Director, MSAT: Scale Biotech Manufacturing Excellence

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

Job summary

Amylyx Pharmaceuticals, based in Cambridge, MA, seeks a Director of Manufacturing Sciences and Technology (MSAT) to lead and scale MSAT capabilities for commercialization. This role owns tech transfer, process validation, and lifecycle management in partnership with External Manufacturing, Quality, and Regulatory CMC.

The ideal leader combines strategic and hands-on experience in a fast-paced biotech with strong cross-functional collaboration and a track record in successful technology

Qualifications

• Experience leading MSAT in biotech or pharma with external partners.
• Strong knowledge of QbD, cGMP, and regulatory expectations.
• Proven ability to transfer processes to manufacturing and scale up.

Responsibilities

• Lead and develop MSAT team with robust tech transfer and process control.
• Provide technical leadership across late-stage development and commercial manufacturing.
• Partner with External Manufacturing and Quality to resolve technical issues.
• Oversee CDMO evaluation, onboarding, validation, and lifecycle management.
• Prepare regulatory content and defend CMC submissions with cross-functional teams.

Skills

MSAT leadership

Process validation

Tech transfer

Cross-functional collaboration

Regulatory CMC

External manufacturing liaison

Education

BA/BS in engineering

MS in related field

Job description

Amylyx Pharmaceuticals, based in Cambridge, MA, seeks a Director of Manufacturing Sciences and Technology (MSAT) to lead and scale MSAT capabilities for commercialization. This role owns tech transfer, process validation, and lifecycle management in partnership with External Manufacturing, Quality, and Regulatory CMC.

The ideal leader combines strategic and hands-on experience in a fast-paced biotech with strong cross-functional collaboration and a track record in successful technology