Aseptic CAR-T Manufacturing Lead Operator

Legend Biotech US; Raritan (NJ); On-site; USD 84,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Generous PTO

Job summary

Legend Biotech US in Raritan, NJ is seeking a Manufacturing Lead Operator for Aseptic Process to join the Manufacturing & Operations team. The role supports CAR‑T production in sterile cGMP environments, requiring a strong engineering or science background and ability to work on a shift schedule.

The candidate will perform cell culture, purification, aseptic processing, and data recording while ensuring quality, safety, and regulatory compliance across ISO 5 and ISO 7 environments.

Qualifications

• Bachelor’s degree in life science or engineering or equivalent experience.
• Minimum 2 years of operations experience in a cGMP biotech/biopharma environment.
• Prior experience in an aseptic manufacturing environment preferred.
• Ability to work in a matrixed, cross-functional environment and communicate clearly.
• Strong written and verbal communication with attention to detail.

Responsibilities

• Provide floor oversight of CAR‑T manufacturing in ISO 5/ISO 7 environments.
• Support manufacturing processes with engineering and quality teams.
• Perform unit operations including cell culture, purification, aseptic processing, and cryopreservation.
• Record production data accurately and maintain compliance with cGMP and safety policies.
• Collaborate with cross-functional teams to implement continuous improvements.
• Contribute to risk analyses and change management to ensure high-quality products.

Skills

cGMP experience

Aseptic processing

Biotech/biopharma

Team collaboration

Problem solving

Education

Bachelor’s degree in life science/engineering

Job description

Legend Biotech US in Raritan, NJ is seeking a Manufacturing Lead Operator for Aseptic Process to join the Manufacturing & Operations team. The role supports CAR‑T production in sterile cGMP environments, requiring a strong engineering or science background and ability to work on a shift schedule.

The candidate will perform cell culture, purification, aseptic processing, and data recording while ensuring quality, safety, and regulatory compliance across ISO 5 and ISO 7 environments.