EC

Ed Ciolkowski

Vice President - CMC Development & Head of Analytical Development at Syner-G BioPharma Group

Ed Ciolkowski has over 20 years of work experience in the pharmaceutical industry. Ed started their career at The Upjohn Company, where they served as a Research Scientist and Group Leader in Animal Health Product Development. In these roles, they provided technical guidance, evaluated registration strategies, and allocated resources for multiple development projects.

Ciolkowski then joined Pharmacia & Upjohn as a Senior Research Scientist, specializing in Solid Formulation Design and Drug Release. Ed developed dissolution test methodologies and applied in vivo-in vitro correlations to support drug release specifications for extended-release formulations.

Ed continued their career at Pfizer, where they held the positions of Associate Research Fellow & Group Leader in Drug Release and Pharmaceutical Sciences Team Leader. In these roles, they supervised scientific staff, developed cross-functional processes, and coordinated activities to support clinical supply preparation.

At Bausch + Lomb, Ciolkowski served as the Director of Global Pharma Technical Services. Ed led a team responsible for analytical method development and validation, manufacturing process development, and technical support for commercial production. Ed also drove the adoption of Quality by Design approaches to new product development.

Most recently, Ciolkowski joined Syner-G BioPharma Group as the Vice President of CMC Development & Head of Analytical Development. In this role, they provide technical leadership and oversees the development of generic ophthalmic products.

Throughout their career, Ciolkowski has demonstrated expertise in various areas such as analytical development, manufacturing process development, technology transfer, and project management. Ed has achieved multiple product approvals and launches, and has implemented innovative approaches to enhance product development and efficiency.

Ed Ciolkowski earned a Bachelor of Arts (B.A.) degree in Chemistry from Wabash College, where they studied from 1984 to 1988. Ed then pursued further education at the University of North Carolina at Chapel Hill, from 1989 to 1993, where they obtained a Doctor of Philosophy (Ph.D.) degree in Analytical Chemistry.

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Timeline

  • Vice President - CMC Development & Head of Analytical Development

    June, 2014 - present

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