Associate Manufacturing
Core
Operate and support the preparation, start-up, and commercial manufacturing of Epogen Drug Substance Intermediate in a classified cleanroom environment.
Role type
Associate Manufacturing Operator (Biopharma)
Builds
Epogen Drug Substance Intermediate for commercial production
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cleanroom operations, equipment setup and cleaning (CIP/SIP), SOP adherence, process monitoring, safety compliance, minor deviation management, technical writing
Preferred skills
aseptic operations, bioreactor and roller bottle operations, UF/DF systems, Delta V software, regulatory knowledge (CFR), chemistry and biology principles
Technologies
Delta V, bioreactors, roller bottle storage and retrieval systems, stainless steel vessels
Responsibilities
Operate in classified cleanroom environments (Grade 9 through Grade 5), set-up and clean production equipment, monitor manufacturing processes, train staff on equipment operation, support equipment commissioning, facilitate continuous improvement, manage minor deviations, review and revise procedures
Seniority
Entry-level to Junior, hands-on IC