Large molecular bioanalysis position (Shanghai, China)
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.
Ph.D. in biology, biochemistry, immunology, cell biology or related discipline
Candidates must have strong scientific understanding of immunoassays. Demonstrated capability of developing assays independently. Experience with MSD or Luminex are strongly 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.