Director, Drug Substance

Director, Drug Substance

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.

Our mission is powered by our people. Our core values be audacious, be curious, be authentic, be engaged, and be accountable create 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 determination, we encourage you to read the opportunity below and apply.

The Opportunity

Amylyx is looking for a Director, Drug Substance, to join our CMC and External Manufacturing team. In this role you will be the technical development drug substance owner for Amylyxs Phase III synthetic peptide, Avexitide, and pre-clinical antisense oligonucleotide, AMX-0114. This position will work directly with external CDMOs to develop, scale-up, and validate drug substance processes. Initially this role will be an individual contributor, however, may evolve into a functional head. In this highly collaborative and visible role, you will be a key member of asset CMC teams. This role reports to the Senior Vice President, Global CMC and External Manufacturing.

Responsibilities

• Lead CMC drug substance phase appropriate development activities to ensure Module 3 content that supports global clinical filings and registration plans
• Serve as the technical SME and process owner for drug substance. Working with contract manufacturing organizations, develop scalable and robust manufacturing processes for oligonucleotides and peptide products
• Author IND and NDA Module 3, Master Batch Records, Validation Plans and Reports
• Ensure robust regulatory plans for all changes while minimizing risk to product supply
• Foster effective teamwork and drive project execution. Proactively track critical path activities, anticipate risks, create contingency plans and decision-making exercises in collaboration with project teams. Update project timelines and budgets, communicate progress, and maintain the CMC program plan
• Regularly interacts with functional areas including Regulatory, Quality, Supply Chain, Commercial, Medical, Clinical, and non-Clinical development
• Manage external resources including Consultants and Contractors, as needed to deliver projects
• Travel to global manufacturing sites to support operations and validation activities

Required Qualifications

Work Location and Conditions

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.