Tech Transfer Lead – Intermediate

About the role

The Tech Transfer Lead (Intermediate) will support process development for new product introductions (NPI) and lifecycle management (LCM) changes, providing technical expertise to biologics drug product manufacturing within a global Process Development organisation.

Key responsibilities

• Lead and support NPI projects from concept through PPQ, ensuring successful product filings and regulatory approval.
• Manage product transfer projects, including line characterisation, engineering studies, process performance qualification, and regulatory submission.
• Troubleshoot drug substance freeze/thaw, formulation, syringe filling, inspection, and transportation issues during NPI and post‑NPI phases.
• Provide process development expertise for sterile processing, process characterisation, technology transfer, and validation of commercial drug products.
• Support manufacturing operations with technical evaluation of Change Control, Non‑conformances, and CAPA.
• Develop documentation and design for characterisation studies, engineering runs, electronic batch records, validation plans, and PPQ for syringe filling.
• Ensure compliance with FDA, EU and international regulations, and pre‑approve/post‑approve validation protocols.
• Act as the primary site contact for transfer projects, collaborating with receiving, sending, and corporate teams.

Required profile

• Intermediate‑level experience in pharmaceutical process development and technology transfer.
• Strong knowledge of sterile manufacturing, syringe filling, and biologics production.
• Familiarity with regulatory requirements (FDA, EU) and CMC business processes.
• Ability to work cross‑functionally and communicate effectively across sites.
• Willingness to travel internationally on a moderate basis.

Required skills

• Process development
• Technology transfer
• Process validation
• Sterile processing
• Syringe filling
• Electronic batch record creation
• Validation planning
• Process performance qualification
• Regulatory compliance (FDA, EU)
• Change control, NC, CAPA evaluation