Remote Senior MSAT Process Engineer, Drug Substance

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Híbrido; USD 156.000 - 176.000; Jornada completa

Descripción de la vacante

Amylyx Pharmaceuticals, Inc. 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 at external CDMOs.

Reporting to the Director of Manufacturing Sciences and Technology, this role will serve as process owner and SME for avexitide drug substance. The role leads technology transfer, process validation, CPV, investigations, change control, and lifecycle management to ensure

Formación

• Bachelor’s degree in chemical engineering or related field with 8+ years or master’s with 5+ years of experience.
• Experience with late-phase or commercial peptide/biologic drug substance manufacturing including downstream operations.
• Comprehensive knowledge of cGMP principles, quality systems, regulatory expectations, and validation.
• Demonstrated experience with technology transfer, process validation, CPV, investigations, CAPAs, risk assessments, and change control.
• Ability to analyze complex manufacturing data and translate findings into practical actions.
• Ability to lead technical discussions with external partners and influence cross-functional decisions.
• Willingness to travel domestically and internationally up to 20%.

Responsabilidades

• 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 root cause analysis and develop CAPAs aligned with regulatory expectations.
• Assess risk assessments and change controls to support manufacturing changes and regulatory filings.
• Ensure strict cGMPs and internal quality systems compliance for drug substance manufacturing.
• Review master batch records and manufacturing documentation to translate process requirements into GMP execution.
• Lead drug substance technology transfer between clinical, validation, and commercial sites.
• Define CPPs, CQAs, and in‑process controls for peptide drug substance operations.
• Develop and execute validation strategies, PPQ planning, sampling plans, and acceptance criteria.
• Support regulatory submissions and responses with technical documentation.

Conocimientos

cGMP knowledge

technology transfer

CPV / DoE / SPC

data analysis

regulatory awareness

cross-functional leadership

Educación

Bachelor’s degree in chemical engineering

Master’s degree in chemical engineering or related field

Herramientas

MATLAB

JMP

Descripción del empleo

Amylyx Pharmaceuticals, Inc. 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 at external CDMOs.

Reporting to the Director of Manufacturing Sciences and Technology, this role will serve as process owner and SME for avexitide drug substance. The role leads technology transfer, process validation, CPV, investigations, change control, and lifecycle management to ensure