Lead, External Manufacturing

4 weeks ago

Belfast, United Kingdom Amylyx Pharmaceuticals Full time

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

***

As a key member of a growing Supply Chain organization the Lead, External Manufacturing is responsible for management of contract manufacturing and packaging operations. Reporting to the Head, External Supply Operations, you will provide strategic leadership and operational execution of all activities and relationships required to ensure the timely and compliant manufacturing and packaging of Amylyx clinical & commercial product.

**RESPONSIBILITIES**
- Collaborating with Amylyx Planning and approved CDMO's, converts manufacturing and/or packaging plans into production schedules at contract sites.
- Develops reporting, metrics, and progress tracking tools to provide routine updates on production schedules, as well as projects and activities impacting production schedules. Develops and manages improvement plans based on metrics.
- Acts as primary Strategic Relationship Management (SRM) contact with manufacturing and/or packaging CDMOs to ensure supply in compliance with regulatory requirements. Plans and executes quarterly business review meetings with contractors, including development of agendas, scheduling, generation of meeting notes, and tracking of action items.
- Acts as Amylyx Person in Plant for applicable manufacturing and/or packaging operations. Monitors execution of production plans at contractors and schedules and maintains routine recurring production meetings with each contract site.
- Monitors and ensures appropriate processing of purchase orders, invoices, quotations for new work, and any other related contractor documentation.
- Participates in technical review of manufacturing and/or packaging documentation as required. Leads ad-hoc cross-functional teams as required.
- Manages implementation of new and/or revised manufacturing and/or packaging materials, components, and new products at manufacturing and/or packaging sites.
- Creates and manages Change Control, Deviation, Investigation, and related documentation as required relative to new or revised manufacturing operations.
- Works with the Logistics team to ensure timely shipments to and from CMOs in compliance with GDP requirements.
- Participate in Global CMC & Development team(s) to align regulatory strategic planning at CMOs.
- Monitors and manages all systems and transactions associated with responsibilities, including internal Amylyx EDM and associated CMO and contractor systems, as well as applicable packaging serialization-related development and operational activities.
- Chairs all internal & contractor related program/project meetings to ensure flawless communication to promote operational excellence at our contact manufacturing sites (CDMO's)
- Manages other employees as required.

**REQUIREMENTS**
- Completed B.S. degree
- 8 +years experience in either pharmaceutical/CMO Supply Chain or Manufacturing
- Ability to understand pharmaceutical-related manufacturing and packaging GMP requirements, regulations, and guidelines
- Working knowledge of small and large molecule manufacturing and packaging operations
- Experience in leading Cross Functional Teams
- Ability to engage in and lead strategy development and flexibility to transition between strategy and operational execution
- Experience collaborating with and managing contract manufacturing and packaging sites
- Strong organizational skills
- Adaptable and comfortable working in a dynamic and fluid environment
- Approximately 25% travel required
- Reside in the country of Ireland _(preferably Northern Ireland)_

**PREFERRED QUALIFICATIONS**
- Experience with a start up drug development company, particularly in the orphan drug space.
- Prior experience working with External manufacturers a plus (internal manufacturing experience is acceptable)
- Prior experience as Responsible Person or Deputy Responsible Person strongl

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