CMC Program Lead - Associate Director

珠海，中国   |   全职   |   Job ID: 11814 

About the role:

We are seeking an experienced and highly motivated CMC Program Lead to drive the successful development and execution of biologics programs in biologic process development full life cycle. The ideal candidate combines deep CMC expertise with exceptional program leadership capabilities and a proven track record of advancing complex biologics programs in a fast-paced, global environment.

Your Contribution:

• Lead end-to-end CMC program planning, execution, and governance for biologics development projects.
• Partner closely with Process Development, Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Clinical Supply, and Project Management teams to ensure successful project advancement.
• Facilitate effective communication and decision-making across multifunctional teams to achieve project objectives and development milestones.
• Escalate critical issues proactively and drive resolution through stakeholder alignment.
• Collaborate with Global Technical Development (GTD) and international stakeholders to advance innovation projects and technology transfer initiatives.
• Track program progress against key milestones and deliverables.
• Lead project reviews and management updates, providing clear visibility on status, risks, and opportunities.
• Act as the primary interface with CDMOs, CROs, and strategic external partners for outsourced development and manufacturing activities

A good match:

• Ph.D. in Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related life science discipline with 10+ years of relevant industry experience; or Master's degree with 15+ years of relevant experience in the biopharmaceutical industry.
• Extensive experience in biologics CMC development, including process development, manufacturing, technology transfer, and regulatory interactions.
• Strong understanding of global regulatory requirements and CMC expectations for China, the United States,
• Demonstrated experience managing CDMO partnerships and outsourced development/manufacturing activities.
• Proven track record of successfully leading complex, cross-functional development programs from concept through clinical and/or commercial stages.
• Exceptional stakeholder management, communication, and influencing skills