Senior Scientist, Drug Product and Formulation Development

Senior Scientist, Drug Product and Formulation Development

Woburn, MA

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.

Ultra curious – Apply your biggest ideas in courageous ways

Looking for a highly motivated individual who has strong passion for science and pharmaceutical development, particularly for drug product and formulation development, as well as downstream process and clinical in-use activities. The ideal candidate will demonstrate curiosity and commitment to understanding the product lifecycle from preclinical formulation to manufacturing, and end-user product handling and administration. A drive for independent and cross-functional learning and collaboration is essential for this role.

The role may involve direct management of team members and the cross-functional team.

Core Lab & Ops:
This role typically requires that the majority of the work be conducted on-site.

• Lead development and optimization of drug product processes for gene therapy products, including chromatography, ultrafiltration/diafiltration, formulation, mixing, filtration, filling, and freeze/thaw operations.
• Lead drug product (DP) process, formulation, characterization and clinical device development studies.
• Apply hands-on downstream development skills in the laboratory, designing and executing laboratory experiments, result analysis, documentation and presentations.
• Author and review technical protocols, study reports, investigation and scientific presentations, and generate, evaluate, and maintain data in a highly organized manner.
• Design and execute chromatography and purification experiments as necessary for formulation development, investigation, DP manual fill and finish for DP vial studies.
• Support the characterization of drug product manufacturing processes, including gap analysis, risk assessment, control strategy and investigation studies.
• Lead or support process parameter robustness study including impact analysis, studies of formulation and excipient impact on freezing, thawing, mixing, hold-time, filtering, filling and product contact on DP.
• Execute container characterization studies including primary container safety (extractables & leachables (E&L)) and impact analysis on product stability.
• Perform clinical device compatibility studies (Drug product with infusion sets, syringes, diluents).
• Support design and help with executing studies associated with drug product formulation stability, degradation pathway, container/closure compatibility, drug product hold-time, shipping, and handling robustness.
• Perform activities on developing formulation appropriate for various clinical administration methods (e.g., IV, SC, ICM, intrathecal), especially for novel modalities.
• Design, select, evaluate, and risk assess delivery devices (syringe pumps, catheters, IV sets, filters, etc.) and ancillary supplies by working with vendors and…