Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.
We are searching for a Bioanalytical Principal Scientist to join our team.
Ardea Biosciences currently has an opening for a Principal Scientist in our Bioanalytical section of our Translational Sciences Department. This position will perform bioanalytical LC/MS/MS method development, validation and sample analysis to quantify drugs and metabolites in biological matrices under GCP and GLP guidelines.
· Develop and validate LC/MS/MS methods for the quantitation of drugs/metabolites in biological matrices under GLP and FDA/EMA guidelines.
· Extract and analyze biological samples under GCP and GLP guidelines.
· Analyze technical data to determine trends and draw conclusions.
· Serve as study director/principal investigator with overall responsibility for bioanalytical conduct.
· Maintain, operate, and troubleshoot API4000 and API5000 LC/MS/MS instruments and other analytical equipment.
· Maintain research records and lab notebooks in a concise, legible and GLP compliant manner.
· Write and revise departmental SOPs, validation and analytical reports.
· Ensure adherence to protocols, SOPs, GCP and GLP guidelines.
· Assist in the preparation of any regulatory submissions.
· May provide training to less experienced departmental staff.
· May manage junior scientists.
· Evaluate and recommend new techniques in sample purification, analysis, and automation.