- Perform routine HPLC/UPLC and/or CE-based assays
- Support protein characterization requirements to facilitate process developments, formulation developments and analytical developments.
- Support product characterization with the focus on differential scanning calorimetry (DSC), SEC-multi-angle light scattering (MALS), dynamic light scattering (DLS) and other state-of-the-art instruments to characterize protein structure, aggregation, and other abnormalities
- Knowledgeable and capable of conducting product quality trouble shooting, deviation investigation and risk assessments
- Development of impurity/residual testing methods
- Evaluations of new methods and novel technologies in protein characterization
- Perform routine equipment maintenance and calibration; maintain equipment logs according to good documentation practice.
- Perform peer review of procedures and methods.
- Documents writing to support clinical trial application (CTA)
- Managing contract testing labs including lead time negotiation, regular data update and data review.
- PhD. degree in a scientific discipline with 2+ years experience in analytical or quality control systems; Master degree in a scientific discipline with 5+ years experience in analytical or quality control systems
- Familiar with HPLC/UPLC, CE, DLS and other state-of-the-art physicochemical analytical tool.
- Good verbal and written English communication skills. Ability to work effectively across departments.
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