Biochemist: Regulatory and Validation Expert

Expertise

Drawing on expertise in the areas of:

• FDA regulations
• New Product Development
• Marketing Research and Marketing
• Financial Aspects of Product Development

Formed my own business. Served clients in the areas listed. Interfaced with FDA on such issues as: establishing Drug Master File (DMF), chemicals extracting from package into medicinal preparation, validation procedures, etc. Prepared and delivered training seminars on Effective Communications, Negotiating Techniques, Business Aspects of the Technical Function, Strategic Planning, and delivered seminars for other seminar/ training organizations.

Experience

AS CONSULTANT

Deliver new products, for clients, from discovery to the marketplace by assisting in areas such as:

• Training, Business and Technical, and transitional training for scientists entering the business areas of marketing, sales, manufacturing and finance.
• Product development
• Process development
• Establishing Standard Operating Procedures
• Various regulatory issues
• Program design
• Business start-up assistance
• Strategic Planning
• Preparation for a Pre approval Inspection
• Good Manufacturing Practices (GMP) audit of pharmaceutical firm
• GMP audit of plastic bottle supplier to a major pharmaceutical firm
• GMP Training Seminars
• Review IND w/ special concern for Chemical Mfg. & Controls
• (CMC) section
• Appraise conditions for contract packaging arrangement between firms
• Prepare Drug Master File, DMF
• Consult/assist regarding firm's compliance with a Consent Decree

MANAGEMENT, DIRECTOR, SCIENCE BRANCH

Philadelphia District FDA

• Direct through intermediate managers, a laboratory staff of 30 persons whose activi-ties involve methods validation of New Drug Applications (NDA's) and Abbreviated New Drug Applications (ANDA's), Drug product surveys, and Research Projects. Interface with my counterparts in the Investigation and Compliance branches, and with Headquarters in Rockville, Maryland.

ASSIST THE REGIONAL DIRECTOR

Special Projects - Philadelphia FDA

• 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.
• Special projects relating to best management structure and assignments for the region. Much of this involved delegating more decision to lower levels.

ASSISTANT DIRECTOR OF LABORATORIES, The West Co.

• Leading manufacturer of elastomeric pharmaceutical packaging components. Held positions of increasing responsibility from Supervising Chemist of Quality control, to Manager of Technical Services to Assistant Director of Laboratories in charge of Research & Development. Responsible for hiring personnel, establishing capital and operating budgets, conducting market research, and analysis of potential acquisitions.

SENIOR RESEARCH CHEMIST, Wyeth Laboratories

• Designed analytical methods for new pharmaceutical raw materials and formula-tions.

RESEARCH CHEMIST, SKF Industries

• Designed new methods and procedures for metals and lubricants.

RESEARCH CHEMIST, Smith Kline & French Laboratories

• Designed analytical methods for new pharmaceutical raw materials and formulations.

Education

• M. B. A., Marketing and Finance, Temple University, Philadelphia, PA
• M. S., Physical Chemistry, St. Joseph's College, Philadelphia, PA
• B. A., Chemistry, La Salle College, Philadephia, PA