Mr. Chunsheng Cai, PhD

FDA/CDER/OPQ/OPF/DPAI/PAB
Chemical Engineer
Dr. Chunsheng Cai is a reviewer at FDA’s Office of Pharmaceutical Quality, CDER, responsible for process assessment of chemistry, manufacturing, and controls for investigational new drug applications, new drug applications, abbreviated new drug applications, and supplemental applications. Prior to joining FDA in June 2016, Dr. Cai worked in pharmaceutical industry for 17 years at Aventis/Sanofi, Wyeth/Pfizer, and most recently, Vertex Pharmaceuticals. In his previous roles in industry, he had been responsible for the development and implementation of process analytical technologies to support the pharmaceutical development and commercial manufacturing of drug products. He has published over 10 papers and presented numerous times at scientific conferences. He led a task group in writing an ASTM standard, and coauthored an ISPE guide and a USP chapter. Dr. Cai has his B.S. and M.S. in Chemistry from Wuhan University, and Ph.D. in Analytical Chemistry from Ohio University.