MSAT Upstream Associate Director

南通，中国   |   全职   |   Job ID: 11621 

Position Summary:

1. Leading upstream technology transfer and scale-up related work

领导上游技术转移和放大等相关工作

2. Support manufacturing related activities, leading upstream process-related deviation investigations and change controls

支持生产相关活动， 负责上游工艺相关偏差调查和变更

Your main responsibilities are:

1. Familiar with upstream related facilities, process flow, equipment operation, material management, tech transfer and PPQ (Process Performance Qualification). 
熟悉上游厂房设施、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。 
2. Support daily manufacturing management, including deviation investigations, Corrective and Preventive Actions (CAPA), change control, and approval of technical plans/reports. 
支持日常生产管理，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。

3. Collaborate closely with all relevant departments to ensure projects progress as planned. 
与所有相关部门紧密合作，确保项目按计划推进。 

4. During PPQ stage, serve as the process owner and drive continuous process optimization and validation work. 
PPQ阶段担任工艺负责人，推动持续工艺优化与验证工作。 

5. Conduct MSAT upstream talent development and training work.
推进MSAT上游人才培养工作。 

6. Support cross-border tech transfer to different CDMOs or production sites. 
支持向不同CDMO或生产基地的跨国技术转移。    

What you have to offer:

Chemical engineering, bioengineering, biology, pharmacy and other life sciences or engineering related majors.

化学工程， 生物工程， 生物学， 药学等生命科学或工程相关专业

Have over 8 years of antibody and recombinant protein upstream process development, MSAT or manufacturing work experience with a Ph.D degree or more than 12 years with a master’s degree

具有博士毕业8年以上或硕士毕业12年以上抗体和重组蛋白上游工艺开发， MSAT或生产相关工作经验

Excellent communication and coordination capability to work with internal and external teams independently

具备较强的沟通协调能力， 能够独立与内外部团队协作

Good written and verbal English proficiency

具有良好的英文水平

Adapt to diverse workflows, management styles and operational systems. 适应不同工作方式