Senior Tech Transfer Lead

About the role

The Senior Tech Transfer Lead will drive process development for new product introductions (NPI) and lifecycle management (LCM) changes, supporting biologics drug product manufacturing. Reporting to the Process Development Manager, the role will oversee end‑to‑end technology transfer, from concept through regulatory approval.

Key responsibilities

• Lead NPI projects from concept to Process Performance Qualification (PPQ) and regulatory filing.
• Manage product transfer activities, including line characterisation, engineering studies, and validation.
• Troubleshoot freezing/thawing, formulation, syringe filling, inspection, and transportation of parenteral products.
• Develop characterisation studies, engineering runs, electronic batch records, validation plans, and process performance qualifications for syringe filling.
• Ensure compliance with FDA, EU and international regulations and CMC business processes.
• Participate in cross‑functional validation teams, pre‑approve and post‑approve protocols, and deliver project milestones.
• Support commercial manufacturing with Change Control, NC, CAPA evaluations and technology transfer.
• Assist in deviation resolution, root‑cause analysis, and product quality assessments.

Required profile

• Bachelor’s degree (or higher) in science, engineering or a related discipline.
• Significant experience in process development, validation, and technology transfer within biologics or pharmaceutical manufacturing.
• Ability to travel internationally on a moderate basis.

Required skills

• Process development
• Process validation
• Technology transfer
• Syringe filling
• Sterile processing
• Electronic batch record creation
• Engineering run execution
• Regulatory filing (FDA, EU)
• Change Control, NC, CAPA management
• Root‑cause analysis