CMC Program Management Lead - Associate Director

Amylyx Pharmaceuticals; Cambridge (MA); Hybrid; USD 178,000 - 200,000; Full time

Job summary

Amylyx Pharmaceuticals is seeking an experienced Associate Director, CMC Program Management in Cambridge, MA. The role leads strategic and operational program management across the CMC portfolio, partnering with Regulatory, Quality, Analytical Development, Supply Chain, and others to translate CMC strategies into executable plans.

The ideal candidate will establish timelines, budgets, and governance, monitor critical-path activities, elevate risks, and ensure alignment with program objectives,

Qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, pharmaceutical sciences, or related discipline.
• Eight to ten years of relevant experience in pharma/biotech, including program management for CMC, Technical Operations, manufacturing, or product development.
• Understanding of CMC development, regulatory CMC requirements, and cGMP pharmaceutical development and manufacturing.
• Experience building and managing complex integrated plans across multiple technical workstreams.
• Ability to lead cross-functional teams and influence in a matrixed environment without direct authority.
• Proactive risk identification, escalation, and mitigation communication.

Responsibilities

• Lead program management for one or more CMC programs with integrated plans including scope, timelines, milestones, and budgets.
• Translate CMC strategy into coordinated execution across development, manufacturing, regulatory filings, and lifecycle management.
• Lead CMC team governance, including agendas, minutes, action tracking, risk registers, and escalation.
• Monitor critical-path activities, identify risks, and collaborate on mitigation and contingency plans.
• Coordinate CMC deliverables across Regulatory, Quality, Analytical Development, Technical Development, and Supply Chain.
• Develop program dashboards and status reports for milestones, risks, decisions, and budgets.
• Support complex CMC initiatives including transfers, process development, validation, and regulatory readiness.
• Establish scalable CMC PM tools, templates, metrics, and ways of working across the organization.

Skills

Program management

Cross-functional collaboration

Strategic thinking

Communication

Risk management

Education

Bachelor’s degree in life sciences

Master’s degree (preferred)

Tools

Smartsheet

Microsoft Project

SharePoint

Job description

Amylyx Pharmaceuticals is seeking an experienced Associate Director, CMC Program Management in Cambridge, MA. The role leads strategic and operational program management across the CMC portfolio, partnering with Regulatory, Quality, Analytical Development, Supply Chain, and others to translate CMC strategies into executable plans.

The ideal candidate will establish timelines, budgets, and governance, monitor critical-path activities, elevate risks, and ensure alignment with program objectives,