Found Description
Position Summary:
We are seeking an experienced Quality Control (QC) Manager – ATMP to lead QC laboratory operations supporting GMP manufacturing of advanced therapy medicinal products. This role is critical in ensuring timely and compliant release of patient-specific therapies and maintaining the highest standards of quality and regulatory compliance.
Key Responsibilities:
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
Ensure timely execution and review of testing to support batch release
Manage external contract workers, ensuring outsourced QC testing operations are performed as required and within the planned timeframe
Author, review and approve technical reports and QC d...
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