Job Description

工作职责

位置：苏州、广州、连云港

一、CMC 战略领导力（Strategic CMC Leadership）

1. 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。

二、全流程项目监督（End-to-End Program Oversight）

1. 对所有 CMC 职能进行整合监督与指导，包括：
2. 细胞系开发与上游工艺开发（Cell Line Development and Upstream Process Development）
3. 下游纯化工艺开发（Downstream Purification Process Development）
4. 分析开发与质量控制（Analytical Development and Quality Control）
5. 制剂开发（配方、冻干、装置兼容性）（Drug Product Development (Formulation, Lyophilization, Device Compatibility)）
6. 技术转移（Manufacturing Science and Technology）
7. 项目管理（CMC Project Management）

三、项目管理领导力（Project Management Leadership）

1. 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
2. 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
3. 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

四、管线分子监督（Pipeline Molecule Oversight）

1. 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
2. 制定并维护分子特异性 CMC 开发计划及风险缓解策略
3. 定期开展管线评审，跟踪进展、识别瓶颈并实施纠正措施

五、跨职能整合（Cross-Functional Integration）

1. 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。

六、技术卓越（Technical Excellence）

1. 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。

七、团队领导力（Team Leadership）

1. 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。

八、风险管理（Risk Management）

1. 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。

任职资格

一、教育背景

生物科学、化学工程、生物化学或相关专业高等学位（优先考虑博士学位）。

二、相关经验

1. 至少 15 年生物药 CMC 开发递进式工作经验。
2. 具备领导多个生物药项目从早期开发推进至 BLA/MAA 批准及商业化的经证实业绩记录。
3. 拥有 CMC 领域 PM 团队管理经验，具备项目管理体系实施经验。

三、语言能力

需精通英语；优先考虑中文普通话能力较强者。

能力要求

一、专业技术能力

具备跨多个 CMC 学科的深厚技术专长，精通：

1. 复杂分子的工艺开发与放大
2. 分析方法开发与验证
3. 制剂开发（含冻干及装置整合）
4. cGMP 生产与质量体系

二、监管沟通能力

精通全球监管要求，具备与监管机构（FDA、EMA 会议及检查）直接沟通的丰富经验。

三、管线管理能力

具备出色的管线管理能力，有同时跟踪多个分子进展的经验。

四、领导影响力

具备强大的领导气场，能够在矩阵式环境中影响各层级人员并推动决策制定。

五、问题解决能力

具备卓越的战略思维与问题解决能力，能够应对复杂的技术与监管挑战。

六、沟通协作能力

具备出色的沟通及利益相关者管理能力。

English Job Description (JD)

Job Responsibilities

Location: Suzhou/ Guangzhou/ Lianyungang

1. Strategic CMC Leadership

1. 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.).

2. End-to-End Program Oversight

1. Provide integrated oversight and direction across all CMC functions including:
2. Cell Line Development and Upstream Process Development
3. Downstream Purification Process Development
4. Analytical Development and Quality Control
5. Drug Product Development (Formulation, Lyophilization, Device Compatibility)
6. Manufacturing Science and Technology (Technology Transfer)
7. CMC Project Management

3. Project Management Leadership

1. Directly manage the CMC Project Management team to ensure effective tracking and reporting of program milestones
2. Implement and maintain robust project management systems and dashboards for real-time program monitoring
3. Ensure cross-functional alignment on timelines, resources, and deliverables across all CMC programs

4. Pipeline Molecule Oversight

1. Provide comprehensive oversight and guidance for all molecules in the pipeline, from early research through commercialization
2. Establish and maintain molecule-specific CMC development plans and risk mitigation strategies
3. Conduct regular portfolio reviews to track progress, identify bottlenecks, and implement corrective actions

5. Cross-Functional Integration

1. 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.

6. Technical Excellence

1. 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.

7. Team Leadership

1. 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.

8. Risk Management

1. Identify and mitigate CMC development risks. Implement effective contingency plans to ensure program success.

Qualifications

1. Education Background

Advanced degree (Ph.D. preferred) in Biological Sciences, Chemical Engineering, Biochemistry, or related field.

2. Relevant Experience

1. Minimum of 15+ years of progressive experience in biologics CMC development
2. Proven track record of successfully leading multiple biologics programs from early development through BLA/MAA approval and commercialization.
3. Strong experience in managing project management teams and implementing project management systems in a CMC environment.

3. Language Proficiency

Fluency in English required; proficiency in Mandarin Chinese is highly advantageous.

Competency Requirements

1. Professional Technical Competence

Deep technical expertise across multiple CMC disciplines with strong knowledge of:

1. Process development and scale-up for complex molecules
2. Analytical method development and validation
3. Drug product development including lyophilization and device integration
4. cGMP manufacturing and quality systems

2. Regulatory Communication Ability

Extensive experience with global regulatory requirements and successful health authority interactions (FDA, EMA meetings and inspections).

3. Pipeline Management Ability

Excellent portfolio management skills with experience tracking multiple molecules simultaneously.

4. Leadership Influence

Strong leadership presence with demonstrated ability to influence at all levels and drive decision-making in a matrix environment.

5. Problem-Solving Ability

Excellent strategic thinking and problem-solving skills, with ability to navigate complex technical and regulatory challenges.

6. Communication and Collaboration Ability

Outstanding communication and stakeholder management skills.

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