1、Responsible for the development, optimization, validation and transfer of analytical methods for bioactive methods (including ELISA, cell-based assay, etc.), biological residues and safety analytical assays (including residual HCP, residual DNA, residual Protein A), etc., writing and revising relevant documents to support project progress.

2、Responsible for the evaluation and application of new technologies/instruments.

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

4, cross-departmental communication skills, effective follow-up and communication of project progress.

5、Analyze and solve abnormal problems encountered in experiments and organize analytical data in a timely manner to support the project progress.

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

1、Bachelor degree or above.

2, cell biology, molecular biology, biochemistry, pharmacology, immunology, biotechnology, basic medicine and other related majors.

3、Experience in optimization of expression vector construction, transfection, Western, ELISA, Cell-based Assay, cell proliferation inhibition, apoptosis, phagocytosis, ADCC, CDC, enzyme activity, flow cytometry, etc. is preferred, and statistical knowledge/mathematical background is preferred.

4、Familiarity with cGMP, pharmacopoeia assay, biological drug declaration and registration regulations is preferred.

5、Ability to search literature, excellent English, fluent in reading and translating English literature.

6、Have a strong curiosity to learn new things.

7、Possess good professionalism, teamwork and communication and coordination skills.