Senior Scientist, Allogeneic T-Cell Therapy Process Development

AstraZeneca•Gaithersburg, MD

3d•Onsite

About The Position

AstraZeneca is seeking a Senior Scientist to join their Allogeneic T-Cell Therapy Process Development team. This role is crucial for supporting the development of clinical manufacturing processes for allogeneic CAR-T and TCR-T products. The position involves evaluating cell therapy process and technology improvements, contributing to process understanding and characterization, and assisting with tech transfer to a cGMP environment. The Gaithersburg, Maryland facility is a vibrant scientific campus focused on R&D and Oncology in the US, featuring modern lab spaces and amenities designed to foster collaboration and employee well-being. The Allogeneic T-Cell Therapy Process Development team, part of the Cell Therapy Technical Operations (CTTO) group, is responsible for developing, optimizing, characterizing, and scaling manufacturing processes for allogeneic CAR-T and TCR-T cell therapies. This includes optimization of gene editing, culture expansion, scale-up, and process characterization. The team also produces material for IND-enabling studies, collaborates on technical transfer to manufacturing sites, and supports product characterization, deviation investigations, regulatory submissions, and continuous process improvement.

Requirements

Experience culturing human primary cells (T cell culture experience necessary).
Knowledgeable about upstream and downstream process development for cell therapies (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.
Ability to think critically, analytically, and demonstrate troubleshooting and problem-solving skills based on deductive reasoning.
Excellent teamwork and communication skills, including proven technical writing skills.
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.

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 hands-on cell culture work, including human CAR-T and TCR-T cell generation, in vitro expansion, scale-up, and characterization of culture processes.
Conduct gene editing activities and manipulation of human primary cells.
Apply scientific judgment to support process optimization, process characterization, and development of scalable manufacturing approaches.
Independently design, execute, analyze, interpret, and document process development studies.
Lead studies with minimal supervision, use data-driven decision-making, troubleshoot technical challenges, and contribute to the technical strategy for allogeneic CAR-T and TCR-T process development.
Collaborate cross-functionally with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and other partner functions.
Provide scientific guidance and mentorship to junior scientists and associates.
Support tech transfer activities, including batch record and SOP development, real-time troubleshooting, deviation investigation and impact assessment, change control management, process monitoring and data analysis, and risk assessments.
Author and contribute to development reports, scientific publications, patents, and regulatory filings.