Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions)

Role: Senior Associate supporting New Product Introduction (NPI) systems at Amgen's biologics manufacturing plant, focusing on GMP-compliant execution of NPI programs. Responsibilities: facilitate cross-functional Quality Risk Assessments, prepare and maintain risk analyses, create and manage process Bills of Materials, own and coordinate Change Control records, track program milestones, and ensure documentation readiness across Manufacturing, Quality, Supply Chain, and Process Development. Requirements: Master's degree or equivalent experience in manufacturing/operations; experience in GMP biotech/pharma manufacturing support, process development, quality, or supply chain; strong coordination, technical writing, and risk management skills; familiarity with Quality Management Systems preferred. High-value: biologics manufacturing, drug substance process support, GMP environment, cross-functional collaboration, electronic batch records, and MES systems. Work setup: likely hybrid or on-site at North Carolina facility, with focus on compliance, documentation, and process integration.