About this role
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 BioNTech 重视每一位团队成员的福祉，为多元化的员工提供全面的福利保障。我们提供具有市场竞争力的薪酬方案，具体将根据职位、工作地点及候选人资历与经验综合确定。注：各项福利的实际适用范围、享有条件及具体内容可能因所在地而异，最终以公司内部政策及当地法律法规为准。
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