Associate Manufacturing - Bulk Drug Substance Downstream - Days

Role: Associate in manufacturing supporting downstream drug substance operations at Amgen's new flexible, tech-enabled facility. Objectives include supporting plant startup, operational readiness, and routine production of biologics. Responsibilities encompass executing cGMP-compliant downstream processes—column packing, chromatography, TFF, viral filtration, and final fill—along with equipment setup, operation, monitoring, and cleaning. The role involves participation in commissioning, qualification, troubleshooting, and continuous improvement activities, with a focus on safety, quality, and compliance. Work schedules include early-phase startup hours and 12-hour shift rotations supporting 24/7 manufacturing. Requirements: High School diploma + 2 years regulated manufacturing experience, or Associate’s Degree + 6 months, or Bachelor's Degree. Preferred skills include completion of NC BioWorks Certification, biotech/pharma industry experience, familiarity with cGMP, and proficiency with electronic systems like EBR/MES. Experience in biologics, process operations, or manufacturing systems is valued. This role reports to operations leadership and collaborates with cross-functional teams during facility startup and routine production phases. Location: North Carolina; shift schedule may include non-standard hours and overtime to support manufacturing operations.