Executive Director, CMC Diligence

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.

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.

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.
• Able 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 effectively in a fast-paced, confidential, and matrixed environment with shifting priorities and compressed timelines.
• Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills.
• Excellent decision-making and collaboration skills with strong attention to detail.
• Six Sigma and statistical knowledge is a plus.
• Able to travel 10-20% domestically and internationally.