Macromolecular analysis /CMC Scientist/Principal/Director

Job description

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.

   Job 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.

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