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Large molecular bioanalysis position (Shanghai, China)

Key Accountibilities:

  • Lead or participate development or transfer of immunochemistry-based bioanalytical methods in PK, PD, Immunogenicity and biomarker areas.
  • Serve as Study Director/Principle Investigator for method validation and clinical sample analysis studies. Ensure GLP compliance. Prepare/review study protocols and reports. Address QA findings and observations.
  • Lead troubleshooting of issues occurred during method development or in-study phase.
  • Participate client visits, teleconferences and provide project updates to clients.
  • Requirements:

  • M.S./B.S. in biology, biochemistry, immunology, cell biology or related discipline with a minimum of 3 years of biopharmaceutical/CRO experience.
  • Candidates must have li scientific understanding of immunoassays. Demonstrated capability of developing assays independently. Experience with MSD or Luminex are lily preferred. Experience in cell culture, flow cytometry and cell-based assays is a plus.
  • Must be trained in or have experience with the requirements of FDA GLP regulation, CFDA GLP regulation, and OECD GLP guidelines. Must be familiar with guidances/standards related to bioanalytical methods.
  • Experienced in immunochemistry-based large molecule bioanalytical method development/validation.
  • Strong communication skills and fluent in both written and oral English.
  • Must be able to openly share information and work in a team setting.