Manager, Upstream Manufacturing
Emergent BioSolutions
June 29, 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.
Responsibilities
- Provide leadership and oversight of upstream manufacturing: media preparation/transfer, cell culture, infection, harvest, and related steps.
- Ensure equipment, materials, and personnel readiness to support production schedules and batch execution.
- Lead execution on the manufacturing floor to ensure adherence to batch records, SOPs, and CGMP requirements.
- Own/manage QMS elements including deviations, CAPAs, change controls, and investigations.
- Ensure batch records/logbooks/supporting documentation are accurate, complete, and inspection-ready.
- Drive compliance with global regulatory requirements (FDA, MFDS, TGA, and others) and 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) and support inspections/audits.
Qualifications
- Bachelor’s degree in Life Sciences, Engineering, or related field (advanced degree preferred).
- 7+ years biopharmaceutical/vaccine manufacturing experience; 3+ years in a leadership role.
- Strong upstream processing experience (cell culture and viral systems preferred).
- Deep CGMP/regulatory knowledge (FDA and global expectations).
- Proven experience managing teams in regulated manufacturing.
- Ability to lead investigations, implement CAPAs, and manage Quality Systems.
- Strong communication/leadership/stakeholder management.
Benefits / Application Instructions
- Estimated base salary: $129,000–$156,000 (new hire). Certain roles may be eligible for additional incentive compensation. Comprehensive benefits package provided (see company careers page).
- If selected for interview, speak with an HR Partner about compensation philosophy and available benefits.
The Manager, Manufacturing is responsible for end-to-end leadership and execution of upstream drug substance operations within a CGMP vaccine manufacturing environment.
Responsibilities
- Provide leadership and oversight of upstream manufacturing: media preparation/transfer, cell culture, infection, harvest, and related steps.
- Ensure equipment, materials, and personnel readiness to support production schedules and batch execution.
- Lead execution on the manufacturing floor to ensure adherence to batch records, SOPs, and CGMP requirements.
- Own/manage QMS elements including deviations, CAPAs, change controls, and investigations.
- Ensure batch records/logbooks/supporting documentation are accurate, complete, and inspection-ready.
- Drive compliance with global regulatory requirements (FDA, MFDS, TGA, and others) and 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) and support inspections/audits.
Qualifications
- Bachelor’s degree in Life Sciences, Engineering, or related field (advanced degree preferred).
- 7+ years biopharmaceutical/vaccine manufacturing experience; 3+ years in a leadership role.
- Strong upstream processing experience (cell culture and viral systems preferred).
- Deep CGMP/regulatory knowledge (FDA and global expectations).
- Proven experience managing teams in regulated manufacturing.
- Ability to lead investigations, implement CAPAs, and manage Quality Systems.
- Strong communication/leadership/stakeholder management.
Benefits / Application Instructions
- Estimated base salary: $129,000–$156,000 (new hire). Certain roles may be eligible for additional incentive compensation. Comprehensive benefits package provided (see company careers page).
- If selected for interview, speak with an HR Partner about compensation philosophy and available benefits.