Associate Director, Quality Control

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 Quality Operations team is expanding and looking to hire an Associate Director of Quality Control reporting to the Senior Director of QC/AD. This individual will be responsible for commercial readiness and ongoing commercial QC operations. This position is a key QC leader responsible for advancing an inspection-ready, globally compliant commercial QC team within a fully outsourced manufacturing and testing network.

The ideal candidate will be a motivated, organized, self-starter, willing to actively collaborate cross functionally and excited about the potential to deliver therapies to patients in need.

• Lead and manage Amylyx’ commercial QC function across external CMOs and CTLs supporting commercial raw material, drug substance, drug product and finished drug product in-process, release and stability testing.
• Monitor quality and operational performance of external testing partners through governance, metrics, trend reviews, deviation/investigation and CAPA oversight
• Provide oversight of commercial stability programs, including protocol governance, pull schedule adherence, data review and trending, shelf-life support, annual stability commitments, comparability assessments, and post-approval stability requirements.
• Manage commercial specification lifecycle activities, including implementation of approved specifications, post-approval revisions, change assessments, market-specific requirements, comparability impacts, and coordination with Regulatory Affairs and external partners.
• Ensure effective lifecycle management of commercial analytical methods, including validation maintenance, transfer, verification, method performance monitoring, troubleshooting, and change implementation across outsourced laboratories.
• Author, review, and approve commercial QC-related documents, including specifications, stability protocols and reports, method transfer and validation documents, SOPs, technical assessments, annual product quality review inputs.
• Collaborate cross functionally with Manufacturing, Supply Chain, Regulatory Affairs, Analytical Development, and Quality Assurance to support commercial lot release, global market supply, process changes, comparability assessments, and regulatory filing commitments.
• Manage one direct report initially, with responsibility for building and expanding the QC commercial team over the following year

• Bachelors or MS in chemistry or biochemistry or related discipline with at least 8+ years of experience with 6+ years of industry experience within Quality Control.
• Experience supporting commercial GMP products is required.
• Demonstrated knowledge of USP, EP, JP, cGMP, ICH, data integrity, global market release expectations, and inspection readiness requirements for commercial QC operations.
• Expertise with commercial method transfer, validation maintenance, verification, performance monitoring, and troubleshooting across…