Join us to be part of bringing life changing medicines to patients in the Biopharmaceutical Development Group! We are now recruiting a Scientist to be a part of the Late Stage Group within Cell Culture & Fermentation Sciences. The position is placed in Gaithersburg, MD, USA.
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 cutting-edge 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 collaboration.
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
Cell Culture & Fermentation Sciences is an arm of the Biopharmaceutical Development Group. We are responsible for developing all of the clinical and commercial processes that use microbial or mammalian cells to generate therapeutic proteins. We are a group of highly motivated and deeply committed scientists who work hard to drive technology forward all with the end goal of helping people.
Main Duties & Responsibilities
In this role you will be part of a team of highly skilled scientists working on late stage cell culture projects.
- Operate bioreactors at bench scale, statistically analyze data from experiments, and generate technical reports and presentations as needed both internally and externally.
- Write CMC sections of regulatory documents.
- Seek to improve processes and maximize innovation using literature reviews.
- Support technical transfers of processes to cGMP production facilities and act as person in plant as a subject matter expert.
- Build and maintain a work environment in which scientific challenge and passion are maximized while ensuring that quality work is performed in accordance with compliance regulations, corporate guidelines and rules.
Education & Experience Requirements
BSc/MSc/PhD degree Chemical/Biochemical Engineering/Biotechnology/ or relevant field and hands on experience with late stage upstream process development and technical transfers. 10+ yrs experience BSc, 8+ yrs experience MSc, 0+ yrs experience PhD.
- Direct operational experience with benchtop and high throughput bioreactors along with ancillary analytical equipment
- Clear understanding of statistical analysis of data sets using JMP
- Has written upstream CMC sections of INDs and BLAs
- Familiar with cGMP upstream operations at large scale
- Involvement in upstream process characterization programs
- Involved with or led technical transfers for large scale bioreactor processes
- Ability to work weekends and off hours
- Harvest expertise
- Cell line development experience
- Prior publications or presentations in field
- Passion for exciting science and constant learning and outstanding teamwork
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.
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?
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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 authorisation and employment eligibility verification requirements.