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 II/Senior Manager or Scientist I/Manager 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 end of 2017. 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.
Main Duties and ResponsibilitiesThe Clinical Pharmacology & DMPK (CPD) Department is seeking a highly motivated individual with strong GLP bioanalysis experience to join the bioanalytical group. Your job responsibilities will include the development, validation and bioanalysis for the determination of drug in biological matrices, assessment of drug immunogenicity and evaluation of pharmacodynamics biomarkers in support of preclinical and clinical studies.
You will design, develop, and qualify/validate qualitative and quantitative immunoassays for drug substances, anti-drug antibodies and biomarkers in biological matrices; Execute and provide significant input into the development, planning, and design of experiments, and interpretation of results; Be creative and have analytical capabilities to troubleshoot challenging immunoassays; Prepare validation protocols, qualification reports, validation reports, bioanalytical reports, Standard Operating Procedures and/or summaries of assay optimization and updates.
You will also conduct sample analysis and data review in a GLP-compliant laboratory; Coordinate assay transfer, establish sample analysis, validation studies with contract laboratories; Present results at internal and external meetings; Serve as mentor to other lab personnel and may supervise, trains other analysts in assay performance and laboratory procedures; Collaborate with other scientists to meet project and program timelines and ensure scientific integrity; and function as Responsible Bioanalytical Scientist in support of various GLP studies.Essential Requirements For Scientist I / Manager:
For Scientist II / Sr Manager:
- BA/BS with a minimum of 10-13 years relevant work experience in conducting immunoassays in an FDA regulated (GLP) bioanalytical lab;
- MS with a minimum of 8-10 years relevant work experience in conducting immunoassays in an FDA regulated (GLP) bioanalytical lab;
- PhD with a minimum of 2 years relevant work experience in conducting immunoassays in an FDA regulated (GLP) bioanalytical lab.
For both roles:
- BA/BS with a minimum of 13-15 years relevant work experience in conducting immunoassays in an FDA regulated (GLP) bioanalytical lab;
- MS with a minimum of 10-13 years relevant work experience in conducting immunoassays in an FDA regulated (GLP) bioanalytical lab;
- PhD with a minimum of 3-7 years relevant work experience in conducting immunoassays in an FDA regulated (GLP) bioanalytical lab.
- People managing experience
- Education degree in biological sciences or related fields
- Ability to work independently and on teams with minimal supervision
- Good knowledge and extensive experience in GLP requirements and practices in bioanalytical lab
- Prior experience and understanding of regulatory requirement for method development and validation for PK, immunogenicity and PD biomarkers
- Strong expertise in immunoassay development and validation
- High level of expertise in bioanalytical fields, including methods and technologies
- Strong ability to trouble shoot bioanalytical methods
- Experience with assay development and validation of immunochemical and bioassays
- Familiarity of GLP regulations
- Good lab GLP knowledge and experience
Next Steps - Apply today!
- Knowledge of drug development
- Experience with regulatory interactions
- Demonstrated ability for scientific insight and conceptual thinking
- Proficiency with Microsoft office software (word, excel, power point) and graphical computer programs (e.g. SIGMAPLOT, etc.)
- Detail oriented, good organizational, documentation and technical writing skills
- Excellent interpersonal, organization and communication skills
- Ability to work in a team environment
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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.