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.

Secondary 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. • Advanced knowledge of cGMP facilities and 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.
  • Ability to exercise judgment within defined procedures and practices to determine appropriate actions.
  • Other: Good eye/hand coordination, effective written and oral communication, a team-oriented approach, and a strong work ethic.