岗位职责 1. 熟悉厂房设施、工艺流程、技术转移及PPQ（工艺性能确认）所需知识要点； Familiar with knowledge related to facilities, process flow, tech transfer and PPQ (Process Performance Qualification). 2. 主导日常生产管理，包括偏差调查、纠正预防措施（CAPA）、变更控制及技术方案/报告的撰写/审批； Lead daily manufacturing management, including deviation investigations, Corrective and Preventive Actions (CAPA), change control, and draft/approval of technical plans/reports 3.PPQ阶段担任工艺负责人，推动持续工艺优化与验证工作； During PPQ stage, serve as the process owner and drive continuous process optimization and validation work. 4.支持向不同CDMO或生产基地的跨国技术转移； Support cross-border tech transfer to different CDMOs or production sites. 5.与所有相关部门紧密合作，确保项目按计划推进； Collaborate closely with all relevant departments to ensure projects progress as planned. 6.做好MSAT下游人才培养工作。 Conduct MSAT downstream talent development and training work.

任职要求 1.熟悉GMP生产，具有技术转移和工艺验证相关经验； Familiar with GMP production, with experience in tech transfer and process validation. 2.拥有生物制药MSAT/PD相关经验； Drug product experience of MSAT/PD in biopharmaceuticals. 3.能够熟练阅读和撰写中英文技术文件； Ability to read and write technical documents in both Chinese and English. 4.具备基础的英语沟通能力 Basic English communication skills.