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Own and drive the site’s sterility assurance strategy. This role ensures compliance with global regulatory requirements and serves as the SME for contamination control, aseptic processing, and sterilization validation. Review sterilization validations
Manage day-to-day QC lab operations, including raw materials, in-process, and final product testing; Lead analytical method qualification, validation, and transfer; Oversee analytical methods including flow cytometry, qPCR/ddPCR, and cell-based assays;