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 Senior Director, Bioanalytical LCMS to serve as a senior scientific leader and subject matter expert for bioanalytical strategy, with a primary focus on LC-MS/MS assays. This individual will lead bioanalytical strategy 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 strategies and execution meet scientific, regulatory, quality, and program requirements. This individual will serve as the bioanalytical functional lead on cross-functional program teams and contribute to vendor strategy, regulatory activities, and evaluation of external opportunities.

Responsibilities

Lead LC-MS/MS bioanalytical strategy across discovery, preclinical, and clinical development, ensuring approaches are scientifically rigorous, phase appropriate, and aligned with program timelines and regulatory requirements.
Serve as Amylyx's senior bioanalytical LCMS subject matter expert across cross-functional program teams, providing strategic 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 leadership across small molecule, peptide, and oligonucleotide bioanalysis; identify assay challenges, determine root causes, implement fit-for-purpose solutions, and oversee critical reagent lifecycle and method performance.
Lead external bioanalytical vendor strategy and oversight, including vendor selection, study planning, technical governance, troubleshooting, performance management, 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.
Provide scientific and technical expertise in evaluating 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 10 years of relevant scientific and technical experience, or an M.S. with at least 12 years of relevant experience, in pharmaceutical, biotechnology, or CRO environments.