Chang Shu

Experienced CMC analytical development and QC professional in the pharmaceutical and biotech industries, supporting programs from pre-IND through commercialization. Skilled in phase-appropriate analytical method development, validation, transfer, and lifecycle management; specification setting; reference standard qualification; and stability study design, data interpretation, and shelf-life justification. Expertise in managing CDMOs for release, stability, and in-process testing, method bridging, comparability studies, and product characterization. Knowledge of ICH, USP, and EP guidelines; cGMP/cGLP compliance; OOS/OOT investigations and CAPA. Experience preparing CMC analytical sections for IND, NDA, and BLA submissions and responding to Agency Information Requests (IRs).