MSAT Process Engineer/Scientist II (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 via large-scale manufacturing
Domain
Biotechnology / Life Sciences / 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, scale-up, GMP compliance, US/EU regulations, statistical data analysis (multiple linear regression, ANOVA, multivariate analysis), root cause analysis (Fishbone, Kepner-Tregoe), process monitoring, change control assessment
Preferred skills
Master's degree in Biotechnology/Biological Sciences/Chemical Engineering, 2+ years of experience with Master's degree
Technologies
bioreactors, disc stack centrifuges, filtration systems
Responsibilities
Develop process understanding and perform gap analysis/FMEA; Author and review process descriptions, definitive formulations, batch records, and change controls; Assess major deviations and identify root causes; Perform complex data analysis for process monitoring; Represent MSAT on project teams and participate in customer/regulatory audits; Provide guidance to junior team members
Seniority
Mid-Senior, hands-on IC
