Legend Biotech
Manufacturing Lead Operator, Aseptic Process
$84K–$110K
Raritan, New Jersey, United States · Full-time · Posted Sep 28, 2026
- Experience
- Minimum 2 years of operations experience in a biotech/biopharma cGMP environment; manufacturing, maintenance, quality, testing, or engineering experience required.
- Education
- Bachelor’s degree in life science/engineering or related field, or equivalent experience.
- Visa sponsorship
- Applicants must be authorized to work in the United States; the employer participates in E-Verify.
About the job
Leads and performs aseptic CAR-T manufacturing operations in a cGMP cleanroom, supporting clinical and commercial production, process improvement, and product quality.
What you'll do
- Oversee production-floor activities and perform cell culture, purification, aseptic processing, and cryopreservation in ISO 5 and ISO 7 environments.
- Troubleshoot patient-specific product and process issues; support process development, continuous improvement, and corrective and preventive actions.
- Record production data according to procedures and batch records, and collaborate with Manufacturing, Engineering, Quality, and other stakeholders.
What they ask for
- Bachelor’s degree in life science/engineering or related field, or equivalent experience.
- At least 2 years of operations experience in a biotech/biopharma cGMP environment; experience in manufacturing, maintenance, quality, testing, or engineering.
- Knowledge of cGMP regulations and FDA guidance related to manufacturing cell-based products.
- Ability to handle human-derived materials in a BSL-2 cleanroom and accommodate shift work, including evenings and weekends, and unplanned overtime.
Nice to have
- Prior experience in an aseptic manufacturing environment.
Pay
$83,711 — $109,870 USD (base pay)
Tools
CAR-T, cGMP, ISO 5, ISO 7, BSL2+, FDA
AI focus
Working knowledge of AI technologies and approved AI tools; use them responsibly to improve productivity and decision-making, apply human oversight to AI-generated outputs, and follow organizational AI policies.
Model-written summary · the original posting is authoritative