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.
FDA Salaries. You can even request information on how much does FDA pay if you want to. Learn about salaries, pros and cons of working for FDA directly from the past employees.
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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
Samantha Kublank O'Brien, DVM Samantha Kublank O'Brien, DVM's FDA Experience February 2012 - March 2012
Job US Technical Marketer (Companion Animal Therapeutics) at Elanco
Industry Pharmaceuticals
Experience
Elanco February 2015 - Present
Elanco March 2014 - Present
Elanco June 2012 - Present
FDA February 2012 - March 2012
FDA October 2011 - November 2011
University of Missouri September 2011 - September 2011
Elanco June 2011 - July 2011
Elanco May 2010 - August 2010
Safeco Insurance August 2007 - July 2008
Skills
Pharmaceutical Industry, Pharmacovigilance, Regulatory Affairs, Veterinary Medicine, Regulatory Requirements, Data Analysis, Veterinary, FDA, Regulatory Submissions, Product Launch, Regulations, Clinical Trials, Sales Effectiveness, Drug Development, Cross-functional Team..., Clinical Development, Infectious Diseases
Education
Indiana University - Kelley School of Business 2015 — 2017
Master of Business Administration (MBA), Marketing
Purdue University 2008 — 2012
Doctor of Veterinary Medicine (DVM), Veterinary Medicine
Butler University 2003 — 2007
Bachelor of Science (B.S.), Biology
Butler University 2003 — 2007
Bachelor of Science (B.S.), Spanish
Elanco February 2015 - Present
Elanco March 2014 - Present
Elanco June 2012 - Present
FDA February 2012 - March 2012
FDA October 2011 - November 2011
University of Missouri September 2011 - September 2011
Elanco June 2011 - July 2011
Elanco May 2010 - August 2010
Safeco Insurance August 2007 - July 2008
Skills
Pharmaceutical Industry, Pharmacovigilance, Regulatory Affairs, Veterinary Medicine, Regulatory Requirements, Data Analysis, Veterinary, FDA, Regulatory Submissions, Product Launch, Regulations, Clinical Trials, Sales Effectiveness, Drug Development, Cross-functional Team..., Clinical Development, Infectious Diseases
Education
Indiana University - Kelley School of Business 2015 — 2017
Master of Business Administration (MBA), Marketing
Purdue University 2008 — 2012
Doctor of Veterinary Medicine (DVM), Veterinary Medicine
Butler University 2003 — 2007
Bachelor of Science (B.S.), Biology
Butler University 2003 — 2007
Bachelor of Science (B.S.), Spanish
Bernard Marasa, Ph.D. Bernard Marasa, Ph.D.'s FDA Experience December 2014 - Present
Job Drug Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA December 2014 - Present
FDA November 2012 - Present
The Catholic University of America April 2010 - November 2012
National Institute of Health October 2007 - April 2010
International Livestock Research Institute April 1997 - August 1999
Skills
Cell Culture, Molecular Biology, Molecular Cloning, Western Blotting, PCR, Cell Biology, DNA, Biochemistry, Protein Expression, Bioinformatics, Cancer Research, Cell, Confocal Microscopy, DNA extraction, ELISA, Flow Cytometry, Gel Electrophoresis, Genetics, Immunohistochemistry, Immunology, Microbiology, Microscopy, Protein Chemistry, Protein Purification, RNA isolation, RT-PCR, Science, Transfection, Virology, qPCR
Education
University of Maryland Baltimore 2003 — 2007
Ph.D, Molecular Pathology
1999 — 2001
M.Sc, Molecular Biology
Jomo Kenyatta University of Agriculture and Technology 1993 — 1997
B.Sc, Biochemistry
FDA December 2014 - Present
FDA November 2012 - Present
The Catholic University of America April 2010 - November 2012
National Institute of Health October 2007 - April 2010
International Livestock Research Institute April 1997 - August 1999
Skills
Cell Culture, Molecular Biology, Molecular Cloning, Western Blotting, PCR, Cell Biology, DNA, Biochemistry, Protein Expression, Bioinformatics, Cancer Research, Cell, Confocal Microscopy, DNA extraction, ELISA, Flow Cytometry, Gel Electrophoresis, Genetics, Immunohistochemistry, Immunology, Microbiology, Microscopy, Protein Chemistry, Protein Purification, RNA isolation, RT-PCR, Science, Transfection, Virology, qPCR
Education
University of Maryland Baltimore 2003 — 2007
Ph.D, Molecular Pathology
1999 — 2001
M.Sc, Molecular Biology
Jomo Kenyatta University of Agriculture and Technology 1993 — 1997
B.Sc, Biochemistry
Marc Carpenter Marc Carpenter's FDA Experience June 2013 - September 2013
Job FERN Scientist I at Division of Consolidated Laboratories
Industry Research
Experience
Division of Consolidated Laboratories March 2015 - Present
Alexandria Renew Enterprises February 2014 - March 2015
FDA June 2013 - September 2013
James Madison University January 2011 - August 2013
James Madison University January 2012 - May 2013
Texas A&M University-Corpus Christi August 2010 - May 2011
Environmental Microbiology Lab at Texas A&M University-Corpus Christi March 2009 - May 2011
Wal-Mart October 2005 - December 2007
Skills
Microbiology, PCR, Laboratory, Water Quality, Environmental Awareness, qPCR, Biology, Statistics, Validation, Water, R, Soil, Media Preparation, Report Writing, SAS, Membrane Filtratoin, QAQC
Education
James Madison University 2010 — 2013
Master of Science, Biology, 3.653
Texas A&M Corpus ChristiCorpus 2008 — 2010
Bachelor of Science, Chemistry
Division of Consolidated Laboratories March 2015 - Present
Alexandria Renew Enterprises February 2014 - March 2015
FDA June 2013 - September 2013
James Madison University January 2011 - August 2013
James Madison University January 2012 - May 2013
Texas A&M University-Corpus Christi August 2010 - May 2011
Environmental Microbiology Lab at Texas A&M University-Corpus Christi March 2009 - May 2011
Wal-Mart October 2005 - December 2007
Skills
Microbiology, PCR, Laboratory, Water Quality, Environmental Awareness, qPCR, Biology, Statistics, Validation, Water, R, Soil, Media Preparation, Report Writing, SAS, Membrane Filtratoin, QAQC
Education
James Madison University 2010 — 2013
Master of Science, Biology, 3.653
Texas A&M Corpus ChristiCorpus 2008 — 2010
Bachelor of Science, Chemistry
Betsy Yakes's FDA Experience 2007 - Present
Job Research Chemist at FDA
Industry Research
Experience
FDA 2007 - Present
Skills
Analytical Chemistry, Immunoassays, Biosensors, Spectroscopy, Surface Plasmon..., Raman, UV/Vis, HPLC, Biochemistry, Chemistry
Education
Iowa State University 2002 — 2007
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Luther College 1998 — 2002
Bachelor of Arts (B.A.), Chemistry/Math
FDA 2007 - Present
Skills
Analytical Chemistry, Immunoassays, Biosensors, Spectroscopy, Surface Plasmon..., Raman, UV/Vis, HPLC, Biochemistry, Chemistry
Education
Iowa State University 2002 — 2007
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Luther College 1998 — 2002
Bachelor of Arts (B.A.), Chemistry/Math
Quoc-Anh Thai Quoc-Anh Thai's FDA Experience 2015 - Present
Job Division Chief, Johns Hopkins NeurosurgeryNational Capital Region
Industry Medical Practice
Experience
Johns Hopkins Medicine August 2013 - Present
Johns Hopkins Neurosurgery--National Capital Region August 2013 - Present
FDA 2015 - Present
Maryland Board of Physicians 2015 - Present
American College of Surgeons 2011 - Present
American Association of Neurological Surgeons 2010 - Present
Royal Society of Medicine 2014 - 2015
Texas Medical Board 2012 - 2013
The University of Texas Health Science Center at Houston 2011 - 2013
Q.A. Thai Neurosurgery 2006 - 2011
Skills
Surgery, Neurosurgery, Medical Education, Clinical Research, Healthcare, Medicine
Education
Johns Hopkins Bloomberg School of Public Health 2015 — 2015
Transforming Health Systems for Accountable Care
Rice University 2012 — 2013
CFP Graduate Certificate Program, Finance
The Johns Hopkins Hospital 1999 — 2005
Neurosurgery Residency
The Johns Hopkins University - Carey Business School 2003 — 2004
Graduate Certificate, Business of Medicine
The Johns Hopkins University 1995 — 1999
Doctor of Medicine (M.D.), School of Medicine
University of Virginia 1991 — 1995
B.A., Interdisciplinary (Biology, Psychology, Philosophy)
Johns Hopkins Medicine August 2013 - Present
Johns Hopkins Neurosurgery--National Capital Region August 2013 - Present
FDA 2015 - Present
Maryland Board of Physicians 2015 - Present
American College of Surgeons 2011 - Present
American Association of Neurological Surgeons 2010 - Present
Royal Society of Medicine 2014 - 2015
Texas Medical Board 2012 - 2013
The University of Texas Health Science Center at Houston 2011 - 2013
Q.A. Thai Neurosurgery 2006 - 2011
Skills
Surgery, Neurosurgery, Medical Education, Clinical Research, Healthcare, Medicine
Education
Johns Hopkins Bloomberg School of Public Health 2015 — 2015
Transforming Health Systems for Accountable Care
Rice University 2012 — 2013
CFP Graduate Certificate Program, Finance
The Johns Hopkins Hospital 1999 — 2005
Neurosurgery Residency
The Johns Hopkins University - Carey Business School 2003 — 2004
Graduate Certificate, Business of Medicine
The Johns Hopkins University 1995 — 1999
Doctor of Medicine (M.D.), School of Medicine
University of Virginia 1991 — 1995
B.A., Interdisciplinary (Biology, Psychology, Philosophy)
srimayee madasu srimayee madasu's FDA Experience November 2013 - Present
Job Sr. Java Developer at Freddie Mac
Industry Information Technology and Services
Experience
FDA November 2013 - Present
Freddie Mac 2013 - Present
FDA 2012 - 2013
National Institutes of Health 2011 - 2012
Capital Technology Information Services 2011 - 2012
Walmart 2010 - 2011
Skills
Java, Spring, Hibernate, JMS, J2EE Application..., Struts, SOA, JPA, SOAP, Agile Methodologies, Oracle, Web Services, jQuery, RESTful WebServices, XML, Schematron, XSLT, MarkLogic, Weblogic, EJB, JSF, Maven, JAXB, ClearCase, Scrum, JavaScript, DB2, AJAX, REST, XSL, JUnit, Stored Procedures, PL/SQL, Tomcat, JDBC, Java Enterprise Edition, JBoss Application Server, JSP, Servlets, SQL, Eclipse, Databases
Education
Jawaharlal Nehru Technological University
Bachelor's degree, Computer Science
FDA November 2013 - Present
Freddie Mac 2013 - Present
FDA 2012 - 2013
National Institutes of Health 2011 - 2012
Capital Technology Information Services 2011 - 2012
Walmart 2010 - 2011
Skills
Java, Spring, Hibernate, JMS, J2EE Application..., Struts, SOA, JPA, SOAP, Agile Methodologies, Oracle, Web Services, jQuery, RESTful WebServices, XML, Schematron, XSLT, MarkLogic, Weblogic, EJB, JSF, Maven, JAXB, ClearCase, Scrum, JavaScript, DB2, AJAX, REST, XSL, JUnit, Stored Procedures, PL/SQL, Tomcat, JDBC, Java Enterprise Edition, JBoss Application Server, JSP, Servlets, SQL, Eclipse, Databases
Education
Jawaharlal Nehru Technological University
Bachelor's degree, Computer Science
Murali Krishna Divi Murali Krishna Divi's FDA Experience July 2013 - Present
Job Staff Fellow, FDA
Industry Pharmaceuticals
Experience
FDA July 2013 - Present
Forest Laboratories January 2011 - July 2013
Forest Laboratories November 2008 - January 2011
Hercules Inc June 2007 - October 2008
University of Tennessee 2003 - 2007
Dr. Reddy's Laboratories Ltd. 2000 - 2003
Skills
Drug Delivery, Pharmaceutical Research, Pharmacokinetics, Formulation, HPLC, ANDA, Technology Transfer, Quality by Design, NDA, Parenteral formulations, Controlled Release, Dissolution, Drug Development, GLP, In Vitro, Drug Metabolism, Sop, Pharmaceutics, LC-MS, Clinical Development, Validation, Pharmaceutical Industry, Drug Discovery, Generic Programming, GMP, IND, Regulatory Affairs, SOP
Education
University of Tennessee-Health Science Center 2003 — 2007
Ph.D, Pharmaceutics and Drug Design
National Institute of Pharmaceutical Education and Research 1999 — 2000
MS, Pharmaceutics
Kakatiya University 1994 — 1998
B.Pharm, Pharmacy
SVG Polytechnic
Diploma in Pharmacy, Pharmacy
FDA July 2013 - Present
Forest Laboratories January 2011 - July 2013
Forest Laboratories November 2008 - January 2011
Hercules Inc June 2007 - October 2008
University of Tennessee 2003 - 2007
Dr. Reddy's Laboratories Ltd. 2000 - 2003
Skills
Drug Delivery, Pharmaceutical Research, Pharmacokinetics, Formulation, HPLC, ANDA, Technology Transfer, Quality by Design, NDA, Parenteral formulations, Controlled Release, Dissolution, Drug Development, GLP, In Vitro, Drug Metabolism, Sop, Pharmaceutics, LC-MS, Clinical Development, Validation, Pharmaceutical Industry, Drug Discovery, Generic Programming, GMP, IND, Regulatory Affairs, SOP
Education
University of Tennessee-Health Science Center 2003 — 2007
Ph.D, Pharmaceutics and Drug Design
National Institute of Pharmaceutical Education and Research 1999 — 2000
MS, Pharmaceutics
Kakatiya University 1994 — 1998
B.Pharm, Pharmacy
SVG Polytechnic
Diploma in Pharmacy, Pharmacy
Christopher Contreras Christopher Contreras's FDA Experience June 2004 - August 2004
Job Graduate Research Associate at Indiana University School of Medicine
Industry Research
Experience
Indiana University School of Medicine August 2009 - Present
University of New Mexico May 2008 - July 2009
FDA June 2004 - August 2004
Skills
Research, Microsoft Office, PowerPoint, Matlab, Biochemistry, Molecular Biology, Mouse Handling, Ion Chromatography, Immunoblotting, Cell Culture, PCR, Western Blotting, Animal Models
Education
Indiana University School of Medicine 2009 — 2015
Doctor of Philosophy (PhD), Biochemistry and Molecular Biology
The University of New Mexico 2002 — 2008
Bachelor of Science (BS), Biochemistry and Molecular Biology
Indiana University School of Medicine August 2009 - Present
University of New Mexico May 2008 - July 2009
FDA June 2004 - August 2004
Skills
Research, Microsoft Office, PowerPoint, Matlab, Biochemistry, Molecular Biology, Mouse Handling, Ion Chromatography, Immunoblotting, Cell Culture, PCR, Western Blotting, Animal Models
Education
Indiana University School of Medicine 2009 — 2015
Doctor of Philosophy (PhD), Biochemistry and Molecular Biology
The University of New Mexico 2002 — 2008
Bachelor of Science (BS), Biochemistry and Molecular Biology
Shantelle Hughes Shantelle Hughes's FDA Experience January 2015 - Present
Job Chemist at the U. S. Food and Drug Administration
Industry Research
Experience
FDA January 2015 - Present
Jackson State University August 2008 - December 2014
Guangxi Normal University August 2009 - August 2009
Department of Chemistry, Indiana University May 2009 - August 2009
USDA-ARS October 2007 - August 2008
Skills
HPLC, Gas Chromatography, Laboratory, UV/Vis, Research, Chemistry, Spectroscopy, Nanoparticles, Microsoft Office, Microsoft Excel
Education
Jackson State University 2008 — 2014
Chemistry, 3.5
Jackson State University 2003 — 2007
Bachelor's of Science, Chemistry, 3.31
FDA January 2015 - Present
Jackson State University August 2008 - December 2014
Guangxi Normal University August 2009 - August 2009
Department of Chemistry, Indiana University May 2009 - August 2009
USDA-ARS October 2007 - August 2008
Skills
HPLC, Gas Chromatography, Laboratory, UV/Vis, Research, Chemistry, Spectroscopy, Nanoparticles, Microsoft Office, Microsoft Excel
Education
Jackson State University 2008 — 2014
Chemistry, 3.5
Jackson State University 2003 — 2007
Bachelor's of Science, Chemistry, 3.31
Alison Robertson's FDA Experience December 2009 - July 2013
Job Research Assistant Professor at University of South Alabama
Industry Research
Experience
University of South Alabama February 2014 - Present
Dauphin Island Sea Lab September 2013 - Present
University of South Alabama August 2013 - Present
FDA December 2009 - July 2013
NOAA: National Oceanic & Atmospheric Administration August 2007 - October 2009
National Research Council Canada April 2005 - May 2007
Skills
Marine Ecotoxicology, Environmental Chemistry, Bioanalytical Chemistry, Biochemistry, Harmful Algal Blooms, Environmental Science, Natural Toxins, Mass Spectrometry, Scientific Writing, Chemistry, Research, Science, Life Sciences, Toxicology, HPLC, Laboratory
Education
James Cook University 2000 — 2005
Doctor of Philosophy (Ph.D.), Biochemistry, Cum Laude, Medal of Excellence
James Cook University 1999 — 2000
Research Honours, Pharmacology, Class 1A
James Cook University 1995 — 1998
Bachelor of Science (B.Sc.), Physiology and Pharmacology
University of South Alabama February 2014 - Present
Dauphin Island Sea Lab September 2013 - Present
University of South Alabama August 2013 - Present
FDA December 2009 - July 2013
NOAA: National Oceanic & Atmospheric Administration August 2007 - October 2009
National Research Council Canada April 2005 - May 2007
Skills
Marine Ecotoxicology, Environmental Chemistry, Bioanalytical Chemistry, Biochemistry, Harmful Algal Blooms, Environmental Science, Natural Toxins, Mass Spectrometry, Scientific Writing, Chemistry, Research, Science, Life Sciences, Toxicology, HPLC, Laboratory
Education
James Cook University 2000 — 2005
Doctor of Philosophy (Ph.D.), Biochemistry, Cum Laude, Medal of Excellence
James Cook University 1999 — 2000
Research Honours, Pharmacology, Class 1A
James Cook University 1995 — 1998
Bachelor of Science (B.Sc.), Physiology and Pharmacology
James Valentine's FDA Experience May 2008 - April 2014
Job Associate* at Hyman, Phelps & McNamara, P.C.
Industry Law Practice
Experience
Hyman, Phelps & McNamara, P.C. May 2014 - Present
FDA May 2008 - April 2014
Hyman, Phelps & McNamara, P.C. June 2013 - August 2013
FDA August 2012 - December 2012
Network for Public Health Law June 2011 - August 2011
Johns Hopkins Bloomberg School of Public Health January 2009 - March 2009
UMBC July 2006 - May 2008
Education
University of Maryland Francis King Carey School of Law 2010 — 2013
Juris Doctor
Johns Hopkins Bloomberg School of Public Health 2008 — 2010
Master of Health Science (M.H.S.)
University of Maryland Baltimore County 2004 — 2008
Bachelor's Degree
Hyman, Phelps & McNamara, P.C. May 2014 - Present
FDA May 2008 - April 2014
Hyman, Phelps & McNamara, P.C. June 2013 - August 2013
FDA August 2012 - December 2012
Network for Public Health Law June 2011 - August 2011
Johns Hopkins Bloomberg School of Public Health January 2009 - March 2009
UMBC July 2006 - May 2008
Education
University of Maryland Francis King Carey School of Law 2010 — 2013
Juris Doctor
Johns Hopkins Bloomberg School of Public Health 2008 — 2010
Master of Health Science (M.H.S.)
University of Maryland Baltimore County 2004 — 2008
Bachelor's Degree
Kevin Kunard's FDA Experience May 2014 - Present
Job Lieutenant Commander, Commissioned Corps of the U.S. Public Health Service
Industry Government Administration
Experience
FDA May 2014 - Present
U.S. Public Health Service Commissioned Corps December 2012 - May 2014
U.S. Public Health Service Commissioned Corps October 2011 - December 2012
U.S. Public Health Service Commissioned Corps September 2008 - October 2011
Skills
Healthcare, Public Health, Government, Policy, Public Speaking, Recruiting, Security Clearance, Community Outreach, Program Management, Data Analysis, Program Development, Program Evaluation, DoD, Nonprofits, Emergency Management, Healthcare Information..., Training, Organizational..., Teaching, Military, Leadership, Project Management, Leadership Development, Human Resources, Federal Government
Education
Indiana Wesleyan University 2006 — 2008
MBA, Healthcare Administration
Purdue University 2000 — 2002
BA, Communications and Advertising
Indiana State University - School of Business 1997 — 2000
Bachelor of Arts (BA), Marketing
FDA May 2014 - Present
U.S. Public Health Service Commissioned Corps December 2012 - May 2014
U.S. Public Health Service Commissioned Corps October 2011 - December 2012
U.S. Public Health Service Commissioned Corps September 2008 - October 2011
Skills
Healthcare, Public Health, Government, Policy, Public Speaking, Recruiting, Security Clearance, Community Outreach, Program Management, Data Analysis, Program Development, Program Evaluation, DoD, Nonprofits, Emergency Management, Healthcare Information..., Training, Organizational..., Teaching, Military, Leadership, Project Management, Leadership Development, Human Resources, Federal Government
Education
Indiana Wesleyan University 2006 — 2008
MBA, Healthcare Administration
Purdue University 2000 — 2002
BA, Communications and Advertising
Indiana State University - School of Business 1997 — 2000
Bachelor of Arts (BA), Marketing
Sara Dutta Sara Dutta's FDA Experience October 2014 - Present
Job ORISE Fellow at FDA
Industry Biotechnology
Experience
FDA October 2014 - Present
University of Oxford October 2009 - September 2014
Sobell House Hospice Charity 2013 - 2014
Imperial College London October 2008 - June 2009
BBVA July 2008 - August 2008
Microsoft India (BMSI) July 2007 - August 2007
Skills
Statistics, Numerical Analysis, Image Processing, Algorithms, LaTeX, Scientific Computing, Matlab, Machine Learning, Computational Biology, R, Biochemistry, Scientific Writing
Education
University of Oxford 2009 — 2014
PhD, Computational Biology, Department of Computer Science
Imperial College London 2006 — 2009
Beng, Computer Science
Lycee Francois Premier, Fontainebleau 2003 — 2006
Baccalauréat scientifique à option internationale
FDA October 2014 - Present
University of Oxford October 2009 - September 2014
Sobell House Hospice Charity 2013 - 2014
Imperial College London October 2008 - June 2009
BBVA July 2008 - August 2008
Microsoft India (BMSI) July 2007 - August 2007
Skills
Statistics, Numerical Analysis, Image Processing, Algorithms, LaTeX, Scientific Computing, Matlab, Machine Learning, Computational Biology, R, Biochemistry, Scientific Writing
Education
University of Oxford 2009 — 2014
PhD, Computational Biology, Department of Computer Science
Imperial College London 2006 — 2009
Beng, Computer Science
Lycee Francois Premier, Fontainebleau 2003 — 2006
Baccalauréat scientifique à option internationale
Nathan Nehrt's FDA Experience June 2010 - March 2012
Job Data Analyst & Predictive Modeler at Centerstone Research Institute
Industry Research
Experience
Centerstone Research Institute April 2012 - Present
University of Maryland Baltimore County June 2010 - March 2012
FDA June 2010 - March 2012
Indiana University School of Informatics and Computing August 2008 - May 2010
Skills
Bioinformatics, R, Perl, MySQL, Programming, SPSS Statistics, SPSS Modeler, Microsoft SQL Server, QlikView Development, SPSS, Data Analysis, Data Mining, Business Intelligence, SPSS Clementine, Statistics, PostgreSQL, SQL, Databases, Analytics
Education
Indiana University Bloomington 2008 — 2010
M.S., Bioinformatics
Indiana University Bloomington 1996 — 2000
B.S., Business, Real Estate Finance
Centerstone Research Institute April 2012 - Present
University of Maryland Baltimore County June 2010 - March 2012
FDA June 2010 - March 2012
Indiana University School of Informatics and Computing August 2008 - May 2010
Skills
Bioinformatics, R, Perl, MySQL, Programming, SPSS Statistics, SPSS Modeler, Microsoft SQL Server, QlikView Development, SPSS, Data Analysis, Data Mining, Business Intelligence, SPSS Clementine, Statistics, PostgreSQL, SQL, Databases, Analytics
Education
Indiana University Bloomington 2008 — 2010
M.S., Bioinformatics
Indiana University Bloomington 1996 — 2000
B.S., Business, Real Estate Finance
Dominick Iacuzio Dominick Iacuzio's FDA Experience 1989 - 1992
Job Experienced Director Scientific & Medical Affairs
Industry Pharmaceuticals
Experience
Sanofi Pasteur September 2011 - April 2013
Roche Pharmaceuticals December 1998 - October 2010
NIH 1992 - 1998
FDA 1989 - 1992
Skills
Clinical Trials, Pharmaceutical Industry, Infectious Diseases, Influenza, Pharmaceutical Sales, Medical Affairs, Rheumatology, Pharmacovigilance, Therapeutic Areas, Immunology, Cardiology, Medicine, Clinical Development, CRO, Diabetes, GCP, Medical Writing, CTMS, Drug Development, Oncology, Hospital Sales, Clinical Research, Biotechnology, Vaccines, Gastroenterology, Hematology, Osteoporosis, Neurology, Market Access
Education
University of Rhode Island 1980 — 1985
Ph.D., Microbiology
University of Bridgeport 1975 — 1979
M.S., Microbiology
John Carroll University 1967 — 1971
B.S., Biology
Sanofi Pasteur September 2011 - April 2013
Roche Pharmaceuticals December 1998 - October 2010
NIH 1992 - 1998
FDA 1989 - 1992
Skills
Clinical Trials, Pharmaceutical Industry, Infectious Diseases, Influenza, Pharmaceutical Sales, Medical Affairs, Rheumatology, Pharmacovigilance, Therapeutic Areas, Immunology, Cardiology, Medicine, Clinical Development, CRO, Diabetes, GCP, Medical Writing, CTMS, Drug Development, Oncology, Hospital Sales, Clinical Research, Biotechnology, Vaccines, Gastroenterology, Hematology, Osteoporosis, Neurology, Market Access
Education
University of Rhode Island 1980 — 1985
Ph.D., Microbiology
University of Bridgeport 1975 — 1979
M.S., Microbiology
John Carroll University 1967 — 1971
B.S., Biology
Stephanie Kloek Stephanie Kloek's FDA Experience February 2015 - Present
Job Laboratory Technician
Industry Government Administration
Experience
FDA February 2015 - Present
Anoka-Ramsey Community College April 2010 - October 2013
Byerly's Grocery June 2006 - October 2013
Como Zoo February 2008 - May 2011
Skills
Customer Service, Laboratory Techniques, Customer Relations, Environmental, Marine Biology, Natural Resources, Outstanding Customer..., Microbiology, Aseptic Technique, Media Preparation, Tutoring, Mentoring, Department Budgeting, Employee Training, Technical Training, Water, Autoclave, Bacterial Culture, Agarose Gel..., PCR, Data Analysis, Time Management, Budgets
Education
University of New Hampshire 2002 — 2006
B.S., Biology: Marine and Freshwater
James Cook University 2005 — 2005
Marine Biology and Conservation Biology
Cretin-Derham Hall High School 1999 — 2002
FDA February 2015 - Present
Anoka-Ramsey Community College April 2010 - October 2013
Byerly's Grocery June 2006 - October 2013
Como Zoo February 2008 - May 2011
Skills
Customer Service, Laboratory Techniques, Customer Relations, Environmental, Marine Biology, Natural Resources, Outstanding Customer..., Microbiology, Aseptic Technique, Media Preparation, Tutoring, Mentoring, Department Budgeting, Employee Training, Technical Training, Water, Autoclave, Bacterial Culture, Agarose Gel..., PCR, Data Analysis, Time Management, Budgets
Education
University of New Hampshire 2002 — 2006
B.S., Biology: Marine and Freshwater
James Cook University 2005 — 2005
Marine Biology and Conservation Biology
Cretin-Derham Hall High School 1999 — 2002
Kelly Lewis, MS, MBA Kelly Lewis, MS, MBA's FDA Experience September 2013 - Present
Job Branch Chief at FDA
Industry Biotechnology
Experience
FDA September 2013 - Present
FDA October 2011 - September 2013
FDA November 2008 - October 2011
sanofi pasteur February 2007 - November 2008
MedImmune January 2002 - February 2007
Skills
Regulatory Affairs, Biotechnology, Biopharmaceuticals, FDA, Technology Transfer, Change Control, Quality Assurance, GMP, CAPA, Pharmaceutical Industry, Vaccines, Quality System, Lifesciences, Validation, Quality Management, Sop, GLP, Medical Devices, V&V, ELISA, 21 CFR Part 11, LIMS, Regulatory Requirements, Regulatory Submissions, Clinical Trials, Microbiology, Drug Development, Immunology
Education
The Johns Hopkins University - Carey Business School 2009 — 2011
MBA, Business
The Johns Hopkins University 2004 — 2006
MS, Biotechnology
James Madison University 1997 — 2001
BS, Integrated Science and Technology: Biotechnology
FDA September 2013 - Present
FDA October 2011 - September 2013
FDA November 2008 - October 2011
sanofi pasteur February 2007 - November 2008
MedImmune January 2002 - February 2007
Skills
Regulatory Affairs, Biotechnology, Biopharmaceuticals, FDA, Technology Transfer, Change Control, Quality Assurance, GMP, CAPA, Pharmaceutical Industry, Vaccines, Quality System, Lifesciences, Validation, Quality Management, Sop, GLP, Medical Devices, V&V, ELISA, 21 CFR Part 11, LIMS, Regulatory Requirements, Regulatory Submissions, Clinical Trials, Microbiology, Drug Development, Immunology
Education
The Johns Hopkins University - Carey Business School 2009 — 2011
MBA, Business
The Johns Hopkins University 2004 — 2006
MS, Biotechnology
James Madison University 1997 — 2001
BS, Integrated Science and Technology: Biotechnology
Kristin (Marshall) Schill Kristin (Marshall) Schill's FDA Experience January 2010 - Present
Job Research Microbiologist at FDA
Industry Government Administration
Experience
FDA January 2010 - Present
Skills
Cell Culture, Molecular Biology, Microbiology, Food Microbiology, Science, Food Science, Life Sciences, Laboratory, Biochemistry, Biotechnology, PCR, Food Safety, Chemistry, GMP
Education
University of Wisconsin-Madison 2004 — 2009
Doctor of Philosophy (Ph.D.), Food Science
Iowa State University 2001 — 2004
Master of Science (M.S.), Food Science and Technology
Iowa State University 1997 — 2001
Bachelor of Science (B.S.), Microbiology
FDA January 2010 - Present
Skills
Cell Culture, Molecular Biology, Microbiology, Food Microbiology, Science, Food Science, Life Sciences, Laboratory, Biochemistry, Biotechnology, PCR, Food Safety, Chemistry, GMP
Education
University of Wisconsin-Madison 2004 — 2009
Doctor of Philosophy (Ph.D.), Food Science
Iowa State University 2001 — 2004
Master of Science (M.S.), Food Science and Technology
Iowa State University 1997 — 2001
Bachelor of Science (B.S.), Microbiology
Fran Daniel Fran Daniel's FDA Experience January 2012 - September 2012
Job Medical Program Director at CME Outfitters, LLC
Industry Hospital & Health Care
Experience
CME Outfitters, LLC January 2014 - Present
Freelance Medical Writer September 2012 - January 2014
FDA January 2012 - September 2012
Reagan-Udall October 2011 - January 2012
Medical Communications Consultants January 2011 - June 2011
Capital Consulting Corporation October 2010 - December 2010
CME Enterprise August 2007 - February 2009
Ice Miller Business and Legal Advisors January 2006 - November 2006
Eli Lilly and Company 2001 - 2006
Eli Lilly and Company 2001 - 2006
Skills
Public Health Project..., Medical Writer, Clinical Research, Public Health, Clinical Trials, Oncology, GCP, Sop, Quality Assurance, Protocol, Strategic Planning, Medical Writing, College Instructor, Training, Medical Education, Pharmacology, Medical Devices, Infectious Diseases, Clinical Development, SOP, Project Management
Education
Indiana University-Purdue University 2005 — 2008
Project Management Certificate, Project Management
Saint Louis University 1990 — 1994
MPH, Public Health
St Louis University 1987 — 1988
BS, Health Information Management
Indiana University Bloomington 1977 — 1981
BA, Psychology
CME Outfitters, LLC January 2014 - Present
Freelance Medical Writer September 2012 - January 2014
FDA January 2012 - September 2012
Reagan-Udall October 2011 - January 2012
Medical Communications Consultants January 2011 - June 2011
Capital Consulting Corporation October 2010 - December 2010
CME Enterprise August 2007 - February 2009
Ice Miller Business and Legal Advisors January 2006 - November 2006
Eli Lilly and Company 2001 - 2006
Eli Lilly and Company 2001 - 2006
Skills
Public Health Project..., Medical Writer, Clinical Research, Public Health, Clinical Trials, Oncology, GCP, Sop, Quality Assurance, Protocol, Strategic Planning, Medical Writing, College Instructor, Training, Medical Education, Pharmacology, Medical Devices, Infectious Diseases, Clinical Development, SOP, Project Management
Education
Indiana University-Purdue University 2005 — 2008
Project Management Certificate, Project Management
Saint Louis University 1990 — 1994
MPH, Public Health
St Louis University 1987 — 1988
BS, Health Information Management
Indiana University Bloomington 1977 — 1981
BA, Psychology
Aloka Chakravarty Aloka Chakravarty's FDA Experience October 2009 - Present
Job Director, Division of Biometrics VII at FDA
Industry Government Administration
Experience
FDA October 2009 - Present
Temple University 1987 - 1992
Tata Consultancy Services 1986 - 1987
Skills
Biostatistics, Statistical Modeling, Drug Safety, Statistics, Clinical Trials, Regulatory Submissions, SAS, Data Analysis, Stata, SPSS, Qualitative Research, Lifesciences, Science, Biotechnology, Statistical Consulting, R, Time Series Analysis, Data Mining, Pharmaceutical Industry, SAS programming, Data Management, Public Health
Education
Temple University
Doctor of Philosophy (Ph.D.), Mathematical Statistics
Indian Statistical Institute
Master's degree, Mathematics and Statistics
Presidency College
Bachelor's degree, Mathematics and Statistics, Economics Minor
FDA October 2009 - Present
Temple University 1987 - 1992
Tata Consultancy Services 1986 - 1987
Skills
Biostatistics, Statistical Modeling, Drug Safety, Statistics, Clinical Trials, Regulatory Submissions, SAS, Data Analysis, Stata, SPSS, Qualitative Research, Lifesciences, Science, Biotechnology, Statistical Consulting, R, Time Series Analysis, Data Mining, Pharmaceutical Industry, SAS programming, Data Management, Public Health
Education
Temple University
Doctor of Philosophy (Ph.D.), Mathematical Statistics
Indian Statistical Institute
Master's degree, Mathematics and Statistics
Presidency College
Bachelor's degree, Mathematics and Statistics, Economics Minor
Sardar Hamidian Sardar Hamidian's FDA Experience May 2015 - August 2015
Job Research Assistant at George Washington University
Industry Computer Software
Experience
George Washington University January 2014 - Present
FDA May 2015 - August 2015
George Washington University August 2013 - January 2014
Ayrya Co May 2004 - December 2010
Sharif University of Technology May 2004 - August 2004
Skills
Java, JavaScript, Programming, Python, Web Applications, Machine Learning, Matlab, Software Engineering, Natural Language..., C++, XML, User Interface, Big Data Analytics, Perl, Web Services, Linux, Oracle, Weka, R, Data Science, Oracle SQL Developer
Education
The George Washington University 2014 — 2018
Doctor of Philosophy (Ph.D.), NLP, Data Mining, Machin Learning
The George Washington University 2012 — 2014
Master's degree, Computer Science, A
Middle East Technical University 2012 — 2012
Master's degree, Computer and Information Systems Security/Information Assurance, BA
Islamic Azad University 2004 — 2010
Bachelor's degree, Computer Software Engineering
Borhan 2000 — 2003
High School Diploma, Mathematic
George Washington University January 2014 - Present
FDA May 2015 - August 2015
George Washington University August 2013 - January 2014
Ayrya Co May 2004 - December 2010
Sharif University of Technology May 2004 - August 2004
Skills
Java, JavaScript, Programming, Python, Web Applications, Machine Learning, Matlab, Software Engineering, Natural Language..., C++, XML, User Interface, Big Data Analytics, Perl, Web Services, Linux, Oracle, Weka, R, Data Science, Oracle SQL Developer
Education
The George Washington University 2014 — 2018
Doctor of Philosophy (Ph.D.), NLP, Data Mining, Machin Learning
The George Washington University 2012 — 2014
Master's degree, Computer Science, A
Middle East Technical University 2012 — 2012
Master's degree, Computer and Information Systems Security/Information Assurance, BA
Islamic Azad University 2004 — 2010
Bachelor's degree, Computer Software Engineering
Borhan 2000 — 2003
High School Diploma, Mathematic
Brenda Stahl's FDA Experience May 2015 - Present
Job Food Safety Research Officer
Industry Food & Beverages
Experience
FDA May 2015 - Present
NSF International January 2013 - May 2015
BBC Microbial Solutions August 2011 - May 2015
AIB International January 2009 - August 2011
ABC Research Laboratories December 2007 - January 2009
Skills
Food Safety Education, HACCP, Environmental Monitoring, Food Safety, GMP, Microbiology, Food, FDA, Ingredients, Laboratory, Food Processing, Food Industry, Quality System, Dairy, Food & Beverage, Product Development, Quality Assurance, Lean Manufacturing, Food Science, Food Technology, Quality Control, Science, Bakery
Education
Iowa State University 2003 — 2007
PhD, Food Science
University of Wisconsin-Madison 1999 — 2003
Bachelors of Science, Animal Sciences
FDA May 2015 - Present
NSF International January 2013 - May 2015
BBC Microbial Solutions August 2011 - May 2015
AIB International January 2009 - August 2011
ABC Research Laboratories December 2007 - January 2009
Skills
Food Safety Education, HACCP, Environmental Monitoring, Food Safety, GMP, Microbiology, Food, FDA, Ingredients, Laboratory, Food Processing, Food Industry, Quality System, Dairy, Food & Beverage, Product Development, Quality Assurance, Lean Manufacturing, Food Science, Food Technology, Quality Control, Science, Bakery
Education
Iowa State University 2003 — 2007
PhD, Food Science
University of Wisconsin-Madison 1999 — 2003
Bachelors of Science, Animal Sciences
Evan Jacobs Evan Jacobs's FDA Experience July 2013 - Present
Job Computer Scientist at FDA
Industry Computer Software
Experience
FDA July 2013 - Present
SPAWAR July 2010 - July 2013
James Madison University January 2009 - July 2010
James Madison University January 2007 - December 2008
NASA May 2008 - July 2008
Education
James Madison University 2008 — 2010
Master of Science (MS), Computer Science, Distinguished Graduate
James Madison University 2005 — 2008
Bachelor of Science (BS), Computer Science, Magna Cum Laude
FDA July 2013 - Present
SPAWAR July 2010 - July 2013
James Madison University January 2009 - July 2010
James Madison University January 2007 - December 2008
NASA May 2008 - July 2008
Education
James Madison University 2008 — 2010
Master of Science (MS), Computer Science, Distinguished Graduate
James Madison University 2005 — 2008
Bachelor of Science (BS), Computer Science, Magna Cum Laude
Hari Nagaradona Hari Nagaradona's FDA Experience September 1993 - August 1997
Job Vice President & Head of Regulatory Affairs at Dr. Reddy's Laboratories, Inc
Industry Pharmaceuticals
Experience
Dr. Reddy's Laboratories, Inc July 2015 - Present
Dr. Reddy's Laboratories, Inc. January 2014 - June 2015
INC Research October 2009 - December 2013
INC Research November 2006 - October 2009
INC Research February 2006 - October 2006
Gene Logic May 2000 - February 2006
McKesson Bioservices September 1997 - April 2000
FDA September 1993 - August 1997
The Ohio State University June 1992 - August 1993
National Institutes of Health May 1986 - June 1992
Skills
Regulatory Affairs, FDA
Education
The Johns Hopkins University 2000 — 2003
Graduate Certificate, Information Systems
Indian Institute of Science 1979 — 1985
Ph.D, Biochemistry
SV University 1977 — 1979
Master's Degree, Biosciences
S.V. University 1974 — 1977
Bachelor's Degree, Chemistry
Dr. Reddy's Laboratories, Inc July 2015 - Present
Dr. Reddy's Laboratories, Inc. January 2014 - June 2015
INC Research October 2009 - December 2013
INC Research November 2006 - October 2009
INC Research February 2006 - October 2006
Gene Logic May 2000 - February 2006
McKesson Bioservices September 1997 - April 2000
FDA September 1993 - August 1997
The Ohio State University June 1992 - August 1993
National Institutes of Health May 1986 - June 1992
Skills
Regulatory Affairs, FDA
Education
The Johns Hopkins University 2000 — 2003
Graduate Certificate, Information Systems
Indian Institute of Science 1979 — 1985
Ph.D, Biochemistry
SV University 1977 — 1979
Master's Degree, Biosciences
S.V. University 1974 — 1977
Bachelor's Degree, Chemistry
Viola Woolums Viola Woolums's FDA Experience January 2014 - April 2014
Job Maryland Attorney
Industry Law Practice
Experience
Rolinski & Suarez, LLC October 2014 - Present
Maryland Center for Developmental Disabilities January 2014 - April 2014
FDA January 2014 - April 2014
Drug Policy and Public Health Strategies Clinic May 2013 - August 2013
University of Maryland School of Law May 2013 - August 2013
Drug Policy and Public Health Strategies Clinic August 2012 - May 2013
Brian Plath for McLean County Circuit Clerk August 2008 - November 2008
Skills
Advocacy, Health Law, Communication, Writing, Public Policy, Legal Research, Experience working with..., Research, Policy, Community Outreach, Legal Writing, Civil Litigation, Criminal Law, Westlaw, Nonprofits, Policy Analysis, Microsoft Office, LexisNexis, Litigation, Public Speaking
Education
University of Maryland School of Law 2011 — 2014
Doctor of Law (J.D.), Health Law
Illinois State University 2006 — 2010
Bachelor of Arts (B.A.), English Studies
Illinois State University 2006 — 2010
Bachelor of Arts (B.A.), Political Science
Rolinski & Suarez, LLC October 2014 - Present
Maryland Center for Developmental Disabilities January 2014 - April 2014
FDA January 2014 - April 2014
Drug Policy and Public Health Strategies Clinic May 2013 - August 2013
University of Maryland School of Law May 2013 - August 2013
Drug Policy and Public Health Strategies Clinic August 2012 - May 2013
Brian Plath for McLean County Circuit Clerk August 2008 - November 2008
Skills
Advocacy, Health Law, Communication, Writing, Public Policy, Legal Research, Experience working with..., Research, Policy, Community Outreach, Legal Writing, Civil Litigation, Criminal Law, Westlaw, Nonprofits, Policy Analysis, Microsoft Office, LexisNexis, Litigation, Public Speaking
Education
University of Maryland School of Law 2011 — 2014
Doctor of Law (J.D.), Health Law
Illinois State University 2006 — 2010
Bachelor of Arts (B.A.), English Studies
Illinois State University 2006 — 2010
Bachelor of Arts (B.A.), Political Science
Mark Vetal's FDA Experience June 2011 - September 2011
Job Clinical Research Quality Assurance Program Lead at Children's National Health System
Industry Biotechnology
Experience
Children's National Health System March 2015 - Present
Technical Resources International, Inc. 2014 - 2015
Technical Resources International 2012 - 2014
FDA June 2011 - September 2011
Skills
Public Relations, Public Speaking, Microsoft Office, Writing, PowerPoint, Excel, Word, Social Media, Data Analysis, Databases, Data Management, Literature Reviews, Experimental Design, Data Mining, Regulatory Affairs, Trackwise, Documentum, Microsoft Office..., Quality Assurance, Quality System, Quality Systems Design, Internal Audit, GDP, GCP, GMP, SOP development, Quality Management, Clinical Site Monitoring, Protocol, Microsoft Word, Biotechnology, FDA, Clinical Monitoring, TrackWise
Education
James Madison University 2008 — 2012
James Madison University, Biotechnology
Children's National Health System March 2015 - Present
Technical Resources International, Inc. 2014 - 2015
Technical Resources International 2012 - 2014
FDA June 2011 - September 2011
Skills
Public Relations, Public Speaking, Microsoft Office, Writing, PowerPoint, Excel, Word, Social Media, Data Analysis, Databases, Data Management, Literature Reviews, Experimental Design, Data Mining, Regulatory Affairs, Trackwise, Documentum, Microsoft Office..., Quality Assurance, Quality System, Quality Systems Design, Internal Audit, GDP, GCP, GMP, SOP development, Quality Management, Clinical Site Monitoring, Protocol, Microsoft Word, Biotechnology, FDA, Clinical Monitoring, TrackWise
Education
James Madison University 2008 — 2012
James Madison University, Biotechnology
Erin Needlman Erin Needlman's FDA Experience May 2011 - August 2011
Job Clinical Research Coordinator at Novavax
Industry Biotechnology
Experience
Novavax February 2015 - Present
New Editions Consulting January 2014 - February 2015
Office on Children and Youth May 2013 - September 2013
Office on Children and Youth March 2013 - May 2013
JBS International, Inc. June 2012 - August 2012
FDA May 2011 - August 2011
FDA May 2010 - August 2010
Skills
Research, Public Policy, Stata, Government, Data Analysis, Public Health, Policy Analysis, Capacity Building, Global Health, Program Evaluation, Grants, Program Development, Health Communication
Education
James Madison University 2009 — 2013
Bachelor of Science (BS), Public Health Education and Promotion
Novavax February 2015 - Present
New Editions Consulting January 2014 - February 2015
Office on Children and Youth May 2013 - September 2013
Office on Children and Youth March 2013 - May 2013
JBS International, Inc. June 2012 - August 2012
FDA May 2011 - August 2011
FDA May 2010 - August 2010
Skills
Research, Public Policy, Stata, Government, Data Analysis, Public Health, Policy Analysis, Capacity Building, Global Health, Program Evaluation, Grants, Program Development, Health Communication
Education
James Madison University 2009 — 2013
Bachelor of Science (BS), Public Health Education and Promotion
David Dean Anderson David Dean Anderson's FDA Experience April 2015 - Present
Job Staff Fellow at CDER
Industry Pharmaceuticals
Experience
FDA April 2015 - Present
BASF March 2013 - March 2015
Purdue University August 2007 - December 2012
Eli Lilly and Company May 2001 - August 2007
Skills
Organic Chemistry, Medicinal Chemistry, Analytical Chemistry, HPLC, Organic Synthesis, Gas Chromatography, Chemistry, NMR, FTIR, Biochemistry, Mass Spectrometry, Validation, Laboratory, Chromatography
Education
Purdue University 2007 — 2011
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences, 3.94
Indiana University-Purdue University at Indianapolis 2002 — 2004
MS, Biochemistry
University of Wisconsin-Madison 1997 — 2001
BS, Chemistry
FDA April 2015 - Present
BASF March 2013 - March 2015
Purdue University August 2007 - December 2012
Eli Lilly and Company May 2001 - August 2007
Skills
Organic Chemistry, Medicinal Chemistry, Analytical Chemistry, HPLC, Organic Synthesis, Gas Chromatography, Chemistry, NMR, FTIR, Biochemistry, Mass Spectrometry, Validation, Laboratory, Chromatography
Education
Purdue University 2007 — 2011
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences, 3.94
Indiana University-Purdue University at Indianapolis 2002 — 2004
MS, Biochemistry
University of Wisconsin-Madison 1997 — 2001
BS, Chemistry
Sandra Morseth Sandra Morseth's FDA Experience January 1990 - January 1993
Job Consultant at Morseth Consulting, LLC
Industry Pharmaceuticals
Experience
Morseth Consulting, LLC January 2004 - Present
Milestone Biomedical Associates January 2000 - January 2004
Quintiles Consulting January 1998 - January 2000
Covance Laboratories, Inc January 1993 - January 1998
FDA January 1990 - January 1993
Hazleton Laboratories America, Inc January 1984 - January 1990
Adria Laboratories, Inc January 1978 - January 1979
International Research and Development Corp January 1976 - January 1978
Skills
IND, FDA, Vaccines, CRO, Toxicology
Education
Washington State University 1980 — 1984
Ph.D, Psychology
Washington State University 1980 — 1982
M.S, Psychology
Washington State University 1979 — 1980
B.S, Psychology
Kalamazoo College 1972 — 1976
B.A, Biology
Morseth Consulting, LLC January 2004 - Present
Milestone Biomedical Associates January 2000 - January 2004
Quintiles Consulting January 1998 - January 2000
Covance Laboratories, Inc January 1993 - January 1998
FDA January 1990 - January 1993
Hazleton Laboratories America, Inc January 1984 - January 1990
Adria Laboratories, Inc January 1978 - January 1979
International Research and Development Corp January 1976 - January 1978
Skills
IND, FDA, Vaccines, CRO, Toxicology
Education
Washington State University 1980 — 1984
Ph.D, Psychology
Washington State University 1980 — 1982
M.S, Psychology
Washington State University 1979 — 1980
B.S, Psychology
Kalamazoo College 1972 — 1976
B.A, Biology
Raj N Misra Raj N Misra's FDA Experience 2003 - 2005
Job Project Officer
Industry Pharmaceuticals
Experience
National Cancer Institute (NCI) August 2015 - Present
National Cancer Institute January 2012 - August 2015
National Cancer Institute December 2005 - August 2015
FDA 2003 - 2005
Bristol-Myers Squibb 1982 - 2003
Skills
Chemistry, Drug Discovery, Organic Synthesis, Organic Chemistry, Drug Development, Biotechnology, Oncology, Drug Design, Chemical Repository..., NIH Grants..., Federal Gov Contracts..., FDA CMC Regulations, Chemical, Regulations, Pharmaceutical Industry, IND, Clinical Research, Technology Transfer, Translational Medicine, FDA, FAC-COR Level II..., HPLC, Patents, Formulation, Microbiology, Science, Cancer, Cancer Research, NMR, Protein Chemistry, Cell Culture, Cell, Cell Biology, Molecular Biology, Genomics, GLP, Immunology, R&D, In Vitro
Education
Princeton University 1980 — 1982
Postdoc
Indiana University Bloomington 1976 — 1980
Ph.D.
Rutgers University-New Brunswick 1972 — 1976
A.B.
National Cancer Institute (NCI) August 2015 - Present
National Cancer Institute January 2012 - August 2015
National Cancer Institute December 2005 - August 2015
FDA 2003 - 2005
Bristol-Myers Squibb 1982 - 2003
Skills
Chemistry, Drug Discovery, Organic Synthesis, Organic Chemistry, Drug Development, Biotechnology, Oncology, Drug Design, Chemical Repository..., NIH Grants..., Federal Gov Contracts..., FDA CMC Regulations, Chemical, Regulations, Pharmaceutical Industry, IND, Clinical Research, Technology Transfer, Translational Medicine, FDA, FAC-COR Level II..., HPLC, Patents, Formulation, Microbiology, Science, Cancer, Cancer Research, NMR, Protein Chemistry, Cell Culture, Cell, Cell Biology, Molecular Biology, Genomics, GLP, Immunology, R&D, In Vitro
Education
Princeton University 1980 — 1982
Postdoc
Indiana University Bloomington 1976 — 1980
Ph.D.
Rutgers University-New Brunswick 1972 — 1976
A.B.
Joshua Corriveau's FDA Experience October 2012 - November 2012
Job Medical Science Liaison (MSL) Dermatology/Rheumatology
Industry Pharmaceuticals
Experience
Novartis May 2014 - Present
Novartis May 2013 - Present
St. Jude Children's Research Hospital January 2013 - February 2013
FDA October 2012 - November 2012
Novartis April 2012 - October 2012
CVS Pharmacy July 2011 - May 2012
Rite Aid Pharmacy October 2009 - September 2011
Novartis June 2011 - August 2011
Memorial Hospital of RI October 2009 - May 2010
Novartis 2010 - 2010
Skills
Healthcare, Pharmacists, Pharmaceutical Industry, Pharmacy, Medical Writing
Education
Isenberg School of Management, UMass Amherst 2015 — 2016
Master of Business Administration (M.B.A.), MBA, concentration in Entrepreneurship and Marketing, In progress
Mount Saint Charles Academy
Diploma
University of Rhode Island
Doctor of Pharmacy (Pharm.D.)
Novartis May 2014 - Present
Novartis May 2013 - Present
St. Jude Children's Research Hospital January 2013 - February 2013
FDA October 2012 - November 2012
Novartis April 2012 - October 2012
CVS Pharmacy July 2011 - May 2012
Rite Aid Pharmacy October 2009 - September 2011
Novartis June 2011 - August 2011
Memorial Hospital of RI October 2009 - May 2010
Novartis 2010 - 2010
Skills
Healthcare, Pharmacists, Pharmaceutical Industry, Pharmacy, Medical Writing
Education
Isenberg School of Management, UMass Amherst 2015 — 2016
Master of Business Administration (M.B.A.), MBA, concentration in Entrepreneurship and Marketing, In progress
Mount Saint Charles Academy
Diploma
University of Rhode Island
Doctor of Pharmacy (Pharm.D.)
VenkatRay Kamath VenkatRay Kamath's FDA Experience December 2011 - August 2013
Job Senior Systems Analyst at Comcast
Industry Financial Services
Experience
Comcast March 2015 - Present
JPMorgan Chase September 2013 - March 2015
FDA December 2011 - August 2013
Federal Trade Commission August 2010 - December 2011
Skills
Requirements Gathering, Requirements Analysis, Agile Methodologies, Testing, Business Process, Software Documentation, User Acceptance Testing, Business Requirements, Scrum, Systems Analysis, Software Development, Functional..., Waterfall
Education
Jawaharlal Nehru Technological University 2006 — 2010
Bachelors in Technology, Information Technology
Comcast March 2015 - Present
JPMorgan Chase September 2013 - March 2015
FDA December 2011 - August 2013
Federal Trade Commission August 2010 - December 2011
Skills
Requirements Gathering, Requirements Analysis, Agile Methodologies, Testing, Business Process, Software Documentation, User Acceptance Testing, Business Requirements, Scrum, Systems Analysis, Software Development, Functional..., Waterfall
Education
Jawaharlal Nehru Technological University 2006 — 2010
Bachelors in Technology, Information Technology
Kaavya Maganti's FDA Experience April 2014 - May 2015
Job Actively looking for fulltime career opportunities in Regulatory Affairs
Industry Pharmaceuticals
Experience
Bayer HealthCare May 2015 - August 2015
FDA April 2014 - May 2015
USC Stevens Center for Innovation, University of Southern California March 2014 - May 2015
Dr. Reddy's Laboratories October 2011 - May 2013
Skills
Regulatory Affairs, Regulatory Submissions, Clinical Trials, ICH-GCP, GCP, FDA, GMP, Pharmaceutical Industry, Analytical Chemistry, Quality Control, SOP, GLP, HPLC, Chromatography, Calibration, UV/Vis, CAPA, Pharmaceutics, Drug Development, IND, Clinical Research, Clinical Development
Education
University of Southern California 2014 — 2015
MS, Regulatory Science
Murray State University 2009 — 2011
MS, Chemistry
Jawaharlal Nehru Technological University 2004 — 2008
Bachelor of Science (BS), Pharmacy
Bayer HealthCare May 2015 - August 2015
FDA April 2014 - May 2015
USC Stevens Center for Innovation, University of Southern California March 2014 - May 2015
Dr. Reddy's Laboratories October 2011 - May 2013
Skills
Regulatory Affairs, Regulatory Submissions, Clinical Trials, ICH-GCP, GCP, FDA, GMP, Pharmaceutical Industry, Analytical Chemistry, Quality Control, SOP, GLP, HPLC, Chromatography, Calibration, UV/Vis, CAPA, Pharmaceutics, Drug Development, IND, Clinical Research, Clinical Development
Education
University of Southern California 2014 — 2015
MS, Regulatory Science
Murray State University 2009 — 2011
MS, Chemistry
Jawaharlal Nehru Technological University 2004 — 2008
Bachelor of Science (BS), Pharmacy
Kristen Nickens, PhD Kristen Nickens, PhD's FDA Experience December 2014 - Present
Job Biologist (Product Quality Reviewer) at FDA
Industry Biotechnology
Experience
FDA December 2014 - Present
FDA September 2013 - Present
Mt. Ennon Baptist Church September 2011 - Present
Henry M Jackson Foundation July 2010 - September 2013
STEM Postdoc Conference and Career Fair January 2012 - July 2012
Scientists and Engineers for America (SEA) January 2011 - April 2011
The George Washington University - Columbian College of Arts & Sciences August 2005 - June 2010
National Cancer Institute August 2004 - August 2005
National Institutes of Health August 2003 - August 2004
University of Pittsburgh Medical Center June 2003 - August 2003
Skills
Strategic Planning, Product/Project..., Collaborative Working, Scientific..., Grant Writing, Molecular Biology, Cell Based Assays, Life Sciences, Lifesciences, Collaborative..., Assay Development, Science, Data Analysis, Cancer Research, Pharmacology, Cancer, Clinical Research
Education
The George Washington University School of Medicine and Health Sciences 2005 — 2010
PhD, Molecular Medicine/Oncology
Johnson C. Smith University - JCSU 1999 — 2003
BS, Biology
Montgomery College 2011 — 2011
Certificate, Chief Science Officer: Pathways to Leadership, Careers in Life Science
National Council of Entrepreneurial Tech Transfer 2012 — 2012
Certificate, Understanding Patents and the Patent Applications Process for Engineers and Scientists
The Ellis School 1995 — 1999
High School Diploma
FDA December 2014 - Present
FDA September 2013 - Present
Mt. Ennon Baptist Church September 2011 - Present
Henry M Jackson Foundation July 2010 - September 2013
STEM Postdoc Conference and Career Fair January 2012 - July 2012
Scientists and Engineers for America (SEA) January 2011 - April 2011
The George Washington University - Columbian College of Arts & Sciences August 2005 - June 2010
National Cancer Institute August 2004 - August 2005
National Institutes of Health August 2003 - August 2004
University of Pittsburgh Medical Center June 2003 - August 2003
Skills
Strategic Planning, Product/Project..., Collaborative Working, Scientific..., Grant Writing, Molecular Biology, Cell Based Assays, Life Sciences, Lifesciences, Collaborative..., Assay Development, Science, Data Analysis, Cancer Research, Pharmacology, Cancer, Clinical Research
Education
The George Washington University School of Medicine and Health Sciences 2005 — 2010
PhD, Molecular Medicine/Oncology
Johnson C. Smith University - JCSU 1999 — 2003
BS, Biology
Montgomery College 2011 — 2011
Certificate, Chief Science Officer: Pathways to Leadership, Careers in Life Science
National Council of Entrepreneurial Tech Transfer 2012 — 2012
Certificate, Understanding Patents and the Patent Applications Process for Engineers and Scientists
The Ellis School 1995 — 1999
High School Diploma
Xiaoxia Li's FDA Experience March 2014 - May 2015
Job Microbiologist at Valent BioSciences Corporation
Industry Food Production
Experience
Valent BioSciences Corporation July 2015 - Present
FDA March 2014 - May 2015
Ocean University of China May 2011 - March 2012
Skills
Food Processing, Food Safety, Food Technology, Food Manufacturing, Chinese, Presentations, Microsoft Office, Microsoft Excel, AutoCAD, Presentation Skills, Quality Assurance, R&D
Education
Illinois Institute of Technology 2013 — 2015
Master of Science (MS), Food processing and Engineering
Ocean University of China 2009 — 2013
Bachelor of Engineering (B.E.), Food science and Engineering, A
Valent BioSciences Corporation July 2015 - Present
FDA March 2014 - May 2015
Ocean University of China May 2011 - March 2012
Skills
Food Processing, Food Safety, Food Technology, Food Manufacturing, Chinese, Presentations, Microsoft Office, Microsoft Excel, AutoCAD, Presentation Skills, Quality Assurance, R&D
Education
Illinois Institute of Technology 2013 — 2015
Master of Science (MS), Food processing and Engineering
Ocean University of China 2009 — 2013
Bachelor of Engineering (B.E.), Food science and Engineering, A
Alicia (Johnson) Hoover's FDA Experience October 2014 - Present
Job ORISE fellow at the Food and Drug Administration
Industry Pharmaceuticals
Experience
FDA October 2014 - Present
Saint Louis University August 2009 - October 2014
Darling International Inc. May 2008 - August 2009
Iowa State University May 2007 - May 2008
Skills
Electrophoresis, Electrochemistry, electrode modifications, Cell Culture, Fluorescence Microscopy, Microscopy, Confocal Microscopy, Gas Chromatography, Contact Angle, Photolithography, flow injection analysis, Solid Phase Extraction, Method Development, training undergraduate..., UV-VIS spectrophotometry, Atomic Absorption, separation science
Education
Saint Louis University 2009 — 2014
Doctor of Philosophy (PhD), Chemistry
Iowa State University 2004 — 2008
Bachelor of Science (BS), Chemistry
FDA October 2014 - Present
Saint Louis University August 2009 - October 2014
Darling International Inc. May 2008 - August 2009
Iowa State University May 2007 - May 2008
Skills
Electrophoresis, Electrochemistry, electrode modifications, Cell Culture, Fluorescence Microscopy, Microscopy, Confocal Microscopy, Gas Chromatography, Contact Angle, Photolithography, flow injection analysis, Solid Phase Extraction, Method Development, training undergraduate..., UV-VIS spectrophotometry, Atomic Absorption, separation science
Education
Saint Louis University 2009 — 2014
Doctor of Philosophy (PhD), Chemistry
Iowa State University 2004 — 2008
Bachelor of Science (BS), Chemistry
Yao Meng Yao Meng's FDA Experience August 2015 - Present
Job Research Assistant at FDA
Industry
Experience
FDA August 2015 - Present
Skills
Statistics, Biostatistics, Food Safety, Biotechnology, SAS, R, Customer Service
Education
Illinois Institute of Technology 2014 — 2016
Food safety and technology, Master of Science (M.S.)
Northwest Agriculture & Forestry University 2009 — 2013
Biotechnology, Bachelor of Science (BS)
FDA August 2015 - Present
Skills
Statistics, Biostatistics, Food Safety, Biotechnology, SAS, R, Customer Service
Education
Illinois Institute of Technology 2014 — 2016
Food safety and technology, Master of Science (M.S.)
Northwest Agriculture & Forestry University 2009 — 2013
Biotechnology, Bachelor of Science (BS)
Marianne Price's FDA Experience 2012 - Present
Job Executive Director, Cornea Research Foundation of America
Industry Research
Experience
Cornea Research Foundation of America 2002 - Present
Marquette July 2011 - Present
Working Vision June 2011 - Present
FDA 2012 - Present
Prevent Blindness Indiana 2006 - March 2012
Praxair 1988 - 1990
Union Carbide 1974 - 1988
Skills
Healthcare, Non-profits, Public Speaking, Fundraising, Strategic Planning, Program Management, Proposal Writing, Data Analysis, Research, Nonprofits, Medical Devices, Event Planning, Grant Writing, Leadership, Project Management, Clinical Research, Leadership Development, Teaching, Public Policy, Volunteer Management, Government, Board Development, Strategic Communications, Grants, Training, Team Building, Program Development, Public Relations, Philanthropy, Politics, Analysis, Budgets, Event Management, Coaching, Public Health, Editing, Social Media, Media Relations, Annual Giving, Organizational..., Marketing, Higher Education, Physicians, Policy, Healthcare Consulting, Newsletters, Spanish, Management, Commercialization, Program Evaluation
Education
Indiana University School of Medicine 1996 — 2002
PhD, Medical and Molecular Genetics
Indiana University - Kelley School of Business 1975 — 1981
MBA, Finance
University of Notre Dame 1970 — 1974
BS, Engineering
Cornea Research Foundation of America 2002 - Present
Marquette July 2011 - Present
Working Vision June 2011 - Present
FDA 2012 - Present
Prevent Blindness Indiana 2006 - March 2012
Praxair 1988 - 1990
Union Carbide 1974 - 1988
Skills
Healthcare, Non-profits, Public Speaking, Fundraising, Strategic Planning, Program Management, Proposal Writing, Data Analysis, Research, Nonprofits, Medical Devices, Event Planning, Grant Writing, Leadership, Project Management, Clinical Research, Leadership Development, Teaching, Public Policy, Volunteer Management, Government, Board Development, Strategic Communications, Grants, Training, Team Building, Program Development, Public Relations, Philanthropy, Politics, Analysis, Budgets, Event Management, Coaching, Public Health, Editing, Social Media, Media Relations, Annual Giving, Organizational..., Marketing, Higher Education, Physicians, Policy, Healthcare Consulting, Newsletters, Spanish, Management, Commercialization, Program Evaluation
Education
Indiana University School of Medicine 1996 — 2002
PhD, Medical and Molecular Genetics
Indiana University - Kelley School of Business 1975 — 1981
MBA, Finance
University of Notre Dame 1970 — 1974
BS, Engineering
Freddy Barnes's FDA Experience November 2014 - Present
Job Training Specalist
Industry E-Learning
Experience
FDA November 2014 - Present
Academy Sports + Outdoors October 2013 - September 2014
Rice University April 2012 - October 2013
Indiana Public Health Training Center December 2010 - April 2012
Apple October 2011 - March 2012
IUPUI May 2007 - December 2009
US Army May 2002 - January 2009
Indianapolis Convention & Visitors Association August 2006 - May 2007
Skills
Video Production, Video, Videography, Editing, Final Cut Studio, Microsoft Office, Final Cut Pro, Adobe Creative Suite, Premiere, Digital Media, Mac, Social Media, Photoshop, Instructional Design, Web Design, Webinars, Training, Digital Photography, Digital Video, Learning Management, Web Analytics, Mac OS X, OS X, Dreamweaver, Video Editing, Website Development, Web 2.0, Videographer, Apple, Articulate, Articulate Presenter, Online Video Production, Web, Basic Photoshop, Photojournalism, Photo Editing, MS Office Suite, Apple Software, Apple Macintosh, Course Development, Post Production, Motion Graphics, Presenter, After Effects, HD Video, Image Editing, WordPress, Flash, Photography, Audio Editing
Education
Indiana University-Purdue University at Indianapolis 2009 — 2011
Masters Media Arts & Science, Video Production/ Instructional Technology
Indiana University-Purdue University at Indianapolis 2003 — 2008
Media Arts & Science, Video Production
FDA November 2014 - Present
Academy Sports + Outdoors October 2013 - September 2014
Rice University April 2012 - October 2013
Indiana Public Health Training Center December 2010 - April 2012
Apple October 2011 - March 2012
IUPUI May 2007 - December 2009
US Army May 2002 - January 2009
Indianapolis Convention & Visitors Association August 2006 - May 2007
Skills
Video Production, Video, Videography, Editing, Final Cut Studio, Microsoft Office, Final Cut Pro, Adobe Creative Suite, Premiere, Digital Media, Mac, Social Media, Photoshop, Instructional Design, Web Design, Webinars, Training, Digital Photography, Digital Video, Learning Management, Web Analytics, Mac OS X, OS X, Dreamweaver, Video Editing, Website Development, Web 2.0, Videographer, Apple, Articulate, Articulate Presenter, Online Video Production, Web, Basic Photoshop, Photojournalism, Photo Editing, MS Office Suite, Apple Software, Apple Macintosh, Course Development, Post Production, Motion Graphics, Presenter, After Effects, HD Video, Image Editing, WordPress, Flash, Photography, Audio Editing
Education
Indiana University-Purdue University at Indianapolis 2009 — 2011
Masters Media Arts & Science, Video Production/ Instructional Technology
Indiana University-Purdue University at Indianapolis 2003 — 2008
Media Arts & Science, Video Production
Eric Rabinovich, PMP®'s FDA Experience August 2014 - Present
Job Contract Specialist at FDA
Industry Government Administration
Experience
FDA August 2014 - Present
PwC November 2012 - July 2014
EMC February 2011 - May 2012
EMC August 2009 - February 2011
EMC August 2008 - August 2009
EMC July 2007 - August 2008
Skills
Microsoft Office, Essbase, Financial Analysis, Financial Reporting, SOX, Excel, Financial Modeling, Process Improvement, PowerPoint, Access, Data Analysis, Compliance, Risk Management, Word, Corporate Finance, Due Diligence, Internal Controls, Audit, Problem Solving, Auditing, Microsoft Word, Microsoft Excel, Team Leadership, Delivering Results, Presentations, Technical Writing, Sarbanes-Oxley Act, Analysis, Business Development, Internal Audit, Accounts Receivable, Accounting, Enterprise Risk...
Education
EMC Financial Training Program/Babson College 2007 — 2009
Financial Training and Leadership Certificate
Isenberg School of Management, UMass Amherst 2003 — 2007
B.B.A, Finance and Economics
Newton South High School 1999 — 2003
FDA August 2014 - Present
PwC November 2012 - July 2014
EMC February 2011 - May 2012
EMC August 2009 - February 2011
EMC August 2008 - August 2009
EMC July 2007 - August 2008
Skills
Microsoft Office, Essbase, Financial Analysis, Financial Reporting, SOX, Excel, Financial Modeling, Process Improvement, PowerPoint, Access, Data Analysis, Compliance, Risk Management, Word, Corporate Finance, Due Diligence, Internal Controls, Audit, Problem Solving, Auditing, Microsoft Word, Microsoft Excel, Team Leadership, Delivering Results, Presentations, Technical Writing, Sarbanes-Oxley Act, Analysis, Business Development, Internal Audit, Accounts Receivable, Accounting, Enterprise Risk...
Education
EMC Financial Training Program/Babson College 2007 — 2009
Financial Training and Leadership Certificate
Isenberg School of Management, UMass Amherst 2003 — 2007
B.B.A, Finance and Economics
Newton South High School 1999 — 2003
Quan Wan Quan Wan's FDA Experience October 2014 - Present
Job Research Associate at George Washington University
Industry Biotechnology
Experience
George Washington University January 2015 - Present
FDA October 2014 - Present
George Washington University May 2013 - December 2014
Skills
Java, C++, Python, Amazon Web Services..., MySQL, Relational Databases, PHP, jQuery, HTML, CSS, JavaScript, AJAX, R
Education
The George Washington University 2013 — 2014
Master's Degree, Bioinformatics, 3.5
Jilin University 2008 — 2012
Bachelor's Degree, Biotechnology
George Washington University January 2015 - Present
FDA October 2014 - Present
George Washington University May 2013 - December 2014
Skills
Java, C++, Python, Amazon Web Services..., MySQL, Relational Databases, PHP, jQuery, HTML, CSS, JavaScript, AJAX, R
Education
The George Washington University 2013 — 2014
Master's Degree, Bioinformatics, 3.5
Jilin University 2008 — 2012
Bachelor's Degree, Biotechnology
Hyo Song Hyo Song's FDA Experience June 2010 - January 2012
Job FDA Research Fellow | Musician | Proud Nerd | Lifelong Learner |
Industry Research
Experience
FDA Center for Biologics Evaluation and Research (CBER) September 2015 - Present
Ashley Tutors January 2014 - Present
FDA Center for Veterinary Medicine June 2014 - September 2015
Vista Eye Center December 2013 - May 2014
Glaucoma Consultants of Washington December 2012 - December 2013
FDA June 2010 - January 2012
Skills
PCR, Gel Electrophoresis, Molecular Biology, Biology, PCR-RFLP, Micropipette, Double Bass, Piano, DNA extraction, real-time PCR, DNA, Assay Development, RNA Isolation, Public Speaking, qPCR, DNA Extraction, Microsoft Office, Research, Biochemistry, Laboratory, Cell Biology, Biotechnology
Education
Johns Hopkins University Advanced Academic Programs 2014 — 2016
Master's Degree, Biotechnology with Concentration in Molecular Targets and Drug Discovery Technologies
University of Maryland Baltimore County 2007 — 2012
Bachelor of Science (BS), Biology/Biological Sciences, General
University of Maryland Baltimore County 2007 — 2012
Bachelor of Arts (B.A.), Music Performance, General
Colonel Zadok Magruder High School 2003 — 2007
High School
FDA Center for Biologics Evaluation and Research (CBER) September 2015 - Present
Ashley Tutors January 2014 - Present
FDA Center for Veterinary Medicine June 2014 - September 2015
Vista Eye Center December 2013 - May 2014
Glaucoma Consultants of Washington December 2012 - December 2013
FDA June 2010 - January 2012
Skills
PCR, Gel Electrophoresis, Molecular Biology, Biology, PCR-RFLP, Micropipette, Double Bass, Piano, DNA extraction, real-time PCR, DNA, Assay Development, RNA Isolation, Public Speaking, qPCR, DNA Extraction, Microsoft Office, Research, Biochemistry, Laboratory, Cell Biology, Biotechnology
Education
Johns Hopkins University Advanced Academic Programs 2014 — 2016
Master's Degree, Biotechnology with Concentration in Molecular Targets and Drug Discovery Technologies
University of Maryland Baltimore County 2007 — 2012
Bachelor of Science (BS), Biology/Biological Sciences, General
University of Maryland Baltimore County 2007 — 2012
Bachelor of Arts (B.A.), Music Performance, General
Colonel Zadok Magruder High School 2003 — 2007
High School
Frederick Hyman Frederick Hyman's FDA Experience July 1989 - Present
Job Dental Officer at FDA
Industry Government Administration
Experience
FDA July 1989 - Present
Private Dental Practice September 1981 - July 1989
Education
Johns Hopkins Bloomberg School of Public Health 1986 — 1990
MPH, Epidemiology
University of Maryland School of Dentistry 1977 — 1981
Doctor of Dental Surgery
University of Maryland College Park 1971 — 1975
Bachelor's Degree, College of Computer, Mathematics and Natural Sciences
FDA July 1989 - Present
Private Dental Practice September 1981 - July 1989
Education
Johns Hopkins Bloomberg School of Public Health 1986 — 1990
MPH, Epidemiology
University of Maryland School of Dentistry 1977 — 1981
Doctor of Dental Surgery
University of Maryland College Park 1971 — 1975
Bachelor's Degree, College of Computer, Mathematics and Natural Sciences
Mary Ferren's FDA Experience 2013 - Present
Job Consumer Safety Technician at FDA
Industry Government Administration
Experience
FDA 2013 - Present
U.S. Census Bureau August 2009 - April 2012
Army National Guard December 2001 - December 2009
Office of The Adjutant General February 2006 - August 2009
Skills
Microsoft Office, ArcGIS, Geography
Education
Indiana University-Southeast 2012 — 2016
Bachelor's Degree, Geological and Earth Sciences/Geosciences, 3.3 GPA
FDA 2013 - Present
U.S. Census Bureau August 2009 - April 2012
Army National Guard December 2001 - December 2009
Office of The Adjutant General February 2006 - August 2009
Skills
Microsoft Office, ArcGIS, Geography
Education
Indiana University-Southeast 2012 — 2016
Bachelor's Degree, Geological and Earth Sciences/Geosciences, 3.3 GPA
Junguk Hur Junguk Hur's FDA Experience February 2013 - April 2013
Job Assistant Professor at University of North Dakota, School of Medicine and Health Sciences
Industry Higher Education
Experience
University of North Dakota January 2015 - Present
University of Michigan July 2010 - January 2015
FDA February 2013 - April 2013
Skills
Bioinformatics, Microarray Analysis, R, Transcriptomics, Perl, Molecular Biology, Systems Biology, Computational Biology, Sequence Analysis, Microarray, Machine Learning, Genomics, Genetics
Education
University of Michigan 2006 — 2010
Ph.D., Bioinformatics
Indiana University Bloomington 2004 — 2006
M.S., Bioinformatics
Pohang University of Science and Technology 1994 — 2001
B.S, Life Science
University of North Dakota January 2015 - Present
University of Michigan July 2010 - January 2015
FDA February 2013 - April 2013
Skills
Bioinformatics, Microarray Analysis, R, Transcriptomics, Perl, Molecular Biology, Systems Biology, Computational Biology, Sequence Analysis, Microarray, Machine Learning, Genomics, Genetics
Education
University of Michigan 2006 — 2010
Ph.D., Bioinformatics
Indiana University Bloomington 2004 — 2006
M.S., Bioinformatics
Pohang University of Science and Technology 1994 — 2001
B.S, Life Science
Ripujeet Madan's FDA Experience March 2015 - Present
Job Supervisory IT Specialist (Team Lead) at FDA
Industry Information Technology and Services
Experience
FDA March 2015 - Present
FDA February 2012 - Present
Skills
Healthcare, Healthcare IT, Business Solutions, Business Intelligence, Software Project..., Agile Project Management, Product Management, Software Development, PMP, Business Process..., Workflow Automation, Information Architecture, Requirements Management, Distributed Team..., Innovation, Innovative Problem..., SOA, Microsoft Office, .NET, Mobile Solutions, SQL Server, Enterprise Software, Enterprise Solutions, Proposal Writing, proposal development, SDLC, Program Management, SharePoint, Healthcare Information..., Project Management, Solutions Marketing, Microsoft SQL Server, Vendor Management, Integration, Cross-functional Team..., Software Documentation, Databases, Project Portfolio..., Security, CRM, Requirements Analysis, Change Management, ERP, Visio, Management, Enterprise Architecture, Web Services, Team Leadership, Agile Methodologies, Project Planning
Education
Indian Institute Of Technology 1991 — 1994
M.Tech, Computer Technology
Indian Institute of Technology, Delhi 1991 — 1994
M.Tech, Computer Technology
Swami Ramanand Teerth Marathwada University 1985 — 1989
B.E., Computer Engineering
GHPS 1977 — 1985
High School, Science
FDA March 2015 - Present
FDA February 2012 - Present
Skills
Healthcare, Healthcare IT, Business Solutions, Business Intelligence, Software Project..., Agile Project Management, Product Management, Software Development, PMP, Business Process..., Workflow Automation, Information Architecture, Requirements Management, Distributed Team..., Innovation, Innovative Problem..., SOA, Microsoft Office, .NET, Mobile Solutions, SQL Server, Enterprise Software, Enterprise Solutions, Proposal Writing, proposal development, SDLC, Program Management, SharePoint, Healthcare Information..., Project Management, Solutions Marketing, Microsoft SQL Server, Vendor Management, Integration, Cross-functional Team..., Software Documentation, Databases, Project Portfolio..., Security, CRM, Requirements Analysis, Change Management, ERP, Visio, Management, Enterprise Architecture, Web Services, Team Leadership, Agile Methodologies, Project Planning
Education
Indian Institute Of Technology 1991 — 1994
M.Tech, Computer Technology
Indian Institute of Technology, Delhi 1991 — 1994
M.Tech, Computer Technology
Swami Ramanand Teerth Marathwada University 1985 — 1989
B.E., Computer Engineering
GHPS 1977 — 1985
High School, Science
Rana Rais Rana Rais's FDA Experience July 2010 - November 2010
Job Assistant Professor at Johns Hopkins School of Medicine
Industry Research
Experience
Johns Hopkins School of Medicine September 2014 - Present
Johns Hopkins Brain Science Instittue July 2013 - Present
Johns Hopkins University November 2010 - July 2013
FDA July 2010 - November 2010
University of Maryland School of Pharmacy 2005 - 2010
Skills
Drug Metabolism, Pharmacokinetics, Biopharmacuetics, CNS therapeutics, Drug Delivery, Drug Development, HPLC, Pharmaceutical Research, Drug Discovery, Drug Design, Formulation, UV/Vis, Cell Culture, Mass Spectrometry, Analytical Chemistry, FDA, Assay Development, Life Sciences
Education
University of Maryland Baltimore 2005 — 2010
Ph.D., pharmaceutical sciences
Jamia Hamdard
Bachelor of Pharmacy (B.Pharm.)
Johns Hopkins School of Medicine September 2014 - Present
Johns Hopkins Brain Science Instittue July 2013 - Present
Johns Hopkins University November 2010 - July 2013
FDA July 2010 - November 2010
University of Maryland School of Pharmacy 2005 - 2010
Skills
Drug Metabolism, Pharmacokinetics, Biopharmacuetics, CNS therapeutics, Drug Delivery, Drug Development, HPLC, Pharmaceutical Research, Drug Discovery, Drug Design, Formulation, UV/Vis, Cell Culture, Mass Spectrometry, Analytical Chemistry, FDA, Assay Development, Life Sciences
Education
University of Maryland Baltimore 2005 — 2010
Ph.D., pharmaceutical sciences
Jamia Hamdard
Bachelor of Pharmacy (B.Pharm.)
Maggie R. Redden Maggie R. Redden's FDA Experience April 2015 - Present
Job Paralegal Specialist with the Food and Drug Administration
Industry Legal Services
Experience
FDA April 2015 - Present
Skills
International Relations, Technology, Customer Service, Critical Thinking, Data Entry, Time Management, Leadership, Spanish, Volunteer Management, Teamwork, Research, Data Analysis, Training
Education
State University of New York College at Brockport 2011 — 2014
Bachelor of Arts (B.A.)
Syracuse University 2010 — 2011
Project Advance
Jamestown Community College 2009 — 2011
General Education
FDA April 2015 - Present
Skills
International Relations, Technology, Customer Service, Critical Thinking, Data Entry, Time Management, Leadership, Spanish, Volunteer Management, Teamwork, Research, Data Analysis, Training
Education
State University of New York College at Brockport 2011 — 2014
Bachelor of Arts (B.A.)
Syracuse University 2010 — 2011
Project Advance
Jamestown Community College 2009 — 2011
General Education
Chaitanya Kesari Chaitanya Kesari's FDA Experience June 2008 - March 2011
Job Developer
Industry Computer Software
Experience
Coventry Health Care March 2013 - Present
Albridge, an Affiliate of Pershing - BNY MELLON Company March 2012 - October 2012
Goldman Sachs March 2011 - February 2012
Platinum Solutions June 2008 - March 2011
FDA June 2008 - March 2011
Wipro Technologies May 2005 - May 2008
Skills
Struts, Spring, J2EE, JSP, PL/SQL, Web Services, XML, Agile Methodologies, SQL, Oracle, SOA, SDLC, Java Enterprise Edition, Spring Framework, Weblogic, Java, Hibernate, Business Analysis, Requirements Analysis, Tomcat, JDBC
Education
Jawaharlal Nehru Technological University 2001 — 2005
Bachelors from JNTU Kakinada, Electrical, Electronics and Communications Engineering
Coventry Health Care March 2013 - Present
Albridge, an Affiliate of Pershing - BNY MELLON Company March 2012 - October 2012
Goldman Sachs March 2011 - February 2012
Platinum Solutions June 2008 - March 2011
FDA June 2008 - March 2011
Wipro Technologies May 2005 - May 2008
Skills
Struts, Spring, J2EE, JSP, PL/SQL, Web Services, XML, Agile Methodologies, SQL, Oracle, SOA, SDLC, Java Enterprise Edition, Spring Framework, Weblogic, Java, Hibernate, Business Analysis, Requirements Analysis, Tomcat, JDBC
Education
Jawaharlal Nehru Technological University 2001 — 2005
Bachelors from JNTU Kakinada, Electrical, Electronics and Communications Engineering
Tara Garwood Tara Garwood's FDA Experience July 2009 - January 2015
Job Filmmaker / Actor / Government Employee
Industry Entertainment
Experience
Tarakata Films March 2011 - Present
Freelance 2000 - Present
FDA July 2009 - January 2015
OuterLoop Films November 2008 - May 2010
Molotov Theatre Group June 2007 - October 2009
Montgomery College September 2008 - June 2009
Skills
Video Production, Video Editing, Directing, Camera Operator, DSLR, Lighting, Audio Recording, Screenwriting, Graphic Design, Web Design, Adobe Photoshop, Final Cut Pro, Adobe Premiere, DVD Studio Pro, Compressor, Episode Pro, Adobe Media Encoder, Motion, LiveType, After Effects, Soundtrack Pro, Adobe Audition, Mac, PC, Microsoft Office, Film, Recording, Camera Operating, Premiere, Voice Over, Adobe Creative Suite, Photoshop, Broadcast, Documentaries, Acting, Sound, Comedy, Final Cut Studio, Theatre, Videography, New Media, Commercials, Television, Drama, Voice Acting, Video, Independent Film, Film Production, Performing Arts, Camera
Education
Boston University's Center for Digital Imaging Arts 2010 — 2011
Certificate, Digital Filmmaking
Montgomery College 2007 — 2009
Film, TV, and Radio Production
Jacksonville University 1995 — 1999
BFA, Musical Theatre
Tarakata Films March 2011 - Present
Freelance 2000 - Present
FDA July 2009 - January 2015
OuterLoop Films November 2008 - May 2010
Molotov Theatre Group June 2007 - October 2009
Montgomery College September 2008 - June 2009
Skills
Video Production, Video Editing, Directing, Camera Operator, DSLR, Lighting, Audio Recording, Screenwriting, Graphic Design, Web Design, Adobe Photoshop, Final Cut Pro, Adobe Premiere, DVD Studio Pro, Compressor, Episode Pro, Adobe Media Encoder, Motion, LiveType, After Effects, Soundtrack Pro, Adobe Audition, Mac, PC, Microsoft Office, Film, Recording, Camera Operating, Premiere, Voice Over, Adobe Creative Suite, Photoshop, Broadcast, Documentaries, Acting, Sound, Comedy, Final Cut Studio, Theatre, Videography, New Media, Commercials, Television, Drama, Voice Acting, Video, Independent Film, Film Production, Performing Arts, Camera
Education
Boston University's Center for Digital Imaging Arts 2010 — 2011
Certificate, Digital Filmmaking
Montgomery College 2007 — 2009
Film, TV, and Radio Production
Jacksonville University 1995 — 1999
BFA, Musical Theatre
Frances Fagan's FDA Experience June 2010 - January 2011
Job Healthcare Educator Outreach Manager at Vanda Pharmaceuticals
Industry Health, Wellness and Fitness
Experience
Vanda Pharmaceuticals August 2014 - Present
Terrapin Care Center June 2013 - August 2014
National Institutes of Health December 2010 - July 2011
FDA June 2010 - January 2011
Georgetown Aquatics 2006 - 2011
Skills
Cpr Certified, First Aid, AED certified, Microsoft Office, Data Entry, People Skills, Exceptionally well..., Close Attention to..., Microsoft Word, Microsoft Excel, PowerPoint, SPSS, Time Management, Healthcare, Critical Thinking, Teamwork, Community Outreach, Management, CPR Certified, Customer Service
Education
Montgomery College 2012 — 2014
Registered Nursing/Registered Nurse
James Madison University 2008 — 2012
Bachelor of Science (B.S.), Health Services/Allied Health/Health Sciences, General
Winston Churchill High School 2005 — 2008
Vanda Pharmaceuticals August 2014 - Present
Terrapin Care Center June 2013 - August 2014
National Institutes of Health December 2010 - July 2011
FDA June 2010 - January 2011
Georgetown Aquatics 2006 - 2011
Skills
Cpr Certified, First Aid, AED certified, Microsoft Office, Data Entry, People Skills, Exceptionally well..., Close Attention to..., Microsoft Word, Microsoft Excel, PowerPoint, SPSS, Time Management, Healthcare, Critical Thinking, Teamwork, Community Outreach, Management, CPR Certified, Customer Service
Education
Montgomery College 2012 — 2014
Registered Nursing/Registered Nurse
James Madison University 2008 — 2012
Bachelor of Science (B.S.), Health Services/Allied Health/Health Sciences, General
Winston Churchill High School 2005 — 2008
Jesse Wells's FDA Experience June 2007 - Present
Job
Industry Pharmaceuticals
Experience
FDA June 2007 - Present
Education
University of Rochester School of Medicine and Dentistry 2000 — 2005
Ph.D.
Ithaca College 1995 — 1999
FDA June 2007 - Present
Education
University of Rochester School of Medicine and Dentistry 2000 — 2005
Ph.D.
Ithaca College 1995 — 1999
Pradeep Mittal's FDA Experience April 2011 - January 2013
Job Data Warehouse Manager at Front Point Security
Industry Computer Software
Experience
FrontPoint Security January 2013 - Present
FDA April 2011 - January 2013
Altum, Inc. January 2009 - January 2013
mclagan January 2004 - January 2009
i-flex solutions 2000 - 2003
Skills
Business Intelligence, Business Analysis, Data Warehousing, ETL, SSIS, SQL, Data Modeling, SDLC, SSRS, Business Objects, Microsoft SQL Server, Data Analysis
Education
Indian Institute of Technology, Bombay 1995 — 1999
B Tech
FrontPoint Security January 2013 - Present
FDA April 2011 - January 2013
Altum, Inc. January 2009 - January 2013
mclagan January 2004 - January 2009
i-flex solutions 2000 - 2003
Skills
Business Intelligence, Business Analysis, Data Warehousing, ETL, SSIS, SQL, Data Modeling, SDLC, SSRS, Business Objects, Microsoft SQL Server, Data Analysis
Education
Indian Institute of Technology, Bombay 1995 — 1999
B Tech
Dakshina Chilukuri's FDA Experience
Job Clinical Pharmacology Reviewer at FDA
Industry Pharmaceuticals
Experience
FDA
Skills
Pharmaceutical Industry, Clinical Pharmacology, Pharmacology, IND, Pharmacokinetics, Clinical Trials, Regulatory Affairs, Drug Development, Clinical Development
Education
Medical University of South Carolina 1995 — 1999
Ph.D., Pharmaceutical Sciences
Kakatiya University 1990 — 1994
B.Pharm, Pharmacy
FDA
Skills
Pharmaceutical Industry, Clinical Pharmacology, Pharmacology, IND, Pharmacokinetics, Clinical Trials, Regulatory Affairs, Drug Development, Clinical Development
Education
Medical University of South Carolina 1995 — 1999
Ph.D., Pharmaceutical Sciences
Kakatiya University 1990 — 1994
B.Pharm, Pharmacy
Shashi Amur's FDA Experience September 2011 - Present
Job Biomarker Qualification Scientific Lead at fda
Industry Biotechnology
Experience
FDA September 2011 - Present
fda May 2005 - February 2012
Neotropix, Inc February 2005 - May 2005
Immune Tolerance Network March 2003 - April 2004
Applied Biosystems July 1998 - March 2003
Specialty Laboratories 1996 - 1998
Skills
Biotechnology, Molecular Biology, Pharmacogenomics, Biochemistry, Molecular & Cellular..., Neuroscience, Autoimmune Diseases, Biomarkers, Translational Science, Genomics, Molecular Cloning, PCR, Assay Development, Science, Proteomics, Validation, Cancer, Pharmacology, Immunology
Education
Indian Institute of Science 1975 — 1981
FDA September 2011 - Present
fda May 2005 - February 2012
Neotropix, Inc February 2005 - May 2005
Immune Tolerance Network March 2003 - April 2004
Applied Biosystems July 1998 - March 2003
Specialty Laboratories 1996 - 1998
Skills
Biotechnology, Molecular Biology, Pharmacogenomics, Biochemistry, Molecular & Cellular..., Neuroscience, Autoimmune Diseases, Biomarkers, Translational Science, Genomics, Molecular Cloning, PCR, Assay Development, Science, Proteomics, Validation, Cancer, Pharmacology, Immunology
Education
Indian Institute of Science 1975 — 1981
Blakeley Fitzpatrick's FDA Experience December 2008 - Present
Job Interdisciplinary Nutrition Scientist at FDA
Industry Health, Wellness and Fitness
Experience
FDA December 2008 - Present
U.S. Public Health Service Commissioned Corps February 2004 - Present
National Institutes of Health October 2001 - December 2008
Education
The George Washington University School of Medicine and Health Sciences 2001 — 2006
MPH, Epidemiology, Biostatistics
James Madison University 1995 — 2000
B.S, Dietetics, Biology
FDA December 2008 - Present
U.S. Public Health Service Commissioned Corps February 2004 - Present
National Institutes of Health October 2001 - December 2008
Education
The George Washington University School of Medicine and Health Sciences 2001 — 2006
MPH, Epidemiology, Biostatistics
James Madison University 1995 — 2000
B.S, Dietetics, Biology
Anurag Sharadendu's FDA Experience March 2008 - Present
Job Review Chemist, FDA
Industry Pharmaceuticals
Experience
FDA March 2008 - Present
Epix Pharmaceuticals August 2002 - August 2007
Predix Pharmaceuticals 2002 - 2006
Naeja Pharmaceuticals September 1999 - June 2002
IGT 1996 - 1997
Education
The University of British Columbia 1989 — 1996
phd, chemistry
Indian Institute of Technology, Kanpur 1987 — 1989
M.Sc., Chemistry
FDA March 2008 - Present
Epix Pharmaceuticals August 2002 - August 2007
Predix Pharmaceuticals 2002 - 2006
Naeja Pharmaceuticals September 1999 - June 2002
IGT 1996 - 1997
Education
The University of British Columbia 1989 — 1996
phd, chemistry
Indian Institute of Technology, Kanpur 1987 — 1989
M.Sc., Chemistry
Dawes, Debbie's FDA Experience March 2003 - Present
Job Secretary at FDA
Industry Consumer Services
Experience
FDA March 2003 - Present
Skills
Research, Microsoft Office, Policy, Administrative..., Government, Data Entry, Outlook, Office Management, Public Policy, Policy Analysis, Public Speaking, Community Outreach
Education
Trident University International 2015 — 2017
Bachelor's degree, Business Administration and Management, General, GPA 3.7.7
Trident University International 2015 — 2017
Bachelor of Applied Science (B.A.Sc.), Business Administration and Management, General, GPA 3.7.1
Jones International University 2014 — 2015
Bachelor of Business Administration (B.B.A.), General Studies, GPA-4
FDA March 2003 - Present
Skills
Research, Microsoft Office, Policy, Administrative..., Government, Data Entry, Outlook, Office Management, Public Policy, Policy Analysis, Public Speaking, Community Outreach
Education
Trident University International 2015 — 2017
Bachelor's degree, Business Administration and Management, General, GPA 3.7.7
Trident University International 2015 — 2017
Bachelor of Applied Science (B.A.Sc.), Business Administration and Management, General, GPA 3.7.1
Jones International University 2014 — 2015
Bachelor of Business Administration (B.B.A.), General Studies, GPA-4
Vaishali Adkar's FDA Experience May 2005 - October 2005
Job Project Manager I at PRA Health Sciences
Industry Biotechnology
Experience
PRA Health Sciences July 2015 - Present
ICON /docs global INC July 2012 - February 2015
Delcath INC -Contracted by Docs/ICON global July 2011 - July 2012
University of Maryland School of Medicine May 2010 - December 2010
KAI Research, Inc April 2008 - June 2010
Accelovance Inc May 2006 - April 2007
FDA May 2005 - October 2005
Skills
Oncology, Clinical Research, Physiology, Infectious Diseases, Clinical Trials, Immunology, Vaccines, Lifesciences, GCP, CTMS, Molecular Biology, Cancer, Data Management, Neuroscience
Education
University of Maryland Baltimore 2010 — 2013
MSN, Nursing CNL
San Jose State University 2004 — 2005
MS/MBA, Biotechnology
University of Mumbai 1994 — 1998
DHMS (Diploma in homeopathic medicine and surgery), Medicine/Homeopathy
Indian Institute of Science 1992 — 1994
BS, Zoology/Animal Physiology
PRA Health Sciences July 2015 - Present
ICON /docs global INC July 2012 - February 2015
Delcath INC -Contracted by Docs/ICON global July 2011 - July 2012
University of Maryland School of Medicine May 2010 - December 2010
KAI Research, Inc April 2008 - June 2010
Accelovance Inc May 2006 - April 2007
FDA May 2005 - October 2005
Skills
Oncology, Clinical Research, Physiology, Infectious Diseases, Clinical Trials, Immunology, Vaccines, Lifesciences, GCP, CTMS, Molecular Biology, Cancer, Data Management, Neuroscience
Education
University of Maryland Baltimore 2010 — 2013
MSN, Nursing CNL
San Jose State University 2004 — 2005
MS/MBA, Biotechnology
University of Mumbai 1994 — 1998
DHMS (Diploma in homeopathic medicine and surgery), Medicine/Homeopathy
Indian Institute of Science 1992 — 1994
BS, Zoology/Animal Physiology
J.P. McWatters's FDA Experience May 2006 - Present
Job Regulatory project manager at FDA
Industry Government Administration
Experience
FDA May 2006 - Present
FDA September 2001 - May 2006
Eastern Virginia Medical School, Department of Cell Molecular Biology 1995 - 2001
Skills
FDA, Vaccines, Research, Regulatory Affairs, Infectious Diseases, Lifesciences, Biotechnology, Policy, Molecular Biology, Regulatory Requirements, Virology, IND, Public Policy, Regulatory Submissions, Public Health, CMC, Chemistry, Life Sciences, Clinical Development, GCP
Education
Old Dominion University 1994 — 2001
Ph.D., Biomedical Science - Virology
James Madison University 1988 — 1992
B.S., Biology
FDA May 2006 - Present
FDA September 2001 - May 2006
Eastern Virginia Medical School, Department of Cell Molecular Biology 1995 - 2001
Skills
FDA, Vaccines, Research, Regulatory Affairs, Infectious Diseases, Lifesciences, Biotechnology, Policy, Molecular Biology, Regulatory Requirements, Virology, IND, Public Policy, Regulatory Submissions, Public Health, CMC, Chemistry, Life Sciences, Clinical Development, GCP
Education
Old Dominion University 1994 — 2001
Ph.D., Biomedical Science - Virology
James Madison University 1988 — 1992
B.S., Biology
Richard Mallonee's FDA Experience April 2014 - Present
Job Consumer Safety Officer at FDA
Industry Medical Devices
Experience
FDA April 2014 - Present
Qiagen May 2002 - December 2013
BD 2000 - 2002
BD 1989 - 2000
BD 1986 - 1989
Skills
Biotechnology, Molecular Biology, DNA, PCR, Lifesciences, Genetics, Genomics, Cell Culture, Biochemistry, Bioinformatics, ELISA, Validation, Immunoassays, Assay Development, Medical Devices, Infectious Diseases, Protein Chemistry, GMP, Purification, GLP, Immunology, Protein Expression, FDA, Regulatory Affairs, Primer Design, Cell, Proteomics, R&D, Molecular Diagnostics, Protein Purification, Biopharmaceuticals, Life Sciences
Education
The Johns Hopkins University - Carey Business School 1983 — 1985
MAS, Management
James Madison University 1979 — 1981
MS, Biology
James Madison University 1975 — 1979
BS, Biology
FDA April 2014 - Present
Qiagen May 2002 - December 2013
BD 2000 - 2002
BD 1989 - 2000
BD 1986 - 1989
Skills
Biotechnology, Molecular Biology, DNA, PCR, Lifesciences, Genetics, Genomics, Cell Culture, Biochemistry, Bioinformatics, ELISA, Validation, Immunoassays, Assay Development, Medical Devices, Infectious Diseases, Protein Chemistry, GMP, Purification, GLP, Immunology, Protein Expression, FDA, Regulatory Affairs, Primer Design, Cell, Proteomics, R&D, Molecular Diagnostics, Protein Purification, Biopharmaceuticals, Life Sciences
Education
The Johns Hopkins University - Carey Business School 1983 — 1985
MAS, Management
James Madison University 1979 — 1981
MS, Biology
James Madison University 1975 — 1979
BS, Biology
Sandy Menzies's FDA Experience Quality Manager for the Managed Review ProcessFDAMarch 2012 - February 2013
Job Quality Specialist at FDA
Industry Research
Experience
FDA Quality Manager for the Managed Review ProcessFDAMarch 2012 - February 2013
FDA June 2003 - March 2012
TherImmune Research Corporation April 2002 - May 2003
Skills
Public Health, Biostatistics, Statistics, Data Analysis, Clinical Research, Research, Policy Analysis, Technical Writing, Qualitative Research, Policy, Public Policy, Government, Grants, Infectious Diseases, Epidemiology, Lifesciences, Quality Assurance, Life Sciences
Education
The Johns Hopkins University 1992 — 1996
Master's degree, Biotechnology
James Madison University 1989 — 1991
Bachelor's degree, Biology, General
FDA Quality Manager for the Managed Review ProcessFDAMarch 2012 - February 2013
FDA June 2003 - March 2012
TherImmune Research Corporation April 2002 - May 2003
Skills
Public Health, Biostatistics, Statistics, Data Analysis, Clinical Research, Research, Policy Analysis, Technical Writing, Qualitative Research, Policy, Public Policy, Government, Grants, Infectious Diseases, Epidemiology, Lifesciences, Quality Assurance, Life Sciences
Education
The Johns Hopkins University 1992 — 1996
Master's degree, Biotechnology
James Madison University 1989 — 1991
Bachelor's degree, Biology, General
Luis V Santana's FDA Experience August 2012 - Present
Job Post Doctoral Scientist at FDA
Industry Research
Experience
FDA August 2012 - Present
George Mason University August 2009 - April 2011
CINVESTAV-IPN January 2005 - November 2008
Skills
C/C++, Python, Machine Learning, Evolutionary Computation, Multi-Objective..., Java, Cloud Computing, Software Development, NextGen
Education
Centro de Investigación y de Estudios Avanzados del IPN 2005 — 2008
PhD, Computer Science, 99
Centro de Investigación y de Estudios Avanzados del IPN 2002 — 2004
MSc, COMPUTER SCIENCE, 96
Instituto Politécnico Nacional 1998 — 2002
ENGINEER, COMPUTER SCIENCE, 92
Cecyt 9 "Juan de Diós Bátiz" 1995 — 1998
Técnico, Sistemas Digitales
FDA August 2012 - Present
George Mason University August 2009 - April 2011
CINVESTAV-IPN January 2005 - November 2008
Skills
C/C++, Python, Machine Learning, Evolutionary Computation, Multi-Objective..., Java, Cloud Computing, Software Development, NextGen
Education
Centro de Investigación y de Estudios Avanzados del IPN 2005 — 2008
PhD, Computer Science, 99
Centro de Investigación y de Estudios Avanzados del IPN 2002 — 2004
MSc, COMPUTER SCIENCE, 96
Instituto Politécnico Nacional 1998 — 2002
ENGINEER, COMPUTER SCIENCE, 92
Cecyt 9 "Juan de Diós Bátiz" 1995 — 1998
Técnico, Sistemas Digitales
Danielle (Dani) Drummond's FDA Experience December 2012 - June 2014
Job IT Project Manager
Industry Hospital & Health Care
Experience
Novant Health August 2015 - Present
MBO Partners October 2014 - Present
FDA December 2012 - June 2014
Booz Allen Hamilton May 2004 - December 2012
Skills
SDLC, IT Strategy, Requirements Analysis, PMP, Program Management, Business Process..., Integration, Enterprise Architecture, Business Analysis, Management, Change Management, PMO, SharePoint, Proposal Writing, Telecommunications, Risk Management, Project Portfolio..., Management Consulting, IT Management, Business Process, Business Process..., Consulting, Process Improvement, Software Documentation, Vendor Management, Project Management, Analysis, Strategy, Visio, Cross-functional Team..., CRM, Business Intelligence
Education
James Madison University - College of Business 2001 — 2005
Marketing Information Systems
Novant Health August 2015 - Present
MBO Partners October 2014 - Present
FDA December 2012 - June 2014
Booz Allen Hamilton May 2004 - December 2012
Skills
SDLC, IT Strategy, Requirements Analysis, PMP, Program Management, Business Process..., Integration, Enterprise Architecture, Business Analysis, Management, Change Management, PMO, SharePoint, Proposal Writing, Telecommunications, Risk Management, Project Portfolio..., Management Consulting, IT Management, Business Process, Business Process..., Consulting, Process Improvement, Software Documentation, Vendor Management, Project Management, Analysis, Strategy, Visio, Cross-functional Team..., CRM, Business Intelligence
Education
James Madison University - College of Business 2001 — 2005
Marketing Information Systems
Mara Bauman Miller's FDA Experience January 2011 - Present
Job Regulatory Project Manager at FDA
Industry Pharmaceuticals
Experience
FDA January 2011 - Present
Westat July 2004 - December 2010
The EMMES Corporation March 2002 - June 2004
New York Eye and Ear Infirmary September 2000 - February 2002
Education
University of North Carolina at Chapel Hill 1996 — 1998
MA, Exercise Physiology
Indiana University Bloomington 1992 — 1996
BS, Kinesiology
FDA January 2011 - Present
Westat July 2004 - December 2010
The EMMES Corporation March 2002 - June 2004
New York Eye and Ear Infirmary September 2000 - February 2002
Education
University of North Carolina at Chapel Hill 1996 — 1998
MA, Exercise Physiology
Indiana University Bloomington 1992 — 1996
BS, Kinesiology
Al Chester, RAC's FDA Experience August 1990 - August 2003
Job Manager, Regulatory Compliance at Johnson & Johnson Vision Care, Inc.
Industry Medical Devices
Experience
Johnson & Johnson Vision Care, Inc. May 2014 - Present
Johnson & Johnson Vision Care, Inc. July 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - August 2012
Duke Clinical Research Institute July 2007 - January 2011
FDA August 1990 - August 2003
Skills
Pharmaceutical Industry, Quality Assurance, FDA, GCP, Sop, Data Management, Regulatory Affairs, Clinical Trials, CTMS, Clinical Research, Validation, Lifesciences, Oncology, Clinical Development, GMP, Biotechnology, Regulatory Submissions, CAPA, GLP, Research, 21 CFR Part 11, Clinical Monitoring, Medical Devices
Education
University of South Carolina-Columbia 1985 — 1990
Bachelor of Science, Biological Sciences
Illinois State University 1987 — 1988
Johnson & Johnson Vision Care, Inc. May 2014 - Present
Johnson & Johnson Vision Care, Inc. July 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - August 2012
Duke Clinical Research Institute July 2007 - January 2011
FDA August 1990 - August 2003
Skills
Pharmaceutical Industry, Quality Assurance, FDA, GCP, Sop, Data Management, Regulatory Affairs, Clinical Trials, CTMS, Clinical Research, Validation, Lifesciences, Oncology, Clinical Development, GMP, Biotechnology, Regulatory Submissions, CAPA, GLP, Research, 21 CFR Part 11, Clinical Monitoring, Medical Devices
Education
University of South Carolina-Columbia 1985 — 1990
Bachelor of Science, Biological Sciences
Illinois State University 1987 — 1988
Jared Lantzy, PMP's FDA Experience June 2013 - August 2015
Job Manager, Global Regulatory Agencies and Processes
Industry Information Technology and Services
Experience
LORENZ Life Sciences Group August 2015 - Present
North American Stage Rally February 2009 - Present
FDA June 2013 - August 2015
FDA January 2010 - June 2013
Sports Car Club of America (SCCA) October 2010 - December 2012
Grant Thornton August 2007 - December 2009
InDyne Inc. June 2006 - August 2007
SAIC September 2005 - May 2006
Datatel August 2004 - August 2005
CERMUSA 2003 - 2004
Skills
Business Process..., Project Management, Requirements Analysis, Business Analysis, Program Management, Software Documentation, Process Improvement, Integration, FDA, Regulatory Submissions, Analysis, SDLC, Enterprise Architecture, eCTD, CMC Regulatory Affairs, Quality Assurance, Data Management, Project Portfolio..., Business Process, Regulatory Affairs, Strategy, Governance, IT Strategy
Education
Juniata College 1998 — 2002
BS, Information Technology
Bishop Carroll High School, Ebensburg, PA 1994 — 1998
LORENZ Life Sciences Group August 2015 - Present
North American Stage Rally February 2009 - Present
FDA June 2013 - August 2015
FDA January 2010 - June 2013
Sports Car Club of America (SCCA) October 2010 - December 2012
Grant Thornton August 2007 - December 2009
InDyne Inc. June 2006 - August 2007
SAIC September 2005 - May 2006
Datatel August 2004 - August 2005
CERMUSA 2003 - 2004
Skills
Business Process..., Project Management, Requirements Analysis, Business Analysis, Program Management, Software Documentation, Process Improvement, Integration, FDA, Regulatory Submissions, Analysis, SDLC, Enterprise Architecture, eCTD, CMC Regulatory Affairs, Quality Assurance, Data Management, Project Portfolio..., Business Process, Regulatory Affairs, Strategy, Governance, IT Strategy
Education
Juniata College 1998 — 2002
BS, Information Technology
Bishop Carroll High School, Ebensburg, PA 1994 — 1998
Marla Hallacy's FDA Experience October 2014 - Present
Job Consumer Safety Officer at FDA
Industry Law Practice
Experience
FDA October 2014 - Present
Johns Hopkins Medicine May 2013 - October 2014
Johns Hopkins Bloomberg School of Public Health June 2011 - May 2013
Special Counsel 2005 - 2011
Skills
Legal Research, Legal Writing, Litigation, Civil Litigation, Research, Public Speaking, Commercial Litigation, Policy, Policy Analysis
Education
Johns Hopkins Bloomberg School of Public Health 2012 — 2015
Master of Public Health (MPH), Environmental and Occupational Health, Risk Sciences and Public Policy
University of Kansas School of Law 1998 — 2001
Juris Doctorate
The University of Kansas 1992 — 1997
BA, BFA, Political Science, Art History
University of Kansas 1992 — 1997
Bachelor's degree, Political Science and Government
FDA October 2014 - Present
Johns Hopkins Medicine May 2013 - October 2014
Johns Hopkins Bloomberg School of Public Health June 2011 - May 2013
Special Counsel 2005 - 2011
Skills
Legal Research, Legal Writing, Litigation, Civil Litigation, Research, Public Speaking, Commercial Litigation, Policy, Policy Analysis
Education
Johns Hopkins Bloomberg School of Public Health 2012 — 2015
Master of Public Health (MPH), Environmental and Occupational Health, Risk Sciences and Public Policy
University of Kansas School of Law 1998 — 2001
Juris Doctorate
The University of Kansas 1992 — 1997
BA, BFA, Political Science, Art History
University of Kansas 1992 — 1997
Bachelor's degree, Political Science and Government
Ishmael Lara, Jr.'s FDA Experience August 2009 - Present
Job Project Specialist / FAC COR @ FDA
Industry Government Administration
Srikanth Nallani C's FDA Experience February 2003 - Present
Job Clinical Pharmacologist at FDA
Industry Government Administration
Experience
FDA February 2003 - Present
Skills
Clinical Pharmacology, FDA, Pharmacokinetics, Clinical Research, Pharmacology, Drug Development
Education
University of Cincinnati 1996 — 2002
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Kakatiya University 1994 — 1996
Master’s Degree, Pharmacology
Kakatiya University 1990 — 1994
B. Pharm, Pharmaceutical Sciences
FDA February 2003 - Present
Skills
Clinical Pharmacology, FDA, Pharmacokinetics, Clinical Research, Pharmacology, Drug Development
Education
University of Cincinnati 1996 — 2002
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Kakatiya University 1994 — 1996
Master’s Degree, Pharmacology
Kakatiya University 1990 — 1994
B. Pharm, Pharmaceutical Sciences
Ben Blumberg's FDA Experience June 2007 - June 2009
Job Experienced Postdoctoral Fellow, Independent Project Manager and Subject Matter Expert
Industry Research
Experience
Johns Hopkins Bloomberg School of Public Health April 2015 - Present
Johns Hopkins Bloomberg School of Public Health August 2009 - January 2015
FDA June 2007 - June 2009
Skills
Vaccines, FDA, Virology, Immunology, recombinant DNA..., PCR, Recombinant DNA, Cell Culture, DNA, Cell Biology, Data Analysis
Education
Johns Hopkins Bloomberg School of Public Health 2009 — 2015
Doctor of Philosophy (Ph.D.), Molecular Microbiology and Immunology
University of Vermont 2002 — 2006
BS, Biology
Johns Hopkins Bloomberg School of Public Health April 2015 - Present
Johns Hopkins Bloomberg School of Public Health August 2009 - January 2015
FDA June 2007 - June 2009
Skills
Vaccines, FDA, Virology, Immunology, recombinant DNA..., PCR, Recombinant DNA, Cell Culture, DNA, Cell Biology, Data Analysis
Education
Johns Hopkins Bloomberg School of Public Health 2009 — 2015
Doctor of Philosophy (Ph.D.), Molecular Microbiology and Immunology
University of Vermont 2002 — 2006
BS, Biology
Kimberly Benson's FDA Experience September 2014 - Present
Job Director, Division of Nonclinical Science, Center for Tobacco Products at FDA
Industry Research
Experience
FDA September 2014 - Present
FDA 2013 - September 2014
FDA 2010 - 2013
FDA 1999 - 2010
Armed Forces Radiobiology Research Institute 1992 - 1999
Skills
Biotechnology, Life Sciences, Clinical Trials, Research, Drug Development, Molecular Biology, FDA, Science
Education
University of Mississippi 1987 — 1992
Ph.D., Pharmacology/Toxicology
Indiana University of Pennsylvania
FDA September 2014 - Present
FDA 2013 - September 2014
FDA 2010 - 2013
FDA 1999 - 2010
Armed Forces Radiobiology Research Institute 1992 - 1999
Skills
Biotechnology, Life Sciences, Clinical Trials, Research, Drug Development, Molecular Biology, FDA, Science
Education
University of Mississippi 1987 — 1992
Ph.D., Pharmacology/Toxicology
Indiana University of Pennsylvania
Jessica Tytel's FDA Experience July 2006 - April 2007
Job at U.S. Department of Health and Human Services
Industry Public Policy
Experience
Office on Women's Health, US Department of Health and Human Services July 2014 - Present
Office of the Assistant Secretary for Preparedness and Response, Dept. of Health & Human Services December 2009 - July 2014
ASPR, US Department of Health & Human Services April 2007 - December 2009
FDA July 2006 - April 2007
Johns Hopkins University September 2005 - May 2006
AIDS United (then AIDS Action) March 2002 - June 2005
Equal Justice Works October 2000 - March 2002
Skills
Policy, Public Policy, Government, Program Development, Public Health, Program Management, Grants, Health Policy, Analysis, Leadership Development, Emergency Management, Healthcare, Project Planning, Policy Analysis, Legislative Relations, Leadership, Budgets, Homeland Security, Program Evaluation, Global Health, Event Planning, Proposal Writing, Epidemiology, Stakeholder Management, Research, International Health
Education
Center for Government Leadership 2010 — 2011
Excellence in Government Fellows Training Program
National Defense University 2009 — 2010
Program for Emerging Leaders
Johns Hopkins Bloomberg School of Public Health 2005 — 2006
MPH, Public Health
Pomona College 1996 — 2000
BA, Women's Studies and Theatre
College Year in Athens 1998 — 1998
Study abroad
Office on Women's Health, US Department of Health and Human Services July 2014 - Present
Office of the Assistant Secretary for Preparedness and Response, Dept. of Health & Human Services December 2009 - July 2014
ASPR, US Department of Health & Human Services April 2007 - December 2009
FDA July 2006 - April 2007
Johns Hopkins University September 2005 - May 2006
AIDS United (then AIDS Action) March 2002 - June 2005
Equal Justice Works October 2000 - March 2002
Skills
Policy, Public Policy, Government, Program Development, Public Health, Program Management, Grants, Health Policy, Analysis, Leadership Development, Emergency Management, Healthcare, Project Planning, Policy Analysis, Legislative Relations, Leadership, Budgets, Homeland Security, Program Evaluation, Global Health, Event Planning, Proposal Writing, Epidemiology, Stakeholder Management, Research, International Health
Education
Center for Government Leadership 2010 — 2011
Excellence in Government Fellows Training Program
National Defense University 2009 — 2010
Program for Emerging Leaders
Johns Hopkins Bloomberg School of Public Health 2005 — 2006
MPH, Public Health
Pomona College 1996 — 2000
BA, Women's Studies and Theatre
College Year in Athens 1998 — 1998
Study abroad
Philippa Hillyer's FDA Experience July 2011 - Present
Job Visiting Associate at FDA
Industry Research
Experience
FDA July 2011 - Present
FDA June 2007 - June 2011
Imperial College London May 2005 - April 2007
Cardiff University April 2003 - March 2005
Skills
Immunology, Flow Cytometry, Research, Molecular Biology, ELISA, real-time PCR, Cell Culture, Biochemistry, Tissue Culture, Confocal Microscopy, PCR
Education
The Open University 1999 — 2003
PhD, Immunology
Imperial College London 1997 — 1998
MSc, Immunology
University of Reading 1994 — 1997
BSc (Hons), Biological Sciences
FDA July 2011 - Present
FDA June 2007 - June 2011
Imperial College London May 2005 - April 2007
Cardiff University April 2003 - March 2005
Skills
Immunology, Flow Cytometry, Research, Molecular Biology, ELISA, real-time PCR, Cell Culture, Biochemistry, Tissue Culture, Confocal Microscopy, PCR
Education
The Open University 1999 — 2003
PhD, Immunology
Imperial College London 1997 — 1998
MSc, Immunology
University of Reading 1994 — 1997
BSc (Hons), Biological Sciences
Pamela Mesite's FDA Experience December 2014 - Present
Job Document Delivery Librarian at FDA
Industry Information Services
Experience
FDA December 2014 - Present
US Army May 2010 - December 2014
Pacific Institute for Research and Evaluation October 2005 - December 2009
CQL The Council on Quality and Leadership June 1998 - September 2005
University of Maryland, Baltimore June 1988 - June 1998
University of Maryland, Baltimore March 1985 - June 1988
Army National Guard March 1985 - February 1988
Army National Guard September 1981 - March 1985
National Library of Medicine July 1983 - August 1984
Library of Congress, Archive of Folk Culture January 1984 - May 1984
Skills
Library, Cataloging, Databases, Library Science, Training, Data Analysis, Research, Project Management, Analysis, Web Design, Online Research, Knowledge Management, Records Management
Education
Stevenson University 2005 — 2008
MS, Advanced Information Technologies
Community College of Baltimore County 2009 — 2010
The Maryland Institute College of Art 2007 — 2007
The Catholic University of America 1982 — 1984
MSLS, Library Science
Ithaca College 1979 — 1981
MM, Music Education
West Chester University of Pennsylvania 1971 — 1975
Bachelor of Science, Music Education
FDA December 2014 - Present
US Army May 2010 - December 2014
Pacific Institute for Research and Evaluation October 2005 - December 2009
CQL The Council on Quality and Leadership June 1998 - September 2005
University of Maryland, Baltimore June 1988 - June 1998
University of Maryland, Baltimore March 1985 - June 1988
Army National Guard March 1985 - February 1988
Army National Guard September 1981 - March 1985
National Library of Medicine July 1983 - August 1984
Library of Congress, Archive of Folk Culture January 1984 - May 1984
Skills
Library, Cataloging, Databases, Library Science, Training, Data Analysis, Research, Project Management, Analysis, Web Design, Online Research, Knowledge Management, Records Management
Education
Stevenson University 2005 — 2008
MS, Advanced Information Technologies
Community College of Baltimore County 2009 — 2010
The Maryland Institute College of Art 2007 — 2007
The Catholic University of America 1982 — 1984
MSLS, Library Science
Ithaca College 1979 — 1981
MM, Music Education
West Chester University of Pennsylvania 1971 — 1975
Bachelor of Science, Music Education
Andy Rink, MD's FDA Experience 2009 - 2009
Job Building the best marketing team in the world at Lully. Join us.
Industry Health, Wellness and Fitness
Experience
Lully July 2014 - Present
RARE Healthtec 2013 - 2015
Acclarent 2013 - 2014
Stanford University July 2012 - 2014
MC10 2013 - 2013
FDA 2009 - 2009
University of Illinois 2006 - 2009
Skills
Biomedical Engineering, Medical Devices, General Surgery, Clinical Research, Spine, Surgery, Medicine, Patents, Cancer, Clinical Trials, Medical Imaging, Medical Education, Healthcare, Hospitals, Lifesciences, Healthcare Information..., Design Control, Life Sciences, Orthopedic
Education
Y Combinator 2015 — 2015
Winter 2015 batch
Northwestern University 2009 — 2015
General Surgery Residency Program
Stanford University 2012 — 2014
Biodesign Innovation Fellowship
Indiana University School of Medicine 2005 — 2009
MD
Vanderbilt University 2001 — 2005
BE, Biomedical Engineering
Lully July 2014 - Present
RARE Healthtec 2013 - 2015
Acclarent 2013 - 2014
Stanford University July 2012 - 2014
MC10 2013 - 2013
FDA 2009 - 2009
University of Illinois 2006 - 2009
Skills
Biomedical Engineering, Medical Devices, General Surgery, Clinical Research, Spine, Surgery, Medicine, Patents, Cancer, Clinical Trials, Medical Imaging, Medical Education, Healthcare, Hospitals, Lifesciences, Healthcare Information..., Design Control, Life Sciences, Orthopedic
Education
Y Combinator 2015 — 2015
Winter 2015 batch
Northwestern University 2009 — 2015
General Surgery Residency Program
Stanford University 2012 — 2014
Biodesign Innovation Fellowship
Indiana University School of Medicine 2005 — 2009
MD
Vanderbilt University 2001 — 2005
BE, Biomedical Engineering
Cherie Hyder's FDA Experience March 1990 - May 1995
Job Medical Affairs
Industry Pharmaceuticals
Experience
Pharmaceutical 2011 - Present
Pfizer July 2003 - March 2011
Novartis May 2001 - August 2003
Managing Director ,Solvay Pharmaceuticals January 2000 - August 2001
Eli Lilly and Company July 1995 - January 2000
FDA March 1990 - May 1995
Skills
Pharmaceutical Industry, Ophthalmology, Medical Writing, Clinical Research, Clinical Trials, Neurology, FDA, Biotechnology, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Clinical Development, Pharmaceutical Sales, GCP, Medicine
Education
British American University
Doctor of Law (JD), contract law
Iowa State University
BS, Molecular Biology / Chemistry
University of Missouri-Kansas City
PharmD, Clinical Pharmacy
Pharmaceutical 2011 - Present
Pfizer July 2003 - March 2011
Novartis May 2001 - August 2003
Managing Director ,Solvay Pharmaceuticals January 2000 - August 2001
Eli Lilly and Company July 1995 - January 2000
FDA March 1990 - May 1995
Skills
Pharmaceutical Industry, Ophthalmology, Medical Writing, Clinical Research, Clinical Trials, Neurology, FDA, Biotechnology, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Clinical Development, Pharmaceutical Sales, GCP, Medicine
Education
British American University
Doctor of Law (JD), contract law
Iowa State University
BS, Molecular Biology / Chemistry
University of Missouri-Kansas City
PharmD, Clinical Pharmacy
Hailin Tang's FDA Experience October 2012 - Present
Job Staff Fellow (Software Developer) at FDA
Industry Government Administration
Experience
FDA October 2012 - Present
ICF International October 2010 - September 2012
Skills
Data Analysis, Python, Statistics, PKI, SSO, OCSP, Relational Databases, JavaScript, Perl, Java, Linux, Transmission Electron..., Scanning Electron..., Apex Programming, Analysis
Education
Iowa State University 2004 — 2008
M.S., Toxicology
University of Arkansas at Little Rock 2009 — 2011
M.S., Information Science
FDA October 2012 - Present
ICF International October 2010 - September 2012
Skills
Data Analysis, Python, Statistics, PKI, SSO, OCSP, Relational Databases, JavaScript, Perl, Java, Linux, Transmission Electron..., Scanning Electron..., Apex Programming, Analysis
Education
Iowa State University 2004 — 2008
M.S., Toxicology
University of Arkansas at Little Rock 2009 — 2011
M.S., Information Science
Pat Wisor's FDA Experience January 2011 - December 2013
Job Sales
Industry Machinery
Experience
Elliott Equipment Company April 2014 - Present
FDA January 2011 - December 2013
FDA October 2008 - December 2010
FDA June 2002 - October 2008
Chemsyn December 2000 - June 2002
Oread Laboratories September 1996 - November 2000
Fort Dodge Animal Health 1994 - 1996
Skills
FDA, GMP, Analytical Chemistry, Sop, CAPA, Quality System, Quality Assurance, HPLC, Validation, GLP, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, Change Control
Education
Iowa State University 1988 — 1994
BS, Chemistry
Elliott Equipment Company April 2014 - Present
FDA January 2011 - December 2013
FDA October 2008 - December 2010
FDA June 2002 - October 2008
Chemsyn December 2000 - June 2002
Oread Laboratories September 1996 - November 2000
Fort Dodge Animal Health 1994 - 1996
Skills
FDA, GMP, Analytical Chemistry, Sop, CAPA, Quality System, Quality Assurance, HPLC, Validation, GLP, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, Change Control
Education
Iowa State University 1988 — 1994
BS, Chemistry
Deborah Ivey's FDA Experience September 2014 - Present
Job Professional Woman
Industry Government Administration
Experience
FDA September 2014 - Present
NIH March 2010 - September 2014
NIH June 2003 - July 2007
Education
Jones International University 2003 — 2007
Masters, Communication w/concentration in Leading a Customer Driven Organization MABC
Potomac College
BS, Management
Central Texas College
AGS, General Studies
FDA September 2014 - Present
NIH March 2010 - September 2014
NIH June 2003 - July 2007
Education
Jones International University 2003 — 2007
Masters, Communication w/concentration in Leading a Customer Driven Organization MABC
Potomac College
BS, Management
Central Texas College
AGS, General Studies
Ziyaur Rahman's FDA Experience November 2012 - Present
Job Scientist at FDA
Industry Research
Experience
FDA November 2012 - Present
Texas A&M Health Science Center September 2011 - November 2012
FDA September 2008 - September 2011
Impax Laboratories 2010 - 2011
University of Mississippi 2007 - 2008
Dabur Research Foundation 2006 - 2007
Torrent Pharmaceuticals Ltd 2005 - 2006
Education
Jamia Hamdard 2002 — 2005
Ph.D., Pharmaceutics
FDA November 2012 - Present
Texas A&M Health Science Center September 2011 - November 2012
FDA September 2008 - September 2011
Impax Laboratories 2010 - 2011
University of Mississippi 2007 - 2008
Dabur Research Foundation 2006 - 2007
Torrent Pharmaceuticals Ltd 2005 - 2006
Education
Jamia Hamdard 2002 — 2005
Ph.D., Pharmaceutics
Suvajyoti Guha's FDA Experience April 2012 - Present
Job ORISE Postdoctoral Fellow at Food and Drug Administration
Industry Nanotechnology
Experience
FDA April 2012 - Present
NIST December 2007 - April 2012
UMCP August 2007 - April 2012
Education
University of Maryland College Park 2007 — 2012
PhD, Mechanical Engineering
Indian Institute of Technology, Delhi 2005 — 2007
M. Tech, Thermal Engineering
Jadavpur University 2001 — 2005
Bachelor's degree, Mechanical Engineering
FDA April 2012 - Present
NIST December 2007 - April 2012
UMCP August 2007 - April 2012
Education
University of Maryland College Park 2007 — 2012
PhD, Mechanical Engineering
Indian Institute of Technology, Delhi 2005 — 2007
M. Tech, Thermal Engineering
Jadavpur University 2001 — 2005
Bachelor's degree, Mechanical Engineering
Seth Carmody's FDA Experience November 2011 - Present
Job Staff Fellow
Industry Medical Devices
Experience
FDA November 2011 - Present
Indiana University Bloomington August 2007 - July 2011
Skills
Organic Synthesis
Education
Indiana University Bloomington 2007 — 2011
PhD, Organic chemistry
University of California, San Diego 2004 — 2006
M.S., Synthetic organic chemistry
Ithaca College
FDA November 2011 - Present
Indiana University Bloomington August 2007 - July 2011
Skills
Organic Synthesis
Education
Indiana University Bloomington 2007 — 2011
PhD, Organic chemistry
University of California, San Diego 2004 — 2006
M.S., Synthetic organic chemistry
Ithaca College
Ashok Illapakurthy's FDA Experience January 2014 - Present
Job Pharmaceutical professional
Industry Pharmaceuticals
Experience
FDA January 2014 - Present
Aizant Drug Research Solutions Pvt. Ltd., Hyderabad January 2012 - January 2014
Aizant Drug Research Solutions Pvt. Ltd., Hyderabad April 2009 - January 2012
Covidien June 2004 - March 2009
Purdue Pharma September 2003 - June 2004
Hoffmann-La Roche September 2002 - September 2003
Education
University of Mississippi 1998 — 2002
Ph.D, Pharmaceutics
Kakatiya University 1993 — 1997
B. Pharmacy, Pharmacy
FDA January 2014 - Present
Aizant Drug Research Solutions Pvt. Ltd., Hyderabad January 2012 - January 2014
Aizant Drug Research Solutions Pvt. Ltd., Hyderabad April 2009 - January 2012
Covidien June 2004 - March 2009
Purdue Pharma September 2003 - June 2004
Hoffmann-La Roche September 2002 - September 2003
Education
University of Mississippi 1998 — 2002
Ph.D, Pharmaceutics
Kakatiya University 1993 — 1997
B. Pharmacy, Pharmacy
Pamela Halpin's FDA Experience July 2001 - December 2002
Job Continuous Improvement Specialist at BASF
Industry Chemicals
Experience
BASF July 2015 - Present
BASF June 2010 - July 2015
Cognis 2010 - 2011
Mad Science August 2009 - June 2010
The Huntington Learning Center November 2008 - February 2010
The Shepherd Color Company November 2005 - February 2009
Dow Corning December 2002 - October 2005
FDA July 2001 - December 2002
Skills
Six Sigma, Analytical Chemistry, FDA, ICP-OES, Adaptation, Root Cause Analysis, Quality Assurance, ISO, Polymers, Quality Control, Chemical Engineering, EHS Management Systems, Powder X-ray Diffraction, Continuous Improvement, Process Improvement, 5S, Kaizen, Lean Manufacturing, SAP QM, LIMS
Education
Northern Illinois University 1996 — 2001
Ph. D., Chemistry
Indiana University Bloomington 1992 — 1996
BS, Chemistry
BASF July 2015 - Present
BASF June 2010 - July 2015
Cognis 2010 - 2011
Mad Science August 2009 - June 2010
The Huntington Learning Center November 2008 - February 2010
The Shepherd Color Company November 2005 - February 2009
Dow Corning December 2002 - October 2005
FDA July 2001 - December 2002
Skills
Six Sigma, Analytical Chemistry, FDA, ICP-OES, Adaptation, Root Cause Analysis, Quality Assurance, ISO, Polymers, Quality Control, Chemical Engineering, EHS Management Systems, Powder X-ray Diffraction, Continuous Improvement, Process Improvement, 5S, Kaizen, Lean Manufacturing, SAP QM, LIMS
Education
Northern Illinois University 1996 — 2001
Ph. D., Chemistry
Indiana University Bloomington 1992 — 1996
BS, Chemistry
George Bakris, MD, FASH, FASN's FDA Experience July 2005 - Present
Job Professor of Medicine, Director, ASH Comprehensive Hypertension Center, The University of Chicago Medicine
Industry Hospital & Health Care
Experience
University of Chicago April 2006 - Present
FDA July 2005 - Present
Rush University Medical Center April 1993 - August 2006
Skills
Public Health, Epidemiology, Healthcare, Medical Education, Clinical Research, Internal Medicine, Hypertension, Nephrology, Chronic Kidney Disease, Diabetes, Clinical Trials, Clinical Development, Hospitals, Prevention, Medicine, Endocrinology, Cardiology, Healthcare Information..., Pharmaceutical Industry, Drug Development, Medical Writing, Medical Research, Cell Biology, Healthcare Management, Pediatrics, Oncology, Board Certified, Cancer, Lifesciences, Physicians, Physiology, Clinical Pharmacology, Biotechnology, Global Health, Life Sciences, Informatics, Patient Safety, Critical Care, Health Policy, Pharmacology, Medical Affairs
Education
University Health Sciences/The Chicago Medical School 1979 — 1981
Doctor of Medicine (MD), Medicine, Honors
University of Chicago 1974 — 1975
Master of Arts (MA), Human Development and Family Studies, General
Indiana University Bloomington 1970 — 1974
Bachelor's degree, Biology/Psychology
University of Chicago April 2006 - Present
FDA July 2005 - Present
Rush University Medical Center April 1993 - August 2006
Skills
Public Health, Epidemiology, Healthcare, Medical Education, Clinical Research, Internal Medicine, Hypertension, Nephrology, Chronic Kidney Disease, Diabetes, Clinical Trials, Clinical Development, Hospitals, Prevention, Medicine, Endocrinology, Cardiology, Healthcare Information..., Pharmaceutical Industry, Drug Development, Medical Writing, Medical Research, Cell Biology, Healthcare Management, Pediatrics, Oncology, Board Certified, Cancer, Lifesciences, Physicians, Physiology, Clinical Pharmacology, Biotechnology, Global Health, Life Sciences, Informatics, Patient Safety, Critical Care, Health Policy, Pharmacology, Medical Affairs
Education
University Health Sciences/The Chicago Medical School 1979 — 1981
Doctor of Medicine (MD), Medicine, Honors
University of Chicago 1974 — 1975
Master of Arts (MA), Human Development and Family Studies, General
Indiana University Bloomington 1970 — 1974
Bachelor's degree, Biology/Psychology
Huiquan Wu's FDA Experience August 2002 - Present
Job Chemical Engineer at FDA
Industry Government Administration
Experience
FDA August 2002 - Present
U.S. Food and Drug Administration 2002 - Present
ACM Research, Inc. October 2001 - August 2002
LSI logic 2001 - 2001
Skills
R&D, Chemical Engineering, Process Simulation, Drug Development, Chemistry, Technology Transfer, HPLC, Analytical Chemistry, UV/Vis, Validation, Chromatography, Organic Chemistry, Formulation, Spectroscopy, GMP
Education
Iowa State University 1996 — 2001
Ph.D., Chemical Engineering
Tianjin University 1994 — 1995
Ph.D. candidate, Chemical Engineering
Sichuan University (Former Chengdu University of Science & Technology) 1985 — 1988
MSc, Chemical Engineering
Wuhan Institute of Technology (Former Wuhan Institute of Chemical Technology) 1981 — 1985
BSc, Chemical Engineering
FDA August 2002 - Present
U.S. Food and Drug Administration 2002 - Present
ACM Research, Inc. October 2001 - August 2002
LSI logic 2001 - 2001
Skills
R&D, Chemical Engineering, Process Simulation, Drug Development, Chemistry, Technology Transfer, HPLC, Analytical Chemistry, UV/Vis, Validation, Chromatography, Organic Chemistry, Formulation, Spectroscopy, GMP
Education
Iowa State University 1996 — 2001
Ph.D., Chemical Engineering
Tianjin University 1994 — 1995
Ph.D. candidate, Chemical Engineering
Sichuan University (Former Chengdu University of Science & Technology) 1985 — 1988
MSc, Chemical Engineering
Wuhan Institute of Technology (Former Wuhan Institute of Chemical Technology) 1981 — 1985
BSc, Chemical Engineering
Karunakar Neelam's FDA Experience February 2014 - Present
Job CMC Reviewer / Staff Fellow at FDA
Industry Government Administration
Experience
FDA February 2014 - Present
Abon Pharmaceuticals LLC January 2010 - February 2014
Formurex, Inc. October 2009 - December 2009
University of the Pacific May 2005 - October 2009
Ranbaxy Research Labs October 2004 - May 2005
Dabur Research Foundation January 2001 - September 2004
Skills
In Vitro, Formulation, Pharmaceutics, HPLC, R&D, Drug Delivery, Chromatography, Regulatory Submissions, Pharmacokinetics, Pharmaceutical Industry, Pharmaceutical Research, Pharmacology, UV/Vis, Drug Development
Education
Kakatiya University 1997 — 2001
Ph.D, Pharmaceutical Sciences
Jamia Hamdard 1994 — 1996
M.Pharmacy, Pharmaceutical Sciences
Kakatiya University
B.Pharmacy, Pharmaceutical Sciences
FDA February 2014 - Present
Abon Pharmaceuticals LLC January 2010 - February 2014
Formurex, Inc. October 2009 - December 2009
University of the Pacific May 2005 - October 2009
Ranbaxy Research Labs October 2004 - May 2005
Dabur Research Foundation January 2001 - September 2004
Skills
In Vitro, Formulation, Pharmaceutics, HPLC, R&D, Drug Delivery, Chromatography, Regulatory Submissions, Pharmacokinetics, Pharmaceutical Industry, Pharmaceutical Research, Pharmacology, UV/Vis, Drug Development
Education
Kakatiya University 1997 — 2001
Ph.D, Pharmaceutical Sciences
Jamia Hamdard 1994 — 1996
M.Pharmacy, Pharmaceutical Sciences
Kakatiya University
B.Pharmacy, Pharmaceutical Sciences
Naresh Pavurala, Ph.D.'s FDA Experience April 2014 - Present
Job ORISE Fellow at U.S. FDA
Industry Pharmaceuticals
Experience
FDA April 2014 - Present
Virginia Tech January 2009 - December 2013
Engineers India Limited July 2008 - November 2008
Skills
Chemical Engineering, Research, Matlab, Programming, Mechanistic Modeling, Mathematical Modeling, Optimizations, Artificial Neural..., Group Contributions, Computer Aided..., Aspen Plus, Mixed Integer Nonlinear..., PK/PD, Process Design, Nonlinear Optimization, Modeling, NI LabVIEW, C, C++, AutoCAD, Windows, Macintosh, Linux, Ordinary Differential..., Partial Differential..., Finite Difference, Numerical Linear Algebra, Discrete Optimization, Integer Programming, Constrained Optimization, Linear Programming, Mass & Energy Balance, P&ID development, Reaction Engineering, Material & Energy..., ADME, Simulations, Mathematica, Statistics, Data Analysis, Process Simulation, Engineering, Kinetics, Microsoft Office, Analysis, Microsoft Excel, Optimization, Spectroscopy, Differential Scanning..., AFM
Education
Virginia Polytechnic Institute and State University 2009 — 2013
PhD, Chemical Engineering
Virginia Polytechnic Institute and State University 2009 — 2012
Master of Engineering (M.Eng.), Chemical Engineering
Indian Institute of Technology, Madras 2004 — 2008
Bachelor of Technology, Chemical Engineering
FDA April 2014 - Present
Virginia Tech January 2009 - December 2013
Engineers India Limited July 2008 - November 2008
Skills
Chemical Engineering, Research, Matlab, Programming, Mechanistic Modeling, Mathematical Modeling, Optimizations, Artificial Neural..., Group Contributions, Computer Aided..., Aspen Plus, Mixed Integer Nonlinear..., PK/PD, Process Design, Nonlinear Optimization, Modeling, NI LabVIEW, C, C++, AutoCAD, Windows, Macintosh, Linux, Ordinary Differential..., Partial Differential..., Finite Difference, Numerical Linear Algebra, Discrete Optimization, Integer Programming, Constrained Optimization, Linear Programming, Mass & Energy Balance, P&ID development, Reaction Engineering, Material & Energy..., ADME, Simulations, Mathematica, Statistics, Data Analysis, Process Simulation, Engineering, Kinetics, Microsoft Office, Analysis, Microsoft Excel, Optimization, Spectroscopy, Differential Scanning..., AFM
Education
Virginia Polytechnic Institute and State University 2009 — 2013
PhD, Chemical Engineering
Virginia Polytechnic Institute and State University 2009 — 2012
Master of Engineering (M.Eng.), Chemical Engineering
Indian Institute of Technology, Madras 2004 — 2008
Bachelor of Technology, Chemical Engineering
Manohar Reddy Nandimandalam's FDA Experience January 2011 - Present
Job •Sr.Oracle Applications Consultant at FDA
Industry Information Technology and Services
Experience
FDA January 2011 - Present
Cyma Systems inc 2006 - Present
National Association of Boards of Pharmacy September 2010 - January 2011
IBM Global Business Services November 2009 - September 2010
Pillar Data Systems August 2008 - March 2009
Emtek Products 2009 - 2009
Silver Spring Networks 2009 - 2009
Brocade Communications 2008 - 2008
World Vision 2008 - 2008
Datacard 2007 - 2007
Skills
GL, Oracle E-Business Suite, Oracle Applications, Oracle, XML Publisher, Oracle Discoverer, PL/SQL, Databases, SDLC, OA Framework, Financials, BI Publisher, Order Management, CRM, Oracle HR, OBIEE, Data Conversion, Data Migration, Oracle Reports, Toad, Requirements Gathering, Data Warehousing
Education
Texas A&M University-Commerce 2004 — 2006
MS, Computer Science
Jawaharlal Nehru Technological University 2000 — 2004
B.Tech, Computer Science
FDA January 2011 - Present
Cyma Systems inc 2006 - Present
National Association of Boards of Pharmacy September 2010 - January 2011
IBM Global Business Services November 2009 - September 2010
Pillar Data Systems August 2008 - March 2009
Emtek Products 2009 - 2009
Silver Spring Networks 2009 - 2009
Brocade Communications 2008 - 2008
World Vision 2008 - 2008
Datacard 2007 - 2007
Skills
GL, Oracle E-Business Suite, Oracle Applications, Oracle, XML Publisher, Oracle Discoverer, PL/SQL, Databases, SDLC, OA Framework, Financials, BI Publisher, Order Management, CRM, Oracle HR, OBIEE, Data Conversion, Data Migration, Oracle Reports, Toad, Requirements Gathering, Data Warehousing
Education
Texas A&M University-Commerce 2004 — 2006
MS, Computer Science
Jawaharlal Nehru Technological University 2000 — 2004
B.Tech, Computer Science
John Thorsky's FDA Experience February 2005 - September 2013
Job District Director at FDA (Retired)
Industry Government Administration
Experience
FDA February 2005 - September 2013
Food and Drug Administration January 2003 - February 2005
FDA March 2000 - January 2003
FDA September 1988 - March 2000
FDA September 1974 - September 1988
Skills
Sop, FDA, Pharmaceutical Industry, V&V, GMP, Biopharmaceuticals, Technology Transfer, Regulatory Requirements, Biotechnology, Lifesciences, Validation, CAPA, Regulatory Affairs, GLP, Toxicology, Regulatory Submissions, Vaccines, Quality Assurance, Medical Devices, IND, LIMS, Change Control, 21 CFR Part 11, Clinical Trials, Clinical Development, GCP, Microbiology, Analytical Chemistry, Chromatography, HPLC, Pharmaceutics, Aseptic Technique, Quality Auditing, Life Sciences, SOP
Education
Purdue University 1973 — 1974
Pharmacology & Toxicology
Indiana State University 1969 — 1973
Bachelor of Science (BS), Life Science (biology, chemistry)
FDA February 2005 - September 2013
Food and Drug Administration January 2003 - February 2005
FDA March 2000 - January 2003
FDA September 1988 - March 2000
FDA September 1974 - September 1988
Skills
Sop, FDA, Pharmaceutical Industry, V&V, GMP, Biopharmaceuticals, Technology Transfer, Regulatory Requirements, Biotechnology, Lifesciences, Validation, CAPA, Regulatory Affairs, GLP, Toxicology, Regulatory Submissions, Vaccines, Quality Assurance, Medical Devices, IND, LIMS, Change Control, 21 CFR Part 11, Clinical Trials, Clinical Development, GCP, Microbiology, Analytical Chemistry, Chromatography, HPLC, Pharmaceutics, Aseptic Technique, Quality Auditing, Life Sciences, SOP
Education
Purdue University 1973 — 1974
Pharmacology & Toxicology
Indiana State University 1969 — 1973
Bachelor of Science (BS), Life Science (biology, chemistry)
Kalyan Marada's FDA Experience September 2012 - April 2013
Job Documentum Technical Lead / Architect
Industry Computer Software
Experience
AbbVie March 2015 - Present
Massachusetts Gaming Commission November 2013 - February 2015
Verizon June 2013 - October 2013
Liberty Mutual Insurance April 2013 - June 2013
FDA September 2012 - April 2013
Blue Cross Blue Shield of Massachusetts June 2012 - September 2012
Sallie Mae September 2010 - June 2012
Fairfax County Government June 2010 - September 2010
i3 Research January 2010 - May 2010
Standard & Poor's April 2009 - December 2009
Skills
Captiva, Solution Architecture, Documentum, WDK, Document Management, Enterprise Content..., Java Enterprise Edition, XML, DQL, Webtop, SOA, Enterprise Architecture, Requirements Analysis, Weblogic, xCP, WebLogic, Consulting, SDLC, SQL
Education
Jawaharlal Nehru Technological University
Bachelor's degree, Computer Science
AbbVie March 2015 - Present
Massachusetts Gaming Commission November 2013 - February 2015
Verizon June 2013 - October 2013
Liberty Mutual Insurance April 2013 - June 2013
FDA September 2012 - April 2013
Blue Cross Blue Shield of Massachusetts June 2012 - September 2012
Sallie Mae September 2010 - June 2012
Fairfax County Government June 2010 - September 2010
i3 Research January 2010 - May 2010
Standard & Poor's April 2009 - December 2009
Skills
Captiva, Solution Architecture, Documentum, WDK, Document Management, Enterprise Content..., Java Enterprise Edition, XML, DQL, Webtop, SOA, Enterprise Architecture, Requirements Analysis, Weblogic, xCP, WebLogic, Consulting, SDLC, SQL
Education
Jawaharlal Nehru Technological University
Bachelor's degree, Computer Science
Olin Bakke's FDA Experience June 2014 - Present
Job Senior Program Manager at the Food and Drug Administration
Industry Government Administration
Experience
FDA June 2014 - Present
Substance Abuse and Mental Health Services Administration June 2011 - June 2014
US Department of Health and Human Services January 2008 - June 2011
US Navy September 2005 - December 2007
Skills
Social Policy, Emergency Management, Literature Reviews, Emergency Services, Community Outreach, Public Administration, Global Health, Health Policy, Policy, Program Evaluation, Federal Government, Information Assurance, Policy Analysis, Analysis, Government, National Security, Preparedness, Homeland Security, Public Health, Public Policy, DoD, Health Equity, Epidemiology, Community Development, Program Management, Disaster Response, Report Writing, Healthcare, Military, Security Clearance, Qualitative Research, International Health
Education
Juniata College 2000 — 2002
Bachelor's degree, Information Technology
FDA June 2014 - Present
Substance Abuse and Mental Health Services Administration June 2011 - June 2014
US Department of Health and Human Services January 2008 - June 2011
US Navy September 2005 - December 2007
Skills
Social Policy, Emergency Management, Literature Reviews, Emergency Services, Community Outreach, Public Administration, Global Health, Health Policy, Policy, Program Evaluation, Federal Government, Information Assurance, Policy Analysis, Analysis, Government, National Security, Preparedness, Homeland Security, Public Health, Public Policy, DoD, Health Equity, Epidemiology, Community Development, Program Management, Disaster Response, Report Writing, Healthcare, Military, Security Clearance, Qualitative Research, International Health
Education
Juniata College 2000 — 2002
Bachelor's degree, Information Technology
Vivek Palepu's FDA Experience September 2013 - Present
Job ORISE Fellow at FDA
Industry Medical Devices
Experience
FDA September 2013 - Present
University of Toledo September 2008 - August 2013
Skills
Finite Element Analysis, Matlab, Biomedical Engineering, Solidworks, Mechanical Testing, Abaqus, Biomechanics, Medical Devices, Labview, Product Development, Microsoft Office, Data Analysis, Modeling, Testing, Biomaterials, COMSOL, Minitab, Signal Processing, Simulations, R&D, Regulatory Submissions, SolidWorks, Research
Education
University of Toledo 2008 — 2013
Doctor of Philosophy (PhD), Biomedical/Medical Engineering
Jawaharlal Nehru Technological University 2004 — 2008
Bachelor of Technology (B.Tech.), Biomedical/Medical Engineering
FDA September 2013 - Present
University of Toledo September 2008 - August 2013
Skills
Finite Element Analysis, Matlab, Biomedical Engineering, Solidworks, Mechanical Testing, Abaqus, Biomechanics, Medical Devices, Labview, Product Development, Microsoft Office, Data Analysis, Modeling, Testing, Biomaterials, COMSOL, Minitab, Signal Processing, Simulations, R&D, Regulatory Submissions, SolidWorks, Research
Education
University of Toledo 2008 — 2013
Doctor of Philosophy (PhD), Biomedical/Medical Engineering
Jawaharlal Nehru Technological University 2004 — 2008
Bachelor of Technology (B.Tech.), Biomedical/Medical Engineering
Darin Achilles's FDA Experience August 2011 - Present
Job
Industry Legal Services
Experience
FDA August 2011 - Present
Pemberton & Englund Law Offices August 2010 - July 2011
Department of Revenue- Wisconsin Lottery May 2010 - August 2010
Center for Patient Partnerships September 2009 - May 2010
Sauk County Circuit Court May 2009 - May 2010
Richland Community College August 2007 - May 2008
University of Northern Iowa August 2005 - May 2006
Elon University August 2004 - May 2005
Radford University August 2003 - May 2005
Skills
Legal Writing, Westlaw, Legal Research
Education
University of Wisconsin Law School 2008 — 2011
JD
University of North Carolina at Greensboro 2001 — 2004
DMA
Indiana University Bloomington 1999 — 2001
MM
Northwestern University 1995 — 1999
BM
FDA August 2011 - Present
Pemberton & Englund Law Offices August 2010 - July 2011
Department of Revenue- Wisconsin Lottery May 2010 - August 2010
Center for Patient Partnerships September 2009 - May 2010
Sauk County Circuit Court May 2009 - May 2010
Richland Community College August 2007 - May 2008
University of Northern Iowa August 2005 - May 2006
Elon University August 2004 - May 2005
Radford University August 2003 - May 2005
Skills
Legal Writing, Westlaw, Legal Research
Education
University of Wisconsin Law School 2008 — 2011
JD
University of North Carolina at Greensboro 2001 — 2004
DMA
Indiana University Bloomington 1999 — 2001
MM
Northwestern University 1995 — 1999
BM
Erik Bungo's FDA Experience January 2002 - May 2002
Job Rapid Response Team (RRT) Coordinator
Industry Government Administration
Experience
Virginia Department of Agriculture and Consumer Services 2015 - Present
Virginia Department of Agriculture & Consumer Services May 2004 - April 2015
FDA January 2002 - May 2002
Hershey Creamery Company June 2001 - January 2002
Pennsylvania Department of Agriculture June 2000 - August 2000
Skills
Public Health, Food Safety, Research, Project Planning, Food Security, Training & Development, Product Reviews, Regulatory Affairs, Complaint Handling, Supervisory Experience, Conference Presentations, Conference Coordination, Investigation, Legal Compliance, Employee Training, GMP, Food Microbiology, Public Speaking, Food Processing, Policy, Quality Auditing, Microbiology, Government, HACCP, Complaint Management, Food Industry, ISO 22000, Meat, Technical Writing, Reviews, Sanitation, Public Policy, Environmental Health, Occupational Health, Environmental Awareness, Food Quality, Risk Assessment, Quality Management, Quality Assurance, Quality Control, Quality System, Supervisory Skills, Leadership, Laboratory, Food Technology, Food, Pest Control, Emergency Management, Food Science, Sop
Education
Juniata College 1997 — 2001
BS, Physical Sciences
Virginia Department of Agriculture and Consumer Services 2015 - Present
Virginia Department of Agriculture & Consumer Services May 2004 - April 2015
FDA January 2002 - May 2002
Hershey Creamery Company June 2001 - January 2002
Pennsylvania Department of Agriculture June 2000 - August 2000
Skills
Public Health, Food Safety, Research, Project Planning, Food Security, Training & Development, Product Reviews, Regulatory Affairs, Complaint Handling, Supervisory Experience, Conference Presentations, Conference Coordination, Investigation, Legal Compliance, Employee Training, GMP, Food Microbiology, Public Speaking, Food Processing, Policy, Quality Auditing, Microbiology, Government, HACCP, Complaint Management, Food Industry, ISO 22000, Meat, Technical Writing, Reviews, Sanitation, Public Policy, Environmental Health, Occupational Health, Environmental Awareness, Food Quality, Risk Assessment, Quality Management, Quality Assurance, Quality Control, Quality System, Supervisory Skills, Leadership, Laboratory, Food Technology, Food, Pest Control, Emergency Management, Food Science, Sop
Education
Juniata College 1997 — 2001
BS, Physical Sciences
Yuzhuo Pan's FDA Experience October 2012 - Present
Job The Commissioner's Fellow at FDA
Industry Government Administration
Experience
FDA October 2012 - Present
University at Buffalo March 2008 - October 2012
Tohoku University, Graduate School of Medicine, Department of Urology April 2006 - 2008
Skills
In Vitro, Pharmacodynamics, Cell Culture, Drug Discovery, Pharmacology, Physiological based..., Pathology, Urology, Prostate cancer, simCYP, PK-sim MOBI, GastroPlus, Matlab, R, Clinical Pharmacology, Clinical Research, Cell, Drug Metabolism, Molecular Biology, Genetics, FDA
Education
State University of New York at Buffalo 2008 — 2012
Postdoc, PK/PD, Drug metabolism, Transporter
Jilin University 2002 — 2007
Ph.D, Pathology and Pharmacology
Jilin University 1997 — 2002
Bachelor of Medicine, Clinical Science
FDA October 2012 - Present
University at Buffalo March 2008 - October 2012
Tohoku University, Graduate School of Medicine, Department of Urology April 2006 - 2008
Skills
In Vitro, Pharmacodynamics, Cell Culture, Drug Discovery, Pharmacology, Physiological based..., Pathology, Urology, Prostate cancer, simCYP, PK-sim MOBI, GastroPlus, Matlab, R, Clinical Pharmacology, Clinical Research, Cell, Drug Metabolism, Molecular Biology, Genetics, FDA
Education
State University of New York at Buffalo 2008 — 2012
Postdoc, PK/PD, Drug metabolism, Transporter
Jilin University 2002 — 2007
Ph.D, Pathology and Pharmacology
Jilin University 1997 — 2002
Bachelor of Medicine, Clinical Science
Judith Gushee's FDA Experience January 2000 - January 2007
Job Partner (+ Gloria Dunnavan) at First Draft and After
Industry Public Safety
Experience
First Draft and After January 2007 - Present
FDA January 2000 - January 2007
FDA January 1996 - January 2000
FDA January 1989 - January 2000
Skills
Regulatory Submissions, FDA, Government, SOP, Regulatory Affairs, Leadership, Food Safety, Policy, Validation, GMP, Regulatory Requirements, Quality Assurance, Quality Auditing, Biotechnology, Quality System, Clinical Trials, Life Sciences
Education
University of Maine 1967 — 1971
BS, Animal and Veterinary Science
Indiana University Bloomington
MPA, Public Administration
First Draft and After January 2007 - Present
FDA January 2000 - January 2007
FDA January 1996 - January 2000
FDA January 1989 - January 2000
Skills
Regulatory Submissions, FDA, Government, SOP, Regulatory Affairs, Leadership, Food Safety, Policy, Validation, GMP, Regulatory Requirements, Quality Assurance, Quality Auditing, Biotechnology, Quality System, Clinical Trials, Life Sciences
Education
University of Maine 1967 — 1971
BS, Animal and Veterinary Science
Indiana University Bloomington
MPA, Public Administration
ben pearl's FDA Experience 2014 - Present
Job Arlington Foot and Ankle
Industry Medical Practice
Experience
Arlington Foot and Ankle May 1993 - Present
FDA 2014 - Present
National Institutes of Health April 1994 - Present
Podiatry Management Magazine 2009 - Present
Skills
Medicine, Medical Education, Research, Clinical Research, Pain Management, Healthcare, Medical Devices, EMR, Surgery, Pediatrics, Healthcare Management, Sports Medicine, Ankle, Treatment, Public Health, Diabetes, Board Certified, Orthotics, Reconstructive Surgery, Emergency Medicine, Public Speaking, Prevention, Podiatry, Wound Care, Healthcare Information..., Hospitals, Rehabilitation, Orthopedic
Education
Indiana University Bloomington
IMP, Medicine
Arlington Foot and Ankle May 1993 - Present
FDA 2014 - Present
National Institutes of Health April 1994 - Present
Podiatry Management Magazine 2009 - Present
Skills
Medicine, Medical Education, Research, Clinical Research, Pain Management, Healthcare, Medical Devices, EMR, Surgery, Pediatrics, Healthcare Management, Sports Medicine, Ankle, Treatment, Public Health, Diabetes, Board Certified, Orthotics, Reconstructive Surgery, Emergency Medicine, Public Speaking, Prevention, Podiatry, Wound Care, Healthcare Information..., Hospitals, Rehabilitation, Orthopedic
Education
Indiana University Bloomington
IMP, Medicine
Maria Colby's FDA Experience May 2007 - Present
Job Program Analyst at FDA
Industry Government Administration
Experience
FDA May 2007 - Present
Skills
Government, Microsoft Excel, Customer Service, Research, Microsoft Office, Policy
Education
James Madison University 2003 — 2007
Bachelors of Science, Communication Studies, Public Administration
Sherwood High School 1999 — 2003
FDA May 2007 - Present
Skills
Government, Microsoft Excel, Customer Service, Research, Microsoft Office, Policy
Education
James Madison University 2003 — 2007
Bachelors of Science, Communication Studies, Public Administration
Sherwood High School 1999 — 2003
Vidya Gottimukkala's FDA Experience May 2007 - December 2007
Job Programmer Analyst at Party City
Industry Retail
Experience
Party City November 2008 - Present
Cablevision December 2007 - September 2008
FDA May 2007 - December 2007
Arbonne International LLC July 2006 - January 2007
CoServ May 2006 - June 2006
SEM Group LP September 2005 - May 2006
stryker orthopedics April 2005 - August 2005
Skills
SQL, PL/SQL, Oracle SQL Developer, SQL*Plus, Toad, Unix, Linux, Shell Scripting, PHP, Oracle Applications, Oracle Financials, Oracle Reports, Oracle Forms, Order to Cash, Java Web Services, JavaBeans, Core Java, C, C++, Oracle E-Business Suite, Web Application..., Customer Service, Leadership, Management, Microsoft Office, Project Management
Education
Illinois Institute of Technology 2003 — 2004
Master of Science (MS), Computer Science
Jawaharlal Nehru Technological University 1998 — 2000
Bachelor of Technology (BTech), Computer Science
Party City November 2008 - Present
Cablevision December 2007 - September 2008
FDA May 2007 - December 2007
Arbonne International LLC July 2006 - January 2007
CoServ May 2006 - June 2006
SEM Group LP September 2005 - May 2006
stryker orthopedics April 2005 - August 2005
Skills
SQL, PL/SQL, Oracle SQL Developer, SQL*Plus, Toad, Unix, Linux, Shell Scripting, PHP, Oracle Applications, Oracle Financials, Oracle Reports, Oracle Forms, Order to Cash, Java Web Services, JavaBeans, Core Java, C, C++, Oracle E-Business Suite, Web Application..., Customer Service, Leadership, Management, Microsoft Office, Project Management
Education
Illinois Institute of Technology 2003 — 2004
Master of Science (MS), Computer Science
Jawaharlal Nehru Technological University 1998 — 2000
Bachelor of Technology (BTech), Computer Science
Sanatan Saraf's FDA Experience June 2012 - August 2012
Job Senior Biostatistician at Merck
Industry Pharmaceuticals
Experience
Merck January 2015 - Present
Axio Research March 2013 - October 2014
National Institutes of Health August 2010 - February 2013
FDA June 2012 - August 2012
FDA June 2011 - August 2011
University of Maryland Baltimore County August 2008 - December 2010
FDA June 2010 - August 2010
Skills
Statistics, SAS, Biostatistics, Statistical Modeling, R, Research, Analysis, Machine Learning, Clinical Research, Maple, Matlab, Microsoft Excel, Microsoft Office, PowerPoint, Microsoft Word, C, Teamwork, Windows, English, Stata, Data Analysis, SAS Programming, Clinical Trials, Pharmaceutical Industry
Education
University of Maryland Baltimore County 2008 — 2013
Doctor of Philosophy (PhD), Statistics, GPA 3.98
Indian Statistical Institute 2005 — 2008
Bachelor of Mathematics, Mathematics
Merck January 2015 - Present
Axio Research March 2013 - October 2014
National Institutes of Health August 2010 - February 2013
FDA June 2012 - August 2012
FDA June 2011 - August 2011
University of Maryland Baltimore County August 2008 - December 2010
FDA June 2010 - August 2010
Skills
Statistics, SAS, Biostatistics, Statistical Modeling, R, Research, Analysis, Machine Learning, Clinical Research, Maple, Matlab, Microsoft Excel, Microsoft Office, PowerPoint, Microsoft Word, C, Teamwork, Windows, English, Stata, Data Analysis, SAS Programming, Clinical Trials, Pharmaceutical Industry
Education
University of Maryland Baltimore County 2008 — 2013
Doctor of Philosophy (PhD), Statistics, GPA 3.98
Indian Statistical Institute 2005 — 2008
Bachelor of Mathematics, Mathematics
Jose Luis Arroyo-Acosta's FDA Experience November 2012 - Present
Job Deputy Director Imports Operations Branch at FDA
Industry Government Administration
Experience
FDA November 2012 - Present
FDA August 2010 - November 2012
FDA April 2009 - August 2010
CSV Group Corp January 2004 - April 2009
Schering-Plough Pharmaceuticals 2001 - 2003
Pfizer 1999 - 2001
Pfizer 1997 - 1999
Pfizer 1995 - 1997
Pfizer 1993 - 1995
Pfizer 1991 - 1993
Skills
Regulatory Affairs, Process Validation, FDA, Compliance, CAPA, Computer System..., Equipment / Utilities..., Total Quality Management, Change Management, Technical Training, Training Delivery, Quality Assurance, 21 CFR Part 11, Quality Auditing, Change Control, cGMP, SOP, GMP, Quality Systems, Validation, Regulatory Requirements, Pharmaceuticals, Medical Devices, Document Management, Biotechnology, GxP, Risk Assessment, QSR, Documentation, Life Sciences, Process Improvement, Regulatory Submissions, Biopharmaceuticals, Technology Transfer, Pharmaceutical Industry, Sop
Education
Inter American University School of Law 2000 — 2004
JD, Law
Universidad de Puerto Rico 1980 — 1985
BS, Biology
FDA November 2012 - Present
FDA August 2010 - November 2012
FDA April 2009 - August 2010
CSV Group Corp January 2004 - April 2009
Schering-Plough Pharmaceuticals 2001 - 2003
Pfizer 1999 - 2001
Pfizer 1997 - 1999
Pfizer 1995 - 1997
Pfizer 1993 - 1995
Pfizer 1991 - 1993
Skills
Regulatory Affairs, Process Validation, FDA, Compliance, CAPA, Computer System..., Equipment / Utilities..., Total Quality Management, Change Management, Technical Training, Training Delivery, Quality Assurance, 21 CFR Part 11, Quality Auditing, Change Control, cGMP, SOP, GMP, Quality Systems, Validation, Regulatory Requirements, Pharmaceuticals, Medical Devices, Document Management, Biotechnology, GxP, Risk Assessment, QSR, Documentation, Life Sciences, Process Improvement, Regulatory Submissions, Biopharmaceuticals, Technology Transfer, Pharmaceutical Industry, Sop
Education
Inter American University School of Law 2000 — 2004
JD, Law
Universidad de Puerto Rico 1980 — 1985
BS, Biology
Bill Hallman's FDA Experience May 2014 - Present
Job Chair at Risk Communication Advisory Committee US Food and Drug Administration
Industry Higher Education
Experience
FDA May 2014 - Present
Risk Communication Advisory Committee - US Food and Drug Administration September 2011 - Present
Rutgers University July 2010 - Present
Rutgers University July 1989 - Present
Rutgers University July 2005 - July 2013
Forschungszentrum Jülich May 1996 - September 1996
South Carolina State Health and Human Services Finance Commission May 1988 - September 1989
South Carolina State Health and Human Services Finance Commission March 1987 - May 1988
Appalachian Health Council (SC, HSA region one) March 1986 - March 1987
University of South Carolina August 1983 - May 1986
Skills
Research, Teaching, Policy, Public Health, Grant Writing, Qualitative Research, Public Speaking, SPSS, Policy Analysis, Higher Education, Health, Administration, Writing, Curriculum Design, Statistics, Psychology, Curriculum Development, Program Evaluation, Community Outreach, Data Analysis, Grants, PowerPoint, Excel, Word, Microsoft Office, Nonprofits, Research Design, University Teaching, Public Policy, Student Development, Student Affairs
Education
University of South Carolina-Columbia 1983 — 1989
PhD, Experimental Psychology
Juniata College 1979 — 1983
B.S., Psychology/Biology
Bishop Kenrick High School 1975 — 1979
High School
FDA May 2014 - Present
Risk Communication Advisory Committee - US Food and Drug Administration September 2011 - Present
Rutgers University July 2010 - Present
Rutgers University July 1989 - Present
Rutgers University July 2005 - July 2013
Forschungszentrum Jülich May 1996 - September 1996
South Carolina State Health and Human Services Finance Commission May 1988 - September 1989
South Carolina State Health and Human Services Finance Commission March 1987 - May 1988
Appalachian Health Council (SC, HSA region one) March 1986 - March 1987
University of South Carolina August 1983 - May 1986
Skills
Research, Teaching, Policy, Public Health, Grant Writing, Qualitative Research, Public Speaking, SPSS, Policy Analysis, Higher Education, Health, Administration, Writing, Curriculum Design, Statistics, Psychology, Curriculum Development, Program Evaluation, Community Outreach, Data Analysis, Grants, PowerPoint, Excel, Word, Microsoft Office, Nonprofits, Research Design, University Teaching, Public Policy, Student Development, Student Affairs
Education
University of South Carolina-Columbia 1983 — 1989
PhD, Experimental Psychology
Juniata College 1979 — 1983
B.S., Psychology/Biology
Bishop Kenrick High School 1975 — 1979
High School
Anita Richardson's FDA Experience 1990 - Present
Job Associate Director for Policy at FDA
Industry Public Policy
Experience
FDA 1990 - Present
Education
The Johns Hopkins University - Carey Business School
MAS, Business Management
Indiana University of Pennsylvania
BS, Medical Technology
FDA 1990 - Present
Education
The Johns Hopkins University - Carey Business School
MAS, Business Management
Indiana University of Pennsylvania
BS, Medical Technology
Shuang Tang's FDA Experience September 2014 - Present
Job Regulatory Scientist
Industry Government Administration
Experience
FDA September 2014 - Present
FDA March 2006 - Present
National Institutes of Health October 2000 - April 2006
Education
Shanghai Institute of Biochemistry, Chinese Academy of Sciences 1997 — 2000
Ph.D., Biochemistry and Molecular Biology
Jilin University
Johns Hopkins University
FDA September 2014 - Present
FDA March 2006 - Present
National Institutes of Health October 2000 - April 2006
Education
Shanghai Institute of Biochemistry, Chinese Academy of Sciences 1997 — 2000
Ph.D., Biochemistry and Molecular Biology
Jilin University
Johns Hopkins University
Janae Price's FDA Experience November 2008 - December 2010
Job Epidemiologist at Federal Occupational Health (FOH)
Industry Health, Wellness and Fitness
Experience
Federal Occupational Health (FOH) December 2010 - Present
FDA November 2008 - December 2010
Indian Health Service July 2005 - November 2008
Skills
Community Health, Public Health, Healthcare, Health Education, Health Promotion, Epidemiology, Prevention, Global Health, Program Evaluation, Program Development, Wellness, Health Communication
Education
Indiana University-Purdue University at Indianapolis 2003 — 2005
MPH, Epidemiology
Purdue University 2001 — 2003
B.S., Health Science
Federal Occupational Health (FOH) December 2010 - Present
FDA November 2008 - December 2010
Indian Health Service July 2005 - November 2008
Skills
Community Health, Public Health, Healthcare, Health Education, Health Promotion, Epidemiology, Prevention, Global Health, Program Evaluation, Program Development, Wellness, Health Communication
Education
Indiana University-Purdue University at Indianapolis 2003 — 2005
MPH, Epidemiology
Purdue University 2001 — 2003
B.S., Health Science
Atasi Poddar's FDA Experience April 2012 - Present
Job Regulatory Health Project Manager at FDA
Industry Higher Education
Experience
FDA April 2012 - Present
SAIC-Frederick March 2010 - December 2011
NIAID/NIH October 2005 - January 2010
University of Virginia December 1999 - October 2005
Bose Institute 1994 - 1999
Education
Jadavpur University 1994 — 1999
PhD, Molecular Biology, Genetics
University of Calcutta 1992 — 1994
MS
FDA April 2012 - Present
SAIC-Frederick March 2010 - December 2011
NIAID/NIH October 2005 - January 2010
University of Virginia December 1999 - October 2005
Bose Institute 1994 - 1999
Education
Jadavpur University 1994 — 1999
PhD, Molecular Biology, Genetics
University of Calcutta 1992 — 1994
MS
Ketaki Singh's FDA Experience June 2010 - July 2015
Job Program Manager at U.S. Pharmacopeia
Industry Government Administration
Experience
U.S. Pharmacopeia August 2015 - Present
FDA June 2010 - July 2015
*Confidential* April 2008 - November 2009
PRISCO July 2007 - April 2008
MacusEvans March 2006 - July 2007
Skills
Program Management, Government, Policy, Policy Analysis, Program Evaluation, PMP, Public Policy, Public Health, Federal Government, SDLC, Program Development, Project Portfolio..., Proposal Writing, Database Design, System Migration, System Integrators, ITEM Report, Business Process..., Client-server..., Microsoft Project, SharePoint, Post Implementation..., Risk Communication, Cross-functional Team..., Strategic Planning, Resource Allocation, Project Scope..., Logistics Management, Microsoft Suites, Change Management, Public Speaking, Freedom of Information..., Biologics, Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, Globe Submit, Workshop Development, Workshop Facilitation, Workforce Planning, SAP CRM, UAT Coordination
Education
Stratford University 2009 — 2010
Master’s Degree, Management Information Systems and Services
James Cook University 2005 — 2006
Master of Business Administration (M.B.A.), International Business
U.S. Pharmacopeia August 2015 - Present
FDA June 2010 - July 2015
*Confidential* April 2008 - November 2009
PRISCO July 2007 - April 2008
MacusEvans March 2006 - July 2007
Skills
Program Management, Government, Policy, Policy Analysis, Program Evaluation, PMP, Public Policy, Public Health, Federal Government, SDLC, Program Development, Project Portfolio..., Proposal Writing, Database Design, System Migration, System Integrators, ITEM Report, Business Process..., Client-server..., Microsoft Project, SharePoint, Post Implementation..., Risk Communication, Cross-functional Team..., Strategic Planning, Resource Allocation, Project Scope..., Logistics Management, Microsoft Suites, Change Management, Public Speaking, Freedom of Information..., Biologics, Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, Globe Submit, Workshop Development, Workshop Facilitation, Workforce Planning, SAP CRM, UAT Coordination
Education
Stratford University 2009 — 2010
Master’s Degree, Management Information Systems and Services
James Cook University 2005 — 2006
Master of Business Administration (M.B.A.), International Business
Adil Mohammad's FDA Experience June 2015 - Present
Job Visiting Associate at FDA
Industry Higher Education
Experience
FDA June 2015 - Present
FDA July 2012 - Present
FDA July 2012 - Present
Saint Marys College August 2011 - July 2012
Purdue University August 2010 - July 2011
Skills
Chemistry, Science, NMR, Mass Spectrometry, Organic Synthesis, Spectroscopy, Analytical Chemistry, HPLC, Organic Chemistry, Chromatography
Education
University of Iowa 2003 — 2010
Doctor of Philosophy (Ph.D.), Inorganic Chemistry
Indian Institute of Technology, Delhi 2000 — 2003
Master of Science (M.Sc.), Chemistry
Indian Institute of Technology, Delhi 2000 — 2002
Master's degree, Chemistry
FDA June 2015 - Present
FDA July 2012 - Present
FDA July 2012 - Present
Saint Marys College August 2011 - July 2012
Purdue University August 2010 - July 2011
Skills
Chemistry, Science, NMR, Mass Spectrometry, Organic Synthesis, Spectroscopy, Analytical Chemistry, HPLC, Organic Chemistry, Chromatography
Education
University of Iowa 2003 — 2010
Doctor of Philosophy (Ph.D.), Inorganic Chemistry
Indian Institute of Technology, Delhi 2000 — 2003
Master of Science (M.Sc.), Chemistry
Indian Institute of Technology, Delhi 2000 — 2002
Master's degree, Chemistry
Keenan Bailey's FDA Experience October 2013 - Present
Job ORISE Research Fellow at FDA
Industry Research
Experience
FDA October 2013 - Present
Walter Reed Army Institute of Research November 2009 - August 2013
Blenheim Vineyards July 2009 - October 2009
Western Michigan University May 2008 - August 2008
Skills
Molecular Biology, Fluorescence Microscopy, Western Blotting, Cell Culture, PCR, Microscopy, Biochemistry, Gel Electrophoresis, Protein Purification, Lifesciences, Neuroscience, Science, Molecular Cloning, Animal Models
Education
Kalamazoo College 2005 — 2009
Bachelor of Arts (B.A.), Biology, General
FDA October 2013 - Present
Walter Reed Army Institute of Research November 2009 - August 2013
Blenheim Vineyards July 2009 - October 2009
Western Michigan University May 2008 - August 2008
Skills
Molecular Biology, Fluorescence Microscopy, Western Blotting, Cell Culture, PCR, Microscopy, Biochemistry, Gel Electrophoresis, Protein Purification, Lifesciences, Neuroscience, Science, Molecular Cloning, Animal Models
Education
Kalamazoo College 2005 — 2009
Bachelor of Arts (B.A.), Biology, General
Jarrod Glenn's FDA Experience August 2012 - Present
Job IT Specialist at FDA
Industry Food Production
Experience
FDA August 2012 - Present
Rosina Food Products, Inc. July 2011 - August 2012
Rosina Food Products July 2011 - August 2012
Johnson Controls Inc February 2011 - July 2011
Johnson Controls February 2011 - July 2011
U & S Services November 2008 - March 2009
Siemens Building Technologies April 2008 - November 2008
Siemens Building Technologies April 2008 - November 2008
Videon Digital USA October 2006 - April 2008
Veterans Hospital June 2005 - September 2005
Skills
Computer Hardware, computer software, Building Automation, Electronics, Electrical Controls, Electrical Industry, Computer Network..., Teamwork, Military Experience, HVAC Controls, HVAC, VoIP, Multifunction Devices, Microsoft Office, microsoft windows, Mac, Linux, CCTV, PoE, Customer Service, Telecommunication..., Food Service, Help Desk Support, Remote Desktop, Apple, vnc, Dameware, VMware, IP Cameras, Automotive, MS-DOS, FoxPro, Visual Basic, SQL, Windows Server, Windows 7, Laptops, Operations Management, Military Training, Wireless Networking, Backup Exec, RAID, Virtual PC, PC, Printers, Visio, Intrusion Detection, Barracuda Spam Firewall, Sonicwall, VPN
Education
Niagara University 2009 — 2011
Bachelor of Science (B.S.), Computer and Information Sciences, General
Niagara University 2009 — 2011
Bachelors of Science, Computer Information Sciences
ITT Technical Institute 2004 — 2006
Associate's Degree: Applied Science, Information Technology; Computer Networking Systems
ITT Technical Institute-Getzville 2004 — 2006
Associate of Arts and Sciences (A.A.S.), Computer Systems Networking and Telecommunications
FDA August 2012 - Present
Rosina Food Products, Inc. July 2011 - August 2012
Rosina Food Products July 2011 - August 2012
Johnson Controls Inc February 2011 - July 2011
Johnson Controls February 2011 - July 2011
U & S Services November 2008 - March 2009
Siemens Building Technologies April 2008 - November 2008
Siemens Building Technologies April 2008 - November 2008
Videon Digital USA October 2006 - April 2008
Veterans Hospital June 2005 - September 2005
Skills
Computer Hardware, computer software, Building Automation, Electronics, Electrical Controls, Electrical Industry, Computer Network..., Teamwork, Military Experience, HVAC Controls, HVAC, VoIP, Multifunction Devices, Microsoft Office, microsoft windows, Mac, Linux, CCTV, PoE, Customer Service, Telecommunication..., Food Service, Help Desk Support, Remote Desktop, Apple, vnc, Dameware, VMware, IP Cameras, Automotive, MS-DOS, FoxPro, Visual Basic, SQL, Windows Server, Windows 7, Laptops, Operations Management, Military Training, Wireless Networking, Backup Exec, RAID, Virtual PC, PC, Printers, Visio, Intrusion Detection, Barracuda Spam Firewall, Sonicwall, VPN
Education
Niagara University 2009 — 2011
Bachelor of Science (B.S.), Computer and Information Sciences, General
Niagara University 2009 — 2011
Bachelors of Science, Computer Information Sciences
ITT Technical Institute 2004 — 2006
Associate's Degree: Applied Science, Information Technology; Computer Networking Systems
ITT Technical Institute-Getzville 2004 — 2006
Associate of Arts and Sciences (A.A.S.), Computer Systems Networking and Telecommunications
Meghal Patel's FDA Experience April 2010 - September 2010
Job Study Manager at Westat
Industry Research
Experience
Westat November 2011 - Present
George Washington University August 2010 - May 2014
Oak Ridge Institute for Science and Education, Food and Drug Administration September 2010 - September 2011
FDA April 2010 - September 2010
CDM Group, Inc. March 2010 - June 2010
Hurco Companies, Inc. May 2008 - August 2008
Hurco Companies, Inc. 2003 - 2007
Skills
Qualitative Research, Research, Public Health, Program Evaluation, Stata, Data Analysis, Policy Analysis, Quantitative Research, Community Outreach, Program Development, Science, Public Policy, Epidemiology, International..., Global Health
Education
The George Washington University 2008 — 2010
Master of Public Health (M.P.H.), Global Health- Policy
Indiana University Bloomington 2004 — 2008
Bachelor of Arts (B.A.), Psychology
Indiana University Bloomington 2004 — 2008
Bachelor of Science (B.S.), Biology, Chemistry
Westat November 2011 - Present
George Washington University August 2010 - May 2014
Oak Ridge Institute for Science and Education, Food and Drug Administration September 2010 - September 2011
FDA April 2010 - September 2010
CDM Group, Inc. March 2010 - June 2010
Hurco Companies, Inc. May 2008 - August 2008
Hurco Companies, Inc. 2003 - 2007
Skills
Qualitative Research, Research, Public Health, Program Evaluation, Stata, Data Analysis, Policy Analysis, Quantitative Research, Community Outreach, Program Development, Science, Public Policy, Epidemiology, International..., Global Health
Education
The George Washington University 2008 — 2010
Master of Public Health (M.P.H.), Global Health- Policy
Indiana University Bloomington 2004 — 2008
Bachelor of Arts (B.A.), Psychology
Indiana University Bloomington 2004 — 2008
Bachelor of Science (B.S.), Biology, Chemistry
Diane Leaman's FDA Experience 2008 - Present
Job Project Manager at FDA
Industry Government Administration
Experience
FDA 2008 - Present
Skills
Government, Leadership, Strategic Planning
Education
Gerogetown University
Indiana State University
FDA 2008 - Present
Skills
Government, Leadership, Strategic Planning
Education
Gerogetown University
Indiana State University
Sandra Barnard's FDA Experience March 2013 - Present
Job Chemist at FDA
Industry Higher Education
Experience
University of Kentucky June 2013 - Present
FDA March 2013 - Present
University of Kentucky August 2008 - May 2013
DuPont Pioneer May 2007 - July 2008
DuPont Pioneer May 2006 - May 2007
Skills
Molecular Cloning, Expression Cloning, Vector Cloning, Vector NTI, geneious, Site-directed..., PCR, PCR primer design, Enzyme Kinetics, Protein Crystallization, HPLC, UV/Vis, NMR spectroscopy, Protein Expression, Protein Purification, Mass Spectrometry, Purification
Education
University of Kentucky 2008 — 2013
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Iowa State University 2002 — 2007
Bachelor of Science (BS), Biochemistry, Biophysics and Molecular Biology
University of Kentucky June 2013 - Present
FDA March 2013 - Present
University of Kentucky August 2008 - May 2013
DuPont Pioneer May 2007 - July 2008
DuPont Pioneer May 2006 - May 2007
Skills
Molecular Cloning, Expression Cloning, Vector Cloning, Vector NTI, geneious, Site-directed..., PCR, PCR primer design, Enzyme Kinetics, Protein Crystallization, HPLC, UV/Vis, NMR spectroscopy, Protein Expression, Protein Purification, Mass Spectrometry, Purification
Education
University of Kentucky 2008 — 2013
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Iowa State University 2002 — 2007
Bachelor of Science (BS), Biochemistry, Biophysics and Molecular Biology
Ramadevi Raghunandan's FDA Experience May 2009 - September 2009
Job Principal Investigator at Hepatitis Foundation International
Industry Biotechnology
Experience
Novavax April 2012 - October 2014
Novavax October 2010 - April 2012
Novavax September 2009 - April 2010
FDA May 2009 - September 2009
CytImmune Sciences Inc. December 2005 - December 2008
FDA April 2002 - December 2005
Nationwide Childrens Hospital October 1997 - July 2001
Massachusetts Institute of Technology (MIT) April 1993 - April 1995
Skills
Pharmaceutical Industry, Biopharmaceuticals, FDA, Biotechnology, Vaccines, SOP, Life Sciences, Molecular Biology, Cell Culture, Technology Transfer, Protein Chemistry, Drug Discovery, Validation, GLP, Clinical Development, CRO, Regulatory Affairs, Drug Development, Cross Functional Team..., Vendor Management, Project Management, Strategic Planning, Report Writing, Budgets, Resource Management, Immunology, Assay Development, Clinical Research, Animal Models, Biochemistry, ELISA, Cell Biology, Leadership, FACS, Management, Data Analysis, ELISPOT, Research, Team Leadership
Education
Massachusetts Institute of Technology 1993 — 1995
Post doctoral researcher, Signaling molecules Alzheimers
Indian Institute of Science 1987 — 1993
PhD, Biochemistry
Novavax April 2012 - October 2014
Novavax October 2010 - April 2012
Novavax September 2009 - April 2010
FDA May 2009 - September 2009
CytImmune Sciences Inc. December 2005 - December 2008
FDA April 2002 - December 2005
Nationwide Childrens Hospital October 1997 - July 2001
Massachusetts Institute of Technology (MIT) April 1993 - April 1995
Skills
Pharmaceutical Industry, Biopharmaceuticals, FDA, Biotechnology, Vaccines, SOP, Life Sciences, Molecular Biology, Cell Culture, Technology Transfer, Protein Chemistry, Drug Discovery, Validation, GLP, Clinical Development, CRO, Regulatory Affairs, Drug Development, Cross Functional Team..., Vendor Management, Project Management, Strategic Planning, Report Writing, Budgets, Resource Management, Immunology, Assay Development, Clinical Research, Animal Models, Biochemistry, ELISA, Cell Biology, Leadership, FACS, Management, Data Analysis, ELISPOT, Research, Team Leadership
Education
Massachusetts Institute of Technology 1993 — 1995
Post doctoral researcher, Signaling molecules Alzheimers
Indian Institute of Science 1987 — 1993
PhD, Biochemistry
Niranjan Bhat's FDA Experience November 2011 - January 2014
Job
Industry Research
Experience
PATH January 2014 - Present
FDA November 2011 - January 2014
Johns Hopkins School of Medicine July 2009 - November 2011
Centers for Disease Control and Prevention 2003 - 2006
Skills
Public Health, Vaccines, Pediatrics, Infectious Diseases, Clinical Research
Education
Johns Hopkins Bloomberg School of Public Health 2009 — 2010
Master of Health Sciences, Clinical Investigation
Vanderbilt University School of Medicine 1995 — 2000
Doctor of Medicine (MD), Medicine
Harvard University 1991 — 1995
Bachelor's Degree, Biochemistry
PATH January 2014 - Present
FDA November 2011 - January 2014
Johns Hopkins School of Medicine July 2009 - November 2011
Centers for Disease Control and Prevention 2003 - 2006
Skills
Public Health, Vaccines, Pediatrics, Infectious Diseases, Clinical Research
Education
Johns Hopkins Bloomberg School of Public Health 2009 — 2010
Master of Health Sciences, Clinical Investigation
Vanderbilt University School of Medicine 1995 — 2000
Doctor of Medicine (MD), Medicine
Harvard University 1991 — 1995
Bachelor's Degree, Biochemistry
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