Senior Process Engineer, MSAT, Drug Substance at Amylyx · LumiJobs

Responsibilities

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.
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.
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.

Qualification

Experience with liquid-phaseExperience with modelingWork Location and ConditionsAt Amylyx

Required

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 downstream operations such as 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.
Experience with modeling, statistical analysis, or process optimization tools such as MATLAB or JMP.
Experience supporting regulatory submissions, health authority questions, inspections, and commercial launch readiness.
Work Location and Conditions
At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska and Hawaii.
You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Senior Process Engineer, MSAT, Drug Substance

Responsibilities

Qualification

Required

Preferred

Benefits

Company

Amylyx

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