For our customer located in Basel/Switzerland we are currently looking for a: Tech Transfer Operations Lead (80%) (m/f/d) with following details:
- Location: Basel
- Branch: Pharma
- Duration: 10 months
- Workload: 80-100%
- Languages: German and English
Tasks & Responsibilities
The Tech Transfer Operations Lead (TTO) is responsible for technical transfer operations regarding combination products/medical device & secondary packaging implementation. The TTO establishes and executes an aligned technical transfer strategy for GDPD with NTO and harmonizes cross-site manufacturing transfers from development to site level and the coordination of development support of product maintenance operations for NTO as a customer. He establishes and upholds aligned template based documentation for design transfers to NTO. He supports but can also act as the TTL (Tech Transfer Lead) in Device & Secondary Packaging activities related to transfer and launch for assigned projects as well as project teams for device assembly and secondary packaging processes within the GDPD manufacturing network. Liaises efficiently with related global functions, in particular Device Development GDPD, TechOps, Regulatory and Supply Chain. Is supporting successful launch / transfer of assembly and packaging processes from Development into Commercial operations and for the availability of launch supplies (in time and in required quantities).
TTO can act as deputy within the TTO team and can also deputise the TTO Group Head.
- 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.
Must Haves
- Education: PhD, Dipl. Ing.. in Mechanical Engineering or Pharmaceutical Technology
- Languages: Fluent in English and German. Other languages beneficial
- 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.
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.
