Lead Operator, Aseptic CAR-T Manufacturing

BioNJ Inc.

Raritan (NJ)

On-site

USD 90,000 - 130,000

Full time

3 days ago

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Job summary

Legend Biotech in Raritan, NJ is seeking a Manufacturing Lead Operator, Aseptic Process to join the Manufacturing & Operations team, supporting CAR-T production in a sterile cGMP environment on an assigned shift.

With a degree in engineering or a life science field, you will perform unit operations (cell culture, purification, aseptic processing, cryopreservation), monitor production data, and drive continuous improvements with cross‑functional partners.

Qualifications

Bachelor's degree in life science/engineering or related field.
2+ years of operations experience in a cGMP biotech/biopharma environment.
Strong communication and cross-functional collaboration skills.
Ability to work shifts including evenings and weekends.
Knowledge of cGMP regulations and FDA guidance for cell-based products.

Responsibilities

Time management and prioritization in a fast-paced CAR-T manufacturing setting.
Support development and improvement of CAR-T manufacturing processes with risk analyses and change management.
Collaborate with engineering and quality teams to drive continuous improvements and CAPAs.
Oversee production floor activities for BCMA CAR-T operations in ISO 5/ISO 7 environments.
Perform unit operations (cell culture, purification, aseptic processing, cryopreservation) and document data.