Head – Global External Manufacturing @ Amylyx Pharmaceuticals

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

In this role you will be a hands-on leader reporting directly to the Global Head, Supply Chain. You will be accountable for developing the external supplier network for the company leveraging a balance of strategic, tactical, and operational plans and processes to support the Company’s clinical and commercial programs. The ideal candidate will be an experienced leader who is familiar with virtual operations through contract development and manufacturing organizations (CDMO’s) ensuring supply continuity for Amylyx requirements.

RESPONSIBILITIES

Lead the CDMO selection process in collaboration with internal stakeholders, including developing and negotiating development, technology transfer, and manufacturing/supply contracts.
Manage the existing CMO/CDMOs and Packaging partners.
Establish governance structures (joint project teams, steering committee) that facilitate timely, open communication with CDMOs and internal stakeholders, and successful delivery of CDMO services.
Oversee and lead interactions with external manufacturing partners to assure on-time quality supply which meets compliance and regulatory requirements.
Assist in alliance development and management as needed.
Establish and manage the necessary manufacturing agreements including MSA’s (Master Services Agreements).
In partnership with the Quality organization, manage and ensure the timely review and release of product from external manufacturing partners.
In partnership with the Regulatory function, manage the process improvements, continuous monitoring and validation and implement and product life cycle management changes per established time commitments.
In partnership with Commercial function, manage the demand and supply.
Author and/or approve technical reports, manufacturing instructions, process validation documents, regulatory submissions and other technical and management documents as needed.
Manage overall External Manufacturing and Supply Chain budget and spending, carefully balancing risk and cost.
Provide leadership for commercial & clinical supply continuity and risk management processes, including ownership of supply chain plans, inventory and forecasts used to support Amylyx programs.
Lead the evaluation of Supply Chain redundancy efforts and programs continuously evaluating the risk of supply partners and operations making necessary recommendations and implementation plans to reduce potential interruptions to supply operations.
Hire, lead, and develop employees to successfully meet group objectives.

REQUIREMENTS

15+ years of outsourced clinical and commercial manufacturing and supply chain management experience in the biotech/pharmaceutical industry.
Bachelor’s degree.
Experience in managing outsourced manufacturing and supply chain.
Track record of developing, negotiating, and administering clinical and/or commercial contract manufacturing agreements.
Strong knowledge and experience in designing and implementing outsourced manufacturing and supply chain best practices.
Deep familiarity in phase-appropriate cGMP quality systems with good understanding of regulatory requirements.
Firsthand experience in authoring and reviewing regulatory documents and participation in regulatory audits from agencies like FDA, EMA, PMDA, etc.
Experience with manufacturing technical support or manufacturing sciences and technical support organization is desirable.
Experience in handling and leading investigations, deviations, and quality events. Participation is CAPA, developing CAPA plans, audit reports, annual reports, validation plans, protocols, assessments, technical memo and other regulatory and quality documents etc.
Experience and comfort level with operating in early-stage pharma/biotech environment
Intercultural experience and ability to operate and adapt in a complex and rapidly changing business environment.
Impeccable problem solving and collaboration skills with quality-driven mindset.
Proven ability to facilitate conversations and drive towards decisions. Ability to influence.
Proven ability to lead teams and develop individuals.

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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.

6 month growth

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