Associate Director, Biologics Manufacturing Management

Role: Provide technical leadership in external manufacturing for Ultragenyx's biologics and gene therapy portfolio, spanning development through commercialization. Responsibilities include overseeing manufacturing of plasmid DNA, biologics, and oligonucleotides; managing CMO relationships; ensuring compliance with cGMP; authoring global CMC filings; leading process optimization and tech transfer; and managing manufacturing risks, quality deviations, and process changes. Requirements: BS in Pharmaceutical, Biological, Bioengineering, or related field; 10+ years in biotech/pharma manufacturing, process development, or MSAT, with experience in biologics, gene therapies, or aseptic drug production; proven CMO/CDMO management; proficiency in cGMPs; financial acumen; strong collaboration and communication skills; ability to support global teams and schedules. Travel up to 25% (domestic and international). High-value biopharma specifics: biologics and gene therapy manufacturing, plasmid DNA, aseptic processes, CMO oversight, global CMC authoring, cGMP compliance, and process optimization. Work setup involves a flexible onsite presence 2-3 days per week.