Executive Director, Small Molecule CMC Lead

Job overview

The Executive Director, Small Molecule CMC Lead role is listed in Pennington, NJ. Compensation is not specified. The position supports BeOne Medicines’ drug programs from clinical development through regulatory submission, approval, and commercialization. The role provides strategic and cross-functional leadership for CMC development and execution, aligning technical development, manufacturing readiness, regulatory requirements, quality expectations, and business objectives to support clinical and commercial success.

What you'll do

• Develop and execute CMC strategies
• lead planning and execution across development stages
• define milestones, timelines, resources, and risk plans
• oversee drug substance, drug product, analytical strategies, CDMOs, and manufacturing partners
• partner with Regulatory Affairs on CMC strategies and submissions
• lead CMC governance and technical decisions
• support commercial manufacturing readiness, PPQ, inspections, launch supply, and lifecycle management.

What we're looking for

Skills & competencies

executive director

small molecule cmc lead

beone medicines

pennington nj

cmc strategy

drug development

regulatory submissions

gmp manufacturing

cdmo oversight

commercial readiness

Work arrangement

• Weekend coverage required

About the employer

BeOne Medicines is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.