Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

Amylyx is seeking an experienced and independently motivated Director, Bioanalytical LCMS to serve as a scientific leader and subject matter expert supporting bioanalytical strategy, with a primary focus on LC-MS/MS assays. This individual will develop and execute bioanalytical strategies across discovery, preclinical, and clinical programs and oversee the design, development, qualification, validation, and implementation of bioanalytical assays supporting small molecules, peptides, and oligonucleotides within Amylyx's highly outsourced development model.

The successful candidate will partner with discovery scientists, nonclinical toxicologists, clinical pharmacologists, biostatisticians, program teams, and external vendors to ensure bioanalytical execution meets scientific, regulatory, quality, and program requirements. This individual will represent the bioanalytical function on cross-functional program teams and contribute to vendor oversight, regulatory activities, and evaluation of external opportunities.

Responsibilities

Develop and execute LC-MS/MS bioanalytical strategies across discovery, preclinical, and clinical development, ensuring approaches are scientifically rigorous, phase appropriate, and aligned with program timelines and regulatory requirements.
Serve as a bioanalytical LCMS subject matter expert on cross-functional program teams, providing guidance on bioanalytical and biomarker science, PK/PD testing, technical risks, timelines, and development decisions.
Oversee outsourced bioanalytical assay development and execution, including method development, qualification, validation, sample analysis, data review, and associated documentation in accordance with applicable FDA, ICH, and quality expectations.
Provide technical expertise across small molecule, peptide, and oligonucleotide bioanalysis; identify assay challenges, determine root causes, implement fit-for-purpose solutions, and manage critical reagent lifecycle and method performance.
Manage external bioanalytical vendors, including vendor selection, study planning, technical oversight, troubleshooting, performance monitoring, and escalation to ensure timely, high-quality execution.
Partner with discovery, toxicology, clinical pharmacology, biostatistics, clinical development, and regulatory colleagues to integrate bioanalytical data into study designs, development plans, program decisions, study reports, and regulatory strategies.
Contribute bioanalytical expertise to protocols, regulatory submissions, reports, abstracts, posters, publications, health authority interactions, and presentations to senior leadership.
Contribute scientific and technical expertise to evaluations of external assets and potential in-licensing opportunities, including bioanalytical strategy, data quality, development risks, and capability requirements.

Required Qualifications

Ph.D. in biology, chemistry, analytical chemistry, pharmaceutical sciences, or a related scientific discipline with at least 7 years of relevant scientific and technical experience; M.S. with 12 years of relevant experience; or B.S./B.A. with 15 years of relevant experience in pharmaceutical, biotechnology, or CRO environments.