Senior Scientist, Allogeneic T-Cell Therapy Process Development

Senior Scientist, Allogeneic T-Cell Therapy Process Development: Cell Therapy CMC 

Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! 

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. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. 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. 

About AstraZeneca in Gaithersburg, MD: 

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.   

Summary of the group: 

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. 

Main Duties & Responsibilities: 

This position within the Allogeneic T-Cell Therapy Process Development team will involve 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. The role will require performing 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. 

As a Senior Scientist, you will independently own the design, execution, analysis, interpretation, and documentation of process development studies. You will be expected to 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.

This role will also require close cross-functional collaboration with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and other partner functions to support process understanding, technology transfer, and clinical manufacturing readiness. In addition, you will provide scientific guidance and mentorship to junior scientists and associates, helping to strengthen technical capability, experimental rigor, and effective execution across the team. Responsibilities will include supporting 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. Additionally, you will author and contribute to development reports, scientific publications, patents, and regulatory filings in different countries and regions. Position may require traveling domestically and abroad.  

Required Skills 

• 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. 

Desired Skills: 

• 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. 

Education/Experience:  

• BS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology, or related field with >6 years of relevant experience or MS degree with a minimum of 4 years or PhD with a minimum of 1 year of relevant proven experience. 

Why AstraZeneca? 

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods, and bringing unexpected teams together. Interested? Come and join our journey. 

So, what’s next!  

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.