Job Description

The Manufacturing Specialist, Cell Processing at ProKidney is responsible for supporting cell processing operations, ensuring compliance with cGMP guidelines in the development and production of regenerative medicine therapies. This role involves setting up and operating production equipment, including control rate freezers, orbital shakers, and other equipment, while contributing to efficient processing, freezing, and storage of cell therapy products.

Essential Duties & Responsibilities:

Coordinate with team members and perform tasks with minimal supervision.

• Participate in cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards.
  • Set up and operate production equipment such as control rate freezers, orbital shakers, and other systems to support cell processing activities.
  • Assist in processing, freezing, and storage of biologic and cell therapy products, ensuring adherence to cGMP standards.
  • Accurately complete GMP documentation, including batch records, logbooks, and forms, ensuring compliance with Good Documentation Practices (GDP).
  • Maintain inventory and monitor conditions related to biologic and cell therapy products, including temperature control, expiration dates, and equipment calibration.
  • Ensure the accuracy and integrity of cell processing workflows, identifying deviations from established procedures and taking corrective actions as necessary.
  • Collaborate with cross-functional teams to support process improvements, troubleshooting, and equipment maintenance.
• Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.

Secondary Responsibilities and Functions:

• Assist in data collection, analysis, and reporting for process improvement initiatives.
  • Support material qualification, process development, and validation efforts as required.
  • Maintain compliance with all relevant safety policies, rules, and regulations.
  • Perform other duties as assigned.

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 0-2 years of experience in cell processing, biotechnology manufacturing, or a related field. Experience with biologic or cell therapy production is highly desirable.
  • Skills/Abilities: Strong understanding of cGMP requirements, with proficiency in operating cell processing equipment. Ability to work independently or collaboratively, demonstrate attention to detail, and follow complex protocols. Strong organizational, record-keeping, and time management skills.
  • Other: Good eye/hand coordination, effective written and oral communication skills, a team-oriented approach, and a strong work ethic are essential for success.