Operational Readiness Manager

Lonza is seeking an Operational Readiness Manager for mammalian manufacturing. This role leads end-to-end operational readiness for new products and capacity expansions in a GMP biologics facility. You will coordinate cross-functional teams to ensure processes, equipment, documentation, training, and materials are ready for tech transfer and commercial manufacturing. Responsibilities include risk identification, readiness planning, KPI tracking, and continuous improvement. You will support deviations, CAPAs, and inspection readiness while driving standardization, safety, and quality in a highly regulated, patient-focused environment.

Responsibilities

• Lead operational readiness for mammalian manufacturing projects from tech transfer through launch
• Develop and implement start-up plans, procedures, and KPIs for new products and equipment
• Coordinate cross-functional teams across manufacturing, QA, QC, MSAT, and engineering to ensure timely readiness
• Identify and mitigate operational risks, capacity constraints, and process bottlenecks
• Standardize workflows, documentation, and training to ensure GMP compliance and inspection readiness
• Drive continuous improvement initiatives to enhance throughput, reliability, and right-first-time performance
• Support deviation investigations, root cause analysis, and CAPA implementation related to start-up activities
• Collaborate with global stakeholders to share best practices and align with Lonza standards
• Support resource planning, material readiness, and materials flow for new product introductions
• Report readiness status and project milestones to site and project leadership

Required Skills

• GMP manufacturing
• Biologics/mammalian cell culture operations
• Tech transfer and new product introduction
• Operational readiness / start-up planning
• Process validation and qualification support
• Quality systems, deviations, CAPACross-functional project management
• Capacity and resource planning
• Regulatory compliance for biopharma
• Data analysis and KPI management