Manufacturing Cell Processing Team Lead

ProKidney Corp.; Winston-Salem (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

ProKidney seeks a Lead Manufacturing Operations for cell processing to ensure cGMP compliance and oversee aseptic processes on-site in Winston-Salem, NC. You will manage daily production activities, troubleshoot issues, and drive improvements.

You will mentor staff, review batch records, support the cleanroom environment and SOP development, and handle GMP documentation and ERP transactions.

Qualifications

• AS/BS in Biotechnology, Biology, Chemistry, or a related field.
• 4–6 years in biotech manufacturing or cell processing, with 3–4 years in a cGMP setting.
• Strong knowledge of biological processing, cGMP compliance, and sterile manufacturing.

Responsibilities

• Manage daily production activities, troubleshoot issues, lead deviations, CAPAs, and process improvements.
• Serve as SME on manufacturing procedures.
• Review batch records.
• Support cleanroom environment and SOP development.
• Mentor staff, and handle routine GMP documentation and ERP system transactions.

Skills

Biotech manufacturing

Cell processing

cGMP compliance

MS Office

Troubleshooting

Communication

Organizational skills

Education

AS/BS in Biotechnology or related field

Tools

ERP system

Job description

Role: Lead manufacturing operations for cell processing at ProKidney, ensuring compliance with cGMP standards and overseeing aseptic processes.

Responsibilities

• manage daily production activities, troubleshoot issues, lead deviations, CAPAs, and process improvements
• serve as SME on manufacturing procedures
• review batch records
• support cleanroom environment and SOP development
• mentor staff, and handle routine GMP documentation and ERP system transactions

Requirements

• AS/BS in Biotechnology, Biology, Chemistry, or related field
• 4-6 years in biotech manufacturing or cell processing with 3-4 years in a cGMP setting
• strong knowledge of biological processing techniques, cGMP compliance, and sterile manufacturing
• proficiency in MS Office
• excellent troubleshooting, organizational, and communication skills

HighValue: cell therapy, biologics, cGMP manufacturing, aseptic processing, on-site in Winston-Salem, NC, with flexible schedule and potential overtime.