Director, MSAT: Scale-Up & Tech Transfer Leader

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Amylyx Pharmaceuticals, Inc. in Cambridge, MA seeks a Director of Manufacturing Sciences and Technology (MSAT) to establish and lead MSAT capabilities as the company prepares for commercialization.

You will own outsourced drug substance and drug product manufacturing, with accountability for process robustness, validation, and lifecycle management. The ideal candidate combines deep MSAT expertise with hands-on leadership in a biotech environment, guiding technology transfers, process validation,

Qualifications

• BA with 10 years’ experience, or MS with 8+ years’ experience in Chemical Engineering, Biological Sciences, Pharmaceutical Sciences, or related discipline.

Responsibilities

• Lead MSAT strategy, technical leadership, and governance for late-stage development to commercial manufacturing.
• Own external manufacturing partnerships, tech transfers, validation, and lifecycle management across drug substance and drug product.
• Provide leadership for CPPs, PPQ, and continued process verification with quality, regulatory, and supply chain partners.
• Oversee readiness activities for process validation, regulatory filings, and manufacturing campaigns.
• Coach and develop internal MSAT teams; manage resources, budgets, and risk mitigation with cross-functional partners.

Job description

Amylyx Pharmaceuticals, Inc. in Cambridge, MA seeks a Director of Manufacturing Sciences and Technology (MSAT) to establish and lead MSAT capabilities as the company prepares for commercialization.

You will own outsourced drug substance and drug product manufacturing, with accountability for process robustness, validation, and lifecycle management. The ideal candidate combines deep MSAT expertise with hands-on leadership in a biotech environment, guiding technology transfers, process validation,