Executive Director, CMC Diligence

Overview

Department: 106800 Technical Operations

Location:

San Diego, USA - Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission to identify, develop and deliver life-changing therapies to people living with rare disease. We focus on values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

We are dedicated to elevating science and service for rare patients.

Travere is seeking an Executive Director, CMC Diligence to lead the CMC assessments of clinical/commercial-stage assets associated with external business development opportunities. This role evaluates potential licensing, acquisition, partnership, and external innovation opportunities, identifying material technical risks and practical mitigation strategies across asset CMC development, manufacturing, supply chain, and commercial readiness. The role collaborates with Business Development, Clinical, Commercial, Legal, Regulatory, and Quality leaders to support transaction decisions and post-deal integration planning.

The successful candidate will ensure CMC considerations are integrated into business development strategy and help Travere distinguish material risks from manageable issues to support informed investment and partnership decisions. The ideal candidate brings deep CMC expertise across small molecules, biologics, RNAi and gene therapy, strong business judgment, experience in confidential transaction environments, and the ability to translate complex technical findings into clear executive-level recommendations.

• Lead the CMC due diligence for licensing, acquisition, partnership, and external innovation opportunities by assessing manufacturing, supply chain, and commercial readiness risks for clinical and commercial assets.
• Evaluate drug substance/product manufacturing, product development, control strategies, analytical, validation, stability, technology transfer, and lifecycle management plans.
• Identify critical CMC risks related to process performance, formulation, raw materials, impurities, comparability, stability, technology transfer, and commercial readiness.
• Review CDMO/CMO capabilities, capacity, compliance history, performance, network redundancy, supply continuity, and readiness to support clinical or commercial supply.
• Identify key technical risks, gaps, assumptions, costs, timelines, and mitigation strategies to support transaction decisions.
• Partner with Business Development, Corporate Strategy, Quality, Regulatory, Finance, Legal, Program Management, and Technical Operations stakeholders.
• Prepare concise technical diligence summaries, risk registers, executive presentations, and post-transaction recommendations.
• Support technical input into term sheets, definitive agreements, quality agreements, supply agreements, and transition plans.
• Establish enterprise CMC diligence strategy, standards, and risk frameworks.
• Advise leadership on CMC considerations for strategic transactions.
• Additional duties assigned as needed.

• Ph.D. in chemistry, chemical engineering, pharmaceutical sciences, biological sciences, engineering, or related scientific discipline. An equivalent combination of education and applicable job experience may be considered.
• 10+ years of relevant experience in pharmaceutical or biotechnology industries with substantial CMC roles in manufacturing, process development, technical operations, or related functions required; preferred experience with progressing late-stage assets from clinical…