This role focuses on quality control method development, execution and analysis, method validation and method transfers, reagent evaluation and characterization for compliance testing, including sourcing and development of comparability testing protocols for alternative sources and secondary suppliers. Will design, coordinate and perform reagent qualification and maintenance programs, monitor frequency of testing and resource availability, and track trend data and report results. The individual will support analytical method validation and stability programs by writing validation protocols incorporating solid study design with appropriate acceptance criteria, conducting qualification and/or validation experiments, analyze data, and prepare scientific information reports.