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Vice President, CMC Strategy at Amylyx Pharmaceuticals - ApplyBlast

Vice President, CMC Strategy

Amylyx Pharmaceuticals

10 hours ago

3.8 on Glassdoor

Remote

Full Time

Executive

0 applicants

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About this role

Amylyx is seeking an experienced Vice President, CMC Strategy to lead integrated Chemistry, Manufacturing, and Controls strategy, global execution, and lifecycle management across the company's preclinical, clinical, and commercial portfolio. This leader will advance the pipeline by aligning CMC priorities with development plans, global regulatory requirements, and long-term product strategies. The role involves leading the CMC asset leadership and program management organization while partnering closely with cross-functional teams to ensure successful execution and commercial readiness.

Responsibilities

Lead integrated CMC strategy and global execution across the preclinical, clinical, and commercial portfolio
Oversee global regulatory submissions and ensure compliance with FDA, EMA, and PMDA requirements
Develop and manage comprehensive CMC lifecycle management strategies for product sustainability and expansion

Skills

About Amylyx Pharmaceuticals

amylyx.com

Headquarters

Cambridge, Massachusetts, United States

Company Size

201-500 employees

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Amylyx Pharmaceuticals is a biopharmaceutical company focused on developing novel therapies for diseases with high unmet needs, including Post-Bariatric Hypoglycemia (PBH), Wolfram Syndrome, and Amyotrophic Lateral Sclerosis (ALS). Its lead program, Avexitide, is being evaluated in the pivotal Phase 3 LUCIDITY clinical trial for PBH. Amylyx advances its pipeline using rigorous science, well-defined mechanistic rationale, and a strong commitment to the patient communities it serves.