Associate Director / Director Immunogenicity Assessment
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 Associate Director / Director of Immunogenicity Assessment you will be a member of the Integrated Bioanalysis team delivering Immunogenicity assessment strategy, scientific oversight, and regulatory interactions and submissions for AstraZeneca biologics including new modalities subject to preclinical and clinical studies, with focus on bioanalytical strategy, method development and validation, GxP Bioanalysis and Regulatory submission.
Associate Director requirements:
- Lead immunogenicity risk assessment, data analysis and interpretation, ADA assay development, validation and bioanalysis for all biotherapeutics including new modalities.
- Review and approve bioanalytical data and reports to ensure quality and integrity. Contribute to regulatory document preparation including integrated summary of immunogenicity (ISI), regulatory responses and submissions.
- Work closely with clinical and bioanalytical teams and contribute to the immunogenicity assessment and bioanalytical strategies.
- Supervise transfer and validation of developed 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 the immunogenicity assessment and neutralizing ADA assay techniques. Propose and implement new techniques as well as strategies and practices that are in line with industry practices and regulatory requirements.
- Establish internal and external influence through initiatives, consortium activities, presentations, and publications.
- Hire and retain talent, develop junior scientists in scientific and professional growth.
- 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
- 10+ years of immunogenicity assessment experience in the pharmaceutical industry or CRO.
- PhD in Immunology, Biochemistry, or related discipline
- 15+ years of immunogenicity assessment and regulatory submission experience in the pharmaceutical industry or CRO.
This position is located in Gaithersburg, MD
- Strong experience with the development and validation of immunogenicity assays including ELISA, MSD as well as cut point analysis with the knowledge of current industry practices and regulatory guidance.
- Experience with immunogenicity assessment strategies, integrated summary of immunogenicity and document preparation for regulatory submissions.
- Experience with complex biologics with multiple domains and new modalities.
- Experience managing individual contributors.
- Laboratory experience with GLP regulations, GxP 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.
- Familiarity with spreadsheet, word processing, and graphical computer programs.
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?
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#immunogenecity #ADA #NAb #followthescienceAstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.