My client is expanding and seeks a Senior Bioanalytical Scientist to support their gene therapy pipeline.
The ideal candidate will take on the following tasks:
- 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.
The ideal candidate will possess the following qualities:
- BS/MS/PhD + 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