At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person!
Senior Scientist, Bioanalysis
We are seeking a highly motivated senior scientist with excellent scientific and technology skills to join our group within Integrated Bioanalysis at Gaithersburg, MD. The successful candidate will lead the development and execution of the Pharmacokinetics (PK), Pharmacodynamics (PD), biomarker and immunogenicity assays to support the preclinical and clinical studies for AstraZeneca's pipeline products across diverse therapeutic areas. She/he will represent the bioanalysis function in multidiscipline drug development teams.
The position is in our Integrated Bioanalysis department which is part of the Clinical Pharmacology and Quantitative Pharmacology group, and is responsible for providing high quality, decision driving data using a variety of platform and novel technologies. Our team primarily focusses on discovery, pre-GLP bioanalyses along with exploratory biomarker assessment in all therapeutic areas. We have a diverse array of scientists working across many technologies to ensure delivery of critical assays and data analysis that drive go/no go decisions and ensure the right combination of medicines get to the right patient, in the right dose, at the right time.
What you'll do:
• Lead the development and execution of PK, PD, biodistribution, viral infectivity and shedding, biomarker and immunogenicity assays to support various programs focusing on but not limited to virotherapy, vaccine and gene therapy.
• Interact with cross-functional teams for understanding the requirement of bioanalysis and advance technologies and methods for biomarker discovery.
• Represent bioanalysis function in the project team. Develop and execute bioanalysis strategy. Provide functional update and responsible for key milestone deliverables.
• Manage the tech transfer and oversee sample analysis with contract labs or internal GXP team. Provide technical support and troubleshooting if needed to ensure quality and timely data delivery. Prepare method SOPs, assay qualification/validation and sample analysis report.
• Contribute to regulatory submission and response.
• Maintain lab documentation and practice. Develop junior scientists.
Required for the role:
• Ph.D. in molecular biology, virology or other related scientific discipline with 0+ years of relevant experience or M.S./B.S. with 10+ years of relevant experience in biopharmaceutical companies.
• Strong scientific knowledge in molecular and cell biology, virology, immunology and related disciplines. Hands-on experience in molecular and virology assays, such as qPCR, digital PCR, virus infectivity assays and virus immunogenicity assays.
• Demonstrated independent thinking and working ability, strong data analysis and problem-solving skills.
• Excellent record keeping and writing skills in preparing study reports or manuscripts.
• Good communication and collaboration skills. Capable of managing multiple projects in a fast pace setting.
Desired for the role:
• Deep understanding the bioanalysis requirement for preclinical studies and clinical studies and hands-on experience in qualifying or validating bioanalytical assays such as ligand-binding assays (e.g. ELISA, MSD), flow cytometry, immunogenicity (e.g. ADA) assays.
• Experience in GLP/GCP compliant studies and contributing to IND/BLA regulatory submissions.
• Experience with advanced data analysis, automation and imaging tools for biomarker studies.
AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It's our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees' varying needs, offers valuable choices, and is highly competitive.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.
Come and join our journey - Apply today!
Where can I find out more?
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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