology
Education
UNT Health Science Center 2001 — 2004
MPH, Evironmental Health
University of North Texas 1993 — 1998
Bachelor of Science (B.S.), Biology, General
Sharon Thoma's FDA Experience March 2007 - Present
Job National Expert at US Department of Health & Human Services
Industry Government Administration
Experience
FDA March 2007 - Present
FDA November 1989 - March 2007
United Indian Health Services November 1987 - October 1989
Veterans Medical Center August 1984 - October 1987
Skills
Public Health, Policy, Government, Epidemiology, Policy Analysis, Program Evaluation, Healthcare, Public Policy, Clinical Research, Research, Emergency Management, Community Outreach, Health Policy, Health Education, Global Health, Public Speaking, Program Development, Data Analysis, Infectious Diseases, Healthcare Management, Biotechnology, Regulatory Submissions
Education
University of Minnesota-Twin Cities 1999 — 2001
Doctor of Pharmacy (PharmD), Pharmacy
University of Minnesota-Twin Cities 1981 — 1984
B.S. Pharmacy, PharmD
University of Minnesota-Twin Cities 1978 — 1981
College of Liberal Arts
University of Minnesota-Twin Cities
FDA March 2007 - Present
FDA November 1989 - March 2007
United Indian Health Services November 1987 - October 1989
Veterans Medical Center August 1984 - October 1987
Skills
Public Health, Policy, Government, Epidemiology, Policy Analysis, Program Evaluation, Healthcare, Public Policy, Clinical Research, Research, Emergency Management, Community Outreach, Health Policy, Health Education, Global Health, Public Speaking, Program Development, Data Analysis, Infectious Diseases, Healthcare Management, Biotechnology, Regulatory Submissions
Education
University of Minnesota-Twin Cities 1999 — 2001
Doctor of Pharmacy (PharmD), Pharmacy
University of Minnesota-Twin Cities 1981 — 1984
B.S. Pharmacy, PharmD
University of Minnesota-Twin Cities 1978 — 1981
College of Liberal Arts
University of Minnesota-Twin Cities
Monica Metz's FDA Experience January 2011 - Present
Job Branch Chief
Industry Food & Beverages
Experience
FDA January 2011 - Present
FDA November 2001 - January 2011
Leprino Foods 1998 - 2001
Skills
Food Safety
Education
University of Nebraska-Lincoln
MS, Food Science and Technology
FDA January 2011 - Present
FDA November 2001 - January 2011
Leprino Foods 1998 - 2001
Skills
Food Safety
Education
University of Nebraska-Lincoln
MS, Food Science and Technology
Na Hu's FDA Experience June 2011 - August 2011
Job Senior Biostatistician at Novartis
Industry Research
Experience
Novartis June 2013 - Present
University of Missouri August 2008 - May 2013
Novartis Oncology Biometrics and Data Management May 2012 - August 2012
FDA June 2011 - August 2011
Skills
Matlab, R, SAS, SQL, Microsoft Office, C, PowerPoint, Data Analysis, Statistics
Education
University of Missouri-Columbia 2008 — 2013
Doctor of Philosophy (PhD), Statistics
Zhejiang University 2004 — 2008
Bachelor of Science, Mathematics
Novartis June 2013 - Present
University of Missouri August 2008 - May 2013
Novartis Oncology Biometrics and Data Management May 2012 - August 2012
FDA June 2011 - August 2011
Skills
Matlab, R, SAS, SQL, Microsoft Office, C, PowerPoint, Data Analysis, Statistics
Education
University of Missouri-Columbia 2008 — 2013
Doctor of Philosophy (PhD), Statistics
Zhejiang University 2004 — 2008
Bachelor of Science, Mathematics
statistician Yuan-Li's FDA Experience October 2004 - Present
Job statistician
Industry Government Administration
Experience
FDA October 2004 - Present
FDA January 2001 - Present
Skills
Analysis, Biostatistics, Data Analysis, Epidemiology, Public Health, Policy Analysis, Research, SAS, Statistics
Education
University of North Carolina at Chapel Hill
Biostatistics
FDA October 2004 - Present
FDA January 2001 - Present
Skills
Analysis, Biostatistics, Data Analysis, Epidemiology, Public Health, Policy Analysis, Research, SAS, Statistics
Education
University of North Carolina at Chapel Hill
Biostatistics
Gerald Blackwell's FDA Experience March 2002 - April 2007
Job Science Writer at Blackwell Device Consulting
Industry Medical Devices
Experience
Blackwell Device Consulting July 2012 - Present
FDA March 2002 - April 2007
Education
University of North Carolina at Greensboro 2007 — 2012
Master of Arts (M.A.), Liberal Arts and Sciences/Liberal Studies
Blackwell Device Consulting July 2012 - Present
FDA March 2002 - April 2007
Education
University of North Carolina at Greensboro 2007 — 2012
Master of Arts (M.A.), Liberal Arts and Sciences/Liberal Studies
Sarmistha Sanyal's FDA Experience August 2014 - Present
Job ORISE Fellow at FDA
Industry Research
Experience
FDA August 2014 - Present
National Institutes of Health March 2013 - July 2013
National Institutes of Health July 2010 - July 2013
University of Minnesota-Twin Cities September 2003 - March 2010
University of Minnesota-Twin Cities March 2002 - March 2003
National Center for Biological Sciences September 2000 - December 2000
Skills
Protein Expression, Protein Purification, Biochemistry, Western Blotting, PCR, Cell Based Assays, Fluorescence Microscopy, Purification, Molecular Biology, Cell Biology, Cell Culture, Macromolecular..., Stopped-Flow..., HPLC, LC-MS, GC-MS, Protein Sequence..., Chromatography, Bioinformatics, EPR, Circular Dichroism, Enzyme Assays, Enzyme Kinetics
Education
University of Minnesota-Twin Cities 2003 — 2010
Ph.D, Biochemistry
FDA August 2014 - Present
National Institutes of Health March 2013 - July 2013
National Institutes of Health July 2010 - July 2013
University of Minnesota-Twin Cities September 2003 - March 2010
University of Minnesota-Twin Cities March 2002 - March 2003
National Center for Biological Sciences September 2000 - December 2000
Skills
Protein Expression, Protein Purification, Biochemistry, Western Blotting, PCR, Cell Based Assays, Fluorescence Microscopy, Purification, Molecular Biology, Cell Biology, Cell Culture, Macromolecular..., Stopped-Flow..., HPLC, LC-MS, GC-MS, Protein Sequence..., Chromatography, Bioinformatics, EPR, Circular Dichroism, Enzyme Assays, Enzyme Kinetics
Education
University of Minnesota-Twin Cities 2003 — 2010
Ph.D, Biochemistry
Renate Reimschuessel's FDA Experience January 1999 - August 2010
Job Director VetLIRN at FDA
Industry Government Administration
Experience
U.S. Government 2010 - Present
aquavet 2006 - 2013
aquavet 2006 - 2013
FDA January 1999 - August 2010
U. Maryland Aquatic Pathobiology Center September 1985 - December 1998
Skills
Veterinary, Veterinary Medicine, Science, Fish, Ecology, Lifesciences, Immunology, Pathology, Epidemiology, Aquaculture, PCR, Wildlife, Marine Biology, Agriculture, Molecular Biology, Microbiology, Animal Husbandry, Scientific Writing, Cell Culture, Pharmacology, Genetics, Toxicology, Animal Welfare, Virology, Physiology, Natural Resource..., Environmental Science, Infectious Diseases, Biology, Environmental Awareness, Biochemistry, Vaccines, Water Quality, Cell Biology, Laboratory, Aquatic Ecology, Animal Behavior, Experimental Design, Life Sciences, Genomics, Medicine, Biotechnology, Public Health, Animal Work, GLP, Animal Models, Histology
Education
University of Pennsylvania 1977 — 1981
vmd
U.S. Government 2010 - Present
aquavet 2006 - 2013
aquavet 2006 - 2013
FDA January 1999 - August 2010
U. Maryland Aquatic Pathobiology Center September 1985 - December 1998
Skills
Veterinary, Veterinary Medicine, Science, Fish, Ecology, Lifesciences, Immunology, Pathology, Epidemiology, Aquaculture, PCR, Wildlife, Marine Biology, Agriculture, Molecular Biology, Microbiology, Animal Husbandry, Scientific Writing, Cell Culture, Pharmacology, Genetics, Toxicology, Animal Welfare, Virology, Physiology, Natural Resource..., Environmental Science, Infectious Diseases, Biology, Environmental Awareness, Biochemistry, Vaccines, Water Quality, Cell Biology, Laboratory, Aquatic Ecology, Animal Behavior, Experimental Design, Life Sciences, Genomics, Medicine, Biotechnology, Public Health, Animal Work, GLP, Animal Models, Histology
Education
University of Pennsylvania 1977 — 1981
vmd
Brian Mundo's FDA Experience August 2010 - October 2012
Job Quality Manager at Orchid Orthopedic Solutions
Industry Medical Devices
Experience
Orchid Orthopedic Solutions October 2014 - Present
Wayne State University 2013 - Present
Orchid Orthopedic Solutions March 2014 - October 2014
CRMP October 2012 - February 2014
FDA August 2010 - October 2012
Wayne State University 2007 - 2010
The Home Depot 2002 - 2007
Skills
Regulatory Affairs, Medical Devices, QSIT, Quality System..., Tissue Engineering, Biomaterials, ISO 13485, CMDCAS, Nanofibers, Wheelchairs, Quality Assurance, Cell Culture, Biomechanics, Quality System, Matlab, FDA, Biomedical Engineering, Data Analysis
Education
Wayne State University 2007 — 2010
Master's degree, Bioengineering and Biomedical Engineering
University of Michigan 2001 — 2006
Bachelor of Engineering (B.E.), Bioengineering and Biomedical Engineering
Orchid Orthopedic Solutions October 2014 - Present
Wayne State University 2013 - Present
Orchid Orthopedic Solutions March 2014 - October 2014
CRMP October 2012 - February 2014
FDA August 2010 - October 2012
Wayne State University 2007 - 2010
The Home Depot 2002 - 2007
Skills
Regulatory Affairs, Medical Devices, QSIT, Quality System..., Tissue Engineering, Biomaterials, ISO 13485, CMDCAS, Nanofibers, Wheelchairs, Quality Assurance, Cell Culture, Biomechanics, Quality System, Matlab, FDA, Biomedical Engineering, Data Analysis
Education
Wayne State University 2007 — 2010
Master's degree, Bioengineering and Biomedical Engineering
University of Michigan 2001 — 2006
Bachelor of Engineering (B.E.), Bioengineering and Biomedical Engineering
Tom Dowell's FDA Experience 1990 - 2000
Job Quality Assurance at Terumo BCT
Industry Medical Devices
Experience
Terumo BCT October 2014 - Present
Biodesix, Inc. October 2012 - Present
Cochlear 2011 - 2012
Medical Modeling Inc. September 2008 - February 2011
Gambro September 2003 - September 2008
Valleylab June 2001 - September 2003
FDA 1990 - 2000
Skills
FDA, Regulatory Affairs, Quality System, Regulatory Requirements, ISO 13485, Quality Assurance, Validation, Quality Management, Regulatory Submissions, CAPA, Change Control, GMP, GxP, Quality Auditing, Medical Devices, Sop, GLP, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, GCP, Lifesciences, Life Sciences, SOP
Education
University of Northern Colorado 1983 — 1988
Bachelor's degree, Biology/Biological Sciences, General
Terumo BCT October 2014 - Present
Biodesix, Inc. October 2012 - Present
Cochlear 2011 - 2012
Medical Modeling Inc. September 2008 - February 2011
Gambro September 2003 - September 2008
Valleylab June 2001 - September 2003
FDA 1990 - 2000
Skills
FDA, Regulatory Affairs, Quality System, Regulatory Requirements, ISO 13485, Quality Assurance, Validation, Quality Management, Regulatory Submissions, CAPA, Change Control, GMP, GxP, Quality Auditing, Medical Devices, Sop, GLP, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, GCP, Lifesciences, Life Sciences, SOP
Education
University of Northern Colorado 1983 — 1988
Bachelor's degree, Biology/Biological Sciences, General
Sandra Titus's FDA Experience Grants ManagerOffice of Research Integrity, Department of Health and Human Services2002 - Present
Job Grants Manager at Office of Research Integrity, Department of Health and Human Services
Industry Government Administration
Experience
FDA Grants ManagerOffice of Research Integrity, Department of Health and Human Services2002 - Present
Education
University of Minnesota-Twin Cities
Doctor of Philosophy (PhD), PhD in Social Psychology and MS in Public Health
FDA Grants ManagerOffice of Research Integrity, Department of Health and Human Services2002 - Present
Education
University of Minnesota-Twin Cities
Doctor of Philosophy (PhD), PhD in Social Psychology and MS in Public Health
Lisa Kay Naeger's FDA Experience 2002 - Present
Job Senior Clinical Virology Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA 2002 - Present
Gilead Sciences 1998 - 2001
Tularik 1997 - 1998
Yale University 1992 - 1997
Skills
Clinical Research
Education
University of Missouri-Columbia 1983 — 1992
Bachelor's of Science and Ph.D., Biochemistry, Molecular Microbiology and Immunology
FDA 2002 - Present
Gilead Sciences 1998 - 2001
Tularik 1997 - 1998
Yale University 1992 - 1997
Skills
Clinical Research
Education
University of Missouri-Columbia 1983 — 1992
Bachelor's of Science and Ph.D., Biochemistry, Molecular Microbiology and Immunology
Dorothy Wawrose's FDA Experience 2002 - 2009
Job Government Administration Professional
Industry Government Administration
Experience
FDA 2002 - 2009
Skills
Public Policy, Policy Analysis, Public Health, Federal Government, Medicine
Education
University of Pennsylvania School of Medicine
FDA 2002 - 2009
Skills
Public Policy, Policy Analysis, Public Health, Federal Government, Medicine
Education
University of Pennsylvania School of Medicine
Lisa Vo Khosla's FDA Experience December 2013 - June 2014
Job
Industry Pharmaceuticals
Experience
AstraZeneca June 2014 - Present
FDA December 2013 - June 2014
FDA December 2012 - December 2013
National Institutes of Health December 2011 - December 2012
National Institutes of Health March 2010 - December 2011
Target Pharmacy August 2009 - March 2010
Potomac Hospital June 2008 - July 2009
Education
Virginia Commonwealth University School of Pharmacy 2004 — 2008
Doctor of Pharmacy (Pharm.D.), Pharmacy
Virginia Commonwealth University 2001 — 2004
Master of Health Administration, Health Policy and Administration
University of North Carolina at Chapel Hill 1997 — 2001
Bachelor of Science, Health Policy and Administration
AstraZeneca June 2014 - Present
FDA December 2013 - June 2014
FDA December 2012 - December 2013
National Institutes of Health December 2011 - December 2012
National Institutes of Health March 2010 - December 2011
Target Pharmacy August 2009 - March 2010
Potomac Hospital June 2008 - July 2009
Education
Virginia Commonwealth University School of Pharmacy 2004 — 2008
Doctor of Pharmacy (Pharm.D.), Pharmacy
Virginia Commonwealth University 2001 — 2004
Master of Health Administration, Health Policy and Administration
University of North Carolina at Chapel Hill 1997 — 2001
Bachelor of Science, Health Policy and Administration
Susan Nickols's FDA Experience March 1987 - Present
Job Senior Analytical Chemist at FDA
Industry Government Administration
Experience
FDA March 1987 - Present
Skills
Chemistry, Microsoft Office, Analytical Chemistry, HPLC, Microsoft Excel, Science, Life Sciences, GMP, Government, Microsoft Word
Education
University of Missouri-Rolla 1982 — 1985
Bachelor's Degree, Dual major in Chemistry and Life Science
FDA March 1987 - Present
Skills
Chemistry, Microsoft Office, Analytical Chemistry, HPLC, Microsoft Excel, Science, Life Sciences, GMP, Government, Microsoft Word
Education
University of Missouri-Rolla 1982 — 1985
Bachelor's Degree, Dual major in Chemistry and Life Science
Gwendolyn Murphy's FDA Experience September 2014 - Present
Job Project Manager at FDA
Industry Pharmaceuticals
Experience
FDA September 2014 - Present
Harris Teeter Pharmacy April 2002 - September 2014
Education
University of North Carolina at Chapel Hill 1995 — 2000
Doctor of Pharmacy (PharmD), Pharmacy
FDA September 2014 - Present
Harris Teeter Pharmacy April 2002 - September 2014
Education
University of North Carolina at Chapel Hill 1995 — 2000
Doctor of Pharmacy (PharmD), Pharmacy
Judy Labiner-Wolfe's FDA Experience August 2003 - January 2010
Job Branch Chief, Policy, Data and Technical Assistance at US Government, Department of Health & Human Services, HRSA
Industry Government Administration
Experience
US Government, Department of Health & Human Services, HRSA December 2014 - Present
USDA September 2012 - Present
US Department of Health and Human Services January 2010 - September 2012
FDA August 2003 - January 2010
University of Pennsylvania January 2003 - May 2009
The Brookings Institution January 2000 - August 2003
Skills
Public Policy, Program Evaluation, Research, Policy Analysis
Education
University of North Carolina at Chapel Hill
Doctor of Philosophy (PhD), Public Policy Analysis
University of Minnesota-Twin Cities
Master of Arts (M.A.), Public Affairs
University of Wisconsin-Madison
Bachelor of Arts (B.A.), Anthropology and French
US Government, Department of Health & Human Services, HRSA December 2014 - Present
USDA September 2012 - Present
US Department of Health and Human Services January 2010 - September 2012
FDA August 2003 - January 2010
University of Pennsylvania January 2003 - May 2009
The Brookings Institution January 2000 - August 2003
Skills
Public Policy, Program Evaluation, Research, Policy Analysis
Education
University of North Carolina at Chapel Hill
Doctor of Philosophy (PhD), Public Policy Analysis
University of Minnesota-Twin Cities
Master of Arts (M.A.), Public Affairs
University of Wisconsin-Madison
Bachelor of Arts (B.A.), Anthropology and French
Karl Lin's FDA Experience Expert mathematical statisticianFDAApril 1987 - Present
Job Expert Mathematical Statistician/Team Leader at FDA
Industry Government Administration
Experience
FDA Expert mathematical statisticianFDAApril 1987 - Present
Education
University of Michigan
FDA Expert mathematical statisticianFDAApril 1987 - Present
Education
University of Michigan
Cheryl (Cheryl Iverson) Kmiec's FDA Experience January 2002 - July 2005
Job Nutrition Labeling And Regulatory Food Compliance Leader
Industry Food & Beverages
Experience
Target October 2011 - Present
Target August 2009 - August 2011
Target September 2007 - August 2009
ConAgra Foods July 2005 - August 2007
FDA January 2002 - July 2005
3M May 2000 - January 2001
Skills
Regulatory Affairs, Food Law, Food Labelling, Cross-functional Team..., FDA, FDA GMP, Product Development, Quality Control, Organic Products
Education
University of Minnesota-Twin Cities 1997 — 2001
Bachelor’s Degree, Chemical Engineering
Target October 2011 - Present
Target August 2009 - August 2011
Target September 2007 - August 2009
ConAgra Foods July 2005 - August 2007
FDA January 2002 - July 2005
3M May 2000 - January 2001
Skills
Regulatory Affairs, Food Law, Food Labelling, Cross-functional Team..., FDA, FDA GMP, Product Development, Quality Control, Organic Products
Education
University of Minnesota-Twin Cities 1997 — 2001
Bachelor’s Degree, Chemical Engineering
Department of Veterans Affairs
US Census Bureau
U.S. Department of Veterans Affairs
US Securities and Exchange Commission
USAID
US Fish and Wildlife Service
TSA
Defense Logistics Agency