Job responsibility 工作职责
Technical responsibility技术系职责
1. To establish and optimize the methods of binding activity and cell activity in quality research.
承担质量研究中结合活性、细胞活性方法的建立与优化；
2. Responsible for the method verification of binding activity and cell activity in the quality research, and write the method verification report after the method verification.
负责质量研究中结合活性、细胞活性的方法验证，并在方法验证完撰写方法验证报告；
3. Responsible for ｃｈａｒacterization of ADCC and CDC in product quality consistency evaluation
负责产品质量一致性评价中ADCC、CDC等表征工作；
4. Responsible for IND registration application product inspection and write pharmaceutical data.
负责IND注册申报产品的检验及药学资料的撰写。
Management responsibility管理系职责
1. Assist process department to complete the project schedule on time;
协助工艺部门按时完成项目进度；

Qualifications 任职资格
Major in bioscience or related field.
生物科学相关专业;
Advanced post-graduate qualification (BS or MS) related to bioprocessing or biopharmaceutical production.
相关专业的本科或硕士学历。
Essential Experience必要经验
BS degree with a minimum of 8~10 years and MS degree with a minimum of 5~8 years of large Biomolecule analysis experience.
本科8~10年，硕士5~8年相关生物大分子分析经验
Experience in managing staff of at least 2 technical specialists.
有过至少5人的管理经验
Expert knowledge in protein biochemistry related to protein purification and ｃｈａｒacterization of MAbs and recombinant proteins.
具有单克隆抗体和重组蛋白分析和表征的蛋白质生物化学方面的专业知识。
Familiar with the literature retrieval and relevant information inspection, and familiar with the IND filing.
熟悉文献检索及相关信息检查，熟悉IND备案；
Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook);
熟练使用Microsoft Office办公软件 (Word、Excel、Powerpoint、Project、Outlook)?Project management of CMC filing for US, EU, and China IND/BLA.
具有美国、欧盟和中国项目申报方面的管理经验。
Biophysical methods for protein ｃｈａｒacterization.
熟悉蛋白表征的分析方法。
Project management training.
具有项目管理能力
Formal root-cause analysis training.
严谨的问题分析能力
Advanced computer system skills including Unicorn, Empower, and DoE and statistical analysis.
高级的计算机系统能力，包括Unicorn, Empower, and DoE和统计学分析。

专业要求：不限