1、In the process of drug product development project, be responsible for leading the development of analytical methods (including HPLC, CE, LC-MS, etc.), method confirmation and method transfer;

2、 Develop and implement the monoclonal antibody characteristic analysis scheme for ind and Bla declaration, mainly including providing support for dosage form development through structure, degradation pathway characteristics and stability related research;

3、 Have a deep understanding of HPLC, LC-MS, CE, DLS, DSC and other detection methods, and be able to independently analyze each detection data and handle abnormal situations;

4、Responsible for the evaluation and application of new detection technologies;

5、Have the ability of cross department communication, effectively follow up and communicate the project progress;

6、 Proactive and able to effectively manage multiple projects with minimal supervision;

7、Be able to take the initiative to undertake a variety of responsibilities and have good decision-making ability.

1、Master's degree or above, major in analysis, biology, pharmacy, etc;

2、At least 3 years of relevant working experience; Experience in ind or BLA project application, protein structure characterization and preparation development is preferred;

3、Familiar with cGMP, Pharmacopoeia, biological drug application and registration regulations is preferred;

4、Familiar with literature review, excellent English, fluent in reading and translating English literature;

5、Have good professional dedication, teamwork spirit and communication and coordination skills.