Sr. Manager Engineering
Legend Biotech
August 10, 2026
On-site
Raritan, NJ
IT
Role Overview
The Senior Manager, Engineering, is responsible for leading a multidisciplinary engineering organization supporting commercial CARVYKTI cell therapy manufacturing operations. Provides strategic and technical leadership for lifecycle management of manufacturing equipment and systems, process optimization, manufacturing troubleshooting, cost of goods (COGs) reduction programs, and management of a Facilities Investigation Team for non-conformance investigations.
Key Responsibilities
- Lead, develop, and mentor engineering professionals supporting cell therapy manufacturing operations and equipment support.
- Establish goals, performance objectives, and development plans aligned to site/business priorities.
- Own lifecycle management for manufacturing equipment, utilities, and process systems.
- Ensure equipment reliability, availability, and compliance; oversee qualification, change management, obsolescence planning, capacity planning, and upgrades.
- Partner with Validation, Maintenance, and Quality to maintain validated/inspection-ready equipment.
- Provide engineering leadership for troubleshooting and lead root cause analyses for deviations and process interruptions.
- Drive process optimization using data/metrics; support automation/digital manufacturing initiatives.
- Develop and execute strategies to reduce costs while maintaining quality, compliance, and patient supply.
- Lead cross-functional continuous improvement (cycle time, yield, labor, waste) and capital/operational efficiency projects.
- Lead Facilities Investigation Team; ensure timely, scientifically sound investigations and effective CAPA.
- Ensure all activities comply with cGMP and applicable regulatory requirements; support audits/inspections; maintain inspection readiness.
Requirements
- Bachelor’s degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, Electrical, or related) required.
- Master’s degree or MBA preferred.
- 10+ years in regulated engineering/manufacturing/process support (pharma/biotech/biologics/cell therapy).
- 5+ years people leadership.
- Experience supporting cGMP manufacturing operations required.
- Root cause analysis, complex investigations, and CAPA experience preferred.
- High preference: commercial biologics/advanced therapies/cell therapy manufacturing.
- Equipment lifecycle management/asset reliability; aseptic manufacturing; deviation/non-conformance investigations; QA/CAPA; regulatory knowledge (FDA, EMA, ICH, cGMP).
The Senior Manager, Engineering, is responsible for leading a multidisciplinary engineering organization supporting commercial CARVYKTI cell therapy manufacturing operations. Provides strategic and technical leadership for lifecycle management of manufacturing equipment and systems, process optimization, manufacturing troubleshooting, cost of goods (COGs) reduction programs, and management of a Facilities Investigation Team for non-conformance investigations.
Key Responsibilities
- Lead, develop, and mentor engineering professionals supporting cell therapy manufacturing operations and equipment support.
- Establish goals, performance objectives, and development plans aligned to site/business priorities.
- Own lifecycle management for manufacturing equipment, utilities, and process systems.
- Ensure equipment reliability, availability, and compliance; oversee qualification, change management, obsolescence planning, capacity planning, and upgrades.
- Partner with Validation, Maintenance, and Quality to maintain validated/inspection-ready equipment.
- Provide engineering leadership for troubleshooting and lead root cause analyses for deviations and process interruptions.
- Drive process optimization using data/metrics; support automation/digital manufacturing initiatives.
- Develop and execute strategies to reduce costs while maintaining quality, compliance, and patient supply.
- Lead cross-functional continuous improvement (cycle time, yield, labor, waste) and capital/operational efficiency projects.
- Lead Facilities Investigation Team; ensure timely, scientifically sound investigations and effective CAPA.
- Ensure all activities comply with cGMP and applicable regulatory requirements; support audits/inspections; maintain inspection readiness.
Requirements
- Bachelor’s degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, Electrical, or related) required.
- Master’s degree or MBA preferred.
- 10+ years in regulated engineering/manufacturing/process support (pharma/biotech/biologics/cell therapy).
- 5+ years people leadership.
- Experience supporting cGMP manufacturing operations required.
- Root cause analysis, complex investigations, and CAPA experience preferred.
- High preference: commercial biologics/advanced therapies/cell therapy manufacturing.
- Equipment lifecycle management/asset reliability; aseptic manufacturing; deviation/non-conformance investigations; QA/CAPA; regulatory knowledge (FDA, EMA, ICH, cGMP).