CMC lead for Biologics

CMC Strategic CMC Leadership

1. CMC FDA EMA NMPA

End-to-End Program Oversight

1. CMC
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
7. CMC Project Management

Project Management Leadership

1. CMC
2. CMC

Pipeline Molecule Oversight

1. CMC

Cross-Functional Integration

1. CMC

Technical Excellence

1. CMC

Team Leadership

1. CMC

Risk Management

1. CMC

1. 15 CMC
2. BLA/MAA
3. CMC PM

CMC

1. cGMP

FDA EMA

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.