Senior CMC Program Manager, Strategy and Execution

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

Job summary

Amylyx Pharmaceuticals is seeking an Associate Director, CMC Program Management in Cambridge, MA. This role leads cross-functional program management across CMC, aligning regulatory, quality, analytical development, supply chain, and manufacturing to deliver integrated plans.

The ideal candidate has 8–10 years in pharma/biotech PM roles, strong CMC knowledge, and proven ability to influence in a matrix organization. Occasional travel to the Cambridge location is expected.

Qualifications

• Bachelor's degree in life sciences, chemistry, engineering, pharmaceutical sciences, or a related discipline.
• Eight to ten years of relevant experience in the pharmaceutical/biotech industry in project or program management supporting CMC, Technical Operations, manufacturing, or product development.
• Understanding of CMC development, regulatory CMC requirements, and cGMP pharmaceutical development.
• Experience creating integrated multi-workstream plans with timelines, milestones, risks, budgets, and resources.
• Proven ability to lead cross-functional teams and influence in a matrixed environment without direct authority.
• Experience identifying, escalating, and managing program risks and decisions.
• Strong written, verbal, facilitation, stakeholder-management, and organizational skills.
• Proficiency with project-management tools and collaboration platforms.

Responsibilities

• Lead program management for one or more CMC programs with integrated plans and governance.
• Translate CMC strategy into coordinated execution plans across development and manufacturing.
• Lead CMC team meetings, agendas, minutes, action items, and risk logs.
• Monitor critical-path activities and mitigate strategic/operational risks.
• Coordinate deliverables across Regulatory, Quality, Analytical Development, and Supply Chain.
• Develop dashboards and status reports for milestones, risks, budgets, and resources.
• Support complex CMC initiatives including tech transfers and lifecycle management.
• Improve program tools, templates, metrics, and ways of working across CMC.

Skills

Project management

Cross-functional leadership

Risk management

Matrix environment influence

Stakeholder management

Facilitation & communication

Analytical skills

Organizational skills

Education

Bachelor’s degree in life sciences/chemistry/engineering/pharmaceutical sciences

Master’s degree in scientific/engineering/business discipline

Tools

Smartsheet

Microsoft Project

SharePoint

Job description

Amylyx Pharmaceuticals is seeking an Associate Director, CMC Program Management in Cambridge, MA. This role leads cross-functional program management across CMC, aligning regulatory, quality, analytical development, supply chain, and manufacturing to deliver integrated plans.

The ideal candidate has 8–10 years in pharma/biotech PM roles, strong CMC knowledge, and proven ability to influence in a matrix organization. Occasional travel to the Cambridge location is expected.