Amylyx Pharmaceuticals · 15 hours ago
Associate Director, Quality Control & Analytical Development
Cambridge, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$164K/yr - $184K/yr
8+ years expAmylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs. They are seeking an Associate Director of Quality Control and Analytical Development to manage analytical development activities supporting their pipeline, including leading analytical control strategies and collaborating cross-functionally to deliver therapies to patients in need.
BiotechnologyHealthcarePharmaceuticalLife ScienceMedicalNeuroscience
Responsibilities
Lead phase-appropriate analytical control strategies for drug substance and drug product development, including specifications and initial shelf-life assignment
Leads method establishment, development and qualification for release, and stability testing of drug substance and drug product for peptides, oligonucleotide and other modalities
Manage and budget analytical activities at various global CMO/CTLS, including method technology transfer across Amylyx programs
Drive robust impurity characterization, profiling, and quantitation of drug substance and drug product across all stages of clinical development with a focus on HPLC and LC/MS
Lead method troubleshooting, optimization and life-cycle management for characterization, release and stability across multiple programs, through direct oversight of CMO/CTLS
Collaborate cross functionally with teams including Preclinical R&D, External Manufacturing, Regulatory and Quality leadership to develop strategies and deliver on key objectives
Author, review and approve documentation including technical reports, SOPs, test methods, specifications and CMC sections of regulatory filings
Travel may be required up to 10%, which may include on-site review of third-party laboratory and manufacturing operations
Qualification
Required
BA/BS, MS or PhD in chemistry, biochemistry or related discipline with at least 8+ years of experience
At least 6+ years of industry experience within Analytical Development and/or Quality Control
Technical expertise in the development of analytical methods for peptides and/or oligonucleotide products is required
Demonstrated knowledge of cGMP/ICH/FDA/EU/PMDA regulations
Highly collaborative team player with strong communication skills
Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities
Preferred
Environmental monitoring investigations to support sterile drug product experience is a plus
Ability to analyze, trend, interpret, organize and present data (experience with JMP and/or other statistical software preferred)
Company
Amylyx Pharmaceuticals
Amylyx Pharmaceuticals specializes in providing solutions for Alzheimer’s and other diseases of the brain.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$623.45MKey Investors
Viking Global InvestorsMorningsideALS Finding a Cure,The ALS Association
2025-09-10Post Ipo Equity· $175M
2022-10-06Post Ipo Equity· $246.3M
2022-01-07IPO
Leadership Team
Jim Frates
Chief Financial Officer
Camille Bedrosian
Chief Medical Officer
Recent News
BioWorld Financial Watch
2026-01-11
Longevity.Technology
2026-01-11
Company data provided by crunchbase