Senior Director /VP CMC

Are you an experienced CMC leader with a passion for advancing biologics from early development through clinical milestones? A cutting-edge biotech company in the Bay Area is seeking a Vice President (VP) of CMC Development to drive their Chemistry, Manufacturing, and Controls (CMC) strategy for a pipeline of innovative biologics.

About the Company:

This fast-growing, venture-backed biotech is pioneering novel biologic therapies to address critical unmet needs. With a strong scientific foundation and significant investor backing, they are entering a pivotal phase of IND filings and early-stage clinical development.

The Opportunity:

As VP of CMC Development, you will join the executive team, driving end-to-end CMC strategy, with a strong focus on IND submissions and early clinical readiness. You will play a critical role in shaping manufacturing processes, and regulatory strategy, and advancing programs from preclinical through Phase 1 and 2 trials.

Key Responsibilities:

• Develop and execute CMC strategies to support IND submissions and early-phase clinical programs.
• Oversee process development, analytical development, technology transfer, and manufacturing operations.
• Lead regulatory interactions, with a primary focus on IND submissions and associated documentation.
• Manage CDMO partnerships, ensuring adherence to quality and regulatory standards.
• Build and lead a high-performing CMC team.

About You:

• Extensive experience in CMC development for biologics, with a proven track record of successful IND submissions.
• Strong knowledge of FDA regulatory requirements for biologics, particularly in early-phase development.
• Demonstrated experience managing CDMO relationships.
• Hands-on leadership style with the ability to thrive in a fast-paced, entrepreneurial environment.

What’s on Offer:

• Competitive base salary with performance-based incentives.
• Equity participation with significant upside potential.
• Opportunity to drive the early clinical development of pioneering biologics.
• Collaborative, mission-driven company culture.

If you are an accomplished CMC leader ready to drive transformative biologics from preclinical to early clinical milestones, we want to hear from you.

To apply or learn more, please contact Will Ashbrook at will@warmanobrien.com.