Executive Director, Small Molecule CMC Lead
About the role
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The CMC Lead is a strategic and cross-functional leader responsible for driving the CMC development strategy and execution for assigned drug programs from clinical development through regulatory submission, approval, and commercialization. The CMC Lead serves as the single point of accountability for CMC program strategy, ensuring alignment of technical development, manufacturing readiness, regulatory requirements, quality expectations, and business objectives. The successful candidate will provide strong scientific and operational leadership, integrate internal and external CMC capabilities, proactively identify technical risks, and enable efficient delivery of high-quality drug substance and drug product to support clinical and commercial success.
Responsibilities
- Develop and execute comprehensive CMC strategies aligned with overall development objectives and corporate goals.
- Lead CMC planning and execution across development stages, including pivotal clinical development, registration submission, commercial manufacturing readiness, post-approval lifecycle management.
- Define critical CMC milestones, deliverables, timelines, resource needs, and risk mitigation strategies.
- Provide strategic oversight of drug substance and drug product development activities. Ensure processes are scientifically sound, robust, scalable, and suitable for GMP manufacturing.
- Partner with CDMOs and manufacturing sites to ensure