Operational Readiness Manager - Mammalian ManufacturingLocation: Portsmouth, NH, USA (100% On-Site).
Schedule: Monday - Friday, 8:00 AM - 5:00 PM.
Budget Responsibility: Management and tracking of an estimated $25M USD Operational Readiness CNEC Budget.
We are seeking a high-caliber capital project leader to join our manufacturing organization in Portsmouth, NH, as the
Operational Readiness Manager. Reporting directly to the End-to-End Project Lead, this role is the core strategic architect for a massive facility expansion and retrofit project that will effectively double our local 6K mammalian manufacturing capacity.
With demolition commencing in the coming months and a target go-live window of Q4 2029, you will own the end-to-end operational readiness strategy. Operating with broad direction, this role bridges the gap between engineering design and long-term commercial sustainability-forecasting that proposed facility designs meet strict on-the-floor operational requirements post-handoff. This is a high-visibility, career-defining role: successful execution sets the stage for a natural career progression into a permanent Operational Asset Manager position or an enterprise-level Campaign Readiness Specialist.
What will you get? - An agile career and dynamic working culture
- An inclusive and ethical workplace
- High-Visibility Start-Up Ownership: Lead the operational synchronization of a milestone capital expansion, building the readiness blueprints for an asset doubling our 6K bioprocessing capacity.
- Complex Portfolio Management: Govern an estimated $25M readiness budget while proactively de-risking system dependencies across nearly a dozen technical workstreams.
- Relocation assistance is available for eligible candidates and their families, if needed.
- Compensation programs that recognize high performance, plus comprehensive health, dental, vision, and generous PTO packages.
What you'll do: - Operational Readiness Strategy: Define, build, and champion the comprehensive start-up and operational readiness execution strategy from initial demolition and construction phases through to final commercial validation.
- Design Forecasting & Modeling: Actively evaluate, stress-test, and forecast that proposed facility layouts, technical designs, and automated systems perfectly align with practical, safe, and efficient GMP manufacturing workflows post-system-handoff.
- Cross-Functional Synchronization: Act as a proactive "center of gravity" on site-facilitating workshops to bridge disparate perspectives across Engineering, MSAT, QA/QC, Construction, Digital Automation, and Global Capital Teams.
- Future Capability Alignment: Partner closely with site leadership to architect the multi-year organizational design, resource models, and talent pipelines required to support the expanded production footprint.
- Budget & Schedule Governance: Manage, forecast, and reconcile the $25M USD operational readiness budget; lead resource planning matrices and align project milestones with corporate financial governance.
- Risk Mitigation & Lifecycle Hand-Off: Proactively identify execution barriers, space/equipment constraints, and technical dependencies; design practical problem-solving strategies to ensure a seamless transition into routine commercial GMP operations.
What we're looking for: - Experience: 10+ years of direct, job-related experience in GMP manufacturing and extensive early-stage/start-up asset execution for pharmaceutical or biotechnology facilities regulated by the FDA or EMA.
- Team Building Track Record: Proven background in organizational design-specifically demonstrating a structured methodology for how to build, scale, and upskill manufacturing teams from scratch.
- Stakeholder Master: Exceptional capability to unite varied operational perspectives, manage high-ambiguity project environments, and proactively drive consensus across highly specialized technical matrix teams.
- Biologics Technical Acumen: Deep working knowledge of current mammalian cell culture bioprocessing, technical transfer frameworks, validation principles, and life science regulatory expectations.
- Education: Bachelor's Degree in a Life Science, Engineering, Business Management, or a related scientific/technical discipline is required.
- Certifications: PMP (Project Management Professional) certification from the Project Management Institute (PMI) is highly preferred.
