Operations Supervisor
Legend Biotech
August 21, 2026
On-site
Raritan, NJ
Operations
Operations Supervisor (CAR-T Operations) — Technical Operations, Raritan, NJ
Shift: Wed–Sat, 2nd Shift
Role Overview
- Direct daily production of a personalized cell therapy in a sterile cGMP environment to support clinical and commercial requirements.
Key Responsibilities
- Lead/supervise CAR-T process operations units (component prep, MFG support, Mock cell, CAR-T) per SOPs and batch records; ensure safe, compliant cGMP manufacturing.
- Run daily shift start/wrap-up meetings; assign daily production tasks and ensure completion and compliance.
- Support production floor guidance and tasks as needed in line with safety, quality systems, and cGMP.
- Support manufacturing investigations; create/revise procedures (work instructions, master batch records/forms) and manage change controls.
- Collaborate with Operations Manager on development and input on personnel performance.
- Partner with Manufacturing, Engineering, and Quality; serve as first point of contact for operator issues.
- Support process development, departmental projects, and continuous improvement.
Requirements
- BS in Science/Engineering (or equivalent experience).
- 6+ years operations experience in a cGMP biotech/biopharma environment; prior manufacturing/quality/engineering required.
- Strong leadership, communication/organization, and Microsoft Office proficiency (Word/Excel/PowerPoint/Outlook).
- Knowledge of cGMP/FDA guidance and cleanroom behaviors.
- Ability to work day shift (1st/2nd), accommodate evenings/weekends/overtime, and lift 25 lbs.
- Vision 20/40 Snellen (with/without correction) and color perception 5/8.
Benefits (explicit)
- Medical/dental/vision, 401(k) match (vests day one), 8 weeks paid parental leave after 3 months, and paid time off (vacation/personal/sick/floating holidays + 11 holidays).
Shift: Wed–Sat, 2nd Shift
Role Overview
- Direct daily production of a personalized cell therapy in a sterile cGMP environment to support clinical and commercial requirements.
Key Responsibilities
- Lead/supervise CAR-T process operations units (component prep, MFG support, Mock cell, CAR-T) per SOPs and batch records; ensure safe, compliant cGMP manufacturing.
- Run daily shift start/wrap-up meetings; assign daily production tasks and ensure completion and compliance.
- Support production floor guidance and tasks as needed in line with safety, quality systems, and cGMP.
- Support manufacturing investigations; create/revise procedures (work instructions, master batch records/forms) and manage change controls.
- Collaborate with Operations Manager on development and input on personnel performance.
- Partner with Manufacturing, Engineering, and Quality; serve as first point of contact for operator issues.
- Support process development, departmental projects, and continuous improvement.
Requirements
- BS in Science/Engineering (or equivalent experience).
- 6+ years operations experience in a cGMP biotech/biopharma environment; prior manufacturing/quality/engineering required.
- Strong leadership, communication/organization, and Microsoft Office proficiency (Word/Excel/PowerPoint/Outlook).
- Knowledge of cGMP/FDA guidance and cleanroom behaviors.
- Ability to work day shift (1st/2nd), accommodate evenings/weekends/overtime, and lift 25 lbs.
- Vision 20/40 Snellen (with/without correction) and color perception 5/8.
Benefits (explicit)
- Medical/dental/vision, 401(k) match (vests day one), 8 weeks paid parental leave after 3 months, and paid time off (vacation/personal/sick/floating holidays + 11 holidays).