MSAT Process Expert, Lengnau
vor 1 Tag
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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.
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 Biologics. 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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