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
Cam Rudolph Cam Rudolph's FDA Experience 1990 - 2011
Job Retired
Industry Government Administration
Experience
FDA 1990 - 2011
Skills
Public Health, Healthcare, Food Safety, Policy, Government, Quality Assurance, Research
Education
Coppell High School 1980 — 1984
North Lake College
FDA 1990 - 2011
Skills
Public Health, Healthcare, Food Safety, Policy, Government, Quality Assurance, Research
Education
Coppell High School 1980 — 1984
North Lake College
Brooke O'Connell's FDA Experience October 2013 - May 2014
Job Student at Northeastern University
Industry Retail
Experience
Sports Authority June 2014 - August 2014
Regal Entertainment Group August 2013 - August 2014
FDA October 2013 - May 2014
O'Connell & Lawrence, Inc. December 2012 - February 2013
Skills
Microsoft Office
Education
Northeastern University 2014 — 2019
Bachelor’s Degree, Electrical Engineering, Sophmore
Sherwood High School 2010 — 2014
High School
Sports Authority June 2014 - August 2014
Regal Entertainment Group August 2013 - August 2014
FDA October 2013 - May 2014
O'Connell & Lawrence, Inc. December 2012 - February 2013
Skills
Microsoft Office
Education
Northeastern University 2014 — 2019
Bachelor’s Degree, Electrical Engineering, Sophmore
Sherwood High School 2010 — 2014
High School
Amir Berhannu, J.D. Amir Berhannu, J.D.'s FDA Experience June 2012 - Present
Job Presidential Management Fellow at the United States Food and Drug Administration
Industry Government Administration
Experience
FDA June 2012 - Present
Skills
Policy Analysis, Public Policy, Legal Writing, Legal Research, Government, Film Production, Media Literacy, Guest Lecturing, Civil Rights, Youth Mentoring, Final Cut Studio, Film Editing, Documentary Research, Social Activism, Abstract Paintings, Creative Writing, T-shirt Graphics, Microsoft Word, Microsoft Excel, Business Objects, Employee Viewpoint..., Activism, Community Outreach, Program Development, Public Speaking
Education
North Carolina Central University School of Law 2009 — 2012
Doctor of Law (J.D.), Constitutional Law and Civil Rights
University of North Carolina at Wilmington 2006 — 2008
Bachelor of Arts (B.A.), Film/Cinema/Video Studies
FDA June 2012 - Present
Skills
Policy Analysis, Public Policy, Legal Writing, Legal Research, Government, Film Production, Media Literacy, Guest Lecturing, Civil Rights, Youth Mentoring, Final Cut Studio, Film Editing, Documentary Research, Social Activism, Abstract Paintings, Creative Writing, T-shirt Graphics, Microsoft Word, Microsoft Excel, Business Objects, Employee Viewpoint..., Activism, Community Outreach, Program Development, Public Speaking
Education
North Carolina Central University School of Law 2009 — 2012
Doctor of Law (J.D.), Constitutional Law and Civil Rights
University of North Carolina at Wilmington 2006 — 2008
Bachelor of Arts (B.A.), Film/Cinema/Video Studies
Julianne Cyr Julianne Cyr's FDA Experience July 2004 - June 2009
Job Project Manager at UNCCH Department of Emergency Medicine
Industry Research
Experience
University of North Carolina at Chapel Hill June 2013 - Present
Washington University in St. Louis July 2011 - June 2013
Washington University in St. Louis August 2011 - December 2012
Washington University in St. Louis July 2010 - June 2011
Saint Louis University December 2009 - June 2010
FDA July 2004 - June 2009
Skills
SPSS, Microsoft SQL Server, Grantee Communication, Literature Reviews, Epidemiology, Public Health, Biostatistics, Research, SAS, Technical Assistance, Training, Publication Development, Program Evaluation, Grant Writing, Statistics, Data Collection
Education
Saint Louis University 2009 — 2011
MPH, Epidemiology, Behavioral Science/Health Education
North Carolina Wesleyan College 2005 — 2009
BA, Psychology, Religious Studies
University of North Carolina at Chapel Hill June 2013 - Present
Washington University in St. Louis July 2011 - June 2013
Washington University in St. Louis August 2011 - December 2012
Washington University in St. Louis July 2010 - June 2011
Saint Louis University December 2009 - June 2010
FDA July 2004 - June 2009
Skills
SPSS, Microsoft SQL Server, Grantee Communication, Literature Reviews, Epidemiology, Public Health, Biostatistics, Research, SAS, Technical Assistance, Training, Publication Development, Program Evaluation, Grant Writing, Statistics, Data Collection
Education
Saint Louis University 2009 — 2011
MPH, Epidemiology, Behavioral Science/Health Education
North Carolina Wesleyan College 2005 — 2009
BA, Psychology, Religious Studies
Steven Ferrara, P.E. Steven Ferrara, P.E.'s FDA Experience January 2009 - February 2010
Job Project Manager at JLL
Industry Construction
Experience
JLL March 2015 - Present
US Navy March 2010 - December 2014
Naval Facilities Engineering Command (NAVFAC) July 2012 - November 2014
Naval Mobile Construction Battalion ELEVEN March 2010 - June 2012
FDA January 2009 - February 2010
Simpson Gumpertz & Heger Inc. July 2007 - December 2008
Skills
Facilities Management, Construction Management, Construction, Contract Management, Civil Engineering, Security Clearance, Process Scheduler, Project Estimation, Navy, Military, Project Planning, Project Management, Operational Planning, DoD, Management, Government
Education
Northeastern University 2002 — 2007
Bachelor of Science (B.S.)
JLL March 2015 - Present
US Navy March 2010 - December 2014
Naval Facilities Engineering Command (NAVFAC) July 2012 - November 2014
Naval Mobile Construction Battalion ELEVEN March 2010 - June 2012
FDA January 2009 - February 2010
Simpson Gumpertz & Heger Inc. July 2007 - December 2008
Skills
Facilities Management, Construction Management, Construction, Contract Management, Civil Engineering, Security Clearance, Process Scheduler, Project Estimation, Navy, Military, Project Planning, Project Management, Operational Planning, DoD, Management, Government
Education
Northeastern University 2002 — 2007
Bachelor of Science (B.S.)
Chao-Wei Chen's FDA Experience September 2011 - August 2012
Job System Software Engineer at KLATencor
Industry Semiconductors
Experience
KLA-Tencor October 2013 - Present
CafePress Inc. July 2013 - October 2013
FDA September 2011 - August 2012
Signal Processing, Inc. January 2009 - May 2009
Genesys Logic, Inc. July 2004 - August 2004
Skills
Matlab, Java, python, Algorithms, Pattern Recognition, System of Systems..., Biomedical Engineering, LaTeX, Verilog, FPGA, Laser Physics, Semiconductor Device, convex optimization, Linear Programming, Image Processing, Signal Processing, Optical Coherence..., Confocal Microscopy, Fluorescence Microscopy, Two-photon Microscopy, Microprocessors, Assembly Language, Sikuli, HTML, SketchUp, Origami, Python
Education
University of Maryland College Park 2007 — 2012
Doctor of Philosophy (PhD), Electrical and Electronics Engineering
National Taiwan University 2005 — 2007
Master of Science (MS), Electrical and Electronics Engineering
National Taiwan University 2001 — 2005
Bachelor of Science (BS), Electrical and Electronics Engineering
UCSC Silicon Valley Extension
coursera
KLA-Tencor October 2013 - Present
CafePress Inc. July 2013 - October 2013
FDA September 2011 - August 2012
Signal Processing, Inc. January 2009 - May 2009
Genesys Logic, Inc. July 2004 - August 2004
Skills
Matlab, Java, python, Algorithms, Pattern Recognition, System of Systems..., Biomedical Engineering, LaTeX, Verilog, FPGA, Laser Physics, Semiconductor Device, convex optimization, Linear Programming, Image Processing, Signal Processing, Optical Coherence..., Confocal Microscopy, Fluorescence Microscopy, Two-photon Microscopy, Microprocessors, Assembly Language, Sikuli, HTML, SketchUp, Origami, Python
Education
University of Maryland College Park 2007 — 2012
Doctor of Philosophy (PhD), Electrical and Electronics Engineering
National Taiwan University 2005 — 2007
Master of Science (MS), Electrical and Electronics Engineering
National Taiwan University 2001 — 2005
Bachelor of Science (BS), Electrical and Electronics Engineering
UCSC Silicon Valley Extension
coursera
Kimberly Swartz's FDA Experience June 2012 - August 2012
Job Member, AMA Council on Ethical and Judicial Affairs
Industry Medical Practice
Experience
American Medical Association May 2014 - July 2014
FDA June 2012 - August 2012
Aesthetic Plastic Surgery January 2010 - August 2011
Cleveland Clinic May 2007 - May 2011
Synovis Surgical Innovations May 2010 - August 2010
The Hastings Center September 2009 - December 2009
Novadaq Technologies Inc. May 2009 - August 2009
Bellevue Medical Center June 2008 - August 2008
Skills
Bioethics, Ethics, Healthcare, Research, Global Health, Public Health, Surgery, PowerPoint, Qualitative Research, Program Evaluation, Public Speaking, Teaching, Health Policy, SPSS, Literature Reviews, Data Analysis, Editing
Education
University of Florida 2011 — 2017
Doctor of Medicine (M.D.)
University of Florida - Fredric G. Levin College of Law 2013 — 2015
Doctor of Law (J.D.)
New York University 2010 — 2011
Master of Arts (M.A.), Bioethics
New York University 2006 — 2009
Bachelor of Arts (B.A.), Biology/Political Science
American Medical Association May 2014 - July 2014
FDA June 2012 - August 2012
Aesthetic Plastic Surgery January 2010 - August 2011
Cleveland Clinic May 2007 - May 2011
Synovis Surgical Innovations May 2010 - August 2010
The Hastings Center September 2009 - December 2009
Novadaq Technologies Inc. May 2009 - August 2009
Bellevue Medical Center June 2008 - August 2008
Skills
Bioethics, Ethics, Healthcare, Research, Global Health, Public Health, Surgery, PowerPoint, Qualitative Research, Program Evaluation, Public Speaking, Teaching, Health Policy, SPSS, Literature Reviews, Data Analysis, Editing
Education
University of Florida 2011 — 2017
Doctor of Medicine (M.D.)
University of Florida - Fredric G. Levin College of Law 2013 — 2015
Doctor of Law (J.D.)
New York University 2010 — 2011
Master of Arts (M.A.), Bioethics
New York University 2006 — 2009
Bachelor of Arts (B.A.), Biology/Political Science
Leslie Tompkins's FDA Experience December 2011 - Present
Job Policy Analyst at FDA
Industry Government Administration
Experience
FDA December 2011 - Present
Oak Ridge Institute for Sciene Education February 2010 - November 2011
University of Maryland School of Pharmacy November 2007 - November 2009
Education
North Carolina State University 1999 — 2007
Doctor of Philosophy (PhD), Molecular Toxicology
University of New Hampshire 1995 — 1999
Bachelor of Science (BS), Biology, General
FDA December 2011 - Present
Oak Ridge Institute for Sciene Education February 2010 - November 2011
University of Maryland School of Pharmacy November 2007 - November 2009
Education
North Carolina State University 1999 — 2007
Doctor of Philosophy (PhD), Molecular Toxicology
University of New Hampshire 1995 — 1999
Bachelor of Science (BS), Biology, General
Monica Terry's FDA Experience October 2014 - June 2015
Job Independent Training Developer Consultant
Industry E-Learning
Experience
MYT Technical Services, LLC March 2008 - Present
FDA October 2014 - June 2015
ttcInnovations August 2014 - June 2015
State Farm Insurance March 2012 - June 2015
Genesys July 2013 - March 2015
HEB November 2013 - January 2014
Labyrinth Learning September 2012 - October 2013
Cisco June 2010 - July 2013
Aligned Leadership Group 2012 - 2012
Aligned Leadership Group 2012 - 2012
Skills
Captivate, WebEx, SharePoint, Visio, SnagIt, Microsoft Office Suite, Articulate Suite, CA Clarity, Clarity, MS Project, Microsoft Publisher, Photoshop, Corel Draw, PhotoDraw, Live Meeting, Corel Word Perfect, Adobe Professional, Flash, Dreamweaver, Adobe Fireworks, FrontPage, Pagemaker, Audacity, Soundbooth, Reason and Pro Tools..., metaDoc Document Manager, Interwoven OpenDeploy, iLearn Content, Plato, ActiveWeb, Toolbook, SAP GUI, SAP Time Management..., SCORM, Training Delivery, Training, Instructional Design, E-Learning, Learning Management..., Adobe Acrobat, Microsoft Office, ADDIE, Project Management, Instructor-led Training, Technical Writing, Camtasia, Needs Analysis
Education
North Carolina Agricultural and Technical State University 1997 — 2002
Masters of Science, Instructional Technology
MYT Technical Services, LLC March 2008 - Present
FDA October 2014 - June 2015
ttcInnovations August 2014 - June 2015
State Farm Insurance March 2012 - June 2015
Genesys July 2013 - March 2015
HEB November 2013 - January 2014
Labyrinth Learning September 2012 - October 2013
Cisco June 2010 - July 2013
Aligned Leadership Group 2012 - 2012
Aligned Leadership Group 2012 - 2012
Skills
Captivate, WebEx, SharePoint, Visio, SnagIt, Microsoft Office Suite, Articulate Suite, CA Clarity, Clarity, MS Project, Microsoft Publisher, Photoshop, Corel Draw, PhotoDraw, Live Meeting, Corel Word Perfect, Adobe Professional, Flash, Dreamweaver, Adobe Fireworks, FrontPage, Pagemaker, Audacity, Soundbooth, Reason and Pro Tools..., metaDoc Document Manager, Interwoven OpenDeploy, iLearn Content, Plato, ActiveWeb, Toolbook, SAP GUI, SAP Time Management..., SCORM, Training Delivery, Training, Instructional Design, E-Learning, Learning Management..., Adobe Acrobat, Microsoft Office, ADDIE, Project Management, Instructor-led Training, Technical Writing, Camtasia, Needs Analysis
Education
North Carolina Agricultural and Technical State University 1997 — 2002
Masters of Science, Instructional Technology
Chad Reiter Chad Reiter's FDA Experience October 2009 - October 2011
Job Research Scientist at Wright State Research Institute; WSU Adjunct in Dept. Biochemistry and Molecular Biology
Industry Research
Experience
Wright State University December 2011 - Present
FDA October 2009 - October 2011
NIH/NCCAM February 2005 - October 2009
Skills
Cell Biology, Molecular Biology, Biochemistry, Animal Models, Cell Culture, In Vivo, Western Blotting, Life Sciences, Physiology, Cell, Science, Human Performance, Lifesciences, Security Clearance, FDA, Immunocytochemistry, Blood Products, IRB, Biologics, SBIR
Education
Penn State University 1998 — 2004
PhD, Physiology
North Central College 1994 — 1998
BS, Biochemistry, Mathematics
Wright State University December 2011 - Present
FDA October 2009 - October 2011
NIH/NCCAM February 2005 - October 2009
Skills
Cell Biology, Molecular Biology, Biochemistry, Animal Models, Cell Culture, In Vivo, Western Blotting, Life Sciences, Physiology, Cell, Science, Human Performance, Lifesciences, Security Clearance, FDA, Immunocytochemistry, Blood Products, IRB, Biologics, SBIR
Education
Penn State University 1998 — 2004
PhD, Physiology
North Central College 1994 — 1998
BS, Biochemistry, Mathematics
Jungmin Heather Yeom's FDA Experience May 2014 - June 2014
Job Pharmacy Intern at Massachusetts General Hospital
Industry Pharmaceuticals
Experience
Lomic Korea, Inc. October 2012 - May 2015
Brigham and Women's Hospital January 2015 - February 2015
Massachusetts General Hospital October 2014 - November 2014
CVS Pharmacy September 2014 - October 2014
Brigham and Women's Hospital July 2014 - September 2014
Cubist Pharmaceuticals June 2014 - July 2014
FDA May 2014 - June 2014
Mount Sinai Hospital, Toronto September 2012 - December 2012
Galleria Pharmacy September 2012 - December 2012
Hanmi Pharmaceuticals September 2011 - December 2011
Education
Northeastern University 2008 — 2015
Pharmacy, Doctor of Pharmacy (PharmD)
Northeastern University 2008 — 2014
Pharmacy Studies, Bachelor’s Degree
Lomic Korea, Inc. October 2012 - May 2015
Brigham and Women's Hospital January 2015 - February 2015
Massachusetts General Hospital October 2014 - November 2014
CVS Pharmacy September 2014 - October 2014
Brigham and Women's Hospital July 2014 - September 2014
Cubist Pharmaceuticals June 2014 - July 2014
FDA May 2014 - June 2014
Mount Sinai Hospital, Toronto September 2012 - December 2012
Galleria Pharmacy September 2012 - December 2012
Hanmi Pharmaceuticals September 2011 - December 2011
Education
Northeastern University 2008 — 2015
Pharmacy, Doctor of Pharmacy (PharmD)
Northeastern University 2008 — 2014
Pharmacy Studies, Bachelor’s Degree
Mona Rahman Mona Rahman's FDA Experience September 2014 - Present
Job FDA Tobacco Regulatory Science Fellow
Industry Marketing and Advertising
Experience
FDA September 2014 - Present
American Legacy Foundation January 2011 - August 2014
Akash Solar Ventures, LLC September 2009 - December 2010
Smart Grid Information Clearinghouse September 2009 - December 2010
Arnold Worldwide June 2007 - August 2009
Arnold Worldwide June 2007 - April 2009
Margeotes Fertitta Powell January 2006 - June 2007
McCann Erickson January 2005 - December 2005
Skills
Integrated Marketing, Digital Strategy, Digital Marketing, Advertising, Interactive Marketing, Creative Strategy, Marketing Communications, Social Media, Social Media Marketing, Digital Media, Interactive Advertising, Strategy, Brand Development, Brand Management, Email Marketing, Online Advertising, New Media, Marketing Research, Brand Architecture, Market Research, Content Strategy, Marketing Management, Marketing, Social Marketing, Brand Awareness, Social Networking, Account Management, Creative Direction, Interactive Creative..., Customer Engagement, Department Budgeting, Leadership, Media Planning, Marketing Strategy
Education
New York University 2005 — 2007
M.A., Culture & Communication
University of Virginia 1998 — 2002
B.A., Government
FDA September 2014 - Present
American Legacy Foundation January 2011 - August 2014
Akash Solar Ventures, LLC September 2009 - December 2010
Smart Grid Information Clearinghouse September 2009 - December 2010
Arnold Worldwide June 2007 - August 2009
Arnold Worldwide June 2007 - April 2009
Margeotes Fertitta Powell January 2006 - June 2007
McCann Erickson January 2005 - December 2005
Skills
Integrated Marketing, Digital Strategy, Digital Marketing, Advertising, Interactive Marketing, Creative Strategy, Marketing Communications, Social Media, Social Media Marketing, Digital Media, Interactive Advertising, Strategy, Brand Development, Brand Management, Email Marketing, Online Advertising, New Media, Marketing Research, Brand Architecture, Market Research, Content Strategy, Marketing Management, Marketing, Social Marketing, Brand Awareness, Social Networking, Account Management, Creative Direction, Interactive Creative..., Customer Engagement, Department Budgeting, Leadership, Media Planning, Marketing Strategy
Education
New York University 2005 — 2007
M.A., Culture & Communication
University of Virginia 1998 — 2002
B.A., Government
JoJo Long JoJo Long's FDA Experience July 2014 - Present
Job Intergovernmental Affairs Specialist, FDA, Office of Policy, Planning, and Legislation
Industry Public Policy
Experience
FDA July 2014 - Present
US Department of Health and Human Services January 2013 - August 2014
Grafted Tree January 2010 - January 2013
Nebraska Supreme Court April 2011 - February 2012
Maryland Department of Corrections September 2009 - April 2011
Lincoln Action Program March 2007 - October 2007
Nebraska Appleseed May 2005 - September 2005
Skills
Legal Research, Legal Writing, Courts, Microsoft Office, Criminal Law, Research, Public Speaking, Microsoft Excel, Mediation, Microsoft Word, PowerPoint, English, Grant Writing, Public Policy, Investigation, Government, Community Outreach, Program Development, Leadership, Policy, Nonprofits, Training, Program Management, Policy Analysis
Education
Nebraska Wesleyan University
Bachelor of Science (B.S.), Social Work
FDA July 2014 - Present
US Department of Health and Human Services January 2013 - August 2014
Grafted Tree January 2010 - January 2013
Nebraska Supreme Court April 2011 - February 2012
Maryland Department of Corrections September 2009 - April 2011
Lincoln Action Program March 2007 - October 2007
Nebraska Appleseed May 2005 - September 2005
Skills
Legal Research, Legal Writing, Courts, Microsoft Office, Criminal Law, Research, Public Speaking, Microsoft Excel, Mediation, Microsoft Word, PowerPoint, English, Grant Writing, Public Policy, Investigation, Government, Community Outreach, Program Development, Leadership, Policy, Nonprofits, Training, Program Management, Policy Analysis
Education
Nebraska Wesleyan University
Bachelor of Science (B.S.), Social Work
Jessica Aranda Jessica Aranda's FDA Experience June 2014 - Present
Job Stakeholder Engagement at FDA
Industry Information Technology and Services
Experience
FDA June 2014 - Present
Michael Kors January 2013 - June 2013
Proenza Schouler November 2012 - February 2013
Harper's Bazaar January 2012 - May 2012
San Diego Harley-Davidson October 2010 - January 2011
USMC September 2006 - December 2010
Skills
Press Releases, Public Relations, Media Relations, Social Media, Crisis Communications, Fashion, Strategic Communications, Facebook, Leadership, Photography, Event Planning, Editing, Blogging, Military, Public Affairs, Crisis Management, Corporate Communications, Journalism, Microsoft Office, Social Media Marketing, Social Networking, Spokesperson, Publicity, Photoshop, Fashion GPS, Military Skills, Microsoft Excel, PowerPoint, Media Skills Training, Publications, Communications Planning, Internal Communications, Marketing Communications, Event Management, Creative Writing, Speech Writing, Writing, Twitter, Information Technology, IT Strategy, Compliance, Trade Compliance, Regulatory Affairs
Education
New York University 2012 — 2013
M.S. Public Relations and Corporate Communication
Fullbridge Program
San Diego State University-California State University 2010 — 2011
B.A Journalism with Emphasis in Public Relations
FDA June 2014 - Present
Michael Kors January 2013 - June 2013
Proenza Schouler November 2012 - February 2013
Harper's Bazaar January 2012 - May 2012
San Diego Harley-Davidson October 2010 - January 2011
USMC September 2006 - December 2010
Skills
Press Releases, Public Relations, Media Relations, Social Media, Crisis Communications, Fashion, Strategic Communications, Facebook, Leadership, Photography, Event Planning, Editing, Blogging, Military, Public Affairs, Crisis Management, Corporate Communications, Journalism, Microsoft Office, Social Media Marketing, Social Networking, Spokesperson, Publicity, Photoshop, Fashion GPS, Military Skills, Microsoft Excel, PowerPoint, Media Skills Training, Publications, Communications Planning, Internal Communications, Marketing Communications, Event Management, Creative Writing, Speech Writing, Writing, Twitter, Information Technology, IT Strategy, Compliance, Trade Compliance, Regulatory Affairs
Education
New York University 2012 — 2013
M.S. Public Relations and Corporate Communication
Fullbridge Program
San Diego State University-California State University 2010 — 2011
B.A Journalism with Emphasis in Public Relations
Denise Wallace Denise Wallace's FDA Experience
Job International Policy Analyst at FDA
Industry Government Administration
Experience
FDA
Skills
Policy
Education
Northeastern University 1994 — 1998
Doctor of Law (J.D.)
New York Institute of Technology-Old Westbury
FDA
Skills
Policy
Education
Northeastern University 1994 — 1998
Doctor of Law (J.D.)
New York Institute of Technology-Old Westbury
Theresa Allio Theresa Allio's FDA Experience May 2010 - January 2011
Job Regulatory Officer at National Institutes of Health
Industry Pharmaceuticals
Experience
Independent June 2012 - October 2012
The Weinberg Group August 2011 - June 2012
Independent February 2011 - August 2011
FDA May 2010 - January 2011
FDA July 2008 - May 2010
Javelin Pharmaceuticals February 2008 - July 2008
Vertex Pharmaceuticals Inc. June 2005 - February 2008
Skills
Development and..., FDA interaction support, IND, NDA, ANDA, CTA..., eCTD, Label preparation and..., Lifecycle management, Product defense, Medical writing, Toxicology, Pharmacology, Clinical, FDA, Regulatory Submissions, Medical Writing, Regulatory Affairs, Drug Development, IND, Clinical Development, Lifesciences, Clinical Trials, Biotechnology, Clinical Research, Life Sciences, CRO, Pharmaceutical Industry
Education
North Carolina State University 1993 — 1999
Ph.D., Toxicology
Independent June 2012 - October 2012
The Weinberg Group August 2011 - June 2012
Independent February 2011 - August 2011
FDA May 2010 - January 2011
FDA July 2008 - May 2010
Javelin Pharmaceuticals February 2008 - July 2008
Vertex Pharmaceuticals Inc. June 2005 - February 2008
Skills
Development and..., FDA interaction support, IND, NDA, ANDA, CTA..., eCTD, Label preparation and..., Lifecycle management, Product defense, Medical writing, Toxicology, Pharmacology, Clinical, FDA, Regulatory Submissions, Medical Writing, Regulatory Affairs, Drug Development, IND, Clinical Development, Lifesciences, Clinical Trials, Biotechnology, Clinical Research, Life Sciences, CRO, Pharmaceutical Industry
Education
North Carolina State University 1993 — 1999
Ph.D., Toxicology
Noravia McCoy Noravia McCoy's FDA Experience June 2008 - August 2011
Job Library Media Specialist at District of Columbia Public Schools (DCPS)
Industry Education Management
Experience
District of Columbia Public Schools (DCPS) August 2014 - Present
Prince George's County Public Schools August 2013 - June 2014
District of Columbia Public Schools (DCPS) August 2012 - August 2013
Greensboro Police Department February 2012 - May 2012
The Telephone Centre, Inc January 2012 - May 2012
FDA June 2008 - August 2011
Children's Rights Council September 2007 - May 2008
Skills
Facebook, Social Media, Public Speaking, Microsoft Office, Press Releases, Avid Media Composer, Twitter, Broadcast Journalism, Creative Writing, News Writing, Public Safety, Education, Elementary Education, Library, Library Instruction, Library Research, Middle School, Secondary Education, School Library Media
Education
The Catholic University of America 2014 — 2016
Master's Degree, Library and Information Science
North Carolina Agricultural and Technical State University 2008 — 2012
B.S, Electronic Media and Journalism
Eleanor Roosevelt High School 2004 — 2008
Diploma, Academy of Information Technology
District of Columbia Public Schools (DCPS) August 2014 - Present
Prince George's County Public Schools August 2013 - June 2014
District of Columbia Public Schools (DCPS) August 2012 - August 2013
Greensboro Police Department February 2012 - May 2012
The Telephone Centre, Inc January 2012 - May 2012
FDA June 2008 - August 2011
Children's Rights Council September 2007 - May 2008
Skills
Facebook, Social Media, Public Speaking, Microsoft Office, Press Releases, Avid Media Composer, Twitter, Broadcast Journalism, Creative Writing, News Writing, Public Safety, Education, Elementary Education, Library, Library Instruction, Library Research, Middle School, Secondary Education, School Library Media
Education
The Catholic University of America 2014 — 2016
Master's Degree, Library and Information Science
North Carolina Agricultural and Technical State University 2008 — 2012
B.S, Electronic Media and Journalism
Eleanor Roosevelt High School 2004 — 2008
Diploma, Academy of Information Technology
Mamta Kapoor Bhushan Mamta Kapoor Bhushan's FDA Experience November 2014 - Present
Job Staff Fellow at FDA
Industry Pharmaceuticals
Experience
FDA November 2014 - Present
University of Minnesota September 2012 - October 2014
University of Connecticut August 2007 - August 2012
University of Connecticut August 2007 - October 2011
Alnylam Pharmaceuticals May 2009 - January 2010
Nicholas Piramal India Ltd July 2006 - July 2007
National Institute of Pharmaceutical Education and Research June 2004 - June 2006
college of pharmacy, delhi 2000 - 2004
Skills
liposome-siRNA..., Formulation Development, preformulation studies, Cell Culture, dynamic light scattering, Fluorescence..., Fluorescence Microscopy, Confocal Microscopy, Agarose Gel..., siRNA delivery, Drug Delivery, HPLC, Enzyme Kinetics, Formulation, Characterization, Polymers, Nanotechnology, Enzyme Assays, Flow Cytometry, Nanoparticles, Cell, Assay Development, Protein Chemistry, In Vitro, DLS, Gel Electrophoresis
Education
The University of Connecticut 2007 — 2012
Ph.D., Pharmaceutics
National Institute of Pharmaceutical Education and Research 2004 — 2006
Masters, Pharmaceutics
Delhi Institute of Pharmaceutical Sciences and Research 2000 — 2004
Bachelors, Pharmacy
FDA November 2014 - Present
University of Minnesota September 2012 - October 2014
University of Connecticut August 2007 - August 2012
University of Connecticut August 2007 - October 2011
Alnylam Pharmaceuticals May 2009 - January 2010
Nicholas Piramal India Ltd July 2006 - July 2007
National Institute of Pharmaceutical Education and Research June 2004 - June 2006
college of pharmacy, delhi 2000 - 2004
Skills
liposome-siRNA..., Formulation Development, preformulation studies, Cell Culture, dynamic light scattering, Fluorescence..., Fluorescence Microscopy, Confocal Microscopy, Agarose Gel..., siRNA delivery, Drug Delivery, HPLC, Enzyme Kinetics, Formulation, Characterization, Polymers, Nanotechnology, Enzyme Assays, Flow Cytometry, Nanoparticles, Cell, Assay Development, Protein Chemistry, In Vitro, DLS, Gel Electrophoresis
Education
The University of Connecticut 2007 — 2012
Ph.D., Pharmaceutics
National Institute of Pharmaceutical Education and Research 2004 — 2006
Masters, Pharmaceutics
Delhi Institute of Pharmaceutical Sciences and Research 2000 — 2004
Bachelors, Pharmacy
Joseph Duca Joseph Duca's FDA Experience Chemistry TeacherLinden Board Of EducationSeptember 2007 - June 2008
Job CSO at FDA
Industry Government Administration
Experience
FDA Chemistry TeacherLinden Board Of EducationSeptember 2007 - June 2008
Engelhard Corp. sold to BASF 1984 - 2007
Education
NJIT 2000 — 2004
Master of Science (MS), Engineering
FDA Chemistry TeacherLinden Board Of EducationSeptember 2007 - June 2008
Engelhard Corp. sold to BASF 1984 - 2007
Education
NJIT 2000 — 2004
Master of Science (MS), Engineering
Alexis Reisin Miller Alexis Reisin Miller's FDA Experience July 2010 - August 2011
Job Senior Director, Global Regulatory Policy and Intelligence at Eisai
Industry Law Practice
Experience
Eisai June 2014 - Present
Morgan, Lewis & Bockius LLP September 2011 - June 2014
FDA July 2010 - August 2011
Morgan, Lewis & Bockius LLP July 2006 - July 2010
Keller and Heckman LLP February 2006 - July 2006
RRD International, LLC August 2004 - February 2006
Goodell, DeVries, Leech, and Dann, LLP May 2002 - June 2004
Skills
Food, Drug, and..., FTC Consumer Protection..., FDA Law, CPSC Counseling, FDA, FTC, CPSC, Consumer Law, Matters, Pharmaceutical Industry, Regulatory Affairs, Litigation, Health Law, Commercial Litigation, Healthcare, Legal Writing, Licensing, Corporate Law, Corporate Governance, Administrative Law, Privacy Law, Legal Advice, Civil Litigation
Education
The Catholic University of America, Columbus School of Law 2000 — 2003
JD
New York University 1996 — 1999
BA, International Business, International Relations
Eisai June 2014 - Present
Morgan, Lewis & Bockius LLP September 2011 - June 2014
FDA July 2010 - August 2011
Morgan, Lewis & Bockius LLP July 2006 - July 2010
Keller and Heckman LLP February 2006 - July 2006
RRD International, LLC August 2004 - February 2006
Goodell, DeVries, Leech, and Dann, LLP May 2002 - June 2004
Skills
Food, Drug, and..., FTC Consumer Protection..., FDA Law, CPSC Counseling, FDA, FTC, CPSC, Consumer Law, Matters, Pharmaceutical Industry, Regulatory Affairs, Litigation, Health Law, Commercial Litigation, Healthcare, Legal Writing, Licensing, Corporate Law, Corporate Governance, Administrative Law, Privacy Law, Legal Advice, Civil Litigation
Education
The Catholic University of America, Columbus School of Law 2000 — 2003
JD
New York University 1996 — 1999
BA, International Business, International Relations
Jalil Isa Jalil Isa's FDA Experience February 2013 - June 2013
Job Writer/Editor at U.S. Customs and Border Protection
Industry Broadcast Media
Experience
U.S. Customs and Border Protection February 2014 - Present
FDA February 2013 - June 2013
Various organizations May 2011 - February 2013
Environmental Protection Agency August 2010 - May 2011
Independent Contractor - various media outlets February 2002 - March 2008
North Carolina Dept. of Health & Human Services February 2002 - March 2008
WNCN-TV NBC17 December 1999 - September 2001
Florida's News Channel August 1998 - November 1999
Skills
Media Relations, Press Releases, Strategic Communications, Social Media, Broadcast, Television, Radio, Storytelling, Politics, Spanish, Spokesperson, Marketing, Government, Interviews, Feature Articles, Journalism, News Writing, Broadcast Journalism, Newspapers, Breaking News, Broadcast Television, Editing, Publicity, Crisis Communications, Speech Writing, Internal Communications, Writing, Corporate Communications, Video, Public Relations, Public Speaking
Education
North Carolina State University 2008 — 2010
Master's, International Studies
University of Florida 1997 — 1998
Bachelor of Science, Telecommunication (News)
Miami-Dade Community College
Associate of Arts
U.S. Customs and Border Protection February 2014 - Present
FDA February 2013 - June 2013
Various organizations May 2011 - February 2013
Environmental Protection Agency August 2010 - May 2011
Independent Contractor - various media outlets February 2002 - March 2008
North Carolina Dept. of Health & Human Services February 2002 - March 2008
WNCN-TV NBC17 December 1999 - September 2001
Florida's News Channel August 1998 - November 1999
Skills
Media Relations, Press Releases, Strategic Communications, Social Media, Broadcast, Television, Radio, Storytelling, Politics, Spanish, Spokesperson, Marketing, Government, Interviews, Feature Articles, Journalism, News Writing, Broadcast Journalism, Newspapers, Breaking News, Broadcast Television, Editing, Publicity, Crisis Communications, Speech Writing, Internal Communications, Writing, Corporate Communications, Video, Public Relations, Public Speaking
Education
North Carolina State University 2008 — 2010
Master's, International Studies
University of Florida 1997 — 1998
Bachelor of Science, Telecommunication (News)
Miami-Dade Community College
Associate of Arts
Carol D'lima Carol D'lima's FDA Experience August 2011 - Present
Job Compliance Officer at FDA Office of Compliance
Industry Food Production
Experience
FDA August 2011 - Present
FDA-CFSAN October 2010 - July 2011
University of CA Davis July 2007 - September 2010
Department of Food Science, UC Davis CA January 2010 - April 2010
North Carolina State University January 2003 - May 2007
NC State University June 2006 - August 2006
Food Products Association May 2005 - August 2005
Purdue University July 2001 - October 2002
Sensient Flavors Inc May 2002 - August 2002
Purdue University 1999 - July 2000
Skills
Food Microbiology, Food Science
Education
North Carolina State University 2003 — 2007
Doctor of Philosophy, Food Science minor Biotechnology
Purdue University 2001 — 2003
Master of Science, Food Science specializing; Food Microbiology
Purdue University 1999 — 2001
Bachelor of Science, Food Science and Microbiology
FDA August 2011 - Present
FDA-CFSAN October 2010 - July 2011
University of CA Davis July 2007 - September 2010
Department of Food Science, UC Davis CA January 2010 - April 2010
North Carolina State University January 2003 - May 2007
NC State University June 2006 - August 2006
Food Products Association May 2005 - August 2005
Purdue University July 2001 - October 2002
Sensient Flavors Inc May 2002 - August 2002
Purdue University 1999 - July 2000
Skills
Food Microbiology, Food Science
Education
North Carolina State University 2003 — 2007
Doctor of Philosophy, Food Science minor Biotechnology
Purdue University 2001 — 2003
Master of Science, Food Science specializing; Food Microbiology
Purdue University 1999 — 2001
Bachelor of Science, Food Science and Microbiology
Loren Gelber Loren Gelber's FDA Experience 1975 - 1985
Job Pharmaceutical consultant Independent
Industry Pharmaceuticals
Experience
Independent July 2015 - Present
Akesis August 2013 - July 2015
BestSweet Inc. January 2012 - July 2012
RRI Group June 2005 - April 2011
NAPM/GPhA 1990 - 2010
Watson Pharmaceuticals 1992 - 2009
Watson Pharmaceuticals, formerly Andrx 2002 - 2005
Andrx Pharmaceuticals 2000 - 2005
FDA 1975 - 1985
Skills
FDA, Regulatory Affairs, GMP, Sop, Pharmaceutical Industry, GxP, Validation, Quality Control, Quality System, Regulatory Submissions, Leadership, Pharmaceutics, Biotechnology, Laboratory, GLP, HPLC, Technology Transfer, LIMS, CAPA, Cleaning Validation, Biopharmaceuticals, Regulatory Requirements, Drug Development, V&V, 21 CFR Part 11, Formulation, Dissolution, ANDA, Generic Programming, Drug Delivery, IND, Aseptic Processing, Change Control, Analytical Chemistry, Clinical Trials, Chromatography, UV, Quality by Design, SOP
Education
Northeastern University 1978 — 1985
Ph.D., Medicinal Chemistry
Brooklyn Polytechnic Institute
Master of Science (M.S.), Chemistry
Independent July 2015 - Present
Akesis August 2013 - July 2015
BestSweet Inc. January 2012 - July 2012
RRI Group June 2005 - April 2011
NAPM/GPhA 1990 - 2010
Watson Pharmaceuticals 1992 - 2009
Watson Pharmaceuticals, formerly Andrx 2002 - 2005
Andrx Pharmaceuticals 2000 - 2005
FDA 1975 - 1985
Skills
FDA, Regulatory Affairs, GMP, Sop, Pharmaceutical Industry, GxP, Validation, Quality Control, Quality System, Regulatory Submissions, Leadership, Pharmaceutics, Biotechnology, Laboratory, GLP, HPLC, Technology Transfer, LIMS, CAPA, Cleaning Validation, Biopharmaceuticals, Regulatory Requirements, Drug Development, V&V, 21 CFR Part 11, Formulation, Dissolution, ANDA, Generic Programming, Drug Delivery, IND, Aseptic Processing, Change Control, Analytical Chemistry, Clinical Trials, Chromatography, UV, Quality by Design, SOP
Education
Northeastern University 1978 — 1985
Ph.D., Medicinal Chemistry
Brooklyn Polytechnic Institute
Master of Science (M.S.), Chemistry
Stelios Viazis Stelios Viazis's FDA Experience February 2015 - Present
Job Response Team 1 Leader
Industry Food & Beverages
Experience
FDA February 2015 - Present
Centers for Disease Control and Prevention May 2015 - August 2015
FDA July 2011 - February 2015
FDA September 2010 - July 2011
University of Minnesota September 2006 - July 2010
North Carolina State University August 2004 - August 2006
Skills
FDA, Food Science, HACCP, Food Microbiology, Food Industry, Microbiology, GMP, Chemistry, PCR, Food Chemistry, Sensory Evaluation, Food Processing, Analytical Chemistry, UV/Vis, Statistics, Cell Culture, Food Safety, Formulation, Microscopy
Education
University of Minnesota 2006 — 2010
Doctorate, Philosophy; Food Science
North Carolina State University 2004 — 2006
Masters, Science 2006; Food Science
Rutgers University-New Brunswick 2000 — 2005
Bachelors, Science 2004; Food Science; Option in Food Chemistry
FDA February 2015 - Present
Centers for Disease Control and Prevention May 2015 - August 2015
FDA July 2011 - February 2015
FDA September 2010 - July 2011
University of Minnesota September 2006 - July 2010
North Carolina State University August 2004 - August 2006
Skills
FDA, Food Science, HACCP, Food Microbiology, Food Industry, Microbiology, GMP, Chemistry, PCR, Food Chemistry, Sensory Evaluation, Food Processing, Analytical Chemistry, UV/Vis, Statistics, Cell Culture, Food Safety, Formulation, Microscopy
Education
University of Minnesota 2006 — 2010
Doctorate, Philosophy; Food Science
North Carolina State University 2004 — 2006
Masters, Science 2006; Food Science
Rutgers University-New Brunswick 2000 — 2005
Bachelors, Science 2004; Food Science; Option in Food Chemistry
Clare Gnecco Clare Gnecco's FDA Experience 1991 - 2004
Job Independent Biometrics Consultant
Industry Pharmaceuticals
Experience
Independent Consultant October 2004 - December 2009
FDA 1991 - 2004
Education
New York University - Polytechnic School of Engineering 1985 — 1991
PhD, Applied Statistics
Independent Consultant October 2004 - December 2009
FDA 1991 - 2004
Education
New York University - Polytechnic School of Engineering 1985 — 1991
PhD, Applied Statistics
Jay Kellett Jay Kellett's FDA Experience 2011 - Present
Job Research and Development Chemist
Industry Research
Experience
FDA 2011 - Present
Johnson Matthey Pharma Services August 2010 - March 2011
W. R. Grace & Co. August 1975 - May 2008
Grace 1975 - 2008
WR Grace 1975 - 2008
WR Grace 1975 - 2008
W. R. Grace & Co.- Conn. 1975 - 2008
Grace Construction Products 1975 - 2008
WR Grace 1980 - 2000
ITEK 1968 - 1975
Skills
Polymers, Six Sigma, Applied Research, R&D, Process Simulation, Minitab, Chemistry, Coatings, Design of Experiments, Product Development, Experimental Design, Microsoft Word, Materials Science, Manufacturing, Formulation, FDA
Education
Northeastern University 1975 — 1980
BS, Chemistry
FDA 2011 - Present
Johnson Matthey Pharma Services August 2010 - March 2011
W. R. Grace & Co. August 1975 - May 2008
Grace 1975 - 2008
WR Grace 1975 - 2008
WR Grace 1975 - 2008
W. R. Grace & Co.- Conn. 1975 - 2008
Grace Construction Products 1975 - 2008
WR Grace 1980 - 2000
ITEK 1968 - 1975
Skills
Polymers, Six Sigma, Applied Research, R&D, Process Simulation, Minitab, Chemistry, Coatings, Design of Experiments, Product Development, Experimental Design, Microsoft Word, Materials Science, Manufacturing, Formulation, FDA
Education
Northeastern University 1975 — 1980
BS, Chemistry
Chia-Pin Liang Chia-Pin Liang's FDA Experience October 2010 - September 2011
Job Postdoctoral Research Fellow at Massachusetts General Hospital/ Harvard Medical School
Industry Research
Experience
Massachusetts General Hospital September 2014 - Present
Fischell Department of Bioengineering, University of Maryland September 2010 - Present
National Cancer Institute (NCI) November 2012 - May 2014
FDA October 2010 - September 2011
Academia Sinica September 2007 - June 2009
Skills
Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Customer Service, Matlab, Labview, Optical Coherence..., Data Analysis, C++, Windows, English, Microscopy, Fluorescence Microscopy
Education
University of Maryland College Park 2009 — 2014
Doctor of Philosophy (PhD), Bioengineering, 3.85
National Yang Ming University 2007 — 2009
Master of Science (MSc), Biophotonics, 4.0
National Cheng Kung University 2001 — 2005
Bachelor of Science (B.S.), Physics, 3.69
Massachusetts General Hospital September 2014 - Present
Fischell Department of Bioengineering, University of Maryland September 2010 - Present
National Cancer Institute (NCI) November 2012 - May 2014
FDA October 2010 - September 2011
Academia Sinica September 2007 - June 2009
Skills
Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Customer Service, Matlab, Labview, Optical Coherence..., Data Analysis, C++, Windows, English, Microscopy, Fluorescence Microscopy
Education
University of Maryland College Park 2009 — 2014
Doctor of Philosophy (PhD), Bioengineering, 3.85
National Yang Ming University 2007 — 2009
Master of Science (MSc), Biophotonics, 4.0
National Cheng Kung University 2001 — 2005
Bachelor of Science (B.S.), Physics, 3.69
Greg Gharst Greg Gharst's FDA Experience September 2008 - Present
Job Microbiologist at FDA
Industry Research
Experience
FDA September 2008 - Present
US Army Reserves July 2007 - Present
Skills
Food Microbiology, Food Science, Microbiology, Food Safety, HACCP, Quality Assurance, Biotechnology, ISO 17025 and 17043
Education
North Carolina State University 2004 — 2007
Ph.D., Protein Chemistry
North Carolina State University 2002 — 2004
Master of Science (MS), Microbiology
FDA September 2008 - Present
US Army Reserves July 2007 - Present
Skills
Food Microbiology, Food Science, Microbiology, Food Safety, HACCP, Quality Assurance, Biotechnology, ISO 17025 and 17043
Education
North Carolina State University 2004 — 2007
Ph.D., Protein Chemistry
North Carolina State University 2002 — 2004
Master of Science (MS), Microbiology
Alberto Viciedo Alberto Viciedo's FDA Experience January 2014 - January 2015
Job Senior Quality Auditor at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca January 2015 - Present
FDA January 2014 - January 2015
FDA April 2009 - January 2014
Pfizer Pharmaceuticals March 2009 - April 2009
Johnson & Johnson May 2007 - December 2008
Pfizer Consumer Healthcare August 2006 - May 2007
Rider University September 2005 - May 2006
Skills
GMP, Quality Auditing, Microbiology, FDA GMP, FDA, Pharmaceutical Industry, Regulatory Affairs, Validation, Quality Assurance, Biopharmaceuticals, Cleaning Validation, Aseptic Technique, Pharmaceuticals, cGMP manufacturing, Biotechnology, Process Validation, Quality Management, cGMP, Quality System, Pharmaceutical..., Continuous Improvement, Aseptic Processing
Education
Rutgers, The State University of New Jersey-Newark 2008 — 2014
M.B.A, Pharmaceutical Management and Marketing
North Carolina State University 2012 — 2013
Biomanufacturing Principles and Processes Course
Union County College 2007 — 2007
Course in Microbiology
Rider University 2002 — 2006
B.S, BioPsychology
AstraZeneca January 2015 - Present
FDA January 2014 - January 2015
FDA April 2009 - January 2014
Pfizer Pharmaceuticals March 2009 - April 2009
Johnson & Johnson May 2007 - December 2008
Pfizer Consumer Healthcare August 2006 - May 2007
Rider University September 2005 - May 2006
Skills
GMP, Quality Auditing, Microbiology, FDA GMP, FDA, Pharmaceutical Industry, Regulatory Affairs, Validation, Quality Assurance, Biopharmaceuticals, Cleaning Validation, Aseptic Technique, Pharmaceuticals, cGMP manufacturing, Biotechnology, Process Validation, Quality Management, cGMP, Quality System, Pharmaceutical..., Continuous Improvement, Aseptic Processing
Education
Rutgers, The State University of New Jersey-Newark 2008 — 2014
M.B.A, Pharmaceutical Management and Marketing
North Carolina State University 2012 — 2013
Biomanufacturing Principles and Processes Course
Union County College 2007 — 2007
Course in Microbiology
Rider University 2002 — 2006
B.S, BioPsychology
Patricia Bradfield's FDA Experience October 1993 - Present
Job Supvsry Management Analyst at FDA
Industry Government Administration
Experience
FDA October 1993 - Present
Standard Federal Savings Bank 1987 - 1992
Skills
Financial Accounting, Human Resources, Government Procurement, Program Management, Contract Management, Health Education, Congressional..., Oracle Reports, SOP development, Women's Health, Mentoring, Project Management, Public Health Education, Mortgage Banking
Education
NYU
Behavioral Aspects of Health
FDA October 1993 - Present
Standard Federal Savings Bank 1987 - 1992
Skills
Financial Accounting, Human Resources, Government Procurement, Program Management, Contract Management, Health Education, Congressional..., Oracle Reports, SOP development, Women's Health, Mentoring, Project Management, Public Health Education, Mortgage Banking
Education
NYU
Behavioral Aspects of Health
Allison Upalawanna Allison Upalawanna's FDA Experience March 2011 - April 2011
Job Clinical Trial Head, Oncology Global Clinical Development
Industry Pharmaceuticals
Experience
Novartis September 2015 - Present
Novartis April 2013 - Present
Novartis June 2011 - April 2013
Rutgers University June 2011 - April 2013
Walgreens June 2011 - January 2013
FDA March 2011 - April 2011
Walgreens Pharmacy January 2010 - March 2011
PPD June 2009 - May 2010
Gentris Corporation June 2006 - June 2008
Skills
Oncology, Clinical Development, Biochemistry, Pharmaceuticals, Pharmacists, Clinical Trials, Pharmaceutical Industry, Biotechnology, Pharmacy, Clinical Research, Drug Development, Cancer, Protocol
Education
University of North Carolina Eshelman School of Pharmacy 2007 — 2011
Pharm.D., Pharmacy
North Carolina State University 2002 — 2006
B.S., Biochemistry, Minor in Economics
Novartis September 2015 - Present
Novartis April 2013 - Present
Novartis June 2011 - April 2013
Rutgers University June 2011 - April 2013
Walgreens June 2011 - January 2013
FDA March 2011 - April 2011
Walgreens Pharmacy January 2010 - March 2011
PPD June 2009 - May 2010
Gentris Corporation June 2006 - June 2008
Skills
Oncology, Clinical Development, Biochemistry, Pharmaceuticals, Pharmacists, Clinical Trials, Pharmaceutical Industry, Biotechnology, Pharmacy, Clinical Research, Drug Development, Cancer, Protocol
Education
University of North Carolina Eshelman School of Pharmacy 2007 — 2011
Pharm.D., Pharmacy
North Carolina State University 2002 — 2006
B.S., Biochemistry, Minor in Economics
Erika Pfeiler Erika Pfeiler's FDA Experience February 2012 - Present
Job Microbiologist at FDA
Industry Government Administration
Experience
FDA February 2012 - Present
FDA March 2011 - February 2012
FDA October 2009 - March 2011
North Carolina State University August 2004 - September 2009
Education
North Carolina State University 2004 — 2009
Ph.D., Food Science, Microbiology, Genomics
University of Tennessee-Knoxville 2000 — 2004
BS, Food Science, Microbiology
FDA February 2012 - Present
FDA March 2011 - February 2012
FDA October 2009 - March 2011
North Carolina State University August 2004 - September 2009
Education
North Carolina State University 2004 — 2009
Ph.D., Food Science, Microbiology, Genomics
University of Tennessee-Knoxville 2000 — 2004
BS, Food Science, Microbiology
Kiya Hamilton Kiya Hamilton's FDA Experience June 2010 - Present
Job Mathematical Statistician at FDA
Industry Research
Experience
FDA June 2010 - Present
Education
University of Alabama at Birmingham 2005 — 2009
Doctor of Philosophy (Ph.D.)
North Carolina State University 2001 — 2003
Masters, Statistics
Spelman College 1997 — 2001
BS, Mathematics
FDA June 2010 - Present
Education
University of Alabama at Birmingham 2005 — 2009
Doctor of Philosophy (Ph.D.)
North Carolina State University 2001 — 2003
Masters, Statistics
Spelman College 1997 — 2001
BS, Mathematics
Dr. Jessica Lee Dr. Jessica Lee's FDA Experience February 2014 - Present
Job Medical Officer at FDA
Industry Hospital & Health Care
Experience
FDA February 2014 - Present
FDA February 2014 - Present
CompHealth December 2012 - January 2014
Atlantic General Hospital July 2010 - November 2012
Heywood Hospital September 2005 - June 2010
Saint Vincent Hospital May 2008 - May 2009
UMass Medical School September 2005 - September 2008
OSF St. Anthony’s Medical Center July 2004 - March 2005
University of Illinois at Chicago July 2001 - June 2004
Dimensions Healthcare System July 1997 - June 2000
Skills
Cancer, Hematology, Internal Medicine, Medical Oncology, ABIM Medical Oncology..., ABIM Hematology..., ABIM Internal Medicine...
Education
The Johns Hopkins University School of Medicine 1993 — 1997
Doctor of Philosophy (Ph.D.), Neurobiology and Neurosciences
National Yang Ming University 1984 — 1991
Doctor of Medicine (M.D.), Medicine
FDA February 2014 - Present
FDA February 2014 - Present
CompHealth December 2012 - January 2014
Atlantic General Hospital July 2010 - November 2012
Heywood Hospital September 2005 - June 2010
Saint Vincent Hospital May 2008 - May 2009
UMass Medical School September 2005 - September 2008
OSF St. Anthony’s Medical Center July 2004 - March 2005
University of Illinois at Chicago July 2001 - June 2004
Dimensions Healthcare System July 1997 - June 2000
Skills
Cancer, Hematology, Internal Medicine, Medical Oncology, ABIM Medical Oncology..., ABIM Hematology..., ABIM Internal Medicine...
Education
The Johns Hopkins University School of Medicine 1993 — 1997
Doctor of Philosophy (Ph.D.), Neurobiology and Neurosciences
National Yang Ming University 1984 — 1991
Doctor of Medicine (M.D.), Medicine
Kia Jackson, Ph.D. Kia Jackson, Ph.D.'s FDA Experience November 2012 - Present
Job Behavioral Pharmacologist at FDA Center for Tobacco Products
Industry Government Relations
Experience
FDA November 2012 - Present
Virginia Commonwealth University September 2008 - November 2012
Virginia State University August 2009 - December 2010
Skills
Pharmacology, Contracting Officer..., Animal Models, Nicotine Studies, Tobacco Control, Publication Writing, Grant Reviewing, Literature Reviews, Document Review, Neuroscience, In Vivo, In Vitro, PCR, RT-PCR, Western Blotting, Immunohistochemistry, Bioinformatics, Genetics, Human Genetics, Toxicology, Molecular Biology, Science, Schizophrenia
Education
Virginia Commonwealth University School of Medicine 2004 — 2008
Ph.D., Pharmacology and Toxicology
North Carolina Agricultural and Technical State University 2000 — 2004
B.S., Biology
FDA November 2012 - Present
Virginia Commonwealth University September 2008 - November 2012
Virginia State University August 2009 - December 2010
Skills
Pharmacology, Contracting Officer..., Animal Models, Nicotine Studies, Tobacco Control, Publication Writing, Grant Reviewing, Literature Reviews, Document Review, Neuroscience, In Vivo, In Vitro, PCR, RT-PCR, Western Blotting, Immunohistochemistry, Bioinformatics, Genetics, Human Genetics, Toxicology, Molecular Biology, Science, Schizophrenia
Education
Virginia Commonwealth University School of Medicine 2004 — 2008
Ph.D., Pharmacology and Toxicology
North Carolina Agricultural and Technical State University 2000 — 2004
B.S., Biology
Su-Lin Lee Su-Lin Lee's FDA Experience November 2014 - Present
Job Staff Fellow at FDA
Industry Pharmaceuticals
Experience
FDA November 2014 - Present
National Institutes of Health August 2012 - November 2014
The Ohio State University June 2007 - June 2012
National Taiwan University January 2005 - June 2007
Skills
Chemistry, Quantum mechanical..., Organic Chemistry, Drug Design, structure/ligand-based..., Retrosynthetic analysis, Total Synthesis, Microwave reaction, Middle-scale reaction, Structure modification..., All kinds of..., HPLC, LC-MS, NMR spectroscopy, Biacore SPR, Isothermal titration..., Molecular Biology, Western Blotting, Immunoprecipitation, Mammalian Cell Culture, RT-PCR, Ligand-receptor docking..., Cell proliferation..., DNA/RNA extraction, Gene transfer/knockdown, Radiometric in vitro..., NMR, Protein Chemistry, Biochemistry
Education
The Ohio State University 2007 — 2012
Ph.D., Medicinal Chemistry
National Taiwan University 2002 — 2004
MS, Pharmacy
National Chung Cheng University 1998 — 2002
Bachelor's Degree, Chemistry
FDA November 2014 - Present
National Institutes of Health August 2012 - November 2014
The Ohio State University June 2007 - June 2012
National Taiwan University January 2005 - June 2007
Skills
Chemistry, Quantum mechanical..., Organic Chemistry, Drug Design, structure/ligand-based..., Retrosynthetic analysis, Total Synthesis, Microwave reaction, Middle-scale reaction, Structure modification..., All kinds of..., HPLC, LC-MS, NMR spectroscopy, Biacore SPR, Isothermal titration..., Molecular Biology, Western Blotting, Immunoprecipitation, Mammalian Cell Culture, RT-PCR, Ligand-receptor docking..., Cell proliferation..., DNA/RNA extraction, Gene transfer/knockdown, Radiometric in vitro..., NMR, Protein Chemistry, Biochemistry
Education
The Ohio State University 2007 — 2012
Ph.D., Medicinal Chemistry
National Taiwan University 2002 — 2004
MS, Pharmacy
National Chung Cheng University 1998 — 2002
Bachelor's Degree, Chemistry
Sarah Stanton Sarah Stanton's FDA Experience June 2006 - January 2009
Job Accounting Consultant
Industry Accounting
Experience
Hoffman CFO Consulting August 2014 - Present
Tribalco February 2013 - Present
Dougherty & Associates, Inc September 2010 - February 2013
CoreLab Partners -Medifacts International December 2009 - August 2010
FDA June 2006 - January 2009
Skills
Deltek, QuickBooks, Costpoint, Microsoft Office, Microsoft Excel, Microsoft Word, Accounting, Account Reconciliation, Bank Reconciliation, Monthly Close Process, Accounts Payable, Accounts Receivable, Deltek GCS, Auditing, General Ledger, Analysis, Payroll, Government, Leadership, Human Resources, Project Accounting, Financial Analysis, Budgets, Financial Accounting, Variance Analysis, Invoicing, Outlook, Spreadsheets, PowerPoint, Government Contracting, Journal Entries, GAAP
Education
North Carolina A&T State University 2005 — 2009
Bachelor of Science (B.S.), Accounting, 3.33
Seneca Valley High School 2001 — 2005
Diploma, High School/Secondary Diplomas and Certificates
Hoffman CFO Consulting August 2014 - Present
Tribalco February 2013 - Present
Dougherty & Associates, Inc September 2010 - February 2013
CoreLab Partners -Medifacts International December 2009 - August 2010
FDA June 2006 - January 2009
Skills
Deltek, QuickBooks, Costpoint, Microsoft Office, Microsoft Excel, Microsoft Word, Accounting, Account Reconciliation, Bank Reconciliation, Monthly Close Process, Accounts Payable, Accounts Receivable, Deltek GCS, Auditing, General Ledger, Analysis, Payroll, Government, Leadership, Human Resources, Project Accounting, Financial Analysis, Budgets, Financial Accounting, Variance Analysis, Invoicing, Outlook, Spreadsheets, PowerPoint, Government Contracting, Journal Entries, GAAP
Education
North Carolina A&T State University 2005 — 2009
Bachelor of Science (B.S.), Accounting, 3.33
Seneca Valley High School 2001 — 2005
Diploma, High School/Secondary Diplomas and Certificates
Shireen Ahmad's FDA Experience July 2013 - Present
Job Regulatory Health Project Manager at FDA
Industry Higher Education
Experience
FDA July 2013 - Present
University of Maryland December 2008 - July 2013
Education
University of Maryland 2010 — 2012
Master's degree, Biotechnology: Biosecurity and Biodefense Specialization
North Carolina State University 2003 — 2007
Bachelor's degree, Biology/Biological Sciences, General
FDA July 2013 - Present
University of Maryland December 2008 - July 2013
Education
University of Maryland 2010 — 2012
Master's degree, Biotechnology: Biosecurity and Biodefense Specialization
North Carolina State University 2003 — 2007
Bachelor's degree, Biology/Biological Sciences, General
Shaneece Davis's FDA Experience July 2014 - Present
Job Management Analyst at FDA
Industry Information Technology and Services
Experience
FDA July 2014 - Present
Centers for Medicare & Medicaid Services July 2012 - July 2014
IT Innovative Solutions Corp December 2011 - May 2012
Surgical Review Corporation June 2011 - August 2011
North Carolina Central University August 2010 - May 2011
Information Technology Services of NCCU April 2009 - May 2011
Skills
Research, Analysis, Databases, Visio, Access, HTML, Software Documentation, Windows, MySQL, Systems Analysis, SharePoint, Big Data, Microsoft Excel, Microsoft Office, HIPAA, Healthcare Information..., Office Administration, PowerPoint, Social Media, Information Management, Project Management, Business Intelligence, Project Planning, Policy, Security, Information Technology, SDLC, System Administration, Government, Data Analysis
Education
University of Maryland College Park 2011 — 2013
Masters, Information Management
North Carolina Central University 2008 — 2011
Bachelor of Science, Computer Information Systems
FDA July 2014 - Present
Centers for Medicare & Medicaid Services July 2012 - July 2014
IT Innovative Solutions Corp December 2011 - May 2012
Surgical Review Corporation June 2011 - August 2011
North Carolina Central University August 2010 - May 2011
Information Technology Services of NCCU April 2009 - May 2011
Skills
Research, Analysis, Databases, Visio, Access, HTML, Software Documentation, Windows, MySQL, Systems Analysis, SharePoint, Big Data, Microsoft Excel, Microsoft Office, HIPAA, Healthcare Information..., Office Administration, PowerPoint, Social Media, Information Management, Project Management, Business Intelligence, Project Planning, Policy, Security, Information Technology, SDLC, System Administration, Government, Data Analysis
Education
University of Maryland College Park 2011 — 2013
Masters, Information Management
North Carolina Central University 2008 — 2011
Bachelor of Science, Computer Information Systems
Barry Hansen Jr Barry Hansen Jr's FDA Experience June 2010 - February 2011
Job Looking for new opportunities in Washington, DC area. Leader, Scientist, Engineer, Brewer.
Industry Biotechnology
Experience
Kraft Foods Group March 2013 - December 2014
#FREEDOM Craft Brewery LLC July 2012 - September 2014
FDA June 2010 - February 2011
Friendly Ice Cream Corporation March 2005 - June 2010
University of Connecticut Health Center March 2010 - May 2010
Skills
Team Leadership, Brewing, Microsoft Office, Research, Testing, Matlab, Market Research, Leadership, Management, Inventor, Medical Devices, Biomedical Engineering, Project Management, Microsoft Excel, Engineering, Data Analysis, C++, Scientific Writing, Personnel Management, Microbiology, Organizational Culture, LabVIEW, SolidWorks, Biotechnology, Yeast Management, Cell Culture, Laboratory, Laboratory Skills, Laboratory Equipment, Microscopy, Spectrophotometry
Education
Northeastern University 2011 — 2012
M.Sc
Swinburne University of Technology 2011 — 2012
M.Sc
University of Hartford 2006 — 2010
Bachelor of Science
Kraft Foods Group March 2013 - December 2014
#FREEDOM Craft Brewery LLC July 2012 - September 2014
FDA June 2010 - February 2011
Friendly Ice Cream Corporation March 2005 - June 2010
University of Connecticut Health Center March 2010 - May 2010
Skills
Team Leadership, Brewing, Microsoft Office, Research, Testing, Matlab, Market Research, Leadership, Management, Inventor, Medical Devices, Biomedical Engineering, Project Management, Microsoft Excel, Engineering, Data Analysis, C++, Scientific Writing, Personnel Management, Microbiology, Organizational Culture, LabVIEW, SolidWorks, Biotechnology, Yeast Management, Cell Culture, Laboratory, Laboratory Skills, Laboratory Equipment, Microscopy, Spectrophotometry
Education
Northeastern University 2011 — 2012
M.Sc
Swinburne University of Technology 2011 — 2012
M.Sc
University of Hartford 2006 — 2010
Bachelor of Science
Lauren Swantko Lauren Swantko's FDA Experience September 2010 - Present
Job Investigator at FDA
Industry Government Administration
Experience
FDA September 2010 - Present
Tripps June 2009 - August 2009
Walton Orthodontics February 2009 - May 2009
Mitchell & Bartlett Orthodontics May 2007 - August 2007
CVS 2004 - 2006
Skills
Customer Service, Time Management, Telephone Skills, Teamwork, Government, Policy, Investigation, Evidence, Federal Government, Surveillance, Regulatory Requirements, Enforcement, Regulations, Federal Law, Regulatory Policy, Law Enforcement..., Regulatory Agencies, Health Law, Public Safety
Education
North Carolina State University 2006 — 2010
BA Chemistry, Chemistry; Biology; Health, Medicine and Human Values
Northwest Guilford High School
FDA September 2010 - Present
Tripps June 2009 - August 2009
Walton Orthodontics February 2009 - May 2009
Mitchell & Bartlett Orthodontics May 2007 - August 2007
CVS 2004 - 2006
Skills
Customer Service, Time Management, Telephone Skills, Teamwork, Government, Policy, Investigation, Evidence, Federal Government, Surveillance, Regulatory Requirements, Enforcement, Regulations, Federal Law, Regulatory Policy, Law Enforcement..., Regulatory Agencies, Health Law, Public Safety
Education
North Carolina State University 2006 — 2010
BA Chemistry, Chemistry; Biology; Health, Medicine and Human Values
Northwest Guilford High School
Mohammed Yousffi Mohammed Yousffi's FDA Experience February 2014 - Present
Job Consumer Safety Officer (Drug Specialist) at FDA
Industry Pharmaceuticals
Experience
FDA February 2014 - Present
Fresenius Kabi USA August 2012 - February 2014
Abbott Molecular June 2012 - August 2012
Blistex Inc. April 2012 - May 2012
Midwest bioResearch September 2011 - November 2011
Ferro Pfanstiehl February 2007 - September 2011
Hospira January 2005 - February 2007
Skills
CAPA, cGMP manufacturing, LIMS, Quality Auditing, Supplier Quality, Change Control, Recalls, GMP, Biopharmaceuticals, Regulatory Affairs, Quality Assurance, Aseptic Processing, Sop, Quality System, Software Documentation, GLP, Calibration, FDA, Pharmaceutical Industry, Quality Management, Technology Transfer, Gas Chromatography, Sterilization, Protein Chemistry, Laboratory, 21 CFR Part 11, Testing, Validation, Analytical Chemistry, Manufacturing, HPLC, Quality Control, UV/Vis, Microbiology, Wet Chemistry, Cleaning Validation, Pharmaceutics, Chemistry, FTIR, ISO 13485, Auditing, V&V, USP
Education
University of Illinois at Chicago 2000 — 2004
Biochemistry
Northeastern Illinois University
FDA February 2014 - Present
Fresenius Kabi USA August 2012 - February 2014
Abbott Molecular June 2012 - August 2012
Blistex Inc. April 2012 - May 2012
Midwest bioResearch September 2011 - November 2011
Ferro Pfanstiehl February 2007 - September 2011
Hospira January 2005 - February 2007
Skills
CAPA, cGMP manufacturing, LIMS, Quality Auditing, Supplier Quality, Change Control, Recalls, GMP, Biopharmaceuticals, Regulatory Affairs, Quality Assurance, Aseptic Processing, Sop, Quality System, Software Documentation, GLP, Calibration, FDA, Pharmaceutical Industry, Quality Management, Technology Transfer, Gas Chromatography, Sterilization, Protein Chemistry, Laboratory, 21 CFR Part 11, Testing, Validation, Analytical Chemistry, Manufacturing, HPLC, Quality Control, UV/Vis, Microbiology, Wet Chemistry, Cleaning Validation, Pharmaceutics, Chemistry, FTIR, ISO 13485, Auditing, V&V, USP
Education
University of Illinois at Chicago 2000 — 2004
Biochemistry
Northeastern Illinois University
Young Kuk Jhon Young Kuk Jhon's FDA Experience July 2015 - Present
Job Staff Fellow at FDA
Industry Higher Education
Experience
FDA July 2015 - Present
FDA July 2014 - July 2015
Army Research Office January 2010 - 2012
North Carolina State University January 2009 - December 2009
SMUDA EnTech Ltd. November 2001 - July 2003
Yonsei Nanotech September 2000 - October 2001
Skills
Surface Modification, Polymer Science, Colloids, Polymer Physics, Polymer Chemistry, Polymer Characterization, AFM, TGA, NMR, Polymers, Nanotechnology, Spectroscopy, SEC reporting, Chromatography, DLS, Characterization, UV-Vis, Nanoparticles, Materials Science, Nanomaterials, Chemistry, XRD, Surface Chemistry, Microscopy, Scanning Electron..., Science, Thin Films, Chemical Engineering, Coatings, FTIR, Ellipsometry, Surface, Biomaterials, Powder X-ray Diffraction, Rheology, Protein Chemistry
Education
North Carolina State University 2003 — 2009
Ph.D., Chemical Engineering
University of Nebraska-Lincoln 2001 — 2001
Language Certificate, Intensive English as Second Language
Yonsei University 1998 — 2000
M.S., Chemical Engineering
Yonsei University 1993 — 1998
B.S., Chemical Engineering
FDA July 2015 - Present
FDA July 2014 - July 2015
Army Research Office January 2010 - 2012
North Carolina State University January 2009 - December 2009
SMUDA EnTech Ltd. November 2001 - July 2003
Yonsei Nanotech September 2000 - October 2001
Skills
Surface Modification, Polymer Science, Colloids, Polymer Physics, Polymer Chemistry, Polymer Characterization, AFM, TGA, NMR, Polymers, Nanotechnology, Spectroscopy, SEC reporting, Chromatography, DLS, Characterization, UV-Vis, Nanoparticles, Materials Science, Nanomaterials, Chemistry, XRD, Surface Chemistry, Microscopy, Scanning Electron..., Science, Thin Films, Chemical Engineering, Coatings, FTIR, Ellipsometry, Surface, Biomaterials, Powder X-ray Diffraction, Rheology, Protein Chemistry
Education
North Carolina State University 2003 — 2009
Ph.D., Chemical Engineering
University of Nebraska-Lincoln 2001 — 2001
Language Certificate, Intensive English as Second Language
Yonsei University 1998 — 2000
M.S., Chemical Engineering
Yonsei University 1993 — 1998
B.S., Chemical Engineering
Hank Hoang's FDA Experience September 2015 - Present
Job Pharmacist at Rite Aid
Industry Pharmaceuticals
Experience
FDA September 2015 - Present
Rite Aid Pharmacy August 2010 - September 2015
Rite Aid Pharmacy August 2010 - June 2015
McKesson April 2010 - May 2013
Rite Aid Pharmacy May 2012 - August 2012
American Legacy Foundation September 2010 - June 2011
Omnicare April 2010 - July 2010
Takeda Pharmaceuticals August 2007 - August 2009
University of California at San Diego March 2007 - September 2008
Skills
Pharmacy, Microsoft Office, Oncology, Management, Research, Data Analysis, Public Speaking, Healthcare, Leadership, Clinical Research, Pharmaceutical Industry, Community Outreach, Lifesciences, Sales, Cell Culture, Event Planning, Market Research, Social Media, Customer Service
Education
The University of Charleston
Doctorate, Pharmacy
Northeastern University
Master's Degree, Business Administration and Finance
University of California, San Diego
B.S., Biology
El Camino Real High School
H.S. Diploma
FDA September 2015 - Present
Rite Aid Pharmacy August 2010 - September 2015
Rite Aid Pharmacy August 2010 - June 2015
McKesson April 2010 - May 2013
Rite Aid Pharmacy May 2012 - August 2012
American Legacy Foundation September 2010 - June 2011
Omnicare April 2010 - July 2010
Takeda Pharmaceuticals August 2007 - August 2009
University of California at San Diego March 2007 - September 2008
Skills
Pharmacy, Microsoft Office, Oncology, Management, Research, Data Analysis, Public Speaking, Healthcare, Leadership, Clinical Research, Pharmaceutical Industry, Community Outreach, Lifesciences, Sales, Cell Culture, Event Planning, Market Research, Social Media, Customer Service
Education
The University of Charleston
Doctorate, Pharmacy
Northeastern University
Master's Degree, Business Administration and Finance
University of California, San Diego
B.S., Biology
El Camino Real High School
H.S. Diploma
Kamilah Blackston Kamilah Blackston's FDA Experience June 2014 - Present
Job WriterEditor at FDA
Industry Public Relations and Communications
Experience
FDA June 2014 - Present
Family Recovery Program July 2013 - June 2014
YMCA of Greensboro August 2012 - December 2012
greiBO media May 2012 - August 2012
1st Step Diabetes Wellness Center May 2011 - January 2012
Baltimore City Public Schools May 2010 - August 2010
FDA May 2007 - August 2009
Skills
Creative Writing, Writing, Copy Editing, Public Relations, Event Planning, Social Media, Public Speaking, Leadership, Research, Nonprofits, Editing, Facebook, Microsoft Excel, Blogging, PowerPoint, Press Releases, Social Networking, Customer Service, Event Management
Education
North Carolina A&T State University 2008 — 2012
Journalism, Public Relations, Advertising, and Applied Communication
Baltimore Polytechnic Institute 2004 — 2008
FDA June 2014 - Present
Family Recovery Program July 2013 - June 2014
YMCA of Greensboro August 2012 - December 2012
greiBO media May 2012 - August 2012
1st Step Diabetes Wellness Center May 2011 - January 2012
Baltimore City Public Schools May 2010 - August 2010
FDA May 2007 - August 2009
Skills
Creative Writing, Writing, Copy Editing, Public Relations, Event Planning, Social Media, Public Speaking, Leadership, Research, Nonprofits, Editing, Facebook, Microsoft Excel, Blogging, PowerPoint, Press Releases, Social Networking, Customer Service, Event Management
Education
North Carolina A&T State University 2008 — 2012
Journalism, Public Relations, Advertising, and Applied Communication
Baltimore Polytechnic Institute 2004 — 2008
LT Tenzin Jangchup LT Tenzin Jangchup's FDA Experience June 2015 - Present
Job PGY1 Resident Pharmacist at Indian Health Service
Industry Pharmaceuticals
Experience
FDA June 2015 - Present
Indian Health Service July 2014 - June 2015
Sanford Health November 2010 - February 2014
Skills
Pharmacology, Regulatory Affairs, Pharmacy, Communication, Team Leadership, Medication..., Clinical Pharmacology, Clinical Pharmacy, Certified Immunizer, Patient Counseling, Pharmacists, Community Pharmacy, Compounding, Pharmacy Practice, Ambulatory Care, Immunization, Anticoagulation, Medication Therapy..., Clinical Research, Patient Education
Education
North Dakota State University 2010 — 2014
Doctor of Pharmacy (PharmD), Pharmacy Practice
North Dakota State University 2008 — 2012
Bachelor of Science (B.S.), Pharmaceutical Sciences
FDA June 2015 - Present
Indian Health Service July 2014 - June 2015
Sanford Health November 2010 - February 2014
Skills
Pharmacology, Regulatory Affairs, Pharmacy, Communication, Team Leadership, Medication..., Clinical Pharmacology, Clinical Pharmacy, Certified Immunizer, Patient Counseling, Pharmacists, Community Pharmacy, Compounding, Pharmacy Practice, Ambulatory Care, Immunization, Anticoagulation, Medication Therapy..., Clinical Research, Patient Education
Education
North Dakota State University 2010 — 2014
Doctor of Pharmacy (PharmD), Pharmacy Practice
North Dakota State University 2008 — 2012
Bachelor of Science (B.S.), Pharmaceutical Sciences
Russell Storms Russell Storms's FDA Experience October 2014 - Present
Job FDA Computer Scientist
Industry Government Administration
Experience
FDA October 2014 - Present
Storms, Inc. December 2006 - Present
Booz Allen Hamilton October 2012 - October 2014
Henry M Jackson Foundation April 2011 - August 2012
Henry M Jackson Foundation October 2010 - March 2011
Henry M Jackson Foundation February 2009 - October 2010
Booz Allen Hamilton October 2008 - February 2009
BMS Title, Inc. January 2005 - June 2008
Skills
Program Management, Strategic Planning, Research, Project Management, Government, Security Clearance, Process Improvement, DoD, Analysis, Business Process..., Change Management, Systems Engineering, Data Analysis, Proposal Writing, Team Leadership, Team Building, Business Development, Business Strategy, Contract Management, Cross-functional Team..., Defense, Enterprise Architecture, Executive Management, Information Assurance, Integration, Leadership, Leadership Development, MS Project, Management, Management Consulting, Military, National Security, Operations Management, Organizational..., PMO, PMP, Project Planning, Quality Assurance, Requirements Analysis, Six Sigma, Software Documentation, Software Project..., Strategy, Technical Writing, Training, Consulting, Government Contracting, Project Portfolio..., Risk Management, Security
Education
Naval Postgraduate School 1995 — 1998
Ph.D., Computer Science
Naval Postgraduate School 1993 — 1995
MS, Computer Science
United States Military Academy at West Point 1982 — 1986
BS, Computer Science
United States Military Academy Preparatory School 1981 — 1982
FDA October 2014 - Present
Storms, Inc. December 2006 - Present
Booz Allen Hamilton October 2012 - October 2014
Henry M Jackson Foundation April 2011 - August 2012
Henry M Jackson Foundation October 2010 - March 2011
Henry M Jackson Foundation February 2009 - October 2010
Booz Allen Hamilton October 2008 - February 2009
BMS Title, Inc. January 2005 - June 2008
Skills
Program Management, Strategic Planning, Research, Project Management, Government, Security Clearance, Process Improvement, DoD, Analysis, Business Process..., Change Management, Systems Engineering, Data Analysis, Proposal Writing, Team Leadership, Team Building, Business Development, Business Strategy, Contract Management, Cross-functional Team..., Defense, Enterprise Architecture, Executive Management, Information Assurance, Integration, Leadership, Leadership Development, MS Project, Management, Management Consulting, Military, National Security, Operations Management, Organizational..., PMO, PMP, Project Planning, Quality Assurance, Requirements Analysis, Six Sigma, Software Documentation, Software Project..., Strategy, Technical Writing, Training, Consulting, Government Contracting, Project Portfolio..., Risk Management, Security
Education
Naval Postgraduate School 1995 — 1998
Ph.D., Computer Science
Naval Postgraduate School 1993 — 1995
MS, Computer Science
United States Military Academy at West Point 1982 — 1986
BS, Computer Science
United States Military Academy Preparatory School 1981 — 1982
Axum Abebe Axum Abebe's FDA Experience 2013 - January 2015
Job Writer
Industry
Experience
FDA 2013 - January 2015
Patch.com July 2010 - August 2011
Skills
Creative Writing, Customer Satisfaction, Communication Skills, Marketing Communications, Business Writing, Mediation, Social Media, Customer Service, Writing
Education
North Carolina Central University
Bachelor of Arts (B.A.), Mass Communication/Media Studies
FDA 2013 - January 2015
Patch.com July 2010 - August 2011
Skills
Creative Writing, Customer Satisfaction, Communication Skills, Marketing Communications, Business Writing, Mediation, Social Media, Customer Service, Writing
Education
North Carolina Central University
Bachelor of Arts (B.A.), Mass Communication/Media Studies
Doug Arbesfeld Doug Arbesfeld's FDA Experience November 2006 - October 2007
Job Marketing Manager at Meadowlink, Cyclist, Backpacker, Hiker
Industry Public Relations and Communications
Experience
Meadowlink November 2014 - Present
Communications Consulting November 2007 - November 2014
FDA November 2006 - October 2007
Johnson & Johnson 2001 - 2006
Manning Selvage & Lee 1999 - 2001
Rhone-Poulenc (now sanofi-aventis) 1996 - 1998
Ciba-Geigy (now Novartis) 1990 - 1996
Hill and Knowlton 1984 - 1990
Dorf & Stanton 1983 - 1984
Skills
Crisis Communications, Strategic Communications, Media Relations, Public Relations, Crisis Management, Marketing Communications, Strategy, Corporate Communications, Spokesperson, Pharmaceutical Industry, Internal Communications, Message Development, Speech Writing, Publicity, Press Releases, Writing, Talking Points, Press Material..., Communication Training, Reputation Management, Communications Planning, Editing, Healthcare, Issues Management, Strategic..., Letters to the Editor, Op-eds, Press Strategy, Crisis Communications..., Strategic Media..., Strategic Public..., Media Skills Training, Internal & External..., Non-profit Volunteering, Non-profit Marketing
Education
New York University 1981 — 1983
Bachelor of Arts, Journalism
Pace University 2014 — 2014
Pace Encore Transition Program
Pace University
Pace University
Meadowlink November 2014 - Present
Communications Consulting November 2007 - November 2014
FDA November 2006 - October 2007
Johnson & Johnson 2001 - 2006
Manning Selvage & Lee 1999 - 2001
Rhone-Poulenc (now sanofi-aventis) 1996 - 1998
Ciba-Geigy (now Novartis) 1990 - 1996
Hill and Knowlton 1984 - 1990
Dorf & Stanton 1983 - 1984
Skills
Crisis Communications, Strategic Communications, Media Relations, Public Relations, Crisis Management, Marketing Communications, Strategy, Corporate Communications, Spokesperson, Pharmaceutical Industry, Internal Communications, Message Development, Speech Writing, Publicity, Press Releases, Writing, Talking Points, Press Material..., Communication Training, Reputation Management, Communications Planning, Editing, Healthcare, Issues Management, Strategic..., Letters to the Editor, Op-eds, Press Strategy, Crisis Communications..., Strategic Media..., Strategic Public..., Media Skills Training, Internal & External..., Non-profit Volunteering, Non-profit Marketing
Education
New York University 1981 — 1983
Bachelor of Arts, Journalism
Pace University 2014 — 2014
Pace Encore Transition Program
Pace University
Pace University
Mihir Jaiswal Mihir Jaiswal's FDA Experience August 2015 - Present
Job ORISE fellow at the Office of Business Informatics, CDER, FDA.
Industry Research
Experience
FDA August 2015 - Present
University of Arkansas for Medical Sciences/ UNiversity of Arkansas at Little Rock January 2012 - May 2015
Self January 2010 - December 2012
Shiksha the Learning Center July 2011 - December 2011
Atlas Pharmachem Industries (India) Pvt. Ltd. July 2009 - December 2009
Skills
Bioinformatics, Drug Discovery, Data Analysis, Molecular Modeling, Business Analysis, Subject Matter Experts, Business Intelligence, Medicinal Chemistry, HPLC, Biochemistry, R, Drug Design, Molecular Biology, Protein Chemistry, Molecular Dynamics, QSAR, Docking, Virtual Screening, Homology Modeling, LC-MS, Survey Research, Computational Chemistry, Western Blotting, Cell Culture, UV/Vis, Mammalian Cell Culture, Bacterial Cell Culture, Data Management, Strategic Planning
Education
University of Arkansas for Medical Sciences 2012 — 2015
Doctor of Philosophy (Ph.D.), Bioinformatics
University of Arkansas at Little Rock 2012 — 2013
Master of Science (MS), Bioinformatics
University of Arkansas for Medical Sciences 2012 — 2013
Master of Science (M.S.), Bioinformatics
National Institute of Pharmaceutical Education and Research 2007 — 2009
Master of Science (MS), Pharmacoinformatics
Sardar Patel University 2003 — 2007
Bachelor of Pharmacy (B.Pharm.), Pharmacy
K. G. Trivedi Sadhana Vinay Mandir 1998 — 2003
High School
FDA August 2015 - Present
University of Arkansas for Medical Sciences/ UNiversity of Arkansas at Little Rock January 2012 - May 2015
Self January 2010 - December 2012
Shiksha the Learning Center July 2011 - December 2011
Atlas Pharmachem Industries (India) Pvt. Ltd. July 2009 - December 2009
Skills
Bioinformatics, Drug Discovery, Data Analysis, Molecular Modeling, Business Analysis, Subject Matter Experts, Business Intelligence, Medicinal Chemistry, HPLC, Biochemistry, R, Drug Design, Molecular Biology, Protein Chemistry, Molecular Dynamics, QSAR, Docking, Virtual Screening, Homology Modeling, LC-MS, Survey Research, Computational Chemistry, Western Blotting, Cell Culture, UV/Vis, Mammalian Cell Culture, Bacterial Cell Culture, Data Management, Strategic Planning
Education
University of Arkansas for Medical Sciences 2012 — 2015
Doctor of Philosophy (Ph.D.), Bioinformatics
University of Arkansas at Little Rock 2012 — 2013
Master of Science (MS), Bioinformatics
University of Arkansas for Medical Sciences 2012 — 2013
Master of Science (M.S.), Bioinformatics
National Institute of Pharmaceutical Education and Research 2007 — 2009
Master of Science (MS), Pharmacoinformatics
Sardar Patel University 2003 — 2007
Bachelor of Pharmacy (B.Pharm.), Pharmacy
K. G. Trivedi Sadhana Vinay Mandir 1998 — 2003
High School
Victoria Chang Victoria Chang's FDA Experience 2012 - 2013
Job Senior Statistician at Boehringer Ingelheim
Industry Pharmaceuticals
Experience
Boehringer Ingelheim September 2014 - Present
Journal of Biopharmaceutical Statistics March 2005 - Present
Temple University - Wellness Resource Center September 2011 - August 2014
FDA 2012 - 2013
Temple University -Department of Statistics January 2010 - August 2011
Taiwan Carol Electronics Co., Ltd, Taiwan November 2005 - February 2008
National Health Research Institute, Taiwan January 2005 - October 2005
Skills
Research, Analytics, Statistics, Leadership, Clinical Trials, SAS, Data Analysis, Biostatistics, R, Matlab, SAS Programming, SPSS, Clinical Research, Statistical Modeling
Education
Temple University - Fox School of Business and Management 2009 — 2014
Doctor of Philosophy (PhD), Statistics
National Taiwan University
Bachelor’s Degree, Landscape Architecture
University of Southampton
Master of Business Administration (M.B.A.)
Boehringer Ingelheim September 2014 - Present
Journal of Biopharmaceutical Statistics March 2005 - Present
Temple University - Wellness Resource Center September 2011 - August 2014
FDA 2012 - 2013
Temple University -Department of Statistics January 2010 - August 2011
Taiwan Carol Electronics Co., Ltd, Taiwan November 2005 - February 2008
National Health Research Institute, Taiwan January 2005 - October 2005
Skills
Research, Analytics, Statistics, Leadership, Clinical Trials, SAS, Data Analysis, Biostatistics, R, Matlab, SAS Programming, SPSS, Clinical Research, Statistical Modeling
Education
Temple University - Fox School of Business and Management 2009 — 2014
Doctor of Philosophy (PhD), Statistics
National Taiwan University
Bachelor’s Degree, Landscape Architecture
University of Southampton
Master of Business Administration (M.B.A.)
Caroline McCarty Caroline McCarty's FDA Experience May 2012 - August 2012
Job Marketing Communications Specialist at Eaton
Industry Public Relations and Communications
Experience
Eaton June 2015 - Present
Largemouth Communications, Inc. January 2015 - April 2015
Eaton March 2014 - December 2014
North Carolina State University Writing and Speaking Tutorial Services December 2013 - March 2014
Smokey Glen Farm BBQ, Inc. May 2008 - August 2013
FDA May 2012 - August 2012
Skills
Microsoft Office, Social Media, Public Speaking, Time Management, Teamwork, Microsoft Excel, Windows 7, SPSS, Camtasia, SnagIt, News Writing, Text Editing, English, PowerPoint, InDesign, Public Relations, Customer Service, Microsoft Word
Education
North Carolina State University 2011 — 2015
Bachelor of Arts (BA), Communication/Public Relations
Clarksburg High School 2007 — 2011
Eaton June 2015 - Present
Largemouth Communications, Inc. January 2015 - April 2015
Eaton March 2014 - December 2014
North Carolina State University Writing and Speaking Tutorial Services December 2013 - March 2014
Smokey Glen Farm BBQ, Inc. May 2008 - August 2013
FDA May 2012 - August 2012
Skills
Microsoft Office, Social Media, Public Speaking, Time Management, Teamwork, Microsoft Excel, Windows 7, SPSS, Camtasia, SnagIt, News Writing, Text Editing, English, PowerPoint, InDesign, Public Relations, Customer Service, Microsoft Word
Education
North Carolina State University 2011 — 2015
Bachelor of Arts (BA), Communication/Public Relations
Clarksburg High School 2007 — 2011
James R. Lawrence, III James R. Lawrence, III's FDA Experience May 2011 - July 2011
Job General Counsel at Crown Laboratories, Inc.
Industry Pharmaceuticals
Experience
Crown Laboratories, Inc. August 2015 - Present
Coats & Bennett, PLLC August 2012 - July 2015
Chambers of the Honorable Paul M. Newby, North Carolina Supreme Court January 2012 - April 2012
Coats & Bennett, PLLC July 2011 - August 2011
FDA May 2011 - July 2011
Merz Pharmaceuticals, LLC May 2010 - August 2010
Accenture October 2007 - August 2009
AVOS Life Sciences (now AVOS Consulting, a Division of INC Research) May 2006 - October 2007
NCSU Biomedical Engineering Senior Design August 2006 - May 2007
North Carolina Institute for Constitutional Law August 2005 - December 2005
Education
University of North Carolina School of Law 2009 — 2012
Juris Doctor
North Carolina State University 2003 — 2007
B.S.
Crown Laboratories, Inc. August 2015 - Present
Coats & Bennett, PLLC August 2012 - July 2015
Chambers of the Honorable Paul M. Newby, North Carolina Supreme Court January 2012 - April 2012
Coats & Bennett, PLLC July 2011 - August 2011
FDA May 2011 - July 2011
Merz Pharmaceuticals, LLC May 2010 - August 2010
Accenture October 2007 - August 2009
AVOS Life Sciences (now AVOS Consulting, a Division of INC Research) May 2006 - October 2007
NCSU Biomedical Engineering Senior Design August 2006 - May 2007
North Carolina Institute for Constitutional Law August 2005 - December 2005
Education
University of North Carolina School of Law 2009 — 2012
Juris Doctor
North Carolina State University 2003 — 2007
B.S.
Micael Guillot Micael Guillot's FDA Experience June 2013 - Present
Job CMC Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA June 2013 - Present
Aprecia Pharmaceuticals October 2011 - September 2012
Aptalis March 2010 - July 2011
sanofi-aventis November 1992 - December 2009
Skills
Technology Transfer, GMP, Drug Delivery, Pharmaceutical Industry, Validation, Pharmaceutics, R&D, Formulation, Drug Development, FDA, Sop, GLP, Biopharmaceuticals, Chromatography, HPLC, Regulatory Submissions, Biotechnology, Regulatory Affairs, Drug Discovery, Analytical Chemistry, LC-MS, Clinical Development, CRO, IND, Lifesciences, CMC, Quality by Design, V&V, 21 CFR Part 11
Education
New Mexico State University 1986 — 1992
MS
New Mexico State University 1986 — 1990
CBER
New Mexico State University 1984 — 1985
BS
New Mexico State University 1980 — 1984
BS
FDA June 2013 - Present
Aprecia Pharmaceuticals October 2011 - September 2012
Aptalis March 2010 - July 2011
sanofi-aventis November 1992 - December 2009
Skills
Technology Transfer, GMP, Drug Delivery, Pharmaceutical Industry, Validation, Pharmaceutics, R&D, Formulation, Drug Development, FDA, Sop, GLP, Biopharmaceuticals, Chromatography, HPLC, Regulatory Submissions, Biotechnology, Regulatory Affairs, Drug Discovery, Analytical Chemistry, LC-MS, Clinical Development, CRO, IND, Lifesciences, CMC, Quality by Design, V&V, 21 CFR Part 11
Education
New Mexico State University 1986 — 1992
MS
New Mexico State University 1986 — 1990
CBER
New Mexico State University 1984 — 1985
BS
New Mexico State University 1980 — 1984
BS
Latecia Anderson-Jackson Latecia Anderson-Jackson's FDA Experience 2015 - Present
Job Student Trainee (Engineering) at FDA
Industry Research
Experience
FDA 2015 - Present
North Carolina A&T State University August 2014 - Present
LabCorp September 2014 - May 2015
Joint School of Nanoscience and Nanoengineering August 2012 - August 2014
CVS Health June 2011 - August 2014
U.S. Department of Energy November 2007 - May 2010
North Carolina A&T State University August 2009 - December 2009
National Renewable Energy Laboratory June 2008 - August 2008
Skills
Sales, Research, Microsoft Word, PowerPoint, Leadership, Microsoft Office, Microsoft Excel, Management, Training, Biomedical Engineering, Photovoltaics, Engineering, Aspen HYSYS, Nanotechnology, Matlab, Photoshop, Process Improvement, Materials Science, Solar Energy, Chemical Engineering, Pharmacy, Solar PV, Materials, Nanomaterials, Data Analysis
Education
North Carolina Agricultural and Technical State University 2014 — 2015
Master of Science (M.S.), Bioengineering and Biomedical Engineering, B+
North Carolina Agricultural and Technical State University 2012 — 2014
Master of Science (M.S.), Nanoengineering, B
North Carolina Agricultural and Technical State University 2006 — 2010
Bachelor of Science (B.S.), Chemical Engineering, B-
FDA 2015 - Present
North Carolina A&T State University August 2014 - Present
LabCorp September 2014 - May 2015
Joint School of Nanoscience and Nanoengineering August 2012 - August 2014
CVS Health June 2011 - August 2014
U.S. Department of Energy November 2007 - May 2010
North Carolina A&T State University August 2009 - December 2009
National Renewable Energy Laboratory June 2008 - August 2008
Skills
Sales, Research, Microsoft Word, PowerPoint, Leadership, Microsoft Office, Microsoft Excel, Management, Training, Biomedical Engineering, Photovoltaics, Engineering, Aspen HYSYS, Nanotechnology, Matlab, Photoshop, Process Improvement, Materials Science, Solar Energy, Chemical Engineering, Pharmacy, Solar PV, Materials, Nanomaterials, Data Analysis
Education
North Carolina Agricultural and Technical State University 2014 — 2015
Master of Science (M.S.), Bioengineering and Biomedical Engineering, B+
North Carolina Agricultural and Technical State University 2012 — 2014
Master of Science (M.S.), Nanoengineering, B
North Carolina Agricultural and Technical State University 2006 — 2010
Bachelor of Science (B.S.), Chemical Engineering, B-
Nick Fragedakis Nick Fragedakis's FDA Experience June 2015 - Present
Job at
Industry Health, Wellness and Fitness
Experience
FDA June 2015 - Present
Food and Drug Protection Division, North Carolina Department of Agriculture September 2014 - May 2015
NCSU Entrepreneurship Initiative May 2010 - August 2014
Food and Drug Protection Division, North Carolina Department of Agriculture 2014 - 2014
ADP 2006 - 2008
Gold's Gym July 2001 - July 2007
Trugreen Chemlawn March 1999 - July 2001
s Roofing and Siding January 1996 - March 1999
Skills
Sales Management, Management, Sales Operations, Sales, Food, New Business Development, Account Management, Training, B2B, Team Building, Time Management, Leadership, Nutrition, Salesforce.com, Business Development, Marketing, Product Development, Customer Service, Team Leadership, Coaching, Customer Satisfaction, Social Networking, Direct Sales, Food Science, Entrepreneurship, Food Processing, Food Industry, Research, Ingredients, Teamwork, Food Technology, Food Safety, Microbiology, Data Analysis, Leadership Development, Microsoft Office, Laboratory, Food Manufacturing, HACCP
Education
North Carolina State University 2012 — 2014
Master's degree, Food Science
North Carolina State University 2009 — 2012
B.S, Food Science, Nutrition, and Sports Science
FDA June 2015 - Present
Food and Drug Protection Division, North Carolina Department of Agriculture September 2014 - May 2015
NCSU Entrepreneurship Initiative May 2010 - August 2014
Food and Drug Protection Division, North Carolina Department of Agriculture 2014 - 2014
ADP 2006 - 2008
Gold's Gym July 2001 - July 2007
Trugreen Chemlawn March 1999 - July 2001
s Roofing and Siding January 1996 - March 1999
Skills
Sales Management, Management, Sales Operations, Sales, Food, New Business Development, Account Management, Training, B2B, Team Building, Time Management, Leadership, Nutrition, Salesforce.com, Business Development, Marketing, Product Development, Customer Service, Team Leadership, Coaching, Customer Satisfaction, Social Networking, Direct Sales, Food Science, Entrepreneurship, Food Processing, Food Industry, Research, Ingredients, Teamwork, Food Technology, Food Safety, Microbiology, Data Analysis, Leadership Development, Microsoft Office, Laboratory, Food Manufacturing, HACCP
Education
North Carolina State University 2012 — 2014
Master's degree, Food Science
North Carolina State University 2009 — 2012
B.S, Food Science, Nutrition, and Sports Science
Hugh Casseire Hugh Casseire's FDA Experience August 2013 - Present
Job Director, Cardiothoracic Intensive Care Unit at North Shore University Hospital
Industry Hospital & Health Care
Experience
North Shore LIJ Health System July 2007 - Present
North Shore-LIJ Health System July 2007 - Present
FDA August 2013 - Present
North Shore-LIJ Health System September 2012 - Present
North Shore-LIJ Health System September 2012 - Present
North Shore-LIJ Health System September 2012 - Present
FDA January 2011 - Present
FDA August 2010 - Present
FDA September 2007 - December 2010
Saint Michael's Medical Center July 2005 - July 2007
Skills
Critical Care, Internal Medicine, Healthcare, Clinical, Hospitals, Board Certified, ICU, Medical Education, Inpatient, Clinical Documentation, Cardiac Surgery, Cardiothoracic Surgery, Clinical Research, Healthcare Consulting, ACLS, Healthcare Management, Patient Safety, EMR, Anesthesiology, BLS, Respiratory Therapy, Physicians, Medical Devices, Documentations, Cardiac Care, Critical Care Medicine, Medicine, Surgery, Healthcare Information...
Education
Stony Brook University Health Sciences Center School of Medicine 1987 — 1991
MD
New York University 1986 — 1988
BS
North Shore LIJ Health System July 2007 - Present
North Shore-LIJ Health System July 2007 - Present
FDA August 2013 - Present
North Shore-LIJ Health System September 2012 - Present
North Shore-LIJ Health System September 2012 - Present
North Shore-LIJ Health System September 2012 - Present
FDA January 2011 - Present
FDA August 2010 - Present
FDA September 2007 - December 2010
Saint Michael's Medical Center July 2005 - July 2007
Skills
Critical Care, Internal Medicine, Healthcare, Clinical, Hospitals, Board Certified, ICU, Medical Education, Inpatient, Clinical Documentation, Cardiac Surgery, Cardiothoracic Surgery, Clinical Research, Healthcare Consulting, ACLS, Healthcare Management, Patient Safety, EMR, Anesthesiology, BLS, Respiratory Therapy, Physicians, Medical Devices, Documentations, Cardiac Care, Critical Care Medicine, Medicine, Surgery, Healthcare Information...
Education
Stony Brook University Health Sciences Center School of Medicine 1987 — 1991
MD
New York University 1986 — 1988
BS
AJ Jain AJ Jain's FDA Experience September 2005 - October 2006
Job Talent Acquisition DoD/Intel
Industry Defense & Space
Experience
WOOD Consulting Services, Inc. July 2015 - Present
Various Organizations October 2013 - June 2015
Various Organizations April 2007 - September 2013
Department of the Interior October 2006 - April 2007
FDA September 2005 - October 2006
Skills
Recruiting, Sourcing, Human Resources, Business Development, Selling, Time Management, SaaS, Teamwork, Account Management, Salesforce.com, Enterprise Software, Negotiation, Strategy, Management, Solution Selling, Sales, Analysis, Leadership, Team Leadership, Project Management, Process Improvement
Education
New York Law School 2001 — 2004
Juris Doctor, Law
Villanova University 1995 — 2000
Bachelor of Science (B.S.), Finance
Georgetown Prep 1991 — 1995
WOOD Consulting Services, Inc. July 2015 - Present
Various Organizations October 2013 - June 2015
Various Organizations April 2007 - September 2013
Department of the Interior October 2006 - April 2007
FDA September 2005 - October 2006
Skills
Recruiting, Sourcing, Human Resources, Business Development, Selling, Time Management, SaaS, Teamwork, Account Management, Salesforce.com, Enterprise Software, Negotiation, Strategy, Management, Solution Selling, Sales, Analysis, Leadership, Team Leadership, Project Management, Process Improvement
Education
New York Law School 2001 — 2004
Juris Doctor, Law
Villanova University 1995 — 2000
Bachelor of Science (B.S.), Finance
Georgetown Prep 1991 — 1995
Pamela Dorsey Pamela Dorsey's FDA Experience July 2014 - Present
Job FDA
Industry Pharmaceuticals
Experience
FDA July 2014 - Present
Boston University July 2012 - June 2014
University of Georgia August 2006 - May 2012
North Carolina A&T State University August 2003 - May 2006
Skills
Luminescence..., UV-Vis, HPLC with UV detection, Gel Electrophoresis, Spectroscopy, HPLC, SDS-PAGE, Biochemistry, Science, Protein Chemistry, Fluorescence Microscopy, UV/Vis
Education
The University of Georgia 2006 — 2012
Doctor of Philosophy (Ph.D.), Pharmaceutical and Biomedical Science
North Carolina Agricultural and Technical State University 2003 — 2006
M.S, Chemical Engineering
North Carolina Agricultural and Technical State University 1998 — 2003
B.S, Chemical Engineering
FDA July 2014 - Present
Boston University July 2012 - June 2014
University of Georgia August 2006 - May 2012
North Carolina A&T State University August 2003 - May 2006
Skills
Luminescence..., UV-Vis, HPLC with UV detection, Gel Electrophoresis, Spectroscopy, HPLC, SDS-PAGE, Biochemistry, Science, Protein Chemistry, Fluorescence Microscopy, UV/Vis
Education
The University of Georgia 2006 — 2012
Doctor of Philosophy (Ph.D.), Pharmaceutical and Biomedical Science
North Carolina Agricultural and Technical State University 2003 — 2006
M.S, Chemical Engineering
North Carolina Agricultural and Technical State University 1998 — 2003
B.S, Chemical Engineering
Dr. Bruce Lerman Dr. Bruce Lerman's FDA Experience February 2010 - Present
Job Drug Reviewer Pharmacologist (FDA)
Industry Pharmaceuticals
Experience
FDA February 2010 - Present
Lawson Builders 2012 - 2012
Children's National Medical Center January 2004 - March 2010
Weil Cornell Medical College 2003 - 2004
Wien Securities January 1999 - January 2003
Wien Securities 1999 - 2003
Education
The George Washington University School of Medicine and Health Sciences 2004 — 2009
University of Florida 1995 — 1999
B.S, Finance
City Colleges of New York
Institute of Biomedical Sciences
Ph.D; Post Baccalaureate Studies, Pharmacology; Biology
New Jersey Institute of Technology
Rutgers University
The George Washington University
University of Florida
Bachelor of Science, Finance; Computer Science
FDA February 2010 - Present
Lawson Builders 2012 - 2012
Children's National Medical Center January 2004 - March 2010
Weil Cornell Medical College 2003 - 2004
Wien Securities January 1999 - January 2003
Wien Securities 1999 - 2003
Education
The George Washington University School of Medicine and Health Sciences 2004 — 2009
University of Florida 1995 — 1999
B.S, Finance
City Colleges of New York
Institute of Biomedical Sciences
Ph.D; Post Baccalaureate Studies, Pharmacology; Biology
New Jersey Institute of Technology
Rutgers University
The George Washington University
University of Florida
Bachelor of Science, Finance; Computer Science
Jennifer Nogle Jennifer Nogle's FDA Experience November 2009 - Present
Job Chemist at FDA
Industry Chemicals
Experience
FDA November 2009 - Present
Arena Pharmaceuticals January 2005 - October 2008
Boston Scientific 2004 - 2004
Henkel 2003 - 2004
ChemResearch 1999 - 1999
Education
National University 2006 — 2009
MS, Forensic Science
Northern Arizona University 1998 — 2000
BS, Chemistry
FDA November 2009 - Present
Arena Pharmaceuticals January 2005 - October 2008
Boston Scientific 2004 - 2004
Henkel 2003 - 2004
ChemResearch 1999 - 1999
Education
National University 2006 — 2009
MS, Forensic Science
Northern Arizona University 1998 — 2000
BS, Chemistry
Grace Yao Grace Yao's FDA Experience June 2009 - August 2009
Job Business Analyst at Addx Corporation
Industry Information Technology and Services
Experience
Addx Corporation April 2014 - Present
Addx Corporation August 2013 - March 2014
High Performance Technologies, Inc. September 2011 - February 2013
FDA June 2009 - August 2009
Skills
SharePoint, SDLC, Access, Data Analysis, MS Project, Project Management, Microsoft SQL Server, Visual Basic, CRM, Requirements Gathering, Testing, C++, Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Project, Rally
Education
New York University 2013 — 2015
Master of Science (M.S.), Management and Systems
University of Maryland - Robert H. Smith School of Business 2007 — 2011
Bachelor of Science (B.S.), Information Systems & Supply Chain Management
Addx Corporation April 2014 - Present
Addx Corporation August 2013 - March 2014
High Performance Technologies, Inc. September 2011 - February 2013
FDA June 2009 - August 2009
Skills
SharePoint, SDLC, Access, Data Analysis, MS Project, Project Management, Microsoft SQL Server, Visual Basic, CRM, Requirements Gathering, Testing, C++, Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Project, Rally
Education
New York University 2013 — 2015
Master of Science (M.S.), Management and Systems
University of Maryland - Robert H. Smith School of Business 2007 — 2011
Bachelor of Science (B.S.), Information Systems & Supply Chain Management
Wen Zeng's FDA Experience 2008 - Present
Job Mathematical Statistician at FDA
Industry Biotechnology
Experience
FDA 2008 - Present
MedImmune Inc 2006 - 2008
Skills
Clinical Trials, Biostatistics
Education
North Carolina State University
Ph.D., Biostatistics
FDA 2008 - Present
MedImmune Inc 2006 - 2008
Skills
Clinical Trials, Biostatistics
Education
North Carolina State University
Ph.D., Biostatistics
Steve Shaheen's FDA Experience January 2011 - Present
Job Deputy Safety Manager US Food and Drug Adminstration
Industry Government Administration
Experience
FDA January 2011 - Present
U.S. Office of Personnel Management July 2007 - January 2011
La Roche College 2004 - 2008
Source One March 2006 - May 2007
US Marines 1983 - 2004
Skills
Emergency Management, Training, Leadership, Program Management, Government, EHS, Risk Management, Policy, Leadership Development, Program Development, Nonprofits, Team Building, Public Speaking, Supervisory Skills, Industrial Hygiene, Risk Assessment, Ergonomics, Investigation, HAZWOPER, Hazardous Materials, Occupational Health, Industrial Safety, Hazardous Waste..., Environmental Awareness, Environmental Compliance, Hazard Recognition, Environmental..., Hazard Analysis
Education
Argosy University Los Angeles 2000 — 2008
Doctorate, Education
US MARINES 1983 — 2004
National University 1998 — 2000
Masters, Management
Thomas Edison State College 1987 — 1992
BS, Environmental Health
Valley High School 1980 — 1984
Diploma
FDA January 2011 - Present
U.S. Office of Personnel Management July 2007 - January 2011
La Roche College 2004 - 2008
Source One March 2006 - May 2007
US Marines 1983 - 2004
Skills
Emergency Management, Training, Leadership, Program Management, Government, EHS, Risk Management, Policy, Leadership Development, Program Development, Nonprofits, Team Building, Public Speaking, Supervisory Skills, Industrial Hygiene, Risk Assessment, Ergonomics, Investigation, HAZWOPER, Hazardous Materials, Occupational Health, Industrial Safety, Hazardous Waste..., Environmental Awareness, Environmental Compliance, Hazard Recognition, Environmental..., Hazard Analysis
Education
Argosy University Los Angeles 2000 — 2008
Doctorate, Education
US MARINES 1983 — 2004
National University 1998 — 2000
Masters, Management
Thomas Edison State College 1987 — 1992
BS, Environmental Health
Valley High School 1980 — 1984
Diploma
Slava Zazansky's FDA Experience September 2012 - April 2014
Job Sr. Architect/Lead Developer at U.S. Department of Homeland Security
Industry Information Technology and Services
Experience
U.S. Department of Homeland Security April 2014 - Present
FDA September 2012 - April 2014
CareFirst BlueCross BlueShield 2008 - 2009
REI Systems 2002 - 2004
Education
Virginia Polytechnic Institute and State University 2006 — 2008
Master, Information Technology
National Technical University of Ukraine 'Kyiv Polytechnic Institute' 1991 — 1997
Master, Computer Systems
U.S. Department of Homeland Security April 2014 - Present
FDA September 2012 - April 2014
CareFirst BlueCross BlueShield 2008 - 2009
REI Systems 2002 - 2004
Education
Virginia Polytechnic Institute and State University 2006 — 2008
Master, Information Technology
National Technical University of Ukraine 'Kyiv Polytechnic Institute' 1991 — 1997
Master, Computer Systems
Yung-Cheng Chen's FDA Experience September 2010 - Present
Job Review Chemist at FDA
Industry Government Administration
Experience
FDA September 2010 - Present
Pfizer (Legacy Wyeth) 2005 - 2010
Pfizer (Legacy Wyeth) 2002 - 2004
Pfizer (Legacy Wyeth) 1998 - 2001
Skills
Drug Discovery, Drug Development, HPLC, Pharmacokinetics, GLP, LC-MS, Formulation, Regulatory Affairs, Pharmaceutical Industry, Pharmacology, Technology Transfer, GMP, Clinical Development, Analytical Chemistry, Biotechnology
Education
Rutgers, The State University of New Jersey-New Brunswick 1991 — 1998
Doctor of Philosophy (Ph.D.), Pharmaceutics and Drug Design
West Virginia University 1989 — 1991
Master of Science (M.S.), Medicinal and Pharmaceutical Chemistry
National Taiwan University 1981 — 1985
Bachelor of Science (B.S.), Pharmacy
FDA September 2010 - Present
Pfizer (Legacy Wyeth) 2005 - 2010
Pfizer (Legacy Wyeth) 2002 - 2004
Pfizer (Legacy Wyeth) 1998 - 2001
Skills
Drug Discovery, Drug Development, HPLC, Pharmacokinetics, GLP, LC-MS, Formulation, Regulatory Affairs, Pharmaceutical Industry, Pharmacology, Technology Transfer, GMP, Clinical Development, Analytical Chemistry, Biotechnology
Education
Rutgers, The State University of New Jersey-New Brunswick 1991 — 1998
Doctor of Philosophy (Ph.D.), Pharmaceutics and Drug Design
West Virginia University 1989 — 1991
Master of Science (M.S.), Medicinal and Pharmaceutical Chemistry
National Taiwan University 1981 — 1985
Bachelor of Science (B.S.), Pharmacy
Heupel, Chad's FDA Experience 2008 - Present
Job Director, Division of Communication Media at US Food and Drug Administration
Industry Broadcast Media
Experience
US Food and Drug Administration June 2008 - Present
FDA 2008 - Present
Freelance Video Professional 1995 - 2010
US Dept of Health April 2004 - June 2008
Freelance Television Production 1995 - 2008
FEMA / National Emergency Training Center October 1992 - April 2004
US Department of Homeland Security 1992 - 2004
- 1990 - 1990
Skills
Government, Editing, Broadcast, Video, Production, Event Planning, Video Production, Broadcast Television, Event Management, Camera, Digital Media, Sound, Media Relations, Avid, Television, Video Editing, Non-linear Editing, Radio
Education
North Dakota State University 1987 — 1991
Bachelor of Applied Science (BASc), Broadcast Production
US Food and Drug Administration June 2008 - Present
FDA 2008 - Present
Freelance Video Professional 1995 - 2010
US Dept of Health April 2004 - June 2008
Freelance Television Production 1995 - 2008
FEMA / National Emergency Training Center October 1992 - April 2004
US Department of Homeland Security 1992 - 2004
- 1990 - 1990
Skills
Government, Editing, Broadcast, Video, Production, Event Planning, Video Production, Broadcast Television, Event Management, Camera, Digital Media, Sound, Media Relations, Avid, Television, Video Editing, Non-linear Editing, Radio
Education
North Dakota State University 1987 — 1991
Bachelor of Applied Science (BASc), Broadcast Production
Dhanya John's FDA Experience 2015 - Present
Job FDA
Industry Law Practice
Experience
FDA 2015 - Present
Georgia Regents Medical Center 2011 - 2013
Education
University of Maryland School of Law 2007 — 2010
Doctor of Law (J.D.)
Bucerius Law School 2005 — 2005
National University of Singapore 2001 — 2005
FDA 2015 - Present
Georgia Regents Medical Center 2011 - 2013
Education
University of Maryland School of Law 2007 — 2010
Doctor of Law (J.D.)
Bucerius Law School 2005 — 2005
National University of Singapore 2001 — 2005
Edmund Nesti's FDA Experience May 2015 - Present
Job ORISE Fellow FDA
Industry Biotechnology
Experience
FDA May 2015 - Present
Vollum Institute November 2006 - July 2014
The University of Vermont September 2000 - October 2006
Skills
Cell Based Assays, Mouse embryonic stem..., Primary mouse cortical..., Porcine open-heart..., Rodent survival surgery..., Rodent subcutaneouse..., Western Blotting, Immunoprecipitation, Protein expression..., Mass spectrometry, Flow cytometry, Spectrophotometric..., Fluorescent, light, and..., Immunohistochemistry, Data analysis: Excel,..., Statistical analysis..., Cell Biology, Cell Culture, Molecular Biology, Biochemistry, Life Sciences, Molecular Cloning, PCR, Confocal Microscopy, Cell, Fluorescence Microscopy
Education
University of Vermont 2000 — 2006
PhD, pharmacology
Northeastern University 1988 — 1992
Bachelor's Degree, Biology
Rice High School 1984 — 1988
FDA May 2015 - Present
Vollum Institute November 2006 - July 2014
The University of Vermont September 2000 - October 2006
Skills
Cell Based Assays, Mouse embryonic stem..., Primary mouse cortical..., Porcine open-heart..., Rodent survival surgery..., Rodent subcutaneouse..., Western Blotting, Immunoprecipitation, Protein expression..., Mass spectrometry, Flow cytometry, Spectrophotometric..., Fluorescent, light, and..., Immunohistochemistry, Data analysis: Excel,..., Statistical analysis..., Cell Biology, Cell Culture, Molecular Biology, Biochemistry, Life Sciences, Molecular Cloning, PCR, Confocal Microscopy, Cell, Fluorescence Microscopy
Education
University of Vermont 2000 — 2006
PhD, pharmacology
Northeastern University 1988 — 1992
Bachelor's Degree, Biology
Rice High School 1984 — 1988
Sushmita Sahu's FDA Experience June 2011 - May 2012
Job Assistant Vice President at Deutsche Bank
Industry Investment Banking
Experience
Deutsche Bank January 2015 - Present
AOL August 2014 - January 2015
PwC September 2012 - August 2014
FDA June 2011 - May 2012
University of Maryland,College Park September 2010 - May 2012
KONY Labs September 2009 - August 2010
Pramati Technologies January 2008 - June 2009
Accenture May 2007 - January 2008
Skills
SPSS, Java, J2EE, SAS, C++, HTML, PL/SQL, JavaScript, Java Enterprise Edition, Perl, Databases, Oracle, Visio, MS Project, MySQL, Web Services, Integration, XML, Management, Project Management, Business Intelligence, Business Analysis, Requirements Gathering, SQL, Testing, Consulting
Education
University of Maryland College Park 2010 — 2012
Masters of Science, Project Management
National Institute of Technology Rourkela 2003 — 2007
Bachelor in Technology, Civil and Environmental Engineering
Deutsche Bank January 2015 - Present
AOL August 2014 - January 2015
PwC September 2012 - August 2014
FDA June 2011 - May 2012
University of Maryland,College Park September 2010 - May 2012
KONY Labs September 2009 - August 2010
Pramati Technologies January 2008 - June 2009
Accenture May 2007 - January 2008
Skills
SPSS, Java, J2EE, SAS, C++, HTML, PL/SQL, JavaScript, Java Enterprise Edition, Perl, Databases, Oracle, Visio, MS Project, MySQL, Web Services, Integration, XML, Management, Project Management, Business Intelligence, Business Analysis, Requirements Gathering, SQL, Testing, Consulting
Education
University of Maryland College Park 2010 — 2012
Masters of Science, Project Management
National Institute of Technology Rourkela 2003 — 2007
Bachelor in Technology, Civil and Environmental Engineering
Andy Gunn's FDA Experience 2008 - 2008
Job Regulatory Affairs & CGxP Compliance at Kymanox
Industry Pharmaceuticals
Experience
Kymanox May 2014 - Present
Alere, Inc. January 2013 - May 2014
Novartis Consumer Health May 2012 - December 2012
BD May 2011 - May 2012
Emergent BioSolutions February 2010 - May 2011
Boston Scientific 2008 - February 2010
FDA 2008 - 2008
Otsuka Pharmaceutical Companies (U.S.) 2005 - 2007
Skills
PMAs, Editing, CAPA, GMP, IND, eCTD, Quality Management, Regulatory Affairs, FDA, Quality Assurance, Quality System, Medical Devices, Biotechnology, Aseptic Processing, V&V, 21 CFR Part 11, GLP, ISO 13485, Technology Transfer, Pharmaceutical Industry, Validation, Vaccines, Regulatory Submissions, Sop, Change Control, Quality Control, Microbiology, Pharmaceutics, Computer System..., Biopharmaceuticals, GxP, Regulatory Requirements, LIMS, Design Control, Cleaning Validation, Quality Auditing, GCP, GAMP, Clinical Trials, Lifesciences, Clinical Development, Drug Development, HPLC, CMC, Sterilization, FDA GMP, SOP, Life Sciences
Education
North Carolina State University 1993 — 1994
Cell Biology
North Carolina State University 1988 — 1991
BS, Zoology
Kymanox May 2014 - Present
Alere, Inc. January 2013 - May 2014
Novartis Consumer Health May 2012 - December 2012
BD May 2011 - May 2012
Emergent BioSolutions February 2010 - May 2011
Boston Scientific 2008 - February 2010
FDA 2008 - 2008
Otsuka Pharmaceutical Companies (U.S.) 2005 - 2007
Skills
PMAs, Editing, CAPA, GMP, IND, eCTD, Quality Management, Regulatory Affairs, FDA, Quality Assurance, Quality System, Medical Devices, Biotechnology, Aseptic Processing, V&V, 21 CFR Part 11, GLP, ISO 13485, Technology Transfer, Pharmaceutical Industry, Validation, Vaccines, Regulatory Submissions, Sop, Change Control, Quality Control, Microbiology, Pharmaceutics, Computer System..., Biopharmaceuticals, GxP, Regulatory Requirements, LIMS, Design Control, Cleaning Validation, Quality Auditing, GCP, GAMP, Clinical Trials, Lifesciences, Clinical Development, Drug Development, HPLC, CMC, Sterilization, FDA GMP, SOP, Life Sciences
Education
North Carolina State University 1993 — 1994
Cell Biology
North Carolina State University 1988 — 1991
BS, Zoology
Joseph Contrera's FDA Experience July 1991 - November 2007
Job Owner, Computational Toxicology Services LLC
Industry Pharmaceuticals
Experience
Computational Toxicology Services LLC January 2008 - Present
FDA July 1991 - November 2007
University of Maryland September 1967 - May 1977
Skills
Research, Chemistry, Biotechnology, Pharmaceutical Industry, Lifesciences, Drug Development, Toxicology, FDA, Pharmacology, Drug Discovery, IND, R&D, Biochemistry, Validation, Regulatory Submissions, Pharmaceutics, Oncology, Regulatory Affairs
Education
New York University 1960 — 1966
Doctor of Philosophy (Ph.D.), Molecular Physiology
Yale University School of Medicine
postdoctoral, Neuropharmacology
Computational Toxicology Services LLC January 2008 - Present
FDA July 1991 - November 2007
University of Maryland September 1967 - May 1977
Skills
Research, Chemistry, Biotechnology, Pharmaceutical Industry, Lifesciences, Drug Development, Toxicology, FDA, Pharmacology, Drug Discovery, IND, R&D, Biochemistry, Validation, Regulatory Submissions, Pharmaceutics, Oncology, Regulatory Affairs
Education
New York University 1960 — 1966
Doctor of Philosophy (Ph.D.), Molecular Physiology
Yale University School of Medicine
postdoctoral, Neuropharmacology
Alek Winiarski's FDA Experience November 2014 - Present
Job Senior Regulatory Health Project Manager at FDA
Industry Government Administration
Experience
FDA November 2014 - Present
FDA September 2011 - November 2014
FDA September 2010 - September 2011
Bayer Pharmaceuticals April 2010 - September 2010
Roche Pharmaceuticals July 2004 - October 2009
Roche Pharmaceuticals July 2003 - June 2004
New Britain General Hospital July 2001 - June 2003
Beth Israel Deaconess Medical Center April 1998 - March 2001
Harvard Vanguard Medical Associates June 1999 - September 1999
Veterans Administration July 1997 - March 1998
Skills
Pharmaceutical Industry, Infectious Diseases, Clinical Trials, Medical Writing, Clinical Research, Clinical Development, Oncology, Healthcare, Pharmacovigilance, Pharmacy
Education
Northeastern University 1995 — 2001
Doctor of Pharmacy (PharmD) Cum Laude
FDA November 2014 - Present
FDA September 2011 - November 2014
FDA September 2010 - September 2011
Bayer Pharmaceuticals April 2010 - September 2010
Roche Pharmaceuticals July 2004 - October 2009
Roche Pharmaceuticals July 2003 - June 2004
New Britain General Hospital July 2001 - June 2003
Beth Israel Deaconess Medical Center April 1998 - March 2001
Harvard Vanguard Medical Associates June 1999 - September 1999
Veterans Administration July 1997 - March 1998
Skills
Pharmaceutical Industry, Infectious Diseases, Clinical Trials, Medical Writing, Clinical Research, Clinical Development, Oncology, Healthcare, Pharmacovigilance, Pharmacy
Education
Northeastern University 1995 — 2001
Doctor of Pharmacy (PharmD) Cum Laude
Kate Kavlock's FDA Experience September 2010 - Present
Job Biomedical Engineer
Industry Medical Devices
Experience
FDA September 2010 - Present
FDA October 2009 - September 2010
Virginia Tech 2004 - 2009
Education
Virginia Polytechnic Institute and State University 2004 — 2009
Ph.D., Biomedical Engineering
North Carolina State University 1999 — 2004
B.S., Biomedical Engineering
FDA September 2010 - Present
FDA October 2009 - September 2010
Virginia Tech 2004 - 2009
Education
Virginia Polytechnic Institute and State University 2004 — 2009
Ph.D., Biomedical Engineering
North Carolina State University 1999 — 2004
B.S., Biomedical Engineering
Susan Schulken's FDA Experience February 2013 - Present
Job Digital Communications Program Manager at FDA
Industry Government Administration
Experience
FDA February 2013 - Present
FDA July 2012 - February 2013
FDA July 2011 - July 2012
US Department of Health and Human Services July 2009 - July 2011
U.S. Department of Justice February 1999 - July 2009
SoftMed Systems, Inc. 1997 - 1999
Skills
Content Management, Government, Strategic Communications, Web Content Management, Program Management, Project Management, Editing, Policy, Web Writing, Information Architecture, Usability, Accessibility, Digital Communication..., Social Media, Blogging, Web Content, Technical Writing, User Experience, Management, Usability Testing, Press Releases, Content Writing
Education
North Carolina State University 1989 — 1994
M.S., Technical Communications
Wake Forest University 1979 — 1983
B.A., Psychology, English
FDA February 2013 - Present
FDA July 2012 - February 2013
FDA July 2011 - July 2012
US Department of Health and Human Services July 2009 - July 2011
U.S. Department of Justice February 1999 - July 2009
SoftMed Systems, Inc. 1997 - 1999
Skills
Content Management, Government, Strategic Communications, Web Content Management, Program Management, Project Management, Editing, Policy, Web Writing, Information Architecture, Usability, Accessibility, Digital Communication..., Social Media, Blogging, Web Content, Technical Writing, User Experience, Management, Usability Testing, Press Releases, Content Writing
Education
North Carolina State University 1989 — 1994
M.S., Technical Communications
Wake Forest University 1979 — 1983
B.A., Psychology, English
Nadia Gabriel's FDA Experience July 2013 - October 2013
Job Librarian & Freelance Translator
Industry Libraries
Experience
Smithsonian Institution June 2014 - Present
Translators without Borders April 2014 - Present
Folger Shakespeare Library January 2014 - Present
Georgetown University June 2014 - January 2015
Smithsonian Institution June 2013 - May 2014
FDA July 2013 - October 2013
Grovewell LLC August 2013 - August 2013
Alliance Francaise de Washington November 2006 - March 2013
United States Holocaust Memorial Museum January 2010 - August 2010
Grovewell LLC June 2008 - June 2008
Skills
Library, Information Retrieval, Books, Non-profits, Library Science, Cataloging, Collection Development, Library Management
Education
NYU School of Professional Studies 2014 — 2016
Certificate in Translation (online), Translation Studies, English > French
CUA 2007 — 2011
Master of Library & Information Science (MLIS), Library and Information Science
The Catholic University of America 2007 — 2010
MLS, Library Science / Technical Services
Université Paris X Nanterre 1993 — 1994
DUT, Library Science
Université Denis Diderot (Paris VII) 1990 — 1993
Licence, English
New York University
Smithsonian Institution June 2014 - Present
Translators without Borders April 2014 - Present
Folger Shakespeare Library January 2014 - Present
Georgetown University June 2014 - January 2015
Smithsonian Institution June 2013 - May 2014
FDA July 2013 - October 2013
Grovewell LLC August 2013 - August 2013
Alliance Francaise de Washington November 2006 - March 2013
United States Holocaust Memorial Museum January 2010 - August 2010
Grovewell LLC June 2008 - June 2008
Skills
Library, Information Retrieval, Books, Non-profits, Library Science, Cataloging, Collection Development, Library Management
Education
NYU School of Professional Studies 2014 — 2016
Certificate in Translation (online), Translation Studies, English > French
CUA 2007 — 2011
Master of Library & Information Science (MLIS), Library and Information Science
The Catholic University of America 2007 — 2010
MLS, Library Science / Technical Services
Université Paris X Nanterre 1993 — 1994
DUT, Library Science
Université Denis Diderot (Paris VII) 1990 — 1993
Licence, English
New York University
Geok Yan Loo's FDA Experience December 2013 - Present
Job Statistician, Food and Drug Administration
Industry Hospital & Health Care
Experience
FDA December 2013 - Present
University of Maryland August 2013 - December 2013
University of Maryland August 2011 - May 2013
The Container Store May 2005 - June 2011
University of Maryland January 2008 - December 2008
National Cancer Centre June 2000 - January 2004
Apex Pharmacy International Pte Ltd March 1995 - May 2000
KK Women's & Children's Hospital May 1992 - January 1995
Skills
SAS Certified Base..., Stata, R, HTML, Matlab, JavaScript, LaTeX, Statistical Data..., Clinical Trials, Clinical Pharmacology, Healthcare, Oncology, SPSS, SAS, Biostatistics, Statistics, Data Analysis
Education
University of Maryland College Park 2011 — 2013
Master of Public Health (MPH), (Biostatistics)
University of Maryland College Park 2006 — 2010
Bachelor of Science (BS), Mathematics and Statistics
University of Maryland College Park 2006 — 2010
Bachelor of Science (BS), Biology/Biological Sciences, General
National University of Singapore 1988 — 1991
Bachelor of Science (BSc), Pharmacy
FDA December 2013 - Present
University of Maryland August 2013 - December 2013
University of Maryland August 2011 - May 2013
The Container Store May 2005 - June 2011
University of Maryland January 2008 - December 2008
National Cancer Centre June 2000 - January 2004
Apex Pharmacy International Pte Ltd March 1995 - May 2000
KK Women's & Children's Hospital May 1992 - January 1995
Skills
SAS Certified Base..., Stata, R, HTML, Matlab, JavaScript, LaTeX, Statistical Data..., Clinical Trials, Clinical Pharmacology, Healthcare, Oncology, SPSS, SAS, Biostatistics, Statistics, Data Analysis
Education
University of Maryland College Park 2011 — 2013
Master of Public Health (MPH), (Biostatistics)
University of Maryland College Park 2006 — 2010
Bachelor of Science (BS), Mathematics and Statistics
University of Maryland College Park 2006 — 2010
Bachelor of Science (BS), Biology/Biological Sciences, General
National University of Singapore 1988 — 1991
Bachelor of Science (BSc), Pharmacy
Paula Chakravarti's FDA Experience October 2014 - Present
Job ORISE Fellow, SEALD, Office of New Drugs at FDA
Industry Research
Experience
FDA October 2014 - Present
Association of Schools and Programs of Public Health May 2014 - September 2014
Pan American Health Organization December 2013 - September 2014
AHRQ, US Department of Health and Human Services June 2013 - September 2013
Pan American Health Organization February 2013 - June 2013
Avalere Health January 2012 - July 2012
Novartis Pharmaceuticals August 2008 - November 2011
Novartis August 2006 - August 2008
Kforce contractor at Hoffmann-La Roche February 2005 - August 2006
Kforce contractor at Hoffmann-La Roche September 2004 - February 2005
Education
Rutgers School of Public Health (formerly UMDNJ School of Public Health) 2008 — 2016
Doctoral candidate, Epidemiology
University of Medicine and Dentistry of New Jersey 2006 — 2008
MPH, Epidemiology
University of Iowa Roy J. and Lucille A. Carver College of Medicine 1999 — 2002
M.S., Pharmacology
University of North Carolina at Greensboro 1997 — 1999
M.A., Liberal Studies
North Carolina State University 1992 — 1995
B.S., Biochemistry
North Carolina State University 1992 — 1995
B.A., Chemistry
FDA October 2014 - Present
Association of Schools and Programs of Public Health May 2014 - September 2014
Pan American Health Organization December 2013 - September 2014
AHRQ, US Department of Health and Human Services June 2013 - September 2013
Pan American Health Organization February 2013 - June 2013
Avalere Health January 2012 - July 2012
Novartis Pharmaceuticals August 2008 - November 2011
Novartis August 2006 - August 2008
Kforce contractor at Hoffmann-La Roche February 2005 - August 2006
Kforce contractor at Hoffmann-La Roche September 2004 - February 2005
Education
Rutgers School of Public Health (formerly UMDNJ School of Public Health) 2008 — 2016
Doctoral candidate, Epidemiology
University of Medicine and Dentistry of New Jersey 2006 — 2008
MPH, Epidemiology
University of Iowa Roy J. and Lucille A. Carver College of Medicine 1999 — 2002
M.S., Pharmacology
University of North Carolina at Greensboro 1997 — 1999
M.A., Liberal Studies
North Carolina State University 1992 — 1995
B.S., Biochemistry
North Carolina State University 1992 — 1995
B.A., Chemistry
ira krefting's FDA Experience
Job medical officer at FDA
Industry Government Administration
Experience
FDA
Skills
Internal Medicine, Clinical Trials, Public Health, Clinical Research, Epidemiology, Medical Education, Regulatory Affairs, Healthcare, Healthcare Management, Oncology, Medicine, Pharmacovigilance, Medical Writing, Pharmacology
Education
NYU
State University of New York Downstate Medical Center College of Medicine
State University of New York Downstate Medical Center College of Medicine
State University of New York Downstate Medical Center College of Medicine
Teaneck High
FDA
Skills
Internal Medicine, Clinical Trials, Public Health, Clinical Research, Epidemiology, Medical Education, Regulatory Affairs, Healthcare, Healthcare Management, Oncology, Medicine, Pharmacovigilance, Medical Writing, Pharmacology
Education
NYU
State University of New York Downstate Medical Center College of Medicine
State University of New York Downstate Medical Center College of Medicine
State University of New York Downstate Medical Center College of Medicine
Teaneck High
Susan Alpert's FDA Experience 1993 - 1999
Job Senior Vice President at Medtronic
Industry Medical Devices
Experience
SFA Consulting, LLC 2011 - 2012
Medtronic July 2003 - May 2011
CR Bard 2000 - 2003
FDA 1993 - 1999
Skills
Regulatory Affairs, Medical Devices, ISO 13485, FDA, Clinical Research, Design Control, Lifesciences, Regulatory Submissions, CAPA, Sop, Biotechnology, Clinical Trials, PMA, R&D, GMP, Market Development, Commercialization, Validation, Pharmaceutical Industry, Cardiology, V&V, Quality System, Cross-functional Team..., Medical Imaging, Product Development, GCP, Clinical Development, Senior Executive..., Board of Directors, Quality Auditing, Healthcare, Business Strategy
Education
New York University School of Medicine
SFA Consulting, LLC 2011 - 2012
Medtronic July 2003 - May 2011
CR Bard 2000 - 2003
FDA 1993 - 1999
Skills
Regulatory Affairs, Medical Devices, ISO 13485, FDA, Clinical Research, Design Control, Lifesciences, Regulatory Submissions, CAPA, Sop, Biotechnology, Clinical Trials, PMA, R&D, GMP, Market Development, Commercialization, Validation, Pharmaceutical Industry, Cardiology, V&V, Quality System, Cross-functional Team..., Medical Imaging, Product Development, GCP, Clinical Development, Senior Executive..., Board of Directors, Quality Auditing, Healthcare, Business Strategy
Education
New York University School of Medicine
Jemin Dedania's FDA Experience September 2009 - Present
Job Biomedical Engineer at FDA
Industry Medical Devices
Experience
FDA September 2009 - Present
USPTO April 2009 - September 2009
UMDNJ October 2007 - April 2009
NJIT October 2007 - June 2008
Skills
Biomedical Engineering, Medical Imaging, Medical Devices, Biomaterials, Labview, Regulatory Affairs, Regulatory Submissions, FDA, Clinical Research, Orthopedic, Biotechnology, Life Sciences, Research, Molecular Biology, R&D, Quality System, Data Analysis, Clinical Trials, Cell Culture, Healthcare, Biomechanics, ISO 13485
Education
New Jersey Institute of Technology 2007 — 2009
MS, Biomedical Engineering
University of Medicine and Dentistry of New Jersey -New Jersey Medical School 2007 — 2009
Biomedical/Medical Engineering
University of Tennessee-Knoxville 2001 — 2005
BS, Biomedical Engineering
FDA September 2009 - Present
USPTO April 2009 - September 2009
UMDNJ October 2007 - April 2009
NJIT October 2007 - June 2008
Skills
Biomedical Engineering, Medical Imaging, Medical Devices, Biomaterials, Labview, Regulatory Affairs, Regulatory Submissions, FDA, Clinical Research, Orthopedic, Biotechnology, Life Sciences, Research, Molecular Biology, R&D, Quality System, Data Analysis, Clinical Trials, Cell Culture, Healthcare, Biomechanics, ISO 13485
Education
New Jersey Institute of Technology 2007 — 2009
MS, Biomedical Engineering
University of Medicine and Dentistry of New Jersey -New Jersey Medical School 2007 — 2009
Biomedical/Medical Engineering
University of Tennessee-Knoxville 2001 — 2005
BS, Biomedical Engineering
Rahul Pandita's FDA Experience August 2011 - 2011
Job Postdoctoral Researcher at North Carolina State University
Industry Computer Software
Experience
NC State University August 2015 - Present
North Carolina State University May 2009 - July 2015
Accenture May 2013 - August 2013
IBM May 2011 - August 2011
FDA August 2011 - 2011
FDA May 2010 - August 2010
Hughes Systique Corporation July 2007 - December 2008
Skills
Software Engineering, Software Verification, Program Analysis, Text Mining, Information Retrieval, Research, Algorithms, Data Structures, Java, JSP, Core Java, Eclipse, Natural Language..., Computer Science, Programming, Software Development, Unix, ClearCase, XML, Object Oriented Design, Tomcat, JavaScript, Design Patterns
Education
North Carolina State University 2010 — 2015
PhD., Computer Science
North Carolina State University 2009 — 2011
MS, Computer Science
University of Pune 2003 — 2007
Engineering(BE), Computer Science
NC State University August 2015 - Present
North Carolina State University May 2009 - July 2015
Accenture May 2013 - August 2013
IBM May 2011 - August 2011
FDA August 2011 - 2011
FDA May 2010 - August 2010
Hughes Systique Corporation July 2007 - December 2008
Skills
Software Engineering, Software Verification, Program Analysis, Text Mining, Information Retrieval, Research, Algorithms, Data Structures, Java, JSP, Core Java, Eclipse, Natural Language..., Computer Science, Programming, Software Development, Unix, ClearCase, XML, Object Oriented Design, Tomcat, JavaScript, Design Patterns
Education
North Carolina State University 2010 — 2015
PhD., Computer Science
North Carolina State University 2009 — 2011
MS, Computer Science
University of Pune 2003 — 2007
Engineering(BE), Computer Science
Irene Bacalocostantis's FDA Experience August 2012 - Present
Job Medical Device Premarket Reviewer at FDA
Industry Biotechnology
Experience
FDA August 2012 - Present
PolyVec Systems Inc July 2011 - May 2012
Functional Macromolecular Laboratory September 2007 - May 2012
Foundation for Research and Technology March 2006 - August 2007
Skills
Microscopy, Molecular Biology, Cell Culture, Fluorescence Microscopy, Western Blotting, PCR, Confocal Microscopy, Biomedical Engineering, Biomaterials, Spectroscopy, Matlab, Statistics, Biochemistry, UV/Vis, Scanning Electron..., Polymers, Cell, Assay Development, Biotechnology, Medical Devices, Bioengineering, Materials Science
Education
University of Maryland College Park 2007 — 2012
Doctor of Philosophy (Ph.D.), Bioengineering
New York University 2001 — 2005
Bachelor of Arts (B.A.), Biochemistry
FDA August 2012 - Present
PolyVec Systems Inc July 2011 - May 2012
Functional Macromolecular Laboratory September 2007 - May 2012
Foundation for Research and Technology March 2006 - August 2007
Skills
Microscopy, Molecular Biology, Cell Culture, Fluorescence Microscopy, Western Blotting, PCR, Confocal Microscopy, Biomedical Engineering, Biomaterials, Spectroscopy, Matlab, Statistics, Biochemistry, UV/Vis, Scanning Electron..., Polymers, Cell, Assay Development, Biotechnology, Medical Devices, Bioengineering, Materials Science
Education
University of Maryland College Park 2007 — 2012
Doctor of Philosophy (Ph.D.), Bioengineering
New York University 2001 — 2005
Bachelor of Arts (B.A.), Biochemistry
Clarence Murray III's FDA Experience 2012 - Present
Job Physical Organic/ Polymer Chemist
Industry Medical Devices
Experience
FDA 2012 - Present
FDA 2008 - 2012
FDA 2003 - 2008
Eastman Kodak May 1998 - August 1998
Skills
Chemistry, Science, Mass Spectrometry, UV/Vis, Chromatography, Regulatory Affairs, Organic Chemistry, R&D, Food & Drug Law, Polymer Chemistry, Polymer Characterization, NMR spectroscopy, Supercritical Fluids, color additives, Food Additives, 510(k), anthropogenic..., NMR, Organic Synthesis, Polymers, LC-MS, Data Analysis
Education
University of North Carolina at Chapel Hill 1998 — 2003
Ph.D, Chemistry
Norfolk State University 1994 — 1998
Bachelor of Science (B.S.), Chemistry
FDA 2012 - Present
FDA 2008 - 2012
FDA 2003 - 2008
Eastman Kodak May 1998 - August 1998
Skills
Chemistry, Science, Mass Spectrometry, UV/Vis, Chromatography, Regulatory Affairs, Organic Chemistry, R&D, Food & Drug Law, Polymer Chemistry, Polymer Characterization, NMR spectroscopy, Supercritical Fluids, color additives, Food Additives, 510(k), anthropogenic..., NMR, Organic Synthesis, Polymers, LC-MS, Data Analysis
Education
University of North Carolina at Chapel Hill 1998 — 2003
Ph.D, Chemistry
Norfolk State University 1994 — 1998
Bachelor of Science (B.S.), Chemistry
Todd Bourcier's FDA Experience 2004 - Present
Job Pharmacologist
Industry Pharmaceuticals
Experience
FDA 2004 - Present
Brigham and Women's Hospital 1995 - 2004
Skills
Endocrinology, Toxicology, Pharmacology, Metabolism, Drug Development, IND, Regulatory Affairs, Diabetes
Education
University of Tennessee-Health Science Center 1992 — 1995
Pharmacology
New York Medical College 1989 — 1995
Ph.D., Pharmacology
Roger Williams University 1985 — 1989
BA, Marine Biology
FDA 2004 - Present
Brigham and Women's Hospital 1995 - 2004
Skills
Endocrinology, Toxicology, Pharmacology, Metabolism, Drug Development, IND, Regulatory Affairs, Diabetes
Education
University of Tennessee-Health Science Center 1992 — 1995
Pharmacology
New York Medical College 1989 — 1995
Ph.D., Pharmacology
Roger Williams University 1985 — 1989
BA, Marine Biology
Benjamin A. Chacko, Pharm.D., JD's FDA Experience January 2015 - Present
Job Associate Director, Regulatory Affairs (Acting), OGD, Office of Bioequivalence
Industry Government Administration
Experience
FDA January 2015 - Present
Skills
Regulatory Affairs, Pharmaceutical Industry, FDA, Lifesciences, Biotechnology, Healthcare, Pharmacists, Regulatory Submissions, Drug Development, Medical Devices, Policy, Regulatory Requirements, GMP, Regulations, Sop, Vaccines, Health Policy, Intellectual Property, Regulatory Analysis, Health Law, GCP, IND, Public Health, Administrative Law, Legal Writing, Clinical Trials, Policy Analysis, Clinical Development, Government, Public Policy, Strategic Planning, Program Management, Life Sciences
Education
Seton Hall University School of Law 2003 — 2007
JD.
University of the Sciences in Philadelphia 1997 — 2002
Pharm.D.
New York University 1995 — 1997
N/A
FDA January 2015 - Present
Skills
Regulatory Affairs, Pharmaceutical Industry, FDA, Lifesciences, Biotechnology, Healthcare, Pharmacists, Regulatory Submissions, Drug Development, Medical Devices, Policy, Regulatory Requirements, GMP, Regulations, Sop, Vaccines, Health Policy, Intellectual Property, Regulatory Analysis, Health Law, GCP, IND, Public Health, Administrative Law, Legal Writing, Clinical Trials, Policy Analysis, Clinical Development, Government, Public Policy, Strategic Planning, Program Management, Life Sciences
Education
Seton Hall University School of Law 2003 — 2007
JD.
University of the Sciences in Philadelphia 1997 — 2002
Pharm.D.
New York University 1995 — 1997
N/A
Kristen Meier's FDA Experience 1995 - 2013
Job Myraqa Senior Director at Illumina
Industry Medical Devices
Experience
Illumina July 2014 - Present
Myraqa, Inc. February 2014 - July 2014
FDA 1995 - 2013
Food Safety and Inspection Service, USDA 1992 - 1995
National Institute of Environmental Health Sciences (NIEHS) 1990 - 1992
Skills
Clinical Study Design, LaTeX, Data Mining, SAS, Stata, Epidemiology, Time Series Analysis, Statistics, Statistical Modeling, R, Clinical Trials, Biostatistics, Data Analysis, FDA, SAS programming
Education
North Carolina State University 1984 — 1990
PhD, Statistics
Millersville University of Pennsylvania 1980 — 1984
BA, Mathematics
Illumina July 2014 - Present
Myraqa, Inc. February 2014 - July 2014
FDA 1995 - 2013
Food Safety and Inspection Service, USDA 1992 - 1995
National Institute of Environmental Health Sciences (NIEHS) 1990 - 1992
Skills
Clinical Study Design, LaTeX, Data Mining, SAS, Stata, Epidemiology, Time Series Analysis, Statistics, Statistical Modeling, R, Clinical Trials, Biostatistics, Data Analysis, FDA, SAS programming
Education
North Carolina State University 1984 — 1990
PhD, Statistics
Millersville University of Pennsylvania 1980 — 1984
BA, Mathematics
Amberly Plummer, MPA's FDA Experience March 2015 - Present
Job Budget Analyst at FDA
Industry Government Administration
Experience
FDA March 2015 - Present
US Department of Health and Human Services October 2013 - Present
Department of Health and Human Services November 2009 - October 2013
State of North Carolina March 2006 - November 2009
North Carolina General Assembly 2005 - 2006
ZC Sterling February 2005 - September 2005
Skills
Budgets, Outlook, Spreadsheets, Account Reconciliation, Policy, Policy Analysis, Customer Service, Managerial Finance, PowerPoint, Training, Accounting, Analysis, Public Administration, Finance, Research, MS Project, Microsoft Word, Legal Research, Management, Employee Relations, Program Management, Public Speaking, Strategic Planning, Public Policy, Time Management, Government, Microsoft Excel, SPSS, Community Outreach
Education
North Carolina Central University 2004 — 2008
Master of Public Administration (MPA), Public Administration
North Carolina Central University 1999 — 2003
Bachelor of Arts (B.A.), Sociology
FDA March 2015 - Present
US Department of Health and Human Services October 2013 - Present
Department of Health and Human Services November 2009 - October 2013
State of North Carolina March 2006 - November 2009
North Carolina General Assembly 2005 - 2006
ZC Sterling February 2005 - September 2005
Skills
Budgets, Outlook, Spreadsheets, Account Reconciliation, Policy, Policy Analysis, Customer Service, Managerial Finance, PowerPoint, Training, Accounting, Analysis, Public Administration, Finance, Research, MS Project, Microsoft Word, Legal Research, Management, Employee Relations, Program Management, Public Speaking, Strategic Planning, Public Policy, Time Management, Government, Microsoft Excel, SPSS, Community Outreach
Education
North Carolina Central University 2004 — 2008
Master of Public Administration (MPA), Public Administration
North Carolina Central University 1999 — 2003
Bachelor of Arts (B.A.), Sociology
Peng Zou's FDA Experience July 2013 - Present
Job Chemistry reviewer at FDA
Industry Pharmaceuticals
Experience
FDA July 2013 - Present
SAIC-Frederick September 2011 - December 2012
Genentech Inc. DMPK department June 2010 - August 2010
College of Pharmacy January 2007 - June 2008
Health Sciences Authority of Singapore October 2006 - December 2006
National University of Singapore August 2003 - February 2006
Beijing Institute of Pharmacology and Toxicology August 2002 - June 2003
Beitaiping Road Hospital August 2000 - July 2002
Skills
Pharmacokinetics, Drug Delivery, Drug Metabolism, Bioanalysis, Nanoparticles, Pharmaceutics, Characterization, Laboratory, Nanotechnology, HPLC, LC-MS, Pharmacology, In Vitro, Drug Discovery, Mass Spectrometry
Education
University of Michigan 2006 — 2011
Ph.D, Pharmaceutics
The Ohio State University 2006 — 2008
Ph.D, Pharmaceutics
National University of Singapore 2003 — 2006
Master, Pharmacy
The Second Military Medical University 1996 — 2000
B.Sc., Pharmacy
FDA July 2013 - Present
SAIC-Frederick September 2011 - December 2012
Genentech Inc. DMPK department June 2010 - August 2010
College of Pharmacy January 2007 - June 2008
Health Sciences Authority of Singapore October 2006 - December 2006
National University of Singapore August 2003 - February 2006
Beijing Institute of Pharmacology and Toxicology August 2002 - June 2003
Beitaiping Road Hospital August 2000 - July 2002
Skills
Pharmacokinetics, Drug Delivery, Drug Metabolism, Bioanalysis, Nanoparticles, Pharmaceutics, Characterization, Laboratory, Nanotechnology, HPLC, LC-MS, Pharmacology, In Vitro, Drug Discovery, Mass Spectrometry
Education
University of Michigan 2006 — 2011
Ph.D, Pharmaceutics
The Ohio State University 2006 — 2008
Ph.D, Pharmaceutics
National University of Singapore 2003 — 2006
Master, Pharmacy
The Second Military Medical University 1996 — 2000
B.Sc., Pharmacy
Sanket Sunny Patel's FDA Experience January 2010 - August 2012
Job Audit Manager, Supply Chain (Corporate) at GlaxoSmithKline
Industry Pharmaceuticals
Experience
GlaxoSmithKline August 2012 - Present
FDA January 2010 - August 2012
Cook Medical Incorporated January 2007 - July 2007
Rice University May 2006 - August 2006
AVOS Life Sciences (now INC Research) September 2005 - December 2005
Pittsburgh Tissue Engineering Initiative May 2005 - August 2005
Skills
Biomedical Engineering, Biotechnology, FDA, Lifesciences, cGMP manufacturing, Risk Management, Biopharmaceuticals, Regulatory Affairs, V&V, Pharmaceutical Industry, Technology Transfer, Validation, Regulatory Submissions, ISO 13485, CAPA, Regulatory Requirements, Six Sigma, Medical Devices, GMP, Clinical Trials, Global R&D, Quality System, 21 CFR Part 11
Education
University of Pittsburgh 2007 — 2009
Master of Science (M.S.), Bioengineering
North Carolina State University 2003 — 2006
Bachelor of Science (B.S.), Biomedical Engineering
GlaxoSmithKline August 2012 - Present
FDA January 2010 - August 2012
Cook Medical Incorporated January 2007 - July 2007
Rice University May 2006 - August 2006
AVOS Life Sciences (now INC Research) September 2005 - December 2005
Pittsburgh Tissue Engineering Initiative May 2005 - August 2005
Skills
Biomedical Engineering, Biotechnology, FDA, Lifesciences, cGMP manufacturing, Risk Management, Biopharmaceuticals, Regulatory Affairs, V&V, Pharmaceutical Industry, Technology Transfer, Validation, Regulatory Submissions, ISO 13485, CAPA, Regulatory Requirements, Six Sigma, Medical Devices, GMP, Clinical Trials, Global R&D, Quality System, 21 CFR Part 11
Education
University of Pittsburgh 2007 — 2009
Master of Science (M.S.), Bioengineering
North Carolina State University 2003 — 2006
Bachelor of Science (B.S.), Biomedical Engineering
Tianrong Cheng's FDA Experience December 2012 - Present
Job Regulatory Review Chemist at FDA
Industry Government Administration
Experience
FDA December 2012 - Present
Huabao International Holdings Ltd. June 2010 - November 2012
Lancaster Laboratories December 2009 - June 2010
Liggett Vector Brands February 2001 - May 2009
Skills
Analytical Chemistry, LC-MS, GLP, Chemistry, R&D, Chromatography, Gas Chromatography, Mass Spectrometry, Spectroscopy, Validation, Organic Synthesis, Laboratory, GMP, HPLC, UV/Vis, Data Analysis, Purification, Lifesciences, NMR, ELISA, Characterization, FTIR, Technology Transfer, Reviews, Life Sciences
Education
North Carolina State University 1998 — 2001
Postdoctoral Training
Peking University 1994 — 1997
Doctoral
University of Kansas 1990 — 1991
Peking University
Bachelor of Science (B.S.)
FDA December 2012 - Present
Huabao International Holdings Ltd. June 2010 - November 2012
Lancaster Laboratories December 2009 - June 2010
Liggett Vector Brands February 2001 - May 2009
Skills
Analytical Chemistry, LC-MS, GLP, Chemistry, R&D, Chromatography, Gas Chromatography, Mass Spectrometry, Spectroscopy, Validation, Organic Synthesis, Laboratory, GMP, HPLC, UV/Vis, Data Analysis, Purification, Lifesciences, NMR, ELISA, Characterization, FTIR, Technology Transfer, Reviews, Life Sciences
Education
North Carolina State University 1998 — 2001
Postdoctoral Training
Peking University 1994 — 1997
Doctoral
University of Kansas 1990 — 1991
Peking University
Bachelor of Science (B.S.)
Derek Ireland's FDA Experience November 2014 - Present
Job Research Scientist
Industry Research
Experience
FDA November 2014 - Present
FDA October 2011 - November 2014
Cleveland Clinic June 2004 - February 2009
Skills
Animal Models, FACS, Flow Cytometry, Fluorescence, Immunology, Laboratory, Mammalian Cell Culture, Neuroscience, real-time PCR, Western Blotting, Autoimmunity, Inflammation, Molecular Biology, Life Sciences, Biotechnology, Cell Biology, Cell Culture, qPCR
Education
New York University 1999 — 2004
PhD, neuroimmunology (Dept of Biology)
FDA November 2014 - Present
FDA October 2011 - November 2014
Cleveland Clinic June 2004 - February 2009
Skills
Animal Models, FACS, Flow Cytometry, Fluorescence, Immunology, Laboratory, Mammalian Cell Culture, Neuroscience, real-time PCR, Western Blotting, Autoimmunity, Inflammation, Molecular Biology, Life Sciences, Biotechnology, Cell Biology, Cell Culture, qPCR
Education
New York University 1999 — 2004
PhD, neuroimmunology (Dept of Biology)
Sheila Weiss's FDA Experience July 1994 - April 1997
Job Research Professor Clinical Innovations and Analytics
Industry Pharmaceuticals
Experience
University of Maryland Baltimore County June 2015 - Present
DrugLogic August 2013 - Present
OptumInsight April 2013 - August 2013
University of Maryland, Baltimore April 1997 - April 2013
Center for Drug Safety January 2009 - June 2011
NIH August 2008 - July 2009
FDA July 1994 - April 1997
Skills
Epidemiology, Pharmacoepidemiology, Pharmacovigilance, Regulatory science, Data mining, Big Data, Oncology, Vaccines, Data Mining, Clinical Trials, Medical Devices, Regulatory Science, Drug Safety, Cancer, Healthcare, Public Health, Biostatistics, Outcomes Research
Education
The Johns Hopkins University 1990 — 1996
PhD, Epidemiology
Northeastern University 1983 — 1986
M.S., Exercise Sciences
University of Maine Orono
BS, Biology
University of Maryland Baltimore County June 2015 - Present
DrugLogic August 2013 - Present
OptumInsight April 2013 - August 2013
University of Maryland, Baltimore April 1997 - April 2013
Center for Drug Safety January 2009 - June 2011
NIH August 2008 - July 2009
FDA July 1994 - April 1997
Skills
Epidemiology, Pharmacoepidemiology, Pharmacovigilance, Regulatory science, Data mining, Big Data, Oncology, Vaccines, Data Mining, Clinical Trials, Medical Devices, Regulatory Science, Drug Safety, Cancer, Healthcare, Public Health, Biostatistics, Outcomes Research
Education
The Johns Hopkins University 1990 — 1996
PhD, Epidemiology
Northeastern University 1983 — 1986
M.S., Exercise Sciences
University of Maine Orono
BS, Biology
Chinedu Ezebuiroh's FDA Experience June 2011 - September 2011
Job
Industry Management Consulting
Experience
FDA June 2011 - September 2011
Stanford University, Biodesign Group March 2011 - June 2011
NJIT, Dept. of Biomedical Engineering September 2009 - May 2010
NJIT: Center for Academic and Personal Enrichment January 2008 - May 2010
UC Irvine: Dept. of Chemical Engineering and Materials Science June 2009 - August 2009
NJIT - Dr. Treena L. Arinzeh’s Biomaterials Lab. October 2008 - May 2009
NJIT September 2008 - December 2008
NJIT - Dr. Bryan J. Pfister's Neural Tissue Engineering Lab. June 2008 - August 2008
Marshalls/Homegoods January 2007 - November 2007
U.S. PIRG July 2005 - August 2005
Education
Stanford University 2010 — 2012
M.S., Mechanical Engineering
New Jersey Institute of Technology 2007 — 2010
B.S., Biomedical Engineering
FDA June 2011 - September 2011
Stanford University, Biodesign Group March 2011 - June 2011
NJIT, Dept. of Biomedical Engineering September 2009 - May 2010
NJIT: Center for Academic and Personal Enrichment January 2008 - May 2010
UC Irvine: Dept. of Chemical Engineering and Materials Science June 2009 - August 2009
NJIT - Dr. Treena L. Arinzeh’s Biomaterials Lab. October 2008 - May 2009
NJIT September 2008 - December 2008
NJIT - Dr. Bryan J. Pfister's Neural Tissue Engineering Lab. June 2008 - August 2008
Marshalls/Homegoods January 2007 - November 2007
U.S. PIRG July 2005 - August 2005
Education
Stanford University 2010 — 2012
M.S., Mechanical Engineering
New Jersey Institute of Technology 2007 — 2010
B.S., Biomedical Engineering
Stephen Friedman EI, Six Sigma Green Belt's FDA Experience July 2010 - January 2011
Job Incident Manager at Cognizant Technology Solutions
Industry Mechanical or Industrial Engineering
Experience
Cognizant Technology Solutions June 2013 - Present
Free Lance Contractor March 2011 - June 2013
NCSU - Furniture Manufacturing and Management Center June 2012 - August 2012
Indian Health Service June 2011 - August 2011
FDA July 2010 - January 2011
National Institutes of Health March 2004 - May 2007
Skills
Visual Basic, Solidworks, Microsoft Excel, Arena Simulation..., AutoCAD, Pro Engineer, Technical Writing, VBA, Matlab, MS Project, Project Management, Pro-Engineer, Microsoft Word, JMP, SQL, Microsoft Office, Microsoft Office 2007, Federal Government, Vlookup, MS Excel Pivot Tables, Furniture Manufacturing, G-Code, CNC manufacturing, CNC Machine, Microsoft Office 2010, Pivot Tables, Machining, Visio, Data Analysis, Statistics, Analysis, Project Planning, Six Sigma, Management, CAD, Access, Engineering, Microsoft Project, SolidWorks
Education
North Carolina State University 2007 — 2013
Bachelor of Science (BS), Industrial Engineering, Furniture Manufacturing
Walter Johnson High School 2003 — 2007
Cognizant Technology Solutions June 2013 - Present
Free Lance Contractor March 2011 - June 2013
NCSU - Furniture Manufacturing and Management Center June 2012 - August 2012
Indian Health Service June 2011 - August 2011
FDA July 2010 - January 2011
National Institutes of Health March 2004 - May 2007
Skills
Visual Basic, Solidworks, Microsoft Excel, Arena Simulation..., AutoCAD, Pro Engineer, Technical Writing, VBA, Matlab, MS Project, Project Management, Pro-Engineer, Microsoft Word, JMP, SQL, Microsoft Office, Microsoft Office 2007, Federal Government, Vlookup, MS Excel Pivot Tables, Furniture Manufacturing, G-Code, CNC manufacturing, CNC Machine, Microsoft Office 2010, Pivot Tables, Machining, Visio, Data Analysis, Statistics, Analysis, Project Planning, Six Sigma, Management, CAD, Access, Engineering, Microsoft Project, SolidWorks
Education
North Carolina State University 2007 — 2013
Bachelor of Science (BS), Industrial Engineering, Furniture Manufacturing
Walter Johnson High School 2003 — 2007
ira krefting's FDA Experience July 2006 - Present
Job Medical Officer at FDA
Industry Government Relations
Experience
FDA July 2006 - Present
Skills
Public Health, Clinical Trials, Healthcare, Drug Development, Clinical Development, Clinical Research, Medicine, Internal Medicine, Medical Education, Medical Writing, Regulatory Affairs, Epidemiology
Education
New York University
Bachelor of Arts (B.A.), Chemistry
Opalenik Course
State University of New York Downstate Medical Center College of Medicine
State University of New York Downstate Medical Center College of Medicine
Doctor of Medicine (MD)
FDA July 2006 - Present
Skills
Public Health, Clinical Trials, Healthcare, Drug Development, Clinical Development, Clinical Research, Medicine, Internal Medicine, Medical Education, Medical Writing, Regulatory Affairs, Epidemiology
Education
New York University
Bachelor of Arts (B.A.), Chemistry
Opalenik Course
State University of New York Downstate Medical Center College of Medicine
State University of New York Downstate Medical Center College of Medicine
Doctor of Medicine (MD)
Marilyn Khanna's FDA Experience October 2008 - Present
Job Microbiologist at FDA
Industry Government Administration
Experience
FDA October 2008 - Present
Department of Health and Human Services September 2006 - Present
Cornell University 1995 - 1997
Education
New York University 1987 — 1993
Doctor of Philosophy (Ph.D.), Microbial and Eukaryotic Genetics
FDA October 2008 - Present
Department of Health and Human Services September 2006 - Present
Cornell University 1995 - 1997
Education
New York University 1987 — 1993
Doctor of Philosophy (Ph.D.), Microbial and Eukaryotic Genetics
Byron Henry's FDA Experience February 2002 - Present
Job Chief Logistics Officer Rapid Deployment Force at United States Public Health Service
Industry Government Administration
Experience
Commissioned Corps of the U.S. Public Health Service 2007 - Present
Mercer University 2004 - Present
FDA February 2002 - Present
Skills
Video Editing, Research, Public Speaking, Social Media, Teaching, Event Planning, Fundraising, Management, Leadership Development, Coaching, Social Networking, Nonprofits, Time Management, Leadership, Training, Editing, Team Building, Community Outreach, Analysis, Science, Higher Education, Grant Writing, Facebook, Microsoft Office, PowerPoint
Education
North Carolina Agricultural and Technical State University 1995 — 1997
Master's, Chemistry
North Carolina Agricultural and Technical State University 1991 — 1995
Bachelor's, Chemistry
Commissioned Corps of the U.S. Public Health Service 2007 - Present
Mercer University 2004 - Present
FDA February 2002 - Present
Skills
Video Editing, Research, Public Speaking, Social Media, Teaching, Event Planning, Fundraising, Management, Leadership Development, Coaching, Social Networking, Nonprofits, Time Management, Leadership, Training, Editing, Team Building, Community Outreach, Analysis, Science, Higher Education, Grant Writing, Facebook, Microsoft Office, PowerPoint
Education
North Carolina Agricultural and Technical State University 1995 — 1997
Master's, Chemistry
North Carolina Agricultural and Technical State University 1991 — 1995
Bachelor's, Chemistry
Andrea Krause's FDA Experience September 2014 - Present
Job Food Technologist at FDA
Industry Food & Beverages
Experience
FDA September 2014 - Present
FDA October 2011 - September 2014
FDA September 2010 - October 2011
University of Minnesota 2007 - July 2010
Land O Lakes January 2007 - May 2007
Kraft Foods 2004 - 2004
Skills
Protein Chemistry, Food Science, Food Safety, GC-MS, Gas Chromatography, Dairy, Food Chemistry, Food
Education
University of Minnesota-Twin Cities 2007 — 2010
PhD., Food Science
North Carolina State University 2004 — 2006
M.S., Food Science
University of Wisconsin-Madison 2000 — 2004
B.S., Food Science
FDA September 2014 - Present
FDA October 2011 - September 2014
FDA September 2010 - October 2011
University of Minnesota 2007 - July 2010
Land O Lakes January 2007 - May 2007
Kraft Foods 2004 - 2004
Skills
Protein Chemistry, Food Science, Food Safety, GC-MS, Gas Chromatography, Dairy, Food Chemistry, Food
Education
University of Minnesota-Twin Cities 2007 — 2010
PhD., Food Science
North Carolina State University 2004 — 2006
M.S., Food Science
University of Wisconsin-Madison 2000 — 2004
B.S., Food Science
Ronda Balham's FDA Experience 1992 - 2005
Job Senior Partner, Medical Device Practice at Kinexum
Industry Medical Devices
Experience
Kinexum August 2011 - January 2015
Regulatory Harmonization Institute 2011 - 2011
Marwood Group 2008 - 2011
Becker & Associates Consulting, Inc. 2007 - 2008
FDA 1992 - 2005
US Navy 1982 - 1989
Skills
FDA, Medical Devices, Regulatory Affairs, Pharmaceutical Industry, Biotechnology, Lifesciences, Regulatory Submissions, ISO 13485, Drug Development, Cross-functional Team..., CAPA, GCP
Education
New England College of Optometry
Norwich University
B.S., Biology
Kinexum August 2011 - January 2015
Regulatory Harmonization Institute 2011 - 2011
Marwood Group 2008 - 2011
Becker & Associates Consulting, Inc. 2007 - 2008
FDA 1992 - 2005
US Navy 1982 - 1989
Skills
FDA, Medical Devices, Regulatory Affairs, Pharmaceutical Industry, Biotechnology, Lifesciences, Regulatory Submissions, ISO 13485, Drug Development, Cross-functional Team..., CAPA, GCP
Education
New England College of Optometry
Norwich University
B.S., Biology
Danielle Lindquist's FDA Experience May 2009 - August 2009
Job Research Assistant at Food Animal Residue Avoidance Databank
Industry Veterinary
Experience
Food Animal Residue Avoidance Databank January 2011 - Present
NC State Veterinary Health Complex at the College of Veterinary Medicine January 2014 - Present
The Institute of Computational Comparative Medicine July 2015 - July 2015
Legion Road Animal Clinic June 2006 - May 2014
FDA May 2009 - August 2009
Skills
Infectious Diseases, Microsoft Office, Pharmacology, Research, Animal Work, Animal Husbandry, Veterinary Medicine, Veterinary, Parasitology, Animal Models, Healthcare, Microsoft Word
Education
NC State College of Veterinary Medicine 2012 — 2019
Doctor of Veterinary Medicine, Food Animal Medicine
NC State College of Veterinary Medicine 2014 — 2017
Doctor of Philosophy (Ph.D.), Comparative Biomedical Sciences - Pharmacology
North Carolina State University 2010 — 2012
Bachelor of Science (BS), Zoology
Food Animal Residue Avoidance Databank January 2011 - Present
NC State Veterinary Health Complex at the College of Veterinary Medicine January 2014 - Present
The Institute of Computational Comparative Medicine July 2015 - July 2015
Legion Road Animal Clinic June 2006 - May 2014
FDA May 2009 - August 2009
Skills
Infectious Diseases, Microsoft Office, Pharmacology, Research, Animal Work, Animal Husbandry, Veterinary Medicine, Veterinary, Parasitology, Animal Models, Healthcare, Microsoft Word
Education
NC State College of Veterinary Medicine 2012 — 2019
Doctor of Veterinary Medicine, Food Animal Medicine
NC State College of Veterinary Medicine 2014 — 2017
Doctor of Philosophy (Ph.D.), Comparative Biomedical Sciences - Pharmacology
North Carolina State University 2010 — 2012
Bachelor of Science (BS), Zoology
Willie Wilson III, Ph.D.'s FDA Experience December 2014 - Present
Job Chemist/ Product Quality Reviewer at FDA
Industry Research
Experience
FDA December 2014 - Present
FDA September 2013 - December 2014
National Institutes of Health November 2012 - September 2013
National Institutes of Health August 2012 - September 2013
National Institutes of Health May 2009 - August 2012
University of North Carolina at Chapel Hill August 2003 - May 2009
North Carolina Central University August 2001 - August 2003
Duke University Medical Center 1999 - 2001
Skills
Molecular Biology, Cancer, Signal Transduction, Immunohistochemistry, Immunoassays, Immunology, Flow Cytometry, Cell Invasion/..., Genetics, In Vitro, In Vivo, Cell Culture
Education
University of North Carolina at Chapel Hill 2003 — 2009
PhD, Genetics
North Carolina Central University 2001 — 2003
MS, Biology
North Carolina State University 1995 — 1999
BS, Zoology
FDA December 2014 - Present
FDA September 2013 - December 2014
National Institutes of Health November 2012 - September 2013
National Institutes of Health August 2012 - September 2013
National Institutes of Health May 2009 - August 2012
University of North Carolina at Chapel Hill August 2003 - May 2009
North Carolina Central University August 2001 - August 2003
Duke University Medical Center 1999 - 2001
Skills
Molecular Biology, Cancer, Signal Transduction, Immunohistochemistry, Immunoassays, Immunology, Flow Cytometry, Cell Invasion/..., Genetics, In Vitro, In Vivo, Cell Culture
Education
University of North Carolina at Chapel Hill 2003 — 2009
PhD, Genetics
North Carolina Central University 2001 — 2003
MS, Biology
North Carolina State University 1995 — 1999
BS, Zoology
Tressa Lewis, MPH, REHS's FDA Experience May 2015 - Present
Job Investigator at U.S. Food & Drug Administration (FDA)
Industry Government Administration
Experience
FDA May 2015 - Present
FDA October 2008 - Present
FDA January 2014 - April 2015
Bloomfield Health Department August 2006 - October 2008
National Everclean Services June 2007 - July 2008
Princeton Radiology January 2001 - January 2003
National Institutes of Health June 2002 - August 2002
University of Toronto May 2001 - August 2001
Temple University Health System June 2000 - August 2000
Skills
Customer Relations, Research, Microsoft Office, Writing, Word, FDA GMP, Public Health, Qualitative Research, Public Speaking, Statistics, Data Analysis, Outlook, Report Writing, Clinical Research, Government, Program Evaluation, Quality Assurance, Quantitative Research, Social Services, Regulations, Interpersonal..., Process Improvement, Code of Federal..., Private Investigations, Regulatory Affairs, Customer Service, Microsoft Word, Fundraising, Health Law, FDA, Community Outreach, Public Policy, Program Development, Policy Analysis, Epidemiology, Policy, Microsoft Excel, PowerPoint, Program Management
Education
New York University 2005 — 2007
MPH, Public Health
Rutgers University-New Brunswick 1999 — 2003
BA, Sociology
University of KwaZulu-Natal / University of Natal 2001 — 2001
Semester Abroad, Sociology
FDA May 2015 - Present
FDA October 2008 - Present
FDA January 2014 - April 2015
Bloomfield Health Department August 2006 - October 2008
National Everclean Services June 2007 - July 2008
Princeton Radiology January 2001 - January 2003
National Institutes of Health June 2002 - August 2002
University of Toronto May 2001 - August 2001
Temple University Health System June 2000 - August 2000
Skills
Customer Relations, Research, Microsoft Office, Writing, Word, FDA GMP, Public Health, Qualitative Research, Public Speaking, Statistics, Data Analysis, Outlook, Report Writing, Clinical Research, Government, Program Evaluation, Quality Assurance, Quantitative Research, Social Services, Regulations, Interpersonal..., Process Improvement, Code of Federal..., Private Investigations, Regulatory Affairs, Customer Service, Microsoft Word, Fundraising, Health Law, FDA, Community Outreach, Public Policy, Program Development, Policy Analysis, Epidemiology, Policy, Microsoft Excel, PowerPoint, Program Management
Education
New York University 2005 — 2007
MPH, Public Health
Rutgers University-New Brunswick 1999 — 2003
BA, Sociology
University of KwaZulu-Natal / University of Natal 2001 — 2001
Semester Abroad, Sociology
James Liubicich's FDA Experience
Job Investigator at FDA
Industry Government Administration
Experience
FDA
Skills
Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, FDA, Clinical Trials, Regulations, Drug Development, Biopharmaceuticals, CAPA, Clinical Development, GLP, IND, Pharmacokinetics, Pharmacovigilance, Team Building, Toxicology, Validation, Research
Education
New York University 1973 — 1977
Bachelor of Arts (B.A.), Biology, General, Post Graduate in 1978
FDA
Skills
Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, FDA, Clinical Trials, Regulations, Drug Development, Biopharmaceuticals, CAPA, Clinical Development, GLP, IND, Pharmacokinetics, Pharmacovigilance, Team Building, Toxicology, Validation, Research
Education
New York University 1973 — 1977
Bachelor of Arts (B.A.), Biology, General, Post Graduate in 1978
Sandra N. Becker's FDA Experience June 2002 - May 2003
Job Botanical artist at SNB Botanicals
Industry Arts and Crafts
Experience
SNB Botanicals former co-coordinator, spring benefitBenedictine Foundation, Ridgely, MD2010 - 2011
FDA June 2002 - May 2003
Fed Energy Regulatory Comm. 1988 - 1992
Skills
Legal Writing, Litigation, Mediation, Corporate Law, Intellectual Property, Legal Research, Licensing, Commercial Litigation, Nonprofits, Health Law
Education
New York University 1978 — 1979
LL.M, Trade regulation
U of San Diego 1975 — 1978
JD, Law
SNB Botanicals former co-coordinator, spring benefitBenedictine Foundation, Ridgely, MD2010 - 2011
FDA June 2002 - May 2003
Fed Energy Regulatory Comm. 1988 - 1992
Skills
Legal Writing, Litigation, Mediation, Corporate Law, Intellectual Property, Legal Research, Licensing, Commercial Litigation, Nonprofits, Health Law
Education
New York University 1978 — 1979
LL.M, Trade regulation
U of San Diego 1975 — 1978
JD, Law
Tzu-Yun McDowell's FDA Experience October 2010 - November 2011
Job Clinical Reviewer/Senior Clinical Analyst at FDA
Industry Government Administration
Experience
FDA/CDER/Office of New Drug/Division of Cardiovascular and Renal Products September 2013 - Present
FDA/CDER/Office of Surveillance and Epidemiology/Division of Epidemiology February 2012 - September 2013
FDA/CDER/Office of Translational Sciences/Office of Clinical Pharmacology November 2011 - February 2012
FDA October 2010 - November 2011
University of Maryland School of Medicine September 2007 - September 2010
University of Maryland School of Medicine September 2003 - August 2007
Skills
Biostatistics, Public Health, Epidemiology, Clinical Research, Clinical Trials, Outcomes Research, Clinical Study Design, Data Analysis, Molecular Biology, Clinical Development, Program Evaluation, SAS, Statistics, Infectious Diseases
Education
University of Maryland Baltimore 2005 — 2010
PhD, Department of Epidemiology and Public Health
University of Maryland College Park 2001 — 2003
MA, Department of Kinesiology
National Taiwan University 1996 — 2000
BS, Department of Physical Therapy
FDA/CDER/Office of New Drug/Division of Cardiovascular and Renal Products September 2013 - Present
FDA/CDER/Office of Surveillance and Epidemiology/Division of Epidemiology February 2012 - September 2013
FDA/CDER/Office of Translational Sciences/Office of Clinical Pharmacology November 2011 - February 2012
FDA October 2010 - November 2011
University of Maryland School of Medicine September 2007 - September 2010
University of Maryland School of Medicine September 2003 - August 2007
Skills
Biostatistics, Public Health, Epidemiology, Clinical Research, Clinical Trials, Outcomes Research, Clinical Study Design, Data Analysis, Molecular Biology, Clinical Development, Program Evaluation, SAS, Statistics, Infectious Diseases
Education
University of Maryland Baltimore 2005 — 2010
PhD, Department of Epidemiology and Public Health
University of Maryland College Park 2001 — 2003
MA, Department of Kinesiology
National Taiwan University 1996 — 2000
BS, Department of Physical Therapy
Rebecca H. Johnson's FDA Experience May 1990 - September 1998
Job Health Science Administrator
Industry Research
Experience
NIGMS/NIH September 1998 - Present
FDA May 1990 - September 1998
Education
The University of Connecticut Health Center
PhD, Biochemistry/Molecular Biology
North Carolina State University
BS, zoology
NIGMS/NIH September 1998 - Present
FDA May 1990 - September 1998
Education
The University of Connecticut Health Center
PhD, Biochemistry/Molecular Biology
North Carolina State University
BS, zoology
Aijin Shen's FDA Experience June 2006 - Present
Job Senior Review Chemist at FDA
Industry Government Administration
Experience
FDA June 2006 - Present
Skills
Analytical Chemistry, HPLC, Chemometrics, Wet Chemistry, LC-MS, UV-Vis, Chromatography, Regulatory Affairs, TLC, FDA, Chemistry, UV, Fluorescence, GMP, Validation, Regulatory Submissions, IR, UV/Vis, Formulation
Education
University of Arizona 1991 — 1996
PhD, Chemistry
NJIT 1987 — 1989
Applied Chemistry
FDA June 2006 - Present
Skills
Analytical Chemistry, HPLC, Chemometrics, Wet Chemistry, LC-MS, UV-Vis, Chromatography, Regulatory Affairs, TLC, FDA, Chemistry, UV, Fluorescence, GMP, Validation, Regulatory Submissions, IR, UV/Vis, Formulation
Education
University of Arizona 1991 — 1996
PhD, Chemistry
NJIT 1987 — 1989
Applied Chemistry
Pau Lian's FDA Experience October 2007 - Present
Job Executive Committee Member at United Zo Organization Inc
Industry Real Estate
Experience
Exit Right Realty June 2011 - Present
United Zo Organization Inc May 2011 - Present
Burmese Community Church December 2010 - Present
FDA October 2007 - Present
Gospel Baptist Church April 2001 - January 2005
Church Of Singapore(Myanmar Service) June 1997 - April 2000
Singapore Piling & Civil Engineering Pvt Ltd August 1994 - April 2000
Education
National University of Singapore 1995 — 2005
Certificate, Supervisory and Adminstrative Management
University of Distance Education, Myanmar 1986 — 1997
Bachelor of Arts, History
Government Technical Institute Insein, Myanmar 1986 — 1992
AGTI, Civil Engineering
Exit Right Realty June 2011 - Present
United Zo Organization Inc May 2011 - Present
Burmese Community Church December 2010 - Present
FDA October 2007 - Present
Gospel Baptist Church April 2001 - January 2005
Church Of Singapore(Myanmar Service) June 1997 - April 2000
Singapore Piling & Civil Engineering Pvt Ltd August 1994 - April 2000
Education
National University of Singapore 1995 — 2005
Certificate, Supervisory and Adminstrative Management
University of Distance Education, Myanmar 1986 — 1997
Bachelor of Arts, History
Government Technical Institute Insein, Myanmar 1986 — 1992
AGTI, Civil Engineering
Edmond Baratta's FDA Experience January 2011 - Present
Job Science Advisor at FDA
Industry Government Administration
Experience
FDA January 2011 - Present
Education
Northeastern University
Bachelor's degree, Analytical Chemistry
FDA January 2011 - Present
Education
Northeastern University
Bachelor's degree, Analytical Chemistry
Dorcas Petite's FDA Experience March 1992 - May 1998
Job Detail Oriented
Industry Retail
Experience
Macy's October 2011 - December 2011
Princess Travel April 2008 - July 2009
OneStop Shopping January 2003 - June 2005
FDA March 1992 - May 1998
Education
Gemological Institute of America (GIA)
New York University
M.A, Media Ecology
University of Maryland University College, College
B.S, Communications
Macy's October 2011 - December 2011
Princess Travel April 2008 - July 2009
OneStop Shopping January 2003 - June 2005
FDA March 1992 - May 1998
Education
Gemological Institute of America (GIA)
New York University
M.A, Media Ecology
University of Maryland University College, College
B.S, Communications
xiaoxia yang's FDA Experience November 2013 - Present
Job FDA Commissioner's Fellow at FDA
Industry Government Administration
Experience
FDA November 2013 - Present
FDA November 2011 - November 2013
The Ohio State University July 2009 - October 2011
University of Kansas Medical Center October 2006 - June 2009
Skills
HPLC, In Vitro, In Vivo, LC-MS, Mass Spectrometry, Life Sciences, Pharmacokinetics, Pharmacology, Cell Culture, Drug Discovery
Education
National University of Singapore / NUS 2003 — 2006
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Sichuan University
Sichuan University
FDA November 2013 - Present
FDA November 2011 - November 2013
The Ohio State University July 2009 - October 2011
University of Kansas Medical Center October 2006 - June 2009
Skills
HPLC, In Vitro, In Vivo, LC-MS, Mass Spectrometry, Life Sciences, Pharmacokinetics, Pharmacology, Cell Culture, Drug Discovery
Education
National University of Singapore / NUS 2003 — 2006
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Sichuan University
Sichuan University
Gabrielle Bravoco's FDA Experience June 2014 - Present
Job Intern at FDA
Industry
Experience
FDA June 2014 - Present
Education
New Jersey Institute of Technology 2013 — 2015
Master of Science (MS), Biomedical/Medical Engineering
The College of New Jersey 2009 — 2013
Bachelor of Science (BS), Biomedical/Medical Engineering
FDA June 2014 - Present
Education
New Jersey Institute of Technology 2013 — 2015
Master of Science (MS), Biomedical/Medical Engineering
The College of New Jersey 2009 — 2013
Bachelor of Science (BS), Biomedical/Medical Engineering
Arjang Talattof's FDA Experience July 2015 - Present
Job ORISE Fellow at FDA
Industry Pharmaceuticals
Experience
FDA July 2015 - Present
University of Michigan May 2015 - July 2015
University of Michigan September 2009 - May 2015
College of Pharmacy, University of Michigan September 2012 - April 2013
Department of Biology, New York University May 2008 - May 2009
Department of Lunar and Planetary Sciences, University of Arizona March 2006 - August 2007
Department of Molecular and Cellular Biology, University of Arizona January 2007 - June 2007
Skills
Research, Statistics, Python, Mathematica, Matlab, R, PK/PD, Data Analysis, LaTeX, Unix, Java, C++, C, qPCR, Public Speaking, Cell Culture, Laboratory, Teaching, Biology, HPLC, Molecular Biology, Confocal Microscopy, Fluorescence Microscopy, Microscopy, Molecular Cloning, UV/Vis, PCR, Flow Cytometry
Education
University of Michigan 2009 — 2015
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
University of Michigan 2009 — 2011
Master of Science (M.Sc.), Pharmaceutical Sciences
New York University 2007 — 2009
Master of Science (M.Sc.), Biology/Biological Sciences, General
University of Arizona 2002 — 2006
Bachelor of Science (B.Sc.), Mathematics
FDA July 2015 - Present
University of Michigan May 2015 - July 2015
University of Michigan September 2009 - May 2015
College of Pharmacy, University of Michigan September 2012 - April 2013
Department of Biology, New York University May 2008 - May 2009
Department of Lunar and Planetary Sciences, University of Arizona March 2006 - August 2007
Department of Molecular and Cellular Biology, University of Arizona January 2007 - June 2007
Skills
Research, Statistics, Python, Mathematica, Matlab, R, PK/PD, Data Analysis, LaTeX, Unix, Java, C++, C, qPCR, Public Speaking, Cell Culture, Laboratory, Teaching, Biology, HPLC, Molecular Biology, Confocal Microscopy, Fluorescence Microscopy, Microscopy, Molecular Cloning, UV/Vis, PCR, Flow Cytometry
Education
University of Michigan 2009 — 2015
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
University of Michigan 2009 — 2011
Master of Science (M.Sc.), Pharmaceutical Sciences
New York University 2007 — 2009
Master of Science (M.Sc.), Biology/Biological Sciences, General
University of Arizona 2002 — 2006
Bachelor of Science (B.Sc.), Mathematics
Brad Benasutti's FDA Experience December 2009 - Present
Job FDA Investigator
Industry Government Administration
Experience
FDA December 2009 - Present
Education
New York Medical College 2010 — 2013
Master of Public Health (MPH), Environmental Science
Penn State University 2002 — 2004
Master of Education (MEd), Public Health Education and Promotion
Slippery Rock University of Pennsylvania 1997 — 2001
Bachelor of Science (BS), Athletic Training/Trainer
FDA December 2009 - Present
Education
New York Medical College 2010 — 2013
Master of Public Health (MPH), Environmental Science
Penn State University 2002 — 2004
Master of Education (MEd), Public Health Education and Promotion
Slippery Rock University of Pennsylvania 1997 — 2001
Bachelor of Science (BS), Athletic Training/Trainer
Joy Intasamakul's FDA Experience December 2008 - Present
Job Consumer Safety Officer at Food & Drug Administration
Industry Government Administration
Experience
FDA December 2008 - Present
A-Sonic Logistics Corp August 2007 - May 2008
Skills
Government, Public Health, Quality Auditing, Import Logistics, Import/Export Operations, Healthcare, Regulatory Affairs, Medical Devices, FDA, Biomedical Engineering, Pharmaceutical Industry, Quality System, Policy, Regulations, 21 CFR Part 11
Education
New Jersey Institute of Technology 2001 — 2006
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
FDA December 2008 - Present
A-Sonic Logistics Corp August 2007 - May 2008
Skills
Government, Public Health, Quality Auditing, Import Logistics, Import/Export Operations, Healthcare, Regulatory Affairs, Medical Devices, FDA, Biomedical Engineering, Pharmaceutical Industry, Quality System, Policy, Regulations, 21 CFR Part 11
Education
New Jersey Institute of Technology 2001 — 2006
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Greg Ryberg's FDA Experience January 2009 - August 2012
Job Lease Operator at Petro Hunt
Industry Oil & Energy
Experience
Petro Hunt February 2015 - Present
Samson Resources May 2014 - February 2015
Samson Resources September 2012 - May 2014
FDA January 2009 - August 2012
US Customs and Border Protection December 2007 - January 2009
US CBP August 2004 - December 2007
US Customs August 2002 - August 2004
Skills
Petroleum, Natural Gas, Environmental Compliance, Energy Industry, Oil & Gas Industry, Drilling, Gas, Pipelines, Upstream, Onshore, Geology, Occupational Health, Oil & Gas, Risk Assessment, Inspection, EHS, Supervisory Skills, Oilfield, Energy, Industrial Safety
Education
North Dakota State University 1992 — 1994
Bachelor of Science (B.S.), Zoology
NDSU Bottineau 1990 — 1992
Associate of Arts and Sciences (AAS), Wildlife Management
Petro Hunt February 2015 - Present
Samson Resources May 2014 - February 2015
Samson Resources September 2012 - May 2014
FDA January 2009 - August 2012
US Customs and Border Protection December 2007 - January 2009
US CBP August 2004 - December 2007
US Customs August 2002 - August 2004
Skills
Petroleum, Natural Gas, Environmental Compliance, Energy Industry, Oil & Gas Industry, Drilling, Gas, Pipelines, Upstream, Onshore, Geology, Occupational Health, Oil & Gas, Risk Assessment, Inspection, EHS, Supervisory Skills, Oilfield, Energy, Industrial Safety
Education
North Dakota State University 1992 — 1994
Bachelor of Science (B.S.), Zoology
NDSU Bottineau 1990 — 1992
Associate of Arts and Sciences (AAS), Wildlife Management
Zhao Liqun's FDA Experience August 2014 - Present
Job ORISE fellow at FDA
Industry Biotechnology
Experience
FDA August 2014 - Present
Emory university July 2009 - June 2014
Skills
Molecular Biology, Cell Culture, Biochemistry, Cell Biology, Western Blotting, Life Sciences, HPLC, Drug Discovery, PCR, Cell, Molecular Cloning, Microinjection, In situ hybridization, Microscope Imaging
Education
National University of Singapore 2004 — 2009
Doctor of Philosophy (Ph.D.), Biological Sciences
Peking Union Medical College 2001 — 2004
Master's degree, Microbiology & Biochemical Pharmacology
Shandong University 1997 — 2001
Bachelor's degree, Pharmacy
FDA August 2014 - Present
Emory university July 2009 - June 2014
Skills
Molecular Biology, Cell Culture, Biochemistry, Cell Biology, Western Blotting, Life Sciences, HPLC, Drug Discovery, PCR, Cell, Molecular Cloning, Microinjection, In situ hybridization, Microscope Imaging
Education
National University of Singapore 2004 — 2009
Doctor of Philosophy (Ph.D.), Biological Sciences
Peking Union Medical College 2001 — 2004
Master's degree, Microbiology & Biochemical Pharmacology
Shandong University 1997 — 2001
Bachelor's degree, Pharmacy
Aziz Mamur's FDA Experience December 2014 - Present
Job Chemist at FDA
Industry Government Administration
Experience
FDA December 2014 - Present
University of Michigan - Professor Matthew Soellner's Lab June 2013 - August 2013
New Jersey City University - Department of Chemistry February 2012 - May 2013
Skills
Protein Chemistry, NMR, Organic Chemistry, UV/Vis, Mass Spectrometry, Organic Synthesis, NMR spectroscopy, GC-MS, LC-MS, HPLC, Flash Chromatography, IR spectroscopy, Drug Discovery, Research, Pymol, Protein Kinases, ChemDraw, SciFinder, Characterization, FTIR, Inorganic Chemistry, Spectroscopy, Science, Experimental Design, Organometallic Chemistry, Nanotechnology, Materials Chemistry, Polymer Chemistry, Atomic Force Microscopy..., Scanning Electron...
Education
New Jersey City University
Bachelor of Science (B.S.), Chemistry
Stevens Institute of Technology
Chemistry
FDA December 2014 - Present
University of Michigan - Professor Matthew Soellner's Lab June 2013 - August 2013
New Jersey City University - Department of Chemistry February 2012 - May 2013
Skills
Protein Chemistry, NMR, Organic Chemistry, UV/Vis, Mass Spectrometry, Organic Synthesis, NMR spectroscopy, GC-MS, LC-MS, HPLC, Flash Chromatography, IR spectroscopy, Drug Discovery, Research, Pymol, Protein Kinases, ChemDraw, SciFinder, Characterization, FTIR, Inorganic Chemistry, Spectroscopy, Science, Experimental Design, Organometallic Chemistry, Nanotechnology, Materials Chemistry, Polymer Chemistry, Atomic Force Microscopy..., Scanning Electron...
Education
New Jersey City University
Bachelor of Science (B.S.), Chemistry
Stevens Institute of Technology
Chemistry
Florine Purdie's FDA Experience 2013 - Present
Job Lead WriterEditor at FDA
Industry Government Administration
Experience
FDA 2013 - Present
FDA 2002 - 2012
Skills
Technical Editing, Technical Writing, Copy Editing, Proofreading
Education
North Carolina Central University 1971 — 1975
Bachelor of Science (B.S.), Business Teacher Education
FDA 2013 - Present
FDA 2002 - 2012
Skills
Technical Editing, Technical Writing, Copy Editing, Proofreading
Education
North Carolina Central University 1971 — 1975
Bachelor of Science (B.S.), Business Teacher Education
Diane Centeno-Deshields's FDA Experience October 1997 - Present
Job Project Officer/Progam Management Officer at FDA
Industry Government Administration
Experience
FDA October 1997 - Present
Skills
Spanish-speaking, Federal Grants..., Federal Government, College Teaching, Teaching, Scientific Writing, Scientific Analysis, Written & Oral..., Communication Skills, Mentoring, Professional Mentoring, Mentoring New Hires, Peer Mentoring, Youth Mentoring, Mentoring Of Staff, Proofreading, Summarizing Information, Summaries, Summary Reports, FDA, Rare Diseases, Orphan Drugs, Pharmacy, Pharmacists, Leadership, Educational Leadership, Team Leadership, Situational Leadership, Business Coaching, Hands-on Training, Employee Training, Program Management, Dependable Team Player, Team-oriented, Writing, Document Review, Reviews, Web Content, Web Content Management, Public Health, Project Coordination, Clinical Trials, Managing Database, Progress Monitoring, Regulatory Requirements, Regulations, Compliance
Education
Northeastern University 1978 — 1983
Bachelor of Science (B.S.), Pharmacy
FDA October 1997 - Present
Skills
Spanish-speaking, Federal Grants..., Federal Government, College Teaching, Teaching, Scientific Writing, Scientific Analysis, Written & Oral..., Communication Skills, Mentoring, Professional Mentoring, Mentoring New Hires, Peer Mentoring, Youth Mentoring, Mentoring Of Staff, Proofreading, Summarizing Information, Summaries, Summary Reports, FDA, Rare Diseases, Orphan Drugs, Pharmacy, Pharmacists, Leadership, Educational Leadership, Team Leadership, Situational Leadership, Business Coaching, Hands-on Training, Employee Training, Program Management, Dependable Team Player, Team-oriented, Writing, Document Review, Reviews, Web Content, Web Content Management, Public Health, Project Coordination, Clinical Trials, Managing Database, Progress Monitoring, Regulatory Requirements, Regulations, Compliance
Education
Northeastern University 1978 — 1983
Bachelor of Science (B.S.), Pharmacy
Ching-Wei Chang's FDA Experience October 2009 - Present
Job Mathematical Statistician at FDA
Industry Government Administration
Experience
FDA October 2009 - Present
National Centre for Toxicological Research, U.S. Food and Drug Administration 2009 - Present
Skills
Biostatistics, Bayesian statistics, Bioinformatics, Genetics, Statistics, Data Analysis, Epidemiology, R, SAS, Public Health, Research, Science, Statistical Modeling, Genomic Statistics
Education
National Taiwan University 1998 — 2002
Doctor of Philosophy (Ph.D.), Biostatistics
National Taiwan University 1996 — 1998
Master's degree, Biostatistics
FDA October 2009 - Present
National Centre for Toxicological Research, U.S. Food and Drug Administration 2009 - Present
Skills
Biostatistics, Bayesian statistics, Bioinformatics, Genetics, Statistics, Data Analysis, Epidemiology, R, SAS, Public Health, Research, Science, Statistical Modeling, Genomic Statistics
Education
National Taiwan University 1998 — 2002
Doctor of Philosophy (Ph.D.), Biostatistics
National Taiwan University 1996 — 1998
Master's degree, Biostatistics
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