Senior MSAT Director: Remote, Global Tech Transfer

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

Job summary

Amylyx Pharmaceuticals seeks a senior MSAT leader to shape strategy and provide technical leadership across late-stage development, process validation, and commercial manufacturing. The role involves global coordination with external partners, ensuring process robustness, and advancing lifecycle management in a fast-paced biotech setting.

Responsibilities include developing transfer and qualification governance, mentoring an MSAT team, and aligning resources with program milestones while travel

Qualifications

• BA/BS or MS with 8–10+ years in chemical/biologic pharma or related field.
• Deep expertise in Quality by Design (QbD) and cGMP regulatory expectations (FDA/EMA/ICH).
• Proven ability to operate independently, influence without authority, and drive decisions in ambiguous settings.

Responsibilities

• Lead MSAT strategy and technical leadership across transfer, qualification, and process control.
• Coach teams across technology transfer, manufacturing support, and troubleshooting to drive operational excellence.
• Oversee PPQ, CPV, and lifecycle management with external partners and CDMOs.

Skills

Leadership

Communication

Collaboration

Technical writing

Executive presentation

Strategic thinking

Remote work

Travel flexibility

QbD

Education

Bachelor's/Master's in Chemical Engineering or related field

Job description

Amylyx Pharmaceuticals seeks a senior MSAT leader to shape strategy and provide technical leadership across late-stage development, process validation, and commercial manufacturing. The role involves global coordination with external partners, ensuring process robustness, and advancing lifecycle management in a fast-paced biotech setting.

Responsibilities include developing transfer and qualification governance, mentoring an MSAT team, and aligning resources with program milestones while travel