1、Complete biochemical assays for biological activity (cellular activity/ELISA, etc.), residues (HCP/HCD/ Protein A residuals), etc. on time and in strict accordance with SOPs, quality standards for stock solutions and finished products.

2、Responsible for transferring, confirming or validating biochemical assays and writing the corresponding technical protocols and technical reports.

3、Responsible for drafting or revising SOPs for biochemical assay-related equipment and methods.

4、Responsible for the use, management and maintenance of biochemical assay-related equipment, such as enzyme markers, PCR instruments and other equipment.

5、Timely reporting of deviations, AD/OOS/OOT problems in the testing process to supervisors and completion of related investigations.

6、Ensure that daily behaviors and operations can fully comply with cGMP requirements as well as relevant company document management requirements.

7、Complete other tasks as assigned by the supervisor.

1、Specialist or above in chemistry, biology, pharmacy or other related majors.

2、Background in biopharmaceuticals, mastering the principles and operations of testing; familiar with GMP-related knowledge.

3、Good English reading ability and proficiency in computer operation.

4、Relevant experience is preferred.