岗位描述
About the Role
We are seeking a highly motivated and experienced scientist to serve as a Subject Matter Expert (SME) in Molecular Interaction Analysis. The successful candidate will lead the development, optimization, and application of SPR/BLI-based binding characterization platforms to support CMC development, biosimilar assessment, and regulatory submissions.
Key Responsibilities
Serve as the technical SME for Molecular Interaction Analysis platforms, including SPR and BLI technologies.
Design, develop, and optimize binding and kinetic assays for monoclonal antibodies, bispecific/multispecific antibodies, fusion proteins, and other biologics.
Provide scientific leadership for complex technical investigations and troubleshooting activities.
Support analytical similarity, comparability assessments, and IND/BLA-enabling CMC programs.
Establish platform best practices, SOPs, and data analysis workflows to ensure scientific rigor and operational excellence.
Collaborate closely with cross-functional stakeholders to ensure successful project execution and client satisfaction.
Qualifications
Master’s degree or above in Biochemistry, Molecular Biology, Immunology, Pharmaceutical Sciences, or a related discipline
Minimum 4 years of experience in biologics analytical characterization, with substantial hands-on experience in SPR and/or BLI technologies.
Extensive experience with Biacore and/or Octet platforms, including method development, optimization, troubleshooting, and scientific data interpretation.
Excellent communication, technical writing, and project leadership skills.