岗位职责： 负责领导、组织分析研发团队的工作，协调项目研究进度，保证项目计划的顺利实施； 负责带领分析团队为支持研发项目的工艺开发、产品放行检测所需的分析方法学开发、稳定性研究，方法确认及方法转移等； 负责带领分析团队进行对上游，下游研发等团队的日常分析检测工作； 负责分析部门内部以及部门间的日常协调工作，审核相关实验结果并及时解决实验过程中出现的问题； 负责与CRO/CDMO进行相关沟通，合理推动项目进行； 监督指导分析人员的实验操作及各项实验规范，保证研究工作的规范、真实和完整性； 负责分析部门实验室日常管理、仪器设备管理； 负责对部门内员工进行员工培训和人才培养，并设立考核制度； 按照注册药品报批要求，撰写或审核相关申报资料及原始记录，配合完成申报和现场核查工作。 任职要求： 硕士10年及以上、博士8年以上经验，药物分析、生物技术或生物化学、分析化学等相关专业； 具有大型生物制药公司相关工作经验，具有五年以上质量分析团队管理经验； 具有表征平台管理经验，有扎实的生物质谱、质量研究基础，熟悉蛋白药物表征策略和方法开发，包括但不限于：一级结构、翻译后修饰、二硫键、高级结构、生物学活性、异质性等； 熟悉表征相关技术（包括但不限于HPLC、LC-MS、CE、iCIEF、DSC、CD、BLI），可指导并解决相关技术问题，管理平台稳健运行； 熟悉并精通分析方法的开发、优化、转移、确认和验证过程中特点，把控整个项目分析方法的时间周期； 熟悉并精通抗体/重组蛋白药物含量检测、结合活性、生物学活性、HCP、ProteinA、残留DNA等所有常规生化质量分析方法； 熟悉NMPA/FDA/ICH等药品研发的法规和指导原则要求；有多个项目的IND和BLA经验； 熟悉相关法律法规，如cGMP，ICH、中国药典、美国药典等 ； 责任心强，具有良好的沟通协调能力及团队精神，包括书面和英文口头表达能力； 了解GMP基本知识者优先。...
About Human Pharmaceutical Business With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs
Overview The Sr. CLS Associate Ⅰ is an exciting position that requires not only excellent technical acumen but also initiative and enthusiasm to be successful. It works closely with the entire CLS team to provide product
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