MSAT下游副总监

南通，中国   |   全职   |   Job ID: 11691 

Position Summary:

• Leading downstream technology transfer and scale-up related work
  领导下游纯化技术转移和放大等相关工作

• Support downstream manufacturing related activities, leading downstream process-related deviation investigations and change controls
  支持下游生产相关活动， 负责下游纯化工艺相关偏差调查和变更 

Your main responsibilities are:

• Familiar with downstream related facilities, process flow, equipment operation, material management, tech transfer and PPQ (Process Performance Qualification)
  熟悉下游厂房设施、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
• 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
• 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
• 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
• Conduct MSAT downstream talent development and training work
  推进MSAT下游纯化人才培养工作
• 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 downstream 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下游纯化工艺开发， 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