Operational Readiness Manager – Mammalian Manufacturing

Lonza • Portsmouth, NH

14d • Onsite

About The Position

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.

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.

Nice To Haves

• PMP (Project Management Professional) certification from the Project Management Institute (PMI) is highly preferred.

Responsibilities

• Define, build, and champion the comprehensive start-up and operational readiness execution strategy from initial demolition and construction phases through to final commercial validation.
• 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.
• 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.
• Partner closely with site leadership to architect the multi-year organizational design, resource models, and talent pipelines to support the expanded production footprint.
• Manage, forecast, and reconcile the $25M USD operational readiness budget; lead resource planning matrices and align project milestones with corporate financial governance.
• 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.

Benefits

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Manager