Manufacturing Cell Processing Team Lead

Requirements

• 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.
• Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Benefits

Additional Information

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.

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