Located in West Chester, PA, Teva Biopharmaceuticals, USA is accountable for the development and oversight of all CMC aspects related to Biologics programs at Teva. Teva Biopharmaceuticals, USA is a division of Teva Pharmaceuticals, with over $20 billion in annual revenue. The rapidly growing staff of Biologics CMC, specializes in the development of innovative biologics, biosimilars, and extended half-life bio-betters. We currently are developing products in various stages of clinical development from IND through BLA filing. TBU combines the financial stability of a large company with a small-company mentality emphasizing scientific-rigor and flexibility within a Regulatory and Quality context.
This role requires significant Biologics Science background with experience managing cross functional biologics CMC Projects and Teams.
The Associate Director of CMC Project Management reports to the Sr. Director of Global Biologics R&D will be a key talent responsible for the implementation of the CMC development strategy across multiple Biologics programs spanning from pre-IND through BLA filing. The Associate Director will be responsible for coordinating the cross functional CMC teams with broader global project teams serving as the key interface with Clinical, Non-Clinical, Regulatory Affairs, and Operations colleagues on Global Project Teams.
MAJOR DUTIES AND RESPONSIBILITIES