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QC Biochemistry Analyst
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- Perform QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, processes and procedures.
- Perform QC biochemistry assay validation and transfer activities, including testing (e.g., DS, DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.
- Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, testing record keeping, etc.
- Working experience in an FDregulated biotechnology, pharmaceutical company are required.
- Serve as subject matter expert for residual DNA by qPCR, host cell protein ELISA, Residual Protein An ELISA, binding activity ELISA, Capillary Electrophoresis (CE), and capillary isoelectric focusing electrophoresis(cIEF), including qualification, assay validation and transfer activities.
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