Director, Manufacturing

Emergent Biosolutions•Canton, MA

3d•$196,000 - $237,100•Onsite

About The Position

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 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. This role has full accountability for upstream and downstream processing, central services (buffer and solution preparation), equipment and component preparation, and detailed manufacturing scheduling within a GMP commercial manufacturing environment. The Director ensures safe, compliant, and reliable operations while delivering throughput, cost, and supply performance aligned with FDA, ICH, and EU Annex 1 regulatory requirements and company objectives.

Requirements

Bachelor’s degree in engineering, biological sciences, chemistry, or a related technical discipline required; advanced degree (MS, PhD) or MBA strongly preferred.
Minimum of 12–15 years of progressive leadership experience in pharmaceutical or biotechnology manufacturing, with substantial experience in commercial vaccine or biologics drug substance operations.
Demonstrated end-to-end operational leadership across upstream and downstream processing, buffer/solution preparation, equipment preparation, and GMP manufacturing scheduling.
Extensive experience leading organizations through FDA inspections and operating in compliance with FDA, ICH, and EU Annex 1 requirements for sterile and biologics manufacturing.
Strong business and financial acumen, including management of large operating budgets, capital investment planning, and cost reduction initiatives.
Proven track record of building inspection-ready organizations with strong quality culture and disciplined execution.
Expertise in operational excellence methodologies (Lean, Six Sigma, TPM) and the application of KPIs and data analytics to drive sustained performance improvement.
Exceptional leadership, communication, and influencing skills with the ability to operate effectively in a matrixed, performance-driven manufacturing environment.
Ability to work on-site in Canton, MA and support occasional off-hours engagement consistent with commercial manufacturing operations.

Nice To Haves

Experience with manufacturing execution systems (MES), ERP platforms, advanced scheduling tools, and digital manufacturing capabilities are preferred.

Responsibilities

Provide end-to-end leadership and accountability for commercial DS manufacturing operations, including upstream, downstream, central services, equipment and component preparation, and execution of the site master production schedule.
Own delivery of commercial supply commitments by proactively managing capacity, supply risk, operational readiness, and execution discipline in a GMP environment.
Ensure manufacturing operations are executed in full compliance with FDA, ICH, EU Annex 1, environmental health and safety (EHS), and internal quality system requirements; serve as the accountable manufacturing leader during regulatory inspections and audits.
Define and execute the manufacturing operating strategy aligned with site and enterprise objectives, including lifecycle management, process robustness, and long-term capacity planning for commercial operations.
Partner closely with Quality, Supply Chain, MSAT, Engineering, Automation, and Facilities to ensure reliable operations, effective deviation management, change control, validation, and sustained state of control.
Lead manufacturing scheduling and coordination of materials, equipment, and staffing to optimize throughput, right-first-time performance, and operational efficiency.
Establish and manage manufacturing performance systems, including safety, quality, delivery, cost, and people metrics, drive accountability through tiered management and visual performance management.
Own the manufacturing operating budget (OPEX) and capital plan (CAPEX); ensure disciplined financial management and delivery of productivity and cost improvement commitments.
Build, lead, and develop a high-performing manufacturing leadership team; drive capability development, succession planning, and talent retention.
Champion continuous improvement initiatives to improve robustness, yield, equipment reliability, and cost of goods (COGS) in a commercial manufacturing environment.
Represent the Canton site manufacturing organization in internal governance forums, network initiatives, due diligence activities, and external stakeholder engagements as required.