Manufacturing Support Specialist 1 Contractor

ProKidney Corp.; Winston-Salem (NC); On-site; USD 52,000 - 78,000; Full time

Job summary

ProKidney Corp. is hiring a Manufacturing Specialist, Cell Processing Contractor in Winston-Salem, NC. The role supports cell processing operations, ensuring cGMP compliance while setting up and operating production equipment such as control rate freezers and orbital shakers.

The position is contractor-based with no company benefits, requiring coordination with the team to process, freeze, and store biologic products according to GDP and regulatory standards.

Qualifications

• AS/BS in Biotechnology, Biology, Chemistry, or related field; relevant experience may substitute.
• 0–2 years in cell processing/biotech manufacturing preferred.
• Strong understanding of cGMP and GDP documentation and traceability.

Responsibilities

• Set up and operate production equipment to support cell processing activities.
• Assist in processing, freezing, and storage of biologic and cell therapy products per cGMP.
• Complete GMP documents, batch records, logs, and forms per GDP.
• Monitor temperature, expiration dates, and equipment calibration.
• Identify deviations and implement corrective actions; support cross-functional improvements.
• Adhere to safety policies and collaborate with team on process enhancements.

Skills

cGMP knowledge

Equipment operation

Attention to detail

Documentation

Education

AS/BS in Biotechnology, Biology, Chemistry or related field

High School Diploma with significant relevant experience

Tools

Control rate freezers

Orbital shakers

Job description

Position Summary

The Manufacturing Specialist, Cell Processing Contractor 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.

This is located in Winston Salem, NC. The shift is Monday - Friday 10am-630pm with overtime required at times depending on the needs of the business. This is a contractor position and will not be eligible for ProKidney benefits.

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.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.