Director, Bioanalytical LCMS

The role

This person will serve as a scientific leader and subject matter expert for bioanalytical strategy. They will develop and execute LC-MS/MS assays across discovery, preclinical, and clinical programs.

What you will do

• Develop and execute LC-MS/MS bioanalytical strategies across discovery, preclinical, and clinical development
• Serve as a bioanalytical LCMS subject matter expert on cross-functional program teams
• Oversee outsourced bioanalytical assay development and execution
• Provide technical expertise across small molecule, peptide, and oligonucleotide bioanalysis
• Manage external bioanalytical vendors including selection, planning, and oversight
• Partner with discovery, toxicology, clinical pharmacology, biostatistics, clinical development, and regulatory colleagues
• Contribute bioanalytical expertise to protocols, regulatory submissions, reports, and presentations
• Contribute scientific and technical expertise to evaluations of external assets and in-licensing opportunities

Required qualifications

• Ph.D. in biology, chemistry, analytical chemistry, pharmaceutical sciences, or related scientific discipline with at least 7 years of relevant experience
• M.S. with 12 years of relevant experience
• B.S./B.A. with 15 years of relevant experience in pharmaceutical, biotechnology, or CRO environments
• Experience developing and managing LC-MS/MS bioanalytical programs spanning preclinical lead nomination, IND-enabling development, and clinical Phase 1-3 programs
• Technical expertise in bioanalytical method development, qualification, validation, and sample analysis for small molecules, antisense oligonucleotides, and peptides
• Expert-level capability in at least two of these modalities
• Knowledge of bioanalytical regulatory requirements and guidance, including ICH M10
• Experience overseeing outsourced bioanalytical work
• Experience contributing to regulatory documents and supporting health authority interactions
• Strong scientific, communication, collaboration, and influencing skills
• Ability to work independently and manage multiple programs and external partners
• Ability to travel up to 20% for vendor site visits, scientific collaboration, conferences, and other business needs

Nice to have

• Experience in a biotechnology environment, particularly within a highly outsourced or virtual development model
• Familiarity with complementary bioanalytical platforms such as RT-qPCR, ELISA, immunogenicity/ADA, or other large-molecule bioanalytical methods
• Experience with CAPA, GxP-regulated bioanalysis, critical reagent lifecycle management, and due diligence of external assets

Benefits

• Competitive base pay
• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

Before you apply

• Unable to hire employees who reside and/or work in certain states
• Not considering applicants from Alaska and Hawaii
• Must have access to a work setting that enables meeting all role requirements including privacy and reliable internet

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).