Steven A. Gordziel, Ph.D.
Practice Head, Pharmaceutical Development
Steven A. Gordziel, Ph.D.
Practice Head, Pharmaceutical Development

Expert in providing technical expertise and leadership to the activities required for the development of pharmaceutical formulations, manufacturing processes, analytical procedures, specifications, and product packaging for PharmaDirections clients.

During Dr. Gordziel's 30-year career in the pharmaceutical industry, he has encom-passed the full spectrum of product development and manufacturing disciplines with a wide range of compounds, product formulations and manufacturing processes. Prior to joining PharmaDirections, Dr. Gordziel was Vice President, Product Development at Hollis-Eden Pharmaceuticals where he led the Company's Chemistry, Manufacturing and Controls (CMC) activities. Dr. Gordziel also served as Vice President of Pharmaceutical Development at Penwest Pharmaceutical Company. At Penwest, he managed a team of 30 members responsible for formulation development, analytical development and validation, stability evaluation, scale up and process development and preparation of clinical supplies for regulatory filings and clinical studies. Previously, Dr. Gordziel was Vice President, Development Research, for the Wallace Pharmaceuticals Division of Carter Wallace, Inc. With Carter Wallace for more than 20 years, Dr. Gordziel had the opportunity to build the company's product development capabilities and assume increasing management responsibility in all aspects of product development. During this time Dr. Gordziel was heavily involved in numerous Investigational New Drug (IND) and New Drug Application (NDA) submissions. Dr. Gordziel began his career at Ortho Pharmaceuticals and Wyeth Laboratories as a formulations scientist. He earned a B.S. in Pharmacy from the Philadelphia College of Pharmacy, and his Ph.D. in Pharmaceutical Sciences from the University of Connecticut, Storrs.