Manager, Upstream Manufacturing

Manager, Upstream Manufacturing

Location:

Canton, MA, US

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

The Manager, Manufacturing is responsible for end-to-end leadership and execution of upstream drug substance operations within a CGMP vaccine manufacturing environment. This role ensures equipment and material readiness, media preparation, cell culture, infection processes, and execution oversight while maintaining strict compliance with regulatory requirements. The incumbent will lead a team of manufacturing professionals, drive operational excellence, collaborate with other SMEs, ensure inspection readiness, and deliver safe, compliant, and reliable production in alignment with site objectives.

Provide direct leadership and oversight of upstream manufacturing operations including media preparation/transfer, cell culture, infection, harvest, and associated process steps. Ensure full readiness of equipment, materials, and personnel to support production schedules and batch execution. Lead and oversee all aspects of execution on the manufacturing floor, ensuring adherence to batch records, SOPs, and CGMP requirements. Own and manage Quality Management System (QMS) elements including deviations, CAPAs, change controls, and investigations.

Ensure all documentation (batch records, logbooks, and supporting records) is accurate, complete, and inspection-ready. Drive compliance with global regulatory requirements (FDA, MFDS, TGA, and other applicable agencies). Lead people management responsibilities including hiring, coaching, performance management, and development of direct reports. Establish a culture of safety, quality, and continuous improvement across upstream operations. Oversee cleaning, decontamination, sterilization, and aseptic practices to maintain a compliant manufacturing environment.

Partner cross-functionally with MSAT, Quality, Supply Chain, Engineering, and QA to ensure successful execution and continuous improvement. Drive operational excellence initiatives including cycle time reduction, right-first-time performance, and capacity optimization. Support regulatory inspections and audits, ensuring sustained inspection readiness.

Bachelor's degree in Life Sciences, Engineering, or a related discipline required (advanced degree preferred). Minimum of 7+ years of experience in biopharmaceutical or vaccine manufacturing, with at least 3 years in a leadership role. Strong experience in upstream processing including cell culture and viral systems preferred. Deep knowledge of CGMP regulations, FDA guidelines, and global regulatory expectations. Proven experience managing teams in a regulated manufacturing environment.

Demonstrated ability to lead investigations, implement CAPAs, and manage complex Quality Systems. Strong communication, leadership, and stakeholder management skills.

Operational leadership and execution focus Strategic thinking with strong tactical delivery Quality and compliance mindset People leadership and team development Problem-solving and decision-making under pressure Continuous improvement orientation

Emergent prepares those entrusted with protecting their communities against current and future health threats. Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

We Believe In Our Values

Lead with Integrity Stand shoulder to shoulder Own it always Breakthrough thinking Compete where it counts