University of Tennessee, Knoxville 1975 - 1980
Master of Science, Doctorates, Masters, Doctor of Philosophy, Philosophy, Chemistry, Food Science
Skills:
Pharmaceutical Industry Biologics Regulatory Affairs Fda Supplements Gmp Biotechnology Glp Clinical Trials Sop Formulation Ind Change Control Cro Clinical Research Validation Quality Assurance Gcp Pharmaceutics Regulatory Submissions Software Documentation Oncology Clinical Development Biopharmaceuticals Pharmacovigilance Capa Regulatory Requirements Medical Devices Therapeutic Areas Technology Transfer Ctms Lifesciences Gxp Vaccines 21 Cfr Part 11 Aseptic Processing Cmc Ectd Life Sciences Cro Management U.s. Food and Drug Administration Electronic Common Technical Document Standard Operating Procedure Good Laboratory Practice Corrective and Preventive Action Good Clinical Practice
Interests:
Civil Rights and Social Action Education Environment Animal Welfare Health
Nov 2011 to 2000 Quintiles, Regulatory/Compliance ConsultantMerck Kenilworth, NJ 2011 to 2011 Global Regulatory Affairs ConsultantPharmalink and Maruho Research
2009 to 2009Major Client, Stiefel Research Institute
2005 to 2008 Reviewer of ModuleRegulatory Affairs Farmingdale, NY Apr 2004 to Sep 2005 DirectorTunnell Consulting King of Prussia, PA Oct 2002 to Apr 2004 Managing ConsultantOsiris Therapeutics, Inc Baltimore, MD Mar 2001 to Oct 2002 Director, Regulatory Affairs and Quality AssuranceBioSpecifics Technologies Corp Lynbrook, NY Oct 1992 to Mar 2001 Director, Regulatory Affairs and Quality AssuranceCaraco Pharmaceutical Laboratories, Ltd Detroit, MI Mar 1991 to Sep 1992 DirectorClinical Research Associates New York, NY May 1990 to Mar 1991 Consultant and Technical CoordinatorMelville Biologics Melville, NY May 1989 to May 1990 Quality Control ManagerNMC Laboratories, Inc New York, NY Aug 1983 to May 1989 Laboratory DirectorForest Laboratories, Inc Inwood, NY Mar 1981 to Jul 1983 Quality Control Director
Education:
University of Tennessee Knoxville, TN 1980 PhD in Food Technology and ScienceUniversity of Tennessee Knoxville, TN 1977 MS in Food Technology and ScienceArnold and Mary Schwartz College of Pharmacy Pharmaceutical SciencesLong Island University