Senior Engineering Manager, Cell Therapy Manufacturing

Legendcareers; Raritan (NJ); On-site; USD 146,000 - 192,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Eight weeks paid parental leave

Paid time off + holidays

Job summary

Legend Biotech in New Jersey leads the development of life‑changing cell therapies and operates a world‑class manufacturing network. We seek a Senior Manager of Engineering to direct a multidisciplinary team supporting commercial CAR‑T manufacturing, drive lifecycle management of equipment, and lead optimization and CAPA initiatives to ensure continuous improvement and regulatory readiness.

The role partners with Manufacturing, Quality, Validation, and MSAT to sustain high uptime, quality, and

Qualifications

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

Responsibilities

• Lead engineering professionals for cell therapy manufacturing operations and equipment support.
• Set team goals and development plans aligned with site priorities.
• Foster safety, accountability, and technical excellence.
• Build capabilities to support commercial growth and technology transfer.
• Own lifecycle management for manufacturing equipment, utilities, and process systems.
• Ensure equipment reliability and compliance across asset lifecycle.
• Oversee qualification, change management, obsolescence, and capacity planning.
• Collaborate with Validation, Maintenance, Quality to maintain validated state.
• Drive CAPA effectiveness with sustainable solutions.
• Lead investigations for deviations and process interruptions and implement corrective actions.
• Partner with cross-functional teams to assess impact of manufacturing events.
• Support new technologies, automation, and digital manufacturing initiatives.
• Develop strategies to reduce costs while maintaining quality and supply.
• Lead continuous improvement initiatives for process efficiency and throughput.
• Establish and monitor metrics to quantify project benefits.

Skills

People leadership

cGMP manufacturing

Process optimization

Root cause analysis

CAPA implementation

Asset lifecycle management

Regulatory compliance

Deviation management

Change control

Data analytics

Education

Bachelor's in Engineering

Master's or MBA preferred

Job description

Legend Biotech in New Jersey leads the development of life‑changing cell therapies and operates a world‑class manufacturing network. We seek a Senior Manager of Engineering to direct a multidisciplinary team supporting commercial CAR‑T manufacturing, drive lifecycle management of equipment, and lead optimization and CAPA initiatives to ensure continuous improvement and regulatory readiness.

The role partners with Manufacturing, Quality, Validation, and MSAT to sustain high uptime, quality, and