Manufacturing Cell Processing Specialist 1 Contractor

ProKidney Corp.; Winston-Salem (NC); On-site; USD 32,000 - 45,000; Part time

Job summary

ProKidney Corp. in Winston-Salem, NC, is seeking a Manufacturing Specialist 1, Cell Processing to support cell processing operations on-site.

The role ensures compliance with cGMP guidelines while setting up and operating production equipment like control rate freezers and orbital shakers. The contractor will assist in processing, freezing, and storage of biologic and cell therapy products, maintain strict documentation, monitor conditions, and collaborate with cross-functional teams to drive

Qualifications

• AS/BS in Biotechnology, Biology, Chemistry, or related field; experience may substitute.
• 0-2 years of cell processing or biotech manufacturing experience.
• Strong cGMP knowledge and equipment operation.
• Excellent documentation and record-keeping skills.

Responsibilities

• Set up and operate production equipment to support cell processing.
• Process, freeze, and store biologic products per GDP.
• Complete GMP documentation including batch records and logbooks.
• Maintain inventory and monitor conditions.
• Identify deviations and implement corrective actions.
• Collaborate with cross-functional teams for process improvements.
• Perform aseptic manufacturing in a cleanroom environment.

Skills

cGMP knowledge

Equipment operation

Documentation

Attention to detail

Education

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

High School Diploma or equivalent

Job description

The Manufacturing Specialist 1, 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.

This is a temporary contractor position which is located onsite in Winston Salem, NC. It is not eligible for ProKidney benefits.

• Coordinate with team members and perform tasks with minimal supervision.
• 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.