- Global Patent Prosecution and Office Action responses- Freedom to operation analysis- IP due diligence Analysis

- Serve as an analytical lead in cross-functional groups and project teams, including collaboration project team between major pharmaceutical companies. Manage projects from preclinical to launch by interacting with multiple function areas.- Author CMC sections for global regulatory submissions, and address regulatory responses. Develop, justify and implement drug substance and drug product specifications. Facilitate multi-project emerging market filings.- Serve as an analytical representative in due diligent assessment team for product acquisitions. Evaluate the CMC status of the potential product; perform risk assessment, and provide remedies for the further development of the potential acquisitions.- Provide analytical support for clinical supply demands, and for API and drug product process development. Collaborate with formulator, process engineers in design process characterization and robustness studies.- Facilitate and provide technical supports to domestic and global analytical technology transfers, including transferring from emerging markets to stability site and release site in mature markets.- Design and execute experiments in developing new methods or improving the fit for purpose methods to meet the robustness requirement for late stage methods.- Evaluate, review and approve method development reports, validation/verification, implementation and execution of analytical test methods for drug products, intermediates, and raw materials.- Manage and direct a group of analysts for project related activities.