Job responsibility: 工作职责:
Job responsibility may include the followings: 工作职责可能包括以下内容:
1. Develop or support development of analytical methods for biological molecules (including monoclonal antibodies, multi-specific antibody, ADC, et.) to enable progression of biopharmaceutical development from preclinical to clinical stages.
开发或支持生物分子(包括单克隆抗体、多特异性抗体、ADC等)分析方法的开发，以推进生物制药从临床前阶段到临床阶段的开发。
2. Perform various analytical sample testing to support development of biological molecules as needed using a variety of Chem-Phys assays. For Chem-Phys assays may include analysis method with HPLC, UPLC, LC-MS, CE, ICIEF, Capliper.
根据需要， 使用各种化学-物理分析方法进行各种分析样品测试，以支持生物分子的开发。理化分析包括HPLC, UPLC, LC-MS, CE, ICIEF, Calipper等分析方法。
3. Write SOP, experimental methods and reports; Support sample preparation, reagent management, stability sample management.
撰写SOP、实验方法及报告;支持样品制备，试剂管理，稳定性样品管理
4. Participate/lead various studies to support CMC development of biological molecules, such as: CQA assessment, comparability study, biological molecular characterization beyond routine testing for product and process understanding and characterization. Support source document preparation including regulatory document authoring/reviewing as needed to support various types of regulatory CMC document submission.
参与/领导各种研究，以支持生物分子的CMC开发，如: CQA评估，可比性研究，生物分子特性非常规测试，以理解和表征产品和工艺。支持源文件的准备，包括法规文件的编写/审阅，以支持各种类型的法规CMC文件的提交。
Job Requirement：工作要求
Academic/Professional Qualification学历/专业资格
Master's degree or above in Pharmacy, Chemistry, Analytical Chemistry, or Biochemistry; or analytical related excellent professional expertise could be considered.
药学，化学，分析化学或生物化学专业硕士或以上学历；或者在分析专业领域表现出卓越能力的申请者也可获得优先考虑。
Technical/Skills Required:技术/技能训练
1. Be familiar with drug analytical testing, laboratory safety knowledge, analysis.
熟悉药品检验知识、实验室安全知识、检验和仪器分析知识。
2. Be familiar with analytical methods such as SEC，IEC，CE_NR&R, etc.
熟悉分析检测方法，如尺寸排阻色谱，离子交换色谱，还原&非还原凝胶毛细管电泳等。
3. Be able to experimental design, experiment execution, collect and summarize data, and resolve problems in experiments under supervision and guidance.
可以在监督指导下进行实验设计、执行实验、收集汇总数据，可以解决实验中的问题。
4. Effective verbal and written communication skills.
良好的口头和书面沟通技巧。
Working Experience: 工作经验
1. At least 3 years of practical experience in Bio-pharmaceutical industry for MS degree.
硕士学历，医药行业3年以上生物制药经验。
2. At least 5 years of practical experience in Bio-pharmaceutical industry for BS degree.
学士学历，医药行业5年以上生物制药经验。
3. Other analytical related excellent professional expertise with more than 8 years of practical experience in Bio-pharmaceutical industry
具备卓越的分析相关专业技能，并在生物制药行业有超过8 年的经验。
Language Ability， Computer Literacy，etc. :语言能力，电脑知识等
Good English at reading & writing, familiar with basic computer skills.
英语读写水平良好，会熟练使用电脑
Others: 其他
1. Proactive and dedicated with a strong sense of responsibility and integrity.
积极敬业、主动进取、责任心强、正直向上；
2. Competent in organization and coordination, team spirit, analytical skills and problem solving.
有较强的组织协调能力、良好的团队精神、较强的分析和解决问题的能力
3. Good communication skills.
具有良好的沟通表达能力；