QA Shop Floor Specialist II

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a QA Shop Floor Specialist III as part of the Quality Operations team, based in Raritan, New Jersey.

The QA Shop Floor Specialist is an exempt level position responsible for floor quality oversight of the production of autologous CAR‑T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment. The role ensures compliance with company policies, procedures, and applicable regulations.

Schedule:

Wed‑Sat 1st Shift.

• Provide quality oversight of all aspects of the cell therapy clinical manufacturing process.
• Support manufacturing activities for cGMP compliance through spot checks and internal audits.
• Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
• Review all documentation in accordance with Good Documentation Practices (GDP).
• Review, revise, or draft Standard Operating Procedures (SOPs).
• Support processes that include aseptic process simulations and commercial or clinical manufacturing to ensure sterility of the product/process is not compromised.
• Support batch review and material release in SAP for in‑house reagents.
• Strive to reduce non‑conformances in supported areas by proactively driving compliance.
• Support investigations team by providing quality and compliance input for continuous improvement and remediations.
• Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
• Utilize multiple electronic quality systems, batch records, and SAP.
• Work in a team‑based, cross‑functional environment to complete tasks required to meet business objectives.
• Must be able to aseptically gown to support Grade B clean rooms and practice aseptic behavior in controlled areas.
• Provide QA shop floor support for extended periods of time.
• Support regulatory inspections and audits as needed.
• Consistently perform tasks in adherence to safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
• Other duties will be assigned as the need arises.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.

• Bachelor’s degree in Life Sciences or Engineering.
• 0–2+ years of biotech/pharmaceutical experience or equivalent industry experience.
• Relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
• Experience with quality support in clinical manufacture is preferred.
• Flexible to work on weekends as needed.
• Mobile and able to transport between sites as required.
• Strong verbal and written communication skills.
• Ability to lift 20 lbs.
• Strong proficiency utilizing SAP, electronic batch records, and quality systems.
• Knowledge of cGMP regulations and FDA/EU guidance related to cell‑based products and Good Tissue Practices.
• Aseptic processing experience in ISO 5 clean rooms and biosafety cabinets.
• Great attention to detail and ability to follow procedures.
• Highly organized and capable of working in a team environment with a positive attitude under minimal supervision.