Associate Director, Quality Control

📋 Description

• Lead and manage Amylyx’ commercial QC function across external CMOs and CTLs supporting commercial
• Monitor quality and operational performance of external testing partners through governance
• Provide oversight of commercial stability programs, including protocol governance, pull schedule
• Manage commercial specification lifecycle activities, including implementation of approved
• Ensure effective lifecycle management of commercial analytical methods, including validation
• Author, review, and approve commercial QC-related documents, including specifications, stability

🎯 Requirements

• Bachelors or MS in chemistry or biochemistry or related discipline with at least 8+ years of
• Experience supporting commercial GMP products is required.
• Demonstrated knowledge of USP, EP, JP, cGMP, ICH, data integrity, global market release
• Expertise with commercial method transfer, validation maintenance, verification, performance
• Experience supporting commercial stability programs, including shelf-life support, data trending
• Involvement with commercial specification implementation, justification, market-specific

🎁 Benefits

• Remote work opportunities within the United States
• Travel to corporate location in Cambridge, MA several times a year