Senior Research Associate 1, Assay Strategy and Development, Translational SciencesLocation San Rafael, California Workstyle Onsite Only Apply
Who We Are
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
The Assay Strategy and Development group within Translational Sciences develops methods for the detection of drugs, antibodies to therapeutics, and biomarkers in biological matrices to support projects through multiple stages of development. We are searching for a talented and highly motivated Senior Research Associate (SRA) to join a bioanalytical team that will be responsible for the generation of data to enable the successful development of pre-clinical and clinical programs. The candidate will be responsible for the development of assays for diverse modalities, which may include gene therapies, monoclonal antibodies, oligonucleotides, biologics, and small molecules. Candidates should be familiar with guidance documents for regulated sample testing and should have experience developing bioanalytical methods.
The successful candidate will participate in programs that range from exploratory in vitro and animal studies to non-clinical efficacy, safety studies, and clinical trials. You will be responsible for developing new methods, evaluating novel technologies, and conducting translational research internally at the BioMarin Research Center and externally in partnership with contract research organizations. 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 SRA position will report to a Scientist II in the Assay Strategy and Development group and will have the opportunity to advance our most promising pipeline programs to treat rare genetic diseases.
- Leads the development and characterization of quantitative and semi-quantitative bioanalytical methods to support pharmacokinetic, pharmacodynamic, biomarkers, and immunogenicity assessments. Techniques may include (but are not limited to) ELISA, ligand binding assays, polymerase chain reaction (qPCR and ddPCR), single-cell sequencing, sequence-tagged molecular tracing, cell-based and ex vivo culture assays.
- Develops new techniques or brings in new technologies to enhance the analytical capabilities of the group.
- Presents results, conclusions, and implications to bioanalytical and project teams.
- Documents all experimental procedures and data in electronic lab notebook.
- Shares responsibility for lab management duties.
- Participates in internal and external development and validation of a variety of bioanalytical methods to detect drug, antibodies to protein therapeutics, and biomarkers in biological matrices.
- Maintains awareness of industry guidance and standards for assay validation and performance.
- Participates in technology and process transfers between groups and vendors.
- Authors, reviews, and contributes to non-clinical and clinical study protocols.
- Authors and reviews reports and documents such as validation protocols, validation reports, and sample analysis reports.
- Independently carries out the aforementioned tasks and plans, implements, and completes projects with minimal supervision.
- Participates in departmental and external scientific meetings and contributes to original peer-reviewed publications
- Other duties as assigned.
Education & Experience
- Bachelor’s degree and at least 6 years of experience; Master’s degree with at least 4 years of relevant experience
- Broad technical proficiency.
- Familiar with, or willingness to learn relevant GLP, GxP, and other FDA guidances.
- Excellent verbal and written communication skills: ability to cogently prepare and present data in group settings, prepare formal reports, give and receive useful feedback.
- Ability to use computers effectively for data analysis and presentation.
- Demonstrated experience initiating new methods or technologies in an experimental laboratory setting.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
In the U.S., the salary range for this position is $ 92,000 to $ 138,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.