Senior Scientist / Associate Principal Scientist, Pharmacology
- Experience Level
- Experienced (non-manager)
Senior Scientist / Associate Principal Scientist, Pharmacology
Do you have expertise in, and passion for, Drug development, Clinical Pharmacology, and Integrated Bioanalysis? Would you like to apply your expertise to impact the drug development in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. We pride ourselves on making sure that each decision we make puts patient needs first! This mentality means that our people have permission to take the more unusual path. If they can think of a better, smarter way in which we can change lives through science, at we want to hear it.
AstraZeneca is searching for a lab-based Senior Scientist-Pharmacology or Associate Principal Scientist-Pharmacology with a focus on Target Engagement Biomarker assay design and Contest-of-use Biomarker development to support a robust clinical pipeline
As a member of the GxP Testing Lab in Integrated Bioanalysis within the Clinical Pharmacology and Quantitative Pharmacology Department, you will be responsible for TE and soluble biomarker development and bioanalysis in support of the AstraZeneca pipeline across multiple Therapeutic Areas. You will have an immediate and lasting impact to our pipeline supporting all Therapeutic Areas supporting TE and soluble biomarker identification, assay design, validation to context of use, and leading sample testing around these pursuits. This position will also strive to lead the bioanalytical strategy around molecules in our preclinical and clinical pipeline as an Integrated Bioanalysis (iBA) lead.
Clinical Pharmacology and Quantitative Pharmacology provides broad discovery, preclinical, and clinical support across all Therapeutic Areas enabling pipeline delivery, decision making, regulatory filing, and advancement.
The Senior Scientist-Pharmacology or Associate Principal Scientist is a member of the bioanalytical science group supporting AstraZeneca biologics projects subject to DRF, toxicology, PK/PD and clinical studies. These molecule types include but are not limited to antibodies, bispecifics, cell therapies, gene therapies, oncolytic viruses, antibody-drug conjugates, and DNA technologies. The functions will include but are not limited to the development, qualification/validation, and implementation of immunoassays/cell-based assays/internalization assays for determination of primary efficacy and safety biomarkers in biological matrices in a GLP/GCP environment. This position emphasizes Target Engagement and soluble biomarker target identification, assay design, and implementation for context-of-use. As a member of South San Francisco innovation site, the candidate will explore and utilize multiple technology platforms, including ELISA, MSD, fluorescence/luminescence, and Luminex. This position may also be involved in molecular technologies, LCMS, or flow cytometry based on previous experience. As a member of the Integrated Bioanalysis group within This position will also manage external vendors for the transfer, development, validation and execution of their assays.
Essential Education/ Experience
PhD and 2 years relevant experience
BS/MS and 10 years relevant experience
Associate Principal Scientist
PhD and at least 5 years relevant experience
BS/MS and at least 15 years relevant experience
Strong background in immunochemical and cell-based assays, including experience with ELISA, MSD, cell culture techniques, and drug development.
Familiarity with the role of PK, ADA and biomarker testing in pre-clinical or clinical trial settings, with a strong focus on implementation of Target Engagement and soluble biomarker assays.
Experience working with biological matrices such as serum and plasma.
Development of biomarker assays for context-of-use (COU) to support pipeline development.
Regulatory requirements around biomarker COU.
Prior experience with Good Documentation practices.
Biological understanding of Oncology disease states.
Desirable for the role
Laboratory experience with GLP regulations, GxP documentation, regulatory guidance, and regulatory submission.
Development of Bioanalytical strategy including PD area of expertise, around oncology projects.
Familiarity with Automation platforms.
Experience with CRO/Pharma interaction and relationship management
Familiarity with spreadsheet, word processing, and graphical computer programs (e.g. Excel, Word, GraphPad Prism, etc.).
Experience with other analytical equipment such as Luminex, Gyros, Envision, Alphalisa, LCMS, Flow Cytometry, microscopy, and Singulex.
Detail oriented, good documentation, technical writing and verbal communication skills.
Ability to multi-task and work in a team environment.
This position is located in South San Francisco, CA
South San Francisco, CA
South San Francisco is a single world-class facility in the Cove at Oyster Point, in the heart of the area's vibrant biotechnology and technology community. It's our newest site that's been designed to enable side-by-side talent to make the impossible, possible at the center of the biotechnology and high-tech industry.
Situated in the heart of the world's most prestigious life science and tech cluster, The Cove's location provides access and visibility, thoughtfully designed, the amenities center and outdoor spaces enhance each person's daily experience and create an active environment.
The Cove has a full-service amenities center which includes:
30,000 square foot facility
Group exercise rooms
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. Interested? Come and join our journey.
Come and join our journey - Apply today!
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