Director, Bioanalytical LCMS

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Remoto; USD 221.000 - 249.000; Tempo pieno

Vantaggi offerti da questo lavoro

Remote work within the United States

Descrizione del lavoro

Amylyx Pharmaceuticals, Inc. is seeking an experienced Director of Bioanalytical LCMS to lead bioanalytical strategy for discovery through clinical programs. The role focuses on LC-MS/MS assays and oversight of outsourced development within Amylyx's highly outsourced model.

The successful candidate will partner with discovery scientists, toxicology, and regulatory teams to ensure rigor, quality, and timely execution. Travel up to 20% is anticipated to support vendor visits and collaborations.

Competenze

• Ph.D. with at least 7 years of experience in pharma/biotech/CRO environments; M.S. with 12 years; or B.S./B.A. with 15 years.
• Demonstrated experience leading LC-MS/MS bioanalytical programs across preclinical to clinical phases.
• Strong knowledge of bioanalytical regulatory requirements (ICH M10) and phase-appropriate regulatory rigor.

Mansioni

• Develop and execute LC-MS/MS bioanalytical strategies across discovery, preclinical, and clinical development.
• Serve as bioanalytical LCMS SME on cross-functional teams; guide bioanalytical and biomarker science, PK/PD testing, and risks.
• Oversee outsourced bioanalytical assay development and validation; ensure FDA, ICH and quality expectations are met.
• Manage external vendors; planning, oversight, troubleshooting, and performance monitoring.
• Integrate bioanalytical data into study designs, development plans, and regulatory strategies.
• Contribute to regulatory submissions, reports, abstracts, posters, and interactions with authorities.
• Evaluate external assets for in-licensing opportunities from a bioanalytical perspective.

Conoscenze

LC-MS/MS

Bioanalytical leadership

Cross-functional collaboration

Regulatory strategy

Vendor management

Communication

Travel readiness

Formazione

Ph.D. in biology/chemistry/analytical chemistry/pharmaceutical sciences

M.S. with 12 years of experience

B.S./B.A. with 15 years of experience

Strumenti

LC-MS/MS platforms

CAPA systems

Descrizione del lavoro

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 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.

The 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.

Responsibilities

• Develop 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.
• Serve 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.
• 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 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.
• Manage external bioanalytical vendors, including vendor selection, study planning, technical oversight, troubleshooting, performance monitoring, 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.
• Contribute scientific and technical expertise to evaluations of 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 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.
• Demonstrated experience developing and managing 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.
• Strong 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.
• 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, 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, 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.

$221,000 - $249,000 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.