Remote VP, Global CMC Strategy & Lifecycle Leadership

Amylyx Pharmaceuticals; United States; Remote; USD 303,000 - 341,000; Full time

Benefits offered by this job

Remote-friendly policy

Competitive compensation

Job summary

Amylyx Pharmaceuticals is seeking an experienced Vice President, CMC Strategy to lead integrated CMC strategy, global execution, and lifecycle management across the company’s preclinical, clinical, and commercial portfolio.

This senior leader will align CMC priorities with development plans, regulatory requirements, and commercialization readiness while partnering with regulatory, quality, MSAT, and manufacturing teams.

Qualifications

• Advanced degree in chemistry, chemical engineering, pharmaceutical sciences or related field.
• Progressive leadership experience in pharmaceutical/biotechnology CMC.
• Strong understanding of global CMC regulatory requirements and lifecycle management.

Responsibilities

• Develop and lead integrated CMC strategies across preclinical, clinical, and commercial portfolios.
• Provide strategic leadership of CMC activities from early development to lifecycle management.
• Establish portfolio priorities, resource allocation, and risk mitigation for multiple programs.
• Partner with cross-functional leadership to align CMC with clinical milestones and regulatory commitments.
• Drive governance and decision-making across CMC functions for timely execution.
• Lead lifecycle management including post-approval changes and site transfers.
• Mentor CMC teams and ensure organizational capabilities to support global pipeline.

Skills

CMC strategy

Global leadership

Regulatory submissions

Cross-functional leadership

Strategic planning

Risk management

Communication

Travel up to 10%

Education

Advanced degree in chemistry, chemical engineering, pharmaceutical sciences

Job description

Amylyx Pharmaceuticals is seeking an experienced Vice President, CMC Strategy to lead integrated CMC strategy, global execution, and lifecycle management across the company’s preclinical, clinical, and commercial portfolio.

This senior leader will align CMC priorities with development plans, regulatory requirements, and commercialization readiness while partnering with regulatory, quality, MSAT, and manufacturing teams.