Are you a current Elekta employee? Please click here to apply through our internal career site Find Jobs - Elekta. Want to join a team with a mission to improve and save lives? We continually look
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。...
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