Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.

At Amylyx, we're bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer's disease, Wolfram Syndrome and others.

Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.

Recent milestones include:

• The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
• Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
• AMX0035 is currently under review with the European Medicines Agency
• 280 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands - and growing strong!

The Opportunity

In this newly created role, the GMP Specialist will provide operational Quality oversight of bulk drug product and finished drug product production, testing, packaging, and disposition. You will provide support on Quality Management Systems within GMP operations for internal implementation as well as integration with contracted partners. As a GMP Quality Specialist you are accountable for ensuring all Company, regional, and global GMP and GDP standards and regulations are met, and that the GMP Quality department performs to a standard that ensures the quality of products and materials produced by our contracted partners. As we prepare for global commercialization, you will support the implementation and operation of commercial quality systems.

The Role

• Provide quality oversight of production and testing activities, including review and approval of internal and external batch documentation, records, and reports.
• Participate in regular meetings with CMOs and 3PLs.
• Review executed manufacturing and packaging Batch Production Records and associated batch documentation, including QC records, labeling, change controls, and deviations, to ensure all approved procedures were followed and all specifications are met.
• Prepare and approve product disposition for bulk drug product, IP/IMP, and Finished Drug Product.
• Provide QA review and approval of master manufacturing and packaging batch records, product specifications, deviations, and internal and third-party change controls.
• Maintain quality metrics and communicate with external partners.
• Assist in the review of source data and information used in regulatory submissions and validation activities.
• Travel may be required up to 10%, which may include on-site review of third-party operations.

The Requirements

• BS. in Pharmaceutical Sciences or related field (advanced degree a plus).
• Minimum 1 year of experience within the Pharmaceutical or Biotechnology industry in a Quality role. QC experience is a plus.
• Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations.
• General knowledge of CMC and Regulatory Filing requirements.
• Understanding of product process and development, from discovery to commercialization.
• Experience with small molecules and oral dosage forms is highly preferred.
• Knowledgeable in FDA cGMP regulations, EudraLex and ICH Guidance, as well as other Biopharma industry guidance and regulations.

Preferred Qualifications

• Clinical knowledge in neurodegenerative diseases (i.e., ALS, Alzheimer's disease).
• Experience in supporting functions during FDA, EMA, or other regulatory agency inspections.

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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. 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.

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