Client is looking to vet 2 or 3 QC Labs to do testing for their CAR-T (anti-CD33) therapy for Acute Myeloid Leukemia.
Goal is to conduct Vendor Qualification Audit of these potential laboratories regarding their capabilities and ability to provide the testing methods and results needed by the client and capabilities for analytical development.
Required Skills/ Experience
Experts in QC Lab audits (CLIA labs) is required, and experience in hematology/oncology is strongly recommended.
The labs will be looking at various biomarkers, cytokines, the CAR-T material itself, plus CD33 exposure, SNP genotyping, PK, and flow cytometry (MRD assessment).
Remote: Analytical Lab Qualifying Auditor (232391)