Senior Process Engineer, MSAT, Drug Substance

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

Role overview

Own the technical performance and lifecycle of peptide drug substance manufacturing at external manufacturing partners. This senior process engineering role supports late-stage clinical and commercial production, connecting manufacturing operations with quality, regulatory, and CMC teams to keep processes reliable, compliant, and ready to scale.

Responsibilities

• Provide engineering guidance during manufacturing campaigns and attend partner sites when needed.
• Lead technology transfers, process validation planning, continued process verification, and commercial launch readiness.
• Define critical process parameters, quality attributes, in-process controls, sampling plans, and acceptance criteria.
• Investigate deviations, conduct root cause analysis, and develop corrective actions, risk assessments, and change controls.
• Review manufacturing records and technical documents, and contribute to regulatory submissions and agency responses.
• Trend process data to spot drift, yield or impurity changes, and opportunities to improve robustness, capacity, and efficiency.

Requirements

• Bachelor's degree in chemical engineering or a related field with at least 8 years of relevant experience, or a master's degree with at least 5 years.
• Experience supporting late-stage or commercial peptide or biologic drug substance manufacturing, including downstream operations such as chromatography, ultrafiltration or diafiltration, and lyophilization.
• Strong knowledge of cGMP, quality systems, regulatory expectations, and process, equipment, or facility validation.
• Hands-on experience with technology transfer, process validation, continued verification, investigations, CAPAs, risk assessments, and change control.
• Ability to interpret complex process data, communicate risks clearly, and influence decisions across external partners and internal teams.
• Willingness to travel domestically and internationally to manufacturing partner sites, up to 20%.

Nice to have

• Experience with liquid-phase, hybrid, or tag-assisted synthesis approaches.
• Familiarity with Quality by Design, design of experiments, statistical process control, and risk-based process improvement.

Benefits and work setup

• Remote work is supported where the employee has a suitable private workspace, reliable internet, and phone and video conferencing access.
• The role includes several trips each year to a corporate location in Cambridge, Massachusetts, and travel to manufacturing sites.
• Eligible employees may receive performance bonuses and equity awards, alongside a comprehensive benefits package.