Regulatory, FDA & Pharmaceutical Chemist (687)
Expertise
Former FDA Official with a vast background in FDA regulations and compliance in pharmaceutical manufacturing, pilot and laboratory facilities.
Regulatory
Food and Drug Administration Compliance
Prepare submissions to the Food and Drug Administration
Quality Audits and implementation of changes
Establish/Review Quality Assurance Procedures., GMP and GLP
Technical
Laboratory Procedures
Package/Product Compatibility. Selection and testing of rubber stoppers and plastic and glass components
Various aspects of lyophilization.
Management
Laboratory Management
Work Flow Design
Experience
1997 - Present Consultant
1992 - 1996 FDA, Philadelphia District, Director Science Branch
Direct through intermediate managers, a laboratory staff of 30 persons whose activities involve methods validation of New Drug Applications (NDA's) and Abbreviated New Drug Applications (ANDA's), Drug product surveys, Drug Master File and Research Projects. Interface with my counterparts in the Investigation and Compliance branches, and with Headquarters in Rockville, Maryland.
1989 - 1992 FDA, Philadelphia District, Assist the Regional Director, Special Projects
Conducted a management review of supervisory persons which led to a major revision of assignments to streamline their work, primarily eliminating redundancies. Assisted in the establishment of a forensic program for generic drugs to insure regulatory compliance.
1982 - 1989 Consulting
Consulting on FDA food and pharmaceutical regulations.
1966 - 1982 The West Company, Assistant Director of Laboratories
West was a leading manufacturer of elastomeric pharmaceutical packaging components. Positions of Supervising Chemist of Quality control, Manager of Technical Services and Assistant Director of Laboratories.
1964 - 1966 Wyeth Laboratories, Senior Research Chemist
1961 - 1964 SKF Industries, Research Chemist
1957 - 1961 Smith Kline & French Laboratories, Research Chemist
Education
B. A., Chemistry, La Salle College, Philadephia, PA
M. S., Physical Chemistry, St. Joseph's College, Philadelphia, PA
M. B. A., Marketing and Finance, Temple University, Philadelphia, PA