Senior Director, LC-MS Bioanalysis & Strategy

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Hybrid; USD 260,000 - 292,000; Full time

Benefits offered by this job

Equity awards

Performance-based bonuses

Comprehensive benefits

Job summary

Amylyx Pharmaceuticals, Inc. is seeking a Senior Director of Bioanalytical LCMS to lead bioanalytical strategy across discovery, preclinical, and clinical programs.

The role focuses on LC-MS/MS assays and oversight of outsourced development, ensuring regulatory and quality standards are met while collaborating with discovery, toxicology, clinical pharmacology, and regulatory teams in a fast-paced biotech setting.

Qualifications

• Experience leading LC-MS/MS bioanalytical programs across discovery to clinical phases.
• Expert knowledge of bioanalytical regulatory requirements (ICH M10) and phase-appropriate rigor.
• Extensive experience with vendor management, study planning, and data review.

Responsibilities

• Lead LC-MS/MS bioanalytical strategy across discovery, preclinical, and clinical development.
• Oversee outsourced bioanalytical assay development, qualification, validation, and data review.
• Provide strategic guidance on bioanalytical and biomarker science, PK/PD, and development decisions.
• Partner with cross-functional teams to integrate bioanalytical data into study designs and regulatory strategies.

Skills

LC-MS/MS bioanalysis

Regulatory strategy

Vendor management

Cross-functional leadership

Independent program management

Education

Ph.D. in biology, chemistry, analytical chemistry, pharmaceutical sciences (or related)

M.S. with 12+ years of relevant experience

Job description

Amylyx Pharmaceuticals, Inc. is seeking a Senior Director of Bioanalytical LCMS to lead bioanalytical strategy across discovery, preclinical, and clinical programs.

The role focuses on LC-MS/MS assays and oversight of outsourced development, ensuring regulatory and quality standards are met while collaborating with discovery, toxicology, clinical pharmacology, and regulatory teams in a fast-paced biotech setting.