Vice President, CMC Strategy

The role

This leader will lead integrated Chemistry, Manufacturing, and Controls (CMC) strategy, global execution, and lifecycle management. The role covers the company's preclinical, clinical, and commercial portfolio.

What you will do

• Develop and lead integrated CMC strategies across the preclinical, clinical, and commercial portfolio.
• Provide strategic leadership and oversight of CMC activities from early development through lifecycle management.
• Establish portfolio-level priorities, resource allocation strategies, and risk mitigation plans.
• Partner with cross-functional leadership to support clinical development and commercial readiness.
• Translate asset objectives into phase-appropriate, risk-based integrated CMC plans.
• Provide strategic oversight of CMC components of global regulatory submissions.
• Lead strategic planning for post-approval CMC activities including manufacturing changes and site transfers.
• Lead, mentor, and develop the CMC organization and asset leaders.
• Oversee CMC program timelines, budget assumptions, and critical milestones.
• Represent CMC in senior leadership discussions.

Required qualifications

• Advanced degree in chemistry, chemical engineering, pharmaceutical sciences, or related scientific discipline.
• At least 15 years of progressive experience in pharmaceutical or biotechnology CMC.
• Significant leadership experience overseeing complex development programs and global CMC activities.
• Demonstrated experience leading CMC organizations and managing high-performing teams.
• Extensive experience executing global CMC strategies across preclinical, clinical, and commercial-stage programs.
• Proven track record leading successful global regulatory submissions and product approvals.
• Strong understanding of global CMC regulatory requirements including FDA, EMA, PMDA, ICH, and cGMP standards.
• Demonstrated expertise in CMC lifecycle management.
• Experience leading complex cross-functional programs.
• Strong business acumen.
• Ability to establish priorities, manage competing demands, and drive execution across multiple programs.
• Ability to travel internationally up to 10%.

Nice to have

• Strong understanding of pharmaceutical development and manufacturing, with experience in both large and small molecules

Benefits

• Competitive base pay
• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

Before you apply

• Unable to hire employees who reside and/or work in certain states
• Currently not considering applicants from Alaska and Hawaii

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).