Position Summary:

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. This role involves operating and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and driving continuous improvement. The Manufacturing Specialist 3 is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance.

This position is located in Winston Salem, NC.

Responsibilities:

• Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and ProKidneys 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.
• Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance.
• 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.

Qualifications:

• Education: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may be a substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.
• Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 2-3 years of proven expertise in a cGMP-regulated environment.
• Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs.
• Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills.
• Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role.