Tech transfer lead

As Technical Transfer Lead, you will drive the transfer of processes for combination products and medical device packaging from development to commercial manufacturing. You will collaborate with cross-functional teams to ensure alignment, launch readiness, and lifecycle management of innovative pharma products. You’ll shape transfer strategies, manage design transfers, and support audits and regulatory submissions. This role offers impact across development, manufacturing, and packaging, enabling safe, compliant product launches.

• Oversee technical transfer operations for combination products and medical device secondary packaging
• Provide expertise on combination product and medical device platforms during development, commercialization, and lifecycle management
• Develop and execute aligned technical transfer strategies with harmonized design transfer documentation
• Coordinate development support for product maintenance and manage teams implementing changes to medical device platforms
• Act as Transfer Team Lead for launch site decisions and technical transfer activities related to assembly and packaging
• Support manufacturing representatives during device development stages, including design control and packaging design processes
• Assist with internal and external audits on packaging and medical device-related matters
• Prepare function-related documents for regulatory submissions and respond to health authority inquiries

• Advanced degree in Mechanical Engineering, Pharmaceutical Technology, or related field
• Strong experience in pharmaceutical manufacturing, especially assembly and packaging
• Solid understanding of product processes, applied statistics, quality systems, and regulatory requirements
• Expertise in reviewing and writing technical reports
• Strong project management, communication, and intercultural skills
• Knowledge of design control documentation, risk management, and processes such as DMR, DHF, pFMEA, and URS
• Familiarity with 21 CFR parts 210-211, 21 CFR parts 4-820, ISO 13485, ISTA, ASTM, and EMA medical device directives
• Right to work in location or EU passport

• cross-functional collaboration
• intercultural communication
• proactive problem solving
• design control documentation
• risk management (pFMEA, URS)
• DMR and DHF familiarity