Director Chemical (Drug Substance) Manufacturing Management

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team . Position Summary: ultra focused – Work together to fearlessly uncover new possibilities The Director, Drug Substance Manufacturing provides technical and operational leadership for drug substance manufacturing activities supporting Ultragenyx’s small molecule and oligonucleotide programs. This role is responsible for execution of departmental manufacturing strategies, management of external CMOs, and delivery of reliable clinical and commercial supply under cGMP conditions. The Director partners cross ‑ functionally to ensure safe, compliant, and efficient manufacturing while operating within established functional strategies. Work Model: Flex: This role will typically require onsite work 2-3 days each week or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. Responsibilities: Lead and manage drug substance manufacturing for synthetic molecules and oligonucleotides in a cGMP environment, supporting both clinical and commercial supply. Oversee production planning, execution, and performance tracking to ensure reliable fulfillment of agreed manufacturing services. Manage and strengthen CMO relationships, including selection, onboarding, governance, and ongoing performance management. Lead or contribute to CMC projects across the small molecule and oligonucleotide portfolio, ensuring alignment with development and supply strategies. Author and/or provide expert input into CMC sections for global regulatory filings, including INDs, IMPDs, NDAs, and MAAs. Serve as an integral member of cross ‑ functional and cross ‑ discipline CMC teams for programs containing synthetic components. Oversee process development, optimization, technology transfer, and lifecycle management, including change controls, deviations, and investigations. Ensure development and maintenance of manufacturing-related documentation, including Design History Files and Quality Risk Management Plans. Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing and quality governance documents. Promote continuous improvement, knowledge management, and operational excellence while representing Drug Substance Manufacturing on global and cross ‑ functional teams. Requirements: Ph.D. in chemistry, chemical engineering, organic chemistry, or a related discipline, or equivalent industry experience. 8–12 years of pharmaceutical or biopharmaceutical experience with progressive responsibility in CMC and manufacturing. Demonstrated experience in managing small molecule synthetic chemistry, pharmaceutical CMC development, process scale ‑ u ... (truncated, view full listing at source)