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

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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重要提示：

• 我们仅接受通过链接在线提交的求职申请。

• 提交申请即视为您知悉，招聘流程中将依相关法律法规进行背景调查。如您进入候选名单，BioNTech 将通过合作服务机构“HireRight”开展背景调查工作，招聘专员将及时与您沟通具体安排。

• 我们诚挚期待您的加入。