Mike Darj

Quality Assessment Lead (Acting), OLDP, OPQ, CDER
Mike has been with the Agency in various roles since 2003. He currently serves as Quality Assessment Lead (acting) in the Office of Lifecycle Drug Products of the FDA. Mike is also actively involved in working groups and expert committees as pertain to guidance and USP monograph developments. Prior to joining the FDA, Mike spent four years in pharmaceutical and polymer industries (Merck Research Laboratories, Henkel Corp and Bracco Research) in the product development groups. Mike holds a doctoral degree in physical chemistry from Stevens Institute of Technology.

My Speakers Sessions

Tuesday, June 25