Senior Director, External Manufacturing

Responsibilities

• Provide strategic leadership and oversight of external manufacturing across clinical development and commercial supply
• Establish and govern CDMO partnerships to ensure strong performance and alignment with program objectives
• Define and execute manufacturing strategies for technology transfer, scale-up, and commercialization
• Establish supplier performance metrics and business review processes
• Mentor and build a team of relationship owners for internal supplier relationship teams
• Ensure supply continuity through proactive risk identification and mitigation
• Oversee technology transfer, manufacturing execution, and process performance across a global network
• Support commercial launch readiness, including validation and inspection preparedness
• Partner cross-functionally with Finance, Legal, CMC, Quality, and Supply Chain
• Build scalable external manufacturing infrastructure and governance frameworks

Requirements

• Bachelor’s degree in engineering, life sciences, or related field
• 15+ years of experience in pharmaceutical or biotechnology manufacturing
• Significant external manufacturing leadership experience
• Proven track record managing CDMOs in clinical and commercial environments
• Deep understanding of cGMP regulations and global manufacturing requirements
• Experience in manufacturing strategy, technology transfer, and commercialization
• Experience supporting commercial product launches and negotiating supply agreements
• Experience across multiple supply nodes (API, Drug Product, Packaging, Device)
• Ability to travel domestically and internationally approximately 10%

Preferred Qualifications

• Advanced degree in a related field
• Experience across multiple modalities including small molecule, peptide, and oligonucleotide
• Track record of process scale-up, validation, and continuous improvement

About the Company

Amylyx is a clinical-stage company focused on treating diseases with high unmet needs, including post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).