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Our client is expanding and seeks a Senior Bioanalytical Scientist , supporting their gene therapy pipeline, who will
- Develop, qualify and validate robust bioanalytical methods for cell-based and ligand binding assays
- Conduct technology transfer and ensure analytical development and validation activities (conducted internally and with CROs) lead to robust methods
- Serve as the lead for the bioanalytical portion of non-regulated as well as GLP and GCP studies.
- Write and review study protocols, analytical procedures, reports for regulatory submissions.
- Perform technical reviews of analytical data and be responsible for data interpretation, analysis, and reporting of results for method development and validation.
- significant industry experience and demonstrated ability with execution of immunoassays including ELISA, ECL, ELISPOT and cell-based assays like qPCR, and LCMS.
- Ability to plan and perform experiments and lead internal and external functional projects
- Familiarity with statistical analysis tools and able to apply the basic statistic tools
- Knowledge with gene therapy is preferred