Director, Drug Substance

Role Summary

A Director, Drug Substance at Amylyx will serve as the technical development drug substance owner for the company’s Phase III synthetic peptide and pre-clinical antisense oligonucleotide programs, working with external CDMOs to develop, scale-up, and validate drug substance processes. Initially an individual contributor, the role may evolve into a functional head within a highly collaborative asset CMC team.

Responsibilities

• Lead CMC drug substance development activities to support Module 3 content for global clinical filings and registration plans
• Serve as the technical SME and process owner for drug substance; develop scalable and robust manufacturing processes for oligonucleotides and peptide products with contract manufacturing organizations
• Author IND and NDA Module 3, Master Batch Records, Validation Plans and Reports
• Ensure robust regulatory plans for changes while minimizing risk to product supply
• Foster teamwork and drive project execution; track critical path activities, anticipate risks, create contingency plans, update project timelines and budgets, and maintain the CMC program plan
• Interact with Regulatory, Quality, Supply Chain, Commercial, Medical, Clinical, and non-Clinical development teams
• Manage external resources including Consultants and Contractors as needed
• Travel to global manufacturing sites to support operations and validation activities

Qualifications

• Bachelor‚Äôs 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 experience leading or serving on a CMC team preferred
• Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents
• Strong track record of successful global CMC submissions and approvals
• Ability to function independently and influence stakeholders with scientifically rigorous, risk-based solutions
• Experience working with contract manufacturing organizations
• Excellent communication and teamwork skills
• Ability to travel internationally up to 10%

Education

• Bachelor‚Äôs degree required; advanced degree preferred

Additional Requirements

• Travel to Cambridge, MA location several times per year; remote work opportunities within the United States with state restrictions
• Ability to work in a setting with reliable internet, privacy, and video conferencing capabilities