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Standort: South San Francisco, Kalifornien, USA
Anzeigen-ID: R-056890
Veröffentlichungsdatum: Sep. 04, 2019

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.  We lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has big impact on science and medicine.

The Clinical Immunology and Bioanalysis Scientist I is a member of the bioanalytical science group supporting AstraZeneca projects of biologics subject to toxicology, PK/PD and clinical studies. His/her functions will include but are not limited to the development, qualification/validation, and implementation of immunoassays/cell-based assays for determination of drug in biological matrices, assessment of drug immunogenicity and measurement of biomarkers in a GLP/GCP environment. The candidate will utilize multiple technology platforms, including ELISA, MSD, fluorescence/luminescent plate readers, and Luminex. This position will also manage external vendors for the transfer, development, validation and execution of their assays.

Major Responsibilities:
•    Function as a bioanalytical lead in the cross-functional teams, responsible for the bioanalytical support on preclinical and clinical studies of biotherapeutics across multiple therapeutic areas. 
•    Oversee development, qualification/validation and execution of immunoassays/cell-based assays for quantification of drug levels, assessment of immunogenicity, and measurement of relevant biomarkers in biological matrices such as serum and/or plasma. 
•    Design bioanalytical strategies and utilize analytical capabilities to troubleshoot challenging immunoassays/cell-based assays. Conduct sample analysis and data review in support of pharmacology, toxicology and clinical studies in a GLP/GCP-compliant laboratory.  
•    Author method qualification/validation protocols/reports, sample testing plans, bioanalytical reports and Standard Operating Procedures.  
•    Facilitate method transfer, qualification/validation, sample analysis and report generation, and coordinate resources and timelines for various contracted activities via collaborating with clinical project teams and CRO companies.  
•    Summarize PK/ADA/biomarker data and present bioanalytical results to other research functions representing the team of clinical pharmacology biologics and bioanalysis.
•    Keep abreast of regulatory guidance and implement into bioanalytical practices. Train and supervise junior members in a matrix and dynamic environment.

Scientist I Qualifications (Education, Experience):
•    PhD. in Biological Sciences or related field with 0-3 years relevant experience in conducting immunoassays and cell-based assays.
•    Master’s degree in Biological Sciences or related fields with 8-10 years relevant experience in conducting immunoassays and cell-based assays.
•    Bachelor’s degree in Biological Sciences or related fields with 10-13 years relevant experience in conducting immunoassays and cell-based assays.

Skills Required:
•    Strong background in immunochemical and cell-based assays, including experience with ELISA, MSD, cell culture techniques, and general knowledge of antibodies.
•    Familiarity with the role of PK, ADA and biomarker testing in pre-clinical or clinical trial settings.
•    Experience working with biological matrices such as serum and plasma.
•    Familiarity of GLP regulations, GxP documentation and regulatory guidance is a plus.
•    Familiarity with Automation platforms is a plus.
•    Familiarity with spreadsheet, word processing, and graphical computer programs (e.g. Excel, Word, GraphPad Prism, etc.).
•    Detail oriented, good documentation, technical writing and verbal communication skills.
•    Ability to multi-task and work in a team environment.

Supervision:

•    The Scientist I is expected to perform duties with minimal supervision. 

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.

Scientist I - Clinical Immunology and Bioanalysis
Wissenschaftsbereich

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