FDA Company
Industry: Federal agency
DescriptionThe Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Headquarters: Silver Spring, Maryland, United States Employees: 14,824 (2010) Jurisdiction: United States of America Founded: 30 June 1906 Subsidiaries: Center for Drug Evaluation and Research, Founders: Theodore Roosevelt, Harvey Washington Wiley
FDA List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at FDA. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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4,886 FDA employees in database. Find out everything there's to know about FDA employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
FDA Employees
Employee
Years
Job
Industry
Louis Payne Louis Payne's FDA Experience May 2012 - August 2012
Job Kids Assistant at Family YMCA
Industry Computer & Network Security
Experience
Family YMCA October 2013 - Present
FDA May 2012 - August 2012
Roland Grocery Store May 2011 - July 2011
Office of Generic Drugs May 2010 - August 2010
John Catering June 2009 - August 2009
James Television Service June 2009 - July 2009
Capital Sports Center March 2009 - June 2009
Rick Weber Basketball Camp June 2008 - July 2008
Skills
Computer Repair, Computer Security, Sales, Hip-Hop Dance, Dance, Jazz Dance, Basketball, Basketball Coaching, College Basketball, Drums, Drum Set, Shoes
Education
Pennsylvania State University-Penn State New Kensington 2013 — 2016
Bachelor of Science (BS), Information Technology
Waynesburg College 2011 — 2015
Bachelor's degree, Computer Science
Family YMCA October 2013 - Present
FDA May 2012 - August 2012
Roland Grocery Store May 2011 - July 2011
Office of Generic Drugs May 2010 - August 2010
John Catering June 2009 - August 2009
James Television Service June 2009 - July 2009
Capital Sports Center March 2009 - June 2009
Rick Weber Basketball Camp June 2008 - July 2008
Skills
Computer Repair, Computer Security, Sales, Hip-Hop Dance, Dance, Jazz Dance, Basketball, Basketball Coaching, College Basketball, Drums, Drum Set, Shoes
Education
Pennsylvania State University-Penn State New Kensington 2013 — 2016
Bachelor of Science (BS), Information Technology
Waynesburg College 2011 — 2015
Bachelor's degree, Computer Science
Djamila Harouaka Djamila Harouaka's FDA Experience December 2014 - Present
Job Consumer Safety Officer at FDA
Industry Research
Experience
FDA December 2014 - Present
National Institutes of Health August 2012 - December 2014
University of Virginia January 2011 - August 2012
University of Alabama at Birmingham 2003 - 2010
Pennsylvania State University February 2000 - July 2002
Skills
PCR, Western Blotting, Molecular Biology, Microscopy, Biochemistry, Cell Biology, Biotechnology, Immunoprecipitation, Protein Chemistry, Flow Cytometry, Immunofluorescence, Cell Culture, Protein Expression, qPCR, Genetics, ELISA, Assay Development, Tissue Culture, SDS-PAGE, Immunohistochemistry, Transfection, Fluorescence, Molecular Cloning, Protein Purification, Confocal Microscopy, Research, RT-PCR, Cell, Animal Models
Education
University of Alabama at Birmingham 2003 — 2010
PhD, Microbiology/Virology
Penn State University 1999 — 2003
BSc, Microbiology
FDA December 2014 - Present
National Institutes of Health August 2012 - December 2014
University of Virginia January 2011 - August 2012
University of Alabama at Birmingham 2003 - 2010
Pennsylvania State University February 2000 - July 2002
Skills
PCR, Western Blotting, Molecular Biology, Microscopy, Biochemistry, Cell Biology, Biotechnology, Immunoprecipitation, Protein Chemistry, Flow Cytometry, Immunofluorescence, Cell Culture, Protein Expression, qPCR, Genetics, ELISA, Assay Development, Tissue Culture, SDS-PAGE, Immunohistochemistry, Transfection, Fluorescence, Molecular Cloning, Protein Purification, Confocal Microscopy, Research, RT-PCR, Cell, Animal Models
Education
University of Alabama at Birmingham 2003 — 2010
PhD, Microbiology/Virology
Penn State University 1999 — 2003
BSc, Microbiology
Nicky Whitmire Nicky Whitmire's FDA Experience November 2003 - December 2006
Job Health & Lifestyle Coach
Industry Health, Wellness and Fitness
Experience
Eating Healthy With Nicky August 2012 - Present
Whitapirations January 2011 - Present
Amazing Balance September 2010 - Present
TSS Photography May 2010 - Present
FDA November 2003 - December 2006
FDA January 1993 - November 2003
Skills
Coaching, Community Outreach, Customer Service, Editing, Entrepreneurship, Event Planning, Fundraising, Government, Microsoft Excel, Microsoft Word, Microsoft Office, Non-profits, Photography, PowerPoint, Program Development, Public Health, Public Speaking, Research, Sales, Social Media, Team Building, Wellness, Event Management, Blogging, Nonprofits, Social Networking, Public Relations
Education
Prince George's Community College 1993 — 1996
Potomac Senior High School 1985 — 1988
High School Diploma
Eating Healthy With Nicky August 2012 - Present
Whitapirations January 2011 - Present
Amazing Balance September 2010 - Present
TSS Photography May 2010 - Present
FDA November 2003 - December 2006
FDA January 1993 - November 2003
Skills
Coaching, Community Outreach, Customer Service, Editing, Entrepreneurship, Event Planning, Fundraising, Government, Microsoft Excel, Microsoft Word, Microsoft Office, Non-profits, Photography, PowerPoint, Program Development, Public Health, Public Speaking, Research, Sales, Social Media, Team Building, Wellness, Event Management, Blogging, Nonprofits, Social Networking, Public Relations
Education
Prince George's Community College 1993 — 1996
Potomac Senior High School 1985 — 1988
High School Diploma
Stephanie (Kleyman) Gernant, PharmD, MS Stephanie (Kleyman) Gernant, PharmD, MS's FDA Experience May 2012 - June 2012
Job Assistant Professor at Nova Southeastern University
Industry Pharmaceuticals
Experience
Nova Southeastern University July 2015 - Present
Purdue University College of Pharmacy July 2013 - July 2015
Penobscot Community Health Care June 2012 - June 2013
FDA May 2012 - June 2012
Kroger Pharmacy February 2009 - February 2012
Covidien January 2008 - August 2008
Skills
Medication Therapy..., Certified Immunizer, Pharmacy Practice, FDA, Immunization, Patient Counseling, Clinical Pharmacology, Diabetes, Pharmaceutical Industry, Pharmacy Automation, Pharmacology, Healthcare, Pharmacy, Clinical Research, Pharmacists, Patient Safety
Education
Purdue University 2013 — 2015
Master of Science (MS), Medication Safety
The Ohio State University 2008 — 2012
Doctor of Pharmacy (PharmD)
University of Missouri-Columbia 2003 — 2007
BS, Biology
Nova Southeastern University July 2015 - Present
Purdue University College of Pharmacy July 2013 - July 2015
Penobscot Community Health Care June 2012 - June 2013
FDA May 2012 - June 2012
Kroger Pharmacy February 2009 - February 2012
Covidien January 2008 - August 2008
Skills
Medication Therapy..., Certified Immunizer, Pharmacy Practice, FDA, Immunization, Patient Counseling, Clinical Pharmacology, Diabetes, Pharmaceutical Industry, Pharmacy Automation, Pharmacology, Healthcare, Pharmacy, Clinical Research, Pharmacists, Patient Safety
Education
Purdue University 2013 — 2015
Master of Science (MS), Medication Safety
The Ohio State University 2008 — 2012
Doctor of Pharmacy (PharmD)
University of Missouri-Columbia 2003 — 2007
BS, Biology
Jake O'Donnell Jake O'Donnell's FDA Experience 1996 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA 1996 - Present
Naval Air Warfare Center 1983 - 1996
Skills
FDA, CAPA, Federal Government, Quality Assurance, Quality Management, Quality Auditing
Education
Penn State University
Bachelor of Science (BS), Mechanical Engineering
FDA 1996 - Present
Naval Air Warfare Center 1983 - 1996
Skills
FDA, CAPA, Federal Government, Quality Assurance, Quality Management, Quality Auditing
Education
Penn State University
Bachelor of Science (BS), Mechanical Engineering
Laura Whare Laura Whare's FDA Experience February 2012 - Present
Job Consumer Safety Officer at FDA
Industry Government Administration
Experience
FDA February 2012 - Present
Lancaster Laboratories June 2008 - February 2012
Education
Penn State University 2003 — 2007
Bachelor of Science (BS), Life Science
West York HS
West York HS
FDA February 2012 - Present
Lancaster Laboratories June 2008 - February 2012
Education
Penn State University 2003 — 2007
Bachelor of Science (BS), Life Science
West York HS
West York HS
Deyi Zhang's FDA Experience February 2015 - Present
Job Scientist at FDA
Industry Pharmaceuticals
Experience
FDA February 2015 - Present
CrownBio January 2013 - January 2015
CrownBio January 2012 - December 2012
CrownBio August 2010 - December 2011
Eli Lilly July 2000 - June 2010
University of Pennsylvania 1998 - 2000
Skills
Medicinal Chemistry, Drug Design, Neuroscience, GPCRs, Cell, Oncology, Cancer, Kinases, Synthetic Organic..., Inflammation, Ion Channels, Drug Discovery, Organic Chemistry, Lead Change, Organic Synthesis, Pharmacology, Chemistry, Assay Development, Drug Development, ADME, Clinical Development
Education
University of Pennsylvania 1998 — 2000
Post-Doc, Organic chemistry
University of Notre Dame 1994 — 1998
Doctor of Philosophy (Ph.D.), Organic Chemistry
Peking University 1988 — 1991
MS, Organic chemistry
Peking University 1984 — 1988
BS, Chemistry
FDA February 2015 - Present
CrownBio January 2013 - January 2015
CrownBio January 2012 - December 2012
CrownBio August 2010 - December 2011
Eli Lilly July 2000 - June 2010
University of Pennsylvania 1998 - 2000
Skills
Medicinal Chemistry, Drug Design, Neuroscience, GPCRs, Cell, Oncology, Cancer, Kinases, Synthetic Organic..., Inflammation, Ion Channels, Drug Discovery, Organic Chemistry, Lead Change, Organic Synthesis, Pharmacology, Chemistry, Assay Development, Drug Development, ADME, Clinical Development
Education
University of Pennsylvania 1998 — 2000
Post-Doc, Organic chemistry
University of Notre Dame 1994 — 1998
Doctor of Philosophy (Ph.D.), Organic Chemistry
Peking University 1988 — 1991
MS, Organic chemistry
Peking University 1984 — 1988
BS, Chemistry
Juliana Peters Juliana Peters's FDA Experience May 2006 - August 2006
Job Senior Research Analyst at Beyond
Industry Research
Experience
Beyond April 2015 - Present
Beyond April 2013 - April 2015
Beyond April 2013 - April 2014
Penn State University August 2011 - August 2012
Penn State University August 2009 - May 2012
NAVAIR May 2008 - August 2008
University of Florida August 2006 - May 2008
FDA May 2006 - August 2006
Skills
SPSS, E-Prime, R, Minitab, Research, Cognition, Bilingualism, Psycholinguistics, Statistics, Research Design, Spanish, Cognitive Psychology, Project Management, Online Technology, Matlab, Qualitative Research, Psychology, fMRI
Education
Penn State University 2009 — 2012
Master of Science (M.S.), Cognitive Psychology and Psycholinguistics
University of Florida 2005 — 2009
Bachelor of Science (B.S.), Psychology
University of Florida 2005 — 2009
Bachelor of Arts (B.A.), Spanish
Beyond April 2015 - Present
Beyond April 2013 - April 2015
Beyond April 2013 - April 2014
Penn State University August 2011 - August 2012
Penn State University August 2009 - May 2012
NAVAIR May 2008 - August 2008
University of Florida August 2006 - May 2008
FDA May 2006 - August 2006
Skills
SPSS, E-Prime, R, Minitab, Research, Cognition, Bilingualism, Psycholinguistics, Statistics, Research Design, Spanish, Cognitive Psychology, Project Management, Online Technology, Matlab, Qualitative Research, Psychology, fMRI
Education
Penn State University 2009 — 2012
Master of Science (M.S.), Cognitive Psychology and Psycholinguistics
University of Florida 2005 — 2009
Bachelor of Science (B.S.), Psychology
University of Florida 2005 — 2009
Bachelor of Arts (B.A.), Spanish
Chris Dugard's FDA Experience October 2014 - Present
Job Biologist/Lead Reviewer at FDA
Industry Research
Experience
FDA October 2014 - Present
U.S. Food and Drug Administration August 2013 - September 2014
Purdue University August 2011 - May 2013
Purdue University May 2010 - August 2011
Skills
Analytical Chemistry, HPLC, Chemistry, UV/Vis, Mass Spectrometry, Chromatography, LC-MS, Biochemistry, Science, Organic Chemistry, Microbiology, Laboratory, DNA sequencing, DNA Sequencing
Education
Purdue University 2011 — 2013
Master of Science (MS), Botany and Plant Pathology
Purdue University 2004 — 2008
Bachelor of Science (BS), Genetics
FDA October 2014 - Present
U.S. Food and Drug Administration August 2013 - September 2014
Purdue University August 2011 - May 2013
Purdue University May 2010 - August 2011
Skills
Analytical Chemistry, HPLC, Chemistry, UV/Vis, Mass Spectrometry, Chromatography, LC-MS, Biochemistry, Science, Organic Chemistry, Microbiology, Laboratory, DNA sequencing, DNA Sequencing
Education
Purdue University 2011 — 2013
Master of Science (MS), Botany and Plant Pathology
Purdue University 2004 — 2008
Bachelor of Science (BS), Genetics
Ricky ALI Ricky ALI's FDA Experience 2011 - Present
Job Department of Defense Police
Industry Security and Investigations
Experience
Department of Defense Police January 2012 - Present
The Kitchen Staff Restaurant and Catering Services 2011 - Present
FDA 2011 - Present
United States Marine Corps October 2009 - Present
Wired For Business Incorporated January 2008 - Present
United States Marine Corps November 2004 - Present
United States Marine Corps January 2004 - Present
APM Financial Solutions August 2007 - January 2009
Citizens Bank March 2006 - June 2007
2004-2006PNC Bank January 2004 - January 2006
Skills
Finance, Military, Enforcement, Team Building, Government, Public Speaking, Public Relations, Management, Event Management, PowerPoint, Crisis Management, Microsoft Excel, Budgets, Operations Management, Business Analysis, French, Customer Service, Event Planning, Physical Security, Negotiation, Patrol, Training, Accounts Receivable, Homeland Security, Emergency Management, Police, Microsoft Office, Leadership, Change Management, Personal Security, Counterterrorism, Project Management, Banking, International Relations, Risk Management, Strategic Planning, Team Leadership, Protection, Marketing Strategy, Project Planning, New Business Development, Security, Microsoft Word, Research, Recruiting, Social Networking, Strategic Communications, Logistics, Program Management, Marketing Communications
Education
Philadelphia University 2002 — 2003
Bachelor of Business Administration (B.B.A.), Business
Baccalauréat Français 1997 — 1999
Diploma, French Language and Civilization
University of Ghana 1997 — 1999
Associate of Arts (A.A.), Literature
Alliance Francaise d Paris 1993 — 1997
Diploma, Human and Social Sciences
Legon UniversityAccra
Business administration; English Literature
Marine Corps Institute
Philadelphia University
Marketing and business
Department of Defense Police January 2012 - Present
The Kitchen Staff Restaurant and Catering Services 2011 - Present
FDA 2011 - Present
United States Marine Corps October 2009 - Present
Wired For Business Incorporated January 2008 - Present
United States Marine Corps November 2004 - Present
United States Marine Corps January 2004 - Present
APM Financial Solutions August 2007 - January 2009
Citizens Bank March 2006 - June 2007
2004-2006PNC Bank January 2004 - January 2006
Skills
Finance, Military, Enforcement, Team Building, Government, Public Speaking, Public Relations, Management, Event Management, PowerPoint, Crisis Management, Microsoft Excel, Budgets, Operations Management, Business Analysis, French, Customer Service, Event Planning, Physical Security, Negotiation, Patrol, Training, Accounts Receivable, Homeland Security, Emergency Management, Police, Microsoft Office, Leadership, Change Management, Personal Security, Counterterrorism, Project Management, Banking, International Relations, Risk Management, Strategic Planning, Team Leadership, Protection, Marketing Strategy, Project Planning, New Business Development, Security, Microsoft Word, Research, Recruiting, Social Networking, Strategic Communications, Logistics, Program Management, Marketing Communications
Education
Philadelphia University 2002 — 2003
Bachelor of Business Administration (B.B.A.), Business
Baccalauréat Français 1997 — 1999
Diploma, French Language and Civilization
University of Ghana 1997 — 1999
Associate of Arts (A.A.), Literature
Alliance Francaise d Paris 1993 — 1997
Diploma, Human and Social Sciences
Legon UniversityAccra
Business administration; English Literature
Marine Corps Institute
Philadelphia University
Marketing and business
Angie Gravois, RN Angie Gravois, RN's FDA Experience May 2011 - Present
Job Case Manager
Industry Health, Wellness and Fitness
Experience
FDA May 2011 - Present
Virginia College June 2013 - July 2014
Health and Wellness Resources February 2005 - July 2014
Skills
Chronic Illness, Fibromyalgia, Chronic Pain, Public Health, Wellness, Patient Advocacy, Treatment, Health Promotion, Health Policy, Healthcare, Pain Management, Health Communication, Health Literacy, Health Advocacy, Patient Education, Mobile Health, Program Evaluation, Nutrition, Women's Health, Community Outreach, Case Management, Public Speaking, Health Education
Education
Pensacola Junior College 1990 — 1992
ASN, Registered Nursing
FDA May 2011 - Present
Virginia College June 2013 - July 2014
Health and Wellness Resources February 2005 - July 2014
Skills
Chronic Illness, Fibromyalgia, Chronic Pain, Public Health, Wellness, Patient Advocacy, Treatment, Health Promotion, Health Policy, Healthcare, Pain Management, Health Communication, Health Literacy, Health Advocacy, Patient Education, Mobile Health, Program Evaluation, Nutrition, Women's Health, Community Outreach, Case Management, Public Speaking, Health Education
Education
Pensacola Junior College 1990 — 1992
ASN, Registered Nursing
Andrew Townes Andrew Townes's FDA Experience May 2011 - August 2014
Job Designer & Coder, Web Design
Industry Design
Experience
Townes Bros Design Company May 2015 - Present
Philadelphia University January 2011 - May 2015
Design Expo 2015 - 2015
FDA May 2011 - August 2014
Philadelphia 76ers 2013 - 2014
Philadelphia University September 2011 - May 2012
Kumon October 2008 - September 2011
Skills
Illustrator, InDesign, Sketching, Adobe Design Programs, Idea Generation, Microsoft Office, Industrial Design, Finesse, Sewing, Industrial Sewing, Pattern Making, Pattern Design, 3D Modeling, Web Design, HTML5, CSS, JavaScript
Education
Philadelphia University 2010 — 2015
Bachelor’s Degree, Industrial Design
Townes Bros Design Company May 2015 - Present
Philadelphia University January 2011 - May 2015
Design Expo 2015 - 2015
FDA May 2011 - August 2014
Philadelphia 76ers 2013 - 2014
Philadelphia University September 2011 - May 2012
Kumon October 2008 - September 2011
Skills
Illustrator, InDesign, Sketching, Adobe Design Programs, Idea Generation, Microsoft Office, Industrial Design, Finesse, Sewing, Industrial Sewing, Pattern Making, Pattern Design, 3D Modeling, Web Design, HTML5, CSS, JavaScript
Education
Philadelphia University 2010 — 2015
Bachelor’s Degree, Industrial Design
Jason Woods Jason Woods's FDA Experience February 2015 - Present
Job Tobacco Inspector, ISN at FDA
Industry Law Enforcement
Experience
FDA February 2015 - Present
Kingdom Capitol Funding January 2009 - Present
Shawnee Police Department 2013 - 2015
Obetz Division of Police 2005 - 2009
Village of Shawnee Hills 1996 - 2005
Skills
Funding, Private Investigations, Investigation, Fraud, Protection, Enforcement, Criminal Justice, Police, Criminal Investigations, Government, Venture Capital, Risk Management, Asset Management, Project Finance, Commodity, Internal Investigations, Public Safety, Firearms, Homeland Security, Executive Protection, Counterterrorism, Background Checks, Tactics, Security Operations, Disaster Response, Corporate Security, Emergency Services, Physical Security, Police Training, Surveillance, Dignitary Protection, Police Administration, Security Training, Crime Scene..., Undercover, Community Policing, Federal Law Enforcement, Field Training Officer, Homicide Investigations, Field Training, SWAT, Criminal Intelligence, Certified Firearms..., Law Enforcement..., Evidence Collection, Taser, Active Shooter, Crime Scene, Hostage Negotiator, Law Enforcement...
Education
St. Petersburg College 2014 — 2014
Florida EOT#96
Central Ohio Peace Officer Training Academy 1995 — 1995
Ohio Peace Officer Certification
Penn State University
Bachelor of Applied Science (B.A.Sc.), Criminal Justice/Law Enforcement Administration
FDA February 2015 - Present
Kingdom Capitol Funding January 2009 - Present
Shawnee Police Department 2013 - 2015
Obetz Division of Police 2005 - 2009
Village of Shawnee Hills 1996 - 2005
Skills
Funding, Private Investigations, Investigation, Fraud, Protection, Enforcement, Criminal Justice, Police, Criminal Investigations, Government, Venture Capital, Risk Management, Asset Management, Project Finance, Commodity, Internal Investigations, Public Safety, Firearms, Homeland Security, Executive Protection, Counterterrorism, Background Checks, Tactics, Security Operations, Disaster Response, Corporate Security, Emergency Services, Physical Security, Police Training, Surveillance, Dignitary Protection, Police Administration, Security Training, Crime Scene..., Undercover, Community Policing, Federal Law Enforcement, Field Training Officer, Homicide Investigations, Field Training, SWAT, Criminal Intelligence, Certified Firearms..., Law Enforcement..., Evidence Collection, Taser, Active Shooter, Crime Scene, Hostage Negotiator, Law Enforcement...
Education
St. Petersburg College 2014 — 2014
Florida EOT#96
Central Ohio Peace Officer Training Academy 1995 — 1995
Ohio Peace Officer Certification
Penn State University
Bachelor of Applied Science (B.A.Sc.), Criminal Justice/Law Enforcement Administration
Kerry Jo Lee Kerry Jo Lee's FDA Experience January 2014 - Present
Job Pediatric Gastroenterology, Hepatology, and Nutrition MD at the FDA Division of Gastroenterology and Inborn Error Prod.
Industry Hospital & Health Care
Experience
FDA January 2014 - Present
Center for Infection and Immunity July 2011 - January 2014
Columbia University Medical Center July 2010 - June 2013
Children's Hospital Los Angeles (CHLA) July 2007 - June 2010
World Health Organization June 2002 - August 2002
National Bioethics Advisory Commission July 1999 - May 2001
Skills
Gastroenterology, Hepatology, Public Health, Nutrition, Microbiome, Ethics, Microbiology, Policy, Research, Pediatrics, Hospitals, Medical Research, Stem Cells, Board Certified, Molecular Biology, Medicine, Medical Education, Life Sciences, Infectious Diseases, Healthcare, Cell, Clinical Research, Clinical Trials
Education
NYU School of Medicine 2003 — 2007
Doctor of Medicine (M.D.), Honors in Microbiology
Princeton University 1995 — 1999
Bachelor of Arts (B.A.), Ecology and Evolutionary Biology
FDA January 2014 - Present
Center for Infection and Immunity July 2011 - January 2014
Columbia University Medical Center July 2010 - June 2013
Children's Hospital Los Angeles (CHLA) July 2007 - June 2010
World Health Organization June 2002 - August 2002
National Bioethics Advisory Commission July 1999 - May 2001
Skills
Gastroenterology, Hepatology, Public Health, Nutrition, Microbiome, Ethics, Microbiology, Policy, Research, Pediatrics, Hospitals, Medical Research, Stem Cells, Board Certified, Molecular Biology, Medicine, Medical Education, Life Sciences, Infectious Diseases, Healthcare, Cell, Clinical Research, Clinical Trials
Education
NYU School of Medicine 2003 — 2007
Doctor of Medicine (M.D.), Honors in Microbiology
Princeton University 1995 — 1999
Bachelor of Arts (B.A.), Ecology and Evolutionary Biology
Heather S. Rosecrans Heather S. Rosecrans's FDA Experience April 1992 - September 2010
Job Executive VP, Medical Devices & Combination Products, Greenleaf Health LLC & VP of Regulatory Affairs, MDMA
Industry Medical Devices
Experience
Greenleaf Health LLC October 2010 - Present
Medical Device Manufacturers Association October 2010 - Present
FDA April 1992 - September 2010
FDA July 1977 - April 1992
Skills
FDA, Regulatory Requirements, Regulatory Submissions, Regulatory Affairs, Clinical Trials, Program Management, Medical Devices, Lifesciences, CAPA, GMP, V&V, Validation, Clinical Development, Quality System, IND, Regulations, Biotechnology, ISO 13485, Pharmaceutical Industry, GLP, GCP, Biopharmaceuticals, 21 CFR Part 11, Sop, Life Sciences
Education
Pfeiffer University 1974 — 1976
Bachelor's degree, Biology, General
Greenleaf Health LLC October 2010 - Present
Medical Device Manufacturers Association October 2010 - Present
FDA April 1992 - September 2010
FDA July 1977 - April 1992
Skills
FDA, Regulatory Requirements, Regulatory Submissions, Regulatory Affairs, Clinical Trials, Program Management, Medical Devices, Lifesciences, CAPA, GMP, V&V, Validation, Clinical Development, Quality System, IND, Regulations, Biotechnology, ISO 13485, Pharmaceutical Industry, GLP, GCP, Biopharmaceuticals, 21 CFR Part 11, Sop, Life Sciences
Education
Pfeiffer University 1974 — 1976
Bachelor's degree, Biology, General
Deidra Jappa Deidra Jappa's FDA Experience May 2001 - March 2008
Job VP of Operations/Registered Agent/Owner at Jappa & Associates, LLC
Industry Management Consulting
Experience
Jappa & Associates, LLC December 2014 - Present
Spectrum Consulting Group January 2009 - December 2014
The Capitol Events, Inc October 2012 - December 2012
New York & Company August 2009 - November 2009
FDA May 2001 - March 2008
Skills
Business Planning, Stylists, Computer Operations, Mediation, Operations Management, Marketing, Computer Information..., Event Planning, Retail, Event Management, Organizational..., Leadership, Entrepreneurship, Market Research, Government, Team Building, Public Speaking, Project Management, Research, Inventory Management, Training, Program Management, Sales, Conflict Resolution, Microsoft Office, Customer Service, Outlook, Coaching, Security Clearance, Access, Management, Human Resources, Social Networking, PowerPoint, Social Media, Teamwork, Public Relations, Microsoft Excel, Microsoft Word, Strategy, Account Management, Community Outreach, Staff Development, Leadership Development, Grant Writing, Policy Analysis, Policy, Analysis
Education
Penn State University 1998 — 2014
Bachelor of Science, Business - Management and Marketing Option, 3.20
Archbishop Carroll High School 1995 — 1998
High School Diploma
Jappa & Associates, LLC December 2014 - Present
Spectrum Consulting Group January 2009 - December 2014
The Capitol Events, Inc October 2012 - December 2012
New York & Company August 2009 - November 2009
FDA May 2001 - March 2008
Skills
Business Planning, Stylists, Computer Operations, Mediation, Operations Management, Marketing, Computer Information..., Event Planning, Retail, Event Management, Organizational..., Leadership, Entrepreneurship, Market Research, Government, Team Building, Public Speaking, Project Management, Research, Inventory Management, Training, Program Management, Sales, Conflict Resolution, Microsoft Office, Customer Service, Outlook, Coaching, Security Clearance, Access, Management, Human Resources, Social Networking, PowerPoint, Social Media, Teamwork, Public Relations, Microsoft Excel, Microsoft Word, Strategy, Account Management, Community Outreach, Staff Development, Leadership Development, Grant Writing, Policy Analysis, Policy, Analysis
Education
Penn State University 1998 — 2014
Bachelor of Science, Business - Management and Marketing Option, 3.20
Archbishop Carroll High School 1995 — 1998
High School Diploma
Milad Bahrami's FDA Experience December 2012 - January 2015
Job Division Director
Industry Information Technology and Services
Experience
National Institutes of Health January 2015 - Present
FDA December 2012 - January 2015
U.S. Department of Justice October 2010 - December 2012
Lockheed Martin January 2008 - November 2010
Booz Allen Hamilton 2007 - 2008
Keane Federal Systems 2006 - 2006
SAIC 2004 - 2006
Lockheed Martin 2002 - 2004
Skills
Requirements Management, SDLC, Process Management, Earned Value Management, Integration, Program Management, Vendor Management, PMO, IT Management, Software Development, Enterprise Software, Outsourcing, Technical Leadership, Security, Process Improvement, Project Management, Configuration Management, Systems Engineering
Education
The Johns Hopkins University 2003 — 2005
MS, Technical Management, Concentration Program Management
Purdue University 1997 — 2001
BS, Computer Information Systems
National Institutes of Health January 2015 - Present
FDA December 2012 - January 2015
U.S. Department of Justice October 2010 - December 2012
Lockheed Martin January 2008 - November 2010
Booz Allen Hamilton 2007 - 2008
Keane Federal Systems 2006 - 2006
SAIC 2004 - 2006
Lockheed Martin 2002 - 2004
Skills
Requirements Management, SDLC, Process Management, Earned Value Management, Integration, Program Management, Vendor Management, PMO, IT Management, Software Development, Enterprise Software, Outsourcing, Technical Leadership, Security, Process Improvement, Project Management, Configuration Management, Systems Engineering
Education
The Johns Hopkins University 2003 — 2005
MS, Technical Management, Concentration Program Management
Purdue University 1997 — 2001
BS, Computer Information Systems
David Shapinsky David Shapinsky's FDA Experience April 2013 - February 2014
Job Deputy Director, Communications at Office of Foods and Veterinary Medicine, U.S. Food and Drug Administration
Industry Public Relations and Communications
Experience
Office of Foods and Veterinary Medicine, U.S. Food and Drug Administration February 2014 - Present
FDA April 2013 - February 2014
FDA September 2010 - April 2013
FDA November 2009 - August 2010
O'Connor, Bilotta and Associates November 2007 - November 2009
Shapinsky MultiMedia January 2005 - November 2009
Howard University August 2005 - June 2006
Howard University Television (WHUT-PBS) January 2003 - June 2005
kaisernetwork.org/Kaiser Family Foundation April 2000 - January 2003
World News Tonight with Peter Jennings September 1999 - March 2000
Skills
Journalism, Editing, Public Relations, Broadcast, Strategic Communications, Social Marketing, Copy Editing, Politics, Digital Media, Social Media, Video Production, Non-profits, Television, Public Speaking, Video, International Relations, Public Affairs, Radio, Government, Strategy, Multimedia, Media Relations, Crisis Communications, Press Releases, Leadership, Internal Communications, Public Policy, Corporate Communications, Broadcast Journalism, Online Journalism, Blogging, Web Content, Interviews, Publicity, Policy Analysis, Communications Planning, Social Networking, Publications, Nonprofits, Grant Writing, Editorial, Research, Storytelling, Proposal Writing, New Media, Content Strategy, Newsletters, News Writing, Message Development, Speech Writing
Education
University of Chicago 1982 — 1990
Ph.D., History
Pitzer College 1978 — 1982
BA, Double Major in History and Sociology
Friends Seminary 1972 — 1978
High School, High School/Secondary Diplomas and Certificates
Office of Foods and Veterinary Medicine, U.S. Food and Drug Administration February 2014 - Present
FDA April 2013 - February 2014
FDA September 2010 - April 2013
FDA November 2009 - August 2010
O'Connor, Bilotta and Associates November 2007 - November 2009
Shapinsky MultiMedia January 2005 - November 2009
Howard University August 2005 - June 2006
Howard University Television (WHUT-PBS) January 2003 - June 2005
kaisernetwork.org/Kaiser Family Foundation April 2000 - January 2003
World News Tonight with Peter Jennings September 1999 - March 2000
Skills
Journalism, Editing, Public Relations, Broadcast, Strategic Communications, Social Marketing, Copy Editing, Politics, Digital Media, Social Media, Video Production, Non-profits, Television, Public Speaking, Video, International Relations, Public Affairs, Radio, Government, Strategy, Multimedia, Media Relations, Crisis Communications, Press Releases, Leadership, Internal Communications, Public Policy, Corporate Communications, Broadcast Journalism, Online Journalism, Blogging, Web Content, Interviews, Publicity, Policy Analysis, Communications Planning, Social Networking, Publications, Nonprofits, Grant Writing, Editorial, Research, Storytelling, Proposal Writing, New Media, Content Strategy, Newsletters, News Writing, Message Development, Speech Writing
Education
University of Chicago 1982 — 1990
Ph.D., History
Pitzer College 1978 — 1982
BA, Double Major in History and Sociology
Friends Seminary 1972 — 1978
High School, High School/Secondary Diplomas and Certificates
Zhen Zhang Zhen Zhang's FDA Experience September 2014 - Present
Job Pharmacologist at FDA
Industry Research
Experience
FDA September 2014 - Present
National Institutes of Health June 2010 - September 2014
University of Wisconsin-Madison May 2009 - May 2010
Education
University of Wisconsin-Madison 2004 — 2009
Doctor of Philosophy (Ph.D.), Pharmacology
Peking Union Medical College 2001 — 2004
Master of Science (MS), Biochemistry and Molecular Biology
Peking University 1997 — 2001
Bachelor of Science (BS), Biotechnology
FDA September 2014 - Present
National Institutes of Health June 2010 - September 2014
University of Wisconsin-Madison May 2009 - May 2010
Education
University of Wisconsin-Madison 2004 — 2009
Doctor of Philosophy (Ph.D.), Pharmacology
Peking Union Medical College 2001 — 2004
Master of Science (MS), Biochemistry and Molecular Biology
Peking University 1997 — 2001
Bachelor of Science (BS), Biotechnology
Susan DeCorte McMillin Susan DeCorte McMillin's FDA Experience 1988 - 1992
Job Medicines Team Leader at Pfizer
Industry Pharmaceuticals
Experience
Pfizer Medicines Team LeaderPfizerJuly 2014 - Present
Pfizer Global Research & Development 1997 - Present
Pfizer 1997 - Present
sanofi 1992 - 1997
sterling 1992 - 1997
Sanofi Winthrop 1992 - 1997
FDA 1988 - 1992
Education
Post University 2010 — 2014
Master of Business Administration (M.B.A.), Leadership
Quinnipiac University School of Law 2004 — 2008
JD, Law
University of the Sciences in Philadelphia 1980 — 1985
BS, pharmacy
Pfizer Medicines Team LeaderPfizerJuly 2014 - Present
Pfizer Global Research & Development 1997 - Present
Pfizer 1997 - Present
sanofi 1992 - 1997
sterling 1992 - 1997
Sanofi Winthrop 1992 - 1997
FDA 1988 - 1992
Education
Post University 2010 — 2014
Master of Business Administration (M.B.A.), Leadership
Quinnipiac University School of Law 2004 — 2008
JD, Law
University of the Sciences in Philadelphia 1980 — 1985
BS, pharmacy
Jason Sluzynski Jason Sluzynski's FDA Experience March 2010 - May 2014
Job Capital Controller at Kinder Morgan
Industry Oil & Energy
Experience
Kinder Morgan August 2015 - Present
Kinder Morgan June 2014 - Present
FDA March 2010 - May 2014
Kean University January 2012 - January 2014
Jersey City Medical Center EMS September 2009 - March 2010
United States Marine Corps October 2000 - December 2007
Skills
Leadership, Research, Project Management, Data Analysis, Program Management, Public Speaking, Time Management, Security Clearance, Microsoft Office, Analysis, Microsoft Excel, PowerPoint, Statistics, Community Outreach, Negotiation, Technical Writing, Customer Service, Government, cGMP practices, Procurement, CAPA, Data Mining, Business Intelligence, HACCP, SAP, MDR, Sourcing, Strategic Sourcing
Education
Rutgers, The State University of New Jersey - Rutgers Business School 2012 — 2014
Master of Business Administration (M.B.A.), Supply Chain Management
Penn State University 2004 — 2009
Bachelor of Science (BS), Biology, General
Kinder Morgan August 2015 - Present
Kinder Morgan June 2014 - Present
FDA March 2010 - May 2014
Kean University January 2012 - January 2014
Jersey City Medical Center EMS September 2009 - March 2010
United States Marine Corps October 2000 - December 2007
Skills
Leadership, Research, Project Management, Data Analysis, Program Management, Public Speaking, Time Management, Security Clearance, Microsoft Office, Analysis, Microsoft Excel, PowerPoint, Statistics, Community Outreach, Negotiation, Technical Writing, Customer Service, Government, cGMP practices, Procurement, CAPA, Data Mining, Business Intelligence, HACCP, SAP, MDR, Sourcing, Strategic Sourcing
Education
Rutgers, The State University of New Jersey - Rutgers Business School 2012 — 2014
Master of Business Administration (M.B.A.), Supply Chain Management
Penn State University 2004 — 2009
Bachelor of Science (BS), Biology, General
Sherea Dillon's FDA Experience October 2012 - Present
Job Compliance Officer at FDA
Industry Government Administration
Experience
FDA October 2012 - Present
Food and Drug Administration January 2009 - Present
US Department of Health & Human Services, Food and Drug Administration January 2009 - October 2012
Kraft Foods May 2008 - September 2008
Education
University of Arkansas at Fayetteville 2006 — 2008
Master of Science, Agricultiure Economics
Purdue University 2000 — 2006
Bachelor, Food Science and Agriculture Economics
FDA October 2012 - Present
Food and Drug Administration January 2009 - Present
US Department of Health & Human Services, Food and Drug Administration January 2009 - October 2012
Kraft Foods May 2008 - September 2008
Education
University of Arkansas at Fayetteville 2006 — 2008
Master of Science, Agricultiure Economics
Purdue University 2000 — 2006
Bachelor, Food Science and Agriculture Economics
Lana Pauls Lana Pauls's FDA Experience 2002 - 2009
Job Associate Director, Executive Operations and Strategic Planning
Industry Government Administration
Experience
Office of Surveillance and Epidemiology, U.S. Food and Drug Administration May 2011 - Present
US Department of Health & Human Services 2009 - 2011
US Department of Health & Human Services 2009 - 2011
FDA 2002 - 2009
Skills
Regulatory Affairs, FDA, Public Health, Training, Quality Management, Strategic Planning, Pharmaceutical Industry, Regulatory Submissions, Clinical Development, Regulatory Requirements, Biotechnology, Lifesciences, Sop, Medical Devices, Clinical Research, GCP, Clinical Trials, Oncology, SOP, Life Sciences
Education
Uniformed Services University of the Health Sciences - F Edward Hebert SOM 1992 — 1993
MPH, Epidemiology
Penn State University 1980 — 1984
B.S., Animal Bioscience
Office of Surveillance and Epidemiology, U.S. Food and Drug Administration May 2011 - Present
US Department of Health & Human Services 2009 - 2011
US Department of Health & Human Services 2009 - 2011
FDA 2002 - 2009
Skills
Regulatory Affairs, FDA, Public Health, Training, Quality Management, Strategic Planning, Pharmaceutical Industry, Regulatory Submissions, Clinical Development, Regulatory Requirements, Biotechnology, Lifesciences, Sop, Medical Devices, Clinical Research, GCP, Clinical Trials, Oncology, SOP, Life Sciences
Education
Uniformed Services University of the Health Sciences - F Edward Hebert SOM 1992 — 1993
MPH, Epidemiology
Penn State University 1980 — 1984
B.S., Animal Bioscience
Wally Pellerite Wally Pellerite's FDA Experience 1984 - 2005
Job Medical Device Consultant
Industry Medical Devices
Experience
Pellerite Medical Device Consulting Chairman, Medical Device Compliance CommitteeBecker & AssociatesApril 2011 - November 2012
Quintiles Consulting 2005 - 2007
U.S. Food & Drug Administration 1984 - 2005
FDA 1984 - 2005
Skills
CAPA, Complaint Handling, Investigations, Management Review, QSR, FDA, Medical Devices, Quality Systems, Surveillance, Quality System, Regulatory Affairs, Pharmaceutical Industry, Quality Assurance, ISO 13485, Quality Auditing, V&V, Lifesciences, Complaint Management, Technology Transfer, Regulations, 21 CFR Part 11, Change Control, GMP, Biotechnology, Quality Control, Clinical Research, Regulatory Submissions, Regulatory Requirements, Pharmaceutics, Validation, ISO 14971, GxP, Design Control, PMA, Quality Management, Private Investigations, Sop, Clinical Trials, Strategy, Oncology, Clinical Development, R&D, GLP, ISO, Hardware Diagnostics, Biopharmaceuticals, Drug Development, Computer System..., GCP, Life Sciences
Education
Penn State 1966 — 1970
Pellerite Medical Device Consulting Chairman, Medical Device Compliance CommitteeBecker & AssociatesApril 2011 - November 2012
Quintiles Consulting 2005 - 2007
U.S. Food & Drug Administration 1984 - 2005
FDA 1984 - 2005
Skills
CAPA, Complaint Handling, Investigations, Management Review, QSR, FDA, Medical Devices, Quality Systems, Surveillance, Quality System, Regulatory Affairs, Pharmaceutical Industry, Quality Assurance, ISO 13485, Quality Auditing, V&V, Lifesciences, Complaint Management, Technology Transfer, Regulations, 21 CFR Part 11, Change Control, GMP, Biotechnology, Quality Control, Clinical Research, Regulatory Submissions, Regulatory Requirements, Pharmaceutics, Validation, ISO 14971, GxP, Design Control, PMA, Quality Management, Private Investigations, Sop, Clinical Trials, Strategy, Oncology, Clinical Development, R&D, GLP, ISO, Hardware Diagnostics, Biopharmaceuticals, Drug Development, Computer System..., GCP, Life Sciences
Education
Penn State 1966 — 1970
Minal Lalpuria Minal Lalpuria's FDA Experience August 2012 - May 2013
Job Compliance & Regulatory Affairs Specialist at Aseptic Solutions USA
Industry Food & Beverages
Experience
Aseptic Solutions USA (Glanbia Nutritionals-Ingredient Technology) June 2013 - Present
FDA August 2012 - May 2013
The Pennsylvania State University August 2007 - July 2012
Penn State University May 2011 - May 2011
Penn State University January 2009 - May 2010
Britannia Industries Ltd June 2006 - July 2006
Frolic Foods (P) Ltd June 2005 - July 2005
Skills
Food Science, HPLC, R&D, Food Technology, Food Industry, Laboratory, Food, Cross-functional Team..., FTIR, Leadership, Quality Control, Analysis, Scanning Electron..., Microbiology, Food Microbiology, Engineering, Chemistry, Materials, Food Safety, UV/Vis
Education
Penn State University 2007 — 2012
PhD, Food Science
University Institute of Chemical Technology (previously UDCT) 2003 — 2007
Bachelor, Food Technology and Engineering
Aseptic Solutions USA (Glanbia Nutritionals-Ingredient Technology) June 2013 - Present
FDA August 2012 - May 2013
The Pennsylvania State University August 2007 - July 2012
Penn State University May 2011 - May 2011
Penn State University January 2009 - May 2010
Britannia Industries Ltd June 2006 - July 2006
Frolic Foods (P) Ltd June 2005 - July 2005
Skills
Food Science, HPLC, R&D, Food Technology, Food Industry, Laboratory, Food, Cross-functional Team..., FTIR, Leadership, Quality Control, Analysis, Scanning Electron..., Microbiology, Food Microbiology, Engineering, Chemistry, Materials, Food Safety, UV/Vis
Education
Penn State University 2007 — 2012
PhD, Food Science
University Institute of Chemical Technology (previously UDCT) 2003 — 2007
Bachelor, Food Technology and Engineering
Bill Fritsch's FDA Experience June 2012 - Present
Job Senior Policy Advisor at FDA
Industry Government Administration
Experience
FDA June 2012 - Present
FDA July 2011 - June 2012
FDA October 2010 - July 2011
FDA March 2009 - June 2011
CTI July 2006 - April 2008
Kendle International May 2003 - February 2006
Pharmacia May 1992 - May 1994
Marion Merrell Dow Pharmaceuticals August 1990 - June 1992
Skills
GCP, Regulatory Affairs, FDA, Pharmaceutical Industry, GMP, Sop, GLP, Regulatory Requirements, Validation, Clinical Development, Quality Auditing, CAPA, Clinical Trials, Change Control, Quality System, 21 CFR Part 11, Pharmacovigilance, Drug Development, Regulatory Submissions, IND, Pharmaceutics, Quality Assurance, Microbiology, Clinical Research, Laboratory, Biotechnology, Chemistry, Biopharmaceuticals, Technology Transfer, V&V, FDA GMP, Vaccines, Lifesciences, HPLC, Regulations, Pharmacology, Analytical Chemistry, Chromatography, Quality Control, CRO, ISO 13485, UV/Vis, LIMS, Medical Devices, eCTD, CMC, Drug Discovery, GxP, ELISA, Protocol
Education
Purdue University
Master of Science (M.S.), Industrial & Physical Pharmacy (Drug Regulatory and Quality Compliance)
Purdue University 2006 — 2008
Graduate Certificate, Drug Regulatory and Quality Compliance
Northern Kentucky University
Bachelor of Science (B.S.), Biology (Pre-Medicine)
FDA June 2012 - Present
FDA July 2011 - June 2012
FDA October 2010 - July 2011
FDA March 2009 - June 2011
CTI July 2006 - April 2008
Kendle International May 2003 - February 2006
Pharmacia May 1992 - May 1994
Marion Merrell Dow Pharmaceuticals August 1990 - June 1992
Skills
GCP, Regulatory Affairs, FDA, Pharmaceutical Industry, GMP, Sop, GLP, Regulatory Requirements, Validation, Clinical Development, Quality Auditing, CAPA, Clinical Trials, Change Control, Quality System, 21 CFR Part 11, Pharmacovigilance, Drug Development, Regulatory Submissions, IND, Pharmaceutics, Quality Assurance, Microbiology, Clinical Research, Laboratory, Biotechnology, Chemistry, Biopharmaceuticals, Technology Transfer, V&V, FDA GMP, Vaccines, Lifesciences, HPLC, Regulations, Pharmacology, Analytical Chemistry, Chromatography, Quality Control, CRO, ISO 13485, UV/Vis, LIMS, Medical Devices, eCTD, CMC, Drug Discovery, GxP, ELISA, Protocol
Education
Purdue University
Master of Science (M.S.), Industrial & Physical Pharmacy (Drug Regulatory and Quality Compliance)
Purdue University 2006 — 2008
Graduate Certificate, Drug Regulatory and Quality Compliance
Northern Kentucky University
Bachelor of Science (B.S.), Biology (Pre-Medicine)
Robert Lionberger Robert Lionberger's FDA Experience November 2014 - Present
Job Director, Office of Research and Standards, Office of Generic Drugs at FDA
Industry Government Administration
Experience
FDA November 2014 - Present
FDA July 2014 - November 2014
FDA April 2013 - July 2014
FDA 2003 - 2013
University of Michigan 1998 - 2002
University of Melbourne 1996 - 1998
Skills
Mathematical Modeling, FDA, Chemical Engineering, Colloids, Pharmacokinetics, Regulatory Science, Fluid Mechanics, Bioequivalence, Nanotechnology
Education
Princeton University 1990 — 1995
Doctor of Philosophy (Ph.D.), Chemical Engineering
Stanford University 1986 — 1990
BSE, Chemical Engineering
FDA November 2014 - Present
FDA July 2014 - November 2014
FDA April 2013 - July 2014
FDA 2003 - 2013
University of Michigan 1998 - 2002
University of Melbourne 1996 - 1998
Skills
Mathematical Modeling, FDA, Chemical Engineering, Colloids, Pharmacokinetics, Regulatory Science, Fluid Mechanics, Bioequivalence, Nanotechnology
Education
Princeton University 1990 — 1995
Doctor of Philosophy (Ph.D.), Chemical Engineering
Stanford University 1986 — 1990
BSE, Chemical Engineering
Jian Potak's FDA Experience
Job Budget Analyst at FDA
Industry Financial Services
Experience
FDA
Education
Purdue University 1999 — 2001
Bachelor's degree, Accounting and Finance
FDA
Education
Purdue University 1999 — 2001
Bachelor's degree, Accounting and Finance
Yuan Xue Yuan Xue's FDA Experience June 2012 - August 2012
Job Ph.D. Candidate in University of Virginia
Industry Research
Experience
Mayo Clinic May 2013 - August 2013
FDA June 2012 - August 2012
Citi June 2011 - August 2011
China Banking Regulatory Commission July 2009 - September 2009
Bank of China June 2008 - August 2008
Industrial bank July 2007 - August 2007
Education
University of Virginia 2010 — 2014
Ph.D., Statistics, 4.0
University of Virginia 2010 — 2012
Master's degree, Statistics, 4.0
Peking University 2006 — 2010
Bachelor's degree, Financial Mathematics, 3.7
Mayo Clinic May 2013 - August 2013
FDA June 2012 - August 2012
Citi June 2011 - August 2011
China Banking Regulatory Commission July 2009 - September 2009
Bank of China June 2008 - August 2008
Industrial bank July 2007 - August 2007
Education
University of Virginia 2010 — 2014
Ph.D., Statistics, 4.0
University of Virginia 2010 — 2012
Master's degree, Statistics, 4.0
Peking University 2006 — 2010
Bachelor's degree, Financial Mathematics, 3.7
Jerry Zon Jerry Zon's FDA Experience 1983 - 1987
Job Director of Business Development at TriLink BioTechnologies I The Modified Nucleic Acid Experts I Oligos, NTPs, mRNA
Industry Biotechnology
Experience
TriLink BioTechnologies January 2013 - Present
Consultant (Self-Employed) December 2010 - January 2013
Life Technologies November 2008 - December 2010
Applied Biosystems 2005 - 2008
Sel-Employed Consultant 2003 - 2005
Applera Corporation 1998 - 2003
Inex Pharmaceuticals-USA 1997 - 1998
Lynx Therapeutics 1992 - 1997
Applied Biosystems 1986 - 1992
FDA 1983 - 1987
Skills
Analysis, Analytical Chemistry, Assay Development, Biochemistry, Bioinformatics, Biotechnology, Cell Biology, Cell Culture, Chemistry, Chromatography, Clinical Research, Commercialization, DNA, DNA Sequencing, DNA sequencing, Drug Discovery, Genetics, Genomics, HPLC, Immunology, Life Sciences, Lifesciences, Molecular Biology, Oligonucleotides, Oncology, Pharmaceutical Industry, Protein Chemistry, Technology Transfer, Sop, Sequencing, qPCR, Validation, Regulatory Affairs, R, Blogging, Blogger
Education
Princeton University 1967 — 1971
TriLink BioTechnologies January 2013 - Present
Consultant (Self-Employed) December 2010 - January 2013
Life Technologies November 2008 - December 2010
Applied Biosystems 2005 - 2008
Sel-Employed Consultant 2003 - 2005
Applera Corporation 1998 - 2003
Inex Pharmaceuticals-USA 1997 - 1998
Lynx Therapeutics 1992 - 1997
Applied Biosystems 1986 - 1992
FDA 1983 - 1987
Skills
Analysis, Analytical Chemistry, Assay Development, Biochemistry, Bioinformatics, Biotechnology, Cell Biology, Cell Culture, Chemistry, Chromatography, Clinical Research, Commercialization, DNA, DNA Sequencing, DNA sequencing, Drug Discovery, Genetics, Genomics, HPLC, Immunology, Life Sciences, Lifesciences, Molecular Biology, Oligonucleotides, Oncology, Pharmaceutical Industry, Protein Chemistry, Technology Transfer, Sop, Sequencing, qPCR, Validation, Regulatory Affairs, R, Blogging, Blogger
Education
Princeton University 1967 — 1971
Daniello Sepe's FDA Experience June 2014 - July 2015
Job MPH Graduate Student
Industry Public Policy
Experience
FDA June 2014 - July 2015
FDA - Office of External Affairs, Office of Health and Constituent Affairs November 2010 - July 2014
FDA - Office of Foods and Veterinary Medicine June 2013 - February 2014
Stay-At-Home-Sons September 2011 - September 2013
FDA June 2010 - November 2010
Penn State University October 2008 - May 2010
NBC June 2009 - August 2009
ComRadio September 2006 - May 2009
Clear Channel May 2008 - August 2008
Skills
HTML, Audio Editing, Video Production, Editing, Video Editing, Press Releases, Social Media, Digital Media, Video, Broadcast, Storytelling, Television, Radio, Public Speaking, Community Outreach, Government, Film, Final Cut Pro, Blogging, Facebook, Management, Social Networking, Sound
Education
The Johns Hopkins University 2015 — 2016
Master of Public Health (MPH)
Penn State University 2005 — 2010
BS, Biological and Evolutionary Psychology
Penn State University 2005 — 2010
BA, Broadcast Journalism
FDA June 2014 - July 2015
FDA - Office of External Affairs, Office of Health and Constituent Affairs November 2010 - July 2014
FDA - Office of Foods and Veterinary Medicine June 2013 - February 2014
Stay-At-Home-Sons September 2011 - September 2013
FDA June 2010 - November 2010
Penn State University October 2008 - May 2010
NBC June 2009 - August 2009
ComRadio September 2006 - May 2009
Clear Channel May 2008 - August 2008
Skills
HTML, Audio Editing, Video Production, Editing, Video Editing, Press Releases, Social Media, Digital Media, Video, Broadcast, Storytelling, Television, Radio, Public Speaking, Community Outreach, Government, Film, Final Cut Pro, Blogging, Facebook, Management, Social Networking, Sound
Education
The Johns Hopkins University 2015 — 2016
Master of Public Health (MPH)
Penn State University 2005 — 2010
BS, Biological and Evolutionary Psychology
Penn State University 2005 — 2010
BA, Broadcast Journalism
Sujin Key's FDA Experience July 2012 - August 2012
Job Sr Clinical Supplies Coordinator II | Clinical Packaging & Labeling | Gilead Sciences
Industry Pharmaceuticals
Experience
Gilead Sciences June 2015 - Present
Genzyme July 2013 - April 2015
MCPHS University July 2013 - April 2015
Purdue University-Center for Medication Safety Advancement (CMSA) April 2013 - April 2013
Indiana University Health March 2013 - March 2013
FDA July 2012 - August 2012
Eli Lilly and Company May 2012 - June 2012
Purdue University February 2010 - February 2011
Skills
Pharmacists, Clinical Research, Pharmacy, Pharmaceutical Industry, Clinical Trials, Healthcare, Biopharmaceuticals, Regulatory Affairs, Microsoft Office, FDA, Research
Education
Purdue University 2007 — 2013
Doctor of Pharmacy (PharmD), College of Pharmacy
Gilead Sciences June 2015 - Present
Genzyme July 2013 - April 2015
MCPHS University July 2013 - April 2015
Purdue University-Center for Medication Safety Advancement (CMSA) April 2013 - April 2013
Indiana University Health March 2013 - March 2013
FDA July 2012 - August 2012
Eli Lilly and Company May 2012 - June 2012
Purdue University February 2010 - February 2011
Skills
Pharmacists, Clinical Research, Pharmacy, Pharmaceutical Industry, Clinical Trials, Healthcare, Biopharmaceuticals, Regulatory Affairs, Microsoft Office, FDA, Research
Education
Purdue University 2007 — 2013
Doctor of Pharmacy (PharmD), College of Pharmacy
Darnell Slaughter Darnell Slaughter's FDA Experience November 2011 - March 2012
Job Research Assistant at Penn State University
Industry Biotechnology
Experience
Penn State University August 2013 - Present
Senseonics, Inc. August 2012 - December 2012
FDA November 2011 - March 2012
Skills
Matlab, Laboratory Equipment, Continuum Mechanics, Product Design, Microsoft Excel, Microsoft Office, Academic Writing
Education
Penn State University 2013 — 2015
Master's Candidate, Mechanical Engineering
University of Maryland College Park 2008 — 2012
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Penn State University August 2013 - Present
Senseonics, Inc. August 2012 - December 2012
FDA November 2011 - March 2012
Skills
Matlab, Laboratory Equipment, Continuum Mechanics, Product Design, Microsoft Excel, Microsoft Office, Academic Writing
Education
Penn State University 2013 — 2015
Master's Candidate, Mechanical Engineering
University of Maryland College Park 2008 — 2012
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Adrianne Jacobs Adrianne Jacobs's FDA Experience January 2012 - Present
Job Project Manager Animal Biotechnology Group at FDA
Industry Biotechnology
Experience
FDA January 2012 - Present
US Department of Health & Human Services January 2009 - January 2012
Skills
Public Health, Government, Policy, Federal Government, Policy Analysis, Emergency Management, Epidemiology, Public Policy, Disaster Response, Program Evaluation, Health Communication, Regulatory Affairs, Global Health, Environmental Health, Regulations
Education
Kings College Wilkes Barre PA
Bachelor of Science (BS), Neuroscience
Penn State University
FDA January 2012 - Present
US Department of Health & Human Services January 2009 - January 2012
Skills
Public Health, Government, Policy, Federal Government, Policy Analysis, Emergency Management, Epidemiology, Public Policy, Disaster Response, Program Evaluation, Health Communication, Regulatory Affairs, Global Health, Environmental Health, Regulations
Education
Kings College Wilkes Barre PA
Bachelor of Science (BS), Neuroscience
Penn State University
Vincent Chinnappan Vincent Chinnappan's FDA Experience April 2014 - Present
Job Sr Consultant at FDA / GlobalNet Services Inc
Industry Information Technology and Services
Experience
FDA April 2014 - Present
New York City Department of Health and Mental Hygiene April 2011 - Present
Hexaware Technologies November 2009 - April 2011
UST Global October 2006 - December 2009
3i Infotech June 2005 - October 2006
Qbase Technologies June 2003 - June 2005
Skills
WebSphere MQ, JBPM, JBoss ESB, Java Enterprise Edition, Struts, JSP, Spring, Hibernate, Web Services, SOA, Weblogic, Oracle, XML, Servlets, Java, Design Patterns, JAXB, Eclipse, JDBC, Core Java, Requirements Analysis, SDLC, Integration, MySQL, Web Applications, OOP, PL/SQL, JavaSE, Databases, Sybase, Spring Framework
Education
Pondicherry University 2000 — 2003
B.Tech, Computer Science Engineering
FDA April 2014 - Present
New York City Department of Health and Mental Hygiene April 2011 - Present
Hexaware Technologies November 2009 - April 2011
UST Global October 2006 - December 2009
3i Infotech June 2005 - October 2006
Qbase Technologies June 2003 - June 2005
Skills
WebSphere MQ, JBPM, JBoss ESB, Java Enterprise Edition, Struts, JSP, Spring, Hibernate, Web Services, SOA, Weblogic, Oracle, XML, Servlets, Java, Design Patterns, JAXB, Eclipse, JDBC, Core Java, Requirements Analysis, SDLC, Integration, MySQL, Web Applications, OOP, PL/SQL, JavaSE, Databases, Sybase, Spring Framework
Education
Pondicherry University 2000 — 2003
B.Tech, Computer Science Engineering
Christian Parra Christian Parra's FDA Experience June 2015 - Present
Job It's a new day!
Industry Law Enforcement
Experience
FDA June 2015 - Present
East Meadow Fire Department January 2012 - Present
New York City Department of Environmental Protection July 2012 - June 2015
Penn State University January 2011 - May 2011
FDA July 2009 - August 2009
General Motors May 2008 - August 2008
Skills
Civil Engineering, Structural Engineering, Construction, Chemistry, Concrete, Structural Analysis, Customer Service, Spanish, Construction Management, Hazardous Materials, Environmental Awareness, Contract Management, Construction Safety, ArcGIS
Education
Veebs Nassau County EMS Academy 2013 — 2013
NYS EMT-B Certification, Emergency Care Attendant (EMT Ambulance)
Penn State University 2007 — 2011
BS, Civil Engineering
FDA June 2015 - Present
East Meadow Fire Department January 2012 - Present
New York City Department of Environmental Protection July 2012 - June 2015
Penn State University January 2011 - May 2011
FDA July 2009 - August 2009
General Motors May 2008 - August 2008
Skills
Civil Engineering, Structural Engineering, Construction, Chemistry, Concrete, Structural Analysis, Customer Service, Spanish, Construction Management, Hazardous Materials, Environmental Awareness, Contract Management, Construction Safety, ArcGIS
Education
Veebs Nassau County EMS Academy 2013 — 2013
NYS EMT-B Certification, Emergency Care Attendant (EMT Ambulance)
Penn State University 2007 — 2011
BS, Civil Engineering
Linglu (Vicky) Wang Linglu (Vicky) Wang's FDA Experience June 2009 - August 2009
Job Manager, Economic and Valuation Services at KPMG
Industry Financial Services
Experience
KPMG US October 2014 - Present
KPMG August 2011 - September 2014
George Washington University September 2007 - June 2011
George Washington University July 2010 - August 2010
FDA June 2009 - August 2009
Statistics Collaborative June 2008 - August 2008
Skills
Statistics, SAS, Data Analysis, Biostatistics, Linear Regression, Analysis, Valuation, Mandarin, Statistical Modeling, Stata, R, Matlab, Data Mining
Education
The George Washington University 2007 — 2011
PhD, Statistics
Peking University 2003 — 2007
BS, Statistics
KPMG US October 2014 - Present
KPMG August 2011 - September 2014
George Washington University September 2007 - June 2011
George Washington University July 2010 - August 2010
FDA June 2009 - August 2009
Statistics Collaborative June 2008 - August 2008
Skills
Statistics, SAS, Data Analysis, Biostatistics, Linear Regression, Analysis, Valuation, Mandarin, Statistical Modeling, Stata, R, Matlab, Data Mining
Education
The George Washington University 2007 — 2011
PhD, Statistics
Peking University 2003 — 2007
BS, Statistics
Kassi Dawkins Kassi Dawkins's FDA Experience July 2013 - Present
Job Management Analyst at FDA
Industry Government Administration
Experience
FDA July 2013 - Present
National Nuclear Security Administration February 2012 - July 2013
National Nuclear Security Administration August 2007 - February 2012
National Nuclear Security Administration March 2005 - August 2007
U.S. Department of Energy June 2000 - March 2005
Skills
Government, Policy, Policy Analysis, Federal Government, Public Speaking, Research, Workshop Facilitation, Strategic Planning, Public Policy, Program Management, National Security, Community Outreach, Leadership Development, Social Media, Event Planning, Project Management, Human Capital, Editing, Workforce Development, Microsoft Office, Graphic Design, Adobe Creative Suite, Creativity Skills, Video Editing, Web Design, Instructional Design, E-Learning, Analysis, Defense, Legislative Relations
Education
Walden University 2010 — 2011
Instructional Design and Technology
University of Maryland College Park 2000 — 2002
BA, Communications
Prince George's Community College 1998 — 2000
AA, General
FDA July 2013 - Present
National Nuclear Security Administration February 2012 - July 2013
National Nuclear Security Administration August 2007 - February 2012
National Nuclear Security Administration March 2005 - August 2007
U.S. Department of Energy June 2000 - March 2005
Skills
Government, Policy, Policy Analysis, Federal Government, Public Speaking, Research, Workshop Facilitation, Strategic Planning, Public Policy, Program Management, National Security, Community Outreach, Leadership Development, Social Media, Event Planning, Project Management, Human Capital, Editing, Workforce Development, Microsoft Office, Graphic Design, Adobe Creative Suite, Creativity Skills, Video Editing, Web Design, Instructional Design, E-Learning, Analysis, Defense, Legislative Relations
Education
Walden University 2010 — 2011
Instructional Design and Technology
University of Maryland College Park 2000 — 2002
BA, Communications
Prince George's Community College 1998 — 2000
AA, General
Louis Payne Jr Louis Payne Jr's FDA Experience May 2012 - August 2012
Job Help Desk Specialist at Bills Computer Repair Service
Industry Information Technology and Services
Experience
Bills Computer Repair Service May 2015 - Present
FDA May 2012 - August 2012
Skills
Microsoft Office, Customer Service, Microsoft Excel, Management, Microsoft Word, PowerPoint, Public Speaking, Research, Project Management, Leadership, Windows 7, Windows XP, Windows 8, Oracle Applications, Mac OS, Help Desk Support, Computer Repair, Oracle Database, Computer Networking, Software Project..., Hardware Support
Education
Pennsylvania State University-Penn State New Kensington 2013 — 2015
Bachelor of Science (B.S.), Information Technology, Senior
Waynesburg University 2011 — 2013
Bachelor's degree, Computer and Information Sciences and Support Services
Bills Computer Repair Service May 2015 - Present
FDA May 2012 - August 2012
Skills
Microsoft Office, Customer Service, Microsoft Excel, Management, Microsoft Word, PowerPoint, Public Speaking, Research, Project Management, Leadership, Windows 7, Windows XP, Windows 8, Oracle Applications, Mac OS, Help Desk Support, Computer Repair, Oracle Database, Computer Networking, Software Project..., Hardware Support
Education
Pennsylvania State University-Penn State New Kensington 2013 — 2015
Bachelor of Science (B.S.), Information Technology, Senior
Waynesburg University 2011 — 2013
Bachelor's degree, Computer and Information Sciences and Support Services
Jordan Gaines Lewis's FDA Experience June 2010 - August 2010
Job Neuroscience Ph.D. Candidate | Science Communicator
Industry Research
Experience
Penn State College of Medicine August 2011 - Present
The Conversation UK January 2014 - Present
The Journal of Science Policy and Governance April 2015 - Present
ScienceSeeker March 2014 - Present
Psychology Today August 2012 - Present
St. Mary's College of Maryland September 2008 - May 2011
FDA June 2010 - August 2010
University of Pittsburgh May 2009 - July 2009
Skills
Neuroscience, Blogging, Science Writing, Science Communication, Social Networking, Writing, Editing, Literature Reviews, Social Media, Creative Writing, Microsoft Office, Excel, PowerPoint, Word, SPSS, SAS, HTML, Statistics, Science Journalism
Education
Penn State University 2011 — 2016
Doctor of Philosophy (Ph.D.), Neuroscience
St. Mary's College of Maryland 2007 — 2011
Bachelor of Arts (B.A.), Biology, Neuroscience
Howard High School 2003 — 2007
Penn State College of Medicine August 2011 - Present
The Conversation UK January 2014 - Present
The Journal of Science Policy and Governance April 2015 - Present
ScienceSeeker March 2014 - Present
Psychology Today August 2012 - Present
St. Mary's College of Maryland September 2008 - May 2011
FDA June 2010 - August 2010
University of Pittsburgh May 2009 - July 2009
Skills
Neuroscience, Blogging, Science Writing, Science Communication, Social Networking, Writing, Editing, Literature Reviews, Social Media, Creative Writing, Microsoft Office, Excel, PowerPoint, Word, SPSS, SAS, HTML, Statistics, Science Journalism
Education
Penn State University 2011 — 2016
Doctor of Philosophy (Ph.D.), Neuroscience
St. Mary's College of Maryland 2007 — 2011
Bachelor of Arts (B.A.), Biology, Neuroscience
Howard High School 2003 — 2007
Alan Gong's FDA Experience May 2010 - July 2010
Job Senior Consultant at IBM
Industry Management Consulting
Experience
IBM August 2014 - Present
IBM Global Business Services October 2012 - August 2014
Johnson & Johnson June 2011 - November 2011
FDA May 2010 - July 2010
FDA May 2009 - August 2009
Skills
Finance, Analysis, Data Analysis, Financial Modeling, Financial Analysis, Process Improvement, Microsoft Office, Project Management, CRM, Business Process..., Client Development, Customer Relationship..., Business Process, Management, Requirements Gathering, Business Development, Consulting, PowerPoint, Leadership
Education
Penn State University 2008 — 2012
Smeal College of Business - B.S. Finance
Dulaney High School
Dulaney High School
IBM August 2014 - Present
IBM Global Business Services October 2012 - August 2014
Johnson & Johnson June 2011 - November 2011
FDA May 2010 - July 2010
FDA May 2009 - August 2009
Skills
Finance, Analysis, Data Analysis, Financial Modeling, Financial Analysis, Process Improvement, Microsoft Office, Project Management, CRM, Business Process..., Client Development, Customer Relationship..., Business Process, Management, Requirements Gathering, Business Development, Consulting, PowerPoint, Leadership
Education
Penn State University 2008 — 2012
Smeal College of Business - B.S. Finance
Dulaney High School
Dulaney High School
John Wasson John Wasson's FDA Experience May 2012 - March 2014
Job Cybersecurity C&A Continous Monitoring at DISA
Industry Computer & Network Security
Experience
CSC, Inc April 2014 - March 2015
FDA May 2012 - March 2014
DISA December 2010 - March 2012
Guaranteach, Inc. May 2009 - November 2010
Scanlon Associates / DrugPak LLC August 1998 - August 2008
Skills
Security, Pre-sales, Solution Architecture, Proposal Writing, Analysis, ePolicy Orchestrator, Wireshark, Websense, McAfee, Nessus, Triton, Splunk, Peregrine, McAfee Enterprise..., Zenoss, Mandiant Intelligence..., NetWitness, Checkpoint Security, Customer Relations, Access, Problem Solving, Operating Systems, Agiliance RiskVision, Putty, OSForensics, NetworkMiner, HASH, MD5, Cyber-security
Education
Penn State University
Associates, Information Systems
Penn State University
Computer and Information Sciences and Support Services
CSC, Inc April 2014 - March 2015
FDA May 2012 - March 2014
DISA December 2010 - March 2012
Guaranteach, Inc. May 2009 - November 2010
Scanlon Associates / DrugPak LLC August 1998 - August 2008
Skills
Security, Pre-sales, Solution Architecture, Proposal Writing, Analysis, ePolicy Orchestrator, Wireshark, Websense, McAfee, Nessus, Triton, Splunk, Peregrine, McAfee Enterprise..., Zenoss, Mandiant Intelligence..., NetWitness, Checkpoint Security, Customer Relations, Access, Problem Solving, Operating Systems, Agiliance RiskVision, Putty, OSForensics, NetworkMiner, HASH, MD5, Cyber-security
Education
Penn State University
Associates, Information Systems
Penn State University
Computer and Information Sciences and Support Services
Hannah Xu Hannah Xu's FDA Experience September 2008 - August 2009
Job Anesthesia resident at New YorkPresbyterian Hospital Weill Cornell
Industry Medical Practice
Experience
New York-Presbyterian Hospital May 2015 - Present
Rutgers Robert Wood Johnson Medical School June 2011 - May 2015
Partners for the Common Good September 2009 - July 2011
FDA September 2008 - August 2009
J.P. Morgan June 2008 - August 2008
Merrill Lynch June 2007 - August 2007
Skills
Healthcare, Analysis, Statistics, Data Analysis, Research, Anesthesia, Public Health, Pain Management
Education
Rutgers Robert Wood Johnson Medical School 2011 — 2015
M.D., Medicine
Princeton University 2004 — 2008
B.S.E., Chemical Engineering, Bioengineering, Finance
New York-Presbyterian Hospital May 2015 - Present
Rutgers Robert Wood Johnson Medical School June 2011 - May 2015
Partners for the Common Good September 2009 - July 2011
FDA September 2008 - August 2009
J.P. Morgan June 2008 - August 2008
Merrill Lynch June 2007 - August 2007
Skills
Healthcare, Analysis, Statistics, Data Analysis, Research, Anesthesia, Public Health, Pain Management
Education
Rutgers Robert Wood Johnson Medical School 2011 — 2015
M.D., Medicine
Princeton University 2004 — 2008
B.S.E., Chemical Engineering, Bioengineering, Finance
Sarah Maibach Sarah Maibach's FDA Experience June 2011 - August 2011
Job Lead Education Programs Producer at General Assembly
Industry Education Management
Experience
General Assembly August 2015 - Present
General Assembly September 2014 - July 2015
Stanford University May 2013 - August 2014
FDA June 2011 - August 2011
Pitzer College August 2010 - December 2010
UCSF Medical Center May 2010 - July 2010
Education Program for Gifted Youth June 2008 - August 2008
Education
Columbia University in the City of New York 2013 — 2014
Master of Arts (MA), Comparative International Education
Pitzer College 2009 — 2013
Bachelor of Arts (BA), Human Biology major, Asian Studies minor
Peking University
Certificate, Chinese Language, Culture, and Traditional Chinese Medicine
General Assembly August 2015 - Present
General Assembly September 2014 - July 2015
Stanford University May 2013 - August 2014
FDA June 2011 - August 2011
Pitzer College August 2010 - December 2010
UCSF Medical Center May 2010 - July 2010
Education Program for Gifted Youth June 2008 - August 2008
Education
Columbia University in the City of New York 2013 — 2014
Master of Arts (MA), Comparative International Education
Pitzer College 2009 — 2013
Bachelor of Arts (BA), Human Biology major, Asian Studies minor
Peking University
Certificate, Chinese Language, Culture, and Traditional Chinese Medicine
John Finkbohner John Finkbohner's FDA Experience 2004 - 2004
Job Senior Policy Director at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca February 2014 - Present
Parenteral Drug Association (PDA) February 2012 - February 2015
MedImmune April 2012 - February 2014
MedImmune November 2010 - April 2012
Johns Hopkins University January 2007 - January 2011
MedImmune LLC, an Astra Zeneca Company June 2007 - November 2010
MedImmune May 2006 - June 2007
Food and Drug Administration 2003 - May 2006
FDA 2004 - 2004
FDA 2000 - 2003
Skills
Regulatory Affairs, Vaccines, FDA, GMP, Biologics, Biopharmaceuticals, Biotechnology, Regulatory Policy, Regulatory Requirements, Validation, Microbiology, CMC, Strategy, Protein Purification, Pharmaceutical Industry, Aseptic Processing, Chemistry, Drug Development, IND, Regulations, Monoclonal Antibodies, Regulatory Submissions, Purification, Pharmaceutics
Education
Penn State University 1982 — 1989
PhD, Protein Purification/Characterization
University of Central Florida 1978 — 1982
BS, Chemistry, Microbiology
AstraZeneca February 2014 - Present
Parenteral Drug Association (PDA) February 2012 - February 2015
MedImmune April 2012 - February 2014
MedImmune November 2010 - April 2012
Johns Hopkins University January 2007 - January 2011
MedImmune LLC, an Astra Zeneca Company June 2007 - November 2010
MedImmune May 2006 - June 2007
Food and Drug Administration 2003 - May 2006
FDA 2004 - 2004
FDA 2000 - 2003
Skills
Regulatory Affairs, Vaccines, FDA, GMP, Biologics, Biopharmaceuticals, Biotechnology, Regulatory Policy, Regulatory Requirements, Validation, Microbiology, CMC, Strategy, Protein Purification, Pharmaceutical Industry, Aseptic Processing, Chemistry, Drug Development, IND, Regulations, Monoclonal Antibodies, Regulatory Submissions, Purification, Pharmaceutics
Education
Penn State University 1982 — 1989
PhD, Protein Purification/Characterization
University of Central Florida 1978 — 1982
BS, Chemistry, Microbiology
Amina L. Gilyard Amina L. Gilyard's FDA Experience April 2014 - Present
Job Training & Quality Assurance Specialist at FDA
Industry Professional Training & Coaching
Experience
FDA April 2014 - Present
FDA November 2012 - March 2014
Lupus Foundation of America DC/MD/VA Chapter, Inc. June 2011 - May 2012
George Washington University Cancer Institute September 2009 - June 2011
Penn State University September 2008 - May 2009
Penn State University 2009 - 2009
Summer Study at Penn State July 2008 - July 2008
Pennsylvania State University General Clinical Research Center June 2005 - December 2005
Skills
Community Outreach, Policy, Qualitative Research, Public Speaking, Health Education, Program Evaluation, Program Development, Non-profits, Public Health, Non-profit Volunteer, Nonprofits, Grant Writing, Event Planning, Microsoft Office, Teaching, Leadership, Program Management
Education
The George Washington University 2013 — 2017
Doctor of Education (Ed.D.), Human & Organizational Learning
The George Washington University 2010 — 2010
Certificate, Grief, Loss & Life Transitions Counseling
Penn State University 2008 — 2009
M.Ed., Health Education
Penn State University 2003 — 2007
B.S., BioBehavioral Health
FDA April 2014 - Present
FDA November 2012 - March 2014
Lupus Foundation of America DC/MD/VA Chapter, Inc. June 2011 - May 2012
George Washington University Cancer Institute September 2009 - June 2011
Penn State University September 2008 - May 2009
Penn State University 2009 - 2009
Summer Study at Penn State July 2008 - July 2008
Pennsylvania State University General Clinical Research Center June 2005 - December 2005
Skills
Community Outreach, Policy, Qualitative Research, Public Speaking, Health Education, Program Evaluation, Program Development, Non-profits, Public Health, Non-profit Volunteer, Nonprofits, Grant Writing, Event Planning, Microsoft Office, Teaching, Leadership, Program Management
Education
The George Washington University 2013 — 2017
Doctor of Education (Ed.D.), Human & Organizational Learning
The George Washington University 2010 — 2010
Certificate, Grief, Loss & Life Transitions Counseling
Penn State University 2008 — 2009
M.Ed., Health Education
Penn State University 2003 — 2007
B.S., BioBehavioral Health
Alex Matushek's FDA Experience September 2013 - October 2013
Job Advanced Pharmacy Practice Experience at FDA
Industry Pharmaceuticals
Experience
Porter Memorial Hospital April 2014 - April 2014
Adventist LaGrange Memorial Hospital March 2014 - March 2014
St. Margaret's Health February 2014 - February 2014
Walgreens January 2014 - January 2014
St. Clare Health Clinic October 2013 - November 2013
FDA September 2013 - October 2013
Walgreens August 2013 - September 2013
Eli Lilly and Company July 2013 - August 2013
US Steel Family Medical Center May 2013 - May 2013
Community Hospital May 2010 - December 2012
Skills
Pharmacy, Cpr Certified, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Patient Counseling, Pharmacists, Medication Therapy..., Research, Fitness, Clinical Research, Regulatory Affairs, Public Speaking, Medicine, Teaching, Healthcare, Time Management, Prescription, Community Pharmacy, Pharmacology, Clinical Pharmacy, Clinical Pharmacology
Education
Purdue University 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy
Lake Central High School
Porter Memorial Hospital April 2014 - April 2014
Adventist LaGrange Memorial Hospital March 2014 - March 2014
St. Margaret's Health February 2014 - February 2014
Walgreens January 2014 - January 2014
St. Clare Health Clinic October 2013 - November 2013
FDA September 2013 - October 2013
Walgreens August 2013 - September 2013
Eli Lilly and Company July 2013 - August 2013
US Steel Family Medical Center May 2013 - May 2013
Community Hospital May 2010 - December 2012
Skills
Pharmacy, Cpr Certified, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Patient Counseling, Pharmacists, Medication Therapy..., Research, Fitness, Clinical Research, Regulatory Affairs, Public Speaking, Medicine, Teaching, Healthcare, Time Management, Prescription, Community Pharmacy, Pharmacology, Clinical Pharmacy, Clinical Pharmacology
Education
Purdue University 2008 — 2014
Doctor of Pharmacy (Pharm.D.), Pharmacy
Lake Central High School
Sai Vikram Vemula Sai Vikram Vemula's FDA Experience May 2013 - April 2015
Job Associate Scientist at Merck
Industry Pharmaceuticals
Experience
Merck April 2015 - Present
FDA May 2013 - April 2015
Purdue University May 2007 - January 2013
Microtest Innovations Pvt.Ltd. January 2004 - January 2007
Skills
Cell Culture, Protein Purification, Molecular Biology, Flow Cytometry, RT-PCR, ELISA, Molecular Cloning, Protein Expression, Confocal Microscopy, qPCR, SDS-PAGE, PCR, Immunofluorescence, Western Blotting, Animal Models, Virology, Immunology, ELISPOT, CTL, Proliferation assay, Vaccines, Infectious Diseases
Education
Purdue University 2007 — 2012
Doctor of Philosophy (PhD), Molecular Virology
Sri Sathya Sai Institute of Higher Learning 2000 — 2002
Master of Science (MSc), Biological Sciences
Merck April 2015 - Present
FDA May 2013 - April 2015
Purdue University May 2007 - January 2013
Microtest Innovations Pvt.Ltd. January 2004 - January 2007
Skills
Cell Culture, Protein Purification, Molecular Biology, Flow Cytometry, RT-PCR, ELISA, Molecular Cloning, Protein Expression, Confocal Microscopy, qPCR, SDS-PAGE, PCR, Immunofluorescence, Western Blotting, Animal Models, Virology, Immunology, ELISPOT, CTL, Proliferation assay, Vaccines, Infectious Diseases
Education
Purdue University 2007 — 2012
Doctor of Philosophy (PhD), Molecular Virology
Sri Sathya Sai Institute of Higher Learning 2000 — 2002
Master of Science (MSc), Biological Sciences
Daniel Weingarten Daniel Weingarten's FDA Experience August 2013 - Present
Job Contract Specialist at FDA
Industry Government Administration
Experience
FDA August 2013 - Present
Law Offices of Terry Finkelstein July 2012 - August 2012
The Jacobson Firm, P.C. May 2012 - June 2012
Dimartino Law May 2011 - August 2011
Fort Monmouth PM DCATS June 2009 - December 2010
Pittsburgh Pirates Organization June 2008 - September 2009
Meals on Wheels June 2005 - June 2009
Howell Township Little League May 2005 - September 2008
Skills
Legal Writing, Westlaw, Management, Policy Analysis, Litigation, Training, Leadership, Social Media, Customer Service, PowerPoint, Legal Research, Microsoft Excel
Education
Syracuse University College of Law 2010 — 2013
Penn State University 2006 — 2010
Bachelor of Arts (B.A.), Economics
FDA August 2013 - Present
Law Offices of Terry Finkelstein July 2012 - August 2012
The Jacobson Firm, P.C. May 2012 - June 2012
Dimartino Law May 2011 - August 2011
Fort Monmouth PM DCATS June 2009 - December 2010
Pittsburgh Pirates Organization June 2008 - September 2009
Meals on Wheels June 2005 - June 2009
Howell Township Little League May 2005 - September 2008
Skills
Legal Writing, Westlaw, Management, Policy Analysis, Litigation, Training, Leadership, Social Media, Customer Service, PowerPoint, Legal Research, Microsoft Excel
Education
Syracuse University College of Law 2010 — 2013
Penn State University 2006 — 2010
Bachelor of Arts (B.A.), Economics
Jan Elicker Jan Elicker's FDA Experience
Job program analyst, web content manager at FDA
Industry Government Administration
Experience
FDA
Skills
Government, Public Policy, Public Health, Policy Analysis, Community Outreach, Program Evaluation, Qualitative Research, Policy, Research, Grant Writing, Grants, International Relations, Data Analysis
Education
Pennsylvania State University 1973 — 1977
FDA
Skills
Government, Public Policy, Public Health, Policy Analysis, Community Outreach, Program Evaluation, Qualitative Research, Policy, Research, Grant Writing, Grants, International Relations, Data Analysis
Education
Pennsylvania State University 1973 — 1977
Emily Gebbia Emily Gebbia's FDA Experience January 2014 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA January 2014 - Present
Hogan Lovells October 2008 - January 2014
Ninth Circuit Court of Appeals August 2007 - September 2008
AmeriCorps August 2002 - June 2003
Skills
Health Law, Food & Drug Law
Education
The Catholic University of America, Columbus School of Law 2003 — 2006
Doctor of Law (J.D.)
Penn State University 1998 — 2002
Bachelor of Arts (B.A.), Spanish Language and Literature
FDA January 2014 - Present
Hogan Lovells October 2008 - January 2014
Ninth Circuit Court of Appeals August 2007 - September 2008
AmeriCorps August 2002 - June 2003
Skills
Health Law, Food & Drug Law
Education
The Catholic University of America, Columbus School of Law 2003 — 2006
Doctor of Law (J.D.)
Penn State University 1998 — 2002
Bachelor of Arts (B.A.), Spanish Language and Literature
Dana Mallen's FDA Experience March 2009 - April 2010
Job Quality Engineer at Bihler of America
Industry Medical Devices
Experience
Bihler of America January 2014 - Present
dinaliC June 2013 - January 2014
Javan Engineering November 2011 - May 2013
Piezo Resonance Innovations, Inc May 2010 - April 2011
FDA March 2009 - April 2010
The Drucker Company May 2008 - August 2008
Ethicon Endo-Surgery August 2007 - December 2007
Skills
Solidworks, Medical Devices, Biomedical Engineering, R&D
Education
Penn State University 2004 — 2008
B.S., Bioengineering
Bihler of America January 2014 - Present
dinaliC June 2013 - January 2014
Javan Engineering November 2011 - May 2013
Piezo Resonance Innovations, Inc May 2010 - April 2011
FDA March 2009 - April 2010
The Drucker Company May 2008 - August 2008
Ethicon Endo-Surgery August 2007 - December 2007
Skills
Solidworks, Medical Devices, Biomedical Engineering, R&D
Education
Penn State University 2004 — 2008
B.S., Bioengineering
Xiaoxiao Pan Xiaoxiao Pan's FDA Experience September 2012 - Present
Job Staff Fellow at Food and Drug Administration
Industry Research
Experience
FDA September 2012 - Present
Weill Cornell Medical College February 2009 - August 2012
Yale University September 2002 - December 2008
Education
Yale University 2002 — 2008
Ph.D., Microbiology; Molecular, Cellular, and Developmental Biology
Peking University 1998 — 2002
B.S., Molecular Biology & Biochemistry
FDA September 2012 - Present
Weill Cornell Medical College February 2009 - August 2012
Yale University September 2002 - December 2008
Education
Yale University 2002 — 2008
Ph.D., Microbiology; Molecular, Cellular, and Developmental Biology
Peking University 1998 — 2002
B.S., Molecular Biology & Biochemistry
Laurence Dusold Laurence Dusold's FDA Experience December 2013 - Present
Job Supervisory Sr. Computer Scientist at FDA
Industry Information Technology and Services
Experience
FDA December 2013 - Present
FDA October 2007 - December 2013
FDA / CFSAN October 1985 - October 2007
UMUC January 1973 - December 2000
FDA October 1980 - October 1985
FDA October 1975 - October 1980
FDA October 1971 - October 1975
Skills
Chemistry, Science, Lifesciences, Bioinformatics, FDA, Biochemistry, Biotechnology, Research, Scientific Computing, Molecular Biology, Data Analysis, Organic Chemistry, Life Sciences, High Performance..., HPLC, Spectroscopy, Windows 7, Technical Writing, Drug Discovery, Computational Chemistry, R&D, Microbiology, Technology Transfer, GLP, GMP, Ubuntu, Scientific Writing, PCR, Regulatory Affairs, XP, Statistics, Cell Culture, R, Clinical Trials, Validation, LC-MS, Genomics, Chromatography, Protein Chemistry, Nanotechnology, Mass Spectrometry, Windows XP
Education
Wayne State University 1969 — 1971
Chemistry and Computers
University of North Carolina at Chapel Hill 1966 — 1969
MS in Chemistry, Analytical Chemistry
Purdue University 1962 — 1966
BS in Chemistry, Chemistry
FDA December 2013 - Present
FDA October 2007 - December 2013
FDA / CFSAN October 1985 - October 2007
UMUC January 1973 - December 2000
FDA October 1980 - October 1985
FDA October 1975 - October 1980
FDA October 1971 - October 1975
Skills
Chemistry, Science, Lifesciences, Bioinformatics, FDA, Biochemistry, Biotechnology, Research, Scientific Computing, Molecular Biology, Data Analysis, Organic Chemistry, Life Sciences, High Performance..., HPLC, Spectroscopy, Windows 7, Technical Writing, Drug Discovery, Computational Chemistry, R&D, Microbiology, Technology Transfer, GLP, GMP, Ubuntu, Scientific Writing, PCR, Regulatory Affairs, XP, Statistics, Cell Culture, R, Clinical Trials, Validation, LC-MS, Genomics, Chromatography, Protein Chemistry, Nanotechnology, Mass Spectrometry, Windows XP
Education
Wayne State University 1969 — 1971
Chemistry and Computers
University of North Carolina at Chapel Hill 1966 — 1969
MS in Chemistry, Analytical Chemistry
Purdue University 1962 — 1966
BS in Chemistry, Chemistry
Dahui Liu's FDA Experience July 2014 - Present
Job Chemistry Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA July 2014 - Present
Fox Chase Chemical Diversity Center Inc. September 2013 - 2014
PolyMedix January 2008 - 2013
PolyMedix, Inc. January 2004 - December 2007
University of Pennsylvania 1999 - 2003
Skills
Project Management, Drug Development, Drug Discovery, HPLC, Analytical chemistry, Fluent in Chinese, Bioanalysis, Articulate Oral and..., GMP and GLP Compiliance, Patent for PolyMedix..., Organization Scheduling, Highly organized and..., Leadership and Strategy, Business Solutions, Problem solving and..., Process Development, CMC, Evaluation and Research, IND filing, Lead Change, Lifesciences, Chemistry, Protein Chemistry, UV/Vis, Drug Design, Analytical Chemistry, Organic Chemistry, Medicinal Chemistry, GMP, Technology Transfer, Biochemistry, Biotechnology, Pharmacology, Process Simulation, Mass Spectrometry, LC-MS, Business Intelligence, Molecular Biology, Cell Culture, Cell, Assay Development
Education
University of Pennsylvania 1999 — 2013
Postdoctorial Researcher, Protein Design, Foldmer Design
University of Kansas 1994 — 1999
Ph.D., Organic Chemistry
Peking university 1987 — 1994
B.S., chemistry
DIA CMC class 2010 — 2010
ACS Course 2011 — 2011
Effective Technical Writing
ACS Course 2012 — 2012
Organic Coating
FDA July 2014 - Present
Fox Chase Chemical Diversity Center Inc. September 2013 - 2014
PolyMedix January 2008 - 2013
PolyMedix, Inc. January 2004 - December 2007
University of Pennsylvania 1999 - 2003
Skills
Project Management, Drug Development, Drug Discovery, HPLC, Analytical chemistry, Fluent in Chinese, Bioanalysis, Articulate Oral and..., GMP and GLP Compiliance, Patent for PolyMedix..., Organization Scheduling, Highly organized and..., Leadership and Strategy, Business Solutions, Problem solving and..., Process Development, CMC, Evaluation and Research, IND filing, Lead Change, Lifesciences, Chemistry, Protein Chemistry, UV/Vis, Drug Design, Analytical Chemistry, Organic Chemistry, Medicinal Chemistry, GMP, Technology Transfer, Biochemistry, Biotechnology, Pharmacology, Process Simulation, Mass Spectrometry, LC-MS, Business Intelligence, Molecular Biology, Cell Culture, Cell, Assay Development
Education
University of Pennsylvania 1999 — 2013
Postdoctorial Researcher, Protein Design, Foldmer Design
University of Kansas 1994 — 1999
Ph.D., Organic Chemistry
Peking university 1987 — 1994
B.S., chemistry
DIA CMC class 2010 — 2010
ACS Course 2011 — 2011
Effective Technical Writing
ACS Course 2012 — 2012
Organic Coating
Traci Gillig's FDA Experience August 2011 - July 2012
Job Communication and Research Professional
Industry Public Relations and Communications
Experience
University of Southern California August 2014 - Present
MDVIP February 2014 - July 2014
Edelman August 2012 - September 2013
FDA August 2011 - July 2012
Purdue University August 2009 - May 2011
AstraZeneca May 2010 - August 2010
Centers for Disease Control and Prevention May 2009 - August 2009
Purdue University January 2007 - May 2009
State Farm January 2009 - April 2009
Infostrada Sports July 2008 - August 2008
Skills
Health Communication, Digital Communication, Sales, Presentational Speaking, Writing, Strategic Communications, Public Relations, Crisis Communications, Internal Communications, Journalism, Teaching, Social Media, Presentations, Copywriting, Event Planning, Marketing Communications, Social Media Marketing, Facebook, Public Speaking, Corporate Communications, Qualitative Research, Marketing, Editing, Blogging, Newsletters, Social Networking
Education
Purdue University 2009 — 2011
MA, Health Communication
Purdue University 2005 — 2009
BA with Honors, Communication
IES London Summer Study Abroad 2006 — 2006
Lake Park 2001 — 2005
University of Southern California August 2014 - Present
MDVIP February 2014 - July 2014
Edelman August 2012 - September 2013
FDA August 2011 - July 2012
Purdue University August 2009 - May 2011
AstraZeneca May 2010 - August 2010
Centers for Disease Control and Prevention May 2009 - August 2009
Purdue University January 2007 - May 2009
State Farm January 2009 - April 2009
Infostrada Sports July 2008 - August 2008
Skills
Health Communication, Digital Communication, Sales, Presentational Speaking, Writing, Strategic Communications, Public Relations, Crisis Communications, Internal Communications, Journalism, Teaching, Social Media, Presentations, Copywriting, Event Planning, Marketing Communications, Social Media Marketing, Facebook, Public Speaking, Corporate Communications, Qualitative Research, Marketing, Editing, Blogging, Newsletters, Social Networking
Education
Purdue University 2009 — 2011
MA, Health Communication
Purdue University 2005 — 2009
BA with Honors, Communication
IES London Summer Study Abroad 2006 — 2006
Lake Park 2001 — 2005
Maria Ida Iacono's FDA Experience April 2012 - Present
Job Scientist at FDA
Industry Hospital & Health Care
Experience
FDA April 2012 - Present
Harvard Medical School, Martinos Center for Biomedical Imaging, Department of Radiology, MGH January 2011 - April 2012
Martinos Center for Biomedical Imaging, Harvard-MIT HST March 2010 - March 2011
Politecnico di Milano January 2008 - March 2011
Fondazione I.R.C.C.S. Policlinico San Matteo Pavia - Clinical Engineering Department October 2006 - January 2008
Skills
Image Processing, Biomedical Engineering, Simulations, MRI, Medical Imaging, Image Analysis, Matlab, Bioengineering, Image Segmentation, Medical Devices, Signal Processing, Mathematical Modeling, Modeling, Computational Modeling, Computer Vision, Image Registration, Deep Brain Stimulation, FDA, Neuroimaging, Neuroanatomy, Experimentation, Science, Research
Education
Politecnico di Milano
Doctor of Philosophy (PhD) in Biomedical Engineering
Harvard-MIT HST
Visiting PhD student
Politecnico di Milano
Master's degree in Biomedical Engineering
Liceo Classico Umberto I, Ragusa, Italy
Diploma
FDA April 2012 - Present
Harvard Medical School, Martinos Center for Biomedical Imaging, Department of Radiology, MGH January 2011 - April 2012
Martinos Center for Biomedical Imaging, Harvard-MIT HST March 2010 - March 2011
Politecnico di Milano January 2008 - March 2011
Fondazione I.R.C.C.S. Policlinico San Matteo Pavia - Clinical Engineering Department October 2006 - January 2008
Skills
Image Processing, Biomedical Engineering, Simulations, MRI, Medical Imaging, Image Analysis, Matlab, Bioengineering, Image Segmentation, Medical Devices, Signal Processing, Mathematical Modeling, Modeling, Computational Modeling, Computer Vision, Image Registration, Deep Brain Stimulation, FDA, Neuroimaging, Neuroanatomy, Experimentation, Science, Research
Education
Politecnico di Milano
Doctor of Philosophy (PhD) in Biomedical Engineering
Harvard-MIT HST
Visiting PhD student
Politecnico di Milano
Master's degree in Biomedical Engineering
Liceo Classico Umberto I, Ragusa, Italy
Diploma
Ron Chamrin Ron Chamrin's FDA Experience March 2012 - Present
Job Regulatory Project Manager/Consumer Safety Officer at FDA/CBER/OCTGT
Industry Government Relations
Experience
FDA March 2012 - Present
IPC - Association Connecting Electronics Industries September 2008 - November 2011
New Light Technologies May 2008 - September 2008
New Light Technologies May 2008 - August 2008
Recreation Equipment Inc April 2000 - May 2008
REI - Recreation Equipment Inc. March 2000 - May 2008
The American Legion November 2006 - April 2008
The American Legion March 2006 - April 2008
U.S Army Reserves March 1996 - March 2008
United States Army Reserve March 1996 - March 2008
Skills
Proficient in Microsoft..., Microsoft Office, Word, Policy, Program Management, Leadership, Analysis, Management, Security Clearance, Legal Writing, Strategic Planning, Legislative Relations, Public Speaking, National Security, Team Building
Education
University of Maryland College Park 2001 — 2005
Bachelor of Science, Biological Sciences
Plymouth State University 1997 — 1999
Biology, General
FDA March 2012 - Present
IPC - Association Connecting Electronics Industries September 2008 - November 2011
New Light Technologies May 2008 - September 2008
New Light Technologies May 2008 - August 2008
Recreation Equipment Inc April 2000 - May 2008
REI - Recreation Equipment Inc. March 2000 - May 2008
The American Legion November 2006 - April 2008
The American Legion March 2006 - April 2008
U.S Army Reserves March 1996 - March 2008
United States Army Reserve March 1996 - March 2008
Skills
Proficient in Microsoft..., Microsoft Office, Word, Policy, Program Management, Leadership, Analysis, Management, Security Clearance, Legal Writing, Strategic Planning, Legislative Relations, Public Speaking, National Security, Team Building
Education
University of Maryland College Park 2001 — 2005
Bachelor of Science, Biological Sciences
Plymouth State University 1997 — 1999
Biology, General
Manuel Rovira Gonzalez Manuel Rovira Gonzalez's FDA Experience August 2015 - Present
Job ORISE Postbaccalaureate Research Fellow at FDA
Industry Research
Experience
FDA August 2015 - Present
George Washington University March 2015 - Present
NIH Clinical Center (CC) June 2014 - August 2015
Penn State University September 2013 - May 2014
Hershey Medical Center May 2013 - August 2013
Kellogg Company January 2013 - May 2013
Skills
Flow Cytometry, Western Blotting, ELISA, Research, Data Analysis, Gene Sequencing, Molecular Biology, Microbiology, Aseptic Technique, Biochemistry, Teamwork, Public Speaking, Customer Service, Leadership, Clinical Research, Biotechnology, Spectrophotometry, Team Leadership, Analysis, Event Management, Inventory Management, Time Management, Fundraising, Access, Data Entry, Team Building, Project Planning, Training, Healthcare, Statistics, Gram Staining, Fermentation, Community Outreach, System Administration, TLC, Bacterial Identification, Titration, Spanish
Education
Pennsylvania State University-Penn State Berks 2013 — 2014
Bachelor of Science (B.S.), Biology, Genetics and Developmental Biology Option, GPA: 3.69
Inter American University of Puerto Rico 2010 — 2013
Bachelor of Science (B.S.), Microbiology, General, GPA: 3.83
FDA August 2015 - Present
George Washington University March 2015 - Present
NIH Clinical Center (CC) June 2014 - August 2015
Penn State University September 2013 - May 2014
Hershey Medical Center May 2013 - August 2013
Kellogg Company January 2013 - May 2013
Skills
Flow Cytometry, Western Blotting, ELISA, Research, Data Analysis, Gene Sequencing, Molecular Biology, Microbiology, Aseptic Technique, Biochemistry, Teamwork, Public Speaking, Customer Service, Leadership, Clinical Research, Biotechnology, Spectrophotometry, Team Leadership, Analysis, Event Management, Inventory Management, Time Management, Fundraising, Access, Data Entry, Team Building, Project Planning, Training, Healthcare, Statistics, Gram Staining, Fermentation, Community Outreach, System Administration, TLC, Bacterial Identification, Titration, Spanish
Education
Pennsylvania State University-Penn State Berks 2013 — 2014
Bachelor of Science (B.S.), Biology, Genetics and Developmental Biology Option, GPA: 3.69
Inter American University of Puerto Rico 2010 — 2013
Bachelor of Science (B.S.), Microbiology, General, GPA: 3.83
Shengde Liang's FDA Experience September 2009 - June 2011
Job Director, Analytics and Research
Industry Insurance
Experience
Travelers October 2012 - Present
Medtronic June 2011 - September 2012
FDA September 2009 - June 2011
Travelers 2008 - September 2009
University of Minnesota September 2001 - August 2008
Wells Fargo Home Mortgage June 2007 - August 2007
Skills
Statistical Modeling, Clinical Trials, Bayesian statistics, SAS, Biostatistics, R, Predictive Modeling, Statistics, Data Mining, SAS programming, Survival Analysis, S-Plus, Data Analysis, Machine Learning, Mathematical Modeling
Education
University of Minnesota-Twin Cities 2001 — 2008
PhD, Biostatistics
Peking University 1994 — 1998
bachelor, mathematics
Travelers October 2012 - Present
Medtronic June 2011 - September 2012
FDA September 2009 - June 2011
Travelers 2008 - September 2009
University of Minnesota September 2001 - August 2008
Wells Fargo Home Mortgage June 2007 - August 2007
Skills
Statistical Modeling, Clinical Trials, Bayesian statistics, SAS, Biostatistics, R, Predictive Modeling, Statistics, Data Mining, SAS programming, Survival Analysis, S-Plus, Data Analysis, Machine Learning, Mathematical Modeling
Education
University of Minnesota-Twin Cities 2001 — 2008
PhD, Biostatistics
Peking University 1994 — 1998
bachelor, mathematics
Paul Stauffer's FDA Experience February 1991 - Present
Job Development Team Leader
Industry Information Technology and Services
Experience
FDA February 1991 - Present
IBM 1990 - 1991
Skills
Requirements Analysis, Web Content Management, Databases, Government, Content Management, SharePoint, Software Development, Leadership, FDA, HTML, Technical Writing, Information Architecture, CSS, XML, Web Development, Software Documentation
Education
Providence College 1986 — 1990
FDA February 1991 - Present
IBM 1990 - 1991
Skills
Requirements Analysis, Web Content Management, Databases, Government, Content Management, SharePoint, Software Development, Leadership, FDA, HTML, Technical Writing, Information Architecture, CSS, XML, Web Development, Software Documentation
Education
Providence College 1986 — 1990
Haitao Li's FDA Experience April 2008 - Present
Job Senior Chemistry Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA April 2008 - Present
NIH, IPDC 2007 - 2008
Pfizer, La Jolla 2000 - 2006
Agouron Pharmaceuticals June 1998 - July 2000
Skills
Drug Discovery, Medicinal Chemistry, LC-MS, Organic Synthesis, Organic Chemistry, Drug Development, Drug Design, Mass Spectrometry, HPLC, Lead Change, Biochemistry, Purification, Protein Chemistry, NMR, Analytical Chemistry, Chemistry, Lifesciences, Chromatography, Biotechnology, Technology Transfer, Pharmacokinetics, Assay Development, Infectious Diseases, Life Sciences
Education
Peking University 1987 — 1992
FDA April 2008 - Present
NIH, IPDC 2007 - 2008
Pfizer, La Jolla 2000 - 2006
Agouron Pharmaceuticals June 1998 - July 2000
Skills
Drug Discovery, Medicinal Chemistry, LC-MS, Organic Synthesis, Organic Chemistry, Drug Development, Drug Design, Mass Spectrometry, HPLC, Lead Change, Biochemistry, Purification, Protein Chemistry, NMR, Analytical Chemistry, Chemistry, Lifesciences, Chromatography, Biotechnology, Technology Transfer, Pharmacokinetics, Assay Development, Infectious Diseases, Life Sciences
Education
Peking University 1987 — 1992
Steve Gang Bai's FDA Experience March 2005 - Present
Job MATH STAT at FDA
Industry Government Administration
Experience
FDA March 2005 - Present
Skills
SAS, Statistics, R, Data Analysis
Education
Penn State University
FDA March 2005 - Present
Skills
SAS, Statistics, R, Data Analysis
Education
Penn State University
Joe Leginus's FDA Experience February 2008 - Present
Job Review Chemist at FDA
Industry Research
Experience
FDA February 2008 - Present
SD Nanosciences 2007 - 2007
BioVeris Corporation 1996 - 2007
BioVeris Corporation 1996 - 2007
BioVeris 1996 - 2007
Education
Penn State University 1980 — 1985
PhD, Chemistry
FDA February 2008 - Present
SD Nanosciences 2007 - 2007
BioVeris Corporation 1996 - 2007
BioVeris Corporation 1996 - 2007
BioVeris 1996 - 2007
Education
Penn State University 1980 — 1985
PhD, Chemistry
Subha Maruvada's FDA Experience October 2003 - Present
Job Research Engineer at FDA
Industry Medical Devices
Experience
FDA October 2003 - Present
Skills
Ultrasound, Matlab, Medical Devices, Acoustics, Research, Biomedical Engineering, R&D
Education
Pennsylvania State University
FDA October 2003 - Present
Skills
Ultrasound, Matlab, Medical Devices, Acoustics, Research, Biomedical Engineering, R&D
Education
Pennsylvania State University
Melanie Hartsough's FDA Experience 2001 - 2006
Job Senior Consultant at Biologics Consulting Group, Inc
Industry Biotechnology
Experience
Biologics Consulting Group, Inc February 2007 - Present
FDA 2001 - 2006
Skills
Biopharmaceuticals, Regulatory Affairs, Lifesciences, Clinical Development, FDA, Regulatory Submissions, Biotechnology, Pharmaceutical Industry, Drug Discovery, R&D, Drug Development, GLP, IND, Pharmaceutics, Vaccines, Toxicology, Clinical Trials, Pharmacology, CRO, Oncology, Immunology, Sop, Validation, Life Sciences
Education
Pennsylvania State University College of Medicine 1991 — 1996
Ph.D., Pharmacology
Biologics Consulting Group, Inc February 2007 - Present
FDA 2001 - 2006
Skills
Biopharmaceuticals, Regulatory Affairs, Lifesciences, Clinical Development, FDA, Regulatory Submissions, Biotechnology, Pharmaceutical Industry, Drug Discovery, R&D, Drug Development, GLP, IND, Pharmaceutics, Vaccines, Toxicology, Clinical Trials, Pharmacology, CRO, Oncology, Immunology, Sop, Validation, Life Sciences
Education
Pennsylvania State University College of Medicine 1991 — 1996
Ph.D., Pharmacology
Jeannie Jeong-Im's FDA Experience January 2009 - Present
Job FDA
Industry Public Safety
Experience
FDA January 2009 - Present
Florida State University August 2007 - December 2008
University of Maryland, Baltimore 1998 - 2001
Education
Penn State University 2001 — 2007
PhD, Synthetic Chemistry
FDA January 2009 - Present
Florida State University August 2007 - December 2008
University of Maryland, Baltimore 1998 - 2001
Education
Penn State University 2001 — 2007
PhD, Synthetic Chemistry
Anand Kali's FDA Experience 2010 - 2011
Job Senior Management Consultant
Industry Management Consulting
Experience
Satori Consulting August 2004 - Present
Litton Loan Servicing 2011 - 2011
FDA 2010 - 2011
Goldman Sachs August 2004 - April 2008
Atlantic Software Technologies 2001 - 2004
CoreCommerce 1999 - 2001
American Management Systems 1997 - 1999
Education
Pennsylvania State University 1992 — 1997
Satori Consulting August 2004 - Present
Litton Loan Servicing 2011 - 2011
FDA 2010 - 2011
Goldman Sachs August 2004 - April 2008
Atlantic Software Technologies 2001 - 2004
CoreCommerce 1999 - 2001
American Management Systems 1997 - 1999
Education
Pennsylvania State University 1992 — 1997
Dharmesh Naik's FDA Experience August 2014 - Present
Job Operations Research Analyst at FDA
Industry Government Administration
Experience
FDA August 2014 - Present
FDA December 2012 - August 2014
HeiTech Services, Inc. January 2012 - December 2012
India Development and Relief Fund, Inc. September 2008 - June 2012
HeiTech Services, Inc. April 2011 - December 2011
HeiTech Services, Inc. July 2009 - March 2011
mBeat, Inc. August 2007 - August 2008
India Development and Relief Fund, Inc. April 2006 - August 2007
Juarez & Associates Inc July 2006 - January 2007
Investor Shareholder Services November 2005 - March 2006
Skills
Microsoft Excel, QuickBooks, Microsoft Word, Mobile Marketing, Online Social Networking, Customer Service, Public Speaking, Accounts Payable, Data Analysis, Social Media, Leadership, Project Management, Management Consulting, Quality Assurance, Quality Management, Management, Social Networking, Problem Solving, Account Reconciliation, Accounting, Email Clients
Education
University of Maryland College Park 1999 — 2002
B.A.
Prince George's Community College 1998 — 1999
N/A, General
FDA August 2014 - Present
FDA December 2012 - August 2014
HeiTech Services, Inc. January 2012 - December 2012
India Development and Relief Fund, Inc. September 2008 - June 2012
HeiTech Services, Inc. April 2011 - December 2011
HeiTech Services, Inc. July 2009 - March 2011
mBeat, Inc. August 2007 - August 2008
India Development and Relief Fund, Inc. April 2006 - August 2007
Juarez & Associates Inc July 2006 - January 2007
Investor Shareholder Services November 2005 - March 2006
Skills
Microsoft Excel, QuickBooks, Microsoft Word, Mobile Marketing, Online Social Networking, Customer Service, Public Speaking, Accounts Payable, Data Analysis, Social Media, Leadership, Project Management, Management Consulting, Quality Assurance, Quality Management, Management, Social Networking, Problem Solving, Account Reconciliation, Accounting, Email Clients
Education
University of Maryland College Park 1999 — 2002
B.A.
Prince George's Community College 1998 — 1999
N/A, General
Steve Leshin's FDA Experience
Job Pharmacologist at FDA
Industry Pharmaceuticals
Experience
FDA
Skills
Toxicology, Pharmacology, Pharmacokinetics, Drug Development, In Vivo, Drug Discovery, Regulatory Affairs, IND, In Vitro, Clinical Development, Clinical Pharmacology, Lifesciences
Education
The University of Georgia 1995 — 2000
DVM
Purdue University 1979 — 1983
PhD, animal science (neuroendocrinology)
University of California, Irvine 1972 — 1974
FDA
Skills
Toxicology, Pharmacology, Pharmacokinetics, Drug Development, In Vivo, Drug Discovery, Regulatory Affairs, IND, In Vitro, Clinical Development, Clinical Pharmacology, Lifesciences
Education
The University of Georgia 1995 — 2000
DVM
Purdue University 1979 — 1983
PhD, animal science (neuroendocrinology)
University of California, Irvine 1972 — 1974
Kim Trautman's FDA Experience August 1991 - Present
Job Associate Director International Affairs, Office of the Center Director, CDRH, FDA
Industry Medical Devices
Experience
FDA August 1991 - Present
US Army May 1986 - September 1994
US Patent and Trademark Office July 1989 - August 1991
Medical Device Industry 1983 - 1987
Skills
ISO 13485, FDA, Regulatory Affairs, CAPA, Quality System, Medical Devices, Validation, GMP, V&V, Biomedical Engineering, Quality Assurance, International Medical..., Medical Device Auditing, Regulatory Submissions, ISO 14971, Biotechnology, Regulatory Requirements, Quality Management
Education
University of Virginia 1987 — 1989
Master's Degree, Biomedical/Medical Engineering
Pennsylvania State University - Main Campus 1982 — 1986
Bachelor of Science (BS), Molecular and Cell Biology and Engineering Sciences
FDA August 1991 - Present
US Army May 1986 - September 1994
US Patent and Trademark Office July 1989 - August 1991
Medical Device Industry 1983 - 1987
Skills
ISO 13485, FDA, Regulatory Affairs, CAPA, Quality System, Medical Devices, Validation, GMP, V&V, Biomedical Engineering, Quality Assurance, International Medical..., Medical Device Auditing, Regulatory Submissions, ISO 14971, Biotechnology, Regulatory Requirements, Quality Management
Education
University of Virginia 1987 — 1989
Master's Degree, Biomedical/Medical Engineering
Pennsylvania State University - Main Campus 1982 — 1986
Bachelor of Science (BS), Molecular and Cell Biology and Engineering Sciences
Carla Cummins Tuite's FDA Experience August 2014 - Present
Job Food and Feed Policy at FDA
Industry Government Administration
Experience
FDA August 2014 - Present
FDA August 2011 - August 2014
FDA May 2011 - January 2012
Food and Drug Administration - CVM December 2008 - July 2011
FDA July 2006 - December 2008
FDA May 2002 - June 2006
Purdue University January 2000 - May 2002
CNA Insurance May 2001 - August 2001
Skills
FDA, GMP, Clinical Research, Emergency Management, Training, Public Health, Medical Devices, Food Safety, Regulatory Affairs, Data Analysis, Environmental Health, Environmental Awareness
Education
University of Maryland University College 2010 — 2014
MBA, Business Administration
University of Maryland University College 2010 — 2013
MS, Environmental Management
Purdue University 1998 — 2002
BS, Industrial Hygiene
FDA August 2014 - Present
FDA August 2011 - August 2014
FDA May 2011 - January 2012
Food and Drug Administration - CVM December 2008 - July 2011
FDA July 2006 - December 2008
FDA May 2002 - June 2006
Purdue University January 2000 - May 2002
CNA Insurance May 2001 - August 2001
Skills
FDA, GMP, Clinical Research, Emergency Management, Training, Public Health, Medical Devices, Food Safety, Regulatory Affairs, Data Analysis, Environmental Health, Environmental Awareness
Education
University of Maryland University College 2010 — 2014
MBA, Business Administration
University of Maryland University College 2010 — 2013
MS, Environmental Management
Purdue University 1998 — 2002
BS, Industrial Hygiene
Steve Trach's FDA Experience Network AdministrationNIH1990 - 1998
Job Project Manager and Information Systems Security Officer at FDA
Industry Government Administration
Laura Pillsbury's FDA Experience November 2012 - Present
Job Food Technologist | Office of Foods & Veterinary Medicine | FDA
Industry Public Policy
Experience
FDA November 2012 - Present
Institute of Medicine January 2010 - November 2012
Holyoke Food & Fitness Policy Council November 2009 - January 2010
Holyoke Food and Fitness Policy Council 2006 - January 2010
University of Massachusetts Amherst September 2006 - May 2008
UNDP August 2007 - August 2007
International Food Information Council June 2007 - August 2007
Nuestras Raices, Inc October 2006 - June 2007
Purdue University August 2002 - August 2006
General Mills May 2005 - August 2005
Skills
Food, Research, Food Safety, Community Development, Food Science, Policy, Policy Analysis, Public Health, Leadership, Agriculture, Data Analysis, Public Policy, Nutrition, Grants, Event Planning
Education
University of Massachusetts, Amherst 2006 — 2008
MPPA, Public Policy & Administration Food Science Policy
Purdue University 2002 — 2006
BS, Food Science
FDA November 2012 - Present
Institute of Medicine January 2010 - November 2012
Holyoke Food & Fitness Policy Council November 2009 - January 2010
Holyoke Food and Fitness Policy Council 2006 - January 2010
University of Massachusetts Amherst September 2006 - May 2008
UNDP August 2007 - August 2007
International Food Information Council June 2007 - August 2007
Nuestras Raices, Inc October 2006 - June 2007
Purdue University August 2002 - August 2006
General Mills May 2005 - August 2005
Skills
Food, Research, Food Safety, Community Development, Food Science, Policy, Policy Analysis, Public Health, Leadership, Agriculture, Data Analysis, Public Policy, Nutrition, Grants, Event Planning
Education
University of Massachusetts, Amherst 2006 — 2008
MPPA, Public Policy & Administration Food Science Policy
Purdue University 2002 — 2006
BS, Food Science
Robert Wittorf's FDA Experience April 2015 - Present
Job CMO/CRO Management, Pharma Manufacturing, Regulatory and QA leader
Industry Pharmaceuticals
Experience
FDA April 2015 - Present
FDA August 2013 - April 2015
University of North Carolina at Chapel Hill June 2012 - August 2013
Paddock Laboratories/Perrigo Company July 2008 - June 2012
Eli Lilly July 2004 - July 2008
Skills
Regulatory Submissions, Validation, GMP, FDA, Technology Transfer, CAPA, Pharmaceutics, Clinical Trials, Combination Products, Sop, Pharmaceutical Industry, Regulatory Affairs, Aseptic Processing, Quality System, Root Cause Analysis, Medical Devices, R&D, Dissolution, V&V, Formulation, Drug Development, Site Inspections, Biotechnology, Drug Delivery, Quality Auditing, Quality Control, 21 CFR Part 11, Change Control, Regulatory Requirements, Positron Emission..., Quality Management, Quality Assurance, Manufacturing, Process Improvement, IND, Commercialization
Education
University of Minnesota-Twin Cities 2008 — 2012
Pharm. D., Pharmacy
Purdue University
Bachelor's degree, Pharmaceutical Sciences
FDA April 2015 - Present
FDA August 2013 - April 2015
University of North Carolina at Chapel Hill June 2012 - August 2013
Paddock Laboratories/Perrigo Company July 2008 - June 2012
Eli Lilly July 2004 - July 2008
Skills
Regulatory Submissions, Validation, GMP, FDA, Technology Transfer, CAPA, Pharmaceutics, Clinical Trials, Combination Products, Sop, Pharmaceutical Industry, Regulatory Affairs, Aseptic Processing, Quality System, Root Cause Analysis, Medical Devices, R&D, Dissolution, V&V, Formulation, Drug Development, Site Inspections, Biotechnology, Drug Delivery, Quality Auditing, Quality Control, 21 CFR Part 11, Change Control, Regulatory Requirements, Positron Emission..., Quality Management, Quality Assurance, Manufacturing, Process Improvement, IND, Commercialization
Education
University of Minnesota-Twin Cities 2008 — 2012
Pharm. D., Pharmacy
Purdue University
Bachelor's degree, Pharmaceutical Sciences
David Opalenik's FDA Experience March 1996 - March 1998
Job Network Administrator at US Dept. of the Interior
Industry Information Technology and Services
Experience
US Dept. of the Interior July 2001 - Present
Boise VA Medical Center March 1998 - July 2001
FDA March 1996 - March 1998
CNA 1986 - 1988
Skills
Windows XP, Firewalls, Active Directory, Servers, Solaris, XP, Troubleshooting, Windows Server, DHCP, TCP/IP, Networking, Switches, Hardware, Management, Microsoft Office, HP-UX, Leadership, Routers, Windows 7
Education
Johns Hopkins University 1989 — 1991
Master of Science, Computer Science
University of Baltimore 1984 — 1987
Bachelor of Science, Computer Science
Penn State University 1979 — 1982
Bachelor of Science, Food Service and Housing Administration
Charleroi Area High Schol
US Dept. of the Interior July 2001 - Present
Boise VA Medical Center March 1998 - July 2001
FDA March 1996 - March 1998
CNA 1986 - 1988
Skills
Windows XP, Firewalls, Active Directory, Servers, Solaris, XP, Troubleshooting, Windows Server, DHCP, TCP/IP, Networking, Switches, Hardware, Management, Microsoft Office, HP-UX, Leadership, Routers, Windows 7
Education
Johns Hopkins University 1989 — 1991
Master of Science, Computer Science
University of Baltimore 1984 — 1987
Bachelor of Science, Computer Science
Penn State University 1979 — 1982
Bachelor of Science, Food Service and Housing Administration
Charleroi Area High Schol
Andrea Swingle's FDA Experience November 2008 - June 2014
Job Regulatory Scientist at Cook General Biotechnology
Industry Public Safety
Experience
Cook General Biotechnology June 2014 - Present
FDA November 2008 - June 2014
Indiana University School of Medicine June 2006 - November 2008
Skills
Inspection, Regulatory Affairs, Regulatory Requirements, Immunohistochemistry, Genetics, Animal Models, Gel Electrophoresis, RNA isolation, Laboratory, PCR
Education
Purdue University 2001 — 2006
Bachelor's degree, Behavioral Neuroscience, Concentration in Pyschology
Cook General Biotechnology June 2014 - Present
FDA November 2008 - June 2014
Indiana University School of Medicine June 2006 - November 2008
Skills
Inspection, Regulatory Affairs, Regulatory Requirements, Immunohistochemistry, Genetics, Animal Models, Gel Electrophoresis, RNA isolation, Laboratory, PCR
Education
Purdue University 2001 — 2006
Bachelor's degree, Behavioral Neuroscience, Concentration in Pyschology
Sherri Dennis's FDA Experience September 1999 - Present
Job Director, Divison of Risk and Decision Analysis at FDA
Industry Research
Experience
FDA September 1999 - Present
Jellinek, Schwartz & Connolly, Inc September 1991 - September 1999
Dynamac Corporation September 1989 - September 1991
Education
Virginia Polytechnic Institute and State University 1985 — 1989
MS & PhD, Agronomy/ Animal Science
Penn State University 1978 — 1982
BS, Animal BioScience
FDA September 1999 - Present
Jellinek, Schwartz & Connolly, Inc September 1991 - September 1999
Dynamac Corporation September 1989 - September 1991
Education
Virginia Polytechnic Institute and State University 1985 — 1989
MS & PhD, Agronomy/ Animal Science
Penn State University 1978 — 1982
BS, Animal BioScience
Uchenna Alexander's FDA Experience January 2012 - Present
Job Congressional Affairs Specialist at US Food and Drug Administration
Industry Government Administration
Experience
FDA January 2012 - Present
FDA May 2009 - January 2012
FDA August 2005 - April 2009
Bethel New Life September 2000 - August 2001
Skills
Public Policy, Policy Analysis, Policy, Program Evaluation, Budget Analysis, project management, Strategic Planning, public speaking, Public Health Policy
Education
University of Michigan 2002 — 2005
MPH, MPP, Public Health, Public Policy
Princeton University 1996 — 2000
BA, Psychology
FDA January 2012 - Present
FDA May 2009 - January 2012
FDA August 2005 - April 2009
Bethel New Life September 2000 - August 2001
Skills
Public Policy, Policy Analysis, Policy, Program Evaluation, Budget Analysis, project management, Strategic Planning, public speaking, Public Health Policy
Education
University of Michigan 2002 — 2005
MPH, MPP, Public Health, Public Policy
Princeton University 1996 — 2000
BA, Psychology
Giuseppe Randazzo's FDA Experience 2005 - Present
Job Project Management Officer at FDA
Industry Government Administration
Experience
FDA 2005 - Present
Skills
FDA, Government, Regulatory Requirements, Regulatory Affairs, Regulatory Submissions, Biotechnology, CAPA, Clinical Trials, Drug Development, GMP, IND, Life Sciences, Pharmaceutical Industry, Policy, Sop, Strategic Planning
Education
The Johns Hopkins University 2006 — 2007
MS, Bioscience Regulatory Affairs
Penn State University 1990 — 1995
FDA 2005 - Present
Skills
FDA, Government, Regulatory Requirements, Regulatory Affairs, Regulatory Submissions, Biotechnology, CAPA, Clinical Trials, Drug Development, GMP, IND, Life Sciences, Pharmaceutical Industry, Policy, Sop, Strategic Planning
Education
The Johns Hopkins University 2006 — 2007
MS, Bioscience Regulatory Affairs
Penn State University 1990 — 1995
Patrick Swann's FDA Experience May 1998 - May 2013
Job Senior Director at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec June 2013 - Present
FDA May 1998 - May 2013
Skills
FDA, IND, Drug Development, Biotechnology, Biopharmaceuticals, Regulatory Submissions, Lifesciences, Regulatory Affairs, Pharmaceutical Industry, Validation, Clinical Trials, Immunology, Vaccines, Drug Discovery, Technology Transfer, Clinical Development, Life Sciences
Education
University of Illinois at Chicago 1985 — 1990
PhD, Pharmacology
Purdue University 1982 — 1985
MS, Veterinary Physiology and Pharmacology
University of Maryland College Park 1977 — 1982
BS, Individual Studies - Neuroscience
Biogen Idec June 2013 - Present
FDA May 1998 - May 2013
Skills
FDA, IND, Drug Development, Biotechnology, Biopharmaceuticals, Regulatory Submissions, Lifesciences, Regulatory Affairs, Pharmaceutical Industry, Validation, Clinical Trials, Immunology, Vaccines, Drug Discovery, Technology Transfer, Clinical Development, Life Sciences
Education
University of Illinois at Chicago 1985 — 1990
PhD, Pharmacology
Purdue University 1982 — 1985
MS, Veterinary Physiology and Pharmacology
University of Maryland College Park 1977 — 1982
BS, Individual Studies - Neuroscience
Wei (Lisa) Lin's FDA Experience August 2013 - Present
Job Information Technology Project Manager at FDA
Industry Biotechnology
Experience
FDA August 2013 - Present
MedImmune July 2011 - July 2013
Merck January 2006 - August 2011
Skills
CDISC, Biostatistics, EDC, Clinical Data Management, Data Mining, Clinical Development, Statistical Programming
Education
Philadelphia University 2005 — 2005
SAS Programming Certificate for Pharmaceutical Industry
West Chester University of Pennsylvania 1993 — 1995
Master of Business Administration (MBA), Business Administration and Management, General, 3.78
Saint Joseph's University 1991 — 1993
Graduate School of Computer Science
FDA August 2013 - Present
MedImmune July 2011 - July 2013
Merck January 2006 - August 2011
Skills
CDISC, Biostatistics, EDC, Clinical Data Management, Data Mining, Clinical Development, Statistical Programming
Education
Philadelphia University 2005 — 2005
SAS Programming Certificate for Pharmaceutical Industry
West Chester University of Pennsylvania 1993 — 1995
Master of Business Administration (MBA), Business Administration and Management, General, 3.78
Saint Joseph's University 1991 — 1993
Graduate School of Computer Science
Peter A. Manilla's FDA Experience 1982 - 1990
Job Regulatory Affairs Professional
Industry Biotechnology
Experience
United States Department of Defense November 2005 - Present
Manilla LLC March 2014 - Present
VIRxSYS 2003 - 2005
AMDEX Corporation 2001 - 2003
Omrix Biopharmaceuticals 2000 - 2001
Nabi Biopharmaceuticals 1997 - 2000
AkzoNobel/ Organon Teknika Biotechnology Research Institute 1992 - 1997
Sigma-tau 1990 - 1992
FDA 1982 - 1990
US Army 1982 - 1985
Skills
Biodefense, DoD CBRN MCM Acquisition, FDA, Regulatory Affairs, Human Subjects..., IRB, GCP, GLP, Regulatory Submissions, GMP, Vaccines, Medical Devices, Biotechnology, Strategy, Quality System, Technology Transfer, Product Development, Virology, Assay Development, Sop, Quality Assurance, Lifesciences, Infectious Diseases, Clinical Trials, R&D, Oncology, Microbiology, Pharmaceutical Industry, Immunology, Protocol, Clinical Research, Validation, Molecular Biology, Hardware Diagnostics, Clinical Development, Program Evaluation, Life Sciences
Education
The Johns Hopkins University
Master of Science (MSc), Biotechnology
Penn State University
Master of Public Administration (M.P.A.)
Youngstown State University
Bachelor of Science (BSc), Biology/Biological Sciences, General
United States Department of Defense November 2005 - Present
Manilla LLC March 2014 - Present
VIRxSYS 2003 - 2005
AMDEX Corporation 2001 - 2003
Omrix Biopharmaceuticals 2000 - 2001
Nabi Biopharmaceuticals 1997 - 2000
AkzoNobel/ Organon Teknika Biotechnology Research Institute 1992 - 1997
Sigma-tau 1990 - 1992
FDA 1982 - 1990
US Army 1982 - 1985
Skills
Biodefense, DoD CBRN MCM Acquisition, FDA, Regulatory Affairs, Human Subjects..., IRB, GCP, GLP, Regulatory Submissions, GMP, Vaccines, Medical Devices, Biotechnology, Strategy, Quality System, Technology Transfer, Product Development, Virology, Assay Development, Sop, Quality Assurance, Lifesciences, Infectious Diseases, Clinical Trials, R&D, Oncology, Microbiology, Pharmaceutical Industry, Immunology, Protocol, Clinical Research, Validation, Molecular Biology, Hardware Diagnostics, Clinical Development, Program Evaluation, Life Sciences
Education
The Johns Hopkins University
Master of Science (MSc), Biotechnology
Penn State University
Master of Public Administration (M.P.A.)
Youngstown State University
Bachelor of Science (BSc), Biology/Biological Sciences, General
Hongna Wang's FDA Experience March 2014 - Present
Job Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA March 2014 - Present
Putney, Inc. 2013 - February 2014
Endo Pharmaceuticals 2011 - 2012
Endo (Qualitest) Pharmaceuticals 2010 - 2011
Bausch & Lomb 2004 - 2010
Murty Pharmaceuticals 2002 - 2003
PUMCH 1992 - 1996
Skills
Validation, HPLC, FDA, R&D, Drug Development, GMP, Pharmaceutical Industry, Sop, Drug Delivery, GLP, Technology Transfer, Formulation, Analytical Chemistry, Regulatory Submissions, Regulatory Affairs
Education
University of Kentucky 1998 — 2002
Ph.D., Pharmaceutical Sciences
Saint John's University 1996 — 1998
Master, Industrial Pharmacy
Peking University 1987 — 1992
BS, Pharmaceutical Sciences
FDA March 2014 - Present
Putney, Inc. 2013 - February 2014
Endo Pharmaceuticals 2011 - 2012
Endo (Qualitest) Pharmaceuticals 2010 - 2011
Bausch & Lomb 2004 - 2010
Murty Pharmaceuticals 2002 - 2003
PUMCH 1992 - 1996
Skills
Validation, HPLC, FDA, R&D, Drug Development, GMP, Pharmaceutical Industry, Sop, Drug Delivery, GLP, Technology Transfer, Formulation, Analytical Chemistry, Regulatory Submissions, Regulatory Affairs
Education
University of Kentucky 1998 — 2002
Ph.D., Pharmaceutical Sciences
Saint John's University 1996 — 1998
Master, Industrial Pharmacy
Peking University 1987 — 1992
BS, Pharmaceutical Sciences
Sheena Hailin Wang's FDA Experience July 2013 - Present
Job CMC reviewer at FDA
Industry Pharmaceuticals
Experience
FDA July 2013 - Present
Novartis Vaccines and Diagnostics September 2010 - June 2013
Skills
LC-MS, HPLC, Purification, Drug Delivery, Drug Discovery, Drug Development, Protein Chemistry, R&D, Chromatography, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, Technology Transfer, GLP, Medicinal Chemistry
Education
University of North Carolina at Chapel Hill 2006 — 2010
Ph.D., Molecular Pharmaceutics
The Johns Hopkins University 2001 — 2004
Master, Bioinorganic Chemistry
Peking University 1996 — 2000
Bachelor's, Organic Chemistry
High School Affiliated to BIT
FDA July 2013 - Present
Novartis Vaccines and Diagnostics September 2010 - June 2013
Skills
LC-MS, HPLC, Purification, Drug Delivery, Drug Discovery, Drug Development, Protein Chemistry, R&D, Chromatography, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, Technology Transfer, GLP, Medicinal Chemistry
Education
University of North Carolina at Chapel Hill 2006 — 2010
Ph.D., Molecular Pharmaceutics
The Johns Hopkins University 2001 — 2004
Master, Bioinorganic Chemistry
Peking University 1996 — 2000
Bachelor's, Organic Chemistry
High School Affiliated to BIT
Yunzhao Ren's FDA Experience August 2013 - Present
Job Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA August 2013 - Present
FDA March 2012 - August 2013
Johns Hopkins University October 2008 - February 2012
Skills
Pharmacometrics, Pharmacokinetics, Clinical Pharmacology, Pharmacogenetics, Oncology, Drug Repurposing, Drug Discovery, Molecular Biology, Cell Biology, Immunology, Cell Culture, Biotechnology, Western Blotting, Biochemistry, Life Sciences, Cell, Molecular Cloning, PCR
Education
The Johns Hopkins University School of Medicine 2002 — 2008
Ph.D., Pharmacology, Biochemistry, Cellular and Molecular Biology
University of Illinois at Urbana-Champaign 2001 — 2002
Cellular and Structural Biology
Peking Union Medical College 1993 — 2001
M.D.
no 2 highschool of east china normal university
FDA August 2013 - Present
FDA March 2012 - August 2013
Johns Hopkins University October 2008 - February 2012
Skills
Pharmacometrics, Pharmacokinetics, Clinical Pharmacology, Pharmacogenetics, Oncology, Drug Repurposing, Drug Discovery, Molecular Biology, Cell Biology, Immunology, Cell Culture, Biotechnology, Western Blotting, Biochemistry, Life Sciences, Cell, Molecular Cloning, PCR
Education
The Johns Hopkins University School of Medicine 2002 — 2008
Ph.D., Pharmacology, Biochemistry, Cellular and Molecular Biology
University of Illinois at Urbana-Champaign 2001 — 2002
Cellular and Structural Biology
Peking Union Medical College 1993 — 2001
M.D.
no 2 highschool of east china normal university
Gary Dzidowski's FDA Experience May 1974 - August 2014
Job Retired Biologist, student of life. at Self employed hobby farmer
Industry Food & Beverages
Experience
Self employed hobby farmer August 2014 - Present
US Food and Drug Administration May 1974 - August 2014
FDA May 1974 - August 2014
FDA 1974 - 2014
Skills
FDA, Toxicology, Regulatory Affairs, Lifesciences, Food Safety, Food Additives, Cosmetic colors, Seafood HACCP, HACCP, Food Science, In Vitro, Protein Purification, Immunology, Pharmacology, Infectious Diseases, Vaccines, Protein Chemistry, GLP, Cell Biology, Life Sciences, Laboratory
Education
Wayne State University 1968 — 1977
Bachelor of Science (B.S.), Biology, General
Purdue University 1975 — 1975
Post. Grad., Cannery Technology
Self employed hobby farmer August 2014 - Present
US Food and Drug Administration May 1974 - August 2014
FDA May 1974 - August 2014
FDA 1974 - 2014
Skills
FDA, Toxicology, Regulatory Affairs, Lifesciences, Food Safety, Food Additives, Cosmetic colors, Seafood HACCP, HACCP, Food Science, In Vitro, Protein Purification, Immunology, Pharmacology, Infectious Diseases, Vaccines, Protein Chemistry, GLP, Cell Biology, Life Sciences, Laboratory
Education
Wayne State University 1968 — 1977
Bachelor of Science (B.S.), Biology, General
Purdue University 1975 — 1975
Post. Grad., Cannery Technology
Martin Hoagland's FDA Experience December 2008 - January 2015
Job Regulatory Affairs Specialist
Industry Research
Experience
Ecolab, Inc. March 2015 - Present
FDA December 2008 - January 2015
University of Illinois at Urbana-Champaign March 2005 - December 2008
Skills
Lifesciences, Toxicology, Nutrition, Molecular Biology, Cell Culture, Science, Biochemistry
Education
University of Kentucky 1997 — 2005
Ph.D., Molecular and Biomedical Pharmacology
Purdue University 1993 — 1997
B.S., Biochemistry
Ecolab, Inc. March 2015 - Present
FDA December 2008 - January 2015
University of Illinois at Urbana-Champaign March 2005 - December 2008
Skills
Lifesciences, Toxicology, Nutrition, Molecular Biology, Cell Culture, Science, Biochemistry
Education
University of Kentucky 1997 — 2005
Ph.D., Molecular and Biomedical Pharmacology
Purdue University 1993 — 1997
B.S., Biochemistry
Sam Reinhold's FDA Experience February 2015 - Present
Job Reviewer, Chemistry
Industry Pharmaceuticals
Experience
FDA February 2015 - Present
Upsher-Smith Laboratories May 2009 - February 2015
University of Michigan September 2003 - May 2009
ViroPharma Incorporated May 2003 - August 2003
McNeil Consumer & Specialty Pharmaceuticals December 2001 - August 2002
Skills
Drug Delivery, HPLC, Pharmaceutical Industry, UV/Vis, Analytical Chemistry, Dissolution, Pharmacokinetics, GMP, Technology Transfer, Drug Development, Chromatography, Validation, Differential Scanning..., GLP, Drug Discovery, Formulation, Quality by Design, Pharmaceutics, FDA, Sop, Protein Chemistry, SOP
Education
University of Michigan 2003 — 2009
Ph.D., Pharmaceutical Sciences
Penn State University 1998 — 2003
B.S., Chemistry
Penn State University 1998 — 2003
B.S., Biology
FDA February 2015 - Present
Upsher-Smith Laboratories May 2009 - February 2015
University of Michigan September 2003 - May 2009
ViroPharma Incorporated May 2003 - August 2003
McNeil Consumer & Specialty Pharmaceuticals December 2001 - August 2002
Skills
Drug Delivery, HPLC, Pharmaceutical Industry, UV/Vis, Analytical Chemistry, Dissolution, Pharmacokinetics, GMP, Technology Transfer, Drug Development, Chromatography, Validation, Differential Scanning..., GLP, Drug Discovery, Formulation, Quality by Design, Pharmaceutics, FDA, Sop, Protein Chemistry, SOP
Education
University of Michigan 2003 — 2009
Ph.D., Pharmaceutical Sciences
Penn State University 1998 — 2003
B.S., Chemistry
Penn State University 1998 — 2003
B.S., Biology
Laurence Burke's FDA Experience 1976 - 1984
Job President at FDARCI
Industry Pharmaceuticals
Experience
FDA Regulatory Consulting, Inc March 1994 - Present
Medeikon, Inc. August 2003 - June 2007
Johnson Matthey, Inc July 1990 - March 1994
Lemmon Company March 1987 - August 1989
Food and Drug Administration September 1976 - March 1987
FDA 1976 - 1984
Skills
Regulatory Affairs, FDA, Medical Devices, GMP, Validation, Pharmaceutical Industry, Sop, Regulatory Submissions, Technology Transfer, Biotechnology, Quality Assurance, Product Development, Quality System, Clinical Trials, R&D, CAPA, Quality Control, ISO 13485, Pharmaceutics, IND, Quality Auditing, Oncology, Change Control, Lifesciences, V&V, Auditing, Quality Management, Training, ISO, Cross-functional Team..., 21 CFR Part 11, Document Management, GCP, Biopharmaceuticals, GLP, Software Documentation, Clinical Research, Process Simulation, HPLC, Start-ups, CRO
Education
Temple University, School of Pharmacy 1980 — 1988
MS, Pharmaceutical Quality Assurance Control
Penn State University 1972 — 1976
BS, Pre-Medicine
FDA Regulatory Consulting, Inc March 1994 - Present
Medeikon, Inc. August 2003 - June 2007
Johnson Matthey, Inc July 1990 - March 1994
Lemmon Company March 1987 - August 1989
Food and Drug Administration September 1976 - March 1987
FDA 1976 - 1984
Skills
Regulatory Affairs, FDA, Medical Devices, GMP, Validation, Pharmaceutical Industry, Sop, Regulatory Submissions, Technology Transfer, Biotechnology, Quality Assurance, Product Development, Quality System, Clinical Trials, R&D, CAPA, Quality Control, ISO 13485, Pharmaceutics, IND, Quality Auditing, Oncology, Change Control, Lifesciences, V&V, Auditing, Quality Management, Training, ISO, Cross-functional Team..., 21 CFR Part 11, Document Management, GCP, Biopharmaceuticals, GLP, Software Documentation, Clinical Research, Process Simulation, HPLC, Start-ups, CRO
Education
Temple University, School of Pharmacy 1980 — 1988
MS, Pharmaceutical Quality Assurance Control
Penn State University 1972 — 1976
BS, Pre-Medicine
Kimberly Kontson's FDA Experience March 2015 - Present
Job Biomedical Research Associate at FDA
Industry Medical Devices
Experience
FDA March 2015 - Present
University of Houston October 2014 - March 2015
University of Maryland September 2010 - October 2014
Maryland Psychiatric Research Center June 2009 - September 2011
Maryland Psychiatric Research Center May 2007 - August 2008
Hershey Medical Center July 2008 - July 2008
Hanger Prosthetics & Orthotics May 2007 - August 2007
Skills
Matlab, Computed Tomography, Medical Devices, Medical Imaging, Labview, Image Analysis, Analysis, Biomedical Engineering, Biomaterials, MRI, Biomechanics, Statistics, Medicine, Research, EEG, Neuroscience, LabVIEW
Education
University of Maryland - A. James Clark School of Engineering 2010 — 2014
Ph.D., Bioengineering
Penn State University 2004 — 2008
B.S., Biomedical Engineering
FDA March 2015 - Present
University of Houston October 2014 - March 2015
University of Maryland September 2010 - October 2014
Maryland Psychiatric Research Center June 2009 - September 2011
Maryland Psychiatric Research Center May 2007 - August 2008
Hershey Medical Center July 2008 - July 2008
Hanger Prosthetics & Orthotics May 2007 - August 2007
Skills
Matlab, Computed Tomography, Medical Devices, Medical Imaging, Labview, Image Analysis, Analysis, Biomedical Engineering, Biomaterials, MRI, Biomechanics, Statistics, Medicine, Research, EEG, Neuroscience, LabVIEW
Education
University of Maryland - A. James Clark School of Engineering 2010 — 2014
Ph.D., Bioengineering
Penn State University 2004 — 2008
B.S., Biomedical Engineering
Ping Zhao's FDA Experience April 2013 - Present
Job Lead, PBPK Program, Division of Pharmacometrics, Office of Clinical Pharmacology, at FDA
Industry Health, Wellness and Fitness
Experience
FDA April 2013 - Present
FDA June 2008 - Present
Amgen February 2008 - June 2008
Sonus Pharmaceuticals September 2005 - December 2007
PGRD October 2002 - September 2005
Education
University of Washington 1998 — 2002
PhD, Pharmaceutics
Peking University 1990 — 1994
BS, Pharmacy
FDA April 2013 - Present
FDA June 2008 - Present
Amgen February 2008 - June 2008
Sonus Pharmaceuticals September 2005 - December 2007
PGRD October 2002 - September 2005
Education
University of Washington 1998 — 2002
PhD, Pharmaceutics
Peking University 1990 — 1994
BS, Pharmacy
Tongtong Xu's FDA Experience December 2013 - Present
Job is actively looking for a R&D and regulatory affair related job
Industry Food & Beverages
Experience
FDA December 2013 - Present
PreScouter, Inc. January 2013 - December 2013
Penn State University August 2009 - December 2012
University of Missouri August 2005 - May 2008
Skills
PCR, UV/Vis, Gel Electrophoresis, Molecular Biology, HPLC, Cell Culture, Protein Purification, Food Microbiology, Microbiology, Spectroscopy, Chemistry, Science, Pilot Plant Production..., Proteomics, Biotechnology, Genetics, Food Science, Molecular Cloning, RT-PCR, qPCR, Cell, Analytical Chemistry, Fermentation, Sensory Evaluation, Food Processing, Food Industry, Laboratory, Western Blotting, ELISA, Protein Chemistry, Biochemistry, Experimental Design, Mass Spectrometry, Microscopy, SDS-PAGE, Team Building, Spectrophotometry, NMR, Positive Team Player, Chromatography, DNA extraction, GC-MS
Education
Penn State University 2008 — 2012
Doctor of Philosophy (PhD), Food Science
University of Missouri-Columbia 2005 — 2008
Master of Science (M.S.), Entomology
FDA December 2013 - Present
PreScouter, Inc. January 2013 - December 2013
Penn State University August 2009 - December 2012
University of Missouri August 2005 - May 2008
Skills
PCR, UV/Vis, Gel Electrophoresis, Molecular Biology, HPLC, Cell Culture, Protein Purification, Food Microbiology, Microbiology, Spectroscopy, Chemistry, Science, Pilot Plant Production..., Proteomics, Biotechnology, Genetics, Food Science, Molecular Cloning, RT-PCR, qPCR, Cell, Analytical Chemistry, Fermentation, Sensory Evaluation, Food Processing, Food Industry, Laboratory, Western Blotting, ELISA, Protein Chemistry, Biochemistry, Experimental Design, Mass Spectrometry, Microscopy, SDS-PAGE, Team Building, Spectrophotometry, NMR, Positive Team Player, Chromatography, DNA extraction, GC-MS
Education
Penn State University 2008 — 2012
Doctor of Philosophy (PhD), Food Science
University of Missouri-Columbia 2005 — 2008
Master of Science (M.S.), Entomology
Zheng (Alex) Tu's FDA Experience February 2014 - Present
Job Reviewer at FDA
Industry Government Administration
Experience
FDA February 2014 - Present
McCormick December 2010 - February 2014
Altria August 2006 - December 2010
Eli Lilly June 2004 - August 2006
Skills
R&D, Chemistry, Molecular Biology, HPLC, Cell Biology, Lifesciences, Biotechnology, GMP, Analytical Chemistry, Biochemistry, Cell Culture, FDA, GLP, UV/Vis, Chromatography, Protein Chemistry, ELISA, Mass Spectrometry, Commercialization, Purification, PCR, Microbiology, Protein Purification, Western Blotting, Life Sciences
Education
University of Pennsylvania 1996 — 2003
PhD, Cell and Molecular Biology
Peking University 1989 — 1994
MD
Peking Union Medical College
FDA February 2014 - Present
McCormick December 2010 - February 2014
Altria August 2006 - December 2010
Eli Lilly June 2004 - August 2006
Skills
R&D, Chemistry, Molecular Biology, HPLC, Cell Biology, Lifesciences, Biotechnology, GMP, Analytical Chemistry, Biochemistry, Cell Culture, FDA, GLP, UV/Vis, Chromatography, Protein Chemistry, ELISA, Mass Spectrometry, Commercialization, Purification, PCR, Microbiology, Protein Purification, Western Blotting, Life Sciences
Education
University of Pennsylvania 1996 — 2003
PhD, Cell and Molecular Biology
Peking University 1989 — 1994
MD
Peking Union Medical College
Josh Bilenker's FDA Experience 2004 - 2006
Job Chief Executive Officer at Loxo Oncology
Industry Biotechnology
Experience
Loxo Oncology July 2013 - Present
Aisling Capital January 2012 - Present
Aisling Capital 2008 - December 2011
Aisling Capital 2006 - 2008
FDA 2004 - 2006
Hospital of the University of Pennsylvania 1999 - 2004
Skills
Drug Development, Drug Testing, FDA, Venture Capital, Oncology, Corporate Finance
Education
The Johns Hopkins University School of Medicine 1995 — 1999
MD
Princeton University 1990 — 1994
AB, English
Loxo Oncology July 2013 - Present
Aisling Capital January 2012 - Present
Aisling Capital 2008 - December 2011
Aisling Capital 2006 - 2008
FDA 2004 - 2006
Hospital of the University of Pennsylvania 1999 - 2004
Skills
Drug Development, Drug Testing, FDA, Venture Capital, Oncology, Corporate Finance
Education
The Johns Hopkins University School of Medicine 1995 — 1999
MD
Princeton University 1990 — 1994
AB, English
Ron Dundore's FDA Experience 1995 - 1996
Job Principal Consultant at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL June 2013 - Present
Pharmaxis, Inc May 2012 - June 2013
InfaCare Pharmaceutical Corp September 2006 - May 2012
AstraZeneca 2000 - 2006
Rhone-Poulenc Rorer 1997 - 2000
Zeneca Pharmaceuticals 1996 - 1997
FDA 1995 - 1996
Sterling Winthrop Pharmaceuticals 1988 - 1994
Skills
Regulatory Affairs, Regulatory Strategy..., Drug Development, Clinical Development, Clinical Trials, Regulatory Submissions, Pharmacology, Technology Transfer, Medical Writing, Infectious Diseases, Regulatory Requirements, Sop, Biotechnology, Toxicology, Oncology, Biologics, eCTD, Pharmaceutical Industry, IND, GCP, CRO, Biopharmaceuticals, Therapeutic Areas, FDA, Medical Affairs, Pharmacovigilance
Education
Pennsylvania State University College of Medicine 1981 — 1985
PhD, Pharmacology
Penn State University 1972 — 1976
BS, Biology
PAREXEL June 2013 - Present
Pharmaxis, Inc May 2012 - June 2013
InfaCare Pharmaceutical Corp September 2006 - May 2012
AstraZeneca 2000 - 2006
Rhone-Poulenc Rorer 1997 - 2000
Zeneca Pharmaceuticals 1996 - 1997
FDA 1995 - 1996
Sterling Winthrop Pharmaceuticals 1988 - 1994
Skills
Regulatory Affairs, Regulatory Strategy..., Drug Development, Clinical Development, Clinical Trials, Regulatory Submissions, Pharmacology, Technology Transfer, Medical Writing, Infectious Diseases, Regulatory Requirements, Sop, Biotechnology, Toxicology, Oncology, Biologics, eCTD, Pharmaceutical Industry, IND, GCP, CRO, Biopharmaceuticals, Therapeutic Areas, FDA, Medical Affairs, Pharmacovigilance
Education
Pennsylvania State University College of Medicine 1981 — 1985
PhD, Pharmacology
Penn State University 1972 — 1976
BS, Biology
James Bertram's FDA Experience July 2014 - Present
Job CDRH Product Jurisdictional Officer at FDA
Industry Biotechnology
Experience
FDA July 2014 - Present
FDA April 2014 - June 2014
US Food and Drug Administration (FDA) October 2010 - March 2014
US Food and Drug Administration October 2009 - September 2010
Skills
Biomedical Engineering, FDA, Biomaterials, Cell Culture, Medical Devices, Lifesciences, Biotechnology, Microscopy, Regulatory Affairs, Molecular Biology, Fluorescence Microscopy, Nanotechnology, Biochemistry, Science, Regulatory Affairs...
Education
Yale University 2005 — 2009
Doctor of Philosophy (PhD), Biomedical Engineering
Yale University 2003 — 2005
Master of Science (MS), Biomedical Engineering
Penn State University 1999 — 2003
Bachelor's degree, Mechanical Engineering
FDA July 2014 - Present
FDA April 2014 - June 2014
US Food and Drug Administration (FDA) October 2010 - March 2014
US Food and Drug Administration October 2009 - September 2010
Skills
Biomedical Engineering, FDA, Biomaterials, Cell Culture, Medical Devices, Lifesciences, Biotechnology, Microscopy, Regulatory Affairs, Molecular Biology, Fluorescence Microscopy, Nanotechnology, Biochemistry, Science, Regulatory Affairs...
Education
Yale University 2005 — 2009
Doctor of Philosophy (PhD), Biomedical Engineering
Yale University 2003 — 2005
Master of Science (MS), Biomedical Engineering
Penn State University 1999 — 2003
Bachelor's degree, Mechanical Engineering
Lauren Mihalcik's FDA Experience January 2007 - May 2015
Job Toxicologist
Industry Pharmaceuticals
Experience
Amgen June 2015 - Present
FDA January 2007 - May 2015
SRA International July 2004 - February 2007
Cardiovascular Research Center, University of Virginia January 2000 - January 2004
Skills
Clinical Development, Pharmacology, Life Sciences, In Vivo, In Vitro, FDA, Toxicology, Molecular Biology, Biochemistry, Biotechnology, GLP, Drug Development, Drug Safety
Education
University of Virginia 1998 — 2004
Ph.D., Pharmacology
Princeton University 1994 — 1998
BSE, Chemical Engineering
Amgen June 2015 - Present
FDA January 2007 - May 2015
SRA International July 2004 - February 2007
Cardiovascular Research Center, University of Virginia January 2000 - January 2004
Skills
Clinical Development, Pharmacology, Life Sciences, In Vivo, In Vitro, FDA, Toxicology, Molecular Biology, Biochemistry, Biotechnology, GLP, Drug Development, Drug Safety
Education
University of Virginia 1998 — 2004
Ph.D., Pharmacology
Princeton University 1994 — 1998
BSE, Chemical Engineering
Debara Reese's FDA Experience September 2014 - Present
Job Consumer Safety Officer at FDA
Industry Medical Devices
Experience
FDA September 2014 - Present
Maetrics, LLC March 2013 - August 2014
Zimmer June 2008 - March 2013
Maetrics, LLC March 2007 - June 2008
Roche Diagnostics November 1982 - March 2007
Roche Diagnostics 1998 - 2007
Boehringer Mannheim 1990 - 1997
Skills
Trained Lead Assessor, Passed RAC in 1993, CAPA, FDA, ISO 13485, V&V, Quality System, Design Control, Validation, Medical Devices, GMP, Regulatory Affairs, 21 CFR Part 11, Quality Auditing, Sop, Change Control, ISO 14971, Quality Assurance, 21 CFR, Auditing, CE marking, FDA GMP, GxP, SOP, V
Education
Purdue University 1977 — 1981
Bachelor of Science, Microbiology
FDA September 2014 - Present
Maetrics, LLC March 2013 - August 2014
Zimmer June 2008 - March 2013
Maetrics, LLC March 2007 - June 2008
Roche Diagnostics November 1982 - March 2007
Roche Diagnostics 1998 - 2007
Boehringer Mannheim 1990 - 1997
Skills
Trained Lead Assessor, Passed RAC in 1993, CAPA, FDA, ISO 13485, V&V, Quality System, Design Control, Validation, Medical Devices, GMP, Regulatory Affairs, 21 CFR Part 11, Quality Auditing, Sop, Change Control, ISO 14971, Quality Assurance, 21 CFR, Auditing, CE marking, FDA GMP, GxP, SOP, V
Education
Purdue University 1977 — 1981
Bachelor of Science, Microbiology
Weijie Chen's FDA Experience
Job Visiting Scientist at FDA
Industry Government Administration
Experience
FDA
Skills
Science, Mathematical Statistics, ROC, Machine Learning, Image Analysis, Image Processing, Medical Devices, Clinical Trials, Matlab, Medical Physics, Statistical Modeling, Physics, R, Statistics
Education
The University of Chicago 2001 — 2007
PhD
Peking University 1998 — 2001
MSc
University of Science and Technology of China 1993 — 1998
BS
FDA
Skills
Science, Mathematical Statistics, ROC, Machine Learning, Image Analysis, Image Processing, Medical Devices, Clinical Trials, Matlab, Medical Physics, Statistical Modeling, Physics, R, Statistics
Education
The University of Chicago 2001 — 2007
PhD
Peking University 1998 — 2001
MSc
University of Science and Technology of China 1993 — 1998
BS
Dimitrio Little's FDA Experience January 2009 - May 2012
Job Mechanical Engineer at US Environmental Protection Agency (EPA)
Industry Mechanical or Industrial Engineering
Experience
US Environmental Protection Agency (EPA) December 2014 - Present
NASA Goddard Space Flight Center, & Exelis Coorporation April 2013 - May 2014
FDA January 2009 - May 2012
US Army Natick Soldier Research, Development, and Engineering Center January 2003 - December 2008
US Army January 1997 - June 2002
Skills
Microsoft Office, Microsoft Excel, PowerPoint, Public Speaking, Microsoft Word, Customer Service, Leadership, Research, Teaching, Time Management, Outlook, Team Building, Windows, Social Networking, Team Leadership, Teamwork, Data Analysis, Java, Community Outreach, Event Planning, Social Media, Access, HVAC, Sales, Negotiation, Strategic Planning
Education
University of the District of Columbia 2014 — 2016
Bachelor of Engineering (B.E.), Environmental Engineering Technology/Environmental Technology
Prince George's Community College 2010 — 2012
Associate of Arts (AA), Psychology
US Environmental Protection Agency (EPA) December 2014 - Present
NASA Goddard Space Flight Center, & Exelis Coorporation April 2013 - May 2014
FDA January 2009 - May 2012
US Army Natick Soldier Research, Development, and Engineering Center January 2003 - December 2008
US Army January 1997 - June 2002
Skills
Microsoft Office, Microsoft Excel, PowerPoint, Public Speaking, Microsoft Word, Customer Service, Leadership, Research, Teaching, Time Management, Outlook, Team Building, Windows, Social Networking, Team Leadership, Teamwork, Data Analysis, Java, Community Outreach, Event Planning, Social Media, Access, HVAC, Sales, Negotiation, Strategic Planning
Education
University of the District of Columbia 2014 — 2016
Bachelor of Engineering (B.E.), Environmental Engineering Technology/Environmental Technology
Prince George's Community College 2010 — 2012
Associate of Arts (AA), Psychology
Thomas J. Laubacher's FDA Experience August 2011 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA August 2011 - Present
United States Marine Corps September 2009 - July 2011
United States Marine Corps October 2008 - September 2009
Skills
Government Contracting, Contract Negotiation, Legal Research, Legal Writing, Administrative Law, Military Justice, Criminal Law, Military, Security Clearance, Defense, Legal Assistance, Legal Issues, Trials
Education
The George Washington University Law School 2011 — 2013
Master of Laws (LL.M.), Government Procurement Law
Pepperdine University School of Law 2004 — 2007
JD
University of Notre Dame 2000 — 2004
BA, Political Science, Philosophy
FDA August 2011 - Present
United States Marine Corps September 2009 - July 2011
United States Marine Corps October 2008 - September 2009
Skills
Government Contracting, Contract Negotiation, Legal Research, Legal Writing, Administrative Law, Military Justice, Criminal Law, Military, Security Clearance, Defense, Legal Assistance, Legal Issues, Trials
Education
The George Washington University Law School 2011 — 2013
Master of Laws (LL.M.), Government Procurement Law
Pepperdine University School of Law 2004 — 2007
JD
University of Notre Dame 2000 — 2004
BA, Political Science, Philosophy
Donald Pell's FDA Experience AccountantFood and Drug Administration
Job Accountant at FDA
Industry Government Administration
Experience
FDA AccountantFood and Drug Administration
Education
Purdue University 1977 — 1981
BS, Accounting
FDA AccountantFood and Drug Administration
Education
Purdue University 1977 — 1981
BS, Accounting
Minming Li's FDA Experience June 2014 - August 2014
Job Ph.D in Biostatistics & Statistics
Industry Higher Education
Experience
University of Massachusetts Amherst August 2013 - Present
Amgen June 2015 - August 2015
FDA June 2014 - August 2014
Purdue University August 2009 - July 2013
Skills
R, SAS, Perl, C, Minitab, Matlab, Python, Genetics, Machine Learning, Statistics, Data Mining, Statistical Modeling
Education
Purdue University
Statistics, Bioinformatics
University of Massachusetts, Amherst
Biostatistics, Statistics
University of Massachusetts Amherst August 2013 - Present
Amgen June 2015 - August 2015
FDA June 2014 - August 2014
Purdue University August 2009 - July 2013
Skills
R, SAS, Perl, C, Minitab, Matlab, Python, Genetics, Machine Learning, Statistics, Data Mining, Statistical Modeling
Education
Purdue University
Statistics, Bioinformatics
University of Massachusetts, Amherst
Biostatistics, Statistics
Sharon Benz's FDA Experience November 2004 - Present
Job director at FDA
Industry Government Administration
Experience
FDA November 2004 - Present
National Research Council, US November 1986 - January 2000
Skills
Policy, Science, FDA, Strategic Planning, Regulations, Food Safety, Agriculture, Animal Nutrition
Education
Virgina Tech 1979 — 1984
Master of Science (M.S.) and Ph.D., Animal Sciences
Penn State University 1973 — 1977
Bachelor's degree in Science, Animal agriculture
Chichester high school 1970 — 1973
FDA November 2004 - Present
National Research Council, US November 1986 - January 2000
Skills
Policy, Science, FDA, Strategic Planning, Regulations, Food Safety, Agriculture, Animal Nutrition
Education
Virgina Tech 1979 — 1984
Master of Science (M.S.) and Ph.D., Animal Sciences
Penn State University 1973 — 1977
Bachelor's degree in Science, Animal agriculture
Chichester high school 1970 — 1973
emy pfeil's FDA Experience October 2011 - Present
Job Interdisciplinary Scientist Biologist at FDA
Industry
Experience
FDA October 2011 - Present
USDA 2001 - Present
USDA - National Institute of Food and Agriculture March 2011 - May 2011
Education
Graduate School, USDA 2010 — 2011
Completion Certificate, Professional Development - Executive Leadership Program
University of Maryland College Park 1999 — 2000
Professional Development - Graduate Level Coursework, Chemistry
Penn State University 1977 — 1988
BS, Plant Science and Graduate-Level Coursework
FDA October 2011 - Present
USDA 2001 - Present
USDA - National Institute of Food and Agriculture March 2011 - May 2011
Education
Graduate School, USDA 2010 — 2011
Completion Certificate, Professional Development - Executive Leadership Program
University of Maryland College Park 1999 — 2000
Professional Development - Graduate Level Coursework, Chemistry
Penn State University 1977 — 1988
BS, Plant Science and Graduate-Level Coursework
Qiong Chen's FDA Experience July 2013 - Present
Job ORISE FELLOW, FDA
Industry Higher Education
Experience
FDA July 2013 - Present
University of Maryland 2010 - June 2013
Skills
Cell Culture, Protein Expression, Molecular Biology, Molecular Cloning, Tissue Culture, Animal Models, Fluorescence Microscopy, PCR, RT-PCR, Cell, ELISA, RNA isolation, Western Blotting, Life Sciences, Microbiology, Science, Biochemistry, Cell Biology, Biotechnology, Research, Genetics, Microscopy
Education
Peking University
University of Manitoba
FDA July 2013 - Present
University of Maryland 2010 - June 2013
Skills
Cell Culture, Protein Expression, Molecular Biology, Molecular Cloning, Tissue Culture, Animal Models, Fluorescence Microscopy, PCR, RT-PCR, Cell, ELISA, RNA isolation, Western Blotting, Life Sciences, Microbiology, Science, Biochemistry, Cell Biology, Biotechnology, Research, Genetics, Microscopy
Education
Peking University
University of Manitoba
Doris Terry's FDA Experience Cardiovascular Research TechnologistUSPHS HospitalJune 1970 - August 1980
Job Senior Scientific Reviewer at FDA
Industry Government Administration
Experience
FDA Cardiovascular Research TechnologistUSPHS HospitalJune 1970 - August 1980
Education
The Johns Hopkins University - Carey Business School 2000 — 2000
Master of Business Administration (MBA), Business Management
The Johns Hopkins University - Carey Business School 1992 — 1994
M.S. Business Management, Business Administration and Management, General
Philander Smith College
Bachelor of Science (B.S.), Biology/Biological Sciences, General, B+
Tuskegee University
Master of Science (M.S.), Cell/Cellular Biology and Histology
FDA Cardiovascular Research TechnologistUSPHS HospitalJune 1970 - August 1980
Education
The Johns Hopkins University - Carey Business School 2000 — 2000
Master of Business Administration (MBA), Business Management
The Johns Hopkins University - Carey Business School 1992 — 1994
M.S. Business Management, Business Administration and Management, General
Philander Smith College
Bachelor of Science (B.S.), Biology/Biological Sciences, General, B+
Tuskegee University
Master of Science (M.S.), Cell/Cellular Biology and Histology
Lyndsay Hennessey's FDA Experience February 2013 - Present
Job Regulatory Health Project Manager at FDA
Industry Pharmaceuticals
Experience
FDA February 2013 - Present
Octagon Research Solutions Inc August 2007 - February 2013
Skills
eCTD, Regulatory Submissions, Regulatory Affairs, IND, NDA, Regulatory Requirements, Clinical Trials
Education
Penn State University 2003 — 2007
Temple University
FDA February 2013 - Present
Octagon Research Solutions Inc August 2007 - February 2013
Skills
eCTD, Regulatory Submissions, Regulatory Affairs, IND, NDA, Regulatory Requirements, Clinical Trials
Education
Penn State University 2003 — 2007
Temple University
Haiyan Lu's FDA Experience October 2014 - Present
Job BE reviewer at FDA
Industry Pharmaceuticals
Experience
FDA October 2014 - Present
FDA November 2012 - October 2014
Skills
MODEL BASED META..., META ANALYSIS, NONMEM, SAS, SIMCYP, DDI, POP PK/PD MODELING AND..., CLINICAL PHARMACOLOGY, CLINICAL TRIAL ANALYSIS, CLINICAL TRIAL DESIGN, IBD, ONCOLOGY, DMPK, Clinical Data Management, PBPK
Education
Peking Union Medical College
Ph.D., Oncology Pharmacology
Shandong University, Pharmacy School
Bachelor of Science (B.S.), Pharmacy
FDA October 2014 - Present
FDA November 2012 - October 2014
Skills
MODEL BASED META..., META ANALYSIS, NONMEM, SAS, SIMCYP, DDI, POP PK/PD MODELING AND..., CLINICAL PHARMACOLOGY, CLINICAL TRIAL ANALYSIS, CLINICAL TRIAL DESIGN, IBD, ONCOLOGY, DMPK, Clinical Data Management, PBPK
Education
Peking Union Medical College
Ph.D., Oncology Pharmacology
Shandong University, Pharmacy School
Bachelor of Science (B.S.), Pharmacy
Aria Pezeshk's FDA Experience December 2012 - Present
Job Fellow at FDA/OSEL/CDRH/DIDSR
Industry Research
Experience
FDA December 2012 - Present
Intel Corporation August 2011 - December 2012
GE Global Research May 2008 - August 2008
Skills
Semiconductors, Matlab, JMP, Simulations, Characterization, Physics, Algorithms
Education
Penn State University 2005 — 2011
Doctor of Philosophy (PhD), Electrical and Electronics Engineering
FDA December 2012 - Present
Intel Corporation August 2011 - December 2012
GE Global Research May 2008 - August 2008
Skills
Semiconductors, Matlab, JMP, Simulations, Characterization, Physics, Algorithms
Education
Penn State University 2005 — 2011
Doctor of Philosophy (PhD), Electrical and Electronics Engineering
Karen Kennard's FDA Experience April 2010 - Present
Job Sr. Supr. Admin. Proceedings Officer
Industry Government Administration
Experience
FDA April 2010 - Present
Education
Hershey High School
Penn State University
Social Sciences
FDA April 2010 - Present
Education
Hershey High School
Penn State University
Social Sciences
Thomas Dumas's FDA Experience June 2013 - Present
Job Management Operations Specialist at FDA
Industry Government Administration
Experience
FDA June 2013 - Present
FDA August 2002 - June 2013
Europe (Miesau, Zweibrucken, Baumholder, Hanau) Ft Jackson, Colorado, Aberdeen, Ft Gillem, MI June 1978 - December 1998
Education
Pikes Peak Community College 1987 — 1988
Automotive Tech
Harris County, GA 1974 — 1978
HS Diploma, General Studies
FDA June 2013 - Present
FDA August 2002 - June 2013
Europe (Miesau, Zweibrucken, Baumholder, Hanau) Ft Jackson, Colorado, Aberdeen, Ft Gillem, MI June 1978 - December 1998
Education
Pikes Peak Community College 1987 — 1988
Automotive Tech
Harris County, GA 1974 — 1978
HS Diploma, General Studies
Thomas Nerney's FDA Experience May 2010 - Present
Job Investigator at FDA
Industry Government Administration
Experience
FDA May 2010 - Present
Rhode Island Department of Health December 1999 - May 2010
Skills
Food Safety
Education
Providence College
Bachelor of Arts (B.A.)
Salve Regina University
Certificate of Graduate Studies, Business Management
FDA May 2010 - Present
Rhode Island Department of Health December 1999 - May 2010
Skills
Food Safety
Education
Providence College
Bachelor of Arts (B.A.)
Salve Regina University
Certificate of Graduate Studies, Business Management
James Nadeau's FDA Experience August 2014 - Present
Job Senior Staff Fellow at FDA
Industry Medical Devices
Experience
FDA August 2014 - Present
BD November 1999 - October 2013
BD October 1994 - November 1999
BD April 1990 - October 1994
Skills
Biotechnology, Molecular Diagnostics, DNA, Life Sciences, Medical Devices, R&D, Intellectual Property, Medical Diagnostics, Patents, Biochemistry
Education
Yale University 1985 — 1990
Post-doctoral Fellow, Biophysical Chemistry
Purdue University 1978 — 1985
Doctor of Philosophy (Ph.D.), Nucleic Acid Chemistry
Winona State University 1974 — 1978
Bachelor's Degree, Chemistry
FDA August 2014 - Present
BD November 1999 - October 2013
BD October 1994 - November 1999
BD April 1990 - October 1994
Skills
Biotechnology, Molecular Diagnostics, DNA, Life Sciences, Medical Devices, R&D, Intellectual Property, Medical Diagnostics, Patents, Biochemistry
Education
Yale University 1985 — 1990
Post-doctoral Fellow, Biophysical Chemistry
Purdue University 1978 — 1985
Doctor of Philosophy (Ph.D.), Nucleic Acid Chemistry
Winona State University 1974 — 1978
Bachelor's Degree, Chemistry
Kimberly Gauvin's FDA Experience February 2010 - July 2013
Job Executive Assistant at FDA
Industry Government Administration
Experience
FDA, Center for Food Safety and Applied Nutrition (CFSAN) July 2013 - Present
FDA February 2010 - July 2013
Safeway Pharmacy Operations July 2006 - February 2010
Giant Food August 2001 - June 2006
Education
Prince George's Community College
Associate's Degree, Registered Nursing/Registered Nurse
FDA, Center for Food Safety and Applied Nutrition (CFSAN) July 2013 - Present
FDA February 2010 - July 2013
Safeway Pharmacy Operations July 2006 - February 2010
Giant Food August 2001 - June 2006
Education
Prince George's Community College
Associate's Degree, Registered Nursing/Registered Nurse
Danielle Sholly's FDA Experience March 2009 - Present
Job Animal Scientist, Center for Veterinary Medicine at FDA
Industry Veterinary
Experience
FDA March 2009 - Present
Aarhus University September 2006 - December 2006
Education
Purdue University 2004 — 2009
Doctor of Philosophy (PhD), Swine Nutrition
Purdue University 2002 — 2004
Master of Science (M.S.), Swine Nutrition
Purdue University 1998 — 2002
Bachelor of Science (B.S.), Animal Science
FDA March 2009 - Present
Aarhus University September 2006 - December 2006
Education
Purdue University 2004 — 2009
Doctor of Philosophy (PhD), Swine Nutrition
Purdue University 2002 — 2004
Master of Science (M.S.), Swine Nutrition
Purdue University 1998 — 2002
Bachelor of Science (B.S.), Animal Science
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