STEPHEN BERGE, Ph.D.

Overview
Dr. Berge is a highly skilled and disciplined R&D Executive with broadly diverse expertise encompassing all phases of CMC development for a wide variety of dosage forms. Stephen has successfully led the laboratories responsible for the product development (preformulation, formulation development, analysis and scale-up) of numerous NDA and ANDA projects, both internally and externally developed projects. He is a skilled executive with an affinity to help teams develop appropriate processes for tracking project progress, allocating adequate resources and conducting periodic business reviews to assure alignment with organizational goals.
Noteworthy
  • 35+ years of pharmaceutical industry leadership
  • Skilled in preformulation of drug substances, formulation of solutions, suspensions, tablets, capsules, oral controlled release, metered dose inhalers, topical, transdermal and transmucosal delivery systems, scale-up, clinical supply manufacturing and production support
Positions Held
  • President, “PRN” Consulting
  • Vice President, Pharmaceutical Sciences and Project Management,
    Upsher-Smith Laboratories
  • Director, R&D/Technical Services, Hawkins Pharmaceutical Group
  • Director, Pharmaceutical Development, Abbott Laboratories (TAP)
  • Laboratory Manager, 3M Pharmaceuticals/3M Drug Delivery Systems
    Section Head, Berlex Laboratories
Education
  • B.S., Pharmacy, University of Iowa
  • Ph.D., Pharmaceutics, University of Iowa

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