pManufacturing Science and Technology Expert - Drug Product /ppLonza /ppVisp, Switzerland /ph3Key responsibilities: /h3ulliResponsible for implementing the manufacturing process in the plant, as received from DP process development or customer. /liliSecuring success during technology transfer by applying formal processes and tools to handle the transfer of information, process related risks and change control. /liliParticipate in GMP risk analysis for the manufacturing processes. /liliCommunication of manufacturing updates to the customer. /liliLeading and/or participating in cross-functional teams as a MSAT guide tasked with technology transfers (process implementation and transfer) and timely process implementation at manufacturing scale. This includes the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals. /liliLeading/participate in change controls and deviation investigations. /liliPrepare and perform Qualification and Validation activities in compliance with cGMP regulations and specification requirements. /liliContributing to the development and implementation of standardized MSAT procedures and processes. /liliResponsible for continuous improvement of process performance and product quality. /liliProactively anticipates, evaluates, and resolves scientifical and technical challenges within area of expertise. /liliActing as a mentor for scientific and production staff in different fields of expertise. /liliActs a link between Drug Product Services (DPS Basel), mainly formulation, process development and manufacturing, QC and Visp. /liliLooks after process monitoring and process control strategy as well as sophisticated data analysis. /li /ulh3Key requirements: /h3ulliDegree in Pharmaceutical Technology, Biotechnology, Chemistry, Process Engineering or equivalent scientific degree. /liliMore than 3 years of proven track record in the area of sterile manufacturing on the shopfloor and/or MSAT, QA/QC. /liliProficiency in English. /liliProven process understanding in sterile manufacturing (Pharma, Regulatory aspects, freeze-drying). /liliVery good interpersonal skills with all kinds of interfaces within customers and the project organization. /liliStrong team orientation and collaboration across groups within a matrix organization. /liliStructured, focused and well-organized working demeanor. /liliOpen-minded for new insights and suggestions. /liliAgile, highly motivated and dynamic drive. /liliDriven to resolve issues. /li /ul #J-18808-Ljbffr
