FDA Company
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Headquarters: Silver Spring, Maryland, United States Employees: 14,824 (2010) Jurisdiction: United States of America Founded: 30 June 1906 Subsidiaries: Center for Drug Evaluation and Research, Founders: Theodore Roosevelt, Harvey Washington Wiley
FDA List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at FDA. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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FDA Employees
Employee
Years
Job
Industry
Juneous Pettijohn Juneous Pettijohn's FDA Experience November 2010 - Present
Job Owner of CALMFIDENCE Institute
Industry Health, Wellness and Fitness
Experience
CALMFIDENCE Institute August 2011 - Present
FDA November 2010 - Present
Spiritual Essence Yoga January 2010 - March 2013
Centers for Medicare and Medicaid Services February 2005 - November 2010
Skills
Yoga, Reiki, Lifestyle, Nutrition, Hatha Yoga, Bodywork, Life Coaching, Thai Massage, Health Education, Wellness, Fitness, Holistic Health, Wellness Coaching, Lifestyle Coaching, Stress Management, Healing, Nutrition Education, Motivational Speaking, Teaching, Prevention, Small Business, Treatment, Wellbeing, Weight Management, Program Development, Stress, Coaching, Personal Training, Program Evaluation, Personal Development, Energy Healing, Meditation, Weight, Public Speaking, Entrepreneurship, Workshop Facilitation, Employee Wellness, Healthcare, Relaxation, Corporations, Fitness Training
Education
The University of Akron 1999 — 2002
MPH, Public Health
Kent State University 1993 — 1998
Bachelor's of Science, Community Health Education
CALMFIDENCE Institute August 2011 - Present
FDA November 2010 - Present
Spiritual Essence Yoga January 2010 - March 2013
Centers for Medicare and Medicaid Services February 2005 - November 2010
Skills
Yoga, Reiki, Lifestyle, Nutrition, Hatha Yoga, Bodywork, Life Coaching, Thai Massage, Health Education, Wellness, Fitness, Holistic Health, Wellness Coaching, Lifestyle Coaching, Stress Management, Healing, Nutrition Education, Motivational Speaking, Teaching, Prevention, Small Business, Treatment, Wellbeing, Weight Management, Program Development, Stress, Coaching, Personal Training, Program Evaluation, Personal Development, Energy Healing, Meditation, Weight, Public Speaking, Entrepreneurship, Workshop Facilitation, Employee Wellness, Healthcare, Relaxation, Corporations, Fitness Training
Education
The University of Akron 1999 — 2002
MPH, Public Health
Kent State University 1993 — 1998
Bachelor's of Science, Community Health Education
Shelby Marler Shelby Marler's FDA Experience December 2014 - Present
Job Consumer Safety Officer
Industry Government Administration
Experience
FDA December 2014 - Present
Kalon Biotherapeutics, LLC December 2011 - August 2014
Caliber Biotherapeutics, LLC August 2010 - December 2011
US Census Bureau April 2010 - July 2010
VGXI, Inc. January 2009 - August 2009
Opexa Therapeutics July 2004 - November 2008
Skills
GMP, Sop, Biotechnology, Biopharmaceuticals, CAPA, GxP, Quality Assurance, Software Documentation, Validation, FDA, Microbiology, Pharmaceutical Industry, GLP, Quality System, Clinical Trials, Microsoft Excel, Microsoft Word, SOP, Life Sciences
Education
University of Houston-Downtown 2005 — 2008
Bachelor of Science, Biotechnology
Lone Star College System 2002 — 2005
Associates Applied Science, Biotechnology
FDA December 2014 - Present
Kalon Biotherapeutics, LLC December 2011 - August 2014
Caliber Biotherapeutics, LLC August 2010 - December 2011
US Census Bureau April 2010 - July 2010
VGXI, Inc. January 2009 - August 2009
Opexa Therapeutics July 2004 - November 2008
Skills
GMP, Sop, Biotechnology, Biopharmaceuticals, CAPA, GxP, Quality Assurance, Software Documentation, Validation, FDA, Microbiology, Pharmaceutical Industry, GLP, Quality System, Clinical Trials, Microsoft Excel, Microsoft Word, SOP, Life Sciences
Education
University of Houston-Downtown 2005 — 2008
Bachelor of Science, Biotechnology
Lone Star College System 2002 — 2005
Associates Applied Science, Biotechnology
Elizabeth Cathy Baker Elizabeth Cathy Baker's FDA Experience September 2015 - Present
Job Administrative Support at FDA
Industry Facilities Services
Experience
FDA September 2015 - Present
FEMA June 2014 - January 2015
Villa Ventura Retirement August 2012 - June 2014
US Government August 2011 - March 2012
Truman Medical Center - Lakewood June 2011 - December 2011
Citifinancial June 2000 - January 2009
Citigroup August 1990 - June 2000
Skills
Leadership, Team Leadership, Team Building, Management, Recruiting, Training, Strategic Planning, Project Planning, Event Planning, Public Speaking, Analytical Skills, Finance, Budgets, Research, Marketing, Customer Service, Cross-cultural..., Time Management, Microsoft Word 2010, Microsoft Word, Microsoft Excel 2010, Microsoft Excel, Microsoft Access 2010, Access, Microsoft Powerpoint..., PowerPoint, Microsoft Publisher 2010, Microsoft Outllook 2010, Programming VBA 2010, Leadership Development, Highly motivated...
Education
Rockhurst University 2015 — 2017
Master of Business Administration (M.B.A.), and M.S. Business Intelligence and Analytics (dual degree)
Coursera
Data Science
Rockhurst University 2012 — 2015
Bachelor of Science in Business Administration (BSBA) International Business, and Bachelor of Arts (BA) Non-profit Leadership Studies with Fundraising Concentration, 3.93
Longview Community College 2009 — 2012
AA and AAB, Business, 3.82
Holden HIgh 1984 — 1988
Diploma
FDA September 2015 - Present
FEMA June 2014 - January 2015
Villa Ventura Retirement August 2012 - June 2014
US Government August 2011 - March 2012
Truman Medical Center - Lakewood June 2011 - December 2011
Citifinancial June 2000 - January 2009
Citigroup August 1990 - June 2000
Skills
Leadership, Team Leadership, Team Building, Management, Recruiting, Training, Strategic Planning, Project Planning, Event Planning, Public Speaking, Analytical Skills, Finance, Budgets, Research, Marketing, Customer Service, Cross-cultural..., Time Management, Microsoft Word 2010, Microsoft Word, Microsoft Excel 2010, Microsoft Excel, Microsoft Access 2010, Access, Microsoft Powerpoint..., PowerPoint, Microsoft Publisher 2010, Microsoft Outllook 2010, Programming VBA 2010, Leadership Development, Highly motivated...
Education
Rockhurst University 2015 — 2017
Master of Business Administration (M.B.A.), and M.S. Business Intelligence and Analytics (dual degree)
Coursera
Data Science
Rockhurst University 2012 — 2015
Bachelor of Science in Business Administration (BSBA) International Business, and Bachelor of Arts (BA) Non-profit Leadership Studies with Fundraising Concentration, 3.93
Longview Community College 2009 — 2012
AA and AAB, Business, 3.82
Holden HIgh 1984 — 1988
Diploma
Kevin Dong Kevin Dong's FDA Experience May 2013 - June 2013
Job Long term Care Pharmacist at Pacific West Pharmacy
Industry Pharmaceuticals
Experience
Pacific West Pharmacy May 2015 - Present
Target October 2014 - Present
Rite Aid Pharmacy October 2010 - October 2014
Sacramento County Main Jail March 2014 - May 2014
FDA May 2013 - June 2013
Skills
Patient Counseling, Community Pharmacy, Medication Therapy..., Clinical Research, Data Analysis
Education
California Northstate University College of Pharmacy 2010 — 2014
Doctor of Pharmacy, Pharmacy
University of California, San Diego 2007 — 2009
BS, Pharmacological Chemistry
Liaoning University
Liaoning University
liaoning
liaoning
liaoning
Pacific West Pharmacy May 2015 - Present
Target October 2014 - Present
Rite Aid Pharmacy October 2010 - October 2014
Sacramento County Main Jail March 2014 - May 2014
FDA May 2013 - June 2013
Skills
Patient Counseling, Community Pharmacy, Medication Therapy..., Clinical Research, Data Analysis
Education
California Northstate University College of Pharmacy 2010 — 2014
Doctor of Pharmacy, Pharmacy
University of California, San Diego 2007 — 2009
BS, Pharmacological Chemistry
Liaoning University
Liaoning University
liaoning
liaoning
liaoning
Lindsey Clawson Lindsey Clawson's FDA Experience September 2004 - April 2008
Job at
Industry Pharmaceuticals
Experience
U.S. Pharmacopeia January 2014 - Present
U.S. Pharmacopeia December 2010 - January 2014
U.S. Pharmacopeia July 2008 - December 2010
FDA September 2004 - April 2008
Skills
Proofreading, Publications, Editing, Copy Editing, Publishing, Content Management, Web Content, Technical Writing, Strategic Communications, Pharmaceutical Industry, Internal Communications, Editorial, Public Relations, Content Strategy, Web Content Management
Education
University of Maryland University College 2012 — 2013
Master of Business Administration (MBA), MBA
Kenyon College 1999 — 2003
Bachelor of Arts (B.A.), English and Psychology
U.S. Pharmacopeia January 2014 - Present
U.S. Pharmacopeia December 2010 - January 2014
U.S. Pharmacopeia July 2008 - December 2010
FDA September 2004 - April 2008
Skills
Proofreading, Publications, Editing, Copy Editing, Publishing, Content Management, Web Content, Technical Writing, Strategic Communications, Pharmaceutical Industry, Internal Communications, Editorial, Public Relations, Content Strategy, Web Content Management
Education
University of Maryland University College 2012 — 2013
Master of Business Administration (MBA), MBA
Kenyon College 1999 — 2003
Bachelor of Arts (B.A.), English and Psychology
Michelle Frazier Michelle Frazier's FDA Experience 1997 - 2007
Job Senior Director, CMC Regulatory Affairs at AbbVie
Industry Biotechnology
Experience
AbbVie January 2015 - Present
Amgen July 2013 - January 2015
Amgen March 2012 - July 2013
Micromet/acquired by Amgen January 2011 - February 2013
MacroGenics, Inc. June 2009 - December 2010
MedImmune, an Astra Zeneca company May 2007 - June 2009
FDA 1997 - 2007
Skills
Immunology, Clinical Trials, CRO, FDA, Biotechnology, IND, Biologics, 21 CFR Part 11, Regulatory Submissions, GLP, Biopharmaceuticals, Molecular Biology, CAPA, Sop, Regulatory Affairs, Validation, Drug Development, Pharmaceutical Industry, Technology Transfer, Clinical Development, Oncology, V&V, Change Control, Monoclonal Antibodies, Regulatory Requirements, Vaccines, GMP, GCP, Lifesciences, CMC Regulatory Affairs
Education
Loyola University Chicago 1988 — 1994
Ph.D., Cell Biology, Neurobiology & Anatomy
Washington State University 1983 — 1988
B.S., Microbiology
AbbVie January 2015 - Present
Amgen July 2013 - January 2015
Amgen March 2012 - July 2013
Micromet/acquired by Amgen January 2011 - February 2013
MacroGenics, Inc. June 2009 - December 2010
MedImmune, an Astra Zeneca company May 2007 - June 2009
FDA 1997 - 2007
Skills
Immunology, Clinical Trials, CRO, FDA, Biotechnology, IND, Biologics, 21 CFR Part 11, Regulatory Submissions, GLP, Biopharmaceuticals, Molecular Biology, CAPA, Sop, Regulatory Affairs, Validation, Drug Development, Pharmaceutical Industry, Technology Transfer, Clinical Development, Oncology, V&V, Change Control, Monoclonal Antibodies, Regulatory Requirements, Vaccines, GMP, GCP, Lifesciences, CMC Regulatory Affairs
Education
Loyola University Chicago 1988 — 1994
Ph.D., Cell Biology, Neurobiology & Anatomy
Washington State University 1983 — 1988
B.S., Microbiology
Brian Czornyj's FDA Experience June 2014 - Present
Job Operations Research Analyst at FDA
Industry Pharmaceuticals
Experience
FDA June 2014 - Present
St. Luke's University Health Network 2012 - 2013
Lehigh University June 2009 - December 2010
Lehigh University August 2008 - December 2008
Skills
Access, Microsoft Excel, MS Excel Pivot Tables, PowerPoint, Stata, Arena Simulation..., SQL, Oracle SQL Developer, Optimization, Mathematical Modeling, Statistics, Mathematical Analysis, Healthcare Management, Healthcare Information..., Change Management, Presentations, Teamwork, Data Analysis, Databases, Data Modeling, Data Management, Data Mining, Analysis, Business Analysis, Analytics
Education
Lehigh University 2011 — 2013
Master of Engineering (MEng), Healthcare Systems Engineering, 3.4
Lehigh University 2007 — 2011
Bachelor of Science (BS), Biochemistry, 3.8
Lehigh University 2007 — 2011
Bachelor of Arts (BA), Economics, 3.8
FDA June 2014 - Present
St. Luke's University Health Network 2012 - 2013
Lehigh University June 2009 - December 2010
Lehigh University August 2008 - December 2008
Skills
Access, Microsoft Excel, MS Excel Pivot Tables, PowerPoint, Stata, Arena Simulation..., SQL, Oracle SQL Developer, Optimization, Mathematical Modeling, Statistics, Mathematical Analysis, Healthcare Management, Healthcare Information..., Change Management, Presentations, Teamwork, Data Analysis, Databases, Data Modeling, Data Management, Data Mining, Analysis, Business Analysis, Analytics
Education
Lehigh University 2011 — 2013
Master of Engineering (MEng), Healthcare Systems Engineering, 3.4
Lehigh University 2007 — 2011
Bachelor of Science (BS), Biochemistry, 3.8
Lehigh University 2007 — 2011
Bachelor of Arts (BA), Economics, 3.8
Alexey Khalenkov Alexey Khalenkov's FDA Experience July 2014 - Present
Job ORISE fellow at FDA
Industry Biotechnology
Experience
FDA July 2014 - Present
ImmuNext March 2013 - July 2014
Dartmouth-Hitchcock September 2012 - March 2013
Dartmouth College, Dartmouth Hitchcock Medical Center December 2010 - March 2012
St. Jude Children's Research Hospital September 2006 - December 2010
Skills
Molecular Biology, ELISA, Monoclonal Antibodies, Animal Models, Transfection, RT-PCR, Gel Electrophoresis, Genotyping, Purification, In Vivo, Virology, SDS-PAGE, Herpes simplex, Tumor Immunology, Molecular Microbiology, Southern Blot, Luciferase Assay, Sequencing, Sequence Analysis, Influenza, Laser Physics, Surface Plasmon..., Biacore
Education
P.N. Lebedev Moscow Institute of Physics, Russian Academy of Science 2001 — 2006
Doctor of Philosophy (PhD), Physics, Mathematics
Lomonosov Moscow State University (MSU) 1995 — 2001
Master of Science (M.Sc.), Physics
FDA July 2014 - Present
ImmuNext March 2013 - July 2014
Dartmouth-Hitchcock September 2012 - March 2013
Dartmouth College, Dartmouth Hitchcock Medical Center December 2010 - March 2012
St. Jude Children's Research Hospital September 2006 - December 2010
Skills
Molecular Biology, ELISA, Monoclonal Antibodies, Animal Models, Transfection, RT-PCR, Gel Electrophoresis, Genotyping, Purification, In Vivo, Virology, SDS-PAGE, Herpes simplex, Tumor Immunology, Molecular Microbiology, Southern Blot, Luciferase Assay, Sequencing, Sequence Analysis, Influenza, Laser Physics, Surface Plasmon..., Biacore
Education
P.N. Lebedev Moscow Institute of Physics, Russian Academy of Science 2001 — 2006
Doctor of Philosophy (PhD), Physics, Mathematics
Lomonosov Moscow State University (MSU) 1995 — 2001
Master of Science (M.Sc.), Physics
Danyell Wilson Danyell Wilson's FDA Experience June 2000 - August 2000
Job Assistant Professor at Bowie State University
Industry Higher Education
Experience
Bowie State University September 2013 - Present
Danyell W. Medical Writing March 2013 - September 2013
University of South Florida September 2010 - 2013
Florida Department of Health August 2012 - September 2012
Moffitt Cancer Center February 2010 - July 2012
J. Proyer Group October 2011 - November 2011
University of Florida, Chemistry Department May 2003 - May 2009
Wadsworth Center, BioNanotechnology Center with Cornell University June 2002 - September 2002
University of Florida June 2001 - September 2001
FDA June 2000 - August 2000
Skills
Scientific Writing, Data Analysis, Program Management, Grant Writing, Interviewing, microsoft office suites, Public Speaking, Publications, systematic reviews, Training & Development, SPSS, SAS, Technical Writing, Report Writing, Medical Writing, PowerPoint, Prezi, Meta Analysis, Western Blotting, Protein Chemistry, Meta-analysis, Employee Training, HPLC, Cell Culture, Chemistry, Proposal Writing, Microsoft Office, Clinical Research, Spectroscopy, Clinical Trials, Interviews, Qualitative Research, Systematic Reviews, Cancer, Biochemistry
Education
University of Florida 2006 — 2009
PhD
University of Florida 2003 — 2006
Masters
Lincoln University 1999 — 2003
BS, Chemistry
Bowie State University September 2013 - Present
Danyell W. Medical Writing March 2013 - September 2013
University of South Florida September 2010 - 2013
Florida Department of Health August 2012 - September 2012
Moffitt Cancer Center February 2010 - July 2012
J. Proyer Group October 2011 - November 2011
University of Florida, Chemistry Department May 2003 - May 2009
Wadsworth Center, BioNanotechnology Center with Cornell University June 2002 - September 2002
University of Florida June 2001 - September 2001
FDA June 2000 - August 2000
Skills
Scientific Writing, Data Analysis, Program Management, Grant Writing, Interviewing, microsoft office suites, Public Speaking, Publications, systematic reviews, Training & Development, SPSS, SAS, Technical Writing, Report Writing, Medical Writing, PowerPoint, Prezi, Meta Analysis, Western Blotting, Protein Chemistry, Meta-analysis, Employee Training, HPLC, Cell Culture, Chemistry, Proposal Writing, Microsoft Office, Clinical Research, Spectroscopy, Clinical Trials, Interviews, Qualitative Research, Systematic Reviews, Cancer, Biochemistry
Education
University of Florida 2006 — 2009
PhD
University of Florida 2003 — 2006
Masters
Lincoln University 1999 — 2003
BS, Chemistry
Andre Ferrell Andre Ferrell's FDA Experience September 2002 - October 2004
Job Business Analyst at Vision Technology Services
Industry Management Consulting
Experience
Vision Technology Services January 2015 - Present
PwC March 2012 - January 2015
PwC March 2012 - January 2015
Hugh O'Brian Youth Leadership Maryland Seminar 1996 - January 2015
Deloitte May 2009 - March 2012
BearingPoint February 2008 - May 2009
StartingBloc February 2008 - March 2008
DOJ October 2004 - February 2008
FDA September 2002 - October 2004
Skills
Program Management, Business Process..., Management, Training, Management Consulting, Analysis, Leadership, Policy, Leadership Development, Microsoft Office, Nonprofits, Process Improvement, Business Process, Visio, Youth Mentoring, Functional Analysis, User Acceptance Testing, HR Consulting, Volunteer Management, Litigation Support, Valuation, Program Development, System Testing, End User Training, Training & Development, Retreat Facilitation, Project Coordination, MS Office Suite, Teamwork, PeopleTools, Business Management, Volunteering, Higher Education, Education, Non-profits, Staff Development, Workshop Facilitation, Project Planning, Adult Learning..., Blackboard
Education
Trinity University-Washington 2005 — 2006
MSA, Organizational Management
Loyola University Maryland 1998 — 2002
BBA, Business
Albert Einstein High School 1994 — 1998
HS Diploma
Vision Technology Services January 2015 - Present
PwC March 2012 - January 2015
PwC March 2012 - January 2015
Hugh O'Brian Youth Leadership Maryland Seminar 1996 - January 2015
Deloitte May 2009 - March 2012
BearingPoint February 2008 - May 2009
StartingBloc February 2008 - March 2008
DOJ October 2004 - February 2008
FDA September 2002 - October 2004
Skills
Program Management, Business Process..., Management, Training, Management Consulting, Analysis, Leadership, Policy, Leadership Development, Microsoft Office, Nonprofits, Process Improvement, Business Process, Visio, Youth Mentoring, Functional Analysis, User Acceptance Testing, HR Consulting, Volunteer Management, Litigation Support, Valuation, Program Development, System Testing, End User Training, Training & Development, Retreat Facilitation, Project Coordination, MS Office Suite, Teamwork, PeopleTools, Business Management, Volunteering, Higher Education, Education, Non-profits, Staff Development, Workshop Facilitation, Project Planning, Adult Learning..., Blackboard
Education
Trinity University-Washington 2005 — 2006
MSA, Organizational Management
Loyola University Maryland 1998 — 2002
BBA, Business
Albert Einstein High School 1994 — 1998
HS Diploma
Marie Bradley, PhD Marie Bradley, PhD's FDA Experience January 2014 - Present
Job Cancer Prevention FellowPharmacoepidemiologist, National Cancer Institute and FDA, United States,
Industry Research
Experience
Georgetown Lombardi Comprehensive Cancer Center April 2014 - Present
FDA January 2014 - Present
National Cancer Institute September 2012 - Present
Alliance Boots August 2006 - August 2013
Royal College of Surgeons in Ireland September 2011 - September 2012
DocMorris September 2011 - September 2012
Queen's University Belfast September 2009 - September 2011
Queen's University Belfast September 2006 - August 2009
Gordons Chemists July 2005 - July 2006
Skills
Pharmacoepidemiology, Public Health, Cancer, Research, Epidemiology, Clinical Research, Statistics, Clinical Trials, Stata, Molecular Biology, Cancer Research, Pharmacy, Cancer prevention, Chemoprevention, Pharmacy in primary care, Medicines Management, Translational Research, Inappropriate...
Education
London School of Hygiene and Tropical Medicine, U. of London 2012 — 2013
Master of Science (MSc) Public Health, Public Health
Queen's University Belfast 2006 — 2009
PhD, Pharmacoepidemiology
Queen's University Belfast 2001 — 2005
MPharm, Pharmacy, 1st Class Honors (3rd in Class)
Georgetown Lombardi Comprehensive Cancer Center April 2014 - Present
FDA January 2014 - Present
National Cancer Institute September 2012 - Present
Alliance Boots August 2006 - August 2013
Royal College of Surgeons in Ireland September 2011 - September 2012
DocMorris September 2011 - September 2012
Queen's University Belfast September 2009 - September 2011
Queen's University Belfast September 2006 - August 2009
Gordons Chemists July 2005 - July 2006
Skills
Pharmacoepidemiology, Public Health, Cancer, Research, Epidemiology, Clinical Research, Statistics, Clinical Trials, Stata, Molecular Biology, Cancer Research, Pharmacy, Cancer prevention, Chemoprevention, Pharmacy in primary care, Medicines Management, Translational Research, Inappropriate...
Education
London School of Hygiene and Tropical Medicine, U. of London 2012 — 2013
Master of Science (MSc) Public Health, Public Health
Queen's University Belfast 2006 — 2009
PhD, Pharmacoepidemiology
Queen's University Belfast 2001 — 2005
MPharm, Pharmacy, 1st Class Honors (3rd in Class)
Tamara Brey, Esq. Tamara Brey, Esq.'s FDA Experience January 1996 - December 2001
Job Regulatory Management at Becton, Dickinson and Company
Industry Medical Devices
Experience
BD December 2014 - Present
Amin Talati, LLC January 2013 - December 2014
Barnes & Thornburg LLP February 2012 - May 2012
Navistar Inc January 2011 - January 2012
U.S. Department of Energy May 2011 - August 2011
Clinimetrics January 2001 - October 2004
FDA January 1996 - December 2001
Skills
Legal Research, Legal Writing, Patent Prosecution, Patentability, FDA, Medical Devices, Clinical Trials, Patents, Intellectual Property, Due Diligence, Copyright Law, Licensing, Invention, Trademarks, Dietary Supplement and..., FDA Food Faciliy..., FDA Drug Facility..., Over the Counter (OTC)..., Patent Drafting, Homeopathic Drugs, Prosecution, Pharmaceutical Industry, Legal Issues, Client Counseling, Patent Applications, Trials, Tax Law, Legal Assistance, Document Review, Appeals, Registered Patent..., Product Liability, Lexis, Litigation Support, Trademark Infringement, Westlaw, Corporate Law, Administrative Law, Dispute Resolution, Alternative Dispute..., Criminal Law, Health Law, International Law, Courts, Class Actions, Legal Compliance
Education
Loyola University Chicago School of Law 2008 — 2012
J.D., Juris Doctor
The University of Chicago
Graham School of General Studies - Certificate, Clinical Trials Management
Marquette University
B.S., Biomedical Engineering
BD December 2014 - Present
Amin Talati, LLC January 2013 - December 2014
Barnes & Thornburg LLP February 2012 - May 2012
Navistar Inc January 2011 - January 2012
U.S. Department of Energy May 2011 - August 2011
Clinimetrics January 2001 - October 2004
FDA January 1996 - December 2001
Skills
Legal Research, Legal Writing, Patent Prosecution, Patentability, FDA, Medical Devices, Clinical Trials, Patents, Intellectual Property, Due Diligence, Copyright Law, Licensing, Invention, Trademarks, Dietary Supplement and..., FDA Food Faciliy..., FDA Drug Facility..., Over the Counter (OTC)..., Patent Drafting, Homeopathic Drugs, Prosecution, Pharmaceutical Industry, Legal Issues, Client Counseling, Patent Applications, Trials, Tax Law, Legal Assistance, Document Review, Appeals, Registered Patent..., Product Liability, Lexis, Litigation Support, Trademark Infringement, Westlaw, Corporate Law, Administrative Law, Dispute Resolution, Alternative Dispute..., Criminal Law, Health Law, International Law, Courts, Class Actions, Legal Compliance
Education
Loyola University Chicago School of Law 2008 — 2012
J.D., Juris Doctor
The University of Chicago
Graham School of General Studies - Certificate, Clinical Trials Management
Marquette University
B.S., Biomedical Engineering
Tara Greene's FDA Experience August 2008 - May 2014
Job Director of Site Quality; Patheon Biologics, LLC
Industry Biotechnology
Experience
Patheon January 2015 - Present
Patheon October 2014 - January 2015
Gallus BioPharmaceuticals June 2014 - January 2015
FDA August 2008 - May 2014
Hematech LLC 1999 - 2008
Skills
Biotechnology, Biopharmaceuticals, Aseptic Processing, Validation, cGMP practices, Quality Auditing, cGMP manufacturing, Quality by Design, Pharmacueticals, Quality Management, APIs, API manufacturing, Process Improvement, Cleaning Validation, Analytical Method..., Cell Biology, Aseptic Technique, Mammalian Cell Culture, Cell Culture, Raw Materials, Technical Reports, Quality System, Supplier Quality, Report Writing, Site Investigation, Pharmaceutical Industry, FDA, Quality Assurance, GLP, Life Sciences, Quality Control, Change Control, SOP, 21 CFR Part 11, CAPA, Regulatory Affairs, Laboratory, Pharmaceutics, GMP, GxP
Education
San Diego State University-California State University 2006 — 2008
Master's of Science, Biomedical Quality Systems
Kansas State University 1996 — 1999
Bachelor of Science, Animal Sciences and Industry
Patheon January 2015 - Present
Patheon October 2014 - January 2015
Gallus BioPharmaceuticals June 2014 - January 2015
FDA August 2008 - May 2014
Hematech LLC 1999 - 2008
Skills
Biotechnology, Biopharmaceuticals, Aseptic Processing, Validation, cGMP practices, Quality Auditing, cGMP manufacturing, Quality by Design, Pharmacueticals, Quality Management, APIs, API manufacturing, Process Improvement, Cleaning Validation, Analytical Method..., Cell Biology, Aseptic Technique, Mammalian Cell Culture, Cell Culture, Raw Materials, Technical Reports, Quality System, Supplier Quality, Report Writing, Site Investigation, Pharmaceutical Industry, FDA, Quality Assurance, GLP, Life Sciences, Quality Control, Change Control, SOP, 21 CFR Part 11, CAPA, Regulatory Affairs, Laboratory, Pharmaceutics, GMP, GxP
Education
San Diego State University-California State University 2006 — 2008
Master's of Science, Biomedical Quality Systems
Kansas State University 1996 — 1999
Bachelor of Science, Animal Sciences and Industry
Enette Reese Enette Reese's FDA Experience June 2014 - Present
Job Management and Program Analyst at FDA
Industry Government Administration
Experience
FDA June 2014 - Present
Substance Abuse and Mental Health Service Administration 2013 - June 2014
US Army September 2005 - January 2013
US Army October 1996 - December 2005
Skills
Protocol, General Administrative..., Staff Supervision, Personnel Management, Radiologic Technology, Healthcare, Organization, Logistics, Equipment Management, Fundraising, File Management, Records Management, Written Correspondence, Travel Arrangements, Typing, Research, Employee Training, Public Relations, Editing, Time & Attendance, Document Management, Document Review, Policy, Project Coordination, Computer Proficiency, Training, Program Management, Spreadsheets, Microsoft Word, Government, Critical Thinking, Office Management, Medical Terminology, Military Experience, Cpr Certified, Organizational..., Defense Travel System, HIPAA, Office Equipment, Public Health, Force Protection, Outlook, Team-oriented, Office Administration, Time Management, Human Resources, Analysis, Management, Conflict Resolution, Federal Government
Education
University of Maryland University College 2010 — 2014
Bachelor's Degree, Psychology
Academy of Health Science 2006 — 2007
Certificate, Radiologic Technology/Science - Radiographer
Keiser College 2002 — 2003
Certificate, Phlebotomy Technician/Phlebotomist
FDA June 2014 - Present
Substance Abuse and Mental Health Service Administration 2013 - June 2014
US Army September 2005 - January 2013
US Army October 1996 - December 2005
Skills
Protocol, General Administrative..., Staff Supervision, Personnel Management, Radiologic Technology, Healthcare, Organization, Logistics, Equipment Management, Fundraising, File Management, Records Management, Written Correspondence, Travel Arrangements, Typing, Research, Employee Training, Public Relations, Editing, Time & Attendance, Document Management, Document Review, Policy, Project Coordination, Computer Proficiency, Training, Program Management, Spreadsheets, Microsoft Word, Government, Critical Thinking, Office Management, Medical Terminology, Military Experience, Cpr Certified, Organizational..., Defense Travel System, HIPAA, Office Equipment, Public Health, Force Protection, Outlook, Team-oriented, Office Administration, Time Management, Human Resources, Analysis, Management, Conflict Resolution, Federal Government
Education
University of Maryland University College 2010 — 2014
Bachelor's Degree, Psychology
Academy of Health Science 2006 — 2007
Certificate, Radiologic Technology/Science - Radiographer
Keiser College 2002 — 2003
Certificate, Phlebotomy Technician/Phlebotomist
Michele Patrick Michele Patrick's FDA Experience September 2011 - February 2012
Job Director of Communications at White House Conference on Aging
Industry Public Relations and Communications
Experience
White House Conference on Aging September 2014 - Present
Centers for Medicare & Medicaid Services March 2012 - October 2014
FDA September 2011 - February 2012
University of Pennsylvania September 2010 - August 2011
Georgetown University December 2006 - August 2010
Merck Institute of Aging and Health February 2001 - July 2006
US Department of Health and Human Services September 1997 - January 2001
United States Senate May 1996 - August 1997
City of Philadelphia July 1993 - May 1996
Skills
Press Releases, Strategic Communications, Media Relations, Corporate Communications, Internal Communications, Public Relations, Speech Writing, Public Affairs, Editing, Message Development, Copywriting, Newsletters, Public Speaking, Partner Development, International Economics, Editorial writing, Creative Writing, Script Writing, Social Media..., Research, Executive Managment, Copy Editing, Bylined Articles, Talking Points, Promo Videos, Report Writing, Nonprofits, Government, Politics, Public Policy, Editorial
Education
University of Pennsylvania 1988 — 1990
Masters Degree, Government Administration
University of London 1985 — 1986
Fulbright Scholar, Economics/Eastern European Studies
La Salle University 1981 — 1985
Bachelor of Arts (BA), economics/history, Magna Cum Laude
White House Conference on Aging September 2014 - Present
Centers for Medicare & Medicaid Services March 2012 - October 2014
FDA September 2011 - February 2012
University of Pennsylvania September 2010 - August 2011
Georgetown University December 2006 - August 2010
Merck Institute of Aging and Health February 2001 - July 2006
US Department of Health and Human Services September 1997 - January 2001
United States Senate May 1996 - August 1997
City of Philadelphia July 1993 - May 1996
Skills
Press Releases, Strategic Communications, Media Relations, Corporate Communications, Internal Communications, Public Relations, Speech Writing, Public Affairs, Editing, Message Development, Copywriting, Newsletters, Public Speaking, Partner Development, International Economics, Editorial writing, Creative Writing, Script Writing, Social Media..., Research, Executive Managment, Copy Editing, Bylined Articles, Talking Points, Promo Videos, Report Writing, Nonprofits, Government, Politics, Public Policy, Editorial
Education
University of Pennsylvania 1988 — 1990
Masters Degree, Government Administration
University of London 1985 — 1986
Fulbright Scholar, Economics/Eastern European Studies
La Salle University 1981 — 1985
Bachelor of Arts (BA), economics/history, Magna Cum Laude
Ryan Gallen Ryan Gallen's FDA Experience 2012 - 2012
Job LiveIn Nanny
Industry Individual & Family Services
Experience
Private Home December 2014 - Present
Right at Home Northern VA February 2014 - Present
AttentVision February 2013 - July 2014
FDA 2012 - 2012
Los Alamos National Lab October 2007 - May 2008
Skills
Microsoft Word, Microsoft Publisher, Microsoft Excel, PowerPoint, Windows, Apple, Adobe Photoshop, TEFL, Photoshop, Program Development, Management, Administrative..., Public Speaking, Marketing, Event Planning, Leadership Development, Training, Volunteer Management, Social Media, Teaching, Community Outreach, Government, Editing, Fundraising, Organizational..., Leadership, Nonprofits, Social Networking, Team Building, Research, Grant Writing
Education
The University of New Mexico 2008 — 2012
Bachelor of Arts (B.A.), Theatre/Theater
Landmark Education
Private Home December 2014 - Present
Right at Home Northern VA February 2014 - Present
AttentVision February 2013 - July 2014
FDA 2012 - 2012
Los Alamos National Lab October 2007 - May 2008
Skills
Microsoft Word, Microsoft Publisher, Microsoft Excel, PowerPoint, Windows, Apple, Adobe Photoshop, TEFL, Photoshop, Program Development, Management, Administrative..., Public Speaking, Marketing, Event Planning, Leadership Development, Training, Volunteer Management, Social Media, Teaching, Community Outreach, Government, Editing, Fundraising, Organizational..., Leadership, Nonprofits, Social Networking, Team Building, Research, Grant Writing
Education
The University of New Mexico 2008 — 2012
Bachelor of Arts (B.A.), Theatre/Theater
Landmark Education
Dhaval shah Dhaval shah's FDA Experience March 2015 - Present
Job ORISE Fellow at FDA/CDER
Industry Pharmaceuticals
Experience
FDA March 2015 - Present
Long Island University September 2010 - November 2014
Pfizer May 2014 - August 2014
Pfizer May 2012 - August 2012
Par Pharmaceutical May 2009 - August 2009
Skills
Formulation, HPLC, Dissolution, Drug Delivery, Pharmaceutics, Pharmaceutical Research, UV/Vis, FTIR, Chromatography, IR, Pharmacokinetics, Analytical Chemistry, Characterization, TGA, Pre-formulation, Nanotechnology, Differential Scanning..., Pharmaceutical Industry
Education
LIU Brooklyn 2010 — 2014
Doctor of Philosophy (PhD), Pharmaceutical science
Long Island University 2008 — 2010
M.S, Industrial and Physical Pharmacy
L.M.College of Pharmacy 2003 — 2007
B.Pharm
FDA March 2015 - Present
Long Island University September 2010 - November 2014
Pfizer May 2014 - August 2014
Pfizer May 2012 - August 2012
Par Pharmaceutical May 2009 - August 2009
Skills
Formulation, HPLC, Dissolution, Drug Delivery, Pharmaceutics, Pharmaceutical Research, UV/Vis, FTIR, Chromatography, IR, Pharmacokinetics, Analytical Chemistry, Characterization, TGA, Pre-formulation, Nanotechnology, Differential Scanning..., Pharmaceutical Industry
Education
LIU Brooklyn 2010 — 2014
Doctor of Philosophy (PhD), Pharmaceutical science
Long Island University 2008 — 2010
M.S, Industrial and Physical Pharmacy
L.M.College of Pharmacy 2003 — 2007
B.Pharm
Kimberly Danetta Story's FDA Experience May 1992 - Present
Job Pharmaceutical Chemist at FDA
Industry Government Administration
Experience
JAZZMIN'S EVENT PLANNING GROUP, LLC 2008 - Present
FDA May 1992 - Present
Skills
Leadership, Microsoft Office, PowerPoint, Research, Nonprofits, Teaching, Public Speaking, Grant Writing, Data Analysis, Fundraising, Microsoft Word, Community Development, Microsoft Excel, Community Outreach, Customer Service, Project Management, Access, Analysis, Public Relations, Policy, Program Management, Leadership Development, Training, Government, Organizational..., FOOD & DRUG..., Event Planning, Entrepreneurship, Contract Negotiation, Process Improvement, Strategic Planning, Team Building, Staff Development, Social Networking, Social Media, Event Management, Coaching
Education
University of Missouri-Saint Louis 1991 — 1993
Bachelor of Arts (B.A.), Chemistry
Lincoln University (MO) 1983 — 1988
Bachelor's degree, Mathematics
St. Louis Community College
Event Planning Certification
JAZZMIN'S EVENT PLANNING GROUP, LLC 2008 - Present
FDA May 1992 - Present
Skills
Leadership, Microsoft Office, PowerPoint, Research, Nonprofits, Teaching, Public Speaking, Grant Writing, Data Analysis, Fundraising, Microsoft Word, Community Development, Microsoft Excel, Community Outreach, Customer Service, Project Management, Access, Analysis, Public Relations, Policy, Program Management, Leadership Development, Training, Government, Organizational..., FOOD & DRUG..., Event Planning, Entrepreneurship, Contract Negotiation, Process Improvement, Strategic Planning, Team Building, Staff Development, Social Networking, Social Media, Event Management, Coaching
Education
University of Missouri-Saint Louis 1991 — 1993
Bachelor of Arts (B.A.), Chemistry
Lincoln University (MO) 1983 — 1988
Bachelor's degree, Mathematics
St. Louis Community College
Event Planning Certification
Smruti Chaudhari, Ph.D. Smruti Chaudhari, Ph.D.'s FDA Experience February 2015 - Present
Job ORISE Fellow at FDA/CDER
Industry Pharmaceuticals
Experience
FDA February 2015 - Present
Long Island University May 2014 - December 2014
Long Island University September 2010 - April 2014
GlaxoSmithKline July 2013 - September 2013
GlaxoSmithKline May 2012 - August 2012
Perrigo June 2011 - August 2011
Long Island University January 2009 - May 2010
Long Island University January 2009 - May 2010
Long Island University October 2008 - May 2009
Cognizant Technology Solutions January 2008 - July 2008
Skills
FTIR, Particle Size Analysis, Pharmaceutics, Formulation, UV, Research, UV/Vis, HPLC, Pharmacokinetics, Dissolution, TLC, Drug Delivery, Differential Scanning..., Pharmaceutical Research, Gas Chromatography, GMP, Sop, R&D, Pharmacology, SOP
Education
Long Island University 2010 — 2014
Doctor of Philosophy (Ph.D.), Pharmaceutics
Long Island University 2008 — 2010
M.S, Industrial Pharmacy
saraswati vidya bhavan college of pharmacy 2003 — 2007
Bachelor of Pharmacy (B.Pharm.)
FDA February 2015 - Present
Long Island University May 2014 - December 2014
Long Island University September 2010 - April 2014
GlaxoSmithKline July 2013 - September 2013
GlaxoSmithKline May 2012 - August 2012
Perrigo June 2011 - August 2011
Long Island University January 2009 - May 2010
Long Island University January 2009 - May 2010
Long Island University October 2008 - May 2009
Cognizant Technology Solutions January 2008 - July 2008
Skills
FTIR, Particle Size Analysis, Pharmaceutics, Formulation, UV, Research, UV/Vis, HPLC, Pharmacokinetics, Dissolution, TLC, Drug Delivery, Differential Scanning..., Pharmaceutical Research, Gas Chromatography, GMP, Sop, R&D, Pharmacology, SOP
Education
Long Island University 2010 — 2014
Doctor of Philosophy (Ph.D.), Pharmaceutics
Long Island University 2008 — 2010
M.S, Industrial Pharmacy
saraswati vidya bhavan college of pharmacy 2003 — 2007
Bachelor of Pharmacy (B.Pharm.)
Elizabeth Trainor Elizabeth Trainor's FDA Experience January 2014 - Present
Job Staff Fellow at FDA
Industry Government Administration
Experience
FDA January 2014 - Present
FDA January 2013 - January 2014
Mississippi State University May 2003 - July 2007
Skills
Molecular Biology, Cell Culture, PCR, Microbiology, Scientific Writing, Animal Models, Molecular Cloning
Education
Louisiana State University Health Sciences Center 2007 — 2012
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Mississippi State University 2003 — 2007
Bachelor of Science (B.S.), Microbiology, General
FDA January 2014 - Present
FDA January 2013 - January 2014
Mississippi State University May 2003 - July 2007
Skills
Molecular Biology, Cell Culture, PCR, Microbiology, Scientific Writing, Animal Models, Molecular Cloning
Education
Louisiana State University Health Sciences Center 2007 — 2012
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Mississippi State University 2003 — 2007
Bachelor of Science (B.S.), Microbiology, General
Dynna Bigby's FDA Experience August 2011 - Present
Job Project Manager at FDA
Industry Government Administration
Experience
FDA August 2011 - Present
FDA September 2008 - March 2009
Department of Health and Human Services January 2005 - August 2008
National Cancer Institute December 2001 - December 2004
Skills
Microsoft Office, Government Contracting, Travel Management, Program Management, FDA, Government, Contract Management, Contract Negotiation, PMP, Budgets, DoD, Public Relations, Event Planning, Business Development, Change Management, Customer Service, Nonprofits, Marketing Communications, Financial Analysis, MS Project, Social Media Marketing, Marketing, Policy
Education
Kaplan University 2011 — 2012
Project Management
J.H. Rose High School
FDA August 2011 - Present
FDA September 2008 - March 2009
Department of Health and Human Services January 2005 - August 2008
National Cancer Institute December 2001 - December 2004
Skills
Microsoft Office, Government Contracting, Travel Management, Program Management, FDA, Government, Contract Management, Contract Negotiation, PMP, Budgets, DoD, Public Relations, Event Planning, Business Development, Change Management, Customer Service, Nonprofits, Marketing Communications, Financial Analysis, MS Project, Social Media Marketing, Marketing, Policy
Education
Kaplan University 2011 — 2012
Project Management
J.H. Rose High School
Maksim Levenchuk Maksim Levenchuk's FDA Experience May 2015 - Present
Job Consumer Safety Officer
Industry Government Administration
Experience
FDA May 2015 - Present
University of Chicago Medicine August 2012 - August 2013
U.S. Army February 2010 - May 2013
Medtronic January 2012 - July 2012
U.S. Army September 2004 - January 2008
Skills
Military, Troubleshooting, Microsoft Office, First Aid, Leadership, Cpr Certified, Medicine, Microsoft Excel, Phlebotomy, Analysis, Customer Service, PowerPoint, Heavy Equipment, Team Leadership, Microsoft Word, Quality Assurance, Data Analysis, Training, Laboratory, Healthcare Information..., Team Building, Strategic Planning
Education
Loyola University of Chicago 2013 — 2015
Bachelor's Degree, Biology
US Army
Diploma, MLT
FDA May 2015 - Present
University of Chicago Medicine August 2012 - August 2013
U.S. Army February 2010 - May 2013
Medtronic January 2012 - July 2012
U.S. Army September 2004 - January 2008
Skills
Military, Troubleshooting, Microsoft Office, First Aid, Leadership, Cpr Certified, Medicine, Microsoft Excel, Phlebotomy, Analysis, Customer Service, PowerPoint, Heavy Equipment, Team Leadership, Microsoft Word, Quality Assurance, Data Analysis, Training, Laboratory, Healthcare Information..., Team Building, Strategic Planning
Education
Loyola University of Chicago 2013 — 2015
Bachelor's Degree, Biology
US Army
Diploma, MLT
Alyxandria Schubert Alyxandria Schubert's FDA Experience September 2015 - Present
Job Ph.D. in Microbiology & Immunology from the University of Michigan
Industry Research
Experience
FDA September 2015 - Present
University of Michigan September 2009 - April 2015
Loyola University Chicago May 2008 - August 2009
Skills
Microbiology, Bioinformatics, Sequence Analysis, Molecular Biology, Data Analysis, Microbial Ecology, Research, Animal Models, R, PCR, Machine Learning, Oral & Written..., Collaboration, Project Management, Leadership, Perl, Infectious Diseases, Python, Java, C++, Github, Organization, Computational Biology, Microsoft Office, Large-scale Data..., Social Media, Computer Science, Fluorescence Microscopy, Science
Education
University of Michigan 2009 — 2015
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Loyola University of Chicago 2005 — 2009
BS, Bioinformatics
FDA September 2015 - Present
University of Michigan September 2009 - April 2015
Loyola University Chicago May 2008 - August 2009
Skills
Microbiology, Bioinformatics, Sequence Analysis, Molecular Biology, Data Analysis, Microbial Ecology, Research, Animal Models, R, PCR, Machine Learning, Oral & Written..., Collaboration, Project Management, Leadership, Perl, Infectious Diseases, Python, Java, C++, Github, Organization, Computational Biology, Microsoft Office, Large-scale Data..., Social Media, Computer Science, Fluorescence Microscopy, Science
Education
University of Michigan 2009 — 2015
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Loyola University of Chicago 2005 — 2009
BS, Bioinformatics
Catherine Kennedy Catherine Kennedy's FDA Experience July 2015 - Present
Job Contractor at FDA Office of Acquisitions and Grant Services OAGS
Industry Nonprofit Organization Management
Experience
FDA July 2015 - Present
Asphalt Green May 2013 - August 2015
Asphalt Green August 2012 - June 2013
USA Pools Inc. June 2012 - September 2012
Sullivan & Kennedy DDS PC January 2004 - June 2012
Town of Brunswick June 2006 - August 2011
Sunnyview Rehabilitation Hospital 2010 - 2011
Sugar Free Gang Kidz Kamp of Ellis Hospital July 2009 - July 2010
Some Girls Boutique 2009 - 2010
Skills
Healthcare, Microsoft Office, Microsoft Excel, Hospitals, Microsoft Word, PowerPoint, Customer Service, Strategic Planning, Project Management, Clinical Research, Healthcare Management, Research, Public Speaking, Lifeguarding, Cpr Certified, Community Outreach, Fundraising, Event Planning, Nonprofits, Data Entry, Facebook, Outlook, Time Management, Social Networking
Education
Le Moyne College 2008 — 2012
Bachelor of Arts (B.A.), Human Biology
FDA July 2015 - Present
Asphalt Green May 2013 - August 2015
Asphalt Green August 2012 - June 2013
USA Pools Inc. June 2012 - September 2012
Sullivan & Kennedy DDS PC January 2004 - June 2012
Town of Brunswick June 2006 - August 2011
Sunnyview Rehabilitation Hospital 2010 - 2011
Sugar Free Gang Kidz Kamp of Ellis Hospital July 2009 - July 2010
Some Girls Boutique 2009 - 2010
Skills
Healthcare, Microsoft Office, Microsoft Excel, Hospitals, Microsoft Word, PowerPoint, Customer Service, Strategic Planning, Project Management, Clinical Research, Healthcare Management, Research, Public Speaking, Lifeguarding, Cpr Certified, Community Outreach, Fundraising, Event Planning, Nonprofits, Data Entry, Facebook, Outlook, Time Management, Social Networking
Education
Le Moyne College 2008 — 2012
Bachelor of Arts (B.A.), Human Biology
Robert McQuate's FDA Experience 1977 - 1980
Job CEO & CoFounder at GRAS Associates, LLC.
Industry Food & Beverages
Experience
GRAS Associates March 2005 - Present
National Soft Drink Association 1983 - 1986
The Dial Corporation 1980 - 1983
FDA 1977 - 1980
Skills
Supplements, Food Safety, Food, FDA, Commercialization, Regulatory Affairs, New Business Development, Editing, Product Development, Science, Food Science, Nutrition, Clinical Trials, Ingredients, Start-ups, R&D, Leadership, Food Industry, Personal Care, Consumer Products, Nutraceuticals, Product Innovation
Education
New Mexico State University 1973 — 1974
NA, Bioinorganic Chemistry
The Ohio State University 1969 — 1973
Ph. D., Chemistry/Biochemistry
Lebanon Valley College 1965 — 1969
B S, Chemistry
GRAS Associates March 2005 - Present
National Soft Drink Association 1983 - 1986
The Dial Corporation 1980 - 1983
FDA 1977 - 1980
Skills
Supplements, Food Safety, Food, FDA, Commercialization, Regulatory Affairs, New Business Development, Editing, Product Development, Science, Food Science, Nutrition, Clinical Trials, Ingredients, Start-ups, R&D, Leadership, Food Industry, Personal Care, Consumer Products, Nutraceuticals, Product Innovation
Education
New Mexico State University 1973 — 1974
NA, Bioinorganic Chemistry
The Ohio State University 1969 — 1973
Ph. D., Chemistry/Biochemistry
Lebanon Valley College 1965 — 1969
B S, Chemistry
Aditi Thakur Aditi Thakur's FDA Experience March 2015 - Present
Job Interdisciplinary Scientist at FDA
Industry Pharmaceuticals
Experience
FDA March 2015 - Present
Patheon February 2012 - September 2014
Civitas Therapeutics September 2011 - January 2012
Long Island University January 2009 - December 2010
Skills
Manufacturing, GLP, Validation, UV, Pharmaceutical Industry, FDA, Gas Chromatography, LC-MS, TLC, Technology Transfer, FTIR, Regulatory Affairs, Wet Chemistry, Chemistry, CAPA
Education
LIU Brooklyn 2008 — 2010
Master, Industrial Pharmacy
Punjab Technical University 2003 — 2007
Bachelor, Pharmacy
FDA March 2015 - Present
Patheon February 2012 - September 2014
Civitas Therapeutics September 2011 - January 2012
Long Island University January 2009 - December 2010
Skills
Manufacturing, GLP, Validation, UV, Pharmaceutical Industry, FDA, Gas Chromatography, LC-MS, TLC, Technology Transfer, FTIR, Regulatory Affairs, Wet Chemistry, Chemistry, CAPA
Education
LIU Brooklyn 2008 — 2010
Master, Industrial Pharmacy
Punjab Technical University 2003 — 2007
Bachelor, Pharmacy
Arthur Howell's FDA Experience February 2009 - January 2010
Job Forensics and eDiscovery Examiner at Apple
Industry Computer & Network Security
Experience
Apple February 2012 - Present
Nuclear Regulatory Commission January 2001 - Present
FDA February 2009 - January 2010
Drug Enforcement Agency June 2008 - December 2008
US State Department January 2008 - June 2008
ICS Incorporated September 2007 - January 2008
NNMC- National Naval Medical Center April 2007 - May 2007
Skills
Operating Systems, Network Architecture, Vulnerability Assessment, CISSP, Hardening, Network Security, Forensic Analysis, Computer Forensics, Computer Security, Information Assurance, Information Security, Physical Security, Research, Networking, Security, Servers, Hard Drives
Education
Kaplan University
Associate of Applied Science, Computer Forensics
Apple February 2012 - Present
Nuclear Regulatory Commission January 2001 - Present
FDA February 2009 - January 2010
Drug Enforcement Agency June 2008 - December 2008
US State Department January 2008 - June 2008
ICS Incorporated September 2007 - January 2008
NNMC- National Naval Medical Center April 2007 - May 2007
Skills
Operating Systems, Network Architecture, Vulnerability Assessment, CISSP, Hardening, Network Security, Forensic Analysis, Computer Forensics, Computer Security, Information Assurance, Information Security, Physical Security, Research, Networking, Security, Servers, Hard Drives
Education
Kaplan University
Associate of Applied Science, Computer Forensics
Robert Meyer's FDA Experience 2002 - 2007
Job Director, Virginia Center for Regulatory and Translational Science
Industry Higher Education
Experience
Cardiome Pharma Corp September 2015 - Present
United States Pharmacopeia July 2015 - Present
University of Virginia School of Medicine 2013 - Present
PhRMA January 2012 - January 2013
Merck November 2009 - January 2013
Merck February 2008 - November 2009
FDA 2002 - 2007
MTOC/ATOC 1998 - 2007
U.S. FDA 1994 - 2007
Skills
Drug Development, regulatory strategy, regulatory policy, drug safety, Clinical Development, Drug Safety, Regulatory Submissions, Strategy, Regulatory Affairs, Medicine, Regulatory Policy, Clinical Trials, Pharmaceutical Industry, Vaccines, Regulatory Requirements, IND, Biomarkers, Translational Medicine, Regulations, Drug Delivery, Biotechnology, Biopharmaceuticals, Lifesciences, Outcomes Research, Clinical Research, FDA, Life Sciences, Oncology
Education
University of Vermont College of Medicine 1988 — 1991
Fellowship, Pulmonary and Critical Care Medicine, Pulmonary Disease Residency Program
The University of Connecticut School of Medicine 1984 — 1988
Residency/Chief Residency, Internal Medicine Residency Program
The University of Connecticut School of Medicine 1980 — 1984
MD, Medicine
Lehigh University 1976 — 1980
BS, Natural Science
Thompson Memorial School 1964 — 1972
Cardiome Pharma Corp September 2015 - Present
United States Pharmacopeia July 2015 - Present
University of Virginia School of Medicine 2013 - Present
PhRMA January 2012 - January 2013
Merck November 2009 - January 2013
Merck February 2008 - November 2009
FDA 2002 - 2007
MTOC/ATOC 1998 - 2007
U.S. FDA 1994 - 2007
Skills
Drug Development, regulatory strategy, regulatory policy, drug safety, Clinical Development, Drug Safety, Regulatory Submissions, Strategy, Regulatory Affairs, Medicine, Regulatory Policy, Clinical Trials, Pharmaceutical Industry, Vaccines, Regulatory Requirements, IND, Biomarkers, Translational Medicine, Regulations, Drug Delivery, Biotechnology, Biopharmaceuticals, Lifesciences, Outcomes Research, Clinical Research, FDA, Life Sciences, Oncology
Education
University of Vermont College of Medicine 1988 — 1991
Fellowship, Pulmonary and Critical Care Medicine, Pulmonary Disease Residency Program
The University of Connecticut School of Medicine 1984 — 1988
Residency/Chief Residency, Internal Medicine Residency Program
The University of Connecticut School of Medicine 1980 — 1984
MD, Medicine
Lehigh University 1976 — 1980
BS, Natural Science
Thompson Memorial School 1964 — 1972
Vioela Caze Vioela Caze's FDA Experience December 2014 - Present
Job Chemist at FDA
Industry Pharmaceuticals
Experience
FDA December 2014 - Present
Actavis July 2014 - December 2014
Forest Laboratories April 2010 - June 2014
Antech Diagnostics May 2008 - June 2010
FDA August 2005 - August 2006
Skills
LIMS, E-notebook, HPLC,..., Management, organizational, Ability to teach, Biotechnology, Pharmaceutical Industry, Medical Devices, GLP, Sop, Analytical Chemistry, Quality Assurance, Lifesciences, GMP, FDA, Chemistry, Chromatography, Molecular Biology, Validation, Immunology, Gas Chromatography, Infectious Diseases, ELISA, Protocol, Laboratory
Education
Long Island University, Brooklyn Campus
Master of Science (MS), Chemistry
City University of New York-York College 2002 — 2007
Bachelor of Applied Science (B.A.Sc.), Chemistry
FDA December 2014 - Present
Actavis July 2014 - December 2014
Forest Laboratories April 2010 - June 2014
Antech Diagnostics May 2008 - June 2010
FDA August 2005 - August 2006
Skills
LIMS, E-notebook, HPLC,..., Management, organizational, Ability to teach, Biotechnology, Pharmaceutical Industry, Medical Devices, GLP, Sop, Analytical Chemistry, Quality Assurance, Lifesciences, GMP, FDA, Chemistry, Chromatography, Molecular Biology, Validation, Immunology, Gas Chromatography, Infectious Diseases, ELISA, Protocol, Laboratory
Education
Long Island University, Brooklyn Campus
Master of Science (MS), Chemistry
City University of New York-York College 2002 — 2007
Bachelor of Applied Science (B.A.Sc.), Chemistry
Lorelle Carroll Lorelle Carroll's FDA Experience December 2011 - Present
Job Executive Assistant to Director of Microbiology, Food and Drug Administration
Industry Government Relations
Experience
Federal Drug Administration May 2013 - Present
FDA December 2011 - Present
The Analysis Group/ Erimax December 2008 - June 2011
NSS Plus - Fairfax, Virginia June 2008 - October 2008
Boeing March 2007 - March 2008
FOWGroup, Inc July 2006 - February 2007
SmithGroup September 2001 - July 2006
Skills
Microsoft Excel, Public Speaking, Social Media, Customer Service, Administrative..., Government, Program Management, Access, Management, Software Documentation, Logistics, Recruiting, Analysis, Office Management, System Administration, Administration, Project Management, Event Management
Education
Bowie State University, Bowie, MD 1996 — 1999
Psychology
Livingstone College 1989 — 1994
BS, Psychology
Federal Drug Administration May 2013 - Present
FDA December 2011 - Present
The Analysis Group/ Erimax December 2008 - June 2011
NSS Plus - Fairfax, Virginia June 2008 - October 2008
Boeing March 2007 - March 2008
FOWGroup, Inc July 2006 - February 2007
SmithGroup September 2001 - July 2006
Skills
Microsoft Excel, Public Speaking, Social Media, Customer Service, Administrative..., Government, Program Management, Access, Management, Software Documentation, Logistics, Recruiting, Analysis, Office Management, System Administration, Administration, Project Management, Event Management
Education
Bowie State University, Bowie, MD 1996 — 1999
Psychology
Livingstone College 1989 — 1994
BS, Psychology
J. Cornell Crawford's FDA Experience June 2014 - Present
Job Technical Information Specialist at FDA
Industry Government Administration
Experience
FDA June 2014 - Present
FEMA February 2014 - May 2014
Acclaro Research Solutions, Inc. November 2012 - February 2014
Infina, Ltd. July 2012 - November 2012
Kauffman & Associates, Inc. October 2008 - July 2012
Telesis Corporation March 2007 - August 2009
Tomorrow's Solutions Today July 2006 - October 2008
Skills
Management, Program Management, Government, Proposal Writing, Project Management, Leadership, Policy, Strategic Planning, Public Speaking, Change Management, Research, Process Improvement, Training, Team Building, Analysis, Event Planning, Organizational..., Microsoft Office, Budgets
Education
Southeastern Louisiana University 2003 — 2006
Masters
Louisiana State University 1998 — 2002
Bachelors
FDA June 2014 - Present
FEMA February 2014 - May 2014
Acclaro Research Solutions, Inc. November 2012 - February 2014
Infina, Ltd. July 2012 - November 2012
Kauffman & Associates, Inc. October 2008 - July 2012
Telesis Corporation March 2007 - August 2009
Tomorrow's Solutions Today July 2006 - October 2008
Skills
Management, Program Management, Government, Proposal Writing, Project Management, Leadership, Policy, Strategic Planning, Public Speaking, Change Management, Research, Process Improvement, Training, Team Building, Analysis, Event Planning, Organizational..., Microsoft Office, Budgets
Education
Southeastern Louisiana University 2003 — 2006
Masters
Louisiana State University 1998 — 2002
Bachelors
Elizabeth Moten Elizabeth Moten's FDA Experience June 2006 - September 2007
Job Acquisition Manager at General Services Administration
Industry Government Administration
Experience
General Services Administration July 2012 - Present
General Services Administration August 2007 - July 2012
GSA August 2011 - December 2011
FDA June 2006 - September 2007
FDA August 2005 - July 2006
FDA January 2005 - August 2005
US Army January 2001 - January 2005
US Army March 1999 - January 2001
Skills
Government, Government Contracting, Federal Government, Government Procurement, Contract Management, Security Clearance, DoD, Management, FAR, Homeland Security, Leadership, Military, Project Planning, National Security, Local Government, Defense, Public Administration, Contract Negotiation, Team Building, Earned Value Management
Education
Strayer University (VA) 2012 — 2016
Master's degree, Acquisitions and Government Contracting
Kent State University 2000 — 2004
Bachelor of Science (B.S.), Political Science and Government
General Services Administration July 2012 - Present
General Services Administration August 2007 - July 2012
GSA August 2011 - December 2011
FDA June 2006 - September 2007
FDA August 2005 - July 2006
FDA January 2005 - August 2005
US Army January 2001 - January 2005
US Army March 1999 - January 2001
Skills
Government, Government Contracting, Federal Government, Government Procurement, Contract Management, Security Clearance, DoD, Management, FAR, Homeland Security, Leadership, Military, Project Planning, National Security, Local Government, Defense, Public Administration, Contract Negotiation, Team Building, Earned Value Management
Education
Strayer University (VA) 2012 — 2016
Master's degree, Acquisitions and Government Contracting
Kent State University 2000 — 2004
Bachelor of Science (B.S.), Political Science and Government
Daniel Connally Daniel Connally's FDA Experience August 2014 - Present
Job Management and Program Analyst at FDA
Industry Government Relations
Experience
FDA August 2014 - Present
US Department of Health and Human Services January 2014 - August 2014
US Department of Health and Human Services May 2012 - January 2014
US Department of Health and Human Services June 2008 - May 2012
US Marine Corps Reserves, Combat Engineer May 2004 - May 2012
Gleaning For The World January 2008 - May 2008
Skills
Communication Analysis, Press Releases, Government, Emergency Management, Crisis Management, Government Relations, Public Relations, Crisis Communications, Social Media, Public Speaking, Strategic Communications, Media Relations, Leadership Development, Community Relations, Microsoft Office, International Relations, PowerPoint, Non-profits, Government Liaison, Analysis, Social Networking, Mentoring, Supervisory Skills, Excel, Military, Homeland Security, Policy Analysis, Security Clearance, Federal Government, Microsoft Excel, Community Development, Disaster Response, Nonprofits, Community Outreach, Military Operations, Tactics, Preparedness, Defense, Command, Leadership, Counterterrorism, National Security, Exercises, Training, Foreign Policy, DoD, Policy, Program Management, Management
Education
Liberty University 2003 — 2008
Bachelor of Science, Public Relations, Advertising
McNeil High School 1999 — 2003
FDA August 2014 - Present
US Department of Health and Human Services January 2014 - August 2014
US Department of Health and Human Services May 2012 - January 2014
US Department of Health and Human Services June 2008 - May 2012
US Marine Corps Reserves, Combat Engineer May 2004 - May 2012
Gleaning For The World January 2008 - May 2008
Skills
Communication Analysis, Press Releases, Government, Emergency Management, Crisis Management, Government Relations, Public Relations, Crisis Communications, Social Media, Public Speaking, Strategic Communications, Media Relations, Leadership Development, Community Relations, Microsoft Office, International Relations, PowerPoint, Non-profits, Government Liaison, Analysis, Social Networking, Mentoring, Supervisory Skills, Excel, Military, Homeland Security, Policy Analysis, Security Clearance, Federal Government, Microsoft Excel, Community Development, Disaster Response, Nonprofits, Community Outreach, Military Operations, Tactics, Preparedness, Defense, Command, Leadership, Counterterrorism, National Security, Exercises, Training, Foreign Policy, DoD, Policy, Program Management, Management
Education
Liberty University 2003 — 2008
Bachelor of Science, Public Relations, Advertising
McNeil High School 1999 — 2003
Namita Sharma Namita Sharma's FDA Experience July 2011 - Present
Job Senior Drupal/Web Developer at GlobalNet Services, Inc.
Industry Information Technology and Services
Experience
Triple I - BU GlobalNet Services, Inc., FDA July 2011 - Present
FDA July 2011 - Present
Case Design January 2009 - July 2011
SmithGroup May 2008 - January 2009
Skills
Web Development, Drupal, jQuery, CSS, JavaScript, MySQL, HTML, AJAX, ColdFusion, PHP, Microsoft SQL Server, HTML 5, XML, CMS, Apache, Java, Software Development, Software Project..., System Administration, Web Applications, Web Design, Testing, Web Services, HTML5
Education
The George Washington University 2007 — 2008
M.S, Computer Science
Kurukshetra University 2002 — 2006
B.Tech, Computer Science
Triple I - BU GlobalNet Services, Inc., FDA July 2011 - Present
FDA July 2011 - Present
Case Design January 2009 - July 2011
SmithGroup May 2008 - January 2009
Skills
Web Development, Drupal, jQuery, CSS, JavaScript, MySQL, HTML, AJAX, ColdFusion, PHP, Microsoft SQL Server, HTML 5, XML, CMS, Apache, Java, Software Development, Software Project..., System Administration, Web Applications, Web Design, Testing, Web Services, HTML5
Education
The George Washington University 2007 — 2008
M.S, Computer Science
Kurukshetra University 2002 — 2006
B.Tech, Computer Science
Quamrul Majumder, Ph.D. Quamrul Majumder, Ph.D.'s FDA Experience January 2009 - Present
Job Quality Reviewer at FDA
Industry Government Administration
Experience
FDA January 2009 - Present
Barr Pharmaceuticals December 2001 - December 2008
Skills
GMP, Regulatory Affairs, Pharmaceutical Industry, Pharmaceutics, FDA, Process Simulation, Sop, Validation, Formulation, Quality by Design, GLP, Regulatory Submissions, Technology Transfer, Pharmacovigilance, Drug Development, V&V, Pharmacokinetics
Education
LIU Brooklyn 1995 — 2001
Ph.D., Pharmaceutics
FDA January 2009 - Present
Barr Pharmaceuticals December 2001 - December 2008
Skills
GMP, Regulatory Affairs, Pharmaceutical Industry, Pharmaceutics, FDA, Process Simulation, Sop, Validation, Formulation, Quality by Design, GLP, Regulatory Submissions, Technology Transfer, Pharmacovigilance, Drug Development, V&V, Pharmacokinetics
Education
LIU Brooklyn 1995 — 2001
Ph.D., Pharmaceutics
Andrew Kelson's FDA Experience August 2015 - Present
Job Senior Advisor at FDA
Industry Government Administration
Experience
FDA August 2015 - Present
FDA January 2015 - August 2015
FDA December 2012 - January 2015
U.S. Department of Justice January 2010 - January 2012
U.S. Department of Justice February 2007 - December 2009
US Army May 1997 - November 2003
Skills
Program Development, Program Management, Microsoft Excel, Defense, Policy Analysis
Education
Liberty University 2014 — 2016
Master's Degree, Public Health
The George Washington University 2012 — 2013
Graduate Certificate, Climate Change Policy and Management
University of Maryland College Park 2008 — 2010
Master's degree, Public Management
University of Maryland College Park 2003 — 2006
BS, Government and Politics
FDA August 2015 - Present
FDA January 2015 - August 2015
FDA December 2012 - January 2015
U.S. Department of Justice January 2010 - January 2012
U.S. Department of Justice February 2007 - December 2009
US Army May 1997 - November 2003
Skills
Program Development, Program Management, Microsoft Excel, Defense, Policy Analysis
Education
Liberty University 2014 — 2016
Master's Degree, Public Health
The George Washington University 2012 — 2013
Graduate Certificate, Climate Change Policy and Management
University of Maryland College Park 2008 — 2010
Master's degree, Public Management
University of Maryland College Park 2003 — 2006
BS, Government and Politics
Amy Amaro's FDA Experience June 2015 - Present
Job Consumer Safety Officer at FDA
Industry Pharmaceuticals
Experience
FDA June 2015 - Present
Octapharma Plasma, Inc. January 2013 - May 2015
Prince William County Public Schools November 2012 - January 2013
Senior Services of Southeastern Virginia May 2012 - July 2012
Skills
Validation, Pharmaceutical Industry, Sop, GMP, Customer Service, Training, Regulatory Submissions, Auditing, Process Improvement, Management, Medical Devices, Microsoft Office, Data Entry, Quality Control, Microsoft Excel, Recruiting, Quality Management, Employee Relations, Outlook, Performance Management, Time Management
Education
Liberty University 2014 — 2015
Master of Public Health (M.P.H.), Public Health
Old Dominion University 2009 — 2012
Bachelor of Science (B.S.), Public Health
FDA June 2015 - Present
Octapharma Plasma, Inc. January 2013 - May 2015
Prince William County Public Schools November 2012 - January 2013
Senior Services of Southeastern Virginia May 2012 - July 2012
Skills
Validation, Pharmaceutical Industry, Sop, GMP, Customer Service, Training, Regulatory Submissions, Auditing, Process Improvement, Management, Medical Devices, Microsoft Office, Data Entry, Quality Control, Microsoft Excel, Recruiting, Quality Management, Employee Relations, Outlook, Performance Management, Time Management
Education
Liberty University 2014 — 2015
Master of Public Health (M.P.H.), Public Health
Old Dominion University 2009 — 2012
Bachelor of Science (B.S.), Public Health
Arlene Faria-Feldman Arlene Faria-Feldman's FDA Experience
Job Compliance Officer at FDA
Industry Government Administration
Experience
FDA
Skills
Regulatory Analysis, Federal Government
Education
Long Island University, Brooklyn Campus
FDA
Skills
Regulatory Analysis, Federal Government
Education
Long Island University, Brooklyn Campus
William Weissinger William Weissinger's FDA Experience January 2012 - Present
Job
Industry Government Administration
Experience
FDA January 2012 - Present
FDA February 2009 - January 2012
FDA October 2003 - February 2009
Kroger December 2001 - September 2003
Kroger April 2001 - December 2001
Kroger September 2000 - April 2001
Purdue University May 1997 - August 1998
Skills
Regulatory Affairs, Food Science, Microbiology, FDA, GMP, Government, Policy Analysis, Food Safety, HACCP, Public Health, Research, Food Microbiology, Food Technology, Laboratory, Dairy, Food, Quality Assurance, Quality Auditing
Education
The University of Georgia 1998 — 2000
MS, Food Science
Purdue University 1992 — 1997
BS, Biology
Lancaster University
Lancaster University
FDA January 2012 - Present
FDA February 2009 - January 2012
FDA October 2003 - February 2009
Kroger December 2001 - September 2003
Kroger April 2001 - December 2001
Kroger September 2000 - April 2001
Purdue University May 1997 - August 1998
Skills
Regulatory Affairs, Food Science, Microbiology, FDA, GMP, Government, Policy Analysis, Food Safety, HACCP, Public Health, Research, Food Microbiology, Food Technology, Laboratory, Dairy, Food, Quality Assurance, Quality Auditing
Education
The University of Georgia 1998 — 2000
MS, Food Science
Purdue University 1992 — 1997
BS, Biology
Lancaster University
Lancaster University
Len Valenti Len Valenti's FDA Experience 1999 - 2002
Job Senior FDA Compliance Expert
Industry Pharmaceuticals
Experience
Valtech LLc July 2006 - Present
Guidepoint Global 2010 - 2015
Guidepoint Global 2010 - 2015
Guidepoint Global 2010 - 2015
Lachman Consulting Services, 2006 - 2008
U S Food and Drug Administration 2002 - 2006
US Food and Drug Admin 1997 - 2006
US Food and Drug Administration 2002 - 2004
FDA 1999 - 2002
FDA/CDRH 1995 - 1999
Skills
GMP, FDA, Regulatory Affairs, Quality System, Pharmaceutical Industry, Medical Devices, CAPA, Policy, 21 CFR Part 11, ISO 13485, Validation, Food, Auditing, Biotechnology, Due Diligence, Clinical Trials, Compliance, HACCP, Internal Audit, ISO 14971, Design Control, ISO, Risk Management, CE marking, PMA, Risk Assessment, Veterinary, Registration, Internal Controls, Menu Development, Accounting, Valuation, Food Industry, Wine, Food Safety, Cooking, OTC Drug Registration, cGMP, FD&C Labeling, Dietary Supplement..., Quality Systems, Audit, 510 K, Animal Health, SOX, QSR, Pharmaceuticals, Mergers, Process Validation, Culinary
Education
LIU CW Post 1974 — 1977
BS, CHEMISTRY
SUNY Farmingdale 1971 — 1972
Associate of Arts and Sciences (AAS), Liberal Arts and Sciences/Liberal Studies
Valtech LLc July 2006 - Present
Guidepoint Global 2010 - 2015
Guidepoint Global 2010 - 2015
Guidepoint Global 2010 - 2015
Lachman Consulting Services, 2006 - 2008
U S Food and Drug Administration 2002 - 2006
US Food and Drug Admin 1997 - 2006
US Food and Drug Administration 2002 - 2004
FDA 1999 - 2002
FDA/CDRH 1995 - 1999
Skills
GMP, FDA, Regulatory Affairs, Quality System, Pharmaceutical Industry, Medical Devices, CAPA, Policy, 21 CFR Part 11, ISO 13485, Validation, Food, Auditing, Biotechnology, Due Diligence, Clinical Trials, Compliance, HACCP, Internal Audit, ISO 14971, Design Control, ISO, Risk Management, CE marking, PMA, Risk Assessment, Veterinary, Registration, Internal Controls, Menu Development, Accounting, Valuation, Food Industry, Wine, Food Safety, Cooking, OTC Drug Registration, cGMP, FD&C Labeling, Dietary Supplement..., Quality Systems, Audit, 510 K, Animal Health, SOX, QSR, Pharmaceuticals, Mergers, Process Validation, Culinary
Education
LIU CW Post 1974 — 1977
BS, CHEMISTRY
SUNY Farmingdale 1971 — 1972
Associate of Arts and Sciences (AAS), Liberal Arts and Sciences/Liberal Studies
Robert McQuate Robert McQuate's FDA Experience 1977 - 1980
Job President & CEO
Industry Food & Beverages
Experience
R S McQuate & Associates, Inc January 1988 - Present
Advanced Science and Technology Institute 1986 - 1997
National Soft Drink Association 1983 - 1986
FDA 1977 - 1980
Skills
FDA, Licensing, Regulatory Affairs, Start-ups, Food, Consumer Products, Nutraceuticals, Supplements, Food Industry, Toxicology, Nutritional Counseling, Cross-functional Team..., Biotechnology, GMP, Food Safety, Corporations, Executive Management, Lifesciences, Commercialization, Nutrition, Entrepreneurship, Microbiology, Food Science, Mergers & Acquisitions, Product Development, Cosmetics, Ingredients, Business Planning, Brand Development, International Business, New Business Development, Patents, R&D, Lifestyle, Packaging, Vitamins, Food Processing, Chemistry
Education
New Mexico State University 1973 — 1974
NA, Bioinorganic Chemistry
The Ohio State University 1969 — 1973
Doctor of Philosophy (Ph.D.), Chemistry
Lebanon Valley College 1965 — 1969
B.S. in Chemistry, Chemistry
R S McQuate & Associates, Inc January 1988 - Present
Advanced Science and Technology Institute 1986 - 1997
National Soft Drink Association 1983 - 1986
FDA 1977 - 1980
Skills
FDA, Licensing, Regulatory Affairs, Start-ups, Food, Consumer Products, Nutraceuticals, Supplements, Food Industry, Toxicology, Nutritional Counseling, Cross-functional Team..., Biotechnology, GMP, Food Safety, Corporations, Executive Management, Lifesciences, Commercialization, Nutrition, Entrepreneurship, Microbiology, Food Science, Mergers & Acquisitions, Product Development, Cosmetics, Ingredients, Business Planning, Brand Development, International Business, New Business Development, Patents, R&D, Lifestyle, Packaging, Vitamins, Food Processing, Chemistry
Education
New Mexico State University 1973 — 1974
NA, Bioinorganic Chemistry
The Ohio State University 1969 — 1973
Doctor of Philosophy (Ph.D.), Chemistry
Lebanon Valley College 1965 — 1969
B.S. in Chemistry, Chemistry
Kwame Ulmer's FDA Experience 2009 - 2014
Job Medical Device Executive
Industry Medical Devices
Experience
Implant Direct - a Danaher Joint Venture July 2015 - Present
Danaher Corporation June 2014 - June 2015
FDA 2009 - 2014
FDA 2006 - 2009
FDA 2002 - 2006
Skills
Medical Devices, Strategy, Public Speaking, Leadership, FDA
Education
University of Virginia - Darden Graduate School of Business Administration 2013 — 2015
Master of Business Administration (M.B.A.)
University of Virginia 1996 — 1998
MS
Lincoln University 1992 — 1996
BS
Implant Direct - a Danaher Joint Venture July 2015 - Present
Danaher Corporation June 2014 - June 2015
FDA 2009 - 2014
FDA 2006 - 2009
FDA 2002 - 2006
Skills
Medical Devices, Strategy, Public Speaking, Leadership, FDA
Education
University of Virginia - Darden Graduate School of Business Administration 2013 — 2015
Master of Business Administration (M.B.A.)
University of Virginia 1996 — 1998
MS
Lincoln University 1992 — 1996
BS
Joyce Emocling's FDA Experience September 2009 - March 2013
Job Quality Assurance Manager at Quinoa Corporation
Industry Government Administration
Experience
Quinoa Corporation May 2013 - Present
FDA September 2009 - March 2013
LB Jordan High School January 2002 - June 2010
Enterprise Rent-A-Car January 2007 - November 2007
Skills
Quality Assurance, Quality Auditing, Data Entry, Data Management, File Management, FDA, Microbiology, Software Documentation, Validation, Sop, Data Analysis, Document Management, Technical Writing, Regulatory Affairs, GLP, Customer Service, SOP, Microsoft Excel
Education
California State University Dominguez Hills 2007 — 2012
Bachelor of Arts (B.A.), Biology, General
Long Beach City College 2001 — 2006
Transfer Student, Biology/Biological Sciences, General
Quinoa Corporation May 2013 - Present
FDA September 2009 - March 2013
LB Jordan High School January 2002 - June 2010
Enterprise Rent-A-Car January 2007 - November 2007
Skills
Quality Assurance, Quality Auditing, Data Entry, Data Management, File Management, FDA, Microbiology, Software Documentation, Validation, Sop, Data Analysis, Document Management, Technical Writing, Regulatory Affairs, GLP, Customer Service, SOP, Microsoft Excel
Education
California State University Dominguez Hills 2007 — 2012
Bachelor of Arts (B.A.), Biology, General
Long Beach City College 2001 — 2006
Transfer Student, Biology/Biological Sciences, General
J'Nai Parrish's FDA Experience June 2008 - June 2013
Job Government Administration Professional
Industry Government Administration
Experience
Maryland Live Casino August 2013 - July 2015
FDA June 2008 - June 2013
Skills
Government, Policy, Microsoft Office, Research, Policy Analysis, Microsoft Excel, Public Policy, Community Outreach, PowerPoint, Customer Service
Education
Kaplan University-Davenport Campus 2014 — 2015
Associate’s Degree, Criminology
Maryland Live Casino August 2013 - July 2015
FDA June 2008 - June 2013
Skills
Government, Policy, Microsoft Office, Research, Policy Analysis, Microsoft Excel, Public Policy, Community Outreach, PowerPoint, Customer Service
Education
Kaplan University-Davenport Campus 2014 — 2015
Associate’s Degree, Criminology
Jeff Richard's FDA Experience October 1991 - April 1992
Job at
Industry Military
Experience
Air National Guard January 2014 - Present
Air National Guard June 1992 - Present
Air National Guard July 1995 - January 2014
State of California Department of Health Services October 1993 - July 1995
FDA October 1991 - April 1992
USAF February 1986 - September 1990
Skills
Process Improvement, Systems Engineering, Customer Service, Business Analysis, Policy, Project Management, Analysis, Information Security, Management, Technical Writing, Emergency Management, Change Management, Information Security..., Research, Information Technology, Physical Security, Requirements Analysis, Network Security, Integration, Aviation, Military Operations, Defense, National Security, Top Secret, Cross-functional Team..., Military Experience, Risk Assessment, Operational Planning, Troubleshooting, Organizational..., IT Management
Education
Louisiana State University 1981 — 1986
General Studies, Science, History
Air National Guard January 2014 - Present
Air National Guard June 1992 - Present
Air National Guard July 1995 - January 2014
State of California Department of Health Services October 1993 - July 1995
FDA October 1991 - April 1992
USAF February 1986 - September 1990
Skills
Process Improvement, Systems Engineering, Customer Service, Business Analysis, Policy, Project Management, Analysis, Information Security, Management, Technical Writing, Emergency Management, Change Management, Information Security..., Research, Information Technology, Physical Security, Requirements Analysis, Network Security, Integration, Aviation, Military Operations, Defense, National Security, Top Secret, Cross-functional Team..., Military Experience, Risk Assessment, Operational Planning, Troubleshooting, Organizational..., IT Management
Education
Louisiana State University 1981 — 1986
General Studies, Science, History
Kimberly Giordano Kimberly Giordano's FDA Experience May 2015 - Present
Job Project Specialist/Training Coordinator at FDA
Industry Human Resources
Experience
FDA May 2015 - Present
FDA September 2014 - May 2015
FDA June 2012 - September 2014
FDA June 2009 - June 2012
Montgomery County Board of Elections January 2008 - November 2008
Maxim Healthcare Services May 2007 - August 2007
Skills
Training & Development, Training Coordination, SharePoint, Microsoft Office, Captivate, Lync, Smartboard, Teamwork, Team Building, PowerPoint, Access, Scheduling, Employee Relations, Mentoring, Word, Excel, Visio, Microsoft Publisher, Adobe Connect, Adobe LiveCycle Designer, Camtasia, Microsoft Excel, Management, Leadership, Data Entry, Process Scheduler, Microsoft Word
Education
Liberty University 2008 — 2012
B.S, Human Resources Management
FDA May 2015 - Present
FDA September 2014 - May 2015
FDA June 2012 - September 2014
FDA June 2009 - June 2012
Montgomery County Board of Elections January 2008 - November 2008
Maxim Healthcare Services May 2007 - August 2007
Skills
Training & Development, Training Coordination, SharePoint, Microsoft Office, Captivate, Lync, Smartboard, Teamwork, Team Building, PowerPoint, Access, Scheduling, Employee Relations, Mentoring, Word, Excel, Visio, Microsoft Publisher, Adobe Connect, Adobe LiveCycle Designer, Camtasia, Microsoft Excel, Management, Leadership, Data Entry, Process Scheduler, Microsoft Word
Education
Liberty University 2008 — 2012
B.S, Human Resources Management
Socrates Trujillo's FDA Experience International Food Safety Policy ManagerFDAJune 2014 - Present
Job International Policy Analyst, FDA
Industry Government Relations
Experience
FDA International Food Safety Policy ManagerFDAJune 2014 - Present
University of Maryland 2001 - 2003
Skills
Regulatory Affairs, Federal Government, Government, Policy, Public Health, International Relations, Food Safety, Policy Analysis, Emergency Management, Food Microbiology, Microbiology, HACCP, Environmental Health, Food Science, Research, Biotechnology, Science, Analytical Chemistry, Life Sciences, Molecular Biology
Education
Louisiana State University 1995 — 1997
Doctor of Philosophy (Ph.D.), Food Science
FDA International Food Safety Policy ManagerFDAJune 2014 - Present
University of Maryland 2001 - 2003
Skills
Regulatory Affairs, Federal Government, Government, Policy, Public Health, International Relations, Food Safety, Policy Analysis, Emergency Management, Food Microbiology, Microbiology, HACCP, Environmental Health, Food Science, Research, Biotechnology, Science, Analytical Chemistry, Life Sciences, Molecular Biology
Education
Louisiana State University 1995 — 1997
Doctor of Philosophy (Ph.D.), Food Science
Rebecca Frey-Cooper Rebecca Frey-Cooper's FDA Experience September 2013 - Present
Job FDA Chemist
Industry Pharmaceuticals
Experience
FDA September 2013 - Present
Noramco, Inc. June 2011 - September 2013
University of South Carolina June 2006 - December 2010
Copperhead Chemical Company May 2002 - August 2004
Skills
UV-Vis, NMR, IR, Chromatography, Chemistry, cGMP, GMP, SOP, GC/MS, Column Chromatography, Mass Spectrometry, HPLC, NMR spectroscopy, Spectroscopy, Science, GC-MS, Gas Chromatography, Analytical Chemistry, IR spectroscopy, Organic Chemistry, Organic Synthesis, LC-MS, FDA, UV/Vis, Pharmaceutical Industry, Method Development, Technology Transfer, Validation, Formulation, ChemDraw, Laboratory, GLP, Sop, Quality Control, Biotechnology, Life Sciences, Pharmaceutics, Biochemistry, R&D
Education
University of South Carolina-Columbia 2006 — 2010
PhD, Chemistry
King's College 2001 — 2006
BS, Chemistry, Neuroscience, Psychology
FDA September 2013 - Present
Noramco, Inc. June 2011 - September 2013
University of South Carolina June 2006 - December 2010
Copperhead Chemical Company May 2002 - August 2004
Skills
UV-Vis, NMR, IR, Chromatography, Chemistry, cGMP, GMP, SOP, GC/MS, Column Chromatography, Mass Spectrometry, HPLC, NMR spectroscopy, Spectroscopy, Science, GC-MS, Gas Chromatography, Analytical Chemistry, IR spectroscopy, Organic Chemistry, Organic Synthesis, LC-MS, FDA, UV/Vis, Pharmaceutical Industry, Method Development, Technology Transfer, Validation, Formulation, ChemDraw, Laboratory, GLP, Sop, Quality Control, Biotechnology, Life Sciences, Pharmaceutics, Biochemistry, R&D
Education
University of South Carolina-Columbia 2006 — 2010
PhD, Chemistry
King's College 2001 — 2006
BS, Chemistry, Neuroscience, Psychology
John Sciacchitano John Sciacchitano's FDA Experience June 2010 - Present
Job Investigator Medical Device Specialist at FDA
Industry Medical Devices
Experience
FDA June 2010 - Present
Skills
FDA, Medical Devices, Healthcare, Microsoft Office, Biomedical Engineering, Program Management, Research, Strategic Planning, Leadership, Management, Data Analysis, Validation, Analysis, Investigation, FDA GMP, Radiology, Laser Physics, Interpersonal..., Root Cause Problem..., Quality Assurance, ISO 13485
Education
Life University 1993 — 1998
Doctor of Chiropractic
Manhattan College 1985 — 1989
Bachelor of Engineering (B.E.), Mechanical Engineering
FDA June 2010 - Present
Skills
FDA, Medical Devices, Healthcare, Microsoft Office, Biomedical Engineering, Program Management, Research, Strategic Planning, Leadership, Management, Data Analysis, Validation, Analysis, Investigation, FDA GMP, Radiology, Laser Physics, Interpersonal..., Root Cause Problem..., Quality Assurance, ISO 13485
Education
Life University 1993 — 1998
Doctor of Chiropractic
Manhattan College 1985 — 1989
Bachelor of Engineering (B.E.), Mechanical Engineering
Haleh Saber Haleh Saber's FDA Experience 2003 - October 2014
Job Principal Consultant at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL October 2014 - Present
FDA 2003 - October 2014
Cato Research 2001 - 2003
Fox Chase Cancer Center 1999 - 2001
Skills
Toxicology, Drug Development, Pharmacology, Oncology, IND, FDA, GLP, Pharmacokinetics, Drug Discovery, Life Sciences, Immunology, In Vivo, Regulatory Submissions, Biosimilars, In Vitro, Nonclinical Drug..., Lifesciences, 505(b)(2), Oncology and benign..., Antibody-drug conjugates
Education
Lehigh University 1994 — 1997
Doctor of Philosophy (Ph.D.), Biochemistry
PAREXEL October 2014 - Present
FDA 2003 - October 2014
Cato Research 2001 - 2003
Fox Chase Cancer Center 1999 - 2001
Skills
Toxicology, Drug Development, Pharmacology, Oncology, IND, FDA, GLP, Pharmacokinetics, Drug Discovery, Life Sciences, Immunology, In Vivo, Regulatory Submissions, Biosimilars, In Vitro, Nonclinical Drug..., Lifesciences, 505(b)(2), Oncology and benign..., Antibody-drug conjugates
Education
Lehigh University 1994 — 1997
Doctor of Philosophy (Ph.D.), Biochemistry
Brandon C. Heitmeier, MPH, CPH's FDA Experience April 2002 - Present
Job Senior Regulatory Officer Drug Specialist at FDA
Industry Government Administration
Experience
USPHS July 2008 - Present
FDA April 2002 - Present
Skills
Government, Public Policy, Policy, Public Health, Policy Analysis, Program Evaluation
Education
University of Massachusetts, Amherst 2006 — 2008
MPH, Public Health
LSU 1997 — 2001
BS, Biochemistry
Comeaux High School, Lafayette, LA 1994 — 1997
High School
USPHS July 2008 - Present
FDA April 2002 - Present
Skills
Government, Public Policy, Policy, Public Health, Policy Analysis, Program Evaluation
Education
University of Massachusetts, Amherst 2006 — 2008
MPH, Public Health
LSU 1997 — 2001
BS, Biochemistry
Comeaux High School, Lafayette, LA 1994 — 1997
High School
John Pierre Ruiz John Pierre Ruiz's FDA Experience 2015 - Present
Job Staff Fellow at FDA
Industry Biotechnology
Experience
FDA 2015 - Present
Sarepta Therapeutics August 2013 - May 2014
Coté Orphan Consulting, LLC May 2013 - August 2013
Keck Graduate Institute September 2012 - December 2012
The BioFactory Pte. Ltd. September 2012 - December 2012
University of Florida May 2010 - July 2012
University of Florida- ICBR August 2009 - December 2010
Skills
Bioinformatics, Biotechnology, Agarose Gel..., Apologetics, Technical Writing, Corporate Finance, Team Management, DNA extraction, DNA sequencing, Microsoft Office, Primer Design, Technology Development, Troubleshooting, Conversational Japanese, Spanish, Project Management, Business Development, Business Strategy, Patents, Information Technology, Intellectual Property, Leadership, Life Sciences, Molecular Biology, Data Analysis, PCR, Microsoft Excel, Pharmaceutical Industry, Biochemistry, Microbiology, Public Speaking
Education
Keck Graduate Institute 2012 — 2014
Master of Bioscience, Business of Bioscience, Graduate Student
University of Florida 2006 — 2010
Bachelor of Science (B.S.), Plant Cellular and Molecular Biology
FDA 2015 - Present
Sarepta Therapeutics August 2013 - May 2014
Coté Orphan Consulting, LLC May 2013 - August 2013
Keck Graduate Institute September 2012 - December 2012
The BioFactory Pte. Ltd. September 2012 - December 2012
University of Florida May 2010 - July 2012
University of Florida- ICBR August 2009 - December 2010
Skills
Bioinformatics, Biotechnology, Agarose Gel..., Apologetics, Technical Writing, Corporate Finance, Team Management, DNA extraction, DNA sequencing, Microsoft Office, Primer Design, Technology Development, Troubleshooting, Conversational Japanese, Spanish, Project Management, Business Development, Business Strategy, Patents, Information Technology, Intellectual Property, Leadership, Life Sciences, Molecular Biology, Data Analysis, PCR, Microsoft Excel, Pharmaceutical Industry, Biochemistry, Microbiology, Public Speaking
Education
Keck Graduate Institute 2012 — 2014
Master of Bioscience, Business of Bioscience, Graduate Student
University of Florida 2006 — 2010
Bachelor of Science (B.S.), Plant Cellular and Molecular Biology
Bob Gump, CMAR's FDA Experience August 2014 - Present
Job Animal Program Manager at FDA
Industry Research
Experience
FDA August 2014 - Present
SoBran, Inc. December 2009 - August 2014
SoBran-Inc October 2009 - August 2014
University of Florida 2005 - 2009
University of Illinois at Urbana-Champaign 1999 - 2005
Louisiana Army National Guard 1988 - 2001
Xavier University of Louisiana 1994 - 1999
Skills
animal facility design,..., animal care staffing, IACUC chair & member, heating, ventilation,..., vaporized hydrogen..., physical security, Animal Care, Animal Husbandry, Animal Welfare, Facility Operations, Facilities Management, Facility Design, Facility Layout, Training & Development, Community Outreach, Leadership, Facilities Operations, Employee Training, Renovation, Building Design, Physical Security, Animals, Lifesciences, IACUC, Training, Laboratory, Management, Science, Infectious Diseases, Biotechnology, Immunology, Sop, Drug Discovery, CRO, Vaccines, Validation, Toxicology, GLP, SOP, Life Sciences
Education
Louisiana State University 1980 — 1986
Bachelor of Science (BS), Pre-Veterinary Studies/Natural Sciences
FDA August 2014 - Present
SoBran, Inc. December 2009 - August 2014
SoBran-Inc October 2009 - August 2014
University of Florida 2005 - 2009
University of Illinois at Urbana-Champaign 1999 - 2005
Louisiana Army National Guard 1988 - 2001
Xavier University of Louisiana 1994 - 1999
Skills
animal facility design,..., animal care staffing, IACUC chair & member, heating, ventilation,..., vaporized hydrogen..., physical security, Animal Care, Animal Husbandry, Animal Welfare, Facility Operations, Facilities Management, Facility Design, Facility Layout, Training & Development, Community Outreach, Leadership, Facilities Operations, Employee Training, Renovation, Building Design, Physical Security, Animals, Lifesciences, IACUC, Training, Laboratory, Management, Science, Infectious Diseases, Biotechnology, Immunology, Sop, Drug Discovery, CRO, Vaccines, Validation, Toxicology, GLP, SOP, Life Sciences
Education
Louisiana State University 1980 — 1986
Bachelor of Science (BS), Pre-Veterinary Studies/Natural Sciences
Shalini W.S.Yapa Shalini W.S.Yapa's FDA Experience July 2015 - Present
Job Clinical Pharmacology Reviewer
Industry Research
Experience
FDA July 2015 - Present
GlaxoSmithKline July 2014 - June 2015
University of North Carolina at Chapel Hill July 2013 - June 2014
Monash University 2007 - 2013
Monash University 2007 - 2013
Nucleus Network 2011 - 2012
Alfred Hospital 2009 - 2012
Fullife Pharmacy December 2006 - 2007
Skills
In Vitro, Science, Drug Delivery, In Vivo, HPLC, Research, Pharmacology, Pharmacokinetics, Statistics, Pharmaceutical Research, Analytical Chemistry, Chromatography, Clinical Study Design, Pre-clinical Studies, Clinical Research, Pharmaceutics, Pharmaceutical Industry, Clinical Trials
Education
Monash University 2007 — 2013
Doctor of Philosophy (Ph.D.), Drug Delivery, Disposition and Dynamics
Monash University 2003 — 2006
Bachelor of Pharmacy (B.Pharm.) (Hons)
La Trobe University
Bachelor of Pharmacy (B.Pharm.)
FDA July 2015 - Present
GlaxoSmithKline July 2014 - June 2015
University of North Carolina at Chapel Hill July 2013 - June 2014
Monash University 2007 - 2013
Monash University 2007 - 2013
Nucleus Network 2011 - 2012
Alfred Hospital 2009 - 2012
Fullife Pharmacy December 2006 - 2007
Skills
In Vitro, Science, Drug Delivery, In Vivo, HPLC, Research, Pharmacology, Pharmacokinetics, Statistics, Pharmaceutical Research, Analytical Chemistry, Chromatography, Clinical Study Design, Pre-clinical Studies, Clinical Research, Pharmaceutics, Pharmaceutical Industry, Clinical Trials
Education
Monash University 2007 — 2013
Doctor of Philosophy (Ph.D.), Drug Delivery, Disposition and Dynamics
Monash University 2003 — 2006
Bachelor of Pharmacy (B.Pharm.) (Hons)
La Trobe University
Bachelor of Pharmacy (B.Pharm.)
Emal Wahab Emal Wahab's FDA Experience September 2014 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA September 2014 - Present
Kaiser Permanente March 2012 - September 2014
State of Oregon March 2006 - March 2012
Multnomah County Health Department March 2003 - March 2006
Skills
Government, Policy, Public Policy, Policy Analysis, Emergency Management, Environmental Awareness, Data Analysis, Program Management, Research, Analysis, Technical Writing, Public Health, Community Outreach, Risk Assessment, Quality Control, Quality Management, Regulatory Requirements, Compliance Regulations, Quality Auditing, Program Evaluation, System Monitoring, Progress Monitoring
Education
Portland State University 2009 — 2012
Master's degree, Master of public administration: Health Administration
Lewis and Clark College 1994 — 1998
Bachelor's degree, Chemistry
Wilson High School
FDA September 2014 - Present
Kaiser Permanente March 2012 - September 2014
State of Oregon March 2006 - March 2012
Multnomah County Health Department March 2003 - March 2006
Skills
Government, Policy, Public Policy, Policy Analysis, Emergency Management, Environmental Awareness, Data Analysis, Program Management, Research, Analysis, Technical Writing, Public Health, Community Outreach, Risk Assessment, Quality Control, Quality Management, Regulatory Requirements, Compliance Regulations, Quality Auditing, Program Evaluation, System Monitoring, Progress Monitoring
Education
Portland State University 2009 — 2012
Master's degree, Master of public administration: Health Administration
Lewis and Clark College 1994 — 1998
Bachelor's degree, Chemistry
Wilson High School
Dr. Akm Khairuzzaman Dr. Akm Khairuzzaman's FDA Experience April 2015 - Present
Job Quality Assessment Lead at FDA
Industry Government Administration
Experience
FDA April 2015 - Present
FDA August 2008 - Present
Barr Pharmaceuticals December 2001 - August 2008
Skills
FDA, Sop, IND, Chemistry, CMC, Process Simulation, Regulatory Affairs, GMP, Formulation, Pharmacokinetics, HPLC, GLP, Drug Development, Lifesciences, Technology Transfer, Pharmaceutics, Regulatory Submissions, Analytical Chemistry, UV/Vis, Pharmaceutical Industry, Validation, Clinical Trials, Drug Delivery, Quality by Design, Clinical Research, Cell Culture, Chromatography, Dissolution, Biopharmaceuticals, Biotechnology, Drug Discovery, NDA, Pharmacology, LC-MS, In Vivo, Regulatory Requirements, Pharmaceutical Research, In Vitro, Clinical Pharmacology, Protein Chemistry, Clinical Development, Purification, V&V, LIMS, Toxicology, Immunology, Biochemistry, ELISA, Vaccines, Gas Chromatography
Education
Long Island University, Brooklyn Campus
M.S. & Ph.D, Pharmaceutics
FDA April 2015 - Present
FDA August 2008 - Present
Barr Pharmaceuticals December 2001 - August 2008
Skills
FDA, Sop, IND, Chemistry, CMC, Process Simulation, Regulatory Affairs, GMP, Formulation, Pharmacokinetics, HPLC, GLP, Drug Development, Lifesciences, Technology Transfer, Pharmaceutics, Regulatory Submissions, Analytical Chemistry, UV/Vis, Pharmaceutical Industry, Validation, Clinical Trials, Drug Delivery, Quality by Design, Clinical Research, Cell Culture, Chromatography, Dissolution, Biopharmaceuticals, Biotechnology, Drug Discovery, NDA, Pharmacology, LC-MS, In Vivo, Regulatory Requirements, Pharmaceutical Research, In Vitro, Clinical Pharmacology, Protein Chemistry, Clinical Development, Purification, V&V, LIMS, Toxicology, Immunology, Biochemistry, ELISA, Vaccines, Gas Chromatography
Education
Long Island University, Brooklyn Campus
M.S. & Ph.D, Pharmaceutics
Aviva Copaken's FDA Experience January 2009 - August 2011
Job Executive Asst. Professional with a proven track record of supporting highlevel executives in fastpaced environments
Industry Public Relations and Communications
Experience
National Cancer Institute (NCI) July 2015 - August 2015
Sirens Media February 2015 - May 2015
Sullivan & Company, CPAs August 2012 - July 2014
LivingSocial 2012 - 2012
Washington Energy Summit September 2011 - September 2011
FDA January 2009 - August 2011
Friends and Company June 2008 - January 2009
Ultimate Staffing Temp Agency June 2008 - January 2009
Skills
Microsoft Office, Public Relations, Customer Service, Editing, Access, Adobe Creative Suite, Social Media, Leadership, Microsoft Excel, Advertising, Event Planning, QuickBooks, Interviews, Data Entry, Research, Social Networking, Budgets, Program Management, Facebook, Event Management, Microsoft Word, PowerPoint, Marketing, Time Management, Blogging, Nonprofits, Community Outreach, Strategic Planning, Management
Education
Charles E Smith Jewish Day School
LIU Post 2004 — 2008
BA, Public Relations
Rockville High School 2000 — 2004
High School Diploma, High School/Secondary Diplomas and Certificates
National Cancer Institute (NCI) July 2015 - August 2015
Sirens Media February 2015 - May 2015
Sullivan & Company, CPAs August 2012 - July 2014
LivingSocial 2012 - 2012
Washington Energy Summit September 2011 - September 2011
FDA January 2009 - August 2011
Friends and Company June 2008 - January 2009
Ultimate Staffing Temp Agency June 2008 - January 2009
Skills
Microsoft Office, Public Relations, Customer Service, Editing, Access, Adobe Creative Suite, Social Media, Leadership, Microsoft Excel, Advertising, Event Planning, QuickBooks, Interviews, Data Entry, Research, Social Networking, Budgets, Program Management, Facebook, Event Management, Microsoft Word, PowerPoint, Marketing, Time Management, Blogging, Nonprofits, Community Outreach, Strategic Planning, Management
Education
Charles E Smith Jewish Day School
LIU Post 2004 — 2008
BA, Public Relations
Rockville High School 2000 — 2004
High School Diploma, High School/Secondary Diplomas and Certificates
Jennifer Antonacci Jennifer Antonacci's FDA Experience August 2011 - Present
Job Bioengineering PhD
Industry Biotechnology
Experience
FDA August 2011 - Present
University of California at San Diego September 2004 - March 2011
IBM June 2001 - August 2003
Education
University of California, San Diego 2004 — 2011
M.S./Ph.D, Bioengineering
Lehigh University 1997 — 2001
B.S., Materials Science and Engineering
FDA August 2011 - Present
University of California at San Diego September 2004 - March 2011
IBM June 2001 - August 2003
Education
University of California, San Diego 2004 — 2011
M.S./Ph.D, Bioengineering
Lehigh University 1997 — 2001
B.S., Materials Science and Engineering
Bryan Newman Bryan Newman's FDA Experience July 2014 - Present
Job Pharmacologist at FDA
Industry Pharmaceuticals
Experience
FDA July 2014 - Present
FDA September 2012 - July 2014
University of Michigan June 2008 - July 2012
The Ohio State University August 2006 - June 2008
Louisiana State University School of Veterinary Medicine 2005 - 2006
Skills
Expertise in LC/MS for..., Expertise in Animal..., HPLC, Pharmaceutical Industry, Validation, Flow Cytometry, Cell Culture, Stem Cells, Drug Discovery, Drug Testing, Immunohistochemistry, Immunocytochemistry, Luciferase Assay, RT-PCR, DNA extraction, Laboratory
Education
University of Michigan 2008 — 2012
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences, 8.5/9
The Ohio State University 2006 — 2008
Biochemistry, 3.7
Louisiana State University 2002 — 2006
B.S., Biochemistry, 3.8
FDA July 2014 - Present
FDA September 2012 - July 2014
University of Michigan June 2008 - July 2012
The Ohio State University August 2006 - June 2008
Louisiana State University School of Veterinary Medicine 2005 - 2006
Skills
Expertise in LC/MS for..., Expertise in Animal..., HPLC, Pharmaceutical Industry, Validation, Flow Cytometry, Cell Culture, Stem Cells, Drug Discovery, Drug Testing, Immunohistochemistry, Immunocytochemistry, Luciferase Assay, RT-PCR, DNA extraction, Laboratory
Education
University of Michigan 2008 — 2012
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences, 8.5/9
The Ohio State University 2006 — 2008
Biochemistry, 3.7
Louisiana State University 2002 — 2006
B.S., Biochemistry, 3.8
Samantha Schilsky's FDA Experience September 2015 - Present
Job ORISE fellow at FDA
Industry Medical Practice
Experience
FDA September 2015 - Present
The Global Health Fellows Program II/The Public Health Institute June 2015 - Present
Lang Youth Medical Program-New York Presbyterian Hospital October 2014 - Present
Columbia University Medical Center September 2014 - Present
Columbia University Mailman School of Public Health September 2013 - May 2015
Ministry of Health and Quality of Life, Mauritius May 2014 - August 2014
National Alliance for Mental Illness NYC Metro September 2013 - May 2014
Camp Wildwood June 2013 - August 2013
Lawrence Lifeline January 2012 - June 2013
Lawrence University Information Desk September 2010 - June 2013
Skills
Scientific Writing, Research, Swimming, Friendly Personality, Wildlife, PowerPoint, Time Management, Microsoft Word, Microsoft Excel, iMovie, Drawing, Tissue Culture, Cpr Certified, QPR certified, American Red Cross..., SAS, Stata, MetaXL, Public Speaking, Microsoft Office, Data Analysis, Event Planning, Social Media, Teaching, Community Outreach, Public Health, Nonprofits, CPR Certified
Education
Columbia University Mailman School of Public Health 2013 — 2015
Master of Public Health (MPH), Epidemiology
Lawrence University 2009 — 2013
Bachelor of Arts (BA), Biology, General
FDA September 2015 - Present
The Global Health Fellows Program II/The Public Health Institute June 2015 - Present
Lang Youth Medical Program-New York Presbyterian Hospital October 2014 - Present
Columbia University Medical Center September 2014 - Present
Columbia University Mailman School of Public Health September 2013 - May 2015
Ministry of Health and Quality of Life, Mauritius May 2014 - August 2014
National Alliance for Mental Illness NYC Metro September 2013 - May 2014
Camp Wildwood June 2013 - August 2013
Lawrence Lifeline January 2012 - June 2013
Lawrence University Information Desk September 2010 - June 2013
Skills
Scientific Writing, Research, Swimming, Friendly Personality, Wildlife, PowerPoint, Time Management, Microsoft Word, Microsoft Excel, iMovie, Drawing, Tissue Culture, Cpr Certified, QPR certified, American Red Cross..., SAS, Stata, MetaXL, Public Speaking, Microsoft Office, Data Analysis, Event Planning, Social Media, Teaching, Community Outreach, Public Health, Nonprofits, CPR Certified
Education
Columbia University Mailman School of Public Health 2013 — 2015
Master of Public Health (MPH), Epidemiology
Lawrence University 2009 — 2013
Bachelor of Arts (BA), Biology, General
Kara Johnson, PharmD's FDA Experience 2002 - 2002
Job Senior Drug Information Specialist at Anthem, Inc.
Industry Hospital & Health Care
Experience
Anthem, Inc. April 2015 - Present
Anthem, Inc. November 2008 - April 2015
OSI Pharmaceuticals October 2007 - October 2008
National Health Service (NHS), United Kingdom June 2006 - June 2007
Kaiser Permanente August 2003 - September 2005
University of Kansas Medical Center July 2002 - June 2003
FDA 2002 - 2002
Skills
Pharmacy, Pharmacy Benefit..., Managed Care, Healthcare, Medicare Part D, Medical Writing, Clinical Pharmacy, Disease Management, Health Policy, Pharmacists
Education
University of Kansas School of Pharmacy 1998 — 2002
PharmD, Pharmacy
Kansas State University 1995 — 1997
BS, Life Sciences
Anthem, Inc. April 2015 - Present
Anthem, Inc. November 2008 - April 2015
OSI Pharmaceuticals October 2007 - October 2008
National Health Service (NHS), United Kingdom June 2006 - June 2007
Kaiser Permanente August 2003 - September 2005
University of Kansas Medical Center July 2002 - June 2003
FDA 2002 - 2002
Skills
Pharmacy, Pharmacy Benefit..., Managed Care, Healthcare, Medicare Part D, Medical Writing, Clinical Pharmacy, Disease Management, Health Policy, Pharmacists
Education
University of Kansas School of Pharmacy 1998 — 2002
PharmD, Pharmacy
Kansas State University 1995 — 1997
BS, Life Sciences
Kelsy Hoffman, Ph.D. Kelsy Hoffman, Ph.D.'s FDA Experience July 2010 - Present
Job Primary Regulatory Reviewer
Industry Government Relations
Experience
FDA July 2010 - Present
FDA April 2009 - June 2010
University of Maryland School of Medicine September 2006 - March 2009
State University of New York at Buffalo March 2004 - May 2006
A&E Testing July 2002 - April 2003
Skills
Microarray, Pharmacology, qPCR, In Vivo, Microbiology, Protein Chemistry, DNA, Protein Expression, Molecular Biology, Public Health, PCR, Research, Literature Reviews, Immunostaining
Education
University of Maryland Baltimore 2006 — 2009
PhD, Microbial Pathogenesis
University at Buffalo 2003 — 2006
PhD Candidacy, Microbial Pathogenesis
Louisiana State University 1998 — 2002
BS, Microbiology
FDA July 2010 - Present
FDA April 2009 - June 2010
University of Maryland School of Medicine September 2006 - March 2009
State University of New York at Buffalo March 2004 - May 2006
A&E Testing July 2002 - April 2003
Skills
Microarray, Pharmacology, qPCR, In Vivo, Microbiology, Protein Chemistry, DNA, Protein Expression, Molecular Biology, Public Health, PCR, Research, Literature Reviews, Immunostaining
Education
University of Maryland Baltimore 2006 — 2009
PhD, Microbial Pathogenesis
University at Buffalo 2003 — 2006
PhD Candidacy, Microbial Pathogenesis
Louisiana State University 1998 — 2002
BS, Microbiology
Benjamin Eastman Benjamin Eastman's FDA Experience June 2013 - August 2013
Job Compliance Analyst at Evergreen Health Coop
Industry Legal Services
Experience
Evergreen Health Co-op September 2015 - Present
United States Attorney's Office January 2015 - April 2015
Centers for Medicare & Medicaid Services June 2014 - August 2014
CareFirst BlueCross BlueShield January 2014 - April 2014
FDA June 2013 - August 2013
Excellus BlueCross BlueShield March 2007 - August 2012
Skills
Microsoft Excel, Access, Data Analysis, Microsoft Office, PowerPoint, Microsoft Word, Customer Service, Analysis, Insurance, Teamwork, Outlook
Education
University of Maryland School of Law 2013 — 2015
Juris Doctor
University of the District of Columbia - The David A. Clarke School of Law 2012 — 2013
Juris Doctor (J.D.), Law
Le Moyne College 2002 — 2006
Bachelors of the Arts, Economics
Newfield High School
Evergreen Health Co-op September 2015 - Present
United States Attorney's Office January 2015 - April 2015
Centers for Medicare & Medicaid Services June 2014 - August 2014
CareFirst BlueCross BlueShield January 2014 - April 2014
FDA June 2013 - August 2013
Excellus BlueCross BlueShield March 2007 - August 2012
Skills
Microsoft Excel, Access, Data Analysis, Microsoft Office, PowerPoint, Microsoft Word, Customer Service, Analysis, Insurance, Teamwork, Outlook
Education
University of Maryland School of Law 2013 — 2015
Juris Doctor
University of the District of Columbia - The David A. Clarke School of Law 2012 — 2013
Juris Doctor (J.D.), Law
Le Moyne College 2002 — 2006
Bachelors of the Arts, Economics
Newfield High School
Stephan Ortiz, RPh, PhD's FDA Experience May 2003 - December 2006
Job Associate Director at Alexion
Industry Pharmaceuticals
Experience
Alexion Pharmaceuticals, Inc. June 2014 - Present
Forest Research Institute January 2011 - August 2014
Forest Research Institute December 2007 - January 2011
Forest Research Institute November 2006 - December 2007
FDA May 2003 - December 2006
Skills
Clinical Trials, Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Industry, Clinical Research, Regulatory Affairs, Drug Development, FDA, R&D, Clinical Development, Lifesciences, Clinical Study Design, GMP, Pharmacology, CRO, CTMS, Technology Transfer, Formulation, Regulatory Submissions, Drug Delivery, GCP
Education
LIU Brooklyn 1992 — 2003
B.S., Ph.D.
Alexion Pharmaceuticals, Inc. June 2014 - Present
Forest Research Institute January 2011 - August 2014
Forest Research Institute December 2007 - January 2011
Forest Research Institute November 2006 - December 2007
FDA May 2003 - December 2006
Skills
Clinical Trials, Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Industry, Clinical Research, Regulatory Affairs, Drug Development, FDA, R&D, Clinical Development, Lifesciences, Clinical Study Design, GMP, Pharmacology, CRO, CTMS, Technology Transfer, Formulation, Regulatory Submissions, Drug Delivery, GCP
Education
LIU Brooklyn 1992 — 2003
B.S., Ph.D.
Richard Siarey's FDA Experience February 2008 - Present
Job Pharmacologist, FDA
Industry Pharmaceuticals
Experience
FDA February 2008 - Present
USUHS January 2002 - February 2008
Solvay Pharmaceuticals September 1999 - January 2002
National Institutes of Health September 1994 - September 1999
Skills
Pharmaceutical Industry, Neuroscience, Molecular Biology, Drug Discovery, Science, Lifesciences, Pharmacology, Clinical Research, Cell Culture, Genetics, In Vitro, Clinical Development, Biochemistry, Biotechnology, Drug Development, Assay Development, Life Sciences, In Vivo
Education
University of Bristol 1988 — 1992
Kingston University 1984 — 1987
FDA February 2008 - Present
USUHS January 2002 - February 2008
Solvay Pharmaceuticals September 1999 - January 2002
National Institutes of Health September 1994 - September 1999
Skills
Pharmaceutical Industry, Neuroscience, Molecular Biology, Drug Discovery, Science, Lifesciences, Pharmacology, Clinical Research, Cell Culture, Genetics, In Vitro, Clinical Development, Biochemistry, Biotechnology, Drug Development, Assay Development, Life Sciences, In Vivo
Education
University of Bristol 1988 — 1992
Kingston University 1984 — 1987
Wm. Dewey Rushing's FDA Experience March 1997 - October 2001
Job Manager, Validations at Bayer HealthCare Pharmaceuticals
Industry Biotechnology
Experience
Bayer HealthCare Pharmaceuticals Manager, QA ValidationZymoGeneticsJuly 2004 - July 2006
BiogenIdec January 2001 - August 2004
FDA March 1997 - October 2001
Amgen November 1991 - March 1997
Education
San Diego State University-California State University 2005 — 2008
MS, Regulatory Affairs
Kansas State University 1984 — 1989
BS, Microbiology
Bayer HealthCare Pharmaceuticals Manager, QA ValidationZymoGeneticsJuly 2004 - July 2006
BiogenIdec January 2001 - August 2004
FDA March 1997 - October 2001
Amgen November 1991 - March 1997
Education
San Diego State University-California State University 2005 — 2008
MS, Regulatory Affairs
Kansas State University 1984 — 1989
BS, Microbiology
Dhaval Gaglani's FDA Experience January 2015 - Present
Job
Industry Government Administration
Experience
FDA January 2015 - Present
FDA/CDER/OPS March 2014 - January 2015
FDA August 2010 - March 2014
Pfizer October 2009 - July 2010
Wyeth Pharmaceuticals November 2000 - October 2009
CorePharma LLC December 1998 - October 2000
Indo Pharma 1995 - 1995
Skills
Formulation, Technology Transfer, Quality by Design, Regulatory Affairs, Product Development, Pharmaceutical Industry, GMP, Sop, Validation, Drug Development, Pharmaceutics, CMC, Biotechnology, Regulatory Submissions, CMC Regulatory Affairs, prod, pharm, Drug Delivery, R&D, SOP, GLP, HPLC
Education
Long Island University 1996 — 1999
Master of Science (MS)-Pharmaceutics
College of Pharmacy 1991 — 1994
Bachelor of Pharmacy (B.Pharm.)
Long Island University
Doctor of Philosophy (Ph.D.)
FDA January 2015 - Present
FDA/CDER/OPS March 2014 - January 2015
FDA August 2010 - March 2014
Pfizer October 2009 - July 2010
Wyeth Pharmaceuticals November 2000 - October 2009
CorePharma LLC December 1998 - October 2000
Indo Pharma 1995 - 1995
Skills
Formulation, Technology Transfer, Quality by Design, Regulatory Affairs, Product Development, Pharmaceutical Industry, GMP, Sop, Validation, Drug Development, Pharmaceutics, CMC, Biotechnology, Regulatory Submissions, CMC Regulatory Affairs, prod, pharm, Drug Delivery, R&D, SOP, GLP, HPLC
Education
Long Island University 1996 — 1999
Master of Science (MS)-Pharmaceutics
College of Pharmacy 1991 — 1994
Bachelor of Pharmacy (B.Pharm.)
Long Island University
Doctor of Philosophy (Ph.D.)
Chris Jacquette's FDA Experience November 2013 - July 2015
Job International Program Specialist at USDA
Industry International Affairs
Experience
USDA July 2015 - Present
FDA November 2013 - July 2015
USDA July 2010 - November 2013
USDA September 2007 - July 2010
Skills
International Trade, Policy Analysis, International Relations, Public Policy, Economic Development, Microsoft Office, Government, International..., Economics, Nonprofits
Education
King's College London, U. of London 2004 — 2005
Master's degree, International Relations
USDA July 2015 - Present
FDA November 2013 - July 2015
USDA July 2010 - November 2013
USDA September 2007 - July 2010
Skills
International Trade, Policy Analysis, International Relations, Public Policy, Economic Development, Microsoft Office, Government, International..., Economics, Nonprofits
Education
King's College London, U. of London 2004 — 2005
Master's degree, International Relations
Malgorzata Norton's FDA Experience 2000 - 2004
Job Biologist at FDA
Industry Pharmaceuticals
Experience
FDA/CBER 2006 - Present
Nabi Biopharmaceuticals 2004 - 2006
FDA 2000 - 2004
Louisiana State University 1999 - 2000
Skills
Immunology, Protein Chemistry, Cell Culture, Biosensors, Surface Plasmon..., Regulatory Research, Assay Development, Protein Purification, Regulations, Western Blotting, Purification, Flow Cytometry, In Vitro, Virology, GLP, Biopharmaceuticals, Biotechnology, Molecular Biology, In Vivo, Biochemistry, ELISA, Life Sciences
Education
Louisiana State University School of Veterinary Medicine 1998 — 1999
MS, Veterinary Medical Sciences / Immunology
Louisiana State University 1994 — 1997
BS, Zoology
University of Denver 1993 — 1994
Biology
FDA/CBER 2006 - Present
Nabi Biopharmaceuticals 2004 - 2006
FDA 2000 - 2004
Louisiana State University 1999 - 2000
Skills
Immunology, Protein Chemistry, Cell Culture, Biosensors, Surface Plasmon..., Regulatory Research, Assay Development, Protein Purification, Regulations, Western Blotting, Purification, Flow Cytometry, In Vitro, Virology, GLP, Biopharmaceuticals, Biotechnology, Molecular Biology, In Vivo, Biochemistry, ELISA, Life Sciences
Education
Louisiana State University School of Veterinary Medicine 1998 — 1999
MS, Veterinary Medical Sciences / Immunology
Louisiana State University 1994 — 1997
BS, Zoology
University of Denver 1993 — 1994
Biology
Cheryl Curet's FDA Experience 1996 - 2000
Job Lead Specialist GCP at sanofiaventis
Industry Pharmaceuticals
Experience
sanofi-aventis April 2013 - Present
sanofi-aventis October 2001 - March 2013
Schering Plough 2000 - 2001
FDA 1996 - 2000
Skills
Auditing, FDA, SOP, GCP, Quality Assurance, CAPA, Compliance, Sop, GMP, Pharmaceutical Industry, Regulatory Affairs, 21 CFR Part 11, Validation, Protocol, Clinical Development, CRO, Clinical Research, Clinical Trials, Quality Auditing, Change Control, Regulatory Submissions
Education
Kean University 1985 — 1989
Bachelor of Science
sanofi-aventis April 2013 - Present
sanofi-aventis October 2001 - March 2013
Schering Plough 2000 - 2001
FDA 1996 - 2000
Skills
Auditing, FDA, SOP, GCP, Quality Assurance, CAPA, Compliance, Sop, GMP, Pharmaceutical Industry, Regulatory Affairs, 21 CFR Part 11, Validation, Protocol, Clinical Development, CRO, Clinical Research, Clinical Trials, Quality Auditing, Change Control, Regulatory Submissions
Education
Kean University 1985 — 1989
Bachelor of Science
Elena Shmidt's FDA Experience 2011 - 2012
Job Clinical Safety Reviewer at CRF
Industry Pharmaceuticals
Experience
CRF 2012 - Present
FDA 2011 - 2012
Novartis 2001 - 2011
Kessler Institute for Rehabilitation 2004 - 2007
Bon Secours Health System 1999 - 2001
Beth Israel Medical center 1989 - 1991
Skills
Pharmacovigilance, Pharmaceutical Industry, Clinical Research, Clinical Trials, Oncology, Regulatory Affairs, Clinical Development, Medical Writing
Education
Long Island University, Brooklyn Campus
Bachelor of Science (BS), Pharmacy
Shenandoah University
PharmD
CRF 2012 - Present
FDA 2011 - 2012
Novartis 2001 - 2011
Kessler Institute for Rehabilitation 2004 - 2007
Bon Secours Health System 1999 - 2001
Beth Israel Medical center 1989 - 1991
Skills
Pharmacovigilance, Pharmaceutical Industry, Clinical Research, Clinical Trials, Oncology, Regulatory Affairs, Clinical Development, Medical Writing
Education
Long Island University, Brooklyn Campus
Bachelor of Science (BS), Pharmacy
Shenandoah University
PharmD
CDR Jed Virata, USPHS's FDA Experience September 2008 - Present
Job FDA Investigator / USPHS RIST2 Responder
Industry Government Administration
Experience
U.S. Public Health Service Commissioned Corps April 2010 - Present
FDA September 2008 - Present
CPD 2006 - Present
USPHS 2001 - Present
DHS/Office of Infrastructure Protection March 2003 - September 2008
HRSA/BPHC/DIHS July 2001 - March 2003
NIPD January 1999 - December 2002
EVVNA September 1996 - July 2001
Skills
Certified Correctional..., Emergency Management, Public Health, Policy, Healthcare, Clinical Research, Government, Epidemiology, Program Management, Budget, Public Speaking, Program Evaluation, Research, PowerPoint, Program Development, Teaching, Risk Assessment, Data Analysis, Project Management, Regulatory Affairs, Health and Safety, Repatriation, Health Education, Community Outreach, Healthcare Management, Disaster Response, Preparedness, Emergency Medicine, Health Policy, Hospitals
Education
Kean University 2000 — 2003
MPA, Health Administration
Kean University 2000 — 2003
MSN, Transcultural Health / Community Health / Nursing Administration
Rutgers, The State University of New Jersey-Newark 1992 — 1996
BS, Nursing
U.S. Public Health Service Commissioned Corps April 2010 - Present
FDA September 2008 - Present
CPD 2006 - Present
USPHS 2001 - Present
DHS/Office of Infrastructure Protection March 2003 - September 2008
HRSA/BPHC/DIHS July 2001 - March 2003
NIPD January 1999 - December 2002
EVVNA September 1996 - July 2001
Skills
Certified Correctional..., Emergency Management, Public Health, Policy, Healthcare, Clinical Research, Government, Epidemiology, Program Management, Budget, Public Speaking, Program Evaluation, Research, PowerPoint, Program Development, Teaching, Risk Assessment, Data Analysis, Project Management, Regulatory Affairs, Health and Safety, Repatriation, Health Education, Community Outreach, Healthcare Management, Disaster Response, Preparedness, Emergency Medicine, Health Policy, Hospitals
Education
Kean University 2000 — 2003
MPA, Health Administration
Kean University 2000 — 2003
MSN, Transcultural Health / Community Health / Nursing Administration
Rutgers, The State University of New Jersey-Newark 1992 — 1996
BS, Nursing
Mindi Byrd's FDA Experience April 2009 - November 2010
Job IPT QA Coordinator at Merck
Industry Research
Experience
Merck June 2011 - Present
Novartis Diagnostic and Vaccine February 2010 - May 2011
FDA April 2009 - November 2010
Association of Public Health Lab August 2007 - April 2009
Skills
LIMS, Biotechnology, Pharmaceutical Industry, GLP, Aseptic Processing, Sop, GMP, Validation, Microbiology
Education
Kansas State University 2004 — 2006
M.S., Food Microbiology/Public Health
Kansas State University 2001 — 2003
B.S, Food Science
Merck June 2011 - Present
Novartis Diagnostic and Vaccine February 2010 - May 2011
FDA April 2009 - November 2010
Association of Public Health Lab August 2007 - April 2009
Skills
LIMS, Biotechnology, Pharmaceutical Industry, GLP, Aseptic Processing, Sop, GMP, Validation, Microbiology
Education
Kansas State University 2004 — 2006
M.S., Food Microbiology/Public Health
Kansas State University 2001 — 2003
B.S, Food Science
Aakanksha Khandelwal's FDA Experience 2008 - September 2011
Job US Brand Lead, avelumab at EMD Serono
Industry Pharmaceuticals
Experience
EMD Serono, Inc. June 2015 - Present
Merck Group January 2015 - June 2015
Merck Serono April 2014 - December 2014
EMD Serono, Inc. June 2013 - March 2014
Roche August 2012 - September 2012
Johnson & Johnson June 2012 - August 2012
University of Maryland School of Medicine June 2010 - June 2012
FDA 2008 - September 2011
Education
London Business School
MBA
University of Maryland Baltimore
Ph.D., Pharmacology
University of Maryland Baltimore County
B.S., Biochemistry/Molecular Biology
EMD Serono, Inc. June 2015 - Present
Merck Group January 2015 - June 2015
Merck Serono April 2014 - December 2014
EMD Serono, Inc. June 2013 - March 2014
Roche August 2012 - September 2012
Johnson & Johnson June 2012 - August 2012
University of Maryland School of Medicine June 2010 - June 2012
FDA 2008 - September 2011
Education
London Business School
MBA
University of Maryland Baltimore
Ph.D., Pharmacology
University of Maryland Baltimore County
B.S., Biochemistry/Molecular Biology
Andrei Breazna's FDA Experience June 1999 - April 2001
Job Director Statistics at Pfizer
Industry Pharmaceuticals
Experience
Pfizer April 2004 - Present
GSK April 2001 - April 2004
FDA June 1999 - April 2001
Skills
Drug Development, Infectious Diseases, Oncology, Clinical Development, Clinical Study Design, Biostatistics, Pharmaceutical Industry, SAS programming, Clinical Trials, Clinical Research, SAS, CDISC, Statistical Modeling, GCP, EDC, Clinical Data Management, Survival Analysis, Regulatory Submissions, Protocol, CRO, Therapeutic Areas
Education
University of Rochester School of Medicine and Dentistry 1998 — 1999
Postdoc, Biostatistics
The University of Memphis 1997 — 1998
PhD, Mathematical Sciences
Louisiana State University
Pfizer April 2004 - Present
GSK April 2001 - April 2004
FDA June 1999 - April 2001
Skills
Drug Development, Infectious Diseases, Oncology, Clinical Development, Clinical Study Design, Biostatistics, Pharmaceutical Industry, SAS programming, Clinical Trials, Clinical Research, SAS, CDISC, Statistical Modeling, GCP, EDC, Clinical Data Management, Survival Analysis, Regulatory Submissions, Protocol, CRO, Therapeutic Areas
Education
University of Rochester School of Medicine and Dentistry 1998 — 1999
Postdoc, Biostatistics
The University of Memphis 1997 — 1998
PhD, Mathematical Sciences
Louisiana State University
Paul Zhichkin's FDA Experience October 2010 - Present
Job FDA Commissioner's Fellow
Industry Pharmaceuticals
Experience
FDA October 2010 - Present
AMRI June 1998 - October 2010
Education
Lomonosov Moscow State University (MSU) 1987 — 1994
MS with Honors and PhD, Organic Chemistry
FDA October 2010 - Present
AMRI June 1998 - October 2010
Education
Lomonosov Moscow State University (MSU) 1987 — 1994
MS with Honors and PhD, Organic Chemistry
Paul Schuette's FDA Experience August 2008 - Present
Job Mathematical Statistician at FDA
Industry Pharmaceuticals
Experience
FDA August 2008 - Present
Meredith College August 2002 - August 2008
Skills
Probability Theory, Mathematical Modeling, FDA, Statistics, Mathematics, SAS, Data Analysis, Stochastic Processes, Government, Grants, R, Statistical Modeling, Stata, Matlab, LaTeX, Data Mining, Biostatistics, Research, Analysis, Programming, Teaching, Minitab, Mathematica, Simulation, C++, Algorithms, Writing, Clinical Trials, Simulations, College Teaching, Higher Education, Applied Mathematics, Bayesian statistics, Multivariate Statistics, Clinical Study Design, Epidemiology, S-Plus, Statistical Computing, Machine Learning, Bioinformatics, Experimental Design, Statistical Programming
Education
University of Wisconsin-Madison 1984 — 1991
MA, PhD, Mathematics, Probability Theory
Kansas State University 1981 — 1984
BS, Mathematics
Manhattan High School
Manhattan High School
FDA August 2008 - Present
Meredith College August 2002 - August 2008
Skills
Probability Theory, Mathematical Modeling, FDA, Statistics, Mathematics, SAS, Data Analysis, Stochastic Processes, Government, Grants, R, Statistical Modeling, Stata, Matlab, LaTeX, Data Mining, Biostatistics, Research, Analysis, Programming, Teaching, Minitab, Mathematica, Simulation, C++, Algorithms, Writing, Clinical Trials, Simulations, College Teaching, Higher Education, Applied Mathematics, Bayesian statistics, Multivariate Statistics, Clinical Study Design, Epidemiology, S-Plus, Statistical Computing, Machine Learning, Bioinformatics, Experimental Design, Statistical Programming
Education
University of Wisconsin-Madison 1984 — 1991
MA, PhD, Mathematics, Probability Theory
Kansas State University 1981 — 1984
BS, Mathematics
Manhattan High School
Manhattan High School
Andrey Galkin's FDA Experience April 2014 - Present
Job ORISE fellow at FDA
Industry Biotechnology
Experience
FDA April 2014 - Present
University of Maryland June 2000 - June 2013
Institute for Chemical Research, Kyoto University, Japan April 1996 - May 2000
"NBO Immunotech" Inc. January 1992 - March 1996
Skills
Protein Chemistry, Protein Purification, Protein Expression, Biochemistry, ELISA, Western Blotting, Assay Development, Molecular Biology, Cell, Molecular Cloning, HPLC, Cell Biology, FPLC, Bioinformatics, Drug Discovery, DNA, PCR, Lifesciences, DNA sequencing, RT-PCR, Microbiology, qPCR, Purification
Education
Lomonosov Moscow State University (MSU) 1987 — 1991
Doctor of Philosophy (Ph.D.), Chemical Kinetics and Enzyme Catalysis
Lomonosov Moscow State University (MSU) 1982 — 1987
Diploma (with Honors; M. S. equivalent), Chemistry
FDA April 2014 - Present
University of Maryland June 2000 - June 2013
Institute for Chemical Research, Kyoto University, Japan April 1996 - May 2000
"NBO Immunotech" Inc. January 1992 - March 1996
Skills
Protein Chemistry, Protein Purification, Protein Expression, Biochemistry, ELISA, Western Blotting, Assay Development, Molecular Biology, Cell, Molecular Cloning, HPLC, Cell Biology, FPLC, Bioinformatics, Drug Discovery, DNA, PCR, Lifesciences, DNA sequencing, RT-PCR, Microbiology, qPCR, Purification
Education
Lomonosov Moscow State University (MSU) 1987 — 1991
Doctor of Philosophy (Ph.D.), Chemical Kinetics and Enzyme Catalysis
Lomonosov Moscow State University (MSU) 1982 — 1987
Diploma (with Honors; M. S. equivalent), Chemistry
David Hilfiker's FDA Experience 2001 - 2005
Job Senior Director, Strategic QA Clinical Development Team Leader at Johnson & Johnson
Industry Pharmaceuticals
Experience
Johnson & Johnson February 2015 - Present
Johnson & Johnson December 2012 - February 2015
Johnson & Johnson June 2011 - December 2012
Johnson & Johnson March 2008 - June 2011
Johnson & Johnson November 2005 - March 2008
FDA 2001 - 2005
FDA 1997 - 2001
Skills
Regulatory Affairs, IND, FDA, Clinical Development, Product Development, Pharmaceutical Industry, GCP, NDA, Drug Development, Biotechnology, Pharmacology, Regulations, Strategy, Clinical Trials, Toxicology, Policy, Regulatory Submissions, Project Management, Leadership
Education
University of Maryland College Park 1995 — 1997
M.S., Biochemistry
Lafayette College 1990 — 1994
B.S., Biochemistry
Johnson & Johnson February 2015 - Present
Johnson & Johnson December 2012 - February 2015
Johnson & Johnson June 2011 - December 2012
Johnson & Johnson March 2008 - June 2011
Johnson & Johnson November 2005 - March 2008
FDA 2001 - 2005
FDA 1997 - 2001
Skills
Regulatory Affairs, IND, FDA, Clinical Development, Product Development, Pharmaceutical Industry, GCP, NDA, Drug Development, Biotechnology, Pharmacology, Regulations, Strategy, Clinical Trials, Toxicology, Policy, Regulatory Submissions, Project Management, Leadership
Education
University of Maryland College Park 1995 — 1997
M.S., Biochemistry
Lafayette College 1990 — 1994
B.S., Biochemistry
Katelyn Wannage's FDA Experience June 2014 - Present
Job Management Analyst at FDA
Industry Financial Services
Experience
FDA June 2014 - Present
US Department of Homeland Security July 2011 - June 2014
Pure Solutions December 2010 - June 2011
The White House September 2010 - November 2010
The White House June 2010 - September 2010
Clinton Foundation June 2009 - August 2009
Skills
SPSS, SharePoint, French
Education
The George Washington University 2010 — 2012
Masters in Public Administration, Federal Politics, Policy & Management
Louisiana State University 2006 — 2010
Bachelor of the Arts, International Studies & French
FDA June 2014 - Present
US Department of Homeland Security July 2011 - June 2014
Pure Solutions December 2010 - June 2011
The White House September 2010 - November 2010
The White House June 2010 - September 2010
Clinton Foundation June 2009 - August 2009
Skills
SPSS, SharePoint, French
Education
The George Washington University 2010 — 2012
Masters in Public Administration, Federal Politics, Policy & Management
Louisiana State University 2006 — 2010
Bachelor of the Arts, International Studies & French
Jennifer DeGroot's FDA Experience June 2009 - Present
Job CSO at FDA
Industry Biotechnology
Munjal Patel's FDA Experience August 2015 - Present
Job ORISE Fellow at Division of Pharmacometrics,Office of Clinical Pharmacology,FDA
Industry Pharmaceuticals
Experience
FDA August 2015 - Present
Long Island University September 2010 - Present
Takeda Pharmaceuticals November 2014 - March 2015
Takeda Pharmaceuticals May 2014 - October 2014
Long Island University January 2008 - April 2014
Long Island University May 2008 - December 2013
Unique Pharmaceuticals Ltd,India January 2007 - May 2007
Skills
Pharmacokinetics, R, NONMEM, Mathematical Modeling, WinNonlin, Phoenix, Scientific Programming, PK/PD, Biostatistics, Simulations, Drug Delivery, HPLC, UV/Vis, Dissolution, In Vitro, Formulation, In Vivo, Microdialysis, Bioanalysis, Pharmacology, SPSS, in Vivo Microdialysis, Clinical Trials, GraphPad Prism, Pharmaceutical Industry, Pharmaceutics
Education
Long Island University 2010 — 2015
PhD, Pharmaceutics and Drug Design
Long Island University 2008 — 2010
MS, Pharmaceutical Sciences (Industrial and Physical Pharmacy)
Rajiv Gandhi University of Health Sciences 2002 — 2006
BS, Pharmacy
FDA August 2015 - Present
Long Island University September 2010 - Present
Takeda Pharmaceuticals November 2014 - March 2015
Takeda Pharmaceuticals May 2014 - October 2014
Long Island University January 2008 - April 2014
Long Island University May 2008 - December 2013
Unique Pharmaceuticals Ltd,India January 2007 - May 2007
Skills
Pharmacokinetics, R, NONMEM, Mathematical Modeling, WinNonlin, Phoenix, Scientific Programming, PK/PD, Biostatistics, Simulations, Drug Delivery, HPLC, UV/Vis, Dissolution, In Vitro, Formulation, In Vivo, Microdialysis, Bioanalysis, Pharmacology, SPSS, in Vivo Microdialysis, Clinical Trials, GraphPad Prism, Pharmaceutical Industry, Pharmaceutics
Education
Long Island University 2010 — 2015
PhD, Pharmaceutics and Drug Design
Long Island University 2008 — 2010
MS, Pharmaceutical Sciences (Industrial and Physical Pharmacy)
Rajiv Gandhi University of Health Sciences 2002 — 2006
BS, Pharmacy
Claudine Kabera's FDA Experience July 2013 - Present
Job Epidemiologist
Industry Government Administration
Experience
FDA July 2013 - Present
U.S. FOOD AND DRUG ADMINISTRATION July 2011 - Present
FDA April 2009 - July 2011
US Food and Drug Administration April 2009 - July 2011
Loma Linda University Medical Center September 2008 - March 2009
LOMA LINDA UNVERSITY HEALTH CARE September 2008 - March 2009
Skills
Epidemiology, Statistics, Public Health, Healthcare, Program Evaluation, SAS, Grant Writing, Data Analysis, Global Health, Analysis, Research, Biostatistics, Health Equity, Literature Reviews, International Health, SPSS
Education
LOMA LINDA UNIVERSITY, SCHOOL OF PUBLIC HEALTH 2006 — 2008
Masters, Public Health
Loma Linda University 2006 — 2008
MPH, Epidemiology
UNIVERSITY OF SOUTHER CALIFORNIA 2002 — 2006
Bachelor of Arts, Health and Humanity, Pre-medicine
University of Southern California 2002 — 2006
BA, Health and Humanity
FDA July 2013 - Present
U.S. FOOD AND DRUG ADMINISTRATION July 2011 - Present
FDA April 2009 - July 2011
US Food and Drug Administration April 2009 - July 2011
Loma Linda University Medical Center September 2008 - March 2009
LOMA LINDA UNVERSITY HEALTH CARE September 2008 - March 2009
Skills
Epidemiology, Statistics, Public Health, Healthcare, Program Evaluation, SAS, Grant Writing, Data Analysis, Global Health, Analysis, Research, Biostatistics, Health Equity, Literature Reviews, International Health, SPSS
Education
LOMA LINDA UNIVERSITY, SCHOOL OF PUBLIC HEALTH 2006 — 2008
Masters, Public Health
Loma Linda University 2006 — 2008
MPH, Epidemiology
UNIVERSITY OF SOUTHER CALIFORNIA 2002 — 2006
Bachelor of Arts, Health and Humanity, Pre-medicine
University of Southern California 2002 — 2006
BA, Health and Humanity
Dennis Sleister's FDA Experience 2002 - 2010
Job Owner, Niche Medical Inc
Industry Medical Devices
Experience
Niche Medical Inc January 1995 - Present
FDA 2002 - 2010
Surgilase Inc May 1984 - July 1992
C R Bard Inc November 1978 - May 1984
Air Products December 1970 - November 1978
Skills
Strategic Planning, Start-ups, Leadership, Business Strategy, Management, New Business Development, Mergers & Acquisitions, Sales, Medical Devices, Recruiting, Venture Capital, Entrepreneurship, Marketing Strategy, Product Development, Real Estate, Strategy, Team Building, Small Business, Business Planning, Mergers, Marketing, Selling, Business Development, Strategic Partnerships
Education
Lehigh University - College of Business and Economics 1975 — 1977
MBA, Marketing and Finance
Niche Medical Inc January 1995 - Present
FDA 2002 - 2010
Surgilase Inc May 1984 - July 1992
C R Bard Inc November 1978 - May 1984
Air Products December 1970 - November 1978
Skills
Strategic Planning, Start-ups, Leadership, Business Strategy, Management, New Business Development, Mergers & Acquisitions, Sales, Medical Devices, Recruiting, Venture Capital, Entrepreneurship, Marketing Strategy, Product Development, Real Estate, Strategy, Team Building, Small Business, Business Planning, Mergers, Marketing, Selling, Business Development, Strategic Partnerships
Education
Lehigh University - College of Business and Economics 1975 — 1977
MBA, Marketing and Finance
Nisha Narayan's FDA Experience May 2014 - Present
Job Intellectual Property and Partnerships Manager
Industry Research
Experience
FDA May 2014 - Present
FDA July 2013 - April 2014
National Institutes of Health October 2012 - July 2013
NIH January 2009 - October 2012
NHLBI Office of Technology Transfer and Development March 2011 - November 2011
ICGEB October 2004 - December 2008
University of Madras June 2002 - April 2004
Dr. Reddy's Laboratories April 2002 - July 2002
National Centre for Biological Sciences, TIFR April 2001 - June 2001
Education
Open University, UK 2004 — 2008
PhD
University of Madras 2002 — 2004
Masters
Osmania University 1999 — 2002
Bachelors degree
Kendriya Vidyalaya 1987 — 1999
FDA May 2014 - Present
FDA July 2013 - April 2014
National Institutes of Health October 2012 - July 2013
NIH January 2009 - October 2012
NHLBI Office of Technology Transfer and Development March 2011 - November 2011
ICGEB October 2004 - December 2008
University of Madras June 2002 - April 2004
Dr. Reddy's Laboratories April 2002 - July 2002
National Centre for Biological Sciences, TIFR April 2001 - June 2001
Education
Open University, UK 2004 — 2008
PhD
University of Madras 2002 — 2004
Masters
Osmania University 1999 — 2002
Bachelors degree
Kendriya Vidyalaya 1987 — 1999
Ramana Bhavanasi's FDA Experience December 2014 - Present
Job Hadoop/Documentum Specialist at FDA
Industry Government Administration
Experience
FDA December 2014 - Present
Dominion March 2013 - December 2014
United Therapeutics February 2012 - March 2013
United Guaranty Corporation September 2011 - February 2012
Dominion Virginia Power September 2009 - September 2011
Bristol-Myers Squibb August 2007 - August 2009
Pfizer February 2007 - August 2007
Computer Associates (CA) - XECA February 2005 - January 2007
Citi Bank at Singapore January 2004 - January 2005
Birlasoft February 2000 - December 2003
Skills
Webtop, WDK, SharePoint, ASP.NET, J2EE, Task Space, Documentum Administrator, Business Management, BAM, Documentum..., .NET, Input Accel, DocLoader, Crystal Reports, Java Enterprise Edition, Management, Microsoft SQL Server, Requirements Analysis, Solution Architecture, Enterprise Architecture, XML, SDLC, Oracle, Java, Web Services, SOA, Tomcat, Content Management, Enterprise Content..., Software Development, C#, SQL, Documentum, Consulting, Agile Methodologies, Integration, Software Project..., WebLogic, Business Intelligence, Document Management, Vendor Management, Spring Framework, Unix, JSP, Databases, JavaScript, PL/SQL, Enterprise Software, WebSphere
Education
Kuvempu Vishwavidyanilaya 1997 — 2000
MCA, Computers
NIIT 1995 — 1997
GNIIT, Computer
FDA December 2014 - Present
Dominion March 2013 - December 2014
United Therapeutics February 2012 - March 2013
United Guaranty Corporation September 2011 - February 2012
Dominion Virginia Power September 2009 - September 2011
Bristol-Myers Squibb August 2007 - August 2009
Pfizer February 2007 - August 2007
Computer Associates (CA) - XECA February 2005 - January 2007
Citi Bank at Singapore January 2004 - January 2005
Birlasoft February 2000 - December 2003
Skills
Webtop, WDK, SharePoint, ASP.NET, J2EE, Task Space, Documentum Administrator, Business Management, BAM, Documentum..., .NET, Input Accel, DocLoader, Crystal Reports, Java Enterprise Edition, Management, Microsoft SQL Server, Requirements Analysis, Solution Architecture, Enterprise Architecture, XML, SDLC, Oracle, Java, Web Services, SOA, Tomcat, Content Management, Enterprise Content..., Software Development, C#, SQL, Documentum, Consulting, Agile Methodologies, Integration, Software Project..., WebLogic, Business Intelligence, Document Management, Vendor Management, Spring Framework, Unix, JSP, Databases, JavaScript, PL/SQL, Enterprise Software, WebSphere
Education
Kuvempu Vishwavidyanilaya 1997 — 2000
MCA, Computers
NIIT 1995 — 1997
GNIIT, Computer
Allison A. Aldridge, Ph.D.'s FDA Experience July 2013 - Present
Job Team Lead at FDA
Industry Pharmaceuticals
Experience
FDA July 2013 - Present
FDA January 2011 - July 2013
Speed Laboratory, Inc. November 2009 - January 2011
Revogenex.com April 2009 - September 2009
Mikart, Inc. September 2005 - April 2009
Abbott Laboratories June 2000 - July 2005
Unilever HPC, USA November 1997 - June 2000
Skills
Analytical Chemistry, GMP, Chemistry, Chromatography, Change Control, CAPA, FDA, Gas Chromatography, GC-MS, HPLC, LC-MS, Mass Spectrometry, NMR, Pharmaceutical Industry
Education
Loyola University Chicago 1993 — 1997
Ph.D., Chemistry
University of Illinois at Urbana-Champaign 1979 — 1983
B.S., Biology
FDA July 2013 - Present
FDA January 2011 - July 2013
Speed Laboratory, Inc. November 2009 - January 2011
Revogenex.com April 2009 - September 2009
Mikart, Inc. September 2005 - April 2009
Abbott Laboratories June 2000 - July 2005
Unilever HPC, USA November 1997 - June 2000
Skills
Analytical Chemistry, GMP, Chemistry, Chromatography, Change Control, CAPA, FDA, Gas Chromatography, GC-MS, HPLC, LC-MS, Mass Spectrometry, NMR, Pharmaceutical Industry
Education
Loyola University Chicago 1993 — 1997
Ph.D., Chemistry
University of Illinois at Urbana-Champaign 1979 — 1983
B.S., Biology
Cyrus Bett's FDA Experience August 2015 - Present
Job Visiting Associate at FDA
Industry Research
Experience
FDA August 2015 - Present
FDA September 2014 - July 2015
University of California, San Diego January 2010 - August 2014
Louisiana State University August 2003 - May 2009
Skills
Spectroscopy, UV/Vis, PCR, Cell Culture, Chemistry, Microscopy, Nanotechnology, Mass Spectrometry, Protein Purification, Fluorescence..., Analytical Chemistry, Fluorescence, Peptides, AFM, Organic Synthesis, Molecular Biology, Biochemistry, Scanning Electron..., Western Blotting, Characterization, Protein Expression, Protein Chemistry, Cell Biology, HPLC, NMR, ELISA, Axonal transport, Drug Testing
Education
Louisiana State University 2003 — 2009
Doctor of Philosophy (PhD), Organic and peptide Chemistry
FDA August 2015 - Present
FDA September 2014 - July 2015
University of California, San Diego January 2010 - August 2014
Louisiana State University August 2003 - May 2009
Skills
Spectroscopy, UV/Vis, PCR, Cell Culture, Chemistry, Microscopy, Nanotechnology, Mass Spectrometry, Protein Purification, Fluorescence..., Analytical Chemistry, Fluorescence, Peptides, AFM, Organic Synthesis, Molecular Biology, Biochemistry, Scanning Electron..., Western Blotting, Characterization, Protein Expression, Protein Chemistry, Cell Biology, HPLC, NMR, ELISA, Axonal transport, Drug Testing
Education
Louisiana State University 2003 — 2009
Doctor of Philosophy (PhD), Organic and peptide Chemistry
Lezette Earhart's FDA Experience May 1998 - Present
Job Consumer Safety Officer at US Government
Industry Government Administration
Experience
FDA May 1998 - Present
Education
Louisiana State University 1973 — 1977
BS, Environmental Health
Louisiana State University
FDA May 1998 - Present
Education
Louisiana State University 1973 — 1977
BS, Environmental Health
Louisiana State University
AuBrei Weigand's FDA Experience October 2009 - April 2011
Job Product Development Scientist at McCormick & Company
Industry Food & Beverages
Experience
McCormick & Company December 2014 - Present
McCormick March 2011 - December 2014
FDA October 2009 - April 2011
Penn State University July 2007 - November 2009
The Hershey Company August 2006 - May 2007
Lebanon Valley College May 2005 - August 2006
Skills
Sensory Evaluation, Consumer Products, Qualitative Research, Quantitative Research, Cross-functional Team..., HPLC, Focus Groups, Chemistry, Food Science, Science, Product Innovation, Food Technology, Customer Insight, Consumer Insight, Food, Analytical Chemistry, Product Development, Nutrition, Food Industry, Food Chemistry
Education
Penn State University 2007 — 2009
Master, Food Science
Lebanon Valley College 2003 — 2007
B.S., Chemistry
McCormick & Company December 2014 - Present
McCormick March 2011 - December 2014
FDA October 2009 - April 2011
Penn State University July 2007 - November 2009
The Hershey Company August 2006 - May 2007
Lebanon Valley College May 2005 - August 2006
Skills
Sensory Evaluation, Consumer Products, Qualitative Research, Quantitative Research, Cross-functional Team..., HPLC, Focus Groups, Chemistry, Food Science, Science, Product Innovation, Food Technology, Customer Insight, Consumer Insight, Food, Analytical Chemistry, Product Development, Nutrition, Food Industry, Food Chemistry
Education
Penn State University 2007 — 2009
Master, Food Science
Lebanon Valley College 2003 — 2007
B.S., Chemistry
Elena Mishina's FDA Experience January 1996 - January 1999
Job Senior Pharmacologist at US FDA
Industry Government Administration
Experience
US FDA 1999 - Present
FDA January 1996 - January 1999
University at Buffalo 1991 - 1995
Kursk Medical University June 1986 - October 1991
Kursk Medical University March 1984 - June 1986
Skills
Pharmacokinetics, Pharmacology, Biochemistry, Regulatory Affairs, Toxicology, Molecular Biology, Lifesciences, Cell Culture, In Vivo, ELISA, Drug Discovery, HPLC, Clinical Trials, Biotechnology, Drug Development, PCR, GLP, In Vitro, IND, Regulatory Requirements, NDA, Clinical Research, LC-MS, Clinical Development, Immunology, Mass Spectrometry, Assay Development, Analytical Chemistry, Protein Chemistry, Medicinal Chemistry, Chromatography, Regulatory Submissions, Biopharmaceuticals, Cell, Animal Models, FDA, Infectious Diseases, CRO, Life Sciences
Education
SUNY at Buffalo 1991 — 1993
Post-Doctoral, Pharmacokinetics/Pharmacodynamics
Lomonosov Moscow State University (MSU)
Doctor of Philosophy (PhD), Organic Chemistry
highschool
US FDA 1999 - Present
FDA January 1996 - January 1999
University at Buffalo 1991 - 1995
Kursk Medical University June 1986 - October 1991
Kursk Medical University March 1984 - June 1986
Skills
Pharmacokinetics, Pharmacology, Biochemistry, Regulatory Affairs, Toxicology, Molecular Biology, Lifesciences, Cell Culture, In Vivo, ELISA, Drug Discovery, HPLC, Clinical Trials, Biotechnology, Drug Development, PCR, GLP, In Vitro, IND, Regulatory Requirements, NDA, Clinical Research, LC-MS, Clinical Development, Immunology, Mass Spectrometry, Assay Development, Analytical Chemistry, Protein Chemistry, Medicinal Chemistry, Chromatography, Regulatory Submissions, Biopharmaceuticals, Cell, Animal Models, FDA, Infectious Diseases, CRO, Life Sciences
Education
SUNY at Buffalo 1991 — 1993
Post-Doctoral, Pharmacokinetics/Pharmacodynamics
Lomonosov Moscow State University (MSU)
Doctor of Philosophy (PhD), Organic Chemistry
highschool
Maureen Coakley's FDA Experience September 1998 - Present
Job Supervisory Microbiologist at Department of Health and Human Services
Industry Government Administration
Experience
FDA September 1998 - Present
Department of Health and Human Services January 2010 - 2012
Skills
Biotechnology, Genetics, Cell Culture, Food Microbiology, Virology, Regulatory Affairs, Flow Cytometry, HPLC, Molecular Cloning, PCR, GLP, Lifesciences, ELISA, Environmental Health, Protein Purification, Molecular Biology, Science, Microscopy, Cell Biology, Public Health, Gel Electrophoresis, Epidemiology, Protein Chemistry, Immunology, Western Blotting, Infectious Diseases, Biochemistry, Laboratory, Bacterial Culture
Education
Long Island University, Brooklyn Campus
Bachelor's degree, Biology/Biological Sciences, General
FDA September 1998 - Present
Department of Health and Human Services January 2010 - 2012
Skills
Biotechnology, Genetics, Cell Culture, Food Microbiology, Virology, Regulatory Affairs, Flow Cytometry, HPLC, Molecular Cloning, PCR, GLP, Lifesciences, ELISA, Environmental Health, Protein Purification, Molecular Biology, Science, Microscopy, Cell Biology, Public Health, Gel Electrophoresis, Epidemiology, Protein Chemistry, Immunology, Western Blotting, Infectious Diseases, Biochemistry, Laboratory, Bacterial Culture
Education
Long Island University, Brooklyn Campus
Bachelor's degree, Biology/Biological Sciences, General
Soma Chowdhury's FDA Experience July 2010 - August 2014
Job Communications Editor at National Institute of General Medical Sciences (NIGMS)
Industry Writing and Editing
Experience
National Institute of General Medical Sciences (NIGMS) August 2015 - Present
National Institutes of Health September 2014 - Present
FDA July 2010 - August 2014
Federal Drug Administration July 2010 - August 2014
National Institutes of Health January 2009 - March 2010
Louisiana State University March 2009 - June 2009
Department of Zoology, Lady Brabourne College August 2004 - July 2006
Victoria College July 2004 - July 2006
Calcutta University July 2004 - July 2006
Lady Brabourne College January 2004 - July 2006
Skills
PCR, Genetics, qPCR, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Research, FACS analysis, Vero cell culture, Primary T cell culture, Comet Assay, Immunohistochemistry, Mouse scarification, Mouse Handling, GraphPad Prism, ELISA, Genomics, Cancer
Education
Louisiana State University 2006 — 2008
Master of Science (MS), Immunology
Louisiana State University (LSU) 2006 — 2008
Master of Science, Pathobiological Sciences
Calcutta University 2001 — 2003
Master of Science (MS), Zoology/Animal Biology
University of Calcutta 2001 — 2003
Master of Science, Zoology; Parasitology and Immunology
Lady Brabourne College 1998 — 2001
Bachelor of Science, Zoology; Chemistry and Botany
National Institute of General Medical Sciences (NIGMS) August 2015 - Present
National Institutes of Health September 2014 - Present
FDA July 2010 - August 2014
Federal Drug Administration July 2010 - August 2014
National Institutes of Health January 2009 - March 2010
Louisiana State University March 2009 - June 2009
Department of Zoology, Lady Brabourne College August 2004 - July 2006
Victoria College July 2004 - July 2006
Calcutta University July 2004 - July 2006
Lady Brabourne College January 2004 - July 2006
Skills
PCR, Genetics, qPCR, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Research, FACS analysis, Vero cell culture, Primary T cell culture, Comet Assay, Immunohistochemistry, Mouse scarification, Mouse Handling, GraphPad Prism, ELISA, Genomics, Cancer
Education
Louisiana State University 2006 — 2008
Master of Science (MS), Immunology
Louisiana State University (LSU) 2006 — 2008
Master of Science, Pathobiological Sciences
Calcutta University 2001 — 2003
Master of Science (MS), Zoology/Animal Biology
University of Calcutta 2001 — 2003
Master of Science, Zoology; Parasitology and Immunology
Lady Brabourne College 1998 — 2001
Bachelor of Science, Zoology; Chemistry and Botany
Craig Masi's FDA Experience September 2010 - March 2011
Job Law Enforcement Professional
Industry Law Enforcement
Experience
US Department of Homeland Security 2011 - 2015
FDA September 2010 - March 2011
U.S. Consumer Product Safety Commission January 2010 - September 2010
USDA-FSIS September 2008 - January 2010
Molloy College January 2008 - January 2010
Skills
Policy, Regulations, Regulatory Requirements, Class III Medical..., Medical Devices, Food Safety, HACCP, CPSIA, Academic Tutoring, Peer Mentoring, Academia, Federal Government, Risk Assessment, Investigation, Quality System
Education
University of Saint Mary 2014 — 2015
Master of Business Administration (MBA), Organizational Health and Leadership
Long Island University, Southampton Campus 2000 — 2004
BS, Marine Biology
US Department of Homeland Security 2011 - 2015
FDA September 2010 - March 2011
U.S. Consumer Product Safety Commission January 2010 - September 2010
USDA-FSIS September 2008 - January 2010
Molloy College January 2008 - January 2010
Skills
Policy, Regulations, Regulatory Requirements, Class III Medical..., Medical Devices, Food Safety, HACCP, CPSIA, Academic Tutoring, Peer Mentoring, Academia, Federal Government, Risk Assessment, Investigation, Quality System
Education
University of Saint Mary 2014 — 2015
Master of Business Administration (MBA), Organizational Health and Leadership
Long Island University, Southampton Campus 2000 — 2004
BS, Marine Biology
Maan Abduldayem's FDA Experience Fermentation manager / Project managerBaxter HealthcareAugust 1997 - July 2008
Job Consumer safety Officer at FDA
Industry Government Administration
Experience
FDA Fermentation manager / Project managerBaxter HealthcareAugust 1997 - July 2008
Skills
GLP, Change Control, Vaccines, Sop, 21 CFR Part 11, Biopharmaceuticals, Biotechnology, CAPA, FDA, GMP, Lifesciences, Pharmaceutical Industry, Quality System, Regulatory Affairs, Regulatory Requirements, V&V, Validation, Regulatory Submissions, LIMS, Drug Development, IND, Clinical Trials, Microbiology
Education
The Johns Hopkins University - Carey Business School 2002 — 2004
MBA, Managemnt
King Saud University 1985 — 1990
B.Sc., Biomedical Instrumentation
FDA Fermentation manager / Project managerBaxter HealthcareAugust 1997 - July 2008
Skills
GLP, Change Control, Vaccines, Sop, 21 CFR Part 11, Biopharmaceuticals, Biotechnology, CAPA, FDA, GMP, Lifesciences, Pharmaceutical Industry, Quality System, Regulatory Affairs, Regulatory Requirements, V&V, Validation, Regulatory Submissions, LIMS, Drug Development, IND, Clinical Trials, Microbiology
Education
The Johns Hopkins University - Carey Business School 2002 — 2004
MBA, Managemnt
King Saud University 1985 — 1990
B.Sc., Biomedical Instrumentation
Angela Kohls's FDA Experience December 2010 - Present
Job Consumer Safety OfficerManufactured Foods Specialist
Industry Government Relations
Experience
FDA December 2010 - Present
Kansas Department of Agriculture October 2008 - December 2010
Skills
Food Safety, Food Processing, Public Policy, Food, GMP, Continuous Improvement, Food Technology, Government, Food Microbiology, Microbiology, Food Science, Nutrition, Customer Service, Microsoft Excel
Education
Kansas State University 1983 — 1987
Bachelor of Science, Extension
FDA December 2010 - Present
Kansas Department of Agriculture October 2008 - December 2010
Skills
Food Safety, Food Processing, Public Policy, Food, GMP, Continuous Improvement, Food Technology, Government, Food Microbiology, Microbiology, Food Science, Nutrition, Customer Service, Microsoft Excel
Education
Kansas State University 1983 — 1987
Bachelor of Science, Extension
Izabela Antczak's FDA Experience June 2010 - Present
Job Bilingual Consumer Safety Officer
Industry Public Safety
Experience
FDA June 2010 - Present
Polish American Association 2002 - 2011
Skills
accommodate multiple..., apply information..., manage time effectively
Education
Robert Morris University 2009 — 2011
B.A, Business Administration with concentration in Management
Kaplan University
Master's degree, Public Health, 20 graduate hours completed; expected graduation date 2014
Edwin G. Foreman H.S
FDA June 2010 - Present
Polish American Association 2002 - 2011
Skills
accommodate multiple..., apply information..., manage time effectively
Education
Robert Morris University 2009 — 2011
B.A, Business Administration with concentration in Management
Kaplan University
Master's degree, Public Health, 20 graduate hours completed; expected graduation date 2014
Edwin G. Foreman H.S
Jason Strachman Miller's FDA Experience January 2015 - Present
Job Strategic Health Communications and Public Engagement
Industry Government Relations
Experience
FDA January 2015 - Present
FDA July 2013 - Present
- Freelance July 2013 - Present
NBC News June 2011 - July 2013
Kansas State Collegian January 2011 - May 2011
Kansas State Collegian August 2010 - December 2010
msnbc.com June 2010 - July 2010
US Army July 1999 - March 2008
Skills
Editing, AP Style, Journalism, Social Media, Copy Editing, News Writing, Blogging, Facebook, InDesign, Newspapers, Public Relations, Creative Writing, Ap Style, Editorial, Newsletters, Staff Management, Storytelling, Social media
Education
Kansas State University 2008 — 2011
Print and Electronic Journalism, Communication and Media Studies, 3.7
FDA January 2015 - Present
FDA July 2013 - Present
- Freelance July 2013 - Present
NBC News June 2011 - July 2013
Kansas State Collegian January 2011 - May 2011
Kansas State Collegian August 2010 - December 2010
msnbc.com June 2010 - July 2010
US Army July 1999 - March 2008
Skills
Editing, AP Style, Journalism, Social Media, Copy Editing, News Writing, Blogging, Facebook, InDesign, Newspapers, Public Relations, Creative Writing, Ap Style, Editorial, Newsletters, Staff Management, Storytelling, Social media
Education
Kansas State University 2008 — 2011
Print and Electronic Journalism, Communication and Media Studies, 3.7
Brijesh Vaghasia's FDA Experience January 2012 - April 2012
Job Student at Long Island University, Brooklyn Campus
Industry Pharmaceuticals
Experience
FDA January 2012 - April 2012
Skills
HPLC, UV/Vis, Dissolution, Pharmacokinetics, Regulatory Affairs, Pharmaceutical Industry, Pharmaceutics, Formulation, Drug Delivery, GLP, Pharmaceutical Research, Analytical Chemistry
Education
LIU Brooklyn 2006 — 2012
FDA January 2012 - April 2012
Skills
HPLC, UV/Vis, Dissolution, Pharmacokinetics, Regulatory Affairs, Pharmaceutical Industry, Pharmaceutics, Formulation, Drug Delivery, GLP, Pharmaceutical Research, Analytical Chemistry
Education
LIU Brooklyn 2006 — 2012
Kirk Sooter's FDA Experience August 2009 - Present
Job Philadelphia District Director
Industry Government Administration
Experience
Temple University September 2010 - Present
FDA August 2009 - Present
FDA 2003 - 2009
FDA 1998 - 2003
FDA 1996 - 1998
FDA 1989 - 1996
Skills
Regulatory Affairs, Government, Public Health, FDA, Biotechnology, Risk Assessment, Lifesciences, Public Policy, Policy Analysis, Drug Development, Policy
Education
Louisiana College 1985 — 1989
Bachelor of Science, Biology & Chemistry
Temple University September 2010 - Present
FDA August 2009 - Present
FDA 2003 - 2009
FDA 1998 - 2003
FDA 1996 - 1998
FDA 1989 - 1996
Skills
Regulatory Affairs, Government, Public Health, FDA, Biotechnology, Risk Assessment, Lifesciences, Public Policy, Policy Analysis, Drug Development, Policy
Education
Louisiana College 1985 — 1989
Bachelor of Science, Biology & Chemistry
Shantel Wright-Hines's FDA Experience August 2014 - Present
Job Secretary with the Federal Government
Industry Government Administration
Experience
FDA August 2014 - Present
NIH/NIAMS January 2012 - August 2014
MasterKey Consulting Company / NIH / NCRR / NCATS May 2010 - January 2012
Montgomery County Public Schools October 2009 - May 2010
MES PTA 2007 - 2009
Skills
Customer Service, Training, Community Outreach, Teaching, Public Speaking, Coaching, Leadership, Microsoft Office, Social Networking, Editing, Interviews, Grant Writing, Program Development, Team Building, Staff Development, Higher Education, Outlook, Leadership Development, Policy
Education
LeMoyne-Owen College 1990 — 1994
Bachelor's degree, Early Childhood Education and Teaching
FDA August 2014 - Present
NIH/NIAMS January 2012 - August 2014
MasterKey Consulting Company / NIH / NCRR / NCATS May 2010 - January 2012
Montgomery County Public Schools October 2009 - May 2010
MES PTA 2007 - 2009
Skills
Customer Service, Training, Community Outreach, Teaching, Public Speaking, Coaching, Leadership, Microsoft Office, Social Networking, Editing, Interviews, Grant Writing, Program Development, Team Building, Staff Development, Higher Education, Outlook, Leadership Development, Policy
Education
LeMoyne-Owen College 1990 — 1994
Bachelor's degree, Early Childhood Education and Teaching
Edwin Villacorte's FDA Experience October 2012 - Present
Job Information Security specialist at FDA
Industry Information Technology and Services
Experience
FDA October 2012 - Present
General Dynamics Information Technology August 2006 - October 2012
US Navy Reserve December 1998 - February 2011
MCI\Verizon March 2005 - July 2006
The Engle Group March 2003 - March 2005
UUNET\WCOM October 1998 - March 2003
United States Navy March 1991 - September 1998
Skills
Windows Server, Active Directory
Education
Kaplan University 2006 — 2010
BS, Information Technology
FDA October 2012 - Present
General Dynamics Information Technology August 2006 - October 2012
US Navy Reserve December 1998 - February 2011
MCI\Verizon March 2005 - July 2006
The Engle Group March 2003 - March 2005
UUNET\WCOM October 1998 - March 2003
United States Navy March 1991 - September 1998
Skills
Windows Server, Active Directory
Education
Kaplan University 2006 — 2010
BS, Information Technology
Sondra Ellis-Tucker's FDA Experience February 1999 - March 2002
Job ENV. SCIENTIST at US Environmental Protection Agency (EPA)
Industry Environmental Services
Experience
US Environmental Protection Agency (EPA) October 2005 - Present
USEPA February 2002 - October 2005
FDA February 1999 - March 2002
EMS/Heritage May 1989 - June 1991
Skills
Analysis, Grant Writing, Leadership, Nonprofits, Research, Community Outreach, Laboratory, Volunteer Management, Policy, Teaching, Public Speaking, Environmental Chemistry, EPA, CERCLA, Data Analysis, RCRA, Gas Chromatography, Environmental Science, Air Quality, CWA, Environmental Awareness, Strategic Planning, Customer Service, Team Building, Management, Fundraising, Training, Program Management, Microsoft Office
Education
Park University 1984 — 1989
BS, Chemistry & Biology
Kansas City Kansas Community College
SouthWest High School
US Environmental Protection Agency (EPA) October 2005 - Present
USEPA February 2002 - October 2005
FDA February 1999 - March 2002
EMS/Heritage May 1989 - June 1991
Skills
Analysis, Grant Writing, Leadership, Nonprofits, Research, Community Outreach, Laboratory, Volunteer Management, Policy, Teaching, Public Speaking, Environmental Chemistry, EPA, CERCLA, Data Analysis, RCRA, Gas Chromatography, Environmental Science, Air Quality, CWA, Environmental Awareness, Strategic Planning, Customer Service, Team Building, Management, Fundraising, Training, Program Management, Microsoft Office
Education
Park University 1984 — 1989
BS, Chemistry & Biology
Kansas City Kansas Community College
SouthWest High School
Margaret Amankwa-Sakyi's FDA Experience December 2012 - Present
Job Biostatistician at Food and Drug Administration
Industry Research
Experience
FDA December 2012 - Present
Food and Drug Administration August 2009 - August 2011
U.S Department of Health and Human Services Food and Drug Administration (FDA) August 2009 - August 2011
University of Maryland, School of Public Health January 2009 - May 2009
Georgetown University, Department of Biostatistics May 2008 - August 2008
Washington Hospital, Department of Bioethics May 2008 - August 2008
Skills
SAS, Data Analysis, Statistics, Data Management, Biostatistics, Epidemiology, Analysis, Research, Public Health, Data Collection, FDA, Clinical Research, Qualitative Research, SPSS, Statistical Consulting, Microsoft Excel, Program Evaluation, Analytics
Education
University of Maryland College Park 2008 — 2010
MPH(Biostatistics), Public Health
Kwame Nkrumah' University of Science and Technology, Kumasi 1997 — 2001
Bsc Agriculture, Economics
FDA December 2012 - Present
Food and Drug Administration August 2009 - August 2011
U.S Department of Health and Human Services Food and Drug Administration (FDA) August 2009 - August 2011
University of Maryland, School of Public Health January 2009 - May 2009
Georgetown University, Department of Biostatistics May 2008 - August 2008
Washington Hospital, Department of Bioethics May 2008 - August 2008
Skills
SAS, Data Analysis, Statistics, Data Management, Biostatistics, Epidemiology, Analysis, Research, Public Health, Data Collection, FDA, Clinical Research, Qualitative Research, SPSS, Statistical Consulting, Microsoft Excel, Program Evaluation, Analytics
Education
University of Maryland College Park 2008 — 2010
MPH(Biostatistics), Public Health
Kwame Nkrumah' University of Science and Technology, Kumasi 1997 — 2001
Bsc Agriculture, Economics
Brandon Zell's FDA Experience June 2006 - December 2009
Job Media and Graphics Designer at Infolinx
Industry Computer Software
Experience
Infolinx June 2011 - June 2015
Liberty University Police Department August 2010 - May 2011
FDA June 2006 - December 2009
Skills
Illustrator, Photoshop, After Effects, HTML, CSS, SEO, jQuery, Web Design, Graphic Design, JavaScript, Posters, Flyers, Web Development, Website Development, User Interface, HTML 5, Graphics
Education
Liberty University 2008 — 2011
BS, Web Technology and Design
Jackson Hole Bible College 2007 — 2008
1 year degree, Biblical Studies
Infolinx June 2011 - June 2015
Liberty University Police Department August 2010 - May 2011
FDA June 2006 - December 2009
Skills
Illustrator, Photoshop, After Effects, HTML, CSS, SEO, jQuery, Web Design, Graphic Design, JavaScript, Posters, Flyers, Web Development, Website Development, User Interface, HTML 5, Graphics
Education
Liberty University 2008 — 2011
BS, Web Technology and Design
Jackson Hole Bible College 2007 — 2008
1 year degree, Biblical Studies
Matt Nan Tie's FDA Experience June 2011 - August 2011
Job Senior Regulatory Affairs Specialist at Kerry
Industry Food & Beverages
Experience
Kerry March 2015 - Present
Kerry August 2012 - March 2015
FDA June 2011 - August 2011
Bernacchi Lab August 2008 - December 2009
University of Illinois at Urbana-Champaign June 2007 - August 2007
Skills
FDA, Food Science, HACCP, Food, Leadership, Food Safety, Food Industry, Statistics, Research, Data Analysis
Education
University of Illinois at Urbana-Champaign
Master of Science (M.S.), Food Science
Knox College
Bachelor of Arts (B.A.), Biology
Kerry March 2015 - Present
Kerry August 2012 - March 2015
FDA June 2011 - August 2011
Bernacchi Lab August 2008 - December 2009
University of Illinois at Urbana-Champaign June 2007 - August 2007
Skills
FDA, Food Science, HACCP, Food, Leadership, Food Safety, Food Industry, Statistics, Research, Data Analysis
Education
University of Illinois at Urbana-Champaign
Master of Science (M.S.), Food Science
Knox College
Bachelor of Arts (B.A.), Biology
Yukun Wu's FDA Experience June 2008 - August 2008
Job Principal Statistician at Emergent BioSolutions
Industry Research
Experience
Emergent BioSolutions March 2014 - Present
Center for Vaccine Development, University of Maryland School of Medicine December 2013 - January 2015
Nutrient Data Laboratory, USDA-ARS November 2013 - March 2014
Center for Vaccine Development, University of Maryland School of Medicine September 2011 - November 2013
Center for Vaccine Development, University of Maryland School of Medicine August 2009 - August 2011
FDA June 2008 - August 2008
Skills
Statistical Consulting, Survival Analysis, Statistical Computing, Statistical Modeling, Time Series Analysis, Biostatistics, Logistic Regression, SAS programming, R, SAS, Matlab, SPSS, Epidemiology, Multivariate Statistics, Statistics, Stata, Data Mining, Clinical Trials, Research, Data Analysis
Education
University of Maryland Baltimore County 2005 — 2009
Ph.D, Statistics
Louisiana Tech University 2002 — 2005
Master of Science (MS), Mathematics and Statistics
Xiamen University
B.A., Statistics
Emergent BioSolutions March 2014 - Present
Center for Vaccine Development, University of Maryland School of Medicine December 2013 - January 2015
Nutrient Data Laboratory, USDA-ARS November 2013 - March 2014
Center for Vaccine Development, University of Maryland School of Medicine September 2011 - November 2013
Center for Vaccine Development, University of Maryland School of Medicine August 2009 - August 2011
FDA June 2008 - August 2008
Skills
Statistical Consulting, Survival Analysis, Statistical Computing, Statistical Modeling, Time Series Analysis, Biostatistics, Logistic Regression, SAS programming, R, SAS, Matlab, SPSS, Epidemiology, Multivariate Statistics, Statistics, Stata, Data Mining, Clinical Trials, Research, Data Analysis
Education
University of Maryland Baltimore County 2005 — 2009
Ph.D, Statistics
Louisiana Tech University 2002 — 2005
Master of Science (MS), Mathematics and Statistics
Xiamen University
B.A., Statistics
David Leiby's FDA Experience 2015 - Present
Job Chief, Product Review Branch at FDA CBER
Industry Government Administration
Experience
FDA 2015 - Present
Skills
Public Health, Infectious Diseases, Healthcare Information..., Program Development, Clinical Research, Research, Epidemiology, Teaching, Medical Devices, Biotechnology, Global Health, Healthcare, Hospitals, Lifesciences, Public Speaking, Policy, Healthcare Management, Medical Education, EMR, Medicine, International Health, Clinical Trials, Immunology, Health Policy, Hematology, Laboratory Medicine, Life Sciences
Education
Lafayette College
Rutgers, The State University of New Jersey-Camden
The Ohio State University
FDA 2015 - Present
Skills
Public Health, Infectious Diseases, Healthcare Information..., Program Development, Clinical Research, Research, Epidemiology, Teaching, Medical Devices, Biotechnology, Global Health, Healthcare, Hospitals, Lifesciences, Public Speaking, Policy, Healthcare Management, Medical Education, EMR, Medicine, International Health, Clinical Trials, Immunology, Health Policy, Hematology, Laboratory Medicine, Life Sciences
Education
Lafayette College
Rutgers, The State University of New Jersey-Camden
The Ohio State University
Sidra (Sidra Bhatti) Mirza's FDA Experience June 2014 - Present
Job Scientific Reviewer at FDA
Industry Hospital & Health Care
Experience
FDA June 2014 - Present
Shady Grove Adventist Hospital February 2012 - January 2015
Seton Healthcare Network March 1999 - April 2013
HCA September 1998 - August 1999
Springfield Oregon September 1997 - July 1998
Skills
Adult ICU, NICU and..., Respiratory Care, Acute Care, ACLS, Mechanical Ventilation, Ventilators, PICU, Airway Management, NICU, Clinical Research, Patient Education, BLS, ICU
Education
Texas State University-San Marcos 2008 — 2012
BSRC, Respiratory Care Therapy/Therapist
Lane Community College 1996 — 1998
Associate of Science (A.S.), Respiratory Care Therapy/Therapist
FDA June 2014 - Present
Shady Grove Adventist Hospital February 2012 - January 2015
Seton Healthcare Network March 1999 - April 2013
HCA September 1998 - August 1999
Springfield Oregon September 1997 - July 1998
Skills
Adult ICU, NICU and..., Respiratory Care, Acute Care, ACLS, Mechanical Ventilation, Ventilators, PICU, Airway Management, NICU, Clinical Research, Patient Education, BLS, ICU
Education
Texas State University-San Marcos 2008 — 2012
BSRC, Respiratory Care Therapy/Therapist
Lane Community College 1996 — 1998
Associate of Science (A.S.), Respiratory Care Therapy/Therapist
Kristin Schultz-Kuszak's FDA Experience October 2011 - August 2013
Job Scientist I at MedImmune
Industry Research
Experience
MedImmune September 2013 - Present
FDA October 2011 - August 2013
The National Institute on Drug Abuse (NIDA) May 2009 - November 2011
University of Michigan August 2003 - April 2009
Skills
Capillary..., HPLC, Analytical Method..., Chromatography, Chemistry, Mass Spectrometry, UV-Vis, NMR, Analytical Chemistry, Spectroscopy, UV/Vis, LC-MS/MS, Cell, Biochemistry, Assay Development, In Vivo, Analysis, LC-MS
Education
University of Michigan 2003 — 2009
PhD, Analytical Chemistry. Neuroscience
Lawrence University 1999 — 2003
Bachelor of Arts, Major: Chemistry Minor: Psychology
MedImmune September 2013 - Present
FDA October 2011 - August 2013
The National Institute on Drug Abuse (NIDA) May 2009 - November 2011
University of Michigan August 2003 - April 2009
Skills
Capillary..., HPLC, Analytical Method..., Chromatography, Chemistry, Mass Spectrometry, UV-Vis, NMR, Analytical Chemistry, Spectroscopy, UV/Vis, LC-MS/MS, Cell, Biochemistry, Assay Development, In Vivo, Analysis, LC-MS
Education
University of Michigan 2003 — 2009
PhD, Analytical Chemistry. Neuroscience
Lawrence University 1999 — 2003
Bachelor of Arts, Major: Chemistry Minor: Psychology
Aurora Breazna's FDA Experience June 1999 - July 2001
Job Associate Director Biostatistics at Cardiovascular research foundation
Industry Pharmaceuticals
Experience
Cardiovascular research foundation December 2014 - Present
Allergan September 2013 - Present
Pfizer August 2004 - September 2013
GlaxoSmithKline May 2002 - July 2004
Bristol-Myers Squibb, Princeton, New Jersey August 2001 - April 2002
FDA June 1999 - July 2001
University of Rochester Medical Center July 1998 - June 1999
Skills
Oncology, Biostatistics, Clinical Research, Clinical Development, Clinical Trials, CRO, GCP, Clinical Data Management, Regulatory Submissions, Drug Development, EDC, Clinical Study Design, CDISC, Pharmaceutical Industry, CTMS
Education
The University of Memphis 1997 — 1999
PhD, applied mathematics
Louisiana State University 1992 — 1997
masters in applied mathemtics, Applied Mathematics
Louisiana State University 1992 — 1997
MS, Applied Math
Universitatea din București 1981 — 1987
Diploma (5y) in applied mathematics, mathematics
Cardiovascular research foundation December 2014 - Present
Allergan September 2013 - Present
Pfizer August 2004 - September 2013
GlaxoSmithKline May 2002 - July 2004
Bristol-Myers Squibb, Princeton, New Jersey August 2001 - April 2002
FDA June 1999 - July 2001
University of Rochester Medical Center July 1998 - June 1999
Skills
Oncology, Biostatistics, Clinical Research, Clinical Development, Clinical Trials, CRO, GCP, Clinical Data Management, Regulatory Submissions, Drug Development, EDC, Clinical Study Design, CDISC, Pharmaceutical Industry, CTMS
Education
The University of Memphis 1997 — 1999
PhD, applied mathematics
Louisiana State University 1992 — 1997
masters in applied mathemtics, Applied Mathematics
Louisiana State University 1992 — 1997
MS, Applied Math
Universitatea din București 1981 — 1987
Diploma (5y) in applied mathematics, mathematics
Barbara Palmisano's FDA Experience July 1994 - July 1996
Job
Industry Hospital & Health Care
Experience
Medical College of Wisconsin August 1985 - Present
FDA July 1994 - July 1996
Skills
Hospitals, Research, Board Certified, Pediatrics, Anesthesiology
Education
University of Wisconsin-Milwaukee 2000 — 2002
Masters of Business Administration, Business
University of California, San Francisco - School of Medicine 1983 — 1985
Anesthesiology Residency
University of California, San Francisco - School of Medicine 1982 — 1983
Cardiovascular Research Institute
University of California, San Francisco - School of Medicine 1981 — 1982
Pediatric Critical Care Fellowship
University of Pittsburgh School of Medicine 1980 — 1981
Pediatric Critical Care Fellowship
Tulane School of Medicine 1978 — 1980
Pediatric Residency
Tulane School of Medicine 1973 — 1977
MD
Louisiana State University 1969 — 1973
BS, Biochemistry
Medical College of Wisconsin August 1985 - Present
FDA July 1994 - July 1996
Skills
Hospitals, Research, Board Certified, Pediatrics, Anesthesiology
Education
University of Wisconsin-Milwaukee 2000 — 2002
Masters of Business Administration, Business
University of California, San Francisco - School of Medicine 1983 — 1985
Anesthesiology Residency
University of California, San Francisco - School of Medicine 1982 — 1983
Cardiovascular Research Institute
University of California, San Francisco - School of Medicine 1981 — 1982
Pediatric Critical Care Fellowship
University of Pittsburgh School of Medicine 1980 — 1981
Pediatric Critical Care Fellowship
Tulane School of Medicine 1978 — 1980
Pediatric Residency
Tulane School of Medicine 1973 — 1977
MD
Louisiana State University 1969 — 1973
BS, Biochemistry
Richard` Anderson's FDA Experience June 1988 - September 2007
Job Site Security Supervisor(Mgr.) at Housing Development Fund Corporation
Industry Security and Investigations
Experience
Housing Development Fund Corporation June 2001 - Present
FDA June 1988 - September 2007
U.S Food and Drug Administration June 1988 - September 2007
U.S. Air Force March Air March 1984 - March 1988
Skills
Microsoft Office 2010, Computer Repair, Microsoft Access, Training, Management, Human Resources, Employee Relations, Access, Security, Coaching, Auditing, Interviews, Healthcare, Private Investigations, Process Scheduler, Surveillance, Risk Management, Team Building, Policy, Research, Government, Public Speaking, Microsoft Excel, Investigation
Education
Lincoln University 1979 — 1983
BS, Political Science/Pre-Law
Housing Development Fund Corporation June 2001 - Present
FDA June 1988 - September 2007
U.S Food and Drug Administration June 1988 - September 2007
U.S. Air Force March Air March 1984 - March 1988
Skills
Microsoft Office 2010, Computer Repair, Microsoft Access, Training, Management, Human Resources, Employee Relations, Access, Security, Coaching, Auditing, Interviews, Healthcare, Private Investigations, Process Scheduler, Surveillance, Risk Management, Team Building, Policy, Research, Government, Public Speaking, Microsoft Excel, Investigation
Education
Lincoln University 1979 — 1983
BS, Political Science/Pre-Law
Nicholas Allec's FDA Experience November 2012 - July 2014
Job Sensing at Apple
Industry Medical Devices
Experience
Apple July 2014 - Present
FDA November 2012 - July 2014
University of Waterloo 2009 - 2012
University of Waterloo 2008 - 2012
Queen's University 2006 - 2008
Skills
Image Processing, C++, Matlab, C, Medical Imaging, X-ray, Research, Electronics, Characterization, Optical Sensors, Simulations, Java, Electrical Engineering, Python, Semiconductors, SAXS, Digital Imaging, Signal Processing, Nanotechnology, Sensors
Education
University of Waterloo 2008 — 2012
Doctor of Philosophy (PhD), Electrical and Computer Engineering
Queen's University 2006 — 2008
Master of Science (MSc), Electrical and Computer Engineering
Lakehead University 2004 — 2006
Bachelor of Engineering (B.Eng.), Electrical Engineering
Red River College 2002 — 2004
Diploma, Electronic Engineering Technology
Apple July 2014 - Present
FDA November 2012 - July 2014
University of Waterloo 2009 - 2012
University of Waterloo 2008 - 2012
Queen's University 2006 - 2008
Skills
Image Processing, C++, Matlab, C, Medical Imaging, X-ray, Research, Electronics, Characterization, Optical Sensors, Simulations, Java, Electrical Engineering, Python, Semiconductors, SAXS, Digital Imaging, Signal Processing, Nanotechnology, Sensors
Education
University of Waterloo 2008 — 2012
Doctor of Philosophy (PhD), Electrical and Computer Engineering
Queen's University 2006 — 2008
Master of Science (MSc), Electrical and Computer Engineering
Lakehead University 2004 — 2006
Bachelor of Engineering (B.Eng.), Electrical Engineering
Red River College 2002 — 2004
Diploma, Electronic Engineering Technology
Miguel Martinez-Pere Martinez's FDA Experience June 2002 - January 2011
Job Veterinarian at DHS
Industry Veterinary
Experience
DHS January 1998 - Present
FDA June 2002 - January 2011
Skills
Surgery, Pets, Dogs, Veterinary, Animal Nutrition, Animal Behavior, Animal Welfare, Client Education, Medicine, Public Health, Epidemiology, Infectious Diseases, Veterinary Medicine, Clinical Research, Research, Science, Emergency Medicine, Public Speaking, Lifesciences, Life Sciences
Education
Universidad Nacional Pedro Henríquez Ureña 1980 — 1984
Doctor in Veterinary Medicine, Veterinary Medicine
Kansas State University 1977 — 1979
Bachelor of Applied Science (B.A.Sc.), Animal Sciences
DHS January 1998 - Present
FDA June 2002 - January 2011
Skills
Surgery, Pets, Dogs, Veterinary, Animal Nutrition, Animal Behavior, Animal Welfare, Client Education, Medicine, Public Health, Epidemiology, Infectious Diseases, Veterinary Medicine, Clinical Research, Research, Science, Emergency Medicine, Public Speaking, Lifesciences, Life Sciences
Education
Universidad Nacional Pedro Henríquez Ureña 1980 — 1984
Doctor in Veterinary Medicine, Veterinary Medicine
Kansas State University 1977 — 1979
Bachelor of Applied Science (B.A.Sc.), Animal Sciences
Pat Curry's FDA Experience June 2002 - November 2002
Job Senior Biologist, IIT Research Institute
Industry Research
Experience
IIT Research Institute 2002 - Present
FDA June 2002 - November 2002
DuPont Pharmaceuticals 1999 - June 2002
Covance Laboratories 1997 - 1999
Independant Contractor 1996 - 1997
Microbiological Associates 1992 - 1996
Warner Lambert 1990 - 1992
University of Cincinnati 1988 - 1990
Skills
Cytogenetics, Genetic Toxicology, Zoology, Micronucleus, Chromosome Aberration, Molecular Biology, Microbiology, Mutagenesis, Clastogenesis, Cytotoxicity, Comet Assay, Lymphoma Assay, Ames Assay, Immunotoxicology, Preclinical Safety, Nonclinical Safety, IND Enabling Studies, In Vivo Host Defense..., Local Lymph Node Assay, Natural Killer Assay, Plaque Forming Cell..., Cytokine Detection, ELISA Development, Wound Models, Toxicology, GLP, ELISA, Molecular Genetics, In Vivo, Assay Development, Cell, Cell Culture, In Vitro, Genetics, Life Sciences
Education
University of Wyoming
PhD, Zoology and Physiology
University of Wyoming
MS, Zoology and Physiology
Loras College
BS, Biology
IIT Research Institute 2002 - Present
FDA June 2002 - November 2002
DuPont Pharmaceuticals 1999 - June 2002
Covance Laboratories 1997 - 1999
Independant Contractor 1996 - 1997
Microbiological Associates 1992 - 1996
Warner Lambert 1990 - 1992
University of Cincinnati 1988 - 1990
Skills
Cytogenetics, Genetic Toxicology, Zoology, Micronucleus, Chromosome Aberration, Molecular Biology, Microbiology, Mutagenesis, Clastogenesis, Cytotoxicity, Comet Assay, Lymphoma Assay, Ames Assay, Immunotoxicology, Preclinical Safety, Nonclinical Safety, IND Enabling Studies, In Vivo Host Defense..., Local Lymph Node Assay, Natural Killer Assay, Plaque Forming Cell..., Cytokine Detection, ELISA Development, Wound Models, Toxicology, GLP, ELISA, Molecular Genetics, In Vivo, Assay Development, Cell, Cell Culture, In Vitro, Genetics, Life Sciences
Education
University of Wyoming
PhD, Zoology and Physiology
University of Wyoming
MS, Zoology and Physiology
Loras College
BS, Biology
Mindi Byrd's FDA Experience April 2008 - November 2009
Job
Industry
Experience
Merck June 2011 - June 2014
Novartis February 2010 - May 2011
FDA April 2008 - November 2009
APHL - Association of Public Health Laboratories August 2006 - April 2008
Education
Kansas State University
Bachelor's degree, Food Science and Technology
Kansas State University
Master of Food Science/Master of Public Health, Food Science / Food Safety
Merck June 2011 - June 2014
Novartis February 2010 - May 2011
FDA April 2008 - November 2009
APHL - Association of Public Health Laboratories August 2006 - April 2008
Education
Kansas State University
Bachelor's degree, Food Science and Technology
Kansas State University
Master of Food Science/Master of Public Health, Food Science / Food Safety
Shelley Buchen's FDA Experience February 2007 - June 2013
Job Independent Medical Device Consultant
Industry Medical Devices
Experience
Self-employed June 2013 - Present
FDA February 2007 - June 2013
Clinical Research Consultants, Inc. April 2006 - February 2007
Advanced Medical Optics 2002 - 2005
Allergan 1991 - 2002
American Medical Optics 1983 - 1991
Skills
Intraocular lenses, Corneal implants, Ophthalmic..., Contact lenses, Contact lens care..., FDA regulations, FDA submissions, Animal model development, ISO/ANSI standards, GLP, Preclinical testing, TASS, Microbiology, FDA, Biocompatibility, Animal Models, Shelf Life, Validation
Education
Lake Forest College
A.B., Biology
University of Wisconsin-Madison
Master of Science (M.S.), Food Science
Self-employed June 2013 - Present
FDA February 2007 - June 2013
Clinical Research Consultants, Inc. April 2006 - February 2007
Advanced Medical Optics 2002 - 2005
Allergan 1991 - 2002
American Medical Optics 1983 - 1991
Skills
Intraocular lenses, Corneal implants, Ophthalmic..., Contact lenses, Contact lens care..., FDA regulations, FDA submissions, Animal model development, ISO/ANSI standards, GLP, Preclinical testing, TASS, Microbiology, FDA, Biocompatibility, Animal Models, Shelf Life, Validation
Education
Lake Forest College
A.B., Biology
University of Wisconsin-Madison
Master of Science (M.S.), Food Science
Alexandria Staples Wagner's FDA Experience August 2010 - Present
Job Student at Whittier Law School
Industry Legal Services
Experience
FDA August 2010 - Present
Education
Whittier Law School 2011 — 2015
Juris Doctor (J.D.)
University of California, Santa Barbara 2007 — 2009
Bachelor's Degree, Political Science and Government
Long Beach City College 2005 — 2007
Associate’s Degree
FDA August 2010 - Present
Education
Whittier Law School 2011 — 2015
Juris Doctor (J.D.)
University of California, Santa Barbara 2007 — 2009
Bachelor's Degree, Political Science and Government
Long Beach City College 2005 — 2007
Associate’s Degree
Dana Klimavicz's FDA Experience July 1998 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA July 1998 - Present
Education
Louisiana State University 1993 — 1996
Bachelor of Science (BS), Zoology
Opelousas Catholic School
FDA July 1998 - Present
Education
Louisiana State University 1993 — 1996
Bachelor of Science (BS), Zoology
Opelousas Catholic School
Cynthia Medlin's FDA Experience October 1998 - Present
Job Investigator at FDA
Industry Government Administration
Experience
FDA October 1998 - Present
Skills
Government, Policy, Research, Microsoft Office, Policy Analysis, Public Policy, Microsoft Excel, Customer Service, Program Management, Strategic Planning
Education
Kansas State University 1987 — 1991
Bachelor's degree, Life Sciences
FDA October 1998 - Present
Skills
Government, Policy, Research, Microsoft Office, Policy Analysis, Public Policy, Microsoft Excel, Customer Service, Program Management, Strategic Planning
Education
Kansas State University 1987 — 1991
Bachelor's degree, Life Sciences
Dr. William Triplett, MBA's FDA Experience 2013 - Present
Job Senior Business Analyst at FDA
Industry Government Administration
Experience
FDA 2013 - Present
University of Maryland University College 2011 - Present
National Institutes of Health 2012 - 2013
Department of Veteran Affairs 2011 - 2012
US Navy 2005 - 2011
Central Texas College 2007 - 2008
Skills
Leadership Development, Leadership, Strategic Planning, Project Management, Data Analysis, Program Management, Coaching, Management Consulting, Workshop Facilitation, Employee Training, Training, Policy, Contract Management, Qualitative Research, Analysis, Team Building, Management, Government, Data Audit, Teacher Training, SharePoint Designer, Contr, Security Clearance, Public Speaking, Military, Organizational..., Microsoft Office, DoD
Education
Liberty University
Masters of Business Adminstrations, Business Administration and Management, General
Regent University
Doctor of Strategic Leadership, Strategic Leadership
Southern Illinois University, Carbondale
Bachelor of Science, Health/Health Care Administration/Management
FDA 2013 - Present
University of Maryland University College 2011 - Present
National Institutes of Health 2012 - 2013
Department of Veteran Affairs 2011 - 2012
US Navy 2005 - 2011
Central Texas College 2007 - 2008
Skills
Leadership Development, Leadership, Strategic Planning, Project Management, Data Analysis, Program Management, Coaching, Management Consulting, Workshop Facilitation, Employee Training, Training, Policy, Contract Management, Qualitative Research, Analysis, Team Building, Management, Government, Data Audit, Teacher Training, SharePoint Designer, Contr, Security Clearance, Public Speaking, Military, Organizational..., Microsoft Office, DoD
Education
Liberty University
Masters of Business Adminstrations, Business Administration and Management, General
Regent University
Doctor of Strategic Leadership, Strategic Leadership
Southern Illinois University, Carbondale
Bachelor of Science, Health/Health Care Administration/Management
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