Senior Director, Bioanalytical LCMS

The role

This person will lead bioanalytical strategy across discovery, preclinical, and clinical programs. They will oversee the design, development, and implementation of bioanalytical assays for small molecules, peptides, and oligonucleotides within an outsourced model.

What you will do

• Lead LC-MS/MS bioanalytical strategy across discovery, preclinical, and clinical development
• Serve as senior bioanalytical LCMS subject matter expert across cross-functional program teams
• Oversee outsourced bioanalytical assay development and execution
• Provide technical leadership across small molecule, peptide, and oligonucleotide bioanalysis
• Lead external bioanalytical vendor strategy and oversight
• Partner with discovery, toxicology, clinical pharmacology, biostatistics, clinical development, and regulatory colleagues
• Contribute bioanalytical expertise to protocols, regulatory submissions, reports, and presentations
• Provide scientific and technical expertise in evaluating external assets and in-licensing opportunities

Required qualifications

• Ph.D. in biology, chemistry, analytical chemistry, pharmaceutical sciences, or a related scientific discipline with at least 10 years of relevant scientific and technical experience, or an M.S. with a
• Significant experience developing and leading LC-MS/MS bioanalytical programs spanning preclinical lead nomination, IND-enabling development, and clinical Phase 1-3 programs
• Demonstrated technical expertise in bioanalytical method development, qualification, validation, and sample analysis for small molecules, antisense oligonucleotides, and peptides, with expert-level ca
• Expert knowledge of bioanalytical regulatory requirements and guidance, including ICH M10 Bioanalytical Method Validation
• Extensive experience overseeing outsourced bioanalytical work
• Demonstrated experience contributing to regulatory documents and supporting health authority interactions
• Strong scientific leadership, communication, collaboration, and influencing skills
• Ability to operate independently, manage multiple programs and external partners, and adapt to evolving priorities
• Ability to travel up to 20% for vendor site visits, scientific collaboration, conferences, and other business needs
• Access to a work setting that enables meeting all requirements including privacy, reliable internet access, phone, and ability to video conference

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

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The company has a mission to treat diseases with high unmet needs using rigorous science.