Analytical Development Scientist

The position will support a client team that is responsible for ensuring the consistency, safety, and efficacy of biologics, including cutting-edge cell and gene therapies. The successful candidate will work in close partnership with analytical development, bioprocessing, formulation, and data science groups to support manufacturing and quality control activities across the client’s development pipeline.We are seeking a skilled analytical development scientist who will contribute to the development of the client’s islet cell therapy platform. This role will involve designing, optimizing, and executing bioanalytical assays for use in process development, in-process testing, and lot release. Knowledge and expertise in mammalian cell culture, flow cytometry, and molecular assays, including PCR, are a must.  The successful candidate must be self-motivated and able to work independently to troubleshoot and interpret experimental results and effectively present conclusions. Job Responsibilities and RequirementsDevelop, optimize, and execute a range of analytical assays to support product development and batch release.Perform sample analysis using a broad set of platforms such as flow cytometry, ELISA, PCR, and cell-based assays.Investigate and resolve assay-related challenges by applying scientific and technical problem-solving skills.Support assay qualification, validation, and lifecycle management to ensure reliability and regulatory compliance.Collaborate with cross-functional teams, including R&D, manufacturing, and quality to ensure alignment on analytical goals and timelines.Contribute to preclinical study support by aligning analytical strategies with experimental objectives.Interpret experimental data, summarize results clearly, and communicate findings to technical and non-technical audiences.Support assay transfer and technical communication with CDMOs, including troubleshooting, documentation review, and knowledge transfer.Maintain laboratory infrastructure, including oversight of reagents, reference materials, and analytical equipment.Author technical documentation such as protocols, reports, and standard operating procedures.Continuously evaluate emerging technologies and scientific approaches to improve assay performance and robustness.