Lead QC analytical testing for clinical and commercial DS/DP manufacturing (in-process, release, stability).
Align laboratory capacity and scheduling with manufacturing timelines and supply chain.
Oversee analytical testing for drug substance and product; drive on-time batch disposition.
Maintain biosafety and biosecurity practices, including chain-of-custody and material accountability.
Prepare for inspections with the Responsible Official and biosafety teams; oversee select agents training.
Lead method validation/verification/transfer and lifecycle management; review COAs and CAPAs.

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