Principal Process Engineer - Manufacturing Sciences & Technology, Upstream
Core
Lead technical support for GMP biologics manufacturing, overseeing process transfer, risk assessments, and continuous improvement for mammalian cell culture and downstream processes.
Role type
Principal Process Engineer (Upstream/Downstream Biologics)
Builds
Clinical and early-stage commercial biologic drug substances using single-use systems
Domain
Biopharmaceuticals / Upstream & Downstream Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mammalian cell culture expertise, downstream purification (chromatography, filtration), GMP compliance, process scaling, technology transfer, deviation/CAPA management, statistical data analysis, SOP authoring, equipment troubleshooting, cross-functional leadership
Preferred skills
Late-phase commercial program experience, process performance qualification (PPQ)
Technologies
Single-use systems, chromatography, tangential flow filtration, viral filtration
Responsibilities
Develop and execute technical work plans; author and review protocols, tech transfer reports, and batch records; lead risk assessments, gap analysis, and CAPAs; mentor staff and coach coworkers; collaborate with clients on process transfer and facility fit; evaluate processes to recommend efficiency improvements
Seniority
Principal, hands-on IC with strategic oversight