The Opportunity

This position is responsible for providing CMC quality oversight of drug substance manufacturing, packaging and distribution.

As the CMC quality expert, this role is accountable for ensuring all company, regional, and global GMP and GDP standards and regulations are met, and that the CMC Quality department performs to a standard that ensures the quality of products and materials produced by Amylyx contracted partners.

Responsibilities

• Provide quality oversight of drug substance production activities.
  • Provide QA review and approval on drug substance validation documents, equipment validation documents, master production records, product specifications (in-process, release, and stability), analytical method qualification/validation documents, method transfer documents, and stability plans.
  • Review executed Batch Production and QC Control Records to ensure all approved procedures were followed and all specifications are met.
  • Prepare and /or approve batch disposition packages.
  • Provide QA review and approval on quality system records, including but not limited to deviations, OOS, change controls, CAPAs, and product quality complaints.
  • Lead or participate in regular meetings internally and externally as Quality SME to ensure Amylyx’s quality expectations are met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice.
• Write, review and/or approve SOPs as QA SME for manufacturing, labeling, packaging, and transportation of late stage and commercial products.
• Provide QA review on NDAs. Assure that source data and information used in regulatory submissions and validation activities is maintained and traceable.
• Support FDA, EMA or other regulatory agency inspections.

Requirements

• Minimum 5 years of experience with B.S. in Pharmaceutical Sciences or minimum 3 years of experience with advanced degrees in Pharmaceutical Sciences.
• Minimum 3 years of experience directly related to peptide and or oligonucleotide (ASO) manufacturing, including but not limited to quality operations, QC, MSAT, etc.
• Experience with authoring and reviewing NDA CMC sections and addressing Regulatory Filing requirements in FDA cGMP regulations, Eudralex and ICH Guidance, as well as other Biopharma industry guidance and regulations.
• Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations.
• Travel may be required up to 10% within US, which may include on-site review of third-party operations.

Preferred Qualifications

• QC experience is a plus.

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.