Job Responsibilities 工作职责：
1.Participate in protein LC-MS characterization, including molecular weight, peptide mapping sequence coverage, disulfide linkage, glycosylation site, and post-translational modifications (PTM).
参与蛋白质谱结构表征，包括分子量、肽图序列覆盖率、二硫键、糖基化位点和翻译后修饰等；
2.Participate in characterization and analytical method development.
参与表征和分析方法开发；
3.Provide analytical technical support to upstream/downstream process development groups during process development and trouble shooting. Support formulation development, tech transfer and scale-up activities.
对上下游的工艺开发提供分析支持并协助排查与解决问题，对制剂开发、技术转移、放大工艺提供分析技术支持；
4.Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, and etc.
负责起草技术文件包括操作规程，方案，报告，风险评估，实验室调查报告等；
5.Per SOPs, perform routine analysis of samples of process development from PD and other non-GMP samples, including in-process samples.
根据SOP执行PD部门工艺开发样品和其它non-GMP 样品的常规分析，包括中控样品等；
6.Perform analytical data analysis, data review and trending analysis.
负责数据分析，数据审核和趋势分析；
7.Other work arranged by superior leaders.
上级领导安排的其他工作。
Qualification 任职资格：
1.Bachelor degree or above in chemistry, biology, life sciences or related disciplines.
本科及以上学历，化学、生物学、生命科学或相关专业；
2.Analytical experience in biopharmaceutical industry is preferred.
如具有生物制药行业的分析相关工作经验者优先考虑；
3.HPLC operation experience was necessary, practical operation experience in Waters-QTOF or Thermo Orbitrap mass spectrometry, and familiar with the structure of protein biopharmaceuticals is preferred.
必须具备HPLC操作经验，有Waters-QTOF或者Thermo Orbitrap质谱实际操作经验、熟悉蛋白生物药结构者为佳；
4.Be familiar with equipment for protein/biologics analysis, such as UV spe2ctrometer, HPLC, UPLC, CE and etc.
熟悉蛋白生物药分析仪器，包括UV分光仪、HPLC、UPLC、毛细管电泳仪等；
5.Be familiar with analytical method development, qualification, validation and method transfer of physicochemical tests.
熟悉理化分析的方法开发，确认，验证和转移过程；
6.Understand ICH，ChP regulations and guidelines.
了解ICH, ChP法规和指导原则；
7.Excellent oral and written communication skills in English.
良好的英文口语和书面沟通能力。