Shivanthi C.
Sr. Director, Product Quality, BMS Cell Therapy
- Role
- Sr Director, Product Quality, Cell Therapy at Bristol Myers Squibb
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Shivanthi C.
Dedicated quality professional with experience in cell therapy and biologics. My professional journey has included analytical development, viral safety testing, managing quality systems, product quality, and most recently method transfer and validation.
Experience
Sr Director, Product Quality, Cell Therapy
Jan 2018 — Present · Seattle, WA, US
Built and lead a team of scientists responsible for designing commercial method validation and transfer strategies for CT commercial assets. Responsible for life-cycle management of drug product, vector, cell bank methods across a multi-product portfolio for the cell therapy organization. Provide strategic and technical leadership on global submissions, inclusive of Health Authority interactions, on drug product and vector release analytics. Successfully delivered on relevant analytical components for all BMS commercial applications in a variety of jurisdictions.Drive cross-functional collaboration with Development, Regulatory, Internal and External Operations teams.Provide strategic direction to matrixed teams on major investigations and delivered scientifically sound resolutions, in compliance with cGMP expectations.
Education
McGill University
BS, Microbiology and Immunology
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