Overview

This role provides senior technical leadership across Drug Product manufacturing and development within a cross-functional biosimilars environment. The position reports to the Head of CMC/SCM and carries end-to-end accountability for technical transfers, Clinical and external manufacturing oversight, and lifecycle support.

Key Responsibilities:

● Lead end-to-end technical transfers to and between CDMOs, with full accountability for planning, execution, risk, and budget management across global partners.
● Act as senior SME for Drug Product manufacturing and formulation development, supporting development, scale-up, validation, and commercial readiness.
● Drive technical due diligence and strategic assessment of CDMOs, influencing partner selection and long-term manufacturing strategy.
● Provide technical oversight of external manufacturing, including troubleshooting, change controls, deviations, CAPAs, and inspection readiness (e.g. PAI).
● Support Regulatory Affairs with technical input for IND/BLA submissions, health authority interactions, and responses, while ensuring strong cross-functional alignment.

Experience & Skills:
● 7+ years in the (bio)pharmaceutical industry with hands-on experience in biologics/biosimilars manufacturing, MSAT, and technical transfers, including CDMO oversight.
● Strong knowledge of cGMP and regulatory expectations, with proven ability to operate independently in a matrix, fast-paced, global environment.
● Excellent communication, documentation, and stakeholder management skills, with a hands-on, accountable, and pragmatic mindset.