CMC lead for Biologics -??-??????

English Job Description (JD)

Job Responsibilities

Location : Suzhou / Guangzhou / Lianyungang

• Strategic CMC Leadership
• 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.).
• End-to-End Program Oversight
• Provide integrated oversight and direction across all CMC functions including :
• Cell Line Development and Upstream Process Development
• Downstream Purification Process Development
• Analytical Development and Quality Control
• Drug Product Development (Formulation, Lyophilization, Device Compatibility)
• Manufacturing Science and Technology (Technology Transfer)
• CMC Project Management
• Project Management Leadership
• Directly manage the CMC Project Management team to ensure effective tracking and reporting of program milestones
• Implement and maintain robust project management systems and dashboards for real-time program monitoring
• Ensure cross-functional alignment on timelines, resources, and deliverables across all CMC programs
• Pipeline Molecule Oversight
• Provide comprehensive oversight and guidance for all molecules in the pipeline, from early research through commercialization
• Establish and maintain molecule-specific CMC development plans and risk mitigation strategies
• Conduct regular portfolio reviews to track progress, identify bottlenecks, and implement corrective actions
• Cross-Functional Integration
• 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.
• Technical Excellence
• 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.
• Team Leadership
• 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.
• Risk Management
• Identify and mitigate CMC development risks. Implement effective contingency plans to ensure program success.

Qualifications

• Education Background

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

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

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

Competency Requirements

• Professional Technical Competence

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

• Process development and scale-up for complex molecules
• Analytical method development and validation
• Drug product development including lyophilization and device integration
• cGMP manufacturing and quality systems
• Regulatory Communication Ability

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

• Pipeline Management Ability

Excellent portfolio management skills with experience tracking multiple molecules simultaneously.

• Leadership Influence

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

• Problem-Solving Ability

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

• Communication and Collaboration Ability

Outstanding communication and stakeholder management skills.