理化分析经理（BsAb分析方向）

Job description

理化分析经理（BsAb分析方向） 珠海，中国 | 全职 | Job ID: 11766 About the role: 负责领导理化分析团队及平台建设，支持 BsAbs 项目从早期开发到商业化申报阶段的分析开发工作，涵盖关键质量属性（ CQA ）分析方法开发、验证与转移，以及复杂分析问题解决。负责技术报告和注册申报文件的撰写与审核，确保数据符合科学和法规要求。 Lead the Physicochemical Analysis team and BsAb analytical platform development, supporting analytical development activities for ADCs from early development through regulatory submission. Oversee CQA method development, validation, transfer, and complex analytical troubleshooting. Author and review technical and regulatory documents, ensuring scientific rigor and regulatory compliance. Your contribution: 领导并发展高绩效理化分析团队，负责双特异性抗体（BsAbs）分析能力建设与持续提升，包括分析平台规划、先进分析技术引入、方法体系开发及团队专业能力培养。建立并完善BsAbs分析平台，推动关键分析技术创新与最佳实践落地，解决复杂BsAbs分子开发过程中的分析挑战，为项目开发和全球注册提供技术支持。 Lead and develop a high-performing physicochemical analysis team, driving the establishment and continuous advancement of analytical capabilities for bispecific antibodies (BsAbs). This includes strategic planning of analytical platforms, implementation of advanced analytical technologies, development of fit-for-purpose methodologies, and cultivation of technical excellence within the team. Establish and enhance BsAb analytical platforms, drive analytical innovation and best practices, and provide scientific leadership in resolving complex analytical challenges associated with next-generation bispecific antibody formats. ​负责双特异性抗体项目全生命周期的分析开发工作，涵盖关键质量属性（CQA）分析方法的开发、优化、确认、验证、转移及生命周期管理。 Provide scientific and technical leadership for end-to-end analytical development of BsAb programs throughout the product lifecycle. Responsibilities include the development, optimization, qualification, validation, transfer, and lifecycle management of analytical methods for critical quality attributes (CQAs). ​以中英文撰写、审核技术报告及注册申报相关文件（IND、BLA），确保分析数据的准确性、科学性、合规性。 Author and review technical reports and regulatory documents (IND, BLA) in both English and Chinese. ​与 CMC、法规事务（RA）、项目管理（PM）及全球团队保持紧密合作，高效推进项目进展。 Collaborate closely with CMC, RA, PM, and global teams to drive projects forward.​ A good match: 生物化学、分析化学或相关专业硕士或博士学位。 Master’s/Ph.D. in Biochemistry, Analytical Chemistry, or a related field. 8年以上mAb或BsAb理化分析开发相关的扎实经验；2 年以上治疗性抗体表征分析的实操经验；3 年以上技术团队管理经验。 Over 8 years of proficient experience in mAb or BsAb physicochemical analysis development, over 2 years of hands-on experience in therapeutic antibody characterization, and over 3 years of team leadership experience.​ ​​具备良好的中英文口语沟通能力，能够流利进行专业交流与技术写作。 Fluently communicate in both Chinese and English . ​具备扎实的单克隆抗体（mAb）或双特异性抗体（BsAb）理化分析方法开发经验，能够独立开展并解决复杂分析问题，相关经验包括但不限于：含量及浓度分析（Titer、SoloVPE）、纯度分析（SEC、CE-SDS、RP-HPLC/UPLC）、电荷异质性分析（IEX-HPLC、icIEF、CZE）、肽图分析及一级结构表征（RP-UPLC Peptide Mapping）、糖基化修饰分析（HILIC Glycan Profiling）、制剂辅料分析（HPLC-ELSD、CAD）、颗粒及聚集体分析（DLS、MFI、MALS）、残留杂质分析、降解产物及稳定性相关杂质分析 。 Demonstrated hands-on expertise in physicochemical method development for mAbs and/or BsAbs, with the ability to independently troubleshoot and solve complex analytical challenges. Experience should include, but is not limited to: Protein concentration and titer determination (Titer, SoloVPE) 、Purity assessment (SEC, CE-SDS, RP-HPLC/UPLC), Charge heterogeneity (IEX-HPLC, icIEF, CZE), Peptide mapping (RP-UPLC) 、Glycosylation profiling (HILIC-based glycan analysis), Formulation excipient analysis (HPLC-ELSD, CAD), Particle and aggregate (DLS, MFI, MALS), Residual impurity analysis, Degradation product and stability-related impurity analysis . ​熟练掌握色谱、电泳及光谱等分析技术，能够将相关分析工具应用于治疗性抗体关键质量属性（CQA）的控制，支持工艺开发、制剂开发、可比性研究及注册申报工作。具备解决复杂双特异性抗体分析挑战的能力，能够独立设计分析策略并推动技术问题解决。 Strong knowledge of chromatographic, electrophoretic, and spectroscopic analytical techniques, with the ability to apply these tools to the control of CQAs of therapeutic antibodies. Capable of supporting process development, formulation development, comparability studies, and regulatory submissions. Proven ability to develop analytical strategies and address complex analytical challenges associated with bispecific antibody molecules. ​具备对治疗性抗体研发及生产工艺流程的理解，能够将工艺认知与产品质量特性相结合，识别关键质量属性（CQA），并建立科学、风险导向的质量控制策略。 Demonstrated strong understanding of therapeutic antibody development and manufacturing processes. Capable of integrating process knowledge with product quality understanding to establish science- and risk-based control strategies, and to define CQAs. ​具备成熟的中、美、欧药品注册申报支持经验，参与不少于8个IND项目的分析开发及CMC申报工作。具备临床后期开发、可比性研究、上市申报（BLA/NDA）或生命周期管理经验者优先。 Extensive experience supporting regulatory submissions in China, the United States, and Europe, with direct involvement in analytical development and CMC dossier preparation for at least eight IND programs. Experience with late-stage development, comparability studies, BLA/NDA submissions, or lifecycle management is highly preferred. ​熟悉 ICH Q14《分析方法开发》指导原则及分析方法生命周期管理理念，能够运用科学和风险导向的方法开展分析方法开发、关键方法参数（CMP）识别、实验设计（DoE）、方法稳健性评估及分析方法设计空间（MODR）的建立，支持方法验证、技术转移及注册申报工作。 Thorough understanding of ICH Q14 Analytical Procedure Development and analytical lifecycle management principles. Capable of applying science- and risk-based approaches to analytical method development, including identification of critical method parameters (CMPs), design of experiments (DoE), method robustness assessment, and establishment of analytical design spaces (Method Operable Design Region, MODR). Able to support method validation, technology transfer, and regulatory submissions throughout the product lifecycle. 具备良好的技术团队管理经验。 Demonstrated experience leading technical teams. 自我驱动，具备良好的团队合作精神，能够赋能团队成员并促进整体能力提升。 Self-motivation, and a collaborative spirit that empowers the team. 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