Senior Director/Technical Advisor, Drug Product

This role involves leading formulation development and manufacturing strategies for monoclonal antibodies. It requires providing oversight for drug product production, ensuring supply continuity. The position includes technical leadership in issue resolution with CMO partners, including experiment design and results interpretation.

Key tasks include overseeing technical transfer protocols into cGMP facilities. The role requires maintaining up-to-date knowledge of the regulatory environment. Managing SOPs, change controls, deviations, and CAPAs with thorough knowledge of Good Manufacturing Practices is essential.

Ideal candidates should have relevant biopharmaceutical industry experience. Demonstrated ability to work with contract manufacturing partners is crucial. The ability to work in a dynamic, multi-disciplined team is highly valued.