Elastomeric Formulation Expert in the Pharmaceutical and Medical Device Industries

Technical Consultant #1874


Expertise

  • Elastodynamics formulation development in the pharmaceutical and medical device industries.
  • Pharmaceutical rubber manufacturing procedures, SOP's and work instructions.
  • Validation procedures for installing and qualifying new mixing and extrusion equipment used in processing rubber.
  • Rubber replacement formulations.
  • Ultra clean elastomeric formulations.

Experience

Independent Consultant, Present

Helvoet Pharma, Pennsauken, NJ, Polymer Science Manager, 2007 - 2009

  • Managed the pharmaceutical rubber formulations and maintained drug master file for all pharmaceutical rubber formulations.
  • Managed Quality Laboratory and the technicians employed in the in-process testing of rubber mixed prior to molding into closures.
  • Managed the changes in raw materials used in all rubber formulations.
  • Wrote and implemented the validation procedures for installing and qualifying new mixing and extrusion equipment used in processing rubber.
  • Managed the Analytical Laboratory used for testing raw materials and final product testing.
  • Wrote the SOP's and work instructions for all procedures in the manufacturing of pharmaceutical rubber closures.

Hospira Inc., (formally, Abbott Laboratories) Ashland, OH, Manager Polymer Science, 1999 - 2007

  • Managed programs, personnel, and equipment for research and development, and Analytical Laboratories in support of drug compatible elastomeric formulations.
  • Provided technical support to third party customers in pharmaceutical, medical, dental, and biological areas.
  • Managed the changes for formulations in the company drug master file.
  • Developed a replacement rubber formulation that saved the company in excess of one million dollars annually.
  • Developed two new ultra clean elastomeric formulations that will be used on over 30 new generic drugs in the next twenty years or more.

Tompkins Rubber Company, Blue Bell, PA, Technical Director, 1990 - 1998

  • Directed activities, personnel, and programs for Research and Development, Quality, and Analytical Laboratories.
  • Provided technical support for sales team in the pharmaceutical and medical device arena.
  • Managed the changes for formulations in the company drug master file.

Director - Research and Development, 1978 - 1989

  • Developed elastomeric formulations for pharmaceutical and medical device applications.
  • Managed changes in raw materials for existing elastomeric formulations.
  • Directed a staff of six chemists and laboratory technicians in research and development programs.

Manager Quality Assurance, 1972 - 1978

  • Developed quality program including writing of quality manual, SOP's, work instructions, and forms.
  • Trained quality technicians in sampling and inspection plans.
  • Interfaced with customers and developed certified vendor status for Tompkins Rubber Company.

Education

  • B.A. Chemistry, Temple University, Philadelphia, PA
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