Job Responsibilities:

1.       Develop and validate bioactivity analysis methods for protein therapeutics.

2.       Perform biological and functional assays for protein drugs, including ELISA/BLI/SPR-based antigen-binding activity tests and cell-based functional experiments.

3.       Support bioactivity testing of samples across different development stages, including R&D, process development, and pilot-scale production.

4.       Contribute to regulatory submission activities by providing technical reports and information required for documentation.

5.       Establish and maintain SOPs for bioactivity analysis to ensure full compliance with GLP/GMP standards throughout method development, transfer, and testing processes.

6.       Complete other tasks assigned by supervisors.

Qualifications:

1.       Bachelor’s or Master’s degree in Biochemistry, Molecular Biology, Cell Biology, Biotechnology, or a related field; relevant experience is preferred.

2.       Proficient in protein activity detection techniques, including SPR, WB, ELISA, BLI, and ligand-receptor/antibody binding affinity assays.

3.       Experience with cell culture, reporter gene assays, or cell proliferation tests is preferred.

4.       Detail-oriented, responsible, proactive, and team-oriented with strong time management and organizational skills.