Cell Development l Scientist, Process Development Full-time

CAR-T Manufacturing Process Developer

Major responsibilities

Develop robust CAR-T manufacturing process with in-depth experience in multiple unit operations (e.g., viral/non-viral gene delivery, large scale expansion, formulation).

Optimize critical process parameters and workflow to improve process performance and facilitate operation efficiency, including designing and executing experiments, analyzing data, and providing science-based insight for process improvement with application of professional skills such as DoE, PAT (process analytical technology) and statistical modelling.

Drive platform evolution via exploring novel technologies and innovations (i.e. industry trends, emerging methods, and best practices in the area of cell therapy).

Analyze, document, and present experimental data and findings to internal teams and relevant stakeholders as needed.

Author and review technical documents such as batch records, process development reports, process transfer documents, laboratory and equipment SOPs.

Take a role in lab operation and support team management to promote high-efficiency collaboration within and across teams.

Work closely with cross-function stakeholders to facilitate smooth transfer of developed processes to manufacturing teams, providing detailed process documents, training, and technical support.

Support late-stage development for IND/BLA readiness such as process characterization, providing technical support for PPQ and clinical manufacturing, documentation for regulatory submission.

Ensure data authenticity and compliance with comprehensive documentation including databases, batch records, and other required technical records.

Education, Qualifications, Skills and Experience

PhD or MSc in Cell Biology, Immunology, Molecular Biology, Bioengineering, Pharmacy, or related fields.

Minimum of 3-year industry experience in cell therapy process development. Experience in both autologous and allogeneic CAR-T process development is a plus.

Hands-on experience with large-scale, automated closed processes and multiple unit operations, including electroporation, cell expansion, and high-throughput fill-finish systems. Demonstrated success in process scale-up and scale-down is preferred.

Hands-on experience in development and optimization of process parameters in representative small-scale models. Proven success of transferring developed process to manufacturing is a plus.

Proficiency with statistical analysis software (e.g., JMP/Minitab /GraphPad Prism /Flowjo) is highly desired.

Experience in management of lab operation and team management is a plus.

Creative thinker and proactive doer that can identify and effectively address issues and gaps.

Demonstrated ability to collaborate efficiently with cross-function teams to drive project move forward.

End-to-end experience in IIT, IND or BLA projects is a plus.

Good English skills in reading, writing and speaking is a must.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.