Manager, Upstream Manufacturing
Emergent BioSolutions
August 14, 2026
On-site
Canton, MA
Operations
Job Summary
The Manager, Manufacturing is responsible for end-to-end leadership and execution of upstream drug substance operations within a CGMP vaccine manufacturing environment. Ensures equipment/material readiness, media preparation, cell culture, infection processes, and execution oversight while maintaining strict regulatory compliance.
Essential Functions
- Provide direct leadership and oversight of upstream manufacturing operations including media preparation/transfer, cell culture, infection, harvest, and associated process steps.
- Ensure readiness of equipment, materials, and personnel to support production schedules and batch execution.
- Lead execution on the manufacturing floor, ensuring adherence to batch records, SOPs, and CGMP requirements.
- Own and manage QMS elements including deviations, CAPAs, change controls, and investigations.
- Ensure documentation (batch records, logbooks, supporting records) is accurate, complete, and inspection-ready.
- Drive compliance with global regulatory requirements; lead people management (hiring, coaching, performance management, development).
- Establish a culture of safety, quality, and continuous improvement.
- Oversee cleaning, decontamination, sterilization, and aseptic practices.
- Partner cross-functionally with MSAT, Quality, Supply Chain, Engineering, and QA.
- Drive operational excellence (cycle time reduction, right-first-time, capacity optimization).
- Support regulatory inspections and audits; maintain inspection readiness.
Minimum Education, Experience, Skills
- Bachelor’s degree in Life Sciences, Engineering, or related field (advanced degree preferred).
- 7+ years in biopharmaceutical or vaccine manufacturing, with 3+ years in a leadership role.
- Strong upstream processing experience (cell culture and viral systems preferred).
- Deep CGMP/regulatory knowledge (FDA and global expectations).
- Experience managing teams in a regulated manufacturing environment.
- Ability to lead investigations, implement CAPAs, and manage Quality Systems.
- Strong communication, leadership, and stakeholder management skills.
Benefits
- Comprehensive benefits package (eligibility governed by plan documents/policies).
The Manager, Manufacturing is responsible for end-to-end leadership and execution of upstream drug substance operations within a CGMP vaccine manufacturing environment. Ensures equipment/material readiness, media preparation, cell culture, infection processes, and execution oversight while maintaining strict regulatory compliance.
Essential Functions
- Provide direct leadership and oversight of upstream manufacturing operations including media preparation/transfer, cell culture, infection, harvest, and associated process steps.
- Ensure readiness of equipment, materials, and personnel to support production schedules and batch execution.
- Lead execution on the manufacturing floor, ensuring adherence to batch records, SOPs, and CGMP requirements.
- Own and manage QMS elements including deviations, CAPAs, change controls, and investigations.
- Ensure documentation (batch records, logbooks, supporting records) is accurate, complete, and inspection-ready.
- Drive compliance with global regulatory requirements; lead people management (hiring, coaching, performance management, development).
- Establish a culture of safety, quality, and continuous improvement.
- Oversee cleaning, decontamination, sterilization, and aseptic practices.
- Partner cross-functionally with MSAT, Quality, Supply Chain, Engineering, and QA.
- Drive operational excellence (cycle time reduction, right-first-time, capacity optimization).
- Support regulatory inspections and audits; maintain inspection readiness.
Minimum Education, Experience, Skills
- Bachelor’s degree in Life Sciences, Engineering, or related field (advanced degree preferred).
- 7+ years in biopharmaceutical or vaccine manufacturing, with 3+ years in a leadership role.
- Strong upstream processing experience (cell culture and viral systems preferred).
- Deep CGMP/regulatory knowledge (FDA and global expectations).
- Experience managing teams in a regulated manufacturing environment.
- Ability to lead investigations, implement CAPAs, and manage Quality Systems.
- Strong communication, leadership, and stakeholder management skills.
Benefits
- Comprehensive benefits package (eligibility governed by plan documents/policies).