Associate Director, CMC, Program Management

Associate Director, CMC, Program Management

Cambridge, MA

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.

Amylyx is seeking an experienced Associate Director, CMC Program Management to provide strategic and operational program management leadership across our CMC portfolio. This individual will partner closely with CMC asset leads and colleagues across Regulatory, Quality, Analytical Development, Supply Chain, External Manufacturing, Clinical, and Nonclinical Development to translate CMC strategies into integrated, executable plans.

The Associate Director will establish clear timelines, milestones, dependencies, budgets, and governance practices for assigned CMC programs. This role will facilitate CMC teams, monitor critical-path activities, drive timely decision-making, identify and escalate risks, and ensure that technical, manufacturing, and regulatory deliverables remain aligned with program objectives. The ideal candidate is an experienced biopharmaceutical program manager who combines strong CMC knowledge with disciplined execution, strategic thinking, and the ability to influence in a cross-functional matrix environment.

• Lead program management for one or more CMC programs, developing and maintaining integrated plans that include scope, timelines, milestones, dependencies, deliverables, resources, budgets, and key decision points.
• Partner with CMC asset leads and functional subject matter experts to translate CMC strategy into coordinated execution plans that support development, manufacturing, lifecycle management, regulatory filings, and program objectives.
• Lead CMC team meetings and governance processes, including agendas, minutes, action-item tracking, decision logs, risk registers, and escalation of issues requiring leadership attention.
• Proactively monitor critical-path activities, identify strategic and operational risks, assess downstream impacts, and partner with stakeholders to develop mitigation and contingency plans.
• Coordinate CMC deliverables across Regulatory, Quality, Analytical Development, Technical Development, and Supply Chain ensuring clear ownership, accountability, and communication across work streams.
• Develop concise program dashboards and status reports that provide visibility into milestones, risks, decisions, budget status, resource needs, and overall CMC readiness.
• Support planning and execution of complex CMC initiatives, which may include technical transfers, process development and validation activities, regulatory submission readiness, and lifecycle-management programs.
• Establish and continuously improve scalable CMC program management tools, templates, metrics, meeting structures, and ways of working that strengthen execution across the broader CMC organization.

• Bachelor's degree in life sciences, chemistry, engineering, pharmaceutical sciences, or a related discipline.
• Eight to ten years of relevant experience in the pharmaceutical or biotechnology industry, including significant experience in project or program management supporting CMC, Technical Operations, manufacturing, or product development.
• Demonstrated understanding of CMC development, regulatory CMC requirements, and cGMP-compliant pharmaceutical development and manufacturing.
• Experience building and managing complex, integrated plans across multiple technical work streams, including timelines, milestones, dependencies, risks, budgets, and resource requirements.
• Proven ability to lead cross-functional teams and drive execution through influence in a matrixed environment without relying on direct authority.
• Experience proactively identifying, communicating, escalating, and managing program risks, issues, decisions, and competing priorities.
• Strong written, verbal, facilitation, stakeholder-management, analytical, and organizational skills, with the ability to communicate technical and program information clearly to different audiences.
• Proficiency with project-management and collaboration tools used to maintain plans, trackers, dashboards, actions, and program documentation.

• Master's degree in a scientific, engineering, or business discipline.
• Direct experience supporting CMC programs from early…