Executive Director, CMC Diligence

Scorpion Therapeutics; United States; On-site; USD 246,000 - 332,000; Full time

Benefits offered by this job

Premium health

Financial planning support

Work-life/well-being programs

Life insurance

Disability

Retirement match

Generous paid time off

Job summary

Scorpion Therapeutics is seeking an Executive Director, CMC Diligence to lead due diligence of clinical and commercial assets for licensing and partnerships. You will evaluate manufacturing, supply chain, and regulatory readiness, and collaborate with BD, Clinical, Commercial, Legal, Regulatory, Quality, and post-deal teams.

The role requires a PhD with 10+ years in pharma/biotech CMC, strong leadership, and proven ability to synthesize complex technical risks into actionable recommendations for

Qualifications

• PhD in chemistry/related field required.
• 10+ years pharma/biotech with CMC experience.
• 6+ years leadership/people management.
• Experience interacting with executive leadership in strategic roles.
• Strong GMP and CMC regulatory knowledge (validation, analytical development, tech transfer).

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, tech 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.

Skills

CMC due diligence

GMP/CMC knowledge

Stakeholder mgmt

Risk assessment

Technical due diligence

Lifecycle management

Cross-functional leadership

Education

PhD in chemistry/related field

Job description

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.