Director, Oligonucleotide Process Development

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 impact – Make a difference for those who need it most The Director of Oligonucleotide Process Development provides independent technical leadership for oligonucleotide and small molecule drug substance development activities, including process development, scaleup, technology transfer, and GMP manufacturing. The role supports multiple development programs from preIND through NDA submission and serves as a core member of CMC program teams. This position requires deep expertise in oligonucleotide and small molecule synthesis, purification technologies, and analytical methods, along with a strong understanding of cGMP requirements, CMC control strategies, and global regulatory expectations . The Director operates with a high degree of autonomy, manages complex external partnerships, and is accountable for technical execution, risk mitigation, and regulatory readiness. 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 drug substance process development, optimization, scaleup, technology transfer, process characterization, validation, and manufacturing support for ASO, siRNA, and smallmolecule programs within Ultragenyx’s pipeline. Provide technical leadership and expert oversight for oligonucleotide (ASO) process development and manufacturing activities conducted at CROs, CMOs, and CDMOs . Serve as a core technical contributor within crossfunctional CMC project teams , driving execution of program milestones on schedule and within budget. Lead or actively participate in the selection, evaluation, and governance of external partners, ensuring delivery of highquality, compliant work packages. Author, review, and approve drug substance–related sections of IND, IMPD, NDA, and MAA submissions. Support Manufacturing, Quality, and Supply Chain teams in deviation investigations, rootcause analysis, change management, and product lifecycle activities . Act as a technical subjectmatter expert for Research and Business Development initiatives, including technical assessments and due diligence support as needed. Prepare and manage program budgets; develop and issue RFPs; review and approve work orders; and partner with Legal and Quality to establish and maintain MSAs and QTAs . Draft, review, and approve drug substance technical documentation, including process development reports, master batch records, campaign reports, validation documentation, and change controls. Oversee review of ex ... (truncated, view full listing at source)