Senior Research Associate, Bioanalytics - Novato, CA | Biospace
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Senior Research Associate, Bioanalytics

Ultragenyx Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
7/20/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Bioanalytical, Senior Research Associate,

Job Description

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 located 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 is located at the Buck Institute for Research on Aging in Novato, CA.

Position Summary:

The Bioanalytical Development group seeks a highly motivated Senior Research Associate to provide Bioanalytical method development to support the translational research team and for the programs in pre-clinical and clinical development. We develop, validate and implement bioanalytical methods for pre-clinical and clinical sample analyses which support the development of our therapeutic programs. Our data and expertise enable the characterization of the pharmacokinetic, immunogenic and biological activities of company therapeutics during all phases of drug development.

Responsibilities, including but not limited to:

•     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 pharmacokinetic (PK) and immunogenicity properties 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. Contribute to writing regulatory documents as needed.
•     Evaluate new analytical technology and work on multiple projects.

Requirements

•   BS or MS in Chemistry, Biochemistry, Biology, Immunology, or equivalent
•   Five  or more years’ experience in  biotechnology environment
•   Experience developing and qualifying PK, biomarker, ADA and NAb assays
•   Experience with cell-based bioassay development
•   Experience in a broad range of protein techniques including Western, ELISA, multiplexing platforms such as MSD/Luminex, protein expression, antibody development/characterization and establishment of diverse biochemical assays
•   Able to work independently to design experiments
•   Demonstrate independence at the bench and ability to work collaboratively on project
•   Some experience with data management systems and statistical software
•   Position requires excellent organizational skills and time management to meet deadlines in a fast-paced organization. Ability to multitask and work on diverse projects is an advantage
•   Familiarity with regulatory and industry guidance documents including requirements for GLP bioanalytical assays

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.