Independent Pharmaceutical Consultant
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Independent Pharmaceutical Consultant Employees
Catamaran July 2013 - Present
Catalyst Rx September 2012 - July 2013
Independent Pharmaceutical Consultant March 2009 - September 2012
Independent Pharmaceutical Consultants April 2007 - March 2009
WellPoint March 2005 - April 2007
WellPoint Pharmacy Management January 2003 - March 2005
Healthlink October 2001 - January 2003
Express Scripts July 1997 - October 2001
Skills
Medicare Part D, Pharmacy Benefit..., Employee Benefits, Strategy, Healthcare Management, Account Management, Key Account Management, Trend Analysis, Program Management, Pharmacy Consulting, Pharmacy Benefit..., Healthcare Industry, Managed Care, Medicare, Process Improvement, Healthcare, Strategic Planning, Management, Leadership
Education
Lindenwood University
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
INDEPENDENT PHARMACEUTICAL CONSULTANT August 2014 - Present
Eisai August 2008 - August 2014
Emisphere Technologies July 1998 - July 2008
Pfizer (Wyeth) September 1987 - July 1998
Skills
Process Engineering, Statistical Modeling, Process Validation, Validation, Technology Transfer, GMP, Pharmaceuticals, Manufacturing, V&V, Pharmaceutical Industry, Drug Development, Pharmaceutics, Organic Chemistry, Clinical Trials, Analytical Chemistry, Sop, Biotechnology, CAPA, SOP, FDA
Education
New Jersey Institute of Technology 1977 — 1982
MS, Chemical Engineering
Manhattan College 1973 — 1977
BE, Chemical Engineering
Good Hat Consulting 2012 - Present
Lundback U.S. 2009 - 2012
Independent Pharmaceutical Consultant 2005 - 2007
Quark Biotech 2002 - 2005
Fujisawa 1991 - 2002
Hazelton Laboratories (Now Covance) 1987 - 1991
Hoffmann Laroche 1971 - 1987
Skills
Drug Development, Global Drug Development, Effective Drug..., Pre-IND, IND, NDA, Toxicology, Clinical Pharmacology, Toxicokinetics, Nonclinical Studies, Clinical Study Design
Education
Hunter College
Bachelor of Arts (B.A.), Biology and Chemistry
New York University
Doctor of Philosophy (Ph.D.), Biochemistry
New York University
Master of Science (M.S.), Biochemistry
Independent Pharmaceutical Consultant January 2011 - Present
Advanced Testing Laboratory September 2013 - Present
YourEncore, inc. January 2011 - Present
Eli Lilly and Company September 1979 - December 2010
Skills
Drug Discovery, Clinical Development, Pharmacokinetics, Drug Development, Pharmaceutical Industry, Neuroscience, Pharmacology, Drug Metabolism, Biotechnology, ADME
Education
Michigan State University 1977 — 1979
Post Doc, Biochemistry
University of Minnesota-Twin Cities 1973 — 1977
Ph.D., Pharmacology and Biochemistry
Augsburg College 1969 — 1973
BA, Chemistry and Biology
Site Management Solutions May 2009 - Present
CSSi (Formerly Clinical Site Services) May 2009 - Present
Independent Pharmaceutical Consultant November 2008 - Present
CytImmune Sciences, Inc September 2001 - January 2009
CytImmune Sciences, Inc. September 2003 - March 2006
CytImmune Sciences, Inc September 2001 - September 2003
Focus Technologies 2000 - 2001
Skills
Clinical Research, Study Start Up, Site Selection, Clinical Trials, GMP, Clinical Operations, CRO, CTMS, Study Skills, Pharmaceutical Industry, GCP, Strategic Partnerships, Location Intelligence, Regulatory Submissions, Clinical Development, Biotechnology, Clinical Monitoring, Infectious Diseases, CMO management, Oncology, Medical Writing, Therapeutic Areas, Business Operations, Drug Development, Patient Recruitment, FDA, IND, GLP, Lifesciences, Validation, Technology Transfer, Pharmaceutics, Vaccines, Regulatory Affairs
Education
Morgan State University 1995 — 2000
BS, Medical Technology
Lackey HS 1991 — 1995
Novartis January 2015 - Present
Aseptic Training Institute 2008 - Present
Novartis May 2013 - January 2015
Novartis September 2012 - May 2013
Novartis January 2011 - September 2012
Corthera August 2009 - December 2011
Independent Pharmaceutical Consultant January 2009 - August 2009
Anesiva, Inc. April 2007 - January 2009
Genentech August 1998 - April 2007
Perritt Laboratories 1991 - September 1998
Skills
Auditing, FDA, Quality Assurance, Pharmaceutical Industry, GMP, Quality System, Aseptic Processing, Medical Devices, Clinical Trials, Pharmaceutics, ISO 13485, Microbiology, Laboratory, ISO, Clinical Research
Education
Rutgers University-New Brunswick 1988 — 1996
BS, MS, Biology, Environmental Science, Environmental Microbiology
Alexion Pharmaceuticals, Inc. March 2014 - Present
Johnson & Johnson March 2013 - March 2014
Independent Pharmaceutical Consultant October 2012 - March 2013
Pfizer Pharmaceuticals 2003 - November 2012
Pfizer 1998 - 2003
Medicines Control Agency, UK 1991 - 1998
University of Cambridge 1986 - 1990
Lothian Health Board, Scotland 1983 - 1986
Skills
Pharmacovigilance, Regulatory Submissions, Pharmaceutical Industry, Regulatory Affairs, Drug Development, Medical Writing, GCP, Clinical Research, Therapeutic Areas, Pharmacology, Diabetes, Pharmaceutics, Infectious Diseases, Medicine, IND, Clinical Pharmacology, Cardiology
Education
University of Edinburgh Medical School 1977 — 1983
MB ChB, Medicine
University of Cambridge 1986 — 1990
PhD, Clinical Pharmacology
University of Edinburgh Medical School 1977 — 1981
BSc, Pharmacology first class honours
University of Virginia August 2007 - Present
Independent Pharmaceutical Consultant August 2007 - Present
Engineering Conferences International 2011 - Present
HemoShear LLC February 2009 - Present
Delaware INBRE (Idea Network of Biomedical Excellence) 2008 - Present
Merck May 2005 - August 2007
Merck 1995 - 2007
Merck 1994 - 1995
Merck 1991 - 1994
Merck 1989 - 1991
Skills
Process Development, Vaccines, Pharmaceuticals, Biotechnology, Product Development, Technology Transfer, Commercialization, Manufacturing, Strategy Development, Strategic Planning, Change Management, Organizational Design, Capital Projects, Higher Education, Organizational..., Pharmaceutical Industry, Strategy, Process Simulation, Cross-functional Team..., R&D, Leadership, FDA, Quality Assurance, Project Management, Lifesciences, Product Management, Business Strategy, GMP, Drug Development, Process Engineering, Science, Engineering, Quality System, Life Sciences
Education
University of Delaware 1976 — 1980
PhD, Chemical Engineering
University of Virginia 1974 — 1976
MS, Chemical Engineering
Virginia Polytechnic Institute and State University 1970 — 1974
BS, Chemical Engineering
Elliptical Therapeutics, LLC July 2015 - Present
AnRo Therapeutics, LLC July 2013 - Present
Independent Pharmaceutical Consultant February 2012 - June 2013
Amneal Pharmaceuticals January 2011 - January 2012
Roy Consultant August 2009 - January 2011
Pinnacle Pharmaceuticals (subsidiary of NRP) May 2007 - July 2009
Shire Pharmaceuticals (formerly NRP, Inc.) August 2006 - April 2007
Actavis, Inc. (formerly Watson) January 2004 - July 2006
Insite Vision June 1997 - January 2004
Pfizer (formerly Agouron) April 1995 - May 1997
Skills
Drug Delivery, Technology Transfer, Protein Chemistry, Formulation, R&D, V&V, Pharmaceutics, Pharmacology, Drug Development, Biopharmaceuticals, Chemistry, Lifesciences, GMP, Pharmaceutical Industry, Product Development, GLP, FDA, Sop, Transdermal, Analytical Chemistry, Validation, Regulatory Affairs, HPLC, Regulatory Submissions, Generic Programming, Clinical Trials, Quality by Design, Clinical Development, Drug Discovery, Biotechnology, Dissolution, IND, CAPA, CMC, Pharmacokinetics, ANDA, NDA, SOP, Life Sciences
Education
University of Michigan 1985 — 1987
Post-Doctoral Fellowship funded by NIDA, Transdermal delivery of narcotic analgesics
University of Saskatchewan 1981 — 1985
PHD, Pharmaceutical Chemistry and Pharmacokinetics
Indian Institute of Technology (Banaras Hindu University), Varanasi 1976 — 1981
BS in Pharmacy and M. Pharm (1 yr)
Independent Pharmaceutical Consultant 2011 - Present
Sanofi April 2011 - September 2011
Merck 2009 - 2010
Schering-Plough 1997 - 2009
Bristol-Myers Squibb April 1994 - March 1997
Sinai Hospital of Baltimore 1988 - 1994
Education
The Johns Hopkins University School of Medicine 1985 — 1994
Associate Professor in Cardiology
The Johns Hopkins Hospital 1982 — 1985
Cardiovascular Fellowship
The Mount Sinai Hospital 1979 — 1982
Internal Medicine Residency Program
University of Medicine and Dentistry of New Jersey -New Jersey Medical School 1975 — 1979
M.D.
Rutgers, The State University of New Jersey-New Brunswick 1971 — 1975
Bachelor's degree, Biology/Biological Sciences, General
Talecris Biotherapeutics, Inc. April 2011 - August 2011
Independent Pharmaceutical Consultant 2003 - 2009
Covance 1999 - 2003
Duke Clinical Research Institute 1998 - 1999
Bristol-Myers Squibb 1997 - 1998
Clintrials Research Inc. 1996 - 1997
Rangos Research 1994 - 1996
Centerville Medical Center 1990 - 1994
Rancho Medical Center 1983 - 1990
Skills
Clinical Research, Pharmacovigilance, Research Project..., Clinical Operations, Drug Safety
Education
University of Pittsburgh 1992 — 1993
Continuing Credits, HIV/AIDS
Universidad Autónoma de Guadalajara 1973 — 1980
M.D., General Medicine
Loma Linda University 1968 — 1972
Bachelors, Biology, Chemistry
Self-employed September 2011 - Present
Independent Pharmaceutical Consultant 2014 - 2014
Independent Pharmaceutical Consultant 2014 - 2014
Independent Pharmaceutical Consultant 2014 - 2014
Independent Pharmaceutical Consultant 2014 - 2014
Sandoz, Inc September 2009 - August 2011
Ebewe Parenta Pharmaceuticals May 2006 - September 2009
Self-employed 2003 - May 2006
Monsanto 1999 - 2003
Schein Pharmaceuticals - Steris Laboratories 1995 - 1999
Skills
Regulatory Affairs, Quality Assurance, Quality System, FDA, Quality Auditing, Analytical Chemistry, Laboratory, Quality Control, GMP, FDA GMP, Chemistry, Pharmaceutics, SOP, Supplier Quality, Environmental Monitoring, Manufacturing Operations, Validation, CAPA, Quality System..., Microbiology, Generic Programming, Change Control, Data Integrity, Quality Control..., Compliance Auditing, Quality Control..., Laboratory Operations, Sterilization (Aseptic..., Equipment and..., V
Education
Mississippi College 1982 — 1986
BS, Chemistry
AbbVie June 2014 - Present
AbbVie (formerly Abbott Laboratories) January 2013 - June 2014
Abbott Laboratories 2008 - January 2013
Independent Pharmaceutical Consultant 2004 - 2008
Pfizer 2001 - 2004
Pharmacia 2000 - 2001
Independent Pharmaceutical Consultant 1999 - 2001
Fujisawa 1990 - 1999
Perrigo 1981 - 1990
Skills
Pharmaceutical Industry, FDA, Regulatory Submissions, Regulatory Affairs, IND, eCTD, Quality Assurance, Regulatory Documentation, Drug Development, Validation, CMC, GMP, SOP, Clinical Development, Clinical Trials, Regulatory Requirements, Biotechnology, GCP, CAPA, Life Sciences, GLP
Education
Temple University 2001 — 2003
Graduate Certificate, Drug Development
Alma College 1979 — 1981
BS, Biology
Kalamazoo Valley Community College 1977 — 1979
AS, Pre-Science
Alma College
Bachelor's degree, Biology, General
Temple University
Master of Science (MS), Quality Assurance/Regulatory Affairs