CMC Chief & Strategy Leader for Biotech Pipelines

R1 Therapeutics; San Francisco (CA); On-site; USD 260,000 - 420,000; Full time

Job summary

R1 Therapeutics in California seeks a Head of CMC to set and execute the CMC strategy across the pipeline, ensuring quality, regulatory compliance, and seamless clinical supply from development through commercialization. You will lead internal teams, coordinate with regulatory and clinical operations, and manage external CDMOs and CMOs.

Reporting to the COO and serving on the executive leadership team, you will drive scale-up, technology transfer, risk mitigation, budgets, and strategic

Qualifications

• 12+ years of leadership experience in CMC/pharmaceutical sciences or manufacturing.
• Experience leading CMC development for small molecule programs through IND/NDAs.
• Strong regulatory knowledge with CMC filings and FDA/EMA interactions.
• Experience managing CDMOs and external manufacturing partnerships.

Responsibilities

• Own and drive CMC strategy covering drug substance, drug product, formulation, analytics, and clinical supply.
• Build the internal CMC function with hiring and development of team members as needed.
• Lead CMC regulatory strategy and author/oversee CMC sections of INDs, CTAs, NDAs/BLAs.
• Select, manage, and oversee CDMOs/CMOs; establish governance, timelines, and quality standards.
• Lead scale-up and technology transfer from development to manufacturing.
• Ensure GMP compliance across manufacturing and testing operations.
• Partner with clinical teams to align CMC timelines with program milestones.
• Develop and manage CMC budgets and report progress to executive stakeholders.
• Identify manufacturing risks and develop contingency plans for clinical supply.
• Contribute to business development due diligence with a CMC lens.

Skills

CMC leadership

Regulatory strategy

CDMO management

Cross-functional collaboration

Education

Advanced degree in pharmaceutical sciences, chemistry, chemical engineering, or related discipline

Job description

R1 Therapeutics in California seeks a Head of CMC to set and execute the CMC strategy across the pipeline, ensuring quality, regulatory compliance, and seamless clinical supply from development through commercialization. You will lead internal teams, coordinate with regulatory and clinical operations, and manage external CDMOs and CMOs.

Reporting to the COO and serving on the executive leadership team, you will drive scale-up, technology transfer, risk mitigation, budgets, and strategic