Lead CAR-T Process Scientist (Autologous)

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 116,000 - 174,000; Full time

Job summary

AstraZeneca is seeking a Senior Scientist to lead CAR‑T process development at the Gaithersburg site in Maryland. You will drive autologous manufacturing workflows, evaluate processing equipment, and collaborate across research, analytics, drug product, manufacturing, quality, and regulatory groups to move programs from preclinical to clinical stages.

The role requires strong scientific judgment, hands-on mammalian cell culture, and ability to transfer processes to GMP environments.

Qualifications

• PhD in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, Biological Sciences, Immunology, or related field with 1+ year of relevant experience; or MS with 4+ years; or BS with 6+ years in industry or academia.
• Demonstrated experience in cell therapy process development, preferably autologous CAR‑T or other modified immune-cell products.
• Experience leading complex experimental programs in a matrixed, cross‑functional environment.

Responsibilities

• Design, execute, and interpret lab studies for CAR‑T process development (cell selection, activation, gene modification, expansion, harvest, formulation, cryopreservation).
• Develop and optimize unit operations and workflows for autologous CAR‑T products with QbD and risk-based principles.
• Evaluate and implement cell therapy processing equipment; assess scalability and manufacturing readiness.
• Define critical process parameters and troubleshoot cell processing platforms and single-use systems.
• Characterize cells with flow cytometry; collaborate on panel strategy, assays, and data interpretation.
• Perform statistical/multivariate analysis to understand process performance and variability.
• Lead cross-functional discussions and communicate study outcomes to project teams.
• Support tech transfer to GMP sites, including documentation, training, deviations, and troubleshooting.
• Author/Review reports, protocols, risk assessments, transfer docs, regulatory content, publications, and inventions.
• Mentor junior scientists and foster a rigorous lab culture.

Skills

Cell culture

Aseptic processing

CAR‑T process development

Data analysis

Cross-functional collaboration

Mentoring

Experimental design

Education

PhD in Chemical/Biochemical/Biomedical Engineering or related field

MS with 4+ years of relevant experience

BS with 6+ years of relevant experience

Tools

CliniMACS Prodigy

Sepax/Sefia

LOVO/CUE

DynaCellect

G‑Rex

Flow cytometry software

Job description

AstraZeneca is seeking a Senior Scientist to lead CAR‑T process development at the Gaithersburg site in Maryland. You will drive autologous manufacturing workflows, evaluate processing equipment, and collaborate across research, analytics, drug product, manufacturing, quality, and regulatory groups to move programs from preclinical to clinical stages.

The role requires strong scientific judgment, hands-on mammalian cell culture, and ability to transfer processes to GMP environments.