CMC lead for Biologics — 恒瑞-全球精英计划

工作职责

位置：苏州、广州、连云港

一、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。

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

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

四、管线分子监督（Pipeline Molecule Oversight）

五、跨职能整合（Cross-Functional Integration）

六、技术卓越（Technical Excellence）

七、团队领导力（Team Leadership）

八、风险管理（Risk Management）

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

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：

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

2. End-to-End Program Oversight

3. Project Management Leadership

4. Pipeline Molecule Oversight

5. Cross-Functional Integration

6. Technical Excellence

7. Team Leadership

8. Risk Management

Qualifications

1. Education Background

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

2. Relevant Experience

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 :

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.