)
)
Tech Transfer Operations Lead (M/F/D)
Tasks:
Responsible for technical transfer operations regarding combination products/medical device & secondary packaging implementation.
Provide expertise from combination product/medical device platform point of view for strategical, process, technical, and esystems related topics during device development, commercialization and for commercial products.
Establish and execute an aligned technical transfer strategy for GDPD with NTO and harmonizes cross-site manufacturing transfers from development to site level including alignment and upholding of template-based documentation for design transfers to NTO.
Coordinate development support of product maintenance (LCM) for NTO as a customer and manage teams to implement changes concerning the medical device platform.
Support but can also act as Transfer Team lead in Launch Site Decisions and in technical transfer and launch activities for assembly and packaging at involved sites and is member of the GDPD Device Development Sub Team.
Support the manufacturing representative during device development stages (design control) and in the assembly and packaging design process for the GDPD product portfolio.
Support internal & external audits on packaging and medical devices related matters.
Drive preparation of the function related documents (sections) for registration of medical device/combination products and provide input to health authority questions.
Additional mutually agreed roles defined by trainings assigned.
Qualification:
PhD, Dipl. Ing.. in Mechanical Engineering or Pharmaceutical Technology
Minimum 5 years professional experience in Pharmaceutical Manufacturing (preferably assembly & packaging) / Manufacturing Science and Technology / technical Development in assembly & secondary packaging projects.
Thorough understanding of product processes and strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
Fundamental understanding of standard device/packaging analytical testing.
Expert in reviewing and writing technical reports.
Strong Project management skills.
Strong communication and intercultural skills with ability to work in a global matrix environment.
Knowledge in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications).
Knowledge of 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485, ISTA, ASTM and EMA medical device directive.
Requirements:
Start: 01.10.2026
Duration: 12 months
Capacity: 4-5 days per week
Location: Basel, Switzerland
)