Thomas Rosanske, PhD

Managing Director, Chemistry, Manufacturing and Controls

Thomas Rosanske, PhD, is Managing Director, Chemistry, Manufacturing and Controls (CMC), for the Regulatory Sciences group of Cardinal Health Specialty Solutions.

Role responsibilities

Dr. Rosanske manages a team of CMC consultants who are responsible for all CMC and compliance aspects of product development.

Professional experience

Dr. Rosanske has more than 35 years of experience in the pharmaceutical industry, including senior leadership roles in product development for large pharmaceutical companies and contract research organizations. Prior to joining Cardinal Health, Dr. Rosanske served in laboratory and technical leadership roles at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel Inc. and Eli Lilly and Company. He was Vice President of Analytics at Quintiles and Executive Director of Specialty Services at PPD Inc. He also held an adjunct professorship in the School of Pharmacy at the University of Kansas. Dr. Rosanske has also served on the faculty of several short courses and workshops on analytical method development and validation.
Dr. Rosanske has authored or co-authored more than a dozen research articles and book chapters and has co-edited two books on analytical method development and validation.

Professional affiliations

Dr. Rosanske serves on a United States Pharmacopeia (USP) Chemical Medicines Expert Committee. He has also held leadership positions and served on the executive council for the American Association of Pharmaceutical Scientists (AAPS).

Education

Dr. Rosanske received a master’s degree in analytical chemistry and a doctorate in pharmacy (pharmaceutics) from the University of Wisconsin–Madison.

Areas of Expertise


CMC product development

Preparation of standard operating procedures

Formulation development

Analytical development

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