Director, Manufacturing
Emergent BioSolutions
5 months ago
On-site
Canton, MA
Operations
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 Annex 1 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.
Application Instruction
- If interested in interviewing, discuss your interest with your current manager before an interview is scheduled.
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 Annex 1 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.
Application Instruction
- If interested in interviewing, discuss your interest with your current manager before an interview is scheduled.