Associate Scientist / Scientist For CAR-T Technology Transfer & Non-Clinical Material Generation (CAR-T Cell therapy)
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the right place for you! 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.
About AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most pioneering technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and teamwork. The Gaithersburg campus includes a CAR-T development laboratory in the main Jose Baselga Building (JBB), as well as a CAR-T clinical manufacturing facility at the West Watkins Mill (WWM) satellite site in Gaithersburg.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
Summary of the group:
The CAR-T Cell Therapy upstream group sits within the Cell Culture and Fermentation Sciences (CCFS) department in the broader Biopharmaceutical Development organization. The CAR-T group is accountable for the process development, process characterization, and technology transfer of various CAR-T cell manufacturing platforms, as well as the generation of non-clinical CAR-T material to support studies in other departments. This group includes a sub-team responsible for the technical transfer of manufacturing processes and ongoing manufacturing campaign support to different global clinical manufacturing facilities.
Main Duties & Responsibilities:
A successful candidate will be expected to have a solid background in cell culture manufacturing processes in a cGMP-regulated environment, as well as sound knowledge of manufacturing processes for engineered T cell therapies. The candidate will demonstrate scientific rigor in assessing own data and that of others to support successful manufacturing campaigns.
This position within Cell Culture and Fermentation Sciences will involve two main responsibilities:
1) Support the technology transfer and ongoing manufacturing campaign support of leukapheresis washing / cryopreservation and CAR-T drug product manufacturing (from leukapheresis thaw through drug product cryopreservation) processes at internal and external clinical manufacturing facilities. The candidate will
- Author process-related documentation (process descriptions, procedures, risk assessments) through collaboration with development leads and coordination with Manufacturing, Quality Control, and Quality representatives at the manufacturing site
- Serve as main point of contact of the process development team for manufacturing facility staff for assigned products, including leading technology transfer activities, on-the-floor and on-call support, training manufacturing staff on new processes, and supporting non-conformance investigations and product impact assessments
- Monitor process performance during clinical manufacturing via data tracking, analysis, and trending
- Design and conduct experiments in development laboratory to support process changes, generate process robustness data, and/or resolve manufacturing non-conformances, and maintain lab-scale satellite cultures of clinical batches
- Contribute to the establishment and improvement of the CAR-T technology transfer business processes
2) Assist in the generation of non-clinical CAR-T material to support collaborative studies with other departments outside of CCFS including Analytical Development, Dosage Form Design & Development, Clinical Pharmacology & Safety Sciences, and Research. The candidate will
- Execute hands-on laboratory CAR-T generation batches to provide product, samples, and batch data as required by collaborating departments
- Maintain a thorough, accurate, complete, and up-to-date laboratory notebook
- BS or MS in Chemical/Biochemical/Biomedical Engineering, Biotechnology, Biochemistry, Biological Sciences or related field of study
- Level B: BS and 2+ years of experience in a GMP-regulated environment, or MS and 0+ years of experience in a GMP-regulated environment
- Level C: BS and 5+, or MS and 2+ years of experience in a GMP-regulated environment
- Previous experience in a GMP-regulated environment in cell therapy process development and/or technology transfer, along with hands-on experience with common cell therapy laboratory equipment and technology platforms
- Strong hands-on background in working across operations, such as leukapheresis, human T and immunological cell culture, lentiviral transduction, cell cryopreservation, and aseptic technique
- Fundamental understanding of molecular and cellular biology, immunological assays, and cell transfection/transduction; Working knowledge of the scale-up/scale-down principles of cell culture processes
- Experience with statistical analysis of process and product quality data
- Cell processing in a cGMP-regulated environment
- Large scale electroporation of human cells
- Analysis of cell characteristics and phenotype using flow cytometry-based instruments and data analysis programs
- Designing and conducting experiments using design of experiments (DOE) principles
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 innovative methods and bringing unexpected teams together. Interested? Come and join our journey.So, what's next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.Where can I find out more?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
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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.
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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