Responsibilities of the Bioanalytical Scientist:
- Develop, qualify and execute biomarker assays with most appropriate technical platforms.
- Interact with external CRO and internal project teams to develop biomarker plans for new programs in the pipeline and transfer, qualify and validate assays in support of first-in human clinical trial.
- Design, execute, interpret and report bioanalytical assay with primary tissues for clinical development.
- Be able to follow the relevant FDA guideline to develop and qualify the assay.
- Prepare and review bioanalytical reports and packages for regulatory submissions.
Requirements of the Bioanalytical Scientist:
- Ph.D. in Immunology, Biology or bioanalytical field of study with at least 1 year of hands-on experience in bioanalytical assays and assay development.
- Experience in development of ELISPOT, ADA, flow-cytometry, cytokine profiling, ELISA and cell-based assay is highly desirable.
- Working experiences with biologics, human tissue samples, nucleic acid, gene and cell therapies is highly desirable.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.