Scientist I / Scientist II, GXP Bioanalysis -- (Mountain View, CA) - Mountain View, CA | Biospace
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Scientist I / Scientist II, GXP Bioanalysis -- (Mountain View, CA)

MedImmune, LLC

Mountain View, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                                       Location:Mountain View, United States
Job reference: 5000122430410
Posted date: Sep. 16, 2016

 If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions -- join us.

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Scientist I / Scientist II in Mountain View, CA, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.

We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent

Main Duties and Responsibilities

This position can be filled at either the Scientist I or Scientist II level depending upon experience.

You will provide bioanalytical support for preclinical and clinical studies of biotherapeutics across multiple therapeutic areas. The bioanalytical functions will include development, validation, and performance of immunoassays and / or LCMS assays for quantification of drug levels in biological matrices, assessment of immunogenicity, and measurement of relevant biomarkers. You will serve as a bioanalytical lead on cross-functional teams supporting the development of biotherapeutics pipeline as well as function as Principal Investigator or Responsible Bioanalytical Scientist for non-clinical and clinical studies.

You will design bioanalytical strategies supporting pre-clinical and clinical development of biotherapeutics, develop immuno- or LCMS- assays for determination of drug substances, anti-drug antibodies and biomarkers, utilize creative and analytical capabilities to troubleshoot challenging assays, as well as design and execute assay qualification and validation. Also, you will prepare validation protocols, validation reports and Standard Operating Procedures , conduct bioanalytical sample analysis and data review in a GLP-compliant laboratory, evaluate and implement new technologies to expand capabilities and enhance efficiencies, manage CROs for method transfer, validation, sample analysis and report generation, coordinate timelines for activities in collaboration with project management, and train and supervise junior members in a matrix environment.



Essential Requirements

* Scientist I: PhD in Biological Sciences or related field with zero to three years of experience, or MS in Biological Sciences or related field with eight to ten of experience, or BS in Biological Sciences or related field with ten to twelve years of experience

* Scientist II: PhD in Biological Sciences or related field with three to five years of experience, or MS in Biological Sciences or related field with ten to twelve years of experience, or BS in Biological Sciences or related field with thirteen to fifteen years of experience

* Familiarity with GLP regulations and extensive experience as a principal investigator for GLP studies

* Proven track record of supporting GLP studies and clinical studies as principal investigator or responsible scientist

Desirable Requirements

* Experience with immuno- and/or LCMS-based assay development and validation

* Extensive experience as a principal investigator supporting GLP studies

* Experience in bioanalysis in GLP compliance environment

* Experience in CRO management or work in CRO environment

* Experience with IND- report writing is preferred

* Experience with regulatory agency inspection

* Strong documentation and technical writing skills

* Excellent organizational skills and ability to multi-task with clear prioritization when needed

* Creative and critical scientific thinking

* Highly proficient communication skills, both verbal and written

* Detail oriented and ability to work in a team environment

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 law