Director of Biologics
Directors of Biologics lead scientific and operational strategy for the development and manufacturing of biologic drugs, such as monoclonal antibodies, recombinant proteins, or biosimilars.
Responsibilities include:
Overseeing early- and late-stage biologics development – Directing teams in cell line development, upstream/downstream processing, and analytical characterization.
Driving regulatory and quality strategy – Ensuring readiness for IND/IMPD and managing responses to regulatory queries.
Establishing partnerships with CROs/CDMOs – Leading outsourcing strategy for tech transfer, scale-up, and production.
Managing departmental budgets and resourcing – Forecasting project needs, hiring, and developing internal capability.
Representing biologics programs at executive level – Reporting to C-suite stakeholders and aligning with commercial strategy.
Ideal candidates have extensive leadership experience and scientific depth in bioprocessing, CMC, and regulatory submissions for biologics.