QA Shop Floor Specialist

Overview

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 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 Operations team based in Raritan, New Jersey
.

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.

• 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.
• 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.
• Aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas.
• Provide QA shop floor support for extended periods of time.
• Support regulatory inspections and audits as needed.
• Adhere to safety policies, quality systems, and cGMP requirements, as well as applicable state and federal regulations.
• Operate on-site as required and participate in departmental meetings.
• Demonstrate good interpersonal and communication skills and a team-oriented attitude.
• Learn new skills, procedures, and processes as assigned by management and continue professional development.
• Assist in troubleshooting issues related to manufacturing and contribute to projects.
• Demonstrate knowledge of manufacturing applications (SAP), electronic batch records (E ), and quality systems.
• Read and interpret documents such as safety rules, operating instructions, and logbooks; provide SOP feedback as needed.
• Ability to manage complexity across drug product, manufacturing process, and end-to-end supply chain.
• Apply problem-solving skills to resolve issues and ensure compliance and minimize risk.
• Collaborate with stakeholders, customers and peers; communicate effectively with management on complex issues.
• Maintain high attention to detail and strong organization in a fast-paced environment.

• Bachelor’s degree in Life Sciences or Engineering.
• 0-2+ years biotech/pharmaceutical experience or equivalent industry experience.
• Relevant experience in an aseptic…