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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.
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