岗位职责： 61参与实验室的日常管理，包括但不限于：人员培训、项目追踪、实验室5S建设、EHS风险控制；同时负责日常记录的完整性检查与关键设备确认状态的定期确认，确保实验室运行符合质量和合规要求 61Participate in the routine management of the MSAT DS laboratory, including but not limited to personnel training, project tracking, 5S implementation, and EHS risk control. In addition, responsible for checking the completeness of routine records and regularly verifying the qualification status of critical equipment to ensure laboratory operations meet quality and compliance requirements. 61作为SD负责项目会（内、外部）汇报及Q&A；负责沟通方案、报告撰写；主导项目实验设计、实验数据整理，产生明确结论；主导完成实验室规模验证批生产 61Act as Study Director (SD) to lead internal and external project meetings, including presentations and Q&A sessions. Responsible for drafting study protocols and reports, designing experiments, consolidating and analyzing data, and drawing clear conclusions. Lead confirmation runs at lab scale. 61指导SD推进项目，识别风险点，攻克技术难点，确保SD工作的顺利进行 61Support Study Directors in project execution by identifying risks, resolving technical challenges, and ensuring smooth project progression and timely completion. 61实验室新技术平台建设，包括但不限于：连续生产工艺（CM），Raman技术应用等 61Contribute to the development of new technology platforms in the lab, including but not limited to continuous manufacturing (CM) processes and the application of Raman spectroscopy in PAT. 61负责trouble shooting 的实验设计及执行 61Design and execute troubleshooting studies as needed. 任职要求： 61大学硕士及以上学历，生物、化学、医药工程等相关专业，或具有同等工作经验的人员 61Master’s degree or above in biology, chemistry, pharmaceutical engineering, or related disciplines. Equivalent industry experience may also be considered.30% 61熟悉上游或下游工艺，具有一定的理论基础，能够熟练操作相关实验设备，具有实验设计和数据分析的能力 61Familiar with upstream or downstream bioprocesses, with a solid theoretical foundation. Proficient in operating relevant laboratory equipment, with experience in experimental design and data analysis.30% 61具有良好的逻辑思维能力以及良好的英语水平 61Strong logical thinking skills and good command of English (written and spoken).20% 61熟悉GMP、GLP等质量体系要求，能够在实验执行和数据记录中遵循相关法规和指南，确保实验可追溯、数据完整；具有在受监管环境中工作的经验者优先 61Familiar with quality system requirements such as GMP and GLP, with the ability to execute experiments and document data in compliance with relevant regulations and guidelines. Able to ensure traceability and data integrity throughout the study process. Experience in a regulated environment is preferred.*******************