Technology Transfer Leader

About the role

The Technology Transfer Leader will drive the successful hand‑over of insulin manufacturing technologies from Sanofi’s Frankfurt sending unit to an external Contract Manufacturing Organization. This role ensures that new processes are integrated seamlessly, meet the highest quality and regulatory standards, and align with project timelines for validation, batch production, and commercialization.

Key responsibilities

• Coordinate and manage the transfer of manufacturing technologies, processes, and analytical methods from the sending unit to the receiving CMO.
• Collaborate with cross‑functional teams—including production, quality assurance, regulatory affairs, and supply chain—to ensure a smooth technology transfer.
• Develop and execute detailed technology transfer plans, guaranteeing thorough documentation and compliance with all regulatory and quality requirements.
• Maintain adherence to GMP, local country regulations, and other relevant pharmaceutical standards throughout the transfer.
• Design and deliver training programs for operational staff and stakeholders on new processes, technologies, and equipment.
• Provide expertise in aseptic processes for sterile injectable products, supporting equipment acquisition, process validation, MFT, and cleaning validation.
• Support the implementation of quality systems within the project scope.

Required profile

• Proven experience in pharmaceutical technology transfer, preferably with insulin or sterile injectable products.
• Strong knowledge of GMP, regulatory compliance, and aseptic processing.
• Ability to lead cross‑functional teams and manage complex projects to meet strict timelines.
• Excellent documentation and training skills.

Required skills

• GMP
• Process validation
• Cleaning validation
• Aseptic processing
• Analytical methods