Manager, Quality Operations

The role

This person will provide CMC quality oversight of drug substance manufacturing, packaging, and distribution. They will ensure all company, regional, and global GMP and GDP standards and regulations are met.

What you will do

• Provide quality oversight of drug substance production activities.
• Provide QA review and approval on validation documents, production records, specifications, and stability plans.
• Review executed Batch Production and QC Control Records.
• Prepare and/or approve batch disposition packages.
• Provide QA review and approval on quality system records including deviations, OOS, change controls, CAPAs, and product quality complaints.
• Lead or participate in regular meetings as Quality SME.
• Write, review and/or approve SOPs for manufacturing, labeling, packaging, and transportation.
• Provide QA review on NDAs and assure source data traceability.
• Support FDA, EMA or other regulatory agency inspections.

Required qualifications

• 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
• 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.
• Access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.)

Nice to have

• QC experience is a plus

Benefits

• Competitive base pay
• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

Before you apply

• Unable to hire employees who reside and/or work in Alaska and Hawaii

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The company has a mission to usher in a new era for treating diseases with high unmet needs.