FDA Company
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Headquarters: Silver Spring, Maryland, United States Employees: 14,824 (2010) Jurisdiction: United States of America Founded: 30 June 1906 Subsidiaries: Center for Drug Evaluation and Research, Founders: Theodore Roosevelt, Harvey Washington Wiley
FDA List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at FDA. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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4,886 FDA employees in database. Find out everything there's to know about FDA employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
FDA Employees
Employee
Years
Job
Industry
Jessica Motherwell Jessica Motherwell's FDA Experience 2015 - 2015
Job Graduate Student at Tulane University
Industry Biotechnology
Experience
Tulane University July 2014 - Present
FDA 2015 - 2015
FDA 2015 - 2015
George Laboratory March 2012 - June 2014
In N Out Burger August 2007 - June 2014
Skills
Immunohistochemistry, Immunostaining, Fluorescence Microscopy, Transfection, Transduction, Matlab, ImageJ, 3D Tissue Culture, Mouse Models, Mammalian Cell Culture, Cell Culture
Education
Tulane University 2014 — 2019
Doctor of Philosophy (Ph.D.), BioInnovation
University of California, Irvine 2011 — 2014
Bachelor's Degree, Biomedical Engineering
Tulane University July 2014 - Present
FDA 2015 - 2015
FDA 2015 - 2015
George Laboratory March 2012 - June 2014
In N Out Burger August 2007 - June 2014
Skills
Immunohistochemistry, Immunostaining, Fluorescence Microscopy, Transfection, Transduction, Matlab, ImageJ, 3D Tissue Culture, Mouse Models, Mammalian Cell Culture, Cell Culture
Education
Tulane University 2014 — 2019
Doctor of Philosophy (Ph.D.), BioInnovation
University of California, Irvine 2011 — 2014
Bachelor's Degree, Biomedical Engineering
Will Glindmeyer, Ph.D. Will Glindmeyer, Ph.D.'s FDA Experience August 2013 - May 2015
Job Equity Research Associate at TimesSquare Capital Management
Industry Biotechnology
Experience
TimesSquare Capital Management, LLC June 2015 - Present
FDA August 2013 - May 2015
Tulane University May 2013 - August 2013
Tulane University September 2007 - April 2013
Skills
Fluid Mechanics, Biomedical Engineering, Biomechanics, Microdevices, Mathematics, Lung, Pulmonary Diseases, Cell Culture, Surfactants, Image Processing, Adobe Creative Suite, Teaching, Microfluidics, Flow Cytometry, Tissue Engineering, Surface Modification, Biomaterials, Respiratory, Drug Delivery, Matlab, Mathematical Modeling, Mathematica, Scanning Electron..., Medical Devices, Confocal Microscopy, Microscopy, COMSOL, Image Analysis, Fluorescence Microscopy, ImageJ, Bioengineering, Biotechnology, Financial Modeling, LabVIEW
Education
Tulane University 2007 — 2013
Doctor of Philosophy (PhD), Biomedical Engineering
Tulane University 2003 — 2007
Bachelor of Science (BS), Biomedical Engineering
TimesSquare Capital Management, LLC June 2015 - Present
FDA August 2013 - May 2015
Tulane University May 2013 - August 2013
Tulane University September 2007 - April 2013
Skills
Fluid Mechanics, Biomedical Engineering, Biomechanics, Microdevices, Mathematics, Lung, Pulmonary Diseases, Cell Culture, Surfactants, Image Processing, Adobe Creative Suite, Teaching, Microfluidics, Flow Cytometry, Tissue Engineering, Surface Modification, Biomaterials, Respiratory, Drug Delivery, Matlab, Mathematical Modeling, Mathematica, Scanning Electron..., Medical Devices, Confocal Microscopy, Microscopy, COMSOL, Image Analysis, Fluorescence Microscopy, ImageJ, Bioengineering, Biotechnology, Financial Modeling, LabVIEW
Education
Tulane University 2007 — 2013
Doctor of Philosophy (PhD), Biomedical Engineering
Tulane University 2003 — 2007
Bachelor of Science (BS), Biomedical Engineering
Ross Spears Ross Spears's FDA Experience May 2002 - March 2003
Job Emergency Response Planning and Occupational Safety
Industry Government Administration
Experience
Centers for Disease Control July 2009 - Present
Centers for Disease Control and Prevention August 2015 - September 2015
CDC January 2015 - February 2015
CDC October 2012 - October 2012
Centers for Disease Control and Prevention November 2006 - July 2009
Centers for Disease Control and Prevention March 2003 - November 2006
FDA May 2002 - March 2003
Global Stone April 2000 - March 2001
Linatex January 1996 - November 2000
US Bureau of Mines January 1995 - January 1996
Skills
Public Health, Preparedness, Epidemiology, Emergency Management, Program Evaluation, Prevention, Infectious Diseases, Policy Analysis, Government, Virology, GIS, Policy, ArcGIS, Grants, Environmental Science, Grant Writing, Surveillance, Research, Data Analysis, Statistics, Emergency Services, Program Management, Project Planning, Science, Disaster Response, Security Clearance, Exercises, Environmental Health, Points of Dispensing..., Global Health, International Health, Homeland Security, Emergency Planning, Training, CBRN, NIMS, Risk Assessment
Education
University of South Florida 2004 — 2006
Gradudate Certificate, Disaster Management
University of Alabama 1984 — 1991
Doctor of Philosophy (PhD), Chemistry
Western Kentucky University 1982 — 1984
Master's degree, Chemistry
Centers for Disease Control July 2009 - Present
Centers for Disease Control and Prevention August 2015 - September 2015
CDC January 2015 - February 2015
CDC October 2012 - October 2012
Centers for Disease Control and Prevention November 2006 - July 2009
Centers for Disease Control and Prevention March 2003 - November 2006
FDA May 2002 - March 2003
Global Stone April 2000 - March 2001
Linatex January 1996 - November 2000
US Bureau of Mines January 1995 - January 1996
Skills
Public Health, Preparedness, Epidemiology, Emergency Management, Program Evaluation, Prevention, Infectious Diseases, Policy Analysis, Government, Virology, GIS, Policy, ArcGIS, Grants, Environmental Science, Grant Writing, Surveillance, Research, Data Analysis, Statistics, Emergency Services, Program Management, Project Planning, Science, Disaster Response, Security Clearance, Exercises, Environmental Health, Points of Dispensing..., Global Health, International Health, Homeland Security, Emergency Planning, Training, CBRN, NIMS, Risk Assessment
Education
University of South Florida 2004 — 2006
Gradudate Certificate, Disaster Management
University of Alabama 1984 — 1991
Doctor of Philosophy (PhD), Chemistry
Western Kentucky University 1982 — 1984
Master's degree, Chemistry
Anthony Mire-Sluis Anthony Mire-Sluis's FDA Experience August 2002 - August 2004
Job Vice President, North America, Singapore, Contract and Product Quality at Amgen
Industry Biotechnology
Experience
Amgen August 2004 - Present
FDA August 2002 - August 2004
CancerVax Corporation August 2001 - August 2002
Genentech October 1999 - August 2001
NIBSC January 1990 - October 1999
Skills
Product Development, Quality Management, Quality Assurance, Quality System, Quality Control, Analytical Methods..., Analytical Method..., Bioassay, Biotechnology, Regulatory Affairs, Regulatory Submissions, Biotechnology Industry, Immunogenicity, Management, Comedic Timing, Quality System..., Compliance, Corporate Quality, Product Quality, Validation, Biochemistry, GMP, SOP, FDA, Pharmaceutical Industry, Biopharmaceuticals, Drug Development, Life Sciences
Education
Royal Free Hospital 1984 — 1987
Doctor of Philosophy (Ph.D.), Immunology and Biochemistry
UCL 1981 — 1984
Bachelor's Degree, Genetics and Biometry
Amgen August 2004 - Present
FDA August 2002 - August 2004
CancerVax Corporation August 2001 - August 2002
Genentech October 1999 - August 2001
NIBSC January 1990 - October 1999
Skills
Product Development, Quality Management, Quality Assurance, Quality System, Quality Control, Analytical Methods..., Analytical Method..., Bioassay, Biotechnology, Regulatory Affairs, Regulatory Submissions, Biotechnology Industry, Immunogenicity, Management, Comedic Timing, Quality System..., Compliance, Corporate Quality, Product Quality, Validation, Biochemistry, GMP, SOP, FDA, Pharmaceutical Industry, Biopharmaceuticals, Drug Development, Life Sciences
Education
Royal Free Hospital 1984 — 1987
Doctor of Philosophy (Ph.D.), Immunology and Biochemistry
UCL 1981 — 1984
Bachelor's Degree, Genetics and Biometry
Lisa Nash's FDA Experience June 2010 - August 2010
Job Marketing and Communications Associate at Green Seal
Industry Political Organization
Experience
Green Seal March 2015 - Present
Green Seal February 2014 - March 2015
Green Seal November 2013 - February 2014
Chesapeake Climate Action Network October 2013 - February 2014
True Run Media - thebeijinger, beijingkids, agenda June 2012 - August 2012
FDA June 2010 - August 2010
Skills
Mandarin (proficient), Spanish (proficient), Microsoft Office..., Creative Writing, Editing
Education
Tulane University 2009 — 2013
Bachelor of Arts (B.A.), Political Science- International Relations and Asian Studies
Green Seal March 2015 - Present
Green Seal February 2014 - March 2015
Green Seal November 2013 - February 2014
Chesapeake Climate Action Network October 2013 - February 2014
True Run Media - thebeijinger, beijingkids, agenda June 2012 - August 2012
FDA June 2010 - August 2010
Skills
Mandarin (proficient), Spanish (proficient), Microsoft Office..., Creative Writing, Editing
Education
Tulane University 2009 — 2013
Bachelor of Arts (B.A.), Political Science- International Relations and Asian Studies
Maureen Davidson, Ph.D Maureen Davidson, Ph.D's FDA Experience July 2007 - Present
Job Research Microbiologist at FDA
Industry Government Administration
Experience
FDA Center for Veterinary Medicine December 2012 - Present
FDA July 2007 - Present
Purdue Universtiy August 2003 - July 2007
University of Florida June 1993 - July 2003
University of Alabama at Birmingham 1972 - 1993
Skills
Infectious Diseases, Lifesciences, Research, Biotechnology, In Vivo, Microbiology, Science, Animal Work, FDA, Laboratory, Flow Cytometry, Animal Models, Immunology, Cell Culture, Molecular Biology, ELISA, GLP, Immunohistochemistry, Tissue Culture, Western Blotting, Microscopy, Fluorescence Microscopy, Histology, Biology, Veterinary, Genomics, Regulatory Affairs, In Vitro, Assay Development, qPCR, DNA, Immunoassays, Gel Electrophoresis, DNA sequencing, DNA extraction, Scientific Writing, Aseptic Technique, Food Microbiology, PCR, Epidemiology
Education
University of Alabama at Birmingham 1981 — 1988
PhD, Experimental Pathology
University of Alabama at Birmingham 1977 — 1981
Master of Science (MS), Experimental Pathology
University of Alabama at Birmingham 1969 — 1973
Bachelor of Science (BS), Medical Technology
Universtiy of Alabama at Birmingham 1969 — 1972
Bachelor of Science (BS), Biology
FDA Center for Veterinary Medicine December 2012 - Present
FDA July 2007 - Present
Purdue Universtiy August 2003 - July 2007
University of Florida June 1993 - July 2003
University of Alabama at Birmingham 1972 - 1993
Skills
Infectious Diseases, Lifesciences, Research, Biotechnology, In Vivo, Microbiology, Science, Animal Work, FDA, Laboratory, Flow Cytometry, Animal Models, Immunology, Cell Culture, Molecular Biology, ELISA, GLP, Immunohistochemistry, Tissue Culture, Western Blotting, Microscopy, Fluorescence Microscopy, Histology, Biology, Veterinary, Genomics, Regulatory Affairs, In Vitro, Assay Development, qPCR, DNA, Immunoassays, Gel Electrophoresis, DNA sequencing, DNA extraction, Scientific Writing, Aseptic Technique, Food Microbiology, PCR, Epidemiology
Education
University of Alabama at Birmingham 1981 — 1988
PhD, Experimental Pathology
University of Alabama at Birmingham 1977 — 1981
Master of Science (MS), Experimental Pathology
University of Alabama at Birmingham 1969 — 1973
Bachelor of Science (BS), Medical Technology
Universtiy of Alabama at Birmingham 1969 — 1972
Bachelor of Science (BS), Biology
Marilyn Diaz Marilyn Diaz's FDA Experience June 2006 - August 2006
Job Project Manager at U.S. Nuclear Regulatory Commission
Industry Government Administration
Experience
U.S. Nuclear Regulatory Commission August 2008 - Present
FDA June 2006 - August 2006
Skills
Nuclear, Chemical Engineering, MS Project, Program Management, Federal Government, Government, PMP, Project Management, Engineering, Process Simulation, Policy, Renewable Energy, Environmental Impact..., Environmental Science, Environmental Awareness, Energy, Analysis, Technical Writing, Process Engineering, Microsoft Project, Process Improvement, Project Coordination, Project Planning, Proposal Writing
Education
The George Washington University
Master of Public Health (M.P.H.), Environmental Health Sciences and Policy
University of Puerto Rico 2003 — 2008
Chemical Engineering, Chemical Engineering
U.S. Nuclear Regulatory Commission August 2008 - Present
FDA June 2006 - August 2006
Skills
Nuclear, Chemical Engineering, MS Project, Program Management, Federal Government, Government, PMP, Project Management, Engineering, Process Simulation, Policy, Renewable Energy, Environmental Impact..., Environmental Science, Environmental Awareness, Energy, Analysis, Technical Writing, Process Engineering, Microsoft Project, Process Improvement, Project Coordination, Project Planning, Proposal Writing
Education
The George Washington University
Master of Public Health (M.P.H.), Environmental Health Sciences and Policy
University of Puerto Rico 2003 — 2008
Chemical Engineering, Chemical Engineering
Warren Flatau Warren Flatau's FDA Experience February 1995 - September 1995
Job Public Affairs and Strategic Communications
Industry Public Relations and Communications
Experience
Federal Railroad Administration, U.S. Department of Transportation May 2003 - Present
Federal Railroad Administration October 1999 - May 2003
Federal Railroad Administration July 1997 - October 1999
Federal Highway Administration September 1995 - July 1997
FDA February 1995 - September 1995
Skills
Press Releases, Public Affairs, Government, Strategic Communications, Policy, Media Relations, Crisis Communications, Public Policy, Politics, Policy Analysis, Legislation, Internal Communications, Spokesperson, Social Media, Speech Writing, Legislative Relations, Corporate Communications, Public Speaking, Public Relations, Strategy, International Relations, Coalitions, Web Content Management, Proposal Writing, Research, Management, Message Development, Community Development, Budgets, Publications, Web Content, Political Campaigns, Railway Systems, Rail Operations, Rail Safety, Federal Government, Project Management, Program Evaluation, Facilitation, Public Transport, Regulatory Affairs, Stakeholder Engagement, Stakeholder Management, Editorial, Freight Transportation, Commuter Rail, Marketing Communications
Education
University of Arizona 1990 — 1994
Political Science & Public Policy
University of Wisconsin-Madison 1986 — 1990
Bachelor's Degree, Political Science
Federal Railroad Administration, U.S. Department of Transportation May 2003 - Present
Federal Railroad Administration October 1999 - May 2003
Federal Railroad Administration July 1997 - October 1999
Federal Highway Administration September 1995 - July 1997
FDA February 1995 - September 1995
Skills
Press Releases, Public Affairs, Government, Strategic Communications, Policy, Media Relations, Crisis Communications, Public Policy, Politics, Policy Analysis, Legislation, Internal Communications, Spokesperson, Social Media, Speech Writing, Legislative Relations, Corporate Communications, Public Speaking, Public Relations, Strategy, International Relations, Coalitions, Web Content Management, Proposal Writing, Research, Management, Message Development, Community Development, Budgets, Publications, Web Content, Political Campaigns, Railway Systems, Rail Operations, Rail Safety, Federal Government, Project Management, Program Evaluation, Facilitation, Public Transport, Regulatory Affairs, Stakeholder Engagement, Stakeholder Management, Editorial, Freight Transportation, Commuter Rail, Marketing Communications
Education
University of Arizona 1990 — 1994
Political Science & Public Policy
University of Wisconsin-Madison 1986 — 1990
Bachelor's Degree, Political Science
Marianita Perez Marianita Perez's FDA Experience 2007 - 2011
Job PreMARC Mentor, General Chemistry at University of Puerto Rico
Industry Research
Experience
ORISE FDA August 2014 - Present
University of Puerto Rico at Rio Piedras January 2013 - May 2014
University of Puerto Rico at Rio Piedras August 2010 - May 2014
University of Puerto Rico at Rio Piedras August 2013 - December 2013
University of Puerto Rico at Rio Piedras July 2013 - August 2013
UAB - Universitat Autònoma de Barcelona December 2011 - September 2012
University of Puerto Rico August 2010 - May 2011
FDA 2007 - 2011
University of Puerto Rico at Rio Piedras August 2009 - July 2010
University of Puerto Rico at Rio Piedras August 2008 - May 2009
Skills
HPLC, UV/Vis, Analytical Chemistry, Mass Spectrometry, Chemistry, TLC, GC-MS, Chromatography, Wet Chemistry, Spectroscopy, IR, UV-Vis, Empower, Atomic Absorption, Solid Phase Extraction, SPME, Requisitions, Ion Chromatography, Food Science, Flavors, Method Development, Microsoft Excel, SAS, R, EndNote, Spanish-English, American Sign Language, Gas Chromatography
Education
University of Puerto Rico-Rio Piedras 2010 — 2016
Graduate Studies MS - PhD, Chemistry, 3.42
Universitat Autònoma de Barcelona 2011 — 2012
Master's Degree, Màsters oficials - Recerca en Ciència Animal i dels Aliments, 3.66
University of Puerto Rico-Rio Piedras 2004 — 2010
Bachelor's Degree, Chemistry, 3.179
ORISE FDA August 2014 - Present
University of Puerto Rico at Rio Piedras January 2013 - May 2014
University of Puerto Rico at Rio Piedras August 2010 - May 2014
University of Puerto Rico at Rio Piedras August 2013 - December 2013
University of Puerto Rico at Rio Piedras July 2013 - August 2013
UAB - Universitat Autònoma de Barcelona December 2011 - September 2012
University of Puerto Rico August 2010 - May 2011
FDA 2007 - 2011
University of Puerto Rico at Rio Piedras August 2009 - July 2010
University of Puerto Rico at Rio Piedras August 2008 - May 2009
Skills
HPLC, UV/Vis, Analytical Chemistry, Mass Spectrometry, Chemistry, TLC, GC-MS, Chromatography, Wet Chemistry, Spectroscopy, IR, UV-Vis, Empower, Atomic Absorption, Solid Phase Extraction, SPME, Requisitions, Ion Chromatography, Food Science, Flavors, Method Development, Microsoft Excel, SAS, R, EndNote, Spanish-English, American Sign Language, Gas Chromatography
Education
University of Puerto Rico-Rio Piedras 2010 — 2016
Graduate Studies MS - PhD, Chemistry, 3.42
Universitat Autònoma de Barcelona 2011 — 2012
Master's Degree, Màsters oficials - Recerca en Ciència Animal i dels Aliments, 3.66
University of Puerto Rico-Rio Piedras 2004 — 2010
Bachelor's Degree, Chemistry, 3.179
Valerie Merkle Valerie Merkle's FDA Experience May 2014 - Present
Job Biomedical Engineer at FDA
Industry Medical Devices
Experience
FDA May 2014 - Present
Tech Launch Arizona January 2014 - April 2014
The University of Arizona August 2009 - December 2013
FDA June 2013 - August 2013
University Medical Center, University of Arizona June 2010 - December 2011
The University of Arizona August 2009 - May 2010
Exelon Nuclear June 2007 - July 2009
PPL Corporation June 2006 - May 2007
Skills
Engineering, Biomedical Engineering, Matlab, Materials, Troubleshooting, Spectroscopy, Characterization, AFM, Tissue Engineering, FTIR, Cell, Medical Devices, Chemical Engineering, Stem Cells, Protein Chemistry, FDA, Scanning Electron..., Cell Culture, Technical Writing, Data Analysis, Technical Presentations, Experimentation, R
Education
University of Arizona 2009 — 2013
Ph.D., Biomedical Engineering, 4.0/4.0
Bucknell University 2003 — 2007
B.S., Chemical Engineering, 3.61/4.00
University of Nottingham 2006 — 2006
Chemical Engineering
FDA May 2014 - Present
Tech Launch Arizona January 2014 - April 2014
The University of Arizona August 2009 - December 2013
FDA June 2013 - August 2013
University Medical Center, University of Arizona June 2010 - December 2011
The University of Arizona August 2009 - May 2010
Exelon Nuclear June 2007 - July 2009
PPL Corporation June 2006 - May 2007
Skills
Engineering, Biomedical Engineering, Matlab, Materials, Troubleshooting, Spectroscopy, Characterization, AFM, Tissue Engineering, FTIR, Cell, Medical Devices, Chemical Engineering, Stem Cells, Protein Chemistry, FDA, Scanning Electron..., Cell Culture, Technical Writing, Data Analysis, Technical Presentations, Experimentation, R
Education
University of Arizona 2009 — 2013
Ph.D., Biomedical Engineering, 4.0/4.0
Bucknell University 2003 — 2007
B.S., Chemical Engineering, 3.61/4.00
University of Nottingham 2006 — 2006
Chemical Engineering
Charley Boehlert Charley Boehlert's FDA Experience 1984 - 1988
Job Associate Site Management Lead at Quintiles
Industry Pharmaceuticals
Experience
Quintiles June 2015 - Present
PPD January 2007 - June 2015
PPD February 2006 - December 2006
PPD August 2004 - January 2006
PPD July 2003 - July 2004
PPD July 2003 - July 2004
GlaxoSmithKline 1995 - 2002
GlaxoSmithKline 1988 - 1995
FDA 1984 - 1988
Skills
Clinical Monitoring, CTMS, CRO, GCP, ICH-GCP, EDC, Clinical Development, Therapeutic Areas, Pharmaceutical Industry, Clinical Research, Drug Development, Sop, Protocol, Clinical Trials, Regulatory Submissions, FDA, GLP, Biotechnology, Oncology, Life Sciences, Validation, Clinical Data Management, Infectious Diseases
Education
University of Maryland College Park 1980 — 1983
Master of Science (MS), Biochemistry
SUNY at Buffalo 1975 — 1979
Bachelor of Arts (B.A.), Biology, General
Quintiles June 2015 - Present
PPD January 2007 - June 2015
PPD February 2006 - December 2006
PPD August 2004 - January 2006
PPD July 2003 - July 2004
PPD July 2003 - July 2004
GlaxoSmithKline 1995 - 2002
GlaxoSmithKline 1988 - 1995
FDA 1984 - 1988
Skills
Clinical Monitoring, CTMS, CRO, GCP, ICH-GCP, EDC, Clinical Development, Therapeutic Areas, Pharmaceutical Industry, Clinical Research, Drug Development, Sop, Protocol, Clinical Trials, Regulatory Submissions, FDA, GLP, Biotechnology, Oncology, Life Sciences, Validation, Clinical Data Management, Infectious Diseases
Education
University of Maryland College Park 1980 — 1983
Master of Science (MS), Biochemistry
SUNY at Buffalo 1975 — 1979
Bachelor of Arts (B.A.), Biology, General
Garcia Swider Marlene Garcia Swider Marlene's FDA Experience January 2010 - Present
Job Organizational Management, Ph.D. and Quality Manager, CSO at FDA
Industry Government Administration
Experience
FDA January 2010 - Present
Skills
Analysis, Project Management, Management, Editing, Pharmaceutical Industry, Policy
Education
University of Puerto Rico, Med Campus 1983 — 1985
Masters Health Services Administration, Health Services Administration
University of Puerto Rico 1979 — 1983
Bachelor in Science, Biology, General
FDA January 2010 - Present
Skills
Analysis, Project Management, Management, Editing, Pharmaceutical Industry, Policy
Education
University of Puerto Rico, Med Campus 1983 — 1985
Masters Health Services Administration, Health Services Administration
University of Puerto Rico 1979 — 1983
Bachelor in Science, Biology, General
Justin Bueno Justin Bueno's FDA Experience July 2014 - Present
Job Research Fellow at FDA
Industry Pharmaceuticals
Experience
FDA July 2014 - Present
University at Albany January 2014 - June 2014
University at Albany June 2009 - December 2013
University at Albany June 2009 - December 2013
Skills
Spectroscopy, Experimental Design, Analytical Chemistry, UV/Vis, IR, Research, Chemometrics, Raman, Mass Spectrometry, GC-MS, Teamwork, Team Leadership, GC-FID, Raman Microscopy, Vibrational Spectroscopy, Atomic Force Microscopy..., Tip-enhanced Raman..., Circular Dichroism
Education
University at Albany 2010 — 2013
Doctor of Philosophy (Ph.D.), Analytical Chemistry, 3.82 GPA
University at Albany 2006 — 2010
Bachelor of Science (B.S.), Chemistry
FDA July 2014 - Present
University at Albany January 2014 - June 2014
University at Albany June 2009 - December 2013
University at Albany June 2009 - December 2013
Skills
Spectroscopy, Experimental Design, Analytical Chemistry, UV/Vis, IR, Research, Chemometrics, Raman, Mass Spectrometry, GC-MS, Teamwork, Team Leadership, GC-FID, Raman Microscopy, Vibrational Spectroscopy, Atomic Force Microscopy..., Tip-enhanced Raman..., Circular Dichroism
Education
University at Albany 2010 — 2013
Doctor of Philosophy (Ph.D.), Analytical Chemistry, 3.82 GPA
University at Albany 2006 — 2010
Bachelor of Science (B.S.), Chemistry
Marco Cannella's FDA Experience 2011 - Present
Job
Industry
Experience
FDA 2011 - Present
Drexel University 2008 - 2011
Education
Università degli Studi di Padova 1998 — 2001
Ph.D., Measurement science for engineering
FDA 2011 - Present
Drexel University 2008 - 2011
Education
Università degli Studi di Padova 1998 — 2001
Ph.D., Measurement science for engineering
Sonja Brooks Fulmer Sonja Brooks Fulmer's FDA Experience June 2015 - Present
Job Regulatory Policy Analyst at FDA
Industry Research
Experience
FDA June 2015 - Present
FDA September 2014 - May 2015
Vanderbilt University School of Medicine June 2009 - July 2014
Life Science Tennessee January 2014 - March 2014
The University of Alabama at Birmingham June 2006 - May 2009
The University of Alabama at Birmingham August 2005 - May 2009
Max Planck Institute for Medical Research May 2007 - August 2007
Skills
Protein Purification, Biochemistry, Science Communication, Scientific Writing, Protein Chemistry, Chemistry, DNA, Physical Chemistry, Biology, Lifesciences, Science Policy, Life Sciences, Cell Biology, Molecular Biology, Cell Culture, Research, PCR, Science, Fluorescence Microscopy, Organic Chemistry, Protein Expression
Education
Vanderbilt University School of Medicine 2009 — 2014
Doctor of Philosophy (Ph.D.), Chemical and Physical Biology
University of Alabama at Birmingham 2005 — 2009
Bachelor of Science (BS), Chemistry, Biochemistry Concentration
FDA June 2015 - Present
FDA September 2014 - May 2015
Vanderbilt University School of Medicine June 2009 - July 2014
Life Science Tennessee January 2014 - March 2014
The University of Alabama at Birmingham June 2006 - May 2009
The University of Alabama at Birmingham August 2005 - May 2009
Max Planck Institute for Medical Research May 2007 - August 2007
Skills
Protein Purification, Biochemistry, Science Communication, Scientific Writing, Protein Chemistry, Chemistry, DNA, Physical Chemistry, Biology, Lifesciences, Science Policy, Life Sciences, Cell Biology, Molecular Biology, Cell Culture, Research, PCR, Science, Fluorescence Microscopy, Organic Chemistry, Protein Expression
Education
Vanderbilt University School of Medicine 2009 — 2014
Doctor of Philosophy (Ph.D.), Chemical and Physical Biology
University of Alabama at Birmingham 2005 — 2009
Bachelor of Science (BS), Chemistry, Biochemistry Concentration
María José López Barragán's FDA Experience May 2015 - Present
Job Microbiology Reviewer at U.S. Food and Drug Administration
Industry Hospital & Health Care
Experience
FDA May 2015 - Present
GeneDx March 2014 - May 2015
GlaxoSmithKline March 2012 - March 2014
National Institutes of Health 2006 - 2011
University of Coimbra January 2006 - June 2006
Harvard Medical School October 2004 - December 2004
Mikrobiologie Universität Freiburg September 2001 - November 2001
University of Jaen 1999 - 2001
Skills
Parasitology, Malaria, Environmental..., DNA, Infectious Diseases, Protein Chemistry, DNA sequencing, Cell Biology, Molecular Biology, Animal Models, Flow Cytometry, Transfection, RT-PCR, qPCR, Molecular Cloning, Protein Purification, Cell Culture, Western Blotting, Immunology, ELISA, recombinant DNA..., Drug Development, Microbiology, Cell, In Vitro, Drug Discovery, Genetics, Molecular & Cellular..., Enzyme Assays, Assay Development, Clinical Development, Confocal Microscopy, DNA Sequencing, Fluorescence Microscopy, Genomics, High Throughput..., Immunofluorescence, In Vivo, Molecular Genetics, PCR, Protein Expression
Education
Complutense University 2001 — 2005
PhD, Biochemistry and Molecular Biology, Summa cum Laude
Universidad de Jaén 1995 — 1999
Bachelors of Science, Experimental Biology, Honors
FDA May 2015 - Present
GeneDx March 2014 - May 2015
GlaxoSmithKline March 2012 - March 2014
National Institutes of Health 2006 - 2011
University of Coimbra January 2006 - June 2006
Harvard Medical School October 2004 - December 2004
Mikrobiologie Universität Freiburg September 2001 - November 2001
University of Jaen 1999 - 2001
Skills
Parasitology, Malaria, Environmental..., DNA, Infectious Diseases, Protein Chemistry, DNA sequencing, Cell Biology, Molecular Biology, Animal Models, Flow Cytometry, Transfection, RT-PCR, qPCR, Molecular Cloning, Protein Purification, Cell Culture, Western Blotting, Immunology, ELISA, recombinant DNA..., Drug Development, Microbiology, Cell, In Vitro, Drug Discovery, Genetics, Molecular & Cellular..., Enzyme Assays, Assay Development, Clinical Development, Confocal Microscopy, DNA Sequencing, Fluorescence Microscopy, Genomics, High Throughput..., Immunofluorescence, In Vivo, Molecular Genetics, PCR, Protein Expression
Education
Complutense University 2001 — 2005
PhD, Biochemistry and Molecular Biology, Summa cum Laude
Universidad de Jaén 1995 — 1999
Bachelors of Science, Experimental Biology, Honors
Cassandra Porchas Cassandra Porchas's FDA Experience June 2007 - August 2007
Job EHS Engineer at Alcoa
Industry Mining & Metals
Experience
Alcoa January 2015 - Present
Georgia-Pacific LLC January 2013 - December 2014
Virginia Commonwealth University September 2012 - January 2013
Ventana Medical Systems May 2010 - July 2012
The University of Arizona January 2012 - May 2012
California Department of Public Health June 2011 - August 2011
Radiant Research August 2007 - March 2009
FDA June 2007 - August 2007
Skills
Research, Science, Public Health, Microbiology, Field Sampling, Mining, Spanish, Industrial Hygiene, Safety, Risk Assessment, Laboratory, Lifesciences, Occupational Health, Industrial Safety, Hazardous Waste..., Histology, Indoor Air Quality, Safety Management..., RCRA, Environmental Awareness, GLP, Microscopy, Public Speaking, Noise, Supervisory Experience, Environmental Compliance, Chemistry, Air Quality, Environmental Science, Ergonomics, Exposure Assessment, Remediation, EPA, Environmental..., Supervisory Skills
Education
University of Arizona 2010 — 2012
MPH, Occupational Health
University of Arizona 2005 — 2007
BS, Microbiology
Alcoa January 2015 - Present
Georgia-Pacific LLC January 2013 - December 2014
Virginia Commonwealth University September 2012 - January 2013
Ventana Medical Systems May 2010 - July 2012
The University of Arizona January 2012 - May 2012
California Department of Public Health June 2011 - August 2011
Radiant Research August 2007 - March 2009
FDA June 2007 - August 2007
Skills
Research, Science, Public Health, Microbiology, Field Sampling, Mining, Spanish, Industrial Hygiene, Safety, Risk Assessment, Laboratory, Lifesciences, Occupational Health, Industrial Safety, Hazardous Waste..., Histology, Indoor Air Quality, Safety Management..., RCRA, Environmental Awareness, GLP, Microscopy, Public Speaking, Noise, Supervisory Experience, Environmental Compliance, Chemistry, Air Quality, Environmental Science, Ergonomics, Exposure Assessment, Remediation, EPA, Environmental..., Supervisory Skills
Education
University of Arizona 2010 — 2012
MPH, Occupational Health
University of Arizona 2005 — 2007
BS, Microbiology
Alexander Ziskind's FDA Experience 2008 - 2010
Job SharePoint Architect and Full Stack JavaScript/.NET Engineer at Nuvious
Industry Information Technology and Services
Experience
TripScanner, Inc. January 2015 - Present
Nuvious May 2010 - Present
TripScanner, Inc. January 2014 - December 2014
FDA 2008 - 2010
Lockheed Martin July 2005 - December 2008
Good Taste Media 2004 - 2005
Guitar center 2000 - 2000
Skills
Software Development, Enterprise Architecture, Program Management, Security, Information Assurance, Integration, Malware Analysis, SharePoint, JavaScript, Windows Azure, SQL Azure, Silverlight, ASP.NET MVC, PaaS, SaaS, IaaS, SDLC, User Experience, C#, Microsoft SQL Server, SQL, Web Development, CSS
Education
State University of New York at Buffalo 1998 — 2005
Bachelor of Science (BS), Computer Science
TripScanner, Inc. January 2015 - Present
Nuvious May 2010 - Present
TripScanner, Inc. January 2014 - December 2014
FDA 2008 - 2010
Lockheed Martin July 2005 - December 2008
Good Taste Media 2004 - 2005
Guitar center 2000 - 2000
Skills
Software Development, Enterprise Architecture, Program Management, Security, Information Assurance, Integration, Malware Analysis, SharePoint, JavaScript, Windows Azure, SQL Azure, Silverlight, ASP.NET MVC, PaaS, SaaS, IaaS, SDLC, User Experience, C#, Microsoft SQL Server, SQL, Web Development, CSS
Education
State University of New York at Buffalo 1998 — 2005
Bachelor of Science (BS), Computer Science
Tiffany Ricks, Ph.D. Tiffany Ricks, Ph.D.'s FDA Experience June 2013 - Present
Job Pharmacologist
Industry Research
Experience
FDA June 2013 - Present
National Institutes of Health August 2010 - May 2013
NIH Fellow Award for Research Excellence (FARE) competition April 2012 - May 2012
Fellows Award for Research Excellence Committee October 2011 - May 2012
5th Annual NIH Career Symposium September 2011 - May 2012
University of North Carolina at Chapel Hill August 2004 - May 2010
Skills
Pharmacology, Tissue Culture, Cell Biology, Western Blotting, Flow Cytometry, Microscopy, Cell Culture, Assay Development, Molecular Biology, Genetics, PCR, Immunoprecipitation, Confocal Microscopy, Cell Signaling, Immunofluorescence, Bioinformatics, Mouse Models, Mouse Handling, real-time PCR, siRNA, Site-directed...
Education
University of North Carolina at Chapel Hill School of Medicine 2004 — 2010
PhD, Pharmacology
University of Arkansas at Fayetteville 1999 — 2003
B.S., Chemistry with a Biochemistry concentration
FDA June 2013 - Present
National Institutes of Health August 2010 - May 2013
NIH Fellow Award for Research Excellence (FARE) competition April 2012 - May 2012
Fellows Award for Research Excellence Committee October 2011 - May 2012
5th Annual NIH Career Symposium September 2011 - May 2012
University of North Carolina at Chapel Hill August 2004 - May 2010
Skills
Pharmacology, Tissue Culture, Cell Biology, Western Blotting, Flow Cytometry, Microscopy, Cell Culture, Assay Development, Molecular Biology, Genetics, PCR, Immunoprecipitation, Confocal Microscopy, Cell Signaling, Immunofluorescence, Bioinformatics, Mouse Models, Mouse Handling, real-time PCR, siRNA, Site-directed...
Education
University of North Carolina at Chapel Hill School of Medicine 2004 — 2010
PhD, Pharmacology
University of Arkansas at Fayetteville 1999 — 2003
B.S., Chemistry with a Biochemistry concentration
Karen Rulli, Ph.D.'s FDA Experience September 2014 - April 2015
Job Associate Director, Regulatory Affairs Advertising and Promotion
Industry Pharmaceuticals
Experience
Gilead Sciences May 2015 - Present
FDA September 2014 - April 2015
FDA November 2010 - September 2014
FDA July 2008 - November 2010
SAIC 2004 - 2008
National Cancer Institute 2001 - 2004
Skills
Life Sciences, Oncology, Molecular Biology, Virology, Microsoft Office, Protein Chemistry, Infectious Diseases, Biotechnology, Clinical Trials, Pharmaceuticals, Regulatory Affairs, Microbiology, Data Analysis, Research, Cell Biology, DNA, PCR, Western Blotting, Technical Writing, Cancer, Scientific Writing, Assay Development, qPCR, Cancer Research, Medical Writing, RT-PCR, Lifesciences, In Vivo, Biochemistry
Education
Tulane University School of Medicine 1996 — 2000
PhD, Molecular Biology
University of Virginia 1992 — 1996
B.A., Biology
SLHS 1988 — 1992
Gilead Sciences May 2015 - Present
FDA September 2014 - April 2015
FDA November 2010 - September 2014
FDA July 2008 - November 2010
SAIC 2004 - 2008
National Cancer Institute 2001 - 2004
Skills
Life Sciences, Oncology, Molecular Biology, Virology, Microsoft Office, Protein Chemistry, Infectious Diseases, Biotechnology, Clinical Trials, Pharmaceuticals, Regulatory Affairs, Microbiology, Data Analysis, Research, Cell Biology, DNA, PCR, Western Blotting, Technical Writing, Cancer, Scientific Writing, Assay Development, qPCR, Cancer Research, Medical Writing, RT-PCR, Lifesciences, In Vivo, Biochemistry
Education
Tulane University School of Medicine 1996 — 2000
PhD, Molecular Biology
University of Virginia 1992 — 1996
B.A., Biology
SLHS 1988 — 1992
Nadeem Chaudhry Nadeem Chaudhry's FDA Experience August 2008 - Present
Job USFDA Drugs Expert
Industry Public Safety
Experience
FDA August 2008 - Present
State of Ohio - Department of Agriculture January 2000 - August 2008
Department of Livestock & Dairy Development Punjab, Pakistan January 1993 - December 1998
Skills
Regulatory Affairs, FDA, Regulatory Requirements, GMP, SOP, GLP, CAPA, Validation, Pharmacovigilance, Quality System, Change Control, 21 CFR Part 11, Quality Auditing, Quality Assurance, Immunology, Quality Control, Microsoft Office, Public Health
Education
University of Agriculture, Faisalabad 1986 — 1993
DVM, MS (Hons) Microbiology, Veterinary Medicine
FDA August 2008 - Present
State of Ohio - Department of Agriculture January 2000 - August 2008
Department of Livestock & Dairy Development Punjab, Pakistan January 1993 - December 1998
Skills
Regulatory Affairs, FDA, Regulatory Requirements, GMP, SOP, GLP, CAPA, Validation, Pharmacovigilance, Quality System, Change Control, 21 CFR Part 11, Quality Auditing, Quality Assurance, Immunology, Quality Control, Microsoft Office, Public Health
Education
University of Agriculture, Faisalabad 1986 — 1993
DVM, MS (Hons) Microbiology, Veterinary Medicine
David Thorn David Thorn's FDA Experience 2015 - Present
Job Staff Fellow at FDA
Industry Higher Education
Experience
FDA 2015 - Present
ZeptoMetrix Corporation January 2009 - August 2010
ZeptoMetrix Corporation May 2008 - August 2008
Skills
Pharmacology, Drug Development, Pre-clinical Studies, Behavioral Models, Analgesia, Opioids, Rat Models, Receptor Theory, Addiction Medicine, GraphPad Prism, Animal Models, Molecular Biology, PCR, Neuroscience, Biotechnology, Assay Development, Science
Education
University at Buffalo 2010 — 2014
Doctor of Philosophy (Ph.D.), Pharmacology
University at Buffalo
Bachelor of Science (B.S.), Biotechnology, Pharmacology and Toxicology (Minor)
FDA 2015 - Present
ZeptoMetrix Corporation January 2009 - August 2010
ZeptoMetrix Corporation May 2008 - August 2008
Skills
Pharmacology, Drug Development, Pre-clinical Studies, Behavioral Models, Analgesia, Opioids, Rat Models, Receptor Theory, Addiction Medicine, GraphPad Prism, Animal Models, Molecular Biology, PCR, Neuroscience, Biotechnology, Assay Development, Science
Education
University at Buffalo 2010 — 2014
Doctor of Philosophy (Ph.D.), Pharmacology
University at Buffalo
Bachelor of Science (B.S.), Biotechnology, Pharmacology and Toxicology (Minor)
Loriano Galeotti's FDA Experience July 2015 - Present
Job Device Reviewer / Scientist at FDA
Industry Research
Experience
FDA July 2015 - Present
FDA July 2011 - Present
Everex s.r.l. January 2009 - June 2011
University of Florence 2008 - April 2011
Lund University Hospital May 2008 - December 2008
Biochemical System International 2007 - 2008
University of Florence 2003 - 2008
Hydra 2003 - 2006
Skills
Signal Processing, Programming, Automation, Microcontrollers, Biomedical Engineering, Matlab, Algorithms, C, Software Engineering, Teaching, Software Development, Windows, English, Eclipse, Physiology, Image Processing, Bioinformatics, Assembly, ecg, electrocardiography, TI C2000, Microchip PIC, Embedded Systems, Testing, Electronics, Medical Devices, R&D, DSP, Simulations
Education
Lund University Hospital 2008 — 2008
postdoc, Biomedical engineering
Università di Bologna 2005 — 2008
PhD, Biomedical Engineering
Università degli Studi di Firenze 1998 — 2007
laurea / Master Degree, Electronic Engineering, Major Biomedical Engineering
itis buzzi, prato 1992 — 1998
High School Diploma, Electronic
FDA July 2015 - Present
FDA July 2011 - Present
Everex s.r.l. January 2009 - June 2011
University of Florence 2008 - April 2011
Lund University Hospital May 2008 - December 2008
Biochemical System International 2007 - 2008
University of Florence 2003 - 2008
Hydra 2003 - 2006
Skills
Signal Processing, Programming, Automation, Microcontrollers, Biomedical Engineering, Matlab, Algorithms, C, Software Engineering, Teaching, Software Development, Windows, English, Eclipse, Physiology, Image Processing, Bioinformatics, Assembly, ecg, electrocardiography, TI C2000, Microchip PIC, Embedded Systems, Testing, Electronics, Medical Devices, R&D, DSP, Simulations
Education
Lund University Hospital 2008 — 2008
postdoc, Biomedical engineering
Università di Bologna 2005 — 2008
PhD, Biomedical Engineering
Università degli Studi di Firenze 1998 — 2007
laurea / Master Degree, Electronic Engineering, Major Biomedical Engineering
itis buzzi, prato 1992 — 1998
High School Diploma, Electronic
Louis Nowaczyk II Louis Nowaczyk II's FDA Experience August 2009 - August 2013
Job Operations Supervisor
Industry Biotechnology
Experience
Silliker February 2015 - Present
Silliker February 2015 - Present
Silliker April 2014 - February 2015
Silliker September 2013 - April 2014
FDA August 2009 - August 2013
Don Levy Laboratories May 2009 - August 2009
Crown Holdings, Inc. September 2008 - April 2009
Silliker April 2004 - August 2008
Skills
Molecular Biology, Microbiology, real-time PCR, PFGE, ELISA, Southern Blot, DNA extraction, DNA electrophoresis, Microscopy, ISO, Salmonella, Listeria, E. coli, Anaerobic Microbiology, GLP, PCR, Laboratory, LIMS, Gel Electrophoresis, Food Microbiology, Food Safety, SOP, Quality System
Education
University of Arizona 2000 — 2003
Bachelor of Science (B.S.), Biology, General
Silliker February 2015 - Present
Silliker February 2015 - Present
Silliker April 2014 - February 2015
Silliker September 2013 - April 2014
FDA August 2009 - August 2013
Don Levy Laboratories May 2009 - August 2009
Crown Holdings, Inc. September 2008 - April 2009
Silliker April 2004 - August 2008
Skills
Molecular Biology, Microbiology, real-time PCR, PFGE, ELISA, Southern Blot, DNA extraction, DNA electrophoresis, Microscopy, ISO, Salmonella, Listeria, E. coli, Anaerobic Microbiology, GLP, PCR, Laboratory, LIMS, Gel Electrophoresis, Food Microbiology, Food Safety, SOP, Quality System
Education
University of Arizona 2000 — 2003
Bachelor of Science (B.S.), Biology, General
Demiana William Demiana William's FDA Experience April 2009 - 2011
Job Director, Clinical Pharmacology at Mirati Therapeutics Inc
Industry Pharmaceuticals
Experience
Mirati Therapeutics Inc March 2015 - Present
Mirati Therapeutics Inc February 2014 - February 2015
Amylin Pharmaceuticals - a wholly owned subsidiary of Bristol-Myers Squibb April 2011 - January 2014
FDA April 2009 - 2011
Johnson and Johnson April 2007 - April 2009
J&J 2007 - 2009
INSERM U720 January 2006 - March 2007
INSERM, U720 January 2003 - December 2005
Skills
Clinical Pharmacology, Pharmacokinetics, PK/PD, FDA, Drug Metabolism, Pharmacometrics, Clinical Development, Clinical Trials, Pharmacology, Drug Discovery, Infectious Diseases, Pharmaceutical Industry, Diabetes, Clinical Research, IND, Drug Development, Pharmacodynamics
Education
Université Paris Descartes 2002 — 2006
PhD, M&S, PK/PD, Clinical Pharmacology
Université Paris Sud (Paris XI) 2003 — 2004
Master's Degree, Pharmacokinetics and drug metabolism
Université Henri Poincaré (Nancy I) 2001 — 2002
Master’s degree in Clinical Pharmacology, “Pro and anti-oxidant aspects of thiol containing drugs”.
Mirati Therapeutics Inc March 2015 - Present
Mirati Therapeutics Inc February 2014 - February 2015
Amylin Pharmaceuticals - a wholly owned subsidiary of Bristol-Myers Squibb April 2011 - January 2014
FDA April 2009 - 2011
Johnson and Johnson April 2007 - April 2009
J&J 2007 - 2009
INSERM U720 January 2006 - March 2007
INSERM, U720 January 2003 - December 2005
Skills
Clinical Pharmacology, Pharmacokinetics, PK/PD, FDA, Drug Metabolism, Pharmacometrics, Clinical Development, Clinical Trials, Pharmacology, Drug Discovery, Infectious Diseases, Pharmaceutical Industry, Diabetes, Clinical Research, IND, Drug Development, Pharmacodynamics
Education
Université Paris Descartes 2002 — 2006
PhD, M&S, PK/PD, Clinical Pharmacology
Université Paris Sud (Paris XI) 2003 — 2004
Master's Degree, Pharmacokinetics and drug metabolism
Université Henri Poincaré (Nancy I) 2001 — 2002
Master’s degree in Clinical Pharmacology, “Pro and anti-oxidant aspects of thiol containing drugs”.
Maria Isabel Tejero's FDA Experience September 2009 - Present
Job Lead Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA September 2009 - Present
FDA 2009 - Present
George Washington University January 2002 - September 2009
Skills
FDA, Biotechnology, Public Health, Clinical Trials, Regulatory Affairs, Lifesciences, Drug Development, Regulatory Submissions, Regulatory Requirements, Infectious Diseases, Clinical Development, GLP, Life Sciences, Pharmaceutical Industry, Clinical Research, Microbiology
Education
Universidad de Oviedo 1981 — 1987
MD, General Medicine and Surgery
Universidad de Oviedo 1981 — 1987
M.D., Medicina
FDA September 2009 - Present
FDA 2009 - Present
George Washington University January 2002 - September 2009
Skills
FDA, Biotechnology, Public Health, Clinical Trials, Regulatory Affairs, Lifesciences, Drug Development, Regulatory Submissions, Regulatory Requirements, Infectious Diseases, Clinical Development, GLP, Life Sciences, Pharmaceutical Industry, Clinical Research, Microbiology
Education
Universidad de Oviedo 1981 — 1987
MD, General Medicine and Surgery
Universidad de Oviedo 1981 — 1987
M.D., Medicina
Steven Pollack's FDA Experience August 2009 - August 2015
Job retired (for the moment)
Industry Medical Devices
Experience
Crump-Pollack Packing and Moving September 2015 - Present
FDA August 2009 - August 2015
FDA April 2005 - August 2009
Naval Research Laboratory April 2004 - April 2005
Naval Research Laboratory 2001 - 2004
Howard University 1994 - 2001
University of Cincinnati June 1989 - December 1993
University of Massachusetts Amherst, Depoartment of Polymer Science and Engineering June 1987 - June 1989
Springborn Laboratories 1986 - 1987
Allergan 1985 - 1986
Skills
Chemistry, Physical Chemistry, Analytical Chemistry, FDA, R&D, Laboratory, Polymers, Science, Spectroscopy, Organic Chemistry, Research, Nanomaterials, NMR, IR, Public Health, Data Analysis, python, Arduino, Management, Linux, Medical Devices, Materials Science, UV/Vis
Education
University of California, Irvine 1975 — 1981
Ph.D.Chemistry, Physical Organic Chemistry
University at Albany, SUNY 1971 — 1975
B.S., Chemistry
University of Massachusetts, Amherst 1987 — 1989
Postdoctoral Study, Polymer Science
Crump-Pollack Packing and Moving September 2015 - Present
FDA August 2009 - August 2015
FDA April 2005 - August 2009
Naval Research Laboratory April 2004 - April 2005
Naval Research Laboratory 2001 - 2004
Howard University 1994 - 2001
University of Cincinnati June 1989 - December 1993
University of Massachusetts Amherst, Depoartment of Polymer Science and Engineering June 1987 - June 1989
Springborn Laboratories 1986 - 1987
Allergan 1985 - 1986
Skills
Chemistry, Physical Chemistry, Analytical Chemistry, FDA, R&D, Laboratory, Polymers, Science, Spectroscopy, Organic Chemistry, Research, Nanomaterials, NMR, IR, Public Health, Data Analysis, python, Arduino, Management, Linux, Medical Devices, Materials Science, UV/Vis
Education
University of California, Irvine 1975 — 1981
Ph.D.Chemistry, Physical Organic Chemistry
University at Albany, SUNY 1971 — 1975
B.S., Chemistry
University of Massachusetts, Amherst 1987 — 1989
Postdoctoral Study, Polymer Science
Rachel Levine Rachel Levine's FDA Experience June 2013 - Present
Job Event Coordinator/ Front Desk at The Club by George Foreman III
Industry Health, Wellness and Fitness
Experience
The Club by George Foreman III May 2015 - Present
Down Dog Yoga June 2014 - Present
FDA June 2013 - Present
TRU2U U January 2013 - May 2013
Room to Read January 2013 - May 2013
University of Massachusetts Amherst August 2012 - May 2013
University of Massachusetts External Relations and University Events May 2012 - May 2013
Honor Society Alpha Lambda Delta September 2010 - December 2012
Rafanelli Events May 2011 - October 2012
University of Massachusetts Amherst September 2010 - May 2011
Skills
Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Word, Customer Service, Research, Social Media, Teamwork, Public Speaking, Communicative Skills, Blogging, Event Planning, Organization, Leadership, Transcribing, Conversational Spanish, Nonprofits, Spanish, Communication
Education
University of Massachusetts, Amherst 2009 — 2013
Bachelor of Arts (B.A.), Communication
University of Massachusetts, Amherst 2009 — 2013
Bachelor of Arts (B.A.), Theatre/Theater
Universitat Autònoma de Barcelona 2012 — 2012
Bachelor of Arts (B.A.), Communication
The Club by George Foreman III May 2015 - Present
Down Dog Yoga June 2014 - Present
FDA June 2013 - Present
TRU2U U January 2013 - May 2013
Room to Read January 2013 - May 2013
University of Massachusetts Amherst August 2012 - May 2013
University of Massachusetts External Relations and University Events May 2012 - May 2013
Honor Society Alpha Lambda Delta September 2010 - December 2012
Rafanelli Events May 2011 - October 2012
University of Massachusetts Amherst September 2010 - May 2011
Skills
Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Word, Customer Service, Research, Social Media, Teamwork, Public Speaking, Communicative Skills, Blogging, Event Planning, Organization, Leadership, Transcribing, Conversational Spanish, Nonprofits, Spanish, Communication
Education
University of Massachusetts, Amherst 2009 — 2013
Bachelor of Arts (B.A.), Communication
University of Massachusetts, Amherst 2009 — 2013
Bachelor of Arts (B.A.), Theatre/Theater
Universitat Autònoma de Barcelona 2012 — 2012
Bachelor of Arts (B.A.), Communication
Synim Rivers, MPH, CHES's FDA Experience November 2013 - December 2014
Job Vice President, Healthcare
Industry Public Relations and Communications
Experience
Edelman January 2015 - Present
FDA November 2013 - December 2014
FDA December 2012 - November 2013
FDA November 2011 - December 2012
U.S. Food and Drug Administration April 2010 - November 2011
CEPH February 2008 - April 2010
Skills
Public Health, Program Evaluation, Policy Analysis, Global Health, Grant Writing, Grants, Public Policy, Epidemiology, Nonprofits, Community Health, Research, Policy, Health Education, Community Outreach, Certified Health..., Program Development, Health Policy, Qualitative Research, Non-profits, Strategic Communications, Social Media Outreach, Media Relations
Education
The George Washington University 2011 — 2012
Masters Certificate in Project Management
Tulane University 2004 — 2006
MPH, Public Health - Health Education & Communications
Xavier University of Louisiana 1999 — 2003
BS, Biology
Edelman January 2015 - Present
FDA November 2013 - December 2014
FDA December 2012 - November 2013
FDA November 2011 - December 2012
U.S. Food and Drug Administration April 2010 - November 2011
CEPH February 2008 - April 2010
Skills
Public Health, Program Evaluation, Policy Analysis, Global Health, Grant Writing, Grants, Public Policy, Epidemiology, Nonprofits, Community Health, Research, Policy, Health Education, Community Outreach, Certified Health..., Program Development, Health Policy, Qualitative Research, Non-profits, Strategic Communications, Social Media Outreach, Media Relations
Education
The George Washington University 2011 — 2012
Masters Certificate in Project Management
Tulane University 2004 — 2006
MPH, Public Health - Health Education & Communications
Xavier University of Louisiana 1999 — 2003
BS, Biology
Savannah Cheo's FDA Experience June 2013 - August 2014
Job Emergency Department Scribe at ScribeAmerica
Industry Hospital & Health Care
Experience
ScribeAmerica April 2015 - Present
Health Leads February 2015 - May 2015
Health Leads September 2013 - May 2015
FDA June 2013 - August 2014
U.S. Department of Commerce May 2012 - August 2012
National Institutes of Health June 2010 - August 2010
Skills
Microsoft Office, PowerPoint, Microsoft Excel, Research, Social Media, Customer Service, Community Outreach, Health Advocacy
Education
University of Maryland College Park 2011 — 2015
Physiology and Neurobiology, Minor in Global Poverty
Universitat Autònoma de Barcelona
Spanish Language
Montgomery Blair High School Science, Mathematics, Computer Science Magnet 2007 — 2011
ScribeAmerica April 2015 - Present
Health Leads February 2015 - May 2015
Health Leads September 2013 - May 2015
FDA June 2013 - August 2014
U.S. Department of Commerce May 2012 - August 2012
National Institutes of Health June 2010 - August 2010
Skills
Microsoft Office, PowerPoint, Microsoft Excel, Research, Social Media, Customer Service, Community Outreach, Health Advocacy
Education
University of Maryland College Park 2011 — 2015
Physiology and Neurobiology, Minor in Global Poverty
Universitat Autònoma de Barcelona
Spanish Language
Montgomery Blair High School Science, Mathematics, Computer Science Magnet 2007 — 2011
Daniela Conrado Daniela Conrado's FDA Experience March 2012 - March 2013
Job Modeling and Simulation Scientist at Metrum Research Group LLC
Industry Pharmaceuticals
Experience
Metrum Research Group LLC May 2015 - Present
Pfizer April 2014 - April 2015
Pfizer April 2013 - March 2014
FDA March 2012 - March 2013
Universidade Regional Integrada do Alto Uruguai e das Missões - URI February 2007 - December 2008
UFRGS August 2006 - December 2007
Skills
Pharmacokinetics, NONMEM, Clinical Pharmacology, Pharmacodynamics, R, Pharmacometrics, Biostatistics, SAS, PsN, Model-based..., Disease progression..., Quantitative..., Pharmacogenomics, qEEG, Pre-Clinical..., PLINK, JMP Genomics, BESA, Matlab, WFN, Phoenix, Pirana
Education
University of Florida 2009 — 2012
Ph.D., Pharmaceutical Sciences, 4.0
Universidade Federal do Rio Grande do Sul 2004 — 2006
M.S., Pharmaceutical Sciences
Universidade Federal do Rio Grande do Sul 1999 — 2003
B.S., Pharmacy
Metrum Research Group LLC May 2015 - Present
Pfizer April 2014 - April 2015
Pfizer April 2013 - March 2014
FDA March 2012 - March 2013
Universidade Regional Integrada do Alto Uruguai e das Missões - URI February 2007 - December 2008
UFRGS August 2006 - December 2007
Skills
Pharmacokinetics, NONMEM, Clinical Pharmacology, Pharmacodynamics, R, Pharmacometrics, Biostatistics, SAS, PsN, Model-based..., Disease progression..., Quantitative..., Pharmacogenomics, qEEG, Pre-Clinical..., PLINK, JMP Genomics, BESA, Matlab, WFN, Phoenix, Pirana
Education
University of Florida 2009 — 2012
Ph.D., Pharmaceutical Sciences, 4.0
Universidade Federal do Rio Grande do Sul 2004 — 2006
M.S., Pharmaceutical Sciences
Universidade Federal do Rio Grande do Sul 1999 — 2003
B.S., Pharmacy
Alina Kerimbekov, PharmD Alina Kerimbekov, PharmD's FDA Experience 2009 - 2009
Job Consultant Pharmacist
Industry Health, Wellness and Fitness
Experience
Simple But Needed, Inc. February 2011 - Present
Pharmaca Integrative Pharmacy November 2010 - Present
UCSF August 2012 - Present
University of the Pacific November 2010 - Present
GLG - Gerson Lehrman Group 2009 - Present
Walgreens Pharmacy May 2009 - November 2010
Consumer Health Information Corporation 2009 - 2009
FDA 2009 - 2009
Rite Aid Pharmacy September 2001 - September 2008
U.S. Pharmacopeia May 2008 - August 2008
Skills
Clinical, Dispensing, Compounding, Treatment, Counseling, Pharmacists, University Teaching, FDA, Holistic Health, Health Education, Nutritional Counseling, Chinese Herbal Medicine, Herbal Remedies, Homeopathy, Pharmaceutics, Clinical Research, Psychotherapy, Medication Therapy..., Vaccination Clinic, Drug Information, Drug Interactions, Pharmacology, Pharmaceutical Industry, Pharmacy Automation, Patient Counseling, Pain Management, Immunization, Diabetes, Healthcare, Pharmacy Practice, Pharmacy
Education
University at Buffalo 2003 — 2009
Doctor of Pharmacy, Pharmacy
East West School of Planetary Herbology, San Francisco 2010 — 2012
Certified Herbalist
Simple But Needed, Inc. February 2011 - Present
Pharmaca Integrative Pharmacy November 2010 - Present
UCSF August 2012 - Present
University of the Pacific November 2010 - Present
GLG - Gerson Lehrman Group 2009 - Present
Walgreens Pharmacy May 2009 - November 2010
Consumer Health Information Corporation 2009 - 2009
FDA 2009 - 2009
Rite Aid Pharmacy September 2001 - September 2008
U.S. Pharmacopeia May 2008 - August 2008
Skills
Clinical, Dispensing, Compounding, Treatment, Counseling, Pharmacists, University Teaching, FDA, Holistic Health, Health Education, Nutritional Counseling, Chinese Herbal Medicine, Herbal Remedies, Homeopathy, Pharmaceutics, Clinical Research, Psychotherapy, Medication Therapy..., Vaccination Clinic, Drug Information, Drug Interactions, Pharmacology, Pharmaceutical Industry, Pharmacy Automation, Patient Counseling, Pain Management, Immunization, Diabetes, Healthcare, Pharmacy Practice, Pharmacy
Education
University at Buffalo 2003 — 2009
Doctor of Pharmacy, Pharmacy
East West School of Planetary Herbology, San Francisco 2010 — 2012
Certified Herbalist
Jamie Chin's FDA Experience August 2012 - September 2012
Job Pharmacy Practice Resident at WinthropUniversity Hospital
Industry Hospital & Health Care
Experience
Winthrop-University Hospital June 2015 - Present
New York City Department of Health and Mental Hygiene August 2014 - May 2015
Memorial Sloan-Kettering Cancer Center September 2013 - July 2014
CVS Health August 2009 - July 2013
North Shore-LIJ Health System February 2013 - March 2013
Buffalo Medical Group September 2012 - November 2012
FDA August 2012 - September 2012
Wegmans Food Markets July 2012 - August 2012
Roswell Park Cancer Institute May 2012 - June 2012
Cardinal Health May 2010 - August 2010
Skills
SPSS, WinNonlin, Minitab, GraphPad Prism, NONMEM, Oncology, Clinical Research, Clinical Pharmacology, Medicine, Pharmacy, Pharmacy Practice, Diabetes, Clinical Pharmacy, Pharmacy Automation, Medication Therapy..., Pharmacokinetics, Pharmacists, Hematology
Education
State University of New York at Buffalo 2008 — 2013
Doctor of Pharmacy (Pharm.D.) and Masters of Science (M.S.), Pharmacy and Pharmaceutical Sciences
Winthrop-University Hospital June 2015 - Present
New York City Department of Health and Mental Hygiene August 2014 - May 2015
Memorial Sloan-Kettering Cancer Center September 2013 - July 2014
CVS Health August 2009 - July 2013
North Shore-LIJ Health System February 2013 - March 2013
Buffalo Medical Group September 2012 - November 2012
FDA August 2012 - September 2012
Wegmans Food Markets July 2012 - August 2012
Roswell Park Cancer Institute May 2012 - June 2012
Cardinal Health May 2010 - August 2010
Skills
SPSS, WinNonlin, Minitab, GraphPad Prism, NONMEM, Oncology, Clinical Research, Clinical Pharmacology, Medicine, Pharmacy, Pharmacy Practice, Diabetes, Clinical Pharmacy, Pharmacy Automation, Medication Therapy..., Pharmacokinetics, Pharmacists, Hematology
Education
State University of New York at Buffalo 2008 — 2013
Doctor of Pharmacy (Pharm.D.) and Masters of Science (M.S.), Pharmacy and Pharmaceutical Sciences
Abigail Smets's FDA Experience March 2010 - March 2010
Job Pharmacist at Rite Aid Pharmacy
Industry Pharmaceuticals
Experience
Rite Aid Pharmacy November 2013 - Present
Rite Aid February 2012 - November 2013
Coleman Pharmacy June 2010 - August 2011
Select Specialty Hospital November 2010 - July 2011
USA Drug Express June 2006 - July 2010
FDA March 2010 - March 2010
Skills
Outstanding Customer..., Medication Therapy..., Dispensing, Pharmacists, Customer Service, Pharmacy, Immunization, Hospital Pharmacy, Community Pharmacy, Prescription
Education
University of Arkansas for Medical Sciences 2006 — 2010
PharmD, Pharmacy
University of Arkansas at Fayetteville 2002 — 2006
Pre Pharmacy Curriculum
Rite Aid Pharmacy November 2013 - Present
Rite Aid February 2012 - November 2013
Coleman Pharmacy June 2010 - August 2011
Select Specialty Hospital November 2010 - July 2011
USA Drug Express June 2006 - July 2010
FDA March 2010 - March 2010
Skills
Outstanding Customer..., Medication Therapy..., Dispensing, Pharmacists, Customer Service, Pharmacy, Immunization, Hospital Pharmacy, Community Pharmacy, Prescription
Education
University of Arkansas for Medical Sciences 2006 — 2010
PharmD, Pharmacy
University of Arkansas at Fayetteville 2002 — 2006
Pre Pharmacy Curriculum
Jeff Cooper Jeff Cooper's FDA Experience 2003 - 2005
Job Director of IT Customer Service at Health First
Industry Information Technology and Services
Experience
Health First March 2014 - Present
Delhaize Group October 2012 - March 2014
Darden Restaurants 2011 - 2012
Walt Disney 2006 - 2011
FDA 2003 - 2005
IRS 2001 - 2003
Marriott International 1998 - 2001
Hughes Network Systems 1996 - 1998
Target 1992 - 1996
Wal-Mart 1989 - 1992
Skills
Strategic Thinking, Enterprise Software, Policy, Competitive Analysis, PeopleSoft, Leadership, Program Management, Management, Cross-functional Team..., Process Improvement, Project Planning, IT Service Management, Data Center, Security, Business Strategy, ITIL, Vendor Management, Telecommunications, Organizational...
Education
Wilkes University 1987 — 1990
MBA, Business
United States Military Academy at West Point 1975 — 1979
BS, Engineering
Gardiner Area High School 1971 — 1975
Health First March 2014 - Present
Delhaize Group October 2012 - March 2014
Darden Restaurants 2011 - 2012
Walt Disney 2006 - 2011
FDA 2003 - 2005
IRS 2001 - 2003
Marriott International 1998 - 2001
Hughes Network Systems 1996 - 1998
Target 1992 - 1996
Wal-Mart 1989 - 1992
Skills
Strategic Thinking, Enterprise Software, Policy, Competitive Analysis, PeopleSoft, Leadership, Program Management, Management, Cross-functional Team..., Process Improvement, Project Planning, IT Service Management, Data Center, Security, Business Strategy, ITIL, Vendor Management, Telecommunications, Organizational...
Education
Wilkes University 1987 — 1990
MBA, Business
United States Military Academy at West Point 1975 — 1979
BS, Engineering
Gardiner Area High School 1971 — 1975
Nelson (NIH/NCI) Aguila Nelson (NIH/NCI) Aguila's FDA Experience December 1999 - June 2001
Job Deputy Director Center to Reduce Cancer Health Disparities at National Cancer Institutes (NCI)
Industry Government Administration
Experience
National Cancer Institute (NCI) 2013 - Present
National Cancer Institute June 2011 - May 2013
National Cancer Institute (NCI) June 2001 - June 2011
FDA December 1999 - June 2001
Sanofi-Aventis (formerly known as Rhone-Poulenc) March 1999 - December 1999
University of Miami, Miller School of Medicine January 1996 - February 1999
Skills
Cancer, Animal Models, Research Administration, Federal Government, Molecular Biology, Cancer Research, Research, Clinical Research, Cell Culture, Science, In Vivo, Cell Biology, Neuroscience, Life Sciences
Education
UT Southwestern Medical Center, Dallas TX 1983 — 1996
Postdoctoral training, Neurobiology of Aging, N/A
Universidad Austral de Chile 1974 — 1980
Doctor of Veterinary Medicine, Veterinary Physiology
National Cancer Institute (NCI) 2013 - Present
National Cancer Institute June 2011 - May 2013
National Cancer Institute (NCI) June 2001 - June 2011
FDA December 1999 - June 2001
Sanofi-Aventis (formerly known as Rhone-Poulenc) March 1999 - December 1999
University of Miami, Miller School of Medicine January 1996 - February 1999
Skills
Cancer, Animal Models, Research Administration, Federal Government, Molecular Biology, Cancer Research, Research, Clinical Research, Cell Culture, Science, In Vivo, Cell Biology, Neuroscience, Life Sciences
Education
UT Southwestern Medical Center, Dallas TX 1983 — 1996
Postdoctoral training, Neurobiology of Aging, N/A
Universidad Austral de Chile 1974 — 1980
Doctor of Veterinary Medicine, Veterinary Physiology
Patrick Moon Patrick Moon's FDA Experience May 2011 - September 2011
Job Intern Physician at Walter Reed National Military Medical Center
Industry Hospital & Health Care
Experience
United States Navy May 2014 - Present
United States Navy May 2010 - May 2014
FDA May 2011 - September 2011
University of New Hampshire September 2007 - May 2010
University of New Hampshire January 2008 - April 2010
Skills
Basic Life Support, Tactical Combat..., Operational Emergency..., AutoCAD, MS Office, REVIT..., Pro-Engineer, LabVIEW, PZ Flex, Technical Writing, Arduino, Basic Welding (TIG/MIG), RISA, Microsoft Office, Labview, Revit, Matlab
Education
Uniformed Services University of the Health Sciences - F Edward Hebert SOM 2010 — 2014
Doctor of Medicine (MD)
University of New Hampshire 2006 — 2010
B.S., Civil Engineering
United States Navy May 2014 - Present
United States Navy May 2010 - May 2014
FDA May 2011 - September 2011
University of New Hampshire September 2007 - May 2010
University of New Hampshire January 2008 - April 2010
Skills
Basic Life Support, Tactical Combat..., Operational Emergency..., AutoCAD, MS Office, REVIT..., Pro-Engineer, LabVIEW, PZ Flex, Technical Writing, Arduino, Basic Welding (TIG/MIG), RISA, Microsoft Office, Labview, Revit, Matlab
Education
Uniformed Services University of the Health Sciences - F Edward Hebert SOM 2010 — 2014
Doctor of Medicine (MD)
University of New Hampshire 2006 — 2010
B.S., Civil Engineering
Bob Kuykendall's FDA Experience 2002 - Present
Job criminal investigator, writer, speaker, instigator
Industry Law Enforcement
Experience
FDA 2002 - Present
postal inspection service 1994 - 2002
fbi 1987 - 1994
US Army January 1990 - January 1993
US Navy January 1987 - January 1990
Skills
Private Investigations, Internal Investigations, Enforcement, Fraud, Evidence, Published Author, Criminal Investigations, Engaging Public Speaker, Presentation Coaching, Writing, Public Speaking, Criminal Justice, Interrogation, Counterintelligence, Crime Prevention, HUMINT, Undercover, Homeland Security, Intelligence, Law Enforcement, Surveillance
Education
University of Alabama at Birmingham 1987 — 1991
Bachelor's degree, Criminalistics and Criminal Science
Utica College
Master's degree, Criminology
FDA 2002 - Present
postal inspection service 1994 - 2002
fbi 1987 - 1994
US Army January 1990 - January 1993
US Navy January 1987 - January 1990
Skills
Private Investigations, Internal Investigations, Enforcement, Fraud, Evidence, Published Author, Criminal Investigations, Engaging Public Speaker, Presentation Coaching, Writing, Public Speaking, Criminal Justice, Interrogation, Counterintelligence, Crime Prevention, HUMINT, Undercover, Homeland Security, Intelligence, Law Enforcement, Surveillance
Education
University of Alabama at Birmingham 1987 — 1991
Bachelor's degree, Criminalistics and Criminal Science
Utica College
Master's degree, Criminology
Eduard Porta Martín-Moreno Eduard Porta Martín-Moreno's FDA Experience January 2013 - Present
Job Analista Programador en FDA
Industry Information Technology and Services
Experience
FDA January 2013 - Present
Gestión Tributaria Territorial June 2012 - December 2012
Helados Alacant May 2012 - June 2012
Tecnocom April 2012 - May 2012
IFEN GmbH March 2011 - September 2011
Instituto de Biocomputacion y Fisica de Sistemas Complejos - BIFI September 2010 - February 2011
C.M.U. Pedro Cerbuna February 2006 - February 2011
Skills
Software Engineering, Web Applications, User Experience Design, GNU/Linux, Robotics, Team Leadership, Interpersonal..., Self-directed Learning, Enjoy Challenges, C#, Javascript, C++, Java, OpenCV, Computer Vision, Digital Image Processing, Arduino, Natural Language..., Artificial Intelligence, HTML5, KnockoutJS, DurandalJS, Android Development, Perl, Bash, Solr, JavaScript
Education
Universidad de Zaragoza 2005 — 2011
Ingeniería Informática Superior, Informática
Universidad de Alicante 2011 — 2012
Master en Automática y Robótica, Robótica
University of Federal Armed Forces Munich 2011 — 2011
Programa de intercambio Erasmus Prácticas, Desarrollo de Interfaces y Optimización de Algoritmos
Universidad de La Laguna 2009 — 2010
Programa de intercambio SICUE
FDA January 2013 - Present
Gestión Tributaria Territorial June 2012 - December 2012
Helados Alacant May 2012 - June 2012
Tecnocom April 2012 - May 2012
IFEN GmbH March 2011 - September 2011
Instituto de Biocomputacion y Fisica de Sistemas Complejos - BIFI September 2010 - February 2011
C.M.U. Pedro Cerbuna February 2006 - February 2011
Skills
Software Engineering, Web Applications, User Experience Design, GNU/Linux, Robotics, Team Leadership, Interpersonal..., Self-directed Learning, Enjoy Challenges, C#, Javascript, C++, Java, OpenCV, Computer Vision, Digital Image Processing, Arduino, Natural Language..., Artificial Intelligence, HTML5, KnockoutJS, DurandalJS, Android Development, Perl, Bash, Solr, JavaScript
Education
Universidad de Zaragoza 2005 — 2011
Ingeniería Informática Superior, Informática
Universidad de Alicante 2011 — 2012
Master en Automática y Robótica, Robótica
University of Federal Armed Forces Munich 2011 — 2011
Programa de intercambio Erasmus Prácticas, Desarrollo de Interfaces y Optimización de Algoritmos
Universidad de La Laguna 2009 — 2010
Programa de intercambio SICUE
Helena Sviglin Helena Sviglin's FDA Experience 2010 - Present
Job Regulatory Infomation Specialist at FDA
Industry Information Services
Experience
FDA 2010 - Present
Humana 2010 - 2010
Clinical Trials and Surveys October 2007 - September 2009
National Science Foundation 2003 - 2006
University of Alabama at Birmingham 2001 - 2006
BioCryst Pharmaceuticals 1991 - 1997
Skills
Clinical Trials, SAS, Life Sciences, Biostatistics, Data Analysis, Legacy Data Conversion, Epidemiology, Population analysis, TTE
Education
University of Alabama at Birmingham 1998 — 2001
MPH, Epidemiology
Life
Life
Life
Life
FDA 2010 - Present
Humana 2010 - 2010
Clinical Trials and Surveys October 2007 - September 2009
National Science Foundation 2003 - 2006
University of Alabama at Birmingham 2001 - 2006
BioCryst Pharmaceuticals 1991 - 1997
Skills
Clinical Trials, SAS, Life Sciences, Biostatistics, Data Analysis, Legacy Data Conversion, Epidemiology, Population analysis, TTE
Education
University of Alabama at Birmingham 1998 — 2001
MPH, Epidemiology
Life
Life
Life
Life
Shonoi Ming Shonoi Ming's FDA Experience January 2014 - December 2014
Job Staff Fellow at USFDA
Industry Research
Experience
USFDA December 2014 - Present
FDA January 2014 - December 2014
Johns Hopkins School of Medicine November 2009 - December 2013
Skills
Biochemistry, Cell Biology, Cell Culture, Enzyme Kinetics, Molecular Biology, Protein Purification, Proteomics, Western Blotting
Education
University at Buffalo 2004 — 2010
Doctor of Philosophy (Ph.D.), Chemistry
University at Buffalo 1999 — 2003
Bachelor of Science (BS), Medicinal and Pharmaceutical Chemistry
USFDA December 2014 - Present
FDA January 2014 - December 2014
Johns Hopkins School of Medicine November 2009 - December 2013
Skills
Biochemistry, Cell Biology, Cell Culture, Enzyme Kinetics, Molecular Biology, Protein Purification, Proteomics, Western Blotting
Education
University at Buffalo 2004 — 2010
Doctor of Philosophy (Ph.D.), Chemistry
University at Buffalo 1999 — 2003
Bachelor of Science (BS), Medicinal and Pharmaceutical Chemistry
Andrei Ponta Andrei Ponta's FDA Experience June 2014 - Present
Job Review Chemist at FDA
Industry Pharmaceuticals
Experience
FDA June 2014 - Present
University of Kentucky October 2013 - March 2014
University of Kentucky August 2008 - December 2013
University of Alabama August 2007 - May 2008
Skills
HPLC, High Performance Liquid..., Mammalian Cell Culture, in Vitro Toxicology, In Vivo, UV/Vis, Pharmaceutical Research, Drug Development, GraphPad Prism, WinNonlin, Cell Culture, Particle Size Analysis, 1H NMR, NMR Spectroscopy, Microscopy, ChemDraw, Drug Delivery, Microsoft Office, GPC, Cryostat, Analytical Chemistry, DLS, Nanoparticles, NMR, Pharmacokinetics, Fluorescence Microscopy, Fluorescence..., In Vitro, Polymers, Formulation, Pharmaceutics
Education
University of Kentucky 2008 — 2013
Ph.D., Pharmaceutical Science
University of Alabama 2004 — 2008
Bachelor of Science, Chemical Engineering
Università Cattolica del Sacro Cuore 2007 — 2007
FDA June 2014 - Present
University of Kentucky October 2013 - March 2014
University of Kentucky August 2008 - December 2013
University of Alabama August 2007 - May 2008
Skills
HPLC, High Performance Liquid..., Mammalian Cell Culture, in Vitro Toxicology, In Vivo, UV/Vis, Pharmaceutical Research, Drug Development, GraphPad Prism, WinNonlin, Cell Culture, Particle Size Analysis, 1H NMR, NMR Spectroscopy, Microscopy, ChemDraw, Drug Delivery, Microsoft Office, GPC, Cryostat, Analytical Chemistry, DLS, Nanoparticles, NMR, Pharmacokinetics, Fluorescence Microscopy, Fluorescence..., In Vitro, Polymers, Formulation, Pharmaceutics
Education
University of Kentucky 2008 — 2013
Ph.D., Pharmaceutical Science
University of Alabama 2004 — 2008
Bachelor of Science, Chemical Engineering
Università Cattolica del Sacro Cuore 2007 — 2007
Juan F. DeVillena's FDA Experience June 2000 - December 2001
Job Operations Manager at Wayne Farms, LLC
Industry Food Production
Experience
Wayne Farms, LLC - Pendergrass Complex, GA February 2012 - Present
Wayne Farms, LLC - Pendergrass Complex, GA February 2010 - February 2012
Wayne Farms, LLC - Pendergrass Complex, GA September 2006 - February 2010
Wayne Farms, LLC - Danville, Complex, AR June 2005 - September 2006
Wayne Farms, LLC - Pendergrass Complex, GA August 2004 - June 2005
Perdue Farms, Inc - Georgetown Complex, DE January 2002 - August 2004
FDA June 2000 - December 2001
University of Maryland September 1999 - December 2001
Liofilizadora del Pacifico, SRLtda. March 1996 - August 1998
Skills
Process Improvement, Yield Management, Employee Engagement, Food Safety, Process Consulting, Sports Coaching, Sports Management, Operations Management, Process Control, Strategic Communications, Continuous Improvement, Food Processing, Quality Assurance, Manufacturing, HACCP, Food Industry, Team Building, Strategic Planning, 5S, Analysis, Cross-functional Team..., Food, Food Manufacturing, Food Microbiology, Food Quality, Food Science, Food Technology, Forecasting, Frozen Food, GMP, Leadership, Management, Meat, PCR, Poultry, Product Development, Quality Management, Quality System, SQF, Training
Education
University of Maryland College Park 1999 — 2001
M.S., Food Science/ Food Microbiology
Universidad Nacional Agraria La Molina 1996 — 1999
Professional, Food Engineering
Universidad Nacional Agraria La Molina 1994 — 1998
B.S., Food Processing
Colegio de la Inmaculada 1983 — 1993
High School, Elementary School through High School
Wayne Farms, LLC - Pendergrass Complex, GA February 2012 - Present
Wayne Farms, LLC - Pendergrass Complex, GA February 2010 - February 2012
Wayne Farms, LLC - Pendergrass Complex, GA September 2006 - February 2010
Wayne Farms, LLC - Danville, Complex, AR June 2005 - September 2006
Wayne Farms, LLC - Pendergrass Complex, GA August 2004 - June 2005
Perdue Farms, Inc - Georgetown Complex, DE January 2002 - August 2004
FDA June 2000 - December 2001
University of Maryland September 1999 - December 2001
Liofilizadora del Pacifico, SRLtda. March 1996 - August 1998
Skills
Process Improvement, Yield Management, Employee Engagement, Food Safety, Process Consulting, Sports Coaching, Sports Management, Operations Management, Process Control, Strategic Communications, Continuous Improvement, Food Processing, Quality Assurance, Manufacturing, HACCP, Food Industry, Team Building, Strategic Planning, 5S, Analysis, Cross-functional Team..., Food, Food Manufacturing, Food Microbiology, Food Quality, Food Science, Food Technology, Forecasting, Frozen Food, GMP, Leadership, Management, Meat, PCR, Poultry, Product Development, Quality Management, Quality System, SQF, Training
Education
University of Maryland College Park 1999 — 2001
M.S., Food Science/ Food Microbiology
Universidad Nacional Agraria La Molina 1996 — 1999
Professional, Food Engineering
Universidad Nacional Agraria La Molina 1994 — 1998
B.S., Food Processing
Colegio de la Inmaculada 1983 — 1993
High School, Elementary School through High School
Feiran Jiao Feiran Jiao's FDA Experience June 2015 - August 2015
Job
Industry
Experience
FDA June 2015 - August 2015
ACT November 2011 - May 2012
Skills
R, Microsoft Office, Statistics, SAS, Matlab, Java, Microsoft Word, Management, Microsoft Excel, SPSS
Education
University of Iowa 2010 — 2015
Doctor of Philosophy (Ph.D.), Statistics
University of Alaska Fairbanks 2008 — 2010
Master of Science (M.S.), Statistics
FDA June 2015 - August 2015
ACT November 2011 - May 2012
Skills
R, Microsoft Office, Statistics, SAS, Matlab, Java, Microsoft Word, Management, Microsoft Excel, SPSS
Education
University of Iowa 2010 — 2015
Doctor of Philosophy (Ph.D.), Statistics
University of Alaska Fairbanks 2008 — 2010
Master of Science (M.S.), Statistics
Jose Mendoza Silveiras's FDA Experience November 2011 - Present
Job Director, Clinical Research Operations at DaVita HealthCare Partners, Inc.
Industry Pharmaceuticals
Experience
DaVita HealthCare Partners, Inc. August 2015 - Present
Independent Research Consultant June 2015 - Present
FDA November 2011 - Present
Colon Cancer Alliance March 2008 - Present
NRI - National Research Institute March 2013 - May 2015
Social & Scientific Systems August 2011 - August 2012
Naval Medical Research Center U.S. Military Vaccine Program May 2006 - August 2011
Naval Medical Research Center U.S. Military Vaccine Program November 2005 - April 2006
Care Resource August 2004 - September 2005
Sanar Espacio Terapeutico January 2001 - January 2003
Skills
Infectious Diseases, Clinical Trials, Clinical Research, FDA, Vaccines, CRO, Healthcare, Clinical Monitoring, Sop, Medical Writing, Clinical Operations, International Project..., Patient Advocacy, Pharmaceutical Industry, Regulatory Affairs, Clinical Development, Biotechnology, Cancer, Clinical Study Design, Regulatory Submissions, Medical Devices, Clinical Data Management, Lifesciences, Protocol, Regulatory Requirements, Pharmacovigilance, CTMS, Drug Development, Oncology, Medicine, IRB, Diabetes, Immunology, Pharmacology, ICH-GCP, EDC, Medical Research, Patient Recruitment, Hematology, Therapeutic Areas, Clinical Pharmacology, Medical Affairs, Cardiology, Epidemiology, Psychiatry, Neurology, SOP, Life Sciences
Education
Universidad Central de Venezuela 1993 — 1998
Medical Doctor
Universidad Central de Venezuela 1995 — 1997
Bachelor
DaVita HealthCare Partners, Inc. August 2015 - Present
Independent Research Consultant June 2015 - Present
FDA November 2011 - Present
Colon Cancer Alliance March 2008 - Present
NRI - National Research Institute March 2013 - May 2015
Social & Scientific Systems August 2011 - August 2012
Naval Medical Research Center U.S. Military Vaccine Program May 2006 - August 2011
Naval Medical Research Center U.S. Military Vaccine Program November 2005 - April 2006
Care Resource August 2004 - September 2005
Sanar Espacio Terapeutico January 2001 - January 2003
Skills
Infectious Diseases, Clinical Trials, Clinical Research, FDA, Vaccines, CRO, Healthcare, Clinical Monitoring, Sop, Medical Writing, Clinical Operations, International Project..., Patient Advocacy, Pharmaceutical Industry, Regulatory Affairs, Clinical Development, Biotechnology, Cancer, Clinical Study Design, Regulatory Submissions, Medical Devices, Clinical Data Management, Lifesciences, Protocol, Regulatory Requirements, Pharmacovigilance, CTMS, Drug Development, Oncology, Medicine, IRB, Diabetes, Immunology, Pharmacology, ICH-GCP, EDC, Medical Research, Patient Recruitment, Hematology, Therapeutic Areas, Clinical Pharmacology, Medical Affairs, Cardiology, Epidemiology, Psychiatry, Neurology, SOP, Life Sciences
Education
Universidad Central de Venezuela 1993 — 1998
Medical Doctor
Universidad Central de Venezuela 1995 — 1997
Bachelor
Gerrit Hamre Gerrit Hamre's FDA Experience September 2014 - April 2015
Job Clinical Project Manager at Duke Clinical Research Institute
Industry Hospital & Health Care
Experience
Duke Clinical Research Institute April 2015 - Present
FDA September 2014 - April 2015
FDA October 2011 - September 2014
U.S. Department of Health and Human Services October 2009 - October 2011
United States Peace Corps September 2004 - November 2006
Novartis March 2000 - June 2004
A.M.A. Pharmaceuticals September 1998 - February 2000
Education
UC San Diego School of Global Policy and Strategy (GPS) 2007 — 2009
Master, International Management
University of Florida - Warrington College Of Business 1993 — 1997
Bachelor, Business Administration
Duke Clinical Research Institute April 2015 - Present
FDA September 2014 - April 2015
FDA October 2011 - September 2014
U.S. Department of Health and Human Services October 2009 - October 2011
United States Peace Corps September 2004 - November 2006
Novartis March 2000 - June 2004
A.M.A. Pharmaceuticals September 1998 - February 2000
Education
UC San Diego School of Global Policy and Strategy (GPS) 2007 — 2009
Master, International Management
University of Florida - Warrington College Of Business 1993 — 1997
Bachelor, Business Administration
Ashley Fahle Ashley Fahle's FDA Experience June 2013 - Present
Job Health Communication Professional
Industry Health, Wellness and Fitness
Experience
FDA June 2013 - Present
Louisiana Office of Public Health, Bureau of Family Health January 2013 - May 2013
Tulane University August 2012 - December 2012
Louisiana Office of Public Health, Maternal and Child Health Section June 2012 - August 2012
Education
Tulane University School of Public Health and Tropical Medicine 2012 — 2013
Master of Public Health (MPH)
University of Oklahoma 2009 — 2011
Bachelor of Science (BS)
FDA June 2013 - Present
Louisiana Office of Public Health, Bureau of Family Health January 2013 - May 2013
Tulane University August 2012 - December 2012
Louisiana Office of Public Health, Maternal and Child Health Section June 2012 - August 2012
Education
Tulane University School of Public Health and Tropical Medicine 2012 — 2013
Master of Public Health (MPH)
University of Oklahoma 2009 — 2011
Bachelor of Science (BS)
Monica Yun Monica Yun's FDA Experience May 2013 - August 2013
Job Legislative Intern at Texas State Capitol
Industry Marketing and Advertising
Experience
Texas State Capitol June 2015 - Present
Madison Advertising July 2014 - August 2014
IrisPortal May 2014 - August 2014
FDA May 2013 - August 2013
Tadashi Restaurant May 2012 - August 2012
Children's Association for Maximum Potential (CAMP) June 2009 - August 2011
Skills
Research, Social Media, Event Planning, PowerPoint, Teamwork, Microsoft Excel, Marketing, Restaurant Marketing, Public Speaking, Data Analysis, Statistical Computing, Statistical Data..., Cloud Applications, Customer Service, Facebook, Microsoft Office, Twitter, Tumblr
Education
Wesleyan University 2012 — 2016
Bachelor of Arts (B.A.), Economics
Universidad Carlos III de Madrid 2014 — 2014
Economics
Universidad Complutense de Madrid 2014 — 2014
Economics
Texas State Capitol June 2015 - Present
Madison Advertising July 2014 - August 2014
IrisPortal May 2014 - August 2014
FDA May 2013 - August 2013
Tadashi Restaurant May 2012 - August 2012
Children's Association for Maximum Potential (CAMP) June 2009 - August 2011
Skills
Research, Social Media, Event Planning, PowerPoint, Teamwork, Microsoft Excel, Marketing, Restaurant Marketing, Public Speaking, Data Analysis, Statistical Computing, Statistical Data..., Cloud Applications, Customer Service, Facebook, Microsoft Office, Twitter, Tumblr
Education
Wesleyan University 2012 — 2016
Bachelor of Arts (B.A.), Economics
Universidad Carlos III de Madrid 2014 — 2014
Economics
Universidad Complutense de Madrid 2014 — 2014
Economics
Pierre Canisius Mbarushimana Pierre Canisius Mbarushimana's FDA Experience May 2012 - August 2012
Job Graduate Student & Teaching Assistant at the University of Alabama
Industry Chemicals
Experience
University Of Alabama 2013 - Present
Apple Project at Lyon College January 2010 - May 2013
FDA May 2012 - August 2012
Lyon College January 2010 - May 2012
Lyon College May 2010 - August 2011
National Institute of Statistics of Rwanda January 2008 - April 2009
Skills
Chemistry, Research, Data Analysis, Science, NMR, Analytical Chemistry, Polymer Chemistry, Biochemistry, Protein Chemistry, Microbiology, DNA sequencing, Mass Spectrometry, MALDI-TOF, ESI-MS, UV/Vis, IR spectroscopy, Mathematics, Physics, C, HTML 5, French, Teaching
Education
University of Alabama 2013 — 2018
Doctor of Philosophy (PhD), Analytical Chemistry
Lyon College 2009 — 2013
Bachelor of Science (B.Sc.), Chemistry
Université de Poitiers 2012 — 2012
Associate's Degree, Chemistry
Kigali Institute of Technology 2008 — 2009
Associate's Degree, Civil Engineering
Groupe Scolaire Saint Joseph de Kabgayi 2005 — 2007
High School, Mathematics & Physics
University Of Alabama 2013 - Present
Apple Project at Lyon College January 2010 - May 2013
FDA May 2012 - August 2012
Lyon College January 2010 - May 2012
Lyon College May 2010 - August 2011
National Institute of Statistics of Rwanda January 2008 - April 2009
Skills
Chemistry, Research, Data Analysis, Science, NMR, Analytical Chemistry, Polymer Chemistry, Biochemistry, Protein Chemistry, Microbiology, DNA sequencing, Mass Spectrometry, MALDI-TOF, ESI-MS, UV/Vis, IR spectroscopy, Mathematics, Physics, C, HTML 5, French, Teaching
Education
University of Alabama 2013 — 2018
Doctor of Philosophy (PhD), Analytical Chemistry
Lyon College 2009 — 2013
Bachelor of Science (B.Sc.), Chemistry
Université de Poitiers 2012 — 2012
Associate's Degree, Chemistry
Kigali Institute of Technology 2008 — 2009
Associate's Degree, Civil Engineering
Groupe Scolaire Saint Joseph de Kabgayi 2005 — 2007
High School, Mathematics & Physics
Alicia Mozzachio Alicia Mozzachio's FDA Experience January 2015 - Present
Job Acting Division Director at FDA
Industry Government Administration
Experience
FDA January 2015 - Present
FDA June 2012 - January 2015
FDA January 2004 - June 2012
FDA June 1994 - January 2004
Skills
GMP, APIs, Cleaning Validation, Policy, FDA, Federal Government, Policy Analysis, Program Management, Government, Public Policy, National Security, Emergency Management, Government Contracting, CAPA, Homeland Security, Biotechnology, Pharmaceutical Industry, Validation, Regulatory Submissions, SOP, Quality Assurance, Quality System, Clinical Trials, Change Control
Education
Uniformed Services University of the Health Sciences 2006 — 2007
Master's Degree, Public Health, 4.0
Temple University School of Pharmacy 1990 — 1993
Bachelor's Degree, Pharmacy
FDA January 2015 - Present
FDA June 2012 - January 2015
FDA January 2004 - June 2012
FDA June 1994 - January 2004
Skills
GMP, APIs, Cleaning Validation, Policy, FDA, Federal Government, Policy Analysis, Program Management, Government, Public Policy, National Security, Emergency Management, Government Contracting, CAPA, Homeland Security, Biotechnology, Pharmaceutical Industry, Validation, Regulatory Submissions, SOP, Quality Assurance, Quality System, Clinical Trials, Change Control
Education
Uniformed Services University of the Health Sciences 2006 — 2007
Master's Degree, Public Health, 4.0
Temple University School of Pharmacy 1990 — 1993
Bachelor's Degree, Pharmacy
Fatima Sequeira Fatima Sequeira's FDA Experience March 2014 - Present
Job Chemist Reviewer at FDA
Industry Chemicals
Experience
FDA March 2014 - Present
NIST June 2012 - March 2014
University at Buffalo September 2007 - June 2012
SUNY at Buffalo September 2008 - December 2010
University at Buffalo January 2004 - September 2007
New York University June 2005 - August 2005
Skills
Organic Synthesis, Biochemistry, Cellular Assays, HPLC, Chromatography, IR spectroscopy, NMR spectroscopy, Conference Coordination, Large Scale Deployments, Validation, Chemistry, Organic Chemistry, UV/Vis, Wet Chemistry, Nanomaterials, ChemDraw, Laboratory, Protein Expression, NMR, IR, Fluorescence, Spectroscopy, Characterization
Education
SUNY at Buffalo
Doctor of Philosophy (Ph.D.), Orangic Chemistry; BS in Medicinal Chemistry and Chemistry
FDA March 2014 - Present
NIST June 2012 - March 2014
University at Buffalo September 2007 - June 2012
SUNY at Buffalo September 2008 - December 2010
University at Buffalo January 2004 - September 2007
New York University June 2005 - August 2005
Skills
Organic Synthesis, Biochemistry, Cellular Assays, HPLC, Chromatography, IR spectroscopy, NMR spectroscopy, Conference Coordination, Large Scale Deployments, Validation, Chemistry, Organic Chemistry, UV/Vis, Wet Chemistry, Nanomaterials, ChemDraw, Laboratory, Protein Expression, NMR, IR, Fluorescence, Spectroscopy, Characterization
Education
SUNY at Buffalo
Doctor of Philosophy (Ph.D.), Orangic Chemistry; BS in Medicinal Chemistry and Chemistry
Ivan Albino Flores Ivan Albino Flores's FDA Experience September 2013 - Present
Job Research Assistant/Laboratory Technician at FDA
Industry Biotechnology
Experience
FDA September 2013 - Present
National Institutes of Health 2011 - August 2013
SUIP Program June 2011 - August 2011
REU Microbiology June 2010 - August 2010
SMART Program June 2009 - August 2009
Skills
Tissue Culture, Cell Culture, Bacterial Culture, Bacterial Transformation, Bacterial Genetics, Molecular Biology, Molecular Cloning, Research, Microbiology, Western Blotting, Dot Blot, Molecular Genetics, Bacterial Physiology, Protein Chemistry, Biotechnology
Education
University of Puerto Rico 2007 — 2011
BS, Industrial Microbiology, 3.64
Centro Residencial de Oportunidades Educativas de Mayagüez 2005 — 2007
High School, Sciences and Mathematics
FDA September 2013 - Present
National Institutes of Health 2011 - August 2013
SUIP Program June 2011 - August 2011
REU Microbiology June 2010 - August 2010
SMART Program June 2009 - August 2009
Skills
Tissue Culture, Cell Culture, Bacterial Culture, Bacterial Transformation, Bacterial Genetics, Molecular Biology, Molecular Cloning, Research, Microbiology, Western Blotting, Dot Blot, Molecular Genetics, Bacterial Physiology, Protein Chemistry, Biotechnology
Education
University of Puerto Rico 2007 — 2011
BS, Industrial Microbiology, 3.64
Centro Residencial de Oportunidades Educativas de Mayagüez 2005 — 2007
High School, Sciences and Mathematics
Megan Pardeck Megan Pardeck's FDA Experience August 2002 - December 2002
Job Senior Chemical Process Engineer
Industry Design
Experience
Burns & McDonnell November 2011 - Present
BIS Frucon Engineering Inc. May 2011 - November 2011
Anheuser-Busch InBev May 2005 - April 2011
Open Biosystems May 2004 - May 2005
FDA August 2002 - December 2002
Skills
Project Management, Troubleshooting, Research, Training & Development, College Recruiting, Process Engineering, Process Improvement, Operations Management, Maintenance Management, Preventive Maintenance, Maintenance Planning, Budget Management, Construction, Root Cause Analysis, Engineering, Continuous Improvement
Education
University of Missouri-Rolla 1997 — 2002
Bachelor of Science, Biochemical Engineering
University of Alabama in Huntsville 2003 — 2005
Masters of Science, Chemical Engineering emphasizing in Biochemical Engineering
Burns & McDonnell November 2011 - Present
BIS Frucon Engineering Inc. May 2011 - November 2011
Anheuser-Busch InBev May 2005 - April 2011
Open Biosystems May 2004 - May 2005
FDA August 2002 - December 2002
Skills
Project Management, Troubleshooting, Research, Training & Development, College Recruiting, Process Engineering, Process Improvement, Operations Management, Maintenance Management, Preventive Maintenance, Maintenance Planning, Budget Management, Construction, Root Cause Analysis, Engineering, Continuous Improvement
Education
University of Missouri-Rolla 1997 — 2002
Bachelor of Science, Biochemical Engineering
University of Alabama in Huntsville 2003 — 2005
Masters of Science, Chemical Engineering emphasizing in Biochemical Engineering
Peter Patriarca's FDA Experience January 1994 - August 2001
Job Senior Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group May 2005 - Present
MedImmune, Inc. August 2001 - April 2005
FDA January 1994 - August 2001
Centers for Disease Control and Prevention July 1980 - December 1993
Skills
Regulatory Affairs, Vaccines, Clinical Development, Virology, Influenza, Pediatrics, Antiviral Agents, Pharmacovigilance, Clinical Research, Regulatory Submissions, Infectious Diseases, Public Health, Biologics, FDA, Antiviral, Epidemiology, Lifesciences, Medicine, Monoclonal Antibodies, Life Sciences, Biotechnology
Education
Tulane University School of Medicine
M.D., Medicine
University of Colorado Affiliated Hospitals
Internship and Residency in Pediatrics, Board Certification
University of Notre Dame
B.S., Pre-professional Studies
Biologics Consulting Group May 2005 - Present
MedImmune, Inc. August 2001 - April 2005
FDA January 1994 - August 2001
Centers for Disease Control and Prevention July 1980 - December 1993
Skills
Regulatory Affairs, Vaccines, Clinical Development, Virology, Influenza, Pediatrics, Antiviral Agents, Pharmacovigilance, Clinical Research, Regulatory Submissions, Infectious Diseases, Public Health, Biologics, FDA, Antiviral, Epidemiology, Lifesciences, Medicine, Monoclonal Antibodies, Life Sciences, Biotechnology
Education
Tulane University School of Medicine
M.D., Medicine
University of Colorado Affiliated Hospitals
Internship and Residency in Pediatrics, Board Certification
University of Notre Dame
B.S., Pre-professional Studies
Mario Urdaneta's FDA Experience June 2015 - August 2015
Job Science and Technology Fellow at AAAS
Industry Mechanical or Industrial Engineering
Experience
AAAS August 2015 - Present
FDA June 2015 - August 2015
Additive Electromagnetics June 2013 - May 2015
Weinberg Medical Physics February 2009 - May 2015
Svelte Medical Systems, Inc. June 2008 - February 2009
University of Maryland, College Park 2003 - 2007
University of Arizona 2001 - 2003
The University of Arizona 1997 - 2000
DuPont 1999 - 1999
Youth For Understanding USA (YFU) 1994 - 1995
Education
University of Maryland College Park 2003 — 2007
PhD
University of Arizona 1997 — 2002
MSc, BS
High school
High school
High school
AAAS August 2015 - Present
FDA June 2015 - August 2015
Additive Electromagnetics June 2013 - May 2015
Weinberg Medical Physics February 2009 - May 2015
Svelte Medical Systems, Inc. June 2008 - February 2009
University of Maryland, College Park 2003 - 2007
University of Arizona 2001 - 2003
The University of Arizona 1997 - 2000
DuPont 1999 - 1999
Youth For Understanding USA (YFU) 1994 - 1995
Education
University of Maryland College Park 2003 — 2007
PhD
University of Arizona 1997 — 2002
MSc, BS
High school
High school
High school
Sydnee Logan's FDA Experience June 2014 - Present
Job Digital Communication Fellow at FDA
Industry Public Relations and Communications
Experience
FDA June 2014 - Present
American Diabetes Association January 2014 - May 2014
Walter Reed Army Institute of Research January 2011 - April 2014
Shape Shifter Entertainment September 2010 - December 2010
Music Business Institute May 2010 - August 2010
The Trumpet January 2008 - May 2008
Skills
Blogging, Market Research, Program Development
Education
Johns Hopkins University 2013 — 2016
Master's Degree, Communication, Concentrations: Health, Digital, Corporate, Public and Media Relations
Tulane University 2006 — 2010
BA, Communication
Western HS 2003 — 2006
FDA June 2014 - Present
American Diabetes Association January 2014 - May 2014
Walter Reed Army Institute of Research January 2011 - April 2014
Shape Shifter Entertainment September 2010 - December 2010
Music Business Institute May 2010 - August 2010
The Trumpet January 2008 - May 2008
Skills
Blogging, Market Research, Program Development
Education
Johns Hopkins University 2013 — 2016
Master's Degree, Communication, Concentrations: Health, Digital, Corporate, Public and Media Relations
Tulane University 2006 — 2010
BA, Communication
Western HS 2003 — 2006
Narjol Gonzalez-Escalona's FDA Experience August 2008 - Present
Job Microbiologist at FDA
Industry Government Administration
Experience
FDA August 2008 - Present
FDA November 2007 - July 2008
NCSU (but located at FDA in Dauphin Island, AL) August 2005 - October 2007
Cecmed Havana 1997 - 2000
Skills
Molecular Biology, Food Microbiology, PCR, Validation, Science, qPCR, Research, DNA, Biochemistry, Public Health, Diagnostics, Food Safety, Bioinformatics, Microsoft Office, Epidemiology, Genomics, Microbiology, Hardware Diagnostics
Education
Universidad de Chile 2000 — 2004
PhD, Microbiology
Universidad Havana 1992 — 1997
Licenciate in Microbiology, Microbiology
FDA August 2008 - Present
FDA November 2007 - July 2008
NCSU (but located at FDA in Dauphin Island, AL) August 2005 - October 2007
Cecmed Havana 1997 - 2000
Skills
Molecular Biology, Food Microbiology, PCR, Validation, Science, qPCR, Research, DNA, Biochemistry, Public Health, Diagnostics, Food Safety, Bioinformatics, Microsoft Office, Epidemiology, Genomics, Microbiology, Hardware Diagnostics
Education
Universidad de Chile 2000 — 2004
PhD, Microbiology
Universidad Havana 1992 — 1997
Licenciate in Microbiology, Microbiology
Max Brewster Max Brewster's FDA Experience April 2010 - Present
Job Investigator/Compliance in Import Operations at FDA
Industry Government Administration
Experience
FDA April 2010 - Present
HONDA TRADING June 2008 - April 2009
Savino Del Bene October 2006 - September 2007
CIMBA Six Sigma and Business Consulting December 2005 - July 2006
CIMBA 2001 - 2006
Louis Dreyfus Corporation September 2004 - May 2005
Gerber Agri International, LLC October 2002 - August 2004
Alabama International Trade Center May 2002 - August 2002
Alabama International Trade Center 2002 - 2002
Education
Consortium Institute of Management and Business Analysis 2005 — 2006
MBA, Master International Business
University of Kansas - Graduate School of Business 2005 — 2006
Master, Master's of Business Administration
University of Kansas - Graduate School of Business 2005 — 2006
MBA, CIMBA
University of Alabama 1998 — 2002
Bachelor, International Marketing/Spanish/Italian
Consortium International University 2001 — 2001
n/a, International Business
Universidad de Cádiz 1998 — 1998
n/a, Spanish
FDA April 2010 - Present
HONDA TRADING June 2008 - April 2009
Savino Del Bene October 2006 - September 2007
CIMBA Six Sigma and Business Consulting December 2005 - July 2006
CIMBA 2001 - 2006
Louis Dreyfus Corporation September 2004 - May 2005
Gerber Agri International, LLC October 2002 - August 2004
Alabama International Trade Center May 2002 - August 2002
Alabama International Trade Center 2002 - 2002
Education
Consortium Institute of Management and Business Analysis 2005 — 2006
MBA, Master International Business
University of Kansas - Graduate School of Business 2005 — 2006
Master, Master's of Business Administration
University of Kansas - Graduate School of Business 2005 — 2006
MBA, CIMBA
University of Alabama 1998 — 2002
Bachelor, International Marketing/Spanish/Italian
Consortium International University 2001 — 2001
n/a, International Business
Universidad de Cádiz 1998 — 1998
n/a, Spanish
Pasquale Maio Pasquale Maio's FDA Experience June 2008 - Present
Job Of Counsel at Paterno' & Associates, PC
Industry Law Practice
Experience
Paterno' & Associates, PC January 2013 - Present
New York Italians June 2009 - Present
Cilento Experience December 2008 - Present
FDA June 2008 - Present
Skills
Commercial Litigation, Immigration Law, Employment Law, Alternative Dispute..., Import Export, Litigation, Legal Research, Legal Writing, Criminal Law, Corporate Law, Arbitration, Trials, Legal Assistance, Appeals, Civil Litigation, Public Relations, Real Estate, International Law, Courts, Mediation, Family Law, Personal Injury, Negotiation, Italian, Nonprofits, Management, Community Outreach, Intellectual Property, Westlaw, Mergers & Acquisitions, Social Networking, Licensing, Government, Research, Depositions, Competition Law, International Trade, Bankruptcy, Policy, Public Policy, Dispute Resolution, Wills, Interviews, Due Diligence, Medical Malpractice, Joint Ventures, Contract Negotiation, Analysis, Civil Rights, Torts
Education
RS
Università degli Studi di Napoli 'Federico II'
Doctor of Law (J.D.), Law School
Paterno' & Associates, PC January 2013 - Present
New York Italians June 2009 - Present
Cilento Experience December 2008 - Present
FDA June 2008 - Present
Skills
Commercial Litigation, Immigration Law, Employment Law, Alternative Dispute..., Import Export, Litigation, Legal Research, Legal Writing, Criminal Law, Corporate Law, Arbitration, Trials, Legal Assistance, Appeals, Civil Litigation, Public Relations, Real Estate, International Law, Courts, Mediation, Family Law, Personal Injury, Negotiation, Italian, Nonprofits, Management, Community Outreach, Intellectual Property, Westlaw, Mergers & Acquisitions, Social Networking, Licensing, Government, Research, Depositions, Competition Law, International Trade, Bankruptcy, Policy, Public Policy, Dispute Resolution, Wills, Interviews, Due Diligence, Medical Malpractice, Joint Ventures, Contract Negotiation, Analysis, Civil Rights, Torts
Education
RS
Università degli Studi di Napoli 'Federico II'
Doctor of Law (J.D.), Law School
Sean Xiao Zhu Sean Xiao Zhu's FDA Experience July 2012 - October 2013
Job Research Investigator at BristolMyers Squibb
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb October 2013 - Present
FDA July 2012 - October 2013
University of Maryland, Baltimore (UMB) January 2007 - July 2012
MarketSource Inc. June 2006 - February 2007
National Research Council - Biotechnology Research Institute June 2005 - January 2007
University of Maryland, Baltimore (UMB) May 2005 - August 2005
Jewish General Hospital September 2004 - May 2005
University of Maryland, Baltimore (UMB) May 2004 - August 2004
Université de Montréal January 2004 - April 2004
University of Maryland April 2003 - September 2003
Skills
Computational Chemistry, Force Field Development, Molecular Dynamics, Molecular Modeling, Drug Design, Drug Discovery, Docking, Structural..., QSAR, Protein Purification, Protein Expression, Protein Characterization, French, Chinese, Discovery Studio, Programming, Java, Perl, Bash, Linux, R, MOE, C++, Sound Editing, Protein Chemistry, Molecular Biology, Biochemistry, Cheminformatics, Pharmacokinetics, DNA
Education
University of Maryland Baltimore 2007 — 2012
Ph.D
Université de Montréal 2005 — 2007
M.Sc
Université de Montréal 2002 — 2005
B.Sc
Vanier College 2000 — 2002
DEC; Equivalent to Associate's
Bristol-Myers Squibb October 2013 - Present
FDA July 2012 - October 2013
University of Maryland, Baltimore (UMB) January 2007 - July 2012
MarketSource Inc. June 2006 - February 2007
National Research Council - Biotechnology Research Institute June 2005 - January 2007
University of Maryland, Baltimore (UMB) May 2005 - August 2005
Jewish General Hospital September 2004 - May 2005
University of Maryland, Baltimore (UMB) May 2004 - August 2004
Université de Montréal January 2004 - April 2004
University of Maryland April 2003 - September 2003
Skills
Computational Chemistry, Force Field Development, Molecular Dynamics, Molecular Modeling, Drug Design, Drug Discovery, Docking, Structural..., QSAR, Protein Purification, Protein Expression, Protein Characterization, French, Chinese, Discovery Studio, Programming, Java, Perl, Bash, Linux, R, MOE, C++, Sound Editing, Protein Chemistry, Molecular Biology, Biochemistry, Cheminformatics, Pharmacokinetics, DNA
Education
University of Maryland Baltimore 2007 — 2012
Ph.D
Université de Montréal 2005 — 2007
M.Sc
Université de Montréal 2002 — 2005
B.Sc
Vanier College 2000 — 2002
DEC; Equivalent to Associate's
Carlos M. Gonzalez, PhD. Carlos M. Gonzalez, PhD.'s FDA Experience September 2015 - Present
Job Compliance Officer at FDA
Industry Pharmaceuticals
Experience
FDA September 2015 - Present
FDA September 2011 - Present
FDA 2011 - 2015
University of North Carolina at Chapel Hill November 2009 - July 2011
University of North Carolina at Chapel Hill May 2009 - November 2009
University of North Carolina at Chapel Hill May 2002 - May 2009
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), NIH, Bethesda, MD. January 2000 - August 2002
University of Puerto Rico August 1998 - January 2000
Skills
Histology, Small Animal Models, Confocal Microscopy, Fluorescence Microscopy, Molecular Biology, Protein Chemistry, Cell Culture, qPCR, Biochemistry, Western Blotting, Molecular Cloning, Immunology, Microscopy, Tissue Culture, In Vivo, Flow Cytometry, Virology, PCR, Immunohistochemistry, Genetics, ELISA, In Vitro, Cell Biology, Cell Signaling, Microbiology, Fluorescence, Infectious Diseases, real-time PCR, Animal Models, Molecular Genetics, Immunoprecipitation, Cancer, Scientific Writing, Cell, RT-PCR, Cancer Research, Assay Development, Transfection, Bioinformatics, Biotechnology, Genomics, Protein Purification, Immunofluorescence, Science, Mouse Models, DNA, Protein Expression, Neuroscience, Drug Discovery, RNA isolation
Education
University of North Carolina at Chapel Hill 2002 — 2009
Ph.D., Microbiology and Immunology
University of Puerto Rico 1993 — 1999
B.S., Biological Sciences
Carvin High School
FDA September 2015 - Present
FDA September 2011 - Present
FDA 2011 - 2015
University of North Carolina at Chapel Hill November 2009 - July 2011
University of North Carolina at Chapel Hill May 2009 - November 2009
University of North Carolina at Chapel Hill May 2002 - May 2009
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), NIH, Bethesda, MD. January 2000 - August 2002
University of Puerto Rico August 1998 - January 2000
Skills
Histology, Small Animal Models, Confocal Microscopy, Fluorescence Microscopy, Molecular Biology, Protein Chemistry, Cell Culture, qPCR, Biochemistry, Western Blotting, Molecular Cloning, Immunology, Microscopy, Tissue Culture, In Vivo, Flow Cytometry, Virology, PCR, Immunohistochemistry, Genetics, ELISA, In Vitro, Cell Biology, Cell Signaling, Microbiology, Fluorescence, Infectious Diseases, real-time PCR, Animal Models, Molecular Genetics, Immunoprecipitation, Cancer, Scientific Writing, Cell, RT-PCR, Cancer Research, Assay Development, Transfection, Bioinformatics, Biotechnology, Genomics, Protein Purification, Immunofluorescence, Science, Mouse Models, DNA, Protein Expression, Neuroscience, Drug Discovery, RNA isolation
Education
University of North Carolina at Chapel Hill 2002 — 2009
Ph.D., Microbiology and Immunology
University of Puerto Rico 1993 — 1999
B.S., Biological Sciences
Carvin High School
Mitchell Mathis Mitchell Mathis's FDA Experience December 2012 - Present
Job Division Director at FDA
Industry Government Administration
Experience
FDA December 2012 - Present
FDA December 2012 - Present
Skills
Psychiatric Drug..., Pharmacology, Pharmaceutics
Education
Uniformed Services University of the Health Sciences 1990 — 1994
Doctor of Medicine (M.D.), Medicine
FDA December 2012 - Present
FDA December 2012 - Present
Skills
Psychiatric Drug..., Pharmacology, Pharmaceutics
Education
Uniformed Services University of the Health Sciences 1990 — 1994
Doctor of Medicine (M.D.), Medicine
Esther Salazar's FDA Experience February 2015 - Present
Job Mathematical Statistician at FDA
Industry Government Administration
Experience
FDA February 2015 - Present
Duke University August 2012 - January 2015
Duke University September 2010 - August 2012
Statistical and Applied Mathematical Sciences Institute (SAMSI) January 2010 - August 2010
Federal University of Rio de Janeiro September 2008 - November 2009
Skills
Statistical Modeling, Bayesian methods, Research, Statistics, Bayesian statistics, R, Time Series Analysis, Monte Carlo Simulation, Biostatistics, Survival Analysis, Logistic Regression, LaTeX, Mathematical Modeling, Statistical Computing, Machine Learning, Predictive Modeling, Applied Mathematics, Statistical Consulting, Multivariate Analysis
Education
UFRJ - Universidade Federal do Rio de Janeiro 2004 — 2008
PhD, Statistics
FDA February 2015 - Present
Duke University August 2012 - January 2015
Duke University September 2010 - August 2012
Statistical and Applied Mathematical Sciences Institute (SAMSI) January 2010 - August 2010
Federal University of Rio de Janeiro September 2008 - November 2009
Skills
Statistical Modeling, Bayesian methods, Research, Statistics, Bayesian statistics, R, Time Series Analysis, Monte Carlo Simulation, Biostatistics, Survival Analysis, Logistic Regression, LaTeX, Mathematical Modeling, Statistical Computing, Machine Learning, Predictive Modeling, Applied Mathematics, Statistical Consulting, Multivariate Analysis
Education
UFRJ - Universidade Federal do Rio de Janeiro 2004 — 2008
PhD, Statistics
Monica Kulkarni Monica Kulkarni's FDA Experience June 2009 - August 2009
Job Paralegal at Kelley Drye & Warren
Industry Legal Services
Experience
Kelley Drye & Warren LLP September 2015 - Present
Sidley Austin LLP October 2013 - September 2015
Center for Audit Quality September 2013 - October 2013
The Bullitt Agency July 2013 - September 2013
LIMA Restaurant & Lounge July 2012 - August 2013
Phil Sarna Business Management December 2012 - January 2013
Office of the Chief Financial Officer, Government of the District of Columbia June 2011 - August 2011
FDA June 2009 - August 2009
Skills
Document Review, Research, Legal Assistance, Litigation, Music Management, Copyright Law, Operating Systems, White Collar Litigation, Accounting, Government Agencies, Government Proposals, Legal Documents, Legal Issues, Legal Research, Contract Law, Microsoft Office, Communication, Social Media, Microsoft Excel, Public Speaking, Leadership
Education
University of Maryland College Park 2009 — 2013
Bachelor of Arts (B.A.), Government and Politics; Philosophy
Universitat Autònoma de Barcelona
Spanish and Political Science
Kelley Drye & Warren LLP September 2015 - Present
Sidley Austin LLP October 2013 - September 2015
Center for Audit Quality September 2013 - October 2013
The Bullitt Agency July 2013 - September 2013
LIMA Restaurant & Lounge July 2012 - August 2013
Phil Sarna Business Management December 2012 - January 2013
Office of the Chief Financial Officer, Government of the District of Columbia June 2011 - August 2011
FDA June 2009 - August 2009
Skills
Document Review, Research, Legal Assistance, Litigation, Music Management, Copyright Law, Operating Systems, White Collar Litigation, Accounting, Government Agencies, Government Proposals, Legal Documents, Legal Issues, Legal Research, Contract Law, Microsoft Office, Communication, Social Media, Microsoft Excel, Public Speaking, Leadership
Education
University of Maryland College Park 2009 — 2013
Bachelor of Arts (B.A.), Government and Politics; Philosophy
Universitat Autònoma de Barcelona
Spanish and Political Science
Jason Gross's FDA Experience July 1993 - August 1997
Job Vice President Scientific Affairs at HLS Therapeutics Inc.
Industry Pharmaceuticals
Experience
HLS Therapeutics Inc. September 2014 - Present
Aluna Research October 2014 - June 2015
Cipher Pharmaceuticals Inc. January 2007 - July 2014
MDS Capital January 2003 - January 2006
The Due Diligence Group January 2002 - January 2006
DrugAbuse Sciences January 2000 - January 2002
IVAX January 1997 - January 2000
FDA July 1993 - August 1997
NIH June 1992 - July 1993
Skills
FDA, Clinical Development, Drug Development, Pharmaceutics, CMC, Manufacturing, Science, Biology, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Clinical Trials, Biopharmaceuticals, Regulatory Submissions, Lifesciences, Medical Affairs, Commercialization, Healthcare, Technology Transfer, R&D, Formulation, Life Sciences
Education
University of Arizona 1988 — 1992
Pharm.D.
HLS Therapeutics Inc. September 2014 - Present
Aluna Research October 2014 - June 2015
Cipher Pharmaceuticals Inc. January 2007 - July 2014
MDS Capital January 2003 - January 2006
The Due Diligence Group January 2002 - January 2006
DrugAbuse Sciences January 2000 - January 2002
IVAX January 1997 - January 2000
FDA July 1993 - August 1997
NIH June 1992 - July 1993
Skills
FDA, Clinical Development, Drug Development, Pharmaceutics, CMC, Manufacturing, Science, Biology, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Clinical Trials, Biopharmaceuticals, Regulatory Submissions, Lifesciences, Medical Affairs, Commercialization, Healthcare, Technology Transfer, R&D, Formulation, Life Sciences
Education
University of Arizona 1988 — 1992
Pharm.D.
Louis Carlacci's FDA Experience October 2008 - Present
Job Chemistry reviewer at U.S. FDA
Industry Government Administration
Experience
FDA October 2008 - Present
Network Computing Services Inc. / U.S. Army High Performance Computing Research Center November 2000 - April 2007
University of South Florida August 1993 - May 2000
University of Pennsylvania October 1990 - July 1993
Upjohn (now known as Pfizer) July 1988 - October 1990
Education
University at Buffalo 1984 — 1988
Ph.D.
University at Buffalo 1979 — 1984
B.S.
FDA October 2008 - Present
Network Computing Services Inc. / U.S. Army High Performance Computing Research Center November 2000 - April 2007
University of South Florida August 1993 - May 2000
University of Pennsylvania October 1990 - July 1993
Upjohn (now known as Pfizer) July 1988 - October 1990
Education
University at Buffalo 1984 — 1988
Ph.D.
University at Buffalo 1979 — 1984
B.S.
Anthony Watson's FDA Experience March 2004 - November 2009
Job Director, Regulatory Affairs, Combination Products, Biogen, Inc.
Industry Biotechnology
Experience
Biogen Idec, Inc. June 2013 - Present
US Food and Drug Administration November 2009 - May 2013
FDA March 2004 - November 2009
FDA June 1994 - March 2004
United States Navy May 1990 - March 1994
Skills
FDA, Medical Devices, Regulatory Affairs, Policy, Government, Biotechnology, Clinical Trials, Lifesciences, Pharmaceutical Industry, Program Management, Public Health, Regulatory Submissions, Clinical Research, Quality Assurance, Process Improvement, Cross-functional Team..., Data Analysis, Regulatory Requirements, Regulations, Navy, Biopharmaceuticals, Biomedical Engineering, Strategic Planning
Education
University of Maryland University College 2004 — 2005
MBA, Business
University of Maryland University College 1999 — 2004
MS, Management Information Systems
United States Naval Academy 1986 — 1990
BS, General Engineering
Biogen Idec, Inc. June 2013 - Present
US Food and Drug Administration November 2009 - May 2013
FDA March 2004 - November 2009
FDA June 1994 - March 2004
United States Navy May 1990 - March 1994
Skills
FDA, Medical Devices, Regulatory Affairs, Policy, Government, Biotechnology, Clinical Trials, Lifesciences, Pharmaceutical Industry, Program Management, Public Health, Regulatory Submissions, Clinical Research, Quality Assurance, Process Improvement, Cross-functional Team..., Data Analysis, Regulatory Requirements, Regulations, Navy, Biopharmaceuticals, Biomedical Engineering, Strategic Planning
Education
University of Maryland University College 2004 — 2005
MBA, Business
University of Maryland University College 1999 — 2004
MS, Management Information Systems
United States Naval Academy 1986 — 1990
BS, General Engineering
Nina Ni's FDA Experience October 2009 - Present
Job Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA October 2009 - Present
Bristol-Myers Squibb January 2003 - November 2009
Education
University of Arizona 1998 — 2002
FDA October 2009 - Present
Bristol-Myers Squibb January 2003 - November 2009
Education
University of Arizona 1998 — 2002
Emanuela Lacana's FDA Experience December 2013 - Present
Job Associate Director for Biosimilars and Biologics Policy, Office of Biotechnology Products
Industry Pharmaceuticals
Experience
FDA December 2013 - Present
FDA August 2009 - Present
FDA November 2001 - July 2009
Georgetown University October 1999 - August 2001
NIH October 1991 - October 1999
University of Milano September 1983 - October 1991
Skills
Molecular Biology, Cell Biology, Cell Culture, Biotechnology, Microbiology, Immunology, ELISA, Biochemistry, Protein Chemistry, Drug Development
Education
Università degli Studi di Milano 1983 — 1992
PhD, molecular Biology and Biotechnology
FDA December 2013 - Present
FDA August 2009 - Present
FDA November 2001 - July 2009
Georgetown University October 1999 - August 2001
NIH October 1991 - October 1999
University of Milano September 1983 - October 1991
Skills
Molecular Biology, Cell Biology, Cell Culture, Biotechnology, Microbiology, Immunology, ELISA, Biochemistry, Protein Chemistry, Drug Development
Education
Università degli Studi di Milano 1983 — 1992
PhD, molecular Biology and Biotechnology
Dhananjay Marathe's FDA Experience May 2014 - Present
Job Senior Staff Fellow (Senior Pharmacometric Reviewer) at FDA
Industry Pharmaceuticals
Experience
FDA May 2014 - Present
FDA August 2011 - April 2014
Immunetrics December 2008 - July 2011
State University of New York at Buffalo September 2008 - November 2008
Skills
Pharmacokinetics, Biotechnology, Drug Discovery, Drug Development, In Vivo, HPLC, Clinical Development, Pharmacology, Lifesciences, Cell, Cell Culture, Western Blotting, Molecular Biology, Flow Cytometry, Pharmaceutical Industry
Education
State University of New York at Buffalo 2001 — 2008
PhD, Chemical and Biological Engineering
University of Mumbai 1997 — 2001
BS, Chemical Engineering
Dharampeth M.P.Deo Memorial Science College 1995 — 1997
HSC
Dharampeth High School 1992 — 1995
NONMEM Class
SimCyp Workshop
FDA May 2014 - Present
FDA August 2011 - April 2014
Immunetrics December 2008 - July 2011
State University of New York at Buffalo September 2008 - November 2008
Skills
Pharmacokinetics, Biotechnology, Drug Discovery, Drug Development, In Vivo, HPLC, Clinical Development, Pharmacology, Lifesciences, Cell, Cell Culture, Western Blotting, Molecular Biology, Flow Cytometry, Pharmaceutical Industry
Education
State University of New York at Buffalo 2001 — 2008
PhD, Chemical and Biological Engineering
University of Mumbai 1997 — 2001
BS, Chemical Engineering
Dharampeth M.P.Deo Memorial Science College 1995 — 1997
HSC
Dharampeth High School 1992 — 1995
NONMEM Class
SimCyp Workshop
Kimberly Benton's FDA Experience May 2004 - May 2006
Job Deputy Director at FDA CBER
Industry Biotechnology
Experience
FDA CBER May 2006 - Present
FDA May 2004 - May 2006
FDA June 2000 - April 2004
Education
University of Alabama at Birmingham 1990 — 1997
FDA CBER May 2006 - Present
FDA May 2004 - May 2006
FDA June 2000 - April 2004
Education
University of Alabama at Birmingham 1990 — 1997
Christine Lee-Flemming's FDA Experience August 2014 - Present
Job Pharmacist at FDA
Industry Pharmaceuticals
Experience
FDA August 2014 - Present
FDA November 2013 - Present
Office of the Assistant Secretary for Health (ASH) October 2012 - October 2013
University of Florida August 2007 - May 2013
University of Florida August 2007 - May 2012
University of Florida June 2007 - May 2012
University at Buffalo May 2005 - May 2006
Skills
Research, Microsoft Office, Data Analysis, Statistics, PowerPoint, Public Speaking, Microsoft Excel, Lifesciences, Science, Teaching, Clinical Research, Microsoft Word, Healthcare
Education
University of Florida 2007 — 2011
Doctor of Philosophy (PhD), Pharmaceutical Outcomes and Policy
University at Buffalo 2003 — 2007
Doctor of Pharmacy (PharmD), Pharmacy
FDA August 2014 - Present
FDA November 2013 - Present
Office of the Assistant Secretary for Health (ASH) October 2012 - October 2013
University of Florida August 2007 - May 2013
University of Florida August 2007 - May 2012
University of Florida June 2007 - May 2012
University at Buffalo May 2005 - May 2006
Skills
Research, Microsoft Office, Data Analysis, Statistics, PowerPoint, Public Speaking, Microsoft Excel, Lifesciences, Science, Teaching, Clinical Research, Microsoft Word, Healthcare
Education
University of Florida 2007 — 2011
Doctor of Philosophy (PhD), Pharmaceutical Outcomes and Policy
University at Buffalo 2003 — 2007
Doctor of Pharmacy (PharmD), Pharmacy
David Oryang's FDA Experience August 2008 - Present
Job Risk Analyst and Modeler at FDA
Industry Public Policy
Experience
FDA August 2008 - Present
USDA July 2001 - August 2008
Tuskegee University November 1988 - July 2001
Education
Tuskegee University 1986 — 1988
MS, Mechanical Engineering
Washington State University 1982 — 1984
B.Sc, Mechanical Engineering
FDA August 2008 - Present
USDA July 2001 - August 2008
Tuskegee University November 1988 - July 2001
Education
Tuskegee University 1986 — 1988
MS, Mechanical Engineering
Washington State University 1982 — 1984
B.Sc, Mechanical Engineering
Carla R Lankford's FDA Experience May 2013 - Present
Job
Industry Biotechnology
Experience
FDA May 2013 - Present
Skills
Regulatory Affairs, GMP, Lifesciences, Quality System, FDA, Auditing, Sop, Biotechnology, Regulatory Submissions, Clinical Development, Pharmaceutical Industry, Validation, Clinical Trials, Technology Transfer, GLP, GCP, Drug Development, Life Sciences
Education
University of Maryland Baltimore 1996 — 2001
Ph.D., Pharmacology/Molecular Oncology
Universidad Centro Occidental 'Lisandro Alvarado' 1989 — 1994
Doctor of Medicine (M.D.)
FDA May 2013 - Present
Skills
Regulatory Affairs, GMP, Lifesciences, Quality System, FDA, Auditing, Sop, Biotechnology, Regulatory Submissions, Clinical Development, Pharmaceutical Industry, Validation, Clinical Trials, Technology Transfer, GLP, GCP, Drug Development, Life Sciences
Education
University of Maryland Baltimore 1996 — 2001
Ph.D., Pharmacology/Molecular Oncology
Universidad Centro Occidental 'Lisandro Alvarado' 1989 — 1994
Doctor of Medicine (M.D.)
Ji Hyun LaRose's FDA Experience April 2008 - Present
Job Senior Health Promotional Officer
Industry Public Safety
Experience
FDA April 2008 - Present
Omnicare February 2007 - April 2008
Aon Consulting June 2005 - June 2006
Skills
Pharmacy, Clinical Research, Science, Microsoft Excel, Healthcare, Microsoft Office
Education
University of Maryland School of Pharmacy 2001 — 2005
Doctor of Pharmacy (PharmD)
Union College 1995 — 1999
B.S., Biochemistry
National Institutes of Health
Post-Bacc Fellow, Laboratory of Molecular Pharmacology, National Cancer Institute
FDA April 2008 - Present
Omnicare February 2007 - April 2008
Aon Consulting June 2005 - June 2006
Skills
Pharmacy, Clinical Research, Science, Microsoft Excel, Healthcare, Microsoft Office
Education
University of Maryland School of Pharmacy 2001 — 2005
Doctor of Pharmacy (PharmD)
Union College 1995 — 1999
B.S., Biochemistry
National Institutes of Health
Post-Bacc Fellow, Laboratory of Molecular Pharmacology, National Cancer Institute
Gerald Fetterly's FDA Experience 2000 - 2002
Job Vice President, Clinical Pharmacology and Regulatory Affairs at Kinex Pharmaceuticals
Industry Pharmaceuticals
Experience
Kinex Pharmaceuticals January 2015 - Present
RPCI 2008 - January 2015
Cognigen Corporation 2002 - 2007
FDA 2000 - 2002
Skills
Clinical Trials, Pharmacology, Clinical Development, Oncology, Pharmaceutical Industry, Clinical Pharmacology, Clinical Research, Drug Development, Pharmacokinetics, Drug Discovery
Education
University at Buffalo 1990 — 2000
Kinex Pharmaceuticals January 2015 - Present
RPCI 2008 - January 2015
Cognigen Corporation 2002 - 2007
FDA 2000 - 2002
Skills
Clinical Trials, Pharmacology, Clinical Development, Oncology, Pharmaceutical Industry, Clinical Pharmacology, Clinical Research, Drug Development, Pharmacokinetics, Drug Discovery
Education
University at Buffalo 1990 — 2000
Rial Christensen's FDA Experience 2003 - Present
Job Animal Scientist at Food and Drug Administration
Industry Dairy
Experience
Food and Drug Administration December 2003 - Present
FDA 2003 - Present
Caritas St. Elizabeth's Medical Center December 1996 - December 2003
Rutgers University September 1993 - December 1996
Skills
Dairy nutrition, Molecular Biology, Biology, Signal Transduction, Dairy Products, Research, Regulatory Affairs, Animal Nutrition, Biotechnology, Biochemistry, Cell Culture, Cell Signaling, Microbiology
Education
University of Illinois at Urbana-Champaign 1988 — 1993
Ph.D., Dairy Nutrition
University of Alberta 1985 — 1988
M.Sc., Animal physiology
University of Alberta 1975 — 1979
B.Sc., Animal Science
Food and Drug Administration December 2003 - Present
FDA 2003 - Present
Caritas St. Elizabeth's Medical Center December 1996 - December 2003
Rutgers University September 1993 - December 1996
Skills
Dairy nutrition, Molecular Biology, Biology, Signal Transduction, Dairy Products, Research, Regulatory Affairs, Animal Nutrition, Biotechnology, Biochemistry, Cell Culture, Cell Signaling, Microbiology
Education
University of Illinois at Urbana-Champaign 1988 — 1993
Ph.D., Dairy Nutrition
University of Alberta 1985 — 1988
M.Sc., Animal physiology
University of Alberta 1975 — 1979
B.Sc., Animal Science
Ileana Elder's FDA Experience July 2009 - March 2012
Job Postmarket Team Leader at FDA/CDRH/OIR
Industry Medical Devices
Experience
FDA/CDRH/OIR March 2012 - Present
FDA July 2009 - March 2012
FDA/CDRH/OIVD April 2009 - July 2009
State of Idaho 2005 - 2009
OD 260 2005 - 2005
University of Florida 2001 - 2004
Universidad de Puerto Rico 1997 - 2000
Skills
FDA, OIR, In Vitro Diagnostic..., Quality System..., Medical Devices, Laboratory Developed..., 21 CFR 820, 21 CFR 803, 21 CFR 806, Medical Device Reports..., Complaints, Recalls, CAPA, Life Sciences, Chemistry, Regulatory Affairs, Clinical Research, ELISA, Laboratory, Quality Assurance, GMP, In Vitro, Toxicology, Biotechnology, Clinical, Diagnostics
Education
University of Florida College of Medicine 2000 — 2004
Ph.D., Biomedical Sciences
University of Puerto Rico 1996 — 2000
B.S., Chemistry
FDA/CDRH/OIR March 2012 - Present
FDA July 2009 - March 2012
FDA/CDRH/OIVD April 2009 - July 2009
State of Idaho 2005 - 2009
OD 260 2005 - 2005
University of Florida 2001 - 2004
Universidad de Puerto Rico 1997 - 2000
Skills
FDA, OIR, In Vitro Diagnostic..., Quality System..., Medical Devices, Laboratory Developed..., 21 CFR 820, 21 CFR 803, 21 CFR 806, Medical Device Reports..., Complaints, Recalls, CAPA, Life Sciences, Chemistry, Regulatory Affairs, Clinical Research, ELISA, Laboratory, Quality Assurance, GMP, In Vitro, Toxicology, Biotechnology, Clinical, Diagnostics
Education
University of Florida College of Medicine 2000 — 2004
Ph.D., Biomedical Sciences
University of Puerto Rico 1996 — 2000
B.S., Chemistry
Erika Armani's FDA Experience June 2012 - February 2013
Job Deputy Ethics Counselor at Bureau of Reclamation
Industry Government Administration
Experience
Bureau of Reclamation March 2013 - Present
FDA June 2012 - February 2013
ImagineDesign August 2011 - July 2012
Food and Drug Administration November 2004 - June 2012
Food and Drug Administration August 2003 - May 2005
Skills
Process Improvement, Customer Service, Ethics, Problem Solving, Marketing Research, Web Development, Strategy, Strategic Advice, Competitive Analysis, HTML, Government..., Learning Management..., Organizational..., Technical Writing, CSS, Market Research, Public Speaking, Liasoning, Social Media, Marketing Strategy, Medical Devices, FDA, Marketing Communications, Industry Analysis, Diabetes, Regulatory Analysis
Education
University of Maryland - Robert H. Smith School of Business 2009 — 2012
MBA, Business
Tulane University 1999 — 2003
BSE, Biomedical Engineering
Bureau of Reclamation March 2013 - Present
FDA June 2012 - February 2013
ImagineDesign August 2011 - July 2012
Food and Drug Administration November 2004 - June 2012
Food and Drug Administration August 2003 - May 2005
Skills
Process Improvement, Customer Service, Ethics, Problem Solving, Marketing Research, Web Development, Strategy, Strategic Advice, Competitive Analysis, HTML, Government..., Learning Management..., Organizational..., Technical Writing, CSS, Market Research, Public Speaking, Liasoning, Social Media, Marketing Strategy, Medical Devices, FDA, Marketing Communications, Industry Analysis, Diabetes, Regulatory Analysis
Education
University of Maryland - Robert H. Smith School of Business 2009 — 2012
MBA, Business
Tulane University 1999 — 2003
BSE, Biomedical Engineering
Giovanna Fantoni's FDA Experience May 2012 - June 2015
Job research fellow
Industry Research
Experience
National Institutes of Health June 2015 - Present
FDA May 2012 - June 2015
Education
Università degli Studi di Milano 2001 — 2004
PhD, Public Health
National Institutes of Health June 2015 - Present
FDA May 2012 - June 2015
Education
Università degli Studi di Milano 2001 — 2004
PhD, Public Health
Ray Russo's FDA Experience 1996 - 2008
Job Independent Consultant at Ray L Russo
Industry Information Technology and Services
Experience
Ray L Russo May 2008 - Present
FDA 1996 - 2008
Skills
FDA, Regulatory Affairs, Federal Government, Government, Program Management, Enterprise Software, SDLC, Project Management, Enterprise Architecture, Policy, PMP, Change Management, Business Process..., Integration, PMO, IT Strategy, Software Documentation, Requirements Analysis, Process Improvement, Governance, Quality Assurance, Software Project..., Security, Business Intelligence, Analysis, IT Management, Risk Management, Management Consulting, Business Analysis, Strategy, Business Process, Project Portfolio..., SharePoint, CMMI, Disaster Recovery, ITIL, Regulatory Requirements, Regulatory Submissions, Cloud Computing, Proposal Writing, Data Analysis, Software Development, Health Policy, Cross-functional Team..., Healthcare Information..., Lifesciences, Business Process...
Education
Tulane University 1973 — 1975
Ph.D., Matthematics
Tulane University 1969 — 1971
Master of Science (M.S.), Mathematics
Louisiana State University in New Orleans 1965 — 1969
Bachelor of Science (B.S.), Mathematics and Physics
Benjamin Franklin High School 1962 — 1965
Ray L Russo May 2008 - Present
FDA 1996 - 2008
Skills
FDA, Regulatory Affairs, Federal Government, Government, Program Management, Enterprise Software, SDLC, Project Management, Enterprise Architecture, Policy, PMP, Change Management, Business Process..., Integration, PMO, IT Strategy, Software Documentation, Requirements Analysis, Process Improvement, Governance, Quality Assurance, Software Project..., Security, Business Intelligence, Analysis, IT Management, Risk Management, Management Consulting, Business Analysis, Strategy, Business Process, Project Portfolio..., SharePoint, CMMI, Disaster Recovery, ITIL, Regulatory Requirements, Regulatory Submissions, Cloud Computing, Proposal Writing, Data Analysis, Software Development, Health Policy, Cross-functional Team..., Healthcare Information..., Lifesciences, Business Process...
Education
Tulane University 1973 — 1975
Ph.D., Matthematics
Tulane University 1969 — 1971
Master of Science (M.S.), Mathematics
Louisiana State University in New Orleans 1965 — 1969
Bachelor of Science (B.S.), Mathematics and Physics
Benjamin Franklin High School 1962 — 1965
Joel Merriman, MPH's FDA Experience January 2015 - Present
Job Let's Go Buffalo
Industry Government Administration
Experience
FDA January 2015 - Present
State of Montana February 2013 - January 2015
Ecology and Environment, Inc May 2011 - January 2013
The Research Foundation for SUNY August 2011 - October 2012
Vail Resorts October 2009 - April 2010
Liberty Mutual March 2008 - July 2009
University of North Carolina at Chapel Hill September 2005 - December 2007
Purdue University May 2005 - August 2005
Skills
Environmental Health, Epidemiology, Environmental..., Toxicology, Risk Assessment, Technical Writing, Public Health, Statistical Modeling, Hazardous Waste..., Hazardous Materials, HAZWOPER, Statistics, Environmental Awareness, Grant Writing, Capacity Building, Infectious Diseases, Program Management
Education
State University of New York at Buffalo 2010 — 2012
Master of Public Health (MPH), Environmental Health
University of North Carolina at Chapel Hill 2003 — 2007
Bachelor of Science (B.S.), Public Health
FDA January 2015 - Present
State of Montana February 2013 - January 2015
Ecology and Environment, Inc May 2011 - January 2013
The Research Foundation for SUNY August 2011 - October 2012
Vail Resorts October 2009 - April 2010
Liberty Mutual March 2008 - July 2009
University of North Carolina at Chapel Hill September 2005 - December 2007
Purdue University May 2005 - August 2005
Skills
Environmental Health, Epidemiology, Environmental..., Toxicology, Risk Assessment, Technical Writing, Public Health, Statistical Modeling, Hazardous Waste..., Hazardous Materials, HAZWOPER, Statistics, Environmental Awareness, Grant Writing, Capacity Building, Infectious Diseases, Program Management
Education
State University of New York at Buffalo 2010 — 2012
Master of Public Health (MPH), Environmental Health
University of North Carolina at Chapel Hill 2003 — 2007
Bachelor of Science (B.S.), Public Health
Rafael Arroyo's FDA Experience January 2012 - Present
Job FDA/CDER/OC Senior Policy Advisor
Industry Pharmaceuticals
Experience
FDA January 2012 - Present
FDA January 2009 - January 2012
Stryker August 2008 - December 2008
Amgen January 2006 - October 2007
Skills
Regulatory Affairs, GMP, FDA, Pharmaceutical Industry, V&V, CAPA, Regulatory Requirements, Sop, Change Control, Quality System, Technology Transfer, Regulatory Submissions, Validation, Medical Devices, Biotechnology, Clinical Trials, Drug Development, LIMS, HPLC, Quality Auditing, Quality Assurance, GxP, Microbiology, Lifesciences, Analytical Chemistry, 21 CFR Part 11, Biopharmaceuticals, IND, Pharmaceutics, GLP, Chemistry
Education
Universidad de Puerto Rico 1988 — 1992
Master Science, Analytical Chemistry, Master of Science
Universidad de Puerto Rico 1983 — 1988
BS Chemistry, Analytical Chemistry, BS
FDA January 2012 - Present
FDA January 2009 - January 2012
Stryker August 2008 - December 2008
Amgen January 2006 - October 2007
Skills
Regulatory Affairs, GMP, FDA, Pharmaceutical Industry, V&V, CAPA, Regulatory Requirements, Sop, Change Control, Quality System, Technology Transfer, Regulatory Submissions, Validation, Medical Devices, Biotechnology, Clinical Trials, Drug Development, LIMS, HPLC, Quality Auditing, Quality Assurance, GxP, Microbiology, Lifesciences, Analytical Chemistry, 21 CFR Part 11, Biopharmaceuticals, IND, Pharmaceutics, GLP, Chemistry
Education
Universidad de Puerto Rico 1988 — 1992
Master Science, Analytical Chemistry, Master of Science
Universidad de Puerto Rico 1983 — 1988
BS Chemistry, Analytical Chemistry, BS
David Feria's FDA Experience September 2014 - Present
Job Consumer Safety Officer at FDA
Industry Medical Devices
Experience
FDA September 2014 - Present
Department of Veterans Affairs October 2010 - September 2014
American Red Cross National Headquarters May 2009 - October 2010
National Health Services Blood and Transplant February 2008 - September 2008
Indiana Blood Center January 2002 - August 2007
Indiana Blood Center July 2000 - January 2002
Skills
Clinical Research, Hospitals, Clinical Trials, Healthcare Management, Healthcare, CLIA, ISO 9001:2008, FDA, CQA, Good Manufacturing..., Good Clinical Practices, Good Laboratory..., Training, Quality Assurance, Quality Auditing, Quality Management, Validation, GMP, Quality System, Process Improvement, CAPA, GCP, GLP
Education
University of Arizona 1989 — 1995
B.S., Psychology, Microbiology
FDA September 2014 - Present
Department of Veterans Affairs October 2010 - September 2014
American Red Cross National Headquarters May 2009 - October 2010
National Health Services Blood and Transplant February 2008 - September 2008
Indiana Blood Center January 2002 - August 2007
Indiana Blood Center July 2000 - January 2002
Skills
Clinical Research, Hospitals, Clinical Trials, Healthcare Management, Healthcare, CLIA, ISO 9001:2008, FDA, CQA, Good Manufacturing..., Good Clinical Practices, Good Laboratory..., Training, Quality Assurance, Quality Auditing, Quality Management, Validation, GMP, Quality System, Process Improvement, CAPA, GCP, GLP
Education
University of Arizona 1989 — 1995
B.S., Psychology, Microbiology
Christine Yuen-Yi Hon's FDA Experience November 2012 - Present
Job Clinical Pharmacology Reviewer at Food and Drug Administration
Industry Pharmaceuticals
Experience
FDA November 2012 - Present
NIH August 2003 - October 2012
Mercer University 1999 - 2003
St. Jude Children's Research Hospital 1996 - 1999
Buffalo General Hospital 1993 - 1994
Skills
Clinical Research, Clinical Pharmacology, Clinical Trials, Pharmacokinetics, Clinical Development, Drug Development, Pharmacology, Oncology, Pharmacy, Mass Spectrometry, Drug Delivery, HPLC, Drug Discovery, Pharmacodynamics
Education
State University of New York at Buffalo 1994 — 1996
Doctor of Pharmacy (Pharm.D.), Pharmacy
FDA November 2012 - Present
NIH August 2003 - October 2012
Mercer University 1999 - 2003
St. Jude Children's Research Hospital 1996 - 1999
Buffalo General Hospital 1993 - 1994
Skills
Clinical Research, Clinical Pharmacology, Clinical Trials, Pharmacokinetics, Clinical Development, Drug Development, Pharmacology, Oncology, Pharmacy, Mass Spectrometry, Drug Delivery, HPLC, Drug Discovery, Pharmacodynamics
Education
State University of New York at Buffalo 1994 — 1996
Doctor of Pharmacy (Pharm.D.), Pharmacy
Samanthi Wickramasekara's FDA Experience June 2014 - Present
Job FDA
Industry Research
Experience
FDA June 2014 - Present
Oregon State University December 2011 - May 2014
The University of Arizona February 2009 - January 2012
University of Arizona June 2005 - December 2008
· 2005 May 2005 - December 2008
Ventana Medical Systems 2007 - 2007
University of Arizona August 2003 - May 2005
University of Kelaniya January 2003 - August 2003
University of Arizona January 2002 - December 2002
Education
University of Arizona 2003 — 2008
Ph.D, Analytical Chemistry
University of Arizona
Graduate; Ph.D; B.Sc, Studies; Chemistry; Analytical Chemistry; Chemistry
FDA June 2014 - Present
Oregon State University December 2011 - May 2014
The University of Arizona February 2009 - January 2012
University of Arizona June 2005 - December 2008
· 2005 May 2005 - December 2008
Ventana Medical Systems 2007 - 2007
University of Arizona August 2003 - May 2005
University of Kelaniya January 2003 - August 2003
University of Arizona January 2002 - December 2002
Education
University of Arizona 2003 — 2008
Ph.D, Analytical Chemistry
University of Arizona
Graduate; Ph.D; B.Sc, Studies; Chemistry; Analytical Chemistry; Chemistry
Hilary Sheevers's FDA Experience 1994 - 2000
Job President, CEO at Aclairo PDG, Inc.
Industry Pharmaceuticals
Experience
Aclairo PDG, Inc. 2004 - Present
Milestone Biomedical Associates 2000 - 2004
FDA 1994 - 2000
Skills
Toxicology, Pharmacology, Drug Development, Drug Discovery, Clinical Development, Pharmacokinetics, CRO, GLP, Regulatory Submissions, Biomarkers, Biopharmaceuticals, GCP, Translational Medicine, IND, Oncology, Lifesciences, Biotechnology, In Vivo, Regulatory Affairs, FDA, Life Sciences, Pharmaceutical Industry
Education
University of Arizona 1990 — 1994
PhD, Pharmacology &Toxicology
Aclairo PDG, Inc. 2004 - Present
Milestone Biomedical Associates 2000 - 2004
FDA 1994 - 2000
Skills
Toxicology, Pharmacology, Drug Development, Drug Discovery, Clinical Development, Pharmacokinetics, CRO, GLP, Regulatory Submissions, Biomarkers, Biopharmaceuticals, GCP, Translational Medicine, IND, Oncology, Lifesciences, Biotechnology, In Vivo, Regulatory Affairs, FDA, Life Sciences, Pharmaceutical Industry
Education
University of Arizona 1990 — 1994
PhD, Pharmacology &Toxicology
Randall Gnatt's FDA Experience September 2011 - Present
Job Regulatory Counsel, FDA
Industry Government Administration
Experience
FDA September 2011 - Present
National Commission on Children and Disasters January 2011 - May 2011
Brown Sims, P.C. December 2006 - January 2009
Education
Tulane University Law School 2003 — 2006
Juris Doctor, Law
Tulane University 1998 — 2002
BA, Commnications
FDA September 2011 - Present
National Commission on Children and Disasters January 2011 - May 2011
Brown Sims, P.C. December 2006 - January 2009
Education
Tulane University Law School 2003 — 2006
Juris Doctor, Law
Tulane University 1998 — 2002
BA, Commnications
Hoi Kei (Cecilia) Lon's FDA Experience July 2012 - November 2012
Job Senior Clinical Pharmacokineticist at AbbVie
Industry Pharmaceuticals
Experience
AbbVie August 2013 - Present
State University of New York at Buffalo August 2008 - September 2013
FDA July 2012 - November 2012
Pfizer May 2011 - August 2011
Pfizer May 2008 - August 2008
Skills
Pharmacodynamics, Pharmacokinetics, NONMEM, Clinical Pharmacology, Drug Metabolism, WinNonlin, Pharmacology, HPLC, PK/PD, In Vitro, In Vivo, Clinical Development, Bioanalysis, ELISA, Drug Delivery, Pharmaceutical Research, Drug Development, Cell Culture, ADME, Drug Discovery, Flow Cytometry, LC-MS, Clinical Study Design, Translational Research
Education
State University of New York at Buffalo 2008 — 2013
Doctor of Philosophy (PhD), Pharmaceutical Sciences
State University of New York at Buffalo 2003 — 2008
BS / MS, Pharmaceuitcal Sciences
AbbVie August 2013 - Present
State University of New York at Buffalo August 2008 - September 2013
FDA July 2012 - November 2012
Pfizer May 2011 - August 2011
Pfizer May 2008 - August 2008
Skills
Pharmacodynamics, Pharmacokinetics, NONMEM, Clinical Pharmacology, Drug Metabolism, WinNonlin, Pharmacology, HPLC, PK/PD, In Vitro, In Vivo, Clinical Development, Bioanalysis, ELISA, Drug Delivery, Pharmaceutical Research, Drug Development, Cell Culture, ADME, Drug Discovery, Flow Cytometry, LC-MS, Clinical Study Design, Translational Research
Education
State University of New York at Buffalo 2008 — 2013
Doctor of Philosophy (PhD), Pharmaceutical Sciences
State University of New York at Buffalo 2003 — 2008
BS / MS, Pharmaceuitcal Sciences
Lai Wei's FDA Experience September 2013 - June 2014
Job Senior Scientist at Altria
Industry Research
Experience
Altria June 2014 - Present
FDA September 2013 - June 2014
Digital System, Inc September 2012 - August 2013
George Washington University January 2013 - May 2013
University at Buffalo September 2011 - December 2012
University at Buffalo September 2010 - August 2011
PING AN INSURANCE (GROUP) COMPANY OF CHINA ,LTD June 2008 - August 2008
Skills
SAS, R, Biostatistics, Statistical Modeling, Statistics, Data Analysis, Survival Analysis, SPSS, Clinical Trials, Matlab, Mathematical Modeling, LaTeX, SAS programming, Statistical Programming, Logistic Regression, Data Management, SAS Certified Base...
Education
State University of New York at Buffalo 2011 — 2013
Doctor of Philosophy (Ph.D.), Biostatistics
State University of New York at Buffalo 2009 — 2011
MA, Biostatistics
University of Science and Technology Beijing 2005 — 2009
Bachelor's degree, Mathematics and Applied Mathematics
Altria June 2014 - Present
FDA September 2013 - June 2014
Digital System, Inc September 2012 - August 2013
George Washington University January 2013 - May 2013
University at Buffalo September 2011 - December 2012
University at Buffalo September 2010 - August 2011
PING AN INSURANCE (GROUP) COMPANY OF CHINA ,LTD June 2008 - August 2008
Skills
SAS, R, Biostatistics, Statistical Modeling, Statistics, Data Analysis, Survival Analysis, SPSS, Clinical Trials, Matlab, Mathematical Modeling, LaTeX, SAS programming, Statistical Programming, Logistic Regression, Data Management, SAS Certified Base...
Education
State University of New York at Buffalo 2011 — 2013
Doctor of Philosophy (Ph.D.), Biostatistics
State University of New York at Buffalo 2009 — 2011
MA, Biostatistics
University of Science and Technology Beijing 2005 — 2009
Bachelor's degree, Mathematics and Applied Mathematics
Jaimina Patel's FDA Experience December 2012 - Present
Job Records Management Specialist at FDA
Industry Financial Services
Experience
FDA December 2012 - Present
Ridgewells Inc April 2010 - October 2012
Bank of America July 1996 - January 2009
Skills
Microsoft Excel, Accounts Payable, Account Reconciliation, Accounts Receivable, Financial Reporting, General Ledger, Journal Entries, Credit Analysis, Customer Service, Management, Accounting, Time Management
Education
University of Alabama at Birmingham 1988 — 1993
Bachelor, Accounting
FDA December 2012 - Present
Ridgewells Inc April 2010 - October 2012
Bank of America July 1996 - January 2009
Skills
Microsoft Excel, Accounts Payable, Account Reconciliation, Accounts Receivable, Financial Reporting, General Ledger, Journal Entries, Credit Analysis, Customer Service, Management, Accounting, Time Management
Education
University of Alabama at Birmingham 1988 — 1993
Bachelor, Accounting
Newton Woo's FDA Experience July 2008 - Present
Job Pharmacologist/Toxicologist (Visiting Associate) at Center for Drug Evaluation and Research (CDER), FDA
Industry Government Administration
Experience
FDA July 2008 - Present
NIH 2003 - 2008
University of Alberta 1999 - 2003
Skills
Molecular Biology, In Vitro, Western Blotting, Neuroscience, Confocal Microscopy, Small Molecules, Epidemiology, Lifesciences, Cell Culture, NDA, ELISA, Science, Biochemistry, Protein Chemistry, Cell Biology, Pharmacology, FDA, IND, Life Sciences
Education
University of Alberta 1999 — 2003
Doctor of Philosophy (Ph.D.), Physiology, Neuroscience
UBC
Bachelors of Science, Pharmacology and Therapeutics
FDA July 2008 - Present
NIH 2003 - 2008
University of Alberta 1999 - 2003
Skills
Molecular Biology, In Vitro, Western Blotting, Neuroscience, Confocal Microscopy, Small Molecules, Epidemiology, Lifesciences, Cell Culture, NDA, ELISA, Science, Biochemistry, Protein Chemistry, Cell Biology, Pharmacology, FDA, IND, Life Sciences
Education
University of Alberta 1999 — 2003
Doctor of Philosophy (Ph.D.), Physiology, Neuroscience
UBC
Bachelors of Science, Pharmacology and Therapeutics
Niquiche Sangster-Guity's FDA Experience August 2014 - Present
Job Scientific Reviewer, Food and Drug Administration
Industry Medical Devices
Experience
FDA August 2014 - Present
Johns Hopkins University June 2014 - July 2014
Friends School of Baltimore August 2013 - June 2014
Johns Hopkins School of Medicine September 2010 - July 2013
Johns Hopkins School of Medicine November 2006 - August 2010
Education
University at Albany, SUNY 1997 — 2004
Ph.D, Molecular and Cellular Biology
FDA August 2014 - Present
Johns Hopkins University June 2014 - July 2014
Friends School of Baltimore August 2013 - June 2014
Johns Hopkins School of Medicine September 2010 - July 2013
Johns Hopkins School of Medicine November 2006 - August 2010
Education
University at Albany, SUNY 1997 — 2004
Ph.D, Molecular and Cellular Biology
Gouri Chattopadhyay's FDA Experience 2013 - 2013
Job Fellow at CDER, FDA
Industry Research
Experience
NIH August 2008 - May 2013
FDA 2013 - 2013
USUHS 2004 - 2004
USUHS 2004 - 2004
USUHS 2003 - 2004
Skills
Immunology, Molecular Biology, Tissue isolation from..., Flow Cytometry, Realtime PCR, Mammalian Cell Culture, In vivo, Translational Research, Vaccines, qPCR, Laboratory, Protein Chemistry, FDA, In Vivo, Animal Models, Molecular Cloning, Cell, Transfection, Cell Culture, Cell Biology
Education
Uniformed Services University of the Health Sciences 2004 — 2008
Ph.D., Immunology, Biochemistry
NIH August 2008 - May 2013
FDA 2013 - 2013
USUHS 2004 - 2004
USUHS 2004 - 2004
USUHS 2003 - 2004
Skills
Immunology, Molecular Biology, Tissue isolation from..., Flow Cytometry, Realtime PCR, Mammalian Cell Culture, In vivo, Translational Research, Vaccines, qPCR, Laboratory, Protein Chemistry, FDA, In Vivo, Animal Models, Molecular Cloning, Cell, Transfection, Cell Culture, Cell Biology
Education
Uniformed Services University of the Health Sciences 2004 — 2008
Ph.D., Immunology, Biochemistry
ivette valentin negron's FDA Experience August 2010 - November 2010
Job Validation Specialist at Pfizer
Industry Pharmaceuticals
Experience
Pfizer March 2012 - Present
ERM: Environmental Resources Management February 2005 - Present
FDA August 2010 - November 2010
Veterans Health Administration December 2008 - May 2010
Skills
Cell Culture, DNA extraction, Team work, Team Leadership, Bilingual, Solid computer skills, Industrial Safety, Pharmacogenetic Research, Teamwork, Validation, Clinical Research, Cleaning Validation, GLP, Protocol, Sop
Education
Universidad de Puerto Rico 2006 — 2010
Master's degree, Pharmaceutical Sciences, Master
University of Puerto Rico
Pre-Medical
Pfizer March 2012 - Present
ERM: Environmental Resources Management February 2005 - Present
FDA August 2010 - November 2010
Veterans Health Administration December 2008 - May 2010
Skills
Cell Culture, DNA extraction, Team work, Team Leadership, Bilingual, Solid computer skills, Industrial Safety, Pharmacogenetic Research, Teamwork, Validation, Clinical Research, Cleaning Validation, GLP, Protocol, Sop
Education
Universidad de Puerto Rico 2006 — 2010
Master's degree, Pharmaceutical Sciences, Master
University of Puerto Rico
Pre-Medical
Okpo Eradiri's FDA Experience November 2012 - Present
Job Clinical Pharmacology | Pharmaceutical R&D | Pharmacokinetics | Biopharmaceutics
Industry Pharmaceuticals
Experience
FDA November 2012 - Present
Pharma Regulatory Science Consulting, LLC April 2012 - October 2012
PAREXEL International March 2011 - March 2012
Biovail Technologies Ltd January 2007 - January 2011
Biovail Technologies Ltd October 2000 - December 2006
PHARMA MEDICA RESEARCH, INC February 1999 - September 2000
BIOVAIL CORPORATION INTERNATIONAL July 1991 - February 1999
Skills
Regulatory Affairs, Due Diligence, Technology Transfer, Pharmaceutical Industry, Clinical Development, Drug Development, Clinical Pharmacology, Pharmacokinetics, FDA, Recruiting, ADME, Clinical Trials, GMP, Bioanalysis, Formulation, CRO, Biotechnology, Clinical Research, NDA, GLP, Sop, Pharmacology, R&D, Biologics
Education
University of Alberta 1983 — 1987
Ph.D., Pharmaceutical Sciences (Pharmacokinetics)
Obafemi Awolowo University (University of Ife) 1982 — 1983
Master of Science, Pharmaceutics
Obafemi Awolowo University (University of Ife) 1978 — 1981
Bachelor of Pharmacy
FDA November 2012 - Present
Pharma Regulatory Science Consulting, LLC April 2012 - October 2012
PAREXEL International March 2011 - March 2012
Biovail Technologies Ltd January 2007 - January 2011
Biovail Technologies Ltd October 2000 - December 2006
PHARMA MEDICA RESEARCH, INC February 1999 - September 2000
BIOVAIL CORPORATION INTERNATIONAL July 1991 - February 1999
Skills
Regulatory Affairs, Due Diligence, Technology Transfer, Pharmaceutical Industry, Clinical Development, Drug Development, Clinical Pharmacology, Pharmacokinetics, FDA, Recruiting, ADME, Clinical Trials, GMP, Bioanalysis, Formulation, CRO, Biotechnology, Clinical Research, NDA, GLP, Sop, Pharmacology, R&D, Biologics
Education
University of Alberta 1983 — 1987
Ph.D., Pharmaceutical Sciences (Pharmacokinetics)
Obafemi Awolowo University (University of Ife) 1982 — 1983
Master of Science, Pharmaceutics
Obafemi Awolowo University (University of Ife) 1978 — 1981
Bachelor of Pharmacy
Jim MacGregor's FDA Experience May 1997 - March 2004
Job Consultant
Industry Pharmaceuticals
Experience
Toxicology Consulting Services April 2004 - Present
FDA May 1997 - March 2004
SRI International 1990 - 1997
USDA Western Regional Research Center 1972 - 1987
Skills
Toxicology, Assay Development, Laboratory, GLP, Regulatory Affairs, Drug Development, FDA, Lifesciences, Drug Discovery, Pharmaceutical Industry, Biotechnology, Pharmacology
Education
UCSF 1970 — 1972
Postdoctoral Trainee, Toxicology
University of Rochester School of Medicine 1965 — 1970
Ph.D., Toxicology
Union College 1961 — 1965
B.S., Chemistry
Toxicology Consulting Services April 2004 - Present
FDA May 1997 - March 2004
SRI International 1990 - 1997
USDA Western Regional Research Center 1972 - 1987
Skills
Toxicology, Assay Development, Laboratory, GLP, Regulatory Affairs, Drug Development, FDA, Lifesciences, Drug Discovery, Pharmaceutical Industry, Biotechnology, Pharmacology
Education
UCSF 1970 — 1972
Postdoctoral Trainee, Toxicology
University of Rochester School of Medicine 1965 — 1970
Ph.D., Toxicology
Union College 1961 — 1965
B.S., Chemistry
Veronica M. Atterbeary MBA, PMP, CQM/OE's FDA Experience April 2014 - Present
Job Consumer Safety Officer
Industry Biotechnology
Experience
FDA April 2014 - Present
Novavax October 2013 - April 2014
Novavax January 2012 - October 2013
Trevigen, Inc. June 2010 - January 2012
Baxter Healthcare October 2009 - June 2010
Baxter Healthcare June 2008 - October 2009
Baxter Healthcare October 2007 - June 2008
Amgen April 2005 - October 2007
Stiefel, a GSK company June 1999 - February 2005
Skills
Quality Management, ISO 13485, CAPA, Quality System, GMP, Change Management, Project Management, SPC, Quality Assurance, Validation, Pharmaceutical Industry, Strategic Planning, PMP, Six Sigma, Process Improvement, FDA, Change Control, Supply Chain Management, Sop
Education
Universidad del Turabo 2005 — 2007
MBA, Quality Management
University of Puerto Rico 1995 — 1999
BS, Microbiology
FDA April 2014 - Present
Novavax October 2013 - April 2014
Novavax January 2012 - October 2013
Trevigen, Inc. June 2010 - January 2012
Baxter Healthcare October 2009 - June 2010
Baxter Healthcare June 2008 - October 2009
Baxter Healthcare October 2007 - June 2008
Amgen April 2005 - October 2007
Stiefel, a GSK company June 1999 - February 2005
Skills
Quality Management, ISO 13485, CAPA, Quality System, GMP, Change Management, Project Management, SPC, Quality Assurance, Validation, Pharmaceutical Industry, Strategic Planning, PMP, Six Sigma, Process Improvement, FDA, Change Control, Supply Chain Management, Sop
Education
Universidad del Turabo 2005 — 2007
MBA, Quality Management
University of Puerto Rico 1995 — 1999
BS, Microbiology
Yoni Kaplan's FDA Experience June 2010 - August 2010
Job TriState Campus Coordinator
Industry Nonprofit Organization Management
Experience
Tulane University May 2011 - Present
FDA June 2010 - August 2010
Summer Institute for the Gifted July 2009 - August 2009
Skills
Tissue Engineering, Research, Biomechanics, Fluorescence Microscopy, Data Analysis, Biomedical Engineering, Social Media, Communication, Guest Lecturing, Community Organizing, Public Speaking
Education
Tulane University 2009 — 2013
Bachelor of Science (BS), Biomedical Engineering
Tulane University May 2011 - Present
FDA June 2010 - August 2010
Summer Institute for the Gifted July 2009 - August 2009
Skills
Tissue Engineering, Research, Biomechanics, Fluorescence Microscopy, Data Analysis, Biomedical Engineering, Social Media, Communication, Guest Lecturing, Community Organizing, Public Speaking
Education
Tulane University 2009 — 2013
Bachelor of Science (BS), Biomedical Engineering
Hina Pinto's FDA Experience January 2012 - Present
Job Regulatory Advisor at FDA
Industry Medical Devices
Experience
FDA January 2012 - Present
FDA January 2001 - December 2011
Skills
FDA, Regulatory Affairs, Medical Devices, Clinical Trials, Biomedical Engineering, Regulatory Submissions, Clinical Development, Clinical Research, Policy, Regulatory Requirements
Education
Tulane University 1998 — 2000
Master of Science in Engineering (MSE), Biomedical Engineering
University of North Carolina at Chapel Hill 1993 — 1997
Bachelor of Science (BS), Applied Science
FDA January 2012 - Present
FDA January 2001 - December 2011
Skills
FDA, Regulatory Affairs, Medical Devices, Clinical Trials, Biomedical Engineering, Regulatory Submissions, Clinical Development, Clinical Research, Policy, Regulatory Requirements
Education
Tulane University 1998 — 2000
Master of Science in Engineering (MSE), Biomedical Engineering
University of North Carolina at Chapel Hill 1993 — 1997
Bachelor of Science (BS), Applied Science
Angela Ballesteros Morcillo's FDA Experience September 2012 - October 2013
Job Robert Wenthold postdoctoral Fellow at NIDCD at National Institutes of Health
Industry Research
Experience
National Institute on Deafness and Other Communication Disorders (NIDCD) November 2013 - Present
National Institutes of Health November 2013 - March 2014
FDA September 2012 - October 2013
CNB-CSIC August 2006 - July 2012
National Institutes of Health March 2011 - June 2011
Skills
Protein Purification, Protein Expression, Life Sciences, Protein Crystallography, Surface Plasmon..., X-ray crystallography, FPLC, ELISA, Flow Cytometry, Fluorescence..., liposomes preparation, langmuir balance..., Tissue Culture, compression isotherms...
Education
Universidad Autonoma de Madrid 2006 — 2012
Doctor of Philosophy (PhD), Molecular Biology
Universidad Complutense de Madrid 2008 — 2009
Master's degree, Secondary Education and Teaching, Teaching Certificate
University of Zaragoza, Spain 2007 — 2009
Master's degree, Biochemistry and Molecular Biology
Universidad Autonoma de Madrid 2000 — 2006
Bachelor's degree, Biochemistry
Universidad Autonoma de Madrid 2000 — 2004
Primer ciclo (Diplomada), Chemistry
National Institute on Deafness and Other Communication Disorders (NIDCD) November 2013 - Present
National Institutes of Health November 2013 - March 2014
FDA September 2012 - October 2013
CNB-CSIC August 2006 - July 2012
National Institutes of Health March 2011 - June 2011
Skills
Protein Purification, Protein Expression, Life Sciences, Protein Crystallography, Surface Plasmon..., X-ray crystallography, FPLC, ELISA, Flow Cytometry, Fluorescence..., liposomes preparation, langmuir balance..., Tissue Culture, compression isotherms...
Education
Universidad Autonoma de Madrid 2006 — 2012
Doctor of Philosophy (PhD), Molecular Biology
Universidad Complutense de Madrid 2008 — 2009
Master's degree, Secondary Education and Teaching, Teaching Certificate
University of Zaragoza, Spain 2007 — 2009
Master's degree, Biochemistry and Molecular Biology
Universidad Autonoma de Madrid 2000 — 2006
Bachelor's degree, Biochemistry
Universidad Autonoma de Madrid 2000 — 2004
Primer ciclo (Diplomada), Chemistry
Dr. Absar Alum's FDA Experience 2011 - 2013
Job Assistant Professor Research at Arizona State University
Industry Higher Education
Experience
Arizona State University August 2006 - Present
FDA 2011 - 2013
Arizona State University March 2001 - August 2006
Skills
Science, Microscopy, Molecular Biology, Experimental Design, Statistics, PCR, Bioinformatics, Cell Culture, Biochemistry, Genetics, Western Blotting, Cell Biology, Scientific Writing
Education
University of Arizona 1995 — 2001
Ph.D., Environmental Microbiology
University of Agriculture, Faisalabad 1984 — 1986
Master of Science (MSc), Mycology
Arizona State University August 2006 - Present
FDA 2011 - 2013
Arizona State University March 2001 - August 2006
Skills
Science, Microscopy, Molecular Biology, Experimental Design, Statistics, PCR, Bioinformatics, Cell Culture, Biochemistry, Genetics, Western Blotting, Cell Biology, Scientific Writing
Education
University of Arizona 1995 — 2001
Ph.D., Environmental Microbiology
University of Agriculture, Faisalabad 1984 — 1986
Master of Science (MSc), Mycology
Vilmali Lopez-Mejias's FDA Experience January 2005 - May 2005
Job Assistant Professor of Chemistry University of Puerto Rico Río Piedras
Industry Higher Education
Experience
University of Puerto Rico, Río Piedras June 2014 - Present
Washington and Lee University July 2013 - June 2014
MIT June 2011 - May 2013
University of Michigan September 2006 - April 2011
University of Kansas June 2005 - August 2005
FDA January 2005 - May 2005
Skills
Chemistry, Powder X-ray Diffraction, HPLC, Spectroscopy, UV/Vis, NMR, SEM, AFM, Materials Science, Crystallization, Crystal Engineering, Microscopy, Characterization, Molecular Modeling, Formulation, TGA
Education
University of Michigan
Ph.D, Chemistry
University of Michigan
M.S, Chemistry
University of Puerto Rico
B. S, Chemistry
University of Puerto Rico, Río Piedras June 2014 - Present
Washington and Lee University July 2013 - June 2014
MIT June 2011 - May 2013
University of Michigan September 2006 - April 2011
University of Kansas June 2005 - August 2005
FDA January 2005 - May 2005
Skills
Chemistry, Powder X-ray Diffraction, HPLC, Spectroscopy, UV/Vis, NMR, SEM, AFM, Materials Science, Crystallization, Crystal Engineering, Microscopy, Characterization, Molecular Modeling, Formulation, TGA
Education
University of Michigan
Ph.D, Chemistry
University of Michigan
M.S, Chemistry
University of Puerto Rico
B. S, Chemistry
Waesoo Chang's FDA Experience June 2013 - Present
Job Chemist at FDA
Industry Consumer Services
Experience
FDA June 2013 - Present
U.S. Department of Justice 2012 - 2013
SUNY Empire State College June 2010 - January 2011
Young Nail Salon Inc. 2007 - 2011
United States Marine Corps June 2000 - June 2004
Education
University at Buffalo 2005 — 2008
Chemistry
FDA June 2013 - Present
U.S. Department of Justice 2012 - 2013
SUNY Empire State College June 2010 - January 2011
Young Nail Salon Inc. 2007 - 2011
United States Marine Corps June 2000 - June 2004
Education
University at Buffalo 2005 — 2008
Chemistry
Andrea Feight's FDA Experience January 2008 - Present
Job Regulatory Policy Analyst at FDA
Industry Government Administration
Experience
FDA January 2008 - Present
FDA June 2004 - January 2008
FDA February 1997 - June 2004
Indian Health Service September 1984 - January 1997
Skills
Public Health, Epidemiology, Biostatistics, Global Health, Clinical Research, Pharmacovigilance, Regulatory Affairs, International Health, Clinical Study Design, Health Policy
Education
Oregon Health Science University School of Dentistry
DMD, Dentistry
Uniformed Services University of the Health Sciences
Masters of Public Health, Health Sciences Administration/Epidemiology
FDA January 2008 - Present
FDA June 2004 - January 2008
FDA February 1997 - June 2004
Indian Health Service September 1984 - January 1997
Skills
Public Health, Epidemiology, Biostatistics, Global Health, Clinical Research, Pharmacovigilance, Regulatory Affairs, International Health, Clinical Study Design, Health Policy
Education
Oregon Health Science University School of Dentistry
DMD, Dentistry
Uniformed Services University of the Health Sciences
Masters of Public Health, Health Sciences Administration/Epidemiology
Elizabeth Hillebrenner's FDA Experience December 2012 - Present
Job Policy Advisor at FDA
Industry Government Administration
Experience
FDA Office of In Vitro Diagnostics and Radiological Health June 2015 - Present
FDA December 2012 - Present
FDA June 2012 - November 2012
FDA June 2010 - June 2012
FDA November 2002 - June 2010
Education
Tulane University
Master of Science in Engineering (MSE), Biomedical Engineering
Tulane University
Bachelor of Science (B.S.), Biomedical Engineering
FDA Office of In Vitro Diagnostics and Radiological Health June 2015 - Present
FDA December 2012 - Present
FDA June 2012 - November 2012
FDA June 2010 - June 2012
FDA November 2002 - June 2010
Education
Tulane University
Master of Science in Engineering (MSE), Biomedical Engineering
Tulane University
Bachelor of Science (B.S.), Biomedical Engineering
Richard (HHS/OS) Glabach's FDA Experience 2001 - 2005
Job Program Manager IT implementation at HHS
Industry Government Administration
Experience
HHS October 2006 - Present
U.S. Public Health Service Commissioned Corps 1998 - Present
US Government, Department of Health & Human Services, HRSA 2004 - 2006
FDA 2001 - 2005
HHS - Immigration 1998 - 2001
Pharmacy 1995 - 1998
Skills
Program Management, Program Evaluation, Policy, Government, Project Management, Federal Budget, Pharmacy Benefit..., Strategic Planning, Informatics, Data Analysis, Pharmacy, Regulatory Affairs, Health Policy, Healthcare, Healthcare Information..., Epidemiology, Public Health, Healthcare Management, EHR, Program Development, Health Education, Global Health, Clinical Research, Prevention, Disease Management, Community Health, Quality Improvement
Education
State University of New York at Buffalo 2002 — 2005
Master's degree, Informatics
State University of New York at Buffalo 1992 — 1995
Bachelor of Science (B.S.), Pharmacy
HHS October 2006 - Present
U.S. Public Health Service Commissioned Corps 1998 - Present
US Government, Department of Health & Human Services, HRSA 2004 - 2006
FDA 2001 - 2005
HHS - Immigration 1998 - 2001
Pharmacy 1995 - 1998
Skills
Program Management, Program Evaluation, Policy, Government, Project Management, Federal Budget, Pharmacy Benefit..., Strategic Planning, Informatics, Data Analysis, Pharmacy, Regulatory Affairs, Health Policy, Healthcare, Healthcare Information..., Epidemiology, Public Health, Healthcare Management, EHR, Program Development, Health Education, Global Health, Clinical Research, Prevention, Disease Management, Community Health, Quality Improvement
Education
State University of New York at Buffalo 2002 — 2005
Master's degree, Informatics
State University of New York at Buffalo 1992 — 1995
Bachelor of Science (B.S.), Pharmacy
Chris Eirkson's FDA Experience June 2007 - August 2011
Job Student at University of Pittsburgh
Industry Higher Education
Experience
FDA June 2007 - August 2011
Education
University of Pittsburgh 2011 — 2017
State University of New York at Albany 2007 — 2011
Bachelor of Arts (B.A.), Chinese Studies
FDA June 2007 - August 2011
Education
University of Pittsburgh 2011 — 2017
State University of New York at Albany 2007 — 2011
Bachelor of Arts (B.A.), Chinese Studies
Stephine Keeton, Ph.D.'s FDA Experience November 2009 - March 2011
Job Team Leader at US Food and Drug Administration
Industry Pharmaceuticals
Experience
US Food and Drug Administration June 2014 - Present
PPD April 2014 - June 2014
PPD March 2011 - April 2014
FDA November 2009 - March 2011
FDA December 2005 - November 2009
Skills
Biostatistics, Protocol, Vaccines, Clinical Trials, SAS, Analysis, Clinical Research, Statistics, CRO, Research, Clinical Development, Data Analysis, SAS Programming, Pharmaceutical Industry
Education
University of Mississippi 2001 — 2006
Doctor of Philosophy (Ph.D.), Mathematics
University of Mississippi 1999 — 2001
Master of Science (M.S.), Mathematics
University of Alabama at Birmingham 1992 — 1996
Bachelor of Science (B.S.), Mathematics and Business Administration
US Food and Drug Administration June 2014 - Present
PPD April 2014 - June 2014
PPD March 2011 - April 2014
FDA November 2009 - March 2011
FDA December 2005 - November 2009
Skills
Biostatistics, Protocol, Vaccines, Clinical Trials, SAS, Analysis, Clinical Research, Statistics, CRO, Research, Clinical Development, Data Analysis, SAS Programming, Pharmaceutical Industry
Education
University of Mississippi 2001 — 2006
Doctor of Philosophy (Ph.D.), Mathematics
University of Mississippi 1999 — 2001
Master of Science (M.S.), Mathematics
University of Alabama at Birmingham 1992 — 1996
Bachelor of Science (B.S.), Mathematics and Business Administration
Laiza Garcia's FDA Experience June 2008 - Present
Job Consumer Safety Officer / Investigator / Inspector at FDA
Industry Government Administration
Experience
FDA June 2008 - Present
VWR October 2006 - June 2008
University of Puerto Rico August 2000 - June 2004
Skills
Capable of working..., FDA, Analysis, Sop, Chemistry, Laboratory, Design of Experiments, Manufacturing, Project Planning, Medical Devices, Research, Characterization, Organic Chemistry, Inspection, Physics, Environmental Awareness
Education
University of Puerto Rico 2001 — 2006
Applied Physics, Physics and Electronics / Material Science, Bachelor's Degree in Science
FDA June 2008 - Present
VWR October 2006 - June 2008
University of Puerto Rico August 2000 - June 2004
Skills
Capable of working..., FDA, Analysis, Sop, Chemistry, Laboratory, Design of Experiments, Manufacturing, Project Planning, Medical Devices, Research, Characterization, Organic Chemistry, Inspection, Physics, Environmental Awareness
Education
University of Puerto Rico 2001 — 2006
Applied Physics, Physics and Electronics / Material Science, Bachelor's Degree in Science
Jeanne Perla's FDA Experience October 2008 - Present
Job Learning and Professional Development
Industry Government Administration
Experience
FDA October 2008 - Present
Gaymar Industries October 1998 - March 2008
Gaymar Industries September 1998 - March 2008
Skills
Medical Devices, Healthcare, Strategic Planning, Leadership, Research, Program Management, Training, Clinical Research, Community Outreach, Cross-functional Team...
Education
SUNY at Buffalo
Doctor of Philosophy (Ph.D.), Epidemiology
FDA October 2008 - Present
Gaymar Industries October 1998 - March 2008
Gaymar Industries September 1998 - March 2008
Skills
Medical Devices, Healthcare, Strategic Planning, Leadership, Research, Program Management, Training, Clinical Research, Community Outreach, Cross-functional Team...
Education
SUNY at Buffalo
Doctor of Philosophy (Ph.D.), Epidemiology
Ruth Cordoba's FDA Experience June 2009 - August 2012
Job Director Product Quality at Amgen
Industry Biotechnology
Experience
Amgen September 2012 - Present
FDA June 2009 - August 2012
FDA June 2005 - May 2009
Skills
Physics, Radiopharmaceuticals, Biologics, Monoclonal Antibodies
Education
University of Maryland Baltimore 1990 — 1996
Doctor of Philosophy (Ph.D.), Biophysics
Universidad del Valle (CO) 1980 — 1986
Bachelor's degree, Physics
Amgen September 2012 - Present
FDA June 2009 - August 2012
FDA June 2005 - May 2009
Skills
Physics, Radiopharmaceuticals, Biologics, Monoclonal Antibodies
Education
University of Maryland Baltimore 1990 — 1996
Doctor of Philosophy (Ph.D.), Biophysics
Universidad del Valle (CO) 1980 — 1986
Bachelor's degree, Physics
Elijah Weisberg's FDA Experience November 2013 - Present
Job Regulatory Operations Officer at FDA Foreign Enforcement
Industry Government Administration
Experience
FDA November 2013 - Present
FDA March 2010 - November 2013
National Institutes of Health January 2007 - March 2010
National Institutes of Health January 2004 - January 2007
Skills
Biomedical Engineering, Statistics, Quality Auditing, Presentation Design, Medical Device..., Grant Reviewing, Computer Proficiency, Lifesciences, Laboratory, FDA, Medical Devices, Science, Quality System, Software Documentation
Education
Tulane University 1998 — 2002
Master of Science in Engineering (MSE, Biomedical Engineering
FDA November 2013 - Present
FDA March 2010 - November 2013
National Institutes of Health January 2007 - March 2010
National Institutes of Health January 2004 - January 2007
Skills
Biomedical Engineering, Statistics, Quality Auditing, Presentation Design, Medical Device..., Grant Reviewing, Computer Proficiency, Lifesciences, Laboratory, FDA, Medical Devices, Science, Quality System, Software Documentation
Education
Tulane University 1998 — 2002
Master of Science in Engineering (MSE, Biomedical Engineering
Mei-ying Yu's FDA Experience 1980 - 2011
Job
Industry
Experience
FDA 1980 - 2011
Education
University of Alabama at Birmingham
Doctor of Philosophy (Ph.D.)
FDA 1980 - 2011
Education
University of Alabama at Birmingham
Doctor of Philosophy (Ph.D.)
Donna Volpe's FDA Experience May 1990 - Present
Job Research Chemist at FDA
Industry Government Administration
Experience
FDA May 1990 - Present
Skills
Drug Metabolism, Life Sciences, Research, Cell Culture, Drug Transporters, Drug Permeability
Education
Canisius CollegeB.A.
Bachelor of Arts (B.A.), Biology, General
University at Buffalo
Master of Arts (M.A.), Experimental Hematology
University at Buffalo
Doctor of Philosophy (Ph.D.), Physiology, General
FDA May 1990 - Present
Skills
Drug Metabolism, Life Sciences, Research, Cell Culture, Drug Transporters, Drug Permeability
Education
Canisius CollegeB.A.
Bachelor of Arts (B.A.), Biology, General
University at Buffalo
Master of Arts (M.A.), Experimental Hematology
University at Buffalo
Doctor of Philosophy (Ph.D.), Physiology, General
Reid L's FDA Experience February 2004 - Present
Job Pharmacology/Toxicology Supervisor at FDA
Industry Government Administration
Experience
FDA February 2004 - Present
Education
University of Washington 1990 — 1996
Doctor of Philosophy (Ph.D.), Toxicology
University of Arizona 1988 — 1990
Master's Degree, Toxicology
Univsity of Utah
Bachelor's Degree, Medical Technology
FDA February 2004 - Present
Education
University of Washington 1990 — 1996
Doctor of Philosophy (Ph.D.), Toxicology
University of Arizona 1988 — 1990
Master's Degree, Toxicology
Univsity of Utah
Bachelor's Degree, Medical Technology
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