Aseptic CAR-T Manufacturing Lead Operator

Legendcareers; Raritan (NJ); On-site; USD 84,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company-mq

Paid parental leave

Job summary

Legend Biotech USA Inc. seeks a Manufacturing Lead Operator, Aseptic Process in Raritan, NJ to oversee CAR-T cell therapy production on the technical operations team. You will support development, ensure cGMP compliance, and maintain safety in sterile ISO environments.

The role requires a life sciences/engineering degree and at least 2 years’ cGMP manufacturing experience, with ability to work rotating shifts and collaborate across Manufacturing, Engineering and Quality teams.

Qualifications

• Bachelor’s degree in life science/engineering or related field.
• Minimum 2 years of operations experience in a cGMP biotech/biopharma environment.
• Ability to work independently and manage multiple tasks in a matrix setup.
• Knowledge of cGMP regulations and FDA guidance for cell-based products.

Responsibilities

• Oversee production floor activities for CAR-T cell therapy operations in ISO 5/ISO 7 labs.
• Support development and optimization of CAR-T manufacturing processes.
• Collaborate with Manufacturing, Engineering and Quality to drive improvements.
• Record production data clearly and maintain safety and quality standards.
• Work shift-based schedule including evenings and weekends as required.
• Handle biological materials and hazardous chemicals in controlled environments.

Skills

Engineering background

cGMP experience

Problem solving

Education

Bachelor’s degree in life science/engineering

Job description

Legend Biotech USA Inc. seeks a Manufacturing Lead Operator, Aseptic Process in Raritan, NJ to oversee CAR-T cell therapy production on the technical operations team. You will support development, ensure cGMP compliance, and maintain safety in sterile ISO environments.

The role requires a life sciences/engineering degree and at least 2 years’ cGMP manufacturing experience, with ability to work rotating shifts and collaborate across Manufacturing, Engineering and Quality teams.