Date: 30-Sep-2016
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please visit http://biotech.fyicenter.com/
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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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
