Remote CMC Program Management Lead

Amylyx Pharmaceuticals, Inc.; United States; Remote; USD 178,000 - 200,000; Full time

Benefits offered by this job

Remote work within US

Travel to Cambridge, MA occasionally

Equal Opportunity Employer

Job summary

Amylyx Pharmaceuticals is seeking an experienced Associate Director, CMC Program Management to provide strategic and operational leadership across the CMC portfolio. The role partners with Regulatory, Quality, Analytical Development, Supply Chain, External Manufacturing, Clinical, and Nonclinical Development to translate CMC strategies into executable plans.

The position establishes timelines, budgets, governance, and risk management to ensure alignment with program objectives.

Qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, pharmaceutical sciences, or related.
• Eight to ten years in pharma/biotech, PM experience in CMC, Technical Operations, manufacturing, or product development.
• Understanding of CMC development, regulatory CMC, and cGMP.
• Experience building integrated plans across multiple technical workstreams.

Responsibilities

• Lead program management for one or more CMC programs with integrated plans and budgets.
• Translate CMC strategy into coordinated execution plans across functions.
• Lead CMC team meetings, governance, action-item tracking, and risk escalation.
• Monitor critical-path activities and develop mitigation plans.
• Coordinate CMC deliverables across Regulatory, Quality, Analytical Development, Technical Development, and Supply Chain.
• Develop dashboards and status reports for milestones, risks, budgets, and readiness.
• Support complex CMC initiatives including tech transfers and regulatory submissions.

Skills

Program management

Cross-functional leadership

Stakeholder management

Analytical skills

Communication

Education

Bachelor’s degree in life sciences/related

Master’s degree (preferred)

Tools

Smartsheet

Microsoft Project

SharePoint

Job description

Amylyx Pharmaceuticals is seeking an experienced Associate Director, CMC Program Management to provide strategic and operational leadership across the CMC portfolio. The role partners with Regulatory, Quality, Analytical Development, Supply Chain, External Manufacturing, Clinical, and Nonclinical Development to translate CMC strategies into executable plans.

The position establishes timelines, budgets, governance, and risk management to ensure alignment with program objectives.