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
Thomas Steele Thomas Steele's FDA Experience 1995 - 1998
Job President/CEO Nonclinical Safety Solutions LLC
Industry Pharmaceuticals
Experience
Nonclinical Safety Solutions May 2014 - Present
ARIAD Pharmaceuticals, Inc. June 2013 - May 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly, January 2009 - May 2013
Roche 2003 - 2008
Roche 1998 - 2003
FDA 1995 - 1998
Interneuron Pharmaceuticals 1992 - 1994
Johns Hopkins University 1990 - 1992
University of Maryland School of Medicine 1988 - 1990
Skills
Drug Development, Drug Discovery, Pharmaceutical Industry, Clinical Development, Clinical Trials, Biotechnology, Life Sciences, Pharmacology, Regulatory Submissions, In Vivo
Education
Purdue University 1986 — 1988
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology
Purdue University 1983 — 1986
Master of Science (MS), Pharmacology and Toxicology
Nonclinical Safety Solutions May 2014 - Present
ARIAD Pharmaceuticals, Inc. June 2013 - May 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly, January 2009 - May 2013
Roche 2003 - 2008
Roche 1998 - 2003
FDA 1995 - 1998
Interneuron Pharmaceuticals 1992 - 1994
Johns Hopkins University 1990 - 1992
University of Maryland School of Medicine 1988 - 1990
Skills
Drug Development, Drug Discovery, Pharmaceutical Industry, Clinical Development, Clinical Trials, Biotechnology, Life Sciences, Pharmacology, Regulatory Submissions, In Vivo
Education
Purdue University 1986 — 1988
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology
Purdue University 1983 — 1986
Master of Science (MS), Pharmacology and Toxicology
Ember Poole-Kroner Ember Poole-Kroner's FDA Experience May 2008 - August 2011
Job Automation Clerk/Intern at FDA
Industry Political Organization
Experience
Montgomery County Circuit Court August 2011 - Present
FDA May 2008 - August 2011
Institute for Public Affairs and Civic Engagement September 2010 - May 2011
Skills
Microsoft Excel, Microsoft Word, HP, Court Cases, Customer Service, exce, Access, Microsoft Publisher
Education
Salisbury University 2007 — 2011
Bachelor of Arts, Political Science
Montgomery County Circuit Court August 2011 - Present
FDA May 2008 - August 2011
Institute for Public Affairs and Civic Engagement September 2010 - May 2011
Skills
Microsoft Excel, Microsoft Word, HP, Court Cases, Customer Service, exce, Access, Microsoft Publisher
Education
Salisbury University 2007 — 2011
Bachelor of Arts, Political Science
Jen Patro Jen Patro's FDA Experience September 2010 - Present
Job Microbiologist at FDA
Industry Research
Experience
FDA September 2010 - Present
Battelle 2009 - 2010
University of Colorado January 2007 - July 2009
Skills
Research, Microbiology, Analytical Chemistry, Spectroscopy, GLP, Emergency Management, Security Clearance, Chemistry, Cell Culture, Mass Spectrometry, Biochemistry, NMR, Molecular Biology, PCR, HPLC
Education
The Johns Hopkins University 2002 — 2006
Doctor of Philosophy (PhD), Chemistry
Salisbury University 1998 — 2002
Bachelor of Science (BS), Chemistry
FDA September 2010 - Present
Battelle 2009 - 2010
University of Colorado January 2007 - July 2009
Skills
Research, Microbiology, Analytical Chemistry, Spectroscopy, GLP, Emergency Management, Security Clearance, Chemistry, Cell Culture, Mass Spectrometry, Biochemistry, NMR, Molecular Biology, PCR, HPLC
Education
The Johns Hopkins University 2002 — 2006
Doctor of Philosophy (PhD), Chemistry
Salisbury University 1998 — 2002
Bachelor of Science (BS), Chemistry
Kathy (Chen) Tran Kathy (Chen) Tran's FDA Experience January 1999 - February 1999
Job Clinical Project Manager at Rexahn Pharmaceuticals
Industry Pharmaceuticals
Experience
Rexahn Pharmaceuticals 2012 - Present
Hoffmann-La Roche 2006 - 2012
Hoffmann-La Roche 2003 - 2005
Covance 2001 - 2003
Covance 1999 - 2001
FDA January 1999 - February 1999
Skills
International Project..., Drug Development, Clinical Trial..., Clinical Trials, Clinical Research, Clinical Operations, Global Operations, Operations Management, Financial Management, Vendor Management, CRO, CTMS, Randomization, ICH-GCP, eCRF, Virology, Oncology, HCV, NSCLC, Mentoring, Biotechnology, Pharmaceutical Industry, Global Clinical Studies, Managerial Finance, EDC, Inform, GCP, Clinical Development
Education
Rutgers University-New Brunswick
BS, Pharmacy
Rexahn Pharmaceuticals 2012 - Present
Hoffmann-La Roche 2006 - 2012
Hoffmann-La Roche 2003 - 2005
Covance 2001 - 2003
Covance 1999 - 2001
FDA January 1999 - February 1999
Skills
International Project..., Drug Development, Clinical Trial..., Clinical Trials, Clinical Research, Clinical Operations, Global Operations, Operations Management, Financial Management, Vendor Management, CRO, CTMS, Randomization, ICH-GCP, eCRF, Virology, Oncology, HCV, NSCLC, Mentoring, Biotechnology, Pharmaceutical Industry, Global Clinical Studies, Managerial Finance, EDC, Inform, GCP, Clinical Development
Education
Rutgers University-New Brunswick
BS, Pharmacy
David Olmsted David Olmsted's FDA Experience January 2009 - Present
Job Technology Consultant at HewlettPackard
Industry Information Technology and Services
Experience
FDA January 2009 - Present
Hewlett-Packard November 1997 - Present
Bristol-Myers Squibb January 2008 - December 2008
Xerox November 1997 - January 2008
Skills
DNS, Microsoft Exchange, Enterprise Architecture, Active Directory, ITIL, Data Center, Disaster Recovery, Virtualization, HP, IT Service Management, Windows Server, Unix, VMware ESX, IT Strategy, Cloud Computing, Servers, VMware, SharePoint, Solution Architecture, Integration, Cluster, Windows, System Deployment, IT Operations, Security, IT Management, Solaris, Citrix, Shell Scripting, SAN, Network Architecture, System Administration, Storage, Incident Management, High Availability, IIS, Enterprise Software
Education
Rochester Institute of Technology 1992 — 1996
Bachelor of Science (BS), Electrical Engineering Technology
FDA January 2009 - Present
Hewlett-Packard November 1997 - Present
Bristol-Myers Squibb January 2008 - December 2008
Xerox November 1997 - January 2008
Skills
DNS, Microsoft Exchange, Enterprise Architecture, Active Directory, ITIL, Data Center, Disaster Recovery, Virtualization, HP, IT Service Management, Windows Server, Unix, VMware ESX, IT Strategy, Cloud Computing, Servers, VMware, SharePoint, Solution Architecture, Integration, Cluster, Windows, System Deployment, IT Operations, Security, IT Management, Solaris, Citrix, Shell Scripting, SAN, Network Architecture, System Administration, Storage, Incident Management, High Availability, IIS, Enterprise Software
Education
Rochester Institute of Technology 1992 — 1996
Bachelor of Science (BS), Electrical Engineering Technology
Paul F Lizzul, MD, PhD, MPH, MBA Paul F Lizzul, MD, PhD, MPH, MBA's FDA Experience 2011 - 2012
Job Senior Medical Director at Kythera Biopharmaceuticals
Industry Biotechnology
Experience
Kythera Biopharmaceuticals 2012 - Present
California Health & Longevity Institute, Inc 2012 - Present
FDA 2011 - 2012
Tufts-New England Medical Center 2009 - 2012
UC Davis 2006 - 2009
Greenwich Hospital, Yale University School of Medicine 2005 - 2006
Rutgers University 2002 - 2003
Depfa Bank 2002 - 2002
Skills
Clinical Trials, Inflammation, Laser Surgery, Business Development, Technology Evaluation, Fillers, Psoriasis, Autoimmunity, Clinical Research, Clinical Development, Oncology, Biotechnology, Medicine, Immunology, Infectious Diseases, Internal Medicine, Drug Development, FDA, Biopharmaceuticals, Dermatology, Medical Affairs, Surgery, Vaccines, Cancer, CTMS, Lifesciences, Pharmacovigilance, Medical Writing, Commercialization, Technology Transfer, Biochemistry, Pharmaceutical Industry, GCP, Aesthetics, Translational Medicine, Therapeutic Areas, Life Sciences
Education
Rensselaer Polytechnic Institute
BS, Biology
Rutgers Business School
MBA, Entrepreneurship
University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School
MD, PhD, Medicine
University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School
MPH, Epidemiology/Outcomes
University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School
PhD, Molecular Genetics and Microbiology
Kythera Biopharmaceuticals 2012 - Present
California Health & Longevity Institute, Inc 2012 - Present
FDA 2011 - 2012
Tufts-New England Medical Center 2009 - 2012
UC Davis 2006 - 2009
Greenwich Hospital, Yale University School of Medicine 2005 - 2006
Rutgers University 2002 - 2003
Depfa Bank 2002 - 2002
Skills
Clinical Trials, Inflammation, Laser Surgery, Business Development, Technology Evaluation, Fillers, Psoriasis, Autoimmunity, Clinical Research, Clinical Development, Oncology, Biotechnology, Medicine, Immunology, Infectious Diseases, Internal Medicine, Drug Development, FDA, Biopharmaceuticals, Dermatology, Medical Affairs, Surgery, Vaccines, Cancer, CTMS, Lifesciences, Pharmacovigilance, Medical Writing, Commercialization, Technology Transfer, Biochemistry, Pharmaceutical Industry, GCP, Aesthetics, Translational Medicine, Therapeutic Areas, Life Sciences
Education
Rensselaer Polytechnic Institute
BS, Biology
Rutgers Business School
MBA, Entrepreneurship
University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School
MD, PhD, Medicine
University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School
MPH, Epidemiology/Outcomes
University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School
PhD, Molecular Genetics and Microbiology
Ryan Foringer Ryan Foringer's FDA Experience August 2015 - Present
Job Chemical Engineer at FDA
Industry Medical Devices
Experience
FDA August 2015 - Present
FDA December 2013 - Present
New York State Pollution Prevention Institute November 2012 - May 2013
Briggs of Burton PLC March 2012 - August 2012
FDA June 2011 - August 2011
Rochester Institute of Technology June 2010 - September 2010
Skills
R&D, Design of Experiments, Matlab, Chemical Engineering, Engineering, Microscopy, Process Engineering, Research, Data Analysis, Statistics, Characterization, Microsoft Office, Chemistry, Materials Science
Education
Rochester Institute of Technology 2008 — 2013
Bachelor's Degree, Chemical Engineering
FDA August 2015 - Present
FDA December 2013 - Present
New York State Pollution Prevention Institute November 2012 - May 2013
Briggs of Burton PLC March 2012 - August 2012
FDA June 2011 - August 2011
Rochester Institute of Technology June 2010 - September 2010
Skills
R&D, Design of Experiments, Matlab, Chemical Engineering, Engineering, Microscopy, Process Engineering, Research, Data Analysis, Statistics, Characterization, Microsoft Office, Chemistry, Materials Science
Education
Rochester Institute of Technology 2008 — 2013
Bachelor's Degree, Chemical Engineering
Corey Bodmer Corey Bodmer's FDA Experience July 2015 - Present
Job Program Analyst at FDA
Industry Research
Experience
FDA July 2015 - Present
National Cancer Institute 2012 - July 2015
National Cancer Institute March 2009 - 2012
Skills
Data Analysis, Research, Statistics, Policy Analysis, Microsoft Office, Program Evaluation, PowerPoint, Policy, Public Health, Government, Analysis, Grants
Education
Salisbury University - Perdue School of Business 2004 — 2008
Bachelor's degree, Business, Management, Marketing, and Related Support Services
FDA July 2015 - Present
National Cancer Institute 2012 - July 2015
National Cancer Institute March 2009 - 2012
Skills
Data Analysis, Research, Statistics, Policy Analysis, Microsoft Office, Program Evaluation, PowerPoint, Policy, Public Health, Government, Analysis, Grants
Education
Salisbury University - Perdue School of Business 2004 — 2008
Bachelor's degree, Business, Management, Marketing, and Related Support Services
Sanchali Kasbekar, Pharm.D., R.Ph Sanchali Kasbekar, Pharm.D., R.Ph's FDA Experience May 2011 - June 2011
Job Regulatory Affairs Manager at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca July 2014 - Present
Bristol-Myers Squibb June 2012 - July 2014
Novartis January 2012 - February 2012
FDA May 2011 - June 2011
Novartis Pharmaceuticals May 2010 - July 2010
Novartis Pharmaceuticals June 2009 - August 2009
Rutgers University December 2006 - August 2007
Skills
Regulatory Affairs, Pharmaceutical Industry, Pharmacy, Clinical Trials, Clinical Development, Pharmacology, Diabetes, Pharmaceutics, Pharmacists, Therapeutic Areas, Clinical Research, FDA, Neuroscience, Oncology, Regulatory Submissions, Strategic Planning, Rare Diseases, Drug Development
Education
Rutgers, The State University of New Jersey-New Brunswick 2006 — 2012
Doctorate of Pharmacy
AstraZeneca July 2014 - Present
Bristol-Myers Squibb June 2012 - July 2014
Novartis January 2012 - February 2012
FDA May 2011 - June 2011
Novartis Pharmaceuticals May 2010 - July 2010
Novartis Pharmaceuticals June 2009 - August 2009
Rutgers University December 2006 - August 2007
Skills
Regulatory Affairs, Pharmaceutical Industry, Pharmacy, Clinical Trials, Clinical Development, Pharmacology, Diabetes, Pharmaceutics, Pharmacists, Therapeutic Areas, Clinical Research, FDA, Neuroscience, Oncology, Regulatory Submissions, Strategic Planning, Rare Diseases, Drug Development
Education
Rutgers, The State University of New Jersey-New Brunswick 2006 — 2012
Doctorate of Pharmacy
Joanna Lucero's FDA Experience December 2008 - March 2009
Job Physics Teacher
Industry Primary/Secondary Education
Experience
Pflugerville ISD - John B. Connally High School June 2012 - Present
Round Rock ISD January 2012 - June 2012
Round Rock ISD August 2011 - December 2011
Mathnasium - The Math Learning Center February 2011 - August 2011
Tapestry Dance Company November 2010 - May 2011
Peter R. Hill P.C. March 2009 - April 2009
FDA December 2008 - March 2009
Rochester Institute of Technology March 2006 - May 2008
Ward's Natural Science June 2007 - November 2007
Rochester Institute of Technology - Housing Operations June 2006 - August 2006
Skills
Teaching, Microsoft Office, Statistics, Research, Data Analysis, Science, PowerPoint, Microsoft Excel, Public Speaking, Technical Writing, Microsoft Word, Higher Education, Editing, Mathematica, HTML, Photography, Curriculum Development, Management
Education
Educators of Excellence 2011 — 2011
Texas Teacher Certification, Science, grades 8-12
Rochester Institute of Technology 2006 — 2008
MBA, Technology Management
Rochester Institute of Technology 2002 — 2006
B.S., Physics
Pflugerville ISD - John B. Connally High School June 2012 - Present
Round Rock ISD January 2012 - June 2012
Round Rock ISD August 2011 - December 2011
Mathnasium - The Math Learning Center February 2011 - August 2011
Tapestry Dance Company November 2010 - May 2011
Peter R. Hill P.C. March 2009 - April 2009
FDA December 2008 - March 2009
Rochester Institute of Technology March 2006 - May 2008
Ward's Natural Science June 2007 - November 2007
Rochester Institute of Technology - Housing Operations June 2006 - August 2006
Skills
Teaching, Microsoft Office, Statistics, Research, Data Analysis, Science, PowerPoint, Microsoft Excel, Public Speaking, Technical Writing, Microsoft Word, Higher Education, Editing, Mathematica, HTML, Photography, Curriculum Development, Management
Education
Educators of Excellence 2011 — 2011
Texas Teacher Certification, Science, grades 8-12
Rochester Institute of Technology 2006 — 2008
MBA, Technology Management
Rochester Institute of Technology 2002 — 2006
B.S., Physics
Sydney Wang Sydney Wang's FDA Experience June 2011 - August 2011
Job at
Industry Pharmaceuticals
Experience
Giant Food June 2015 - Present
Stop & Shop September 2012 - Present
WestStar Mortgage July 2009 - July 2012
FDA June 2011 - August 2011
Education
Rutgers, The State University of New Jersey-New Brunswick 2009 — 2015
Giant Food June 2015 - Present
Stop & Shop September 2012 - Present
WestStar Mortgage July 2009 - July 2012
FDA June 2011 - August 2011
Education
Rutgers, The State University of New Jersey-New Brunswick 2009 — 2015
Samantha Wirth, M.S.'s FDA Experience January 2015 - Present
Job Research Microbiologist
Industry Research
Experience
FDA January 2015 - Present
Health Research, Inc. March 2010 - December 2014
APHL /CDC September 2008 - March 2010
University of Tennessee January 2005 - January 2008
Forest Park Clinic for Cats and Dogs 2003 - 2004
Skills
PCR, Molecular Biology, Molecular Cloning, Fluorescence Microscopy, Microbiology, Gel Electrophoresis, Cell Biology, Genetics, Microscopy, Scientific Writing, Science, Bacterial Culture, DNA extraction, Protein Expression, Bacterial Transformation, Agarose Gel..., Aseptic Technique, Molecular Genetics, recombinant DNA..., Site-directed..., Research, DNA Sequencing, Genomics, Laboratory, DNA
Education
University of Tennessee-Knoxville 2005 — 2008
Master of Science (M.S.), Microbial Pathogenesis
Rutgers University-New Brunswick 1999 — 2003
Bachelor's degree, Animal Sciences
FDA January 2015 - Present
Health Research, Inc. March 2010 - December 2014
APHL /CDC September 2008 - March 2010
University of Tennessee January 2005 - January 2008
Forest Park Clinic for Cats and Dogs 2003 - 2004
Skills
PCR, Molecular Biology, Molecular Cloning, Fluorescence Microscopy, Microbiology, Gel Electrophoresis, Cell Biology, Genetics, Microscopy, Scientific Writing, Science, Bacterial Culture, DNA extraction, Protein Expression, Bacterial Transformation, Agarose Gel..., Aseptic Technique, Molecular Genetics, recombinant DNA..., Site-directed..., Research, DNA Sequencing, Genomics, Laboratory, DNA
Education
University of Tennessee-Knoxville 2005 — 2008
Master of Science (M.S.), Microbial Pathogenesis
Rutgers University-New Brunswick 1999 — 2003
Bachelor's degree, Animal Sciences
Lindsey Pelster Lindsey Pelster's FDA Experience June 2009 - August 2009
Job Electrochemical Scientist | Analytical | Problemsolver | Ph.D. Candidate
Industry Biotechnology
Experience
University of Utah, Department of Chemistry July 2011 - Present
Saint Louis University August 2009 - June 2011
FDA June 2009 - August 2009
Saint Louis University August 2008 - May 2009
Saint Louis University August 2008 - May 2009
Pfizer Pharmaceuticals May 2008 - August 2008
American Laboratories, Inc. June 2007 - August 2007
Skills
Protein Chemistry, Protein Chromatography, UV/Vis, Spectroscopy, Electrochemistry, Analytical Chemistry, IR spectroscopy, Fluorescence..., Fluorescence Microscopy, Cyclic Voltammetry, HPLC
Education
University of Utah 2011 — 2015
Ph.D., Analytical Chemistry
Saint Louis University 2009 — 2011
M.S., Chemistry
Saint Louis University 2004 — 2009
B.S., Biochemistry
University of Utah, Department of Chemistry July 2011 - Present
Saint Louis University August 2009 - June 2011
FDA June 2009 - August 2009
Saint Louis University August 2008 - May 2009
Saint Louis University August 2008 - May 2009
Pfizer Pharmaceuticals May 2008 - August 2008
American Laboratories, Inc. June 2007 - August 2007
Skills
Protein Chemistry, Protein Chromatography, UV/Vis, Spectroscopy, Electrochemistry, Analytical Chemistry, IR spectroscopy, Fluorescence..., Fluorescence Microscopy, Cyclic Voltammetry, HPLC
Education
University of Utah 2011 — 2015
Ph.D., Analytical Chemistry
Saint Louis University 2009 — 2011
M.S., Chemistry
Saint Louis University 2004 — 2009
B.S., Biochemistry
Robert Nusser Robert Nusser's FDA Experience 1972 - 1985
Job Real Estate AppraiserRETIRED
Industry Real Estate
Experience
Independent Fee Appraiser January 2014 - Present
Self-employed August 1985 - Present
US Food & Drug Administration July 1972 - August 1985
FDA 1972 - 1985
Skills
Residential Real Estate..., Investment Properties, Appraisals, REO, Residential Homes, Real Estate
Education
Rutgers, The State University of New Jersey-Newark 1968 — 1972
Bachelor's degree
Independent Fee Appraiser January 2014 - Present
Self-employed August 1985 - Present
US Food & Drug Administration July 1972 - August 1985
FDA 1972 - 1985
Skills
Residential Real Estate..., Investment Properties, Appraisals, REO, Residential Homes, Real Estate
Education
Rutgers, The State University of New Jersey-Newark 1968 — 1972
Bachelor's degree
Rita Habib's FDA Experience 2013 - 2013
Job Congressional Healthcare Policy Fellow
Industry Pharmaceuticals
Experience
ASHP/ACCP/VCU August 2015 - Present
Allegheny General Hospital July 2013 - Present
Robert Wood Johnson University Hospital May 2008 - May 2013
FDA 2013 - 2013
Janssen, Pharmaceutical Companies of Johnson and Johnson June 2011 - August 2011
Skills
Clinical Trials, Clinical Pharmacy, Cpr Certified, EMR, HIPAA, Healthcare Information..., Healthcare Management, Hospital Pharmacy, Hospitals, Immunization, Informatics, Managed Care, Medical Education, Medical Writing, Medication Therapy..., Medicine, Oncology, Patient Safety, Pediatrics, Pharmacists, Pharmacy, Pharmacy Automation, Process Improvement, Public Health, Public Speaking, Pyxis, CPR Certified
Education
University of Pittsburgh 2013 — 2014
Master of Public Health (M.P.H.), Public Health
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2013
Doctor of Pharmacy (Pharm.D.), Pharmacy
ASHP/ACCP/VCU August 2015 - Present
Allegheny General Hospital July 2013 - Present
Robert Wood Johnson University Hospital May 2008 - May 2013
FDA 2013 - 2013
Janssen, Pharmaceutical Companies of Johnson and Johnson June 2011 - August 2011
Skills
Clinical Trials, Clinical Pharmacy, Cpr Certified, EMR, HIPAA, Healthcare Information..., Healthcare Management, Hospital Pharmacy, Hospitals, Immunization, Informatics, Managed Care, Medical Education, Medical Writing, Medication Therapy..., Medicine, Oncology, Patient Safety, Pediatrics, Pharmacists, Pharmacy, Pharmacy Automation, Process Improvement, Public Health, Public Speaking, Pyxis, CPR Certified
Education
University of Pittsburgh 2013 — 2014
Master of Public Health (M.P.H.), Public Health
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2013
Doctor of Pharmacy (Pharm.D.), Pharmacy
Jenna Dao Jenna Dao's FDA Experience September 2014 - September 2014
Job Grad Intern at Albertsons Savon Pharmacy
Industry Pharmaceuticals
Experience
Albertsons September 2009 - Present
Eli Lilly and Company February 2015 - March 2015
TLC Xpress Pharmacy January 2015 - January 2015
Indiana University Health November 2014 - November 2014
CVS Health October 2014 - October 2014
FDA September 2014 - September 2014
Indiana University Health August 2014 - August 2014
Family Health Clinics July 2014 - August 2014
Center of Medication Safety and Advancement June 2014 - July 2014
Walgreens May 2014 - June 2014
Skills
Medication Therapy..., Pharmacy, Pharmacists, Pharmacy Automation, Compounding, Immunization, Pharmacy Benefit..., Clinical Pharmacology, Pharmacology, Medicare Part D, Pharmacoeconomics, Ambulatory Care, Pharmacy Practice
Education
Purdue University 2011 — 2015
Doctor of Pharmacy (PharmD), Pharmacy
University of California, Irvine 2006 — 2010
Bachelor of Science (BS), Biochemistry
Albertsons September 2009 - Present
Eli Lilly and Company February 2015 - March 2015
TLC Xpress Pharmacy January 2015 - January 2015
Indiana University Health November 2014 - November 2014
CVS Health October 2014 - October 2014
FDA September 2014 - September 2014
Indiana University Health August 2014 - August 2014
Family Health Clinics July 2014 - August 2014
Center of Medication Safety and Advancement June 2014 - July 2014
Walgreens May 2014 - June 2014
Skills
Medication Therapy..., Pharmacy, Pharmacists, Pharmacy Automation, Compounding, Immunization, Pharmacy Benefit..., Clinical Pharmacology, Pharmacology, Medicare Part D, Pharmacoeconomics, Ambulatory Care, Pharmacy Practice
Education
Purdue University 2011 — 2015
Doctor of Pharmacy (PharmD), Pharmacy
University of California, Irvine 2006 — 2010
Bachelor of Science (BS), Biochemistry
Jeremy Schreier Jeremy Schreier's FDA Experience August 2014 - Present
Job ORISE PostBaccalaureate Fellow at FDA/CBER at FDA
Industry Research
Experience
FDA August 2014 - Present
Institute of Marine and Coastal Science October 2012 - Present
Institute of Marine and Environmental Technology May 2011 - August 2011
Skills
Molecular & Cellular..., Aquaculture, Microbiology, Flow Cytometry, Research, PCR, Molecular Biology, Cell Culture, Genetics, Laboratory, Biology, Gel Electrophoresis, Data Analysis
Education
Rutgers University-New Brunswick 2010 — 2014
Marine Biology and Biological Oceanography
FDA August 2014 - Present
Institute of Marine and Coastal Science October 2012 - Present
Institute of Marine and Environmental Technology May 2011 - August 2011
Skills
Molecular & Cellular..., Aquaculture, Microbiology, Flow Cytometry, Research, PCR, Molecular Biology, Cell Culture, Genetics, Laboratory, Biology, Gel Electrophoresis, Data Analysis
Education
Rutgers University-New Brunswick 2010 — 2014
Marine Biology and Biological Oceanography
Katelyn Mineo Katelyn Mineo's FDA Experience January 2015 - April 2015
Job Associate at Reed Smith LLP
Industry
Experience
Reed Smith LLP September 2015 - Present
FDA January 2015 - April 2015
Reed Smith LLP May 2014 - August 2014
Johnson & Johnson June 2013 - August 2013
Merck November 2011 - August 2012
Merck June 2011 - August 2011
Rutgers Universty September 2009 - January 2011
Douglass Residential College May 2008 - January 2010
Middlesex County Prosecutor's Office January 2009 - January 2009
Skills
Microsoft Excel, Analytical Chemistry
Education
Seton Hall Law School 2012 — 2015
Doctor of Law (J.D.)
Rutgers University 2007 — 2011
BS, Marine Chemistry
University of Queensland 2010 — 2010
Reed Smith LLP September 2015 - Present
FDA January 2015 - April 2015
Reed Smith LLP May 2014 - August 2014
Johnson & Johnson June 2013 - August 2013
Merck November 2011 - August 2012
Merck June 2011 - August 2011
Rutgers Universty September 2009 - January 2011
Douglass Residential College May 2008 - January 2010
Middlesex County Prosecutor's Office January 2009 - January 2009
Skills
Microsoft Excel, Analytical Chemistry
Education
Seton Hall Law School 2012 — 2015
Doctor of Law (J.D.)
Rutgers University 2007 — 2011
BS, Marine Chemistry
University of Queensland 2010 — 2010
Brianna Schoen Brianna Schoen's FDA Experience September 2008 - February 2013
Job Research Scientist
Industry Research
Experience
FDA September 2008 - February 2013
National Institutes of Health July 2006 - July 2007
Roanoke College June 2004 - August 2005
Skills
ELISA, Microbiology, Laboratory, Molecular Biology, Assay Development, Fluorescence, Research, SDS-PAGE, PCR, RT-PCR, Taqman, DNA microarray, Western Blotting, In Vivo
Education
Sentara RMH School of Medical Laboratory Science 2013 — 2014
Medical Laboratory Scientist
The George Washington University 2007 — 2011
M.S., Public Health Microbiology and Infectious Diseases
Roanoke College 2002 — 2006
B.S., Biology
FDA September 2008 - February 2013
National Institutes of Health July 2006 - July 2007
Roanoke College June 2004 - August 2005
Skills
ELISA, Microbiology, Laboratory, Molecular Biology, Assay Development, Fluorescence, Research, SDS-PAGE, PCR, RT-PCR, Taqman, DNA microarray, Western Blotting, In Vivo
Education
Sentara RMH School of Medical Laboratory Science 2013 — 2014
Medical Laboratory Scientist
The George Washington University 2007 — 2011
M.S., Public Health Microbiology and Infectious Diseases
Roanoke College 2002 — 2006
B.S., Biology
Angelina Leibenguth's FDA Experience May 2007 - August 2007
Job Program Management, Manager at Biologics, Inc.
Industry Pharmaceuticals
Experience
Biologics, Inc. May 2013 - Present
Biologics, Inc. September 2010 - Present
CSA Medical Inc July 2008 - September 2010
FDA May 2007 - August 2007
Skills
FDA, Lifesciences, Biomedical Engineering, Biotechnology, Medical Devices, Clinical Trials, Product Launch, Pharmaceutical Industry, Clinical Development, Oncology, Healthcare, Regulatory Submissions, Regulatory Affairs, Design Control, Clinical Research, GCP, Validation, Biopharmaceuticals, Medicare Part D, Protocol, Commercialization, Sop
Education
Rensselaer Polytechnic Institute 2004 — 2008
B.S, Biomedical Engineering
Biologics, Inc. May 2013 - Present
Biologics, Inc. September 2010 - Present
CSA Medical Inc July 2008 - September 2010
FDA May 2007 - August 2007
Skills
FDA, Lifesciences, Biomedical Engineering, Biotechnology, Medical Devices, Clinical Trials, Product Launch, Pharmaceutical Industry, Clinical Development, Oncology, Healthcare, Regulatory Submissions, Regulatory Affairs, Design Control, Clinical Research, GCP, Validation, Biopharmaceuticals, Medicare Part D, Protocol, Commercialization, Sop
Education
Rensselaer Polytechnic Institute 2004 — 2008
B.S, Biomedical Engineering
Koushik Sowrirajan Koushik Sowrirajan's FDA Experience May 2013 - May 2014
Job Pharm Tech Specialist I at Actavis
Industry Pharmaceuticals
Experience
Actavis June 2014 - Present
FDA May 2013 - May 2014
ERC-SOPS, Rutgers May 2012 - May 2013
Rutgers University July 2012 - August 2012
Skills
Chemical Engineering, Dissolution, Quality by Design, Pharmaceutics, NIR spectroscopy, Thermodynamics, HPLC, Chromatography, Formulation, UV/Vis, Pharmaceutical Industry, Organic Chemistry, Biotechnology, FDA, Spectroscopy
Education
Rutgers, The State University of New Jersey-New Brunswick 2011 — 2013
Master of Science (M.S.), Chemical Engineering, 3.67
Chaitanya Bharathi Institute of Technology 2007 — 2011
Bachelor of Technology (B.Tech.), Biotechnology
Actavis June 2014 - Present
FDA May 2013 - May 2014
ERC-SOPS, Rutgers May 2012 - May 2013
Rutgers University July 2012 - August 2012
Skills
Chemical Engineering, Dissolution, Quality by Design, Pharmaceutics, NIR spectroscopy, Thermodynamics, HPLC, Chromatography, Formulation, UV/Vis, Pharmaceutical Industry, Organic Chemistry, Biotechnology, FDA, Spectroscopy
Education
Rutgers, The State University of New Jersey-New Brunswick 2011 — 2013
Master of Science (M.S.), Chemical Engineering, 3.67
Chaitanya Bharathi Institute of Technology 2007 — 2011
Bachelor of Technology (B.Tech.), Biotechnology
Keith Nocho Keith Nocho's FDA Experience September 2012 - Present
Job FDA
Industry Program Development
Experience
FDA September 2012 - Present
Department of the Army March 2010 - September 2012
U.S. Army Reserve August 2007 - March 2010
Cigna October 2005 - June 2007
Serco February 2003 - December 2004
US Army November 1996 - January 2003
United States Marine Corps August 1992 - July 1996
Skills
Program Management, Department Budgeting, Negotiation, Government Contracting, Space Management, Government Procurement, Strategic Planning, Operational Planning, Organizational..., Customer Service, Security Clearance, Government, Army, Command, Policy, Analysis, DoD, Team Leadership
Education
The George Washington University - School of Business 2013 — 2014
Project Management
Rutgers, The State University of New Jersey-New Brunswick 1992 — 1996
Bachelor of Business Administration (BBA), Business Administration and Management, General
FDA September 2012 - Present
Department of the Army March 2010 - September 2012
U.S. Army Reserve August 2007 - March 2010
Cigna October 2005 - June 2007
Serco February 2003 - December 2004
US Army November 1996 - January 2003
United States Marine Corps August 1992 - July 1996
Skills
Program Management, Department Budgeting, Negotiation, Government Contracting, Space Management, Government Procurement, Strategic Planning, Operational Planning, Organizational..., Customer Service, Security Clearance, Government, Army, Command, Policy, Analysis, DoD, Team Leadership
Education
The George Washington University - School of Business 2013 — 2014
Project Management
Rutgers, The State University of New Jersey-New Brunswick 1992 — 1996
Bachelor of Business Administration (BBA), Business Administration and Management, General
Jingjing Pan Jingjing Pan's FDA Experience May 2014 - Present
Job Chemist at FDA
Industry Chemicals
Experience
FDA May 2014 - Present
Puget Sound Naval Shipyard & Intermediate Maintenance Facility July 2009 - April 2014
Department of Science & Mathematics, Rochester Institute of Technology (RIT) September 2006 - May 2009
Merck & Co., Inc., Center for Material Science and Engineering June 2006 - August 2006
Center on Polymer Interfaces and Macromolecular Assemblies (CPIMA),Stanford University June 2005 - August 2005
Tufts University July 2004 - August 2004
Skills
Water Analysis, Government, Chemistry, Scanning Electron..., Polymers, Inductively Coupled..., Organic Chemistry, Analytical Chemistry, Differential Scanning..., Analysis, Detrimental Materials..., Pure Water Analysis, Ion Chromatography (IC), Inductively Coupled..., Differential Scanning..., Petroleum and Hydraulic..., Chemical Analysis of..., Direct Mercury Analyzer..., Karl Fischer..., Total Organic Carbon..., Infrared and Ultraviolet, Polymer Characterization, Polymer Nanocomposites, Laboratory Information..., Microsoft Office (Word,..., Chloride Swipes Analysis, SITA DynoTester, Air/Gas Testing, Oil Swipes Analysis, Beckman-Coulter pH/mV..., Omega conductivity..., UV/Vis, NMR
Education
Rochester Institute of Technology 2006 — 2009
Master's degree, Chemistry, 3.9
Rochester Institute of Technology 2002 — 2006
Bachelor of Science (BS), Chemistry, 3.7
FDA May 2014 - Present
Puget Sound Naval Shipyard & Intermediate Maintenance Facility July 2009 - April 2014
Department of Science & Mathematics, Rochester Institute of Technology (RIT) September 2006 - May 2009
Merck & Co., Inc., Center for Material Science and Engineering June 2006 - August 2006
Center on Polymer Interfaces and Macromolecular Assemblies (CPIMA),Stanford University June 2005 - August 2005
Tufts University July 2004 - August 2004
Skills
Water Analysis, Government, Chemistry, Scanning Electron..., Polymers, Inductively Coupled..., Organic Chemistry, Analytical Chemistry, Differential Scanning..., Analysis, Detrimental Materials..., Pure Water Analysis, Ion Chromatography (IC), Inductively Coupled..., Differential Scanning..., Petroleum and Hydraulic..., Chemical Analysis of..., Direct Mercury Analyzer..., Karl Fischer..., Total Organic Carbon..., Infrared and Ultraviolet, Polymer Characterization, Polymer Nanocomposites, Laboratory Information..., Microsoft Office (Word,..., Chloride Swipes Analysis, SITA DynoTester, Air/Gas Testing, Oil Swipes Analysis, Beckman-Coulter pH/mV..., Omega conductivity..., UV/Vis, NMR
Education
Rochester Institute of Technology 2006 — 2009
Master's degree, Chemistry, 3.9
Rochester Institute of Technology 2002 — 2006
Bachelor of Science (BS), Chemistry, 3.7
Evan Cutler Evan Cutler's FDA Experience July 1990 - February 1996
Job Managing Director at Cutler Solutions, LLC
Industry Pharmaceuticals
Experience
Cutler Solutions, LLC January 2012 - Present
Meridan Consulting, LLC June 2011 - Present
MonoSol Rx, LLC September 2014 - July 2015
MonoSol Rx November 2012 - February 2014
Johnson & Johnson - Noramco, Inc. March 2007 - November 2012
VTS Consultants, Inc. February 1998 - November 2012
The Validation Group February 1997 - February 1998
FDA July 1990 - February 1996
Skills
Quality Assurance, Validation, FDA, Change Control, CAPA, GMP, Pharmaceutical Industry, 21 CFR Part 11, Quality System, V&V, Regulatory Affairs, Computer System..., Medical Devices, Regulatory Submissions, GAMP, Biopharmaceuticals, Quality Auditing, Regulatory Requirements, ISO, Pharmaceutics, Biotechnology, ISO 13485, GLP, Quality Control, SOP, Auditing, Risk Assessment, Quality Management, Software Documentation, Management, Packaging, Design Control, Documentation, Qualification Testing, Lifesciences, Quality Systems, cGMP, Pharmaceuticals, Compliance, Investigations, Process Validation
Education
Rutgers, The State University of New Jersey-New Brunswick 1986 — 1990
Bachelor, Biology
Cherry Hill High School East 1982 — 1986
Diploma
Cutler Solutions, LLC January 2012 - Present
Meridan Consulting, LLC June 2011 - Present
MonoSol Rx, LLC September 2014 - July 2015
MonoSol Rx November 2012 - February 2014
Johnson & Johnson - Noramco, Inc. March 2007 - November 2012
VTS Consultants, Inc. February 1998 - November 2012
The Validation Group February 1997 - February 1998
FDA July 1990 - February 1996
Skills
Quality Assurance, Validation, FDA, Change Control, CAPA, GMP, Pharmaceutical Industry, 21 CFR Part 11, Quality System, V&V, Regulatory Affairs, Computer System..., Medical Devices, Regulatory Submissions, GAMP, Biopharmaceuticals, Quality Auditing, Regulatory Requirements, ISO, Pharmaceutics, Biotechnology, ISO 13485, GLP, Quality Control, SOP, Auditing, Risk Assessment, Quality Management, Software Documentation, Management, Packaging, Design Control, Documentation, Qualification Testing, Lifesciences, Quality Systems, cGMP, Pharmaceuticals, Compliance, Investigations, Process Validation
Education
Rutgers, The State University of New Jersey-New Brunswick 1986 — 1990
Bachelor, Biology
Cherry Hill High School East 1982 — 1986
Diploma
Edward Bonny Edward Bonny's FDA Experience June 2015 - Present
Job Regulatory Counsel
Industry Government Administration
Experience
FDA June 2015 - Present
Bed Bath & Beyond November 2013 - June 2015
Toys R Us September 2000 - July 2010
Wizards of the Coast June 1995 - March 2008
Skills
Writing, Editing, Research, Legal Research, Advertising, French, Copy Editing, Creative Writing, PowerPoint, Public Speaking, Copywriting, Social Media, Government, Editorial, Legal Writing, Nonprofits, Microsoft Office, Adobe Creative Suite
Education
Rutgers University School of Law - Newark 2008 — 2012
J.D.
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts, Political Sicence
FDA June 2015 - Present
Bed Bath & Beyond November 2013 - June 2015
Toys R Us September 2000 - July 2010
Wizards of the Coast June 1995 - March 2008
Skills
Writing, Editing, Research, Legal Research, Advertising, French, Copy Editing, Creative Writing, PowerPoint, Public Speaking, Copywriting, Social Media, Government, Editorial, Legal Writing, Nonprofits, Microsoft Office, Adobe Creative Suite
Education
Rutgers University School of Law - Newark 2008 — 2012
J.D.
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts, Political Sicence
Katie Hourigan, PMP Katie Hourigan, PMP's FDA Experience May 2006 - November 2008
Job Senior Manager, Loyalty Marketing & Member Experience for Marriott Rewards & The RitzCarlton Rewards
Industry Hospitality
Experience
Marriott International June 2015 - Present
Marriott Rewards & The Ritz-Carlton Rewards, PMP October 2012 - Present
Marriott International January 2011 - November 2012
Marriott International December 2009 - January 2011
Marriott International November 2008 - December 2009
FDA May 2006 - November 2008
Skills
Marketing, Project Management, Marketing Strategy, Brand Loyalty, Customer Loyalty..., Incentive Programs, Vendor Relationships, Incentive Travel, Marketing Communications, Hospitality, Program Management, Event Planning, Partnerships, B2B Marketing, Cross Functional..., Vendor Management, Loyalty Marketing, Business Process, Change Management, Hotels, Sales Process, Gift Cards, Direct Mail Campaigns, Event Management, Loyalty Programs, Strategic Planning, Sales
Education
Salisbury University - Perdue School of Business
Bachelor of Science (BS), Marketing
Marriott International June 2015 - Present
Marriott Rewards & The Ritz-Carlton Rewards, PMP October 2012 - Present
Marriott International January 2011 - November 2012
Marriott International December 2009 - January 2011
Marriott International November 2008 - December 2009
FDA May 2006 - November 2008
Skills
Marketing, Project Management, Marketing Strategy, Brand Loyalty, Customer Loyalty..., Incentive Programs, Vendor Relationships, Incentive Travel, Marketing Communications, Hospitality, Program Management, Event Planning, Partnerships, B2B Marketing, Cross Functional..., Vendor Management, Loyalty Marketing, Business Process, Change Management, Hotels, Sales Process, Gift Cards, Direct Mail Campaigns, Event Management, Loyalty Programs, Strategic Planning, Sales
Education
Salisbury University - Perdue School of Business
Bachelor of Science (BS), Marketing
Meena Ramachandra Meena Ramachandra's FDA Experience June 2015 - Present
Job Regulatory Reviewer FDA Office of Prescription Drug Promotion
Industry Pharmaceuticals
Experience
FDA June 2015 - Present
Stop & Shop June 2013 - Present
Bayer HealthCare July 2013 - May 2015
Novel Laboratories, Inc. March 2013 - April 2013
FDA February 2013 - March 2013
Novartis May 2011 - June 2011
Skills
Community Pharmacy, Healthcare, Immunization, Internal Medicine, Medical Affairs, Pharmaceutical Industry, Patient Counseling, Regulatory Affairs, Risk Management, Clinical Development, Pharmacists, Pharmacueticals
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2013
Doctor of Pharmacy (PharmD)
FDA June 2015 - Present
Stop & Shop June 2013 - Present
Bayer HealthCare July 2013 - May 2015
Novel Laboratories, Inc. March 2013 - April 2013
FDA February 2013 - March 2013
Novartis May 2011 - June 2011
Skills
Community Pharmacy, Healthcare, Immunization, Internal Medicine, Medical Affairs, Pharmaceutical Industry, Patient Counseling, Regulatory Affairs, Risk Management, Clinical Development, Pharmacists, Pharmacueticals
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2013
Doctor of Pharmacy (PharmD)
Emily DiMambro's FDA Experience June 2015 - Present
Job Writing Consultant at RPI Center for Communication Practices
Industry Biotechnology
Experience
FDA June 2015 - Present
Center for Architecture Science and Ecology February 2015 - Present
RPI Center for Communication Practices August 2014 - Present
Ecovative Design May 2014 - August 2014
Rensselaer Polytechnic Institute January 2014 - May 2014
Environment Virginia June 2013 - July 2013
Skills
Laboratory Skills, Spanish, Team Leadership, Biomaterials, Scientific Writing, Quality Control, Aseptic Technique, Machining, CAD, Microsoft Office, Poster Presentations, Public Speaking
Education
Rensselaer Polytechnic Institute 2012 — 2015
Bachelor of Science (B.S.), Biomedical Engineering
Richard Montgomery High School 2008 — 2012
International Baccalaureate Diploma
FDA June 2015 - Present
Center for Architecture Science and Ecology February 2015 - Present
RPI Center for Communication Practices August 2014 - Present
Ecovative Design May 2014 - August 2014
Rensselaer Polytechnic Institute January 2014 - May 2014
Environment Virginia June 2013 - July 2013
Skills
Laboratory Skills, Spanish, Team Leadership, Biomaterials, Scientific Writing, Quality Control, Aseptic Technique, Machining, CAD, Microsoft Office, Poster Presentations, Public Speaking
Education
Rensselaer Polytechnic Institute 2012 — 2015
Bachelor of Science (B.S.), Biomedical Engineering
Richard Montgomery High School 2008 — 2012
International Baccalaureate Diploma
Joycene Harrell Joycene Harrell's FDA Experience June 2013 - Present
Job Information Specialist
Industry Government Relations
Experience
FDA June 2013 - Present
U.S. Navy 2000 - 2005
Education
University of Phoenix
Master of Business Administration (M.B.A.)
Villanova University 2013 — 2013
Six Sigma Green Belt
Villanova University 2013 — 2013
Lean Six Sigma
Saint Leo University
Bachelors, Criminal Justice
FDA June 2013 - Present
U.S. Navy 2000 - 2005
Education
University of Phoenix
Master of Business Administration (M.B.A.)
Villanova University 2013 — 2013
Six Sigma Green Belt
Villanova University 2013 — 2013
Lean Six Sigma
Saint Leo University
Bachelors, Criminal Justice
Mark D. Kramer Mark D. Kramer's FDA Experience February 2002 - April 2007
Job President, Regulatory Strategies, Inc.
Industry Medical Devices
Experience
Regulatory Strategies, Inc. October 2009 - Present
GE Healthcare April 2007 - July 2010
FDA February 2002 - April 2007
FDA 2001 - 2001
FDA 1999 - 2001
FDA 1998 - 1999
EDAP TMS 1996 - 1998
Self-Employed 1996 - 1998
CL McIntosh & Associates 1995 - 1996
FDA 1990 - 1995
Skills
Regulatory Strategy..., Regulatory Affairs, Medical Devices, Combination Products, Pharmacueticals, Product Jurisdiction, FDA, Regulatory Submissions, Regulatory Development, Regulatory Intelligence, Regulatory Interactions, Due Diligence, Litigation Support
Education
Rensselaer Polytechnic Institute
MS, Biomedical Engineering
Rutgers, The State University of New Jersey-New Brunswick
BA, Mathematics, With Highest Honors and with High Distinction in Mathematics
Regulatory Affairs Professional Society
RAC (Regulatory Affairs Certification)
The George Washington University
Certificate, Quality Management
Regulatory Strategies, Inc. October 2009 - Present
GE Healthcare April 2007 - July 2010
FDA February 2002 - April 2007
FDA 2001 - 2001
FDA 1999 - 2001
FDA 1998 - 1999
EDAP TMS 1996 - 1998
Self-Employed 1996 - 1998
CL McIntosh & Associates 1995 - 1996
FDA 1990 - 1995
Skills
Regulatory Strategy..., Regulatory Affairs, Medical Devices, Combination Products, Pharmacueticals, Product Jurisdiction, FDA, Regulatory Submissions, Regulatory Development, Regulatory Intelligence, Regulatory Interactions, Due Diligence, Litigation Support
Education
Rensselaer Polytechnic Institute
MS, Biomedical Engineering
Rutgers, The State University of New Jersey-New Brunswick
BA, Mathematics, With Highest Honors and with High Distinction in Mathematics
Regulatory Affairs Professional Society
RAC (Regulatory Affairs Certification)
The George Washington University
Certificate, Quality Management
Nickita Rokad's FDA Experience July 2012 - August 2012
Job Senior Associate, International Regulatory at Ortho Clinical Diagnostics
Industry Pharmaceuticals
Experience
Ortho Clinical Diagnostics March 2015 - Present
Ortho Clinical Diagnostics, Johnson & Johnson February 2014 - Present
TPSI Group June 2011 - January 2014
Indian Health Service March 2013 - April 2013
Chilton Hospital February 2013 - March 2013
St. Joseph's Healthcare System November 2012 - December 2012
Princeton Healthcare System October 2012 - November 2012
Bristol-Myers Squibb September 2012 - October 2012
FDA July 2012 - August 2012
Pathmark Stores, Inc. June 2012 - July 2012
Skills
GMP, Clinical Trials, Clinical Research, Pharmacology, Biotechnology, Pharmaceutical Industry, Internal Medicine, Infectious Diseases, Diabetes, Pharmacy, Pharmacists, Patient Safety, Medicine, Medication Therapy..., Regulatory Affairs, Regulatory Compliance, Quality Assurance
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2013
Doctor of Pharmacy
Ortho Clinical Diagnostics March 2015 - Present
Ortho Clinical Diagnostics, Johnson & Johnson February 2014 - Present
TPSI Group June 2011 - January 2014
Indian Health Service March 2013 - April 2013
Chilton Hospital February 2013 - March 2013
St. Joseph's Healthcare System November 2012 - December 2012
Princeton Healthcare System October 2012 - November 2012
Bristol-Myers Squibb September 2012 - October 2012
FDA July 2012 - August 2012
Pathmark Stores, Inc. June 2012 - July 2012
Skills
GMP, Clinical Trials, Clinical Research, Pharmacology, Biotechnology, Pharmaceutical Industry, Internal Medicine, Infectious Diseases, Diabetes, Pharmacy, Pharmacists, Patient Safety, Medicine, Medication Therapy..., Regulatory Affairs, Regulatory Compliance, Quality Assurance
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2013
Doctor of Pharmacy
Josh Van De Riet Josh Van De Riet's FDA Experience September 2014 - Present
Job Regulatory Counsel at FDA
Industry Legal Services
Experience
FDA September 2014 - Present
Cohen & Dwin, PA May 2013 - May 2014
Basyuk & Klaproth LLP December 2011 - August 2012
Center for Regulatory Effectiveness August 2010 - August 2011
Skills
Legal Research, Legal Writing, Hearings, Immigration Law, Office Administration, Management, Filing, Claim, Westlaw, Personal Injury, Motions, Courts, Lexis, Criminal Law, Appeals
Education
University of Baltimore School of Law 2012 — 2014
Doctor of Law (J.D.)
Radford University 2004 — 2009
Bachelor of Science (BS), Anthropology
FDA September 2014 - Present
Cohen & Dwin, PA May 2013 - May 2014
Basyuk & Klaproth LLP December 2011 - August 2012
Center for Regulatory Effectiveness August 2010 - August 2011
Skills
Legal Research, Legal Writing, Hearings, Immigration Law, Office Administration, Management, Filing, Claim, Westlaw, Personal Injury, Motions, Courts, Lexis, Criminal Law, Appeals
Education
University of Baltimore School of Law 2012 — 2014
Doctor of Law (J.D.)
Radford University 2004 — 2009
Bachelor of Science (BS), Anthropology
Tania Vizcaino Tania Vizcaino's FDA Experience August 2013 - Present
Job Radiological Health/MQSA Specialist at FDA
Industry Public Safety
Experience
FDA August 2013 - Present
FDA May 2002 - September 2013
Skills
Medical Devices, Manufacturing, FDA, Clinical Research, X-ray, CAPA, Quality System, GLP, GCP
Education
Rutgers, The State University of New Jersey-Rutgers Engineering School 1995 — 2001
Bachelor of Engineering (BEng), Biomedical/Medical Engineering
FDA August 2013 - Present
FDA May 2002 - September 2013
Skills
Medical Devices, Manufacturing, FDA, Clinical Research, X-ray, CAPA, Quality System, GLP, GCP
Education
Rutgers, The State University of New Jersey-Rutgers Engineering School 1995 — 2001
Bachelor of Engineering (BEng), Biomedical/Medical Engineering
Peter Sylvers Peter Sylvers's FDA Experience May 2010 - August 2010
Job Graduate Student
Industry Education Management
Experience
Rice University Lab TechnicianRice UniversitySeptember 2010 - May 2011
FDA May 2010 - August 2010
FDA June 2008 - August 2009
Skills
Immunofluorescence, Animal Work, Scientific Writing, Ecology, Research, Laboratory, Fluorescence, Evolutionary Biology, Laboratory Safety, Laboratory Skills, Laboratory Equipment, Sustainability, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Photoshop, Social Media, Teamwork
Education
Rice University 2009 — 2013
Bachelor of Arts (B.A.), Ecology and Evolutionary Biology
Damascus High School 2005 — 2009
Rice University Lab TechnicianRice UniversitySeptember 2010 - May 2011
FDA May 2010 - August 2010
FDA June 2008 - August 2009
Skills
Immunofluorescence, Animal Work, Scientific Writing, Ecology, Research, Laboratory, Fluorescence, Evolutionary Biology, Laboratory Safety, Laboratory Skills, Laboratory Equipment, Sustainability, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Photoshop, Social Media, Teamwork
Education
Rice University 2009 — 2013
Bachelor of Arts (B.A.), Ecology and Evolutionary Biology
Damascus High School 2005 — 2009
Wojciech Jankowski Wojciech Jankowski's FDA Experience 2015 - Present
Job FDA
Industry Pharmaceuticals
Experience
FDA 2015 - Present
Rutgers University 2012 - 2014
Rutgers University 2006 - 2012
Skills
Protein Purification, Biochemistry, PCR, Cell Culture, Molecular Biology, Protein Expression, Science, Chemistry, UV/Vis, Cell Biology, NMR, Molecular Cloning, Microscopy, Fluorescence Microscopy, Protein Chemistry, ELISA, Western Blotting, Confocal Microscopy, HPLC, qPCR, Mass Spectrometry
Education
Rutgers University 2006 — 2012
Doctor of Philosophy (Ph.D.), Chemistry
Warsaw University of Technology 2000 — 2005
Master's degree, Biotechnology
FDA 2015 - Present
Rutgers University 2012 - 2014
Rutgers University 2006 - 2012
Skills
Protein Purification, Biochemistry, PCR, Cell Culture, Molecular Biology, Protein Expression, Science, Chemistry, UV/Vis, Cell Biology, NMR, Molecular Cloning, Microscopy, Fluorescence Microscopy, Protein Chemistry, ELISA, Western Blotting, Confocal Microscopy, HPLC, qPCR, Mass Spectrometry
Education
Rutgers University 2006 — 2012
Doctor of Philosophy (Ph.D.), Chemistry
Warsaw University of Technology 2000 — 2005
Master's degree, Biotechnology
Sean Forbes's FDA Experience May 2015 - Present
Job Social Manager
Industry Marketing and Advertising
Experience
FDA May 2015 - Present
US Navy February 2009 - Present
U.S. Navy Helicopter Sea Combat Squadron Two-Five January 2005 - January 2009
US Navy January 2007 - January 2008
US Navy January 1997 - January 2005
Skills
Analysis, Program Management, Social Media Marketing, Digital Marketing, Marketing, Social Media Strategist, Social Media Outreach, Social Media Measurement, Social Media Integration, Marketing Strategy, Digital Strategy, Advertising, Strategic Communications, Social Media, Navy, Public Relations, Media Relations, Government, Recruiting, Human Resources, Strategy, Management, Organizational...
Education
Skagit Valley College 2006 — 2009
Associates, Art
Brazen
Social Media Strategy
Rockhurst University
Social Media Marketing
U.S. Navy
Leadership Development
FDA May 2015 - Present
US Navy February 2009 - Present
U.S. Navy Helicopter Sea Combat Squadron Two-Five January 2005 - January 2009
US Navy January 2007 - January 2008
US Navy January 1997 - January 2005
Skills
Analysis, Program Management, Social Media Marketing, Digital Marketing, Marketing, Social Media Strategist, Social Media Outreach, Social Media Measurement, Social Media Integration, Marketing Strategy, Digital Strategy, Advertising, Strategic Communications, Social Media, Navy, Public Relations, Media Relations, Government, Recruiting, Human Resources, Strategy, Management, Organizational...
Education
Skagit Valley College 2006 — 2009
Associates, Art
Brazen
Social Media Strategy
Rockhurst University
Social Media Marketing
U.S. Navy
Leadership Development
Christina Lopez Christina Lopez's FDA Experience August 2015 - Present
Job Accountant at FDA
Industry Accounting
Experience
FDA August 2015 - Present
Coastal Tax Service December 2011 - Present
USDA June 2015 - August 2015
Wolfe & Fiedler CPA February 2015 - June 2015
American Standard Brands July 2014 - October 2014
Ocean Partnership for Children, Inc November 2011 - July 2014
Jackson Hewitt January 2010 - April 2014
B & B Department Stores North November 2010 - January 2011
Arcadia University January 2007 - May 2010
Arcadia University September 2009 - December 2009
Skills
Accounts Payable, Tax, Payroll, Peachtree, Outlook, Bookkeeping, Accounting, Bank Reconciliation, QuickBooks, Payroll Processing, Excel, Word, PowerPoint, Data Entry, Customer Service, Non-profits, Teamwork, Petty Cash, Flexible Spending..., Answering Telephones, ADP Payroll, Telephone Skills, Reference Checking, Human Resources, Leadership, Organized Multi-tasker, Paychex, Highly detail oriented, Highly Reliable, Microsoft Excel, Analysis, Microsoft Word, General Ledger, Spreadsheets, Nonprofits, Management, Invoicing
Education
Rutgers, The State University of New Jersey-Newark 2013 — 2014
Master's Degree, Taxation
Arcadia University, College of Business, Health & Sciences 2006 — 2010
Bachelor of Arts, Accounting
FDA August 2015 - Present
Coastal Tax Service December 2011 - Present
USDA June 2015 - August 2015
Wolfe & Fiedler CPA February 2015 - June 2015
American Standard Brands July 2014 - October 2014
Ocean Partnership for Children, Inc November 2011 - July 2014
Jackson Hewitt January 2010 - April 2014
B & B Department Stores North November 2010 - January 2011
Arcadia University January 2007 - May 2010
Arcadia University September 2009 - December 2009
Skills
Accounts Payable, Tax, Payroll, Peachtree, Outlook, Bookkeeping, Accounting, Bank Reconciliation, QuickBooks, Payroll Processing, Excel, Word, PowerPoint, Data Entry, Customer Service, Non-profits, Teamwork, Petty Cash, Flexible Spending..., Answering Telephones, ADP Payroll, Telephone Skills, Reference Checking, Human Resources, Leadership, Organized Multi-tasker, Paychex, Highly detail oriented, Highly Reliable, Microsoft Excel, Analysis, Microsoft Word, General Ledger, Spreadsheets, Nonprofits, Management, Invoicing
Education
Rutgers, The State University of New Jersey-Newark 2013 — 2014
Master's Degree, Taxation
Arcadia University, College of Business, Health & Sciences 2006 — 2010
Bachelor of Arts, Accounting
Anya Bauer Anya Bauer's FDA Experience June 2012 - August 2014
Job Student Researcher at Department of Medical Sciences Laboratory, RIT
Industry Biotechnology
Experience
Department of Medical Sciences, RIT November 2012 - Present
FDA June 2012 - August 2014
Cosmetic Dental Center, PC June 2013 - August 2013
Eurasia Consulting LLC June 2012 - August 2012
Skills
Microsoft Office, Research, Russian, Biomedical Sciences, Statistics, PCR, Cell Culture, Monoclonal Antibodies, Multiplex PCR
Education
Rochester Institute of Technology 2012 — 2015
Biomedical Sciences, B.S., Pre-Medicine/Pre-Medical Studies, 4th year
Department of Medical Sciences, RIT November 2012 - Present
FDA June 2012 - August 2014
Cosmetic Dental Center, PC June 2013 - August 2013
Eurasia Consulting LLC June 2012 - August 2012
Skills
Microsoft Office, Research, Russian, Biomedical Sciences, Statistics, PCR, Cell Culture, Monoclonal Antibodies, Multiplex PCR
Education
Rochester Institute of Technology 2012 — 2015
Biomedical Sciences, B.S., Pre-Medicine/Pre-Medical Studies, 4th year
Reena Nadpara Reena Nadpara's FDA Experience October 2013 - November 2013
Job PostDoctoral Fellow, Regulatory Affairs at Allergan, formerly Actavis plc
Industry Pharmaceuticals
Experience
Allergan June 2014 - Present
St. John's University June 2014 - Present
Boyt Drug Store August 2014 - Present
Boyt Drug Store March 2010 - August 2014
FDA October 2013 - November 2013
Tricore Interactive May 2011 - November 2012
NJ Center for Biomaterials January 2011 - August 2012
Novartis May 2012 - July 2012
Skills
Research, Medical Writing, Pharmaceuticals, Pharmaceutics, Pharmaceutical Industry, Clinical Trials, Pharmacy, Clinical Research, Pharmacovigilance, Pharmacists, Infectious Diseases, Medicine, Hospitals, Pediatrics, Healthcare, Oncology, Regulatory Affairs
Education
Rutgers, The State University of New Jersey-New Brunswick 2008 — 2014
Pharm.D., Pharmacy
Allergan June 2014 - Present
St. John's University June 2014 - Present
Boyt Drug Store August 2014 - Present
Boyt Drug Store March 2010 - August 2014
FDA October 2013 - November 2013
Tricore Interactive May 2011 - November 2012
NJ Center for Biomaterials January 2011 - August 2012
Novartis May 2012 - July 2012
Skills
Research, Medical Writing, Pharmaceuticals, Pharmaceutics, Pharmaceutical Industry, Clinical Trials, Pharmacy, Clinical Research, Pharmacovigilance, Pharmacists, Infectious Diseases, Medicine, Hospitals, Pediatrics, Healthcare, Oncology, Regulatory Affairs
Education
Rutgers, The State University of New Jersey-New Brunswick 2008 — 2014
Pharm.D., Pharmacy
Agnes Hong Agnes Hong's FDA Experience January 2014 - February 2014
Job Rutgers PostDoctoral Fellow at Pfizer Inc.
Industry Pharmaceuticals
Experience
Pfizer January 2015 - Present
Pfizer Consumer Healthcare June 2014 - Present
Rutgers University June 2014 - Present
Hackensack University Medical Center March 2014 - May 2014
ShopRite Pharmacy February 2014 - March 2014
FDA January 2014 - February 2014
St. Barnabas Hospital October 2013 - November 2013
Chilton Hospital September 2013 - October 2013
Robert Wood Johnson University Hospital July 2013 - August 2013
CVS Caremark Corporation June 2013 - July 2013
Skills
Pharmacists, Pharmacy, Regulatory Affairs, Pharmacy Automation, Clinical Research, Healthcare, Oncology, Medicine, Community Pharmacy
Education
Rutgers University-New Brunswick 2014 — 2016
Master's Degree, Health Outcomes, Policy and Economics
Rutgers, The State University of New Jersey-New Brunswick 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy
Pfizer January 2015 - Present
Pfizer Consumer Healthcare June 2014 - Present
Rutgers University June 2014 - Present
Hackensack University Medical Center March 2014 - May 2014
ShopRite Pharmacy February 2014 - March 2014
FDA January 2014 - February 2014
St. Barnabas Hospital October 2013 - November 2013
Chilton Hospital September 2013 - October 2013
Robert Wood Johnson University Hospital July 2013 - August 2013
CVS Caremark Corporation June 2013 - July 2013
Skills
Pharmacists, Pharmacy, Regulatory Affairs, Pharmacy Automation, Clinical Research, Healthcare, Oncology, Medicine, Community Pharmacy
Education
Rutgers University-New Brunswick 2014 — 2016
Master's Degree, Health Outcomes, Policy and Economics
Rutgers, The State University of New Jersey-New Brunswick 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy
Natalie King-Lyons Natalie King-Lyons's FDA Experience August 2002 - August 2003
Job Research Assistant Professor at SUNY Buffalo
Industry Higher Education
Experience
SUNY Buffalo September 2003 - Present
FDA August 2002 - August 2003
UC Berkeley January 2001 - May 2002
Skills
Western Blotting, Protein Purification, Tissue Culture, qPCR, RT-PCR, Molecular Biology, Biochemistry, In Vitro, Protein Chemistry, Cell Culture, ELISA, PCR, Microbiology, SDS-PAGE, Cell Biology, Flow Cytometry, Molecular Cloning, Cell, Fluorescence Microscopy, Protein Expression, Purification
Education
SUNY at Buffalo 1993 — 2000
Ph.D., Biochemistry
Rochester Institute of Technology 1989 — 1992
BS, Chemistry
SUNY Buffalo September 2003 - Present
FDA August 2002 - August 2003
UC Berkeley January 2001 - May 2002
Skills
Western Blotting, Protein Purification, Tissue Culture, qPCR, RT-PCR, Molecular Biology, Biochemistry, In Vitro, Protein Chemistry, Cell Culture, ELISA, PCR, Microbiology, SDS-PAGE, Cell Biology, Flow Cytometry, Molecular Cloning, Cell, Fluorescence Microscopy, Protein Expression, Purification
Education
SUNY at Buffalo 1993 — 2000
Ph.D., Biochemistry
Rochester Institute of Technology 1989 — 1992
BS, Chemistry
Salaheldin Hamed Salaheldin Hamed's FDA Experience March 2014 - Present
Job Chemical Engineer at FDA/CDER/OPS
Industry Pharmaceuticals
Experience
FDA March 2014 - Present
FDA February 2012 - March 2014
University at Buffalo, Pharmaceutical Sciences March 2010 - October 2011
Education
Rutgers University-New Brunswick 2003 — 2010
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
FDA March 2014 - Present
FDA February 2012 - March 2014
University at Buffalo, Pharmaceutical Sciences March 2010 - October 2011
Education
Rutgers University-New Brunswick 2003 — 2010
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
Jennifer Piselli Jennifer Piselli's FDA Experience 2014 - Present
Job Biomedical Engineer at FDA
Industry Higher Education
Experience
FDA 2014 - Present
Rensselaer Polytechnic Institute February 2012 - January 2014
Boston Children's Hospital June 2013 - August 2013
Sikorsky Aircraft June 2011 - August 2011
Yale New Haven Hospital March 2010 - May 2010
Independent June 2009 - August 2009
Yale University's Environmental Science Center November 2006 - March 2007
Skills
Microsoft Office, Cell culture, Immunofluorescence, ImageJ, Experimental Design, Cell Culture, Biomedical Engineering, Cell, Biomaterials, Experimentation, Microscopy, Materials Science
Education
Rensselaer Polytechnic Institute 2010 — 2014
B.S. Biomedical Engineering,Minor in Materials Science, Minor in Communications, Biomaterials, Senior Standing
FDA 2014 - Present
Rensselaer Polytechnic Institute February 2012 - January 2014
Boston Children's Hospital June 2013 - August 2013
Sikorsky Aircraft June 2011 - August 2011
Yale New Haven Hospital March 2010 - May 2010
Independent June 2009 - August 2009
Yale University's Environmental Science Center November 2006 - March 2007
Skills
Microsoft Office, Cell culture, Immunofluorescence, ImageJ, Experimental Design, Cell Culture, Biomedical Engineering, Cell, Biomaterials, Experimentation, Microscopy, Materials Science
Education
Rensselaer Polytechnic Institute 2010 — 2014
B.S. Biomedical Engineering,Minor in Materials Science, Minor in Communications, Biomaterials, Senior Standing
Samantha McCormick Samantha McCormick's FDA Experience February 2009 - August 2013
Job CSO/Investigator at FDA DFDT
Industry Security and Investigations
Experience
Marymount University August 2014 - Present
FDA Division of Food Defense Targeting August 2013 - Present
FDA February 2009 - August 2013
Skills
Regulatory Affairs, Public Health, FDA, Microbiology, Epidemiology, Federal Government, Food Safety, Sop, Regulations, Laboratory, Bioterrorism, Compliance, Food Science, Drug Safety, FDA GMP, Quality Assurance, Public Safety, Security, GIS systems, C++, HTML, Java, Policy, Emergency Management, HACCP, Government, Data Analysis, Microsoft Office, Leadership, Policy Analysis, Management, Strategic Planning, Public Speaking, Life Sciences, Research, SOP
Education
Queens College 2009 — 2011
MS, Molecular, Cellular and Developmental Biology
State University of New York College at Old Westbury 2004 — 2008
BS, Biology
Marymount University August 2014 - Present
FDA Division of Food Defense Targeting August 2013 - Present
FDA February 2009 - August 2013
Skills
Regulatory Affairs, Public Health, FDA, Microbiology, Epidemiology, Federal Government, Food Safety, Sop, Regulations, Laboratory, Bioterrorism, Compliance, Food Science, Drug Safety, FDA GMP, Quality Assurance, Public Safety, Security, GIS systems, C++, HTML, Java, Policy, Emergency Management, HACCP, Government, Data Analysis, Microsoft Office, Leadership, Policy Analysis, Management, Strategic Planning, Public Speaking, Life Sciences, Research, SOP
Education
Queens College 2009 — 2011
MS, Molecular, Cellular and Developmental Biology
State University of New York College at Old Westbury 2004 — 2008
BS, Biology
Ashley-Rae Emerson Ashley-Rae Emerson's FDA Experience February 2012 - September 2013
Job Associate Quality Engineer at NeoGraft Technologies, Inc.
Industry Biotechnology
Experience
NeoGraft Technologies, Inc. February 2015 - Present
Pfizer October 2014 - February 2015
Tedor Pharma Inc. March 2014 - September 2014
Dr. Pettengill D.D.S. June 2008 - May 2014
FDA February 2012 - September 2013
CVS Pharmacy May 2007 - September 2007
Skills
Cell Culture, Microbiology, PCR, Biochemistry, Biotechnology, Molecular Biology, Lifesciences, ELISA, Research, Western Blotting, Gel Electrophoresis, Regulatory Affairs, FDA, Cell Biology, DNA extraction, Genetics, Protein Purification, Public Health, Immunology, Infectious Diseases, Life Sciences
Education
Rhode Island College 2006 — 2012
Bachelor of Science (B.S.), Biology/Biological Sciences, General
NeoGraft Technologies, Inc. February 2015 - Present
Pfizer October 2014 - February 2015
Tedor Pharma Inc. March 2014 - September 2014
Dr. Pettengill D.D.S. June 2008 - May 2014
FDA February 2012 - September 2013
CVS Pharmacy May 2007 - September 2007
Skills
Cell Culture, Microbiology, PCR, Biochemistry, Biotechnology, Molecular Biology, Lifesciences, ELISA, Research, Western Blotting, Gel Electrophoresis, Regulatory Affairs, FDA, Cell Biology, DNA extraction, Genetics, Protein Purification, Public Health, Immunology, Infectious Diseases, Life Sciences
Education
Rhode Island College 2006 — 2012
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Ruey Ju PharmD, JD Ruey Ju PharmD, JD's FDA Experience September 2012 - Present
Job General Attorney at FDA
Industry Law Practice
Experience
FDA September 2012 - Present
Walgreens 2006 - July 2014
US Department of Health and Human Services May 2011 - March 2012
DC Office of Attorney General January 2011 - May 2011
Department of Justice September 2010 - November 2010
Schering-Plough Research Institute June 2008 - August 2009
AstraZeneca May 2004 - August 2004
Skills
Foreign Languages, mandarin, Litigation, Legal Writing, Mandarin, Legal Research, Research, Pharmaceutical Industry, Government
Education
The George Washington University Law School 2009 — 2012
J.D., Law
Rutgers University-New Brunswick 2000 — 2006
Doctor of Pharmacy, Pharmacy
FDA September 2012 - Present
Walgreens 2006 - July 2014
US Department of Health and Human Services May 2011 - March 2012
DC Office of Attorney General January 2011 - May 2011
Department of Justice September 2010 - November 2010
Schering-Plough Research Institute June 2008 - August 2009
AstraZeneca May 2004 - August 2004
Skills
Foreign Languages, mandarin, Litigation, Legal Writing, Mandarin, Legal Research, Research, Pharmaceutical Industry, Government
Education
The George Washington University Law School 2009 — 2012
J.D., Law
Rutgers University-New Brunswick 2000 — 2006
Doctor of Pharmacy, Pharmacy
David Scarpetti David Scarpetti's FDA Experience 1994 - 1998
Job Scientific Information Analyst at Chemical Abstracts Service
Industry Information Technology and Services
Experience
Chemical Abstracts Service 2000 - Present
Guilford Pharmaceuticals 1998 - 2000
FDA 1994 - 1998
Abbott Laboratories 1991 - 1994
Skills
Searching all files on..., Intellectual Property, GMP, Patent Searching, Data Curation, Active Pharmaceutical..., Quality Assurance, Patent Applications, Organic Chemistry
Education
Purdue University 1986 — 1991
Ph.D., Organic Chemistry
University of Massachusetts Boston 1981 — 1986
B.S., Chemistry
Chemical Abstracts Service 2000 - Present
Guilford Pharmaceuticals 1998 - 2000
FDA 1994 - 1998
Abbott Laboratories 1991 - 1994
Skills
Searching all files on..., Intellectual Property, GMP, Patent Searching, Data Curation, Active Pharmaceutical..., Quality Assurance, Patent Applications, Organic Chemistry
Education
Purdue University 1986 — 1991
Ph.D., Organic Chemistry
University of Massachusetts Boston 1981 — 1986
B.S., Chemistry
Samantha Llanos, PharmD's FDA Experience April 2010 - April 2010
Job Medical Science Liaison at Onyx Pharmaceuticals, an Amgen subsidiary
Industry Pharmaceuticals
Experience
Onyx Pharmaceuticals June 2014 - Present
Sanofi November 2012 - June 2014
Massachusetts College of Pharmacy and Health Sciences July 2010 - June 2014
Genzyme June 2012 - November 2012
Genzyme July 2010 - June 2012
FDA April 2010 - April 2010
CVS Pharmacy September 2006 - December 2009
Integrated Communications July 2009 - August 2009
Skills
Oncology, Medical Affairs, Medical Education, Pharmaceutical Industry, Medical Writing, Scientific..., Cardiovascular Disease, Medicine, Biopharmaceuticals, Transplant, Pharmacists, Drug Development, Endocrinology, Clinical Trials, Clinical Development, Pharmacy, Biotechnology, Medical Communications, Advisory Boards, Hematology, Clinical Pharmacology, Publication Planning, FDA
Education
Rutgers, The State University of New Jersey-New Brunswick 2004 — 2010
Pharm.D., Pharmacy
Onyx Pharmaceuticals June 2014 - Present
Sanofi November 2012 - June 2014
Massachusetts College of Pharmacy and Health Sciences July 2010 - June 2014
Genzyme June 2012 - November 2012
Genzyme July 2010 - June 2012
FDA April 2010 - April 2010
CVS Pharmacy September 2006 - December 2009
Integrated Communications July 2009 - August 2009
Skills
Oncology, Medical Affairs, Medical Education, Pharmaceutical Industry, Medical Writing, Scientific..., Cardiovascular Disease, Medicine, Biopharmaceuticals, Transplant, Pharmacists, Drug Development, Endocrinology, Clinical Trials, Clinical Development, Pharmacy, Biotechnology, Medical Communications, Advisory Boards, Hematology, Clinical Pharmacology, Publication Planning, FDA
Education
Rutgers, The State University of New Jersey-New Brunswick 2004 — 2010
Pharm.D., Pharmacy
Lisa Simone's FDA Experience December 2014 - Present
Job Software Review and Policy at FDA
Industry Medical Devices
Experience
FDA December 2014 - Present
FDA August 2010 - December 2014
Consultant for DoD January 2010 - February 2010
Danaher June 2009 - December 2009
Simone Concepts LLC January 2005 - June 2009
New Jersey Institute of Technology February 2006 - September 2008
Spadix Technologies Inc September 1995 - January 2008
The Kessler Foundation Research Center March 2003 - February 2006
Motorola 1998 - 2003
Lucent Technologies August 1996 - November 1998
Skills
Medical Devices, FDA, Risk Management, Software policy, Root Cause Analysis, Mobile Devices, Recalls, Product Development, Quality System, Home Healthcare, Biomedical Engineering, Regulatory Guidance, Software Development, Systems Engineering, Cross-functional Team..., Embedded Systems, R&D, System Architecture, Technical Writing, Public Speaking, Testing, Management, Embedded Software, Signal Processing, Leadership
Education
University of Pennsylvania - The Wharton School 2001 — 2004
MS Management of Technology
Rutgers University-New Brunswick 1988 — 1994
Ph.D.
Rutgers University-New Brunswick 1988 — 1992
MS
FDA December 2014 - Present
FDA August 2010 - December 2014
Consultant for DoD January 2010 - February 2010
Danaher June 2009 - December 2009
Simone Concepts LLC January 2005 - June 2009
New Jersey Institute of Technology February 2006 - September 2008
Spadix Technologies Inc September 1995 - January 2008
The Kessler Foundation Research Center March 2003 - February 2006
Motorola 1998 - 2003
Lucent Technologies August 1996 - November 1998
Skills
Medical Devices, FDA, Risk Management, Software policy, Root Cause Analysis, Mobile Devices, Recalls, Product Development, Quality System, Home Healthcare, Biomedical Engineering, Regulatory Guidance, Software Development, Systems Engineering, Cross-functional Team..., Embedded Systems, R&D, System Architecture, Technical Writing, Public Speaking, Testing, Management, Embedded Software, Signal Processing, Leadership
Education
University of Pennsylvania - The Wharton School 2001 — 2004
MS Management of Technology
Rutgers University-New Brunswick 1988 — 1994
Ph.D.
Rutgers University-New Brunswick 1988 — 1992
MS
Amber Chen Amber Chen's FDA Experience November 2014 - December 2014
Job Medical Writer at Ross Medical
Industry Pharmaceuticals
Experience
Ross Medical Corporation June 2014 - Present
Dougherty's Pharmacy, Inc. March 2015 - May 2015
Target February 2015 - March 2015
FDA November 2014 - December 2014
Children's Specialized Hospital October 2014 - November 2014
Robert Wood Johnson University Hospital September 2014 - October 2014
University Medical Center of Princeton at Plainsboro August 2014 - September 2014
Pharmcare USA June 2014 - July 2014
princeton house behvioral health center May 2014 - June 2014
Novartis May 2013 - August 2013
Skills
Word, PowerPoint, Excel, Fluent in Mandarin..., Reference Manager 12, Data Entry, Prescription, Healthcare, Microsoft Excel, Microsoft Office, Pharmacy, Research, Customer Service, Microsoft Word, Medical Writing, Clinical Research, Diabetes, Pharmacists
Education
Rutgers University-New Brunswick 2009 — 2015
Doctor of Pharmacy (Pharm.D.), Pharmacy
Rutgers, The State University of New Jersey-New Brunswick 2009 — 2015
Doctor of Pharmacy (Pharm.D.)
Ross Medical Corporation June 2014 - Present
Dougherty's Pharmacy, Inc. March 2015 - May 2015
Target February 2015 - March 2015
FDA November 2014 - December 2014
Children's Specialized Hospital October 2014 - November 2014
Robert Wood Johnson University Hospital September 2014 - October 2014
University Medical Center of Princeton at Plainsboro August 2014 - September 2014
Pharmcare USA June 2014 - July 2014
princeton house behvioral health center May 2014 - June 2014
Novartis May 2013 - August 2013
Skills
Word, PowerPoint, Excel, Fluent in Mandarin..., Reference Manager 12, Data Entry, Prescription, Healthcare, Microsoft Excel, Microsoft Office, Pharmacy, Research, Customer Service, Microsoft Word, Medical Writing, Clinical Research, Diabetes, Pharmacists
Education
Rutgers University-New Brunswick 2009 — 2015
Doctor of Pharmacy (Pharm.D.), Pharmacy
Rutgers, The State University of New Jersey-New Brunswick 2009 — 2015
Doctor of Pharmacy (Pharm.D.)
Deborah B Smith Deborah B Smith's FDA Experience October 1996 - April 2000
Job Manager, Quality Systems at Ethicon, Inc.
Industry Pharmaceuticals
Experience
Ethicon, Inc. December 2013 - Present
International Technidyne Corporation September 2010 - December 2013
Hoffmann-La Roche April 2000 - September 2010
FDA October 1996 - April 2000
Skills
FDA, cGMP, Validation, Quality Systems, Quality Assurance, CAPA, Quality System, V&V, GMP, Pharmaceutical Industry, 21 CFR Part 11, Change Control, Sop, Computer System..., Medical Devices, Manufacturing, Regulatory Requirements, Regulatory Affairs, FMEA, Quality Auditing, ISO 13485, Technology Transfer, GxP, Biotechnology, Cross-functional Team..., Continuous Improvement, Root Cause Analysis, Regulatory Submissions, Quality Management, R&D, Biopharmaceuticals, Quality Control, Lifesciences, Aseptic Processing, Six Sigma, Design Control, LIMS, Internal Audit, Trackwise, ISO, Pharmaceutics, Contract Manufacturing, Minitab, Drug Development, Laboratory, Life Sciences, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick 1991 — 1996
B.A., Economics
John P. Stevens High School
Ethicon, Inc. December 2013 - Present
International Technidyne Corporation September 2010 - December 2013
Hoffmann-La Roche April 2000 - September 2010
FDA October 1996 - April 2000
Skills
FDA, cGMP, Validation, Quality Systems, Quality Assurance, CAPA, Quality System, V&V, GMP, Pharmaceutical Industry, 21 CFR Part 11, Change Control, Sop, Computer System..., Medical Devices, Manufacturing, Regulatory Requirements, Regulatory Affairs, FMEA, Quality Auditing, ISO 13485, Technology Transfer, GxP, Biotechnology, Cross-functional Team..., Continuous Improvement, Root Cause Analysis, Regulatory Submissions, Quality Management, R&D, Biopharmaceuticals, Quality Control, Lifesciences, Aseptic Processing, Six Sigma, Design Control, LIMS, Internal Audit, Trackwise, ISO, Pharmaceutics, Contract Manufacturing, Minitab, Drug Development, Laboratory, Life Sciences, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick 1991 — 1996
B.A., Economics
John P. Stevens High School
Sharon Lappalainen Sharon Lappalainen's FDA Experience August 1990 - December 2012
Job Deputy Director, Standards Management Staff at the Center for Devices and Radiological Health, FDA
Industry Government Administration
Experience
US Department of Health and Human Services January 2012 - Present
FDA August 1990 - December 2012
National Institutes of Health Clinical Center October 1989 - August 1990
Florida Hospital June 1982 - February 1989
Skills
Sailing, Bird Watching, gardening with native..., Travel, Federal Government
Education
Randolph-Macon Woman's College 1978 — 1982
Bachelor of Arts (B.A.), Biology and Medical Technology
Merritt Island High School 1975 — 1978
US Department of Health and Human Services January 2012 - Present
FDA August 1990 - December 2012
National Institutes of Health Clinical Center October 1989 - August 1990
Florida Hospital June 1982 - February 1989
Skills
Sailing, Bird Watching, gardening with native..., Travel, Federal Government
Education
Randolph-Macon Woman's College 1978 — 1982
Bachelor of Arts (B.A.), Biology and Medical Technology
Merritt Island High School 1975 — 1978
Dipti Desai Dipti Desai's FDA Experience February 2014 - March 2014
Job Director of Scientific Affairs at Pharmacy Times Office of Continuing Professional Education
Industry Pharmaceuticals
Experience
Pharmacy Times Office of Continuing Professional Education May 2015 - Present
CVS Health November 2014 - Present
Robert Wood Johnson University Hospital March 2014 - May 2014
FDA February 2014 - March 2014
Hackensack University Medical Center January 2014 - February 2014
CVS Caremark Corporation June 2009 - 2014
Target Pharmacy November 2013 - December 2013
University Medical Center of Princeton at Plainsboro October 2013 - November 2013
NYU Clinical Cancer Center September 2013 - October 2013
Indian Health Services June 2013 - July 2013
Skills
Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel, Hospitals, Customer Service, Pharmacy, Healthcare, Pharmacists, Critical Care, Internal Medicine
Education
Rutgers, The State University of New Jersey-New Brunswick 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy
The Dalton School 2004 — 2008
De La Salle 2001 — 2004
Pharmacy Times Office of Continuing Professional Education May 2015 - Present
CVS Health November 2014 - Present
Robert Wood Johnson University Hospital March 2014 - May 2014
FDA February 2014 - March 2014
Hackensack University Medical Center January 2014 - February 2014
CVS Caremark Corporation June 2009 - 2014
Target Pharmacy November 2013 - December 2013
University Medical Center of Princeton at Plainsboro October 2013 - November 2013
NYU Clinical Cancer Center September 2013 - October 2013
Indian Health Services June 2013 - July 2013
Skills
Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel, Hospitals, Customer Service, Pharmacy, Healthcare, Pharmacists, Critical Care, Internal Medicine
Education
Rutgers, The State University of New Jersey-New Brunswick 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy
The Dalton School 2004 — 2008
De La Salle 2001 — 2004
Blessy George's FDA Experience September 2013 - October 2013
Job PharmD, RPh, Ph.D. Candidate
Industry Higher Education
Experience
Raritan Bay Medical Center July 2015 - Present
Ross Medical Corporation May 2014 - August 2014
Walgreens Pharmacy December 2010 - May 2014
Rutgers University, Pharmacology/Toxicology Lab September 2010 - May 2014
FDA September 2013 - October 2013
Bristol-Myers Squibb June 2012 - July 2012
Rutgers University May 2009 - December 2009
Rutgers University June 2006 - August 2006
Skills
Microsoft Office, Western Blotting, Cell Culture, Pharmacy Practice, AutoCAD, RT-PCR, Photoshop, NMR spectroscopy, ELISA, Cpr Certified, Certified Immunizer, Immunohistochemistry
Education
Rutgers Graduate School of Education 2012 — 2017
Doctor of Philosophy (Ph.D.), Toxicology
Rutgers University-New Brunswick 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy, Summa Cum Laude
Middlesex County Academy for Science Mathematics and Engineering Technologies 2004 — 2008
High School, Civil/Mechanical Engineering, 3.8/4.0
Raritan Bay Medical Center July 2015 - Present
Ross Medical Corporation May 2014 - August 2014
Walgreens Pharmacy December 2010 - May 2014
Rutgers University, Pharmacology/Toxicology Lab September 2010 - May 2014
FDA September 2013 - October 2013
Bristol-Myers Squibb June 2012 - July 2012
Rutgers University May 2009 - December 2009
Rutgers University June 2006 - August 2006
Skills
Microsoft Office, Western Blotting, Cell Culture, Pharmacy Practice, AutoCAD, RT-PCR, Photoshop, NMR spectroscopy, ELISA, Cpr Certified, Certified Immunizer, Immunohistochemistry
Education
Rutgers Graduate School of Education 2012 — 2017
Doctor of Philosophy (Ph.D.), Toxicology
Rutgers University-New Brunswick 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy, Summa Cum Laude
Middlesex County Academy for Science Mathematics and Engineering Technologies 2004 — 2008
High School, Civil/Mechanical Engineering, 3.8/4.0
Tony La Judice Tony La Judice's FDA Experience July 2015 - Present
Job FDA Program Support Specialist
Industry Public Safety
Experience
FDA July 2015 - Present
Education
Regis University
MBA
FDA July 2015 - Present
Education
Regis University
MBA
Ezra Taylor Ezra Taylor's FDA Experience February 2015 - Present
Job Consumer Safety Officer at FDA
Industry Medical Devices
Experience
FDA February 2015 - Present
DarksideCostumes September 2007 - Present
Beacon Policy Advisors LLC March 2014 - January 2015
Mathnasium - The Math Learning Center August 2013 - February 2014
Peace Corps November 2012 - July 2013
Peace Corps September 2010 - November 2012
The Men's Wearhouse, Inc November 2009 - May 2010
Johns Hopkins University August 2008 - May 2009
Johns Hopkins University June 2006 - May 2009
Johns Hopkins University August 2008 - December 2008
Skills
Laboratory, Science, Government, Research, Matlab, Teaching, Community Outreach, Data Analysis, Biomedical Engineering, Clinical Research, SAS, Grant Writing, Medical Devices, Statistics, SPSS, Stata, Public Speaking, International..., Leadership, International Relations, Qualitative Research, Program Management, Global Health, Molecular Biology, Higher Education, Program Evaluation, Analysis, Biotechnology, Critical Thinking, Spanish, Chemistry, Cell Culture, Lifesciences, Program Development
Education
Rensselaer Polytechnic Institute at Hartford 2009 — 2010
MS, Global Enterprise Management
The Johns Hopkins University 2005 — 2009
BS, Biomedical Engineering
FDA February 2015 - Present
DarksideCostumes September 2007 - Present
Beacon Policy Advisors LLC March 2014 - January 2015
Mathnasium - The Math Learning Center August 2013 - February 2014
Peace Corps November 2012 - July 2013
Peace Corps September 2010 - November 2012
The Men's Wearhouse, Inc November 2009 - May 2010
Johns Hopkins University August 2008 - May 2009
Johns Hopkins University June 2006 - May 2009
Johns Hopkins University August 2008 - December 2008
Skills
Laboratory, Science, Government, Research, Matlab, Teaching, Community Outreach, Data Analysis, Biomedical Engineering, Clinical Research, SAS, Grant Writing, Medical Devices, Statistics, SPSS, Stata, Public Speaking, International..., Leadership, International Relations, Qualitative Research, Program Management, Global Health, Molecular Biology, Higher Education, Program Evaluation, Analysis, Biotechnology, Critical Thinking, Spanish, Chemistry, Cell Culture, Lifesciences, Program Development
Education
Rensselaer Polytechnic Institute at Hartford 2009 — 2010
MS, Global Enterprise Management
The Johns Hopkins University 2005 — 2009
BS, Biomedical Engineering
Arthur Bray-Simons Arthur Bray-Simons's FDA Experience March 2014 - 2014
Job Consultant
Industry Public Policy
Experience
Deloitte August 2015 - Present
Leonard D. Schaeffer Center for Health Policy and Economics August 2013 - July 2015
University of Southern California Sol Price School of Public Policy August 2013 - May 2015
Paladin Healthcare Capital LLC June 2014 - August 2014
FDA March 2014 - 2014
Drug Policy Alliance November 2012 - February 2013
USC Brain Project July 2011 - October 2012
Arc Enterprises, LLC. May 2011 - August 2012
BioDistrict New Orleans August 2010 - 2011
New Orleans BioInnovation Center April 2010 - August 2010
Skills
Biotechnology, Lifesciences, Technology Transfer, Bioinformatics, Commercialization, Research, Patents, Market Research, Healthcare, Competitive Analysis, Market Analysis, Intellectual Property, Entrepreneurship, Immunology, Fundraising, Pharmaceutical Industry, Cell Culture, Cell Biology, Biochemistry, Neuroscience, Molecular Biology, Cancer, Program Management, Start-ups, Biomedical Engineering, Policy, Public Policy, Community Outreach, Data Analysis, Economic Development, Statistics, Policy Analysis, Analysis, Qualitative Research, Grant Writing, Life Sciences
Education
University of Southern California 2013 — 2015
Master, Public Policy
Rochester Institute of Technology 2004 — 2008
Bachelor of Science (BS), Biotechnology, art history, philosopy, 3.62
Deloitte August 2015 - Present
Leonard D. Schaeffer Center for Health Policy and Economics August 2013 - July 2015
University of Southern California Sol Price School of Public Policy August 2013 - May 2015
Paladin Healthcare Capital LLC June 2014 - August 2014
FDA March 2014 - 2014
Drug Policy Alliance November 2012 - February 2013
USC Brain Project July 2011 - October 2012
Arc Enterprises, LLC. May 2011 - August 2012
BioDistrict New Orleans August 2010 - 2011
New Orleans BioInnovation Center April 2010 - August 2010
Skills
Biotechnology, Lifesciences, Technology Transfer, Bioinformatics, Commercialization, Research, Patents, Market Research, Healthcare, Competitive Analysis, Market Analysis, Intellectual Property, Entrepreneurship, Immunology, Fundraising, Pharmaceutical Industry, Cell Culture, Cell Biology, Biochemistry, Neuroscience, Molecular Biology, Cancer, Program Management, Start-ups, Biomedical Engineering, Policy, Public Policy, Community Outreach, Data Analysis, Economic Development, Statistics, Policy Analysis, Analysis, Qualitative Research, Grant Writing, Life Sciences
Education
University of Southern California 2013 — 2015
Master, Public Policy
Rochester Institute of Technology 2004 — 2008
Bachelor of Science (BS), Biotechnology, art history, philosopy, 3.62
Emily D'Iorio Emily D'Iorio's FDA Experience June 2015 - Present
Job Health Communication Fellow at FDA
Industry Health, Wellness and Fitness
Experience
FDA June 2015 - Present
Centers for Disease Control and Prevention September 2013 - May 2015
Fulton County Department of Health and Wellness August 2014 - December 2014
Healthy Beginnings System of Care January 2014 - September 2014
Beth Israel Deaconess Medical Center May 2014 - August 2014
Urban Health Initiative January 2014 - May 2014
City of Cambridge May 2013 - September 2013
Roger Williams University January 2013 - June 2013
Roger Williams University January 2013 - May 2013
AmeriCorps May 2012 - September 2012
Skills
Research, Community Outreach, Public Health, Microsoft Office, PowerPoint, Spanish, Microsoft Excel, Public Speaking, Microsoft Word, SPSS, Program Management, Fundraising, Social Media, Event Planning, Facebook, Curriculum Development, Health Program Planning, Program Evaluation, Community Needs...
Education
Emory University Rollins School of Public Health 2013 — 2015
Master of Public Health (M.P.H.), Behavioral Sciences
Roger Williams University 2009 — 2013
Bachelor's degree, Sociology and Anthropology, Psychology, American Sign Language
FDA June 2015 - Present
Centers for Disease Control and Prevention September 2013 - May 2015
Fulton County Department of Health and Wellness August 2014 - December 2014
Healthy Beginnings System of Care January 2014 - September 2014
Beth Israel Deaconess Medical Center May 2014 - August 2014
Urban Health Initiative January 2014 - May 2014
City of Cambridge May 2013 - September 2013
Roger Williams University January 2013 - June 2013
Roger Williams University January 2013 - May 2013
AmeriCorps May 2012 - September 2012
Skills
Research, Community Outreach, Public Health, Microsoft Office, PowerPoint, Spanish, Microsoft Excel, Public Speaking, Microsoft Word, SPSS, Program Management, Fundraising, Social Media, Event Planning, Facebook, Curriculum Development, Health Program Planning, Program Evaluation, Community Needs...
Education
Emory University Rollins School of Public Health 2013 — 2015
Master of Public Health (M.P.H.), Behavioral Sciences
Roger Williams University 2009 — 2013
Bachelor's degree, Sociology and Anthropology, Psychology, American Sign Language
Kiki Janssens Kiki Janssens's FDA Experience May 2007 - January 2008
Job Sales Manager at Coreapps
Industry Events Services
Experience
Association of Women in Events March 2015 - Present
Core-Apps July 2011 - Present
National Confectioners Association January 2010 - July 2011
St. Joseph's University May 2008 - August 2008
FDA May 2007 - January 2008
Skills
Event Planning, Social Media Marketing, Management, Social Networking, Event Management, Fundraising, Social Media, Blogging, Marketing Communications, Sales, Marketing, Sponsorship, Research, Email Marketing
Education
Saint Joseph's University 2005 — 2009
Bachelor of Science, Food Marketing, Fine Arts
Holy Child
Holy Child
Association of Women in Events March 2015 - Present
Core-Apps July 2011 - Present
National Confectioners Association January 2010 - July 2011
St. Joseph's University May 2008 - August 2008
FDA May 2007 - January 2008
Skills
Event Planning, Social Media Marketing, Management, Social Networking, Event Management, Fundraising, Social Media, Blogging, Marketing Communications, Sales, Marketing, Sponsorship, Research, Email Marketing
Education
Saint Joseph's University 2005 — 2009
Bachelor of Science, Food Marketing, Fine Arts
Holy Child
Holy Child
Chenchao Gao Chenchao Gao's FDA Experience June 2015 - September 2015
Job ORISE Fellow at FDA
Industry Pharmaceuticals
Experience
Rutgers University September 2010 - Present
Sino-American Pharmaceutical Professionals Association (SAPA) September 2013 - Present
FDA June 2015 - September 2015
Center for Global Service, Rutgers University March 2014 - September 2014
Rutgers Chinese Student & Scholar Asso. (RCSSA) April 2012 - August 2013
International Student Office @ Rutgers University March 2011 - September 2011
Asian Cultural Association @ Rowan University March 2008 - September 2009
Skills
Molecular Biology, Cell Culture, PCR, Western Blotting, Pharmacology, Leadership, Biochemistry, Cell Biology, Genetics, SDS-PAGE, Microbiology, Gel Electrophoresis, Pharmacokinetics, Data Analysis, Data Collection, Fluorescence Microscopy, Mass Spectrometry, Spectrometer, Operations Management, Interpersonal..., Public Speaking, Research, Microsoft Office
Education
Rutgers, The State University of New Jersey-New Brunswick 2010 — 2015
Doctor of Philosophy (PhD), Pharmacology
Rowan University 2006 — 2010
Bachelor, Biology
Rutgers University-New Brunswick
No-degree, Biostatistics, Probability and Introduction to Biopharmaceutics and Pharmacokinetics
Rutgers University September 2010 - Present
Sino-American Pharmaceutical Professionals Association (SAPA) September 2013 - Present
FDA June 2015 - September 2015
Center for Global Service, Rutgers University March 2014 - September 2014
Rutgers Chinese Student & Scholar Asso. (RCSSA) April 2012 - August 2013
International Student Office @ Rutgers University March 2011 - September 2011
Asian Cultural Association @ Rowan University March 2008 - September 2009
Skills
Molecular Biology, Cell Culture, PCR, Western Blotting, Pharmacology, Leadership, Biochemistry, Cell Biology, Genetics, SDS-PAGE, Microbiology, Gel Electrophoresis, Pharmacokinetics, Data Analysis, Data Collection, Fluorescence Microscopy, Mass Spectrometry, Spectrometer, Operations Management, Interpersonal..., Public Speaking, Research, Microsoft Office
Education
Rutgers, The State University of New Jersey-New Brunswick 2010 — 2015
Doctor of Philosophy (PhD), Pharmacology
Rowan University 2006 — 2010
Bachelor, Biology
Rutgers University-New Brunswick
No-degree, Biostatistics, Probability and Introduction to Biopharmaceutics and Pharmacokinetics
Jessica Yueh Jessica Yueh's FDA Experience February 2013 - March 2013
Job Medical Communications Specialist at Allergan
Industry Pharmaceuticals
Experience
Allergan January 2015 - Present
CVS Health October 2013 - Present
CVS Pharmacy April 2011 - October 2013
Holy Name Medical Center March 2013 - April 2013
FDA February 2013 - March 2013
Walgreens December 2012 - February 2013
Hackensack University Medical Center November 2012 - December 2012
Target October 2012 - November 2012
Hackensack University Medical Center July 2012 - August 2012
ICC Lowe Trio June 2012 - July 2012
Skills
Pharmacy, Pharmacists, Medication Therapy..., Community Pharmacy, Hospitals, Immunization, Medical Writing, Ambulatory Care, Pharmaceutical Industry, Microsoft Office, Cpr Certified, Microsoft Excel, Communication, Healthcare, Medical Terminology, Drug Safety, Clinical Trials
Education
Ernest Mario School of Pharmacy 2007 — 2013
Doctor of Pharmacy (PharmD), Pharmacy
Rutgers University-New Brunswick 2007 — 2013
PharmD, Pharmacy
Allergan January 2015 - Present
CVS Health October 2013 - Present
CVS Pharmacy April 2011 - October 2013
Holy Name Medical Center March 2013 - April 2013
FDA February 2013 - March 2013
Walgreens December 2012 - February 2013
Hackensack University Medical Center November 2012 - December 2012
Target October 2012 - November 2012
Hackensack University Medical Center July 2012 - August 2012
ICC Lowe Trio June 2012 - July 2012
Skills
Pharmacy, Pharmacists, Medication Therapy..., Community Pharmacy, Hospitals, Immunization, Medical Writing, Ambulatory Care, Pharmaceutical Industry, Microsoft Office, Cpr Certified, Microsoft Excel, Communication, Healthcare, Medical Terminology, Drug Safety, Clinical Trials
Education
Ernest Mario School of Pharmacy 2007 — 2013
Doctor of Pharmacy (PharmD), Pharmacy
Rutgers University-New Brunswick 2007 — 2013
PharmD, Pharmacy
Shamir Kalaria's FDA Experience May 2015 - Present
Job ORISE Fellow at Office of Clinical Pharmacology, Division II
Industry Pharmaceuticals
Experience
FDA May 2015 - Present
FDA June 2014 - August 2014
CVS Caremark Corporation May 2010 - May 2014
Novartis June 2013 - August 2013
CDER, U.S. Food and Drug Administration (FDA) June 2012 - May 2013
Skills
Pharmacology, Pharmaceutics, Research, Pharmaceutical Industry, Drug Development, Pharmacy, FDA, In Vivo, Medical Writing, Healthcare, Pharmacists, Laboratory, Clinical Trials, Infectious Diseases, Regulatory Submissions, Regulatory Affairs, Clinical Pharmacology, Clinical Development, Pharmacokinetics, Oncology, Clinical Research
Education
University of Maryland School of Pharmacy 2015 — 2019
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences, Pharmacometrics
Rutgers, The State University of New Jersey-New Brunswick 2009 — 2015
Doctor of Pharmacy (Pharm.D.)
Thomas S. Wootton High School 2005 — 2009
FDA May 2015 - Present
FDA June 2014 - August 2014
CVS Caremark Corporation May 2010 - May 2014
Novartis June 2013 - August 2013
CDER, U.S. Food and Drug Administration (FDA) June 2012 - May 2013
Skills
Pharmacology, Pharmaceutics, Research, Pharmaceutical Industry, Drug Development, Pharmacy, FDA, In Vivo, Medical Writing, Healthcare, Pharmacists, Laboratory, Clinical Trials, Infectious Diseases, Regulatory Submissions, Regulatory Affairs, Clinical Pharmacology, Clinical Development, Pharmacokinetics, Oncology, Clinical Research
Education
University of Maryland School of Pharmacy 2015 — 2019
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences, Pharmacometrics
Rutgers, The State University of New Jersey-New Brunswick 2009 — 2015
Doctor of Pharmacy (Pharm.D.)
Thomas S. Wootton High School 2005 — 2009
David Sing's FDA Experience May 2015 - Present
Job Food and Drug Administration Research Fellow, Spinal Devices
Industry Medical Practice
Experience
FDA May 2015 - Present
VuMedi, Inc 2014 - Present
UCSF July 2014 - June 2015
Harvard Business School January 2015 - January 2015
Nano-3D Biosciences, Inc. July 2009 - July 2011
Mikos Research Group, Rice University June 2008 - June 2011
Skills
Microsoft Office, Labview, Tissue Culture, Regenerative Medicine, Biomaterials, Tissue Engineering, Molecular Biology, Matlab, LabVIEW, Data Analysis, Research, Microsoft Excel, Cell Culture, Analysis, Statistics, Biomedical Engineering
Education
University of California, San Francisco 2011 — 2017
Doctor of Medicine (MD)
Rice University 2007 — 2011
Bachelor of Science (BS), Bioengineering, Summa cum Laude
FDA May 2015 - Present
VuMedi, Inc 2014 - Present
UCSF July 2014 - June 2015
Harvard Business School January 2015 - January 2015
Nano-3D Biosciences, Inc. July 2009 - July 2011
Mikos Research Group, Rice University June 2008 - June 2011
Skills
Microsoft Office, Labview, Tissue Culture, Regenerative Medicine, Biomaterials, Tissue Engineering, Molecular Biology, Matlab, LabVIEW, Data Analysis, Research, Microsoft Excel, Cell Culture, Analysis, Statistics, Biomedical Engineering
Education
University of California, San Francisco 2011 — 2017
Doctor of Medicine (MD)
Rice University 2007 — 2011
Bachelor of Science (BS), Bioengineering, Summa cum Laude
Nicole Goodsell Nicole Goodsell's FDA Experience July 2014 - Present
Job Biomedical Engineer at FDA
Industry Medical Devices
Experience
FDA July 2014 - Present
ZetroZ LLC May 2013 - August 2013
Rensselaer Polytechnic Institute January 2011 - May 2013
Mount Sinai School of Medicine June 2012 - August 2012
Skills
ImageJ, PowerPoint, Cell Culture, Microsoft Office, Labview, Laboratory, Biomaterials, Immunocytochemistry
Education
Rensselaer Polytechnic Institute 2013 — 2014
Master of Engineering (MEng), Biomedical/Medical Engineering
Rensselaer Polytechnic Institute 2009 — 2013
Bachelor of Science (B.S.), Biomedical/Medical Engineering
FDA July 2014 - Present
ZetroZ LLC May 2013 - August 2013
Rensselaer Polytechnic Institute January 2011 - May 2013
Mount Sinai School of Medicine June 2012 - August 2012
Skills
ImageJ, PowerPoint, Cell Culture, Microsoft Office, Labview, Laboratory, Biomaterials, Immunocytochemistry
Education
Rensselaer Polytechnic Institute 2013 — 2014
Master of Engineering (MEng), Biomedical/Medical Engineering
Rensselaer Polytechnic Institute 2009 — 2013
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Jasminder Kumar's FDA Experience November 2014 - Present
Job Risk Management Analyst at FDA
Industry Pharmaceuticals
Experience
FDA November 2014 - Present
Quick Chek Pharmacy September 2013 - Present
BGB Group July 2014 - August 2014
Horizon Blue Cross Blue Shield of New Jersey July 2013 - June 2014
CVS Caremark Corporation June 2007 - July 2013
BGB New York April 2013 - June 2013
Children's Specialized Hospital March 2013 - April 2013
Walgreens February 2013 - March 2013
Quick Chek Pharmacy January 2013 - February 2013
RevHealth December 2012 - December 2012
Skills
Pharmacy, Pharmacists, Pharmaceutical Industry, Certified Immunizer, Community Pharmacy, Hospital Pharmacy, Managed Care, Clinical Research, Patient Counseling, Medical Writing, Medication Therapy...
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2013
Pharm.D, Pharmacy
FDA November 2014 - Present
Quick Chek Pharmacy September 2013 - Present
BGB Group July 2014 - August 2014
Horizon Blue Cross Blue Shield of New Jersey July 2013 - June 2014
CVS Caremark Corporation June 2007 - July 2013
BGB New York April 2013 - June 2013
Children's Specialized Hospital March 2013 - April 2013
Walgreens February 2013 - March 2013
Quick Chek Pharmacy January 2013 - February 2013
RevHealth December 2012 - December 2012
Skills
Pharmacy, Pharmacists, Pharmaceutical Industry, Certified Immunizer, Community Pharmacy, Hospital Pharmacy, Managed Care, Clinical Research, Patient Counseling, Medical Writing, Medication Therapy...
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2013
Pharm.D, Pharmacy
Maarika (Liivak) Kimbrell Maarika (Liivak) Kimbrell's FDA Experience September 2014 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA September 2014 - Present
Covington & Burling July 2005 - August 2014
Morrison & Foerster LLP October 2003 - June 2005
The National Academies January 2000 - July 2000
Skills
Intellectual Property, Licensing, Corporate Law, Technology Transfer, Lifesciences
Education
Yale Law School 2000 — 2003
Doctor of Law (JD)
Yale University 1998 — 2000
Master of Science (MS), Genetics
Rutgers University 1994 — 1998
Bachelor of Arts (BA), Biochemistry and Molecular Biology
FDA September 2014 - Present
Covington & Burling July 2005 - August 2014
Morrison & Foerster LLP October 2003 - June 2005
The National Academies January 2000 - July 2000
Skills
Intellectual Property, Licensing, Corporate Law, Technology Transfer, Lifesciences
Education
Yale Law School 2000 — 2003
Doctor of Law (JD)
Yale University 1998 — 2000
Master of Science (MS), Genetics
Rutgers University 1994 — 1998
Bachelor of Arts (BA), Biochemistry and Molecular Biology
Karen Potocki Karen Potocki's FDA Experience April 2009 - Present
Job Management Analyst at FDA
Industry Government Administration
Experience
FDA April 2009 - Present
CYLOGIX INFORMATION TECHNOLOGIES, Inc. 1998 - 2009
Skills
Business Analysis
Education
Rutgers University-New Brunswick 1973 — 1977
BA, Economics
Lawrence High School 1971 — 1973
FDA April 2009 - Present
CYLOGIX INFORMATION TECHNOLOGIES, Inc. 1998 - 2009
Skills
Business Analysis
Education
Rutgers University-New Brunswick 1973 — 1977
BA, Economics
Lawrence High School 1971 — 1973
Robert Langsner Robert Langsner's FDA Experience July 2011 - September 2011
Job Chief Systems Architect at Abbott Diagnostics Division
Industry Medical Devices
Experience
Abbott Diagnostics Division March 2015 - Present
Abbott Diagnostics Division November 2013 - March 2015
Abbott Diagnostics July 2013 - November 2013
Rice University April 2013 - June 2013
Alpha Dev, LLC January 2012 - June 2013
University of Texas M.D. Anderson Cancer Center August 2009 - April 2013
Rice University May 2008 - April 2013
FDA July 2011 - September 2011
Procyrion, Inc. April 2011 - June 2011
Valhalla March 2009 - March 2010
Skills
Biotechnology, Nanotechnology, Cell Culture, Microsoft Office, Matlab, Immunohistochemistry, Confocal Microscopy, Biomedical Engineering, Fluorescence Microscopy
Education
Rice University 2008 — 2013
PhD, Bioengineering
University of California, San Diego 2003 — 2007
B.S., Bioengineering: (Biotechnology)
Reno High School
Abbott Diagnostics Division March 2015 - Present
Abbott Diagnostics Division November 2013 - March 2015
Abbott Diagnostics July 2013 - November 2013
Rice University April 2013 - June 2013
Alpha Dev, LLC January 2012 - June 2013
University of Texas M.D. Anderson Cancer Center August 2009 - April 2013
Rice University May 2008 - April 2013
FDA July 2011 - September 2011
Procyrion, Inc. April 2011 - June 2011
Valhalla March 2009 - March 2010
Skills
Biotechnology, Nanotechnology, Cell Culture, Microsoft Office, Matlab, Immunohistochemistry, Confocal Microscopy, Biomedical Engineering, Fluorescence Microscopy
Education
Rice University 2008 — 2013
PhD, Bioengineering
University of California, San Diego 2003 — 2007
B.S., Bioengineering: (Biotechnology)
Reno High School
Bradford Perry Bradford Perry's FDA Experience 2009 - 2009
Job Senior Manager of Regulatory Affairs at Pacira Pharmaceuticals
Industry Pharmaceuticals
Experience
Parsippany Rescue and Recovery August 2015 - Present
Denville Fire Department June 2014 - Present
Pacira Pharmaceuticals, Inc. June 2015 - Present
Pacira Pharmaceuticals, Inc. August 2013 - June 2015
Eli Lilly June 2009 - August 2013
CVS Caremark Corporation April 2010 - February 2012
Pathmark Stores, Inc. August 2008 - April 2009
FDA 2009 - 2009
Novartis June 2007 - August 2007
Schering-Plough June 2006 - August 2006
Skills
Regulatory Affairs, Pharmacists, Oncology, eFiles, eCTD, RAPS, Eagle Scout, Regulatory Requirements, Regulatory Submissions, Regulatory Strategy..., Clinical Development, Pharmacy, Pharmacy Benefit..., Medication Therapy..., Medical Writing, Pharmacovigilance, Pharmaceutics, Pharmacology, Medical Affairs, Pharmaceutical Industry, Clinical Trials, IND, Drug Development, Clinical Pharmacology
Education
Rutgers University-New Brunswick 2003 — 2009
Pharm.D., Pharmacy
Parsippany Rescue and Recovery August 2015 - Present
Denville Fire Department June 2014 - Present
Pacira Pharmaceuticals, Inc. June 2015 - Present
Pacira Pharmaceuticals, Inc. August 2013 - June 2015
Eli Lilly June 2009 - August 2013
CVS Caremark Corporation April 2010 - February 2012
Pathmark Stores, Inc. August 2008 - April 2009
FDA 2009 - 2009
Novartis June 2007 - August 2007
Schering-Plough June 2006 - August 2006
Skills
Regulatory Affairs, Pharmacists, Oncology, eFiles, eCTD, RAPS, Eagle Scout, Regulatory Requirements, Regulatory Submissions, Regulatory Strategy..., Clinical Development, Pharmacy, Pharmacy Benefit..., Medication Therapy..., Medical Writing, Pharmacovigilance, Pharmaceutics, Pharmacology, Medical Affairs, Pharmaceutical Industry, Clinical Trials, IND, Drug Development, Clinical Pharmacology
Education
Rutgers University-New Brunswick 2003 — 2009
Pharm.D., Pharmacy
Pat McNally's FDA Experience 1987 - 1987
Job Site Quality Director at Mallinckrodt Pharmaceuticals
Industry Pharmaceuticals
Experience
Mallinckrodt Pharmaceuticals February 2015 - Present
Padraig Consulting LLC January 2006 - Present
QS Pharma March 2014 - February 2015
Alliance Contract Pharma, LLC March 2008 - September 2013
Elan March 2006 - October 2007
PMRS November 1994 - February 2006
Ohmeda, PPD 1994 - 1994
Greenwich Pharmaceuticals, Inc 1992 - 1994
Rhone-Poulenc Rorer 1988 - 1992
FDA 1987 - 1987
Skills
Pharmaceutical Industry, GMP, FDA, 21 CFR Part 11, Quality Assurance, Computer System..., Cleaning Validation, Operations Management, Technology Transfer, Change Control, GLP, GxP, Pharmaceutics, Regulatory Affairs, Continuous Improvement, Quality Management, Sop, Validation, Clinical Development, CAPA, V&V, Quality System, Medical Devices, Biotechnology, Manufacturing, Biopharmaceuticals, Drug Development, Contract Manufacturing, Regulatory Requirements, GCP, CRO, Formulation, Regulatory Submissions, Laboratory, CTMS, SOP
Education
Temple University 1991 — 1994
MBA, Operations Management
Rutgers University – Camden 1982 — 1986
BA, Biology
Mallinckrodt Pharmaceuticals February 2015 - Present
Padraig Consulting LLC January 2006 - Present
QS Pharma March 2014 - February 2015
Alliance Contract Pharma, LLC March 2008 - September 2013
Elan March 2006 - October 2007
PMRS November 1994 - February 2006
Ohmeda, PPD 1994 - 1994
Greenwich Pharmaceuticals, Inc 1992 - 1994
Rhone-Poulenc Rorer 1988 - 1992
FDA 1987 - 1987
Skills
Pharmaceutical Industry, GMP, FDA, 21 CFR Part 11, Quality Assurance, Computer System..., Cleaning Validation, Operations Management, Technology Transfer, Change Control, GLP, GxP, Pharmaceutics, Regulatory Affairs, Continuous Improvement, Quality Management, Sop, Validation, Clinical Development, CAPA, V&V, Quality System, Medical Devices, Biotechnology, Manufacturing, Biopharmaceuticals, Drug Development, Contract Manufacturing, Regulatory Requirements, GCP, CRO, Formulation, Regulatory Submissions, Laboratory, CTMS, SOP
Education
Temple University 1991 — 1994
MBA, Operations Management
Rutgers University – Camden 1982 — 1986
BA, Biology
Agnes Kivuvani's FDA Experience June 2006 - Present
Job Project Manager
Industry Health, Wellness and Fitness
Experience
FDA June 2006 - Present
FDA October 2003 - Present
Verizon March 1995 - April 2001
MCI Corporation November 1987 - June 1995
Skills
Project Management, Marketing Strategy, Entrepreneurship, Social Media Marketing, Public Speaking, Strategic Planning, Project Planning, Blogging, Social Media, Program Management, Social Networking, Policy, Leadership, Customer Service, Event Planning, Training, SEO, Team Building, Online Advertising, Coaching, Marketing, Research, Nonprofits, Online Marketing, Microsoft Office, Facebook, Management, Analysis, Small Business, Public Relations, Non-profits, Community Outreach, Team Leadership, Leadership Development, Software Documentation, Business Strategy, Change Management, Fundraising, Business Analysis, Email Marketing, Management Consulting, Government, Budgets, Marketing Communications, Organizational..., Event Management, Start-ups, Strategy, Proposal Writing
Education
Ramapo College of New Jersey 1980 — 1983
Bachelor of Science (BSc), Business Administration and Management, General
FDA June 2006 - Present
FDA October 2003 - Present
Verizon March 1995 - April 2001
MCI Corporation November 1987 - June 1995
Skills
Project Management, Marketing Strategy, Entrepreneurship, Social Media Marketing, Public Speaking, Strategic Planning, Project Planning, Blogging, Social Media, Program Management, Social Networking, Policy, Leadership, Customer Service, Event Planning, Training, SEO, Team Building, Online Advertising, Coaching, Marketing, Research, Nonprofits, Online Marketing, Microsoft Office, Facebook, Management, Analysis, Small Business, Public Relations, Non-profits, Community Outreach, Team Leadership, Leadership Development, Software Documentation, Business Strategy, Change Management, Fundraising, Business Analysis, Email Marketing, Management Consulting, Government, Budgets, Marketing Communications, Organizational..., Event Management, Start-ups, Strategy, Proposal Writing
Education
Ramapo College of New Jersey 1980 — 1983
Bachelor of Science (BSc), Business Administration and Management, General
Jismi Johnson's FDA Experience January 2015 - Present
Job Regulatory Advisor at FDA
Industry Government Administration
Experience
FDA January 2015 - Present
Food and Drug Administration August 2006 - December 2014
Rehabilitation Institute of Chicago May 2005 - July 2005
Stryker Orthopaedics September 2004 - January 2005
National Aeronautics and Space Administration May 2004 - August 2004
Wadsworth Center, NYS Department of Health June 2003 - July 2003
Education
The Johns Hopkins University 2007 — 2009
MS, Applied Biomedical Engineering
Rensselaer Polytechnic Institute 2002 — 2006
BS, Biomedical Engineering
FDA January 2015 - Present
Food and Drug Administration August 2006 - December 2014
Rehabilitation Institute of Chicago May 2005 - July 2005
Stryker Orthopaedics September 2004 - January 2005
National Aeronautics and Space Administration May 2004 - August 2004
Wadsworth Center, NYS Department of Health June 2003 - July 2003
Education
The Johns Hopkins University 2007 — 2009
MS, Applied Biomedical Engineering
Rensselaer Polytechnic Institute 2002 — 2006
BS, Biomedical Engineering
Katelin Mao's FDA Experience January 2010 - Present
Job Regulatory Scientist/Microbiologist at FDA
Industry Government Administration
Experience
FDA January 2010 - Present
KPL, Inc July 2004 - January 2010
Skills
Microbiology, R&D, Manufacturing, Biotechnology, Lifesciences, ELISA, Molecular Biology, GMP, GLP, Life Sciences, Protein Chemistry, PCR, SOP
Education
Purdue University
Ph.D., Microbiology, Moleular Biology
FDA January 2010 - Present
KPL, Inc July 2004 - January 2010
Skills
Microbiology, R&D, Manufacturing, Biotechnology, Lifesciences, ELISA, Molecular Biology, GMP, GLP, Life Sciences, Protein Chemistry, PCR, SOP
Education
Purdue University
Ph.D., Microbiology, Moleular Biology
Brian Chiu's FDA Experience May 2008 - Present
Job Toxicologist at FDA
Industry Government Administration
Experience
FDA May 2008 - Present
Memorial Sloan-Kettering Cancer Center August 2003 - May 2008
Skills
Toxicology, In Vivo, Pharmacology, Drug Development, Molecular Biology, Lifesciences, In Vitro, Immunology, Animal Models, qPCR, Biomarkers, Assay Development, Western Blotting, ELISA, Pharmacokinetics, Cell Culture, Cell, Flow Cytometry, Life Sciences
Education
Rutgers, The State University of New Jersey/University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School 1996 — 2003
Ph.D., Pharmacology and Toxicology
Rutgers University-New Brunswick 1991 — 1996
B.A., Molecular Biology and Biochemistry
FDA May 2008 - Present
Memorial Sloan-Kettering Cancer Center August 2003 - May 2008
Skills
Toxicology, In Vivo, Pharmacology, Drug Development, Molecular Biology, Lifesciences, In Vitro, Immunology, Animal Models, qPCR, Biomarkers, Assay Development, Western Blotting, ELISA, Pharmacokinetics, Cell Culture, Cell, Flow Cytometry, Life Sciences
Education
Rutgers, The State University of New Jersey/University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School 1996 — 2003
Ph.D., Pharmacology and Toxicology
Rutgers University-New Brunswick 1991 — 1996
B.A., Molecular Biology and Biochemistry
Molly Ray, MT(ASCP)SBB, CSQE(ASQ)'s FDA Experience September 1995 - April 1999
Job Partner/Consultant at SoftwareCPR
Industry Computer Software
Experience
SoftwareCPR March 2004 - Present
SoftwareCPR March 2004 - Present
American Red Cross October 2002 - March 2004
Electronic Data Systems 2000 - 2002
Department of Veterans Affairs April 1999 - May 2000
FDA September 1995 - April 1999
VA Blood Bank 1976 - 1978
Skills
Medical Devices, Quality Management, 21 CFR Part 11, CAPA, Quality Assurance, Quality Auditing, FDA, Preparing FDA..., Quality System, GMP, Testing, Validation, Change Control, Process Improvement, Regulatory Requirements, Management, FMEA, Design Control, Software Quality..., Biomedical Engineering, Computer System..., R&D, Manufacturing, ISO, V&V, ISO 13485, Process Simulation, Sop, Biotechnology, Regulatory Affairs, Quality Control, Commercialization, Lifesciences, GxP, Iso 9000, Regulatory Submissions, Root Cause Analysis, Pharmaceutical Industry, Hardware Diagnostics, Product Launch, Six Sigma, Cross-functional Team..., Clinical Research, Software Documentation, Process Engineering, Auditing, Requirements Management, Complaint Management, Biopharmaceuticals, ISO 14971
Education
Virginia Commonwealth University 1974 — 1975
SBB, Immunohematology
Virginia Commonwealth University 1972 — 1973
BS, Medical Technology
Radford University 1966 — 1970
BS, General Science
SoftwareCPR March 2004 - Present
SoftwareCPR March 2004 - Present
American Red Cross October 2002 - March 2004
Electronic Data Systems 2000 - 2002
Department of Veterans Affairs April 1999 - May 2000
FDA September 1995 - April 1999
VA Blood Bank 1976 - 1978
Skills
Medical Devices, Quality Management, 21 CFR Part 11, CAPA, Quality Assurance, Quality Auditing, FDA, Preparing FDA..., Quality System, GMP, Testing, Validation, Change Control, Process Improvement, Regulatory Requirements, Management, FMEA, Design Control, Software Quality..., Biomedical Engineering, Computer System..., R&D, Manufacturing, ISO, V&V, ISO 13485, Process Simulation, Sop, Biotechnology, Regulatory Affairs, Quality Control, Commercialization, Lifesciences, GxP, Iso 9000, Regulatory Submissions, Root Cause Analysis, Pharmaceutical Industry, Hardware Diagnostics, Product Launch, Six Sigma, Cross-functional Team..., Clinical Research, Software Documentation, Process Engineering, Auditing, Requirements Management, Complaint Management, Biopharmaceuticals, ISO 14971
Education
Virginia Commonwealth University 1974 — 1975
SBB, Immunohematology
Virginia Commonwealth University 1972 — 1973
BS, Medical Technology
Radford University 1966 — 1970
BS, General Science
Larry Lazarus's FDA Experience December 2012 - June 2013
Job Budget Branch Chief, Office of the Chief Information Officer at US Department of Homeland Security
Industry Government Administration
Experience
US Department of Homeland Security May 2014 - Present
International Exchange Program-- New Zealand September 2013 - February 2014
FDA December 2012 - June 2013
US Department of Homeland Security April 2011 - December 2012
US Department of Homeland Security June 2009 - April 2011
US Department of Homeland Security October 2006 - June 2009
US Department of Homeland Security September 2005 - October 2006
FDA June 2003 - September 2005
Skills
Budgets, Federal Government, Policy Analysis, Security Clearance, Government, Program Management, Strategic Planning, Policy, Project Planning
Education
Rutgers University, Bloustein School of Planning and Public Policy 2001 — 2003
Master of Public Policy, Concentration: Science & Technology Policy
Rutgers, The State University of New Jersey-New Brunswick 1997 — 2001
BA, Political Science
US Department of Homeland Security May 2014 - Present
International Exchange Program-- New Zealand September 2013 - February 2014
FDA December 2012 - June 2013
US Department of Homeland Security April 2011 - December 2012
US Department of Homeland Security June 2009 - April 2011
US Department of Homeland Security October 2006 - June 2009
US Department of Homeland Security September 2005 - October 2006
FDA June 2003 - September 2005
Skills
Budgets, Federal Government, Policy Analysis, Security Clearance, Government, Program Management, Strategic Planning, Policy, Project Planning
Education
Rutgers University, Bloustein School of Planning and Public Policy 2001 — 2003
Master of Public Policy, Concentration: Science & Technology Policy
Rutgers, The State University of New Jersey-New Brunswick 1997 — 2001
BA, Political Science
Nikhil Thakur's FDA Experience November 2010 - Present
Job Regulatory Policy Advisor at FDA
Industry Medical Devices
Experience
FDA November 2010 - Present
FDA November 2009 - Present
Food and Drug Administration July 2003 - October 2009
Washington Group International August 1998 - September 2001
Education
Rutgers University-New Brunswick 1994 — 1998
FDA November 2010 - Present
FDA November 2009 - Present
Food and Drug Administration July 2003 - October 2009
Washington Group International August 1998 - September 2001
Education
Rutgers University-New Brunswick 1994 — 1998
Brian Orrison's FDA Experience June 2003 - April 2006
Job Regional Account Manager at Getinge USA, Inc
Industry Biotechnology
Experience
Getinge USA, Inc March 2013 - Present
Rees Scientific Corp April 2006 - March 2013
FDA June 2003 - April 2006
Skills
Direct Sales, Microsoft Office, Team Building, Solution Selling, Customer Service, Project Management, Sales Process, Cold Calling, Marketing Strategy, Cross-functional Team..., Program Management, Sales Management, Management
Education
Salisbury University 1998 — 2002
Bachelor's degree, Biology, General
University of Maryland Eastern Shore 1998 — 2002
Bachelor's degree, Environmental Science
Getinge USA, Inc March 2013 - Present
Rees Scientific Corp April 2006 - March 2013
FDA June 2003 - April 2006
Skills
Direct Sales, Microsoft Office, Team Building, Solution Selling, Customer Service, Project Management, Sales Process, Cold Calling, Marketing Strategy, Cross-functional Team..., Program Management, Sales Management, Management
Education
Salisbury University 1998 — 2002
Bachelor's degree, Biology, General
University of Maryland Eastern Shore 1998 — 2002
Bachelor's degree, Environmental Science
Lisa Lineberger's FDA Experience October 2010 - Present
Job Regulatory Counsel at FDA
Industry Research
Experience
FDA October 2010 - Present
The MayaTech Corporation April 1999 - September 2010
National Association of Surety Bond Producers 1990 - 1999
National Association of Surety Bond Producers 1990 - 1999
Skills
Policy Analysis, Public Policy, Public Health
Education
Salisbury University 1984 — 1988
Triton 1980 — 1984
FDA October 2010 - Present
The MayaTech Corporation April 1999 - September 2010
National Association of Surety Bond Producers 1990 - 1999
National Association of Surety Bond Producers 1990 - 1999
Skills
Policy Analysis, Public Policy, Public Health
Education
Salisbury University 1984 — 1988
Triton 1980 — 1984
Greg Gagliano's FDA Experience March 2015 - Present
Job Environmental Toxicologist at FDA
Industry Government Administration
Experience
FDA March 2015 - Present
Merck January 2009 - March 2015
Schering-Plough Research Institute June 2006 - December 2008
Bayer HealthCare March 1995 - June 2006
20th Century Guitar Magazine 1996 - 2005
Bayer CropScience June 1990 - March 1995
IT Corporation January 1985 - May 1990
Princeton Aqua Science September 1982 - December 1984
Skills
Regulatory Affairs, Ecotoxicology, Pharmaceutical Industry, Risk Assessment, Laboratory, EPA, GLP, Environmental Impact..., Drug Discovery, Toxicology, Regulatory Submissions, Science, Environmental Awareness, Drug Development, Veterinary Medicine, Biotechnology, Regulatory Requirements, Strategy, Ecological Risk..., FDA, Analytical Chemistry, Sop, Lifesciences, Vaccines, Animal Health, Pharmaceuticals, Regulatory Strategy, Product Stewardship, Endocrine Disruption, Nanoparticles, Legislative Affairs, Regulatory Policy, Regulatory Intelligence, Life Sciences, Chemistry, Environmental Policy, Research, Environmental Science, Data Analysis, NEPA, Environmental Compliance, Scientific Writing, Government
Education
Rutgers University-New Brunswick
Master of Science (M.S.), Environmental Science
Rutgers University-New Brunswick
Bachelor of Science (BS), Environmental Science
The University of Kansas
PhD Candidate, Systematics and Ecology
FDA March 2015 - Present
Merck January 2009 - March 2015
Schering-Plough Research Institute June 2006 - December 2008
Bayer HealthCare March 1995 - June 2006
20th Century Guitar Magazine 1996 - 2005
Bayer CropScience June 1990 - March 1995
IT Corporation January 1985 - May 1990
Princeton Aqua Science September 1982 - December 1984
Skills
Regulatory Affairs, Ecotoxicology, Pharmaceutical Industry, Risk Assessment, Laboratory, EPA, GLP, Environmental Impact..., Drug Discovery, Toxicology, Regulatory Submissions, Science, Environmental Awareness, Drug Development, Veterinary Medicine, Biotechnology, Regulatory Requirements, Strategy, Ecological Risk..., FDA, Analytical Chemistry, Sop, Lifesciences, Vaccines, Animal Health, Pharmaceuticals, Regulatory Strategy, Product Stewardship, Endocrine Disruption, Nanoparticles, Legislative Affairs, Regulatory Policy, Regulatory Intelligence, Life Sciences, Chemistry, Environmental Policy, Research, Environmental Science, Data Analysis, NEPA, Environmental Compliance, Scientific Writing, Government
Education
Rutgers University-New Brunswick
Master of Science (M.S.), Environmental Science
Rutgers University-New Brunswick
Bachelor of Science (BS), Environmental Science
The University of Kansas
PhD Candidate, Systematics and Ecology
Thomas Broadbent's FDA Experience 1998 - 2006
Job Associate Director at Eisai, Inc.
Industry Pharmaceuticals
Experience
Eisai Medical Research March 2006 - Present
FDA 1998 - 2006
Skills
Regulatory Affairs, FDA, Chemistry, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Pharmaceuticals, IND, Biotechnology
Education
Rensselaer Polytechnic Institute 1988 — 1993
Ph.D., Organic Chemistry
Eisai Medical Research March 2006 - Present
FDA 1998 - 2006
Skills
Regulatory Affairs, FDA, Chemistry, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Pharmaceuticals, IND, Biotechnology
Education
Rensselaer Polytechnic Institute 1988 — 1993
Ph.D., Organic Chemistry
Elleni Alebachew's FDA Experience August 2012 - Present
Job Regulatory Project Manager at FDA/CDER/OND
Industry Government Administration
Experience
FDA August 2012 - Present
MedImmune May 2008 - August 2012
MedImmune February 2004 - May 2008
Wyeth Research June 2000 - April 2003
Skills
IND
Education
Rutgers, The State University of New Jersey-Newark 1997 — 2000
BS, Chemistry
The Johns Hopkins University
MS, Bioscience Regulatory Affairs
YBS
FDA August 2012 - Present
MedImmune May 2008 - August 2012
MedImmune February 2004 - May 2008
Wyeth Research June 2000 - April 2003
Skills
IND
Education
Rutgers, The State University of New Jersey-Newark 1997 — 2000
BS, Chemistry
The Johns Hopkins University
MS, Bioscience Regulatory Affairs
YBS
Wana Manitpisitkul's FDA Experience January 2014 - Present
Job Safety Evaluator, Division of Pharmacovigilance FDA
Industry Health, Wellness and Fitness
Experience
FDA January 2014 - Present
University of Maryland Medical Center August 2005 - Present
Hennepin County Medical Center June 2004 - July 2005
Skills
Clinical Research, Pharmacists, Clinical Pharmacy, Pharmacy, Pharmacokinetics, Transplant, Nephrology, Pharmacovigilance, Healthcare, Medicine
Education
Rutgers, The State University of New Jersey-New Brunswick 1998 — 2004
Doctor of Pharmacy
FDA January 2014 - Present
University of Maryland Medical Center August 2005 - Present
Hennepin County Medical Center June 2004 - July 2005
Skills
Clinical Research, Pharmacists, Clinical Pharmacy, Pharmacy, Pharmacokinetics, Transplant, Nephrology, Pharmacovigilance, Healthcare, Medicine
Education
Rutgers, The State University of New Jersey-New Brunswick 1998 — 2004
Doctor of Pharmacy
Jon Cuevas's FDA Experience June 2014 - Present
Job U/UI Designer Developer at FDA
Industry Internet
Experience
FDA June 2014 - Present
joncuevas.com January 2001 - Present
IBM October 2014 - February 2015
TRANZACT August 2013 - May 2014
Blast Radius 2012 - 2013
Draftfcb 2009 - 2012
Tag: World Wide 2005 - 2009
Skills
HTML 5, Industrial Design, HTML, Rendering, Design Strategy, Design Thinking, Concept Development, Concept Design, jQuery, JavaScript, Illustration, SEO, User Interface Design, User Experience, Web Design, Graphic Design, Photoshop, HTML5, Brand Development
Education
Rutgers University-New Brunswick
Grapgic Design
FDA June 2014 - Present
joncuevas.com January 2001 - Present
IBM October 2014 - February 2015
TRANZACT August 2013 - May 2014
Blast Radius 2012 - 2013
Draftfcb 2009 - 2012
Tag: World Wide 2005 - 2009
Skills
HTML 5, Industrial Design, HTML, Rendering, Design Strategy, Design Thinking, Concept Development, Concept Design, jQuery, JavaScript, Illustration, SEO, User Interface Design, User Experience, Web Design, Graphic Design, Photoshop, HTML5, Brand Development
Education
Rutgers University-New Brunswick
Grapgic Design
Sergio Gadaleta, Ph.D.'s FDA Experience October 1999 - March 2001
Job Senior Vice President, Regulatory Affairs at BD
Industry Medical Devices
Experience
BD August 2015 - Present
BD April 2014 - August 2015
Becton Dickinson July 2010 - April 2014
Johnson & Johnson June 2008 - June 2010
Allergan June 2007 - June 2008
Johnson & Johnson March 2001 - June 2007
FDA October 1999 - March 2001
Skills
US/EU Regulatory Affairs, PMAs/Combination..., IDEs, Regulatory Affairs
Education
Rutgers, The State University of New Jersey-Newark 1993 — 1997
Ph.D., Chemistry
BD August 2015 - Present
BD April 2014 - August 2015
Becton Dickinson July 2010 - April 2014
Johnson & Johnson June 2008 - June 2010
Allergan June 2007 - June 2008
Johnson & Johnson March 2001 - June 2007
FDA October 1999 - March 2001
Skills
US/EU Regulatory Affairs, PMAs/Combination..., IDEs, Regulatory Affairs
Education
Rutgers, The State University of New Jersey-Newark 1993 — 1997
Ph.D., Chemistry
Elande Baro's FDA Experience September 2015 - Present
Job Mathematical Statistician at FDA
Industry Computer Software
Experience
FDA September 2015 - Present
FDA June 2012 - July 2015
NIH May 2011 - August 2011
NIH May 2010 - July 2010
IBM July 2006 - February 2009
IBM May 2005 - August 2005
Skills
SAS, R, Machine Learning, Java, C++, Research, Time Series Analysis, Data Analysis, Statistics, Programming, SQL, Epidemiology, LaTeX, Data Mining, Analysis
Education
University of Maryland Baltimore County 2010 — 2015
Ph.D, Biostatistics, Causal Inference / Measurement Error / Bayesian analysis
Rutgers, The State University of New Jersey-New Brunswick 2009 — 2010
M.S., Applied Statistics / BioStatistics
Rutgers University-New Brunswick 2003 — 2006
B.S., Computer Science, Mathematics
FDA September 2015 - Present
FDA June 2012 - July 2015
NIH May 2011 - August 2011
NIH May 2010 - July 2010
IBM July 2006 - February 2009
IBM May 2005 - August 2005
Skills
SAS, R, Machine Learning, Java, C++, Research, Time Series Analysis, Data Analysis, Statistics, Programming, SQL, Epidemiology, LaTeX, Data Mining, Analysis
Education
University of Maryland Baltimore County 2010 — 2015
Ph.D, Biostatistics, Causal Inference / Measurement Error / Bayesian analysis
Rutgers, The State University of New Jersey-New Brunswick 2009 — 2010
M.S., Applied Statistics / BioStatistics
Rutgers University-New Brunswick 2003 — 2006
B.S., Computer Science, Mathematics
Sheilyn Huang's FDA Experience November 2010 - Present
Job Safety and Risk Communications Team at FDA
Industry Pharmaceuticals
Experience
FDA November 2010 - Present
FDA July 2008 - November 2010
Scientific Connexions April 2007 - June 2008
The Children's Hospital of Philadelphia July 2006 - March 2007
Robert Wood Johnson University Hospital July 2005 - June 2006
Skills
Drug Information, Medical Writing, Risk Communication, Pharmacists, Medicine, Risk Management, Pharmacology, Pharmacy
Education
Rutgers University-New Brunswick 1999 — 2005
Pharm.D., Pharmacy
FDA November 2010 - Present
FDA July 2008 - November 2010
Scientific Connexions April 2007 - June 2008
The Children's Hospital of Philadelphia July 2006 - March 2007
Robert Wood Johnson University Hospital July 2005 - June 2006
Skills
Drug Information, Medical Writing, Risk Communication, Pharmacists, Medicine, Risk Management, Pharmacology, Pharmacy
Education
Rutgers University-New Brunswick 1999 — 2005
Pharm.D., Pharmacy
Nada Hanafi's FDA Experience September 2004 - December 2008
Job Senior Science Health Advisor at Food and Drug Administration
Industry Medical Devices
Experience
Food and Drug Administration August 2010 - Present
US Food and Drug Administration January 2008 - August 2010
FDA September 2004 - December 2008
Skills
Biomedical Engineering, Biomaterials, Public Policy, Public Health, Medical Devices, Clinical Trials, Women's Health, Project Management, Program Development, Program Evaluation, FDA, Regulatory Requirements, Regulatory Submissions, Regulatory Affairs, Policy, Public Speaking, Change Management, Leadership, Program Management, Community Outreach, Research, Strategic Planning, Biotechnology, Data Analysis, Lifesciences, Clinical Research, Statistics, Life Sciences
Education
The Johns Hopkins University 2007 — 2009
Master of Public Health (MPH)
Queen Mary, U. of London 2001 — 2002
Master of Science (M.Sc.), Biomaterials, Honors
Queen Mary, U. of London 1998 — 2001
Bachelor of Engineering (BEng), Biomedical Materials Science and Engineering, Honors 2:1
Food and Drug Administration August 2010 - Present
US Food and Drug Administration January 2008 - August 2010
FDA September 2004 - December 2008
Skills
Biomedical Engineering, Biomaterials, Public Policy, Public Health, Medical Devices, Clinical Trials, Women's Health, Project Management, Program Development, Program Evaluation, FDA, Regulatory Requirements, Regulatory Submissions, Regulatory Affairs, Policy, Public Speaking, Change Management, Leadership, Program Management, Community Outreach, Research, Strategic Planning, Biotechnology, Data Analysis, Lifesciences, Clinical Research, Statistics, Life Sciences
Education
The Johns Hopkins University 2007 — 2009
Master of Public Health (MPH)
Queen Mary, U. of London 2001 — 2002
Master of Science (M.Sc.), Biomaterials, Honors
Queen Mary, U. of London 1998 — 2001
Bachelor of Engineering (BEng), Biomedical Materials Science and Engineering, Honors 2:1
Courtney Robertson's FDA Experience November 2009 - November 2011
Job Senior Program Manager at GSA
Industry Government Administration
Experience
GSA November 2011 - Present
DCPM Associates November 2011 - May 2014
FDA November 2009 - November 2011
Keane May 2007 - August 2009
Finding Cures Inc March 2007 - May 2007
National Institutes of Health March 2006 - March 2007
GSA January 2004 - March 2006
Skills
Program Management, Project Management, SDLC, DoD Top Secret Clearance, Management, SharePoint, Policy, Security, DoD, Project Planning, Government, Research, Visio, Business Intelligence, MS Project, Training, Business Strategy, Risk Management, Governance, Infectious Diseases, Clinical Trials, Testing, Databases, Microsoft Office
Education
The George Washington University 2003 — 2004
MBA, Business
Salisbury University 1998 — 2002
BA, History/Anthropology
GSA November 2011 - Present
DCPM Associates November 2011 - May 2014
FDA November 2009 - November 2011
Keane May 2007 - August 2009
Finding Cures Inc March 2007 - May 2007
National Institutes of Health March 2006 - March 2007
GSA January 2004 - March 2006
Skills
Program Management, Project Management, SDLC, DoD Top Secret Clearance, Management, SharePoint, Policy, Security, DoD, Project Planning, Government, Research, Visio, Business Intelligence, MS Project, Training, Business Strategy, Risk Management, Governance, Infectious Diseases, Clinical Trials, Testing, Databases, Microsoft Office
Education
The George Washington University 2003 — 2004
MBA, Business
Salisbury University 1998 — 2002
BA, History/Anthropology
Dawn McCabe's FDA Experience February 2009 - Present
Job at FDA
Industry Medical Devices
Experience
FDA February 2009 - Present
Boston Scientific September 2005 - February 2009
Avecia 2003 - 2005
Dow Chemical 2000 - 2003
Associates of Cape Cod 1998 - 2000
Springborn Laboratories 1995 - 1998
Skills
LIMS, Design of Experiments, Aseptic Processing, Aseptic Technique, Biopharmaceuticals, CAPA, Clinical Development, Clinical Research, Continuous Improvement, Environmental Monitoring, FDA, FDA GMP, FMEA, Laboratory, Quality Management, Testing, UV/Vis, cGMP practices, Technology Transfer, Lean Manufacturing, Kaizen, GMP, Quality System
Education
Quinnipiac University
FDA February 2009 - Present
Boston Scientific September 2005 - February 2009
Avecia 2003 - 2005
Dow Chemical 2000 - 2003
Associates of Cape Cod 1998 - 2000
Springborn Laboratories 1995 - 1998
Skills
LIMS, Design of Experiments, Aseptic Processing, Aseptic Technique, Biopharmaceuticals, CAPA, Clinical Development, Clinical Research, Continuous Improvement, Environmental Monitoring, FDA, FDA GMP, FMEA, Laboratory, Quality Management, Testing, UV/Vis, cGMP practices, Technology Transfer, Lean Manufacturing, Kaizen, GMP, Quality System
Education
Quinnipiac University
Laura (Mecker) Pogue's FDA Experience September 2009 - Present
Job Chemist at US FDA, Division of Pharmaceutical Analysis
Industry Research
Experience
FDA September 2009 - Present
Saint Louis University June 2004 - September 2009
Pfizer October 2008 - November 2008
Anheuser-Busch 2003 - 2004
St. Charles County Crime Lab 2002 - 2003
Skills
Microfluidics, Raman Spectroscopy, Ion Mobility..., HPLC, GLP, Analytical Methods..., Analytical Chemistry, Analytical Method..., NDA, ANDAs, Capillary..., Electrochemistry, UV/Vis, LC-MS, Laboratory, Cell Culture, Gas Chromatography, Microscopy, Assay Development, Validation, Cell, GMP
Education
Saint Louis University 2004 — 2009
Ph.D., Chemistry
FDA September 2009 - Present
Saint Louis University June 2004 - September 2009
Pfizer October 2008 - November 2008
Anheuser-Busch 2003 - 2004
St. Charles County Crime Lab 2002 - 2003
Skills
Microfluidics, Raman Spectroscopy, Ion Mobility..., HPLC, GLP, Analytical Methods..., Analytical Chemistry, Analytical Method..., NDA, ANDAs, Capillary..., Electrochemistry, UV/Vis, LC-MS, Laboratory, Cell Culture, Gas Chromatography, Microscopy, Assay Development, Validation, Cell, GMP
Education
Saint Louis University 2004 — 2009
Ph.D., Chemistry
Suktae Choi's FDA Experience 2000 - 2007
Job Associate Director at Celgene
Industry Pharmaceuticals
Experience
Celgene October 2010 - Present
Eli Lilly and Company May 2007 - October 2010
FDA 2000 - 2007
Organon Pharmaceuticals September 1998 - January 2000
Skills
Clinical, Clinical Trials, Biostatistics, Survival Analysis, Clinical Research
Education
Rutgers University-New Brunswick 1993 — 1998
Ph.D, Statistics
Celgene October 2010 - Present
Eli Lilly and Company May 2007 - October 2010
FDA 2000 - 2007
Organon Pharmaceuticals September 1998 - January 2000
Skills
Clinical, Clinical Trials, Biostatistics, Survival Analysis, Clinical Research
Education
Rutgers University-New Brunswick 1993 — 1998
Ph.D, Statistics
Denise Visco's FDA Experience June 2010 - Present
Job Consumer Safety Officer at FDA
Industry Pharmaceuticals
Experience
FDA June 2010 - Present
Merck January 2005 - April 2009
Merck October 1993 - January 2005
Bayer August 1989 - August 1993
Indiana University School of Medicine August 1987 - August 1989
Skills
Regulatory Affairs, Chronic Illness, Inflammation, Animal Models, Pharmaceutical Industry, Veterinary, In Vivo, Vaccines, Infectious Diseases, Toxicology, Pharmacology, Drug Development, Lifesciences, Biotechnology, Clinical Development, Drug Discovery, In Vitro, Life Sciences, Immunology
Education
Purdue University 1983 — 1987
Ph.D., Veterinary Anatomy
University of Tennessee-Knoxville 1979 — 1983
M.S. - 1981, Exercise Physiology, minor Zoology and Statistics
University of New Hampshire 1975 — 1979
B.S., Physical Education
FDA June 2010 - Present
Merck January 2005 - April 2009
Merck October 1993 - January 2005
Bayer August 1989 - August 1993
Indiana University School of Medicine August 1987 - August 1989
Skills
Regulatory Affairs, Chronic Illness, Inflammation, Animal Models, Pharmaceutical Industry, Veterinary, In Vivo, Vaccines, Infectious Diseases, Toxicology, Pharmacology, Drug Development, Lifesciences, Biotechnology, Clinical Development, Drug Discovery, In Vitro, Life Sciences, Immunology
Education
Purdue University 1983 — 1987
Ph.D., Veterinary Anatomy
University of Tennessee-Knoxville 1979 — 1983
M.S. - 1981, Exercise Physiology, minor Zoology and Statistics
University of New Hampshire 1975 — 1979
B.S., Physical Education
Richard Carver's FDA Experience October 1975 - May 1982
Job Senior Regulatory Scientist at Critical Path Services, LLC
Industry Government Relations
Experience
Critical Path Services, LLC August 2014 - Present
DuPont October 1993 - August 2014
DuPont May 1988 - October 1993
DuPont July 1984 - May 1988
Stauffer Chemical Company 1982 - 1984
FDA October 1975 - May 1982
University of Wisconsin-Madison September 1974 - July 1975
Skills
Regulatory Affairs, Pesticide Registration, Pesticide imports and..., EPA tolerances and..., Agriculture, Life Sciences, Chemistry, Biotechnology, R&D, Agribusiness, Market Development, Crop Protection, Product Development, Analytical Chemistry, Regulatory Requirements
Education
University of Minnesota-Twin Cities 1970 — 1974
Ph.D., Organic Chemistry
Rutgers University – Camden 1966 — 1970
BA, Chemistry
Critical Path Services, LLC August 2014 - Present
DuPont October 1993 - August 2014
DuPont May 1988 - October 1993
DuPont July 1984 - May 1988
Stauffer Chemical Company 1982 - 1984
FDA October 1975 - May 1982
University of Wisconsin-Madison September 1974 - July 1975
Skills
Regulatory Affairs, Pesticide Registration, Pesticide imports and..., EPA tolerances and..., Agriculture, Life Sciences, Chemistry, Biotechnology, R&D, Agribusiness, Market Development, Crop Protection, Product Development, Analytical Chemistry, Regulatory Requirements
Education
University of Minnesota-Twin Cities 1970 — 1974
Ph.D., Organic Chemistry
Rutgers University – Camden 1966 — 1970
BA, Chemistry
Ted Carver's FDA Experience 2008 - 2011
Job Principal Consultant at PAREXEL International
Industry Pharmaceuticals
Experience
PAREXEL International 2011 - Present
FDA 2008 - 2011
Ceptor, Inc. 2004 - 2007
Johnson & Johnson PRD 2002 - 2004
3DP 1998 - 2001
The Scripps Research Institute 1992 - 1994
Skills
Regulatory Affairs, Drug Discovery, Biotechnology, Lifesciences, Pharmaceutical Industry, Chemistry, Protein Chemistry, Drug Development, Analytical Chemistry, Biopharmaceuticals, Clinical Development, Clinical Trials, FDA, Purification, Regulatory Submissions, Life Sciences
Education
Rice University
Ph.D., Biochemistry
PAREXEL International 2011 - Present
FDA 2008 - 2011
Ceptor, Inc. 2004 - 2007
Johnson & Johnson PRD 2002 - 2004
3DP 1998 - 2001
The Scripps Research Institute 1992 - 1994
Skills
Regulatory Affairs, Drug Discovery, Biotechnology, Lifesciences, Pharmaceutical Industry, Chemistry, Protein Chemistry, Drug Development, Analytical Chemistry, Biopharmaceuticals, Clinical Development, Clinical Trials, FDA, Purification, Regulatory Submissions, Life Sciences
Education
Rice University
Ph.D., Biochemistry
William I. Baker Jr., MBA, CISSP, ITIL, CPTE, C|EH's FDA Experience February 2010 - March 2012
Job CEO at Ignotus Solutions, LLC.
Industry Computer & Network Security
Experience
Ignotus Solutions, LLC. March 2015 - Present
Internal Revenue Service August 2012 - Present
FDA February 2010 - March 2012
Trident Information Security, LLC. 2012 - 2012
MacFadden and Associates October 2009 - April 2010
Delmarva Foundation for Medical Care November 2005 - August 2009
LCG Systems 2009 - 2009
MPRI, Inc. July 2005 - September 2005
Perdue Farms, Inc May 2000 - June 2005
United States Army September 1990 - October 1995
Skills
Policy, Disaster Recovery, Audit, Business Continuity, Compliance, Internal Controls, Auditing, IT Audit, Risk Management, Risk Assessment, Information Security..., Risk, Enterprise Risk..., Security, Security Program..., Web Application..., Vulnerability Assessment, Penetration Testing, Financial Risk, NIST, FISMA, Cloud Security, Security Policy, Information Security, DIACAP, Information Assurance, HIPAA, PCI DSS, CISSP, C&A, Computer Security, Intrusion Detection, Vulnerability Management, Security Awareness, Information Technology, Computer Forensics, Security Architecture..., Security Audits, Network Security, Incident Response, Identity Management, Security+, CEH, ISO 27001, Firewalls, Vulnerability Scanning, Encryption, Nessus, PKI, Malware Analysis
Education
Mile2 2012 — 2012
CPTE, Certified Penetration Testing Engineer
Ultimate Knowledge Institute 2010 — 2010
CEH, Certified Ethical Hacker
ISC2 2009 — 2009
CISSP, Information Systems Security
Wilmington University 2003 — 2005
MBA, Business Administration
Salisbury University 1997 — 1999
Degree: Bachelor of Science, Liberal Studies; Management Information Systems and Philosophy
Ignotus Solutions, LLC. March 2015 - Present
Internal Revenue Service August 2012 - Present
FDA February 2010 - March 2012
Trident Information Security, LLC. 2012 - 2012
MacFadden and Associates October 2009 - April 2010
Delmarva Foundation for Medical Care November 2005 - August 2009
LCG Systems 2009 - 2009
MPRI, Inc. July 2005 - September 2005
Perdue Farms, Inc May 2000 - June 2005
United States Army September 1990 - October 1995
Skills
Policy, Disaster Recovery, Audit, Business Continuity, Compliance, Internal Controls, Auditing, IT Audit, Risk Management, Risk Assessment, Information Security..., Risk, Enterprise Risk..., Security, Security Program..., Web Application..., Vulnerability Assessment, Penetration Testing, Financial Risk, NIST, FISMA, Cloud Security, Security Policy, Information Security, DIACAP, Information Assurance, HIPAA, PCI DSS, CISSP, C&A, Computer Security, Intrusion Detection, Vulnerability Management, Security Awareness, Information Technology, Computer Forensics, Security Architecture..., Security Audits, Network Security, Incident Response, Identity Management, Security+, CEH, ISO 27001, Firewalls, Vulnerability Scanning, Encryption, Nessus, PKI, Malware Analysis
Education
Mile2 2012 — 2012
CPTE, Certified Penetration Testing Engineer
Ultimate Knowledge Institute 2010 — 2010
CEH, Certified Ethical Hacker
ISC2 2009 — 2009
CISSP, Information Systems Security
Wilmington University 2003 — 2005
MBA, Business Administration
Salisbury University 1997 — 1999
Degree: Bachelor of Science, Liberal Studies; Management Information Systems and Philosophy
Nan Sottosanti's FDA Experience 1972 - 1975
Job marketing at Shenandoah River Outfitters
Industry Farming
Experience
Persimmon Hill Llamas marketingShenandoah River Outfitters1975 - Present
FDA 1972 - 1975
National Institutes of Health 1967 - 1972
Skills
Agriculture, Marketing Strategy, Small Business, Customer Service
Education
University of North Carolina at Chapel Hill 1965 — 1967
BS Chemistry, Chemistry
Salem College 1963 — 1965
Persimmon Hill Llamas marketingShenandoah River Outfitters1975 - Present
FDA 1972 - 1975
National Institutes of Health 1967 - 1972
Skills
Agriculture, Marketing Strategy, Small Business, Customer Service
Education
University of North Carolina at Chapel Hill 1965 — 1967
BS Chemistry, Chemistry
Salem College 1963 — 1965
Ankur Kalola's FDA Experience May 2013 - Present
Job Regulatory Review Officer at FDA
Industry Pharmaceuticals
Experience
FDA May 2013 - Present
Purdue University July 2011 - Present
Lake Parsippany Fire Company 2003 - Present
CVS Caremark Corporation May 2006 - May 2011
CommonHealth June 2009 - August 2009
Drug Fair Group, Inc. May 2008 - June 2008
Skills
Medical Writing, Pharmaceutical Industry, Data Analysis, Pharmacy, Regulatory Affairs, Pharmacists, Clinical Trials, Infectious Diseases, Medicine, Regulatory Submissions, Healthcare
Education
Rutgers University-New Brunswick 2005 — 2011
Pharm D, Pharmacy
FDA May 2013 - Present
Purdue University July 2011 - Present
Lake Parsippany Fire Company 2003 - Present
CVS Caremark Corporation May 2006 - May 2011
CommonHealth June 2009 - August 2009
Drug Fair Group, Inc. May 2008 - June 2008
Skills
Medical Writing, Pharmaceutical Industry, Data Analysis, Pharmacy, Regulatory Affairs, Pharmacists, Clinical Trials, Infectious Diseases, Medicine, Regulatory Submissions, Healthcare
Education
Rutgers University-New Brunswick 2005 — 2011
Pharm D, Pharmacy
Sugato De's FDA Experience March 2014 - Present
Job Senior Policy Advisor, Office of the Center Director at FDA
Industry Medical Devices
Experience
FDA March 2014 - Present
FDA August 2008 - March 2014
Stryker August 2007 - August 2008
Skills
FDA, Regulatory Affairs, Biomedical Engineering, CAPA, Medical Devices, Statistical Modeling, Regulatory Submissions, ISO 13485, Quality System, Clinical Trials
Education
The Johns Hopkins University 2008 — 2010
Master's Degree, Biomedical/Medical Engineering
Rensselaer Polytechnic Institute 2003 — 2007
Bachelor's Degree, Bioengineering and Biomedical Engineering
FDA March 2014 - Present
FDA August 2008 - March 2014
Stryker August 2007 - August 2008
Skills
FDA, Regulatory Affairs, Biomedical Engineering, CAPA, Medical Devices, Statistical Modeling, Regulatory Submissions, ISO 13485, Quality System, Clinical Trials
Education
The Johns Hopkins University 2008 — 2010
Master's Degree, Biomedical/Medical Engineering
Rensselaer Polytechnic Institute 2003 — 2007
Bachelor's Degree, Bioengineering and Biomedical Engineering
Al Brindle's FDA Experience 2002 - 2002
Job Validation Supervisor at Sharp Corporation
Industry Pharmaceuticals
Experience
Sharp Corporation 2008 - Present
VTS Consultants 2004 - 2008
New Jersey Office of Attorney General 2003 - 2004
Kenneth Vercammen & Associates, P.C. 2003 - 2003
FDA 2002 - 2002
U.S. Environmental Protection Agency 2001 - 2002
Bristol-Myers Squibb 2001 - 2001
Vivus Inc 1997 - 1998
US Army 1988 - 1992
Education
Rutgers University School of Law - Camden 1999 — 2002
JD
Rutgers University-New Brunswick 1993 — 1997
BS
Sharp Corporation 2008 - Present
VTS Consultants 2004 - 2008
New Jersey Office of Attorney General 2003 - 2004
Kenneth Vercammen & Associates, P.C. 2003 - 2003
FDA 2002 - 2002
U.S. Environmental Protection Agency 2001 - 2002
Bristol-Myers Squibb 2001 - 2001
Vivus Inc 1997 - 1998
US Army 1988 - 1992
Education
Rutgers University School of Law - Camden 1999 — 2002
JD
Rutgers University-New Brunswick 1993 — 1997
BS
Nooshin Kiarashi's FDA Experience 2015 - Present
Job Lead Reviewer at the FDA
Industry Medical Devices
Experience
FDA 2015 - Present
Carl E. Ravin Advanced Imaging Laboratories 2011 - 2014
Skills
Development and..., Contrast-based Imaging..., Medical Imaging, Signal and Image..., Matlab, Biomedical Engineering, Image Processing, Signal Processing, Algorithms, Digital Signal..., Simulations, Digital Signal..., Mathematical Modeling, Image Analysis, LaTeX, Machine Learning, Digital Image Processing, Computer Vision, C++, Research
Education
Duke University
Doctor of Philosophy (Ph.D.), Electrical and Computer Engineering
Queen's University
Master of Science (M.Sc.), Electrical and Computer Engineering
University of Tehran
Bachelor of Science (B.Sc.), Electrical and Computer Engineering
Université Laval
French Immersion
FDA 2015 - Present
Carl E. Ravin Advanced Imaging Laboratories 2011 - 2014
Skills
Development and..., Contrast-based Imaging..., Medical Imaging, Signal and Image..., Matlab, Biomedical Engineering, Image Processing, Signal Processing, Algorithms, Digital Signal..., Simulations, Digital Signal..., Mathematical Modeling, Image Analysis, LaTeX, Machine Learning, Digital Image Processing, Computer Vision, C++, Research
Education
Duke University
Doctor of Philosophy (Ph.D.), Electrical and Computer Engineering
Queen's University
Master of Science (M.Sc.), Electrical and Computer Engineering
University of Tehran
Bachelor of Science (B.Sc.), Electrical and Computer Engineering
Université Laval
French Immersion
Chandrika Illandarideva's FDA Experience June 2002 - June 2003
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Yeshiva University 2010 - Present
Rutgers University August 2006 - June 2008
LaGuardia Community College June 2004 - June 2006
FDA June 2002 - June 2003
Skills
Chemistry, UV/Vis, HPLC, Biochemistry, Organic Chemistry, Science, Lifesciences, Spectroscopy, Protein Chemistry, •Experienced in...
Education
Rutgers, The State University of New Jersey-Newark 2006 — 2009
Master of Science (M.Sc.), Chemistry
City University of New York, York College 2000 — 2004
Bachelor of Science (B.Sc.), Chemistry
Yeshiva University 2010 - Present
Rutgers University August 2006 - June 2008
LaGuardia Community College June 2004 - June 2006
FDA June 2002 - June 2003
Skills
Chemistry, UV/Vis, HPLC, Biochemistry, Organic Chemistry, Science, Lifesciences, Spectroscopy, Protein Chemistry, •Experienced in...
Education
Rutgers, The State University of New Jersey-Newark 2006 — 2009
Master of Science (M.Sc.), Chemistry
City University of New York, York College 2000 — 2004
Bachelor of Science (B.Sc.), Chemistry
Cherron Blakely's FDA Experience November 2014 - Present
Job Director, Program Management Office (PMO), at FDA
Industry Government Administration
Experience
FDA November 2014 - Present
VHA Compliance and Business Integrity July 2012 - November 2014
Carl Vinson VA Medical Center January 2012 - August 2012
Veterans Health Administration August 2010 - December 2011
Saint Augustine's College 1996 - 2000
Skills
Clinical Research, Psychiatry, Healthcare, Oncology, Neurology, Infectious Diseases, Cardiology, Hematology, Neuroscience, Protocol, Pharmaceutical Industry, Healthcare Management, Managed Care, Hospitals, Healthcare Information..., EMR
Education
Saint Leo University 2011 — 2013
Masters of Business Administration (MBA), Health Care Management
Saint Augustines College 1996 — 2000
BS of Clin Lab Sci, Medical Technology
Woodlawn high school 1988 — 1992
Diploma
FDA November 2014 - Present
VHA Compliance and Business Integrity July 2012 - November 2014
Carl Vinson VA Medical Center January 2012 - August 2012
Veterans Health Administration August 2010 - December 2011
Saint Augustine's College 1996 - 2000
Skills
Clinical Research, Psychiatry, Healthcare, Oncology, Neurology, Infectious Diseases, Cardiology, Hematology, Neuroscience, Protocol, Pharmaceutical Industry, Healthcare Management, Managed Care, Hospitals, Healthcare Information..., EMR
Education
Saint Leo University 2011 — 2013
Masters of Business Administration (MBA), Health Care Management
Saint Augustines College 1996 — 2000
BS of Clin Lab Sci, Medical Technology
Woodlawn high school 1988 — 1992
Diploma
Jason Bunting's FDA Experience December 2013 - Present
Job Science Policy Analyst at FDA
Industry Pharmaceuticals
Experience
FDA December 2013 - Present
FDA September 2012 - Present
CVS Caremark Corporation October 2008 - September 2010
CVS Caremark Corporation 2005 - 2008
Skills
Pharmacy Operations, Medication Therapy..., Community Pharmacy, Pharmacy Automation, REMS, Pharmacy Benefit..., Pharmacists, Pharmacy, Managed Care, Clinical Pharmacy, Immunization, Medicare Part D, Clinical Research, Diabetes, Pharmacology, Drug Safety, Clinical Trials, Patient Safety, Policy, Health Policy, Public Health, Pharmacy Practice, Regulatory Affairs, Patient Counseling, Certified Immunizer
Education
University of Maryland Baltimore 2001 — 2005
PharmD
Salisbury State University 1999 — 2001
FDA December 2013 - Present
FDA September 2012 - Present
CVS Caremark Corporation October 2008 - September 2010
CVS Caremark Corporation 2005 - 2008
Skills
Pharmacy Operations, Medication Therapy..., Community Pharmacy, Pharmacy Automation, REMS, Pharmacy Benefit..., Pharmacists, Pharmacy, Managed Care, Clinical Pharmacy, Immunization, Medicare Part D, Clinical Research, Diabetes, Pharmacology, Drug Safety, Clinical Trials, Patient Safety, Policy, Health Policy, Public Health, Pharmacy Practice, Regulatory Affairs, Patient Counseling, Certified Immunizer
Education
University of Maryland Baltimore 2001 — 2005
PharmD
Salisbury State University 1999 — 2001
Laura Couzens's FDA Experience June 2010 - Present
Job Biologist at FDA
Industry Government Administration
Experience
FDA June 2010 - Present
Education
University of Wisconsin-Madison 2008 — 2009
M.S., Medical Microbiology & Immunology
Salisbury University 2003 — 2007
B.S., Biology
FDA June 2010 - Present
Education
University of Wisconsin-Madison 2008 — 2009
M.S., Medical Microbiology & Immunology
Salisbury University 2003 — 2007
B.S., Biology
Kellie Werner's FDA Experience IACUC CoordinatorFood and Drug Administration-Center for Biologics Evaluation & ResearchNovember 2010 - October 2014
Job IACUC Coordinator at National Institute of Allergy and Infectious Diseases (NIAID)
Industry Government Administration
Experience
National Institute of Allergy and Infectious Diseases (NIAID) October 2014 - Present
FDA IACUC CoordinatorFood and Drug Administration-Center for Biologics Evaluation & ResearchNovember 2010 - October 2014
Skills
PCR, Research, Healthcare, Public Speaking, Data Analysis, Microsoft Excel, PowerPoint, Nonprofits, Community Outreach, Program Management, Leadership, DNA, Policy, Microsoft Office, Government, Event Management, Event Planning
Education
Salisbury University
National Institute of Allergy and Infectious Diseases (NIAID) October 2014 - Present
FDA IACUC CoordinatorFood and Drug Administration-Center for Biologics Evaluation & ResearchNovember 2010 - October 2014
Skills
PCR, Research, Healthcare, Public Speaking, Data Analysis, Microsoft Excel, PowerPoint, Nonprofits, Community Outreach, Program Management, Leadership, DNA, Policy, Microsoft Office, Government, Event Management, Event Planning
Education
Salisbury University
Mohab Alexander's FDA Experience June 2008 - June 2009
Job Hospital & Health Care Professional
Industry Hospital & Health Care
Experience
Naval Hospital Bremerton 2012 - 2013
FDA June 2008 - June 2009
Johns Hopkins School of Medicine 2000 - 2008
Thomas Jefferson University Hospital June 1998 - June 2000
Allegheny University Hospital / Hahenmann Division- June 1996 - June 1997
Skills
Cancer, Clinical Research, Neuroscience, Research, Clinical Trials, Lifesciences, Translational Research, Biotechnology, Medical Imaging, Clinical Trials,..., Clinical Development, Life Sciences, Hospitals
Education
Allegheny University Hospital / Hahenmann Division 2005 — 2006
Doctor of Medicine (M.D.), Internal Medicine
Thomas Jefferson University Hospital 1998 — 2000
Doctor of Medicine (M.D.), Nuclear Medicine
Ross University School of Medicine 1990 — 1995
Doctor of Medicine (MD), Medicine
Saint Peter's University 1979 — 1983
Bachelor of Science, Biochemistry
Naval Hospital Bremerton 2012 - 2013
FDA June 2008 - June 2009
Johns Hopkins School of Medicine 2000 - 2008
Thomas Jefferson University Hospital June 1998 - June 2000
Allegheny University Hospital / Hahenmann Division- June 1996 - June 1997
Skills
Cancer, Clinical Research, Neuroscience, Research, Clinical Trials, Lifesciences, Translational Research, Biotechnology, Medical Imaging, Clinical Trials,..., Clinical Development, Life Sciences, Hospitals
Education
Allegheny University Hospital / Hahenmann Division 2005 — 2006
Doctor of Medicine (M.D.), Internal Medicine
Thomas Jefferson University Hospital 1998 — 2000
Doctor of Medicine (M.D.), Nuclear Medicine
Ross University School of Medicine 1990 — 1995
Doctor of Medicine (MD), Medicine
Saint Peter's University 1979 — 1983
Bachelor of Science, Biochemistry
Wayne Sadowski's FDA Experience September 1978 - 1984
Job Dev QA Director, Regulatory Surveillance and Inspection Management at Novartis
Industry Pharmaceuticals
Experience
Novartis December 2011 - Present
Novartis January 2010 - December 2011
Novartis December 2006 - January 2010
Novartis February 2003 - December 2006
Novartis October 2001 - February 2003
Dupont Merck Pharmacuticals 1994 - 2001
DuPont Pharmaceuticals 1989 - 1994
Schering-Plough Research Institute January 1989 - September 1989
FDA September 1978 - 1984
Skills
Sop, GCP, Regulatory Submissions, 21 CFR Part 11, Data Management, Medical Writing, Medical Devices, FDA, Clinical Trials, Clinical Development, GLP, GMP, GxP, Clinical Research, Regulatory Affairs, Pharmaceutical Industry, Quality System, Regulatory Requirements, Lifesciences, Clinical Data Management, Auditing, CAPA, Validation, V&V, NDA, CTMS, Biopharmaceuticals, Quality Control, Quality Assurance, Clinical Monitoring, Computer System..., Oncology, Change Control, ICH-GCP, IND, Technology Transfer, Quality Auditing, Immunology, Clinical Operations, Biotechnology, Pharmacovigilance, EDC, Infectious Diseases, Quality Management, CRO, Neurology, Protocol, Drug Development, Pharmaceutics, Vaccines
Education
Virginia Polytechnic Institute and State University 1976 — 1978
MS, Fisheries Science
Rutgers University-New Brunswick 1972 — 1976
BS, Environmental Science - Fisheries Science
Novartis December 2011 - Present
Novartis January 2010 - December 2011
Novartis December 2006 - January 2010
Novartis February 2003 - December 2006
Novartis October 2001 - February 2003
Dupont Merck Pharmacuticals 1994 - 2001
DuPont Pharmaceuticals 1989 - 1994
Schering-Plough Research Institute January 1989 - September 1989
FDA September 1978 - 1984
Skills
Sop, GCP, Regulatory Submissions, 21 CFR Part 11, Data Management, Medical Writing, Medical Devices, FDA, Clinical Trials, Clinical Development, GLP, GMP, GxP, Clinical Research, Regulatory Affairs, Pharmaceutical Industry, Quality System, Regulatory Requirements, Lifesciences, Clinical Data Management, Auditing, CAPA, Validation, V&V, NDA, CTMS, Biopharmaceuticals, Quality Control, Quality Assurance, Clinical Monitoring, Computer System..., Oncology, Change Control, ICH-GCP, IND, Technology Transfer, Quality Auditing, Immunology, Clinical Operations, Biotechnology, Pharmacovigilance, EDC, Infectious Diseases, Quality Management, CRO, Neurology, Protocol, Drug Development, Pharmaceutics, Vaccines
Education
Virginia Polytechnic Institute and State University 1976 — 1978
MS, Fisheries Science
Rutgers University-New Brunswick 1972 — 1976
BS, Environmental Science - Fisheries Science
April Holland, Ph.D.'s FDA Experience June 2001 - May 2002
Job Chemistry Laboratory Coordinator at Marymount University
Industry Higher Education
Experience
Marymount University August 2013 - Present
University of North Carolina at Chapel Hill August 2006 - June 2013
University of North Carolina at Chapel Hill September 2012 - May 2013
Citizen Schools 2011 - 2011
University of North Carolina at Chapel Hill September 2008 - May 2009
Rochester Institute of Technology 2002 - 2006
Amgen June 2005 - August 2005
National Institute of Standards and Technology: Chemical Science and Technology Lab May 2004 - August 2004
FDA June 2001 - May 2002
Skills
Analytical Chemistry, Microfluidics, Nanofluidics, Stochastic Sensing, Chemistry, Nanotechnology, Microfabrication, Matlab, LabView, UV-Vis Spectroscopy, Fluorescence..., Surface Chemistry, UV/Vis
Education
University of North Carolina at Chapel Hill 2006 — 2013
Doctor of Philosophy (PhD), Analytical Chemistry
Rochester Institute of Technology 2002 — 2006
Bachelor of Science (BS), Chemistry
Marymount University August 2013 - Present
University of North Carolina at Chapel Hill August 2006 - June 2013
University of North Carolina at Chapel Hill September 2012 - May 2013
Citizen Schools 2011 - 2011
University of North Carolina at Chapel Hill September 2008 - May 2009
Rochester Institute of Technology 2002 - 2006
Amgen June 2005 - August 2005
National Institute of Standards and Technology: Chemical Science and Technology Lab May 2004 - August 2004
FDA June 2001 - May 2002
Skills
Analytical Chemistry, Microfluidics, Nanofluidics, Stochastic Sensing, Chemistry, Nanotechnology, Microfabrication, Matlab, LabView, UV-Vis Spectroscopy, Fluorescence..., Surface Chemistry, UV/Vis
Education
University of North Carolina at Chapel Hill 2006 — 2013
Doctor of Philosophy (PhD), Analytical Chemistry
Rochester Institute of Technology 2002 — 2006
Bachelor of Science (BS), Chemistry
Corey Linen's FDA Experience September 2012 - Present
Job Project Engineer at FDA
Industry Construction
Experience
FDA September 2012 - Present
Veterans Health Administration May 2010 - October 2012
Skills
MS Project, Project Management, Program Management, Contract Management, Engineering, Project Planning, Medical Devices, Six Sigma, Management, Cross-functional Team..., Manufacturing, Continuous Improvement, Procurement
Education
Robert Morris University 2011 — 2012
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of South Carolina-Columbia 1998 — 2003
Bachelor of Science (B.S.), Mechanical Engineering
FDA September 2012 - Present
Veterans Health Administration May 2010 - October 2012
Skills
MS Project, Project Management, Program Management, Contract Management, Engineering, Project Planning, Medical Devices, Six Sigma, Management, Cross-functional Team..., Manufacturing, Continuous Improvement, Procurement
Education
Robert Morris University 2011 — 2012
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of South Carolina-Columbia 1998 — 2003
Bachelor of Science (B.S.), Mechanical Engineering
Ensign Kaul's FDA Experience May 2012 - August 2012
Job Audit Intern Deloitte & Touche
Industry Accounting
Experience
FDA May 2012 - August 2012
FDA May 2011 - August 2011
Best Buy August 2008 - November 2010
Education
Rider University 2014 — 2016
Master's Degree, Accounting
The George Washington University - School of Business 2009 — 2013
Bachelor of Business Administration, Finance, General
WWP HS South
FDA May 2012 - August 2012
FDA May 2011 - August 2011
Best Buy August 2008 - November 2010
Education
Rider University 2014 — 2016
Master's Degree, Accounting
The George Washington University - School of Business 2009 — 2013
Bachelor of Business Administration, Finance, General
WWP HS South
Patsy Benefield's FDA Experience July 2011 - Present
Job Management Operations Specialist at FDA
Industry Government Administration
Experience
FDA July 2011 - Present
US Department of Health & Human Services October 2009 - April 2012
FDA October 2009 - July 2011
Skills
Government, Policy, Policy Analysis, Public Policy, Community Outreach, Research, Federal Government, Public Health, Microsoft Office, Public Administration, Program Evaluation, Data Entry, Nonprofits, Data Analysis, Outlook
Education
Robert Morris College 1980 — 1981
Certificate, Administrative Assistant and Secretarial Science, General
FDA July 2011 - Present
US Department of Health & Human Services October 2009 - April 2012
FDA October 2009 - July 2011
Skills
Government, Policy, Policy Analysis, Public Policy, Community Outreach, Research, Federal Government, Public Health, Microsoft Office, Public Administration, Program Evaluation, Data Entry, Nonprofits, Data Analysis, Outlook
Education
Robert Morris College 1980 — 1981
Certificate, Administrative Assistant and Secretarial Science, General
Lysette Deshields's FDA Experience September 2010 - October 2010
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
FDA September 2010 - October 2010
Education
Rutgers, The State University of New Jersey-New Brunswick 2005 — 2011
Pharm.D., Pharmacy
FDA September 2010 - October 2010
Education
Rutgers, The State University of New Jersey-New Brunswick 2005 — 2011
Pharm.D., Pharmacy
Yongman Kim's FDA Experience August 2003 - Present
Job Mathematical Statistician at US Department of Health and Human Services
Industry Government Administration
Experience
FDA August 2003 - Present
GD Searle February 1999 - July 2003
Eli Lilly November 1996 - January 1999
Johnson & Johnson January 1996 - October 1996
Education
Rutgers University 1991 — 1995
Ph.D., Statistics
University of Chicago 1987 — 1990
MS, Statistics
Yonsei University 1983 — 1985
MA, Statistics
Yonsei University 1979 — 1983
BA, Economics
FDA August 2003 - Present
GD Searle February 1999 - July 2003
Eli Lilly November 1996 - January 1999
Johnson & Johnson January 1996 - October 1996
Education
Rutgers University 1991 — 1995
Ph.D., Statistics
University of Chicago 1987 — 1990
MS, Statistics
Yonsei University 1983 — 1985
MA, Statistics
Yonsei University 1979 — 1983
BA, Economics
Annmarie Matta's FDA Experience September 2012 - Present
Job HR Specialist at FDA
Industry Research
Experience
FDA September 2012 - Present
National Institutes of Health March 2007 - September 2012
United States Department of Defense March 2004 - March 2007
Skills
Research, Community Outreach, Policy, American Sign Language, Non-profits, Public Speaking, Employee Relations, Human Resources, Workforce Planning, Job Analysis, Organizational..., Recruiting, HRIS, Performance Management, Onboarding, Data Analysis, Personnel Management, College Recruiting, Event Planning, Interviews, Resume Writing, Talent Management, Nonprofits, Leadership Development, Deferred Compensation, Temporary Placement, Labor Relations, Training, Employee Training, Succession Planning, Conflict Resolution, Leadership, New Hire Orientations, Applicant Tracking..., Career Counseling, Government, HR Policies
Education
Rochester Institute of Technology 2001 — 2003
Master of Science (MS), HR Development
FDA September 2012 - Present
National Institutes of Health March 2007 - September 2012
United States Department of Defense March 2004 - March 2007
Skills
Research, Community Outreach, Policy, American Sign Language, Non-profits, Public Speaking, Employee Relations, Human Resources, Workforce Planning, Job Analysis, Organizational..., Recruiting, HRIS, Performance Management, Onboarding, Data Analysis, Personnel Management, College Recruiting, Event Planning, Interviews, Resume Writing, Talent Management, Nonprofits, Leadership Development, Deferred Compensation, Temporary Placement, Labor Relations, Training, Employee Training, Succession Planning, Conflict Resolution, Leadership, New Hire Orientations, Applicant Tracking..., Career Counseling, Government, HR Policies
Education
Rochester Institute of Technology 2001 — 2003
Master of Science (MS), HR Development
Jenna Hopkins's FDA Experience September 2010 - May 2011
Job Student at Rochester Institute of Technology
Industry Mechanical or Industrial Engineering
Experience
Rochester Institute of Technology 2011 - Present
Keurig Green Mountain, Inc. January 2015 - July 2015
S.M.A.R.T Laboratory - Rochester Institute of Technology May 2014 - July 2014
DuPont March 2013 - August 2013
S.M.A.R.T. Laboratory - Rochester Institute of Technology June 2012 - August 2012
FDA September 2010 - May 2011
Skills
Microsoft Office, Solidworks, NI LabVIEW, Matlab, VBA, PVElite, Photoshop, PowerPoint, SolidWorks
Education
Rochester Institute of Technology 2011 — 2016
Bachelor's Degree, Mechanical Engineering, 3rd Year
Rochester Institute of Technology 2011 - Present
Keurig Green Mountain, Inc. January 2015 - July 2015
S.M.A.R.T Laboratory - Rochester Institute of Technology May 2014 - July 2014
DuPont March 2013 - August 2013
S.M.A.R.T. Laboratory - Rochester Institute of Technology June 2012 - August 2012
FDA September 2010 - May 2011
Skills
Microsoft Office, Solidworks, NI LabVIEW, Matlab, VBA, PVElite, Photoshop, PowerPoint, SolidWorks
Education
Rochester Institute of Technology 2011 — 2016
Bachelor's Degree, Mechanical Engineering, 3rd Year
Narayan Nair's FDA Experience October 2011 - July 2014
Job Chief Medical Officer, Branch Chief, Division of Injury Compensation Programs, HRSA
Industry Health, Wellness and Fitness
Experience
Commissioned Corps of the U.S. Public Health Service August 2014 - Present
FDA October 2011 - July 2014
Commissioned Corps of the U.S. Public Health Service November 2008 - September 2011
FDA June 2003 - October 2007
FDA July 2002 - June 2003
Indian Health Service June 2000 - May 2002
Commissioned Corps of the U.S. Public Health Service July 1997 - May 2000
Wright Patterson Hospital July 1994 - June 1997
Skills
Epidemiology, Public Health, Health Policy, Emergency Management, Emergency Medicine, Global Health, Health Education, Healthcare Management, Prevention, Emergency Services, Program Development, International Health, Healthcare, Health Promotion, Infectious Diseases, Disaster Response, Grants, Policy, Medicine, Program Evaluation, Community Health, Public Health Emergency..., Health Communication, Preparedness, Medical Education, Disaster Medicine, Environmental Health, Clinical Research, Health Equity, Internal Medicine, Government
Education
Uniformed Services University of the Health Sciences - F Edward Hebert SOM 1990 — 1994
Doctor of Medicine (M.D.), Medicine
Saint Louis University 1986 — 1990
Bachelor of Science (B.S.), Biology, General
Commissioned Corps of the U.S. Public Health Service August 2014 - Present
FDA October 2011 - July 2014
Commissioned Corps of the U.S. Public Health Service November 2008 - September 2011
FDA June 2003 - October 2007
FDA July 2002 - June 2003
Indian Health Service June 2000 - May 2002
Commissioned Corps of the U.S. Public Health Service July 1997 - May 2000
Wright Patterson Hospital July 1994 - June 1997
Skills
Epidemiology, Public Health, Health Policy, Emergency Management, Emergency Medicine, Global Health, Health Education, Healthcare Management, Prevention, Emergency Services, Program Development, International Health, Healthcare, Health Promotion, Infectious Diseases, Disaster Response, Grants, Policy, Medicine, Program Evaluation, Community Health, Public Health Emergency..., Health Communication, Preparedness, Medical Education, Disaster Medicine, Environmental Health, Clinical Research, Health Equity, Internal Medicine, Government
Education
Uniformed Services University of the Health Sciences - F Edward Hebert SOM 1990 — 1994
Doctor of Medicine (M.D.), Medicine
Saint Louis University 1986 — 1990
Bachelor of Science (B.S.), Biology, General
Arnold Solomon's FDA Experience 1976 - 1989
Job President at FDA Strategic Compliance LLC
Industry Medical Devices
Experience
FDA Strategic Compliance LLC September 2011 - Present
Roche Diagnostics April 2000 - October 2011
Roche Corporate August 1989 - April 2000
FDA 1976 - 1989
Food and Drug Administration March 1972 - 1976
Skills
Regulatory Submissions, FDA, GMP, Pharmaceutical Industry, 21 CFR Part 11, Regulatory Affairs, CAPA, Oncology, Quality Control, Validation, Drug Development, Sop, Biotechnology, Technology Transfer, Medical Devices, Clinical Development, GCP, Regulatory Requirements, Pharmaceutics, Clinical Trials
Education
Rutgers University
BS, Physiology, Pathology and Related Sciences
Rutgers, The State University of New Jersey-Newark
Physiology, General
FDA Strategic Compliance LLC September 2011 - Present
Roche Diagnostics April 2000 - October 2011
Roche Corporate August 1989 - April 2000
FDA 1976 - 1989
Food and Drug Administration March 1972 - 1976
Skills
Regulatory Submissions, FDA, GMP, Pharmaceutical Industry, 21 CFR Part 11, Regulatory Affairs, CAPA, Oncology, Quality Control, Validation, Drug Development, Sop, Biotechnology, Technology Transfer, Medical Devices, Clinical Development, GCP, Regulatory Requirements, Pharmaceutics, Clinical Trials
Education
Rutgers University
BS, Physiology, Pathology and Related Sciences
Rutgers, The State University of New Jersey-Newark
Physiology, General
Fiona Chao's FDA Experience September 2013 - October 2013
Job Clinical Pharmacist
Industry Hospital & Health Care
Experience
Indian Health Service June 2014 - Present
National Supply Service Center Rotation June 2015 - June 2015
Walgreens December 2011 - June 2014
Pathmark Stores, Inc. March 2014 - May 2014
St. Joseph's Healthcare System February 2014 - March 2014
Kmart Corporation January 2014 - February 2014
Robert Wood Johnson University Hospital November 2013 - December 2013
St. Joseph's Healthcare System October 2013 - November 2013
FDA September 2013 - October 2013
Englewood Hospital and Medical Center July 2013 - August 2013
Skills
Community Pharmacy, Patient Counseling, Patient Education, Cpr Certified, Diabetes, Pharmacists, Pharmacy Automation, Healthcare, Immunization
Education
Rutgers, The State University of New Jersey-New Brunswick 2010 — 2014
Doctor of Pharmacy (Pharm.D.)
The University of Connecticut 2008 — 2010
Indian Health Service June 2014 - Present
National Supply Service Center Rotation June 2015 - June 2015
Walgreens December 2011 - June 2014
Pathmark Stores, Inc. March 2014 - May 2014
St. Joseph's Healthcare System February 2014 - March 2014
Kmart Corporation January 2014 - February 2014
Robert Wood Johnson University Hospital November 2013 - December 2013
St. Joseph's Healthcare System October 2013 - November 2013
FDA September 2013 - October 2013
Englewood Hospital and Medical Center July 2013 - August 2013
Skills
Community Pharmacy, Patient Counseling, Patient Education, Cpr Certified, Diabetes, Pharmacists, Pharmacy Automation, Healthcare, Immunization
Education
Rutgers, The State University of New Jersey-New Brunswick 2010 — 2014
Doctor of Pharmacy (Pharm.D.)
The University of Connecticut 2008 — 2010
Beth Rogerson's FDA Experience November 2007 - Present
Job CSO at USFDA
Industry Public Safety
Experience
FDA November 2007 - Present
WRAMC March 2004 - November 2007
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Research, Windows, Outlook, Photoshop, Teaching, Healthcare, Public Speaking, Cpr Certified, Retail, Supervisory Skills, Coaching, Team Leadership, Policy, Technical Writing, Team Building, Editing, Management, Project Planning, Training, Data Entry, Nonprofits, Social Networking, SPSS, Sales, Project Management, Data Analysis, Social Media, Risk Management, Budgets, Analysis, Time Management, Access, Teamwork, System Administration, Software Documentation, Event Planning, Government, Negotiation, Quality Assurance, Strategic Planning, Statistics, Fundraising, Spanish, Toxicology
Education
Salisbury State University
Bachelor of Science (BS), Environmental Health
Salisbury State University
Bachelor of Science (BS), Clinical Laboratory Science/Medical Technology/Technologist
FDA November 2007 - Present
WRAMC March 2004 - November 2007
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Research, Windows, Outlook, Photoshop, Teaching, Healthcare, Public Speaking, Cpr Certified, Retail, Supervisory Skills, Coaching, Team Leadership, Policy, Technical Writing, Team Building, Editing, Management, Project Planning, Training, Data Entry, Nonprofits, Social Networking, SPSS, Sales, Project Management, Data Analysis, Social Media, Risk Management, Budgets, Analysis, Time Management, Access, Teamwork, System Administration, Software Documentation, Event Planning, Government, Negotiation, Quality Assurance, Strategic Planning, Statistics, Fundraising, Spanish, Toxicology
Education
Salisbury State University
Bachelor of Science (BS), Environmental Health
Salisbury State University
Bachelor of Science (BS), Clinical Laboratory Science/Medical Technology/Technologist
Julia Jingyu Luan's FDA Experience January 2006 - Present
Job Statistician at FDA
Industry Government Administration
Experience
FDA January 2006 - Present
Johns Hopkins University March 2004 - January 2006
Skills
Epidemiology, Biostatistics, Public Health, SAS, Statistics, Clinical Study Design, Statistical Consulting, Statistical Modeling, Data Analysis
Education
University of Kentucky 1999 — 2004
Ph.D., Statistics
Renmin University of China 1992 — 1996
Bachelor of Science (B.S.), Statistics
FDA January 2006 - Present
Johns Hopkins University March 2004 - January 2006
Skills
Epidemiology, Biostatistics, Public Health, SAS, Statistics, Clinical Study Design, Statistical Consulting, Statistical Modeling, Data Analysis
Education
University of Kentucky 1999 — 2004
Ph.D., Statistics
Renmin University of China 1992 — 1996
Bachelor of Science (B.S.), Statistics
K. Gary Barnette's FDA Experience 1995 - 1998
Job Vice President, Drug Development at Camargo Pharmaceutical Services
Industry Pharmaceuticals
Experience
Camargo Pharmaceutical Services 2012 - Present
GTx, Inc. 2001 - 2012
Solvay Pharmaceuticals 1998 - 2001
FDA 1995 - 1998
Skills
Drug Development, Regulatory Affairs, Clinical Research, Clinical Development, Biotechnology, Pharmaceutical Industry, Oncology, Clinical Trials, CRO, Lifesciences, GCP, Drug Discovery, CTMS, FDA, IND, Regulatory Submissions, EDC, GLP, Infectious Diseases, Sop
Education
West Virginia University 1989 — 1995
Doctor of Philosophy (PhD), Basic Pharmaceutical Sciences
Salem International University 1986 — 1989
Bachelor of Science (BS), Biology (Chemistry minor)
Camargo Pharmaceutical Services 2012 - Present
GTx, Inc. 2001 - 2012
Solvay Pharmaceuticals 1998 - 2001
FDA 1995 - 1998
Skills
Drug Development, Regulatory Affairs, Clinical Research, Clinical Development, Biotechnology, Pharmaceutical Industry, Oncology, Clinical Trials, CRO, Lifesciences, GCP, Drug Discovery, CTMS, FDA, IND, Regulatory Submissions, EDC, GLP, Infectious Diseases, Sop
Education
West Virginia University 1989 — 1995
Doctor of Philosophy (PhD), Basic Pharmaceutical Sciences
Salem International University 1986 — 1989
Bachelor of Science (BS), Biology (Chemistry minor)
Jonathan Myung's FDA Experience September 2012 - June 2013
Job Microbiology Analyst Intern at the FDA
Industry Hospital & Health Care
Experience
FDA September 2012 - June 2013
Itempool Academy December 2006 - May 2013
New York City Department of Environmental Protection August 2012 - December 2012
Flushing Pain Management September 2010 - August 2012
Heo Dental Lab December 2007 - January 2008
Skills
Cell Culture, Microbiology, Lifesciences, Science, Data Analysis, Laboratory, Statistics
Education
University of Maryland Baltimore 2013 — 2017
Doctor of Pharmacy (PharmD), Pharmacy
Queensborough Community College 2012 — 2013
Non-Degree
SUNY Geneseo 2006 — 2010
Bachelor of Science (BS), Biology/Biological Sciences, General
FDA September 2012 - June 2013
Itempool Academy December 2006 - May 2013
New York City Department of Environmental Protection August 2012 - December 2012
Flushing Pain Management September 2010 - August 2012
Heo Dental Lab December 2007 - January 2008
Skills
Cell Culture, Microbiology, Lifesciences, Science, Data Analysis, Laboratory, Statistics
Education
University of Maryland Baltimore 2013 — 2017
Doctor of Pharmacy (PharmD), Pharmacy
Queensborough Community College 2012 — 2013
Non-Degree
SUNY Geneseo 2006 — 2010
Bachelor of Science (BS), Biology/Biological Sciences, General
Meagan Green's FDA Experience May 2012 - Present
Job Student at Salisbury University
Industry Government Administration
Experience
FDA May 2012 - Present
Target June 2008 - August 2008
Mentally Gifted Minors Daycare June 2007 - August 2007
Skills
Microsoft Office, Typing, Writing, SPSS, Qualtrics, PDF Creator, Research, Secretarial Skills, Academic Tutoring
Education
Salisbury University 2009 — 2013
Bachelor's degree, Psychology, 3.3
St. Elizabeth Ann Seton High School 2005 — 2009
FDA May 2012 - Present
Target June 2008 - August 2008
Mentally Gifted Minors Daycare June 2007 - August 2007
Skills
Microsoft Office, Typing, Writing, SPSS, Qualtrics, PDF Creator, Research, Secretarial Skills, Academic Tutoring
Education
Salisbury University 2009 — 2013
Bachelor's degree, Psychology, 3.3
St. Elizabeth Ann Seton High School 2005 — 2009
Lawrence O'Connor Jr's FDA Experience August 1993 - July 1998
Job Asst Chief at United States Marshals Service
Industry Law Enforcement
Experience
United States Marshals Service January 2013 - Present
United States Marine Corps October 1981 - February 2003
FDA August 1993 - July 1998
Skills
Criminal Justice, Homeland Security, Enforcement, Police, Physical Security, Criminal Investigations, Tactics, Counterterrorism, Firearms, Emergency Management, SWAT, Patrol, Weapons of Mass..., Law Enforcement..., Public Safety, Interrogation, Law Enforcement
Education
Saint ALselm College 1977 — 1981
Bachelor of Science (B.S.), Criminal Justice and Corrections
Saint Anselm College 1977 — 1981
United States Marshals Service January 2013 - Present
United States Marine Corps October 1981 - February 2003
FDA August 1993 - July 1998
Skills
Criminal Justice, Homeland Security, Enforcement, Police, Physical Security, Criminal Investigations, Tactics, Counterterrorism, Firearms, Emergency Management, SWAT, Patrol, Weapons of Mass..., Law Enforcement..., Public Safety, Interrogation, Law Enforcement
Education
Saint ALselm College 1977 — 1981
Bachelor of Science (B.S.), Criminal Justice and Corrections
Saint Anselm College 1977 — 1981
Anil Pendse's FDA Experience March 2002 - June 2013
Job Pharma Consultant
Industry Pharmaceuticals
Experience
FDA March 2002 - June 2013
Carter -Wallace Corp January 2001 - January 2002
PMC Specialties Group January 1986 - October 2000
Hatco Chemical Corporation January 1981 - January 1985
Rutgers University January 1980 - January 1982
Lypho-Med January 1978 - January 1979
Skills
Pre-Review of CMC..., Experties in QBR and..., Contact person between..., Regulatory Services, Research, Pharmaceutics, Pharmaceutical Industry, Regulatory Agencies, GMP, Chemistry, R&D, HPLC, Formulation, FDA, IR, Regulatory Submissions, Analytical Chemistry, Quality Assurance, Biotechnology
Education
Rutgers University-New Brunswick 1976 — 1978
Post Doctoral Fellowship, Synthesis and Characterization of Hypervalent Organo Phosphorous compounds
University of Bombay 1970 — 1974
Doctor of Philosophy (Ph.D.), Pharmaceutical Chemistry
University of Bombay 1967 — 1969
Master's degree, Pharmaceuticals and Fine Chemicals
University of Bombay 1964 — 1967
Bachelor's degree, Pharmaceuticals and Fine Chemicals
FDA March 2002 - June 2013
Carter -Wallace Corp January 2001 - January 2002
PMC Specialties Group January 1986 - October 2000
Hatco Chemical Corporation January 1981 - January 1985
Rutgers University January 1980 - January 1982
Lypho-Med January 1978 - January 1979
Skills
Pre-Review of CMC..., Experties in QBR and..., Contact person between..., Regulatory Services, Research, Pharmaceutics, Pharmaceutical Industry, Regulatory Agencies, GMP, Chemistry, R&D, HPLC, Formulation, FDA, IR, Regulatory Submissions, Analytical Chemistry, Quality Assurance, Biotechnology
Education
Rutgers University-New Brunswick 1976 — 1978
Post Doctoral Fellowship, Synthesis and Characterization of Hypervalent Organo Phosphorous compounds
University of Bombay 1970 — 1974
Doctor of Philosophy (Ph.D.), Pharmaceutical Chemistry
University of Bombay 1967 — 1969
Master's degree, Pharmaceuticals and Fine Chemicals
University of Bombay 1964 — 1967
Bachelor's degree, Pharmaceuticals and Fine Chemicals
Jamal Burke, MPH's FDA Experience February 2009 - March 2010
Job Public Health Professional
Industry Hospital & Health Care
Experience
n/a - currently unemployed Student InternBrownsville Multi-Service Family Health CenterSeptember 2012 - August 2013
SUNY Downstate Medical Center September 2011 - May 2012
SUNY Downstate Medical Center-- Infectious Disease Department June 2010 - September 2010
FDA February 2009 - March 2010
SUNY Downstate Medical Center September 2005 - June 2008
Skills
Microsoft Office, Data Analysis, Microsoft Excel, Microsoft Word, Project Management, Management, Customer Service, Social Media, Strategic Planning, Program Management
Education
State University of New York Downstate Medical Center College of Medicine 2010 — 2013
Master’s Degree, Public Health
Rutgers University-New Brunswick 2004 — 2008
Bachelor’s Degree, Biology/Biological Sciences, General
n/a - currently unemployed Student InternBrownsville Multi-Service Family Health CenterSeptember 2012 - August 2013
SUNY Downstate Medical Center September 2011 - May 2012
SUNY Downstate Medical Center-- Infectious Disease Department June 2010 - September 2010
FDA February 2009 - March 2010
SUNY Downstate Medical Center September 2005 - June 2008
Skills
Microsoft Office, Data Analysis, Microsoft Excel, Microsoft Word, Project Management, Management, Customer Service, Social Media, Strategic Planning, Program Management
Education
State University of New York Downstate Medical Center College of Medicine 2010 — 2013
Master’s Degree, Public Health
Rutgers University-New Brunswick 2004 — 2008
Bachelor’s Degree, Biology/Biological Sciences, General
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