Job responsibility 工作职责
61 Technical responsibility技术系职责
61 Responsible for the establishment and optimization of antibody drug process related impurities (Protein A, HCP, DNA etc.), binding activity and cell-based activity methods.
负责抗体药物工艺相关杂质，结合活性、细胞活性方法的建立及优化；
61 Responsible for the method qualification and method transfer of process related impurities (Protein A, HCP, DNA etc.), binding activity and cell-based activity.
负责工艺残留方法（蛋白A，宿主蛋白，宿主DNA等）、结合活性、细胞活性的方法确认和方法转移；
61 Responsible for characterization related to biological activity of antibody drugs, including ADCC, CDC, affinity of Fab and FC receptor (BLI or SPR), etc.
负责抗药药物生物学活性相关的表征，包括ADCC、CDC，Fab及FC受体亲和力（BLI或SPR）的等工作；
61 Responsible for setting up and managing cell banks for testing.
负责检测细胞库的建立及管理。
Safety and environment 现场安全和环境合规
61 Take part in the site safety through promotion of safe workplace and personal action.
通过宣传安全的工作场所和个人行为，参与到工作现场的安全中；
61 Adhere to the Company’s safety and environmental protection procedures.
遵守公司的安全环保程序。
Quality Assurance 质量要求
61 Comply with the Company Quality Management System for development activities.
遵守公司制定的研发质量管理体系。
General 常规要求
61 Take responsibility of the general operation and maintenance of the protein bioactive laboratory facilities.
负责蛋白质活性实验室设施的一般操作和维护;
61 Other reasonably duties as requested by Company Senior Management from time to time.
完成领导提出的其他任务。
Qualifications 任职资格
61 Major in Pharmaceutical analysis or related field.
药物分析相关专业；
61 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
61 BS degree with a minimum of 0~3 years and MS degree with a minimum of 0~2 years of large Biomolecule analysis experience.
本科0~3年，硕士0~2年相关生物大分子分析经验；
61 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；
61 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；
61 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)。
Preferred Experience优先考虑
61 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;
61 Biophysical methods for protein characterization.
熟悉蛋白表征的分析方法;
61 Formal root-cause analysis training.
严谨的问题分析能力;
61 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。