Senior Scientist II-Cell, Process Development Full-time NEW

Job Title

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, IND 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.

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.