CMC lead for Biologics -

CMC Strategic CMC Leadership

• CMC FDA EMA NMPA

End-to-End Program Oversight

Project Management Leadership

Pipeline Molecule Oversight

Cross-Functional Integration

Technical Excellence

Team Leadership

Risk Management

CMC

FDAEMA

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.