Senior Associate - Bulk Drug Substance Manufacturing Services - Days

Role: Senior Associate in Bulk Drug Substance Manufacturing supporting Amgen's NC facility expansion and startup. Primary objectives include enabling manufacturing operations through raw material handling, equipment setup, process support, and ensuring compliance during startup and routine production. Responsibilities involve hands-on process execution, equipment operation, process documentation, safety adherence, cross-functional collaboration, and continuous improvement initiatives. During startup, focus on operational readiness, staff training, and process validation; upon steady-state, oversee daily manufacturing, troubleshooting, and staff coaching. Requirements: High School Diploma + 4 years regulated environment or relevant experience, or higher degrees with less experience; strong cGMP knowledge; experience in biotech or pharma plant startup preferred. Skills include solution prep, equipment handling, inventory control, and proficiency in electronic systems such as EBR/MES. High-value biopharma specifics: biologics manufacturing, GMP compliance, equipment operation, and process validation in a regulated setting. Collaboration spans QA/QC, engineering, and production teams. Work setup involves shift flexibility, including non-standard hours, with some early startup phases requiring extended or non-traditional shifts.