PD分析研究员

职位类别： 嵌入式开发

职责描述：

1、参与蛋白分析相关设备的选型及URS的准备

Participation in equipment selection and URS preparation in upstream analytical lab

2、参与蛋白分析实验室设备的FAT、SAT、安装和测试

Participation in FAT、SAT、installation, and testing of the analytical lab equipment

3、负责分析方法开发、优化、确认和验证。

Responsible for development, optimization, qualification and validation of analytical methods.

4、负责样品检测，以满足研发和生产的分析需要。

Responsible for sample analysis to support PD & MFG.

5、撰写研究方案及相关技术报告。

Prepare research protocols and related technical report

6、参与项目的技术转移，审阅相关文件，与相关部门密切合作做好技术转移。

Participate in technology transfer, review related documents, and cooperate well with related department for successful technology transfer.

7、与上游、下游实验室及QC紧密配合，保证工艺开发的完整性

Cooperate well with USP &DSP &QC for process development.

8、负责实验仪器的维护和实验室内相关区域的清洁。

Responsible for maintenance of instruments and cleaning of Analytical/Formulation Lab.

9、完成其他领导安排的任务；

Finish the other works arranged by supervisor.



任职要求：

1、硕士或以上学历，药学，生物工程或生物化学专业；或本科教育学历，专业能力表现卓越。

Master or above degree in Pharmacy, Bio-Engineering or Biochemistry; alternatively, or Bachelor degree with excellent competence

2、熟悉抗体工艺开发中的一般分析方法，如SEC，IEC，ELISA等。

Familiar with common analytical methods in mAbs PD，such as SEC,IEC,ELISA, etc.

3、熟悉分析方法的开发、优化、确认和验证。

Familiar with development, optimization, qualification and validation of analytical methods.

4、生物制药行业8年以上制药经验并至少两年管理经验

At least six years of practical experience in Bio-pharmaceutical industry with at least 3 years of managerial experiences

5、英语水平良好，会熟练使用电脑

Good English at reading & writing and computer skills

• 年龄要求： 不限
• 语言要求：不限