Macromolecular analysis /CMC Scientist/Principal/Director
1.Design and perform analysis of bioproducts such as antibodies, fusion proteins, and ADCs to support physicochemical characterization and structural characterization in the development of bio-drugs,Search the literature as needed to solve the problem;
2.Analysis and screening to provide support for cell line and process development for CMC projects at early stages;
3.Quality control and stability analysis method development for CMC product at early stage;
4.Provide analytical support for technology transfer of biological products from early to late;
5.Draft SOPs, study protocols and reports to support biologic characterization and comparability studies;
6.Support RS, DS, DP sample management and compliance with regulatory requirements.
1.Master degree or above in pharmacy, biopharmaceutical, biochemistry, analytical chemistry, pharmaceutical analysis, etc., 2-5 years working experience;
2.With strong self-motivation ability, have practical experience in the analysis and development of biological preparation macromolecules such as mAb, BsAb, fusion protein and ADC, including but not limited to HPLC, UPLC, LC-MS, CGE, CZE, ELISA, etc. Support the analytical development of biological products for drug discovery and early CMC development;
3.Well trained with QC basic operation;
4.Familiar with analysis of CTD documents and characterization requirements;
5.With experience of drafting and reviewing development report, standard operation practice and English writing;
6.Be proficient with English, many chances to communicate with technical expert from J&J.