Executive Director, CMC Diligence

Responsibilities

• Lead CMC due diligence for various business opportunities
• Evaluate drug substance and product manufacturing processes
• Identify critical CMC risks related to product development
• Review capabilities of CDMO/CMO for clinical/commercial supply
• Prepare technical diligence summaries and executive presentations
• Possess strong understanding of GMP and CMC regulatory expectations
• Experience with technical due diligence and asset evaluations
• Partner with cross-functional teams to support transactions
• Advise on CMC considerations for strategic transactions

Qualifications

• Ph.D. in a relevant scientific discipline or equivalent experience
• 10+ years in the pharmaceutical/biotech industry with CMC roles
• 6 years of people management and leadership experience
• Experience in strategic management with executive-level interaction