Major responsibilities

• Develop UCAR-T platform across key unit operations (T‑cell isolation/activation, viral/non‑viral gene delivery, in‑vitro expansion system, harvest, formulation and fill/finish) and build up representative small-scale model.
• Optimize process parameters and materials (activation condition, electroporation setting, media component, feeding/control strategies) to improve process performance (knock-in/out efficiency, viability, expansion, etc.) and product quality (viability, purity, etc.) and to ensure lot-to-lot consistency.
• Apply QbD during process development and optimization; implement PAT and statistical modeling (JMP) for parameter optimization, process capability evaluation, and build traceable data chains.
• Provide phase‑appropriate process development and technical deliverables, and support IIT adaptability, INDa filing readiness, late‑stage characterization and PPQ execution.
• Translate lab processes to clinical‑grade closed and automated systems; tech transfer process to clinical manufacturing.
• Draft technical documents including process development reports, manufacturing batch record, IND Module 3 and other related files; partner with Regulatory/Quality to ensure dossier completeness and review readiness.
• Ensure data authenticity and completeness related to the activities conducted.
• Complete other tasks assigned by the line manager.

Education, Qualifications, Skills and Experience

• Education: PhD or MSc in Cell Biology, Immunology, Molecular Biology, Bioengineering, Pharmacy, or related field.
• Technical expertise: Hands-on experience in autologous and allogeneic CAR‑T process development and manufacturing; familiarity with UCAR‑T gene editing tools such as CRISPR/Cas9 based mutation.
• Process and equipment: Experience with closed and automated systems; familiarity with Xenon electroporation system, Xuri W25/WAVE, large-scale filling; proven lab‑to‑clinical scale‑up and tech transfer.
• Data and modeling: Proficiency in statistical design/modeling (JMP) for parameter optimization, process capability, and consistency control.
• Collaboration: Experience in cross-function collaboration (MSAT, QA/QC, Manufacturing, Regulatory, Translational Medicine, Clinical).
• Experience: Typically, 2+ years (PhD) or 5+ years (MSc) in cell therapy or related biopharma; IND or BLA experience is a plus.
• Experience in UCAR-T full scale process platform is a plus.
• Basic English skills in reading and writing.