Senior Process Engineer, MSAT, Drug Substance

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

Amylyx is seeking a Senior Process Engineer, MSAT, Drug Substance to provide technical and GMP leadership for late-stage clinical and commercial peptide drug substance manufacturing performed at external contract development and manufacturing organizations (CDMOs). Reporting to the Director, Manufacturing Sciences and Technology, this role will serve as process owner and technical subject matter expert for avexitide drug substance and partner across Quality, Quality Control, CMC, and External Manufacturing.

The Senior Process Engineer will lead technology transfer, process validation, continued process verification, investigations, change control, and process lifecycle management to support reliable, compliant, and efficient manufacturing.

• Provide technical leadership and day-to-day process engineering support for clinical and commercial drug substance manufacturing at external CDMOs.
• Serve as the process engineering SME during manufacturing operations, providing onsite support when required.
• Lead investigations, perform rigorous root cause analysis and develop scientifically sound CAPAs, ensuring alignment with regulatory expectations and industry best practices.
• Assess and author technical risk assessments and change controls to support manufacturing changes, investigations, and regulatory filings.
• Ensure strict compliance with cGMPs, global regulatory requirements, and internal quality systems for drug substance manufacturing.
• Review and provide technical input into master batch records, campaign readiness plans, process descriptions, and manufacturing documentation to ensure process requirements are accurately translated into GMP execution.

• Lead drug substance technology transfer activities between clinical, validation, and commercial manufacturing sites.
• Define critical process parameters (CPPs), critical quality attributes (CQAs), and in‑process controls for peptide drug substance unit operations.
• Develop and execute process validation strategies, including PPQ planning, statistical sampling plans, and acceptance criteria aligned with regulatory guidance.
• Provide technical authorship and review for regulatory submissions (IND, BLA, NDA, MAA), validation reports, and responses to regulatory agency questions.
• Support new drug substance introductions and commercial launches by ensuring peptide manufacturing processes are validated, scalable, robust, and inspection ready.

• Lead continued process verification (CPV) and routine data trending for manufacturing unit operations, in-process controls, and critical process parameters.
• Develop and maintain data repositories, dashboards, and meaningful KPIs to assess process capability, performance, and trends.
• Identify early signals of process drift, yield loss, impurity shifts, raw material variability, or scale-dependent performance risks and proactively drive corrective or preventive actions.
• Prepare and present quarterly CPV summaries and technical assessments for…