生化分析副总监

珠海，中国 | 全职 | Job ID: 11693

Position Summary:

• 根据公司业务需要，设立AD生化副总监岗位，负责抗体类生物药项目的生化分析和细胞活性分析平台建设及项目支持工作。该岗位重点负责细胞活性分析方法、生物功能分析方法以及HCP、Protein A残留、残留DNA等杂质检测方法的开发、优化、确认、验证、转移和生命周期管理，为细胞株开发、工艺开发、质量研究、稳定性研究、可比性研究及中美欧注册申报提供科学、可靠和符合法规要求的分析数据及技术支持
  Based on business needs, the Associate Director of Biochemical and Cell-Based Bioassay Development position is established to lead biochemical and cell-based bioassay platform development and project support for antibody-based biologics. This role is primarily responsible for development, optimization, qualification, validation, transfer, and lifecycle management of cell-based potency assays, functional bioassays, and impurity assays including HCP, residual Protein A, and residual DNA. The position provides scientifically sound, reliable, and regulatory-compliant analytical data and technical support for cell line development, process development, product characterization, stability studies, comparability studies, and regulatory submissions in China, the United States, and Europe

Your main responsibilities are:

• 负责抗体类分子的细胞活性分析方法开发、优化、确认、验证、转移及生命周期管理。
Lead development, optimization, qualification, validation, transfer, and lifecycle management of cell-based potency assays for antibody-related molecules.
• 根据产品作用机制建立合适的生物活性和功能分析策略，支持产品关键质量属性研究。
Establish appropriate bioactivity and functional assay strategies based on product mechanism of action to support critical quality attribute assessment.
• 建立并优化细胞功能分析方法，包括但不限于报告基因法、细胞增殖法、细胞毒性法、中和活性法、ADCC、CDC、受体结合及信号通路相关分析。
Establish and optimize cell-based functional assays, including but not limited to reporter gene assays, cell proliferation assays, cytotoxicity assays, neutralization assays, ADCC, CDC, receptor binding assays, and signaling pathway-related assays.
• 负责HCP、Protein A残留、残留DNA等杂质检测方法的开发、优化、确认、验证、转移及持续改进。
Lead development, optimization, qualification, validation, transfer, and continuous improvement of impurity assays, including HCP, residual Protein A, and residual DNA assays.
• 支持细胞株开发、工艺开发、制剂开发、质量研究、稳定性研究和可比性研究，提供及时、准确、可靠的分析数据和技术判断。
Support cell line development, process development, formulation development, product characterization, stability studies, and comparability studies by providing timely, accurate, reliable analytical data and scientific judgment.
• 负责分析方法开发方案、验证方案、方法转移方案、技术报告、SOP及相关质量文件的撰写和审核。
Prepare and review analytical method development protocols, validation protocols, method transfer protocols, technical reports, SOPs, and related quality documents.
• 负责或支持中美欧注册申报资料中生化分析、细胞活性分析及杂质检测相关章节的撰写、审核和问询回复。
Lead or support preparation, review, and response to questions for biochemical assays, cell-based potency assays, and impurity testing sections in regulatory submissions for China, the United States, and Europe.
• 负责细胞活性分析和生化分析相关技术问题的调查、根因分析、风险评估及纠正预防措施制定。
Lead technical investigations, root cause analyses, risk assessments, and CAPA development for cell-based bioassays and biochemical assays.
• 参与OOS/OOT、偏差、变更、方法异常及实验室调查，并提供科学合理的技术支持。
Participate in OOS/OOT, deviation, change control, method abnormality, and laboratory investigations, and provide scientifically justified technical support.
• 建立并持续提升生化和细胞活性分析技术平台，推动方法标准化、平台化和能力建设。
Establish and continuously enhance biochemical and cell-based bioassay platforms, and drive method standardization, platform development, and capability building.
• 负责团队日常管理、人员培养、绩效管理、资源规划和项目优先级协调，确保项目按计划高质量交付。
Manage daily team operations, talent development, performance management, resource planning, and project prioritization to ensure high-quality and timely project delivery.
• 与研发、CMC、质量、注册、临床及外部合作方保持高效沟通，支持跨部门和跨区域项目推进。
Maintain effective communication with Research, CMC, Quality, Regulatory Affairs, Clinical, and external partners to support 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、审计交流和国际会议沟通。
Use fluent English to conduct technical presentations, project discussions, audit communications, and global meeting interactions.

What you have to offer:

• 生物学、生物化学、细胞生物学、药学、生物工程或相关专业硕士及以上学历。
Master’s degree or above in Biology, Biochemistry, Cell Biology, Pharmaceutical Sciences, Bioengineering, or related disciplines.
• 具有10年以上生物制药行业分析开发工作经验，其中至少5年以上团队管理经验；
At least 10 years of experience in analytical development within the biopharmaceutical industry, including a minimum of 5 years of people management experience.
• 具备单克隆抗体、双特异性抗体或重组蛋白产品分析方法开发与验证经验；
Hands-on experience in analytical development and qualification/validation for monoclonal antibodies, bispecific antibodies, or recombinant proteins.
• 精通单克隆抗体、双特异性抗体、融合蛋白等生物药产品的作用机制（MOA）研究和分析策略开发；
Extensive experience in mechanism-of-action (MOA) studies and analytical strategy development for monoclonal antibodies, bispecific antibodies, fusion proteins, and other biologics.
• 精通细胞活性分析（Cell-based Potency Assay）的开发、优化、确认、验证、转移及生命周期管理；
Expert knowledge in development, optimization, qualification, validation, transfer, and lifecycle management of cell-based potency assays.
• 熟悉受体结合、信号通路激活、细胞增殖、细胞毒性、ADCC、CDC、中和活性等功能分析方法；
Strong expertise in receptor-binding, signaling pathway activation, proliferation, cytotoxicity, ADCC, CDC, neutralization assays, and other functional bioassays.
• 具有宿主细胞蛋白（HCP）、Protein A残留、残留DNA等杂质分析方法开发和验证经验；
Experienced in development and validation of impurity assays including HCP, residual Protein A, and residual DNA.
• 熟悉ELISA、MSD、qPCR/ddPCR、流式细胞术（Flow Cytometry）、细胞成像等分析平台；
Experienced with ELISA, MSD, qPCR/ddPCR, Flow Cytometry, and cell imaging platforms.
• 熟悉国内外生物药品质量控制的相应政策和法律法规（ICH、NMPA、FDA、EMA、USP、ChP、EP），GMP要求；
Familiar with relevant domestic and international policies, laws and regulations for quality control of biological products (ICH, NMPA, FDA, EMA, USP, ChP, EP), as well as GMP requirements;
• 具有中、美、欧IND/BLA/MAA申报经验；
Experience supporting IND, BLA, and MAA submissions in major regulatory regions.
• 精通英文技术文件的阅读、撰写和审核，并具备流利的英文口语沟通能力，能够独立参与或主持国际技术会议、跨国项目讨论、客户沟通及审计交流。
Proficient in reading, writing, and reviewing technical documents in English, with fluent verbal English communication skills and the ability to independently participate in or lead global technical meetings, cross-regional project discussions, client communications, and audit interactions.

• 具备扎实的细胞生物学、免疫学、生物化学及抗体药物分析基础。
Possess solid knowledge of cell biology, immunology, biochemistry, and analytical characterization of antibody therapeutics.
• 具备较强的细胞活性分析方法开发能力，能够解决细胞状态、方法变异、信噪比、剂量反应曲线、系统适用性及方法耐用性等关键技术问题。
Strong capability in cell-based bioassay development, with the ability to troubleshoot key technical issues related to cell status, assay variability, signal-to-background ratio, dose-response curves, system suitability, and method robustness.
• 具备良好的统计学和数据分析能力，能够支持细胞活性方法的参数设定、趋势分析和方法性能评估。
Good understanding of statistics and data analysis, with the ability to support parameter setting, trend analysis, and performance evaluation of cell-based potency assays.
• 具备良好的科学判断能力和问题解决能力，能够独立制定复杂项目的分析开发策略。
Demonstrated scientific judgment and problem-solving skills, with the ability to independently develop analytical strategies for complex biologics development programs.
• 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，能够与细胞株开发、工艺开发、制剂、质量、注册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 Cell Line Development, Process Development, Formulation, Quality, Regulatory Affairs, and external partners.
• 具备团队建设、人才培养、绩效管理及技术能力建设经验。
Experience in team building, talent development, performance management, and technical capability building.
• 熟练使用Office等办公软件，能够高质量完成技术报告、方案、SOP及注册资料相关文件。
Proficient in Office and other commonly used software, with the ability to prepare high-quality technical reports, protocols, SOPs, and regulatory submission-related documents.