Perform comprehensive review and approval of cGMP analytical data packages generated by internal and external laboratories for release, stability, in-process, and characterization testing including but not limited cell-based assays, quantitative PCR, ELISA, microbiological test methods, HPLC, and capillary electrophoresis. The role is responsible for reviewing drug substance and drug product release, stability, and characterization testing data generated from a variety of analytical methods including Molecular Biology, Bioassay, Microbiology, and Biochemical techniques.