Scientist, Process Development - Cell Therapy (CAR-T)

About the role

AstraZeneca is hiring a Scientist, Process Development for its cell therapy business in Shanghai (Guilin Road). The role focuses on developing robust CAR-T manufacturing processes, optimizing them and supporting their transfer to manufacturing and late-stage development.

Key responsibilities

• Develop robust CAR-T manufacturing processes with experience in multiple unit operations such as viral/non-viral gene delivery, large-scale expansion and formulation.
• Optimize critical process parameters and workflows by designing and running experiments, analyzing data and applying DoE, PAT and statistical modelling.
• Explore new technologies and innovations in cell therapy and drive platform evolution.
• Analyze, document and present experimental data to internal teams and stakeholders.
• Author and review batch records, process development reports, process transfer documents and SOPs.
• Support lab operations and team management, and help transfer developed processes to manufacturing teams with training and technical support.
• Support late-stage development for IND/BLA readiness, including process characterization, PPQ and clinical manufacturing support and regulatory documentation.
• Ensure data authenticity and compliance through complete documentation.

Required profile

• PhD or MSc in Cell Biology, Immunology, Molecular Biology, Bioengineering, Pharmacy or a related field.
• At least 3 years of industry experience in cell therapy process development; experience with both autologous and allogeneic CAR-T is a plus.
• Hands-on experience with large-scale, automated closed processes and unit operations such as electroporation, cell expansion and high-throughput fill-finish systems; proven scale-up/scale-down and process transfer is preferred.
• Good English in reading, writing and speaking is a must.

Required skills

• Statistical analysis software (JMP, Minitab, GraphPad Prism, FlowJo) highly desired.
• Experience managing lab operations and teams is a plus.
• End-to-end experience in IIT, IND or BLA projects is a plus.