Amylyx Senior Director, Bioanalytical LCMS leads bioanalytical strategy focusing on LC-MS/MS assays across discovery, preclinical, and clinical programs. Oversees outsourced assay development and serves as subject matter expert.
Responsibilities
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.
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.
Qualification
PhStrong scientific leadershipAbility to operate independentlyExperience with CAPAWork Location and ConditionsAt Amylyx
Required
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.
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 capability in at least two of these modalities.
Expert knowledge of bioanalytical regulatory requirements and guidance, including ICH M10 Bioanalytical Method Validation, and the ability to apply phase-appropriate regulatory rigor throughout drug development.
Extensive experience overseeing outsourced bioanalytical work, including vendor management, technical issue resolution, study execution, data review, and documentation.
Demonstrated experience contributing to regulatory documents and supporting health authority interactions, with the ability to translate complex bioanalytical science into clear recommendations.
Strong scientific leadership, communication, collaboration, and influencing skills, including success working across disciplines in a fast-paced biotechnology environment.
Ability to operate independently, manage multiple programs and external partners, adapt to evolving priorities, and travel up to 20% for vendor site visits, scientific collaboration, conferences, and other business needs.
Preferred
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.
Work Location and Conditions
At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska and Hawaii.
You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.
