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
Jay Arora Jay Arora's FDA Experience September 2014 - November 2014
Job Research Assistant at Health Canada
Industry Food & Beverages
Experience
FDA September 2014 - November 2014
Health Canada January 2014 - July 2014
McGill University 2012 - 2014
McGill University October 2013 - December 2013
American Eagle Outfitters June 2013 - September 2013
Health Canada May 2013 - August 2013
McGill Office for Students with Disabilities September 2012 - April 2013
Indian Institute of Science May 2011 - July 2012
Shreemaya Group June 2010 - May 2011
Ranbaxy June 2010 - June 2010
Skills
Quality Assurance, Quality Control, Molecular Biology, Microbiology, Food Science, Food Safety, Food Chemistry, Research, Biotechnology, Microsoft Office, PCR, Biochemistry, Public Speaking, Lifesciences, Food Microbiology, Gel Electrophoresis, DNA extraction, Science, Bioinformatics, English, Cell Culture, Genetics, Laboratory, Data Analysis, Life Sciences, Food Processing, Analytical Chemistry, Quantitative Research, Teaching, Computational Biology, ELISA, Western Blotting, food microbi, RT-PCR, Multiplex PCR, qRT-PCR, GMP
Education
McGill University 2012 — 2014
Master of Science (M.Sc.), Food Science
University of Saskatchewan 2014 — 2014
Post Graduate Exchange Student, Infectious Diseases, Food Safety and Public Policy
P.E.S Institute of Technology, Bangalore, India 2008 — 2012
Bachelor of Engineering (B.E.), Biotechnology
FDA September 2014 - November 2014
Health Canada January 2014 - July 2014
McGill University 2012 - 2014
McGill University October 2013 - December 2013
American Eagle Outfitters June 2013 - September 2013
Health Canada May 2013 - August 2013
McGill Office for Students with Disabilities September 2012 - April 2013
Indian Institute of Science May 2011 - July 2012
Shreemaya Group June 2010 - May 2011
Ranbaxy June 2010 - June 2010
Skills
Quality Assurance, Quality Control, Molecular Biology, Microbiology, Food Science, Food Safety, Food Chemistry, Research, Biotechnology, Microsoft Office, PCR, Biochemistry, Public Speaking, Lifesciences, Food Microbiology, Gel Electrophoresis, DNA extraction, Science, Bioinformatics, English, Cell Culture, Genetics, Laboratory, Data Analysis, Life Sciences, Food Processing, Analytical Chemistry, Quantitative Research, Teaching, Computational Biology, ELISA, Western Blotting, food microbi, RT-PCR, Multiplex PCR, qRT-PCR, GMP
Education
McGill University 2012 — 2014
Master of Science (M.Sc.), Food Science
University of Saskatchewan 2014 — 2014
Post Graduate Exchange Student, Infectious Diseases, Food Safety and Public Policy
P.E.S Institute of Technology, Bangalore, India 2008 — 2012
Bachelor of Engineering (B.E.), Biotechnology
Isabelle Dagenais Isabelle Dagenais's FDA Experience June 1999 - August 1999
Job Group Marketing Manager at L'Oreal
Industry Cosmetics
Experience
L'Oréal June 2014 - Present
L'Oréal March 2011 - June 2014
L'Oréal February 2008 - March 2011
L'Oréal January 2004 - January 2008
Just For Laughs June 2003 - September 2003
McGill University May 2002 - May 2003
L'Oréal June 2001 - August 2001
Alcatel Optronics June 2000 - August 2000
FDA June 1999 - August 1999
Skills
Bi-Lingial (Fr, Eng), PowerPoint, Excel, Marketing Communications, Marketing Strategy, Brand Development, Sales, Microsoft Excel, Market Research, Budgets, Merchandising, Advertising, Retail, Strategy, Brand Management, Marketing Management, Competitive Analysis, Market Analysis, Marketing, Marketing Research, Consumer Products, Social Media Marketing, Forecasting, Public Relations, Social Media, Luxury Goods, Coaching, Event Management, New Business Development, Pricing, Event Planning, Market Planning, Product Marketing, Customer Insight, Entrepreneurship, FMCG, Beauty Industry, Brand Awareness, P, B2B, Pricing Strategy, Media Planning, Strategic Thinking, Leadership, International Marketing, Product Development, Product Launch, Digital Marketing
Education
University of Toronto 2008 — 2011
M.B.A Rotman School, Business; Marketing
McGill University 1999 — 2003
Bachelor of Commerce, Marketing and International Management
Advanced Diploma Holton Arms School 1995 — 1999
L'Oréal June 2014 - Present
L'Oréal March 2011 - June 2014
L'Oréal February 2008 - March 2011
L'Oréal January 2004 - January 2008
Just For Laughs June 2003 - September 2003
McGill University May 2002 - May 2003
L'Oréal June 2001 - August 2001
Alcatel Optronics June 2000 - August 2000
FDA June 1999 - August 1999
Skills
Bi-Lingial (Fr, Eng), PowerPoint, Excel, Marketing Communications, Marketing Strategy, Brand Development, Sales, Microsoft Excel, Market Research, Budgets, Merchandising, Advertising, Retail, Strategy, Brand Management, Marketing Management, Competitive Analysis, Market Analysis, Marketing, Marketing Research, Consumer Products, Social Media Marketing, Forecasting, Public Relations, Social Media, Luxury Goods, Coaching, Event Management, New Business Development, Pricing, Event Planning, Market Planning, Product Marketing, Customer Insight, Entrepreneurship, FMCG, Beauty Industry, Brand Awareness, P, B2B, Pricing Strategy, Media Planning, Strategic Thinking, Leadership, International Marketing, Product Development, Product Launch, Digital Marketing
Education
University of Toronto 2008 — 2011
M.B.A Rotman School, Business; Marketing
McGill University 1999 — 2003
Bachelor of Commerce, Marketing and International Management
Advanced Diploma Holton Arms School 1995 — 1999
Patrick Cannon Patrick Cannon's FDA Experience June 2014 - Present
Job Regulatory Counsel at FDA
Industry Law Practice
Experience
FDA June 2014 - Present
Sopher, Adler & Gibison, P.A. March 2013 - June 2014
Cannon Legal LLC February 2012 - April 2014
Robert Half Legal October 2012 - March 2013
ROBERTS Real Estate Development October 2009 - August 2012
Efficient Home LLC April 2011 - February 2012
Wolfe Law Group, LLC June 2008 - September 2008
Montgomery County State's Attorney February 2006 - May 2006
Skills
Contract Negotiation, Customer Service, Sales, Pro Forma Development, Public Speaking, Creative Writing, Blogging, Team Leadership, Regulatory Requirements, Project Management, Human Resources, Business Development, Acquisitions, Due Diligence, Litigation, Document Review, Corporate Law, Legal Research, Legal Writing, Marketing
Education
Loyola University New Orleans College of Law 2006 — 2009
J.D., International Law
University of Maryland University College 2009 — 2011
MBA
Universität Wien 2007 — 2007
Comparative Studies of International Law
University of Maryland College Park 2002 — 2005
B.A., Communications
Penn State University 2001 — 2002
FDA June 2014 - Present
Sopher, Adler & Gibison, P.A. March 2013 - June 2014
Cannon Legal LLC February 2012 - April 2014
Robert Half Legal October 2012 - March 2013
ROBERTS Real Estate Development October 2009 - August 2012
Efficient Home LLC April 2011 - February 2012
Wolfe Law Group, LLC June 2008 - September 2008
Montgomery County State's Attorney February 2006 - May 2006
Skills
Contract Negotiation, Customer Service, Sales, Pro Forma Development, Public Speaking, Creative Writing, Blogging, Team Leadership, Regulatory Requirements, Project Management, Human Resources, Business Development, Acquisitions, Due Diligence, Litigation, Document Review, Corporate Law, Legal Research, Legal Writing, Marketing
Education
Loyola University New Orleans College of Law 2006 — 2009
J.D., International Law
University of Maryland University College 2009 — 2011
MBA
Universität Wien 2007 — 2007
Comparative Studies of International Law
University of Maryland College Park 2002 — 2005
B.A., Communications
Penn State University 2001 — 2002
Anna Trier Anna Trier's FDA Experience June 2015 - Present
Job ORISE Fellow at FDA
Industry Research
Experience
FDA June 2015 - Present
National Institutes of Health July 2013 - May 2015
Macalester College January 2010 - June 2013
Mayo Clinic June 2011 - August 2011
Skills
Flow Cytometry, FlowJo, RT-PCR, Cell Culture, Research, Mouse Models, Immunology, PCR
Education
Macalester College 2009 — 2013
Bachelor of Arts (B.A.), Biology, General; Concentration in Global and Community Health
FDA June 2015 - Present
National Institutes of Health July 2013 - May 2015
Macalester College January 2010 - June 2013
Mayo Clinic June 2011 - August 2011
Skills
Flow Cytometry, FlowJo, RT-PCR, Cell Culture, Research, Mouse Models, Immunology, PCR
Education
Macalester College 2009 — 2013
Bachelor of Arts (B.A.), Biology, General; Concentration in Global and Community Health
Tocher Kellom Tocher Kellom's FDA Experience 2004 - 2005
Job Biomedical Engineer at Veterans Health Administration
Industry Government Administration
Experience
Veterans Health Administration July 2007 - Present
FDA 2004 - 2005
Skills
Biomedical Engineering, Data Analysis, Clinical Engineering, Lean Management, Process Improvement..., Business Process..., Medical Devices, Medical Equipment..., Healthcare Information..., MRI, Healthcare, PACS, Biomechanics
Education
Marquette University 2001 — 2007
Bachelor of Science (BS), Biomedical/Medical Engineering
Veterans Health Administration July 2007 - Present
FDA 2004 - 2005
Skills
Biomedical Engineering, Data Analysis, Clinical Engineering, Lean Management, Process Improvement..., Business Process..., Medical Devices, Medical Equipment..., Healthcare Information..., MRI, Healthcare, PACS, Biomechanics
Education
Marquette University 2001 — 2007
Bachelor of Science (BS), Biomedical/Medical Engineering
Melodi Anahtar Melodi Anahtar's FDA Experience June 2010 - August 2010
Job Student at Massachusetts Institute of Technology
Industry Research
Experience
Rockefeller University June 2015 - August 2015
The Picower Institute for Learning & Memory at MIT June 2013 - May 2015
Make-A-Wish America June 2012 - August 2012
Dana-Farber Cancer Institute June 2011 - August 2011
FDA June 2010 - August 2010
Education
Massachusetts Institute of Technology 2012 — 2016
Biological/Biosystems Engineering
Rockefeller University June 2015 - August 2015
The Picower Institute for Learning & Memory at MIT June 2013 - May 2015
Make-A-Wish America June 2012 - August 2012
Dana-Farber Cancer Institute June 2011 - August 2011
FDA June 2010 - August 2010
Education
Massachusetts Institute of Technology 2012 — 2016
Biological/Biosystems Engineering
Brittney Herrera's FDA Experience July 2015 - Present
Job Consumer Safety Technician at FDA
Industry Government Administration
Experience
FDA July 2015 - Present
FDA November 2010 - July 2015
Education
Metropolitan State College of Denver 2013 — 2015
Bachelor’s Degree, Business Administration and Management, General
FDA July 2015 - Present
FDA November 2010 - July 2015
Education
Metropolitan State College of Denver 2013 — 2015
Bachelor’s Degree, Business Administration and Management, General
Rachael Moliver's FDA Experience July 2013 - August 2013
Job PharmD
Industry Pharmaceuticals
Experience
Global Health International APPE Pharmacy Rotation September 2013 - November 2013
FDA July 2013 - August 2013
National Association of Chain Drug Stores (NACDS) May 2013 - June 2013
Z-Medica March 2009 - March 2012
Publix June 2011 - August 2011
UMass Medical School June 2009 - September 2010
PhRMA January 2009 - April 2009
Skills
Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Word, Research, Public Speaking, Writing, FDA, Analysis, Medical Devices, Management, Data Analysis, HPLC, Hospitals
Education
Massachusetts College of Pharmacy and Health Sciences 2010 — 2014
Doctor of Pharmacy (PharmD)
The George Washington University 2006 — 2009
Bachelor of Arts (BA), Biology/Biological Sciences, General
Gulliver Preparatory 2002 — 2006
High School, International Baccalaureate (IB)
Global Health International APPE Pharmacy Rotation September 2013 - November 2013
FDA July 2013 - August 2013
National Association of Chain Drug Stores (NACDS) May 2013 - June 2013
Z-Medica March 2009 - March 2012
Publix June 2011 - August 2011
UMass Medical School June 2009 - September 2010
PhRMA January 2009 - April 2009
Skills
Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Word, Research, Public Speaking, Writing, FDA, Analysis, Medical Devices, Management, Data Analysis, HPLC, Hospitals
Education
Massachusetts College of Pharmacy and Health Sciences 2010 — 2014
Doctor of Pharmacy (PharmD)
The George Washington University 2006 — 2009
Bachelor of Arts (BA), Biology/Biological Sciences, General
Gulliver Preparatory 2002 — 2006
High School, International Baccalaureate (IB)
Faisal Mirza's FDA Experience March 2015 - Present
Job Orthopaedic Surgeon, Consultant, Advisor, Entrepreneur
Industry Medical Practice
Experience
Good Samaritan San Jose, CA June 2015 - Present
Mazda Raceway Laguna Seca January 2015 - Present
OrthoSynthesis April 2015 - Present
Clarity Synergy Solutions December 2014 - Present
American Academy of Orthopaedic Surgeons February 2011 - Present
ASTM International February 2015 - Present
FDA March 2015 - Present
Amgen June 2013 - December 2014
Hazel Hawkins Memorial Hospital July 2012 - 2014
CCRMC January 2011 - 2014
Skills
Orthopedic, Surgery, Sports Medicine, Medical Devices, Clinical Research, Healthcare, Bone, Medical Education, Regulatory Affairs, Musculoskeletal..., Leadership, Regulatory Analysis, Regulatory Guidelines, Medical Writing, Grant Writing, Data Analysis, Regulatory Documentation, Training, Grant Preparation, Surgical Navigation, Bone Grafting, Metabolic Bone Disease, Bone Metabolism, Fracture Care, Art, Innovation, Patents, Surgical Devices, Grants, Combination Products, Computational Modeling, Regulations, Team Building, Education, Grantsmanship, Grant Coordination, Grant Reviewing, Federal Grant Management, Surgical Technology, Surgical Centers, Patent Applications, Orthopedic..., Outpatient Orthopedics, Orthopaedic Surgery, Bone Density, Fracture Mechanics, Biotechnology, Clinical Trials, Clinical Development, Clinical Monitoring
Education
McMaster University 1995 — 2001
FRCSC, Orthopaedic Surgery Residency/Fellowship
Western University 1990 — 1994
MD, Medicine
University of New Brunswick 1988 — 1998
Shad Valley Summer Science Program
Good Samaritan San Jose, CA June 2015 - Present
Mazda Raceway Laguna Seca January 2015 - Present
OrthoSynthesis April 2015 - Present
Clarity Synergy Solutions December 2014 - Present
American Academy of Orthopaedic Surgeons February 2011 - Present
ASTM International February 2015 - Present
FDA March 2015 - Present
Amgen June 2013 - December 2014
Hazel Hawkins Memorial Hospital July 2012 - 2014
CCRMC January 2011 - 2014
Skills
Orthopedic, Surgery, Sports Medicine, Medical Devices, Clinical Research, Healthcare, Bone, Medical Education, Regulatory Affairs, Musculoskeletal..., Leadership, Regulatory Analysis, Regulatory Guidelines, Medical Writing, Grant Writing, Data Analysis, Regulatory Documentation, Training, Grant Preparation, Surgical Navigation, Bone Grafting, Metabolic Bone Disease, Bone Metabolism, Fracture Care, Art, Innovation, Patents, Surgical Devices, Grants, Combination Products, Computational Modeling, Regulations, Team Building, Education, Grantsmanship, Grant Coordination, Grant Reviewing, Federal Grant Management, Surgical Technology, Surgical Centers, Patent Applications, Orthopedic..., Outpatient Orthopedics, Orthopaedic Surgery, Bone Density, Fracture Mechanics, Biotechnology, Clinical Trials, Clinical Development, Clinical Monitoring
Education
McMaster University 1995 — 2001
FRCSC, Orthopaedic Surgery Residency/Fellowship
Western University 1990 — 1994
MD, Medicine
University of New Brunswick 1988 — 1998
Shad Valley Summer Science Program
Zhuohui Gan Zhuohui Gan's FDA Experience July 2004 - August 2005
Job postdoctoral researcher at UC San Diego
Industry Higher Education
Experience
UC San Diego March 2012 - Present
Sanford-Burnham Medical Research Institute August 2012 - Present
Pulmonary Physiology Lab, VA Medical Center August 2007 - December 2011
Agilent Technologies October 2005 - May 2006
FDA July 2004 - August 2005
Regional center lab of drug screening and evaluation, Zhejiang University June 2000 - June 2004
Skills
Systems Biology, Physiology, Data Analysis, Matlab, Mathematical Modeling, Quantitative Analytics, Microarray Analysis, R, Research, Microsoft Office, Biomedical Engineering, Statistics, Signal Processing, Java, SQL, XML, Python, C++, Microsoft SQL Server, Small Animal Models, Animal Surgery, RT-PCR, Protein Assays, PCR, Visual Basic, ClearCase, Passolo, Metabolics, NGS
Education
Marquette University 2007 — 2011
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
Zhejiang University 2001 — 2004
Master of Science (M.S.), Bioengineering and Biomedical Engineering
UC San Diego March 2012 - Present
Sanford-Burnham Medical Research Institute August 2012 - Present
Pulmonary Physiology Lab, VA Medical Center August 2007 - December 2011
Agilent Technologies October 2005 - May 2006
FDA July 2004 - August 2005
Regional center lab of drug screening and evaluation, Zhejiang University June 2000 - June 2004
Skills
Systems Biology, Physiology, Data Analysis, Matlab, Mathematical Modeling, Quantitative Analytics, Microarray Analysis, R, Research, Microsoft Office, Biomedical Engineering, Statistics, Signal Processing, Java, SQL, XML, Python, C++, Microsoft SQL Server, Small Animal Models, Animal Surgery, RT-PCR, Protein Assays, PCR, Visual Basic, ClearCase, Passolo, Metabolics, NGS
Education
Marquette University 2007 — 2011
Doctor of Philosophy (Ph.D.), Bioengineering and Biomedical Engineering
Zhejiang University 2001 — 2004
Master of Science (M.S.), Bioengineering and Biomedical Engineering
Franco Rupcich Franco Rupcich's FDA Experience May 2006 - June 2006
Job Lead CT Systems Engineer at GE Healthcare
Industry Medical Devices
Experience
GE Healthcare July 2014 - Present
Northeastern University and the Department of Homeland Security July 2013 - February 2015
Hospira October 2013 - June 2014
Marquette University June 2009 - March 2013
Baxter International Inc. January 2006 - August 2008
FDA May 2006 - June 2006
Education
Marquette University 2009 — 2013
Ph.D., Biomedical Engineering
Marquette University 2003 — 2008
Bachelor of Science (B.S.), Biomedical Engineering (computing specialization), Mathematics
GE Healthcare July 2014 - Present
Northeastern University and the Department of Homeland Security July 2013 - February 2015
Hospira October 2013 - June 2014
Marquette University June 2009 - March 2013
Baxter International Inc. January 2006 - August 2008
FDA May 2006 - June 2006
Education
Marquette University 2009 — 2013
Ph.D., Biomedical Engineering
Marquette University 2003 — 2008
Bachelor of Science (B.S.), Biomedical Engineering (computing specialization), Mathematics
Nicole Ergen Nicole Ergen's FDA Experience July 2011 - August 2011
Job IT Business Analyst III, Project Manager at Wipfli LLP | Internal IT
Industry Information Technology and Services
Experience
Wipfli LLP January 2015 - Present
Wipfli LLP June 2014 - December 2014
Accenture December 2013 - May 2014
Accenture January 2013 - December 2013
Zywave May 2012 - August 2012
Marquette University August 2011 - May 2012
GE Healthcare August 2011 - May 2012
FDA July 2011 - August 2011
Skills
Microsoft Dynamics CRM, Biomedical Engineering, Biomechanics, Project Management, Camtasia, Leadership, Multisim, Technical Writing, HTML, Matlab, Java, Medical Imaging, Microsoft Excel, Labview, Spring, XML, Microsoft Office, PowerPoint, SharePoint, Critical Thinking, Business Analysis
Education
Marquette University 2008 — 2012
B.S, Biomedical Engineering
Eisenhower High School 2004 — 2008
High School
Wipfli LLP January 2015 - Present
Wipfli LLP June 2014 - December 2014
Accenture December 2013 - May 2014
Accenture January 2013 - December 2013
Zywave May 2012 - August 2012
Marquette University August 2011 - May 2012
GE Healthcare August 2011 - May 2012
FDA July 2011 - August 2011
Skills
Microsoft Dynamics CRM, Biomedical Engineering, Biomechanics, Project Management, Camtasia, Leadership, Multisim, Technical Writing, HTML, Matlab, Java, Medical Imaging, Microsoft Excel, Labview, Spring, XML, Microsoft Office, PowerPoint, SharePoint, Critical Thinking, Business Analysis
Education
Marquette University 2008 — 2012
B.S, Biomedical Engineering
Eisenhower High School 2004 — 2008
High School
Tunde Akinyeke, PhD Tunde Akinyeke, PhD's FDA Experience December 2013 - July 2014
Job Postdoctoral Fellow at OHSU | Oregon Health & Science University
Industry Research
Experience
OHSU Oregon Health & Science University July 2014 - Present
Grand Canyon University October 2013 - Present
FDA December 2013 - July 2014
New York University College of Denistry August 2011 - April 2013
Meharry Medical College August 2004 - May 2011
Center of Marine Biotechnology May 2002 - August 2002
University of Maryland May 2001 - August 2001
Skills
Cell, Biology, Western Blotting, Molecular Biology, PCR, Animal Models, RNA isolation, In Vivo, Cell Biology, Scientific Writing, RT-PCR, Biochemistry, Protein Chemistry, Molecular Cloning, Cancer Research, ELISA, Cell Culture, Immunohistochemistry, Pharmacology, Cancer, Confocal Microscopy, Tissue Culture, Toxicology, Research, Public Speaking, Data Analysis, Transfection, Protein Purification, Neuroscience, Flow Cytometry, RNA Isolation, Community Outreach, Science, Life Sciences, Microscopy
Education
Meharry Medical College 2004 — 2011
Doctor of Philosophy, Biomedical Sciences-Cancer Biology
University of Maryland Eastern Shore 1999 — 2003
Bachelor of Science Degree, Biology
Fairmont heights HS 1995 — 1999
Biotechnology
OHSU Oregon Health & Science University July 2014 - Present
Grand Canyon University October 2013 - Present
FDA December 2013 - July 2014
New York University College of Denistry August 2011 - April 2013
Meharry Medical College August 2004 - May 2011
Center of Marine Biotechnology May 2002 - August 2002
University of Maryland May 2001 - August 2001
Skills
Cell, Biology, Western Blotting, Molecular Biology, PCR, Animal Models, RNA isolation, In Vivo, Cell Biology, Scientific Writing, RT-PCR, Biochemistry, Protein Chemistry, Molecular Cloning, Cancer Research, ELISA, Cell Culture, Immunohistochemistry, Pharmacology, Cancer, Confocal Microscopy, Tissue Culture, Toxicology, Research, Public Speaking, Data Analysis, Transfection, Protein Purification, Neuroscience, Flow Cytometry, RNA Isolation, Community Outreach, Science, Life Sciences, Microscopy
Education
Meharry Medical College 2004 — 2011
Doctor of Philosophy, Biomedical Sciences-Cancer Biology
University of Maryland Eastern Shore 1999 — 2003
Bachelor of Science Degree, Biology
Fairmont heights HS 1995 — 1999
Biotechnology
Casey O'Brien Casey O'Brien's FDA Experience May 2014 - August 2014
Job Teaching Assistant at Marquette University
Industry Computer Software
Experience
Marquette University August 2011 - Present
FDA May 2014 - August 2014
Marquette University May 2009 - August 2011
Skills
Security, Statistics, Research, PHP, Objective-C, Data Analysis, Matlab, Mobile Computing, JavaScript, Programming, C++, C, LaTeX, Java, Python
Education
Marquette University 2011 — 2013
Master of Science, Computational Sciences
Marquette University 2007 — 2011
Bachelor of Science, Computer Science and English Literature
TASIS The American School in England 2003 — 2007
Marquette University August 2011 - Present
FDA May 2014 - August 2014
Marquette University May 2009 - August 2011
Skills
Security, Statistics, Research, PHP, Objective-C, Data Analysis, Matlab, Mobile Computing, JavaScript, Programming, C++, C, LaTeX, Java, Python
Education
Marquette University 2011 — 2013
Master of Science, Computational Sciences
Marquette University 2007 — 2011
Bachelor of Science, Computer Science and English Literature
TASIS The American School in England 2003 — 2007
Celicia Brown Celicia Brown's FDA Experience March 2002 - Present
Job Microbiologist at FDA
Industry Food & Beverages
Experience
FDA March 2002 - Present
University of Colorado Health Sciences Center 1999 - 2002
Skills
Cell Culture, ELISA, Food Microbiology, Immunology, Microbiology, Molecular Biology, PCR, Bacterial Culture, Gel Electrophoresis, Aseptic Technique, DNA Extraction, FDA, Life Sciences, RT-PCR
Education
Metropolitan State College of Denver 1989 — 1999
Bachelor of Arts (BA), Biology, General
FDA March 2002 - Present
University of Colorado Health Sciences Center 1999 - 2002
Skills
Cell Culture, ELISA, Food Microbiology, Immunology, Microbiology, Molecular Biology, PCR, Bacterial Culture, Gel Electrophoresis, Aseptic Technique, DNA Extraction, FDA, Life Sciences, RT-PCR
Education
Metropolitan State College of Denver 1989 — 1999
Bachelor of Arts (BA), Biology, General
Carole C. Carey Carole C. Carey's FDA Experience May 2006 - May 2014
Job Medical Devices Regulatory Consultancy
Industry Medical Devices
Experience
C3-Carey Consultants, LLC March 2015 - Present
IEEE 1998 - Present
FDA May 2006 - May 2014
IEEE 2013 - 2013
FDA August 1990 - April 2006
The Maureen and Mike Mansfield Foundation July 2003 - August 2005
Education
The Johns Hopkins University
Bachelor's degree, Electrical Engineering
Loyola University Maryland
Master's degree in engineering science, Computer Engineering
C3-Carey Consultants, LLC March 2015 - Present
IEEE 1998 - Present
FDA May 2006 - May 2014
IEEE 2013 - 2013
FDA August 1990 - April 2006
The Maureen and Mike Mansfield Foundation July 2003 - August 2005
Education
The Johns Hopkins University
Bachelor's degree, Electrical Engineering
Loyola University Maryland
Master's degree in engineering science, Computer Engineering
Cody Dail's FDA Experience July 2015 - Present
Job Research Assistant
Industry Research
Experience
FDA July 2015 - Present
Minnesota Internship Center High School September 2012 - May 2015
Bonner Foundation September 2011 - May 2015
University of Minnesota June 2014 - August 2014
Macalester College October 2013 - March 2014
Howard Hughes Medical Institute May 2013 - July 2013
Camp Holiday Trails June 2012 - July 2012
Highland Park Middle School September 2011 - May 2012
Coldwater Creek Farm 2007 - 2012
Skills
Volunteer Management, Spanish, Community Outreach, qRT-PCR, Typing, Microsoft Office, Fundraising, Cell Culture, Western Blotting, Far Western Blot, Cardiac Perfusion, Mutant Screen, Immunohistochemistry, Protein Purification, GUS Staining, Hot Plate Latency, FACS, Stata, Python, Wilderness First Aid, Water Safety Instructor, Nonprofits
Education
Macalester College 2011 — 2015
Bachelor of Arts (B.A.), Economics, Biology, 3.93 (Summa Cum Laude)
Governor's School of Southside Virginia 2009 — 2011
Advanced High School Diploma, 4.0
Southside Virginia Community College 2009 — 2011
Associate of Arts and Sciences (A.A.S.), 4.0
Randolph-Henry High School 2007 — 2011
Advanced Diploma, 4.66
Summer Residential Governor's School for Life Sciences and Medicine
FDA July 2015 - Present
Minnesota Internship Center High School September 2012 - May 2015
Bonner Foundation September 2011 - May 2015
University of Minnesota June 2014 - August 2014
Macalester College October 2013 - March 2014
Howard Hughes Medical Institute May 2013 - July 2013
Camp Holiday Trails June 2012 - July 2012
Highland Park Middle School September 2011 - May 2012
Coldwater Creek Farm 2007 - 2012
Skills
Volunteer Management, Spanish, Community Outreach, qRT-PCR, Typing, Microsoft Office, Fundraising, Cell Culture, Western Blotting, Far Western Blot, Cardiac Perfusion, Mutant Screen, Immunohistochemistry, Protein Purification, GUS Staining, Hot Plate Latency, FACS, Stata, Python, Wilderness First Aid, Water Safety Instructor, Nonprofits
Education
Macalester College 2011 — 2015
Bachelor of Arts (B.A.), Economics, Biology, 3.93 (Summa Cum Laude)
Governor's School of Southside Virginia 2009 — 2011
Advanced High School Diploma, 4.0
Southside Virginia Community College 2009 — 2011
Associate of Arts and Sciences (A.A.S.), 4.0
Randolph-Henry High School 2007 — 2011
Advanced Diploma, 4.66
Summer Residential Governor's School for Life Sciences and Medicine
Patrick Cournoyer Patrick Cournoyer's FDA Experience August 2013 - Present
Job Plant Biotechnology Food Safety Regulator at FDA
Industry Biotechnology
Experience
FDA August 2013 - Present
FDA April 2015 - July 2015
Yale University August 2006 - June 2013
Genius GmbH September 2005 - August 2006
Skills
Journalism, Science, Biotechnology, Agriculture, Translation, Molecular Biology, Research, Cell Biology, Protein Chemistry, Microscopy, Biochemistry, Genetics, PCR, Molecular Cloning, Life Sciences, Western Blotting, Protein Expression, Protein Purification, Immunoprecipitation, Confocal Microscopy, Microbiology, Mass Spectrometry, Tissue Culture, Lifesciences, Genomics
Education
Yale University 2006 — 2013
PhD, MS, Molecular and Cell Biology
McGill University 2001 — 2005
B.Sc.Ag.Env., Molecular Plant Biology, German Language & Literature
FDA August 2013 - Present
FDA April 2015 - July 2015
Yale University August 2006 - June 2013
Genius GmbH September 2005 - August 2006
Skills
Journalism, Science, Biotechnology, Agriculture, Translation, Molecular Biology, Research, Cell Biology, Protein Chemistry, Microscopy, Biochemistry, Genetics, PCR, Molecular Cloning, Life Sciences, Western Blotting, Protein Expression, Protein Purification, Immunoprecipitation, Confocal Microscopy, Microbiology, Mass Spectrometry, Tissue Culture, Lifesciences, Genomics
Education
Yale University 2006 — 2013
PhD, MS, Molecular and Cell Biology
McGill University 2001 — 2005
B.Sc.Ag.Env., Molecular Plant Biology, German Language & Literature
Michael Kozowyk Michael Kozowyk's FDA Experience February 2010 - May 2010
Job MBA, Sales Director, Informatics at PerkinElmer
Industry Hospital & Health Care
Experience
PerkinElmer August 2012 - Present
Advanced Practice Strategies (APS) May 2011 - November 2012
BMA Records January 2011 - February 2012
Oxford International August 2010 - January 2011
Harlow Scientific May 2009 - August 2010
FDA February 2010 - May 2010
Walgreens Pharmacy June 2008 - April 2010
Northeastern University May 2005 - October 2008
Skills
Healthcare, Pharmaceutical Industry, Social Networking, Microsoft Excel, Management, Medical Devices, Microsoft Office, Insurance, Marketing, Facebook, Direct Sales, Social Media Marketing, Google Docs, Cold Calling, Digital Marketing, Project Management, Business Development, Office Management, Six Sigma, Pharmacists, Healthcare Management, Higher Education, Google Analytics, Excel, Operations, Lean Manufacturing, Pharmaceuticals, Inside Sales, Project Coordination, Field Sales, CRM, Start-ups, Sales
Education
University of Massachusetts Boston 2010 — 2012
MBA, Masters of Business Administration, Specialization in Healthcare Management, 3.90
University of Massachusetts Boston 2010 — 2011
MBA, Masters of Business Administration, Specialization in Marketing
Massachusetts College of Pharmacy and Health Sciences 2006 — 2010
Bachelor of Pharmaceutical Marketing and Management, Pharmaceutical Marketing and Management, Science, Chemistry, Biology, Pharmaceuticals, Medical, 3.75
Revere High School 2002 — 2006
High School Diploma, General
PerkinElmer August 2012 - Present
Advanced Practice Strategies (APS) May 2011 - November 2012
BMA Records January 2011 - February 2012
Oxford International August 2010 - January 2011
Harlow Scientific May 2009 - August 2010
FDA February 2010 - May 2010
Walgreens Pharmacy June 2008 - April 2010
Northeastern University May 2005 - October 2008
Skills
Healthcare, Pharmaceutical Industry, Social Networking, Microsoft Excel, Management, Medical Devices, Microsoft Office, Insurance, Marketing, Facebook, Direct Sales, Social Media Marketing, Google Docs, Cold Calling, Digital Marketing, Project Management, Business Development, Office Management, Six Sigma, Pharmacists, Healthcare Management, Higher Education, Google Analytics, Excel, Operations, Lean Manufacturing, Pharmaceuticals, Inside Sales, Project Coordination, Field Sales, CRM, Start-ups, Sales
Education
University of Massachusetts Boston 2010 — 2012
MBA, Masters of Business Administration, Specialization in Healthcare Management, 3.90
University of Massachusetts Boston 2010 — 2011
MBA, Masters of Business Administration, Specialization in Marketing
Massachusetts College of Pharmacy and Health Sciences 2006 — 2010
Bachelor of Pharmaceutical Marketing and Management, Pharmaceutical Marketing and Management, Science, Chemistry, Biology, Pharmaceuticals, Medical, 3.75
Revere High School 2002 — 2006
High School Diploma, General
Kip Hanks's FDA Experience 1998 - Present
Job Investigator/Biologics National Expert at FDA
Industry Government Administration
Experience
FDA 1998 - Present
Louisiana Air National Guard 1992 - 1998
Skills
Policy, Regulatory Affairs, FDA, Public Speaking, Quality Assurance, GMP, Microsoft Office, Research, Customer Service, Training, Strategic Planning, Budgets, Government, Public Relations, Team Building, Legal Research, Leadership
Education
McNeese State University 1993 — 1997
BS, Microbiology
ROMAD school
Sulphur High School
FDA 1998 - Present
Louisiana Air National Guard 1992 - 1998
Skills
Policy, Regulatory Affairs, FDA, Public Speaking, Quality Assurance, GMP, Microsoft Office, Research, Customer Service, Training, Strategic Planning, Budgets, Government, Public Relations, Team Building, Legal Research, Leadership
Education
McNeese State University 1993 — 1997
BS, Microbiology
ROMAD school
Sulphur High School
Catherine (Cathy) Carnevale Catherine (Cathy) Carnevale's FDA Experience 2005 - October 2008
Job International Food Safety Consultant at SelfEmployed
Industry International Trade and Development
Experience
Self-Employed October 2010 - Present
FDA 2005 - October 2008
Skills
Food Safety, Policy, Government, Public Policy, Policy Analysis, Regulatory Affairs, Food Microbiology, Public Health, Analysis, Lifesciences, Food, FDA, Program Management, Capacity Building, International Trade, HACCP, International Relations, Research, Training, Biotechnology, GMP, Food Science, Food Processing, Microbiology, Global Health, NGOs, International..., Food Security, Diplomacy, Sanitation, Public Affairs, Science, Food Technology, Foreign Policy, Infectious Diseases, Program Evaluation, Toxicology, Prevention, Proposal Writing, Latin America, Environmental Health, Health Policy, Economic Development, Epidemiology, Public/private..., Technical Assistance, Veterinary Medicine, Biostatistics, Qualitative Research, Grants
Education
Universitiy of Pennsylvania School of Veterinary Medicine 1968 — 1972
VMD, Veterinary Medicine
Mary Baldwin College 1964 — 1968
BA, Biology
Self-Employed October 2010 - Present
FDA 2005 - October 2008
Skills
Food Safety, Policy, Government, Public Policy, Policy Analysis, Regulatory Affairs, Food Microbiology, Public Health, Analysis, Lifesciences, Food, FDA, Program Management, Capacity Building, International Trade, HACCP, International Relations, Research, Training, Biotechnology, GMP, Food Science, Food Processing, Microbiology, Global Health, NGOs, International..., Food Security, Diplomacy, Sanitation, Public Affairs, Science, Food Technology, Foreign Policy, Infectious Diseases, Program Evaluation, Toxicology, Prevention, Proposal Writing, Latin America, Environmental Health, Health Policy, Economic Development, Epidemiology, Public/private..., Technical Assistance, Veterinary Medicine, Biostatistics, Qualitative Research, Grants
Education
Universitiy of Pennsylvania School of Veterinary Medicine 1968 — 1972
VMD, Veterinary Medicine
Mary Baldwin College 1964 — 1968
BA, Biology
Stephen Bertorello Stephen Bertorello's FDA Experience September 2014 - Present
Job Regulatory Information Specialist at FDA
Industry Government Administration
Experience
FDA September 2014 - Present
FDA December 2011 - September 2014
ConTemporaries June 2011 - December 2011
NAI Personnel July 2010 - June 2011
Whole Foods Market January 2010 - July 2010
MSX International May 2000 - September 2008
Barnes & Noble August 2004 - August 2007
Skills
Editing, Research, Photoshop, Customer Service, Microsoft Word, System Administration, Microsoft Excel, Microsoft Office, Human Resources, FDA, Administration, Budgets, Illustrator, Administrative..., Event Planning, Strategic Planning, PowerPoint, Social Media, Public Speaking, Team Building
Education
Macomb Community College 2008 — 2009
Media and Communication Arts
FDA September 2014 - Present
FDA December 2011 - September 2014
ConTemporaries June 2011 - December 2011
NAI Personnel July 2010 - June 2011
Whole Foods Market January 2010 - July 2010
MSX International May 2000 - September 2008
Barnes & Noble August 2004 - August 2007
Skills
Editing, Research, Photoshop, Customer Service, Microsoft Word, System Administration, Microsoft Excel, Microsoft Office, Human Resources, FDA, Administration, Budgets, Illustrator, Administrative..., Event Planning, Strategic Planning, PowerPoint, Social Media, Public Speaking, Team Building
Education
Macomb Community College 2008 — 2009
Media and Communication Arts
Caitlin Pennington Caitlin Pennington's FDA Experience March 2014 - Present
Job Program Support Specialist at FDA
Industry Government Administration
Experience
FDA March 2014 - Present
FDA/OC March 2013 - March 2014
National Consortium for the Study of Terrorism and Responses to Terrorism (START) August 2013 - December 2013
FDA/CDER October 2011 - March 2013
DCMA June 2011 - October 2011
Maryland General Assembly January 2011 - April 2011
Office of Congressman Roscoe Bartlett September 2010 - December 2010
Office of Congressman Aaron Schock May 2010 - August 2010
Skills
Grassroots Organizing, Government, Office Management, Public Policy, Policy Analysis, Budgets, Management, Research, Policy, International Relations, Nonprofits, Public Speaking, PowerPoint, Microsoft Office
Education
University of Maryland University College 2011 — 2014
Master's Degree, Homeland Security Management
McDaniel College 2007 — 2010
Bachelors of Art, Political Science and International Studies
CERT
CERT
FDA March 2014 - Present
FDA/OC March 2013 - March 2014
National Consortium for the Study of Terrorism and Responses to Terrorism (START) August 2013 - December 2013
FDA/CDER October 2011 - March 2013
DCMA June 2011 - October 2011
Maryland General Assembly January 2011 - April 2011
Office of Congressman Roscoe Bartlett September 2010 - December 2010
Office of Congressman Aaron Schock May 2010 - August 2010
Skills
Grassroots Organizing, Government, Office Management, Public Policy, Policy Analysis, Budgets, Management, Research, Policy, International Relations, Nonprofits, Public Speaking, PowerPoint, Microsoft Office
Education
University of Maryland University College 2011 — 2014
Master's Degree, Homeland Security Management
McDaniel College 2007 — 2010
Bachelors of Art, Political Science and International Studies
CERT
CERT
Jessica Gall Jessica Gall's FDA Experience January 2002 - May 2002
Job Engineer at MGA Research Co.
Industry Automotive
Experience
MGA Research Co. June 2003 - Present
Marquette University January 2003 - May 2003
FDA January 2002 - May 2002
Skills
Testing, Analysis, Data Acquisition, Program Management, Medical Devices, Software Development, Solidworks, Labview, Pro Engineer, Matlab, Simulink, Unigraphics, Finite Element Analysis, FMEA, ANSYS, CAD, Mechanical Engineering
Education
Marquette University 1999 — 2003
Bachelor of Science (B.S.), Biomedical/Medical Engineering
MGA Research Co. June 2003 - Present
Marquette University January 2003 - May 2003
FDA January 2002 - May 2002
Skills
Testing, Analysis, Data Acquisition, Program Management, Medical Devices, Software Development, Solidworks, Labview, Pro Engineer, Matlab, Simulink, Unigraphics, Finite Element Analysis, FMEA, ANSYS, CAD, Mechanical Engineering
Education
Marquette University 1999 — 2003
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Anna Fine's FDA Experience 2011 - Present
Job Director, Health Professional Liaison Program at FDA
Industry Government Administration
Experience
FDA 2011 - Present
FDA 2008 - 2011
Stanford University Medical Center 2007 - 2008
Skills
Communication Skills, Leadership, Pharmaceutical Industry, Patient Safety, Critical Thinking, Policy, Drug Safety, FDA, Drug information, Executive, Public Health, MedWatch, Medical Education, Medical Writing, Patient Advocacy, Healthcare Management, Healthcare, Air Force, Veterans, Web Content, Public Outreach, Pharmacists, Risk Communication, Program Management, Epidemiology, Pharmacoeconomics, Global Health, Outcomes Research, Health Education, Clinical Pharmacology
Education
Massachusetts School of Professional Psychology
Master of Science in Psychopharmacology
Northeastern University
Doctor of Pharmacy (PharmD)
FDA 2011 - Present
FDA 2008 - 2011
Stanford University Medical Center 2007 - 2008
Skills
Communication Skills, Leadership, Pharmaceutical Industry, Patient Safety, Critical Thinking, Policy, Drug Safety, FDA, Drug information, Executive, Public Health, MedWatch, Medical Education, Medical Writing, Patient Advocacy, Healthcare Management, Healthcare, Air Force, Veterans, Web Content, Public Outreach, Pharmacists, Risk Communication, Program Management, Epidemiology, Pharmacoeconomics, Global Health, Outcomes Research, Health Education, Clinical Pharmacology
Education
Massachusetts School of Professional Psychology
Master of Science in Psychopharmacology
Northeastern University
Doctor of Pharmacy (PharmD)
Phu Tran Phu Tran's FDA Experience June 2015 - Present
Job CDER ORISE Fellow at FDA
Industry Higher Education
Experience
FDA June 2015 - Present
UW-Madison July 2011 - August 2013
Skills
Cell Culture, Microscopy, Biomedical Engineering, Molecular Biology, PCR, Electrophysiology, Cell Biology, Patch-clamp, In Vitro, Ion Channels, Biochemistry, Research
Education
Regulatory Affairs Professional Society 2013 — 2014
Certificate, Medical Devices and Pharmaceuticals Regulatory Affairs
Marquette University 2005 — 2011
Doctor of Philosophy (Ph.D.), Biological Sciences - Neuroscience
Marquette University 2000 — 2004
Bachelor of Science (BS), Biomedical/Medical Engineering
FDA June 2015 - Present
UW-Madison July 2011 - August 2013
Skills
Cell Culture, Microscopy, Biomedical Engineering, Molecular Biology, PCR, Electrophysiology, Cell Biology, Patch-clamp, In Vitro, Ion Channels, Biochemistry, Research
Education
Regulatory Affairs Professional Society 2013 — 2014
Certificate, Medical Devices and Pharmaceuticals Regulatory Affairs
Marquette University 2005 — 2011
Doctor of Philosophy (Ph.D.), Biological Sciences - Neuroscience
Marquette University 2000 — 2004
Bachelor of Science (BS), Biomedical/Medical Engineering
Devin Koontz Devin Koontz's FDA Experience August 2015 - Present
Job Public Affairs Director at USDA Food and Nutrition Service
Industry Public Relations and Communications
Experience
FDA August 2015 - Present
USDA Food and Nutrition Service August 2013 - August 2015
Food and Drug Administration May 1998 - August 2013
FDA April 1991 - May 1998
Denver Merchandise Mart June 1987 - October 1990
Skills
Media Relations, Community Relations, Mediation, Government Relations, Public Speaking, Public Relations, Event Planning, Crisis Communications, Corporate Communications, Community Outreach, Government Liaison, Government, Lobbying, Press Releases, Research, Strategic Communications, Public Affairs, Internal Communications, Public Policy, Communications Planning, Policy, Newsletters, Policy Analysis, Spokesperson, Strategic Partnerships, Nonprofits, Grant Writing, Community Development
Education
Metropolitan State College of Denver 1991 — 1998
Bachelor of Arts, Organizational Communications
AHS 1985 — 1987
FDA August 2015 - Present
USDA Food and Nutrition Service August 2013 - August 2015
Food and Drug Administration May 1998 - August 2013
FDA April 1991 - May 1998
Denver Merchandise Mart June 1987 - October 1990
Skills
Media Relations, Community Relations, Mediation, Government Relations, Public Speaking, Public Relations, Event Planning, Crisis Communications, Corporate Communications, Community Outreach, Government Liaison, Government, Lobbying, Press Releases, Research, Strategic Communications, Public Affairs, Internal Communications, Public Policy, Communications Planning, Policy, Newsletters, Policy Analysis, Spokesperson, Strategic Partnerships, Nonprofits, Grant Writing, Community Development
Education
Metropolitan State College of Denver 1991 — 1998
Bachelor of Arts, Organizational Communications
AHS 1985 — 1987
Ron Michalak, Ph.D. Ron Michalak, Ph.D.'s FDA Experience June 2013 - Present
Job Lead Chemist Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA June 2013 - Present
Pfizer March 2010 - November 2011
Wyeth Research April 2005 - April 2010
Wyeth 1998 - 2005
Ash Stevens Inc. 1987 - 1998
Skills
Project Management, Pharmaceutical..., Pharmaceutical Research, Process Development, Organic Synthesis, Pilot Plant, Technology Transfer, Product Development, Process Simulation, Pharmaceutical Industry, Pharmaceutics, Drug Development, Clinical Trials, Quality by Design, CMC, Regulatory Submissions, GMP, Formulation, Chemistry, IND, Sop, Medicinal Chemistry, GLP, HPLC, Drug Discovery, Biopharmaceuticals, Chromatography, Analytical Chemistry, Validation, Clinical Development, Organic Chemistry, Pharmacokinetics, LC-MS, CRO, FDA, V&V, Regulatory Affairs, Purification, Vaccines, Therapeutic Areas, 21 CFR Part 11, Pharmacology, Change Control, Toxicology, GxP, Drug Delivery, Assay Development, Lead Change, Biotechnology, SOP
Education
Massachusetts Institute of Technology
Post-Doc, Chemistry
University of Illinois at Urbana-Champaign
Ph.D., Organic Chemistry
University of Michigan
FDA June 2013 - Present
Pfizer March 2010 - November 2011
Wyeth Research April 2005 - April 2010
Wyeth 1998 - 2005
Ash Stevens Inc. 1987 - 1998
Skills
Project Management, Pharmaceutical..., Pharmaceutical Research, Process Development, Organic Synthesis, Pilot Plant, Technology Transfer, Product Development, Process Simulation, Pharmaceutical Industry, Pharmaceutics, Drug Development, Clinical Trials, Quality by Design, CMC, Regulatory Submissions, GMP, Formulation, Chemistry, IND, Sop, Medicinal Chemistry, GLP, HPLC, Drug Discovery, Biopharmaceuticals, Chromatography, Analytical Chemistry, Validation, Clinical Development, Organic Chemistry, Pharmacokinetics, LC-MS, CRO, FDA, V&V, Regulatory Affairs, Purification, Vaccines, Therapeutic Areas, 21 CFR Part 11, Pharmacology, Change Control, Toxicology, GxP, Drug Delivery, Assay Development, Lead Change, Biotechnology, SOP
Education
Massachusetts Institute of Technology
Post-Doc, Chemistry
University of Illinois at Urbana-Champaign
Ph.D., Organic Chemistry
University of Michigan
Joanna Kyriakidis Joanna Kyriakidis's FDA Experience 2014 - 2014
Job PharmD, M.S.
Industry Pharmaceuticals
Experience
Bayview Plaza Pharmacy November 2014 - December 2014
Sentara Healthcare October 2014 - November 2014
Sanofi September 2014 - September 2014
Riverside Health System July 2014 - July 2014
FDA 2014 - 2014
Bon Secours Health System 2013 - 2013
Walgreens 2012 - 2012
Skills
Pharmacists, Pharmaceutical Industry, Medication Therapy..., Pharmacy, Pharmacology, Compounding, Pharmacy Automation, Immunization, Certified Immunizer, Clinical Research
Education
Virginia Commonwealth University School of Pharmacy 2011 — 2015
Doctor of Pharmacy (PharmD), Pharmacy
Old Dominion University 2009 — 2011
Master's Degree, Molecular Biology
Massachusetts College of Pharmacy and Health Sciences 2005 — 2009
Bachelor's Degree, Pre-Medicine and Health Studies
Bayview Plaza Pharmacy November 2014 - December 2014
Sentara Healthcare October 2014 - November 2014
Sanofi September 2014 - September 2014
Riverside Health System July 2014 - July 2014
FDA 2014 - 2014
Bon Secours Health System 2013 - 2013
Walgreens 2012 - 2012
Skills
Pharmacists, Pharmaceutical Industry, Medication Therapy..., Pharmacy, Pharmacology, Compounding, Pharmacy Automation, Immunization, Certified Immunizer, Clinical Research
Education
Virginia Commonwealth University School of Pharmacy 2011 — 2015
Doctor of Pharmacy (PharmD), Pharmacy
Old Dominion University 2009 — 2011
Master's Degree, Molecular Biology
Massachusetts College of Pharmacy and Health Sciences 2005 — 2009
Bachelor's Degree, Pre-Medicine and Health Studies
Sam Raney, PhD's FDA Experience March 2014 - Present
Job FDA Lead Pharmaceutical Scientist
Industry Pharmaceuticals
Experience
FDA March 2014 - Present
FDA September 2013 - February 2014
North Dakota State University September 2009 - September 2013
CDG Group May 2013 - July 2013
PRACS Institute March 2012 - March 2013
PRACS Institute May 2006 - February 2012
Inex Pharmaceuticals January 2001 - December 2005
QLT Inc. January 2000 - December 2002
Dolphin Venture Capital January 2000 - December 2000
Angiotech January 1999 - December 2000
Skills
Pharmaceutical Research, Drug Development, Formulation Development, In Vitro, In Vivo, R&D, Clinical Research, Regulatory Requirements, Regulatory Submissions, FDA, USP, Dermatology, Topicals and..., Nanotechnology, Immunology, Bioanalysis, Bioanalytical Chemistry, Corporate Finance, Business Strategy, Intellectual Property, Client Relationship..., Member of Mensa, Pharmaceutical Industry, Regulatory Affairs, GLP, Formulation, ELISA, HPLC, Pharmacology, Chemistry, CRO, GCP, UV/Vis, Analytical Chemistry, Pharmaceutics, Clinical Study Design
Education
The University of British Columbia 1995 — 2001
Ph.D., Biochemistry and Molecular Biology
Marshall University 1993 — 1995
M.S., Biology
Yale University 1988 — 1992
B.A., Molecular Biophysics & Biochemistry
FDA March 2014 - Present
FDA September 2013 - February 2014
North Dakota State University September 2009 - September 2013
CDG Group May 2013 - July 2013
PRACS Institute March 2012 - March 2013
PRACS Institute May 2006 - February 2012
Inex Pharmaceuticals January 2001 - December 2005
QLT Inc. January 2000 - December 2002
Dolphin Venture Capital January 2000 - December 2000
Angiotech January 1999 - December 2000
Skills
Pharmaceutical Research, Drug Development, Formulation Development, In Vitro, In Vivo, R&D, Clinical Research, Regulatory Requirements, Regulatory Submissions, FDA, USP, Dermatology, Topicals and..., Nanotechnology, Immunology, Bioanalysis, Bioanalytical Chemistry, Corporate Finance, Business Strategy, Intellectual Property, Client Relationship..., Member of Mensa, Pharmaceutical Industry, Regulatory Affairs, GLP, Formulation, ELISA, HPLC, Pharmacology, Chemistry, CRO, GCP, UV/Vis, Analytical Chemistry, Pharmaceutics, Clinical Study Design
Education
The University of British Columbia 1995 — 2001
Ph.D., Biochemistry and Molecular Biology
Marshall University 1993 — 1995
M.S., Biology
Yale University 1988 — 1992
B.A., Molecular Biophysics & Biochemistry
Alain Silk's FDA Experience February 2014 - Present
Job Reviewer at FDA
Industry Government Administration
Experience
FDA February 2014 - Present
American University September 2013 - December 2013
Oregon Health & Science University September 2009 - August 2013
Lewis & Clark College September 2008 - June 2009
Skills
Cell Based Assays, Molecular Biology, Cell Culture, Microscopy, Tissue Culture, Life Sciences, Research, Teaching, Higher Education, Cell Biology, Cell, Immunofluorescence, Lifesciences, Fluorescence Microscopy, Flow Cytometry, Confocal Microscopy, Cancer
Education
University of California, San Diego 2000 — 2008
PhD, Cancer Cell Biology
McGill University 1995 — 1999
B.Sc., Microbiology and Immunology
FDA February 2014 - Present
American University September 2013 - December 2013
Oregon Health & Science University September 2009 - August 2013
Lewis & Clark College September 2008 - June 2009
Skills
Cell Based Assays, Molecular Biology, Cell Culture, Microscopy, Tissue Culture, Life Sciences, Research, Teaching, Higher Education, Cell Biology, Cell, Immunofluorescence, Lifesciences, Fluorescence Microscopy, Flow Cytometry, Confocal Microscopy, Cancer
Education
University of California, San Diego 2000 — 2008
PhD, Cancer Cell Biology
McGill University 1995 — 1999
B.Sc., Microbiology and Immunology
Bhupinder Mann Bhupinder Mann's FDA Experience February 2004 - September 2008
Job Medical Officer / Clinical Investigator, National Cancer Institute USA
Industry Research
Experience
National Cancer Institute (NCI) October 2008 - Present
FDA February 2004 - September 2008
National Cancer Centre Singapore July 2000 - January 2004
King Faisal Specialist Hospital & Research Centre - Gen. Org. February 1999 - June 2000
Highland General Hospital and Alameda County Medical Center 1996 - 1999
California Medical Facility February 1996 - December 1997
High Desert State Prison August 1995 - January 1996
Skills
Oncology, Clinical Trials, Clinical Research, Cancer, Hematology, Molecular Biology, Internal Medicine, FDA, Breast Cancer, IND, Clinical Development, Epidemiology, Public Health
Education
Mayo Graduate School 1991 — 1995
Doctor of Medicine (MD), Medical Oncology and Hematology
Wayne State University School of Medicine 1987 — 1991
Doctor of Medicine (MD), Internal Medicine Residency Program
Government Medical College, Patiala, Punjab, India 1978 — 1985
Bachelor of Medicine, Bachelor of Surgery (MBBS), Medicine and Surgery
DAV College, Jalandhar, Punjab, India 1975 — 1977
Pre University, Pre Med, Physics, Chemistry, English, Biology, Higher Mathematics
FCI Higher Secondary School, Naya Nangal, Punjab, India 1969 — 1974
HS Certificate, English, Hindi, Punjabi, Sanskrit, Biology, Physics, Chemistry, Mathematics
National Cancer Institute (NCI) October 2008 - Present
FDA February 2004 - September 2008
National Cancer Centre Singapore July 2000 - January 2004
King Faisal Specialist Hospital & Research Centre - Gen. Org. February 1999 - June 2000
Highland General Hospital and Alameda County Medical Center 1996 - 1999
California Medical Facility February 1996 - December 1997
High Desert State Prison August 1995 - January 1996
Skills
Oncology, Clinical Trials, Clinical Research, Cancer, Hematology, Molecular Biology, Internal Medicine, FDA, Breast Cancer, IND, Clinical Development, Epidemiology, Public Health
Education
Mayo Graduate School 1991 — 1995
Doctor of Medicine (MD), Medical Oncology and Hematology
Wayne State University School of Medicine 1987 — 1991
Doctor of Medicine (MD), Internal Medicine Residency Program
Government Medical College, Patiala, Punjab, India 1978 — 1985
Bachelor of Medicine, Bachelor of Surgery (MBBS), Medicine and Surgery
DAV College, Jalandhar, Punjab, India 1975 — 1977
Pre University, Pre Med, Physics, Chemistry, English, Biology, Higher Mathematics
FCI Higher Secondary School, Naya Nangal, Punjab, India 1969 — 1974
HS Certificate, English, Hindi, Punjabi, Sanskrit, Biology, Physics, Chemistry, Mathematics
Guohua Li Guohua Li's FDA Experience November 2012 - Present
Job Scientist
Industry Pharmaceuticals
Experience
FDA November 2012 - Present
AllTranz Inc. January 2010 - January 2012
Pfizer Inc. June 2009 - December 2009
Mercer University May 2005 - December 2009
Skills
Drug Delivery, Biotechnology, GLP, Protein Chemistry, Formulation, UV/Vis
Education
Mercer University
FDA November 2012 - Present
AllTranz Inc. January 2010 - January 2012
Pfizer Inc. June 2009 - December 2009
Mercer University May 2005 - December 2009
Skills
Drug Delivery, Biotechnology, GLP, Protein Chemistry, Formulation, UV/Vis
Education
Mercer University
Brian Belz Brian Belz's FDA Experience November 2008 - March 2012
Job Associate Director of GMP Regulatory Compliance at McNeil Consumer Healthcare
Industry Pharmaceuticals
Experience
McNeil Consumer Healthcare June 2013 - Present
McNeil Consumer Healthcare March 2012 - June 2013
FDA November 2008 - March 2012
Merck 1996 - 2008
Skills
GMP, FDA, Data Analysis, Validation, Pharmaceutical Industry, Regulatory Affairs, Spectroscopy, Quality System, Sop, CAPA, Technology Transfer, GLP, LIMS, Change Control, 21 CFR Part 11, Regulatory Requirements, IND, SOP, Biotechnology
Education
Lycoming College 1992 — 1996
Bachelor of Arts (B.A.), Chemistry & Physics
McNeil Consumer Healthcare June 2013 - Present
McNeil Consumer Healthcare March 2012 - June 2013
FDA November 2008 - March 2012
Merck 1996 - 2008
Skills
GMP, FDA, Data Analysis, Validation, Pharmaceutical Industry, Regulatory Affairs, Spectroscopy, Quality System, Sop, CAPA, Technology Transfer, GLP, LIMS, Change Control, 21 CFR Part 11, Regulatory Requirements, IND, SOP, Biotechnology
Education
Lycoming College 1992 — 1996
Bachelor of Arts (B.A.), Chemistry & Physics
Brian L. Baker P.E.'s FDA Experience August 2014 - March 2015
Job Director, Winchester Engineering and Analytical Center at FDA
Industry Government Administration
Experience
US Food and Drug Administration June 2008 - Present
FDA August 2014 - March 2015
Federal Executive Institute August 2013 - September 2013
Northeast Engineers and Consultants Inc. 2006 - 2008
General Services Administration 2005 - 2006
MIT 2000 - 2005
Skills
Government, Policy, Analysis, DoD, Strategic Planning, Project Planning, Leadership, Project Management, Management, Regulatory Affairs, Training, FDA, Human Resources, Medical Devices, Engineering, Program Management, Leadership Development, Policy Analysis, Federal Government, Military, Research, Construction, Public Speaking, Data Analysis, Team Building, Community Outreach, Risk Assessment
Education
Massachusetts Institute of Technology 1990 — 1992
Master of Science (MS), Engineering
Massachusetts Institute of Technology 1990 — 1992
Master of Science (MS), Political Science
University of Rhode Island 1980 — 1984
BS, Civil and Environmental Engineering
US Food and Drug Administration June 2008 - Present
FDA August 2014 - March 2015
Federal Executive Institute August 2013 - September 2013
Northeast Engineers and Consultants Inc. 2006 - 2008
General Services Administration 2005 - 2006
MIT 2000 - 2005
Skills
Government, Policy, Analysis, DoD, Strategic Planning, Project Planning, Leadership, Project Management, Management, Regulatory Affairs, Training, FDA, Human Resources, Medical Devices, Engineering, Program Management, Leadership Development, Policy Analysis, Federal Government, Military, Research, Construction, Public Speaking, Data Analysis, Team Building, Community Outreach, Risk Assessment
Education
Massachusetts Institute of Technology 1990 — 1992
Master of Science (MS), Engineering
Massachusetts Institute of Technology 1990 — 1992
Master of Science (MS), Political Science
University of Rhode Island 1980 — 1984
BS, Civil and Environmental Engineering
Laura Polakowski Laura Polakowski's FDA Experience July 2009 - Present
Job Medical Epidemiologist for the U.S. Government
Industry Health, Wellness and Fitness
Experience
FDA July 2009 - Present
Centers for Disease Control and Prevention July 2007 - June 2009
The Children's Hospital January 2001 - June 2007
Children's Medical Group - Milwaukee, Wisconsin August 1999 - November 2000
Northeast Cincinnati Pediatric Associates September 1998 - June 1999
Medical College of Wisconsin July 1996 - June 1998
Medical College of Wisconsin July 1995 - June 1996
Skills
Public Health, Prevention, Epidemiology, vaccines
Education
University of Colorado Denver 2003 — 2005
MSPH, Public Health
Medical College of Wisconsin 1991 — 1995
MD
University of Wisconsin-Madison 1987 — 1991
B.S., Zoology, Psychology
FDA July 2009 - Present
Centers for Disease Control and Prevention July 2007 - June 2009
The Children's Hospital January 2001 - June 2007
Children's Medical Group - Milwaukee, Wisconsin August 1999 - November 2000
Northeast Cincinnati Pediatric Associates September 1998 - June 1999
Medical College of Wisconsin July 1996 - June 1998
Medical College of Wisconsin July 1995 - June 1996
Skills
Public Health, Prevention, Epidemiology, vaccines
Education
University of Colorado Denver 2003 — 2005
MSPH, Public Health
Medical College of Wisconsin 1991 — 1995
MD
University of Wisconsin-Madison 1987 — 1991
B.S., Zoology, Psychology
Anna Keely's FDA Experience July 2006 - August 2006
Job
Industry Medical Devices
Experience
GE Healthcare October 2014 - Present
GE Healthcare March 2012 - October 2014
GE Healthcare August 2010 - March 2012
GE Healthcare June 2008 - August 2010
Marquette University August 2007 - May 2008
VA Medical Center January 2006 - September 2007
Emageon March 2006 - August 2007
FDA July 2006 - August 2006
City of Blaine 2003 - 2004
Skills
Biomedical Engineering, Medical Devices, Leadership, Teamwork, Process Improvement, Quality System, Radiology, Microsoft Excel, Microsoft Word, PowerPoint, Medical Imaging, Hospitals, Healthcare, Clinical Research, FDA, PACS, Technical Writing, Six Sigma, Image Processing, Troubleshooting, Quality Center, Doors, Matlab, Trackwise, Quality Assurance, Digital Imaging, Software Documentation, Microsoft Office, Systems Engineering, R&D, Design Control, Verification, Validation, CAPA, Engineering, V&V
Education
Marquette University 2003 — 2008
Bachelor of Science Degree, Biomedical Engineering - Biomechanics
GE Healthcare October 2014 - Present
GE Healthcare March 2012 - October 2014
GE Healthcare August 2010 - March 2012
GE Healthcare June 2008 - August 2010
Marquette University August 2007 - May 2008
VA Medical Center January 2006 - September 2007
Emageon March 2006 - August 2007
FDA July 2006 - August 2006
City of Blaine 2003 - 2004
Skills
Biomedical Engineering, Medical Devices, Leadership, Teamwork, Process Improvement, Quality System, Radiology, Microsoft Excel, Microsoft Word, PowerPoint, Medical Imaging, Hospitals, Healthcare, Clinical Research, FDA, PACS, Technical Writing, Six Sigma, Image Processing, Troubleshooting, Quality Center, Doors, Matlab, Trackwise, Quality Assurance, Digital Imaging, Software Documentation, Microsoft Office, Systems Engineering, R&D, Design Control, Verification, Validation, CAPA, Engineering, V&V
Education
Marquette University 2003 — 2008
Bachelor of Science Degree, Biomedical Engineering - Biomechanics
Josh Cirulli Josh Cirulli's FDA Experience March 2008 - May 2008
Job Associate Director, Global Medical Affairs at Celgene
Industry Pharmaceuticals
Experience
Celgene July 2015 - Present
Celgene September 2013 - July 2015
Otsuka America Pharmaceutical, Inc. April 2010 - September 2013
CVS/Pharmacy July 2008 - October 2010
Johnson & Johnson Pharmaceutical Services January 2010 - April 2010
Rutgers University July 2008 - April 2010
Johnson & Johnson Pharmaceutical Services, LLC June 2009 - December 2009
Johnson & Johnson Consumer and Personal Products Worldwide July 2008 - June 2009
FDA March 2008 - May 2008
Pfizer January 2008 - March 2008
Skills
Pharmaceutical Industry, Regulatory Affairs, Clinical Trials, Protocol, Clinical Development, Clinical Research, Leadership, CTMS, Pharmacy, Oncology, Medical Affairs, FDA, Neuroscience, Medicine, Molecular Biology, Validation, Cell, Clinical Study Design
Education
Massachusetts College of Pharmacy and Health Sciences 2004 — 2008
Pharm.D., Pharmacy
Penn State University 1999 — 2004
B.S., Life Science
Celgene July 2015 - Present
Celgene September 2013 - July 2015
Otsuka America Pharmaceutical, Inc. April 2010 - September 2013
CVS/Pharmacy July 2008 - October 2010
Johnson & Johnson Pharmaceutical Services January 2010 - April 2010
Rutgers University July 2008 - April 2010
Johnson & Johnson Pharmaceutical Services, LLC June 2009 - December 2009
Johnson & Johnson Consumer and Personal Products Worldwide July 2008 - June 2009
FDA March 2008 - May 2008
Pfizer January 2008 - March 2008
Skills
Pharmaceutical Industry, Regulatory Affairs, Clinical Trials, Protocol, Clinical Development, Clinical Research, Leadership, CTMS, Pharmacy, Oncology, Medical Affairs, FDA, Neuroscience, Medicine, Molecular Biology, Validation, Cell, Clinical Study Design
Education
Massachusetts College of Pharmacy and Health Sciences 2004 — 2008
Pharm.D., Pharmacy
Penn State University 1999 — 2004
B.S., Life Science
Steven Rush Steven Rush's FDA Experience January 2015 - February 2015
Job PharmD, RPh
Industry Pharmaceuticals
Experience
CVS Pharmacy March 2014 - Present
Beth Israel Deaconess Hospital-Plymouth March 2015 - May 2015
Biogen Idec February 2015 - March 2015
FDA January 2015 - February 2015
Veterans Admin Hospital November 2014 - December 2014
CVS Pharmacy September 2014 - October 2014
Cape Cod Healthcare August 2014 - September 2014
High Point Regional Health September 2013 - October 2013
Walgreens February 2013 - September 2013
CVS Caremark Corporation August 2013 - August 2013
Skills
GLP, HPLC, GMP, FDA, Change Control, Chromatography, UV/Vis, Analytical Chemistry, Gas Chromatography, Mass Spectrometry, Active Learning, Leadership, Critical Thinking, Process Improvement, Time Management, Healthcare, High Pressure..., Multitasking Skills, Laboratory Safety, Laboratory, Communication Skills, Exceptional Listener, Validation, Pharmacokinetics, Pharmacy, Pharmaceutical Industry, Patient Counseling, Patient Safety, Patient Education, Quality Patient Care, Quality Assurance, Quality Control, Quality Management, Quality Improvement, Pharmacoeconomics, Cross-functional Team..., Cross-functional...
Education
Massachusetts College of Pharmacy and Health Sciences 2012 — 2015
Doctor of Pharmacy (PharmD), Pharmacy
North Carolina A&T State University 2005 — 2008
Bachelor of Science (BS), Chemistry
University of North Carolina at Asheville 2003 — 2005
Chemistry
CVS Pharmacy March 2014 - Present
Beth Israel Deaconess Hospital-Plymouth March 2015 - May 2015
Biogen Idec February 2015 - March 2015
FDA January 2015 - February 2015
Veterans Admin Hospital November 2014 - December 2014
CVS Pharmacy September 2014 - October 2014
Cape Cod Healthcare August 2014 - September 2014
High Point Regional Health September 2013 - October 2013
Walgreens February 2013 - September 2013
CVS Caremark Corporation August 2013 - August 2013
Skills
GLP, HPLC, GMP, FDA, Change Control, Chromatography, UV/Vis, Analytical Chemistry, Gas Chromatography, Mass Spectrometry, Active Learning, Leadership, Critical Thinking, Process Improvement, Time Management, Healthcare, High Pressure..., Multitasking Skills, Laboratory Safety, Laboratory, Communication Skills, Exceptional Listener, Validation, Pharmacokinetics, Pharmacy, Pharmaceutical Industry, Patient Counseling, Patient Safety, Patient Education, Quality Patient Care, Quality Assurance, Quality Control, Quality Management, Quality Improvement, Pharmacoeconomics, Cross-functional Team..., Cross-functional...
Education
Massachusetts College of Pharmacy and Health Sciences 2012 — 2015
Doctor of Pharmacy (PharmD), Pharmacy
North Carolina A&T State University 2005 — 2008
Bachelor of Science (BS), Chemistry
University of North Carolina at Asheville 2003 — 2005
Chemistry
Chima Obinna Chima Obinna's FDA Experience July 2008 - September 2011
Job Author of Play Your Game | Founder of Ispire Sports Club| Youth Soccer Coach | Technology Project Manager
Industry Professional Training & Coaching
Experience
Maryland State Department of Education April 2011 - Present
Ispire Sports Club 2012 - Present
FDA July 2008 - September 2011
Guident Technologies 2008 - 2011
Merkle 2006 - 2007
SRA International 2005 - 2006
Skills
Business Intelligence, Operations Management, Business Strategy, PMP, SDLC, Program Management, Business Analysis, Project Portfolio..., Requirements Analysis, PMO, Project Management, Data Warehousing, Software Project..., Process Improvement, SharePoint, Business Objects, MS Project, Change Management, Visio, Certified Project..., Entrepreneurship, Management, Business Process..., Strategy, Team Leadership, Analysis, Business Process, Leadership, Project Planning
Education
Loyola University Maryland 2002 — 2004
MBA, Business Administration
Strayer University (DC) 1998 — 2000
Bachelor of Science (B.Sc.), Computer Information System
Maryland State Department of Education April 2011 - Present
Ispire Sports Club 2012 - Present
FDA July 2008 - September 2011
Guident Technologies 2008 - 2011
Merkle 2006 - 2007
SRA International 2005 - 2006
Skills
Business Intelligence, Operations Management, Business Strategy, PMP, SDLC, Program Management, Business Analysis, Project Portfolio..., Requirements Analysis, PMO, Project Management, Data Warehousing, Software Project..., Process Improvement, SharePoint, Business Objects, MS Project, Change Management, Visio, Certified Project..., Entrepreneurship, Management, Business Process..., Strategy, Team Leadership, Analysis, Business Process, Leadership, Project Planning
Education
Loyola University Maryland 2002 — 2004
MBA, Business Administration
Strayer University (DC) 1998 — 2000
Bachelor of Science (B.Sc.), Computer Information System
Robin Martin, MBA, RAC's FDA Experience January 2004 - April 2004
Job Regulatory Affairs Director Clinical at GE Healthcare
Industry Medical Devices
Experience
GE Healthcare December 2014 - Present
GE Healthcare June 2013 - December 2014
GE Healthcare July 2009 - May 2013
BioForm Medical January 2008 - June 2009
BioForm Medical June 2006 - January 2008
Boston Scientific May 2005 - August 2005
FDA January 2004 - April 2004
Skills
Medical Devices, FDA, Regulatory Affairs, Clinical Trials, Product Development, Quality System, Healthcare, ISO 13485, Cross-functional Team..., Design Control, Biomedical Engineering
Education
Marquette University 2008 — 2011
M.B.A., Business Administration
Marquette University 2002 — 2006
B.S., Biomechanical Engineering
GE Healthcare December 2014 - Present
GE Healthcare June 2013 - December 2014
GE Healthcare July 2009 - May 2013
BioForm Medical January 2008 - June 2009
BioForm Medical June 2006 - January 2008
Boston Scientific May 2005 - August 2005
FDA January 2004 - April 2004
Skills
Medical Devices, FDA, Regulatory Affairs, Clinical Trials, Product Development, Quality System, Healthcare, ISO 13485, Cross-functional Team..., Design Control, Biomedical Engineering
Education
Marquette University 2008 — 2011
M.B.A., Business Administration
Marquette University 2002 — 2006
B.S., Biomechanical Engineering
Christine Rippinger's FDA Experience February 2015 - Present
Job Biological Science Technician at FDA
Industry Research
Experience
FDA February 2015 - Present
FDA July 2012 - February 2015
University of Michigan January 2012 - January 2013
National Institutes of Health January 2008 - December 2011
University of Notre Dame June 2006 - December 2007
Wabash county solid waste managment district May 2006 - May 2006
Manchester College September 2005 - May 2006
Skills
cell culture, qRT-PCR, in vivo studies, Management, Purchasing, Molecular Biology, qPCR, DNA, Genetics, In Vivo, DNA sequencing, Cell Culture, Aseptic Technique, Agarose Gel..., Bacterial Culture, SDS-PAGE, DNA extraction, Gel Electrophoresis, RNA isolation, Tissue Culture, ELISA, RT-PCR, PCR, Sequencing
Education
University of Notre Dame 2006 — 2007
ND, Biochemistry
Manchester College 2002 — 2006
BS, Biology-Chemistry
FDA February 2015 - Present
FDA July 2012 - February 2015
University of Michigan January 2012 - January 2013
National Institutes of Health January 2008 - December 2011
University of Notre Dame June 2006 - December 2007
Wabash county solid waste managment district May 2006 - May 2006
Manchester College September 2005 - May 2006
Skills
cell culture, qRT-PCR, in vivo studies, Management, Purchasing, Molecular Biology, qPCR, DNA, Genetics, In Vivo, DNA sequencing, Cell Culture, Aseptic Technique, Agarose Gel..., Bacterial Culture, SDS-PAGE, DNA extraction, Gel Electrophoresis, RNA isolation, Tissue Culture, ELISA, RT-PCR, PCR, Sequencing
Education
University of Notre Dame 2006 — 2007
ND, Biochemistry
Manchester College 2002 — 2006
BS, Biology-Chemistry
Philip Sager, MD, FACC, FAHA, FHRS Philip Sager, MD, FACC, FAHA, FHRS's FDA Experience 2015 - Present
Job Pharmaceutical & Device Consultant/Biotechnology Executive/Consulting Professor
Industry Pharmaceuticals
Experience
FDA 2015 - Present
Anthera Pharmaceuticals June 2014 - Present
Stanford University School of Medicine 2013 - Present
Sager Consulting Experts 2010 - Present
Gilead Sciences 2009 - 2010
CardioDx 2008 - 2009
AstraZeneca January 2004 - February 2008
AstraZeneca R&D 2004 - 2008
Schering-Plough September 2001 - January 2004
UCLA School of Medicine 1990 - 2001
Skills
Pharmacovigilance, Diabetes, Personalized Medicine, Biotechnology, Heart Failure, Cardiac, Clinical, Heart Disease, Research, Hypertension, Clinical Research, Pharmaceuticals, Medical Devices, Regulatory Affairs, Clinical Trials, Diagnostics, Electrophysiology, Clinical Development, FDA, Cardiology, Pharmacology, Pharmaceutics, Drug Development, IND, Medicine, Pharmaceutical Industry, Lifesciences, Infectious Diseases, Biopharmaceuticals, CRO, Informatics
Education
Yale University School of Medicine 1982 — 1988
Internal Medicine, Cardiology, Cardiac Electrophysiology
Yale University School of Medicine 1978 — 1982
MD, Internal Medicine, Cardiology, EP
Massachusetts Institute of Technology 1973 — 1977
BS, BS, Chemistry, Biology
The Dalton School 1970 — 1973
High School
FDA 2015 - Present
Anthera Pharmaceuticals June 2014 - Present
Stanford University School of Medicine 2013 - Present
Sager Consulting Experts 2010 - Present
Gilead Sciences 2009 - 2010
CardioDx 2008 - 2009
AstraZeneca January 2004 - February 2008
AstraZeneca R&D 2004 - 2008
Schering-Plough September 2001 - January 2004
UCLA School of Medicine 1990 - 2001
Skills
Pharmacovigilance, Diabetes, Personalized Medicine, Biotechnology, Heart Failure, Cardiac, Clinical, Heart Disease, Research, Hypertension, Clinical Research, Pharmaceuticals, Medical Devices, Regulatory Affairs, Clinical Trials, Diagnostics, Electrophysiology, Clinical Development, FDA, Cardiology, Pharmacology, Pharmaceutics, Drug Development, IND, Medicine, Pharmaceutical Industry, Lifesciences, Infectious Diseases, Biopharmaceuticals, CRO, Informatics
Education
Yale University School of Medicine 1982 — 1988
Internal Medicine, Cardiology, Cardiac Electrophysiology
Yale University School of Medicine 1978 — 1982
MD, Internal Medicine, Cardiology, EP
Massachusetts Institute of Technology 1973 — 1977
BS, BS, Chemistry, Biology
The Dalton School 1970 — 1973
High School
Artem Dementyev Artem Dementyev's FDA Experience May 2007 - May 2008
Job Research Assistant at MIT Media Lab
Industry Research
Experience
Massachusetts Institute of Technology (MIT) August 2013 - Present
University of Washington September 2011 - August 2013
Microsoft Research June 2012 - September 2012
FDA May 2007 - May 2008
Education
Massachusetts Institute of Technology 2013 — 2017
Doctor of Philosophy (PhD)
University of Washington 2011 — 2013
Master of Science (M.S.), Electrical and Electronics Engineering
University of Maryland College Park 2006 — 2009
B.S., Bioengineering
Massachusetts Institute of Technology (MIT) August 2013 - Present
University of Washington September 2011 - August 2013
Microsoft Research June 2012 - September 2012
FDA May 2007 - May 2008
Education
Massachusetts Institute of Technology 2013 — 2017
Doctor of Philosophy (PhD)
University of Washington 2011 — 2013
Master of Science (M.S.), Electrical and Electronics Engineering
University of Maryland College Park 2006 — 2009
B.S., Bioengineering
Promita A. Hazra's FDA Experience May 2007 - December 2007
Job Philips Healthcare
Industry Medical Devices
Experience
Philips Healthcare September 2011 - Present
Philips Healthcare February 2011 - September 2011
University Hospital, Indianapolis June 2009 - February 2011
Rehabilitation Engineering Center, Marquette University January 2007 - May 2009
FDA May 2007 - December 2007
Jaslok Hospital and Research Centre June 2005 - November 2005
Skills
Biomedical Engineering, Cross-functional Team..., Project Management, Product Development, V&V, Quality Assurance, Requirements Management, Requirements Analysis, Radiation Therapy, DICOM, FMEA, CAPA, IBM DOORS, ALM, MS Project, Agile Methodologies, Software Project...
Education
Marquette University 2006 — 2009
Master of Science, Biomedical Engineering
Project Management Institute
PMP
University of Mumbai 2002 — 2006
Bachelor of Engineering, Biomedical/Medical Engineering
Philips Healthcare September 2011 - Present
Philips Healthcare February 2011 - September 2011
University Hospital, Indianapolis June 2009 - February 2011
Rehabilitation Engineering Center, Marquette University January 2007 - May 2009
FDA May 2007 - December 2007
Jaslok Hospital and Research Centre June 2005 - November 2005
Skills
Biomedical Engineering, Cross-functional Team..., Project Management, Product Development, V&V, Quality Assurance, Requirements Management, Requirements Analysis, Radiation Therapy, DICOM, FMEA, CAPA, IBM DOORS, ALM, MS Project, Agile Methodologies, Software Project...
Education
Marquette University 2006 — 2009
Master of Science, Biomedical Engineering
Project Management Institute
PMP
University of Mumbai 2002 — 2006
Bachelor of Engineering, Biomedical/Medical Engineering
Alyssa Collier's FDA Experience June 2013 - July 2013
Job Doctor of Physical Therapy Student at Washington University School of Medicine
Industry Medical Practice
Experience
University of Maryland School of Medicine July 2013 - June 2015
FDA June 2013 - July 2013
Kennedy Krieger Institute May 2012 - May 2013
Skills
Research, Data Analysis, Computer Proficiency, Medical Terminology, Laboratory Skills, Small Animal Models, Cell Biology, Muscle Physiology, Scientific Writing, In Vivo, Physiology, Gel Electrophoresis, Western Blotting, H&E staining, Neuroscience, Histology, Cell Culture, PowerPoint, Molecular Biology, In Vitro, Cell, PCR
Education
Washington University School of Medicine in St. Louis 2015 — 2018
Doctor of Physical Therapy, Physical Therapy/Therapist
Loyola University Maryland 2011 — 2013
Bachelor of Science (B.S.), Cum Laude, Biology
University of Maryland School of Medicine July 2013 - June 2015
FDA June 2013 - July 2013
Kennedy Krieger Institute May 2012 - May 2013
Skills
Research, Data Analysis, Computer Proficiency, Medical Terminology, Laboratory Skills, Small Animal Models, Cell Biology, Muscle Physiology, Scientific Writing, In Vivo, Physiology, Gel Electrophoresis, Western Blotting, H&E staining, Neuroscience, Histology, Cell Culture, PowerPoint, Molecular Biology, In Vitro, Cell, PCR
Education
Washington University School of Medicine in St. Louis 2015 — 2018
Doctor of Physical Therapy, Physical Therapy/Therapist
Loyola University Maryland 2011 — 2013
Bachelor of Science (B.S.), Cum Laude, Biology
Irene Darras's FDA Experience August 2014 - September 2014
Job Global Regulatory Affairs Fellow at Bayer
Industry Pharmaceuticals
Experience
Bayer HealthCare July 2015 - Present
Rutgers University July 2015 - Present
Norwood Hospital February 2015 - March 2015
CVS Pharmacy January 2015 - February 2015
U.S. Department of Veterans Affairs September 2014 - October 2014
FDA August 2014 - September 2014
Ziopharm Oncology July 2014 - August 2014
Boston Children's Hospital May 2014 - June 2014
CVS Pharmacy May 2012 - June 2012
CVS Pharmacy May 2011 - January 2012
Skills
Pharmacy, Pharmacists, Medication Therapy..., Patient Counseling, Community Pharmacy, Pharmacueticals, Pharmaceutical Industry, Patient Education, Managed Care, IV, Prescription, Compounding, Pharmacy Practice, Certified Immunizer, Clinical Research, Pharmacology, Diabetes
Education
Massachusetts College of Pharmacy and Health Sciences 2009 — 2015
Doctor of Pharmacy (Pharm.D.), Pharmacy
Bayer HealthCare July 2015 - Present
Rutgers University July 2015 - Present
Norwood Hospital February 2015 - March 2015
CVS Pharmacy January 2015 - February 2015
U.S. Department of Veterans Affairs September 2014 - October 2014
FDA August 2014 - September 2014
Ziopharm Oncology July 2014 - August 2014
Boston Children's Hospital May 2014 - June 2014
CVS Pharmacy May 2012 - June 2012
CVS Pharmacy May 2011 - January 2012
Skills
Pharmacy, Pharmacists, Medication Therapy..., Patient Counseling, Community Pharmacy, Pharmacueticals, Pharmaceutical Industry, Patient Education, Managed Care, IV, Prescription, Compounding, Pharmacy Practice, Certified Immunizer, Clinical Research, Pharmacology, Diabetes
Education
Massachusetts College of Pharmacy and Health Sciences 2009 — 2015
Doctor of Pharmacy (Pharm.D.), Pharmacy
Sam Belongia Sam Belongia's FDA Experience May 2002 - July 2002
Job Regional Manager at Fortinet
Industry Information Technology and Services
Experience
Fortinet December 2012 - Present
PKWARE March 2011 - November 2012
CDW Government, Inc. February 2005 - January 2009
FDA May 2002 - July 2002
Skills
Account Management, Strategic Planning, Business Development, Sales Operations, CRM, Channel Partners, Management, Sales, Sales Management, Strategy, Forecasting, Market Research, Contract Negotiation
Education
Marquette University 2009 — 2010
MBA, Business Administration
Marquette University 1999 — 2003
B.S., Biomedical Engineering
Fortinet December 2012 - Present
PKWARE March 2011 - November 2012
CDW Government, Inc. February 2005 - January 2009
FDA May 2002 - July 2002
Skills
Account Management, Strategic Planning, Business Development, Sales Operations, CRM, Channel Partners, Management, Sales, Sales Management, Strategy, Forecasting, Market Research, Contract Negotiation
Education
Marquette University 2009 — 2010
MBA, Business Administration
Marquette University 1999 — 2003
B.S., Biomedical Engineering
Gregory Bissonette's FDA Experience July 2011 - November 2011
Job
Industry Research
Experience
Food and Wine Blog June 2008 - May 2014
FDA July 2011 - November 2011
University of Maryland, Baltimore (UMB) August 2005 - July 2011
University of Maryland, Baltimore (UMB) June 2004 - August 2005
Skills
Neuroscience, Immunohistochemistry, Molecular Biology, Confocal Microscopy, Microscopy, Animal Models, Science, In Vivo, Histology, Fluorescence Microscopy, Electrophysiology, Scientific Writing, Cell Biology, Physiology, Matlab, Animal Behavior, PCR, Immunofluorescence, Grant Writing, Cyclic Voltammetry, Data Analysis, Life Sciences, Project Management, optogenetics, Pharmacology, Experimentation, Research, Statistics, Science Policy
Education
University of Maryland Baltimore 2005 — 2011
PhD
Loyola University Maryland 2001 — 2005
BS
Food and Wine Blog June 2008 - May 2014
FDA July 2011 - November 2011
University of Maryland, Baltimore (UMB) August 2005 - July 2011
University of Maryland, Baltimore (UMB) June 2004 - August 2005
Skills
Neuroscience, Immunohistochemistry, Molecular Biology, Confocal Microscopy, Microscopy, Animal Models, Science, In Vivo, Histology, Fluorescence Microscopy, Electrophysiology, Scientific Writing, Cell Biology, Physiology, Matlab, Animal Behavior, PCR, Immunofluorescence, Grant Writing, Cyclic Voltammetry, Data Analysis, Life Sciences, Project Management, optogenetics, Pharmacology, Experimentation, Research, Statistics, Science Policy
Education
University of Maryland Baltimore 2005 — 2011
PhD
Loyola University Maryland 2001 — 2005
BS
Caelyn D. Sommerville Caelyn D. Sommerville's FDA Experience June 2012 - August 2012
Job Student at Loyola University Maryland
Industry Performing Arts
Experience
Young Audiences of Maryland June 2015 - July 2015
Team of Stars Musical Theatre Summer Camp June 2014 - August 2014
Private Family Home August 2013 - May 2014
Baltimore Lab School September 2013 - December 2013
FDA June 2012 - August 2012
Press Office of Governor O'Malley June 2011 - August 2011
Panera Bread July 2010 - October 2010
Montgomery Dental Laboratory May 2008 - June 2009
Skills
Singing, Acting, Dance, Musical Theatre, Theatre, Drama, Stage, Music, Vocal
Education
Loyola College in Maryland 2012 — 2016
Speech-Language Pathology/Pathologist
Gaithersburg High School 2008 — 2012
High School Diploma
Young Audiences of Maryland June 2015 - July 2015
Team of Stars Musical Theatre Summer Camp June 2014 - August 2014
Private Family Home August 2013 - May 2014
Baltimore Lab School September 2013 - December 2013
FDA June 2012 - August 2012
Press Office of Governor O'Malley June 2011 - August 2011
Panera Bread July 2010 - October 2010
Montgomery Dental Laboratory May 2008 - June 2009
Skills
Singing, Acting, Dance, Musical Theatre, Theatre, Drama, Stage, Music, Vocal
Education
Loyola College in Maryland 2012 — 2016
Speech-Language Pathology/Pathologist
Gaithersburg High School 2008 — 2012
High School Diploma
Martin Kwok Martin Kwok's FDA Experience May 2015 - Present
Job CDER: Division of Pyschiatry Products at FDA
Industry Pharmaceuticals
Experience
FDA May 2015 - Present
MCPHS University July 2014 - Present
Biogen July 2014 - May 2015
FDA August 2013 - August 2013
The Ohio State University Comprehensive Cancer Center May 2012 - June 2013
The Ohio State University Comprehensive Cancer Center June 2006 - June 2012
Skills
Pharmacists, Pharmacy, Regulatory Affairs, Project Management, Medication Therapy..., Pharmacology, Pharmacy Practice, Clinical Pharmacology, Clinical Pharmacy, Compounding, Pharmacy Automation, Community Pharmacy, Clinical Research
Education
Massachusetts College of Pharmacy and Health Sciences
Graduate Certificate, Regulatory Affairs
The Ohio State University 2010 — 2014
Doctor of Pharmacy (PharmD)
The Ohio State University 2006 — 2010
Bachelor of Science (BS), Pharmaceutical Sciences
FDA May 2015 - Present
MCPHS University July 2014 - Present
Biogen July 2014 - May 2015
FDA August 2013 - August 2013
The Ohio State University Comprehensive Cancer Center May 2012 - June 2013
The Ohio State University Comprehensive Cancer Center June 2006 - June 2012
Skills
Pharmacists, Pharmacy, Regulatory Affairs, Project Management, Medication Therapy..., Pharmacology, Pharmacy Practice, Clinical Pharmacology, Clinical Pharmacy, Compounding, Pharmacy Automation, Community Pharmacy, Clinical Research
Education
Massachusetts College of Pharmacy and Health Sciences
Graduate Certificate, Regulatory Affairs
The Ohio State University 2010 — 2014
Doctor of Pharmacy (PharmD)
The Ohio State University 2006 — 2010
Bachelor of Science (BS), Pharmaceutical Sciences
Brett Boval Brett Boval's FDA Experience January 2014 - February 2015
Job R&D Engineer at Element Science
Industry Medical Devices
Experience
Element Science, Inc. August 2015 - Present
Edelman Lab September 2012 - August 2015
FDA January 2014 - February 2015
Edwards Lifesciences June 2012 - September 2012
Pacific Biosciences June 2011 - September 2011
Altman Vilandrie & Company January 2011 - January 2011
Manalis Lab @ MIT April 2010 - September 2010
Education
Massachusetts Institute of Technology 2012 — 2014
Master's degree, Mechanical Engineering
Massachusetts Institute of Technology 2009 — 2012
BS, Biological Engineering
Tesoro High School
Element Science, Inc. August 2015 - Present
Edelman Lab September 2012 - August 2015
FDA January 2014 - February 2015
Edwards Lifesciences June 2012 - September 2012
Pacific Biosciences June 2011 - September 2011
Altman Vilandrie & Company January 2011 - January 2011
Manalis Lab @ MIT April 2010 - September 2010
Education
Massachusetts Institute of Technology 2012 — 2014
Master's degree, Mechanical Engineering
Massachusetts Institute of Technology 2009 — 2012
BS, Biological Engineering
Tesoro High School
Ann Ferriter Ann Ferriter's FDA Experience 2011 - Present
Job Director, Division of Analysis and Program Operations CDRH/OC at FDA
Industry Medical Devices
Experience
FDA 2011 - Present
FDA October 2009 - November 2011
FDA January 2008 - October 2009
FDA September 2003 - January 2008
Ferriter Associates October 1995 - August 2003
Foster-Miller December 1990 - September 1995
Genus October 1989 - October 1990
Carco Electronics August 1987 - October 1989
Skills
FDA, Medical Devices, Public Health, Regulatory Submissions, Policy, Regulatory Affairs, Lifesciences, Strategy, Regulations, Orthopedic, GMP, Biomedical Engineering, Clinical Trials, Government, Proposal Writing, Quality Assurance, Quality System, Leadership, Risk Management, Biotechnology, Analysis, CAPA, Testing, Cardiology, Regulatory Requirements, Pharmaceutical Industry, Program Management, Quality Auditing, GCP, Clinical Development, Validation, Infectious Diseases, Operations, Business Process..., Strategic Planning
Education
Massachusetts Institute of Technology 1983 — 1987
BS, Mechanical Engineering
FDA 2011 - Present
FDA October 2009 - November 2011
FDA January 2008 - October 2009
FDA September 2003 - January 2008
Ferriter Associates October 1995 - August 2003
Foster-Miller December 1990 - September 1995
Genus October 1989 - October 1990
Carco Electronics August 1987 - October 1989
Skills
FDA, Medical Devices, Public Health, Regulatory Submissions, Policy, Regulatory Affairs, Lifesciences, Strategy, Regulations, Orthopedic, GMP, Biomedical Engineering, Clinical Trials, Government, Proposal Writing, Quality Assurance, Quality System, Leadership, Risk Management, Biotechnology, Analysis, CAPA, Testing, Cardiology, Regulatory Requirements, Pharmaceutical Industry, Program Management, Quality Auditing, GCP, Clinical Development, Validation, Infectious Diseases, Operations, Business Process..., Strategic Planning
Education
Massachusetts Institute of Technology 1983 — 1987
BS, Mechanical Engineering
Eric Holakiewicz Eric Holakiewicz's FDA Experience May 2012 - August 2012
Job Seeking Employment
Industry Medical Devices
Experience
Varsity Tutors LLC January 2014 - Present
MA Engineers April 2013 - August 2013
FDA May 2012 - August 2012
Skills
Matlab, Solidworks, Microsoft Office, Microsoft Excel, AutoCAD, Microsoft Word, PowerPoint, Research, Social Media, Public Speaking, Leadership, Time Management, Teamwork, Data Analysis, SolidWorks, Biotechnology, Mechanical Engineering, Project Management
Education
Marquette University 2010 — 2015
Bachelor of Science, Biomedical Engineering
San Dieguito Academny 2006 — 2010
High School, Biomedical/Medical Engineering
Varsity Tutors LLC January 2014 - Present
MA Engineers April 2013 - August 2013
FDA May 2012 - August 2012
Skills
Matlab, Solidworks, Microsoft Office, Microsoft Excel, AutoCAD, Microsoft Word, PowerPoint, Research, Social Media, Public Speaking, Leadership, Time Management, Teamwork, Data Analysis, SolidWorks, Biotechnology, Mechanical Engineering, Project Management
Education
Marquette University 2010 — 2015
Bachelor of Science, Biomedical Engineering
San Dieguito Academny 2006 — 2010
High School, Biomedical/Medical Engineering
Anastasiya Belyaeva Anastasiya Belyaeva's FDA Experience December 2012 - August 2013
Job PhD Student at Massachusetts Institute of Technology
Industry Research
Experience
University of Maryland September 2013 - August 2015
RePowered September 2014 - June 2015
University of Washington June 2014 - August 2014
FDA December 2012 - August 2013
Maryland Technology Enterprise Institute May 2012 - August 2012
National Institutes of Health June 2010 - August 2010
Skills
Python, Matlab, Research, Data Analysis, Statistics
Education
Massachusetts Institute of Technology 2015 — 2020
Doctor of Philosophy (Ph.D.)
University of Maryland College Park 2011 — 2015
Bachelor of Science (B.S.), Bioengineering, 3.907
University of Maryland September 2013 - August 2015
RePowered September 2014 - June 2015
University of Washington June 2014 - August 2014
FDA December 2012 - August 2013
Maryland Technology Enterprise Institute May 2012 - August 2012
National Institutes of Health June 2010 - August 2010
Skills
Python, Matlab, Research, Data Analysis, Statistics
Education
Massachusetts Institute of Technology 2015 — 2020
Doctor of Philosophy (Ph.D.)
University of Maryland College Park 2011 — 2015
Bachelor of Science (B.S.), Bioengineering, 3.907
Elizabeth (Gaudio) Dunn Elizabeth (Gaudio) Dunn's FDA Experience November 2011 - February 2013
Job SAS Programmer Analyst Health IT at Northrop Grumman Corporation
Industry Hospital & Health Care
Experience
Northrop Grumman Corporation February 2013 - Present
FDA November 2011 - February 2013
Loyola University Maryland September 2008 - May 2012
FDA July 2008 - September 2011
Education
Loyola College in Maryland 2004 — 2008
Mathematical Sciences
Northrop Grumman Corporation February 2013 - Present
FDA November 2011 - February 2013
Loyola University Maryland September 2008 - May 2012
FDA July 2008 - September 2011
Education
Loyola College in Maryland 2004 — 2008
Mathematical Sciences
Emily Canfield's FDA Experience May 2013 - August 2013
Job
Industry Biotechnology
Experience
Rockwell Automation May 2014 - Present
Marquette University 2013 - 2014
Marquette University 2013 - 2014
FDA May 2013 - August 2013
Pittsburgh Ballet Theatre August 2011 - January 2012
Skills
Firmware, FactoryTalk View, Pricing Analysis, Data Analysis, Project Management, Microsoft Excel, C++, Matlab, VNC, SAP, Lotus Notes, Microsoft Office, Scientific Papers, Profilometer, Microscopy, Clinical Research, SolidWorks, Adobe Acrobat, Time Management, Team Building
Education
Marquette University 2012 — 2017
Biomedical engineering, Bioelectronics
Benet Academy 2008 — 2011
High School
Rockwell Automation May 2014 - Present
Marquette University 2013 - 2014
Marquette University 2013 - 2014
FDA May 2013 - August 2013
Pittsburgh Ballet Theatre August 2011 - January 2012
Skills
Firmware, FactoryTalk View, Pricing Analysis, Data Analysis, Project Management, Microsoft Excel, C++, Matlab, VNC, SAP, Lotus Notes, Microsoft Office, Scientific Papers, Profilometer, Microscopy, Clinical Research, SolidWorks, Adobe Acrobat, Time Management, Team Building
Education
Marquette University 2012 — 2017
Biomedical engineering, Bioelectronics
Benet Academy 2008 — 2011
High School
Kenneth Shatzkes's FDA Experience August 2012 - August 2013
Job Ph.D. Candidate at Rutgers Biomedical and Health Sciences
Industry Research
Experience
Rutgers Graduate School of Biomedical Sciences August 2013 - Present
FDA August 2012 - August 2013
J. Craig Venter Institute July 2009 - August 2012
J. Craig Venter Institute May 2008 - August 2008
NYU Langone Medical Center October 2003 - January 2005
Skills
Molecular Biology, Cell Culture, RNA isolation, qPCR, DNA sequencing, Microbiology, Virology, Infectious Diseases, Functional Genomics, Bacterial Cell Culture, Virus Culture, Tissue Culture, Agarose Gel..., DNA extraction, PCR, RT-PCR, DNA microarray, Agilent, RNAseq, Western Blotting, SDS-PAGE, Plaque Assay, Metagenomics, Molecular Cloning, Assay Development, Laboratory Automation, Sonication, Pipetting, Laboratory, DNA, Genomics
Education
Rutgers University 2013 — 2018
Doctor of Philosophy (Ph.D.), Infection, Immunity, and Inflammation (I3)
McGill University 2005 — 2009
Bachelor of Science (B.Sc.), Molecular Genetics and Development
Rutgers Graduate School of Biomedical Sciences August 2013 - Present
FDA August 2012 - August 2013
J. Craig Venter Institute July 2009 - August 2012
J. Craig Venter Institute May 2008 - August 2008
NYU Langone Medical Center October 2003 - January 2005
Skills
Molecular Biology, Cell Culture, RNA isolation, qPCR, DNA sequencing, Microbiology, Virology, Infectious Diseases, Functional Genomics, Bacterial Cell Culture, Virus Culture, Tissue Culture, Agarose Gel..., DNA extraction, PCR, RT-PCR, DNA microarray, Agilent, RNAseq, Western Blotting, SDS-PAGE, Plaque Assay, Metagenomics, Molecular Cloning, Assay Development, Laboratory Automation, Sonication, Pipetting, Laboratory, DNA, Genomics
Education
Rutgers University 2013 — 2018
Doctor of Philosophy (Ph.D.), Infection, Immunity, and Inflammation (I3)
McGill University 2005 — 2009
Bachelor of Science (B.Sc.), Molecular Genetics and Development
Benjamin Rappaport Benjamin Rappaport's FDA Experience May 2014 - July 2014
Job Electrical Engineering CoOp at AWLake Company
Industry
Experience
AW-Lake Company May 2015 - Present
FDA May 2014 - July 2014
Marquette University 2013 - 2014
Moxi Global May 2013 - August 2013
Skills
Troubleshooting, Procedure Manuals, System Testing, Microsoft Excel, Microsoft Office, Science, Microsoft Word, Calibration, Editing, Research, PowerPoint, Facebook
Education
Marquette University 2013 — 2017
Bachelor of Science (B.S.), Biomedical/Bioelectrical Engineering
AW-Lake Company May 2015 - Present
FDA May 2014 - July 2014
Marquette University 2013 - 2014
Moxi Global May 2013 - August 2013
Skills
Troubleshooting, Procedure Manuals, System Testing, Microsoft Excel, Microsoft Office, Science, Microsoft Word, Calibration, Editing, Research, PowerPoint, Facebook
Education
Marquette University 2013 — 2017
Bachelor of Science (B.S.), Biomedical/Bioelectrical Engineering
Trupti Patel's FDA Experience May 2010 - September 2010
Job Systems Engineer for Technology Infrastructure at Avanade
Industry Medical Devices
Experience
Avanade June 2013 - Present
Fenwal, Inc. May 2012 - September 2012
Marquette University August 2010 - September 2012
FDA May 2010 - September 2010
Skills
SharePoint, C++, Matlab, Labview, Microsoft Excel, Microsoft Exchange, Microsoft Office, Medical Devices, Medical Imaging, Biomechanics, Solidworks, Minitab, Validation, Signal Processing, Statistics, 3D Doctor, Linux, Mac OS, Technical Writing, Windows Server, Powershell, System Center Suite, Microsoft SQL Server, Shell Scripting
Education
Marquette University 2009 — 2013
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Avanade June 2013 - Present
Fenwal, Inc. May 2012 - September 2012
Marquette University August 2010 - September 2012
FDA May 2010 - September 2010
Skills
SharePoint, C++, Matlab, Labview, Microsoft Excel, Microsoft Exchange, Microsoft Office, Medical Devices, Medical Imaging, Biomechanics, Solidworks, Minitab, Validation, Signal Processing, Statistics, 3D Doctor, Linux, Mac OS, Technical Writing, Windows Server, Powershell, System Center Suite, Microsoft SQL Server, Shell Scripting
Education
Marquette University 2009 — 2013
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Vivian Pratt's FDA Experience May 1992 - February 1995
Job Counsel at Goodwin Procter LLP
Industry Law Practice
Experience
Goodwin Procter LLP July 2009 - Present
Draeger January 2005 - November 2006
AAI December 1999 - June 2003
Siemens March 1995 - December 1999
FDA May 1992 - February 1995
Jones Walker LLP December 1983 - April 1992
Education
Loyola University New Orleans 1978 — 1981
Juris Doctor, Law
Loyola University New Orleans 1974 — 1978
Bachelor of Arts (B.A.), cum laude, Political Science
Goodwin Procter LLP July 2009 - Present
Draeger January 2005 - November 2006
AAI December 1999 - June 2003
Siemens March 1995 - December 1999
FDA May 1992 - February 1995
Jones Walker LLP December 1983 - April 1992
Education
Loyola University New Orleans 1978 — 1981
Juris Doctor, Law
Loyola University New Orleans 1974 — 1978
Bachelor of Arts (B.A.), cum laude, Political Science
Philip Desjardins Philip Desjardins's FDA Experience 2005 - June 2014
Job Vice President, Johnson & Johnson
Industry Medical Devices
Experience
Johnson & Johnson Vice President, Global Regulatory Policy & IntelligenceJohnson & JohnsonJune 2015 - Present
Arnold & Porter June 2014 - June 2015
FDA 2005 - June 2014
Education
The Catholic University of America 2003 — 2006
Doctor of Law (JD)
Loyola University Maryland 1998 — 2002
Bachelor's degree, Biology
Johnson & Johnson Vice President, Global Regulatory Policy & IntelligenceJohnson & JohnsonJune 2015 - Present
Arnold & Porter June 2014 - June 2015
FDA 2005 - June 2014
Education
The Catholic University of America 2003 — 2006
Doctor of Law (JD)
Loyola University Maryland 1998 — 2002
Bachelor's degree, Biology
CT Viswanathan CT Viswanathan's FDA Experience 1991 - October 2011
Job President
Industry Pharmaceuticals
Experience
CT Viswanathan & Associates, Inc October 2011 - Present
FDA 1991 - October 2011
FDA 1988 - 1991
FDA 1980 - 1988
Skills
GLP, FDA, Pharmacokinetics, IND, Bioanalysis, Regulatory Submissions, Toxicology, NDA, Regulatory Affairs, Clinical Pharmacology, Bioequivalence, Pharmacology, Sop, ANDA, Regulatory Requirements, Clinical Development, CRO
Education
University of Washington, Seattle
Post-doctoral Research, Pharmacokinetics
University of Georgia, Athens
Post-doctoral Research, Pharmacokinetics
University of Wisconsin-Madison 1974 — 1977
Doctor of Philosophy (PhD), Pharmacokinetics
Marquette University
Master of Science (M.S.), Organometallic Chemistry
CT Viswanathan & Associates, Inc October 2011 - Present
FDA 1991 - October 2011
FDA 1988 - 1991
FDA 1980 - 1988
Skills
GLP, FDA, Pharmacokinetics, IND, Bioanalysis, Regulatory Submissions, Toxicology, NDA, Regulatory Affairs, Clinical Pharmacology, Bioequivalence, Pharmacology, Sop, ANDA, Regulatory Requirements, Clinical Development, CRO
Education
University of Washington, Seattle
Post-doctoral Research, Pharmacokinetics
University of Georgia, Athens
Post-doctoral Research, Pharmacokinetics
University of Wisconsin-Madison 1974 — 1977
Doctor of Philosophy (PhD), Pharmacokinetics
Marquette University
Master of Science (M.S.), Organometallic Chemistry
Nick Dermody's FDA Experience August 2003 - December 2003
Job Principal Acquisition Engineer, Due Diligence and Integration Quality Team Lead, ASQ CQE, PMI PMP
Industry Medical Devices
Experience
Boston Scientific November 2013 - Present
Boston Scientific March 2011 - November 2013
Boston Scientific October 2008 - March 2011
Boston Scientific February 2008 - October 2008
Boston Scientific June 2007 - February 2008
Boston Scientific October 2006 - June 2007
Boston Scientific November 2005 - October 2006
FDA August 2003 - December 2003
Skills
Process Validation, Medical Devices, Validation, Quality Systems, Quality Management, Project Management, Team Management, Risk Management, Design Control, Quality System, Testing, Product Development, V&V, Manufacturing
Education
Marquette University 2001 — 2005
Bachelors of Science, Biomedical Engineering (Biomechanical)
Boston Scientific November 2013 - Present
Boston Scientific March 2011 - November 2013
Boston Scientific October 2008 - March 2011
Boston Scientific February 2008 - October 2008
Boston Scientific June 2007 - February 2008
Boston Scientific October 2006 - June 2007
Boston Scientific November 2005 - October 2006
FDA August 2003 - December 2003
Skills
Process Validation, Medical Devices, Validation, Quality Systems, Quality Management, Project Management, Team Management, Risk Management, Design Control, Quality System, Testing, Product Development, V&V, Manufacturing
Education
Marquette University 2001 — 2005
Bachelors of Science, Biomedical Engineering (Biomechanical)
Travis Ready's FDA Experience September 2008 - Present
Job FDA
Industry Pharmaceuticals
Experience
FDA September 2008 - Present
Georgetown University Medical Center September 2013 - September 2013
Skills
Pharmacists, Clinical Research, Pharmacy Automation, Managed Care, Medication Therapy..., Pharmacy, Pharmaceutical Industry, Diabetes, Program Management, Pharmacy Benefit..., Clinical Pharmacology, Healthcare, Medicare Part D, Pharmaceutical Sales, Pharmacology
Education
Mercer University 1996 — 2000
PharmD, Pharmacy
The Johns Hopkins University
Biotech/Regulatory
FDA September 2008 - Present
Georgetown University Medical Center September 2013 - September 2013
Skills
Pharmacists, Clinical Research, Pharmacy Automation, Managed Care, Medication Therapy..., Pharmacy, Pharmaceutical Industry, Diabetes, Program Management, Pharmacy Benefit..., Clinical Pharmacology, Healthcare, Medicare Part D, Pharmaceutical Sales, Pharmacology
Education
Mercer University 1996 — 2000
PharmD, Pharmacy
The Johns Hopkins University
Biotech/Regulatory
Benjamin Paluch Benjamin Paluch's FDA Experience January 2008 - August 2008
Job Ph.D. Student at Roswell Park Cancer Institute
Industry Research
Experience
Roswell Park Cancer Institute June 2010 - Present
FDA January 2008 - August 2008
Education
University at Buffalo, The State University of New York 2010 — 2015
Doctor of Philosophy (Ph.D.), Molecular Pharmacology and Cancer Therapeutics
Marquette University 2006 — 2010
Bachelor of Science (B.S.), Biological Sciences
Canisius High School 2002 — 2006
Roswell Park Cancer Institute June 2010 - Present
FDA January 2008 - August 2008
Education
University at Buffalo, The State University of New York 2010 — 2015
Doctor of Philosophy (Ph.D.), Molecular Pharmacology and Cancer Therapeutics
Marquette University 2006 — 2010
Bachelor of Science (B.S.), Biological Sciences
Canisius High School 2002 — 2006
Seth Gates Seth Gates's FDA Experience January 2012 - Present
Job Biological Science Technician at FDA
Industry Biotechnology
Experience
FDA January 2012 - Present
Murray Brown Laboratories July 2011 - January 2012
American Income Life February 2011 - April 2011
Chili's Bar and Grill March 2007 - March 2011
S.T September 2010 - December 2010
University of Colorado Health Science Center January 2010 - May 2010
Lakeshore Athletic Club January 2006 - January 2007
Skills
Microbiology, Leadership, Food Safety, Food Science, Food, Microsoft Office, Time Management, Science, Sales, Customer Service, Customer Retention
Education
Metropolitan State University of Denver 2006 — 2010
BS, Biology, Minor Business Management
Broomfield High School
FDA January 2012 - Present
Murray Brown Laboratories July 2011 - January 2012
American Income Life February 2011 - April 2011
Chili's Bar and Grill March 2007 - March 2011
S.T September 2010 - December 2010
University of Colorado Health Science Center January 2010 - May 2010
Lakeshore Athletic Club January 2006 - January 2007
Skills
Microbiology, Leadership, Food Safety, Food Science, Food, Microsoft Office, Time Management, Science, Sales, Customer Service, Customer Retention
Education
Metropolitan State University of Denver 2006 — 2010
BS, Biology, Minor Business Management
Broomfield High School
Dr. Courtney (Watson) Schoessow, DHA, MPH Dr. Courtney (Watson) Schoessow, DHA, MPH's FDA Experience November 2013 - Present
Job Federal Appointment
Industry Health, Wellness and Fitness
Experience
FDA November 2013 - Present
Public Health Works! Consulting, LLC February 2010 - Present
Cancer Alliance of Texas 2008 - 2011
National Cancer Institute July 2008 - January 2010
Texas Agrilife Extension Service 2000 - 2008
Skills
Program Evaluation, Non-profits, Healthcare, Grant Writing, Program Development, Public Speaking, Research, Community Outreach, Strategic Planning, Epidemiology, Fundraising, Public Health, Leadership, Training, Nonprofits, Policy Analysis, Government, Program Management, Team Building, Grants, Analysis, Community Health, Policy, Global Health, Health Education, Healthcare Management
Education
Medical University of South Carolina 2011 — 2014
DHA, Doctorate of Health Administration - Inter-professional Studies
University of Hawaii at Manoa 1998 — 1999
Master, Public Health
Texas Woman's University 1991 — 1996
Bachelor of Science (BS), Biology, General
FDA November 2013 - Present
Public Health Works! Consulting, LLC February 2010 - Present
Cancer Alliance of Texas 2008 - 2011
National Cancer Institute July 2008 - January 2010
Texas Agrilife Extension Service 2000 - 2008
Skills
Program Evaluation, Non-profits, Healthcare, Grant Writing, Program Development, Public Speaking, Research, Community Outreach, Strategic Planning, Epidemiology, Fundraising, Public Health, Leadership, Training, Nonprofits, Policy Analysis, Government, Program Management, Team Building, Grants, Analysis, Community Health, Policy, Global Health, Health Education, Healthcare Management
Education
Medical University of South Carolina 2011 — 2014
DHA, Doctorate of Health Administration - Inter-professional Studies
University of Hawaii at Manoa 1998 — 1999
Master, Public Health
Texas Woman's University 1991 — 1996
Bachelor of Science (BS), Biology, General
Harsh Jain Harsh Jain's FDA Experience October 2014 - Present
Job Postdoctoral fellow at Food and Drug Administration
Industry Research
Experience
FDA October 2014 - Present
Skills
Drug Delivery, Synthetic Chemistry, Medicinal Chemistry, Synthetic Biology, FDA, Drug Discovery, LC-MS, NMR, Lifesciences, Molecular Modeling, HPLC, Organic Chemistry, In Vitro, Cell Culture, Chemistry, Pharmaceutical Industry, Biotechnology, Purification, R&D, Chromatography, Organic Synthesis, Drug Design, Assay Development, Flow Cytometry, Fluorescence Microscopy, UV/Vis, Mass Spectrometry, Pharmacology, Biochemistry, Pharmacokinetics, Protein Chemistry, Life Sciences
Education
University at Buffalo 2004 — 2010
Ph.D., Medicinal Chemistry
National Institute of Pharmaceutical Education and Research 2001 — 2002
MS, Medicinal Chemistry
Maharshi Dayanand University 1996 — 2001
B. Pharmacy, Pharmacy
FDA October 2014 - Present
Skills
Drug Delivery, Synthetic Chemistry, Medicinal Chemistry, Synthetic Biology, FDA, Drug Discovery, LC-MS, NMR, Lifesciences, Molecular Modeling, HPLC, Organic Chemistry, In Vitro, Cell Culture, Chemistry, Pharmaceutical Industry, Biotechnology, Purification, R&D, Chromatography, Organic Synthesis, Drug Design, Assay Development, Flow Cytometry, Fluorescence Microscopy, UV/Vis, Mass Spectrometry, Pharmacology, Biochemistry, Pharmacokinetics, Protein Chemistry, Life Sciences
Education
University at Buffalo 2004 — 2010
Ph.D., Medicinal Chemistry
National Institute of Pharmaceutical Education and Research 2001 — 2002
MS, Medicinal Chemistry
Maharshi Dayanand University 1996 — 2001
B. Pharmacy, Pharmacy
Stefan Jellbauer's FDA Experience August 2014 - June 2015
Job Field Application Scientist at Affymetrix
Industry Research
Experience
Affymetrix August 2015 - Present
Gut Microbiota for Health - Experts Exchange June 2015 - Present
Kolabtree May 2015 - Present
American Journal Experts January 2013 - Present
Vaximm AG January 2011 - Present
FDA August 2014 - June 2015
University of California, Irvine December 2010 - August 2014
Freelancer September 2010 - March 2014
U.S. Agency for Health Care Research and Quality's (AHRQ) Healthcare Horizon Scanning System January 2011 - December 2011
LMU-München October 2006 - March 2010
Skills
Microbiology, Cell Culture, Immunofluorescence, qRT-PCR, Mucosal Immunology, Scientific Writing, Mentoring, Flow Cytometry, Molecular Cloning, Training, Teaching, Mass Spectrometry, Mouse Models:..., Elispot/ELISA, Southern/Western/Norther..., Host Pathogen..., High-Performance Liquid..., Molecular Biology, Cell Biology, preclinical models of..., Recombinant Protein..., Confocal Imaging, Bioluminescent In Vivo..., Intravital Two Photon..., Nutritional Immunity, Cell, Biochemistry, Immunology, Protein Purification, Food Safety, Luminex, qPCR, Protein Expression, ELISA
Education
Ludwig-Maximilians Universität München 2000 — 2010
Master Degree (German Diploma), Biology (Molecular and Cellular Biology, Biochemistry; Genetics and Microbiology)
Universidad de Granada, Spain 2004 — 2005
Erasmus semester abroad:, Biology, scientific English, Spanish
Ludwig Maximilian Univ. of Munich
PhD, Biology; Medical Microbiology
Affymetrix August 2015 - Present
Gut Microbiota for Health - Experts Exchange June 2015 - Present
Kolabtree May 2015 - Present
American Journal Experts January 2013 - Present
Vaximm AG January 2011 - Present
FDA August 2014 - June 2015
University of California, Irvine December 2010 - August 2014
Freelancer September 2010 - March 2014
U.S. Agency for Health Care Research and Quality's (AHRQ) Healthcare Horizon Scanning System January 2011 - December 2011
LMU-München October 2006 - March 2010
Skills
Microbiology, Cell Culture, Immunofluorescence, qRT-PCR, Mucosal Immunology, Scientific Writing, Mentoring, Flow Cytometry, Molecular Cloning, Training, Teaching, Mass Spectrometry, Mouse Models:..., Elispot/ELISA, Southern/Western/Norther..., Host Pathogen..., High-Performance Liquid..., Molecular Biology, Cell Biology, preclinical models of..., Recombinant Protein..., Confocal Imaging, Bioluminescent In Vivo..., Intravital Two Photon..., Nutritional Immunity, Cell, Biochemistry, Immunology, Protein Purification, Food Safety, Luminex, qPCR, Protein Expression, ELISA
Education
Ludwig-Maximilians Universität München 2000 — 2010
Master Degree (German Diploma), Biology (Molecular and Cellular Biology, Biochemistry; Genetics and Microbiology)
Universidad de Granada, Spain 2004 — 2005
Erasmus semester abroad:, Biology, scientific English, Spanish
Ludwig Maximilian Univ. of Munich
PhD, Biology; Medical Microbiology
Andrey Yegorov, MBA, PMP, etc's FDA Experience December 2014 - Present
Job Program Analyst at FDA
Industry Information Technology and Services
Experience
FDA December 2014 - Present
DISA June 2010 - December 2014
URS Corporation (Apptis) August 2008 - May 2010
SAIC July 2007 - August 2008
Systalex Corp. January 2007 - April 2007
CACI (Paradigm Solutions) April 2006 - January 2007
URS Corporation (Apptis Corp) January 2001 - April 2006
Eaton Corporation March 2000 - January 2001
Delta Ltd August 1998 - November 1999
Skills
PMP, ITIL v3 Foundations..., Oracle Certified D, Oracle Certified..., IT Service Management, Program Management, Configuration Management, SDLC, CMMI, IT Management, Requirements Analysis, ITIL, DoD, Information Assurance, IT Strategy, Integration, Data Center, MS Project, Enterprise Architecture, Software Project..., Visio, SharePoint, Project Portfolio..., Process Improvement, Disaster Recovery, Security Clearance, Business Analysis, Risk Management, CISSP, Systems Engineering, Government, Resource Management, PMO, Security, Information Technology
Education
University of Maryland - Robert H. Smith School of Business 2004 — 2007
MBA, IT Management, Marketing
Mendeleyev University of Chemical Technology of Russia 1995 — 1999
FDA December 2014 - Present
DISA June 2010 - December 2014
URS Corporation (Apptis) August 2008 - May 2010
SAIC July 2007 - August 2008
Systalex Corp. January 2007 - April 2007
CACI (Paradigm Solutions) April 2006 - January 2007
URS Corporation (Apptis Corp) January 2001 - April 2006
Eaton Corporation March 2000 - January 2001
Delta Ltd August 1998 - November 1999
Skills
PMP, ITIL v3 Foundations..., Oracle Certified D, Oracle Certified..., IT Service Management, Program Management, Configuration Management, SDLC, CMMI, IT Management, Requirements Analysis, ITIL, DoD, Information Assurance, IT Strategy, Integration, Data Center, MS Project, Enterprise Architecture, Software Project..., Visio, SharePoint, Project Portfolio..., Process Improvement, Disaster Recovery, Security Clearance, Business Analysis, Risk Management, CISSP, Systems Engineering, Government, Resource Management, PMO, Security, Information Technology
Education
University of Maryland - Robert H. Smith School of Business 2004 — 2007
MBA, IT Management, Marketing
Mendeleyev University of Chemical Technology of Russia 1995 — 1999
John Cyrus, M.S, PMP® FAC-COR II's FDA Experience January 2014 - Present
Job Office of Business Infomatics at FDA
Industry Information Technology and Services
Experience
FDA January 2014 - Present
Education
Wichita State University 1991 — 1994
MS
Madurai Kamaraj University 1987 — 1991
B.E
Christ Church Anglo Indian Higher Secondary School 1975 — 1985
FDA January 2014 - Present
Education
Wichita State University 1991 — 1994
MS
Madurai Kamaraj University 1987 — 1991
B.E
Christ Church Anglo Indian Higher Secondary School 1975 — 1985
Jessica J Lee's FDA Experience February 2013 - Present
Job Medical Team Leader at FDA
Industry Government Administration
Experience
FDA February 2013 - Present
Children's Hospital Boston January 2011 - Present
Harvard Medical School January 2011 - Present
FDA January 2011 - February 2013
Children's Hospital Boston July 2008 - December 2010
Harvard Medical School July 2008 - December 2010
Children's Hospital Boston July 2005 - June 2008
Children's Hospital at Montefiore, Albert Einstein College of Medicine July 2002 - June 2005
Education
Harvard Medical School 2008 — 2010
M.M.Sc.
State University of New York Upstate Medical University 1998 — 2002
M.D.
Massachusetts Institute of Technology 1992 — 1996
B.S.
FDA February 2013 - Present
Children's Hospital Boston January 2011 - Present
Harvard Medical School January 2011 - Present
FDA January 2011 - February 2013
Children's Hospital Boston July 2008 - December 2010
Harvard Medical School July 2008 - December 2010
Children's Hospital Boston July 2005 - June 2008
Children's Hospital at Montefiore, Albert Einstein College of Medicine July 2002 - June 2005
Education
Harvard Medical School 2008 — 2010
M.M.Sc.
State University of New York Upstate Medical University 1998 — 2002
M.D.
Massachusetts Institute of Technology 1992 — 1996
B.S.
Shay Karls's FDA Experience June 2001 - August 2001
Job Primary Examiner at USPTO
Industry Government Relations
Experience
USPTO June 2002 - Present
FDA June 2001 - August 2001
Skills
Patents, Intellectual Property, Patentability, Patent Prosecution, Prosecution, Patent Litigation, Strategic Planning, Government, Legal Research, Invention, Legal Writing, Customer Service, FDA, Trademarks, Policy
Education
Marquette University 1998 — 2002
Bachelor of Science (BS), Biomedical/Medical Engineering
Oak Creek High School 1994 — 1998
USPTO June 2002 - Present
FDA June 2001 - August 2001
Skills
Patents, Intellectual Property, Patentability, Patent Prosecution, Prosecution, Patent Litigation, Strategic Planning, Government, Legal Research, Invention, Legal Writing, Customer Service, FDA, Trademarks, Policy
Education
Marquette University 1998 — 2002
Bachelor of Science (BS), Biomedical/Medical Engineering
Oak Creek High School 1994 — 1998
Lawrence Baylis's FDA Experience May 2000 - August 2000
Job Business Manager Neonatology at Nationwide Children's Hospital
Industry Hospital & Health Care
Experience
Nationwide Childrens Hospital March 2014 - Present
The Ohio State University Wexner Medical Center May 2013 - March 2014
Nationwide Childrens Hospital April 2012 - May 2013
The James Cancer Hospital and Solove Research Institute September 2011 - April 2012
The Ohio State University Medical Center June 2011 - November 2011
GE Healthcare January 2008 - October 2010
Medtronic July 2003 - January 2008
FDA May 2000 - August 2000
Skills
Healthcare Information..., Healthcare, Healthcare Management, Medical Devices, Public Health, Managed Care, Process Improvement, Leadership, Revenue Cycle, Hospitals, EMR, Informatics, Biomedical Engineering, Clinical Research, EHR, Epic Systems, HIPAA, Quality Assurance
Education
The Ohio State University 2010 — 2012
Masters of Health Adminstration
Marquette University 2009 — 2010
Graduate Business courses
Marquette University 1998 — 2003
Biomedical Engineering, Biomedical/Medical Engineering
Nationwide Childrens Hospital March 2014 - Present
The Ohio State University Wexner Medical Center May 2013 - March 2014
Nationwide Childrens Hospital April 2012 - May 2013
The James Cancer Hospital and Solove Research Institute September 2011 - April 2012
The Ohio State University Medical Center June 2011 - November 2011
GE Healthcare January 2008 - October 2010
Medtronic July 2003 - January 2008
FDA May 2000 - August 2000
Skills
Healthcare Information..., Healthcare, Healthcare Management, Medical Devices, Public Health, Managed Care, Process Improvement, Leadership, Revenue Cycle, Hospitals, EMR, Informatics, Biomedical Engineering, Clinical Research, EHR, Epic Systems, HIPAA, Quality Assurance
Education
The Ohio State University 2010 — 2012
Masters of Health Adminstration
Marquette University 2009 — 2010
Graduate Business courses
Marquette University 1998 — 2003
Biomedical Engineering, Biomedical/Medical Engineering
Alice Hardwick's FDA Experience December 2010 - Present
Job Consumer Safety Officer
Industry Human Resources
Experience
FDA December 2010 - Present
Skills
Regulatory Affairs, Policy, Epidemiology, Data Analysis, Global Health, Public Health, Research, Infectious Diseases
Education
University of Maryland College Park 2008 — 2010
Public Health, Public Health
McDaniel College 2006 — 2010
FDA December 2010 - Present
Skills
Regulatory Affairs, Policy, Epidemiology, Data Analysis, Global Health, Public Health, Research, Infectious Diseases
Education
University of Maryland College Park 2008 — 2010
Public Health, Public Health
McDaniel College 2006 — 2010
TJ Christl's FDA Experience August 2013 - Present
Job Director, Office of Drug Security, Integrity & Recalls at FDA
Industry Government Administration
Experience
FDA August 2013 - Present
Monrovia Medical Unit Team 2 December 2014 - February 2015
FDA January 2012 - August 2013
US Food and Drug Administration August 2011 - January 2012
U.S. Food and Drug Administration 2003 - August 2011
Medical University of South Carolina 1995 - 2005
Skills
Policy, Regulatory Submissions, Research, Lifesciences, Government, FDA, Biotechnology, Clinical Research, Molecular Biology, Pharmaceutical Industry, Public Health, Regulatory Affairs
Education
Medical University of South Carolina 1995 — 2004
MS, Biomedical Technology
University of Miami 1991 — 1995
BS, Biology, Marine Science
FDA August 2013 - Present
Monrovia Medical Unit Team 2 December 2014 - February 2015
FDA January 2012 - August 2013
US Food and Drug Administration August 2011 - January 2012
U.S. Food and Drug Administration 2003 - August 2011
Medical University of South Carolina 1995 - 2005
Skills
Policy, Regulatory Submissions, Research, Lifesciences, Government, FDA, Biotechnology, Clinical Research, Molecular Biology, Pharmaceutical Industry, Public Health, Regulatory Affairs
Education
Medical University of South Carolina 1995 — 2004
MS, Biomedical Technology
University of Miami 1991 — 1995
BS, Biology, Marine Science
Jeffrey Solar's FDA Experience January 2011 - Present
Job IT Program Manager at FDA
Industry Information Technology and Services
Experience
FDA January 2011 - Present
Northrop Grumman January 1993 - January 2010
BDM 1993 - 2000
W.R. Grace 1987 - 1993
Allied Signal 1980 - 1987
Skills
Program Management, Enterprise Architecture
Education
Massachusetts Institute of Technology 1974 — 1978
Ph.D., Inorganic Chemistry
University of California, Berkeley 1971 — 1974
A.B., Chemistry
University of California, San Diego 1970 — 1971
Del Mar High School 1966 — 1970
FDA January 2011 - Present
Northrop Grumman January 1993 - January 2010
BDM 1993 - 2000
W.R. Grace 1987 - 1993
Allied Signal 1980 - 1987
Skills
Program Management, Enterprise Architecture
Education
Massachusetts Institute of Technology 1974 — 1978
Ph.D., Inorganic Chemistry
University of California, Berkeley 1971 — 1974
A.B., Chemistry
University of California, San Diego 1970 — 1971
Del Mar High School 1966 — 1970
Martin P Nevitt, M.D., M.P.H.'s FDA Experience 2004 - Present
Job Senior Medical Officer at FDA
Industry Pharmaceuticals
Experience
FDA 2004 - Present
LaserSight Technologies 1995 - 2003
Skills
Pharmacovigilance, FDA, Medicine, Clinical Research, Internal Medicine, Ophthalmology, Regulatory Affairs, Clinical Trials, Commercialization, Medical Devices, Pharmaceutical Industry, Drug Development, Surgery, Biotechnology, Lifesciences, Regulatory Submissions, Clinical Development, Medical Education, Healthcare, Product Development
Education
University of North Carolina at Chapel Hill 1974 — 1978
Bachelor's degree, Chemistry
Mayo Graduate School
FDA 2004 - Present
LaserSight Technologies 1995 - 2003
Skills
Pharmacovigilance, FDA, Medicine, Clinical Research, Internal Medicine, Ophthalmology, Regulatory Affairs, Clinical Trials, Commercialization, Medical Devices, Pharmaceutical Industry, Drug Development, Surgery, Biotechnology, Lifesciences, Regulatory Submissions, Clinical Development, Medical Education, Healthcare, Product Development
Education
University of North Carolina at Chapel Hill 1974 — 1978
Bachelor's degree, Chemistry
Mayo Graduate School
Jeffrey Blumenstein's FDA Experience 1990 - 1994
Job J&J
Industry Pharmaceuticals
Experience
Johnson & Johnson 2011 - Present
Johnson & Johnson / Janssen Pharmaceutica 2007 - 2011
Pfizer 1998 - 2007
Pfizer Pharmaceuticals 1998 - 2007
FDA 1990 - 1994
FOOD AND DRUG ADMINISTRATION CDER 1990 - 1994
Skills
FDA, Regulatory Affairs, Pharmaceuticals, GMP, R&D, Strategic Planning, Technology Transfer, Validation, Pharmaceutical Industry, HPLC, Clinical Development, Medical Devices, Quality Assurance, Sop, Formulation, Drug Delivery, Drug Development, Clinical Trials, 21 CFR Part 11, GLP, Biopharmaceuticals, SOP
Education
Massachusetts Institute of Technology 1982 — 1987
Johnson & Johnson 2011 - Present
Johnson & Johnson / Janssen Pharmaceutica 2007 - 2011
Pfizer 1998 - 2007
Pfizer Pharmaceuticals 1998 - 2007
FDA 1990 - 1994
FOOD AND DRUG ADMINISTRATION CDER 1990 - 1994
Skills
FDA, Regulatory Affairs, Pharmaceuticals, GMP, R&D, Strategic Planning, Technology Transfer, Validation, Pharmaceutical Industry, HPLC, Clinical Development, Medical Devices, Quality Assurance, Sop, Formulation, Drug Delivery, Drug Development, Clinical Trials, 21 CFR Part 11, GLP, Biopharmaceuticals, SOP
Education
Massachusetts Institute of Technology 1982 — 1987
Elaine Johanson's FDA Experience December 2012 - Present
Job Director, IT PMO at FDA
Industry Information Technology and Services
Experience
FDA December 2012 - Present
FDA April 2011 - Present
USDA-RD April 2010 - March 2011
FDA October 2008 - April 2010
Skills
Federal Government, Enterprise Architecture, Government, SDLC, Policy, Program Management, Integration, Governance, Fundraising, PMO, Government Contracting, PMP, IT Strategy, Security, Project Management, Process Improvement, Risk Management, Business Intelligence, Technical Writing, Information Assurance, Data Analysis, Business Process..., Requirements Analysis, SharePoint, Analysis, Project Portfolio..., IT Management
Education
Loyola University Maryland
FDA December 2012 - Present
FDA April 2011 - Present
USDA-RD April 2010 - March 2011
FDA October 2008 - April 2010
Skills
Federal Government, Enterprise Architecture, Government, SDLC, Policy, Program Management, Integration, Governance, Fundraising, PMO, Government Contracting, PMP, IT Strategy, Security, Project Management, Process Improvement, Risk Management, Business Intelligence, Technical Writing, Information Assurance, Data Analysis, Business Process..., Requirements Analysis, SharePoint, Analysis, Project Portfolio..., IT Management
Education
Loyola University Maryland
Lesley Furlong's FDA Experience October 1999 - Present
Job Acting Director of Division of Clinical Review at FDA"s Office of Generic Drugs
Industry Pharmaceuticals
Experience
FDA"s Office of Generic Drugs July 2014 - Present
FDA/CDER/Office of Generic Drugs/Division of Clinical Review 2014 - Present
FDA October 1999 - Present
FDA/CDER/Division of Nonprescription Clinical Evaluation 2008 - 2014
Food & Drug Administration 1999 - 2008
Skills
Clinical Trials, Infectious Diseases, Drug Development, Medicine, Regulatory Affairs
Education
McGill University
B. Sc., First Class Honours in Biochemistry
University of Wisconsin-Madison
M.S., Molecular Genetics, Wisconsin Alumni Research Foundation Fellow
Washington University in St. Louis School of Medicine
MD
FDA"s Office of Generic Drugs July 2014 - Present
FDA/CDER/Office of Generic Drugs/Division of Clinical Review 2014 - Present
FDA October 1999 - Present
FDA/CDER/Division of Nonprescription Clinical Evaluation 2008 - 2014
Food & Drug Administration 1999 - 2008
Skills
Clinical Trials, Infectious Diseases, Drug Development, Medicine, Regulatory Affairs
Education
McGill University
B. Sc., First Class Honours in Biochemistry
University of Wisconsin-Madison
M.S., Molecular Genetics, Wisconsin Alumni Research Foundation Fellow
Washington University in St. Louis School of Medicine
MD
Janine Morris's FDA Experience February 2012 - July 2015
Job Deputy Director for Policy, Regulatory Science and Strategic Collaboration at FDA Office of Special Medical Programs
Industry Medical Devices
Experience
FDA - Office of Special Medical Programs January 2015 - Present
FDA February 2012 - July 2015
FDA/CDRH/ODE/DRGUD/ULDB August 2010 - January 2012
FDA January 2009 - July 2010
FDA January 2008 - December 2008
Food and Drug Administration January 2008 - December 2008
FDA May 2001 - December 2007
FDA July 1990 - May 2001
Skills
Medical Devices, FDA, Orthopedic, Radiology, Neurology, Urology, Management, Regulatory Affairs, Quality System, Lifesciences, GMP, Program Management, Biotechnology, Government, CAPA
Education
Luleå University of Technology 1984 — 1989
Liscentiate, Engineering
University of Maryland College Park 1982 — 1984
BSME, Mechanical Engineering
FDA - Office of Special Medical Programs January 2015 - Present
FDA February 2012 - July 2015
FDA/CDRH/ODE/DRGUD/ULDB August 2010 - January 2012
FDA January 2009 - July 2010
FDA January 2008 - December 2008
Food and Drug Administration January 2008 - December 2008
FDA May 2001 - December 2007
FDA July 1990 - May 2001
Skills
Medical Devices, FDA, Orthopedic, Radiology, Neurology, Urology, Management, Regulatory Affairs, Quality System, Lifesciences, GMP, Program Management, Biotechnology, Government, CAPA
Education
Luleå University of Technology 1984 — 1989
Liscentiate, Engineering
University of Maryland College Park 1982 — 1984
BSME, Mechanical Engineering
Cindy Cho's FDA Experience April 2008 - Present
Job Regulatory Compliance Officer
Industry Pharmaceuticals
Experience
FDA April 2008 - Present
Giant Pharmacy August 2005 - April 2008
Skills
Regulatory Affairs, Regulatory Requirements, FDA, Pharmacovigilance, GMP, Pharmaceutical Industry, Pharmacists, Risk Management, Program Management, Process Improvement, Project Management, Research, Microsoft Office, Regulatory Submissions, Public Speaking, Strategic Planning, Government, Pharmacology
Education
Massachusetts College of Pharmacy and Health Sciences 1999 — 2005
Doctor of Pharmacy (Pharm.D.), Pharmacy
FDA April 2008 - Present
Giant Pharmacy August 2005 - April 2008
Skills
Regulatory Affairs, Regulatory Requirements, FDA, Pharmacovigilance, GMP, Pharmaceutical Industry, Pharmacists, Risk Management, Program Management, Process Improvement, Project Management, Research, Microsoft Office, Regulatory Submissions, Public Speaking, Strategic Planning, Government, Pharmacology
Education
Massachusetts College of Pharmacy and Health Sciences 1999 — 2005
Doctor of Pharmacy (Pharm.D.), Pharmacy
Rachel Leimbach's FDA Experience July 2001 - August 2001
Job Philips Healthcare
Industry Medical Devices
Experience
United States Air Force March 2007 - Present
Philips Healthcare January 2014 - April 2015
GE Energy July 2010 - March 2012
GE Healthcare May 2003 - July 2010
Siemens Medical Solutions August 2001 - January 2002
FDA July 2001 - August 2001
Skills
Process Improvement, Six Sigma, Operations Management, Manufacturing, DMAIC, Lean Manufacturing, Team Building, Supply Chain, Quality Management, Research, Continuous Improvement, Project Management, Strategic Planning, Change Management, Cross-functional Team..., Leadership, Program Management, Medical Imaging, Military, Medical Devices, Product Development, Quality System, FDA, Root Cause Analysis, Process Engineering, Engineering, Supply Chain Management, Product Management, Value Stream Mapping, FMEA, Kaizen, Healthcare, Quality Assurance, Microsoft Excel, Business Process..., Analysis
Education
Medical College of Wisconsin 2003 — 2005
M.S, Healthcare Technologies Management
Marquette University 1999 — 2003
BS, Bioelectrical Engineering
United States Air Force March 2007 - Present
Philips Healthcare January 2014 - April 2015
GE Energy July 2010 - March 2012
GE Healthcare May 2003 - July 2010
Siemens Medical Solutions August 2001 - January 2002
FDA July 2001 - August 2001
Skills
Process Improvement, Six Sigma, Operations Management, Manufacturing, DMAIC, Lean Manufacturing, Team Building, Supply Chain, Quality Management, Research, Continuous Improvement, Project Management, Strategic Planning, Change Management, Cross-functional Team..., Leadership, Program Management, Medical Imaging, Military, Medical Devices, Product Development, Quality System, FDA, Root Cause Analysis, Process Engineering, Engineering, Supply Chain Management, Product Management, Value Stream Mapping, FMEA, Kaizen, Healthcare, Quality Assurance, Microsoft Excel, Business Process..., Analysis
Education
Medical College of Wisconsin 2003 — 2005
M.S, Healthcare Technologies Management
Marquette University 1999 — 2003
BS, Bioelectrical Engineering
Dakshina Chilukuri's FDA Experience July 2002 - Present
Job Scientist at FDA
Industry Government Administration
Experience
FDA July 2002 - Present
Globomax LLC (now ICON US) March 2001 - July 2002
Genzyme Corporation June 1999 - March 2001
Skills
Drug Development, Regulatory Affairs, Pharmacology, Regulatory Submissions, Pharmacokinetics, GLP, Formulation, Clinical Development, Pharmaceutics, Drug Discovery, HPLC, FDA, IND, In Vitro, Pharmaceutical Industry, Drug Delivery
Education
Medical University of South Carolina 1995 — 1999
PhD, Pharmaceutical Sciences
FDA July 2002 - Present
Globomax LLC (now ICON US) March 2001 - July 2002
Genzyme Corporation June 1999 - March 2001
Skills
Drug Development, Regulatory Affairs, Pharmacology, Regulatory Submissions, Pharmacokinetics, GLP, Formulation, Clinical Development, Pharmaceutics, Drug Discovery, HPLC, FDA, IND, In Vitro, Pharmaceutical Industry, Drug Delivery
Education
Medical University of South Carolina 1995 — 1999
PhD, Pharmaceutical Sciences
Barbara Kass's FDA Experience October 2014 - Present
Job educator and counselor
Industry Hospital & Health Care
Experience
FDA October 2014 - Present
Agency for Healthcare Research and Quality 1998 - 2014
Skills
Process Improvement, Microsoft Excel, Public Speaking, Health Communication, Public Health, Microsoft Office, Healthcare, Policy Analysis, Mental Health, Research, Emergency Management, Global Health, Budgets, Government, Medical Education, Program Evaluation, Community Outreach, Policy, Creative Writing, Leadership Development, Training, Teaching, Coaching, Nonprofits, Healthcare Management, Grants, Psychotherapy, Clinical Research, Program Development, Data Analysis, Prevention, Public Relations, Editing, Grant Writing, Leadership, Analysis, Program Management, Blogging
Education
Loyola University Maryland 2007 — 2013
MS, Pastoral Counseling
The University of Texas Health Science Center at Houston 1996 — 1998
FDA October 2014 - Present
Agency for Healthcare Research and Quality 1998 - 2014
Skills
Process Improvement, Microsoft Excel, Public Speaking, Health Communication, Public Health, Microsoft Office, Healthcare, Policy Analysis, Mental Health, Research, Emergency Management, Global Health, Budgets, Government, Medical Education, Program Evaluation, Community Outreach, Policy, Creative Writing, Leadership Development, Training, Teaching, Coaching, Nonprofits, Healthcare Management, Grants, Psychotherapy, Clinical Research, Program Development, Data Analysis, Prevention, Public Relations, Editing, Grant Writing, Leadership, Analysis, Program Management, Blogging
Education
Loyola University Maryland 2007 — 2013
MS, Pastoral Counseling
The University of Texas Health Science Center at Houston 1996 — 1998
Carol Czerniak's FDA Experience October 2004 - August 2007
Job Healthcare Marketing & Recruitment
Industry Government Administration
Experience
Department of Veterans Affairs 2011 - Present
FDA October 2004 - August 2007
Commissioned Corps of the U.S. Public Health Service December 1998 - August 2007
FDA February 2002 - October 2004
Indian Health Service December 1998 - January 2002
Skills
Federal Government, Community Outreach, Grants, Public Health, Regulatory Affairs, Government, Marketing, Legislative Relations, Program Evaluation, Public Administration, Legislation, Nonprofits, Policy Analysis, Emergency Management, Recruiting, Public Policy, Program Development, Program Management, Proposal Writing, Healthcare, Policy
Education
Marquette University
Ripon College
Department of Veterans Affairs 2011 - Present
FDA October 2004 - August 2007
Commissioned Corps of the U.S. Public Health Service December 1998 - August 2007
FDA February 2002 - October 2004
Indian Health Service December 1998 - January 2002
Skills
Federal Government, Community Outreach, Grants, Public Health, Regulatory Affairs, Government, Marketing, Legislative Relations, Program Evaluation, Public Administration, Legislation, Nonprofits, Policy Analysis, Emergency Management, Recruiting, Public Policy, Program Development, Program Management, Proposal Writing, Healthcare, Policy
Education
Marquette University
Ripon College
Frank Lutterodt's FDA Experience Associate ScientistBiogen1998 - 2008
Job CSO/Regulatory Health Project Manager at FDA
Industry Government Administration
Experience
FDA Associate ScientistBiogen1998 - 2008
Education
Massachusetts College of Pharmacy and Health Sciences 2006 — 2008
MS, Regulatory Affairs
FDA Associate ScientistBiogen1998 - 2008
Education
Massachusetts College of Pharmacy and Health Sciences 2006 — 2008
MS, Regulatory Affairs
Sirarat Sarntivijai's FDA Experience May 2012 - November 2014
Job Bioinformatician Ontologist at EMBLEBI
Industry Biotechnology
Experience
EMBL-EBI December 2014 - Present
FDA May 2012 - November 2014
National Center for Integrative Biomedical Informatics September 2007 - April 2012
Center for Computational Medicine and Bioinformatics, University of Michigan May 2006 - June 2007
CCM Airport Equipment 2003 - 2004
BEA Systems 2002 - 2003
Skills
Bioinformatics, Python, Perl, Algorithms, Java, R, Programming, Systems Biology, Adverse Events, Data Mining, Ontology, Computational Biology, Pharmacology, Informatics, Biostatistics, Statistics, Machine Learning, Genomics, Genetics, Microarray Analysis
Education
University of Michigan 2007 — 2012
Ph.D., Bioinformatics
University of Michigan 2004 — 2006
M.Sc., Bioinformatics
Mahidol University 1998 — 2002
B.Sc., Computer Science
EMBL-EBI December 2014 - Present
FDA May 2012 - November 2014
National Center for Integrative Biomedical Informatics September 2007 - April 2012
Center for Computational Medicine and Bioinformatics, University of Michigan May 2006 - June 2007
CCM Airport Equipment 2003 - 2004
BEA Systems 2002 - 2003
Skills
Bioinformatics, Python, Perl, Algorithms, Java, R, Programming, Systems Biology, Adverse Events, Data Mining, Ontology, Computational Biology, Pharmacology, Informatics, Biostatistics, Statistics, Machine Learning, Genomics, Genetics, Microarray Analysis
Education
University of Michigan 2007 — 2012
Ph.D., Bioinformatics
University of Michigan 2004 — 2006
M.Sc., Bioinformatics
Mahidol University 1998 — 2002
B.Sc., Computer Science
Barbara Myklebust's FDA Experience July 2010 - December 2013
Job Associate Director, Office of Surveillance and Biometrics/CDRH at FDA
Industry Government Administration
Experience
FDA July 2010 - December 2013
George Washington University 2004 - October 2010
National Institutes of Health 2002 - 2004
Department of Health and Human Services 2002 - 2004
George Washington University 1997 - 2002
Skills
Research, Grant Writing, Science, Government, Lifesciences, Higher Education, Program Development, Program Evaluation, Teaching, Policy Analysis, Public Speaking, Policy, Grants, Statistics, Microsoft Office, Data Analysis
Education
Marquette University 1980 — 1986
MS, Biomedical Engineering
Rush Medical College of Rush University Medical Center
PhD, Physiology
FDA July 2010 - December 2013
George Washington University 2004 - October 2010
National Institutes of Health 2002 - 2004
Department of Health and Human Services 2002 - 2004
George Washington University 1997 - 2002
Skills
Research, Grant Writing, Science, Government, Lifesciences, Higher Education, Program Development, Program Evaluation, Teaching, Policy Analysis, Public Speaking, Policy, Grants, Statistics, Microsoft Office, Data Analysis
Education
Marquette University 1980 — 1986
MS, Biomedical Engineering
Rush Medical College of Rush University Medical Center
PhD, Physiology
David Litwack's FDA Experience September 2012 - Present
Job FDA Staff Fellow
Industry Public Policy
Experience
FDA September 2012 - Present
National Cancer Institute September 2010 - August 2012
University of Maryland School of Medicine January 2002 - July 2010
Salk Institute for Biological Studies June 1995 - January 2002
Skills
Cell Biology, Science, Genetics, Lifesciences, Molecular Biology, Biochemistry
Education
Massachusetts Institute of Technology 1988 — 1995
Ph.D., Biology
The University of Chicago 1984 — 1988
B.S., Chemistry
FDA September 2012 - Present
National Cancer Institute September 2010 - August 2012
University of Maryland School of Medicine January 2002 - July 2010
Salk Institute for Biological Studies June 1995 - January 2002
Skills
Cell Biology, Science, Genetics, Lifesciences, Molecular Biology, Biochemistry
Education
Massachusetts Institute of Technology 1988 — 1995
Ph.D., Biology
The University of Chicago 1984 — 1988
B.S., Chemistry
Teena Aiken's FDA Experience 1978 - 1985
Job Investigator at US Food and Drug Administration
Industry Law Enforcement
Experience
The United States Food and Drug Administration 2007 - Present
US Food and Drug Administration 1985 - Present
FDA 1978 - 1985
Skills
FDA, Regulatory Affairs, GLP, GMP, Medical Devices, Validation, Quality Auditing, Clinical Trials, Sop, IND, Regulatory Requirements, Clinical Research, GCP, ISO 13485, Biologics, Pharmacovigilance, 21 CFR Part 11, Clinical Development, Protocol, Regulations, Biopharmaceuticals, Technology Transfer, Analytical Chemistry, Drug Development, Oncology, Change Control, CRO, SOP
Education
Lubbock Christian University 1972 — 1976
B.S., Biology
The United States Food and Drug Administration 2007 - Present
US Food and Drug Administration 1985 - Present
FDA 1978 - 1985
Skills
FDA, Regulatory Affairs, GLP, GMP, Medical Devices, Validation, Quality Auditing, Clinical Trials, Sop, IND, Regulatory Requirements, Clinical Research, GCP, ISO 13485, Biologics, Pharmacovigilance, 21 CFR Part 11, Clinical Development, Protocol, Regulations, Biopharmaceuticals, Technology Transfer, Analytical Chemistry, Drug Development, Oncology, Change Control, CRO, SOP
Education
Lubbock Christian University 1972 — 1976
B.S., Biology
Gabriel Brackman's FDA Experience July 2007 - August 2007
Job Consultant at Accenture
Industry Information Technology and Services
Experience
Accenture October 2009 - Present
Siemens Healthcare June 2009 - October 2009
Marquette University August 2005 - May 2009
Welch Allyn May 2006 - August 2008
FDA July 2007 - August 2007
Skills
Technical Architecture, Technical Solution..., Software Design, JBoss Application Server, Web Architecture, Middleware, Red Hat Linux, Batch Processing, Enterprise Architecture, Spring Batch, Java, Project Management, SQL, Shell Scripting, Program Management, IT Strategy, Product Development, Requirements Analysis, Matlab, C, Testing, Visio, Agile Methodologies, Unix, Software Project..., SDLC, Requirements Gathering, Business Process Design, Business Intelligence, Software Development, SOA
Education
Marquette University 2004 — 2009
Bachlor, Biocomputer Engineering
Lakeshore 1999 — 2004
Accenture October 2009 - Present
Siemens Healthcare June 2009 - October 2009
Marquette University August 2005 - May 2009
Welch Allyn May 2006 - August 2008
FDA July 2007 - August 2007
Skills
Technical Architecture, Technical Solution..., Software Design, JBoss Application Server, Web Architecture, Middleware, Red Hat Linux, Batch Processing, Enterprise Architecture, Spring Batch, Java, Project Management, SQL, Shell Scripting, Program Management, IT Strategy, Product Development, Requirements Analysis, Matlab, C, Testing, Visio, Agile Methodologies, Unix, Software Project..., SDLC, Requirements Gathering, Business Process Design, Business Intelligence, Software Development, SOA
Education
Marquette University 2004 — 2009
Bachlor, Biocomputer Engineering
Lakeshore 1999 — 2004
Breanna McKenny's FDA Experience June 2007 - July 2007
Job Owner/Operator of 9Round Appleton
Industry Medical Devices
Experience
9Round Kickboxing Fitness 2015 - Present
Titan Spine May 2014 - July 2015
Essex Industries September 2013 - May 2014
Alphatec Spine August 2010 - June 2013
DePuy Orthopaedics August 2009 - May 2010
Marquette University College of Engineering August 2008 - May 2010
DePuy Orthopaedics August 2007 - May 2009
FDA June 2007 - July 2007
Skills
GD&T, CAD, Teamcenter, Agile Methodologies, Biomedical Engineering, Medical Devices, Minitab, Solidworks, Unigraphics, Labview, Design for Manufacturing, Matlab, FDA, Design of Experiments, Design Control, SolidWorks, Geometric Dimensioning..., LabVIEW, ISO 13485, Product Development, Cross-functional Team...
Education
Marquette University 2005 — 2010
Bachelor of Science, Biomechanical Engineering
9Round Kickboxing Fitness 2015 - Present
Titan Spine May 2014 - July 2015
Essex Industries September 2013 - May 2014
Alphatec Spine August 2010 - June 2013
DePuy Orthopaedics August 2009 - May 2010
Marquette University College of Engineering August 2008 - May 2010
DePuy Orthopaedics August 2007 - May 2009
FDA June 2007 - July 2007
Skills
GD&T, CAD, Teamcenter, Agile Methodologies, Biomedical Engineering, Medical Devices, Minitab, Solidworks, Unigraphics, Labview, Design for Manufacturing, Matlab, FDA, Design of Experiments, Design Control, SolidWorks, Geometric Dimensioning..., LabVIEW, ISO 13485, Product Development, Cross-functional Team...
Education
Marquette University 2005 — 2010
Bachelor of Science, Biomechanical Engineering
Sam Cincotta's FDA Experience May 2009 - August 2009
Job Pharmacist at Northside hospital
Industry Pharmaceuticals
Experience
Northside Hospital June 2015 - Present
Kingston University January 2014 - March 2015
St Georges Healthcare NHS Trust March 2014 - February 2015
Northside Hospital January 2012 - August 2013
Kroger September 2011 - December 2011
FDA May 2009 - August 2009
Indian Health Service June 2008 - August 2008
Skills
Pharmacists, Pharmacy, Medication Therapy..., Compounding, Hospital Pharmacy, Clinical Pharmacology, Emergency Room, Healthcare, Patient Counseling, Inpatient, Medicine, IV, Clinical Pharmacy, Clinical Trials, Clinical Research, Pharmaceutical Industry
Education
Mercer University 2007 — 2011
Doctor of Pharmacy, Pharmacy
The University of Georgia 2004 — 2007
BS, Biology
Northside Hospital June 2015 - Present
Kingston University January 2014 - March 2015
St Georges Healthcare NHS Trust March 2014 - February 2015
Northside Hospital January 2012 - August 2013
Kroger September 2011 - December 2011
FDA May 2009 - August 2009
Indian Health Service June 2008 - August 2008
Skills
Pharmacists, Pharmacy, Medication Therapy..., Compounding, Hospital Pharmacy, Clinical Pharmacology, Emergency Room, Healthcare, Patient Counseling, Inpatient, Medicine, IV, Clinical Pharmacy, Clinical Trials, Clinical Research, Pharmaceutical Industry
Education
Mercer University 2007 — 2011
Doctor of Pharmacy, Pharmacy
The University of Georgia 2004 — 2007
BS, Biology
Charles Tack's FDA Experience June 2008 - August 2008
Job Technical Support Specialist at Marquette University
Industry Information Technology and Services
Experience
Marquette University September 2010 - Present
Marquette University December 2009 - September 2010
Marquette University August 2009 - May 2010
FDA June 2008 - August 2008
Education
Marquette University 2005 — 2010
Marquette University 2005 — 2010
Biomedical Engineering
Marquette University September 2010 - Present
Marquette University December 2009 - September 2010
Marquette University August 2009 - May 2010
FDA June 2008 - August 2008
Education
Marquette University 2005 — 2010
Marquette University 2005 — 2010
Biomedical Engineering
Brooke Mullican, MS's FDA Experience July 2014 - Present
Job Manager, Career Development at FDA
Industry Human Resources
Experience
FDA July 2014 - Present
U.S. Department of Health & Human Services July 2009 - July 2014
Montgomery County Public Schools June 2008 - July 2009
Montgomery County Public Schools January 2001 - June 2008
Skills
Leadership Development, Coaching, Organizational..., Staff Development, Performance Management, Mentoring, Workforce Development, Adult Education, Career Advising, Public Speaking, Team Building, Employee Engagement, Onboarding, Talent Management, Policy, Strategic Planning, Executive Coaching, Career Counseling
Education
McDaniel College 2007 — 2009
Post Grad
University of Maryland University College 2003 — 2006
MS
Towson University 1997 — 2001
BS
FDA July 2014 - Present
U.S. Department of Health & Human Services July 2009 - July 2014
Montgomery County Public Schools June 2008 - July 2009
Montgomery County Public Schools January 2001 - June 2008
Skills
Leadership Development, Coaching, Organizational..., Staff Development, Performance Management, Mentoring, Workforce Development, Adult Education, Career Advising, Public Speaking, Team Building, Employee Engagement, Onboarding, Talent Management, Policy, Strategic Planning, Executive Coaching, Career Counseling
Education
McDaniel College 2007 — 2009
Post Grad
University of Maryland University College 2003 — 2006
MS
Towson University 1997 — 2001
BS
Benjamin Safron's FDA Experience May 2009 - June 2009
Job Senior Engineer (Contractor) at Baxter International Inc.
Industry Medical Devices
Experience
Baxter International Inc. July 2013 - Present
Northwestern University December 2012 - June 2013
Hospira September 2011 - December 2012
Marquette University January 2011 - May 2011
Baxter Healthcare 2008 - 2010
FDA May 2009 - June 2009
Skills
Verification, Validation, Minitab, Engineering Change..., GMP, Solidworks, Pro Engineer, V&V, Project Planning, Microsoft Excel, Biotechnology, Aseptic Technique, Purification, Medical Devices, Pharmaceutical Industry, Column Chromatography, FDA, Gel Electrophoresis, IR, GDP, Microsoft SQL Server, Matlab, German, NI LabVIEW, Biomechanics, IBM DOORS, Change Control Board, Design Review, Cellular Assays, Risk Assessment, Risk Reviews, Regulations, Product Design, Design Control, Drug Delivery, Cell Culture, Chromatography, Manufacturing Operations, MS Project
Education
Northwestern University 2012 — 2013
Master of Science (MS), Biomedical/Medical Engineering
Marquette University 2007 — 2012
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Baxter International Inc. July 2013 - Present
Northwestern University December 2012 - June 2013
Hospira September 2011 - December 2012
Marquette University January 2011 - May 2011
Baxter Healthcare 2008 - 2010
FDA May 2009 - June 2009
Skills
Verification, Validation, Minitab, Engineering Change..., GMP, Solidworks, Pro Engineer, V&V, Project Planning, Microsoft Excel, Biotechnology, Aseptic Technique, Purification, Medical Devices, Pharmaceutical Industry, Column Chromatography, FDA, Gel Electrophoresis, IR, GDP, Microsoft SQL Server, Matlab, German, NI LabVIEW, Biomechanics, IBM DOORS, Change Control Board, Design Review, Cellular Assays, Risk Assessment, Risk Reviews, Regulations, Product Design, Design Control, Drug Delivery, Cell Culture, Chromatography, Manufacturing Operations, MS Project
Education
Northwestern University 2012 — 2013
Master of Science (MS), Biomedical/Medical Engineering
Marquette University 2007 — 2012
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Brenton Thomas's FDA Experience January 1998 - May 1998
Job Independent Medical Devices Professional
Industry Medical Devices
Donna Bush's FDA Experience 2010 - 2011
Job Senior Forensic Toxicologist at Department of Health and Human Services
Industry Government Administration
Experience
Department of Health and Human Services 1989 - Present
FDA 2010 - 2011
Skills
Mass Spectrometry, HPLC, Chemistry, Chromatography, Immunology, Toxicology, Laboratory, PCR, Forensic Analysis, Science, Analytical Chemistry, Life Sciences, Biochemistry, Research, LC-MS, ELISA, Pharmacology, Gas Chromatography, Biotechnology, GLP, Clinical Research, Data Analysis, GC-MS, Molecular Biology, Healthcare, Validation, LIMS, Policy, UV/Vis, FDA
Education
Loyola University Maryland
Bachelor's Degree, Chemistry
The Johns Hopkins University
Master's Degree, Environmental Toxicology
University of Maryland Baltimore
Doctor of Philosophy (Ph.D.), Forensic Toxicology
University of Maryland Baltimore
Master’s Degree, Medicinal and Pharmaceutical Chemistry
Department of Health and Human Services 1989 - Present
FDA 2010 - 2011
Skills
Mass Spectrometry, HPLC, Chemistry, Chromatography, Immunology, Toxicology, Laboratory, PCR, Forensic Analysis, Science, Analytical Chemistry, Life Sciences, Biochemistry, Research, LC-MS, ELISA, Pharmacology, Gas Chromatography, Biotechnology, GLP, Clinical Research, Data Analysis, GC-MS, Molecular Biology, Healthcare, Validation, LIMS, Policy, UV/Vis, FDA
Education
Loyola University Maryland
Bachelor's Degree, Chemistry
The Johns Hopkins University
Master's Degree, Environmental Toxicology
University of Maryland Baltimore
Doctor of Philosophy (Ph.D.), Forensic Toxicology
University of Maryland Baltimore
Master’s Degree, Medicinal and Pharmaceutical Chemistry
Leah Rosenfeld's FDA Experience May 2012 - Present
Job Toxicologist at FDA
Industry Environmental Services
Experience
FDA May 2012 - Present
FDA May 2011 - May 2012
The National Academies January 2011 - April 2011
Skills
Science, Toxicology, Lifesciences, Molecular Biology, Cell Culture, Biochemistry, Cell Biology, Public Health, Pharmacology, Western Blotting, PCR, Scientific Writing, Biotechnology, Statistics, Life Sciences
Education
The Johns Hopkins University 2004 — 2010
Doctor of Philosophy (PhD), Toxicology
Massachusetts Institute of Technology 1999 — 2004
B.S., Biology, Biomedical Engineering
FDA May 2012 - Present
FDA May 2011 - May 2012
The National Academies January 2011 - April 2011
Skills
Science, Toxicology, Lifesciences, Molecular Biology, Cell Culture, Biochemistry, Cell Biology, Public Health, Pharmacology, Western Blotting, PCR, Scientific Writing, Biotechnology, Statistics, Life Sciences
Education
The Johns Hopkins University 2004 — 2010
Doctor of Philosophy (PhD), Toxicology
Massachusetts Institute of Technology 1999 — 2004
B.S., Biology, Biomedical Engineering
Lee S. Simon's FDA Experience November 2001 - December 2003
Job Principal, consultant at SDG LLC
Industry Pharmaceuticals
Experience
SDG LLC February 2004 - Present
SDG Consulting LLC 2004 - Present
Savient Pharmaceuticals, Inc. 2006 - 2012
omeract 1999 - 2011
Leerink Swann 2004 - 2010
FDA November 2001 - December 2003
Beth Israel Deaconess Medical Center July 1981 - October 2001
Massachusetts General Hospital July 1978 - June 1981
Johns Hopkins Hospital July 1976 - June 1978
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Development, Medicine, Drug Development, Biotechnology, Clinical Research, Rheumatology, Oncology, Internal Medicine, Neuroscience, Medical Education, Lifesciences, Infectious Diseases, Molecular Biology, Regulatory Affairs, Regulatory Submissions, Immunology, Biopharmaceuticals, Medical Writing, Pharmacology, Cancer, GCP, Life Sciences
Education
University of Maryland School of Medicine 1972 — 1976
Doctor of Medicine (MD)
Loyola College in Maryland 1969 — 1972
Biology, General
northwest high
SDG LLC February 2004 - Present
SDG Consulting LLC 2004 - Present
Savient Pharmaceuticals, Inc. 2006 - 2012
omeract 1999 - 2011
Leerink Swann 2004 - 2010
FDA November 2001 - December 2003
Beth Israel Deaconess Medical Center July 1981 - October 2001
Massachusetts General Hospital July 1978 - June 1981
Johns Hopkins Hospital July 1976 - June 1978
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Development, Medicine, Drug Development, Biotechnology, Clinical Research, Rheumatology, Oncology, Internal Medicine, Neuroscience, Medical Education, Lifesciences, Infectious Diseases, Molecular Biology, Regulatory Affairs, Regulatory Submissions, Immunology, Biopharmaceuticals, Medical Writing, Pharmacology, Cancer, GCP, Life Sciences
Education
University of Maryland School of Medicine 1972 — 1976
Doctor of Medicine (MD)
Loyola College in Maryland 1969 — 1972
Biology, General
northwest high
Neda Aghajani Memar, Pharm.D.'s FDA Experience October 2012 - November 2012
Job Senior Manager Regulatory Affairs at Novartis
Industry Pharmaceuticals
Experience
Novartis November 2014 - Present
Daiichi Sankyo, Inc. April 2013 - October 2014
Daiichi Sankyo, Inc. June 2011 - April 2013
FDA October 2012 - November 2012
FDA/CDER Drug Shortage Program March 2011 - April 2011
Johnson & Johnson August 2010 - September 2010
Pfizer Pharmaceuticals June 2009 - August 2009
Pfizer Pharmaceuticals June 2008 - August 2008
Skills
Regulatory Affairs, Pharmaceutical Industry, Pharmacy, Medicine, Pharmacists, Clinical Research, FDA, Pharmacology, Drug Development, Cardiovascular, Clinical Trials, Biotechnology, Clinical Development, Diabetes, Regulatory Submissions
Education
Massachusetts College of Pharmacy and Health Sciences 2005 — 2011
Doctorate, Pharmacy
Novartis November 2014 - Present
Daiichi Sankyo, Inc. April 2013 - October 2014
Daiichi Sankyo, Inc. June 2011 - April 2013
FDA October 2012 - November 2012
FDA/CDER Drug Shortage Program March 2011 - April 2011
Johnson & Johnson August 2010 - September 2010
Pfizer Pharmaceuticals June 2009 - August 2009
Pfizer Pharmaceuticals June 2008 - August 2008
Skills
Regulatory Affairs, Pharmaceutical Industry, Pharmacy, Medicine, Pharmacists, Clinical Research, FDA, Pharmacology, Drug Development, Cardiovascular, Clinical Trials, Biotechnology, Clinical Development, Diabetes, Regulatory Submissions
Education
Massachusetts College of Pharmacy and Health Sciences 2005 — 2011
Doctorate, Pharmacy
Kirthana Ganeshan's FDA Experience May 2004 - July 2004
Job Postdoctoral Scholar at UCSF
Industry Research
Experience
UCSF May 2012 - Present
Northwestern University 2006 - August 2012
The Ohio State University 2005 - 2006
Marquette University 2004 - 2005
FDA May 2004 - July 2004
Skills
Immunology, Cell Culture, Western Blotting, In Vitro, Cell Biology, Molecular Biology, PCR, Microscopy, Science, Flow Cytometry, Immunohistochemistry, Molecular Cloning, Cell, Life Sciences, qPCR, Experimental Design, Immunofluorescence, ELISA, In Vivo, Lifesciences
Education
Northwestern University 2006 — 2011
Ph. D, Immunology
Northwestern University - Kellogg School of Management 2010 — 2010
Certificate, Management
Marquette University 2001 — 2005
B. Sc., Molecular Biology and Biochemistry
UCSF May 2012 - Present
Northwestern University 2006 - August 2012
The Ohio State University 2005 - 2006
Marquette University 2004 - 2005
FDA May 2004 - July 2004
Skills
Immunology, Cell Culture, Western Blotting, In Vitro, Cell Biology, Molecular Biology, PCR, Microscopy, Science, Flow Cytometry, Immunohistochemistry, Molecular Cloning, Cell, Life Sciences, qPCR, Experimental Design, Immunofluorescence, ELISA, In Vivo, Lifesciences
Education
Northwestern University 2006 — 2011
Ph. D, Immunology
Northwestern University - Kellogg School of Management 2010 — 2010
Certificate, Management
Marquette University 2001 — 2005
B. Sc., Molecular Biology and Biochemistry
Amanda Zorn's FDA Experience AmeriCorps VISTAAmeriCorpsJuly 2007 - August 2008
Job Investigator at FDA
Industry Biotechnology
Experience
FDA AmeriCorps VISTAAmeriCorpsJuly 2007 - August 2008
Richland County Health Department 2007 - 2008
Skills
GMP, Research, Policy Analysis, Community Outreach
Education
Miami University 2003 — 2007
Bachelor, Microbiology, Physics
FDA AmeriCorps VISTAAmeriCorpsJuly 2007 - August 2008
Richland County Health Department 2007 - 2008
Skills
GMP, Research, Policy Analysis, Community Outreach
Education
Miami University 2003 — 2007
Bachelor, Microbiology, Physics
Laina Bush's FDA Experience September 1987 - September 1998
Job Associate Deputy Assistant Secretary for Planning and Evaluation, Science and Data Policy
Industry Government Administration
Experience
US Department of Health & Human Services January 2010 - Present
US Department of Health and Human Services October 2005 - January 2010
US Department of Health and Human Services September 1998 - October 2005
FDA September 1987 - September 1998
Skills
Policy Analysis, Government, Public Policy, Public Administration, Policy, Federal Government, Public Finance, Economics, Program Evaluation, International Relations, Politics, Health Policy, Strategic Communications, Environmental Policy, Nonprofits, Strategic Planning, Report Writing, Program Management, Local Government, Foreign Policy, Public Health, Public Speaking, Political Science, International..., Grants, Data Analysis, Political Campaigns, Fundraising, Research
Education
Marymount University
MBA
Vanderbilt University 1981 — 1985
BA, Economics, Business Administration
US Department of Health & Human Services January 2010 - Present
US Department of Health and Human Services October 2005 - January 2010
US Department of Health and Human Services September 1998 - October 2005
FDA September 1987 - September 1998
Skills
Policy Analysis, Government, Public Policy, Public Administration, Policy, Federal Government, Public Finance, Economics, Program Evaluation, International Relations, Politics, Health Policy, Strategic Communications, Environmental Policy, Nonprofits, Strategic Planning, Report Writing, Program Management, Local Government, Foreign Policy, Public Health, Public Speaking, Political Science, International..., Grants, Data Analysis, Political Campaigns, Fundraising, Research
Education
Marymount University
MBA
Vanderbilt University 1981 — 1985
BA, Economics, Business Administration
Rebecca Eichhorn's FDA Experience July 2010 - August 2010
Job Test Engineer 1 at GE Healthcare
Industry Medical Devices
Experience
GE Healthcare January 2014 - Present
TriMedx April 2012 - December 2013
Marquette University November 2009 - December 2011
FDA July 2010 - August 2010
Skills
Matlab, Data Analysis, Technical Writing, Solidworks, Biomedical Engineering, Research, Statistics, Microsoft Office, Biomechanics, Microsoft Excel, PowerPoint, Signal Processing, Design of Experiments, Microsoft Word, Programming, Analysis, Medical Devices, Troubleshooting
Education
Marquette University 2007 — 2011
BS, Biomedical Engineering
GE Healthcare January 2014 - Present
TriMedx April 2012 - December 2013
Marquette University November 2009 - December 2011
FDA July 2010 - August 2010
Skills
Matlab, Data Analysis, Technical Writing, Solidworks, Biomedical Engineering, Research, Statistics, Microsoft Office, Biomechanics, Microsoft Excel, PowerPoint, Signal Processing, Design of Experiments, Microsoft Word, Programming, Analysis, Medical Devices, Troubleshooting
Education
Marquette University 2007 — 2011
BS, Biomedical Engineering
Nicholas Bushar's FDA Experience July 2010 - Present
Job Research fellow at FDA
Industry Government Administration
Experience
FDA July 2010 - Present
University of Maryland, Baltimore August 2009 - July 2010
Education
University of Maryland, Baltimore 2003 — 2009
PhD, Microbiology and Immunology
Loyola College in Maryland
FDA July 2010 - Present
University of Maryland, Baltimore August 2009 - July 2010
Education
University of Maryland, Baltimore 2003 — 2009
PhD, Microbiology and Immunology
Loyola College in Maryland
Wafa Harrouk's FDA Experience November 2001 - Present
Job FDA; George Washington University
Industry Public Safety
Experience
FDA November 2001 - Present
George Washington University January 2006 - Present
FDA January 2000 - November 2001
Skills
Toxicology, Pharmacology, In Vivo, Animal Models, Science, In Vitro, Drug Discovery, Lifesciences, Biochemistry, Cancer, Molecular Biology, Cell Culture, CRO, Immunology, Pharmacokinetics, Pharmaceutical Industry, Neuroscience, Bioinformatics, Clinical Research, Public Health, Drug Development, Cell, R&D, Biotechnology, GLP, Clinical Development, Genomics, Biomarkers, FDA, Regulatory Submissions, Scientific Writing
Education
McGill University 1990 — 2000
Masters in Pathology; Ph.D. in Pharmacology & Therapeutics, Reproductive Biology; Birth Defects; Drug development
University of North Texas 1986 — 1989
Bachelor's degree, Biochemistry; Chemistry (minor)
FDA November 2001 - Present
George Washington University January 2006 - Present
FDA January 2000 - November 2001
Skills
Toxicology, Pharmacology, In Vivo, Animal Models, Science, In Vitro, Drug Discovery, Lifesciences, Biochemistry, Cancer, Molecular Biology, Cell Culture, CRO, Immunology, Pharmacokinetics, Pharmaceutical Industry, Neuroscience, Bioinformatics, Clinical Research, Public Health, Drug Development, Cell, R&D, Biotechnology, GLP, Clinical Development, Genomics, Biomarkers, FDA, Regulatory Submissions, Scientific Writing
Education
McGill University 1990 — 2000
Masters in Pathology; Ph.D. in Pharmacology & Therapeutics, Reproductive Biology; Birth Defects; Drug development
University of North Texas 1986 — 1989
Bachelor's degree, Biochemistry; Chemistry (minor)
Elijah Carrier's FDA Experience August 2013 - Present
Job Biological Laboratory Technician FDA Office of Regulatory Affairs (regulatory science)
Industry Research
Experience
FDA August 2013 - Present
Harvard Medical School September 2012 - August 2013
Massachusetts General Hospital May 2012 - August 2012
Massachusetts General Hospital June 2011 - August 2011
Skills
Research, Molecular Biology, Western Blotting, PCR, DNA recombination, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Immunofluorescence, Cell Culture, ELISA, Protein Chemistry, Data Analysis, Statistics, Immunoprecipitation, Microbiology, Protein-protein..., Microscopy, Laboratory, Cancer Research, Mammalian Cell Culture
Education
Massachusetts College of Pharmacy and Health Sciences 2009 — 2013
Bachelor of Science (B.S.), Medical and Molecular Biology
FDA August 2013 - Present
Harvard Medical School September 2012 - August 2013
Massachusetts General Hospital May 2012 - August 2012
Massachusetts General Hospital June 2011 - August 2011
Skills
Research, Molecular Biology, Western Blotting, PCR, DNA recombination, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Immunofluorescence, Cell Culture, ELISA, Protein Chemistry, Data Analysis, Statistics, Immunoprecipitation, Microbiology, Protein-protein..., Microscopy, Laboratory, Cancer Research, Mammalian Cell Culture
Education
Massachusetts College of Pharmacy and Health Sciences 2009 — 2013
Bachelor of Science (B.S.), Medical and Molecular Biology
Tamara Rosbury's FDA Experience 2010 - 2012
Job FDA Medical Device Specialist
Industry Medical Devices
Experience
FDA 2010 - 2012
Education
Massachusetts Institute of Technology 2000 — 2006
Doctor of Philosophy (Ph.D.), Electrical Engineering and Computer Science
FDA 2010 - 2012
Education
Massachusetts Institute of Technology 2000 — 2006
Doctor of Philosophy (Ph.D.), Electrical Engineering and Computer Science
Patricia Takahara's FDA Experience 2007 - 2010
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Howard Community College 2010 - Present
FDA 2007 - 2010
Roche Pharmaceuticals January 1999 - December 2003
Skills
Pharmaceutical Research, Pharmaceutical Research..., Macromolecular..., STEM Education
Education
Massachusetts Institute of Technology 1991 — 1996
PhD, Chemistry
UC Berkeley 1987 — 1990
BS, Chemistry
Howard Community College 2010 - Present
FDA 2007 - 2010
Roche Pharmaceuticals January 1999 - December 2003
Skills
Pharmaceutical Research, Pharmaceutical Research..., Macromolecular..., STEM Education
Education
Massachusetts Institute of Technology 1991 — 1996
PhD, Chemistry
UC Berkeley 1987 — 1990
BS, Chemistry
Prabha Atreya's FDA Experience September 2010 - Present
Job Director, Division of Scientific Advisors and Consultants at US Department of Health and Human Services
Industry Government Administration
Experience
FDA September 2010 - Present
National Center on Minority Health Disparities, National Institutes of Health 2008 - 2010
Education
Memorial University of Newfoundland
Doctor of Philosophy (PhD), Biochemistry, Biophysics and Molecular Biology
FDA September 2010 - Present
National Center on Minority Health Disparities, National Institutes of Health 2008 - 2010
Education
Memorial University of Newfoundland
Doctor of Philosophy (PhD), Biochemistry, Biophysics and Molecular Biology
David Moeny's FDA Experience November 2014 - Present
Job Deputy Director, Division of Epidemiology at FDA
Industry Government Administration
Experience
FDA November 2014 - Present
Food and Drug Administration September 2005 - November 2014
South East Alaska Regional Health Consortium September 2001 - July 2005
Skills
Public Health, Clinical Research, Healthcare, Infectious Diseases, Epidemiology, Research
Education
Uniformed Services University of the Health Sciences 2008 — 2010
Master of Public Health (MPH), Epidemiology
Massachusetts College of Pharmacy and Health Sciences
Bachelor's degree, pharmacy
FDA November 2014 - Present
Food and Drug Administration September 2005 - November 2014
South East Alaska Regional Health Consortium September 2001 - July 2005
Skills
Public Health, Clinical Research, Healthcare, Infectious Diseases, Epidemiology, Research
Education
Uniformed Services University of the Health Sciences 2008 — 2010
Master of Public Health (MPH), Epidemiology
Massachusetts College of Pharmacy and Health Sciences
Bachelor's degree, pharmacy
Katarina Radmanovic's FDA Experience May 2012 - August 2012
Job Biomechanical Engineering Student at Marquette University
Industry Medical Devices
Experience
Zimmer Biomet May 2015 - August 2015
Marquette University January 2015 - May 2015
Zimmer August 2014 - December 2014
Marquette University June 2014 - August 2014
Zimmer January 2014 - May 2014
Marquette University September 2011 - December 2013
FDA May 2012 - August 2012
Milwaukee Recreation September 2011 - May 2012
Skills
Microsoft Office, Community Outreach, Microsoft Excel, PowerPoint, Microsoft Word, Matlab, Lean Six Sigma Yellow..., Time Management, Leadership, Medical Device R&D, Data Analysis, Geometric Dimensioning..., Research, ASME Y14.5, Design Verification &..., Medical Devices, ISO 13485, Biomedical Engineering, Product Development, Cross-functional..., Minitab, Microsoft Sharepoint, Microsoft Access, Microsoft Office 2013, Teamwork, Social Media
Education
Marquette University 2011 — 2016
Bachelor of Science (B.S.), Biomechanical Engineering
Greendale High School 2007 — 2011
Zimmer Biomet May 2015 - August 2015
Marquette University January 2015 - May 2015
Zimmer August 2014 - December 2014
Marquette University June 2014 - August 2014
Zimmer January 2014 - May 2014
Marquette University September 2011 - December 2013
FDA May 2012 - August 2012
Milwaukee Recreation September 2011 - May 2012
Skills
Microsoft Office, Community Outreach, Microsoft Excel, PowerPoint, Microsoft Word, Matlab, Lean Six Sigma Yellow..., Time Management, Leadership, Medical Device R&D, Data Analysis, Geometric Dimensioning..., Research, ASME Y14.5, Design Verification &..., Medical Devices, ISO 13485, Biomedical Engineering, Product Development, Cross-functional..., Minitab, Microsoft Sharepoint, Microsoft Access, Microsoft Office 2013, Teamwork, Social Media
Education
Marquette University 2011 — 2016
Bachelor of Science (B.S.), Biomechanical Engineering
Greendale High School 2007 — 2011
Grainne Tobin's FDA Experience June 2009 - Present
Job Research Fellow at FDA
Industry Government Administration
Experience
FDA June 2009 - Present
EntreMed, Inc. June 2005 - December 2008
American Red Cross September 1994 - April 2002
Education
Medical College of Ohio 1988 — 1994
Doctor of Philosophy (PhD), Biochemistry and Molecular Biology
Queen's University Belfast 1984 — 1988
Bachelor of Science (B.Sc.), Biochemistry
FDA June 2009 - Present
EntreMed, Inc. June 2005 - December 2008
American Red Cross September 1994 - April 2002
Education
Medical College of Ohio 1988 — 1994
Doctor of Philosophy (PhD), Biochemistry and Molecular Biology
Queen's University Belfast 1984 — 1988
Bachelor of Science (B.Sc.), Biochemistry
Jean-Marc Guettier's FDA Experience August 2013 - Present
Job Division Director at FDA
Industry Government Administration
Experience
FDA August 2013 - Present
FDA December 2011 - August 2013
FDA January 2009 - December 2011
National Institutes of Health June 2004 - January 2009
Skills
Diabetes, Lipid Metabolism, Bone Metabolism, Endocrinology, Clinical Trials, Clinical Development, Clinical Research, Biomarkers, Food & Drug Law, Pharmaceutical Industry, Biotechnology, Drug Development
Education
McGill University
Doctor of Medicine (MD), Medicine
FDA August 2013 - Present
FDA December 2011 - August 2013
FDA January 2009 - December 2011
National Institutes of Health June 2004 - January 2009
Skills
Diabetes, Lipid Metabolism, Bone Metabolism, Endocrinology, Clinical Trials, Clinical Development, Clinical Research, Biomarkers, Food & Drug Law, Pharmaceutical Industry, Biotechnology, Drug Development
Education
McGill University
Doctor of Medicine (MD), Medicine
Chris Burkhart's FDA Experience July 2008 - August 2009
Job Associate at JPMorgan Chase & Co
Industry Information Technology and Services
Experience
JPMorgan Chase & Co. September 2014 - Present
Owl Computing Technologies Inc October 2013 - September 2014
New York Army National Guard 2011 - October 2013
Exceptional Software Strategies, Inc. July 2011 - March 2012
FDA July 2008 - August 2009
Skills
Military, Software Development, Computer Program, Java, C#, JSP, SQL, AJAX, HTML, Python, Tomcat, Visual Studio, SharePoint, BizFlow, Business Process..., InfoPath, Human Resources, Security Clearance, Military Operations, Army, Government, Command, National Security, Operational Planning, Military Experience, Homeland Security, Counterterrorism, Intelligence Analysis, DoD
Education
Loyola University Maryland 2007 — 2011
Bachelor of Science (B.S.), Computer Science
Hershey High School 2003 — 2007
High School Diploma
JPMorgan Chase & Co. September 2014 - Present
Owl Computing Technologies Inc October 2013 - September 2014
New York Army National Guard 2011 - October 2013
Exceptional Software Strategies, Inc. July 2011 - March 2012
FDA July 2008 - August 2009
Skills
Military, Software Development, Computer Program, Java, C#, JSP, SQL, AJAX, HTML, Python, Tomcat, Visual Studio, SharePoint, BizFlow, Business Process..., InfoPath, Human Resources, Security Clearance, Military Operations, Army, Government, Command, National Security, Operational Planning, Military Experience, Homeland Security, Counterterrorism, Intelligence Analysis, DoD
Education
Loyola University Maryland 2007 — 2011
Bachelor of Science (B.S.), Computer Science
Hershey High School 2003 — 2007
High School Diploma
Hee (Sheila) Lianos's FDA Experience December 2010 - Present
Job Senior Policy Advisor at FDA
Industry Government Administration
Experience
FDA December 2010 - Present
Boston Children's Hospital June 2001 - September 2007
Skills
Government, Policy Analysis, Public Health
Education
Massachusetts College of Pharmacy and Health Sciences
Doctor of Pharmacy (Pharm.D.)
FDA December 2010 - Present
Boston Children's Hospital June 2001 - September 2007
Skills
Government, Policy Analysis, Public Health
Education
Massachusetts College of Pharmacy and Health Sciences
Doctor of Pharmacy (Pharm.D.)
Andrew Zajac's FDA Experience June 2006 - Present
Job Division Director at FDA
Industry Government Administration
Experience
FDA June 2006 - Present
Education
The Johns Hopkins University 1994 — 1996
M.S., Environmental Engineering
University of Maryland University College 1987 — 1990
Master of Science (M.S.), Technology Management
Marquette University 1982 — 1986
B.S., Biomedical Engineering
FDA June 2006 - Present
Education
The Johns Hopkins University 1994 — 1996
M.S., Environmental Engineering
University of Maryland University College 1987 — 1990
Master of Science (M.S.), Technology Management
Marquette University 1982 — 1986
B.S., Biomedical Engineering
Adam Mayhew's FDA Experience December 2014 - Present
Job
Industry
Experience
FDA December 2014 - Present
LABS-Inc February 2010 - December 2014
Education
Metropolitan State University of Denver
Bachelor's of Science, Biological sciences
FDA December 2014 - Present
LABS-Inc February 2010 - December 2014
Education
Metropolitan State University of Denver
Bachelor's of Science, Biological sciences
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