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 advanced 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 as part of the Quality team based in Raritan, NJ.

Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Key Responsibilities

Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Support manufacturing activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.

Review of all documentation, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs) Support processes that include aseptic process simulations, Commercial clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. Support batch review material release in SAP for In-house reagents.

Support Floor Spot-check, audit trail review. 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 / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time.

Responsibilities

will include but not limited to tasks mentioned above. Support regulatory inspections and audits as needed.

Requirements

, as well as according to state and federal regulatory

Other duties will be assigned, as the need arises. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.

Color Perception both eyes 5 slides out of 8.

Bachelor’s degree required in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.