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, Quality Control and Aseptic operations in the industry. 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 and as speaker for CCS workshop for PDA. Nidhi has authored “Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool” for PDA along with 4 other Industry colleagues and have participated as a speaker in workshop for the same. In addition, she is an Executive Board Member for ISPE NJ chapter. She is on planning committee for ISPE Global Aseptic Conference and serves as a liaison 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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Building Resilience in ATMP Manufacturing: Insights and Innovations at the 2025 ISPE Aseptic Conference

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...