Executive Director, CMC Diligence

About this role

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 stick by our 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.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients .

Position Summary: 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 individual will evaluate 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 will closely collaborate 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 fully integrated into business development strategy and help Travere distinguish material risks from manageable issues to make informed investment and partnership decisions. The ideal candidate brings deep CMC expertise across small molecules, biologics, RNAi and gene therapy, sound business judgment, experience in confidential transaction environments, and the ability to translate complex technical findings into clear executive-level recommendations.   Key Responsibilities: • Lead the CMC due diligence for licensing, acquisition, partnership, and external innovation opportunities by assessing the manufacturing, supply chain, and commercial readiness risks for clinical/commercial-stage 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.

  Education/Experience Requirements:   • Ph.D. in chemistry, chemical engineering, pharmaceutical sciences, biological sciences, engineering, or related scientific discipline. 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 development through commercialization. • 6 years of previous people management and leadership experience. • Experience in similar strategic management position with significant experience interacting with executive leadership required. • Professional experience in similar role within biotech/pharmaceutical industry, preferably supporting both biologics and small molecule development and commercialization. • Strong understanding of GMP requirements, CMC regulatory expectations, process validation, analytical development, technology transfer, and product lifecycle management. • Demonstrated experience leading or contributing to technical due diligence, asset evaluations, licensing, acquisitions, partnerships, or external manufacturing assessments. • Ability to synthesize complex technical information into clear risks, recommendations, timelines, and mitigation plans. • Excellent communication and influencing skills; rare disease, orphan drug development, global supply, regulatory submission, or post-deal integration experience preferred.

Additional Skills/Experience: • The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork. • Driven, intelligent, passionate about making a difference for patients with rare diseases. • Skilled with building strong partnerships across internal functions and with external partners, consultants, CDMOs, and SMEs. • Contribute to continuous improvement of CMC diligence tools, templates, risk frameworks, and evaluation standards. • Communicate complex technical issues clearly to technical and non-technical audiences. • Operate ef

Similar jobs

• Executive Director, Regulatory Affairs, CMC — BeiGene · Remote
• Associate Director, CMC Lead — AstraZeneca · MA, Boston
• Director/Senior Director, CMC Operations — Beamtherapeutics · Cambridge, MA
• Associate Director, Regulatory CMC — Vaxcyte · Remote
• Commercial Due Diligence Engagement Lead and Director — Alphafmcroles · New York
• Assoc. Dir, Regulatory Affairs-CMC — Merck · Rahway, New Jersey, United States | North Wales (Upper Gwynedd), Pennsylvania, United States
• Director, Regulatory CMC — Iovancebiotherapeutics · Remote
• Associate Director / Director, Regulatory Affairs - CMC — Iambic Therapeutics · San Diego HQ