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工作职责:
1. 负责DMPK苏州/上海实验室的化合物和生物样品的全流程管理，包括但不限于：
86 化合物及样品的接收、分装、分发、储存及销毁
86 确保全流程化合物及样品的安全性、完整性和可追溯性
2. 对接部门上下游功能团队，设计并优化化合物及样品管理流程，提升操作效率与合规性;
3. 制定并持续优化标准操作规程（SOP），识别关键人为操作节点（如手工分装、数据录入等），建立防差错机制，强化质量管理体系；
4. 及时应对操作过程中的异常情况，提供合理的解决方案，并推动问题闭环管理；
5. 客户审计及来访接待：负责客户审计的全程支持，确保审计质量；对外展示专业能力，提升客户信任度；根据审计反馈优化内部流程；
6. 高效完成主管交付的其他任务。
1. Responsible for the end-to-end management of compounds and biological samples across the Suzhou/Shanghai DMPK sites, including but not limited to:
86 Receiving, aliquoting, distributing, storing, and disposing of compounds and samples;
86 Ensuring the safety, integrity, and traceability of compounds and samples throughout the entire process.
2. Collaborate with upstream and downstream functional teams to design and optimize compound and sample management processes, enhancing operational efficiency and compliance.
3. Develop and continuously optimize standard operating procedures (SOPs), identify critical manual operation points (e.g., manual aliquoting, data entry), establish error-proofing mechanisms, and strengthen the quality management system.
4. Promptly address abnormal situations during operations, provide reasonable solutions, and drive closed-loop problem management.
5. Provide full support for client audits to ensure audit quality; demonstrate professional capabilities to enhance client trust; optimize internal processes based on audit feedback.
6. Efficiently complete other tasks assigned by supervisors.
任职资格:
1. 本科及以上学历，硕士优先；化学、医药、生物等相关专业背景；
2. 3年以上医药行业实验室工作经验；有团队管理经验者优先；
3. 具备良好的中英文读写能力，可熟练使用英语沟通的优先；
4. 具备快速学习能力及优秀的沟通协调能力，对新技术、新方法保持开放态度，能持续提升专业能力；
5. 具备敏锐的流程优化意识，善于发现问题并提出改进方案，熟悉GLP/GMP规范者优先。
1. Bachelor’s degree or above, with a Master’s preferred; background in chemistry, pharmaceuticals, biology, or related fields.
2. Over 3 years of laboratory experience in the pharmaceutical industry; team management experience is a plus.
3. Proficient in reading and writing in both Chinese and English; ability to communicate effectively in English is preferred.
4. Quick learner with excellent communication and coordination skills; open to new technologies and methods, and committed to continuous professional development.
5. Keen awareness of process optimization, skilled at identifying issues and proposing improvements; familiarity with GLP/GMP standards is preferred.