Senior Process Engineer, MSAT, Drug Substance

The role

The Senior Process Engineer will lead technical and GMP work for peptide drug substance manufacturing at external contract manufacturers. The role owns the process for avexitide drug substance and works with Quality, Quality Control, CMC and External Manufacturing.

What you will do

• Provide technical leadership and process engineering support for clinical and commercial drug substance manufacturing at external CDMOs.
• Lead drug substance technology transfer between clinical, validation and commercial sites.
• Lead investigations, root cause analysis and CAPAs.
• Write technical risk assessments and change controls.
• Develop process validation strategies, including PPQ planning and acceptance criteria.
• Provide technical input for regulatory submissions such as IND, BLA, NDA and MAA.
• Lead continued process verification and data trending for manufacturing unit operations.
• Prepare and present quarterly CPV summaries to management.
• Lead continuous improvement on robustness, impurity control, yield and cycle time.
• Collaborate with CDMOs on best practices and process enhancements.

Required qualifications

• 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 chromatography, ultrafiltration or diafiltration, and lyophilization.
• Comprehensive knowledge of cGMP, quality systems, global regulatory expectations, and process, equipment and facility validation.
• Demonstrated experience with technology transfer, process validation, continued process verification, investigations, CAPAs, risk assessments and change control.
• Ability to analyze complex manufacturing data and identify subtle process trends.
• Ability to lead technical discussions with external partners and influence decisions without direct authority.
• Excellent written and verbal communication skills.
• Ability to travel domestically and internationally to CDMO sites up to 20%.

Nice to have

• 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.

Benefits

• Annual performance-based bonuses.
• Equity awards.
• Comprehensive benefits package covering health and financial security.

Before you apply

• Remote work is limited to the United States, excluding Alaska and Hawaii, because of health insurance and state tax rules.
• The role requires access to a private remote workspace with reliable internet, phone and video conferencing.

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia, Wolfram syndrome and amyotrophic lateral sclerosis (ALS). Its core values are being audacious, curious, authentic, engaged and accountable.