Process Engineer

Responsibilities

• Provide technical and GMP support for contract manufacturing organizations (CMOs) for late-stage clinical and commercial drug product supply
• Serve as the primary technical subject matter expert (SME) for aseptic processing including sterile filtration, formulation, filling, and container closure systems
• Lead investigations, perform root cause analysis, and develop CAPAs
• Lead aseptic drug product technology transfer activities from development to manufacturing sites
• Define and transfer critical process parameters (CPPs) and critical quality attributes (CQAs)
• Develop and execute aseptic process validation strategies and PPQ planning
• Lead continued process verification (CPV) and routine data trending
• Identify and execute continuous improvement initiatives focused on sterility assurance and operational efficiency

Requirements

• Bachelor’s degree in engineering or related field with 5+ years of experience, or Master’s with 3+ years of experience
• Prior experience in aseptic drug product manufacturing for late-stage development or commercial use
• Proficiency in Quality by Design (QbD), Design of Experiments (DoE), and statistical process control (SPC)
• Comprehensive understanding of cGMP principles and regulatory requirements
• Ability to travel to domestic and international CMOs as needed

Preferred Qualifications

• Device experience
• Familiarity with modeling and optimization tools such as MATLAB or JMP

About the Company

Amylyx is a clinical-stage company focused on treating diseases with high unmet needs, including post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).