Vice President, CMC Strategy

📋 Description

• Develop and lead integrated CMC strategies across Amylyx's preclinical, clinical, and commercial
• Provide strategic leadership and oversight of CMC activities from early development through
• Establish portfolio-level priorities, resource allocation strategies, and risk mitigation plans to
• Partner with cross-functional leadership to ensure CMC strategies support clinical development
• Anticipate and proactively address CMC challenges, dependencies, and risks that could impact
• Serve as a senior CMC representative in portfolio governance, asset leadership, and strategic

🎯 Requirements

• Advanced degree in chemistry, chemical engineering, pharmaceutical sciences, or related scientific
• At least 15 years of progressive experience in pharmaceutical or biotechnology CMC, including
• Demonstrated experience leading CMC organizations, developing organizational capabilities, and
• Extensive experience developing and executing global CMC strategies across preclinical, clinical
• Proven track record leading successful global regulatory submissions, product approvals, and
• Strong understanding of global CMC regulatory requirements, including FDA, EMA, PMDA, ICH, and

🎁 Benefits

• Base salary range: $303,000 - $341,000 USD
• Eligible for annual performance-based bonuses and equity awards
• Comprehensive benefits package designed to support health, well-being, and financial security