- Experience Level
- Experienced (non-manager)
At AstraZeneca, we win through science, it's at the heart of our every success. That science is only possible when we all work together - we'll always make sure you're clear about how your role is connected to our wider mission to really show what science can do!
A Senior Scientist is a member of the Integrated Bioanalysis team delivering bioanalytical strategy, scientific oversight, and regulatory interactions for AstraZeneca biologics with focus on immunogenicity (cell and non-cell based) and PK assay development and validation, regulated Bioanalysis to support preclinical and clinical studies for all biologics modalities
This position is located in Gaithersburg, MD
The AstraZeneca Gaithersburg campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This green, sustainable, modern, vibrant scientific campus is where we host some of the most cutting-edge technology and lab spaces. Newly designed, state of the art research spaces and open seating floor plans are just a couple of ways we work cross functionally and collaboratively.
The Gaithersburg campus also provides an award winning café, free garage parking with electric car charging stations, bike racks, free fitness center to include classed and personal training game rooms, outdoor patio, bocce ball court, arcade games and game tables, recharge Pod's, library, walking trails, onsite dry cleaning pickup, haircutting service, health and wellness center, starbucks café, and much more!
Lead immunogenicity (ADA, Nab) and PK assay development, validation and bioanalysis for all biotherapeutics including new modalities such as cell and gene therapies.
Evaluate and set up new capabilities and bioanalytical platforms to support PK and ADA analysis for new modalities.
Review and approve bioanalytical data and reports to ensure quality and integrity. Contribute to pre-clinical and clinical study document review, regulatory document preparation, regulatory responses and submissions.
Work closely with clinical and bioanalytical teams and contribute to the immunogenicity assessment and bioanalytical strategies.
Supervise the transfer and validation of developed PK/ADA assays to CROs. Work closely with outsourcing team to ensure high quality and timely delivery for the method setup and sample analysis.
Stay current on the bioanalytical techniques and regulations. Implement new techniques as well as strategies and practices that are in line with industry practices and regulatory requirements.
Active contribution to bioanalytical field through initiatives, consortium activities, presentations, and publications.
Ensure that work is conducted in a safe and compliant manner; maintain lab documentation and practice in accordance with established SOPs, GLP and GCP regulation.
PhD in Immunology, Biochemistry, or related discipline
3 or more years of immunogenicity assessment experience in the pharmaceutical industry or CRO.
Strong background in immunochemical and /or cell-based assays, including experience with cell culture techniques, ELISA, hybridization based ELISA , MSD as well as other novel bioanalytical techniques and platforms.
Experience with PK and ADA assays for complex biologics including multi-domains, gene and cell therapy.
Laboratory experience with GLP regulations, GxP documentation, regulatory guidance, and regulatory submission.
Familiarity with spreadsheet, word processing, and graphical computer programs (e.g. Excel, Word, GraphPad Prism, etc.).
Detail oriented, good documentation, technical writing and verbal communication skills.
Ability to multi-task and work in a team environment
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!
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