Manufacturing Cell Processing Team Lead

<p>&nbsp;</p> <p>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.</p> <p>Monday through Friday 10am-630pm onsite in Winston Salem, NC&nbsp;</p> <p>Lead the day-to-day operations of the manufacturing team, ensuring all manufacturing processes are completed efficiently and effectively.<br>• Initiate manufacturing deviations, Corrective and Preventive Actions (CAPAs), and Critical Change Requests (CCRs) as required, leading investigations and compiling relevant data and information.<br>• Serve as a Subject Matter Expert (SME) on all manufacturing processes, providing guidance and training to team members.<br>• Quickly and efficiently troubleshoot manufacturing issues, directing team members on corrective actions.<br>• Complete manufacturing batch record reviews for all manufacturing processes, ensuring compliance with cGMP guidelines.<br>• Participate in the aseptic processing of in-house solutions and patient processes in accordance with cGMPs.<br>• Read, understand, and follow Standard Operating Procedures (SOPs) and assist in the development and revision of SOPs, batch records, and MS forms as needed.<br>• Assist in the selection, hiring, training, and mentoring of new staff, ensuring personnel are adequately trained and scheduled to support manufacturing operations.<br>• Perform routine transactions in the ERP system, including material requisitions, production tracking, work order updates, and managing production BOMs.<br>• Complete GMP documentation, including batch records, logbooks, and forms, according to Good Documentation Practices (GDP).<br>• Support the maintenance of the cleanroom environment, ensuring cleanliness and compliance with alert-level limits.<br>• Comply with all relevant safety policies, rules, and regulations, ensuring team members adhere to safety protocols.<br>• Perform procedures according to written guidelines, recognizing deviations from accepted practices, and taking corrective action as necessary.<br>• Lead and direct the work of others, with a wide degree of creativity and latitude expected. May provide consultation on projects and serve as a high-level contributor/specialist.</p> <ul> <li>Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.</li> </ul> <p>&nbsp;<