Process Engineer

Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs. They are seeking a Process Engineer, Drug Product, to provide technical and GMP support for contract manufacturing organizations, ensuring compliant and efficient manufacturing of aseptically filled drug products.

Responsibilities:

• Support technical leadership and day‑to‑day aseptic process engineering support for clinical and commercial drug product manufacturing at external CMOs
• Serve as the aseptic processing 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 aseptic manufacturing
• Lead and support aseptic drug product technology transfer activities from development to clinical and commercial manufacturing sites
• Define and transfer critical process parameters (CPPs), critical quality attributes (CQAs), and in‑process controls for aseptic unit operations
• Develop and execute aseptic 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 product introductions and commercial launches by ensuring validated, scalable, and inspection‑ready aseptic processes
• Lead continued process verification (CPV) and routine data trending for aseptic unit operations, environmental monitoring, and critical process parameters
• Develop and maintain data repositories, dashboards, and meaningful KPIs to assess aseptic process capability and performance
• Identify early signals of process drift or increased contamination risk and proactively drive corrective or preventive actions
• Prepare and present quarterly CPV summaries and technical assessments for internal management reviews
• Identify and execute continuous improvement initiatives focused on aseptic process robustness, sterility assurance, capacity, and operational efficiency
• Apply Quality by Design (QbD), statistical tools, and risk‑based decision making to optimize aseptic manufacturing processes
• Collaborate with CMOs to implement best practices, new technologies, or process enhancements where appropriate

Requirements:

• Bachelor's degree in engineering or related field with 5+ years/ Master's with 3+ years of relevant experience
• Prior experience in aseptic drug product manufacturing for late-stage development/commercial is required
• Proficiency in Quality by Design (QbD), Design of Experiments (DoE), statistical process control (SPC), and complex data analysis
• Detail-oriented with strong problem-solving skills and ability to identify subtle trends in data
• Comprehensive understanding of cGMP principles and regulatory requirements, including process, equipment, and facility validation
• Excellent communication and teamwork skills
• Ability to travel to domestic and international CMOs as needed
• Device experience is a plus
• Familiarity with modeling and optimization tools (e.g., MATLAB, JMP) is a plus