Director, MSAT — Biotech Manufacturing & Tech Transfer

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

Benefits offered by this job

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Job summary

Amylyx Pharmaceuticals, Inc. is seeking a Director of Manufacturing Sciences and Technology to establish and lead MSAT capabilities for commercialization.

You will serve as the technical owner for outsourced drug substance and drug product manufacturing, owning process robustness, validation, and lifecycle management in collaboration with External Manufacturing, Quality, and Regulatory CMC teams. The role requires strategic and hands-on leadership in a fast-moving biotech environment, leading

Qualifications

• Bachelor's degree 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) and cGMP expectations with global regulatory guidance.

Responsibilities

• Lead and develop a high performing MSAT team for tech transfer and process control.
• Provide technical leadership across late-stage development, process validation, and lifecycle management.
• Partner with External Manufacturing and Quality to resolve technical issues.
• Oversee PPQ, CPQ, CGMP campaigns, and troubleshooting with Quality and CDMO partners.
• Review and approve CDMO technical documents and manufacturing records.

Skills

Leadership

Communication

Executive-level presentation

Strategic thinking

Education

B.S./B.A. in related field (Chemical Eng / Bio Sci / Pharma)

M.S. in related field

Job description

Amylyx Pharmaceuticals, Inc. is seeking a Director of Manufacturing Sciences and Technology to establish and lead MSAT capabilities for commercialization.

You will serve as the technical owner for outsourced drug substance and drug product manufacturing, owning process robustness, validation, and lifecycle management in collaboration with External Manufacturing, Quality, and Regulatory CMC teams. The role requires strategic and hands-on leadership in a fast-moving biotech environment, leading