Research Associate I, BioAnalytical Sciences, Bioanalysis
791 Lincoln Avenue San Rafael, CA 94901
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- Critical to the success of each new therapeutic, the Bioanalysis group characterizes, validates, and performs novel assays to measure pharmacokinetics, immunogenicity, and biomarkers.
- We are searching for a highly motivated bench Research Associate to validate, implement, perform, and maintain assays that will impact non-clinical and clinical studies.
- This position offers a unique career opportunity to work on the entire spectrum of a product lifecycle, from early non-clinical programs through all stages of clinical development.
- The successful candidate will interact with other members of BioAnalytical Sciences as well as key collaborator and stakeholder groups such as Translational Sciences and GLP-Compliance to advance our most promising pipeline candidates.
- You will be able to learn and apply new platforms that further accelerate drug development, while maintaining a critical eye on assay quality and maintaining regulatory standards.
- Perform a variety of analytical methods to detect biomarkers, drug, and antibodies to protein therapeutics in biological matrices. Techniques may include (but are not limited to) nucleic acid extraction, reverse transcription (RT), and polymerase chain reaction (PCR) as well as enzyme-linked immunosorbent assays (ELISA), electrochemiluminescence assays (ECLA), and cell-based assays.
- Perform quantitative analysis within and across multiple experiments, including basic statistical and graphical analysis, and summarize results; then, work with manager for interpretation of results and to propose next steps.
- Experience with laboratory electronic systems and applications (such as ELN and LIMS) and familiarity with assay-associated laboratory instrumentation and laboratory equipment a plus.
- Ensure appropriate level of GxP compliance in sample handling, assay performance and laboratory operations through adherence to SOPs and departmental practices.
- Prepare SOPs and other reports and documents to support nonclinical and clinical programs and associated regulatory submissions. This may include validation protocols, validation reports, memoranda, and data reports for testing results.
- Document all experimental procedures and data.
- Share responsibility for lab maintenance duties.
- Other duties as assigned.
- 2+ years of experience in biomedical sciences preferred (bioanalytical, clinical or nonclinical laboratory).
- Familiar with, or willingness to learn relevant GLP, GxP, and other FDA and EMA guidance.
- 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 computer effectively for data analysis and presentation.
- Bachelor (BS / BA) degree in a biological or biochemical field.