(Associate) Director, Cell Line Engineering and Development (Zhuhai, GD, CN, 519080)

珠海，中国   |   全职   |   Job ID: 11745

Purpose

• 根据公司业务需要，负责抗体及重组蛋白项目的细胞株构建、细胞工程、克隆筛选、细胞株评价、细胞库建立及技术平台建设，为工艺开发、分析开发、质量研究、临床及商业化生产和全球注册申报提供高质量生产细胞株及科学、合规的技术支持。

Based on business needs, lead cell line generation, cell engineering, clone screening, cell line characterization, cell bank establishment, and technology platform development for antibody and recombinant protein programs, providing high-quality production cell lines and scientifically sound, compliant technical support for process development, analytical development, product characterization, clinical and commercial manufacturing, and global regulatory submissions.

Your contribution

• 负责单克隆抗体、双特异性抗体、融合蛋白、ADC抗体及其他重组蛋白项目的细胞株开发，确保按计划、高质量交付；

Lead cell line development for monoclonal antibodies, bispecific antibodies, fusion proteins, ADC antibodies, and other recombinant biologics, ensuring timely and high-quality delivery.

• 根据分子特性、产品质量目标和项目阶段，制定细胞株构建总体策略、技术路线、关键筛选标准及风险缓解计划；

Define overall cell line development strategies, technical approaches, critical screening criteria, and risk mitigation plans based on molecule characteristics, target product quality, and project stage.

• 负责表达载体设计与构建、细胞转染、稳定池建立、单细胞克隆、高通量筛选、克隆评价和主克隆确定；

Lead expression vector design and construction, cell transfection, stable pool generation, single-cell cloning, high-throughput screening, clone characterization, and lead clone selection.

• 负责细胞株生产性能、代谢特征、产品质量、遗传稳定性、表达稳定性及放大潜力的系统评价；

Lead systematic evaluation of cell line productivity, metabolic characteristics, product quality, genetic and expression stability, and scale-up potential.

• 负责细胞工程技术开发与应用，包括CRISPR/Cas9定点整合、基因敲除/敲入、糖基化通路改造及宿主细胞优化；

Lead development and application of cell engineering technologies, including CRISPR/Cas9 targeted integration, gene knockout/knock-in, glycosylation pathway engineering, and host cell optimization.

• 建立并持续优化单细胞克隆、高通量筛选、微型生物反应器和自动化数据分析等CLD技术平台；

Establish and continuously optimize CLD platforms for single-cell cloning, high-throughput screening, miniature bioreactors, automation, and data analytics.

• 负责RCB、MCB和WCB建立策略、细胞库表征、稳定性研究、GMP制备及跨地点技术转移支持；

Lead strategies for RCB, MCB, and WCB establishment, cell bank characterization, stability studies, GMP preparation, and cross-site technology transfer.

• 支持工艺开发、分析开发、制剂开发、质量研究、稳定性研究、可比性研究及工艺变更评估，并提供科学判断；

Support process development, analytical development, formulation development, product characterization, stability studies, comparability studies, and process change assessments, and provide scientific judgment.

• 负责细胞株开发方案、研究报告、SOP、技术转移文件、风险评估及申报资料相关章节的撰写和审核；

Prepare and review cell line development protocols, study reports, SOPs, technology transfer documents, risk assessments, and relevant regulatory submission sections.

• 负责或支持中、美、欧注册申报中细胞基质、细胞库和细胞株开发相关章节的撰写、审核及监管问询回复；

Lead or support preparation, review, and responses to regulatory questions for cell substrate, cell bank, and cell line development sections in submissions in China, the United States, and Europe.

• 负责细胞株开发相关技术问题、异常结果及项目风险的调查、根因分析、风险评估和CAPA制定；

Lead investigations, root cause analyses, risk assessments, and CAPA development for technical issues, atypical results, and project risks related to cell line development.

• 参与偏差、OOS/OOT、变更控制、实验室调查、供应商或CDMO技术评估，并提供科学合理的技术支持；

Participate in deviations, OOS/OOT, change controls, laboratory investigations, and technical assessments of vendors or CDMOs, providing scientifically justified support.

• 建立并持续完善细胞株构建标准化流程、技术规范、数据管理和知识管理体系，推动平台效率和成功率提升；

Establish and continuously improve standardized workflows, technical standards, data management, and knowledge management systems to enhance platform efficiency and success rates.

• 负责团队日常管理、人员培养、绩效管理、资源规划、预算管理和项目优先级协调；

Manage daily team operations, talent development, performance management, resource planning, budget management, and project prioritization.

• 与研发、CMC、PD、AD、MSAT、QA、QC、RA、临床及外部合作方保持高效沟通，推动跨部门和跨区域项目执行；

Maintain effective communication with Research, CMC, PD, AD, MSAT, QA, QC, Regulatory Affairs, Clinical, and external partners to enable cross-functional and cross-regional project execution.

• 能够使用流利英语进行技术汇报、项目讨论、客户沟通、审计交流和国际会议沟通。

Use fluent English for technical presentations, project discussions, client communications, audit interactions, and global meetings.

A good match

• 生物学、分子生物学、细胞生物学、生物工程、生物化学、药学或相关专业硕士及以上学历；博士学历优先。

Master’s degree or above in Biology, Molecular Biology, Cell Biology, Bioengineering, Biochemistry, Pharmaceutical Sciences, or a related discipline; Ph.D. preferred.

• 具有10年以上生物制药行业细胞株开发工作经验，其中至少5年以上团队管理经验；

At least 10 years of experience in cell line development within the biopharmaceutical industry, including a minimum of 5 years of people management experience.

• 具有单克隆抗体、双特异性抗体、融合蛋白、ADC抗体或其他重组蛋白项目的细胞株开发经验；

Extensive cell line development experience for monoclonal antibodies, bispecific antibodies, fusion proteins, ADC antibodies, or other recombinant biologics.

• 精通CHO细胞表达系统开发全流程，包括表达载体构建、细胞转染、稳定池建立、单细胞克隆、高通量筛选、克隆评价及主克隆确定；

Expert knowledge of end-to-end CHO cell line development, including expression vector construction, transfection, stable pool generation, single-cell cloning, high-throughput screening, clone characterization, and lead clone selection.

• 具备CRISPR/Cas9介导的定点整合、基因敲除、基因敲入及宿主细胞工程改造经验；

Hands-on experience with CRISPR/Cas9-mediated targeted integration, gene knockout, gene knock-in, and host cell engineering.

• 具备细胞株产量、产品质量、遗传稳定性、表达稳定性及工艺适应性评价经验；

Experience evaluating cell line productivity, product quality, genetic and expression stability, and process fitness.

• 具有RCB、MCB和WCB建立、表征、稳定性研究、GMP生产及技术转移支持经验；

Experience supporting RCB, MCB, and WCB establishment, characterization, stability studies, GMP manufacture, and technology transfer.

• 熟悉细胞基质和细胞库相关法规与行业指南，包括ICH、NMPA、FDA及EMA要求；

Familiar with regulatory requirements and industry guidelines for cell substrates and cell banks, including ICH, NMPA, FDA, and EMA expectations.

• 具有支持中、美、欧IND、BLA或MAA等注册申报及监管问询回复的经验；

Experience supporting IND, BLA, or MAA submissions and responses to regulatory questions in China, the United States, and Europe.

• 英文技术文件读写能力优秀，口语流利，能够独立参与或主持国际技术会议、跨区域项目讨论、客户沟通及审计交流。

Proficient in reading, writing, and reviewing technical documents in English, with fluent verbal communication skills and the ability to independently participate in or lead global technical meetings, cross-regional project discussions, client communications, and audit interactions.

• 具备扎实的分子生物学、细胞生物学、遗传工程和生物药开发基础；

Possess a strong foundation in molecular biology, cell biology, genetic engineering, and biologics development.

• 熟悉宿主细胞工程策略，包括提高表达量、优化糖基化、降低产品异质性及改善产品可开发性；

Strong understanding of host cell engineering strategies to improve productivity, optimize glycosylation, reduce product heterogeneity, and enhance developability.

• 能够根据分子特性和项目阶段制定细胞株开发策略、筛选标准、风险控制方案及决策路径；

Ability to define cell line development strategies, screening criteria, risk controls, and decision pathways based on molecule characteristics and project stage.

• 熟悉自动化及高通量CLD平台，如单细胞成像、克隆筛选、微型生物反应器和数据集成平台；

Familiar with automated and high-throughput CLD platforms, including single-cell imaging, clone screening, miniature bioreactors, and integrated data systems.

• 具备良好的统计学、实验设计和数据分析能力，能够开展趋势分析、多参数克隆比较和科学决策；

Good knowledge of statistics, design of experiments, and data analysis to support trend analysis, multiparameter clone comparison, and scientific decision-making.

• 具备良好的GMP意识，熟悉数据完整性、偏差调查、变更控制、OOS/OOT处理及质量体系要求；

Strong GMP awareness and familiarity with data integrity, deviation investigation, change control, OOS/OOT handling, and quality system requirements.

• 具备跨部门沟通和项目管理能力，能够与工艺开发、分析开发、制剂、质量、注册、临床及外部合作方高效协作；

Strong cross-functional communication and project management skills, with the ability to collaborate effectively with Process Development, Analytical Development, Formulation, Quality, Regulatory Affairs, Clinical, and external partners.

• 具备团队建设、人才培养、绩效管理、资源规划及技术能力建设经验。

Experience in team building, talent development, performance management, resource planning, and technical capability building.

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