Job Description

岗位职责：

• 熟悉厂房设施、工艺流程、设备操作、物料管理、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, equipment operation, material management, tech transfer and PPQ (Process Performance Qualification).
• 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/报告审批；
• Lead daily manufacturing management, including deviation investigations, Corrective and Preventive Actions (CAPA), change control, and approval of technical plans/reports
• 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.
• 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.
• 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.
• 做好MSAT制剂人才培养工作。
• Conduct MSAT drug product talent development and training work.

任职要求：

• 本科及以上学历，生物工程、发酵工程、细胞生物学、分子生物学等相关专业
• Related degrees in Bioengineering, fermentation engineering, cell biology, molecular biology
• 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.
• 拥有生物制药MSAT（生产科学与技术）制剂相关经验；
• Drug product experience of MSAT (Manufacturing Science and Technology) in biopharmaceuticals.
• 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.
• 具备基础英语会话能力
• Basic English communication skills.