Sr. Manager Engineering

Legend Biotech is seeking a Sr. Manager Engineering as part of the Facilities and Engineering team based in Raritan, NJ.

Role Overview

The Senior Manager, Engineering, is responsible for leading a multidisciplinary engineering organization supporting commercial CARVYKTI® cell therapy manufacturing operations. This role provides strategic and technical leadership for the lifecycle management of manufacturing equipment and systems, process optimization initiatives, manufacturing troubleshooting, cost of goods (COGs) reduction programs, and management of a Facilities Investigation Team responsible for non-conformance investigations.

The successful candidate will lead a team of engineers and investigators that ensure manufacturing equipment reliability, operational excellence, regulatory compliance, and continuous improvement across the cell therapy manufacturing process. This position serves as a key partner to Manufacturing, Quality, Validation, Maintenance, MSAT, Supply Chain, and Regulatory functions to ensure uninterrupted production and continuous advancement of manufacturing capabilities.

Key Responsibilities

• Lead, develop, and mentor a team of engineering professionals responsible for cell therapy manufacturing operations and equipment support.
• Establish team goals, performance objectives, and development plans aligned with site and business priorities.
• Foster a culture of safety, accountability, technical excellence, innovation, and continuous improvement.
• Build organizational capabilities to support commercial growth, technology transfer activities, and future manufacturing expansion.
• Own the lifecycle management strategy for cell therapy manufacturing equipment, utilities, and process systems.
• Ensure equipment reliability, availability, and compliance throughout the asset lifecycle.
• Oversee equipment qualification, change management, obsolescence planning, capacity planning, and technology upgrades.
• Partner with Validation, Maintenance, and Quality organizations to maintain equipment in a validated state and inspection readiness.
• Drive long-term asset management strategies to support manufacturing continuity and operational resilience.
• Provide engineering leadership for troubleshooting complex manufacturing equipment and process performance issues.
• Lead root cause analysis efforts for equipment-related deviations, process interruptions, and manufacturing challenges.
• Identify and implement process optimization opportunities to improve equipment utilization, throughput, yield, reliability, and operational efficiency.
• Utilize data analytics and performance metrics to drive evidence-based decision making and identify improvement opportunities.
• Support implementation of new technologies, automation solutions, and digital manufacturing initiatives.
• Develop and execute engineering strategies to reduce manufacturing costs while maintaining product quality, compliance, and patient supply.
• Lead cross-functional continuous improvement initiatives focused on process efficiency, cycle time reduction, yield improvement, labor optimization, and waste reduction.
• Identify and execute capital and operational efficiency projects with measurable business impact.
• Establish and monitor operational metrics to quantify project benefits and support business case development.
• Lead the Facilities Investigation Team responsible for supporting manufacturing non-conformance, deviation, and investigation activities.
• Ensure timely, thorough, and scientifically sound investigations utilizing structured root cause analysis methodologies.
• Drive effectiveness of corrective and preventive action (CAPA) programs by ensuring sustainable solutions are implemented and monitored.
• Partner with Manufacturing, Quality, MSAT, and Regulatory teams to assess product and process impact of manufacturing events.
• Ensure investigation quality, compliance, and closure timelines meet site and regulatory requirements.
• Identify recurring event trends and proactively implement preventive actions to improve manufacturing performance.
• Ensure all engineering activities comply with cGMP, FDA, EMA, and applicable global regulatory requirements.
• Support internal audits, regulatory inspections, and quality system initiatives.
• Maintain inspection readiness within areas of responsibility.
• Participate in risk assessments, change control reviews, and quality management processes.
• Serve as a key technical leader within the manufacturing organization.
• Collaborate with Manufacturing, MSAT, Quality, Validation, Facilities, Supply Chain, and Global Engineering organizations.
• Support new product introductions, process changes, technology transfers, and facility expansion initiatives.
• Provide technical recommendations and presentations to site leadership and senior management.

Requirements

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, Electrical, or related discipline) required.
• Master's degree or MBA preferred.
• 10+ years of engineering, manufacturing, technical operations, or process support experience within the pharmaceutical, biotechnology, biologics, cell therapy, or related regulated industry.
• 5+ years of people leadership experience managing technical or engineering teams.
• Experience supporting cGMP manufacturing operations required.
• Experience leading complex investigations, root cause analysis, and CAPA implementation preferred.
• Experience supporting commercial biologics, advanced therapies, or cell therapy manufacturing highly preferred.
• Demonstrated success leading continuous improvement and cost reduction initiatives.
• Equipment lifecycle management and asset reliability programs.
• Cell therapy, biologics, or aseptic manufacturing processes.
• Deviation management, non-conformance investigations, and quality systems.
• Root cause analysis methodologies (e.g., Fishbone, 5 Why, Fault Tree Analysis).
• Process optimization and operational excellence methodologies.
• Change control, validation, and risk management principles.
• Regulatory requirements including FDA, EMA, ICH, and cGMP standards.

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