The MSAT Process Expert leads technology transfer, provides expertise in drug substance manufacturing, and supports regulatory filing documentation. Requires collaboration with clients and technical operations.
Work Schedule
Flex with On Call DutyEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
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/Division Specific InformationLengnau (Bern) - Switzerland
Discover Impactful Work:In this function, you will be a key player of the Manufacturing Science & Technology team in Lengnau, a state-of-the-art Drug Substance Manufacturing site for Biologic's. Reporting to the Head of Manufacturing Science & Technology, the MSAT Process Expert will be part of a dynamic and talented 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 and/or downstream drug substance processes (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, complex 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.
- MSc or PhD in engineering, biotechnology, cell biology, molecular biology, biochemistry or related field
- Experience in Drug Substance GMP manufacturing (M.Sc >6yrs, PhD>4yrs) including overall knowledge in upstream and/or downstream process area
- Experience in technical operation environment (>2 yrs)
- 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
Top Skills
Automated Execution Systems
Mes
Pcs
Thermo Fisher Scientific Waltham, Massachusetts, USA Office
168 Third Avenue, Waltham, MA, United States
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Boston is a powerhouse for technology innovation thanks to world-class research universities like MIT and Harvard and a robust pipeline of venture capital investment. Host to the first telephone call and one of the first general-purpose computers ever put into use, Boston is now a hub for biotechnology, robotics and artificial intelligence — though it’s also home to several B2B software giants. So it’s no surprise that the city consistently ranks among the greatest startup ecosystems in the world.
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