Lead Operator, Aseptic CAR-T Manufacturing

BioSpace

Raritan (NJ)

On-site

USD 84,000 - 110,000

Full time

26 hours ago
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Benefits offered by this job

Medical, dental, vision insurance
401(k) with company match
Paid parental leave

Job summary

Legend Biotech, based in Bridgewater, NJ, seeks a Manufacturing Lead Operator, Aseptic Process for the Manufacturing & Operations team in Raritan. This role supports CAR-T cell therapy production in ISO 5 and ISO 7 cleanrooms, performing unit operations and ensuring cGMP compliance on a fast-paced production floor.

You will work with Engineering and Quality groups, apply robust aseptic techniques, manage batch records, and participate in continuous improvement, troubleshooting, and change

Qualifications

  • Bachelor's degree in life science/engineering or related field.
  • Minimum of 2 years of operations experience in a cGMP biotech environment.
  • Experience with aseptic manufacturing and batch records is preferred.

Responsibilities

  • Perform core manufacturing unit operations (cell culture, purification, aseptic processing, cryopreservation).
  • Maintain batch records and production data with accuracy and clarity.
  • Support continuous improvement and change control activities.

Skills

Engineering degree
CAR-T knowledge
cGMP experience

Education

Bachelor's degree in life science/engineering

Tools

ISO 5/ISO 7 cleanroom

Job description

Legend Biotech, based in Bridgewater, NJ, seeks a Manufacturing Lead Operator, Aseptic Process for the Manufacturing & Operations team in Raritan. This role supports CAR-T cell therapy production in ISO 5 and ISO 7 cleanrooms, performing unit operations and ensuring cGMP compliance on a fast-paced production floor.

You will work with Engineering and Quality groups, apply robust aseptic techniques, manage batch records, and participate in continuous improvement, troubleshooting, and change

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