David Doleski

  PhotoDave has been with FDA for over 26 years in technical positions and management positions of increasing responsibility. He is currently the Acting Deputy Director of Office of Process and Facilities in CDER, which is a senior leadership position in an office that performs facility, process and microbiology reviews for all NDAs, ANDAs, and BLAs managed by CDER. Additionally, he has responsibilities for management of the pre-approval inspection program for drugs and biologics. Previously, Dave was a Director of the Division of Good Manufacturing Practice Assessment in CDER Office of Compliance. Prior to that, he was an Acting Branch Chief and Team Leader in CBER's Division of Manufacturing and Product Quality (DMPQ). His branch reviewed the Chemistry, Manufacturing & Controls (CMC) section of biologics license applications and supplements and conducted pre-approval inspections. During his 9 years in CBER, Dave performed numerous CMC reviews and pre-approval inspections for biologic drug substances and drug products. Prior to his involvement in the inspection and review areas, Dave spent 4 years as a legislative analyst in FDA’s Office of Legislation. In this role, he performed liaison activities with Congress regarding FDA’s biologics program, including development of testimony for hearings and management of Agency responses to Congressional Oversight Investigations. Dave received his B.S. degree in Biology from Cornell University and a second B.S. degree in Computer Information Systems from University of Maryland University College. He has nearly completed a M.S. degree in Systems Engineering at Johns Hopkins University.