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.

The Bioanalytical Development group seeks a highly motivated Senior Research Associate to provide bioanalytical method development in support of the Translational Research team and pre-clinical and clinical programs. We develop, transfer or validate bioanalytical methods to analyze samples supporting all phases of drug development. Our expertise produces data which enables the characterization of the immunogenic, pharmacokinetic, and biological activities of novel therapeutic drugs.

Work Model:

Core Lab & Ops: majority of the work requires being in the office or laboratory either pre, during or post pandemic.

Responsibilities:

• Responsible for supporting bioanalytical method development, qualification and technology transfer activities on early phase, pre-clinical and clinical development programs.
• Develop and perform assays to characterize the immunogenicity and physiochemical properties (e.g. PK) of products.
• Develop and perform other biological assays including biomarker and cell-based assays to support preclinical research and early phase development.
• Responsible for tech transfer, bioanalytical assay validation in collaboration with other groups or contract sites.
• Author documents such as method development reports, validation protocols, validation reports, and sample analysis reports.
• Ensure that bioanalytical activities relating to regulatory commitments are supported with quality data and in the time expected.
• Evaluate new analytical technology and work on multiple projects.