CAR-T Manufacturing Engineer: Process & Quality Lead

Legend Biotech US

Raritan (NJ)

On-site

USD 85,000 - 120,000

Full time

4 days ago

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Benefits offered by this job

Performance-based bonus

Equity

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Parental leave

Job summary

Legend Biotech seeks an Associate Manufacturing Engineer, Tech Support, to support development and routine operation of a new CAR‑T manufacturing process. You will be a subject matter expert addressing manufacturing issues and work within the Manufacturing & Supply team in Raritan, NJ.

You will partner with Quality, Compliance and engineering to drive robust problem resolution, support CAPAs and SOPs, and help optimize process health, throughput and waste reduction in a fast-paced biotech

Qualifications

Bachelor’s degree in engineering or related field; advanced degree preferred.
2–3 years of operations in a cGMP biotech/biopharma setting; cell/gene therapy experience preferred.
Provide technical support to Manufacturing team during operations.
Able to work shifts to support operations.
Experience writing SOPs and conducting risk assessments.
Ability to drive process improvements and participate in audits.
Collaborate with Manufacturing, Engineering and Quality teams.

Responsibilities

Partner with Quality, Compliance and experts to resolve process issues while ensuring batch quality.
Support compliant investigations and CAPAs as subject matter expert.
Liaise with equipment suppliers for ongoing support.
Identify opportunities to improve process health and reduce waste.
Conduct regular manufacturing observations and collect data.
Serve as primary contact across manufacturing and support teams.