Associate Manufacturing - Bulk Drug Substance Upstream - Days

Role: Associate in manufacturing at Amgen's new drug substance facility supporting cell culture operations during startup and steady-state production. Responsibilities include execution of cGMP-compliant manufacturing activities, equipment setup, monitoring, sampling, and documentation; supporting facility commissioning, qualification, and operational readiness; and participating in process validation and continuous improvement efforts. Requirements: High School diploma + 2 years regulated environment experience, Associate’s degree + 6 months, or Bachelor’s degree; familiarity with GMP, Electronic Batch Records (EBR), and manufacturing equipment. Preferred: certification in NC BioWork/BioWorks, biopharma manufacturing experience, knowledge of EBR/MES systems, and strong communication skills. High-value specifics: Supporting biologics cell culture processes (seed train, perfusion, centrifugation), working in a biopharma cGMP environment, and contributing to a facility employing Industry 4.0 technologies. Work setup: primarily day shifts during startup, transitioning to 12-hour rotating shifts supporting 24/7 operations; may include non-standard hours, holidays, and overtime.