Tech Transfer Lead – Process Development & Validation

About the role

The Tech Transfer Lead will drive process development and technology transfer for new biologics product introductions and lifecycle changes at our manufacturing site. Reporting to the Process Development Manager, you will support both NPI and commercial operations, ensuring smooth transfer from concept through regulatory approval.

Key responsibilities

• Lead new product introductions (NPI) from concept to Process Performance Qualification (PPQ) and complete product filings.
• Manage end‑to‑end product transfer projects, including line characterization, engineering runs, and validation activities.
• Develop documentation, electronic batch records, validation plans, and performance qualification protocols for syringe‑filling processes.
• Provide technical solutions for drug substance freeze/thaw, formulation, filling, inspection, and transportation challenges.
• Support commercial manufacturing with change control, NC/CAPA assessments, and technology transfer activities.
• Ensure compliance with FDA, EU, and international regulations and internal quality policies.
• Participate in cross‑functional validation teams, pre‑approve and post‑approve validation protocols, and act as the primary site contact for global transfer projects.
• Collaborate with receiving, sending, and corporate sites to meet project milestones.

Required profile

• Strong background in pharmaceutical process development, especially sterile and syringe‑filling operations.
• Proven experience leading technology transfer and process validation projects.
• In‑depth knowledge of CMC regulatory requirements (FDA, EU) and quality systems.
• Ability to troubleshoot complex manufacturing issues and drive corrective actions.
• Excellent communication and collaboration skills across functional groups.
• Willingness to travel internationally on a moderate basis.

Required skills

• Process Development
• Technology Transfer
• Process Validation
• Sterile Processing
• Syringe Filling
• Electronic Batch Record (EBR) creation
• Validation Planning
• FDA regulatory compliance
• EU regulatory compliance
• Change Control
• CAPA management