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Plats: South San Francisco, Kalifornien, USA
Jobb-id R-052062
Datum inlagd: 10/18/2019

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 through scientific research. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Location: South San Francisco, CA

Description:

MedImmune is seeking Scientist I/II to become a part of a bioanalytical science group supporting toxicology, PK/PD and clinical studies. The primary function of the person will be the development and validation/qualification of relevant cell-based and immunoassays for biomarker measurement and the detection of anti-drug antibodies in biological matrices, such as whole blood, sputum, serum and/or plasma. The candidate will utilize multiple technology platforms, including ELISA, MSD, Luminex, fluorescence and luminescent plate readers, fluorescent microscopy and FACS. The candidate will be working in GLP/GCP environment, prepare Standard Operating Procedures, validation protocols, bioanalytical reports and support regulatory submissions. She/he will manage CRO for method transfer/validation, sample analysis and report generation. The candidate must demonstrate technical proficiency, critical thinking, teamwork and creativity in problem solving and implementation of challenging or innovative assays.

Position Summary:

Major Duties and Responsibilities (including supervising others):

  • Develop and validate immunoassays and/or cell-based assays for anti-drug antibodies, including neutralizing anti-drug antibodies in serum and/or plasma
  • Develop immunochemical and cell-based assays for measurement of potential pharmacodynamic markers in biological matrices such as whole blood, serum and/or plasma
  • Utilize multiple technology platforms including ELISA, MSD, Luminex, fluorescent or luminescent plate readers, FACS and fluorescent microscopy
  • Lead bioanalytical sample analysis and data review in support of pharmacology, toxicology and clinical studies in a GLP-compliant laboratory 
  • Prepare Standard Operating Procedures, validation protocols and bioanalytical reports
  • Coordinate assay transfer and establish sample analysis, validation studies and related contracts with CRO
  • Review literature in support of pharmacodynamic marker identification and utilize creative and analytical capabilities to troubleshoot and implement challenging or innovative assays

Qualifications:

Scientist I:

PhD in biological sciences or related field with some experience preferred

Master’s Degree in biological science or related field with a minimum of 8 years of experience

Bachelor’s Degree in biological science or related field with a minimum of 10 years of experience

Scientist II:   

PhD in biological sciences or related field with a minimum of 3 years of experience

Master’s Degree in biological science or related field with a minimum of 10 years of experience

Bachelor’s Degree in biological science or related field with a minimum of 13 years of experience

Experience

  • Strong background in immunochemical and cell-based assays, including experience with ELISA, MSD, cell culture techniques, and general knowledge of antibodies
  • Experience with Luminex, Flow cytometry and Fluorescent Microscopy is a plus
  • Experience working with biological matrices such as whole blood, serum and plasma
  • Knowledge of assay validation guidelines and GLP regulations is a plus
  • Proficiency with spreadsheet, word processing, and graphical computer programs (MS EXCEL, MS WORD, Graphpad Prism, for example)
  • Excellent organizational skills and ability to multi-task
  • Ability to work in a team environment
  • Strong documentation and technical writing skills
  • Attention to details, critical thinking and good trouble-shooting skills

SupervisionThe Scientist I/II is expected to perform duties with minimal supervision. The appropriate candidate should have the ability to carry out complex projects and multi-task. 

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.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by lawAstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Scientist I/II - Clinical Immunology and Bioanalysis
MedImmune

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