Cell Development Principal Scientist , Process Development

Major responsibilities Platform strategy and governance (under PD) : Define and iterate the UCAR‑T platform roadmap (donor strategy, gene editing/immune‑evasion designs, transduction/transfection routes, expansion systems, formulation and release standards); establish end‑to‑end SOPs, specifications, and platform data assets. Core process development and scale‑up : Lead UCAR‑T manufacturing across key unit operations (T‑cell isolation/activation, lentiviral/non‑viral gene delivery, in‑vitro expansion, harvest, and fill/finish); optimize CPPs/CMAs (cell density, media/cytokine cocktails, feeding/control strategies) to improve viability, transduction efficiency, and lot‑to‑lot consistency. Stage‑specific program support (INDa/late stage/IIT) : Provide phase‑appropriate process development and technical deliverables for multiple programs, supporting INDa filing readiness, late‑stage characterization and PPQ planning/execution, and IIT adaptability and risk control; ensure alignment across global/China pathways and trial settings (IIT/registration). Lab‑to‑clinical translation : Transition lab processes to clinical‑grade closed and automated systems; QbD/PAT and data‑driven decisions : Apply QbD to manage CPPs/CMAs and CTQs; implement PAT and statistical modeling (JMP) for parameter optimization, process capability assessment, and deviation root‑cause analysis; build traceable data chains and knowledge bases. Technical documentation and compliance : Lead process development reports, tech transfer packages, IND Module 3; partner with Regulatory/Quality to ensure dossier completeness and review readiness. Team leadership and scope : Direct the UCAR‑T platform team within PD. Education, Qualifications, Skills and Experience Education : PhD in Cell Biology, Molecular Biology, Bioengineering, Immunology, Pharmacy, or related; industry experience required. Technical expertise : End‑to‑end experience in autologous and allogeneic CAR‑T manufacturing; deep familiarity with UCAR‑T gene editing/immune‑evasion, and manufacturing risk mitigation. Process and equipment : Experience with closed and automated systems; familiarity with Xuri W25, G‑Rex100M; proven lab‑to‑clinical scale‑up and tech transfer. Quality and compliance : Knowledge of CGT CMC requirements and IND/BLA technical documentation; Data and modeling : Proficiency in PAT and statistical design/modeling (JMP) for parameter optimization, process capability, and consistency control. Program and collaboration : Track record of cross‑functional collaboration (CMC, MSAT, QA/QC, Clinical, Regulatory, Manufacturing) and global/region program work; ability to translate complex technical results into actionable recommendations. Experience : Typically, 5+ years in cell therapy or related biopharma (relevant PhD/postdoc counted); IND or BLA experience is a plus. Date Posted 06-Jan-2026 Closing Date 29-Apr-2026 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.