Scott Nichols

Scott Nichols graduated from the University of Iowa with a BS in Biochemistry, continued as a Fulbright Scholar in Microbiology at the Pasteur Institute, and completed his Ph.D. at Johns Hopkins in Molecular Biophysics. He worked as a microbial control and sterility assurance lead reviewer and lead inspector at the FDA for CDER regulated BLAs, and as a consultant for regulatory and compliance issues for biotechnology and cell therapy clients. He is now Senior Director of Quality for Kite Pharma, a leading CAR T manufacturing company with facilities in the US and EU that distributes autologous cell therapy products worldwide. He oversees product quality for early-, late-, and commercial-stage autologous cell therapy products, including specifications, regulatory document review, product quality reviews, stability programs, and other product quality/lifecycle management assessments. He is also accountable for quality oversight of process and analytical method transfer and validation.