Senior Scientist, Allogeneic T-Cell Therapy Process Development
PharmaBiotech
Job description
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 process es 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 & Responsibilitie s : 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 cell s (T cell culture experience necessary <spa
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