Senior Director, External Manufacturing

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

The Senior Director, External Manufacturing is a critical leadership role responsible for shaping and executing the external manufacturing strategy across clinical and future commercial programs. This individual will lead a global network of CDMO partners supporting a diverse and growing portfolio spanning peptides, oligonucleotides, and small molecules.

As Amylyx advances toward commercialization and expands its global manufacturing footprint, this role will be instrumental in ensuring supply continuity, operational readiness, and long-term scalability. The Senior Director will partner cross-functionally to enable successful product launches, manage increasing manufacturing complexity, and build the infrastructure needed to support future growth and global expansion.

Responsibilities

Provide strategic leadership and oversight of external manufacturing across clinical development and commercial supply

Establish and govern CDMO partnerships to ensure strong performance, accountability, and alignment with program objectives

Define and execute manufacturing strategies to support technology transfer, scale-up, commercialization, and lifecycle management

Establish supplier performance metrics and business review process

Mentor and build a team of relationship owners responsible for leading the internal supplier relationship teams and serving as the supplier point of contact

Ensure supply continuity through proactive risk identification, mitigation planning, and issue escalation across external partners

Oversee technology transfer, manufacturing execution, and process performance across a global network of external sites

Support commercial launch readiness, including validation, supply planning, and inspection preparedness

Partner cross-functionally with Finance, Legal, CMC, Quality, and Supply Chain to drive aligned execution

Build scalable, robust external manufacturing infrastructure, operating models, and governance frameworks to support organizational growth

Required Qualifications

Bachelor’s degree in engineering, life sciences, or related field; advanced degree preferred

~15+ years of experience in pharmaceutical or biotechnology manufacturing, including significant external manufacturing leadership

Proven track record managing CDMOs across clinical and commercial supply environments

Deep understanding of cGMP regulations, global manufacturing requirements, and regulatory expectations

Experience in manufacturing strategy, technology transfer, and commercialization activities

Demonstrated ability to lead in complex, multi-program environments and drive cross-functional alignment

Strong leadership, communication, and stakeholder management skills

Prior experience supporting commercial product launches, conducting RFPs, negotiating supply agreements, and managing high value budgets

Experience across multiple supply nodes (API, Drug Product, Packaging, Device)

Ability to travel domestically and internationally ~10%

Preferred Requirements

Experience across multiple modalities (small molecule, peptide, oligonucleotide)

A track record of process scale-up, validation and continuous improvement

Work Location and Conditions

At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee. Preference may be given to candidates residing within or near the geographic region they support.

• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data…