Process Engineer

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. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

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.

The Opportunity

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. 

Responsibilities

Manufacturing Support: 

• 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. 

Process Validation:  

• Lead drug substance technology transfer activities between clinical, validation, and commercial manufacturing sites.