Dr. Steven Kozlowski is the Director Office of Product Quality III in the Office of Pharmaceutical Quality, CDER, FDA. Dr. Kozlowski received his medical degree from Northwestern University and trained in Pediatrics at the University of Illinois. Prior to joining the FDA, Dr. Kozlowski worked as a staff fellow in the Molecular Biology Section of the Laboratory of Immunology, NIAID, NIH. Dr. Kozlowski joined the FDA in 1993 and he has been involved in all phases of the regulatory process, from pre-IND product development through inspections, licensing and post approval supplements. He is involved in ongoing policy development for biosimilars and advanced approaches for the manufacture of biopharmaceutical products.
