Associate Director, Quality Control

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

The Quality Operations team is expanding and looking to hire an Associate Director of Quality Control reporting to the Senior Director of QC/AD. This individual will be responsible for commercial readiness and ongoing commercial QC operations. This position is a key QC leader responsible for advancing an inspection-ready, globally compliant commercial QC team within a fully outsourced manufacturing and testing network. The ideal candidate will be a motivated, organized, self-starter, willing to actively collaborate cross functionally and excited about the potential to deliver therapies to patients in need.

Responsibilities

• Lead and manage Amylyx’ commercial QC function across external CMOs and CTLs supporting commercial raw material, drug substance, drug product and finished drug product in-process, release and stability testing.
• Monitor quality and operational performance of external testing partners through governance, metrics, trend reviews, deviation/investigation and CAPA oversight
• Provide oversight of commercial stability programs, including protocol governance, pull schedule adherence, data review and trending, shelf-life support, annual stability commitments, comparability assessments, and post-approval stability requirements.
• Manage commercial specification lifecycle activities, including implementation of approved specifications, post-approval revisions, change assessments, market-specific requirements, comparability impacts, and coordination with Regulatory Affairs and external partners.
• Ensure effective lifecycle management of commercial analytical methods, including validation maintenance, transfer, verification, method performance monitoring, troubleshooting, and change implementation across outsourced laboratories.
• Author, review, and approve commercial QC-related documents, including specifications, stability protocols and reports, method transfer and validation documents, SOPs, technical assessments, annual product quality review inputs.
• Collaborate cross functionally with Manufacturing, Supply Chain, Regulatory Affairs, Analytical Development, and Quality Assurance to support commercial lot release, global market supply, process changes, comparability assessments, and regulatory filing commitments.
• Manage one direct report initially, with responsibility for building and expanding the QC commercial team over the following year

Requirements

• Bachelors or MS in chemistry or biochemistry or related discipline with at least 8+ years of experience with 6+ years of industry experience within Quality Control.
• Experience supporting commercial GMP products is required.
• Demonstrated knowledge of USP, EP, JP, cGMP, ICH, data integrity, global market release expectations, and inspection readiness requirements for commercial QC operations.
• Expertise with commercial method transfer, validation maintenance, verification, performance monitoring, and troubleshooting across contract testing laboratories and manufacturing partners.
• Experience supporting commercial stability programs, including shelf-life support, data trending, protocol governance, annual commitments, and post-approval stability requirements.
• Involvement with commercial specification implementation, justification, market-specific requirements, lifecycle management, post-approval revisions, and change implementation.
• Highly collaborative team player with strong communication skills and the ability to drive internal and external commercial execution.
• Prior experience managing and developing people; track record of building high performing teams
• Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities 

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, Arizona, Hawaii, Michigan and Tennessee.
• 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.

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

To return to our website please click here.

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.