Associate Director, Preclinical Bioanalytical Science

About this role

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 scientist to support preclinical bioanalytical strategy and execution across early-stage and IND-enabling programs. This role will serve as a key contributor and subject matter expert in bioanalytical approaches supporting nonclinical development, with a strong emphasis on outsourced assay development, validation, and sample analysis.

The successful candidate will lead the design, development, and implementation of bioanalytical and biomarker assays (e.g., LCMS, ELISA, qPCR) to support preclinical discovery, PK/PD, immunogenicity, and toxicology studies.

This individual will collaborate closely with nonclinical toxicologists, discovery biology, preclinical leadership, and clinical pharmacology to contribute to study design and manage external bioanalytical vendors. The role requires strong scientific leadership, technical depth, and the ability to operate both strategically and vendor-facing within a fast-paced environment.

We anticipate hiring the Associate Director, Preclinical Bioanalytical Science in September 2026

Responsibilities

• Partner with line management, nonclinical toxicologists, discovery biology, and clinical pharmacologists to align bioanalytical activities with program needs.

• Serve as the preclinical bioanalytical lead and subject matter expert on cross-functional program teams, representing bioanalytical and biomarker strategy, scientific rationale, and key deliverables.

• Define bioanalytical and biomarker method selection criteria, ensuring assays are fit for purpose and aligned with scientific objectives and program timelines.

• Contribute bioanalytical perspective to diligence on external assets and potential in-licensing opportunities.

• Apply deep technical judgment and adaptability to solve problems, prioritize effectively, and deliver under tight timelines and evolving scope.

• Select and manage external vendors for outsourced bioanalytical and biomarker projects, including oversight of scope, deliverables, and timelines.

• Oversee outsourced assay development, qualification, and validation across LCMS, ELISA, RT-qPCR, immunogenicity, and cell-based platforms, ensuring methods meet regulatory expectations for preclinical programs.

• Review bioanalytical method development, validation, and sample analysis reports in collaboration with nonclinical toxicology and clinical pharmacology partners.

• Troubleshoot bioanalytical method issues, support CAPA activities when needed, and manage critical reagent lifecycle risks across program timelines.

• Excellent communication and collaboration skills and ability to work with cross-functional scientists and non-scientists. Ability to convey ideas and opinions clearly, concisely, and with a smile.

• Prepare and organize data for cross-functional presentation. Communicate strategy and results in written and oral reports to various levels of management. Communicate research efforts to executive team members, collaborators, and/or at scientific meetings.

• Participate in planning and authoring of regulatory and clinical documents, abstracts, posters, and publications.

Required Qualifications

• Ph.D. in biology, chemistry or a related field with at least 4 years, or MS with at least 6 years of relevant bioanalytical experience in pharma/biotech/CRO environment. At least 2 years’ experience in biotech is non-negotiable. Past CRO experience is a plus.

• Demonstrated experience developing and leading bioanalysis projects in support of preclinical lead nomination and IND-enabling for LCMS, ELISA, RT-qPCR, ADA, and biomarker assays. LCMS experience preferred.

• Demonstrated previous bioanalytical method technical expertise in small molecule, anti-sense oligonucleotides, peptides, biologics and their requisite guidance documents. Expert level technical knowledge is preferred in at least 3 of the 4, with willingness and ability to quickly learn and adapt to new technologies.

• Knowledge of preclinical and clinical drug development regulations with expert-level knowledge of ICH M10 and experience working in a regulated (GxP) environment.

• Strong knowledge and experience with application of bioanalytical assay development, qualification/validation and sample analysis as it pertains to preclinical and clinical drug development.

• Strong interpersonal skills as well as excellent communication and presentation abilities.

• Ability to function in a biotech team environment by effectively collaborating within and across departments.

• Previous experience contributing to regulatory documents and interacting with health authorities is a plus but not required.

• We are seeking an applicant who thrives in a fast-paced, team-oriented environment, and who is willing to travel up to 20% for vendor site visits per business need.

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

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