Cell Development l Scientist, Process Development

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.