Operational Readiness Manager – Mammalian Manufacturing

Location: Portsmouth, NH, USA (100% On-Site)

About the Role

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.

Budget Responsibility: Management and tracking of an estimated $25M USD Operational Readiness CNEC Budget.

Responsibilities

• 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.

Requirements

• 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.
• Proven background in organizational design—specifically demonstrating a structured methodology for how to build, scale, and upskill manufacturing teams from scratch.
• Exceptional capability to unite varied operational perspectives, manage high-ambiguity project environments, and proactively drive consensus across highly specialized technical matrix teams.
• Deep working knowledge of current mammalian cell culture bioprocessing, technical transfer frameworks, validation principles, and life science regulatory expectations.
• Bachelor's Degree in a Life Science, Engineering, Business Management, or a related scientific/technical discipline is required.
• PMP (Project Management Professional) certification from the Project Management Institute (PMI) is highly preferred.

Benefits

• Relocation assistance available for eligible candidates and their families, if needed.
• Compensation programs that recognize high performance.
• Comprehensive health, dental, and vision packages.
• Generous PTO packages.

Schedule

Monday – Friday, 8:00 AM – 5:00 PM

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion, and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.