秀 石

 Rich experience in drug research and development 5 years of drug R & D experience, in-depth understanding of API and Drug product manufacturing process. Familiar with analytical method development, validation / transfer, specification establishment, stability study and reference standard management; Contributed to multiple submissions, including BGB-3111 US IND, US/CN NDA, BGB-3245 annual report, BGB-11417 US, CN IND; other CNDA project submission.  Extensive Quality Management Responsibilities Lead the Analysis, Formulation, Synthesis team to establish the specifications of API and drug products; Draft and maintain the SOP of quality; As a project QA, lead the change control, deviation and product release related to the project.  Ability to quickly establish quality system Built the commercial quality system in BeiGene Beijing; successfully completed the transfer of quality management for Celgene products.  Good at workflow standardization Be good at workflow standardization, gap analysis, summarization and sort out the processes in work, lead the stability management process with CMO, and standardize the change control process of QC team; Standardization of chromatogram preparation in IND filing (with RA, QC, ARD team); Lead project handover process among various quality teams within BeiGene.  Maintain a strong internal drive for continuous learning Led the gap analysis of the guiding principles of NMPA, including 创新药（化学药）临床技术变更指导原则 and 已上市化学药品药学变更研究技术指导原则（征求意见稿）  Motivated Team Player Cross functions communication skills, effective communication with colleagues from CMC, ARD, PM, RA, SC and PM teams