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
BioNTech 重视每一位团队成员的福祉，为多元化的员工提供全面的福利保障。我们提供具有市场竞争力的薪酬方案，具体将根据职位、工作地点及候选人资历与经验综合确定。注：各项福利的实际适用范围、享有条件及具体内容可能因所在地而异，最终以公司内部政策及当地法律法规为准。
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