Research Associate II, Assay Strategy and Development
781 Lincoln Avenue San Rafael, CA 94903 US
The Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class or best-in-class therapeutics that provide transformative benefits to patients. Come join our team and make a meaningful impact on patients lives.
The Assay Strategy and Development group within Translational Sciences develops analytical methods to measure drugs, antibodies to therapeutics, and biomarkers in biological matrices to support projects through multiple stages of development from pre-clinical models through clinical sample testing. We are searching for a talented and highly motivated Research Associate II to develop assay methods that will provide safety and efficacy data on experimental therapeutics entering clinical studies.The candidate will be responsible for the development of assays for diverse drug modalities, which may include gene therapies, monoclonal antibodies, oligonucleotides, biologics, and small molecules, with guidance from a Principal Scientist in the Assay Strategy and Development group. The ideal candidate should have experience developing and optimizing bioanalytical methods, analyzing and interpreting experimental results, and communicating conclusions to other scientists.
The successful candidate will participate in programs that range from exploratory in vitro and animal studies to non-clinical efficacy and safety studies and clinical trials. You will be responsible for developing new methods, evaluating novel technologies, conducting translational research internally at the company Research Center and externally in partnership with contract research organizations, and communicating results to cross-functional teams.This position offers a unique opportunity to interact with scientific and business colleagues across many functional areas, including Research, Translational Sciences, Regulatory Affairs, and Clinical Sciences.
This RA II position will report to a Principal Scientist in the Assay Strategy and Development group and will have the opportunity to advance our most promising pipeline programs to treat rare genetic diseases.
- Working together with research associates, scientists and project leads, develop a variety of analytical methods to detect drug, antibodies to protein therapeutics, and biomarkers in biological matrices. Techniques may include ELISA/ECL, cell-based assays, enzyme activity assays, PCR, qPCR, ddPCR, capillary electrophoresis, western blot, surface plasmon resonance (Biacore), hybridization ELISA, flow cytometry.
- Characterize performance of selected assays and reagents for transfer to the Bioanalysis group within BioAnalytical Sciences or external labs for method validation and regulated study sample testing.
- May participate in method transfer or validation activities or monitor assay performance at external labs during regulated study sample testing.
- Present results, conclusions, and implications to BioAnalytical Teams, Early Development Teams, and other internal and external forums as appropriate, and share responsibility for project milestones
- Prepare SOPs and other reports and documents such as qualification reports, validation protocols, and data reports for testing results.
- Share responsibility for lab management duties
- Participate in scientific meetings and contribute to original peer-reviewed publications.
- Other duties as assigned.
Bachelor’s or Master’s degree in biological / biochemical sciences or related field. Training in analytical techniques such as immunoassays, cell culture, and molecular biology preferred. Working knowledge of cell and molecular biology and biochemistry.
Bachelor’s degree in a scientific discipline or equivalent with 2 to 5 years hands on lab experience, or Master’s degree with 1 to 3 years experience. Track record of success developing analytical techniques that support scientific investigations. Broad technical proficiency. Ability to work independently and in teams. Experience with industry assay development and validation preferred. Excellent verbal and written communication skills. Ability to use computer software effectively for data analysis.
• Broad technical proficiency.
• Ability to solve moderately complex issues independently.
• Familiar with GLP requirements.
• Excellent verbal and written communication skills.
• Ability to use computer effectively for data analysis.
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