Associate Director, Drug Substance

Amylyx is seeking an Associate Director, Drug Substance, to join our CMC and External Manufacturing team. In this role 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 position will work directly with external CDMOs to develop, scale-up, and validate drug substance processes. This role will be an individual contributor, however, it is a 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. Lead CMC drug substance phase appropriate process development activities from Phase 1 through NDA ensuring Module 3 content supports global clinical filings and registration plans.