Director, Bioanalytical LCMS

Amylyx Pharmaceuticals • Cambridge, MA

4d • Remote

About The Position

Amylyx is seeking an experienced, independently motivated scientific leader and subject matter expert to support bioanalytical strategy, primarily focused on LC-MS/MS assays. The Director will develop and execute strategies across discovery, preclinical, and clinical programs, and oversee the design, development, qualification, validation, and implementation of assays for small molecules, peptides, and oligonucleotides in a highly outsourced development model. The role partners with internal scientific and development teams and external vendors to ensure work meets scientific, regulatory, quality, and program requirements. It represents the bioanalytical function on cross-functional teams and contributes to vendor oversight, regulatory activities, and evaluation of external opportunities.

The role is remote within the United States, subject to state restrictions; Amylyx is not considering applicants residing or working in Alaska or Hawaii. The employee will travel to the Cambridge, Massachusetts corporate location several times a year and attend other company-related events as requested. The remote work setting must support privacy, reliable internet, phone access, and video conferencing. Travel of up to 20% is required for vendor site visits, scientific collaboration, conferences, and other business needs.

Requirements

• 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; or M.S. with 12 years; 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 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 modalities.
• Strong knowledge of bioanalytical regulatory requirements and guidance, including ICH M10 Bioanalytical Method Validation, and 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 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, 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 remote work setting that enables privacy, reliable internet access, phone use, and video conferencing.

Nice To Haves

• 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.

Responsibilities

• Develop and execute scientifically rigorous, phase-appropriate LC-MS/MS bioanalytical strategies across discovery, preclinical, and clinical development, aligned with program timelines and regulatory requirements.
• Serve as a bioanalytical LCMS subject matter expert on cross-functional program teams, advising on bioanalytical and biomarker science, PK/PD testing, technical risks, timelines, and development decisions.
• Oversee outsourced assay development and execution, including method development, qualification, validation, sample analysis, data review, and documentation in line with applicable FDA, ICH, and quality expectations.
• Provide technical expertise in bioanalysis of small molecules, peptides, and oligonucleotides; identify assay challenges, determine root causes, implement fit-for-purpose solutions, and manage critical reagent lifecycle and method performance.
• Manage external bioanalytical vendors, including selection, study planning, technical oversight, troubleshooting, performance monitoring, and escalation.
• 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 assessment of bioanalytical strategy, data quality, development risks, and capability requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Director