Lead Operator — Aseptic CAR-T Manufacturing

HireLifeScience

Raritan (NJ)

On-site

USD 90,000 - 120,000

Full time

5 days ago
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Benefits offered by this job

Restaurant on site

Job summary

Legend Biotech in Raritan, NJ is seeking a Manufacturing Lead Operator, Aseptic Process to join the Manufacturing & Operations team. You will work in a sterile, cGMP environment to produce CAR‑T products, applying engineering principles and rigorous process discipline on a shift basis.

The role requires a degree in engineering or a related field, hands-on experience with aseptic processing and ISO 5/ISO 7 cleanrooms, and strong data analysis to ensure product quality and compliance.

Qualifications

  • Degree in engineering or related field required.
  • Experience with CAR‑T manufacturing processes preferred.
  • Working knowledge of GMP quality systems and regulatory requirements.

Responsibilities

  • Establish time management and prioritization aligned with an engineering background.
  • Support development of CAR‑T manufacturing processes with risk analyses.
  • Drive continuous improvements and CAPA in cell therapy operations.
  • Oversee production floor for BCMA CAR‑T Cell Therapy in ISO 5/ISO 7 environments.
  • Apply lab science knowledge, cellular techniques and data analysis daily.
  • Perform cell culture, purification, aseptic processing and cryopreservation per SOPs.

Skills

CAR-T manufacturing
Aseptic processing
GMP compliance
Data analysis
ISO 5/ISO 7

Education

Engineering or related field

Job description

Legend Biotech in Raritan, NJ is seeking a Manufacturing Lead Operator, Aseptic Process to join the Manufacturing & Operations team. You will work in a sterile, cGMP environment to produce CAR‑T products, applying engineering principles and rigorous process discipline on a shift basis.

The role requires a degree in engineering or a related field, hands-on experience with aseptic processing and ISO 5/ISO 7 cleanrooms, and strong data analysis to ensure product quality and compliance.

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