Scott R. Nichols, PhD Kite, a Gilead Company

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 earned a PhD 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. Following this time at the FDA, he worked and as a consultant for regulatory and compliance issues for biotechnology and cell therapy clients; he advised clients on cGMP compliance issues for small molecule nonsterile drugs, biotechnology drug substance, and all forms of sterile drug product manufacture. He advised regulatory clients on submissions of INDs and BLAs for biotechnology products and vaccines. He started in 2020 working as the Senior Compliance Lead at Kite's new CAR-T manufacturing facility, later leading Kite's Global Quality Compliacne Program. He currently serves at a Product Quality Leader supporting regulatory CMC submissions and overseeing quality data.