h3Senior Lead External Manufacturing – Drug Product Fill Finish /h3pIn 13 years, the bEFOR Group /b has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions. /ppOur ambition is to build a global leading position of our market in 2028. /ppToday, we are an innovative organization working with passionate specialists and committed consultants according to our three values: bCommitment, Excellence and Sharing. /b /ppIn Switzerland, we work with 300 experts who support our customers on their various projects in the French- and German-speaking parts. We help our customers to diversify and to grow through the work of our consultants and the technical expertise of our bSolution Project Delivery Department. /b /ppTo strengthen our team in Schaffhausen we are looking for a bSenior Lead External Manufacturing – Drug Product Fill Finish /b /ph3About the Role /h3pWe are seeking an experienced bSenior Lead External Manufacturing – Drug Product Fill Finish /b to support the technical transfer of Drug Product manufacturing processes from clinical development into scalable and commercially viable manufacturing operations. /ppIn this role, you will work closely with internal development teams and external bCMOs/CDMOs /b, ensuring that manufacturing processes are successfully transferred, scaled up, and prepared for future commercial production. /ppA key focus of this position is bTechnology Transfer, Scale-up, and collaboration with external manufacturing partners /b within Drug Product and Fill Finish operations. /ph3Key Responsibilities /h3ulliEnsure the timely readiness of external bContract Manufacturing Organizations (CMOs/CDMOs) /b and internal pilot plants to support clinical programs. /liliEnsure the timely manufacturing and delivery of clinical materials through internal and external manufacturing partners. /liliAct as the primary point of contact and interface between internal stakeholders and external manufacturing sites. /liliCollaborate closely with bDrug Product Development /b and bPrimary Container Development /b teams to define technical requirements and manufacturing strategies. /liliPlan, coordinate, and support btechnology transfer and scale-up activities /b. /liliEnsure manufacturing processes are robust, reproducible, scalable, and suitable for transfer into larger-scale or commercial manufacturing environments. /liliSupport Drug Product and bFill Finish /b processes with respect to scalability, transferability, and commercial feasibility. /liliManage the sourcing of raw materials and components and coordinate supplier- and material-related topics with CMOs. /liliSupport investigations, deviations, CAPAs, and change controls, including the review of critical GMP documentation and raw data. /liliIdentify opportunities for process optimization and drive continuous improvement initiatives. /liliMonitor project costs, forecasts, and budgets related to external manufacturing activities. /li /ulh3Your Profile /h3ulliBachelor's, Master's, or PhD degree in bPharmacy, Chemistry, Chemical Engineering, Biotechnology, Life Sciences /b, or a related discipline. /liliSeveral years of experience in one or more of the following areas: /liliMSAT (Manufacturing Science Technology) /liliDrug Product Manufacturing /liliFill Finish /liliTechnical Operations /liliProcess Development /liliExternal Manufacturing /liliProven experience in btechnology transfer and scale-up projects /b. /liliExperience working with bCMOs/CDMOs /b. /liliStrong understanding of GMP requirements, process validation, deviations, CAPAs, and change control processes. /liliExcellent communication and stakeholder management skills. /lilibFluent English required; German language skills are highly preferred. /b /li /ulpbThis is an on-site role. /b /ppbOnly applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered. /b /ppbDo you want to join a dynamic and ambitious company? EFOR is made for you. /b /p #J-18808-Ljbffr
MSAT Expert - Drug Product, Fill Finish & Tech Transfer Arbeitgeber: EFOR
Als Arbeitgeber in der biopharmazeutischen Branche bieten wir Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf Teamarbeit und kontinuierliche Verbesserung setzt. Unsere Unternehmenskultur fördert nicht nur die persönliche und berufliche Weiterentwicklung, sondern bietet auch attraktive Benefits wie flexible Arbeitszeiten und ein unterstützendes Arbeitsumfeld. In der Region Rheinland-Pfalz profitieren Sie von einer hervorragenden Lebensqualität und einer starken Gemeinschaft, die Ihre Karriere im Bereich Clean Utilities vorantreibt.
