{"id":3713289,"url":"https://alion.io/job/amylyx-director-bioanalytical-lcms","title":"Director, Bioanalytical LCMS","company":{"id":2594505,"name":"Amylyx","domain":"amylyx.com","url":"https://alion.io/company/amylyx","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":85,"open_postings":5,"ghost_share":0,"stale_share":0.6,"repost_share":0,"time_to_fill_p50_days":38,"computed_at":"2026-11-15T07:52:55Z"}},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":221000,"max":249000,"currency":"USD","period":"year","gross":null,"usd_annual":249000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"ICH Guidelines","optional":false},{"name":"Mass Spectrometry","optional":false},{"name":"Wolfram","optional":false},{"name":"CAPA","optional":true},{"name":"ELISA","optional":true},{"name":"qPCR","optional":true}],"status":"live","first_seen_at":"2026-11-03T20:00:01Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-15T05:19:09Z","board_verified":true,"closed_at":null,"days_open":11,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":11},"description":"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).\nOur 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.\nThe Opportunity\nAmylyx 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.\nThe 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.\nResponsibilities\nDevelop 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.\nServe 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.\nOversee 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.\nProvide 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.\nManage external bioanalytical vendors, including vendor selection, study planning, technical oversight, troubleshooting, performance monitoring, and escalation to ensure timely, high-quality execution.\nPartner 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.\nContribute bioanalytical expertise to protocols, regulatory submissions, reports, abstracts, posters, publications, health authority interactions, and presentations to senior leadership.\nContribute scientific and technical expertise to evaluations of external assets and potential in-licensing opportunities, including bioanalytical strategy, data quality, development risks, and capability requirements.\nRequired Qualifications\nPh.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.\nDemonstrated experience developing and managing LC-MS/MS bioanalytical programs spanning preclinical lead nomination, IND-enabling development, and clinical Phase 1-3 programs.\nDemonstrated 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.\nStrong 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.\nExperience overseeing outsourced bioanalytical work, including vendor management, technical issue resolution, study execution, data review, and documentation.\nDemonstrated experience contributing to regulatory documents and supporting health authority interactions, with the ability to translate complex bioanalytical science into clear recommendations.\nStrong scientific, communication, collaboration, and influencing skills, including success working across disciplines in a fast-paced biotechnology environment.\nAbility 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.\nPreferred Qualifications\nExperience in a biotechnology environment, particularly within a highly outsourced or virtual development model.\nFamiliarity with complementary bioanalytical platforms such as RT-qPCR, ELISA, immunogenicity/ADA, or other large-molecule bioanalytical methods.\nExperience with CAPA, GxP-regulated bioanalysis, critical reagent lifecycle management, and due diligence of external assets.\nWork Location and Conditions\nAt 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.\nYou 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.\nYou 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.\nCompensation\nThe pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.\nEstimated Pay Range\n$221,000—$249,000 USD\nTo stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.\nTo return to our website please click here.\nAmylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.\nIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. 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