President, Lead Project Manager 1988 to present

Advisor on quality compliance and regulatory affairs to senior management of companies producing biologics, cell-based products, pharmaceuticals and medical devices, in the U.S., Germany, France, England, Sweden, Israel, Japan and China.

Help to assure quality and bring robust products to market, and to avoid problems and obtain FDA approvals, by providing counsel, support and project leadership in
· creation and coordination of global quality and regulatory strategies
· development of new products and scale-up of production
· audit and review of facilities and quality operations
· assuring compliance with GMP and ISO
· performance of pre-clinical and clinical trials
· all types of filings, meetings and other interactions with regulatory agencies
· responses to inspection findings and warning letters.

Act, in long-term relationships, as U.S. Agent to the FDA for several international clients.

Technical Director 1981-1988
Head, Cell Products Division and Quality Control 1977-1980
New York Blood Center
New York, NY

Responsible, 1981-1988, for systems development, Quality Control, Quality Assurance and Regulatory Affairs at the Greater New York Blood Program, New York Blood Center, a multi-Divisional organization with over $100,000,000 per year in revenue.

As Blood Center representative, worked with the FDA on new products and licenses, spoke at Advisory Meetings, headed Inspection and Audit teams, and conducted mock and actual FDA inspections in both the United States and Europe.

Consulted, as lead authority in the field, throughout the device and diagnostic industries, on development of products and related information systems.

Led, 1977-1980, development of Cell Products Division and the project that resulted in production and clinical studies of therapeutic Human Interferon from human blood cells.

Education
Ph.D., Biochemistry, Tufts University;
B.S., Chemistry, Brooklyn College