Manufacturing Cell Processing Team Lead

Responsibilities

• Lead day-to-day manufacturing operations and ensure efficient completion of processes
• Initiate manufacturing deviations, CAPAs, and Critical Change Requests (CCRs)
• Serve as a Subject Matter Expert (SME) on manufacturing processes and provide team training
• Troubleshoot manufacturing issues and direct corrective actions
• Complete manufacturing batch record reviews in compliance with cGMP guidelines
• Participate in aseptic processing of in-house solutions and patient processes
• Assist in the development and revision of SOPs, batch records, and MS forms
• Support selection, hiring, training, and mentoring of new staff
• Perform routine ERP transactions including material requisitions and production tracking
• Maintain cleanroom environment and ensure compliance with safety protocols

Requirements

• AS/BS in Biotechnology, Biology, Chemistry, or a related science field
• 4-6 years of experience in cell processing or biotechnology manufacturing
• 3-4 years of expertise in a cGMP-regulated environment
• Thorough knowledge of biological processing techniques and cell culture
• Advanced knowledge of cGMP facilities and requirements
• Proficiency in Microsoft Office (Word, Excel)
• Strong organizational, critical thinking, and troubleshooting skills

About the Company

ProKidney is a biotechnology company focused on advanced manufacturing operations and cell therapy processes.