Pharmaceutical Auditor (430)
Expertise
cGMP audits and compliance evaluations
CMC document preparation
Product formulation and design
Chemical supplies management
Contractor management
Package development
Software validation
Veterinary drug
Experience
Interim Management. Acting Director Quality Assurance, Regulatory & Scientific Affairs. Member of Senior Management Team rebuilding business, restructuring organization and moving into new manufacturing facility.
Built quality systems, rewrote SOPs, designed and implemented new batch record system, directed validation group, and developed and implemented training program.
Formulate, test and commercialize oral care products based on nutritional and homeopathic active ingredients. Direct efforts to patent product concepts. Provide technical management.
Prepare CMC section of IND and verify compliance of clinical supplies with cGMP. Validate analytical methods. Develop stability protocols and implement stability programs.
Prepare SOPs for conversion of laboratories from ISO 9000 to cGMP compliance. Audit cGMP compliance of contract manufacturing facility. Train lead trainers on cGMPs for laboratories.
Audit facilities for cGMP compliance. Coordinate program to upgrade facilities and procedures to bring operations into compliance with cGMPs. Oversee preparation of clinical trial materials for US studies.
AMERICAN HOME PRODUCTS, Boyle-Midway Household Products, Inc
Vice President, Scientific Affairs
Identified and evaluated technology providing strategic opportunities for new business areas and new products
Established and coordinated product development program in cooperation with Fortune 10 chemical manufacturer.
Negotiated exclusive license for novel product providing entry into $5BB market previously untapped by company.
Provided technical leadership for facility and process audit and upgrade. Directed multi-plant quality control department.
Vice President, R & D
Directed R & D, Package Engineering, Multi-Center Quality Control and Regulatory Affairs Departments.
Initiated and managed acquisition of license for novel compound from Fortune 10 AgVet company. Within one year developed and tested new product competing in $50MM market. Coordinated cGMP and GLP compliance during development and field trials.
Developed and introduced new products and new packages.
Directed team developing and engineering new packages and labeling systems.
Directed and audited quality assurance groups and compliance with SOPs.
Validated contract manufacturers and material suppliers.
THE HARTZ MOUNTAIN CORPORATION, Harrison, NJ
Divisional Vice President - Food & Chemical Dev.
Directed development and commercialization of new products.
Created Right-to-Know programs and managed Hazardous Waste Disposal.
Authored and coordinated compliance with SOPs for the production of OTC Veterinary drug product such as wormer capsules, antibiotic seed and vitamin tablets; pet foods; liquid, powder and aerosol chemical specialties.
Developed and tested new packages and validated manufacturing processes for FDA regulated products.
Directed and designed clinical trials of remedies and fortifies foods. Established product stability, wrote protocols, identified cooperators and designed and prepared clinical supplies.
Director - Chemical Sciences
Directed development, analytical and pilot plant departments.
Managed development of new pet foods; OTC veterinary products; and liquid, powder and aerosol chemical products.
Coordinated process introduction to manufacturing, including equipment evaluation, facility engineering and process validation.
Wrote and enforced procedures for production and quality assurance. Audited facilities.
Manager - Chemical Sciences
Directed product development - laboratory formulation, process development, liquid and aerosol package development, stability testing, toxicology, clinical evaluation, manufacturing initiation and quality assurance.
Research Group Leader
Plant manager - designed, constructed and operated PVC extrusion plant producing controlled release product.
Honors & Publications
Writes monthly column in Pharmaceutical Formulation and Quality.
Numerous other Publications and Presentation. A complete list will be provided upon request.
Education
Ph. D., Chemistry, University of Wisconsin- Milwaukee
M. S., Chemistry, University of Wisconsin-Milwaukee
B. S., Chemistry, Illinois Institute of Technology