Job Description
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!
POSITION SUMMARY
Reporting to the Global Head, Technical Operations & CTOO, the Head, Global Supply Chain has direct accountability for building and scaling a global supply chain organization. Establishes strategies and oversees the execution of global supply chain functions including planning, logistics and external manufacturing.
RESPONSIBILITIES
- Establish strong capabilities to support current and future assets resulting from the company’s pipeline.
- Define resource requirements to fulfill global operational needs to execute on demand and business goals.
- Oversee supply planning, procurement and forecasting of demand to guarantee supply capacity requirements are met.
- Lead assessments and analyses resulting in recommendations for contract manufacturing organization (CMO) qualification and negotiations that are consistent with and supportive of the global strategic plan & are approved by GXP Quality.
- Translate strategy into an executable series of pharmaceutical manufacturing plans and quality control systems to ensure deliverables meet approved budgets
- Manage the supply of critical materials to all units to ensure supply through accurate, real-time inventory management and continuous tracking of supplies. Develop strategies to transition from paper-based planning capabilities to a validated MRP system.
- Foster key vendor relationships to ensure availability of critical equipment, materials and uninterrupted supply.
- Ensure all suppliers are compliant with local and international regulatory and import/export requirements by working closely with Quality and Regulatory departments.
- Minimize variability, align logistics, and forecast demand planning and sourcing to ensure minimum financial impact and uninterrupted manufacturing operations and temperature sensitive workflow.
- Oversee the communication of business performance against key performance indicators and associated metrics for production plan adherence, customer service, and inventory management.
REQUIREMENTS
- BS in Engineering, Chemistry, or Business Administration
- 20+ years of pharmaceutical experience directly supporting and/or managing manufacturing or technical operations
- 20+ years of industry background in pharmaceutical product development with a minimum of 10 years in preparing and supporting Chemistry, Manufacturing, and Control (CMC) documentation for INDs, NDAs, BLAs, and EU MAAs.
- Experience in global submission and maintenance of CMC sections of regulatory filings.
- Established leadership skills, with a strong interest for developing team, individuals and talents Preferred Qualifications:
- Strong strategic planning skills, project management, budget management, and process improvement abilities.
- Excellent interpersonal communications, organizational, and presentation skills.
- Superior negotiation and influencing skills
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.
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Date Posted
10/28/2023
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8
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