Research Associate II, BioAnalytical Research and Development (BARD)Location San Rafael, California Apply
Research Associate II, BioAnalytical Research and Development (BARD)
BioAnalytical R&D (BARD) develops analytical methods for detection of drug, antibodies to protein therapeutics, and biomarkers in biological matrices from non-human and human subjects to support projects through multiple stages of development. The Research Associate II (RAII) will design and execute technically complex experiments to support these projects. They will provide quantitative data analysis, interpretation of results, and contribute to technical reports (e.g. assay qualification and validation reports, SOPs). The RA II evaluates complex methods and technologies, identifies new areas requiring process improvement and adapts existing processes or develops new ones with direct input and supervision from a manager. The RAII also evaluates new lab equipment, recommends vendors, and provides assistance to assay development, troubleshooting, and validation. They may contribute to scientific publications and regulatory submissions as required.
- Develop a variety of analytical methods to detect drug, antibodies to protein therapeutics, and biomarkers in biological matrices. Techniques may include but are not limited to protein purification/chromatography, nucleic acid extraction, droplet digital and quantitative polymerase chain reaction (PCR) assays, Western blot assays, enzyme-linked immunosorbent assays (ELISA), electrochemiluminescence assays (ECLA), and enzyme activityand cell-based assays.
- Qualify selected assays or reagents for transfer to BioAnalytical Testing and validation.
- Participate in management and oversight of assay development and validation projects outsourced to contract research organizations (CROs).
- Analyze data, including basic statistical and graphical analysis.
- Present results, conclusions, and implications to the BioAnalyticalSciences group.
- Develop new techniques, or bring in new technology from the outside, to enhance the analytical capabilities of the group.
- Prepare SOPs and other reports and documents to support nonclinical and clinical programs and associated regulatory submissions. This includes qualification protocols, qualification reports, memoranda, and data reports for testing results.
- Share responsibility for lab management duties.
- Participate and present data as a member of BioAnalytical teams, and share responsibility for project milestones.
- Present data and participate in discussions in Research/ Pharmacological Sciences/Translational Sciences (RPT) team meetings as necessary.
- Participate in external scientific meetings and contribute to original peer-reviewed publications.
- Other duties as assigned.
Bachelors degree in a scientific discipline or equivalent with 2-4 years experience with assay development and validation, or Masters degree with 1-2 years experience. 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 and presentation.
- Bachelors or Masters degree in Biology, Chemistry or related field.
- Bachelors with 4 years experience - OR - Masters with 2 years of experience working with immunoassays, biomarker assays, or other analytical methods.
- Working knowledge of cell biology and biochemistry.
- Multi-well absorbance and fluorescence plate readers and associated software.
- Centrifuges and incubators
- Windows network environment, MS Office, etc.
- Electronic Laboratory Notebook