Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days
Core
Execute hands-on manufacturing operations for cell culture upstream processes including seed train, perfusion, and bioreactor runs to support facility startup and steady-state production.
Role type
Senior Associate Manufacturing (Upstream Cell Culture)
Builds
Bulk drug substance via cell culture operations
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
physical/clinical work
Required skills
cGMP compliance, aseptic techniques, equipment operation and monitoring, process documentation, in-process sampling, CAPA implementation, cross-functional collaboration
Preferred skills
Biotechnology/pharmaceutical plant startup experience, Upstream operation knowledge (Vial Thaw, Inoculation, Single Use Bioreactor, ATF, Harvest Centrifuge), NC BioWork Certificate
Technologies
Single Use Bioreactors, Production Bioreactors, Depth Filtration, Centrifuges, Electronic Batch Records (EBR), Delta V, Electronic Quality Systems
Responsibilities
Perform hands-on setup, cleaning, and sanitization of production equipment; run and monitor critical process tasks; execute commissioning, qualification, and startup activities; initiate quality observations and support investigations; draft and revise SOPs and technical reports; collaborate with QA, Engineering, and Regulatory teams.
Seniority
Senior, hands-on IC