Scientist, Bioanalytical (Temp)
Alcock & McFadden - San Diego, CA

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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.
Responsibilities include:
  • 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.

  • Job 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 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.

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