Senior Manager, Drug Substance Manufacturing Upstream

Job description

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 Upstream Manufacturing Manager will report to the Sr. Director of Upstream Manufacturing. The role will be responsible for the supervision of a shift of 5 manufacturing technicians and Associates on a rotating pitman (every other weekend off) 12 hour schedule (7am-7pm). The roles primary focus will be on cell culture operations from vial thaw through to 2K operations for the production of viral particles for gene therapy products. Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site. Responsibilities: Quality Systems: • Act as Area Lead for internal/external Audits as required, including hosting tours. • Front room SME presenting for regulatory inspections. • Drive the manufacturing review of the completed batch records per the release plan. • Driver of all assigned quality system items (Deviations, CAPA, Change Control), SOPs, MBRs, Risk Assessments etc. Plant & Process: • Demonstrate ownership of the process to ensure that all resources (materials, personnel, documentation etc.) required for processing are available. • Identify any Continuous Improvements to the process/equipment and drive through to completion any projects to which may be assigned. • Ensure Business System Ownership (BSO) ownership of the equipment and facility is demonstrated at all times. Leadership: • Oversight and responsibility for technicians that report into the role, including compliance, training, safety and career development within Ultragenyx. • The Manager will also be assigned as a “project lead” on higher level initiatives and expected to drive projects to completion in a highly collaborative manner in a matrix environment. • Leader ensures a calm, strong and robust communications between all managers within Manufacturing and ensuring the appropriate dissemination of communications to support staff. Requirements: · Ideally, degree in Engineering or Scientific Discipline, equivalent education/experience could be considered. · Ability to be on call for Upstream MFG alarms off shift. · 10+ years l