Manufacturing Cell Processing Team Lead

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 cleanroom environment, ensuring cleanliness and compliance with alert-level limits. • Comply with all relevant safety policies, rules, and regulations, ensuring team members adhere to safety protocols.

• Perform procedures according to written guidelines, recognizing deviations from accepted practices, and taking corrective action as necessary. • 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.

Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.

Responsibilities

: Participate in internal and external audits as required. • Compile and analyze data, prepare reports, and make recommendations for process improvements. • Perform routine logbook reviews and data tracking.

• Provide support for process development activities as needed. • Perform other duties as assigned to support manufacturing operations effectively.

Minimum Qualifications

: Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline preferred. High School Diploma or equivalent may be considered with significant relevant experience. • Experience: Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with 3-4 years of proven expertise in a cGMP-regulated environment.

• Skills/Abilities: • Thorough knowledge of various biological processing techniques, including cell culture, relevant to ProKidney’s cell therapy process.

Requirements

• Proficiency in Microsoft applications, especially Word, Excel, etc. • Strong organizational skills and the ability to manage and prioritize multiple projects or assignments, meeting deadlines effectively. • Critical thinking and troubleshooting skills to handle unexpected events.