TeamLead,CellProcessing

The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP guidelines. This role involves overseeing day-to-day operations of the manufacturing team, troubleshooting issues, leading deviation and CAPA investigations, and mentoring staff. The Team Lead is a Subject Matter Expert (SME) in manufacturing processes, driving continuous improvement, ensuring high-quality GMP documentation, and promoting operational efficiency. Lead the day-to-day operations of the manufacturing team, ensuring all manufacturing processes are completed efficiently and effectively. • Initiate manufacturing deviations, Corrective and Preventive Actions (CAPAs), and Critical Change Requests (CCRs) as required, leading investigations and compiling relevant data and information. • Serve as a Subject Matter Expert (SME) on all manufacturing processes, providing guidance and training to team members. • Quickly and efficiently troubleshoot manufacturing issues, directing team members on corrective actions. • Complete manufacturing batch record reviews for all manufacturing processes, ensuring compliance with cGMP guidelines. • Participate in the aseptic processing of in-house solutions and patient processes in accordance with cGMPs. • Read, understand, and follow Standard Operating Procedures (SOPs) and assist in the development and revision of SOPs, batch records, and MS forms as needed. • Assist in the selection, hiring, training, and mentoring of new staff, ensuring personnel are adequately trained and scheduled to support manufacturing operations. • Perform routine transactions in the ERP system, including material requisitions, production tracking, work order updates, and managing production BOMs. • Complete GMP documentation, including batch records, logbooks, and forms, according to Good Documentation Practices (GDP). • Support the maintenance of the cleanroo