Senior Director, Bioanalytical LCMS

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Hybrid; USD 260,000 - 292,000; Full time

Job summary

Amylyx Pharmaceuticals, Inc. seeks an experienced Senior Director, Bioanalytical LCMS to lead bioanalytical strategy across discovery, preclinical, and clinical programs.

You will direct design, qualification, validation, and implementation of LC-MS/MS assays for small molecules, peptides, and oligonucleotides in a highly outsourced development model. The role requires partnering with discovery, toxicology, clinical pharmacology, and regulatory teams to ensure scientific rigor, regulatory

Qualifications

• Ph.D./M.S. with extensive hands-on LC-MS/MS bioanalytical experience across preclinical to clinical development.
• Proven ability to lead outsourced bioanalytical programs and manage cross-functional teams.
• Strong knowledge of regulatory requirements and clear communication for regulatory submissions.

Responsibilities

• Define and execute LC-MS/MS bioanalytical strategy across discovery to clinical programs.
• Serve as senior LC-MS bioanalytical SME for cross-functional program teams.
• Oversee outsourced bioanalytical development, qualification, validation, and data review.
• Provide leadership on PK/PD testing, timing, risks, and development decisions.
• Lead vendor strategy, planning, governance, and performance management.
• Integrate bioanalytical data into study designs and regulatory strategies.
• Contribute to protocols, submissions, reports, abstracts, and health authority interactions.

Skills

LC-MS/MS bioanalysis

Leadership across projects

Regulatory strategy & guidance

Bioanalytical method development

Vendor management

Cross-functional collaboration

PK/PD understanding

Education

Ph.D. in biology/chemistry/analytical sciences

M.S. with 12+ years in pharma/biotech/CRO

Tools

FDA/ICH guidance

Job 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).

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 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.

Responsibilities

• 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.

Required Qualifications

• 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 Qualifications

• 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.

Compensation

The 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.

Estimated Pay Range

$260,000 - $292,000 USD

Amylyx 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.