Aseptic Cell Therapy Manufacturing Lead Operator

Legend Biotech, Inc.

United States

On-site

USD 84,000 - 110,000

Full time

6 days ago

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Benefits offered by this job

Health insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech is seeking a Manufacturing Lead Operator, Aseptic Process to join the Manufacturing & Operations team in Raritan, NJ. The role focuses on CAR-T production in ISO 5 and ISO 7 environments, requiring strong engineering and scientific backgrounds.

The candidate will support process development, drive continuous improvements, and ensure strict adherence to cGMP, quality systems, and safety policies while coordinating with maintenance, engineering and QA teams.

Qualifications

Bachelor’s degree in life sciences or engineering required.
Minimum 2 years of cGMP operations experience in biotech/biopharma.
Ability to lift 50 lbs and stand for long periods.
Strong collaboration across Manufacturing, Engineering and Quality.

Responsibilities

Oversee production floor in ISO 5/ISO 7 cleanrooms for CAR-T operations.
Support development and optimization of CAR-T manufacturing processes.
Maintain documentation and batch records under cGMPs.
Collaborate with QA, Engineering and Quality teams to ensure quality and schedule adherence.
Perform unit operations including cell culture, purification, aseptic processing and cryopreservation.