Senior Tech Transfer Lead

About the role

The Senior Tech Transfer Lead will support new product introductions (NPI) and lifecycle management changes, providing process development expertise for biologics drug product manufacturing. The role oversees the transfer of products from development through validation to regulatory approval, ensuring successful implementation in a new single‑use facility.

Key responsibilities

• Lead NPI projects from concept through process performance qualification (PPQ) and regulatory filing.
• Manage product transfer activities including line characterization, engineering studies, and validation.
• Provide technical solutions for drug substance freezing/thawing, formulation, syringe filling, inspection, and transportation.
• Develop characterization studies, engineering runs, electronic batch records, and validation plans for syringe filling.
• Ensure compliance with FDA, EU and international regulations and maintain quality standards.
• Support commercial manufacturing with change control, NC/CAPA evaluations, and technology transfer.
• Participate in cross‑functional validation teams, approve protocols, and contribute to deviation and root‑cause analyses.

Required profile

• Bachelor’s degree in science, engineering or a related discipline.
• Extensive experience in process development, technology transfer and validation within the biologics/pharmaceutical sector.
• Proven ability to lead complex transfer projects and work collaboratively across functions and sites.

Required skills

• Process Development
• Technology Transfer
• Process Validation and Qualification (PPQ)
• Process Characterization and Engineering Studies
• Electronic Batch Record (EBR) creation
• Sterile Processing and Syringe Filling
• Change Control, NC/CAPA management
• Root Cause Analysis and Deviation handling
• Regulatory submission knowledge (FDA, EU)