Sr Manager, Project Management
Emergent BioSolutions
August 13, 2026
On-site
Canton, MA
Operations
Job Summary
- Senior Manager, Project Management accountable for end-to-end leadership and execution of the GMP commercial manufacturing facility re-start at the Canton, MA vaccine drug substance (DS) site.
- Primary liaison between the Canton site and the client to align on scope, schedule, budget, compliance, risk, and deliver an inspection-ready operation.
- Leads and governs a portfolio of complex technical/capital projects (new equipment, product introductions, remediation, CAPEX) in a highly regulated GMP environment.
- Provides site leadership for Operational Excellence (OE), driving deployment of OE tools and continuous improvement.
Essential Functions
- Lead GMP facility re-start from initiation through execution, qualification, validation, regulatory readiness, and handover to operations.
- Serve as primary client interface; manage communication, escalation, governance, milestones, deliverables, and change management.
- Lead integrated cross-functional teams (Manufacturing, MSAT, Quality, Engineering, Validation, Supply Chain, EHS, Finance, Regulatory).
- Build and control integrated plans, budgets, resources, and forecasts; ensure disciplined project controls and reporting.
- Ensure cGMP, data integrity, EHS, and internal quality system compliance for regulatory inspection readiness.
- Identify and mitigate project risks, challenges, and dependencies.
- Execute capital projects: procurement, installation, commissioning, qualification, validation.
- Support new product introductions, technology transfers, remediation, and continuous improvement initiatives.
- Deliver executive-level project updates and presentations; mentor and develop PM resources.
- Lead/evolve site OE program and embed OE principles into strategy deployment and daily management systems.
Minimum Education, Experience & Skills
- Bachelor’s degree in Engineering/Life Sciences/Biotech/Chemistry or related field (advanced degree preferred).
- 10+ years progressive project/program management in pharma/biotech/vaccine with GMP manufacturing experience.
- Experience leading complex cross-functional regulated programs (facility start-ups/re-starts, capital projects, tech transfers).
- Knowledge of cGMP, validation lifecycle, data integrity, and FDA/EMA expectations for commercial biologics/vaccine manufacturing.
- Client-facing experience; PMP/PgMP (or equivalent) strongly preferred.
- Strong leadership, communication, financial acumen (budgets/forecasts/CAPEX), organization, and integrity.
Required/Preferred Leadership & Behavioral Skills
- Lead in ambiguity; influence without authority; executive communication.
- Partner cross-functionally and demonstrate change leadership, resilience, and adaptability.
Benefits/Application Instructions
- Comprehensive benefits package available (details via company site); eligibility governed by plan documents.
- Senior Manager, Project Management accountable for end-to-end leadership and execution of the GMP commercial manufacturing facility re-start at the Canton, MA vaccine drug substance (DS) site.
- Primary liaison between the Canton site and the client to align on scope, schedule, budget, compliance, risk, and deliver an inspection-ready operation.
- Leads and governs a portfolio of complex technical/capital projects (new equipment, product introductions, remediation, CAPEX) in a highly regulated GMP environment.
- Provides site leadership for Operational Excellence (OE), driving deployment of OE tools and continuous improvement.
Essential Functions
- Lead GMP facility re-start from initiation through execution, qualification, validation, regulatory readiness, and handover to operations.
- Serve as primary client interface; manage communication, escalation, governance, milestones, deliverables, and change management.
- Lead integrated cross-functional teams (Manufacturing, MSAT, Quality, Engineering, Validation, Supply Chain, EHS, Finance, Regulatory).
- Build and control integrated plans, budgets, resources, and forecasts; ensure disciplined project controls and reporting.
- Ensure cGMP, data integrity, EHS, and internal quality system compliance for regulatory inspection readiness.
- Identify and mitigate project risks, challenges, and dependencies.
- Execute capital projects: procurement, installation, commissioning, qualification, validation.
- Support new product introductions, technology transfers, remediation, and continuous improvement initiatives.
- Deliver executive-level project updates and presentations; mentor and develop PM resources.
- Lead/evolve site OE program and embed OE principles into strategy deployment and daily management systems.
Minimum Education, Experience & Skills
- Bachelor’s degree in Engineering/Life Sciences/Biotech/Chemistry or related field (advanced degree preferred).
- 10+ years progressive project/program management in pharma/biotech/vaccine with GMP manufacturing experience.
- Experience leading complex cross-functional regulated programs (facility start-ups/re-starts, capital projects, tech transfers).
- Knowledge of cGMP, validation lifecycle, data integrity, and FDA/EMA expectations for commercial biologics/vaccine manufacturing.
- Client-facing experience; PMP/PgMP (or equivalent) strongly preferred.
- Strong leadership, communication, financial acumen (budgets/forecasts/CAPEX), organization, and integrity.
Required/Preferred Leadership & Behavioral Skills
- Lead in ambiguity; influence without authority; executive communication.
- Partner cross-functionally and demonstrate change leadership, resilience, and adaptability.
Benefits/Application Instructions
- Comprehensive benefits package available (details via company site); eligibility governed by plan documents.