Nitin Agarwal
About Nitin Agarwal
Nitin Agarwal is a Senior Director and Head of Autologous Process Development at Kite Pharma, with expertise in end-to-end process development for biologics. He holds a Ph.D. in Chemical & Biological Engineering from the University of Wisconsin-Madison and has significant experience in regulatory submissions and product commercialization.
Work at Kite Pharma
Nitin Agarwal serves as the Senior Director and Head of Autologous Process Development at Kite Pharma since 2020. In this role, he leads the development of autologous cell therapy processes for key products, including Yescarta and Tecartus. His responsibilities encompass end-to-end process development for biologics, which includes drug substance, drug product, and device design. Under his leadership, the team focuses on ensuring that the processes meet regulatory standards and support successful product commercialization.
Education and Expertise
Nitin Agarwal holds a Ph.D. in Chemical and Biological Engineering from the University of Wisconsin-Madison, where he studied from 2003 to 2008. He also completed the General Management Program at The Wharton School in 2019. His educational background provides a strong foundation for his expertise in end-to-end process development for biologics. Agarwal's knowledge extends to regulatory considerations and business drivers, including the cost of goods manufactured.
Background
Prior to his current role at Kite Pharma, Nitin Agarwal worked at AstraZeneca as a Principal Scientist from 2017 to 2020. Before that, he spent nine years at MedImmune as a Senior Scientist, where he contributed to various projects in biologics. His career began at Frito Lay, where he served as an Operations Manager for one year in 2002-2003. This diverse background has equipped him with a comprehensive understanding of both scientific and operational aspects of the industry.
Achievements
Nitin Agarwal has authored and filed several Investigational New Drug (IND) applications and Biologics License Applications (BLA) with regulatory agencies, including the FDA, EMA, and PMDA. His extensive experience includes supporting product commercialization efforts, particularly in process performance qualification (PPQ) and pre-approval inspections (PAI). These contributions highlight his role in advancing the development and approval of biologic therapies.