MSAT Process Expert
Vor 2 Tagen
When you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
Location: Lengnau (Bern) - Switzerland
Discover Impactful Work:
In this function, you will be a key player of the Manufacturing Science & Technology team in Lengnau, a pioneering Drug Substance Manufacturing site for Biologic's. Reporting to the Head of Manufacturing Science & Technology, the Manufacturing Science SME will be part of a multifaceted and dedicated team of Process Experts to enable manufacturing campaigns by driving technology transfer and process support.
A day in the Life:
Lead technology transfer to support Drug Substance manufacturing of biologics during Engineering Runs, GMP/clinical, PPQ and routine commercial runs. Provide expertise in upstream drug substance processes (cell culture expansion, perfusion systems, feeding strategies, continuous centrifugation, process monitoring and control) using single-use technology and stainless-steel equipment. Translate process requirements into automated execution systems (MES, PCS) interacting with equipment. Technical leadership and support to manufacturing activities including data trending, deviation investigation, impact assessment, risk mitigation and continuous improvement. Direct interaction with clients through preparation, execution, and follow-up of manufacturing campaigns Supports CMC/regulatory filing documentation.
Keys to Success
Education
MSc or PhD in engineering, biotechnology, cell biology, molecular biology, biochemistry or related field
Experience
Experience in Drug Substance GMP manufacturing ( > 4yrs, PhD> 2yrs) including overall knowledge in upstream process area Experience in technical operation environment (> 2 yrs)
Knowledge, Skills, Abilities
Proficiency in working with multicultural and cross-disciplinary project teams Excellent organization, planning, problem solving and critical thinking skills Excellent writing, communication and presentation skills Energy and drive (action oriented, drive for results) Language: Fluency in English, German knowledge preferable-
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