1、Responsible for analysis of items such as protein purity, assay, peptide map, N-terminal amino acid sequence, isoelectric point, pH, osmotic pressure, particulate matter, clarity, visible particulates, etc.
2、Engage in residue detection such as relative binding activity, biological activity, impurity protein A, host cell protein, host DNA, etc. of mAb products
3、Develop and explore potency testing method for protein-based drugs and residue detection method for impurity protein A, host cell protein, host DNA, etc. of protein-based drugs
4、Engage in preparation of technical documents such as product specification, SOPs for analysis, etc.
5、Engage in qualification/validation of analytical method, and prepare analytical method validation protocols and reports
6、Engage in testing and analytical methods transfer for CMO projects
7、Manage culture media, test solution, reagent, etc. for use in Lab
8、Engage in IQ, OQ, and PQ of lab analytical instruments/equipment and calibration management of lab instruments, equipment, and meters
1、Bachelor degree or above, majored in biopharmaceuticals, pharmacy, etc.
2、Over 1 year of experience in analytical assay for mAb or recombinant-based protein drugs
3、Those who possess (one of) the following experiences would be preferred:
1)Analytical assay of biological activity, receptor affinity;
2)residue analysis of protein A, HCP, DNA;
3)SEC, CEX, peptide map, N-glycan analysis
4)cIEF, CE-SDS, etc.