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Sr. Manager, External QC
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- The company develops cellular therapies with the potential to cure disease by inducing immune tolerance and restoring homeostasis.
- More information can be found at DescriptionThe Senior Manager, External Quality Control (QC) will report to the Senior Director of Quality and contribute to the successful achievement of Tr1X's product development objectives through monitoring compliance with all applicable regulations (local, State, FDA, and other applicable agencies).
- The External QC Senior Manager will provide hands-on leadership for the Quality Control function.
- The selected candidate will be responsible for all aspects of Quality Control oversight, including external (CDMO) release and in-process assays, raw data review, method qualification and validation, stability, trending and GMP investigations for any analytical deviation, OOT or OOS. The ideal candidate must have experience with cell therapy analytical techniques, including flow cytometry, PCR (qPCR, QF-PCR, ddPCR, and/or dPCR), ELISA, safety-based assays (sterility, mycoplasma, endotoxin, etc.)
- Key Duties and Responsibilities Oversee - all aspects of external (CMDO) quality control operations including specifications, stability, data review, investigations, batch disposition, and analytical method qualification and validation.
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