Senior Scientist. Cell Therapy Process Development

Job description

About AstraZeneca Do you have a passion for science and a desire to translate ideas into life-changing medicines? At AstraZeneca, we put patients first and foster a collaborative, inclusive environment where diverse perspectives, scientific rigor, and bold thinking help advance innovative therapies for patients worldwide. About the Gaithersburg Site Our Gaithersburg, Maryland campus is a major U.S. hub for R&D and Oncology. The site brings together multidisciplinary scientists, modern laboratories, and cross-functional development teams to advance medicines from discovery through clinical and commercial development. Position Summary We are seeking a highly motivated Senior Scientist to lead and execute CAR-T cell therapy process development activities, with an emphasis on autologous manufacturing processes. The successful candidate will apply strong scientific and technical judgment to develop robust, scalable, and transferable processes; evaluate new cell therapy processing equipment; and collaborate across research, analytical, drug product, manufacturing, quality, and regulatory functions to advance programs from preclinical development through clinical stages. Key Responsibilities • Lead the design, execution, and interpretation of laboratory studies supporting CAR-T process development, including cell selection, activation, gene modification, expansion, harvest, formulation, and cryopreservation. • Develop and optimize unit operations and integrated manufacturing workflows for autologous CAR-T products using quality-by-design and risk-based principles. • Evaluate, select, and implement commercially available cell therapy process equipment and closed or functionally closed processing technologies; assess fit for intended use, scalability, process robustness, and manufacturing readiness. • Develop equipment operating strategies, define critical process parameters, and troubleshoot cell processing platforms and associated single-use consumables. • Apply flow cytometry to characterize cell identity, phenotype, viability, activation, differentiation, and other process-relevant attributes; partner with analytical teams on panel strategy, assay execution, and data interpretation. • Perform statistical and multivariate data analysis to understand process performance, identify sources of variability, and inform process characterization and control strategies. • Lead cross-functional technical discussions, communicate study outcomes, and provide clear recommendations to project teams and governance forums. • Support technology transfer to internal and external GMP manufacturing sites, including process documentation, training, engineering runs, deviation investigations, and manufacturing troubleshooting. • Author and review development reports, protocols, risk assessments, technical transfer documents, regulatory submission content, scientific publications, and invention disclosures. • Mentor junior scientists and contribute to a collaborative, safe, and scientifically rigorous laboratory culture. Education and Experience • PhD in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, Biological Sciences, Immunology, or a related discipline with at least 1 years of relevant experience; or MS with at least 4 years; or BS with at least 6 years of relevant industry or academic experience. • Demonstrated experience in cell therapy process development, preferably with autologous CAR-T or other genetically modified immune-cell products. • Experience leading complex experimental programs and working effectively in a matrixed, cross-functional development environment. Required Skills • Strong hands-on experience with mammalian cell culture, aseptic processing, and development of cell therapy manufacturing processes. • Demonstrated ability to design experiments, analyze complex datasets, draw scientifically sound conclusions, and translate findings into process recommendations. • Experience with flow cytometry-based instruments and analysis software, including sample preparation, acquisition, gating, data review, and interpretation. • Experience operating and troubleshooting cell processing equipment and single-use systems used in cell therapy development. • Working knowledge of process scale-up, technology transfer, process characterization, and manufacturing control strategies. • Excellent written and verbal communication skills, with the ability to prepare high-quality technical documents and present conclusions to multidisciplinary audiences. • Ability to work independently, manage multiple priorities, and adapt effectively in a fast-paced development environment. Desired Skills • Direct experience developing autologous CAR-T processes across multiple unit operations and stages of product development. • Familiarity with available cell therapy processing platforms for cell isolation, washing, concentration, activation, expansion, formulation, and closed-system processing. Experience may include platforms such as CliniMACS Prodigy, Sepax/Sefia, LOVO/CUE, DynaCellect, G-Rex, or comparable systems. • Advanced flow cytometry experience, including multicolor panel design, compensation or spectral unmixing, gating strategy development, and analysis of T-cell phenotype and functional markers. • Knowledge of T-cell biology, immunology, cellular engineering, gene delivery technologies, and the relationship between process conditions and product quality attributes. • Experience supporting GMP manufacturing, process validation, regulatory filings, deviation investigations, and interactions across clinical development stages. • Experience with automation, digital process monitoring, data visualization, or statistical software used in bioprocess development. • Demonstrated scientific leadership through mentoring, publications, patents, regulatory contributions, or cross-functional program leadership. Why AstraZeneca? At AstraZeneca, we follow the science, act with ur