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MSAT Upstream Scientist/Process Engineer
4 months ago
- Represents Manufacturing Science and Technology MSAT on project teams as technical subject matter expert SME and interface with customer technical and quality representatives.
- Develops process understanding and expertise.
- Authors, reviews and owns process related documentation example process description and batch records.
- Authors/reviews change controls including managing the implementation of the change as the assigned change agent.
- Monitors and reports on process performance manufacturing data analysis and delivery of data in the form of live presentations.
- This is an individual contributor position and will NOT have direct reports.
- Minimum of Bachelor of Science degree required, preferred in Biotechnology area, Biological Sciences, or Chemical Engineering.
- A range of experience with biotech, process development, process scale up, tech transfer and/or manufacturing.
- Experience with cell biology, cell culture, scale up and mass transfer, bioreactor operation, disc stack centrifugation, and statistical data analysis.
- Strong knowledge of aseptic technique and mammalian cell culture.
- Experience with large scale 2 kL bioreactors preferred, mammalian manufacturing support preferred, able to follow cGMP and US EU regulations.
- Strong communication skills. Able to clearly express ideas and point of view both verbally and in writing. Has good interpersonal skills. Shows commitment and dedication and strives to be ahead of schedule.
- Practices safety awareness at all times and considers impact of actions prior to executing activities.
- Ability to share 24/7 on-call support while process is being manufactured.