Principal Scientist, Bioanalytical

Organization: 
Ardea Biosciences
Job Location: 
San Diego, CA
Job Description: 

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.

Responsibilities:
· 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.

Requirements: 

· 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 and sample analysis using LC/MS/MS techniques (MS with 8 years +, or BS +15 or more years' experience).
· 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. This experience includes development of study protocols, SOPs, validation and analytical reports; preparation and/or review of study binders ensuring compliance.
· Prior experience with FDA inspections is a plus.
· Experience with Watson LIMS a plus.
· Strong communication skills, as well as the ability to be a team player.

Contact Information: 

Apply today at: www.ardeabio.com/careers