VP, CMC Strategy & Global Portfolio Leadership

Amylyx Pharmaceuticals; Cambridge (MA); Remote; USD 303,000 - 341,000; Full time

Job summary

Amylyx Pharmaceuticals seeks an experienced Vice President, CMC Strategy to lead integrated CMC strategy, global execution, and lifecycle management across preclinical, clinical, and commercial programs. This senior leader partners with Regulatory, Quality, MSAT, and Commercial teams to ensure regulatory readiness and sustained supply.

The role requires deep global CMC expertise, exceptional leadership, and a hands‑on approach to risk management in a dynamic biotech environment.

Qualifications

• Advanced degree and 15+ years in pharmaceutical/biotech CMC leadership.
• Experience leading global CMC strategies across full product lifecycle.
• Proven track record with regulatory submissions and commercial readiness.

Responsibilities

• Develop and lead integrated CMC strategies across preclinical, clinical, and commercial portfolio.
• Provide strategic oversight of CMC activities from development through lifecycle management.
• Establish portfolio priorities, resources, and risk mitigation for multiple programs.
• Partner with cross‑functional leaders to align CMC with clinical and regulatory milestones.
• Drive governance and decision‑making across CMC functions to ensure timely execution.

Skills

Strategic CMC leadership

Portfolio governance

Cross-functional leadership

Risk management

Program management

Education

Advanced degree in chemistry, chemical engineering, pharmaceutical sciences

Job description

Amylyx Pharmaceuticals seeks an experienced Vice President, CMC Strategy to lead integrated CMC strategy, global execution, and lifecycle management across preclinical, clinical, and commercial programs. This senior leader partners with Regulatory, Quality, MSAT, and Commercial teams to ensure regulatory readiness and sustained supply.

The role requires deep global CMC expertise, exceptional leadership, and a hands‑on approach to risk management in a dynamic biotech environment.