Director, Bioanalytical LC-MS Strategy

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Remote; USD 221,000 - 249,000; Full time

Benefits offered by this job

Remote work within the United States

Job summary

Amylyx Pharmaceuticals, Inc. is seeking an experienced Director of Bioanalytical LCMS to lead bioanalytical strategy for discovery through clinical programs. The role focuses on LC-MS/MS assays and oversight of outsourced development within Amylyx's highly outsourced model.

The successful candidate will partner with discovery scientists, toxicology, and regulatory teams to ensure rigor, quality, and timely execution. Travel up to 20% is anticipated to support vendor visits and collaborations.

Qualifications

• Ph.D. with at least 7 years of experience in pharma/biotech/CRO environments; M.S. with 12 years; or B.S./B.A. with 15 years.
• Demonstrated experience leading LC-MS/MS bioanalytical programs across preclinical to clinical phases.
• Strong knowledge of bioanalytical regulatory requirements (ICH M10) and phase-appropriate regulatory rigor.

Responsibilities

• Develop and execute LC-MS/MS bioanalytical strategies across discovery, preclinical, and clinical development.
• Serve as bioanalytical LCMS SME on cross-functional teams; guide bioanalytical and biomarker science, PK/PD testing, and risks.
• Oversee outsourced bioanalytical assay development and validation; ensure FDA, ICH and quality expectations are met.
• Manage external vendors; planning, oversight, troubleshooting, and performance monitoring.
• Integrate bioanalytical data into study designs, development plans, and regulatory strategies.
• Contribute to regulatory submissions, reports, abstracts, posters, and interactions with authorities.
• Evaluate external assets for in-licensing opportunities from a bioanalytical perspective.

Skills

LC-MS/MS

Bioanalytical leadership

Cross-functional collaboration

Regulatory strategy

Vendor management

Communication

Travel readiness

Education

Ph.D. in biology/chemistry/analytical chemistry/pharmaceutical sciences

M.S. with 12 years of experience

B.S./B.A. with 15 years of experience

Tools

LC-MS/MS platforms

CAPA systems

Job description

Amylyx Pharmaceuticals, Inc. is seeking an experienced Director of Bioanalytical LCMS to lead bioanalytical strategy for discovery through clinical programs. The role focuses on LC-MS/MS assays and oversight of outsourced development within Amylyx's highly outsourced model.

The successful candidate will partner with discovery scientists, toxicology, and regulatory teams to ensure rigor, quality, and timely execution. Travel up to 20% is anticipated to support vendor visits and collaborations.