Legend Biotech
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The Sourcing & Procurement Specialist will support transactional purchase requisitions and orders within Technical Operations. Responsibilities include negotiating contracts, supplier onboarding, monitoring contract compliance, and conducting market analysis. The individual will assist in maintaining supplier records and support efficient procurement processes across US business units.
The CQV Specialist will manage commissioning, qualification, and validation activities within a cGMP cell therapy manufacturing facility. Responsibilities include executing protocols, managing projects, conducting investigations, and ensuring compliance with regulations. The role also involves collaboration across various functions to support safe and compliant manufacturing operations.
The Operations Manager will oversee the production of personalized cell therapies, ensuring compliance with cGMP requirements. Responsibilities include managing staff performance, developing operational procedures, monitoring production metrics, and leading continuous improvement efforts within the Technical Operations team.
The Batch Logistics Planner manages cross-functional teams to ensure compliant and timely batch release operations. Responsibilities include overseeing batch release, leading meetings to address challenges, collaborating on quality issues, and providing updates to key stakeholders while promoting continuous improvement.
The QA Batch Disposition Associate Manager manages the team responsible for batch record review and drug product release. They ensure compliance with regulatory standards, establish procedures for cGMP practices, lead continuous improvement projects, and collaborate with cross-functional teams to enhance the batch review process. They also draft and revise Standard Operating Procedures for the batch review and release processes.
The Quality Project Management Specialist is responsible for providing quality oversight for process improvement projects in a GMP environment. Key duties include leading quality tasks, participating in batch investigations, providing quality metrics, and collaborating with various departments to resolve issues while driving continuous improvement efforts.
The HR Generalist will support HR Business Partners in talent acquisition, management, and employee relations at a manufacturing site. Responsibilities include performance management, handling HR inquiries, maintaining employee records, and generating HR reports to aid data analysis.
The CAR-T Batch Logistics Planner will manage the efficient release of patient-specific drug product batches by coordinating with cross-functional teams. Key responsibilities include overseeing batch release processes, resolving issues, and fostering communication among stakeholders to enhance operational efficiency.
The Operations Associate will be responsible for manufacturing procedures and execution of tasks in a cGMP environment, including cell culturing, purification, and documentation in line with compliance standards. They will collaborate with team members, drive continuous improvement, and maintain a safe and clean workspace.
The QC Supervisor will oversee quality control laboratories supporting cell therapy manufacturing, manage staff performance and training, ensure compliance with cGMP regulations, and collaborate with cross-functional teams on testing and regulatory inspections.
The Operations Support Specialist supports process operations in a cGMP environment by performing floor service tasks, maintaining compliance with safety and quality standards, and collaborating with cross-functional teams to improve manufacturing processes.
The CQV Specialist I will oversee commissioning, qualification, and validation activities in a cGMP compliant cell therapy manufacturing plant, ensuring safe operations and adherence to regulations. This role includes managing CQV projects, executing protocols, and collaborating with cross-functional teams for effective production and testing.
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 QC Analyst at Legend Biotech is responsible for performing QC testing related to the manufacturing of cell therapy products in a controlled GMP environment. They work with Process Development, Quality, and Operations teams to transfer processes and conduct analytical testing of samples. The role also involves creating and approving QC documents and ensuring compliance with safety and quality requirements.
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.
The QC Investigations Specialist will lead investigations related to laboratory deviations and corrective actions in a GMP environment. Responsibilities include interviewing personnel, reviewing CAR-T manufacturing nonconformance investigations, collaborating on improvement initiatives, monitoring metrics, and ensuring compliance with quality and safety standards.
QA Investigations Lead responsible for quality oversight in producing personalized cell therapy, ensuring compliance, managing investigations, and tracking metrics in a sterile GMP environment. Collaborates with teams, reviews procedures, and supports regulatory inspections. Requires Bachelor's Degree and 4 years of relevant experience in aseptic manufacturing facility.
The QA Document Control Specialist is responsible for supporting the document management process within a cell therapy manufacturing facility to ensure compliance and meet clinical and commercial requirements. This role involves issuing batch-related documentation, reconciling documents, creating logbooks, storing and archiving documents, and driving continuous improvement.
The Senior Scientist will lead research in cell-based therapies, focusing on CAR-T cell engineering, lentivirus vector design, and optimizing cellular immunoassays. Responsibilities include designing experiments, collaborating with cross-functional teams, and advancing preclinical findings into clinical applications while meeting project timelines.
The Project Engineer (Contractor) will support the execution of engineering and facility projects, including project initiation, budgeting, scheduling, monitoring, and closure. Responsibilities include coordinating with various departments, maintaining compliance, managing project updates, and ensuring project completion according to safety and regulatory standards.