Winston-Salem, North Carolina, United States

Position Title: 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.

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 ProKidneys 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.