Senior Manager, Manufacturing Operations

Role: Senior Manager, Manufacturing Operations responsible for start-up and management of Norton’s new commercial Drug Substance manufacturing train, including equipment commissioning, tech transfer, enterprise system implementation, and production ramp-up. Responsibilities: oversee operational readiness, lead SAP integration supporting GMP manufacturing, manage equipment qualification, plan facility layout, develop electronic workflows, hire/train staff, establish KPIs, ensure GMP compliance, collaborate across functions (Quality, Engineering, Supply Chain), and support regulatory audits. Requirements: B.S. in science or engineering; 10+ years in GMP pharmaceutical/biotech manufacturing; 4+ years supervisory leadership; deep knowledge of cGMP regulations, FDA, EMA standards; hands-on experience with plant startup and troubleshooting; proficiency in SAP, MS Office, process automation tools; experience with MES/eBR systems preferred. HighValue: biologics or small molecule Drug Substance manufacturing, commercial stage, GMP and regulatory audits, cGMP compliance, equipment commissioning, cross-functional leadership in a startup environment. WorkSetup: on-site Norton, MA, with on-call support.