Vice President, CMC Strategy

amylyx; United States; On-site; USD 240,000 - 380,000; Full time

Job summary

Amylyx is seeking an experienced Vice President, CMC Strategy to lead integrated CMC strategy across preclinical, clinical, and commercial portfolios. The role demands strategic leadership, risk management, and hands-on problem solving in a dynamic biotech environment.

The successful candidate will align CMC priorities with development plans, regulatory requirements, and commercialization readiness, while guiding asset leadership and program management to ensure timely global execution.

Qualifications

• Seasoned leadership in CMC strategy across preclinical to commercial stages.
• Experience coordinating with Regulatory, Quality, Supply Chain, and Manufacturing.
• Proven ability to manage dependencies, risks, and budgets across global programs.

Responsibilities

• Develop integrated CMC strategies across preclinical to commercial assets.
• Lead CMC activities from development through lifecycle management.
• Set portfolio priorities, allocate resources, and mitigate risks.
• Partner with Regulatory, Quality, MSAT, and External Manufacturing functions.
• Govern CMC decision-making in portfolio governance and planning.
• Drive alignment of CMC deliverables with program timelines and business goals.

Skills

CMC strategy

Portfolio leadership

Regulatory alignment

Cross-functional leadership

Job description

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 internal program teams and cross-functional stakeholders to ensure alignment of CMC deliverables with program timelines and business objectives.

Product Lifecycle Management

Develop and oversee comprehensive CMC lifecycle management strategies to support product sustainability, global expansion, and long-term commercial objectives.

Lead strategic planning for post-approval CMC activities, including manufacturing changes, site transfers, capacity expansion, and regulatory variations, in partnership with the responsible technical and manufacturing functions.

Partner with Program Teams, Commercial, Supply Chain, Regulatory Affairs to support geographic expansion and evolving market requirements.

Ensure lifecycle management plans anticipate changing regulatory requirements, supply needs, and business priorities.

Drive cross-functional alignment on lifecycle priorities, investment decisions, and execution timelines.

Provide strategic oversight of lifecycle initiatives