Manufacturing Cell Processing Specialist 1 Contractor
About The Position
The Manufacturing Specialist 1, Cell Processing at ProKidney supports cell processing operations and helps ensure compliance with cGMP guidelines in the development and production of regenerative medicine therapies. The role sets up and operates production equipment, including control rate freezers and orbital shakers, and supports the processing, freezing, and storage of cell therapy products. This is an onsite contractor position in Winston-Salem, North Carolina. It is not eligible for ProKidney benefits. The position works with minimal supervision and collaborates with cross-functional teams on process improvement, troubleshooting, equipment maintenance, material qualification, process development, and validation. It also involves aseptic manufacturing in a cleanroom environment and compliance with sterile techniques, regulatory standards, and safety policies.
Requirements
- Associate or bachelor's degree in biotechnology, biology, chemistry, or a related field; relevant experience may substitute for formal education.
- A high school diploma or equivalent may be considered with significant relevant experience.
- Strong understanding of cGMP requirements.
- 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.
- Good eye-hand coordination and effective written and oral communication skills.
- Team-oriented approach and strong work ethic.
- Must be eligible to work in the United States without work visa or residency sponsorship.
Nice To Haves
- Science-related discipline is preferred.
- Preferred minimum of 0–2 years of experience in cell processing, biotechnology manufacturing, or a related field.
- Experience with biologic or cell therapy production is highly desirable.
Responsibilities
- Coordinate with team members and perform tasks with minimal supervision.
- Set up and operate production equipment, including control rate freezers, orbital shakers, and other systems, to support cell processing activities.
- Assist in processing, freezing, and storing biologic and cell therapy products in accordance with cGMP standards.
- Accurately complete GMP documentation, including batch records, logbooks, and forms, following Good Documentation Practices.
- Maintain inventory and monitor conditions related to biologic and cell therapy products, including temperature control, expiration dates, and equipment calibration.
- Ensure cell processing workflows are accurate and complete; identify deviations from established procedures and take corrective action as necessary.
- Collaborate with cross-functional teams on process improvements, troubleshooting, and equipment maintenance.
- Conduct aseptic manufacturing processes in a cleanroom environment, following sterile techniques and regulatory standards.
- Assist with data collection, analysis, and reporting for process improvement initiatives.
- Support material qualification, process development, and validation efforts as required.
- Comply with relevant safety policies, rules, and regulations.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
