CGT Facility-IMCPL

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.

Job Summary

Directs day-to-day laboratory operations while ensuring compliance with safety regulations and best practices. Works with, adapts, and installs scientific equipment in research laboratories. Develops complex projects and procedures independently. Manages inventory and equipment and performs budget functions. Writes grant applications and manuscripts independently.

The Manager, Cell Therapy Process and Analytical Development provides scientific, technical, and managerial leadership for cell therapy process development and analytical capabilities at the Immunologic Monitoring and Cellular Products Laboratory (IMCPL). The position combines hands-on laboratory work with management of development activities, personnel, resources, timelines, and cross-functional technology transfer supporting investigational cell and gene therapy products. The Manager leads primary-cell culture and process optimization, product characterization, assay development, qualification, validation, and analytical lifecycle management. In collaboration with Quality Control (QC), Quality Assurance (QA), Manufacturing, and investigators, the Manager develops scientifically justified methods and proposed specifications addressing identity, potency, safety, purity, process- and product-related impurities, biological activity, stability, and comparability. The Manager works collaboratively with the QC Manager and Product Managers to develop processes, platforms, and tools aligned with program needs. The position leads development and transfer of processes to Manufacturing and analytical methods to QC. The existing QC Manager retains oversight of routine QC operations, controlled testing execution, and QC data review supporting product disposition. Specification approval and product disposition follow established IMCPL quality-system authorities. a. Scientific and managerial leadership. Establish development plans, priorities, milestones, resource needs, and technical deliverables across assigned programs. Supervise and mentor assigned staff, coordinate multidisciplinary work, review scientific data, and communicate progress, risks, and recommendations to IMCPL leadership. Recommend analytical platforms, equipment, training, and external services needed to meet program objectives. Assist the QC Manager and Product Managers in developing and implementing product-specific processes, shared technology platforms, analytical tools, standardized workflows, and data analysis approaches supporting product development, manufacturing, and QC testing.

Sitting and standing for long periods. Reading small print on tubes and vials. Walking around campus to attend meetings. Lifting up to 30 pounds. Bending and lifting to put away supplies. Working under standing office and lab lighting.

The University of Pittsburgh is an equal opportunity employer / disability / veteran.