Process Engineer - Manufacturing Sciences & Technology, Upstream
Core
Support technology transfer and process readiness for biologics manufacturing, ensuring successful execution of upstream processes from development to GMP production.
Role type
Senior IC Process Engineer (Upstream Technology Transfer)
Builds
Biologic drug substances for clinical and commercial manufacturing
Domain
Biopharmaceuticals / Upstream Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Upstream biologics manufacturing (mammalian cell culture, in vitro transcription), Technology transfer, GMP compliance, Deviation/CAPA management, Process scaling, Single-use systems operation, Technical documentation authoring, Cross-functional collaboration
Preferred skills
Large-scale/commercial biologics manufacturing expertise, mRNA product development experience
Technologies
Single-use systems, Filtration, Chromatography, Tangential flow filtration, Viral filtration
Responsibilities
Lead facility fit and equipment alignment for technology transfer; Execute technical work plans and data generation; Perform engineering calculations for process development; Draft and review technical documentation (reports, batch records); Conduct risk assessments and root cause analysis; Mentor junior staff on manufacturing principles; Support GMP manufacturing oversight and client meetings.
Seniority
Senior, hands-on IC