Director CMC

Director, CMC

Position Summary

We are seeking an experienced and strategic Director, CMC to lead and drive CMC activities across our development programs. This individual will play a critical role in advancing assets from early discovery through late-stage development and into commercialization. The ideal candidate brings deep technical expertise across multiple modalities, a strong regulatory background, and a proven track record of leadership and cross-functional collaboration.

Key Responsibilities

• Lead CMC strategy and execution for programs across all stages of development, from preclinical through BLA/NDA submission.
• Oversee development, scale-up, and manufacturing of drug substance and drug product for both small molecules and biologics.
• Serve as the primary CMC representative on cross-functional project teams, ensuring alignment with regulatory, clinical, and commercial objectives.
• Author and review CMC sections of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) and interact with global health authorities.
• Manage and mentor a growing team of CMC professionals and external partners.
• Collaborate with internal stakeholders and CDMOs to ensure timely delivery of high-quality materials.
• Identify and mitigate CMC risks, ensuring compliance with global regulatory requirements and industry best practices.

Qualifications

• Advanced degree (PhD, MS, or equivalent) in Chemistry, Biochemistry, Chemical Engineering, or related field.
• 10+ years of relevant CMC experience in the biopharmaceutical industry.
• Demonstrated experience with both small molecule and biologic development.
• Strong regulatory knowledge with hands-on experience preparing and defending CMC regulatory submissions.
• Proven success in advancing programs from early development through late-stage and commercialization.
• Prior people management experience with a passion for mentoring and team development.
• Excellent communication, leadership, and organizational skills.

Why Join Us?

• Be part of a mission-driven company with a bold vision and a collaborative culture.
• Work on a diverse pipeline with the opportunity to make a real impact.
• Competitive compensation and benefits package.
• Opportunities for professional growth and leadership.