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 in a new facility startup.
Role type
Senior Associate Manufacturing (Upstream Cell Culture)
Builds
Bulk drug substance via cell culture operations
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
cGMP compliance, aseptic techniques, equipment operation, process monitoring, in-process sampling, CAPA implementation, cross-functional collaboration
Preferred skills
Biotech/pharma startup experience, Upstream operation knowledge, NC BioWork Certificate, Electronic Batch Records (EBR) systems
Technologies
Single Use Bioreactors, Production Bioreactors, Depth Filtration, Centrifuges, Delta V, Electronic Quality Systems
Responsibilities
Perform hands-on setup, cleaning, and monitoring of upstream equipment; Execute manufacturing readiness tasks and participate in commissioning/qualification; Initiate quality observations and support investigations; Collaborate cross-functionally on production activities; Implement process improvements and maintain compliance documentation.
Seniority
Senior, hands-on IC