Winston-Salem, North Carolina, United States

Position Title: Manufacturing Cell Processing Specialist 2

The Manufacturing Specialist II, Cell Processing 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 setting up, operating, and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and providing guidance to junior staff while leading improvements in cell processing operations.

Essential Duties & Responsibilities:

• Lead and participate in 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 other team members as needed.
  Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and maintaining preventive maintenance schedules.
  Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to specified procedures and quality standards.
  Revise, update, and ensure adherence to approved documents, including SOPs, batch records, and MS forms, maintaining GMP compliance.
  Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).
  Train and mentor junior team members in cell processing techniques, procedures, and cGMP compliance.
  Perform and support investigations into deviations, incidents, and process improvements.
  Lead efforts in process development, qualification, and validation activities as needed.
  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.

Secondary Responsibilities:

• Lead and assist in material qualification tests to ensure the suitability of manufacturing materials.
  Provide guidance and support for continuous process improvement initiatives.
  Assist in data collection, analysis, and reporting for process optimization and regulatory submissions.
  Perform other duties as assigned to support and improve manufacturing operations.

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 2-4 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 1-2 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.