Biologics Manufacturing Expert
vor 3 Wochen
Thermo Fisher Scientific is seeking a highly skilled Manufacturing Sciences SME to join our team. As a key member of our manufacturing team, you will play a critical role in the successful integration and start-up of our novel single-use technologies (SUT) facility for manufacturing of recombinant products.
Key Responsibilities:- Act as SME on single-use upstream and downstream processing, finding opportunities and tackling challenges for the manufacturing of biologics.
- Prepare, participate in, and coordinate process transfer and implementation activities in cross-functional teams across Manufacturing Sciences, internal and external collaborators.
- Lead the management of process deviations and change controls of moderate to high complexity within area of responsibility.
- Contribute to trending and evaluating process data, proposing, and implementing cGMP and business improvement initiatives in their field of expertise.
- Represent Manufacturing Sciences in multi-functional teams (Quality, Engineering, etc.), including customer meetings.
- Master or PhD degree in biotechnology, chemical engineering, life, or food sciences.
- Proven experience in biopharmaceutical process development or tech-transfer related functions within pharma, biotech, biochemistry, or food industry required.
- Minimum of 2 years of experience in successfully qualifying, running, and/or troubleshooting single-use technologies for biologics.
- Profound knowledge of cGMP guidance applicable to pharmaceutical manufacturing.
At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. We value diversity, inclusion, and innovation, and we are committed to accelerating research, solving complex scientific challenges, and supporting patients in need.
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