Manufacturing Cell Processing Specialist 1

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.