Strategic CMC Program Manager

Amylyx Pharmaceuticals; Cambridge (MA); Hybrid; USD 120,000 - 200,000; Full time

Job summary

Amylyx Pharmaceuticals in Cambridge, MA is seeking an Associate Director, CMC Program Management to provide strategic and operational leadership across the CMC portfolio. You will partner with asset leads and teams across Regulatory, Quality, Analytical Development, Supply Chain, and Manufacturing to translate CMC strategies into executable plans.

The role emphasizes cross-functional influence in a matrix environment, governance of milestones and budgets, and continuous improvement of PM tools

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 supporting CMC, Technical Operations, manufacturing, or product development.
• Understanding of CMC development, regulatory CMC requirements, and cGMP-compliant pharma development and manufacturing.
• Experience building and managing complex, integrated plans across multiple technical workstreams (timelines, milestones, risks, budgets, resources).
• Proven ability to lead cross-functional teams and influence in matrix environments without direct authority.
• Experience proactively identifying, escalating, and managing program risks, issues, decisions, and competing priorities.
• Strong written, verbal, facilitation, stakeholder-management, analytical, and organizational skills.
• Proficiency with PM tools to maintain plans, trackers, dashboards, actions, and program documentation.

Responsibilities

• Lead program management for one or more CMC programs, developing integrated plans with scope, timelines, milestones, dependencies, deliverables, resources, budgets, and key decisions.
• Translate CMC strategy into coordinated execution plans supporting development, manufacturing, lifecycle management, regulatory filings, and program objectives.
• Lead CMC team meetings and governance processes (agendas, minutes, action-item tracking, decisions).
• Monitor critical-path activities, identify risks, and develop mitigation and contingency plans.
• Coordinate CMC deliverables across Regulatory, Quality, Analytical Development, Technical Development, and Supply Chain.
• Develop program dashboards and status reports showing milestones, risks, decisions, budgets, and resource needs.
• Support planning and execution of complex CMC initiatives including transfers, process development, and lifecycle-management programs.
• Establish and improve scalable CMC program management tools, metrics, and meeting structures.

Skills

Cross-functional leadership

Stakeholder management

Project management

Communication

Analytical skills

Organizational skills

Education

Bachelor’s degree

Master’s degree preferred

PMP certification

Tools

Smartsheet

Microsoft Project

SharePoint

Job description

Amylyx Pharmaceuticals in Cambridge, MA is seeking an Associate Director, CMC Program Management to provide strategic and operational leadership across the CMC portfolio. You will partner with asset leads and teams across Regulatory, Quality, Analytical Development, Supply Chain, and Manufacturing to translate CMC strategies into executable plans.

The role emphasizes cross-functional influence in a matrix environment, governance of milestones and budgets, and continuous improvement of PM tools