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 in Mountain View, CA
, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. And we're excited to share that our work at the Mountain View site (along with some other AstraZeneca Group Companies in the Bay Area) will relocate to South San Francisco by early 2018. Click here for more information on this new facility.
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. Position Summary:
The Clinical Pharmacology & DMPK (CPD) Department is seeking a highly motivated individual with experience in biomarker development to join the Clinical Immunology and Bioanalysis group as a Scientist 1. The candidate will support biomarker development for bio-therapeutic products at various stages of research and development. Primary job responsibilities include design, validation and implementation of cell-based biomarker assays (e.g. flow cytometry or ELISPOT) in clinical programs, monitoring assay performance, managing data transfers and reconciliation efforts and analysis and interpretation of biomarker data for clinical teams. Other responsibilities include serving as an onsite expert in flow cytometry experimental design and co-managing in-house flow cytometer use and normal maintenance. Major Duties and Responsibilities:
Serves as bioanalytical/biomarker assay lead on cross-functional teams for programs at various stages of development Design bioanalytical strategies to support preclinical and clinical studies Scientific evaluation and/or hands-on laboratory research in biomarker identification Leads development of cell-based assays for biomarker evaluation Manage CROs for method validation and transfer, sample analysis, data reconciliation and report generation Data interpretation and reporting in support of preclinical and clinical studies Coordinate timelines for activities in collaboration with project management Contribute to regulatory submissions Present results at internal and external meetings Requirements/Qualifications: Education :
Ph.D or advanced degree in Biological Sciences or related field Experience :
Special Skills/Abilities :
- Minimum of 1 year of industry experience
- Experience with BD flow cytometry platforms (e.g. FACSCantoII, Fortessa, LSRI/II)
- Expertise in flow cytometry-based assay development with human biological specimens
- Experience in CRO management or work in CRO environment
- Experience with working in cross-functional teams
- Experience with ELISPOT assays is preferred
- Experience in a GLP-compliant environment is preferred
- Experience writing IND- or BLA- supporting reports is preferred
Demonstrated ability for scientific insight and conceptual thinking Proficiency with spreadsheet, word processing, and graphical computer programs (MS EXCEL, MS WORD, GraphPad Prism, Tibco Spotfire, for example) is required. Detail oriented with excellent organizational, documentation and technical writing skills Highly proficient interpersonal communication skills, both verbal and written Ability to work independently and in a team environment with minimal supervision Expertise in biomarker identification for oncology programs Experience with assay development and validation of biomarker assays Familiarity of GLP regulations is a plus Ability to work in a team environment
Job Complexity : Areas supported are highly complex
Supervision : Work is performed without appreciable directionNext 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.