Senior Biologics Manufacturing & Gene Therapy CMO Lead

Position Summary You will provide technical expertise for critical starting materials, drug substance, and/or drug product manufacturing over the life cycle of the products in the Ultragenyx biologics/gene therapy portfolio from development through commercialization. You will serve as external manufacturing relationship manager at the respective contract manufacturing organizations (CMOs) and represent manufacturing as part of cross‑functional Ultragenyx CMC teams. 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 Oversee external manufacturing of plasmid DNA, biologics and gene therapy drug substance, as well as aseptic drug product manufacturing for biologics and oligonucleotides. Ensure fulfillment of agreed manufacturing services at CMOs for clinical and commercial supply plans. Lead relationships with CMOs and foster collaborative partnership. Participate in Health Authority interactions as a subject matter expert. Author global CMC filings in accordance with applicable regulations and guidance. Identify and enable selection of DS and DP CMOs, ensure CMO compliance to cGMPs and establish strategic fit. Actively identify and manage product or manufacturing process risks. Manage process optimization, tech transfer, and change control. Drive troubleshooting and quality deviation investigations occurring at manufacturing sites. Direct key business agreements, manage budget & cost control, approve purchase orders & invoices, and improve COGS development. Requirements BS in Pharmaceutical, Biological or Bioengineering Sciences or Engineering. 10+ years of relevant combined experience in Process Development, MSAT, Quality Assurance, or Manufacturing in the biotech/pharmaceutical industry. Fewer years are acceptable if combined with a relevant advanced degree. Technical experience in process development and commercial bioprocess manufacturing, including one or more of plasmid DNA, enzymes, antibodies, gene therapies, or aseptic drug product manufacturing. Substantial experience working in an outsourcing model, involving CMO/CDMO management. Proficient in cGMPs and pharmaceutical industry procedures and regulations. Good understanding of financial figures, cost management and financial decision making. Strong collaboration, communication skills and drive for results. Excellent problem‑solving skills and verbal/written communication skills. Ability to support work requirements across multiple Ultragenyx time zones and reflective of 24/7 manufacturing schedules at CMO sites, as applicable. Up to 25% travel commitments (domestic and international) and occasional person‑in‑plant activities. Pay The typical annual salary range for this full‑time position is $179,300 USD – $221,400 USD, and the position is eligible for an annual bonus and equity incentives. Benefits Generous vacation time and public holidays observed by the company Volunteer days Long‑term incentive and employee stock purchase plans or equivalent offerings Employee wellbeing benefits Fitness reimbursementTuition sponsorship Professional development plans Benefits vary by region and country Ultragenyx Pharmaceutical is an equal‑opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law. Applicants can request an accommodation prior to accepting a job offer. Email: View email address on click.appcast.io #J-18808-Ljbffr Ultragenyx