Operational Readiness Manager - Mammalian Manufacturing

Operational Readiness Manager - Mammalian Manufacturing

Location: 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.

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. Innovation thrives when people from all backgrounds bring their unique perspectives to the table.

At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.

If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.