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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.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.