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Plats: South San Francisco, Kalifornien, USA
Jobb-id R-055407
Datum inlagd: 09/04/2019

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. We're proud to have a unique workplace culture that inspires innovation and collaboration. We believe in the potential of our people and you’ll develop beyond what you thought possible.At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re curious about what science can do, then you’re our kind of person.

The Clinical Immunology and Bioanalysis Associate Scientist functions will include but are not limited to the development, validation, and implementation of immunoassays for determination of drug in biological matrices, assessment of drug immunogenicity under supervision for supporting AstraZeneca projects of biologics subject to pre-clinical or clinical analysis. This position will also be involved in technical discussions with external vendors for the transfer, development, validation and execution of their assays. This group primarily functions in the PK and ADA support of AstraZeneca’s biologics platforms in a GLP/GCP environment.

Major Responsibilities

  • Assist in the development, and qualification, or validation of qualitative and quantitative immunoassays for drug substances and anti-drug antibodies in biological matrices such as serum and/or plasma. 
  • To be creative and have analytical capabilities to troubleshoot challenging immunoassays
  • Write qualification/validation protocols and reports and Standard Operating Procedures. 
  • Conduct sample analysis and data review in support of pharmacology, toxicology and clinical studies in a GLP-compliant laboratory. 
  • Coordinate method transfer and establish method qualification/validation and sample analysis studies with contract laboratories. 
  • Compile assay qualification/validation and bioanalytical reports.
  • Summarize PK/ADA data and present bioanalytical results to other research functions representing the team of clinical pharmacology biologics and bioanalysis.
  • General laboratory maintenance and reagent preparation
  • Equipment calibration and maintenance
  • Order laboratory and office supplies
  • External lab assay transfer and oversight

Qualifications:

For Associate Scientist I

  • Bachelor’s degree in Biological Sciences or related fields with 5-8 years relevant experience in conducting immunoassay i.e. ELISA-based assays in a laboratory setting.
  • Master’s degree in Biological Sciences or related fields with 2-5 years relevant experience in conducting immunoassay i.e. ELISA-based assays in a laboratory setting.

​For Associate Scientist II

  • Bachelor’s degree in Biological Sciences or related fields with 8-10 years relevant experience in conducting immunoassay i.e. ELISA-based assays in a laboratory setting.
  • Master’s degree in Biological Sciences or related fields with 5-8 years relevant experience in conducting immunoassay i.e. ELISA-based assays in a laboratory setting.
  • PhD. in Biological Sciences or related field with 0-2 years relevant experience in conducting immunoassay i.e. ELISA-based assays in a laboratory setting.

Skills Required:

  • Experience with ELISA-based assay technology.
  • Familiarity with the role of PK and ADA testing in pre-clinical or clinical trial settings.
  • Familiarity with spreadsheet, word processing, and graphical computer programs (e.g. EXCEL, WORD, SIGMAPLOT, etc.).
  • Detail oriented, good organizational, documentation and technical writing skills.
  • Ability to work in a team environment.
  • Strong written and verbal communication skills.

Preferred skills:

  • Familiarity with MSD ECL platforms is a plus.
  • Familiarity with Automation platforms is a plus.
  • Familiarity of GLP regulations and GxP documentation is a plus.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Associate Scientist I or II - Clinical Pharmacology Biologics & Bioanalysis
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