Senior MSAT Process Engineer, Peptide DS (Remote)

amylyx; United States; Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Performance bonuses

Equity awards

Remote work flexibility

Job summary

Amylyx seeks a senior process engineer to own the technical performance and lifecycle of peptide drug substance manufacturing at external partners. You will support late-stage clinical and commercial production, linking operations with quality, regulatory, and CMC teams to ensure reliable, compliant, and scalable processes.

Responsibilities include guiding campaigns at partner sites, leading tech transfers, defining critical parameters, investigating deviations, and contributing to regulatory

Qualifications

• Bachelor's or master's in chemical engineering with relevant biotech experience.
• Experience in late-stage or commercial peptide/biologic manufacturing.
• Knowledge of cGMP, quality systems, and validation.
• Experience with tech transfer, CAPAs, and change control.

Responsibilities

• Guide engineering during manufacturing campaigns and at partner sites.
• Lead technology transfers, validation planning, and process verification.
• Define critical process parameters, quality attributes, in-process controls, sampling plans, and acceptance criteria.
• Investigate deviations and implement corrective actions and risk assessments.
• Review manufacturing records for regulatory submissions and agency responses.
• Trend process data to spot drift and opportunities to improve robustness and efficiency.

Skills

Data interpretation

Cross-functional collaboration

Risk assessment

Process validation

Regulatory awareness

Education

Bachelor's degree in chemical engineering or related field

Master's degree in chemical engineering or related field

Job description

Amylyx seeks a senior process engineer to own the technical performance and lifecycle of peptide drug substance manufacturing at external partners. You will support late-stage clinical and commercial production, linking operations with quality, regulatory, and CMC teams to ensure reliable, compliant, and scalable processes.

Responsibilities include guiding campaigns at partner sites, leading tech transfers, defining critical parameters, investigating deviations, and contributing to regulatory