Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).
Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.
The Opportunity
Amylyx is seeking an experienced and strategic Vice President, CMC Strategy to lead integrated Chemistry, Manufacturing, and Controls (CMC) strategy, global execution, and lifecycle management across the company’s preclinical, clinical, and commercial portfolio. This leader will advance Amylyx’s pipeline by aligning CMC priorities with development plans, global regulatory requirements, commercialization readiness, and long-term product strategies. The Vice President will lead the CMC asset leadership and program management organization and partner closely with Technical Development, Manufacturing Sciences and Technology (MSAT), External Manufacturing, Regulatory Affairs, Quality, Supply Chain, Clinical Development, Program Management, and Commercial teams. The ideal candidate combines deep global CMC expertise with organizational leadership, rigorous risk management, and hands-on problem solving in a dynamic biotechnology environment.
Responsibilities
CMC Strategy & Portfolio Leadership
Develop and lead integrated CMC strategies across Amylyx’s preclinical, clinical, and commercial portfolio, ensuring alignment with corporate objectives and asset development plans.
Provide strategic leadership and oversight of CMC activities from early development through late-stage clinical programs, regulatory approval, commercialization, and lifecycle management.
Establish portfolio-level priorities, resource allocation strategies, and risk mitigation plans to support successful execution across multiple programs.
Partner with cross-functional leadership to ensure CMC strategies support clinical development milestones, regulatory commitments, and commercial readiness.
Anticipate and proactively address CMC challenges, dependencies, and risks that could impact development timelines, regulatory approvals, or product supply.
Serve as a senior CMC representative in portfolio governance, asset leadership, and strategic planning discussions.
Drive alignment and decision-making across the CMC functions to ensure coordinated execution of portfolio priorities.
Global CMC Execution & Regulatory Strategy
Translate asset objectives into phase-appropriate, risk-based integrated CMC plans, securing functional alignment, resources, and budgets to ensure execution.
Partner with Regulatory Affairs, Quality, and technical functions to ensure CMC strategies meet evolving regulatory requirements across the United States, Europe, Japan, and other international markets.
Provide strategic oversight of CMC components of INDs, NDAs, MAAs, and other global regulatory submissions, including responses to health authority questions and post-approval commitments.
Drive global CMC readiness, ensuring appropriate planning, coordination, and execution of activities required to support clinical development, regulatory approvals, and commercial launches.
Oversee the strategic planning and coordination of CMC-related regulatory changes, commitments, and implementation activities across global markets.
Establish effective governance, risk management, and decision-making processes to ensure timely execution of global CMC priorities.
Collaborate with…