Amylyx Director, Bioanalytical LCMS responsible for leading bioanalytical strategy and execution of LC-MS/MS assays across discovery, preclinical, and clinical programs. Oversees outsourced assay development and manages external vendors.
Responsibilities
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.
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.
Qualification
PhStrong scientificAbility to work 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 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.
Demonstrated experience developing and managing 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.
Strong 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.
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, communication, collaboration, and influencing skills, including success working across disciplines in a fast-paced biotechnology environment.
Ability to work 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.
