Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days

Role: Senior Associate in manufacturing supporting downstream drug substance operations at Amgen's new facility, focusing on process execution, startup, and continuous improvement. Responsibilities include performing downstream purification tasks such as chromatography, TFF, viral filtration, and final fill, ensuring operational readiness, executing commissioning and qualification activities, and collaborating cross-functionally with QA/QC, Engineering, and Process Development. Ensures compliance with cGMP, initiates quality investigations, and maintains safety standards. Requirements: High school diploma/GED with 4+ years regulated environment experience, or higher education plus relevant experience; knowledge of downstream bioprocessing; proficiency in SOPs, EBR, and related systems. Preferred: biotech/pharma startup experience, NC BioWorks certification, understanding of downstream purification technologies. High-value specifics include biotech manufacturing, cGMP environment, downstream purification, facility startup, and shift flexibility for 24/7 operations.