MSAT Director: Process Transfer & Validation Leader

SilverShoots; Cambridge (MA); Hybrid; USD 209,000 - 235,000; Full time

Job summary

Amylyx is seeking a Director, Manufacturing Sciences and Technology to establish MSAT capabilities for commercialization. Lead outsourced drug substance and product manufacturing, drive process validation, lifecycle management, and PPQ readiness with External Manufacturing, Quality, Regulatory CMC, and Supply Chain partners.

The role requires strong MSAT leadership in a fast-paced biotech, hands-on with technology transfers, process validation, and continual improvement, reporting to the Senior

Qualifications

• BA with 10+ years or MS with 8+ years in Chemical Engineering, Biological or Pharmaceutical Sciences.
• Deep expertise in Quality by Design (QbD) and global CMC guidance.
• Ability to influence across matrixed teams and external partners.

Responsibilities

• Lead MSAT strategy and technical leadership across late‑stage development to commercial manufacturing.
• Oversee technology transfer, process validation, PPQ, and lifecycle management.
• Provide regulatory content input and collaboration with CMC/regulatory teams.
• Mentor and develop the MSAT team; manage resources and priorities.
• Collaborate with External Manufacturing, Quality, and Supply Chain to resolve issues.

Skills

Leadership

Communication

Cross-functional collaboration

Technical writing

Executive-level presentation

Education

Bachelor's degree with 10 years'

Master's degree with 8+ years'

Job description

Amylyx is seeking a Director, Manufacturing Sciences and Technology to establish MSAT capabilities for commercialization. Lead outsourced drug substance and product manufacturing, drive process validation, lifecycle management, and PPQ readiness with External Manufacturing, Quality, Regulatory CMC, and Supply Chain partners.

The role requires strong MSAT leadership in a fast-paced biotech, hands-on with technology transfers, process validation, and continual improvement, reporting to the Senior