Ensure effective lifecycle management of analytical methods
Author and approve QC-related documents
Collaborate cross-functionally to support commercial lot release
Manage and expand the QC commercial team
Benefits
Remote work opportunities within the U.S.
Travel to corporate location in Cambridge, MA
Participation in company-related events
Support for a collaborative work environment
Full Job Description
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.
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.
Estimated Pay Range
$171,000-$192,000 USD
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About Amylyx Pharmaceutical
Amylyx Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and other neurodegenerative diseases. The company's lead product candidate, AMX0035, is a combination therapy designed to reduce the death of motor neurons. Amylyx was founded in 2013 by Joshua Cohen, Justin Klee, and Justin Yang, and is headquartered in Cambridge, Massachusetts.
