Head of CMC

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 is a California-based clinical-stage biotechnology company dedicated to transforming outcomesfor patients living with chronic kidney disease. R1 is building a portfolio of differentiated therapies to address the interconnected complications of CKD—starting with hyperphosphatemia, where unmet need remains high and the standard of care has gone largely unchanged for decades.

The Role:

The Head of CMC will serve as R1’s senior leader for all CMC activities, accountable for establishing and executing the CMC strategy across the company’s pipeline. This role is responsible for ensuring the quality, consistency, and regulatory compliance of R1’s drug substances and drug products from early development through clinical supply and eventual commercialization. The Head of CMC will work cross-functionally with regulatory affairs and clinical operations to advance AP306 and future pipeline assets, while building and managing external manufacturing and analytical partnerships. This position reports directly to the COO and will be a member of the Executive Leadership Team.

Key Responsibilities

• Own and drive R1’s CMC strategy, including drug substance and drug product development, formulation, analytical development, and clinical supply chain
• Build the internal CMC function, including hiring and developing team members as warranted by program needs.
• Lead CMC regulatory strategy and author or oversee CMC sections of INDs, CTAs, and NDAs/BLAs; ensure timely and high-quality regulatory submissions
• Select, manage, and oversee CDMOs, CMOs, and other external manufacturing and analytical partners; establish clear governance, timelines, and quality standards
• Lead scale-up and technology transfer activities from development to clinical and commercial manufacturing
• Ensure GMP compliance across all manufacturing and testing operations
• Partner with clinical teams to align CMC timelines with overall program milestones and Phase 2b advancement of AP306
• Develop and manage CMC budgets and resource plans; provide regular updates to the executive team and Board on CMC progress, risks, and mitigation strategies
• Identify and assess manufacturing risks; develop contingency plans to protect clinical supply and program continuity
• Contribute to business development activities, including due diligence and evaluation of potential partnership and licensing opportunities with a CMC lens

Skills and Experience

• 12+ years of progressive leadership experience in CMC, pharmaceutical sciences, or manufacturing within the biotechnology or pharmaceutical industry
• Demonstrated experience leading CMC development for small molecule drug programs through IND, clinical-stage development and late stage development, as well as NDA submission
• Strong regulatory knowledge, including authorship of CMC sections for major regulatory filings (FDA, EMA); experience with Type B/C meetings and regulatory agency interactions a plus
• Proven track record managing CDMOs, in particular Chinese CDMOs and external manufacturing partners, including technology transfers and scale-up activities

Other requirements highly valued

• Deep expertise in pharmaceutical development sciences, including formulation development, analytical chemistry, and GMP manufacturing
• Experience working in a lean, resource-constrained environment; ability to prioritize effectively, operate with ambiguity, and build processes from the ground up
• Excellent communication and collaboration skills; ability to translate complex CMC topics for non-technical audiences including investors and Board members
• Comfortable managing cross-functional relationships across R&D, regulatory, clinical, and external partners
• Advanced degree (PhD, MS, or equivalent) in pharmaceutical sciences, chemistry, chemical engineering, or a related discipline required
• This role can be located anywhere in the US, but there is a strong preference to candidates in the SF Bay Area with willingness to travel.