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US-CA-MountainView: Scientist I / Scientist II, GXP Bioanalysis

Date: 30-Sep-2016
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Scientist I / Scientist II, GXP Bioanalysis

* Serve as a bioanalytical lead on cross-functional teams supporting the development of biotherapeutics pipeline * Function as Principal Investigator or Responsible Bioanalytical Scientist for non-clinical and clinical studies * Design bioanalytical strategies supporting pre-clinical and clinical development of biotherapeutics * Develop immuno- or LCMS- assays for determination of drug substances, anti-drug antibodies and biomarkers. * Utilize creative and analytical capabilities to troubleshoot challenging assays * Design and execute assay qualification and validation * Prepare validation protocols, validation reports and Standard Operating Procedures * Conduct bioanalytical sample analysis and data review in a GLP-compliant laboratory * Evaluate and implement new technologies to expand capabilities and enhance efficiencies * Manage CROs for method transfer, validation, sample analysis and report generation * Coordinate timelines for activities in collaboration with project management * Train and supervise junior members in a matrix environment

PhD in Biological Sciences or related field with 0-3 years of experience MS in Biological Sciences or related field with 8-10 years of experience BS in Biological Sciences or related field with 10-13 years of experience

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