Senior Scientist, Allogeneic T-Cell Therapy Process Development
About The Position
We are looking for a Senior Scientist to join our Allogeneic T-Cell Therapy Process Development team. In this role, you'll be instrumental in supporting the development of clinical manufacturing processes for allogeneic CAR-T and TCR-T products. At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. This is an opportunity to work with curious minds in an inclusive culture, where you'll be evaluating cell therapy process and technology improvements, contributing to process understanding and characterization, and assisting tech transfer to a cGMP environment. Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration. The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly designed, activity-based workspaces to suit a variety of working styles while increasing collaboration between teams. The Allogeneic T-Cell Therapy Process Development team within the Cell Therapy Technical Operations (CTTO) group and Cell Therapy Enterprise Unit is responsible for developing, optimizing, characterizing, and scaling manufacturing processes for allogeneic CAR-T and TCR-T cell therapies. The team supports cell engineering and process development activities required to generate high-quality allogeneic T-cell products, including optimization of gene editing, culture expansion, scale-up, and process characterization strategies. In addition, the group produces material to support IND-enabling studies and works closely with cross-functional partners to enable technical transfer to clinical and commercial manufacturing sites. The team also contributes to product characterization, manufacturing deviation support, regulatory submissions, and continuous improvement of cell therapy manufacturing processes.
Requirements
- Experience culturing human primary cells (T cell culture experience necessary).
- Knowledgeable about upstream and downstream process development for cell therapies both laboratory based and tech transfer based.
- Strong flow cytometry T cell characterization experience.
- Experience engineering cells in scale-up processes with manufacture-ready genome editing tools and DNA/RNA transfection approaches.
- Familiar with the fundamentals of DOE.
- Strong background in experimental design and data analysis skills are essential.
- Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning.
- Excellent teamwork and communication skills including proven technical writing skills are required.
- Position may require weekend work.
Nice To Haves
- Knowledge about immunology is highly desirable.
- Experience with cell editing technologies: CRISPR/Cas9, base editing, etc.
- Experience with viral transduction techniques desirable.
- GMP experience preferred.
- Experience with cell characterization (dPCR, ELISA, NGS) ideal.
- Scientific rigor in assessing own data and that of others.
- Utilizes forward-looking perspective to contribute to “go/no go” decisions.
Responsibilities
- Perform a substantial amount of hands-on cell culture work, including human CAR-T and TCR-T cell generation, in vitro expansion, scale-up, and characterization of culture processes.
- Perform gene editing activities and manipulation of human primary cells, while applying strong scientific judgment to support process optimization, process characterization, and development of scalable manufacturing approaches.
- Independently own the design, execution, analysis, interpretation, and documentation of process development studies.
- Lead studies with minimal supervision, use data-driven decision-making to guide next steps, troubleshoot technical challenges, and contribute to the overall technical strategy for allogeneic CAR-T and TCR-T process development.
- Collaborate closely with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and other partner functions to support process understanding, technology transfer, and clinical manufacturing readiness.
- Provide scientific guidance and mentorship to junior scientists and associates, helping to strengthen technical capability, experimental rigor, and effective execution across the team.
- Support tech transfer activities such as batch record and SOP development, real-time troubleshooting, investigation and impact assessment of deviations, change control management, process monitoring and data analysis, and risk assessments.
- Author and contribute to development reports, scientific publications, patents, and regulatory filings in different countries and regions.
- May require traveling domestically and abroad.
Benefits
- Qualified retirement programs
- Paid time off (i.e., vacation, holiday, and leaves)
- Health coverage
- Dental coverage
- Vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Senior
