理化分析经理（BsAb分析方向）
BioNTech SE · Zhuhai, GD, CN, 519080 · China · On-site
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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…