Sr Manager, Project Management

Emergent BioSolutions•Canton, MI

About The Position

Emergent is a public health company focused on delivering protective and life-saving solutions globally. The Senior Manager, Project Management will lead the end-to-end execution of the GMP commercial manufacturing facility re-start at the Canton, MA vaccine drug substance (DS) site. This role acts as the main point of contact between the Canton site and the client, ensuring alignment on scope, schedule, budget, compliance, and risk to deliver a compliant, inspection-ready operation. The position also oversees a portfolio of complex technical and capital projects, including new equipment, product introductions, remediation, and CAPEX initiatives within a regulated GMP environment. Additionally, the role provides site leadership for Operational Excellence (OE), promoting the use of OE tools and principles to foster continuous improvement and embedding OE thinking into daily operations and strategic execution.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related scientific/technical discipline is required.
10+ years of progressive experience in project or program management within the pharmaceutical, biotech, or vaccine industry, with direct experience supporting GMP manufacturing operations.
Demonstrated experience leading large, complex, cross-functional programs such as facility start-ups/re-starts, capital projects, or technology transfers in a regulated environment.
Strong working knowledge of cGMP requirements, validation lifecycle, data integrity, and regulatory expectations (FDA, EMA) for commercial biologics/vaccine manufacturing.
Proven client-facing experience with the ability to build credibility, manage expectations, and drive alignment in high-stakes, time-sensitive programs.
Formal project management training or certification (PMP, PgMP, or equivalent) strongly preferred, expertise in standard project management methodologies and tools.
Excellent leadership, influence, and communication skills with the ability to operate effectively at executive and site-level forums.
Strong financial acumen, including experience managing project budgets, forecasts, and CAPEX governance.
Highly organized, results-oriented, and detail-focused, with the ability to manage ambiguity, competing priorities, and accelerated timelines.
Demonstrated integrity, sound judgment, and commitment to quality, safety, and compliance.
Proven ability to lead in ambiguity, manage competing priorities, and influence without authority.
Strong executive level communication skills, oral, written, and presentation.
High level of business acumen, accountability, and sound judgment.
Ability to partner effectively across Manufacturing, Quality, Regulatory, Engineering, Supply Chain, and external SMEs.
Demonstrated change leadership, resilience, and adaptability in fast paced environment.

Nice To Haves

An advanced degree (M.S., MBA, or equivalent) is preferred.

Responsibilities

Provide overall program leadership and accountability for the GMP facility re-start, from project initiation through execution, qualification, validation, regulatory readiness, and handover to operations.
Act as the primary site interface with the client, ensuring transparent communication, issue escalation, governance, and alignment on milestones, deliverables, and change management.
Lead integrated, cross-functional project teams spanning Manufacturing, MSAT, Quality (QA/QC), Engineering, Validation, Supply Chain, EHS, Finance, and Regulatory to meet agreed timelines and objectives.
Develop, maintain, and control integrated project plans, budgets, resource plans, and forecasts; ensure disciplined project controls, reporting, and decision-making.
Ensure all project activities are executed in compliance with cGMP, data integrity, EHS, and internal quality system requirements, supporting regulatory inspection readiness.
Identify, assess, and proactively manage project risks, technical challenges, and dependencies; develop and implement robust mitigation and contingency plans.
Lead capital project execution, including equipment procurement, installation, commissioning, qualification, and validation for vaccine drug substance operations.
Support and govern additional site-level initiatives such as new product introductions, process/technology transfers, remediation programs, and continuous improvement projects.
Prepare and deliver clear, concise project updates, dashboards, and executive-level presentations for site leadership, corporate stakeholders, and the client.
Mentor, coach, and develop project management resources; drive best practices, standardization, and a culture of accountability and delivery.
Lead and evolve the site Operational Excellence (OE) program, deploying OE tools and methodologies and partnering with internal and external stakeholders to build sustainable OE capabilities.
Partner with Site Leadership to embed OE principles into strategy deployment, daily management systems, tiered meetings, and value stream performance accountability.
Drive knowledge sharing and best-practice exchange across sites, including OE training, benchmarking, and coordinated continuous improvement initiatives.