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!
As an Associate Director in the Integrated Bioanalysis team you will be delivering bioanalytical strategies, solutions and data for AstraZeneca biologics including new modalities subject to preclinical and clinical studies with focus on cell-based bioanalytical strategy, immunogenicity assessment, method development and validation, GxP Bioanalysis and Regulatory submission.
- As immunogenicity assay expert, lead ADA and neutralizing ADA assay development, validation and immunogenicity assessment for all biotherapeutics including cell and gene therapies with viral or non-viral delivery.
- Responsible for bioanalysis and bioanalytical support of pre-clinical, clinical and biodistribution studies.
- Manage the transfer and validation of ADA and neutralizing 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 a variety of immunogenicity assay techniques. Propose and implement new techniques as well as strategies and practices that are in line with industry practices and regulatory requirements.
- Review and approve bioanalytical data and reports to ensure quality and integrity. Contribute to regulatory document preparation including responses and submissions.
- Establish internal and external influence 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.
This position is located in Gaithersburg, MD
- PhD in immunology, cell biology or related discipline or 5 or more years of immunogenicity assay experience in the pharmaceutical industry or CRO.
- Strong background in the development of immunogenicity assays .
- Strong knowledge of industry practices and regulatory guidance for the development, qualification/ validation of LBA, cell-based assays, and competitive ligand binding assay-based neutralizing assays.
- Experience with supporting complex biologics including multi-domains, cell and gene therapeutic products
- Laboratory experience with GxP regulations, documentation and regulatory guidance.
- Detail oriented, good documentation practices, technical writing and verbal communication skills.
- Ability to handle multiple projects and/or tasks in a fast-paced environment.
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!Benefits:
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.Why AstraZeneca?
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?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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