Overview

Amylyx is a clinical-stage pharmaceutical company headquartered in Cambridge, Massachusetts, focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people and our core values: be audacious, be curious, be authentic, be engaged, and be accountable. We seek passionate, determined individuals to join our team and help advance therapies for high unmet needs.

The Opportunity

Amylyx is looking for a Director, Drug Substance, to join our CMC and External Manufacturing team. You will be the technical development drug substance owner for Amylyx’s Phase III synthetic peptide, Avexitide, and pre-clinical antisense oligonucleotide, AMX-0114. This role will work directly with external CDMOs to develop, scale-up, and validate drug substance processes. Initially this role will be an individual contributor, but it may evolve into a functional head. You will be a key member of asset CMC teams and report 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. Work with contract manufacturing organizations to 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 with project teams. Update project timelines and budgets, and maintain the CMC program plan
• Regularly interact with 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

• Bachelor’s degree in organic chemistry, chemical engineering, or related field; MS or PhD preferred
• Solid understanding of small molecule, RNA, and amino acid chemistries
• At least 15 years of experience in API development from early through late-phase; prior process validation experience preferred
• Experience developing oligonucleotide and/or synthetic peptide processes including impurity control strategies
• Experience leading global, cross-functional, high-performing teams; prior CMC team leadership or service is preferred
• Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents
• Strong track record of successful global CMC submissions and approvals
• Ability to work independently and influence stakeholders with scientifically rigorous, phase-appropriate, risk-management-based solutions
• Experience working with contract manufacturing organizations
• Excellent communication and teamwork skills
• Ability to travel internationally up to 10%

Work Location and Conditions

• Remote work opportunities within the United States are supported. Some states are excluded due to health insurance coverage and tax regulations. Currently not considering applicants from Alaska, Arizona, Delaware, Hawaii, and Kansas.
• Occasional travel to the Cambridge, MA location and to other company-related events as necessary
• Must have access to a work setup that enables privacy, reliable internet, phone, and video conferencing at your remote location

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

Amylyx Pharmaceuticals is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please contact Amylyx Talent Acquisition.