Senior Director Pharmaceutical (Drug Product) Manufacturing

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 Senior Director, Drug Product Manufacturing is an experienced operations leader responsible for CMC development and GMP manufacturing of Ultragenyx’s drug product formulations, including small molecule and oligonucleotide products. This role leads external drug product manufacturing activities, supports reliable clinical and commercial supply, and contributes to strategic planning within Technical Operations. The position serves as a recognized technical expert and partners cross ‑ functionally across Quality, Regulatory, Supply Chain, and Development organizations. 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 external drug product manufacturing for small molecule and oligonucleotide products in a cGMP environment. Oversee production planning, execution, and performance tracking to ensure clinical and commercial supply commitments are met. Manage CMO relationships, including selection, onboarding, and performance management, fostering strong collaborative partnerships. Lead or support CMC activities across the drug product portfolio, including authoring and reviewing CMC sections for global regulatory filings (INDs, IMPDs, NDAs, MAAs). Serve as an integral member of cross ‑ functional CMC teams, partnering with Quality, Regulatory, Supply Chain, Development, and Clinical teams. Develop and maintain manufacturing documentation, including Product Design History Files and Quality Risk Management Plans. Oversee process development, technology transfer, process optimization, and lifecycle management activities. Manage manufacturing-related deviations, change controls, investigations, and complaint responses. Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing governance documents. Promote knowledge management, documentation best practices, continuous improvement, and operational excellence initiatives while representing Drug Product Manufacturing on global and cross ‑ functional teams. Requirements: PhD or equivalent relevant experience in Pharmaceutical Sciences, Engineering, or related discipline. 10–15+ years of experience in pharmaceutical or biopharmaceutical manufacturing, preferably within global organizations. Demonstrated expertise in small molecule drug product development and clinical/commercial manufacturing; experience with multiple dosage forms preferred. Strong knowledge ... (truncated, view full listing at source)