Manufacturing Cell Processing Specialist 1 Contractor

ProKidney; White Settlement (TX); On-site; USD 34,000 - 48,000; Full time

Job summary

ProKidney Corp. seeks a Manufacturing Specialist 1, Cell Processing to support cell processing operations in a cGMP environment. The contractor will set up and operate production equipment, assist in freezing and storage, and ensure accurate GMP documentation in a controlled facility.

Role requires independent work and collaboration with cross-functional teams, adherence to GDP, and meticulous attention to process details in a regulated setting. Onsite in Winston Salem, NC.

Qualifications

• AS/BS in Biotechnology, Biology, Chemistry or related field; relevant experience may substitute.
• 0-2 years in cell processing, biotechnology manufacturing, or related field.
• Strong understanding of cGMP with ability to follow complex protocols.
• Able to work independently or in a team with good record-keeping and time management.

Responsibilities

• Set up and operate production equipment to support cell processing activities.
• Assist in processing, freezing, and storage of biologic products per GDP/cGMP.
• Complete GMP documentation, batch records, logbooks and forms accurately.
• Monitor temperatures, expiry dates, and equipment calibration for products.
• Identify deviations from procedures and take corrective actions.
• Collaborate with cross-functional teams for process improvements and maintenance.
• Conduct aseptic manufacturing in a cleanroom following sterile techniques.

Skills

cGMP knowledge

equipment operation

attention to detail

documentation

time management

teamwork

communication

Education

AS/BS in Biotechnology, Biology, Chemistry

Tools

control rate freezers

orbital shakers

cell processing equipment

Job description

Position Summary

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

Essential Duties & Responsibilities

• 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.