- Develop ligand binding assay (ELISA, MSD, Luminex) for PK/PD/ADA/NAb assays for clinical studies.
- Overcome common issues in biological sample quantitative assay during the stage of method development (sensitivity, specificity), assay transfer (lab-to-lab consistency), sample analysis (change of critical reagent, change of patient population, incurred sample reanalysis, etc).
- Be able to effectively communicate internally and externally.
- Provide training and mentorship to internal staff.
- MS and Ph.D.
- Minimum 3 years of GLP Bioanalysis experience.
- Industrial experience in assay development for large molecules quantitation in support of preclinical and clinical PK/PD/ADA/NAb assay is highly desired.
- Hands-on experience with common ligand-binding assay platforms such as ELISA, MSD, Luminex, cell-based assay. Experience in IHC, PCR, Flow cytometry is a plus.
- Be able to multi-task and handle stress.
- Managerial skill is a plus.
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