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.
Ardea currently has an opening for a 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.
*This is a temporary position. The length of assignment is anticipated to be for 6 months.
Primarily responsible for developing and validating robust and reproducible LC/MS/MS methods for the quantitation of complex analytes 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
May 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.
Evaluate and recommend new techniques in sample purification, analysis, and automation.
B.S., M.S, or PhD in Analytical Chemistry or other related disciplines.
At least five years of CRO or industrial hands-on experience in bioanalytical method development/validation of complex analytes using LC/MS/MS techniques.
In-depth knowledge of LC/MS/MS techniques and sample preparation are a must.
In-depth knowledge of GLP guidelines.
Prior experience serving as a study director/principal investigator is a plus. This experience includes development of study protocols, SOPs, validation and analytical reports; preparation and/or review of study binders ensuring compliance.
Experience with Watson LIMS and Analyst a plus, but not required.
Strong communication skills, as well as the ability to be a team player.
Apply today at: www.ardeabio.com/careers