职位描述
Responsible for routine sample testing to meet the analytical needs of process development and manufacturing;
负责日常样品检测项目，以满足工艺开发和生产的分析需要。
Participation in FAT、SAT、installation, and testing of the analytical lab equipment
参与蛋白分析实验室设备的FAT、SAT、安装和测试。
Draft and update of the SOPs of testing methods.
负责分析检测方法标准操作规程的起草和更新。
Draft the related study protocols, follow up the implementation of study protocols, and draft reports.
撰写并跟进研究方案，撰写研究报告。
Responsible for the development, optimization, qualification and transfer of analytical methods.
负责分析方法的开发、优化、确认和转移。
Responsible for sample analysis to support PD & MFG.
负责样品检测，以满足研发和生产的分析需要。
Participate in technology transfer, responsible for the review of related documents, and cooperate well with related department for successful technology transfer.
参与项目的技术转移，负责分析文件的审阅，与相关部门密切合作做好技术转移。
Cooperate well with USP &DSP &QC for process development.
与上游、下游实验室及QC紧密配合，保证工艺开发的完整性
Responsible for maintenance of instruments and cleaning of Analytical Lab.
负责实验仪器的维护和实验室内相关区域的清洁。
Responsible for the IQ, OQ and PQ of related analytical instruments. Responsible for the daily work of the laboratory.
负责相关分析仪器的安装确认、操作确认和性能确认，负责实验室其他日常工作。
To comply with the requirements of the EHS policies and regulations.
遵守EHS相关政策法规的要求。
Any other assignment as is determined by supervisor.
完成上级安排的其他工作。
博士学位，分析，药学，生物制药，生物工程等相关专业
Be familiar with drug analytical testing, laboratory safety knowledge, biochemical analysis and instrumental analysis.
熟悉药品检验知识、实验室安全知识、生化检验和仪器分析知识。
Be familiar with analytical methods such as residual HCP, DNA, protein A, binding ELISA and cell-based potency. Be familiar with antigen and receptors affinity testing and flow cytometry.
熟悉分析检测方法，如残留HCP、DNA、protein A、结合活性和细胞活性等。熟悉抗原及受体亲和力检测、流式细胞术等。
Be familiar with analytical method development, optimization, qualification and transfer.
熟悉分析方法的开发、优化、确认和转移。
Strong laboratory analysis skills, and trouble shooting ability.
具有较强的实验室分析能力，良好处理问题的能力。
Effective verbal and written communication skills.
良好的口头和书面沟通技巧。
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；
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
Good communication skills;
具有良好的沟通表达能力；
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