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 urgency, and work across boundaries to deliver medicines that can transform patients' lives. Join a team where your expertise in cell therapy process development can help shape robust manufacturing strategies and advance the next generation of cellular therapies. **Equal Opportunity** AstraZeneca is an equal opportunity employer. We value diversity and inclusion and are committed to creating an environment in which all employees can contribute and thrive. Hiring decisions are based on business needs, job requirements, and individual qualifications. Ready to join us on this mission? Apply now! **Competitive remuneration and benefits apply** We offer a competitive Total Reward program including a market driven base salary, bonus and long-term incentive. We have a generous paid time off program and a comprehensive benefits package. *The annual base pay for this position ranges from* *$112,304.00 - $168,456.00**. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.* **Date Posted** 03-Sep-2026 **Closing Date** 25-Sep-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.