Doreen Ciolek

Doreen Ciolek has over 30 years of work experience in the pharmaceutical industry. Doreen most recently worked as the Director - Sr. Program Lead CMC Management and Operations at Daiichi Sankyo, Inc. In this role, they were responsible for the operational and strategic leadership of global and regional CMC development teams. Prior to this, they held the position of Associate Director at the same company, where they facilitated the establishment of integrated global and regional CMC development strategies and operational plans. Before joining Daiichi Sankyo, Inc., Doreen worked at Elusys Therapeutics as a Senior Manager Operations and a Sr. CMC Analytical Scientist. In these roles, they were involved in various aspects of analytics and played a crucial role in the successful licensure of ANTHIM®. Prior to that, they worked at ENZON PHARMACEUTICALS, INC as a Research Associate III and at PD REGULATORY SERVICES, INC as a Document Specialist. Doreen started their career at Roche Pharmaceuticals as an Associate Principal Scientist, where they developed and validated analytical methods for drug substance/product release and stability. Throughout their career, Doreen has demonstrated expertise in CMC management, analytical science, and regulatory affairs.

Doreen Ciolek holds an MS degree in Biotechnology from William Paterson University of New Jersey, which they completed from 1995 to 1999. Prior to that, they pursued a BS degree in Biology at Rutgers University, which they earned from 1985 to 1989. In addition, they have obtained a certification in Effective Listening from LinkedIn in 2019.