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
  • 350 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!

THE ROLE

The Lead of GMP Quality is responsible for providing operational quality oversight of bulk drug product and finished drug product manufacturing, testing, packaging, labeling and distribution. This role provides support on Quality Management Systems within GMP operations for internal implementation as well as integration with contracted partners. As the GMP quality expert, this role is 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 Amylyx contracted partners.  As we prepare for global commercialization, this role will support the implementation and operation of commercial quality systems.

RESPONSIBILITIES

  • Provide quality oversight of production and testing activities, including warehousing and distribution of clinical and commercial products. Participate in regular meetings with CMOs, CTLs and 3PLs.
  • Directly manage the batch release/disposition team. 
  • Review and evaluate Batch Production and QC Control Records for Bulk Drug Product and Finished Drug Product to ensure all approved procedures were followed and all specifications are met. 
  • Prepare and /or approve product disposition for bulk drug product, IP/IMP and FDP.
  • Provide QA support for non-compliance events for example, deviations, OOS, investigations, etc. that occur during production and testing, investigate and support remediation.
  • Provide QA review and approval for Quality Systems for example change controls, CAPA, quality product complaints, etc. 
  • Provide quality oversite and support of labeling documentation. Ensure proper version control and document integrity of packaging component labeling, specifications, printed labeling artworks, etc.
  • Ensure Amylyx’s quality expectations are being met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice. 
  • Provide QA oversite of documents associated with testing, stability, method qualification / validation, method transfer, etc. 
  • Write, review and/or approve SOPs for QA clinical and commercial systems e.g. software usage, complaints, annual product review. 
  • Support implementation and qualification of software for Quality Management Systems 
  • Review and approve SOPs related to QC and supply chain clinical and commercial operations e.g. artwork management, method validation/qualification/transfer, specification management, etc. 
  • Assure that source data and information used in regulatory submissions and validation activities is maintained and traceable.
  • Support quality improvements to maintain compliance and improve efficiency as part of continuous improvement initiatives. 
  • Manage Annual Product Quality Reviews. 
  • Participate in regular meetings held by the Quality organization and represent Amylyx Quality at cross-functional meetings and improvement initiatives.

REQUIREMENTS

  • B.S. in Pharmaceutical Sciences or related scientific discipline. 
  • Minimum 8 years of experience within the Pharmaceutical or Biotechnology industry in a quality role. 
  • Experience with CMC and Regulatory Filing requirements.
  • Ability to provide direct team management in the areas of: batch review and release, product disposition, change control and deviations within quality events. 
  • Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations.
  • Understanding of product process and development, from discovery to commercialization.
  • Knowledgeable in FDA cGMP regulations, Eudralex and ICH Guidance, as well as other Biopharma industry guidance and regulations.
  • Experience in supporting functions during FDA, EMA or other regulatory agency inspections.
  • Travel may be required up to 10%, which may include on-site review of third-party operations

PREFERRED QUALIFICATIONS

  • Advanced Degree
  • Experience in Quality Control  
  • Experience with small molecules and oral dosage forms
  • Prior experience in manufacturing

 

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

To return to our website please click here.

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.

Apply for this Job

* Required

resume chosen  
(File types: pdf, doc, docx, txt, rtf)
cover_letter chosen  
(File types: pdf, doc, docx, txt, rtf)


Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Amylyx Pharmaceuticals’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.


Please reach out to our support team via our help center.
Please complete the reCAPTCHA above.