Director, Manufacturing Sciences and Technology (MSAT)

The role

The Director, MSAT will establish and lead MSAT capabilities to prepare for commercialization. This leader serves as the technical owner for outsourced drug substance and drug product manufacturing.

What you will do

• Lead and develop a high performing MSAT team
• Establish global MSAT strategy and provide technical leadership
• Provide technical leadership for CDMO evaluation, onboarding, and manufacturing
• Partner with External Manufacturing and Quality leadership to resolve issues
• Identify critical path activities, technical risks, and budget implications
• Establish and oversee process qualification policies and procedures
• Ensure manufacturing processes are robust, scalable, and continuously improved
• Provide technical guidance for troubleshooting, deviations, and CAPAs
• Author, review, and defend technical content for CMC regulatory filings
• Lead, mentor, and develop internal technical MSAT team members

Required qualifications

• BA with 10 years’ experience, or MS with 8+ years’ experience in Chemical Engineering, Biological Sciences, Pharmaceutical Sciences, or related discipline
• Experience with drug substance and drug product manufacturing technologies relevant to peptides, proteins, oligonucleotides, small molecules, or other complex modalities
• Deep expertise in Quality by Design (QbD)
• Advanced knowledge of cGMP expectations and relevant FDA, EMA, ICH, and other global CMC guidance and regulatory requirements
• Ability to operate independently and influence without direct authority
• Excellent leadership, communication, collaboration, technical writing, and executive-level presentation skills
• Ability to travel domestically and internationally up to 10%

Nice to have

• Reside in the New England region

Benefits

• Competitive base pay
• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).