Senior MSAT Process Engineer – Remote Peptide Substance

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Hybrid; USD 156,000 - 176,000; Full time

Job summary

Amylyx Pharmaceuticals, Inc. seeks a Senior Process Engineer, MSAT, Drug Substance to provide GMP leadership for late‑stage peptide drug substance manufacturing at CDMOs.

You will own process engineering, transfer, validation, and CPV, collaborating with Quality, CMC, and External Manufacturing to ensure compliant, scalable production. Responsibilities include leading investigations, risk assessments, and change controls while defining CPPs, CQAs, and in‑process controls.

Qualifications

• Bachelor’s degree in chemical engineering or related field with 8+ years of experience; Master’s with 5+ years.
• Experience with late‑phase or commercial peptide or biologic drug substance manufacturing.
• Knowledge of cGMP principles, quality systems, and global regulatory expectations.

Responsibilities

• Provide technical leadership and day‑to‑day process engineering support for clinical and commercial drug substance manufacturing at external CDMOs.
• Lead technology transfer, process validation, CPV, investigations, CAPAs, risk assessments, and change control.
• Develop CPPs/CQAs and in‑process controls; ensure regulatory filings and GMP readiness.
• Prepare and review regulatory documentation (IND, BLA, NDA, MAA) and validation reports.

Skills

Process engineering

Root cause analysis

CAPA investigations

Regulatory compliance

Technical leadership

Education

Bachelor’s degree in chemical engineering

Master’s degree in a related field

Tools

MATLAB

JMP

Job description

Amylyx Pharmaceuticals, Inc. seeks a Senior Process Engineer, MSAT, Drug Substance to provide GMP leadership for late‑stage peptide drug substance manufacturing at CDMOs.

You will own process engineering, transfer, validation, and CPV, collaborating with Quality, CMC, and External Manufacturing to ensure compliant, scalable production. Responsibilities include leading investigations, risk assessments, and change controls while defining CPPs, CQAs, and in‑process controls.