[1] Provide strong analytical support to R&D innovation projects including analytical method development, validation, and transfer. [2] Oversee CROs to ensure timely delivery of high-quality analytical report with technical guidance[3] Act as subject matter expert to support on-site audit from health authority during production launch and transfer[4] Compile and review analytical related document in CMC dossier for regulatory submission[5] Present and attend expert… Show more [1] Provide strong analytical support to R&D innovation projects including analytical method development, validation, and transfer. [2] Oversee CROs to ensure timely delivery of high-quality analytical report with technical guidance[3] Act as subject matter expert to support on-site audit from health authority during production launch and transfer[4] Compile and review analytical related document in CMC dossier for regulatory submission[5] Present and attend expert panel meeting to reply technical inquiry from Center Drug Evaluation Show less

[1] Lead team to provide analytical support for chemical process development and transfer including new analytical method development, validation and transfer to global production site and Chinese supplier[2] Manages laboratory operation activities including recruitment, coaching, supervising, and developing scientific staff.[3] Ensure timely support of suppliers’ quality monitoring by participating in out of specification investigation and evaluation of new supplier[4]… Show more [1] Lead team to provide analytical support for chemical process development and transfer including new analytical method development, validation and transfer to global production site and Chinese supplier[2] Manages laboratory operation activities including recruitment, coaching, supervising, and developing scientific staff.[3] Ensure timely support of suppliers’ quality monitoring by participating in out of specification investigation and evaluation of new supplier[4] Compile and review technical packages document to ensure adequate analytical measurements have been implemented[5] Responsible for implementation and administration and of lab IT system including global chromatographic data system, LIMS and scientific data repository Show less