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SalaryAmylyx 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!
POSITION SUMMARY
The Lead, Quality Control is responsible for providing analytical and Quality Control oversight of raw material testing, bulk drug product, finished drug product testing and stability program for the Amylyx commercial products in US and Canadian markets. When required, this role will support the launch of commercial products for rest of world.
As the SME for Quality Control, the Lead QC is accountable for ensuring all company, regional, global GMP and GDP standards and regulations are met. The Lead, Quality Control will review analytical data for clinical and marketed products provided by CMO/CRO and support Quality Management Systems within GMP operations for internal implementation as well as integration with contracted partners.
RESPONSIBILITIES
- Provide direct oversight for the daily operations of Quality Control activities related to drug product testing, release, stability studies and other analytical activities at US and Canada Operations (and rest of the world when required) within of three domains: QC Operations, QC Quality Systems and QC Documentation Compliance within Amylyx Pharmaceuticals and with CMO/CRO.
- Directly manage a group of QC Scientists/Specialists involved in supporting the QC activities of drug product release, testing of raw materials, in process and finished products.
- Oversee the contract laboratory to resolve technical and compliance issues and ensure testing is conducted in a timely manner.
- Oversee the laboratory investigations and discrepancy reporting of unexpected laboratory developments (e.g. OOS, OOT, OOE) in a timely manner.
- Monitor and implement corrective action and preventative actions as determined through laboratory investigations.
- Resolve technical and operational issues to meet deadlines and advance development programs.
- Provide leadership and mentoring for direct reports in their professional development.
- Drive improvements in methods, systems, databases, and systems as deemed necessary.
- Work with the method validation/method transfer team to ensure QC analytical methods are validated to meet current FDA, ICH, and ISO standards at minimum.
- Oversee transfer of QC analytical methods to entities such as contract laboratories, and commercial testing sites.
- Manage QC Quality Systems such as GMP Stability, QC Reference Standard program for commercial projects.
- Ensure that QC data meets data integrity requirements of accuracy, completeness, consistency, and validity.
- Ensure ALCOA principles for QC data integrity are applicable.
- Represent QC in shelf-life projections for commercial products and development. projects when required, providing technical and compliance support.
- Successfully collaborate with Technical Operations, CMC, Supply chain, Quality Assurance and Regulatory Affairs.
- Support the Head AD and QC in regulatory/Health Authority inspections and in-house audits.
- Represent QC as the Subject Matter Expert in internal and external project meetings and at Specification Committee meetings.
- Support API sited related analytical activities and the regulatory filings.
- Support analytical activities for development projects as and when required by the management.
- Execute the CMO QC data Qualification program.
- Work with internal teams, CMOs and test labs to establish methods and specifications.
- Review stability testing data from studies performed for Amylyx. Identify trends and ensure data is analyzed to help understand degradation pathways and to help develop specifications.
- Review and approve all specifications, stability protocols, method validation and method transfer documents.
- Travel may be required up to 10%, which may include on-site review of third-party laboratory and manufacturing operations.
REQUIREMENTS
- BS or MS in Life Sciences or related science degree.
- Minimum (8) years of experience in Analytical or QC within the Pharmaceutical or Biotechnology industry required.
- Strong technical knowledge of the small molecule research; must be familiar with the drug development process.
- Excellent knowledge with statistical tools for predicting shelf-life projections.
- Able to work with all levels of an organization and external contract service providers to ensure compliance with current regulations.
- Solid understanding of product process and development, from discovery to commercialization.
- Knowledgeable in CGMP regulations and ICH or other industry guidance.
- Experience with the CMC and Regulatory Filing requirements.
- Analytical / QC lab experience a plus.
- Experience with oral dosage forms (tablets, capsules, inhalations) a plus.
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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.
