Director, Manufacturing

Job Summary The Director of Manufacturing Operations is a senior site leader responsible for end-to-end execution and performance of commercial vaccine drug substance (DS) manufacturing operations at the Canton, MA site. Essential Functions Provide end-to-end leadership and accountability for commercial DS manufacturing (upstream, downstream, central services, equipment/component preparation, site master production schedule). Own delivery of commercial supply commitments by managing capacity, supply risk, operational readiness, and execution discipline in a GMP environment. Ensure operations comply with FDA, ICH, EU Annex 1, EHS, and internal quality system requirements; accountable manufacturing leader during regulatory inspections/audits. Define and execute manufacturing operating strategy (lifecycle management, process robustness, long-term capacity planning). Partner with Quality, Supply Chain, MSAT, Engineering, Automation, and Facilities on deviations, change control, validation, and sustained state of control. Lead manufacturing scheduling and coordination of materials, equipment, and staffing to optimize throughput and right-first-time performance. Establish and manage performance systems (safety, quality, delivery, cost, people metrics) and drive accountability. Own OPEX and CAPEX; deliver productivity and cost improvement commitments. Build/lead/develop manufacturing leadership team (capability, succession planning, retention). Champion continuous improvement (robustness, yield, equipment reliability, COGS). Represent the Canton site in governance forums, network initiatives, due diligence, and stakeholder engagements. Minimum Education, Experience & Skills Bachelor’s degree in engineering/biological sciences/chemistry or related field; MS/PhD or MBA strongly preferred. 12–15+ years progressive leadership in pharma/biotech manufacturing; substantial commercial vaccine or biologics DS experience. End-to-end operational leadership across upstream/downstream, buffer/solution preparation, equipment preparation, and GMP scheduling. Extensive experience with FDA inspections and compliance with FDA/ICH/EU Annex1 for sterile/biologics manufacturing. Business/financial acumen (operating budgets, capital planning, cost reduction). Inspection‑ready organization track record and quality culture. Lean/Six Sigma/TPM expertise; KPIs and data analytics. Strong leadership, communication, and influencing skills. Preferred: MES, ERP, advanced scheduling tools, digital manufacturing. Ability to work on‑site in Canton, MA and support occasional off‑hours. #J-18808-Ljbffr