Manufacturing Cell Processing Supervisor

The Manufacturing Supervisor is responsible for leading daily manufacturing operations within a cGMP-regulated biologics production environment. This role provides direct supervision of manufacturing personnel, ensures safe and compliant execution of production activities, and supports delivery of the manufacturing schedule while maintaining inspection readiness, documentation accuracy, and operational efficiency.

This is located onsite in Winston Salem, NC.

Essential Duties & Responsibilities:
• Lead daily manufacturing operations and supervise production personnel to ensure safe, compliant, and efficient execution of manufacturing activities in a cGMP aseptic manufacturing environment. Maintain a strong presence on the manufacturing floor during critical process steps and support troubleshooting as needed.
• Coach, develop, and manage manufacturing staff through training, performance management, one-on-one meetings, and career development planning. Support recruiting, hiring, onboarding, and maintaining training readiness for all team members.
• Oversee execution of the production schedule and coordinate staffing, suite readiness, and raw material availability in partnership with Supply Chain and cross-functional teams to ensure on-time delivery of manufacturing plans.
• Ensure accurate and timely completion and review of manufacturing documentation including batch records, logbooks, deviations, change controls, and ERP transactions to support compliant production and batch release.
• Maintain compliance with cGMP, regulatory, and safety requirements while ensuring continuous inspection readiness and supporting internal and external regulatory audits.
• Support operational improvements and technology transfer activities, including implementation of new processes from Product Development to Manufacturing, participation in continuous improvement initiatives, and development of technical documentation such as SOPs and deviations.

Qualifications
Education/Training

• Associate or Bachelor's degree in Biotechnology, Biology, Chemistry, or related scientific discipline preferred.


• High School Diploma or equivalent may be considered with significant relevant experience.

Experience

• Minimum 4 years of experience in GMP-regulated manufacturing required.


• 7+ years of manufacturing experience may substitute for a degree.


• Previous supervisory or team leadership experience required.

Knowledge

• Strong knowledge of cGMP regulations and quality systems applicable to biologics manufacturing.


• Experience with aseptic processing and cleanroom manufacturing environments.


• Understanding of FDA and EMA regulatory requirements for biologics manufacturing.


• Familiarity with environmental monitoring and facility control procedures

Skills

• Strong leadership, coaching, and team development skills.


• Excellent organizational, documentation, and time management abilities.


• Experience working with ERP systems and production documentation systems.


• Strong technical writing skills for deviations, SOPs, and manufacturing documentation.


• Effective cross-functional communication and problem-solving abilities.

Certifications/Licenses
• None required.

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.