Stelios C. Tsinontides Ph.D., FAIChE

Director, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ, CDER, FDA

A biopharmaceutical leader with proven track record of achieving successful global registrations and commercialization of sterile, solid dose, liposomal and biotechnology products (Xiidra®, Vyvanse®, Firazyr®, Invanz®, Treanda®, Provigil®, Nuvigil®, Trisenox®, Myocet®, etc.), and implementing business value processes to increase process robustness and ensure un-interrupted supply of products to the market. 

A goal-oriented leader with demonstrated achievements in:

  • Facilitating collaborations within multi-disciplinary areas in complex matrix organizations to achieve technical operations goals, such as timely registrations of products at different sites, technical transfers and successful registrations.
  • Initiating and implementing new programs to comply with Regulations, lower risks of supply chain and achieve lower manufacturing costs.
  • Partnering with CMOs worldwide to successfully commercialize products and establish continuous improvement programs.
  • Mentoring technical leaders, direct reports and colleagues to achieve operational unit and individual goals and grow professionally to increase value to the company.