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
Katherine Alejo Katherine Alejo's FDA Experience September 2014 - Present
Job ORISE Fellow with the USFDA
Industry Chemicals
Experience
FDA September 2014 - Present
Borough of Manhattan Community College January 2014 - May 2014
St. John's University September 2010 - May 2014
St. John's University September 2008 - July 2013
Skills
Research, Inorganic Chemistry, Organic Chemistry, Formulation, Characterization, GC-MS, NMR, IR Spectroscopy, UV-Vis-NIR, Fluorescence, Cyclic Voltammetry, Higher Education, Teaching, University Teaching, Student Development, College Teaching, Student Affairs, Curriculum Development, Academic Advising, Adult Education, Curriculum Design, UV, HPLC
Education
St. John's University 2006 — 2013
Master of Science (MS), Chemistry
St. John's University 2006 — 2010
Bachelor of Science (BS), Chemistry
FDA September 2014 - Present
Borough of Manhattan Community College January 2014 - May 2014
St. John's University September 2010 - May 2014
St. John's University September 2008 - July 2013
Skills
Research, Inorganic Chemistry, Organic Chemistry, Formulation, Characterization, GC-MS, NMR, IR Spectroscopy, UV-Vis-NIR, Fluorescence, Cyclic Voltammetry, Higher Education, Teaching, University Teaching, Student Development, College Teaching, Student Affairs, Curriculum Development, Academic Advising, Adult Education, Curriculum Design, UV, HPLC
Education
St. John's University 2006 — 2013
Master of Science (MS), Chemistry
St. John's University 2006 — 2010
Bachelor of Science (BS), Chemistry
Jaewon Hong Jaewon Hong's FDA Experience 2005 - Present
Job FDA/ORA/OEIO
Industry Government Administration
Experience
FDA 2005 - Present
Skills
Pharmacists, Public Health, Pharmacy, Clinical Pharmacology, Clinical Research, Regulatory Affairs, Medication Therapy..., Pharmacy Automation, Pharmacology, Clinical Trials, Infectious Diseases, Healthcare
Education
Shenandoah University
Doctor of Pharmacy (Pharm.D.)
St. John's University
Bachelor of Pharmacy (B.Pharm.)
FDA 2005 - Present
Skills
Pharmacists, Public Health, Pharmacy, Clinical Pharmacology, Clinical Research, Regulatory Affairs, Medication Therapy..., Pharmacy Automation, Pharmacology, Clinical Trials, Infectious Diseases, Healthcare
Education
Shenandoah University
Doctor of Pharmacy (Pharm.D.)
St. John's University
Bachelor of Pharmacy (B.Pharm.)
Mark Saale Mark Saale's FDA Experience March 2009 - Present
Job Supervisory Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA March 2009 - Present
FDA January 2002 - March 2009
Kindred Hospital December 2000 - January 2002
Victor Valley Community Hospital May 1994 - March 2001
Skills
Public Health, Regulatory Affairs, Clinical Research, Healthcare, Policy, Health Education, Health, Supplements, Research, Public Speaking, Medical Devices, Emergency Management
Education
Southern California University of Health Sciences 1997 — 2000
Doctor of Chiropractic, Chiropractic
Victor Valley College 1992 — 1994
Associate of Science (A.S.), Respiratory Care Therapy/Therapist
FDA March 2009 - Present
FDA January 2002 - March 2009
Kindred Hospital December 2000 - January 2002
Victor Valley Community Hospital May 1994 - March 2001
Skills
Public Health, Regulatory Affairs, Clinical Research, Healthcare, Policy, Health Education, Health, Supplements, Research, Public Speaking, Medical Devices, Emergency Management
Education
Southern California University of Health Sciences 1997 — 2000
Doctor of Chiropractic, Chiropractic
Victor Valley College 1992 — 1994
Associate of Science (A.S.), Respiratory Care Therapy/Therapist
Douglas Blayney Douglas Blayney's FDA Experience July 1999 - July 2003
Job
Industry Hospital & Health Care
Experience
CARETMD June 2013 - Present
Stanford University School of Medicine July 2010 - Present
Stanford University Medical Center July 2010 - July 2015
American Society of Clinical Oncology June 2009 - June 2010
University of Michigan Comprehensive Cancer Center July 2003 - June 2010
FDA July 1999 - July 2003
Wilshire Oncology Medical Group, Inc May 1986 - June 2003
Skills
Cancer, Oncology, Clinical Research, Clinical Trials, Healthcare, Medicine, Lifesciences, Healthcare Information..., Hospitals, Clinical Development, Biotechnology, Healthcare Management, Medical Education, Internal Medicine, Informatics, Epidemiology, Public Health, EMR, Quality Management, Life Sciences, Treatment, Drug Discovery, Hematology, Pharmaceutical Industry, Drug Development, FDA, Palliative Care, Infectious Diseases
Education
National Cancer Institute 1980 — 1983
Medical Oncology Fellowship Training
University of California, San Diego - School of Medicine 1977 — 1980
Internal Medicine Residency Program
University of California, San Diego - School of Medicine 1973 — 1977
MD
Stanford University 1968 — 1972
BSEE, Electrical Engineering
CARETMD June 2013 - Present
Stanford University School of Medicine July 2010 - Present
Stanford University Medical Center July 2010 - July 2015
American Society of Clinical Oncology June 2009 - June 2010
University of Michigan Comprehensive Cancer Center July 2003 - June 2010
FDA July 1999 - July 2003
Wilshire Oncology Medical Group, Inc May 1986 - June 2003
Skills
Cancer, Oncology, Clinical Research, Clinical Trials, Healthcare, Medicine, Lifesciences, Healthcare Information..., Hospitals, Clinical Development, Biotechnology, Healthcare Management, Medical Education, Internal Medicine, Informatics, Epidemiology, Public Health, EMR, Quality Management, Life Sciences, Treatment, Drug Discovery, Hematology, Pharmaceutical Industry, Drug Development, FDA, Palliative Care, Infectious Diseases
Education
National Cancer Institute 1980 — 1983
Medical Oncology Fellowship Training
University of California, San Diego - School of Medicine 1977 — 1980
Internal Medicine Residency Program
University of California, San Diego - School of Medicine 1973 — 1977
MD
Stanford University 1968 — 1972
BSEE, Electrical Engineering
Jamie Dion Jamie Dion's FDA Experience July 2010 - Present
Job Consumer Safety Officer at FDA
Industry
Experience
FDA July 2010 - Present
City of St. Louis Park February 2007 - June 2010
Skills
Policy, Emergency Management, Public Health, Government, Policy Analysis, Environmental Science, Epidemiology, Public Policy, Program Development, FDA
Education
University of Minnesota-Twin Cities 2005 — 2007
Master of Public Health (M.P.H.), Environmental Health
St. Olaf College 2000 — 2004
Double Bachelor of Arts, Biology and Asian Studies
FDA July 2010 - Present
City of St. Louis Park February 2007 - June 2010
Skills
Policy, Emergency Management, Public Health, Government, Policy Analysis, Environmental Science, Epidemiology, Public Policy, Program Development, FDA
Education
University of Minnesota-Twin Cities 2005 — 2007
Master of Public Health (M.P.H.), Environmental Health
St. Olaf College 2000 — 2004
Double Bachelor of Arts, Biology and Asian Studies
Francisco M. Franco Francisco M. Franco's FDA Experience September 2014 - October 2014
Job Medical Science Liaison|Drug Development|Clinical Trials|PharmD
Industry Pharmaceuticals
Experience
Walgreens December 2011 - Present
Friends In Village Development Bangladesh (FIVDB) October 2014 - November 2014
FDA September 2014 - October 2014
Washington University School of Medicine April 2009 - December 2011
Pfizer January 2007 - March 2009
Texas A&M University September 2002 - December 2006
Pfizer June 2002 - August 2002
University of Puerto Rico June 2000 - May 2002
Pfizer May 2001 - August 2001
Education
St. Louis College of Pharmacy 2011 — 2015
PharmD, Pharmacy
Washington University in St. Louis 2010 — 2011
Pre-Pharmacy Requirements
Texas A&M University 2002 — 2006
Master's Degree, Organic Chemistry, Natural Product Synthesis
University of Puerto Rico-Rio Piedras 1998 — 2002
Bachelor's Degree, Chemistry
Walgreens December 2011 - Present
Friends In Village Development Bangladesh (FIVDB) October 2014 - November 2014
FDA September 2014 - October 2014
Washington University School of Medicine April 2009 - December 2011
Pfizer January 2007 - March 2009
Texas A&M University September 2002 - December 2006
Pfizer June 2002 - August 2002
University of Puerto Rico June 2000 - May 2002
Pfizer May 2001 - August 2001
Education
St. Louis College of Pharmacy 2011 — 2015
PharmD, Pharmacy
Washington University in St. Louis 2010 — 2011
Pre-Pharmacy Requirements
Texas A&M University 2002 — 2006
Master's Degree, Organic Chemistry, Natural Product Synthesis
University of Puerto Rico-Rio Piedras 1998 — 2002
Bachelor's Degree, Chemistry
E'Lisha Yi E'Lisha Yi's FDA Experience September 2006 - May 2007
Job Enterprise Benefits Client Analyst
Industry Management Consulting
Experience
Paylocity August 2015 - Present
Lowe's Home Improvement November 2012 - July 2015
Self-employed 2013 - January 2015
The Home Depot April 2008 - March 2012
FDA September 2006 - May 2007
Budget Cleaning January 2003 - January 2006
Skills
Management, Customer Service, Sales, Business Development, Troubleshooting, Performance Management, Microsoft Office, Time Management, Training, Process Improvement, Consulting, Management Consulting, Onboarding, Operations Management, Website Development, Small Business, Strategic Financial..., Inventory Management, Leadership, Microsoft Excel, Microsoft Word, Team Building, Team Leadership
Education
State University of New York College at Geneseo 2004 — 2008
Bachelor's degree, Mathematics
Paylocity August 2015 - Present
Lowe's Home Improvement November 2012 - July 2015
Self-employed 2013 - January 2015
The Home Depot April 2008 - March 2012
FDA September 2006 - May 2007
Budget Cleaning January 2003 - January 2006
Skills
Management, Customer Service, Sales, Business Development, Troubleshooting, Performance Management, Microsoft Office, Time Management, Training, Process Improvement, Consulting, Management Consulting, Onboarding, Operations Management, Website Development, Small Business, Strategic Financial..., Inventory Management, Leadership, Microsoft Excel, Microsoft Word, Team Building, Team Leadership
Education
State University of New York College at Geneseo 2004 — 2008
Bachelor's degree, Mathematics
Iacovos Kyprianou Iacovos Kyprianou's FDA Experience September 2011 - Present
Job
Industry Government Administration
Experience
FDA September 2011 - Present
University of Maryland March 2006 - Present
FDA August 2004 - September 2011
National Institutes of Health July 2004 - May 2005
Skills
Medical Devices, Biomedical Engineering, Science, Medical Imaging, Image Processing, Radiation Safety, Image Analysis, X-ray, Nuclear Medicine, x-ray imaging, CT imaging, Management, Molecular Biology, Computer Simulation, Health Sciences, Radiation Health, imaging physics, diagnostic imaging, Medical Counter Measures, Batteries, Computer Modeling, Regulatory Science, Hip Implants, Clinical Research, Research, project management, Physics, Human-centered Design, Computed Tomography
Education
The George Washington University - School of Business 2014 — 2015
Masters certificate
State University of New York College at Buffalo 1999 — 2004
PhD
University of Cyprus 1995 — 1999
Physics
FDA September 2011 - Present
University of Maryland March 2006 - Present
FDA August 2004 - September 2011
National Institutes of Health July 2004 - May 2005
Skills
Medical Devices, Biomedical Engineering, Science, Medical Imaging, Image Processing, Radiation Safety, Image Analysis, X-ray, Nuclear Medicine, x-ray imaging, CT imaging, Management, Molecular Biology, Computer Simulation, Health Sciences, Radiation Health, imaging physics, diagnostic imaging, Medical Counter Measures, Batteries, Computer Modeling, Regulatory Science, Hip Implants, Clinical Research, Research, project management, Physics, Human-centered Design, Computed Tomography
Education
The George Washington University - School of Business 2014 — 2015
Masters certificate
State University of New York College at Buffalo 1999 — 2004
PhD
University of Cyprus 1995 — 1999
Physics
Jameel Singh Jameel Singh's FDA Experience 2010 - 2011
Job Student at St. George's University
Industry Government Administration
Experience
FDA 2010 - 2011
Skills
Research, Analysis, Data Analysis, Chemistry, Analytical Chemistry, Science, HPLC, Customer Service, Strategic Planning, Microbiology
Education
St. George's University 2015 — 2019
Doctor of Medicine (M.D.), Medicine
FDA 2010 - 2011
Skills
Research, Analysis, Data Analysis, Chemistry, Analytical Chemistry, Science, HPLC, Customer Service, Strategic Planning, Microbiology
Education
St. George's University 2015 — 2019
Doctor of Medicine (M.D.), Medicine
Thomas Beckwith Thomas Beckwith's FDA Experience June 2010 - Present
Job Administrative Management Specialist at FDA
Industry Government Administration
Experience
FDA June 2010 - Present
Kaiser Permanente April 2009 - June 2010
U.S. Navy – National Naval Medical Center (NNMC) December 2006 - April 2009
U.S. Navy – Naval Hospital Charleston October 2003 - December 2006
Skills
LOGISTICS AND SUPPLY..., PROGRAM AND BUSINESS..., EVALUATION PROCESSES, SECURITY AND FACILITIES..., EMPLOYEE COUNSELING, TRAINING AND..., RESEARCH AND ANALYSIS, LEADERSHIP /MENTORING, Human Resources, Training, Military, Program Management, Management, Software Documentation, Healthcare, Navy, Emergency Management, Government, Command, Policy, Leadership, Analysis, Strategic Planning, Data Analysis, Security Clearance, Project Planning, DoD, Public Speaking, Military Experience, Team Building
Education
University of Phoenix 2010 — 2012
Master of Business Administration (M.B.A.)
Southern Illinois University, Carbondale 2004 — 2008
Bachelor of Applied Science (BASc), Workforce Development and Training
Development and Training – Southern Illinois University
Bachelors of Science, Workforce Education
University of Phoenix
Masters, Business Administration
FDA June 2010 - Present
Kaiser Permanente April 2009 - June 2010
U.S. Navy – National Naval Medical Center (NNMC) December 2006 - April 2009
U.S. Navy – Naval Hospital Charleston October 2003 - December 2006
Skills
LOGISTICS AND SUPPLY..., PROGRAM AND BUSINESS..., EVALUATION PROCESSES, SECURITY AND FACILITIES..., EMPLOYEE COUNSELING, TRAINING AND..., RESEARCH AND ANALYSIS, LEADERSHIP /MENTORING, Human Resources, Training, Military, Program Management, Management, Software Documentation, Healthcare, Navy, Emergency Management, Government, Command, Policy, Leadership, Analysis, Strategic Planning, Data Analysis, Security Clearance, Project Planning, DoD, Public Speaking, Military Experience, Team Building
Education
University of Phoenix 2010 — 2012
Master of Business Administration (M.B.A.)
Southern Illinois University, Carbondale 2004 — 2008
Bachelor of Applied Science (BASc), Workforce Development and Training
Development and Training – Southern Illinois University
Bachelors of Science, Workforce Education
University of Phoenix
Masters, Business Administration
Lauren Palmier, Pharm.D. Lauren Palmier, Pharm.D.'s FDA Experience January 2014 - February 2014
Job Pharmacy Manager at Schnuck Markets, Inc.
Industry Pharmaceuticals
Experience
Schnuck Markets, Inc. January 2015 - Present
Pharmacy Systems, Inc. January 2015 - Present
St. Louis College of Pharmacy July 2014 - Present
Schnuck Markets, Inc. May 2014 - January 2015
Schnuck Markets, Inc. August 2008 - May 2014
FDA January 2014 - February 2014
Schnuck Markets, Inc. April 2006 - August 2008
Skills
Medication Therapy..., Immunization, Patient Counseling, Patient Safety, Patient Education, Community Pharmacy, Certified Immunizer, Cpr Certified, Diabetes
Education
St. Louis College of Pharmacy 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy
Mehlville Senior High School 2004 — 2008
Schnuck Markets, Inc. January 2015 - Present
Pharmacy Systems, Inc. January 2015 - Present
St. Louis College of Pharmacy July 2014 - Present
Schnuck Markets, Inc. May 2014 - January 2015
Schnuck Markets, Inc. August 2008 - May 2014
FDA January 2014 - February 2014
Schnuck Markets, Inc. April 2006 - August 2008
Skills
Medication Therapy..., Immunization, Patient Counseling, Patient Safety, Patient Education, Community Pharmacy, Certified Immunizer, Cpr Certified, Diabetes
Education
St. Louis College of Pharmacy 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy
Mehlville Senior High School 2004 — 2008
Nahal Nassabeh Nahal Nassabeh's FDA Experience May 2015 - August 2015
Job Center for Drug Evaluation and Research Office of Clinical Pharmacology, Intern at FDA
Industry Pharmaceuticals
Experience
The University of Iowa Health Care September 2014 - Present
FDA May 2015 - August 2015
Genentech August 2012 - August 2013
Skills
Biotechnology, Cell Culture, GMP, PCR, Pharmaceutical Industry, Sop, GLP, Lifesciences, Molecular Biology, Chromatography, Immunology, Cell Biology, Protein Purification, Aseptic Technique, Biochemistry, Oncology, ELISA, Pharmacology, Life Sciences
Education
University of Iowa 2013 — 2017
Doctor of Pharmacy (Pharm.D.)
San Jose State University 2007 — 2011
B.S. Biological Science, Minor: Chemistry & Communications
The University of Iowa Health Care September 2014 - Present
FDA May 2015 - August 2015
Genentech August 2012 - August 2013
Skills
Biotechnology, Cell Culture, GMP, PCR, Pharmaceutical Industry, Sop, GLP, Lifesciences, Molecular Biology, Chromatography, Immunology, Cell Biology, Protein Purification, Aseptic Technique, Biochemistry, Oncology, ELISA, Pharmacology, Life Sciences
Education
University of Iowa 2013 — 2017
Doctor of Pharmacy (Pharm.D.)
San Jose State University 2007 — 2011
B.S. Biological Science, Minor: Chemistry & Communications
Cassandra Lalonde Abellard Cassandra Lalonde Abellard's FDA Experience February 2014 - Present
Job Gov
Industry Pharmaceuticals
Experience
FDA February 2014 - Present
Keurig Green Mountain, Inc. October 2012 - January 2014
Pfizer January 2010 - July 2012
Pfizer January 2006 - January 2010
Pfizer February 2002 - January 2006
Skills
Quality Management, Commitments, Validation, USP, SOP development, GAMP, GLP, Manufacturing, Pharmaceutical Industry, Six Sigma, Cleaning Validation, Computer System..., Continuous Improvement, FDA, Leadership, Quality System, Regulatory Submissions, Root Cause Analysis, Technology Transfer, V, Lean Manufacturing, Analytical Chemistry, LIMS
Education
Plattsburgh State University 1995 — 1997
Bachelor of Science; Associate of Applied Science, Cellular Biochemistry; Veterinary Science Technology
State University of New York at Delhi 1991 — 1993
AAS, Veterinary Science
FDA February 2014 - Present
Keurig Green Mountain, Inc. October 2012 - January 2014
Pfizer January 2010 - July 2012
Pfizer January 2006 - January 2010
Pfizer February 2002 - January 2006
Skills
Quality Management, Commitments, Validation, USP, SOP development, GAMP, GLP, Manufacturing, Pharmaceutical Industry, Six Sigma, Cleaning Validation, Computer System..., Continuous Improvement, FDA, Leadership, Quality System, Regulatory Submissions, Root Cause Analysis, Technology Transfer, V, Lean Manufacturing, Analytical Chemistry, LIMS
Education
Plattsburgh State University 1995 — 1997
Bachelor of Science; Associate of Applied Science, Cellular Biochemistry; Veterinary Science Technology
State University of New York at Delhi 1991 — 1993
AAS, Veterinary Science
Carol Q Wang Carol Q Wang's FDA Experience January 2013 - Present
Job Instructional Design research fellow at FDA
Industry E-Learning
Experience
FDA January 2013 - Present
NADA April 2012 - August 2012
Skills
Instructional Design, Educational Technology, Training, Qualitative Research, Program Evaluation, Higher Education, Adult Education
Education
Syracuse University 2010 — 2012
Master, Education Instructional Design, 3.9
SUNY Potsdam 2010 — 2010
Organizational Leadership
FDA January 2013 - Present
NADA April 2012 - August 2012
Skills
Instructional Design, Educational Technology, Training, Qualitative Research, Program Evaluation, Higher Education, Adult Education
Education
Syracuse University 2010 — 2012
Master, Education Instructional Design, 3.9
SUNY Potsdam 2010 — 2010
Organizational Leadership
Heidi DeBeck's FDA Experience January 2013 - November 2014
Job Emergency Response Coordinator at FDA
Industry Government Administration
Experience
FDA January 2013 - November 2014
Minnesota Department of Health September 2010 - July 2012
Skills
Public Health, Epidemiology, Research, Data Analysis, Healthcare, Non-profits, Infectious Diseases, Public Health..., Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Outbreak Investigation, Disease Surveillance, Policy
Education
University of Minnesota-Twin Cities
M.P.H.
St. Olaf College
FDA January 2013 - November 2014
Minnesota Department of Health September 2010 - July 2012
Skills
Public Health, Epidemiology, Research, Data Analysis, Healthcare, Non-profits, Infectious Diseases, Public Health..., Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Outbreak Investigation, Disease Surveillance, Policy
Education
University of Minnesota-Twin Cities
M.P.H.
St. Olaf College
Nahush Rao Nahush Rao's FDA Experience June 2009 - September 2009
Job Associate at Huron Consulting Group
Industry Hospital & Health Care
Experience
Huron Consulting Group November 2013 - Present
GE Healthcare June 2011 - August 2013
Stanford University January 2011 - July 2011
Philips Research June 2010 - September 2010
FDA June 2009 - September 2009
Stanford University Medical Center June 2008 - June 2009
Skills
Data Analysis, Data Processing, Microsoft Excel, VBA, Algorithms, Statistics, R, Project Management, Spotfire, Medical Imaging, Biomedical Engineering, Medical Devices, Image Analysis, X-ray, Image Processing, Matlab, Healthcare Consulting, Clinical Research, Minitab, Medical Research, Signal Processing, LaTeX, PowerPoint, Microsoft Word, Imaging, Java, C++, IDL, Verilog, Six Sigma, Bioengineering, Microsoft Project
Education
Stanford University 2010 — 2011
MS, Bioengineering
Stanford University 2006 — 2010
BS, Engineering Physics
Huron Consulting Group November 2013 - Present
GE Healthcare June 2011 - August 2013
Stanford University January 2011 - July 2011
Philips Research June 2010 - September 2010
FDA June 2009 - September 2009
Stanford University Medical Center June 2008 - June 2009
Skills
Data Analysis, Data Processing, Microsoft Excel, VBA, Algorithms, Statistics, R, Project Management, Spotfire, Medical Imaging, Biomedical Engineering, Medical Devices, Image Analysis, X-ray, Image Processing, Matlab, Healthcare Consulting, Clinical Research, Minitab, Medical Research, Signal Processing, LaTeX, PowerPoint, Microsoft Word, Imaging, Java, C++, IDL, Verilog, Six Sigma, Bioengineering, Microsoft Project
Education
Stanford University 2010 — 2011
MS, Bioengineering
Stanford University 2006 — 2010
BS, Engineering Physics
Gabriel C Gabriel C's FDA Experience January 2014 - Present
Job Chemist at FDA
Industry Food & Beverages
Experience
FDA January 2014 - Present
San Francisco State University August 2011 - November 2014
Inspectorate April 2011 - December 2013
San Francisco State University August 2011 - August 2013
San Francisco State University August 2011 - May 2013
NeurogesX, Inc. November 2012 - March 2013
Hewlett-Packard June 2012 - September 2012
A+ Learning Center August 2010 - June 2012
Wunderling Learning Center August 2010 - June 2011
NeurogesX, Inc. February 2011 - April 2011
Skills
Chemistry, Analytical Chemistry, UV/Vis, Data Analysis, Science, Research, Teaching, Gas Chromatography, FTIR, Educational Research, Spectroscopy, HPLC, NMR spectroscopy, Wet Chemistry, XRF, ICP-OES, Chromatography, GPC, IC, GC-MS, LC-MS, Mass Spectrometry
Education
San Francisco State University 2011 — 2013
MS
University of California, Davis 2006 — 2010
BS
FDA January 2014 - Present
San Francisco State University August 2011 - November 2014
Inspectorate April 2011 - December 2013
San Francisco State University August 2011 - August 2013
San Francisco State University August 2011 - May 2013
NeurogesX, Inc. November 2012 - March 2013
Hewlett-Packard June 2012 - September 2012
A+ Learning Center August 2010 - June 2012
Wunderling Learning Center August 2010 - June 2011
NeurogesX, Inc. February 2011 - April 2011
Skills
Chemistry, Analytical Chemistry, UV/Vis, Data Analysis, Science, Research, Teaching, Gas Chromatography, FTIR, Educational Research, Spectroscopy, HPLC, NMR spectroscopy, Wet Chemistry, XRF, ICP-OES, Chromatography, GPC, IC, GC-MS, LC-MS, Mass Spectrometry
Education
San Francisco State University 2011 — 2013
MS
University of California, Davis 2006 — 2010
BS
Edwin Chow Edwin Chow's FDA Experience October 2014 - Present
Job Researcher at FDA
Industry Research
Experience
FDA October 2014 - Present
Johnson & Johnson September 2012 - September 2014
Skills
Cell Culture, Western Blotting, Molecular Biology, Biochemistry, Scientific Writing, Animal Models, Immunohistochemistry, Cell Biology, PCR, Microscopy, Pharmacokinetics, Mathematical Modeling, Pharmacodynamics, PK/PD, LC-MS, Solid Phase Extraction, qPCR, Surgery, Biostatistics, Mouse Models, Perfusion, Data Analysis, Physiology, DMPK, Tissue Culture, HPLC, In Vivo
Education
University of Toronto 2007 — 2012
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences (Pharmacokinetics)
University of Toronto 2002 — 2006
Hon.B.Sc., Pharmacology Specialist
Seneca College of Applied Arts and Technology 2012 — 2014
Certificate, Pharmaceutical Regulatory Affairs and Quality Operations
FDA October 2014 - Present
Johnson & Johnson September 2012 - September 2014
Skills
Cell Culture, Western Blotting, Molecular Biology, Biochemistry, Scientific Writing, Animal Models, Immunohistochemistry, Cell Biology, PCR, Microscopy, Pharmacokinetics, Mathematical Modeling, Pharmacodynamics, PK/PD, LC-MS, Solid Phase Extraction, qPCR, Surgery, Biostatistics, Mouse Models, Perfusion, Data Analysis, Physiology, DMPK, Tissue Culture, HPLC, In Vivo
Education
University of Toronto 2007 — 2012
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences (Pharmacokinetics)
University of Toronto 2002 — 2006
Hon.B.Sc., Pharmacology Specialist
Seneca College of Applied Arts and Technology 2012 — 2014
Certificate, Pharmaceutical Regulatory Affairs and Quality Operations
Susan M. Bowley, Ph.D. Susan M. Bowley, Ph.D.'s FDA Experience 2002 - 2006
Job Founder, President & CEO Bowley Inc.
Industry Mechanical or Industrial Engineering
Experience
Yuba College August 2015 - Present
Bowley Inc. 3D Scan Archive 2013 - Present
UCSC Extension Silicon Valley March 2014 - September 2014
Bowley Consulting, LLC 2008 - 2012
Santa Clara University 2008 - 2009
Boster, Kobayashi & Associates 2006 - 2008
George Washington University 2006 - 2006
FDA 2002 - 2006
FDA 2001 - 2002
NASA Ames Research Center 1988 - 2001
Skills
Medical Devices, R&D, Biomedical Engineering, Regulatory Affairs, Engineering, Biomechanics, Product Development, Lifesciences, Accident Reconstruction, Personal Injury, FDA, Forensic Engineering, Teaching, Premises Liability, Product Liability, Animation, Patent Infringement, Patent Litigation, Mechanical Engineering, 3D Laser Scanning, Reverse Engineering, Expert Witness, Finite Element Analysis, Quality Assurance, CAD, Testing, SolidWorks, ISO 13485, Leadership, Research, Biotechnology, Management
Education
ORISE Post Doctoral Fellow 2001 — 2002
Post Doctoral Fellowship, Biomedical Engineering
University of Virginia
Ph.D., Biomedical Engineering
Stanford University
M.S., Mechanical Engineering
University of Connecticut
BS, Mechanical Engineering
Yuba College August 2015 - Present
Bowley Inc. 3D Scan Archive 2013 - Present
UCSC Extension Silicon Valley March 2014 - September 2014
Bowley Consulting, LLC 2008 - 2012
Santa Clara University 2008 - 2009
Boster, Kobayashi & Associates 2006 - 2008
George Washington University 2006 - 2006
FDA 2002 - 2006
FDA 2001 - 2002
NASA Ames Research Center 1988 - 2001
Skills
Medical Devices, R&D, Biomedical Engineering, Regulatory Affairs, Engineering, Biomechanics, Product Development, Lifesciences, Accident Reconstruction, Personal Injury, FDA, Forensic Engineering, Teaching, Premises Liability, Product Liability, Animation, Patent Infringement, Patent Litigation, Mechanical Engineering, 3D Laser Scanning, Reverse Engineering, Expert Witness, Finite Element Analysis, Quality Assurance, CAD, Testing, SolidWorks, ISO 13485, Leadership, Research, Biotechnology, Management
Education
ORISE Post Doctoral Fellow 2001 — 2002
Post Doctoral Fellowship, Biomedical Engineering
University of Virginia
Ph.D., Biomedical Engineering
Stanford University
M.S., Mechanical Engineering
University of Connecticut
BS, Mechanical Engineering
Katya Petrova Katya Petrova's FDA Experience October 2011 - October 2013
Job Scientist III at US Pharmacopeia, Research & Development
Industry Nonprofit Organization Management
Experience
US Pharmacopeia, Research & Development September 2014 - Present
US Pharmacopeia, Research & Development, Monograph Modernization January 2014 - September 2014
FDA October 2011 - October 2013
Vanderbilt University October 2004 - October 2011
Sofia University October 2003 - September 2004
Executive Environment Agency Bulgaria, Dept. of Quality Control and Instrumental Methods of Analysis January 2000 - September 2003
Bulgarian Academy of Sciences, Institute of Organic Chemistry October 1992 - February 1995
Skills
HPLC, Mass Spectrometry, LC-MS, NMR, Chromatography, Organic Chemistry, Purification, NMR spectroscopy, IR, Assay Development, Characterization, DNA, Validation, UV, Cancer, Sample Preparation, Biomarkers, Method Development, Chemistry, Spectroscopy, Logic Synthesis, Analytical Chemistry, UV/Vis, Drug Discovery, Organic Synthesis, Medicinal Chemistry, Biochemistry, Molecular Biology, Nanotechnology, FDA, Metabolomics, Toxicology, Bioanalysis, Fluorescence, TLC, Protein Purification, Protein Chemistry, Protein Expression, In Vitro, GC-MS
Education
Sofia University St. Kliment Ohridski
PhD, Technology of Fine Organic Synthesis and Biochemical Synthesis
Sofia University St. Kliment Ohridski
MS, Chemistry and Physics
US Pharmacopeia, Research & Development September 2014 - Present
US Pharmacopeia, Research & Development, Monograph Modernization January 2014 - September 2014
FDA October 2011 - October 2013
Vanderbilt University October 2004 - October 2011
Sofia University October 2003 - September 2004
Executive Environment Agency Bulgaria, Dept. of Quality Control and Instrumental Methods of Analysis January 2000 - September 2003
Bulgarian Academy of Sciences, Institute of Organic Chemistry October 1992 - February 1995
Skills
HPLC, Mass Spectrometry, LC-MS, NMR, Chromatography, Organic Chemistry, Purification, NMR spectroscopy, IR, Assay Development, Characterization, DNA, Validation, UV, Cancer, Sample Preparation, Biomarkers, Method Development, Chemistry, Spectroscopy, Logic Synthesis, Analytical Chemistry, UV/Vis, Drug Discovery, Organic Synthesis, Medicinal Chemistry, Biochemistry, Molecular Biology, Nanotechnology, FDA, Metabolomics, Toxicology, Bioanalysis, Fluorescence, TLC, Protein Purification, Protein Chemistry, Protein Expression, In Vitro, GC-MS
Education
Sofia University St. Kliment Ohridski
PhD, Technology of Fine Organic Synthesis and Biochemical Synthesis
Sofia University St. Kliment Ohridski
MS, Chemistry and Physics
Yufan (Frank) Liu, PharmD Yufan (Frank) Liu, PharmD's FDA Experience May 2012 - July 2012
Job Pharmacovigilance Scientist at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca July 2014 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson July 2013 - July 2014
Rite Aid January 2008 - May 2013
FDA May 2012 - July 2012
Skills
Pharmaceutical Industry, Clinical Trials, Oncology, GCP, Drug Safety, Pharmacovigilance, Product Safety, Clinical Development, Biotechnology, GMP, Drug Discovery, Lifesciences, CRO, FDA, Microsoft Office, Medicine, Project Management
Education
St. John's University 2007 — 2013
Doctor of Pharmacy (PharmD), Graduated Cum Laude
Bronx High School of Science 2003 — 2007
AstraZeneca July 2014 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson July 2013 - July 2014
Rite Aid January 2008 - May 2013
FDA May 2012 - July 2012
Skills
Pharmaceutical Industry, Clinical Trials, Oncology, GCP, Drug Safety, Pharmacovigilance, Product Safety, Clinical Development, Biotechnology, GMP, Drug Discovery, Lifesciences, CRO, FDA, Microsoft Office, Medicine, Project Management
Education
St. John's University 2007 — 2013
Doctor of Pharmacy (PharmD), Graduated Cum Laude
Bronx High School of Science 2003 — 2007
Fei Ma Fei Ma's FDA Experience June 2012 - August 2012
Job Sr Biostatistician at Novartis
Industry Pharmaceuticals
Experience
Novartis September 2014 - Present
Novartis June 2013 - August 2013
FDA June 2012 - August 2012
Skills
SAS, Matlab, Analysis, Biostatistics, LaTeX, R, Statistical Modeling, Statistics, S-Plus, Flow Cytometry, Data Analysis, Quantitative Analytics, Linear Regression, Mathematica, Stata, Microsoft Excel, Research, SAS Programming, Clinical Research
Education
University of Rochester 2009 — 2014
Ph.D., Statistics
Shanghai University of Finance and Economics 2005 — 2009
B.S., Statistics
Novartis September 2014 - Present
Novartis June 2013 - August 2013
FDA June 2012 - August 2012
Skills
SAS, Matlab, Analysis, Biostatistics, LaTeX, R, Statistical Modeling, Statistics, S-Plus, Flow Cytometry, Data Analysis, Quantitative Analytics, Linear Regression, Mathematica, Stata, Microsoft Excel, Research, SAS Programming, Clinical Research
Education
University of Rochester 2009 — 2014
Ph.D., Statistics
Shanghai University of Finance and Economics 2005 — 2009
B.S., Statistics
Steven Mudd Steven Mudd's FDA Experience August 2010 - May 2011
Job Attorney
Industry Legal Services
Experience
Smith McCartney & Owens, LLC August 2015 - Present
Phillips Mudd, PC December 2014 - Present
Occasions Caterers August 1998 - December 2014
FDA August 2010 - May 2011
Prince George's County Circuit Court January 2010 - May 2010
Skills
Policy, Research, Community Outreach, Training, Proposal Writing, Courts, Creative Writing, Access, Process Improvement, Employee Relations, Project Planning, Legal Research, Legal Writing, Customer Service, Policy Analysis
Education
St. John's College 2011 — 2014
Master's degree, The Great Books Program
University of Baltimore School of Law 2008 — 2011
Juris Doctor, Law
St. Francis College 2002 — 2005
Bachelor of Science, Bachelor of Arts, Mathematics, Philosophy, English
DeMatha Catholic High School 1997 — 2001
Diploma with Highest Honors, College Prep
Smith McCartney & Owens, LLC August 2015 - Present
Phillips Mudd, PC December 2014 - Present
Occasions Caterers August 1998 - December 2014
FDA August 2010 - May 2011
Prince George's County Circuit Court January 2010 - May 2010
Skills
Policy, Research, Community Outreach, Training, Proposal Writing, Courts, Creative Writing, Access, Process Improvement, Employee Relations, Project Planning, Legal Research, Legal Writing, Customer Service, Policy Analysis
Education
St. John's College 2011 — 2014
Master's degree, The Great Books Program
University of Baltimore School of Law 2008 — 2011
Juris Doctor, Law
St. Francis College 2002 — 2005
Bachelor of Science, Bachelor of Arts, Mathematics, Philosophy, English
DeMatha Catholic High School 1997 — 2001
Diploma with Highest Honors, College Prep
Hong Ding Hong Ding's FDA Experience February 2014 - Present
Job Review Chemist at FDA
Industry Government Administration
Experience
FDA February 2014 - Present
Florida International University April 2012 - January 2014
Department of Pharmaceutical Sciences, University at Buffalo, SUNY August 2010 - March 2012
University at Buffalo, Department of Chemistry October 2006 - July 2010
Sichuan Industrial Institute of Antibiotics July 1999 - August 2003
Skills
Formulation, Chemistry, Drug Delivery, Protein Chemistry, Polymers, Immunology, Cancer, R&D, Pharmacokinetics, Nanoparticles, UV/Vis, HPLC, Cell Culture, Oncology, In Vivo, Drug Development, In Vitro, Nanotechnology
Education
Sichuan University
Doctor of Philosophy (PhD), Pharmaceutical Science
Sichuan Industrial Institute of Antibiotics
Master's degree, Pharmaceutical Chemistry
Sichuan University of Science and Engnieering
Bachelor of Science (BS), Microbiology
FDA February 2014 - Present
Florida International University April 2012 - January 2014
Department of Pharmaceutical Sciences, University at Buffalo, SUNY August 2010 - March 2012
University at Buffalo, Department of Chemistry October 2006 - July 2010
Sichuan Industrial Institute of Antibiotics July 1999 - August 2003
Skills
Formulation, Chemistry, Drug Delivery, Protein Chemistry, Polymers, Immunology, Cancer, R&D, Pharmacokinetics, Nanoparticles, UV/Vis, HPLC, Cell Culture, Oncology, In Vivo, Drug Development, In Vitro, Nanotechnology
Education
Sichuan University
Doctor of Philosophy (PhD), Pharmaceutical Science
Sichuan Industrial Institute of Antibiotics
Master's degree, Pharmaceutical Chemistry
Sichuan University of Science and Engnieering
Bachelor of Science (BS), Microbiology
Peter S. Kessler, PhD Peter S. Kessler, PhD's FDA Experience September 2010 - Present
Job CSO at FDA
Industry Law Enforcement
Experience
FDA September 2010 - Present
University of Washington School of Medicine 2007 - September 2010
Temple University November 2006 - January 2007
Seattle Biomedical Research Institute 1999 - 2006
Fred Hutchinson Cancer Research Center January 1990 - January 1992
Skills
Molecular Biology, Cell Culture, Life Sciences, PCR, Cell Biology, Western Blotting, Biotechnology, Biochemistry, qPCR, Protein Chemistry, Immunology, Infectious Diseases, ELISA, Lifesciences, Microbiology, Research, Signal Transduction
Education
University of Washington School of Medicine 1992 — 1998
PhD, Microbiology
University of Washington 1988 — 1990
BS, Biochemistry
Seattle Languages International
Seattle University
FDA September 2010 - Present
University of Washington School of Medicine 2007 - September 2010
Temple University November 2006 - January 2007
Seattle Biomedical Research Institute 1999 - 2006
Fred Hutchinson Cancer Research Center January 1990 - January 1992
Skills
Molecular Biology, Cell Culture, Life Sciences, PCR, Cell Biology, Western Blotting, Biotechnology, Biochemistry, qPCR, Protein Chemistry, Immunology, Infectious Diseases, ELISA, Lifesciences, Microbiology, Research, Signal Transduction
Education
University of Washington School of Medicine 1992 — 1998
PhD, Microbiology
University of Washington 1988 — 1990
BS, Biochemistry
Seattle Languages International
Seattle University
Janice Freeman-Hall's FDA Experience April 2008 - June 2012
Job Program & Management Specialist
Industry Nonprofit Organization Management
Experience
Prince George's County Public Schools 2013 - Present
FDA April 2008 - June 2012
FBI December 1977 - June 1986
Skills
Government, Policy Analysis, Public Policy, Grant Writing, Community Outreach, Program Management, Non-profits, Federal Government, Large-scale Event..., Conference Production, Databases, Computer-savvy, Crowd Control, Wedding Coordinating, Administraion, Research, Web Design, Facilitators, Credibility, Manage Multiple, System Administration, Government Contracting, Community Development, Policy, Microsoft Office, International Relations, Customer Service, Nonprofits, Public Speaking, Volunteer Management, Leadership, Event Planning, Strategic Planning, Management, Training
Education
Savannah Technical College 1975 — 1977
Associate's degree, Business Administration and Management, 4
Prince George's County Public Schools 2013 - Present
FDA April 2008 - June 2012
FBI December 1977 - June 1986
Skills
Government, Policy Analysis, Public Policy, Grant Writing, Community Outreach, Program Management, Non-profits, Federal Government, Large-scale Event..., Conference Production, Databases, Computer-savvy, Crowd Control, Wedding Coordinating, Administraion, Research, Web Design, Facilitators, Credibility, Manage Multiple, System Administration, Government Contracting, Community Development, Policy, Microsoft Office, International Relations, Customer Service, Nonprofits, Public Speaking, Volunteer Management, Leadership, Event Planning, Strategic Planning, Management, Training
Education
Savannah Technical College 1975 — 1977
Associate's degree, Business Administration and Management, 4
Anthony DiLisio's FDA Experience June 2012 - August 2012
Job Business Development Representative
Industry Computer Software
Experience
VoltDB August 2014 - Present
Self-Employed May 2013 - October 2014
DiLisio Brothers Driving Range May 2007 - October 2014
FDA June 2012 - August 2012
Skills
Team Leadership, Competitive Analysis, Contract Negotiation, Pricing Strategy, Leadership, Written & Verbal..., New Business Development, Vendor Management Skills, Public Speaking, Account Management, Market Research, Product Cost Analysis, Strategic Partnerships, Product Development, Salesforce.com, Social Media, Marketing Strategy, Data Analysis, Business Development, Social Media Marketing, Research, Marketing, Facebook, Social Networking, Customer Service, Start-ups, Editing, Sales, Strategy, Business Strategy, Public Relations, Teaching, CRM, Virtualization, Lead Generation, Advertising, Teamwork, Strategic Planning, Project Management, Negotiation, Sales Management, SaaS, Databases, Enterprise Software
Education
Skidmore College 2009 — 2013
Bachelor's Degree, Business Management & Environmental Science
Phillips Exeter Academy
High School
VoltDB August 2014 - Present
Self-Employed May 2013 - October 2014
DiLisio Brothers Driving Range May 2007 - October 2014
FDA June 2012 - August 2012
Skills
Team Leadership, Competitive Analysis, Contract Negotiation, Pricing Strategy, Leadership, Written & Verbal..., New Business Development, Vendor Management Skills, Public Speaking, Account Management, Market Research, Product Cost Analysis, Strategic Partnerships, Product Development, Salesforce.com, Social Media, Marketing Strategy, Data Analysis, Business Development, Social Media Marketing, Research, Marketing, Facebook, Social Networking, Customer Service, Start-ups, Editing, Sales, Strategy, Business Strategy, Public Relations, Teaching, CRM, Virtualization, Lead Generation, Advertising, Teamwork, Strategic Planning, Project Management, Negotiation, Sales Management, SaaS, Databases, Enterprise Software
Education
Skidmore College 2009 — 2013
Bachelor's Degree, Business Management & Environmental Science
Phillips Exeter Academy
High School
Elly Moon Elly Moon's FDA Experience December 2014 - Present
Job ORISE fellow at FDA
Industry Pharmaceuticals
Experience
FDA December 2014 - Present
FDA June 2014 - September 2014
University of Maryland School of Pharmacy August 2010 - May 2014
FDA June 2012 - August 2012
Pfizer Korea March 2010 - July 2010
Vitamin Pharmacy November 2009 - July 2010
Saebyul Pharmacy May 2009 - October 2009
Seoul National University Hospital June 2007 - January 2009
Skills
Clinical Research, Pharmacology, Clinical Pharmacology, Pharmacists, Medication Therapy..., Pharmacokinetics, Epidemiology
Education
University of Maryland Baltimore 2010 — 2014
서울대학교 / Seoul National University 2007 — 2009
Master of Science (M.S.), Clinical pharmacy
서울대학교 / Seoul National University 2003 — 2007
Bachelor of Science (B.S.), Pharmacy
FDA December 2014 - Present
FDA June 2014 - September 2014
University of Maryland School of Pharmacy August 2010 - May 2014
FDA June 2012 - August 2012
Pfizer Korea March 2010 - July 2010
Vitamin Pharmacy November 2009 - July 2010
Saebyul Pharmacy May 2009 - October 2009
Seoul National University Hospital June 2007 - January 2009
Skills
Clinical Research, Pharmacology, Clinical Pharmacology, Pharmacists, Medication Therapy..., Pharmacokinetics, Epidemiology
Education
University of Maryland Baltimore 2010 — 2014
서울대학교 / Seoul National University 2007 — 2009
Master of Science (M.S.), Clinical pharmacy
서울대학교 / Seoul National University 2003 — 2007
Bachelor of Science (B.S.), Pharmacy
Darren Fegley Darren Fegley's FDA Experience March 2008 - Present
Job Pharmacologist/Toxicologist at FDA
Industry Government Administration
Experience
FDA March 2008 - Present
Montgomery College June 2008 - Present
National Institutes of Health October 2005 - March 2008
Skills
Cell Culture, Science, PCR, Lifesciences, Western Blotting, Cell Biology, Toxicology, Scientific Writing, Biochemistry, Animal Models, ELISA, qPCR, In Vivo, Microscopy
Education
University of California, Irvine - College of Medicine 2000 — 2005
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology
State University of New York College of Environmental Sciences and Forestry 1996 — 1999
Bachelor of Science (B.S.), Wildlife Biology
FDA March 2008 - Present
Montgomery College June 2008 - Present
National Institutes of Health October 2005 - March 2008
Skills
Cell Culture, Science, PCR, Lifesciences, Western Blotting, Cell Biology, Toxicology, Scientific Writing, Biochemistry, Animal Models, ELISA, qPCR, In Vivo, Microscopy
Education
University of California, Irvine - College of Medicine 2000 — 2005
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology
State University of New York College of Environmental Sciences and Forestry 1996 — 1999
Bachelor of Science (B.S.), Wildlife Biology
Nima Ossareh's FDA Experience May 2015 - Present
Job Pharmacist
Industry Pharmaceuticals
Experience
FDA May 2015 - Present
Walgreens May 2013 - May 2015
Safeway June 2010 - November 2012
Skills
Pharmacists, Immunization, Medication Therapy..., Clinical Research, Certified Immunizer, Patient Counseling, Clinical Pharmacology, Pharmacy Automation, Pharmacy, Community Pharmacy, Clinical Pharmacy, Pharmacy Practice, Pharmacology, Compounding, Medication..., Pharmaceutical Industry
Education
Howard University College of Pharmacy 2009 — 2013
Doctor of Pharmacy (Pharm.D.), Pharmacy
San Diego State University-California State University 2004 — 2008
Bachelor of Science (B.S.), Biology, General
FDA May 2015 - Present
Walgreens May 2013 - May 2015
Safeway June 2010 - November 2012
Skills
Pharmacists, Immunization, Medication Therapy..., Clinical Research, Certified Immunizer, Patient Counseling, Clinical Pharmacology, Pharmacy Automation, Pharmacy, Community Pharmacy, Clinical Pharmacy, Pharmacy Practice, Pharmacology, Compounding, Medication..., Pharmaceutical Industry
Education
Howard University College of Pharmacy 2009 — 2013
Doctor of Pharmacy (Pharm.D.), Pharmacy
San Diego State University-California State University 2004 — 2008
Bachelor of Science (B.S.), Biology, General
Keith Kocis, MD, MS Keith Kocis, MD, MS's FDA Experience 2010 - 2015
Job Interim Chief, Pediatric Critical Care Medicine at Sidra Medical and Research Center
Industry Medical Devices
Experience
Sidra Medical and Research Center May 2015 - Present
Sidra Medical and Research Center January 2015 - Present
REALTROMINS February 2006 - Present
University of North Carolina at Chapel Hill April 2000 - March 2015
UNC Hospitals April 2000 - March 2015
FDA 2010 - 2015
UNC Project Uganda 2005 - August 2014
UNC Wellstone Center for Muscular Dystrophy 2008 - February 2014
NIH 2010 - 2013
The Food and Drug Administration October 2006 - June 2010
Skills
Clinical Research, Healthcare, Public Health, Pediatrics, Clinical Trials, Medical Devices, Hospitals, Medical Education, Medicine, Lifesciences, Healthcare Management, Healthcare Information..., Informatics, EMR, Infectious Diseases, Board Certified, Biotechnology, Molecular Biology, Critical Care, Cardiology, Physicians, Pharmaceutical Industry
Education
The Johns Hopkins University 1994 — 1996
Fellow, Pediatric Critical Care Medicine Fellowship
University of Michigan 1991 — 1993
MS, Clinical Research Design and Statistics
University of Michigan Medical School 1990 — 1993
Fellow, Pediatric Cardiology
The George Washington University 1987 — 1990
Pediatric Resident, Pediatric Medicine
State University of New York Upstate Medical University 1983 — 1987
MD, Medicine
State University of New York College at Cortland 1979 — 1983
BS, Biology
Massapequa High School 1976 — 1979
Diploma, NYS Regents
Sidra Medical and Research Center May 2015 - Present
Sidra Medical and Research Center January 2015 - Present
REALTROMINS February 2006 - Present
University of North Carolina at Chapel Hill April 2000 - March 2015
UNC Hospitals April 2000 - March 2015
FDA 2010 - 2015
UNC Project Uganda 2005 - August 2014
UNC Wellstone Center for Muscular Dystrophy 2008 - February 2014
NIH 2010 - 2013
The Food and Drug Administration October 2006 - June 2010
Skills
Clinical Research, Healthcare, Public Health, Pediatrics, Clinical Trials, Medical Devices, Hospitals, Medical Education, Medicine, Lifesciences, Healthcare Management, Healthcare Information..., Informatics, EMR, Infectious Diseases, Board Certified, Biotechnology, Molecular Biology, Critical Care, Cardiology, Physicians, Pharmaceutical Industry
Education
The Johns Hopkins University 1994 — 1996
Fellow, Pediatric Critical Care Medicine Fellowship
University of Michigan 1991 — 1993
MS, Clinical Research Design and Statistics
University of Michigan Medical School 1990 — 1993
Fellow, Pediatric Cardiology
The George Washington University 1987 — 1990
Pediatric Resident, Pediatric Medicine
State University of New York Upstate Medical University 1983 — 1987
MD, Medicine
State University of New York College at Cortland 1979 — 1983
BS, Biology
Massapequa High School 1976 — 1979
Diploma, NYS Regents
Alexandra Khachatryan's FDA Experience June 2008 - August 2008
Job Senior Manager, Global Health Economics & Outcomes Research at Baxalta Inc. (formerly Baxter Healthcare)
Industry Hospital & Health Care
Experience
Baxalta July 2015 - Present
Baxter International Inc. April 2014 - Present
Pharmerit October 2011 - March 2014
Pfizer June 2010 - September 2011
Yale School of Public Health September 2008 - May 2010
Pfizer June 2009 - August 2009
FDA June 2008 - August 2008
Skills
Health Outcomes, Pharmacoeconomics, Strategy Development, Dossiers, Value Propositions, Healthcare Reimbursement, Clinical Development, Outcomes Research, Epidemiology, Strategy, Health Economics, Medical Affairs, Clinical Research, Pharmaceutical Industry, Market Access, Regulatory Affairs, Healthcare, Biotechnology, Biostatistics, Drug Development, Infectious Diseases, Oncology, Informatics, CRO, Clinical Trials, Medical Writing, Health Policy, Neuroscience, Immunology, Clinical Study Design, Diabetes, Cancer, SAS, Public Health, Vaccines
Education
Yale School of Public Health 2008 — 2010
MPH, Epidemiology of Microbial Disease
St. Mary's College of Maryland 2004 — 2008
B.A., Biology
The Park School of Baltimore
Baxalta July 2015 - Present
Baxter International Inc. April 2014 - Present
Pharmerit October 2011 - March 2014
Pfizer June 2010 - September 2011
Yale School of Public Health September 2008 - May 2010
Pfizer June 2009 - August 2009
FDA June 2008 - August 2008
Skills
Health Outcomes, Pharmacoeconomics, Strategy Development, Dossiers, Value Propositions, Healthcare Reimbursement, Clinical Development, Outcomes Research, Epidemiology, Strategy, Health Economics, Medical Affairs, Clinical Research, Pharmaceutical Industry, Market Access, Regulatory Affairs, Healthcare, Biotechnology, Biostatistics, Drug Development, Infectious Diseases, Oncology, Informatics, CRO, Clinical Trials, Medical Writing, Health Policy, Neuroscience, Immunology, Clinical Study Design, Diabetes, Cancer, SAS, Public Health, Vaccines
Education
Yale School of Public Health 2008 — 2010
MPH, Epidemiology of Microbial Disease
St. Mary's College of Maryland 2004 — 2008
B.A., Biology
The Park School of Baltimore
Joseph Pierro MD Joseph Pierro MD's FDA Experience 1995 - 1999
Job Chief Medical Officer at Biomedical Systems
Industry Pharmaceuticals
Experience
Biomedical Systems May 2012 - Present
Washington University in St Louis Mallinckrodt Institute Radiology July 1997 - Present
Covidien Pharmaceuticals April 2009 - May 2012
Covidien Healthcare May 2005 - April 2009
GE Healthcare June 2004 - June 2005
Nycomed Amersham Imaging May 2002 - May 2004
Nycomed Imaging June 1999 - May 2002
Mallinckrodt June 1996 - June 1999
FDA 1995 - 1999
Skills
Oncology, Clinical Trials, Clinical Research, Clinical Development, Pharmaceutical Industry, Cardiology, Medical Devices, Healthcare, Medicine, Medical Affairs, Pain Management, Hardware Diagnostics, FDA, Biotechnology, CRO, Regulatory Submissions, Drug Development, Lifesciences, R&D, Pharmacovigilance, Cancer, Clinical Data Management, Diabetes, Regulatory Affairs, GCP, Medical Imaging, Biostatistics, Clinical Study Design, Protocol, Neurology, CTMS, Medical Writing, Infectious Diseases, Pharmacology, Drug Discovery, Biopharmaceuticals, Therapeutic Areas, Hematology, Immunology, Dermatology, Endocrinology, Vaccines, Internal Medicine, Clinical Pharmacology, EDC, ICH-GCP, Gastroenterology, Neuroscience, Psychiatry, Clinical Monitoring
Education
State University of New York College at Buffalo 1981 — 1985
MD, Medicine
State University of New York at Buffalo 1979 — 1981
course work towards MS, Clinical Science
Canisus College 1975 — 1979
BS, Biology
Biomedical Systems May 2012 - Present
Washington University in St Louis Mallinckrodt Institute Radiology July 1997 - Present
Covidien Pharmaceuticals April 2009 - May 2012
Covidien Healthcare May 2005 - April 2009
GE Healthcare June 2004 - June 2005
Nycomed Amersham Imaging May 2002 - May 2004
Nycomed Imaging June 1999 - May 2002
Mallinckrodt June 1996 - June 1999
FDA 1995 - 1999
Skills
Oncology, Clinical Trials, Clinical Research, Clinical Development, Pharmaceutical Industry, Cardiology, Medical Devices, Healthcare, Medicine, Medical Affairs, Pain Management, Hardware Diagnostics, FDA, Biotechnology, CRO, Regulatory Submissions, Drug Development, Lifesciences, R&D, Pharmacovigilance, Cancer, Clinical Data Management, Diabetes, Regulatory Affairs, GCP, Medical Imaging, Biostatistics, Clinical Study Design, Protocol, Neurology, CTMS, Medical Writing, Infectious Diseases, Pharmacology, Drug Discovery, Biopharmaceuticals, Therapeutic Areas, Hematology, Immunology, Dermatology, Endocrinology, Vaccines, Internal Medicine, Clinical Pharmacology, EDC, ICH-GCP, Gastroenterology, Neuroscience, Psychiatry, Clinical Monitoring
Education
State University of New York College at Buffalo 1981 — 1985
MD, Medicine
State University of New York at Buffalo 1979 — 1981
course work towards MS, Clinical Science
Canisus College 1975 — 1979
BS, Biology
Achal Deo Achal Deo's FDA Experience May 2013 - Present
Job Quality System Manager
Industry Public Safety
Experience
FDA May 2013 - Present
US Food & Drug Administration October 2008 - April 2013
Libby Laboratories June 2008 - September 2008
Skills
Gel Electrophoresis, qPCR, Validation, Laboratory, Quality System, Quality Control, Medical Devices, Environmental..., ISO 17025, Sterility, PFGE, FDA, Quality Assurance, Aseptic Technique, Sop, GMP, Lifesciences, Microscopy, Quality Auditing, Food Safety, DNA, DNA extraction, real-time PCR, Agarose Gel..., Life Sciences, SOP
Education
San Francisco State University 2003 — 2008
Bachelor of Science (B.S.), Microbiology
FDA May 2013 - Present
US Food & Drug Administration October 2008 - April 2013
Libby Laboratories June 2008 - September 2008
Skills
Gel Electrophoresis, qPCR, Validation, Laboratory, Quality System, Quality Control, Medical Devices, Environmental..., ISO 17025, Sterility, PFGE, FDA, Quality Assurance, Aseptic Technique, Sop, GMP, Lifesciences, Microscopy, Quality Auditing, Food Safety, DNA, DNA extraction, real-time PCR, Agarose Gel..., Life Sciences, SOP
Education
San Francisco State University 2003 — 2008
Bachelor of Science (B.S.), Microbiology
Lawrence Sproul Lawrence Sproul's FDA Experience April 2010 - Present
Job Lawrence Sproul is a Quality Manager at FDA
Industry Government Administration
Experience
FDA April 2010 - Present
US Navy August 2006 - March 2010
Multi-National Force West September 2008 - July 2009
USNS COMFORT (T-AH 20) June 2007 - October 2007
FDA August 2005 - August 2006
Navy Environmental and Preventive Medicine Unit Six August 2002 - August 2005
Navy Hospital Sigonella August 1999 - August 2002
San Diego State University September 1998 - June 1999
Naval School of Health Sciences- San Diego Det August 1994 - September 1995
US Navy May 1990 - August 1994
Skills
Food Safety, Environmental Health, Public Health, Sanitation, Risk Assessment, Emergency Management, Policy, Government, Military, Training, Food, Epidemiology, Team Building, Program Management, HACCP, Environmental Awareness, Strategic Planning, Change Management, Disaster Response, Analysis, Microsoft Office, Public Speaking, Leadership Development, Environmental Compliance, Coaching, Process Improvement, Team Leadership, Statistics, Leadership, Security Clearance, SPSS, Management, CBRN, Prevention, Sustainability, Organizational..., Workshop Facilitation, Environmental..., Employee Training, Exercises, Hazardous Waste..., Organizational..., Policy Analysis, Navy, Business Process..., Technical Training, International Health, EHS, Military Experience, Industrial Hygiene
Education
San Diego State University-California State University 1997 — 1999
MPH, Environmental Health
San Diego State University-California State University 1995 — 1997
BS, Environmental Health
Pahrump 1980 — 1984
FDA April 2010 - Present
US Navy August 2006 - March 2010
Multi-National Force West September 2008 - July 2009
USNS COMFORT (T-AH 20) June 2007 - October 2007
FDA August 2005 - August 2006
Navy Environmental and Preventive Medicine Unit Six August 2002 - August 2005
Navy Hospital Sigonella August 1999 - August 2002
San Diego State University September 1998 - June 1999
Naval School of Health Sciences- San Diego Det August 1994 - September 1995
US Navy May 1990 - August 1994
Skills
Food Safety, Environmental Health, Public Health, Sanitation, Risk Assessment, Emergency Management, Policy, Government, Military, Training, Food, Epidemiology, Team Building, Program Management, HACCP, Environmental Awareness, Strategic Planning, Change Management, Disaster Response, Analysis, Microsoft Office, Public Speaking, Leadership Development, Environmental Compliance, Coaching, Process Improvement, Team Leadership, Statistics, Leadership, Security Clearance, SPSS, Management, CBRN, Prevention, Sustainability, Organizational..., Workshop Facilitation, Environmental..., Employee Training, Exercises, Hazardous Waste..., Organizational..., Policy Analysis, Navy, Business Process..., Technical Training, International Health, EHS, Military Experience, Industrial Hygiene
Education
San Diego State University-California State University 1997 — 1999
MPH, Environmental Health
San Diego State University-California State University 1995 — 1997
BS, Environmental Health
Pahrump 1980 — 1984
Lisa Nowell Lisa Nowell's FDA Experience 1988 - 1991
Job Research Chemist at U.S. Geological Survey (USGS)
Industry Research
Experience
U.S. Geological Survey (USGS) 1991 - Present
NorCal SETAC 2013 - 2014
FDA 1988 - 1991
Oekotoxzentrum, Eawag-EPFL - Swiss Centre for Applied Ecotoxicology 1986 - 1987
U.S. Environmental Protection Agency June 1985 - August 1985
Skills
Research, Environmental Science, Science, Water Quality, Toxicology, Ecology, Chemistry, Analytical Chemistry, Environmental Policy, Lifesciences, Aquatic Ecology
Education
University of California, Davis 1979 — 1985
Ph.D., Agricultural and Environmental Chemistry
University of California, Davis 1976 — 1979
M.S., Ecology
Stanford University 1970 — 1974
B.A., Human Biology
U.S. Geological Survey (USGS) 1991 - Present
NorCal SETAC 2013 - 2014
FDA 1988 - 1991
Oekotoxzentrum, Eawag-EPFL - Swiss Centre for Applied Ecotoxicology 1986 - 1987
U.S. Environmental Protection Agency June 1985 - August 1985
Skills
Research, Environmental Science, Science, Water Quality, Toxicology, Ecology, Chemistry, Analytical Chemistry, Environmental Policy, Lifesciences, Aquatic Ecology
Education
University of California, Davis 1979 — 1985
Ph.D., Agricultural and Environmental Chemistry
University of California, Davis 1976 — 1979
M.S., Ecology
Stanford University 1970 — 1974
B.A., Human Biology
Stephen Sundlof Stephen Sundlof's FDA Experience January 2008 - March 2010
Job Senior Vice President of Regulatory Affairs
Industry Food Production
Experience
Kindred Biosciences, Inc. 2013 - Present
EAS Consulting Group, LLC May 2012 - Present
Virgina-Maryland Regional College of Veterinary Medicine May 2010 - May 2012
FDA January 2008 - March 2010
FDA March 1994 - January 2008
Skills
Food Safety, Veterinary Medicine, Supplements, FDA, Epidemiology, Regulatory Affairs, Public Health, Food Microbiology, Toxicology, Microbiology, Food, Environmental Health, Science, Regulations, Lifesciences, Food Science, Biotechnology, GMP, Policy, Infectious Diseases, Food Industry, Government, Public Policy
Education
University of Illinois at Urbana-Champaign 1976 — 1980
D.V.M., Veterinary Medicine
University of Illinois at Urbana-Champaign 1974 — 1980
Ph.D., Toxicology
Southern Illinois University, Carbondale 1969 — 1973
BS, Zoology
Kindred Biosciences, Inc. 2013 - Present
EAS Consulting Group, LLC May 2012 - Present
Virgina-Maryland Regional College of Veterinary Medicine May 2010 - May 2012
FDA January 2008 - March 2010
FDA March 1994 - January 2008
Skills
Food Safety, Veterinary Medicine, Supplements, FDA, Epidemiology, Regulatory Affairs, Public Health, Food Microbiology, Toxicology, Microbiology, Food, Environmental Health, Science, Regulations, Lifesciences, Food Science, Biotechnology, GMP, Policy, Infectious Diseases, Food Industry, Government, Public Policy
Education
University of Illinois at Urbana-Champaign 1976 — 1980
D.V.M., Veterinary Medicine
University of Illinois at Urbana-Champaign 1974 — 1980
Ph.D., Toxicology
Southern Illinois University, Carbondale 1969 — 1973
BS, Zoology
Michele DeMeo Michele DeMeo's FDA Experience 2010 - 2011
Job Autistic, Healthcare Expert, Artist, and ...
Industry Hospital & Health Care
Experience
Concentrate on and for People, Causes, Enities or Programs that require unique solutions: September 2011 - Present
Michele DeMeo - volunteer, consultant, activist... 2014 - Present
Disabled "retired" (over 3000 contacts) October 2011 - Present
m March 2005 - October 2011
FDA 2010 - 2011
Hospital for Special Surgery 2001 - 2005
Holy Name Medical Center 1998 - 2002
Newton Memorial Hospital 1993 - 1998
Chilton Hospital 1990 - 1993
Skills
Healthcare, Hospitals, Leadership, Healthcare Management, Process Improvement, Healthcare Consulting, Patient Safety, Training, Management, Sterilization, Team Building, Coaching, Healthcare Information..., Program Management, Public Speaking, Medicine, Surgery, Product Development, Quality Assurance, Nonprofits, Technical Writing, Infection Control, Creative Writing, Published Author, JCAHO, Creative Problem Solving, Qualitative Research, Feature Articles, Physician Relations, Engineering, Business Coaching, Human Factors Analysis, Systems Thinking, Business Process Mapping, Collaborative Problem..., End of Life, Sterile processing, Social Outreach, Feature Writing, Innovative Thinking, Projects, Vision, Book Writing, Dying, Human Factors Analysis..., Process mapping, Capable of being..., Quality assessment,..., Wide, broad and when..., Strategic Planning
Education
Cornell's ilr college in NYC (course work)
course work, business managerment
Somerset County Technology Institute
Cert, sterile processing
Concentrate on and for People, Causes, Enities or Programs that require unique solutions: September 2011 - Present
Michele DeMeo - volunteer, consultant, activist... 2014 - Present
Disabled "retired" (over 3000 contacts) October 2011 - Present
m March 2005 - October 2011
FDA 2010 - 2011
Hospital for Special Surgery 2001 - 2005
Holy Name Medical Center 1998 - 2002
Newton Memorial Hospital 1993 - 1998
Chilton Hospital 1990 - 1993
Skills
Healthcare, Hospitals, Leadership, Healthcare Management, Process Improvement, Healthcare Consulting, Patient Safety, Training, Management, Sterilization, Team Building, Coaching, Healthcare Information..., Program Management, Public Speaking, Medicine, Surgery, Product Development, Quality Assurance, Nonprofits, Technical Writing, Infection Control, Creative Writing, Published Author, JCAHO, Creative Problem Solving, Qualitative Research, Feature Articles, Physician Relations, Engineering, Business Coaching, Human Factors Analysis, Systems Thinking, Business Process Mapping, Collaborative Problem..., End of Life, Sterile processing, Social Outreach, Feature Writing, Innovative Thinking, Projects, Vision, Book Writing, Dying, Human Factors Analysis..., Process mapping, Capable of being..., Quality assessment,..., Wide, broad and when..., Strategic Planning
Education
Cornell's ilr college in NYC (course work)
course work, business managerment
Somerset County Technology Institute
Cert, sterile processing
Nozomi Sakakibara Nozomi Sakakibara's FDA Experience November 2014 - Present
Job Research reviewer at FDA
Industry Research
Experience
FDA November 2014 - Present
NCI-FDA October 2012 - November 2014
NIH Research March 2009 - October 2012
University of Maryland August 2003 - February 2009
Skills
Biochemistry, HPV, Confocal Microscopy, Protein Expression, Protein-protein..., Protein Assays, Cell Culture, Primary Cell Isolation
Education
University of Maryland College Park 2003 — 2009
Doctor of Philosophy (Ph.D.), Biochemistry
St. Olaf College 1996 — 2000
Bachelor of Arts (BA), Chemistry
FDA November 2014 - Present
NCI-FDA October 2012 - November 2014
NIH Research March 2009 - October 2012
University of Maryland August 2003 - February 2009
Skills
Biochemistry, HPV, Confocal Microscopy, Protein Expression, Protein-protein..., Protein Assays, Cell Culture, Primary Cell Isolation
Education
University of Maryland College Park 2003 — 2009
Doctor of Philosophy (Ph.D.), Biochemistry
St. Olaf College 1996 — 2000
Bachelor of Arts (BA), Chemistry
Karolina Kosakowska's FDA Experience May 2013 - August 2013
Job Bioinnovation IGERT Fellow at Tulane University
Industry Research
Experience
Tulane University September 2012 - Present
FDA May 2013 - August 2013
Eutropics Pharmaceuticals June 2011 - September 2011
ABA Hospital 2010 - 2010
Biogen Idec 2010 - 2010
Smith College Chemistry Department May 2009 - August 2009
Skills
Synthetic Chemistry, Biochemistry, Analytical Chemistry, Organic Synthesis, IR spectroscopy, ChemDraw, NMR, NMR spectroscopy, Chromatography, UV/Vis, Column Chromatography, ELISA, Science, HPLC, TLC, PCR, Organic Chemistry, Molecular Biology, Protein Purification, Drug Discovery, Chemistry, MALDI-TOF, GPC, Cancer Research, Cancer, Medicinal Chemistry, Biotechnology, Microscopy
Education
Tulane University 2012 — 2017
Bioinnovation
Smith College 2007 — 2011
BA, Chemistry/Physics
Tulane University September 2012 - Present
FDA May 2013 - August 2013
Eutropics Pharmaceuticals June 2011 - September 2011
ABA Hospital 2010 - 2010
Biogen Idec 2010 - 2010
Smith College Chemistry Department May 2009 - August 2009
Skills
Synthetic Chemistry, Biochemistry, Analytical Chemistry, Organic Synthesis, IR spectroscopy, ChemDraw, NMR, NMR spectroscopy, Chromatography, UV/Vis, Column Chromatography, ELISA, Science, HPLC, TLC, PCR, Organic Chemistry, Molecular Biology, Protein Purification, Drug Discovery, Chemistry, MALDI-TOF, GPC, Cancer Research, Cancer, Medicinal Chemistry, Biotechnology, Microscopy
Education
Tulane University 2012 — 2017
Bioinnovation
Smith College 2007 — 2011
BA, Chemistry/Physics
Janet Higgins Janet Higgins's FDA Experience May 1994 - October 1998
Job Real Estate Agent/Advisor
Industry Real Estate
Experience
REMAX Premier December 2008 - Present
Coldwell Banker Residential Brokerage February 2003 - December 2008
FDA May 1994 - October 1998
Education
Southern Methodist University 1986 — 1991
BS, BM, Chemistry, Violin Performance
REMAX Premier December 2008 - Present
Coldwell Banker Residential Brokerage February 2003 - December 2008
FDA May 1994 - October 1998
Education
Southern Methodist University 1986 — 1991
BS, BM, Chemistry, Violin Performance
Jason Graff's FDA Experience January 2002 - October 2004
Job The Computer Ox, President
Industry Information Technology and Services
Experience
The Computer Ox August 2013 - Present
Tampa Bay Technology Group August 2008 - Present
Tech Data October 2006 - September 2014
Tech Data October 2009 - May 2010
Tech Data October 2008 - October 2009
Tech Data October 2006 - October 2008
First American Title January 2005 - December 2006
FDA January 2002 - October 2004
Renaissance Cruises, Inc. December 1998 - December 2000
Hewlett-Packard December 1997 - November 1999
Skills
Servers, Disaster Recovery, Troubleshooting, Network Security, Hardware, Networking, Management, Project Management, Leadership, Team Management, Sales, Channel, Technical Support, Marketing Strategy, HP, Sales Operations, Business Planning, Pre-sales, Cloud Computing, Quality Assurance, Virtualization, Channel Partners, Information Technology, Data Center, Enterprise Software, Solution Selling, Account Management, CRM, Direct Sales, Integration, Managed Services, Outsourcing, Product Management, Product Marketing, Professional Services, SaaS, Sales Process, Selling, Storage, Strategic Partnerships, Testing, Vendor Management, Salesforce.com
Education
St. Petersburg College 2006 — 2009
BAS, Management and Organizational Leadership (Entrepreneurial)
Microsoft Certified Information Technology Professional: Enterprise Administrator 2008 — 2008
MCITP, Microsoft Certified Information Technology Professional
VMWare Sales Professional 2008 — 2008
VSP, VMWare Sales Professional
The Computer Ox August 2013 - Present
Tampa Bay Technology Group August 2008 - Present
Tech Data October 2006 - September 2014
Tech Data October 2009 - May 2010
Tech Data October 2008 - October 2009
Tech Data October 2006 - October 2008
First American Title January 2005 - December 2006
FDA January 2002 - October 2004
Renaissance Cruises, Inc. December 1998 - December 2000
Hewlett-Packard December 1997 - November 1999
Skills
Servers, Disaster Recovery, Troubleshooting, Network Security, Hardware, Networking, Management, Project Management, Leadership, Team Management, Sales, Channel, Technical Support, Marketing Strategy, HP, Sales Operations, Business Planning, Pre-sales, Cloud Computing, Quality Assurance, Virtualization, Channel Partners, Information Technology, Data Center, Enterprise Software, Solution Selling, Account Management, CRM, Direct Sales, Integration, Managed Services, Outsourcing, Product Management, Product Marketing, Professional Services, SaaS, Sales Process, Selling, Storage, Strategic Partnerships, Testing, Vendor Management, Salesforce.com
Education
St. Petersburg College 2006 — 2009
BAS, Management and Organizational Leadership (Entrepreneurial)
Microsoft Certified Information Technology Professional: Enterprise Administrator 2008 — 2008
MCITP, Microsoft Certified Information Technology Professional
VMWare Sales Professional 2008 — 2008
VSP, VMWare Sales Professional
Sean Hanlon, CISSP Sean Hanlon, CISSP's FDA Experience November 2012 - Present
Job IT Specialist at FDA
Industry Information Technology and Services
Experience
FDA November 2012 - Present
Chickasaw Nation Industries June 2010 - November 2012
MyerEmco Audio Video May 2002 - March 2010
Skills
CISSP, Security, Information Security, Information Technology, Cloud Computing, Information Assurance, Project Management, Compliance, Program Management, Disaster Recovery, Management, Network Security, Training, FedRAMP, Cloud Computing IaaS
Education
Southern Illinois University, Carbondale 1998 — 2002
BA, Administration of Justice - Minor, Business
FDA November 2012 - Present
Chickasaw Nation Industries June 2010 - November 2012
MyerEmco Audio Video May 2002 - March 2010
Skills
CISSP, Security, Information Security, Information Technology, Cloud Computing, Information Assurance, Project Management, Compliance, Program Management, Disaster Recovery, Management, Network Security, Training, FedRAMP, Cloud Computing IaaS
Education
Southern Illinois University, Carbondale 1998 — 2002
BA, Administration of Justice - Minor, Business
Daniel Congdon Daniel Congdon's FDA Experience 2010 - 2011
Job Land Manager and Lab Technician
Industry Government Administration
Experience
Lolo Woods July 2013 - Present
The University of Montana August 2012 - May 2014
FDA 2010 - 2011
Seattle Pacific University September 2008 - June 2010
Skills
Research, Management, Public Speaking, Teaching, Science, Editing, Microsoft Office, PowerPoint, Data Analysis, Community Outreach, Microsoft Excel, Event Planning, Non-profits, Microsoft Word, Public Health, Qualitative Research
Education
The University of Montana 2012 — 2014
Master of Arts (M.A.), Philosophy
Seattle Pacific University 2006 — 2010
BA, Philosophy
Seattle Pacific University 2006 — 2010
BS, Biology
Lolo Woods July 2013 - Present
The University of Montana August 2012 - May 2014
FDA 2010 - 2011
Seattle Pacific University September 2008 - June 2010
Skills
Research, Management, Public Speaking, Teaching, Science, Editing, Microsoft Office, PowerPoint, Data Analysis, Community Outreach, Microsoft Excel, Event Planning, Non-profits, Microsoft Word, Public Health, Qualitative Research
Education
The University of Montana 2012 — 2014
Master of Arts (M.A.), Philosophy
Seattle Pacific University 2006 — 2010
BA, Philosophy
Seattle Pacific University 2006 — 2010
BS, Biology
Thomas C. Radman Thomas C. Radman's FDA Experience August 2010 - July 2012
Job Health Science Administrator at National Institutes of Health
Industry Research
Experience
National Institutes of Health June 2014 - Present
Brainscope Company Inc. July 2012 - June 2014
FDA August 2010 - July 2012
City University of New York September 2009 - June 2011
NYU Medical Center July 2009 - July 2010
The City College of New York September 2005 - 2009
City University of New York (CUNY 2005 - 2009
Skills
Neuroscience, in Vivo..., Electrophysiology, Biomedical Engineering, Patch-clamp, Regulatory Affairs, Regulatory Submissions, Matlab, Visual Basic, Electrical Stimulation, Medical Devices, ISO 14971, 21 CFR, Class III Medical..., ISO 10993, IEC 60601, EMC compliance, Pre-clinical Studies, Performance Testing, Verification, Electromagnetic..., Transcranial Magnetic..., Laboratory, Confocal Microscopy, Labview, Data Analysis, Science, Research, Patents, Teaching, R, Signal Processing, PowerPoint, Image Analysis, Machine Learning, Molecular Biology, Microscopy, Biomaterials, Fluorescence Microscopy, Nanotechnology, Lifesciences, Experimentation, Hardware Diagnostics, Cell Culture, Neuroimaging, Medical Imaging, Mathematical Modeling, Pattern Recognition, Image Processing, Statistics
Education
The Graduate Center, City University of New York 2005 — 2010
PhD, Neurobiology/Biomedical Engineering
Stony Brook University 1998 — 2001
BE, Computer Engineering
Stanford University
Short Course Certificate, Stanford University Statistical Learning and Data Mining III
National Institutes of Health June 2014 - Present
Brainscope Company Inc. July 2012 - June 2014
FDA August 2010 - July 2012
City University of New York September 2009 - June 2011
NYU Medical Center July 2009 - July 2010
The City College of New York September 2005 - 2009
City University of New York (CUNY 2005 - 2009
Skills
Neuroscience, in Vivo..., Electrophysiology, Biomedical Engineering, Patch-clamp, Regulatory Affairs, Regulatory Submissions, Matlab, Visual Basic, Electrical Stimulation, Medical Devices, ISO 14971, 21 CFR, Class III Medical..., ISO 10993, IEC 60601, EMC compliance, Pre-clinical Studies, Performance Testing, Verification, Electromagnetic..., Transcranial Magnetic..., Laboratory, Confocal Microscopy, Labview, Data Analysis, Science, Research, Patents, Teaching, R, Signal Processing, PowerPoint, Image Analysis, Machine Learning, Molecular Biology, Microscopy, Biomaterials, Fluorescence Microscopy, Nanotechnology, Lifesciences, Experimentation, Hardware Diagnostics, Cell Culture, Neuroimaging, Medical Imaging, Mathematical Modeling, Pattern Recognition, Image Processing, Statistics
Education
The Graduate Center, City University of New York 2005 — 2010
PhD, Neurobiology/Biomedical Engineering
Stony Brook University 1998 — 2001
BE, Computer Engineering
Stanford University
Short Course Certificate, Stanford University Statistical Learning and Data Mining III
Joseph Famulare Joseph Famulare's FDA Experience January 2006 - September 2009
Job Vice Chair,International Board of Directors at ISPE
Industry Biotechnology
Experience
ISPE November 2014 - Present
Genentech January 2012 - Present
Genentech October 2009 - January 2012
FDA January 2006 - September 2009
Skills
Pharmaceutical Industry, GMP, SOP, Technology Transfer, Biotechnology, CAPA, Validation, FDA, 21 CFR Part 11, Regulatory Affairs, Cell Culture, Regulatory Submissions, Life Sciences, Clinical Trials, Change Control, Lifesciences, Clinical Development, Molecular Biology, Oncology, Microsoft Excel, Management, Biopharmaceuticals, Quality System
Education
St. John's University 1972 — 1976
Bachelor’s Degree, Biology, General, Enviornmental Studies
Bishop Edmund J Reilly High School, Fresh Meadows, NY
ISPE November 2014 - Present
Genentech January 2012 - Present
Genentech October 2009 - January 2012
FDA January 2006 - September 2009
Skills
Pharmaceutical Industry, GMP, SOP, Technology Transfer, Biotechnology, CAPA, Validation, FDA, 21 CFR Part 11, Regulatory Affairs, Cell Culture, Regulatory Submissions, Life Sciences, Clinical Trials, Change Control, Lifesciences, Clinical Development, Molecular Biology, Oncology, Microsoft Excel, Management, Biopharmaceuticals, Quality System
Education
St. John's University 1972 — 1976
Bachelor’s Degree, Biology, General, Enviornmental Studies
Bishop Edmund J Reilly High School, Fresh Meadows, NY
Nikita M. Floore's FDA Experience August 2015 - Present
Job Regulatory Counsel at FDA
Industry Legal Services
Experience
FDA August 2015 - Present
U.S. Department of Justice 2014 - 2015
National Association of the Deaf January 2014 - December 2014
OutServe May 2013 - July 2013
U.S. Department of Veterans Affairs 2006 - 2012
State of Tennessee 2004 - 2005
Youth Villages 2003 - 2004
US Army 1995 - 1998
Education
University of Maryland Francis King Carey School of Law
Juris Doctor (J.D.), Certificate in Health Law
Oriel STAT A MATRIX Training and Consulting
Lean Practitioners for Healthcare Training Course
Southern Illinois University, Carbondale
Master of Science (M.S.), Rehabilitation Counseling
Southern Illinois University, Carbondale
Bachelor of Arts (B.A.), English, cum laude
FDA August 2015 - Present
U.S. Department of Justice 2014 - 2015
National Association of the Deaf January 2014 - December 2014
OutServe May 2013 - July 2013
U.S. Department of Veterans Affairs 2006 - 2012
State of Tennessee 2004 - 2005
Youth Villages 2003 - 2004
US Army 1995 - 1998
Education
University of Maryland Francis King Carey School of Law
Juris Doctor (J.D.), Certificate in Health Law
Oriel STAT A MATRIX Training and Consulting
Lean Practitioners for Healthcare Training Course
Southern Illinois University, Carbondale
Master of Science (M.S.), Rehabilitation Counseling
Southern Illinois University, Carbondale
Bachelor of Arts (B.A.), English, cum laude
Malcolm Moos Malcolm Moos's FDA Experience November 1986 - Present
Job Senior Investigator at FDA
Industry Biotechnology
Experience
FDA November 1986 - Present
Skills
Life Sciences, Research, Molecular Biology, Biotechnology, Biochemistry, Pharmaceutical Industry, Microsoft Office, Cell Culture, Data Analysis, Policy, Cell Therapy CMC
Education
University of Minnesota-Twin Cities 1974 — 1985
Doctor of Philosophy (PhD), Pharmacology
University of Minnesota-Twin Cities 1974 — 1982
Doctor of Medicine (MD)
Stanford University 1970 — 1974
Bachelor of Science (BS), Biology, General
FDA November 1986 - Present
Skills
Life Sciences, Research, Molecular Biology, Biotechnology, Biochemistry, Pharmaceutical Industry, Microsoft Office, Cell Culture, Data Analysis, Policy, Cell Therapy CMC
Education
University of Minnesota-Twin Cities 1974 — 1985
Doctor of Philosophy (PhD), Pharmacology
University of Minnesota-Twin Cities 1974 — 1982
Doctor of Medicine (MD)
Stanford University 1970 — 1974
Bachelor of Science (BS), Biology, General
Barbara Rusin's FDA Experience November 2007 - Present
Job Investigator (FDA)
Industry Government Administration
Experience
FDA November 2007 - Present
ProMedica June 2007 - November 2007
Wayne State University June 2006 - June 2007
Wayne State University June 2005 - June 2006
Wayne State University March 2001 - June 2005
Wayne State University March 2000 - January 2001
Wayne State University May 1999 - March 2000
Harper Hospital January 1999 - May 1999
Skills
Regulatory Affairs, FDA, Regulatory Submissions, Regulatory Requirements, Source Plasma, Blood Banking, Hematology, Human Tissues, Code of Federal..., Clinical Trials, Clinical Research, Oncology Clinical..., Epidemiology, Cancer Biology, Cancer Cell Biology, Cancer Research, Cell Biology, Cell Signaling, Mammalian Cell Culture, insect cell culture, Protein Chemistry, Protein Purification, Tissue Culture, Clinical Monitoring, Human Investigation..., Protein Trafficking, Pharmacology, Bioequivalence, Pre-clinical Studies
Education
Wayne State University 1991 — 1998
Master of Science (M.S.), Oncology and Cancer Biology
Siena Heights University 1987 — 1991
Bachelor of Science (B.S.), Biology, General, summa cum laude
FDA November 2007 - Present
ProMedica June 2007 - November 2007
Wayne State University June 2006 - June 2007
Wayne State University June 2005 - June 2006
Wayne State University March 2001 - June 2005
Wayne State University March 2000 - January 2001
Wayne State University May 1999 - March 2000
Harper Hospital January 1999 - May 1999
Skills
Regulatory Affairs, FDA, Regulatory Submissions, Regulatory Requirements, Source Plasma, Blood Banking, Hematology, Human Tissues, Code of Federal..., Clinical Trials, Clinical Research, Oncology Clinical..., Epidemiology, Cancer Biology, Cancer Cell Biology, Cancer Research, Cell Biology, Cell Signaling, Mammalian Cell Culture, insect cell culture, Protein Chemistry, Protein Purification, Tissue Culture, Clinical Monitoring, Human Investigation..., Protein Trafficking, Pharmacology, Bioequivalence, Pre-clinical Studies
Education
Wayne State University 1991 — 1998
Master of Science (M.S.), Oncology and Cancer Biology
Siena Heights University 1987 — 1991
Bachelor of Science (B.S.), Biology, General, summa cum laude
Jennifer (Evans) Cahill, M.S. Jennifer (Evans) Cahill, M.S.'s FDA Experience October 2007 - June 2009
Job Molecular Genetic EngineerParalegalPharma Mfg ComplianceFDA Gov. SafetyLaw/ChemistryCom Instrument Helicopter Pilot
Industry Consumer Services
Experience
Ravn Alaska September 2015 - Present
Million Air-Anchorage FBO-Era Helicopters September 2013 - December 2014
Social Security Administration Office of Disability Adjudication and Review September 2011 - May 2012
US Fish and Wildlife Service June 2009 - March 2010
FDA October 2007 - June 2009
Southern Illinois School of Dental Medicine August 2006 - September 2007
Southern Illinois University Edwardsville March 2005 - June 2006
US Army May 1987 - February 1994
63rd MEDEVAC Lanstuhl Germany February 1985 - March 1986
Skills
Research, Quality Assurance, Laboratory, Aviation Regulations, Military Aviation, Instrument Rating, Aviation Law, Flight Dispatch, FAA Licensed Pilot, Flight Safety, Regulations, Helicopter Operations, Regulatory Affairs, FDA, Microbiology, Food Microbiology, Regulatory Submissions, Drug Development, Regulatory Requirements, Public Health, ELISA, Infectious Diseases, Statistical Analysis..., Quality Management, Disability Law, Veterans Law, Jurisdiction, Molecular Genetics, Gene Targeting, Genetic Engineering, Protein Engineering, Protein Design, Molecular Design, General Chemistry, Laboratory Safety, Biosafety, Emerging Infectious..., Molecular Virology, recombinant DNA..., Baculovirus, Vector Design, Expression Cloning, PCR primer design, Restriction Mapping, DNA ligation, Plasmid Isolation, Restriction Enzymes, Bradford Assay, DNA quantification, Commercial Aviation
Education
Southern Illinois University, Edwardsville 2005 — 2007
Master's degree, Cellular and Molecular Biology, 3.909
Southern Illinois University, Edwardsville 2001 — 2005
Bachelor of Science (B.S.)/ Minor, Molecular Genetic Engineering/Chemistry
University of Alaska Fairbanks 1998 — 2000
Associate of Arts and Sciences (AAS), Law/Paralegal
University of Alaska Fairbanks 1990 — 1992
Associate of Arts and Sciences (AAS), Aviation/Airway Management and Operations, Deans List
Ravn Alaska September 2015 - Present
Million Air-Anchorage FBO-Era Helicopters September 2013 - December 2014
Social Security Administration Office of Disability Adjudication and Review September 2011 - May 2012
US Fish and Wildlife Service June 2009 - March 2010
FDA October 2007 - June 2009
Southern Illinois School of Dental Medicine August 2006 - September 2007
Southern Illinois University Edwardsville March 2005 - June 2006
US Army May 1987 - February 1994
63rd MEDEVAC Lanstuhl Germany February 1985 - March 1986
Skills
Research, Quality Assurance, Laboratory, Aviation Regulations, Military Aviation, Instrument Rating, Aviation Law, Flight Dispatch, FAA Licensed Pilot, Flight Safety, Regulations, Helicopter Operations, Regulatory Affairs, FDA, Microbiology, Food Microbiology, Regulatory Submissions, Drug Development, Regulatory Requirements, Public Health, ELISA, Infectious Diseases, Statistical Analysis..., Quality Management, Disability Law, Veterans Law, Jurisdiction, Molecular Genetics, Gene Targeting, Genetic Engineering, Protein Engineering, Protein Design, Molecular Design, General Chemistry, Laboratory Safety, Biosafety, Emerging Infectious..., Molecular Virology, recombinant DNA..., Baculovirus, Vector Design, Expression Cloning, PCR primer design, Restriction Mapping, DNA ligation, Plasmid Isolation, Restriction Enzymes, Bradford Assay, DNA quantification, Commercial Aviation
Education
Southern Illinois University, Edwardsville 2005 — 2007
Master's degree, Cellular and Molecular Biology, 3.909
Southern Illinois University, Edwardsville 2001 — 2005
Bachelor of Science (B.S.)/ Minor, Molecular Genetic Engineering/Chemistry
University of Alaska Fairbanks 1998 — 2000
Associate of Arts and Sciences (AAS), Law/Paralegal
University of Alaska Fairbanks 1990 — 1992
Associate of Arts and Sciences (AAS), Aviation/Airway Management and Operations, Deans List
Peiling Chen Peiling Chen's FDA Experience August 2012 - May 2013
Job Optometry student at Salus University
Industry Hospital & Health Care
Experience
Appelbaum Eyecare Associates August 2011 - September 2013
FDA August 2012 - May 2013
Education
Salus University 2014 — 2018
Doctor of Optometry
University of Maryland 2009 — 2013
Bachelor of Science (BS), Biology, General
Appelbaum Eyecare Associates August 2011 - September 2013
FDA August 2012 - May 2013
Education
Salus University 2014 — 2018
Doctor of Optometry
University of Maryland 2009 — 2013
Bachelor of Science (BS), Biology, General
Chandni Vadgama Chandni Vadgama's FDA Experience August 2014 - December 2014
Job Quality Assurance Technician at PEACOCK ENGINEERING COMPANY, LLC
Industry Food Production
Experience
PEACOCK ENGINEERING COMPANY, LLC September 2015 - Present
IIT Institute for Food Safety and Health ( IFSH ) July 2015 - Present
IIT Institute for Food Safety and Health ( IFSH ) March 2015 - Present
Illinois Institute of Technology October 2013 - May 2015
FDA August 2014 - December 2014
ARIBAS July 2012 - December 2012
Claris Lifesciences, Ahmedabad March 2010 - August 2010
Skills
SDS-PAGE, Western Blotting, Molecular Biology, PCR, Biotechnology, Lifesciences, Cell Biology, Cell Culture, DNA, Electrophoresis, Protein Purification, Gel Electrophoresis, Biochemistry, ELISA, Plant Tissue Culture, Microscopy, Tissue Culture, HPLC, Transfection, Protein Expression, Bioinformatics, Molecular Cloning, Genetics, Genetic Engineering, Assay Development, Immunology, Immunofluorescence, Sop, Protein Engineering, Mutagenesis, Structural..., Biopharmaceuticals, UV/Vis, Cell, Genomics, DNA sequencing, recombinant DNA..., Fluorescence Microscopy, Bacterial Transformation, Antibodies, Monoclonal Antibodies, Enzyme Assays, Affinity Chromatography, Primer Design, DNA Extraction, DNA Sequencing, Recombinant DNA, Life Sciences, SOP, Microbiology
Education
Illinois Institute of Technology 2013 — 2015
Master's Degree, Food Process Engineering
Sardar Patel University 2007 — 2012
Master of Science (MSc), Biotechnology (Industrial Biotechnology), First Class with Distinction
PEACOCK ENGINEERING COMPANY, LLC September 2015 - Present
IIT Institute for Food Safety and Health ( IFSH ) July 2015 - Present
IIT Institute for Food Safety and Health ( IFSH ) March 2015 - Present
Illinois Institute of Technology October 2013 - May 2015
FDA August 2014 - December 2014
ARIBAS July 2012 - December 2012
Claris Lifesciences, Ahmedabad March 2010 - August 2010
Skills
SDS-PAGE, Western Blotting, Molecular Biology, PCR, Biotechnology, Lifesciences, Cell Biology, Cell Culture, DNA, Electrophoresis, Protein Purification, Gel Electrophoresis, Biochemistry, ELISA, Plant Tissue Culture, Microscopy, Tissue Culture, HPLC, Transfection, Protein Expression, Bioinformatics, Molecular Cloning, Genetics, Genetic Engineering, Assay Development, Immunology, Immunofluorescence, Sop, Protein Engineering, Mutagenesis, Structural..., Biopharmaceuticals, UV/Vis, Cell, Genomics, DNA sequencing, recombinant DNA..., Fluorescence Microscopy, Bacterial Transformation, Antibodies, Monoclonal Antibodies, Enzyme Assays, Affinity Chromatography, Primer Design, DNA Extraction, DNA Sequencing, Recombinant DNA, Life Sciences, SOP, Microbiology
Education
Illinois Institute of Technology 2013 — 2015
Master's Degree, Food Process Engineering
Sardar Patel University 2007 — 2012
Master of Science (MSc), Biotechnology (Industrial Biotechnology), First Class with Distinction
Adam Piotrowski's FDA Experience September 2006 - March 2007
Job Head of Innovation and Product Development at Orthology Inc
Industry Health, Wellness and Fitness
Experience
Orthology Inc August 2015 - Present
IntelliDrain, Inc March 2014 - August 2015
Innoblative August 2013 - March 2015
Northwestern University April 2013 - September 2014
Slipstream Health February 2012 - February 2014
Stryker January 2011 - February 2012
CreateBigIdeas May 2010 - December 2010
Fjord Ventures portfolio company - Sonendo October 2007 - May 2010
InSound Medical June 2005 - October 2007
FDA September 2006 - March 2007
Skills
Medical Devices, Business Development, Acquisitions, Venture Capital, Business Strategy, Product Development, FDA, Biomedical Engineering, Marketing, Materials Science, Healthcare Economics, Lifesciences, Entrepreneurship, Quality Assurance, Process Engineering, Clinical Trials, Design of Experiments, ISO 13485, Design Control, Quality System, Start-ups, V&V, Life Sciences, New Product Development, Revenue Modeling, Start-up Formation, New Venture Development, Healthcare Industry, Healthcare Consulting, Surgery, Empathic Design, Entrepreneurial Finance, Advanced Materials, Forecasting, Sales&Marketing, Technical Advisory, Manufacturing Start-Up, Manufacturing Operations, Patent Applications, Patentability Searches, Freedom to Operate, Clinical Strategy, Regulatory Strategy..., Licensing and..., Lean Startup, R&D, Manufacturing, Product Management, Validation, Health Economics
Education
Stanford University 2005 — 2007
Master of Science (MS), Materials Science & Engineering
Stanford University 2000 — 2004
Bachelor of Science (BS), Materials Science
Orthology Inc August 2015 - Present
IntelliDrain, Inc March 2014 - August 2015
Innoblative August 2013 - March 2015
Northwestern University April 2013 - September 2014
Slipstream Health February 2012 - February 2014
Stryker January 2011 - February 2012
CreateBigIdeas May 2010 - December 2010
Fjord Ventures portfolio company - Sonendo October 2007 - May 2010
InSound Medical June 2005 - October 2007
FDA September 2006 - March 2007
Skills
Medical Devices, Business Development, Acquisitions, Venture Capital, Business Strategy, Product Development, FDA, Biomedical Engineering, Marketing, Materials Science, Healthcare Economics, Lifesciences, Entrepreneurship, Quality Assurance, Process Engineering, Clinical Trials, Design of Experiments, ISO 13485, Design Control, Quality System, Start-ups, V&V, Life Sciences, New Product Development, Revenue Modeling, Start-up Formation, New Venture Development, Healthcare Industry, Healthcare Consulting, Surgery, Empathic Design, Entrepreneurial Finance, Advanced Materials, Forecasting, Sales&Marketing, Technical Advisory, Manufacturing Start-Up, Manufacturing Operations, Patent Applications, Patentability Searches, Freedom to Operate, Clinical Strategy, Regulatory Strategy..., Licensing and..., Lean Startup, R&D, Manufacturing, Product Management, Validation, Health Economics
Education
Stanford University 2005 — 2007
Master of Science (MS), Materials Science & Engineering
Stanford University 2000 — 2004
Bachelor of Science (BS), Materials Science
Jennifer Sparrow's FDA Experience 1990 - 1995
Job Senior Director Quality Systems & Compliance at Ortho Clinical Diagnostics
Industry Medical Devices
Experience
Ortho Clinical Diagnostics May 2012 - Present
Ortho Clinical Diagnostics January 2011 - June 2012
Ortho Clinical Diagnostics November 2006 - January 2011
Johnson & Johnson 2004 - 2006
Javic Compliance Consulting LLC 1999 - 2004
Cordis 1997 - 1999
LabCorp 1994 - 1997
FDA 1990 - 1995
Skills
Medical Devices, FDA, Healthcare, Change Control, GMP, Quality System, Design Control, Pharmaceutical Industry, ISO 13485, CAPA, Quality Assurance, V&V
Education
St. Francis University 1986 — 1990
Bachlor of Science, Biology
Ortho Clinical Diagnostics May 2012 - Present
Ortho Clinical Diagnostics January 2011 - June 2012
Ortho Clinical Diagnostics November 2006 - January 2011
Johnson & Johnson 2004 - 2006
Javic Compliance Consulting LLC 1999 - 2004
Cordis 1997 - 1999
LabCorp 1994 - 1997
FDA 1990 - 1995
Skills
Medical Devices, FDA, Healthcare, Change Control, GMP, Quality System, Design Control, Pharmaceutical Industry, ISO 13485, CAPA, Quality Assurance, V&V
Education
St. Francis University 1986 — 1990
Bachlor of Science, Biology
Santina Johnson Santina Johnson's FDA Experience May 2015 - Present
Job Research Assistant at FDA GCSL
Industry Research
Experience
FDA May 2015 - Present
Spring Hill College August 2013 - Present
Spring Hill College August 2012 - Present
Spring Hill College January 2012 - Present
Boston University May 2014 - August 2014
Xavier University of Louisiana May 2013 - August 2013
Skills
Microsoft Office, Public Speaking, Research, PowerPoint, Event Planning, Microsoft Word, Community Outreach, Teaching, Fundraising, Student Affairs, Tutoring, Time Management, Social Media, Microsoft Excel, Customer Service, Facebook, Data Analysis, Teamwork, Chemistry
Education
Spring Hill College 2011 — 2015
Bachelor of Science (B.S.), Biochemistry
Alabama School of Mathematics and Science 2009 — 2011
Mathematics
FDA May 2015 - Present
Spring Hill College August 2013 - Present
Spring Hill College August 2012 - Present
Spring Hill College January 2012 - Present
Boston University May 2014 - August 2014
Xavier University of Louisiana May 2013 - August 2013
Skills
Microsoft Office, Public Speaking, Research, PowerPoint, Event Planning, Microsoft Word, Community Outreach, Teaching, Fundraising, Student Affairs, Tutoring, Time Management, Social Media, Microsoft Excel, Customer Service, Facebook, Data Analysis, Teamwork, Chemistry
Education
Spring Hill College 2011 — 2015
Bachelor of Science (B.S.), Biochemistry
Alabama School of Mathematics and Science 2009 — 2011
Mathematics
Youwei Bi Youwei Bi's FDA Experience May 2015 - Present
Job ORISE Fellow
Industry Pharmaceuticals
Experience
FDA May 2015 - Present
University of Iowa September 2011 - Present
Shanghai Second Military Medical University February 2011 - June 2011
Covance Pharmaceutical R&D Co.Ltd July 2010 - August 2010
Hutchison MediPharma Limited July 2009 - August 2009
Skills
Pharmacokinetics, Pharmacodynamics, Clinical Pharmacology, Biostatistics, NONMEM, ADAPT5, R, SAS, Pirana, Pdx-POP, LC-MS
Education
University of Iowa 2011 — 2016
Doctor of Philosophy (Ph.D.), Clinical Pharmaceutical Sciences, 4.04/4.00
University of Iowa 2014 — 2015
Master's Degree, Biostatistics, 4.05/4.00
Shanghai Jiao Tong University 2007 — 2011
BS, Pharmacy, 3.58/4.00
FDA May 2015 - Present
University of Iowa September 2011 - Present
Shanghai Second Military Medical University February 2011 - June 2011
Covance Pharmaceutical R&D Co.Ltd July 2010 - August 2010
Hutchison MediPharma Limited July 2009 - August 2009
Skills
Pharmacokinetics, Pharmacodynamics, Clinical Pharmacology, Biostatistics, NONMEM, ADAPT5, R, SAS, Pirana, Pdx-POP, LC-MS
Education
University of Iowa 2011 — 2016
Doctor of Philosophy (Ph.D.), Clinical Pharmaceutical Sciences, 4.04/4.00
University of Iowa 2014 — 2015
Master's Degree, Biostatistics, 4.05/4.00
Shanghai Jiao Tong University 2007 — 2011
BS, Pharmacy, 3.58/4.00
Jonathan Mathieu Jonathan Mathieu's FDA Experience July 2001 - April 2010
Job Vice President for Research & Compliance and Chief Economist
Industry Nonprofit Organization Management
Experience
CIVHC Center for Improving Value in Health Care January 2012 - Present
The Nature Conservancy April 2010 - December 2011
FDA July 2001 - April 2010
Georgetown Public Policy Institute, Georgetown University January 1999 - June 2006
Skills
Research, SAS, Teaching, Environmental Economics, Policy Analysis, Program Evaluation, Nonprofits, Public Health, Policy, Strategic Planning, Grant Writing, Grants, Community Outreach, Statistics, Data Analysis, Healthcare, Economics, Public Speaking, Health Policy, Strategic Communications, Public Policy
Education
University of Colorado at Boulder 1992 — 1999
Ph.D., Economics
SUNY Oswego 1985 — 1987
BS, Applied Mathematical Economics
CIVHC Center for Improving Value in Health Care January 2012 - Present
The Nature Conservancy April 2010 - December 2011
FDA July 2001 - April 2010
Georgetown Public Policy Institute, Georgetown University January 1999 - June 2006
Skills
Research, SAS, Teaching, Environmental Economics, Policy Analysis, Program Evaluation, Nonprofits, Public Health, Policy, Strategic Planning, Grant Writing, Grants, Community Outreach, Statistics, Data Analysis, Healthcare, Economics, Public Speaking, Health Policy, Strategic Communications, Public Policy
Education
University of Colorado at Boulder 1992 — 1999
Ph.D., Economics
SUNY Oswego 1985 — 1987
BS, Applied Mathematical Economics
Minh-Ha Tran Minh-Ha Tran's FDA Experience March 2008 - June 2009
Job Associate Medical Director, Transfusion Medicine Service at UC Irvine Medical Center
Industry Hospital & Health Care
Experience
UC Irvine Medical Center July 2009 - Present
FDA March 2008 - June 2009
The Institute for Transfusion Medicine August 2006 - February 2008
National Institutes of Health July 2004 - June 2006
UPMC Mercy July 2001 - June 2004
St. John Medical Center July 2000 - June 2001
Skills
Strategy, Transfusion Medicine, Hemostasis/Thrombosis, Immunohematology, Healthcare, Leadership, Medicine, Infectious Diseases, Informatics, Clinical Research, FDA, Hematology, Laboratory Medicine, Laboratory, Pathology, Medical Education, Hospitals, Internal Medicine, Cancer, Physicians
Education
Western University of Health Sciences 1996 — 2000
Doctor of Osteopathy (DO)
San Diego State University-California State University 1991 — 1996
Bachelor of Science, Biology, General
UC Irvine Medical Center July 2009 - Present
FDA March 2008 - June 2009
The Institute for Transfusion Medicine August 2006 - February 2008
National Institutes of Health July 2004 - June 2006
UPMC Mercy July 2001 - June 2004
St. John Medical Center July 2000 - June 2001
Skills
Strategy, Transfusion Medicine, Hemostasis/Thrombosis, Immunohematology, Healthcare, Leadership, Medicine, Infectious Diseases, Informatics, Clinical Research, FDA, Hematology, Laboratory Medicine, Laboratory, Pathology, Medical Education, Hospitals, Internal Medicine, Cancer, Physicians
Education
Western University of Health Sciences 1996 — 2000
Doctor of Osteopathy (DO)
San Diego State University-California State University 1991 — 1996
Bachelor of Science, Biology, General
Tawanda Smith Tawanda Smith's FDA Experience 2003 - 2005
Job Founder & CEO
Industry Management Consulting
Experience
Intelligent Fiscal Optimal Solutions, LLC 2008 - Present
IBM 2006 - 2007
FDA 2003 - 2005
USDA 2001 - 2003
U.S. Department of Education 2000 - 2002
Skills
Entrepreneurship, Public Sector Financial..., Program Management, Project Management, Forensic Accounting, Financial Accounting, Organizational..., Financial Advisory, Acquisitions, Government Procurement, Small Business Tax, Corporate Social...
Education
Southeastern University 1995 — 1997
Master of Business Administration (M.B.A.), Accounting
University of Maryland College Park 1991 — 1994
Bachelor of Science (B.S.), Public Finance
Intelligent Fiscal Optimal Solutions, LLC 2008 - Present
IBM 2006 - 2007
FDA 2003 - 2005
USDA 2001 - 2003
U.S. Department of Education 2000 - 2002
Skills
Entrepreneurship, Public Sector Financial..., Program Management, Project Management, Forensic Accounting, Financial Accounting, Organizational..., Financial Advisory, Acquisitions, Government Procurement, Small Business Tax, Corporate Social...
Education
Southeastern University 1995 — 1997
Master of Business Administration (M.B.A.), Accounting
University of Maryland College Park 1991 — 1994
Bachelor of Science (B.S.), Public Finance
Michelle Devlin's FDA Experience April 2015 - Present
Job Administrative Assistant at FDA
Industry Mental Health Care
Experience
FDA April 2015 - Present
Nordstrom May 2012 - April 2015
Links Global USA June 2014 - September 2014
Bailey Library August 2010 - May 2014
Skills
Health Communication, Mental Health, Addictive Disorders, Program Development, SPSS, Customer Service, Facebook, Mental Health Counseling, Addiction Recovery, Biostatistics, Microbiology, Counseling Psychology, Photography, Designs, Minitab, Press Releases, Social Media, Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel
Education
Slippery Rock University of Pennsylvania 2010 — 2014
Bachelor of Science (B.S.), Public Health and Psychology
Col. Zadok Magruder High School 2006 — 2010
Early Childhood Education and Teaching
FDA April 2015 - Present
Nordstrom May 2012 - April 2015
Links Global USA June 2014 - September 2014
Bailey Library August 2010 - May 2014
Skills
Health Communication, Mental Health, Addictive Disorders, Program Development, SPSS, Customer Service, Facebook, Mental Health Counseling, Addiction Recovery, Biostatistics, Microbiology, Counseling Psychology, Photography, Designs, Minitab, Press Releases, Social Media, Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel
Education
Slippery Rock University of Pennsylvania 2010 — 2014
Bachelor of Science (B.S.), Public Health and Psychology
Col. Zadok Magruder High School 2006 — 2010
Early Childhood Education and Teaching
Sheila Amara Onyiah Sheila Amara Onyiah's FDA Experience July 2011 - September 2011
Job R&D Test Engineer at Stryker
Industry Mechanical or Industrial Engineering
Experience
Stryker June 2014 - Present
Stanford University April 2012 - 2014
Department of Orthopedics, Stanford School of Medicine January 2010 - June 2013
Stryker June 2012 - August 2012
FDA July 2011 - September 2011
Vaden Health Center September 2010 - June 2011
Global Healthcare Project August 2009 - September 2009
Skills
Tissue Engineering, Medical Device R&D, Biomaterials, Cell Culture, Python, Solidworks, PowerPoint, Microsoft Excel, Databases, Stem Cell Research, Surgical Instruments, Gene Therapy, Milling, Biomedical Engineering
Education
Stanford University 2012 — 2014
Master's degree, Mechanical Engineering
Stanford University 2008 — 2012
Bachelor of Arts (B.A.), Human Biology
Stryker June 2014 - Present
Stanford University April 2012 - 2014
Department of Orthopedics, Stanford School of Medicine January 2010 - June 2013
Stryker June 2012 - August 2012
FDA July 2011 - September 2011
Vaden Health Center September 2010 - June 2011
Global Healthcare Project August 2009 - September 2009
Skills
Tissue Engineering, Medical Device R&D, Biomaterials, Cell Culture, Python, Solidworks, PowerPoint, Microsoft Excel, Databases, Stem Cell Research, Surgical Instruments, Gene Therapy, Milling, Biomedical Engineering
Education
Stanford University 2012 — 2014
Master's degree, Mechanical Engineering
Stanford University 2008 — 2012
Bachelor of Arts (B.A.), Human Biology
Tomas Drgon Tomas Drgon's FDA Experience December 2014 - Present
Job Policy Analyst at FDA
Industry Research
Experience
FDA December 2014 - Present
Center for Scientific Review, NIH May 2010 - November 2014
NIH September 2001 - May 2010
University of Maryland October 1999 - September 2001
NIH December 1994 - October 1999
Comenius University 1990 - 1994
University of Basel March 1992 - October 1992
Slovak University of Technology September 1983 - June 1987
Skills
Molecular Biology, Genetics, Bioinformatics, Science, Genomics, Systems Biology, Biotechnology, Human Genetics, Biochemistry, Biostatistics, Cell Biology, Lifesciences, Cell, Neuroscience, Life Sciences, Computational Biology, Microarray Analysis, Organizational Structure, Process Control, Process Simulation, Research
Education
Univerzita Komenského v Bratislave 1990 — 1994
PhD, Biochemistry and Molecular Biology
Slovenská technická univerzita v Bratislave 1984 — 1988
MSc, Chemical Engineering and Biotechnology
FDA December 2014 - Present
Center for Scientific Review, NIH May 2010 - November 2014
NIH September 2001 - May 2010
University of Maryland October 1999 - September 2001
NIH December 1994 - October 1999
Comenius University 1990 - 1994
University of Basel March 1992 - October 1992
Slovak University of Technology September 1983 - June 1987
Skills
Molecular Biology, Genetics, Bioinformatics, Science, Genomics, Systems Biology, Biotechnology, Human Genetics, Biochemistry, Biostatistics, Cell Biology, Lifesciences, Cell, Neuroscience, Life Sciences, Computational Biology, Microarray Analysis, Organizational Structure, Process Control, Process Simulation, Research
Education
Univerzita Komenského v Bratislave 1990 — 1994
PhD, Biochemistry and Molecular Biology
Slovenská technická univerzita v Bratislave 1984 — 1988
MSc, Chemical Engineering and Biotechnology
Nick Sterling Nick Sterling's FDA Experience June 2012 - August 2012
Job Associate Technical Recruiter at Collabera
Industry Human Resources
Experience
Collabera September 2015 - Present
Social Solutions March 2015 - May 2015
Wyndham Worldwide March 2014 - August 2014
FDA June 2012 - August 2012
Skills
Government Experience, Human Resources, Leadership, Event Planning, Research, Budgets, Community Outreach, Organizational..., Public Speaking, Communication
Education
Salisbury University 2011 — 2014
Bachelor's Degree, Management-BS
Salisbury University - Perdue School of Business 2011 — 2014
Bachelor of Science (BS), Business, Management, Marketing, and Related Support Services
Collabera September 2015 - Present
Social Solutions March 2015 - May 2015
Wyndham Worldwide March 2014 - August 2014
FDA June 2012 - August 2012
Skills
Government Experience, Human Resources, Leadership, Event Planning, Research, Budgets, Community Outreach, Organizational..., Public Speaking, Communication
Education
Salisbury University 2011 — 2014
Bachelor's Degree, Management-BS
Salisbury University - Perdue School of Business 2011 — 2014
Bachelor of Science (BS), Business, Management, Marketing, and Related Support Services
William Raasch's FDA Experience June 2008 - August 2008
Job Albumin Production Manager (Superintendent) at Baxter International Inc.
Industry Biotechnology
Experience
Baxter International Inc. June 2013 - Present
Baxter Healthcare October 2011 - June 2013
Baxter 2009 - October 2011
Keck Graduate Institute 2007 - 2009
FDA June 2008 - August 2008
Education
Keck Graduate Institute 2007 — 2009
MBS, Business of Biotechnology
Stanford University 2003 — 2007
BS, Biological Sciences
Baxter International Inc. June 2013 - Present
Baxter Healthcare October 2011 - June 2013
Baxter 2009 - October 2011
Keck Graduate Institute 2007 - 2009
FDA June 2008 - August 2008
Education
Keck Graduate Institute 2007 — 2009
MBS, Business of Biotechnology
Stanford University 2003 — 2007
BS, Biological Sciences
Mark Malamud Mark Malamud's FDA Experience April 2009 - June 2009
Job Web Analytics & Accessibility Coordinator, and QA Manager; the National Heart, Lung, and Blood Institute
Industry Internet
Experience
National Heart, Lung, and Blood Institute (NHLBI) October 2013 - Present
National Institutes of Health 1990 - Present
NHLBI/NIH January 2009 - September 2013
FDA April 2009 - June 2009
National Heart, Lung, and Blood Institute (NHLBI) March 1996 - December 2008
National Heart, Lung, and Blood Institute 1990 - 1996
Pharmacia / Electronucleonics 1988 - 1990
Veterans Administration 1986 - 1988
University of California 1978 - 1986
Skills
Web Analytics, Web Content Management, SEO, Web Design, Management, Content Management, HTML, Information Architecture, User Experience, Web Project Management, Social Media, Program Management, Google Analytics, Web 2.0, Leadership, Section 508, Project Planning, Accessibility, Usability, Drupal, Technical Writing, Usability Testing
Education
University of California, Berkeley 1986 — 1986
State University of New York College at Buffalo 1970 — 1976
Joint BA, Biology/English
National Heart, Lung, and Blood Institute (NHLBI) October 2013 - Present
National Institutes of Health 1990 - Present
NHLBI/NIH January 2009 - September 2013
FDA April 2009 - June 2009
National Heart, Lung, and Blood Institute (NHLBI) March 1996 - December 2008
National Heart, Lung, and Blood Institute 1990 - 1996
Pharmacia / Electronucleonics 1988 - 1990
Veterans Administration 1986 - 1988
University of California 1978 - 1986
Skills
Web Analytics, Web Content Management, SEO, Web Design, Management, Content Management, HTML, Information Architecture, User Experience, Web Project Management, Social Media, Program Management, Google Analytics, Web 2.0, Leadership, Section 508, Project Planning, Accessibility, Usability, Drupal, Technical Writing, Usability Testing
Education
University of California, Berkeley 1986 — 1986
State University of New York College at Buffalo 1970 — 1976
Joint BA, Biology/English
Ashley Harrigan Scott's FDA Experience May 2013 - September 2013
Job International Affairs and Government Professional | M.A. in Communication Candidate
Industry Government Administration
Experience
US Department of Homeland Security September 2013 - Present
FDA May 2013 - September 2013
FDA January 2012 - May 2013
FDA; Health and Human Services March 2010 - January 2012
U.S. Census Bureau -- Census Coverage Management July 2007 - March 2010
Skills
Meeting Planning, Organizational..., Strategic Planning, Scheduling, Data Analysis, Research Project..., Project Management, Event Planning, Government, PowerPoint, Research, Training, Nonprofits, Management, Proposal Writing, Microsoft Office, SPSS, Process Scheduler, Policy, Policy Analysis, Community Outreach, Public Speaking
Education
Southern New Hampshire University 2014 — 2016
Master of Arts (M.A.), Communications
Spelman College 2005 — 2009
B.A., International Studies
Westlake High School 2001 — 2005
US Department of Homeland Security September 2013 - Present
FDA May 2013 - September 2013
FDA January 2012 - May 2013
FDA; Health and Human Services March 2010 - January 2012
U.S. Census Bureau -- Census Coverage Management July 2007 - March 2010
Skills
Meeting Planning, Organizational..., Strategic Planning, Scheduling, Data Analysis, Research Project..., Project Management, Event Planning, Government, PowerPoint, Research, Training, Nonprofits, Management, Proposal Writing, Microsoft Office, SPSS, Process Scheduler, Policy, Policy Analysis, Community Outreach, Public Speaking
Education
Southern New Hampshire University 2014 — 2016
Master of Arts (M.A.), Communications
Spelman College 2005 — 2009
B.A., International Studies
Westlake High School 2001 — 2005
Melissa Roy Melissa Roy's FDA Experience September 2015 - Present
Job Pharmacy Intern at Walmart
Industry Pharmaceuticals
Experience
FDA September 2015 - Present
Walmart January 2012 - Present
APCER PHARMA September 2014 - October 2014
FDA Division of Drug Information July 2014 - July 2014
Winthrop-University Hospital May 2014 - May 2014
NYS Council of Health-System Pharamcists March 2014 - March 2014
Pfizer January 2014 - January 2014
Actavis 2014 - 2014
Unichem Laboratories Limited July 2013 - September 2013
St. John's University September 2009 - September 2012
Skills
Clinical Research, Compounding, Pharmacy Automation, Clinical Pharmacology, Pharmacology, Patient Counseling, Medication Therapy..., Community Pharmacy, Clinical Pharmacy, Pharmacists, Leadership, Patient Safety, Immunization, Diabetes, Pharmacy, Pharmacy Practice, Pharmacokinetics, Pharmaceutical Industry, Medical Writing, Pharmacoeconomics, Pharmacy Technicians, Healthcare, Microsoft Office, PowerPoint, Microsoft Excel, Public Speaking, Microsoft Word
Education
St. John's University 2009 — 2015
Doctor of Pharmacy (PharmD), Pharmacy
State University of New York at Albany 2010 — 2010
FDA September 2015 - Present
Walmart January 2012 - Present
APCER PHARMA September 2014 - October 2014
FDA Division of Drug Information July 2014 - July 2014
Winthrop-University Hospital May 2014 - May 2014
NYS Council of Health-System Pharamcists March 2014 - March 2014
Pfizer January 2014 - January 2014
Actavis 2014 - 2014
Unichem Laboratories Limited July 2013 - September 2013
St. John's University September 2009 - September 2012
Skills
Clinical Research, Compounding, Pharmacy Automation, Clinical Pharmacology, Pharmacology, Patient Counseling, Medication Therapy..., Community Pharmacy, Clinical Pharmacy, Pharmacists, Leadership, Patient Safety, Immunization, Diabetes, Pharmacy, Pharmacy Practice, Pharmacokinetics, Pharmaceutical Industry, Medical Writing, Pharmacoeconomics, Pharmacy Technicians, Healthcare, Microsoft Office, PowerPoint, Microsoft Excel, Public Speaking, Microsoft Word
Education
St. John's University 2009 — 2015
Doctor of Pharmacy (PharmD), Pharmacy
State University of New York at Albany 2010 — 2010
Ian Millett's FDA Experience November 2004 - November 2006
Job Priincipal at Research Innovations
Industry Biotechnology
Experience
Research Innovations February 2009 - Present
Ivytech Community College 2009 - 2013
Focus Surgery August 2008 - March 2009
Cook Medical April 2007 - August 2008
FDA November 2004 - November 2006
MDL Inc. 1990 - 1996
Skills
Regulatory Affairs, Medical Devices, Validation, Regulatory Submissions, ISO 13485, FDA, Pharmaceutical Industry, CAPA, Biotechnology, Clinical Trials, Lifesciences, GMP, Quality System, Drug Development, Technology Transfer, Oncology
Education
Stanford University 1992 — 1998
Doctor of Philosophy (Ph.D.), Chemistry
University of California, Berkeley
Research Innovations February 2009 - Present
Ivytech Community College 2009 - 2013
Focus Surgery August 2008 - March 2009
Cook Medical April 2007 - August 2008
FDA November 2004 - November 2006
MDL Inc. 1990 - 1996
Skills
Regulatory Affairs, Medical Devices, Validation, Regulatory Submissions, ISO 13485, FDA, Pharmaceutical Industry, CAPA, Biotechnology, Clinical Trials, Lifesciences, GMP, Quality System, Drug Development, Technology Transfer, Oncology
Education
Stanford University 1992 — 1998
Doctor of Philosophy (Ph.D.), Chemistry
University of California, Berkeley
Michael Bui, DDS, JD, MPH's FDA Experience 2010 - 2014
Job Global Medical & Regulatory Strategist and Leader
Industry Pharmaceuticals
Experience
Teva Pharmaceuticals March 2014 - Present
Rutgers Cancer Institute of New Jersey January 2012 - Present
Northeastern University, College of Professional Studies September 2011 - Present
Rutgers University, School of Public Health 2011 - Present
Bayer HealthCare June 2010 - March 2014
FDA 2010 - 2014
Hoffmann - La Roche (Roche) Pharmaceuticals July 2007 - June 2010
Bristol-Myers Squibb Company 2006 - July 2007
Keryx Biopharmaceuticals July 2006 - August 2006
Genentech, Inc. April 2005 - April 2006
Skills
Biotechnology, Regulatory Affairs, Pharmaceutical Industry, Clinical Development, Oncology, Clinical Trials, Clinical Research, FDA, GCP, Pharmacovigilance, Drug Development, Medicine, R&D, Molecular Biology, Cancer, Biopharmaceuticals, CRO, Biochemistry, Biomarkers, Lifesciences, Infectious Diseases, Medical Devices, Epidemiology, Regulatory Submissions, Immunology, Medical Writing, Public Health, Health Economics, Drug Discovery, Informatics, Pharmacology, Medical Affairs, Neuroscience, Diabetes, CTMS, Biologics, Protocol, Pharmaceutics, Vaccines, Hematology, Commercialization, Neurology, GLP, Technology Transfer, Sop, Regulatory Requirements, Hardware Diagnostics, Life Sciences, Strategy, Healthcare
Education
Columbia University, College of Dental Medicine
Doctor of Dental Surgery, Dental Medicine
Columbia University, School of Public Health
Master of Public Health, Public Health
Seton Hall University School of Law
Healthcare Compliance Certificate
State University of New York at Buffalo, School of Law
Juris Doctor, Certificate in Intellectual Property & Technology, Law
University of California, Berkeley
Bachelor of Arts, Molecular Biology
Veterans Affairs Medical Center - Brooklyn
Certificate, General Practice Residency
Teva Pharmaceuticals March 2014 - Present
Rutgers Cancer Institute of New Jersey January 2012 - Present
Northeastern University, College of Professional Studies September 2011 - Present
Rutgers University, School of Public Health 2011 - Present
Bayer HealthCare June 2010 - March 2014
FDA 2010 - 2014
Hoffmann - La Roche (Roche) Pharmaceuticals July 2007 - June 2010
Bristol-Myers Squibb Company 2006 - July 2007
Keryx Biopharmaceuticals July 2006 - August 2006
Genentech, Inc. April 2005 - April 2006
Skills
Biotechnology, Regulatory Affairs, Pharmaceutical Industry, Clinical Development, Oncology, Clinical Trials, Clinical Research, FDA, GCP, Pharmacovigilance, Drug Development, Medicine, R&D, Molecular Biology, Cancer, Biopharmaceuticals, CRO, Biochemistry, Biomarkers, Lifesciences, Infectious Diseases, Medical Devices, Epidemiology, Regulatory Submissions, Immunology, Medical Writing, Public Health, Health Economics, Drug Discovery, Informatics, Pharmacology, Medical Affairs, Neuroscience, Diabetes, CTMS, Biologics, Protocol, Pharmaceutics, Vaccines, Hematology, Commercialization, Neurology, GLP, Technology Transfer, Sop, Regulatory Requirements, Hardware Diagnostics, Life Sciences, Strategy, Healthcare
Education
Columbia University, College of Dental Medicine
Doctor of Dental Surgery, Dental Medicine
Columbia University, School of Public Health
Master of Public Health, Public Health
Seton Hall University School of Law
Healthcare Compliance Certificate
State University of New York at Buffalo, School of Law
Juris Doctor, Certificate in Intellectual Property & Technology, Law
University of California, Berkeley
Bachelor of Arts, Molecular Biology
Veterans Affairs Medical Center - Brooklyn
Certificate, General Practice Residency
Skip Payne's FDA Experience December 2007 - January 2010
Job LCDR at U.S. Public Health Service Commissioned Corps since Jan 2012
Industry Government Administration
Experience
U.S. Public Health Service Commissioned Corps January 2012 - Present
Office of Civilian Volunteer Medical Reserve Corps January 2010 - Present
USPHS December 2007 - January 2012
United States Public Health Service December 2007 - January 2012
FDA December 2007 - January 2010
Ashford University 2007 - 2010
Seneca County General Health District March 2004 - December 2007
Seneca County General Health District October 2002 - September 2006
Skills
Emergency Management, Public Health, Staff Development, Epidemiology, Medicine, Government, Policy, Policy Analysis, Public Speaking, Program Development, Healthcare, Risk Assessment, Environmental Health, Prevention, Homeland Security, Grants, Data Analysis, Military, Disaster Response, Preparedness, Employee Training, Management, Program Management, Infectious Diseases, Proposal Writing, NIMS, Healthcare Management, Training, Qualitative Research, Grant Writing, Preventive Medicine, Leadership, Analysis, Leadership Development, GIS, Public Safety, Program Evaluation, Data Collection, Mental Health, Health Promotion, Research, Nonprofits, Emergency Services, Global Health, Crisis Management, Supervisory Skills, Teaching, Community Health, Incident Command, Counterterrorism
Education
Walden University 2005 — 2008
ABD, Public Health: Epidemiology
Walden University 2002 — 2005
MSPH, Community Health
Spring Arbor University 1998 — 2000
BA, Management and Organizational Development
U.S. Public Health Service Commissioned Corps January 2012 - Present
Office of Civilian Volunteer Medical Reserve Corps January 2010 - Present
USPHS December 2007 - January 2012
United States Public Health Service December 2007 - January 2012
FDA December 2007 - January 2010
Ashford University 2007 - 2010
Seneca County General Health District March 2004 - December 2007
Seneca County General Health District October 2002 - September 2006
Skills
Emergency Management, Public Health, Staff Development, Epidemiology, Medicine, Government, Policy, Policy Analysis, Public Speaking, Program Development, Healthcare, Risk Assessment, Environmental Health, Prevention, Homeland Security, Grants, Data Analysis, Military, Disaster Response, Preparedness, Employee Training, Management, Program Management, Infectious Diseases, Proposal Writing, NIMS, Healthcare Management, Training, Qualitative Research, Grant Writing, Preventive Medicine, Leadership, Analysis, Leadership Development, GIS, Public Safety, Program Evaluation, Data Collection, Mental Health, Health Promotion, Research, Nonprofits, Emergency Services, Global Health, Crisis Management, Supervisory Skills, Teaching, Community Health, Incident Command, Counterterrorism
Education
Walden University 2005 — 2008
ABD, Public Health: Epidemiology
Walden University 2002 — 2005
MSPH, Community Health
Spring Arbor University 1998 — 2000
BA, Management and Organizational Development
Carolyn Yancey's FDA Experience Associate. then Senior Med Dir.CIGNA Healthcare1995 - 2001
Job Senior Medical Officer at FDA
Industry Hospital & Health Care
Experience
FDA Associate. then Senior Med Dir.CIGNA Healthcare1995 - 2001
CIGNA Healthcare 1995 - 2001
Education
Spelman College
FDA Associate. then Senior Med Dir.CIGNA Healthcare1995 - 2001
CIGNA Healthcare 1995 - 2001
Education
Spelman College
Johnny Young's FDA Experience September 2014 - Present
Job Acting Division Director at FDA
Industry Government Administration
Experience
FDA September 2014 - Present
FDA May 2007 - August 2014
Walgreens July 2006 - August 2010
Giant Food May 1988 - July 2006
Education
St. John's College 2007 — 2009
Master's Degree, Liberal Arts and Sciences, General Studies and Humanities
University of Maryland Baltimore County 1999 — 2004
Bachelor's Degree, English Language and Literature, General
University of Maryland Baltimore 1990 — 1993
Bachelor's Degree, Pharmacy
FDA September 2014 - Present
FDA May 2007 - August 2014
Walgreens July 2006 - August 2010
Giant Food May 1988 - July 2006
Education
St. John's College 2007 — 2009
Master's Degree, Liberal Arts and Sciences, General Studies and Humanities
University of Maryland Baltimore County 1999 — 2004
Bachelor's Degree, English Language and Literature, General
University of Maryland Baltimore 1990 — 1993
Bachelor's Degree, Pharmacy
M Khair ElZarrad PhD, MPH's FDA Experience September 2011 - June 2013
Job Science Policy Analyst at National Institutes of Health
Industry Research
Experience
National Institutes of Health June 2013 - Present
FDA September 2011 - June 2013
NCI June 2010 - June 2013
Johns Hopkins Bloomberg School of Public Health June 2010 - June 2011
National Cancer Institute June 2010 - June 2011
National Cancer Institute April 2008 - April 2010
University of South Alabama August 2003 - March 2008
Comenius University, Jessenius Faculty of Medicine January 1999 - January 2000
Skills
Multilingual, Healthcare Management, Regulatory Analysis, Cancer, Oncology, Public Health, Clinical Trials, Epidemiology, Research, Biostatistics, Cancer Research, Chemistry, Health Policy, FDA, Policy, Cell Biology, Animal Models
Education
Johns Hopkins University 2010 — 2011
MPH, Epidemiology
University of South Alabama, College of Medicine 2003 — 2007
PhD, Medical Sciences
Samford University 2000 — 2003
Bachelor of Science (BSc), Biochemistry
National Institutes of Health June 2013 - Present
FDA September 2011 - June 2013
NCI June 2010 - June 2013
Johns Hopkins Bloomberg School of Public Health June 2010 - June 2011
National Cancer Institute June 2010 - June 2011
National Cancer Institute April 2008 - April 2010
University of South Alabama August 2003 - March 2008
Comenius University, Jessenius Faculty of Medicine January 1999 - January 2000
Skills
Multilingual, Healthcare Management, Regulatory Analysis, Cancer, Oncology, Public Health, Clinical Trials, Epidemiology, Research, Biostatistics, Cancer Research, Chemistry, Health Policy, FDA, Policy, Cell Biology, Animal Models
Education
Johns Hopkins University 2010 — 2011
MPH, Epidemiology
University of South Alabama, College of Medicine 2003 — 2007
PhD, Medical Sciences
Samford University 2000 — 2003
Bachelor of Science (BSc), Biochemistry
Deborah (McCarthy) Mesmer's FDA Experience March 2008 - Present
Job Project Manager, CDER/Office of New Drugs Quality Assessment at FDA
Industry Biotechnology
Experience
FDA March 2008 - Present
Celera Genomics October 2001 - December 2007
Karo Bio USA May 2000 - September 2001
AndCare, Inc. March 1999 - May 2000
Vysis (now Abbott Molecular Diagnostics) October 1990 - October 1998
Skills
Lifesciences, Regulatory Affairs, Validation, Drug Development, Genomics, Microbiology
Education
Spring Hill College 1977 — 1981
B.S., Biology
University of Illinois at Urbana-Champaign
M.S., Microbiology
FDA March 2008 - Present
Celera Genomics October 2001 - December 2007
Karo Bio USA May 2000 - September 2001
AndCare, Inc. March 1999 - May 2000
Vysis (now Abbott Molecular Diagnostics) October 1990 - October 1998
Skills
Lifesciences, Regulatory Affairs, Validation, Drug Development, Genomics, Microbiology
Education
Spring Hill College 1977 — 1981
B.S., Biology
University of Illinois at Urbana-Champaign
M.S., Microbiology
Martha Monser's FDA Experience January 2009 - Present
Job Sr Program Coordinator
Industry Government Administration
Experience
FDA January 2009 - Present
Food and Drug Administration March 2008 - December 2008
FDA May 1995 - March 2008
Food and Drug Administration / CBER October 1989 - May 1995
Education
State University of New York College at Oneonta 1985 — 1989
FDA January 2009 - Present
Food and Drug Administration March 2008 - December 2008
FDA May 1995 - March 2008
Food and Drug Administration / CBER October 1989 - May 1995
Education
State University of New York College at Oneonta 1985 — 1989
Nicolette Devore's FDA Experience March 2012 - Present
Job Senior Scientist and Project Manager for Counterterrorism and Emerging Threat Preparedness at FDA
Industry Research
Experience
FDA March 2012 - Present
FDA August 2009 - March 2012
FDA August 2003 - August 2009
Skills
IND, Life Sciences, Molecular Biology, Biochemistry, FDA, Cell Culture, Immunology, Cell Biology, Biotechnology, Lifesciences, Microbiology
Education
University of Alabama at Birmingham 1994 — 2002
St. Mary's College of Maryland 1990 — 1994
B.A., Biology
FDA March 2012 - Present
FDA August 2009 - March 2012
FDA August 2003 - August 2009
Skills
IND, Life Sciences, Molecular Biology, Biochemistry, FDA, Cell Culture, Immunology, Cell Biology, Biotechnology, Lifesciences, Microbiology
Education
University of Alabama at Birmingham 1994 — 2002
St. Mary's College of Maryland 1990 — 1994
B.A., Biology
Darlene Krieger's FDA Experience May 2010 - Present
Job Emergency Response Coordinator for FDA
Industry Government Administration
Experience
FDA May 2010 - Present
FDA March 2010 - February 2012
Skills
Public Health, Epidemiology, Emergency Management, Infectious Diseases, Policy, Environmental Health, Microbiology, Public Policy, Global Health, Statistics, Cell Culture, Research, Program Evaluation, Program Management, Policy Analysis, Laboratory, Disaster Response, Environmental Awareness, Data Analysis, Community Outreach, Program Development, Risk Assessment, Health Policy, Public Speaking, Food Safety, Government, HACCP
Education
Saint Cloud State University - G.R. Herberger College of Business 1994 — 1996
Bachelor of Science (BS), Biology/Biological Sciences, General
University of Minnesota-Twin Cities 1990 — 1994
Bachelor of Science (BS), Biology, General
FDA May 2010 - Present
FDA March 2010 - February 2012
Skills
Public Health, Epidemiology, Emergency Management, Infectious Diseases, Policy, Environmental Health, Microbiology, Public Policy, Global Health, Statistics, Cell Culture, Research, Program Evaluation, Program Management, Policy Analysis, Laboratory, Disaster Response, Environmental Awareness, Data Analysis, Community Outreach, Program Development, Risk Assessment, Health Policy, Public Speaking, Food Safety, Government, HACCP
Education
Saint Cloud State University - G.R. Herberger College of Business 1994 — 1996
Bachelor of Science (BS), Biology/Biological Sciences, General
University of Minnesota-Twin Cities 1990 — 1994
Bachelor of Science (BS), Biology, General
Gary Gensinger's FDA Experience February 2014 - Present
Job Senior Advisor at FDA
Industry Government Administration
Experience
FDA February 2014 - Present
FDA August 1996 - February 2014
Skills
Regulatory Submissions, FDA, Drug Development, Sop, Regulatory Affairs, GLP, Regulatory Requirements, Pharmaceutical Industry, Biopharmaceuticals, Quality Assurance, Pharmacovigilance, Clinical Development, Clinical Trials, Lifesciences, Drug Discovery, GMP, Technology Transfer, Biotechnology, 21 CFR Part 11, Validation, Document Management, Change Control, Life Sciences, GCP, SOP
Education
St. John's University, The Peter J. Tobin College of Business
FDA February 2014 - Present
FDA August 1996 - February 2014
Skills
Regulatory Submissions, FDA, Drug Development, Sop, Regulatory Affairs, GLP, Regulatory Requirements, Pharmaceutical Industry, Biopharmaceuticals, Quality Assurance, Pharmacovigilance, Clinical Development, Clinical Trials, Lifesciences, Drug Discovery, GMP, Technology Transfer, Biotechnology, 21 CFR Part 11, Validation, Document Management, Change Control, Life Sciences, GCP, SOP
Education
St. John's University, The Peter J. Tobin College of Business
Dave Coppersmith's FDA Experience February 2011 - Present
Job Regulatory Counsel, Food and Drug Administration
Industry Law Practice
Experience
FDA February 2011 - Present
Maryland State Bar Association March 2010 - February 2011
MICPEL May 2009 - February 2010
University of Baltimore School of Law Community Development Clinic August 2009 - December 2009
PricewaterhouseCoopers September 2005 - August 2007
Law Offices of Richmond Davis August 2005 - September 2005
Education
University of Baltimore School of Law 2007 — 2010
St. Mary's College of Maryland 2001 — 2005
B.A., Economics, Political Science
FDA February 2011 - Present
Maryland State Bar Association March 2010 - February 2011
MICPEL May 2009 - February 2010
University of Baltimore School of Law Community Development Clinic August 2009 - December 2009
PricewaterhouseCoopers September 2005 - August 2007
Law Offices of Richmond Davis August 2005 - September 2005
Education
University of Baltimore School of Law 2007 — 2010
St. Mary's College of Maryland 2001 — 2005
B.A., Economics, Political Science
Holly Ballance's FDA Experience August 2008 - Present
Job Management Officer at FDA
Industry Government Administration
Experience
FDA August 2008 - Present
FDA- Center for Veterinary Medicine December 2007 - August 2008
FDA- Center for Veterinary Medicine July 2006 - December 2007
Standard Microsystems 1980 - February 1989
Skills
Science Policy, Program Management, Strategic Planning, Analysis, Project Management, Business Intelligence, Leadership, Cross-functional Team..., Organizational..., Government, Leadership Development, Integration, Business Process..., Policy, Process Improvement, Management Consulting, Risk Management, Strategy, Change Management, Team Leadership, Management, Performance Management, Team Building, Start-ups, System Administration
Education
State University of New York College at Geneseo 1971 — 1973
Wellsville High School 1968 — 1971
FDA August 2008 - Present
FDA- Center for Veterinary Medicine December 2007 - August 2008
FDA- Center for Veterinary Medicine July 2006 - December 2007
Standard Microsystems 1980 - February 1989
Skills
Science Policy, Program Management, Strategic Planning, Analysis, Project Management, Business Intelligence, Leadership, Cross-functional Team..., Organizational..., Government, Leadership Development, Integration, Business Process..., Policy, Process Improvement, Management Consulting, Risk Management, Strategy, Change Management, Team Leadership, Management, Performance Management, Team Building, Start-ups, System Administration
Education
State University of New York College at Geneseo 1971 — 1973
Wellsville High School 1968 — 1971
Cindy Loose's FDA Experience November 2011 - Present
Job editor/writer at FDA
Industry Public Relations and Communications
Experience
FDA November 2011 - Present
The Washington Post September 2011 - October 2011
PhRMA June 2008 - May 2011
The Washington Post September 1991 - June 2008
Los Angeles Times January 1989 - August 1991
The Detroit News April 1983 - August 1988
Staten Island Register October 1975 - November 1977
Skills
Newspaper, Journalism, Copy Editing, Storytelling, Press Kits, Ap Style, Editing, Press Releases, Feature Articles, Publications, Web Content, News Writing, AP Style, Public Relations, Magazines, Media Relations, Content Strategy, Editorial, Newspapers, Online Journalism, Blogging, Strategic Communications, Internal Communications, Crisis Communications, Social Media, Freelance Writing, Newsletters, Speech Writing
Education
Stanford University 1987 — 1988
Pennsylvania State University-State College 1969 — 1974
masters
FDA November 2011 - Present
The Washington Post September 2011 - October 2011
PhRMA June 2008 - May 2011
The Washington Post September 1991 - June 2008
Los Angeles Times January 1989 - August 1991
The Detroit News April 1983 - August 1988
Staten Island Register October 1975 - November 1977
Skills
Newspaper, Journalism, Copy Editing, Storytelling, Press Kits, Ap Style, Editing, Press Releases, Feature Articles, Publications, Web Content, News Writing, AP Style, Public Relations, Magazines, Media Relations, Content Strategy, Editorial, Newspapers, Online Journalism, Blogging, Strategic Communications, Internal Communications, Crisis Communications, Social Media, Freelance Writing, Newsletters, Speech Writing
Education
Stanford University 1987 — 1988
Pennsylvania State University-State College 1969 — 1974
masters
Bo Zheng's FDA Experience June 2009 - August 2009
Job UCB | UCSF | Bioengineering | Graduate Student
Industry Medical Devices
Experience
UC Berkeley June 2009 - Present
UCSF June 2009 - Present
UC Berkeley January 2010 - May 2010
FDA June 2009 - August 2009
Proteus Digital Health, Inc July 2008 - June 2009
Skills
Matlab, Image Processing, Medical Imaging, Medical Devices, Programming, Signal Processing, Algorithms, FDA, R&D, Mathematical Modeling, Electronics, Molecular Biology
Education
University of California, Berkeley 2009 — 2014
Ph.D, Bioengineering
University of California, San Francisco 2009 — 2012
Ph.D, Bioengineering
Stanford University 2008 — 2009
M.S., Bioengineering
Stanford University 2004 — 2008
B.S., Electrical Engineering
UC Berkeley June 2009 - Present
UCSF June 2009 - Present
UC Berkeley January 2010 - May 2010
FDA June 2009 - August 2009
Proteus Digital Health, Inc July 2008 - June 2009
Skills
Matlab, Image Processing, Medical Imaging, Medical Devices, Programming, Signal Processing, Algorithms, FDA, R&D, Mathematical Modeling, Electronics, Molecular Biology
Education
University of California, Berkeley 2009 — 2014
Ph.D, Bioengineering
University of California, San Francisco 2009 — 2012
Ph.D, Bioengineering
Stanford University 2008 — 2009
M.S., Bioengineering
Stanford University 2004 — 2008
B.S., Electrical Engineering
Jennifer Romaine, MBA's FDA Experience June 2004 - August 2005
Job Quality Assurance Specialist [C] at NIH/NIAID Office of Regulatory Affairs
Industry Biotechnology
Experience
Office of Regulatory Affairs, NIAID, NIH [C] February 2014 - Present
UCSF-Immune Tolerance Network October 2009 - February 2014
UCSF-Immune Tolerance Network September 2007 - September 2009
UCSF-Immune Tolerance Network September 2006 - September 2007
FDA June 2004 - August 2005
Henry M. Jackson Foundation for the Advancement of Military Medicine May 2003 - August 2003
Skills
Microsoft Office, Adobe Creative Suite, SPSS, Research Project..., Clinical Trial..., Clinical Development, Regulatory Compliance, Innovation Management, Business Process..., Change Management, Compliance, Project Management, Biotechnology, CTMS, Immunology, Lifesciences, Analysis, Cross-functional Team..., Clinical Trials, Leadership, Training, Protocol, Data Analysis, Microsoft Excel, Life Sciences
Education
University of Maryland - Robert H. Smith School of Business 2010 — 2013
MBA, Business Administration
St. Mary's College of Maryland 2002 — 2006
Bachelors of Arts, Biology, General
Bethesda-Chevy Chase High School
International Baccalaureate Diploma
Office of Regulatory Affairs, NIAID, NIH [C] February 2014 - Present
UCSF-Immune Tolerance Network October 2009 - February 2014
UCSF-Immune Tolerance Network September 2007 - September 2009
UCSF-Immune Tolerance Network September 2006 - September 2007
FDA June 2004 - August 2005
Henry M. Jackson Foundation for the Advancement of Military Medicine May 2003 - August 2003
Skills
Microsoft Office, Adobe Creative Suite, SPSS, Research Project..., Clinical Trial..., Clinical Development, Regulatory Compliance, Innovation Management, Business Process..., Change Management, Compliance, Project Management, Biotechnology, CTMS, Immunology, Lifesciences, Analysis, Cross-functional Team..., Clinical Trials, Leadership, Training, Protocol, Data Analysis, Microsoft Excel, Life Sciences
Education
University of Maryland - Robert H. Smith School of Business 2010 — 2013
MBA, Business Administration
St. Mary's College of Maryland 2002 — 2006
Bachelors of Arts, Biology, General
Bethesda-Chevy Chase High School
International Baccalaureate Diploma
Alan Feuerstein's FDA Experience July 2011 - May 2012
Job Attorney
Industry Law Practice
Experience
IMF Development, LLC May 2012 - Present
FDA July 2011 - May 2012
Baltimore Bar Association's Legal Services to the Elderly Program May 2010 - May 2011
Michael A. Gordon, PLLC, Attorney at Law May 2008 - August 2009
Skills
Administrative Law, General Practice of Law, Contract Law, Intellectual Property..., Legal Research, Legal Writing, Government Contracts Law, Word Processing, Computer Troubleshooting
Education
University of Baltimore School of Law 2009 — 2012
Juris Doctorate, Law, 3.0
St. Mary's College of Maryland 2004 — 2008
Bachelor of Arts (B.A.) in Political Science, Bachelor of Arts (B.A.) in Public Policy, Political Science and Public Policy
IMF Development, LLC May 2012 - Present
FDA July 2011 - May 2012
Baltimore Bar Association's Legal Services to the Elderly Program May 2010 - May 2011
Michael A. Gordon, PLLC, Attorney at Law May 2008 - August 2009
Skills
Administrative Law, General Practice of Law, Contract Law, Intellectual Property..., Legal Research, Legal Writing, Government Contracts Law, Word Processing, Computer Troubleshooting
Education
University of Baltimore School of Law 2009 — 2012
Juris Doctorate, Law, 3.0
St. Mary's College of Maryland 2004 — 2008
Bachelor of Arts (B.A.) in Political Science, Bachelor of Arts (B.A.) in Public Policy, Political Science and Public Policy
Strother D. Dixon's FDA Experience April 2012 - Present
Job Regulatory Project Manager
Industry Pharmaceuticals
Experience
FDA April 2012 - Present
Henry M Jackson Foundation February 2011 - March 2012
Baxter 2010 - 2011
Baxter BioScience 2009 - 2010
Baxter 2007 - 2009
PDA November 2004 - April 2005
Eli Lilly 2003 - 2004
KMI (now PAREXEL Consulting) 2002 - 2003
Parenteral Drug Association 2000 - 2002
North American Vaccine (AMVAX) 1997 - 2000
Skills
Software Documentation, GMP, Quality Assurance, Purification, Validation, 21 CFR Part 11, FDA, Sop, Pharmaceutical Industry, Training, Biotechnology, Leadership, Change Control, CAPA, Clinical Trials, Fermentation, Lifesciences, Vaccines, Medical Devices, GLP, Regulatory Affairs, Life Sciences, SOP
Education
Southern University and Agricultural and Mechanical College at Baton Rouge 1994 — 1996
biology
FDA April 2012 - Present
Henry M Jackson Foundation February 2011 - March 2012
Baxter 2010 - 2011
Baxter BioScience 2009 - 2010
Baxter 2007 - 2009
PDA November 2004 - April 2005
Eli Lilly 2003 - 2004
KMI (now PAREXEL Consulting) 2002 - 2003
Parenteral Drug Association 2000 - 2002
North American Vaccine (AMVAX) 1997 - 2000
Skills
Software Documentation, GMP, Quality Assurance, Purification, Validation, 21 CFR Part 11, FDA, Sop, Pharmaceutical Industry, Training, Biotechnology, Leadership, Change Control, CAPA, Clinical Trials, Fermentation, Lifesciences, Vaccines, Medical Devices, GLP, Regulatory Affairs, Life Sciences, SOP
Education
Southern University and Agricultural and Mechanical College at Baton Rouge 1994 — 1996
biology
Lisa Hornback's FDA Experience May 1996 - June 2002
Job Principal Consultant at Hornback Consulting, LLC
Industry Medical Devices
Experience
Hornback Consulting, LLC January 2006 - Present
PAREXEL June 2002 - January 2006
FDA May 1996 - June 2002
Skills
FDA, Regulatory Requirements, Medical Devices, CAPA, Pharmaceutical Industry, Quality System, Validation, Design Control, Manufacturing, V, Auditing, Change Control
Education
Southeast Missouri State University
BS, Medical Technology, Graduate Cum Laude
Hornback Consulting, LLC January 2006 - Present
PAREXEL June 2002 - January 2006
FDA May 1996 - June 2002
Skills
FDA, Regulatory Requirements, Medical Devices, CAPA, Pharmaceutical Industry, Quality System, Validation, Design Control, Manufacturing, V, Auditing, Change Control
Education
Southeast Missouri State University
BS, Medical Technology, Graduate Cum Laude
LaTisha Friend Dorsey's FDA Experience July 2002 - Present
Job Chemist at FDA
Industry Government Administration
Experience
FDA July 2002 - Present
GBI March 1999 - June 2002
Skills
Analytical Chemistry, HPLC, Chemistry, UV/Vis, Mass Spectrometry, Chromatography, Microbiology, Science, Regulatory Affairs, LC-MS, GLP, FDA, Lifesciences, Organic Chemistry, Biochemistry
Education
Southern University and Agricultural and Mechanical College at Baton Rouge 1992 — 1998
Bachelor of Science (BS), Chemistry
Farmington High School 1988 — 1992
FDA July 2002 - Present
GBI March 1999 - June 2002
Skills
Analytical Chemistry, HPLC, Chemistry, UV/Vis, Mass Spectrometry, Chromatography, Microbiology, Science, Regulatory Affairs, LC-MS, GLP, FDA, Lifesciences, Organic Chemistry, Biochemistry
Education
Southern University and Agricultural and Mechanical College at Baton Rouge 1992 — 1998
Bachelor of Science (BS), Chemistry
Farmington High School 1988 — 1992
Candace Gomez-Broughton, Ph.D.'s FDA Experience January 2011 - Present
Job Senior Microbiologist at U.S. Food and Drug Administration
Industry Biotechnology
Experience
FDA January 2011 - Present
Independent Project Analysis, Inc. April 2007 - December 2010
University of North Carolina at Chapel Hill January 2006 - January 2007
Skills
ELISA, Biotechnology, Cell Culture, Microbiology, Molecular Biology, Research, Program Management, Validation, Technical Writing, Writing, Life Sciences, Analysis, PCR, Virology, Microsoft Office, Science, Excel, Genetics, Cell Biology, Western Blotting, Process Engineering, PowerPoint, Compliance, GMP, Immunology, Infectious Diseases, Protein Chemistry, Biochemistry, Fluorescence, Public Health, Tissue Culture, Fluorescence Microscopy, Scientific Writing, Confocal Microscopy, Microscopy, Bioinformatics, Regulatory Affairs, Pharmaceutical Industry, Biology, Laboratory, GLP
Education
University of Illinois at Chicago 2000 — 2005
Ph.D.
Spelman College 1996 — 2000
B.S.
FDA January 2011 - Present
Independent Project Analysis, Inc. April 2007 - December 2010
University of North Carolina at Chapel Hill January 2006 - January 2007
Skills
ELISA, Biotechnology, Cell Culture, Microbiology, Molecular Biology, Research, Program Management, Validation, Technical Writing, Writing, Life Sciences, Analysis, PCR, Virology, Microsoft Office, Science, Excel, Genetics, Cell Biology, Western Blotting, Process Engineering, PowerPoint, Compliance, GMP, Immunology, Infectious Diseases, Protein Chemistry, Biochemistry, Fluorescence, Public Health, Tissue Culture, Fluorescence Microscopy, Scientific Writing, Confocal Microscopy, Microscopy, Bioinformatics, Regulatory Affairs, Pharmaceutical Industry, Biology, Laboratory, GLP
Education
University of Illinois at Chicago 2000 — 2005
Ph.D.
Spelman College 1996 — 2000
B.S.
Brian Booth's FDA Experience 1998 - Present
Job Deputy Director at FDA
Industry Pharmaceuticals
Experience
FDA 1998 - Present
Education
State University of New York College at Buffalo 1993 — 1998
FDA 1998 - Present
Education
State University of New York College at Buffalo 1993 — 1998
Soo-Kwang Lee, Ph.D. DABT's FDA Experience October 2011 - Present
Job Toxicologist, nutrient analysis
Industry Research
Experience
FDA October 2011 - Present
Education
The University of Georgia 2000 — 2007
Ph.D.
University of Pittsburgh
M.S.
Seoul National University
B.S.
FDA October 2011 - Present
Education
The University of Georgia 2000 — 2007
Ph.D.
University of Pittsburgh
M.S.
Seoul National University
B.S.
Chira Chen-Tanyolac's FDA Experience 1987 - 1988
Job SRA at UCSF
Industry Research
Experience
UCSF 1995 - Present
University of California 1995 - Present
Roswell Park Cancer Institute 1993 - 1995
Lawrence Livermore National Laboratory 1988 - 1993
FDA 1987 - 1988
San Francisco State University 1984 - 1987
Skills
Biochemistry, Biotechnology, Cancer, Cancer Research, Cell, Cell Biology, Cell Culture, Genetics, Genomics, Life Sciences, Lifesciences, Molecular, Molecular Biology, PCR, Program Management, Western Blotting, qPCR, Flow Cytometry
Education
San Francisco State University 1981 — 1987
BS, Biochemistry
UCSF 1995 - Present
University of California 1995 - Present
Roswell Park Cancer Institute 1993 - 1995
Lawrence Livermore National Laboratory 1988 - 1993
FDA 1987 - 1988
San Francisco State University 1984 - 1987
Skills
Biochemistry, Biotechnology, Cancer, Cancer Research, Cell, Cell Biology, Cell Culture, Genetics, Genomics, Life Sciences, Lifesciences, Molecular, Molecular Biology, PCR, Program Management, Western Blotting, qPCR, Flow Cytometry
Education
San Francisco State University 1981 — 1987
BS, Biochemistry
Lenin Parrales's FDA Experience January 2009 - Present
Job Chemist at FDA
Industry Research
Experience
FDA January 2009 - Present
San Francisco State University November 2005 - July 2012
Skills
NMR, UV/Vis, NMR spectroscopy, Spectroscopy, HPLC, Mass Spectrometry, LC-MS, Organic Synthesis, Chromatography, Chemistry, Purification, Analytical Chemistry
Education
San Francisco State University 2005 — 2008
San Francisco State University 1998 — 2005
FDA January 2009 - Present
San Francisco State University November 2005 - July 2012
Skills
NMR, UV/Vis, NMR spectroscopy, Spectroscopy, HPLC, Mass Spectrometry, LC-MS, Organic Synthesis, Chromatography, Chemistry, Purification, Analytical Chemistry
Education
San Francisco State University 2005 — 2008
San Francisco State University 1998 — 2005
Denise Garnett, PMP's FDA Experience February 2015 - Present
Job Technical Project Manager at OPM
Industry Information Technology and Services
Experience
FDA February 2015 - Present
U.S. Office of Personnel Management (OPM) October 2010 - February 2015
Freddie Mac October 1996 - October 2010
Principal Health Care 1993 - 1996
Education
The Johns Hopkins University 2004 — 2008
M.S., Information Systems & Technology
Spelman College 1986 — 1990
B.S., Mathematics & Computer Science
FDA February 2015 - Present
U.S. Office of Personnel Management (OPM) October 2010 - February 2015
Freddie Mac October 1996 - October 2010
Principal Health Care 1993 - 1996
Education
The Johns Hopkins University 2004 — 2008
M.S., Information Systems & Technology
Spelman College 1986 — 1990
B.S., Mathematics & Computer Science
Debbie Racioppi's FDA Experience January 2009 - Present
Job Food and Drug Administration, Florida District
Industry Government Administration
Experience
FDA, Florida District June 2010 - Present
FDA January 2009 - Present
Genicon 2008 - 2009
Kensey Nash Corporation July 2000 - November 2007
Skills
Medical Devices, FDA, Validation, Quality System, Regulatory Affairs, Sop, Biotechnology, Regulatory Submissions, V&V, Biopharmaceuticals, Lifesciences, Pharmaceutical Industry, 21 CFR Part 11, GMP, Clinical Trials, Technology Transfer, Life Sciences, SOP
Education
San Diego State University-California State University 2005 — 2008
Masters, Regulatory Affairs
Villanova University 1980 — 1984
Bachelor of Science, Biology/Chemistry
FDA, Florida District June 2010 - Present
FDA January 2009 - Present
Genicon 2008 - 2009
Kensey Nash Corporation July 2000 - November 2007
Skills
Medical Devices, FDA, Validation, Quality System, Regulatory Affairs, Sop, Biotechnology, Regulatory Submissions, V&V, Biopharmaceuticals, Lifesciences, Pharmaceutical Industry, 21 CFR Part 11, GMP, Clinical Trials, Technology Transfer, Life Sciences, SOP
Education
San Diego State University-California State University 2005 — 2008
Masters, Regulatory Affairs
Villanova University 1980 — 1984
Bachelor of Science, Biology/Chemistry
Seongeun Cho's FDA Experience 2009 - Present
Job Pharmacologist/Compliance Officer
Industry Pharmaceuticals
Experience
FDA 2009 - Present
Wyeth Research 2000 - 2009
Wyeth Research 2000 - 2009
Education
The Ohio State University 1991 — 1995
Ph.D., Pharmacology
Seoul National University 1988 — 1990
MS, pharmacology
FDA 2009 - Present
Wyeth Research 2000 - 2009
Wyeth Research 2000 - 2009
Education
The Ohio State University 1991 — 1995
Ph.D., Pharmacology
Seoul National University 1988 — 1990
MS, pharmacology
B.J. Ryan's FDA Experience January 2014 - Present
Job FDA investigator (CSO) Drug Specialist
Industry Government Administration
Experience
FDA January 2014 - Present
Education
State University of New York Upstate Medical University
Medical Biotechnology
FDA January 2014 - Present
Education
State University of New York Upstate Medical University
Medical Biotechnology
Keith Wear's FDA Experience June 1989 - Present
Job Physicist at FDA
Industry Government Administration
Experience
FDA June 1989 - Present
Skills
Ultrasound
Education
Stanford University 1980 — 1986
MS, Ph.D., Applied Physics
University of California, San Diego 1975 — 1980
BA, Applied Physics
FDA June 1989 - Present
Skills
Ultrasound
Education
Stanford University 1980 — 1986
MS, Ph.D., Applied Physics
University of California, San Diego 1975 — 1980
BA, Applied Physics
Suzie Bartram's FDA Experience June 2010 - August 2010
Job Mechanical Engineer at Masimo
Industry Mechanical or Industrial Engineering
Experience
Masimo March 2014 - Present
Stanford University September 2013 - December 2013
Lime Lab - A PCH Solutions Company July 2013 - September 2013
Stanford University April 2013 - June 2013
Stanford University September 2012 - June 2013
WellnessFX June 2011 - March 2012
FDA June 2010 - August 2010
Stanford iGEM January 2009 - November 2009
McLaughlin Research Institute June 2008 - August 2008
Montana Fish, Wildlife, and Parks June 2007 - August 2007
Skills
Mechatronics, C, JavaScript, Solidworks, Matlab, Mechanical Engineering, Rapid Prototyping, Product Design, Microsoft Excel, Assistant Teaching, Tutoring, SolidWorks
Education
Stanford University 2012 — 2013
Master of Science (M.S.), Mechanical Engineering
Stanford University 2008 — 2012
Bachelor of Science (B.S.), Biomechanical Engineering
Masimo March 2014 - Present
Stanford University September 2013 - December 2013
Lime Lab - A PCH Solutions Company July 2013 - September 2013
Stanford University April 2013 - June 2013
Stanford University September 2012 - June 2013
WellnessFX June 2011 - March 2012
FDA June 2010 - August 2010
Stanford iGEM January 2009 - November 2009
McLaughlin Research Institute June 2008 - August 2008
Montana Fish, Wildlife, and Parks June 2007 - August 2007
Skills
Mechatronics, C, JavaScript, Solidworks, Matlab, Mechanical Engineering, Rapid Prototyping, Product Design, Microsoft Excel, Assistant Teaching, Tutoring, SolidWorks
Education
Stanford University 2012 — 2013
Master of Science (M.S.), Mechanical Engineering
Stanford University 2008 — 2012
Bachelor of Science (B.S.), Biomechanical Engineering
Liyan Gu's FDA Experience July 2006 - December 2006
Job Senior Consultant at CGI
Industry Information Technology and Services
Experience
CGI (@Fannie Mae) April 2015 - Present
MicroStrategy May 2012 - March 2015
MicroStrategy February 2010 - April 2012
MicroStrategy July 2008 - January 2010
MicroStrategy January 2007 - June 2008
FDA July 2006 - December 2006
Atlas Copco January 2002 - July 2004
Wonders Information Co. Ltd. July 2001 - December 2001
Skills
Business Intelligence, Data Warehousing, SQL, Data Modeling, Microstrategy, OLAP, Databases, Software Development, Unix, Testing, Enterprise Architecture, Enterprise Software, Performance Improvement, Project Management, Six Sigma, Scalability Testing, Performance Tuning, Performance Testing, High Performance..., MicroStrategy
Education
University of Maryland College Park 2005 — 2007
Master, Systems Engineering
上海交通大学 1997 — 2001
Bachelor's degree, Industrial Engineering
CGI (@Fannie Mae) April 2015 - Present
MicroStrategy May 2012 - March 2015
MicroStrategy February 2010 - April 2012
MicroStrategy July 2008 - January 2010
MicroStrategy January 2007 - June 2008
FDA July 2006 - December 2006
Atlas Copco January 2002 - July 2004
Wonders Information Co. Ltd. July 2001 - December 2001
Skills
Business Intelligence, Data Warehousing, SQL, Data Modeling, Microstrategy, OLAP, Databases, Software Development, Unix, Testing, Enterprise Architecture, Enterprise Software, Performance Improvement, Project Management, Six Sigma, Scalability Testing, Performance Tuning, Performance Testing, High Performance..., MicroStrategy
Education
University of Maryland College Park 2005 — 2007
Master, Systems Engineering
上海交通大学 1997 — 2001
Bachelor's degree, Industrial Engineering
Kim Colson's FDA Experience April 2012 - Present
Job Visual Information Specialist
Industry Government Relations
Experience
FDA April 2012 - Present
NARFE Premier Federal Credit Union November 2007 - July 2012
College of The Albemarle February 2002 - November 2007
The Food and Drug Administration September 1994 - July 2001
Skills
Adobe Creative Suite, Graphic Design, Logo Design, QuarkXPress, Dreamweaver, Web Design, Packaging, Corporate Identity, Graphics, Marketing, Photography, Creative Direction, Advertising, Book Illustration, Fine Art, Branding & Identity
Education
Savannah College of Art and Design
B.F.A., Graphic Design
FDA April 2012 - Present
NARFE Premier Federal Credit Union November 2007 - July 2012
College of The Albemarle February 2002 - November 2007
The Food and Drug Administration September 1994 - July 2001
Skills
Adobe Creative Suite, Graphic Design, Logo Design, QuarkXPress, Dreamweaver, Web Design, Packaging, Corporate Identity, Graphics, Marketing, Photography, Creative Direction, Advertising, Book Illustration, Fine Art, Branding & Identity
Education
Savannah College of Art and Design
B.F.A., Graphic Design
Yared Girmai's FDA Experience July 2010 - Present
Job Contract Specialist at FDA
Industry Government Administration
Experience
FDA July 2010 - Present
Department of the Interior June 2008 - June 2010
Skills
Government Procurement, Federal Government
Education
The George Washington University 2011 — 2013
Masters, Public Policy
St. Mary's College of Maryland 2003 — 2007
B.A., Economics
FDA July 2010 - Present
Department of the Interior June 2008 - June 2010
Skills
Government Procurement, Federal Government
Education
The George Washington University 2011 — 2013
Masters, Public Policy
St. Mary's College of Maryland 2003 — 2007
B.A., Economics
Aaron Sigler's FDA Experience March 2008 - Present
Job Supervisory Project Manager at FDA
Industry Government Administration
Experience
FDA March 2008 - Present
Your 1996 - Present
Skills
Public Health, FDA, Government, Policy, Regulatory Submissions, Validation, Clinical Research, Healthcare, Pharmaceutical Industry, Regulatory Requirements, GMP, Regulatory Affairs, Quality Assurance, Federal Government, Program Management, Biotechnology
Education
St. Louis College of Pharmacy 1991 — 1996
Doctor of Pharmacy (Pharm.D.), Pharmacy
FDA March 2008 - Present
Your 1996 - Present
Skills
Public Health, FDA, Government, Policy, Regulatory Submissions, Validation, Clinical Research, Healthcare, Pharmaceutical Industry, Regulatory Requirements, GMP, Regulatory Affairs, Quality Assurance, Federal Government, Program Management, Biotechnology
Education
St. Louis College of Pharmacy 1991 — 1996
Doctor of Pharmacy (Pharm.D.), Pharmacy
Mathew Rascovich's FDA Experience April 2009 - April 2010
Job Student at University of Maryland College Park
Industry Public Policy
Experience
FDA April 2009 - April 2010
Skills
Military, Nonprofits, Policy, Microsoft Excel, Leadership, Policy Analysis, International Relations, Government, Program Management, Non-profits, Public Policy, Program Evaluation, Research, Community Outreach, Public Speaking, Stata
Education
University of Maryland College Park 2006 — 2008
Santa Fe Community College
FDA April 2009 - April 2010
Skills
Military, Nonprofits, Policy, Microsoft Excel, Leadership, Policy Analysis, International Relations, Government, Program Management, Non-profits, Public Policy, Program Evaluation, Research, Community Outreach, Public Speaking, Stata
Education
University of Maryland College Park 2006 — 2008
Santa Fe Community College
Tri Bui-Nguyen's FDA Experience February 2013 - Present
Job Consumer Safety Officer at FDA
Industry Higher Education
Experience
FDA February 2013 - Present
US Army Center for Environmental Health Research March 2010 - February 2013
George Washington University March 2009 - March 2010
MD Anderson Cancer Center November 2007 - March 2009
R&D Systems October 1999 - August 2002
Skills
Molecular Biology, Cancer, Pharmacology, Cell Culture, Cell Based Assays, Cell Biology, Biochemistry, Microscopy, PCR, Research, Biotechnology, Western Blotting, Confocal Microscopy, Immunohistochemistry, ELISA, qPCR, DNA, In Vitro, Immunofluorescence, Molecular Cloning, Cell, Protein Purification, Fluorescence Microscopy, Tissue Culture, Bioinformatics, Regulatory Affairs, Genomics, Transcriptomics, Proteomics
Education
Stanford University 2012 — 2012
SCPM, Advanced Project Management
The Johns Hopkins University 2009 — 2012
Master, Master of Science in Bioscience Regulatory Affairs program
University of Minnesota-Twin Cities 2002 — 2007
Ph.D., Pharmacology
University of Minnesota-Twin Cities 1995 — 1999
B.S., Biochemistry/Chemistry
FDA February 2013 - Present
US Army Center for Environmental Health Research March 2010 - February 2013
George Washington University March 2009 - March 2010
MD Anderson Cancer Center November 2007 - March 2009
R&D Systems October 1999 - August 2002
Skills
Molecular Biology, Cancer, Pharmacology, Cell Culture, Cell Based Assays, Cell Biology, Biochemistry, Microscopy, PCR, Research, Biotechnology, Western Blotting, Confocal Microscopy, Immunohistochemistry, ELISA, qPCR, DNA, In Vitro, Immunofluorescence, Molecular Cloning, Cell, Protein Purification, Fluorescence Microscopy, Tissue Culture, Bioinformatics, Regulatory Affairs, Genomics, Transcriptomics, Proteomics
Education
Stanford University 2012 — 2012
SCPM, Advanced Project Management
The Johns Hopkins University 2009 — 2012
Master, Master of Science in Bioscience Regulatory Affairs program
University of Minnesota-Twin Cities 2002 — 2007
Ph.D., Pharmacology
University of Minnesota-Twin Cities 1995 — 1999
B.S., Biochemistry/Chemistry
Elizabeth Raveche's FDA Experience 2011 - 2012
Job Professor (retired,adjunct as of 2015) at New Jersey Medical School, UMDNJ
Industry Research
Experience
New Jersey Medical School, UMDNJ 1989 - Present
FDA 2011 - 2012
NIH 1978 - 1985
Skills
Flow Cytometry, Molecular Biology, Genetics, Immunology, Biochemistry, Cell Biology, Animal Models, Stem Cells, Cancer, Cell Culture, PCR, Teacher Mentoring, Immunohistochemistry, Western Blotting
Education
The George Washington University School of Medicine and Health Sciences 1973 — 1977
Doctor of Philosophy (Ph.D.), Immunogenetics
Seton Hill University 1968 — 1972
Bachelor's degree, Chemistry
New Jersey Medical School, UMDNJ 1989 - Present
FDA 2011 - 2012
NIH 1978 - 1985
Skills
Flow Cytometry, Molecular Biology, Genetics, Immunology, Biochemistry, Cell Biology, Animal Models, Stem Cells, Cancer, Cell Culture, PCR, Teacher Mentoring, Immunohistochemistry, Western Blotting
Education
The George Washington University School of Medicine and Health Sciences 1973 — 1977
Doctor of Philosophy (Ph.D.), Immunogenetics
Seton Hill University 1968 — 1972
Bachelor's degree, Chemistry
Yanhui Lu's FDA Experience May 2014 - August 2014
Job Sr Scientist, Quantitative Pharmacology and Pharmacometrics, Merck & Co.
Industry Pharmaceuticals
Experience
Merck September 2014 - Present
FDA May 2014 - August 2014
Johns Hopkins University School of Medicine August 2009 - April 2014
The Ohio State University Medical Center May 2007 - August 2009
School of Pharmacy, The Ohio State University November 2005 - May 2007
Skills
Drug Metabolism, Pharmacokinetics, Bioanalysis, In Vitro, LC-MS, Drug Delivery, Pharmacology, Drug Discovery, Translational Medicine, Toxicology, Cell Culture, Nanoparticles, ELISA, Biochemistry, Western Blotting, Tissue Culture, Cancer, Cell Biology, Molecular Biology, Clinical Development, Chromatography, Biomarkers
Education
The Johns Hopkins University School of Medicine 2009 — 2014
Doctor of Philosophy (Ph.D.), Clinical Pharmacology, Drug Metabolism, Pharmacometrics
The Ohio State University 2007 — 2009
Master of Science (MS), Medicinal Chemistry, School of Pharmacy
Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences 2002 — 2005
Master of Science (MS), Biochemistry and Molecular Biology
Shandong University 1998 — 2002
Bachelor's degree, Biotechnology
Merck September 2014 - Present
FDA May 2014 - August 2014
Johns Hopkins University School of Medicine August 2009 - April 2014
The Ohio State University Medical Center May 2007 - August 2009
School of Pharmacy, The Ohio State University November 2005 - May 2007
Skills
Drug Metabolism, Pharmacokinetics, Bioanalysis, In Vitro, LC-MS, Drug Delivery, Pharmacology, Drug Discovery, Translational Medicine, Toxicology, Cell Culture, Nanoparticles, ELISA, Biochemistry, Western Blotting, Tissue Culture, Cancer, Cell Biology, Molecular Biology, Clinical Development, Chromatography, Biomarkers
Education
The Johns Hopkins University School of Medicine 2009 — 2014
Doctor of Philosophy (Ph.D.), Clinical Pharmacology, Drug Metabolism, Pharmacometrics
The Ohio State University 2007 — 2009
Master of Science (MS), Medicinal Chemistry, School of Pharmacy
Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences 2002 — 2005
Master of Science (MS), Biochemistry and Molecular Biology
Shandong University 1998 — 2002
Bachelor's degree, Biotechnology
Sandra Small's FDA Experience September 2011 - May 2013
Job
Industry Higher Education
Experience
NYS Center of Excellence June 2013 - Present
FDA September 2011 - May 2013
University at Buffalo August 2004 - June 2011
Genencor International 2001 - 2004
Wayne Central Schools and Franklin High School 2003 - 2003
Skills
Molecular Cloning, Western Blotting, Molecular Biology, Biochemistry, qPCR, Science Education, Tissue Culture, Microbiology, Cell, RT-PCR, Teamwork
Education
State University of New York at Buffalo
Ph.D.
St. John Fisher College
B.S.
NYS Center of Excellence June 2013 - Present
FDA September 2011 - May 2013
University at Buffalo August 2004 - June 2011
Genencor International 2001 - 2004
Wayne Central Schools and Franklin High School 2003 - 2003
Skills
Molecular Cloning, Western Blotting, Molecular Biology, Biochemistry, qPCR, Science Education, Tissue Culture, Microbiology, Cell, RT-PCR, Teamwork
Education
State University of New York at Buffalo
Ph.D.
St. John Fisher College
B.S.
Sherri Hubby's FDA Experience December 1989 - September 1998
Job Senior Director, Quality Assurance, Risk and Compliance, U.S., Premier Research
Industry Pharmaceuticals
Experience
Premier Research June 2008 - Present
RCRC IRB October 2006 - June 2008
PPD September 1998 - October 2006
FDA December 1989 - September 1998
Skills
Pharmaceutical Industry, FDA, Regulatory Affairs, GCP, CRO, Sop, Clinical Trials, Clinical Research, ICH-GCP, Quality Assurance, Protocol, Medical Devices, Pharmaceutics, Software Documentation, 21 CFR Part 11, Regulatory Submissions, EDC, CTMS, Clinical Development, Clinical Monitoring, SOP
Education
Schreiner University
Associate's degree, Pharmacy
Texas Woman's University
Bachelor of Science (B.S.), Marketing
The University of Texas at Austin
Pharmacy
UT Health Science Center
Dietetics and Clinical Nutrition Services
Premier Research June 2008 - Present
RCRC IRB October 2006 - June 2008
PPD September 1998 - October 2006
FDA December 1989 - September 1998
Skills
Pharmaceutical Industry, FDA, Regulatory Affairs, GCP, CRO, Sop, Clinical Trials, Clinical Research, ICH-GCP, Quality Assurance, Protocol, Medical Devices, Pharmaceutics, Software Documentation, 21 CFR Part 11, Regulatory Submissions, EDC, CTMS, Clinical Development, Clinical Monitoring, SOP
Education
Schreiner University
Associate's degree, Pharmacy
Texas Woman's University
Bachelor of Science (B.S.), Marketing
The University of Texas at Austin
Pharmacy
UT Health Science Center
Dietetics and Clinical Nutrition Services
Yuri Kuzmycz's FDA Experience 1997 - 1998
Job Director, CM Operations Head of Production Services at RBC Capital Markets
Industry Financial Services
Experience
RBC Capital Markets November 2014 - Present
Barclays May 2004 - November 2014
Nadan & Associates 2000 - 2004
Becton Dickinson & Co 1998 - 2000
FDA 1997 - 1998
Skills
Business Analysis, Commodity, SDLC, Trading Systems, Project Management, Process Improvement, Commodity Markets, Project Delivery, Market Risk, Openlink, Six Sigma, Analysis, Management, Risk Management, ETRM, Middle Office, Change Management, Leadership, Market Data, Governance, Process Optimization, Resource Management, Investment Banking, Derivatives, IT Strategy, Back Office, Dodd-Frank, Requirements Gathering, Steering, Coaching, Cross-functional Team..., PMO, Vendor Management, Financial Services, Software Project..., Business Requirements, Requirements Analysis, Big Data, Program Management, Stakeholder Management, Project Planning, Team Leadership, Hadoop, Oracle
Education
St. Mary's College of Maryland 1993 — 1997
Bachelor's degree, Chemistry
RBC Capital Markets November 2014 - Present
Barclays May 2004 - November 2014
Nadan & Associates 2000 - 2004
Becton Dickinson & Co 1998 - 2000
FDA 1997 - 1998
Skills
Business Analysis, Commodity, SDLC, Trading Systems, Project Management, Process Improvement, Commodity Markets, Project Delivery, Market Risk, Openlink, Six Sigma, Analysis, Management, Risk Management, ETRM, Middle Office, Change Management, Leadership, Market Data, Governance, Process Optimization, Resource Management, Investment Banking, Derivatives, IT Strategy, Back Office, Dodd-Frank, Requirements Gathering, Steering, Coaching, Cross-functional Team..., PMO, Vendor Management, Financial Services, Software Project..., Business Requirements, Requirements Analysis, Big Data, Program Management, Stakeholder Management, Project Planning, Team Leadership, Hadoop, Oracle
Education
St. Mary's College of Maryland 1993 — 1997
Bachelor's degree, Chemistry
Brandon Feinen's FDA Experience May 2010 - July 2014
Job Project Manager at Epic
Industry Information Technology and Services
Experience
Epic July 2014 - Present
FDA May 2010 - July 2014
Education
State University of New York at Buffalo - School of Medicine & Biomedical Sciences 2003 — 2010
Ph.D., Microbiology/Immunology
SUNY Fredonia
B.S., Molecular Genetics
Epic July 2014 - Present
FDA May 2010 - July 2014
Education
State University of New York at Buffalo - School of Medicine & Biomedical Sciences 2003 — 2010
Ph.D., Microbiology/Immunology
SUNY Fredonia
B.S., Molecular Genetics
Sandra Ceballos's FDA Experience November 2011 - Present
Job Management Analyst at FDA
Industry Human Resources
Experience
FDA November 2011 - Present
US Army Retired March 2007 - November 2009
US Army Reserves 99th Regional Readiness Command July 2002 - February 2007
HHS, HRSA-HIV-AIDS Bureau, OPPD May 2001 - September 2004
Skills
Leadership Development, Equal Opportunities, Army, Military, Security Clearance, Leadership, Policy, Command, Program Management, Conflict Resolution, Human Resources, Training, Government, Supervisory Skills, Operations Management, Recruiting, Career Counseling, Management, Administration, Analysis, Military Experience
Education
American Military University 2011 — 2011
BA
San Francisco State University 1992 — 1992
BA, General
FDA November 2011 - Present
US Army Retired March 2007 - November 2009
US Army Reserves 99th Regional Readiness Command July 2002 - February 2007
HHS, HRSA-HIV-AIDS Bureau, OPPD May 2001 - September 2004
Skills
Leadership Development, Equal Opportunities, Army, Military, Security Clearance, Leadership, Policy, Command, Program Management, Conflict Resolution, Human Resources, Training, Government, Supervisory Skills, Operations Management, Recruiting, Career Counseling, Management, Administration, Analysis, Military Experience
Education
American Military University 2011 — 2011
BA
San Francisco State University 1992 — 1992
BA, General
Amber Dhingra's FDA Experience 2005 - 2014
Job Director at Federal Government in Washington DC
Industry Government Administration
Experience
Federal Government in Washington DC 2005 - Present
FDA 2005 - 2014
NOAA: National Oceanic & Atmospheric Administration 1999 - 2004
Skills
CPA, Policy, Policy Analysis, Government
Education
St. Xavier's College 1970 — 1974
Bachelor of Arts (B.A.)Honors, Psychology, Honors
Federal Government in Washington DC 2005 - Present
FDA 2005 - 2014
NOAA: National Oceanic & Atmospheric Administration 1999 - 2004
Skills
CPA, Policy, Policy Analysis, Government
Education
St. Xavier's College 1970 — 1974
Bachelor of Arts (B.A.)Honors, Psychology, Honors
Caitlin Eckert's FDA Experience 2007 - 2008
Job Special Education Long Term Substitute at Frederick County Public Schools
Industry Nonprofit Organization Management
Experience
Frederick County Public Schools April 2013 - Present
Loyola University Maryland June 2012 - May 2013
Frederick County Public Schools January 2013 - April 2013
Genesis HealthCare Glade Valley Center 2011 - April 2013
Carroll County Public Schools September 2012 - December 2012
Center for Adoption Support and Education 2010 - 2012
FDA 2007 - 2008
Skills
Grants, Youth Development, Program Management, Human Resources, Program Development, Grant Writing, Community Outreach, Nonprofits, Program Evaluation, Public Speaking, Research, Volunteer Management, Teaching, Career Counseling, Student Counseling, Grief Counseling, Mental Health Counseling, Peer Mediation, Therapeutic Recreation
Education
Loyola University of Maryland 2011 — 2013
Master of Education (M.Ed.), School Counseling
St. Mary's College of Maryland 2006 — 2010
Bachelor of Arts (B.A.), Psychology
Frederick County Public Schools April 2013 - Present
Loyola University Maryland June 2012 - May 2013
Frederick County Public Schools January 2013 - April 2013
Genesis HealthCare Glade Valley Center 2011 - April 2013
Carroll County Public Schools September 2012 - December 2012
Center for Adoption Support and Education 2010 - 2012
FDA 2007 - 2008
Skills
Grants, Youth Development, Program Management, Human Resources, Program Development, Grant Writing, Community Outreach, Nonprofits, Program Evaluation, Public Speaking, Research, Volunteer Management, Teaching, Career Counseling, Student Counseling, Grief Counseling, Mental Health Counseling, Peer Mediation, Therapeutic Recreation
Education
Loyola University of Maryland 2011 — 2013
Master of Education (M.Ed.), School Counseling
St. Mary's College of Maryland 2006 — 2010
Bachelor of Arts (B.A.), Psychology
Aaron Salgado's FDA Experience January 2009 - August 2012
Job Ramp Agent at Servisair
Industry Government Administration
Experience
Servisair October 2012 - Present
FDA January 2009 - August 2012
RGIS August 2008 - November 2009
Scholastic Book Fairs January 2008 - August 2008
Wendys International July 2005 - November 2007
Skills
Data Entry, Microsoft Office, Microsoft Excel, Customer Service, Outlook, Microsoft Word, PowerPoint, Data Analysis, Time Management, Inventory Management, Software Documentation, Research, Analysis
Education
Everest University 2010 — 2012
AS; BA, Computer Information Science; Computer Information Science
Seminole State College of Florida
Servisair October 2012 - Present
FDA January 2009 - August 2012
RGIS August 2008 - November 2009
Scholastic Book Fairs January 2008 - August 2008
Wendys International July 2005 - November 2007
Skills
Data Entry, Microsoft Office, Microsoft Excel, Customer Service, Outlook, Microsoft Word, PowerPoint, Data Analysis, Time Management, Inventory Management, Software Documentation, Research, Analysis
Education
Everest University 2010 — 2012
AS; BA, Computer Information Science; Computer Information Science
Seminole State College of Florida
Fang Wu's FDA Experience June 2014 - Present
Job Reviewer at FDA
Industry Government Administration
Experience
FDA June 2014 - Present
FDA April 2012 - June 2014
Department of pharmaceutical sciences, University at Buffalo January 2009 - April 2012
Center for Vaccine Biology and Immunology, University of Rochester Medical Center 2007 - January 2009
French National Institute of Health and Medical Research (Inserm), University of Grenoble I 2005 - 2006
Skills
Pharmacokinetics, Drug Delivery, Drug Discovery, Pharmacology, Cell Culture, In Vitro, Cancer, Biomarkers, HPLC, In Vivo, PK/PD
Education
Shenyang Pharmaceutical University
B.S., Pharmacy
Sichuan University
Ph.D., Pharmaceutical Sciences
University at Buffalo
FDA June 2014 - Present
FDA April 2012 - June 2014
Department of pharmaceutical sciences, University at Buffalo January 2009 - April 2012
Center for Vaccine Biology and Immunology, University of Rochester Medical Center 2007 - January 2009
French National Institute of Health and Medical Research (Inserm), University of Grenoble I 2005 - 2006
Skills
Pharmacokinetics, Drug Delivery, Drug Discovery, Pharmacology, Cell Culture, In Vitro, Cancer, Biomarkers, HPLC, In Vivo, PK/PD
Education
Shenyang Pharmaceutical University
B.S., Pharmacy
Sichuan University
Ph.D., Pharmaceutical Sciences
University at Buffalo
Jianmei Zhu's FDA Experience September 2011 - Present
Job Reseach fellow at FDA
Industry Higher Education
Experience
FDA September 2011 - Present
Johns Hopkins Bloomberg School of Public Health August 2005 - September 2011
Education
Shanghai Jiao Tong University 1999 — 2003
Bachelor of Science (B.S.), Biological Sciences
FDA September 2011 - Present
Johns Hopkins Bloomberg School of Public Health August 2005 - September 2011
Education
Shanghai Jiao Tong University 1999 — 2003
Bachelor of Science (B.S.), Biological Sciences
Tabetha M. Bonacci's FDA Experience October 2009 - September 2011
Job Senior Manager, Regulatory Affairs CMC at Amgen
Industry Biotechnology
Experience
Amgen March 2015 - Present
Amgen October 2011 - March 2015
FDA October 2009 - September 2011
Eli Lilly and Company January 2007 - September 2009
Education
University of Rochester School of Medicine and Dentistry 2000 — 2006
PhD, Pharmacology
St. Norbert College 1996 — 2000
BS, Biology and Chemistry
Amgen March 2015 - Present
Amgen October 2011 - March 2015
FDA October 2009 - September 2011
Eli Lilly and Company January 2007 - September 2009
Education
University of Rochester School of Medicine and Dentistry 2000 — 2006
PhD, Pharmacology
St. Norbert College 1996 — 2000
BS, Biology and Chemistry
LaTisha Friend's FDA Experience July 2002 - Present
Job Chemist at FDA
Industry
Experience
FDA July 2002 - Present
Education
Southern University and Agricultural and Mechanical College at Baton Rouge 1992 — 1998
BS, Chemistry
FDA July 2002 - Present
Education
Southern University and Agricultural and Mechanical College at Baton Rouge 1992 — 1998
BS, Chemistry
Fang Yuan's FDA Experience May 2014 - Present
Job Fellow at FDA
Industry Government Administration
Experience
FDA May 2014 - Present
University of Nebraska Medical Center August 2009 - April 2014
Amgen May 2013 - August 2013
College of Pharmacy, Sichuan University September 2005 - August 2008
College of pharmacy, Sichuan University September 2001 - August 2005
Skills
Drug Delivery, Pharmaceutics, Formulation Development, oral care, Cell culture, Microbiology
Education
University of Nebraska Medical Center 2009 — 2014
Ph.D, pharmaceutical science
Sichuan University 2005 — 2008
MS, pharmaceutic science
Sichuan University 2001 — 2005
BS, pharmacy
FDA May 2014 - Present
University of Nebraska Medical Center August 2009 - April 2014
Amgen May 2013 - August 2013
College of Pharmacy, Sichuan University September 2005 - August 2008
College of pharmacy, Sichuan University September 2001 - August 2005
Skills
Drug Delivery, Pharmaceutics, Formulation Development, oral care, Cell culture, Microbiology
Education
University of Nebraska Medical Center 2009 — 2014
Ph.D, pharmaceutical science
Sichuan University 2005 — 2008
MS, pharmaceutic science
Sichuan University 2001 — 2005
BS, pharmacy
Sally Winkler's FDA Experience June 2012 - September 2012
Job Bioengineering Graduate Student, UCB/UCSF
Industry Biotechnology
Experience
UC Berkeley & UCSF Bioengineering August 2014 - Present
Stanford University January 2013 - June 2014
FDA June 2012 - September 2012
Transgenomic June 2011 - September 2011
Skills
Research, Data Analysis, Western Blotting, Matlab, Medical Devices, Statistics, Clinical Research, Cell Culture, PCR
Education
University of California, Berkeley 2014 — 2019
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
University of California, San Francisco 2014 — 2019
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
Stanford University 2010 — 2014
BS, Bioengineering
UC Berkeley & UCSF Bioengineering August 2014 - Present
Stanford University January 2013 - June 2014
FDA June 2012 - September 2012
Transgenomic June 2011 - September 2011
Skills
Research, Data Analysis, Western Blotting, Matlab, Medical Devices, Statistics, Clinical Research, Cell Culture, PCR
Education
University of California, Berkeley 2014 — 2019
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
University of California, San Francisco 2014 — 2019
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
Stanford University 2010 — 2014
BS, Bioengineering
Onianwa Anthony's FDA Experience May 2002 - Present
Job CSO at FDA
Industry Government Administration
Experience
FDA May 2002 - Present
Education
St. Edward's University
B.A., Biology
University of Illinois at Chicago
BS, Medical Laboratory Science
University of Illinois at Chicago
MPH, Environmental Health & Occupational Safety
FDA May 2002 - Present
Education
St. Edward's University
B.A., Biology
University of Illinois at Chicago
BS, Medical Laboratory Science
University of Illinois at Chicago
MPH, Environmental Health & Occupational Safety
Daudrille Lowe's FDA Experience February 2009 - Present
Job Conumer Safety Officer at FDA
Industry Oil & Energy
Experience
FDA February 2009 - Present
USDA, APHIS, PPQ May 1990 - February 2009
Education
Southern University and Agricultural and Mechanical College at Baton Rouge 1988 — 1993
B.S., Agriculture- Plant Science
FDA February 2009 - Present
USDA, APHIS, PPQ May 1990 - February 2009
Education
Southern University and Agricultural and Mechanical College at Baton Rouge 1988 — 1993
B.S., Agriculture- Plant Science
Adam Leung's FDA Experience January 2010 - November 2011
Job Chemist II at Actavis
Industry Pharmaceuticals
Experience
Actavis December 2013 - Present
Par Pharmaceutical May 2013 - December 2013
CGNP Manufacturing March 2012 - May 2013
FDA January 2010 - November 2011
Chevron September 2008 - June 2010
Skills
GMP, HPLC, GC, LC-MS,..., Dissolution Testing, HPLC, Gas Chromatography, UV/Vis, Validation, SOP, Laboratory, Quality Control, Atomic Spectroscopy
Education
San Francisco State University 2010 — 2013
Master's degree, Chemistry, 3.81
San Francisco State University 2006 — 2008
Bachelor, Biochemistry
Actavis December 2013 - Present
Par Pharmaceutical May 2013 - December 2013
CGNP Manufacturing March 2012 - May 2013
FDA January 2010 - November 2011
Chevron September 2008 - June 2010
Skills
GMP, HPLC, GC, LC-MS,..., Dissolution Testing, HPLC, Gas Chromatography, UV/Vis, Validation, SOP, Laboratory, Quality Control, Atomic Spectroscopy
Education
San Francisco State University 2010 — 2013
Master's degree, Chemistry, 3.81
San Francisco State University 2006 — 2008
Bachelor, Biochemistry
Joseph Barbera's FDA Experience 1976 - 1986
Job Environmental Management at National Grid
Industry Utilities
Experience
National Grid June 1986 - Present
FDA 1976 - 1986
FDA 1976 - 1983
FDA 1976 - 1983
Education
St. Francis College 1971 — 1975
Bachelor of Science (BS)
National Grid June 1986 - Present
FDA 1976 - 1986
FDA 1976 - 1983
FDA 1976 - 1983
Education
St. Francis College 1971 — 1975
Bachelor of Science (BS)
Jean Kelahan's FDA Experience June 1994 - February 2008
Job Regional External Affairs at US Department of Health and Human Services
Industry Government Administration
Experience
US Department of Health and Human Services May 2010 - Present
FDA June 1994 - February 2008
Skills
Registered Dietitian, Cpr Certified, Regulatory Compliance, Government Auditing, Food and Drug Law, Health Insurance..., Public Health Educator, Public Health Emergency..., US Public Health..., Computer Literate, Nutrtition Counseling
Education
SUNY Cortland 1985 — 1987
Bachelor of Science (BS), Health Sciences
SUNY Morrisville 1983 — 1985
Associates in Applied Sciences, Nutrtition
US Department of Health and Human Services May 2010 - Present
FDA June 1994 - February 2008
Skills
Registered Dietitian, Cpr Certified, Regulatory Compliance, Government Auditing, Food and Drug Law, Health Insurance..., Public Health Educator, Public Health Emergency..., US Public Health..., Computer Literate, Nutrtition Counseling
Education
SUNY Cortland 1985 — 1987
Bachelor of Science (BS), Health Sciences
SUNY Morrisville 1983 — 1985
Associates in Applied Sciences, Nutrtition
Hyewon Kim's FDA Experience May 2014 - Present
Job Science staff at FDA
Industry Government Administration
Experience
FDA May 2014 - Present
FDA 2012 - April 2014
Pfizer May 2010 - August 2010
Novartis May 2009 - August 2009
Skills
NONMEM, S-Plus, R, WinNonlin, Stella, WinBUGS, SAS, Pharmacokinetics, Clinical Trials, Biostatistics, Pharmacology, Drug Development, Life Sciences, Clinical Development, Pharmacodynamics, Oncology
Education
University of Minnesota-Twin Cities 2007 — 2011
Ph. D., Pharmacometris
Seoul National University 2002 — 2004
MS, Clinical Pharmacy
Seoul National University 1998 — 2002
BS, Pharmacy
FDA May 2014 - Present
FDA 2012 - April 2014
Pfizer May 2010 - August 2010
Novartis May 2009 - August 2009
Skills
NONMEM, S-Plus, R, WinNonlin, Stella, WinBUGS, SAS, Pharmacokinetics, Clinical Trials, Biostatistics, Pharmacology, Drug Development, Life Sciences, Clinical Development, Pharmacodynamics, Oncology
Education
University of Minnesota-Twin Cities 2007 — 2011
Ph. D., Pharmacometris
Seoul National University 2002 — 2004
MS, Clinical Pharmacy
Seoul National University 1998 — 2002
BS, Pharmacy
Hyo L. Lee, PharmD's FDA Experience July 2013 - August 2013
Job Pharmacist at PBRMC
Industry Pharmaceuticals
Experience
Poplar Bluff Regional Medical Center August 2014 - Present
Genzyme, a Sanofi company March 2014 - April 2014
First Databank (FDB) February 2014 - March 2014
Missouri Baptist Medical Center November 2013 - December 2013
Barnes-Jewish Hospital October 2013 - November 2013
The Rehabilitation Institute of St. Louis September 2013 - October 2013
St. Louis College of Pharmacy October 2012 - October 2013
FDA July 2013 - August 2013
Alexian Brothers PACE Program June 2013 - July 2013
Shop 'n Save May 2013 - June 2013
Skills
Research, CPOE, Horizon Meds Manager, Patient Counseling, Patient Safety, Cardiopulmonary..., Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Public Speaking, Written & Oral..., Microsoft Office
Education
St. Louis College of Pharmacy 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy, magna cum laude
Biship Kelly High School 2005 — 2008
Poplar Bluff Regional Medical Center August 2014 - Present
Genzyme, a Sanofi company March 2014 - April 2014
First Databank (FDB) February 2014 - March 2014
Missouri Baptist Medical Center November 2013 - December 2013
Barnes-Jewish Hospital October 2013 - November 2013
The Rehabilitation Institute of St. Louis September 2013 - October 2013
St. Louis College of Pharmacy October 2012 - October 2013
FDA July 2013 - August 2013
Alexian Brothers PACE Program June 2013 - July 2013
Shop 'n Save May 2013 - June 2013
Skills
Research, CPOE, Horizon Meds Manager, Patient Counseling, Patient Safety, Cardiopulmonary..., Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Public Speaking, Written & Oral..., Microsoft Office
Education
St. Louis College of Pharmacy 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy, magna cum laude
Biship Kelly High School 2005 — 2008
Tracy J Washington's FDA Experience February 2009 - March 2012
Job Global Operations Auditor at Mylan
Industry Pharmaceuticals
Experience
Mylan October 2014 - Present
Mylan November 2012 - September 2014
Mylan Specialty April 2012 - November 2012
FDA February 2009 - March 2012
Tulane Medical Center December 2003 - May 2005
Skills
Quality Assurance, Quality Auditing, Quality Assurance Review, Root Cause Analysis, Critical Thinking, Problem Solving, Collaboration, Risk Based Inspection, Clinical Research, Biologics, Customer Service, Regulations, Technical Writing, Regulatory Affairs, Regulatory Requirements, FDA, GMP
Education
Southern Methodist University - Cox School of Business 2012 — 2012
Certificate, Entrepreneurship/Entrepreneurial Studies
Dillard University
Bachelor of Science (B.S.), Public Health Administration
University of New Orleans Graduate School of Education
Mylan October 2014 - Present
Mylan November 2012 - September 2014
Mylan Specialty April 2012 - November 2012
FDA February 2009 - March 2012
Tulane Medical Center December 2003 - May 2005
Skills
Quality Assurance, Quality Auditing, Quality Assurance Review, Root Cause Analysis, Critical Thinking, Problem Solving, Collaboration, Risk Based Inspection, Clinical Research, Biologics, Customer Service, Regulations, Technical Writing, Regulatory Affairs, Regulatory Requirements, FDA, GMP
Education
Southern Methodist University - Cox School of Business 2012 — 2012
Certificate, Entrepreneurship/Entrepreneurial Studies
Dillard University
Bachelor of Science (B.S.), Public Health Administration
University of New Orleans Graduate School of Education
Jeff Wooley's FDA Experience InvestigatorFDAMay 2007 - October 2012
Job Compliance Officer at FDA
Industry Government Administration
Experience
FDA InvestigatorFDAMay 2007 - October 2012
Skills
FDA GMP, Quality Auditing, 21 CFR, Medical Devices, Drug Safety, Food Safety
Education
Sam Houston State University 2004 — 2007
Bachelor of Science (BS), Biology, General
FDA InvestigatorFDAMay 2007 - October 2012
Skills
FDA GMP, Quality Auditing, 21 CFR, Medical Devices, Drug Safety, Food Safety
Education
Sam Houston State University 2004 — 2007
Bachelor of Science (BS), Biology, General
Elizabeth Ruggiero's FDA Experience July 2015 - Present
Job CSO
Industry Consumer Services
Experience
FDA July 2015 - Present
Best Buy May 2015 - July 2015
U.S. Fish and Wildlife Service September 2014 - June 2015
Best Buy June 2012 - May 2015
Best Buy April 2010 - June 2012
Best Buy July 2008 - April 2010
Skills
Microsoft Office, Order Management, Order Processing, Budget Monitoring, Supply Management, Microsoft Excel, Microsoft Word, Data Entry, Customer Service, Job Coaching, Bad Debt, Pipetting, Telephone Skills, Multi Tasking, Work Well Independently, Time Management, Organization, Problem Solving, Troubleshooting, Hiring, Customer Satisfaction, Recruiting, Retail, Interviews, Communication, Teamwork
Education
State University of New York College at Buffalo 2012 — 2014
Bachelor of Arts (B.A.), Biology, General
State University of New York at Buffalo 2008 — 2011
Bachelor of Arts (B.A.), Biology, General
FDA July 2015 - Present
Best Buy May 2015 - July 2015
U.S. Fish and Wildlife Service September 2014 - June 2015
Best Buy June 2012 - May 2015
Best Buy April 2010 - June 2012
Best Buy July 2008 - April 2010
Skills
Microsoft Office, Order Management, Order Processing, Budget Monitoring, Supply Management, Microsoft Excel, Microsoft Word, Data Entry, Customer Service, Job Coaching, Bad Debt, Pipetting, Telephone Skills, Multi Tasking, Work Well Independently, Time Management, Organization, Problem Solving, Troubleshooting, Hiring, Customer Satisfaction, Recruiting, Retail, Interviews, Communication, Teamwork
Education
State University of New York College at Buffalo 2012 — 2014
Bachelor of Arts (B.A.), Biology, General
State University of New York at Buffalo 2008 — 2011
Bachelor of Arts (B.A.), Biology, General
Kyle Chang's FDA Experience August 2012 - Present
Job Accountant at FDA
Industry Government Administration
Experience
FDA August 2012 - Present
JPB Partners February 2007 - August 2012
Deloitte Taiwan January 2000 - June 2003
Skills
Financial Analysis, Auditing, Business Strategy, Strategic Planning, Corporate Finance, Accounting, Financial Accounting, Due Diligence, Risk Management, Budgets
Education
University of Maryland College Park 2003 — 2005
Master of Science (MS), Information Management
Soochow University 1997 — 1999
Master of Business Administration (M.B.A.), Accounting
FDA August 2012 - Present
JPB Partners February 2007 - August 2012
Deloitte Taiwan January 2000 - June 2003
Skills
Financial Analysis, Auditing, Business Strategy, Strategic Planning, Corporate Finance, Accounting, Financial Accounting, Due Diligence, Risk Management, Budgets
Education
University of Maryland College Park 2003 — 2005
Master of Science (MS), Information Management
Soochow University 1997 — 1999
Master of Business Administration (M.B.A.), Accounting
Tessa Geary-Latham's FDA Experience August 2008 - Present
Job Investigator at FDA
Industry Government Administration
Experience
FDA August 2008 - Present
Pfizer (Wyeth) September 2007 - March 2008
Pfizer (Wyeth Research) December 2000 - April 2005
Skills
GLP, GMP, FDA, Validation, HPLC, SOP, Laboratory, Quality Control, Toxicology, Research, Analytical Chemistry, Chromatography, Pharmaceutical Industry
Education
State University of New York College at Plattsburgh 1998 — 2000
Bachelor of Science (B.S.), Biology, General
SUNY Canton 1996 — 1998
Associate of Arts and Sciences (A.A.S.), Liberal Arts and Sciences/Liberal Studies
FDA August 2008 - Present
Pfizer (Wyeth) September 2007 - March 2008
Pfizer (Wyeth Research) December 2000 - April 2005
Skills
GLP, GMP, FDA, Validation, HPLC, SOP, Laboratory, Quality Control, Toxicology, Research, Analytical Chemistry, Chromatography, Pharmaceutical Industry
Education
State University of New York College at Plattsburgh 1998 — 2000
Bachelor of Science (B.S.), Biology, General
SUNY Canton 1996 — 1998
Associate of Arts and Sciences (A.A.S.), Liberal Arts and Sciences/Liberal Studies
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