Full Job Description
b. Cell culture and process development. Lead development and optimization of primary-cell isolation, selection, enrichment, activation, culture, expansion, harvest, and handling procedures. Evaluate cell populations derived from blood, bone marrow, tissues, and tumors, including T cells, TILs, dendritic cells, and other relevant immune populations. Assess how culture conditions, media, stimulation strategies, processing steps, and hold conditions affect yield, viability, phenotype, function, and manufacturing consistency. Support transduction, transfection, or electroporation development with appropriately qualified collaborators where required.c. Product development and process characterization. Design studies that connect manufacturing conditions and process parameters with critical quality attributes. Establish appropriate sampling plans and in-process measurements, evaluate process variability, and support scale translation and comparability assessments. Use manufacturing and product-characterization data to identify improvements; collaborate with investigators to evaluate relationships with clinical outcomes when suitable data are available. d. Analytical development. Lead development, optimization, qualification, validation, execution, troubleshooting, and lifecycle management of molecular, cellular, biochemical, and functional methods. Methods may address safety, identity, purity, impurities, potency, biological activity, gene or transgene expression, residual materials, stability, and vector- or genome-related attributes within assigned program scope. Establish controls, reference materials, system suitability criteria, and standardized data analysis procedures. e. Flow cytometry and cell sorting. Lead multiparameter panel design, sample preparation, staining, instrument setup, compensation, gating, assay controls, and reporting. Develop methods for identity, viability, purity, activation, differentiation, and memory phenotypes, including T-cell memory stem populations where relevant. Apply intracellular cytokine staining and CFSE-based proliferation methods. Provide technical leadership for sorting and isolation of defined or rare immune-cell subsets, with appropriate aseptic controls where required. f. Functional and immunological assays. Develop and optimize assays for T-cell activation, proliferation, cytokine release, target recognition, and real-time cytotoxicity. Apply ELISA, ELISpot, multiplex assays, ADCC, and other relevant immune-effector methods to product development and characterization. Support assessment of TCR specificity, cross-reactivity, alloreactivity, and tumor-reactive cell function where applicable. Translate relevant mechanistic assays into reproducible, practical potency methods suitable for QC implementation.
