1. Generate all necessary test procedure, perform analysis of
in-process sample, drug substance, drug product and stability study sample
under cGMP standards.

撰写所有必须的检测规程，根据检测规程，依照相关cGMP标准对中间样品，原液，制剂和稳定性样品进行分析检测；

2.Perform routine testing such as pH, osmolality, UV, visible
particle, Sub-visible particle, extractable volume, color, clarity, LC related
assay, CE related assay, understand technical aspects of the job, best
practices, and adhere to cGMP compliance.

执行pH, 渗透压，蛋白浓度，可见异物，不溶性微粒，装量，颜色，浊度，液相相关和毛细管电泳相关的日常检测，理解工作的技术原理，最佳做法，并遵守cGMP合规性；

3.Generate method transfer/qualification/validation protocol under
ICH/USP/EP/CP guidelines, and draft method transfer/qualification/validation
report after the completion of experiment.

根据ICH/USP/EP/CP指南生成方法转移/确认/验证方案，实验执行完成后起草方法转移/确认/验证报告；

4.Execute method transfer/qualification/validation of as pH,
osmolality, UV, extractable volume, color, clarity, LC related assay, CE
related assay.

执行pH, 渗透压，蛋白浓度，装量，颜色，浊度，液相相关，毛细管电泳相关的检测方法的转移和方法确认/验证；

5.Perform moderate data analysis and trending, document work
according to GMP and notify management.

进行适当的数据分析和趋势分析，根据GMP进行文件工作并通知管理人员；

6.Handle the quality event such as change control, deviation and

CAPA related to the testing.

负责处理与检测相关的质量事件，例如变更，偏差和纠正及预防措施；

7. Stability study administrator which in charge of stability
protocol/report preparation and storage/management of stability sample.

稳定性研究管理主要负责编写稳定性方案和报告，稳定性样品存储和管理。

8.Sample administrator which mainly responsible for sample receipt/
storage/distribution/disposal, test report and CoA issuance.

样品管理主要负责样品接收，存储，分发和销毁，分析检测报告的出具。

Qualification 任职资格：

1.Bachelor’s/Master’s degree.

本科/硕士。

2.Bachelor’s degree in a scientific discipline with 3+ years’ experience in quality control systems, or Master’s degree with 1+ years’ experience.

3.Extensive experiences in analytical testing for protein analysis,

such as HPLC, CE, MS, iCE3，UV, extensive experience in method development,qualification, validation and method transfer of physical-chemical methods.

具有蛋白质分析测试方面工作经验，如高效液相色谱、毛细管电泳、质谱、ICE3、紫外扫描等；对理化分析方法的方法开发、确认、验证和方法转移方面有丰富经验。

4.Understanding of FDA and ICH guidelines as well as GLP/GMP

principles associated with analytical development, the basic statistics
required in data analysis.

了解FDA和ICH指南以及与分析方法开发相关的GLP / GMP原则和数据分析所需的基本统计学。

5.Highly motivated, flexible, and multi-task.
高度积极性，灵活性和多任务解决能力。

6.Excellent verbal and written communication skills in English.

有良好的英语口语和写作能力。