Director, Manufacturing Sciences and Technology (MSAT)

Role: Director of Manufacturing Sciences and Technology (MSAT) leading process robustness, validation, and lifecycle management for Amylyx's drug manufacturing operations in preparation for commercialization. Responsibilities: establish and lead the MSAT team; oversee technology transfer, process validation, and process performance monitoring for drug substances and products, including peptides, proteins, and complex modalities; partner with external manufacturing, quality, and regulatory teams to resolve technical issues, develop validation strategies, and ensure regulatory compliance; develop scalable processes, technical governance routines, and risk mitigation plans; support regulatory filings and respond to agency questions; manage cross-functional stakeholder relationships. Requirements: BA with 10+ years or MS with 8+ years in Chemical/Biological/Pharmaceutical Sciences; expertise in manufacturing biologics, peptides, or complex modalities with knowledge of QbD, cGMP, and global regulatory standards (FDA, EMA, ICH); proven leadership in external manufacturing partnerships, process validation, and technical troubleshooting; strong communication, strategic thinking, and influence skills; willingness to travel up to 10%, with remote work flexibility within the US and regular in-person meetings in Cambridge, MA. High-Value: biologics, peptides, or complex modalities; late-stage development, process validation, commercial manufacturing, lifecycle management; external manufacturing partnerships; cGMP, regulatory filings, process validation, troubleshooting, risk management.