To be responsible for method development, validation and implementation of ligand based analysis of antibodies/ADC/biomarkers in support GLP clinical large molecule PK/ADA/Nab studies.
- Design, develop and validate the ligand based analysis method in various biological samples including tissues/plasma/serum under GLP regulations.
- Analyze large molecule samples from pre-clinical or clinical GLP studies using immuno-assays or other methodologies for PK/TK studies. Ability to perform immunogenicity assessment with anti-drug antibody assays and cell based neutralization assays. Experience in biomarker measurements (FACS, Cytokines) would be preferred.
- Author and/or review bioanalytical data and all study reports, including assay development, validation, sample analysis reports; timely communicate with the clients for project management, technical troubleshooting, samples and reagents logistics and data delivery.
- Ensure relevant regulatory compliance (GLP/GCLP) and is familiar with Chinese and important global (CDE, FDA, EMA, HGRAO) guidelines.
- Conduct projects and deliver the projects within proposed timeline; perform job assignment with minimal supervision from the management.
- BS or M.S. with 5-10 year working experience with immunology, biochemistry or biology background. Hands on experience in ELISA, MSD, FACS, Luminex and Cell based assays preferred. Proficient in Watson LIMS system.
- Ability to read, write, speak and understand English.
- Must be able to work in a dynamic working environment.
- Good communication skill.
Location: ZJ Hi-tech Park,Shanghai, China