Drug Product Principal

About the role

The Drug Product Principal provides strategic and technical leadership across clinical and commercial development of biologic drug products. Reporting to the Head of TD & Manufacturing, the role ensures robust formulation, process design, technology transfer, manufacturing readiness, lifecycle management, and regulatory compliance.

Key responsibilities

• Lead drug product technology transfers, scale‑up activities and evaluate CDMOs, including budget oversight.
• Act as subject‑matter expert for formulation, process design, container‑closure systems and provide technical oversight throughout the product lifecycle.
• Partner with Quality, Regulatory Affairs, Supply Chain, Program Management and external partners to ensure compliant and timely execution.
• Support regulatory submissions, health‑authority inspections and develop phase‑appropriate control strategies.

Required profile

• Master’s degree in chemical engineering, biotechnology, biochemistry, pharmacy, chemistry or related life science.
• 12+ years of biopharmaceutical experience with a focus on biologic or biosimilar drug product development and manufacturing.
• Proven expertise in MSAT, technical development, technology transfer, commercial manufacturing and CDMO management.
• Strong knowledge of cGMP, regulatory requirements and health‑authority expectations.

Required skills

• Technology transfer
• Scale‑up
• Process design
• Formulation
• Container‑closure systems
• cGMP compliance
• MSAT

What we offer

• Key role with real accountability and direct influence on the device portfolio.
• Broad exposure across biosimilar programmes, device platforms and global regulatory pathways.
• Hybrid working model and competitive employment conditions.