Senior Manager, Manufacturing

Role: Senior Manager, Manufacturing Operations responsible for start-up and oversight of Norton’s new commercial Drug Substance manufacturing train. Main objectives include commissioning, equipment qualification, technology transfer, implementing enterprise systems (notably SAP), and executing successful PPQ batches for commercial launch. Responsibilities encompass managing production schedules, leading cross-functional collaboration for system configurations, overseeing GMP manufacturing shifts, and ensuring compliance with cGMP and regulatory standards. The role also involves staff hiring, training, performance management, fostering continuous improvement, and supporting quality and regulatory audits. Qualifications: B.S. in scientific or engineering field; 10+ years in GMP manufacturing with 4+ years supervisory experience in pharma/biotech, including plant commissioning, troubleshooting, and vendor management. Skills required include deep understanding of GMP manufacturing processes, regulatory standards (FDA, EMA, ICH), proficiency with SAP, MS Office, and experience with MES/eBR systems. High-value specifics: biologics or oligonucleotide manufacturing, commercial stage, active participation in equipment qualification, technology transfer, and regulatory inspections. Collaboration with Engineering, Quality, Supply Chain, and EHS teams. Location: onsite in Norton, MA, with leadership of multiple shifts and on-call support.