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/EMA、ICH、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.