Senior Scientist, Bioanalytical Development

Novato, CA
Ultragenyx – Research
Full-time

Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.  
 
Come join our team during this exciting time of growth and opportunities!
 
We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco.  This position can be located in Novato or Brisbane.

Position Summary:
Bioanalytical Development Senior Scientist will be joining a small and growing team in the Bioanalytical Development group. Responsible for all aspects of non-clinical and clinical bioanalytical methodology including development, trouble-shooting, transfer, qualification, and validation; data interpretation and authoring of sections of regulatory submissions. 

Responsibilities including but not limited to:

    • Interpret pharmacokinetic, pharmacodynamic, immunogenicity and biomarker data, from clinical and non-clinical studies.
    • Author relevant regulatory submission sections and contribute to non-clinical and clinical modules as needed.
    • Author and review non-clinical and clinical study pharmacokinetic, pharmacodynamic and immunogenicity analyses, reports and manuscripts.
    • Interact with regulatory agencies, present and defend data
    • Oversee development, optimization and validation of outsourced bioanalytical assays such as: ligand binding assays, cell-based assays, LC-MS/MS, next-generation sequencing and microarray technologies
    • Manage the review and approval of bioanalytical test data, investigations, method qualifications/validations/ transfer
    • Support clinical core teams in the implementation of applicable methodology
    • Partner with internal organizations such as translational research, development, clinical development and operations, and commercial development and operations

Requirements:

    • PhD in Biochemistry, Biology, Immunology, Chemistry or equivalent
    • 10 or more years’ experience preferably in a biotechnology environment
    • Experience with PK, PD, biomarker and immunogenicity data interpretation
    • Familiarity with regulatory and industry guidance documents including requirements for GLP bioanalytical assays
    • Tech Transfer Experience
    • Skilled in analytical techniques including immunoassays and other plate based assays
    • Experience with cell-based bioassay development
    • Experience with biologics and/or small molecule drug development
    • Some experience with data management systems and statistical software
    • Demonstrated ability to work in a team and in a fast paced environment
    • Excellent written and verbal skills
    • Excellent critical thinking and problem solving skills

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

#LI-YG1

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

#LI-YG1