Manager, 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 dedicated – Your biggest challenges yield rare possibilities The Manager Manufacturing, Drug Product will report to the Director of DP Manufacturing. The Drug Product Manufacturing Manager will support the operations of Ultragenyx’s Gene Therapy Manufacturing Facility in Bedford, MA. The Drug Product Manufacturing Manager will be a hands-on manufacturing SME for drug product filling operations and visual inspection. You will support continuous commercial manufacturing for Drug Product operations . You will be responsible for the training and supervision of manufacturing Associates for the aseptic filling area, and visual inspection and labeling /bulk pack operations. Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site. Responsibilities: • Plans and supervises daily execution of tasks to support published production plan and supervises completion of work • Ensure qualification of operators, consistent with SOP, to support cGMP manufacturing of pharmaceutical products • Supports quality investigations, continuous improvement efforts and engineering/maintenance/quality control/quality operations activities as they directly impact the functionality of the manufacturing area • Ensure maintenance and upkeep of the facility and process employed within the area of responsibility • Generates / Drives / Approves new/revised SOP’s, batch records, and/or protocols in support of the equipment and manufacturing processes associated with the Drug Product manufacturing area • Support the definition and execution of all activity in compliance with environmental health and safety (EHS) requirements. • You will be a manufacturing SME for drug product filling operations, including vial filling and isolator system and visual inspection. • Ensures robust and timely communication of defined operational / planning activities associated with the execution of daily production Requirements: • BS in Engineering, Scientific Discipline preferred or Business equivalent experience • Must have hands-on experience in aseptic operations for filling of a parenteral is required. • Experience with isolator and/or RABS technology is required. • 8 years’ experience preferably in pharmaceutical manufacturing or other regulated industry • Minimum of 2 years of supervisory experience preferred • Experience training and developing team members is preferred • Strong collaboration