Manager, Quality Operations

amylyx; Cambridge (MA); Hybrid; USD 129,000 - 145,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Benefits package

Job summary

Amylyx is seeking a CMC Quality Expert to provide leadership in the oversight of drug substance manufacturing, packaging, and distribution. You will ensure GMP, GDP, and regulatory standards are met and drive quality across the CMC functions with internal teams and external partners.

The role requires working with cross-functional teams, reviewing validation and lot records, and preparing regulatory documentation.

Qualifications

• Minimum 5 years of experience with a B.S. in Pharmaceutical Sciences.
• Minimum 3 years of experience directly related to peptide and/or oligonucleotide manufacturing, including quality operations, QC, MSAT, etc.
• Experience with authoring/reviewing NDA CMC sections and regulatory filings per FDA cGMP, Eudralex and ICH guidelines.

Responsibilities

• Provide quality oversight of drug substance production activities.
• Provide QA review/approval on drug substance validation docs, equipment validation docs, master production records, product specifications (in-process, release, stability).
• Review Batch Production and QC Control Records for compliance with procedures and specs.
• Prepare/approve batch disposition packages.
• Review/approve quality system records (deviations, OOS, CAPAs, PQCs).
• Lead/participate in QA meetings to ensure GMP, GDP, and GDP standards are met.
• Write/review/approve SOPs for manufacturing, labeling, packaging, and transportation of late-stage and commercial products.
• Provide QA review on NDAs and ensure traceability of source data for regulatory submissions.
• Support FDA/EMA or other regulatory inspections.

Skills

Quality Oversight

GMP compliance

GDP compliance

NDA CMC writing

Regulatory filings

Vendor management

Cross-functional collaboration

Education

BS in Pharmaceutical Sciences

MS/PhD in Pharmaceutical Sciences

Job description

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.

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.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.

Base salary is one component of Amylyx's total rewards package. In addition to competitive base pay, eligible employees may receive annual performance-based bonuses and equity awards, providing an opportunity to share in the company's long-term success. Amylyx also offers a comprehensive benefits package designed to support the health, well-being, and financial security of our employees.

Estimated Pay Range

$129,000 - $145,000 USD

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