Dr. Stelios Tsinontides is Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA) under the Office of Pharmaceutical Quality (OPQ) in CDER. Dr. Tsinontides has over 25 years of experience in the pharmaceutical industry. OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at commercial scale and provides leadership and technical expertise to Agency components internal and external to the Office of Pharmaceutical Quality regarding manufacturing quality issues.
Prior to joining the FDA, Dr. Tsinontides served in senior-level positions in the pharmaceutical industry - most recently as Shire’s Head of Small Molecule Drug Product Technical Services. His group was responsible for providing scientific and technical expertise for SM Drug Product scale-up and commercial manufacturing activities worldwide, to ensure establishment of commercial robust manufacturing processes and a continuous supply of product to patients.
Dr. Tsinontides holds a B.E. in Chemical Engineering from City College of CUNY and an M.A. and Ph.D. in Chemical Engineering from Princeton University. He has also attended the Wharton Management Program at the University of Pennsylvania. Dr. Tsinontides was elected Fellow at the American Institute of Chemical Engineering (AIChE) in 2016.