1、Responsible for leading analytical method (including HPLC, CE, LC-MS, etc.) development, method validation and method transfer in the course of drug product development projects.

2、Develop and execute analysis protocols for monoclonal antibody characterization for IND and BLA filing, mainly including support for dosage form development through structural and degradation pathway characterization and stability related studies.

3, have in-depth understanding of HPLC, LC-MS, CE, DLS, DSC and other assays, and be able to independently analyze each assay data and deal with abnormal situations.

4、Responsible for the evaluation and application of new assay technologies.

5、Have the ability to communicate across departments and effectively follow up and communicate project progress.

6, proactive and able to effectively manage multiple projects with minimal supervision.

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

1、Biology, animal medicine, biochemistry, pharmaceutical and other professional background; bachelor degree or above.

2, analytical chemistry, biochemistry, biophysics, pharmaceutical chemistry or related majors.

3、Familiar with cGMP, pharmacopoeia testing, biological drug declaration and registration regulations is especially good.

4、 Familiar with literature review, excellent English, able to read and translate English literature fluently.

5、 Good professionalism, teamwork and communication and coordination skills.