Technical Transfer Operations Lead - 7094

ph3Technical Transfer Operations Lead - 7094 /h3pOur client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organization focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world. /ppFor our clients team, we are seeking a suitable candidate for a bTech Transfer Operations Lead (TTO) /b position. /ppThe 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. The TTO establishes and upholds aligned template based documentation for design transfers to NTO. The TTO 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). /ppTTO can act as deputy within the TTO team and can also deputize the TTO Group Head. /ppThis role is a b1 year contract /b with high chances of extension to be based in bBasel. /b /ph3Main Responsibilities: /h3ulliResponsible for technical transfer operations regarding combination products/medical device secondary packaging implementation. /liliProvide expertise from combination product/medical device platform point of view for strategical, process, technical, and systems related topics during device development, commercialization and for commercial products. /liliEstablish 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. /liliCoordinate development support of product maintenance (LCM) for NTO as a customer and manage teams to implement changes concerning the medical device platform. /liliSupport 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. /liliSupport the manufacturing representative during device development stages (design control) and in the assembly and packaging design process for the GDPD product portfolio. /liliSupport internal external audits on packaging and medical devices related matters. /liliDrive preparation of the function related documents (sections) for registration of medical device/combination products and provide input to health authority questions. /liliAdditional mutually agreed roles defined by trainings assigned. /li /ulh3Qualifications and Experience: /h3ullibRelevant working/residency permit or Swiss/EU-Citizenship required /b /liliPhD, Dipl. Ing.. in Mechanical Engineering or Pharmaceutical Technology /liliMinimum 5 years professional experience in Pharmaceutical Manufacturing (preferably assembly packaging) / Manufacturing Science and Technology / technical Development in assembly secondary packaging projects. /liliThorough understanding of product processes and strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities. /liliFundamental understanding of standard device/packaging analytical testing. /liliExpert in reviewing and writing technical reports. /liliStrong communication and intercultural skills with ability to work in a global matrix environment. /liliKnowledge 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). /liliKnowledge of 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485, ISTA, ASTM and EMA medical device directive. /li /ul /p #J-18808-Ljbffr