Tech transfer lead

Drive the Launch of Life-Changing Products

Join a team where your expertise in technical transfer, medical devices, and pharmaceutical manufacturing will directly support the launch of innovative products. In this role, you will play a key part in ensuring the successful transfer of processes from development to commercial manufacturing, while collaborating with cross-functional teams to maintain alignment and efficiency. This position offers an exciting opportunity to contribute to the launch and lifecycle management of pharmaceutical products.

Key Responsibilities

• 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, including harmonized documentation for design transfers.
• Coordinate development support for product maintenance and manage teams implementing changes to medical device platforms.
• Act as a 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.
• Perform additional responsibilities as mutually agreed upon and assigned.

Essential Skills and Requirements

• Advanced degree in Mechanical Engineering, Pharmaceutical Technology, or a related field.
• Proficiency in English; additional languages are a plus.
• Strong experience in pharmaceutical manufacturing, particularly in assembly and packaging processes.
• 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 relevant regulations, including 21 CFR parts 210-211, 21 CFR parts 4-820, ISO 13485, ISTA, ASTM, and EMA medical device directives.

To be considered for this role, you must have the right to work in this location or hold an EU passport.