Our Gene Therapy Client here in Cambridge, MA is looking to add a Scientist to their biomarker and bioanalytical group! This role will support the development of immunogencity assays for both preclinical and clinical programs (oncology therapeutics). Scientist will be responsible for the design and execution of assays for immunogenicity as well as biomarker discovery and qualification. In addition, will also include assay development, sample testing to support preclinical studies, preclinical to clinical transition and regulatory submission. Other responsibilities include but not limited to:
- Interact with external CRO and internal project teams to develop biomarker plan 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 with consistent quality in proceed development and execution of the studies.
- Prepare and review bioanalytical reports and packages for regulatory submissions.
Our preferred candidate will have:
- 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
- Working experiences with biologics, human tissue samples, nucleic acid, gene and cell therapies is highly desirable