Lead Technical Transfer Operations for Combination Products
Join a leading global pharmaceutical organization headquartered in Basel, Switzerland, as it undergoes a significant cultural and perceptual transformation. The company focuses on novel therapies in Oncology and Ophthalmology while developing a world-leading pipeline in Neuroscience and Dermatology, boasting one of the strongest portfolios of Phase II/III studies globally.
As a key member of the team, you will be responsible for technical transfer operations regarding combination products, medical devices, and secondary packaging implementation. You will establish and execute an aligned technical transfer strategy for GDPD with NTO, harmonizing cross-site manufacturing transfers from development to site level. Additionally, you will coordinate development support for product maintenance operations, treating NTO as a customer, and ensure the establishment and upholding of aligned template-based documentation for design transfers.
In this role, you will support and potentially act as the Tech Transfer Lead in Device and Secondary Packaging activities related to transfer and launch for assigned projects. You will work with project teams for device assembly and secondary packaging processes within the GDPD manufacturing network, liaising efficiently with global functions such as Device Development, TechOps, Regulatory, and Supply Chain. Your efforts will support the successful launch and transfer of assembly and packaging processes from Development into Commercial operations, ensuring the availability of launch supplies in time and in required quantities. You may also serve as a deputy within the TTO team or deputize the TTO Group Head.
Key Responsibilities
- Manage technical transfer operations for combination products, medical devices, and secondary packaging implementation.
- Provide expertise from a combination product and medical device platform perspective for strategic, process, technical, and e-systems topics during development, commercialization, and for commercial products.
- Establish and execute an aligned technical transfer strategy for GDPD with NTO, harmonizing cross-site manufacturing transfers and upholding template-based documentation for design transfers.
- Coordinate development support for product maintenance (LCM) for NTO and manage teams to implement changes concerning the medical device platform.
- Support or act as Transfer Team Lead in Launch Site Decisions and technical transfer and launch activities for assembly and packaging at involved sites, serving as a 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 and external audits on packaging and medical device-related matters.
- Drive the preparation of function-related documents for the registration of medical devices and combination products, providing input to health authority questions.
- Assume additional mutually agreed roles defined by assigned trainings.
Qualifications and Experience
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- PhD or Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology.
- Minimum of 5 years of professional experience in Pharmaceutical Manufacturing (preferably assembly and packaging), Manufacturing Science and Technology, or technical Development in assembly and secondary packaging projects.
- Thorough understanding of product processes, with strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities.
- Fundamental understanding of standard device and packaging analytical testing.
- Expertise in reviewing and writing technical reports.
- Strong project management skills.
- Strong communication and intercultural skills with the 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.