Senior Process Engineer, MSAT, Drug Substance

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🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $156k - $176k / year

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

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Amylyx Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

🏥 Healthcare

💼 Consulting

🛡️ Insurance

Healthcare • Consulting • Insurance

Amylyx Pharmaceuticals is a company dedicated to discovering and developing innovative treatments for diseases with high unmet needs. They focus on conditions such as Amyotrophic Lateral Sclerosis (ALS), Post-Bariatric Hypoglycemia (PBH), Wolfram Syndrome, and Progressive Supranuclear Palsy (PSP). Amylyx is committed to supporting patients and their loved ones, creating more moments of significance for them. They have recently acquired a Phase 3-ready GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation and have shown positive results in clinical trials for Wolfram syndrome. The company emphasizes transparency, setting realistic expectations, and collaborating to make impactful changes in the treatment of neurodegenerative diseases.

📋 Description

• 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 subject matter expert during manufacturing operations, providing onsite support when required • Lead investigations, perform root cause analysis, and develop scientifically sound CAPAs • Author technical risk assessments and change controls for manufacturing changes, investigations, and regulatory filings • Ensure compliance with cGMPs, global regulatory requirements, and internal quality systems • Review and provide technical input into master batch records, campaign readiness plans, process descriptions, and manufacturing documentation • Lead drug substance technology transfer between clinical, validation, and commercial manufacturing sites • Define critical process parameters, critical quality attributes, and in-process controls for peptide drug substance operations • Develop and execute process validation strategies, including PPQ planning, statistical sampling plans, and acceptance criteria • Provide technical authorship and review for IND, BLA, NDA, and MAA submissions, validation reports, and regulatory responses • Support drug substance introductions and commercial launches by ensuring processes are validated, scalable, robust, and inspection ready • Lead continued process verification and routine data trending • Develop and maintain data repositories, dashboards, and KPIs to assess process capability, performance, and trends • Identify process drift, yield loss, impurity shifts, raw material variability, and scale-dependent risks; drive corrective or preventive actions • Prepare and present quarterly CPV summaries and technical assessments for management reviews • Execute continuous improvement initiatives focused on process robustness, impurity control, yield, cycle time, capacity, and operational efficiency • Apply Quality by Design, Design of Experiments, statistical process control, and risk-based decision making • Collaborate with CDMOs to implement best practices, new technologies, and process enhancements

🎯 Requirements

• Bachelor’s degree in chemical engineering or a related field with 8 or more years of relevant experience, or a master’s degree with 5 or more years of relevant experience • Experience supporting late-phase or commercial peptide or biologic drug substance manufacturing, including chromatography purification, ultrafiltration or diafiltration, and lyophilization • Comprehensive knowledge of cGMP principles, quality systems, global regulatory expectations, and process, equipment, and facility validation requirements • Demonstrated experience with technology transfer, process validation, continued process verification, manufacturing investigations, CAPAs, risk assessments, and change control • Ability to analyze complex manufacturing data, identify subtle process trends, and translate findings into practical, scientifically sound actions • Demonstrated ability to lead technical discussions with external partners and influence cross-functional decisions without direct authority • Excellent written and verbal communication skills, with the ability to communicate complex process risks to technical and non-technical stakeholders • Ability to travel domestically and internationally to CDMO sites up to 20% • Preferred: Experience with liquid-phase, hybrid, tag-assisted synthesis, or green chemistry approaches for peptide manufacturing • Preferred: Experience with modeling, statistical analysis, or process optimization tools such as MATLAB or JMP • Preferred: Experience supporting regulatory submissions, health authority questions, inspections, and commercial launch readiness • Must have access to a remote work setting with privacy, reliable internet access, phone, and video conferencing capability • Applicants must reside and/or work in the United States; applicants from Alaska and Hawaii are not currently being considered

🏖️ Benefits

• Annual performance-based bonuses for eligible employees • Equity awards for eligible employees • Comprehensive benefits package supporting health, well-being, and financial security • Remote work opportunities within the United States • Company-related events • Equal opportunity employment • Accommodations available during the selection process

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