Manufacturing Cell Processing Specialist 3

Position Summary:

The Manufacturing Specialist III, Cell Processing at ProKidney plays a key 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 such as control rate freezers and orbital shakers, performing final product freezing and storage, and driving continuous improvement. The Manufacturing Specialist III is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance.

Essential Duties & Responsibilities:

• 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.
• 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 accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).
• Lead investigations into deviations and Corrective and Preventive Action (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 process improvement, incident investigations, and deviation resolutions.
• Ensure all activities comply with safety policies, rules, and regulations, promoting a safe working environment.
• Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.

Secondary Responsibilities:

• 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 any 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 is preferred. Relevant experience may substitute for formal education. 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 2-3 years of proven expertise in a cGMP-regulated environment.
• Skills/Abilities: 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.
• Other: 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.