主要职责:
我们正在寻找一位卓越且具备战略思维的生物药CMC负责人,为公司生物药管线的CMC工作提供整体领导与方向指引。该岗位负责人将负责 CMC 战略的制定与端到端执行,涵盖从早期开发到商业化批准及生命周期管理的全流程。成功入职者需整合并监督工艺开发、分析开发、制剂开发、生产职能及项目管理工作,确保工艺稳健、可放大且符合合规要求,满足全球监管标准。该职位对于推动公司生物药管线成功获得全球注册至关重要。
We are seeking an exceptional and strategic Head of CMC, Biologics, to provide overall leadership and direction for the Chemistry, Manufacturing, and Controls activities of our biologics portfolio. This individual will be responsible for the end-to-end CMC strategy and execution, from early development through commercial approval and lifecycle management. The successful candidate will integrate and oversee Process Development, Analytical Development, Drug Product Development, Manufacturing functions, and Project Management to ensure robust, scalable, and compliant processes that meet global regulatory standards. This role is critical for driving our biologics pipeline to successful global registrations.
CMC 战略领导力(Strategic CMC Leadership)
制定并实施覆盖整个生物药管线的全面 CMC 战略,确保与公司目标及全球监管要求(美国 FDA、欧洲 EMA、中国 NMPA 等)保持一致。
Develop and implement comprehensive CMC strategies for the entire biologics portfolio, ensuring alignment with corporate goals and global regulatory requirements (US FDA, EMA, NMPA, etc.).
全流程项目监督(End-to-End Program Oversight)
对所有 CMC 职能进行整合监督与指导,包括:
- Provide integrated oversight and direction across all CMC functions including:
- 细胞系开发与上游工艺开发(Cell Line Development and Upstream Process Development)
- 下游纯化工艺开发(Downstream Purification Process Development)
- 分析开发与质量控制(Analytical Development and Quality Control)
- 制剂开发(配方、冻干、装置兼容性)(Drug Product Development (Formulation, Lyophilization, Device Compatibility))
- 技术转移(Manufacturing Science and Technology)
项目管理(CMC Project Management)
项目管理领导力(Project Management Leadership)
直接管理 CMC 项目管理团队,确保项目里程碑的有效跟踪与报告
- Directly manage the CMC Project Management team to ensure effective tracking and reporting of program milestones
- 建立并维护稳健的项目管理体系及仪表盘,实现项目实时监控
Implement and maintain robust project management systems and dashboards for real-time program monitoring
- 确保所有 CMC 项目在时间进度、资源分配及交付成果方面的跨职能协同
Ensure cross-functional alignment on timelines, resources, and deliverables across all CMC programs
管线分子监督(Pipeline Molecule Oversight)
为管线中所有分子(从早期研究到商业化阶段)提供全面监督与指导
Provide comprehensive oversight and guidance for all molecules in the pipeline, from early research through commercialization
- 制定并维护分子特异性 CMC 开发计划及风险缓解策略
Establish and maintain molecule-specific CMC development plans and risk mitigation strategies
- 定期开展管线评审,跟踪进展、识别瓶颈并实施纠正措施
Conduct regular portfolio reviews to track progress, identify bottlenecks, and implement corrective actions
跨职能整合(Cross-Functional Integration)
作为 CMC 工作的责任主体,确保各专业模块的无缝协作,并与研究、临床开发、监管事务及质量保证部门实现有效整合。
Serve as the single point of accountability for CMC activities, ensuring seamless collaboration between technical functions and effective integration with Research, Clinical Development, Regulatory Affairs, and Quality Assurance.
技术卓越(Technical Excellence)
为复杂 CMC 挑战提供专业指导,尤其针对先进制剂(抗体药物偶联物、双特异性抗体、融合蛋白)及难表达分子。推动工艺与产品开发创新。
Provide expert guidance on complex CMC challenges, particularly for advanced modalities (ADCs, bispecifics, fusion proteins) and difficult-to-express molecules. Drive innovation in process and product development.
团队领导力(Team Leadership)
搭建、培养并领导一支由 CMC 领导者、项目经理及技术专家组成的高效团队。营造追求科学卓越、创新及持续改进的文化氛围。
Build, mentor, and lead a high-performing team of CMC leaders, project managers, and subject matter experts. Foster a culture of scientific excellence, innovation, and continuous improvement.
风险管理(Risk Management)
识别并缓解 CMC 开发过程中的风险。制定有效的应急预案,保障项目成功推进。
- Identify and mitigate CMC development risks. Implement effective contingency plans to ensure program success.