Manufacturing Cell Processing Specialist 3

The Manufacturing Cell Processing Specialist 3 at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines.

Requirements

• Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards.
• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members.
• Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and preventive maintenance.
• Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards.
• Lead routine cycle counts and ensure accurate inventory tracking and control.
• Execute transactions within the ERP system, including material requisitions and production tracking.
• Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).
• Lead investigations into deviations and Corrective and Preventative Actions (CAPA) efforts, compiling data and information as required.
• Provide mentorship and training to junior team members in cell processing techniques, procedures, and cGMP compliance.
• Drive continuous improvement, incident investigations, and deviation resolutions.
• Perform and support investigations into deviations, incidents, and process improvements.
• Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment.
• Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.
• Perform material qualification tests to qualify lots of incoming manufacturing material.
• Support process development and validation activities as needed.
• Assist in data collection, analysis, and reporting for process optimization and regulatory submissions.
• Perform other duties assigned to support and improve manufacturing operations.

Benefits

• health insurance
• retirement plan
• paid time off