Senior Director, Bioanalytical LCMS

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

Benefits offered by this job

Equity awards

Performance-based bonuses

Comprehensive benefits

Job summary

Amylyx Pharmaceuticals, Inc. is seeking a Senior Director of Bioanalytical LCMS to lead bioanalytical strategy across discovery, preclinical, and clinical programs.

The role focuses on LC-MS/MS assays and oversight of outsourced development, ensuring regulatory and quality standards are met while collaborating with discovery, toxicology, clinical pharmacology, and regulatory teams in a fast-paced biotech setting.

Qualifications

• Experience leading LC-MS/MS bioanalytical programs across discovery to clinical phases.
• Expert knowledge of bioanalytical regulatory requirements (ICH M10) and phase-appropriate rigor.
• Extensive experience with vendor management, study planning, and data review.

Responsibilities

• Lead LC-MS/MS bioanalytical strategy across discovery, preclinical, and clinical development.
• Oversee outsourced bioanalytical assay development, qualification, validation, and data review.
• Provide strategic guidance on bioanalytical and biomarker science, PK/PD, and development decisions.
• Partner with cross-functional teams to integrate bioanalytical data into study designs and regulatory strategies.

Skills

LC-MS/MS bioanalysis

Regulatory strategy

Vendor management

Cross-functional leadership

Independent program management

Education

Ph.D. in biology, chemistry, analytical chemistry, pharmaceutical sciences (or related)

M.S. with 12+ years of relevant experience

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.

Base salary is one component of Amylyx’s total rewards package. In addition to competitive base pay, eligible employees may receive annual performance-based bonuses and equity awards, providing an opportunity to share in the company’s long-term success. Amylyx also offers a comprehensive benefits package designed to support the health, well-being, and financial security of our employees.

$260,000 - $292,000 USD

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn .

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Amylyx Pharmaceuticals’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval, or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.