VP, CMC Strategy & Global Portfolio Leader

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 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.