Manager, Quality Operations

The posting, as Amylyx Pharmaceuticals wrote it

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, we encourage you to read the opportunity below and apply.

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 se

[…]
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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Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.