Manager, Quality Operations

📋 Description

• Provide quality oversight of drug substance production activities.
• Provide QA review and approval on drug substance validation documents, equipment validation
• Review executed Batch Production and QC Control Records to ensure all approved procedures were
• Prepare and/or approve batch disposition packages.
• Provide QA review and approval on quality system records, including but not limited to deviations
• Lead or participate in regular meetings internally and externally as Quality SME to ensure Amylyx’s

🎯 Requirements

• Minimum 5 years of experience with B.S. in Pharmaceutical Sciences or minimum 3 years of experience
• Minimum 3 years of experience directly related to peptide and/or oligonucleotide (ASO)
• Experience with authoring and reviewing NDA CMC sections and addressing Regulatory Filing
• Ability to work with all levels of the organization and external contract service providers to
• Travel may be required up to 10% within US, which may include on-site review of third-party

🎁 Benefits

• Base salary is one component of Amylyx’s total rewards package.
• In addition to competitive base pay, eligible employees may receive annual performance-based
• Amylyx also offers a comprehensive benefits package designed to support the health, well-being, and
• At Amylyx, we proudly support remote work opportunities within the United States. However, due to
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and
• You must have access to work in setting which enables meeting all requirements of the role