MSAT Process Engineer/Scientist III (Downstream)
Core
Primary technical support for mammalian manufacturing processes, including process transfer, scale-up, and lot release.
Role type
Senior IC process engineer/scientist (downstream)
Builds
Mammalian cell culture products at large scale
Domain
Biopharmaceutical manufacturing (downstream processing)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mammalian cell culture, bioreactor operation, disc stack centrifugation, filtration, process transfer, GMP compliance, regulatory knowledge (US/EU), statistical data analysis (ANOVA, multivariate), root cause analysis, process modeling
Preferred skills
large scale manufacturing experience, problem solving tools (Fishbone, Kepner-Tregoe)
Technologies
bioreactors, disc stack centrifuges, filtration systems
Responsibilities
Perform process transfer and support activities, assess major deviations and identify root causes, author and review process descriptions and batch records, represent MSAT on project teams and audits, provide guidance to junior team members
Seniority
Senior, hands-on IC