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Responsible for providing Commissioning, Qualification, and Validation support to a cGMP Cell Therapy Manufacturing plant. Manage day-to-day activities, execute protocols, manage vendors, and ensure compliance with regulations. Collaborate with cross-functional teams to establish a strong CQV program for product release.
Legend Biotech is seeking an Investigation Supervisor to work with the investigation team to identify root causes of investigations and assess product quality impact. Responsibilities include supporting investigators, assigning investigations, implementing corrective measures, and collaborating with stakeholders to improve processes and compliance standards.
The QC Supervisor at Legend Biotech is responsible for supervising quality control laboratories in support of cell therapy manufacturing, managing staff, reviewing laboratory test data, developing QC procedures, and supporting laboratory investigations. Key responsibilities include training associates, managing QC testing scheduling, overseeing test completion in compliance with procedures and regulations, supporting cross-functional departments, troubleshooting laboratory issues, and more.
The QA Document Control Lead at Legend Biotech is responsible for managing document control processes in a cell therapy manufacturing facility to ensure compliance with GMP regulations. This role involves coordinating document issuance, storage, and reconciliation, as well as supporting system users and driving continuous improvement.
Change Control Specialist responsible for managing change control support for the production of autologous CAR-T products in a cGMP cleanroom environment. Key responsibilities include supporting process changes, establishing change control processes, leading cross-functional team meetings, and ensuring compliance with safety and quality standards. Requirements include a Bachelor's degree in engineering, biology, or chemistry, 6 years of operations experience in a cGMP environment, project management skills, and strong analytical abilities.
The Planner / Buyer at Legend Biotech in Raritan, New Jersey, will be responsible for executing plans supporting Supply Chain and Procurement activities, analyzing demand, monitoring supplier execution, and maintaining system planning parameters. This role requires in-depth knowledge of ERP systems, strong analytical skills, and experience in Pharma or Biologics manufacturing.
The Sr. QC Analyst is responsible for performing QC testing of CAR-T cell therapy products under GMP conditions. This includes testing raw materials and final products, complying with regulations, reviewing laboratory data, and maintaining documentation using electronic systems. The position requires collaboration with multiple teams and shifts during evenings and weekends.
The Training Coordinator is responsible for scheduling and coordinating technical training programs for CAR-T Manufacturing team members. This role involves developing training plans for new hires, tracking progress, conducting skill checks, and collaborating with operations and management to ensure effective training systems are in place.
The Global Process Steward at Legend Biotech will lead technical scope for the approved Carvykti commercial process and maintain Legend's competitive advantage in the Multiple Myeloma space. Responsibilities include representing MSAT at joint technical and CMC committees, driving process improvements, and ensuring global alignment on technical parameters.
The Quality Compliance Lead is responsible for ensuring regulatory compliance for the production of autologous CAR-T products. Responsibilities include managing internal audit processes, coordinating health authority audits, resolving audit observations, developing training sessions, conducting data analysis, and maintaining a state of inspection readiness in a cGMP cleanroom environment.
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