Executive Director, CMC Diligence
Travere Therapeutics
August 07, 2026
On-site
United States
Operations
Position Summary:
Executive Director, CMC Diligence to lead CMC assessments of clinical/commercial-stage assets for licensing, acquisition, partnership, and external innovation opportunities. Evaluate technical risks and mitigation strategies across CMC development, manufacturing, supply chain, and commercial readiness; collaborate with Business Development, Clinical, Commercial, Legal, Regulatory, Quality, and post-deal integration stakeholders.
Key Responsibilities:
- Lead CMC due diligence for transactions by assessing manufacturing, supply chain, and commercial readiness risks.
- Evaluate drug substance/product manufacturing, product development, control strategies, analytical/validation, stability, technology transfer, and lifecycle management.
- Identify critical CMC risks (process performance, formulation, raw materials, impurities, comparability, stability, tech transfer, commercial readiness).
- Review CDMO/CMO capabilities, capacity, compliance history, performance, redundancy, supply continuity, and readiness.
- Identify risks/gaps/assumptions plus costs/timelines and mitigation strategies.
- Prepare diligence summaries, risk registers, executive presentations, and post-transaction recommendations.
- Support technical input into term sheets and agreements (quality/supply/transition plans).
- Establish enterprise CMC diligence strategy, standards, and risk frameworks; advise leadership.
Education/Experience Requirements:
- Ph.D. in chemistry, chemical engineering, pharmaceutical sciences, biological sciences, engineering, or related field (or equivalent).
- 10+ years in pharma/biotech with substantial CMC experience; preferred late-stage progression through commercialization.
- 6+ years people management/leadership.
- Experience interacting with executive leadership in strategic management roles.
- Strong GMP and CMC regulatory knowledge (validation, analytical development, tech transfer, lifecycle management).
- Demonstrated technical due diligence/asset evaluations; ability to synthesize into clear risks/recommendations/timelines.
Additional Skills/Experience (Preferred):
- Experience across biologics and small molecules; rare disease/orphan drug/global supply/regulatory submission or post-deal integration.
- Strong communication/influencing, partnership-building (internal/external), continuous improvement mindset, and ability to work in fast-paced confidential matrix environments.
- Six Sigma/statistical knowledge plus.
- Travel 10–20%.
Benefits:
- Premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement match, generous paid time off.
Compensation:
- Target base pay range: $246,000–$332,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.
Executive Director, CMC Diligence to lead CMC assessments of clinical/commercial-stage assets for licensing, acquisition, partnership, and external innovation opportunities. Evaluate technical risks and mitigation strategies across CMC development, manufacturing, supply chain, and commercial readiness; collaborate with Business Development, Clinical, Commercial, Legal, Regulatory, Quality, and post-deal integration stakeholders.
Key Responsibilities:
- Lead CMC due diligence for transactions by assessing manufacturing, supply chain, and commercial readiness risks.
- Evaluate drug substance/product manufacturing, product development, control strategies, analytical/validation, stability, technology transfer, and lifecycle management.
- Identify critical CMC risks (process performance, formulation, raw materials, impurities, comparability, stability, tech transfer, commercial readiness).
- Review CDMO/CMO capabilities, capacity, compliance history, performance, redundancy, supply continuity, and readiness.
- Identify risks/gaps/assumptions plus costs/timelines and mitigation strategies.
- Prepare diligence summaries, risk registers, executive presentations, and post-transaction recommendations.
- Support technical input into term sheets and agreements (quality/supply/transition plans).
- Establish enterprise CMC diligence strategy, standards, and risk frameworks; advise leadership.
Education/Experience Requirements:
- Ph.D. in chemistry, chemical engineering, pharmaceutical sciences, biological sciences, engineering, or related field (or equivalent).
- 10+ years in pharma/biotech with substantial CMC experience; preferred late-stage progression through commercialization.
- 6+ years people management/leadership.
- Experience interacting with executive leadership in strategic management roles.
- Strong GMP and CMC regulatory knowledge (validation, analytical development, tech transfer, lifecycle management).
- Demonstrated technical due diligence/asset evaluations; ability to synthesize into clear risks/recommendations/timelines.
Additional Skills/Experience (Preferred):
- Experience across biologics and small molecules; rare disease/orphan drug/global supply/regulatory submission or post-deal integration.
- Strong communication/influencing, partnership-building (internal/external), continuous improvement mindset, and ability to work in fast-paced confidential matrix environments.
- Six Sigma/statistical knowledge plus.
- Travel 10–20%.
Benefits:
- Premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement match, generous paid time off.
Compensation:
- Target base pay range: $246,000–$332,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.