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Associate Director, CMC, Program Management
Amylyx Pharmaceuticals
Remote, USA
Full-time
Senior · 8+ years experience
Remote
USD 178000-200000 yearly / year
Discovered 1 weeks ago
SmartsheetMicrosoft Project
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The Opportunity
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.
Responsibilities
- 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 workstreams.
- Develop concise program dashboards and status reports that provide visibility into milestones, risks, decisions, budget status, resource needs, and overall CMC readiness.
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