Marin Metro Area, CA
We are searching for an experienced bioanalytical scientist to develop and validate assays that will impact non-clinical and clinical studies with innovative new technologies and methodologies. This position offers a unique career opportunity to work on the entire spectrum of a product lifecycle, from early non-clinical work through all stages of clinical development, including post-marketing work.
The successful candidate will interact with Research and Clinical Scientists, PK scientists and toxicologists to advance our most promising pipeline molecules for rare diseases. You will be in a position to apply various platforms that accelerate drug development, while maintaining a critical eye on assay quality and maintaining regulatory standards.
Specifically, we are looking for a motivated and driven bench scientist with 2 years of LCMS assay development experience, who has a track record for building assays for small molecules, proteins and/or oligonucleotides (drugs, metabolites, biomarkers) that have been critically reviewed by regulatory agencies.
- Develop a variety of analytical methods to detect drug, metabolites and biomarkers in biological matrices. Techniques may include (but are not limited to) mass spectrometry, HPLC/UPLC, and proteomics.
- Present results, conclusions, and implications to group.
- May function as the primary Bioanalytical R&D interface to other departments regarding a designated project and present results to project teams.
- Develops new techniques, or brings in new technology from the outside, to enhance the analytical capabilities of the group.
- Prepares SOPs and other documents such as validation protocols, validation reports, and data reports for testing results.
- Participates and presents data as a member of Bioanalytical teams, and shares responsibility for project milestones.
- May serve as Principal Investigator for GLP assays, participate in audits and inspections, and adhere to regulatory compliance standards.
- Participates in scientific meetings and produces original peer-reviewed publications.
- Doctorate (Ph.D.) degree in Biology, Chemistry or related fields.
- Established field of expertise in protein chemistry, oncology, immunology, metabolic disease or similar.
- At least 2 years of hands-on experience of using the LCMS platform in a biological or biochemical field including 1 year of quantitative analytical method development.
- GLP experience is preferred.
- Ability to solve moderately complex issues independently.
- Excellent verbal and written communication skills.
- Ability to use computer effectively for data analysis.