Job Responsibilities/工作职责

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 residual HCP, residual DNA, residual ProA, mycoplasma test, potency tests which include binding ELISA potency test and cell based potency test, understand technical aspects of the job, best practices, and adhere to cGMP compliance;

执行残留HCP，残留DNA，残留ProA，支原体检测，酶联免疫活性和细胞活性实验的日常检测，理解工作的技术原理，***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 residual HCP, residual DNA, residual ProA, mycoplasma test, potency tests which include binding ELISA potency test and cell based potency test;

执行残留HCP，残留DNA，残留ProA，支原体检测，酶联免疫活性和细胞活性实验的方法转移和方法确认/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，偏差和纠正和预防措施。

Job Requirements/岗位要求

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

本科及三年以上工作经验，或研究生及一年以上工作经验；

2. Strong background in standard and specialized methodologies for biologics products; Experience developing bioassays and biophysical potency assays, developing process impurity assays such as HCP, Residual DNA, and Residual ProA methods is preferred;

具有生物产品方法开发或检测的相关背景，有生物活性检测方法和其他生物学实验方法开发，杂质分析方法开发（如HCP，残留DNA和残留ProA方法）的工作经验者优先考虑；

3. 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；

4. Highly motivated, flexible, and multi-task;

高度积极性，灵活性和多任务解决能力；

5. Excellent verbal and written communication skills in English.

有良好的英语口语和写作能力。