Associate Director, Cell Therapy Discovery

SUMMARY OF THE ROLE
阿斯利康的细胞治疗研发部门致力于研发新一代细胞疗法以满足我们临床产品线中尚未满足的重大医疗需求该候选人应具备细胞治疗项目的科学的专业背景和经验包括早期研发到工艺开发PD及CMC
Cell Therapy R&D within AstraZeneca is dedicated to discovering engineering and developing next generation cellular therapies to address high unmet medical needs across our clinical portfolio. The role holder will provide scientific technical and regulatory expertise for cell therapy programs delivering from discovery through process development (PD) and CMC.
具体职责包括
1. 负责细胞治疗产品异体/自体/体内给药/实体瘤CAR T的设计优化与临床前开发
2. 负责装甲策略逻辑门控设计基因编辑成药性研究以及病毒及细胞工艺开发PD与CMC
3. 负责细胞治疗产品的检测方法建立鉴定与移交
Specifically the role holder will be:
1. Accountable for the design optimization and preclinical development of cell therapy products (allo/auto/in vivo/solid tumor CAR-T).
2. Accountable for armoring strategies logic gated designs gene editing manufacturability and virus and cell manufacture PD/CMC considerations.
3. Accountable for establishing qualifying and transferring cell based assays in testing laboratories.

ROLE & RESPONSIBILITIES
开发实体瘤与血液肿瘤相关的的新型自体/异体/体内CAR-T细胞治疗产品并完成工艺开发PD与CMC
Lead innovative cell therapy science to advance next generation engineered auto/allo/in vivo CAR-T products for solid and hematologic tumors with strong integration of PD and CMC considerations.
负责从靶点选择结构设计到体外效力与功能检测及体内疗效/安全性研究的工作内容建立产品检测方法建立数据质量监控及方法移交能提供科学性的问题排除方案并进行研究报告撰写及汇报
Lead delivery of target selection construct engineering in vitro potency and functional assays and in vivo efficacy/safety studies; establish and transfer cell based assays in partner laboratories monitor data quality troubleshoot scientifically and prepare study reports with presentations at appropriate forums.
负责满足项目特点的病毒工艺开发PD工作包括工艺设计与优化上游生产生产细胞系建立或瞬时转染方法稳定细胞系建立质粒配比培养基/补料生物反应器参数下游纯化及制剂处方在确保工艺可放大及工艺稳定性的同时最大化滴度感染力与关键质量属性
Own virus PD tailored to project characteristics: design and optimize upstream production (producer cell line or transient transfection stable cell line establishment plasmid ratios media/feed bioreactor parameters) downstream purification (clarification chromatography/filtration concentration) and formulation to maximize titer infectivity and quality attributes while ensuring scalability and robustness.
建立病毒分析及鉴定方法感染性与物理滴度效力/功能检测包膜身份残留物/杂质无菌/内毒素/支原体检测复制型慢病毒RCL检测以及稳定性检测
Establish and qualify virus analytical methods: infectious and physical titer potency/functional assays envelope identity residuals/impurities sterility/endotoxin/mycoplasma replication competent lentivirus (RCL) testing and stability indicating assays.
对细胞治疗技术CAR设计基因编辑装甲/逻辑门控制造/CMC等新型业内技术进行跟踪并对可行的新技术及时进行测试及融入项目定期对项目进展风险与机遇进行更新并解决相关问题
Build and maintain up to date knowledge of cell therapy technologies (CAR design gene editing armoring/logic gating manufacturing/CMC) and integrate best practices into program execution. Provide regular updates on progress risks and opportunities to appropriate governance bodies for review challenge and issue resolution.
监督并确保符合所有阿斯利康政策与标准及适用法律/法规
Monitor and ensure compliance with all AstraZeneca Policies and Standards and applicable laws/regulations;

REQUIREMENTS
Essential:
硕士/博士或同等经验相关专业包括细胞/分子生物学免疫学生物工程生物工艺工程等
Masters/PhD (or equivalent experience) in a relevant discipline (Cell/Molecular Biology Immunology Bioengineering Bioprocess Engineering or related).
在细胞治疗的工艺开发PD与CMC方面具备相当的经验并在LVV上游/下游工艺开发和/或工程化自体/异体/体内CAR-T细胞的不同环节激活转导/编辑扩增制剂中具有实操经验
Demonstrable experience in cell therapy PD and CMC with hands-on ownership of LVV upstream/downstream development and/or engineered auto/allo/in vivo CAR-T cell manufacturing unit operations (activation transduction/editing expansion formulation).
具有建立并验证细胞治疗分析方法的成功经验包括鉴定/表型流式细胞术效力/功能检测载体拷贝数转导效率残留/杂质无菌/内毒素/支原体检测以及RCL检测
Proven track record establishing and validating fit-for-purpose analytical methods for cell therapy: identity/phenotype (flow cytometry) potency/functional assays vector copy number transduction efficiency residuals/impurities sterility/endotoxin/mycoplasma and RCL testing.
具备与内部及外部合作伙伴CDMO原材料供应商检测实验室协作的经验推动技术的适时转移放大/扩增与临床部门的沟通与交付有效进行跨职能跨部门的推进项目执行
Experience collaborating with internal and external partners (CDMOs raw material suppliers assay labs) to drive timely tech transfer scale-up/scale-out and successful clinical supply; effective cross-boundary project execution.
熟悉适用于细胞治疗的GxP及实验室/制造法规与规范
Knowledge of applicable GxP and laboratory/manufacturing regulations for cell therapies

Skills & Capabilities
具备独立调研立项及开展细胞治疗相关项目的能力
Ability to independently research initiate and execute projects related to cell therapy.
擅长开展细胞治疗相关产品的PD/CMC研究并具备识别并解决问题的能力
Proficient in conducting PD/CMC studies for cell therapy products with the capability to identify and resolve issues.
优秀人际交往能力具备跨职能部门协同工作的能力能与研发CMC运营及临床及外部供应商协调配合推进项目进展
Excellent interpersonal skills and cross functional collaboration ability; able to coordinate with R&D CMC Operations Clinical and external suppliers to drive project progress.
熟练掌握英文交流与写作
Proficient in English communication and writing.
Desirable:
能够定义关键质量属性CQA/关键工艺参数CPP开展基于试验设计DoE的工艺表征应用统计过程控制优化成本Cost of Goods COGs并确保供应链稳定原材料质粒生产细胞等
Understanding of CQAs/CPPs DoE based process characterization statistical process control cost of goods optimization and supply chain resilience (raw materials plasmids producer cells).
了解细胞/基因治疗的监管框架与指南FDA/EMAICH药典方法及对IND/IMPD/CTA申报
Awareness of regulatory frameworks and guidance for cell/gene therapies (FDA/EMA ICH pharmacopeial methods) and expectations for IND/IMPD/CTA submissions.

Date Posted

Closing Date

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.