Nidhi Shah

Bristol Myers Squibb
Senior Director, Value Stream CAR - T Manufacturing Operations
Nidhi Shah has 30+ years of experience in the Pharma/ Biotech/ Cell Therapy industry. She is a result-oriented leader with extensive knowledge of Business, management, and operations in the industry. She is a resourceful and innovative leader with a broad knowledge of Operations and Quality Control. Nidhi graduated with an EMBA in Business Administration and Management and has her BS degree in Microbiology/ Chemistry. She is certified in Managing Clean Rooms and Controlled Environments, and in Medical Laboratory Technology. Nidhi is Senior Director of CAR-T Cell Therapy Manufacturing Operations at Bristol Myers Squibb. She has represented USA as a Delegate for revision of ISO 14644-5. She has participated in successful audits of health authorities from around the world. Nidhi has served as planning committee for CCS workshop and has served as the panelists in same. In addition, she is an Executive Board Member for ISPE NJ chapter. She is on planning committee for ISPE Global ISPE Aseptic Conference and serves as a liason and a panelist for Women In Pharma. “I am always curious for learning new. As once said by Mahatma Gandhi: 'Live as if you were to die tomorrow and Learn as if you were to live forever.'"

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Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues, or cells. This class of products cannot be terminally sterilized and, in many cases, cannot be filtered and are manufactured by Aseptic processing. The increase in demand for these life-changing products has been fraught with technical and regulatory challenges as laboratory processes are scaled to commercial...