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 one 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 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:
Analytical Sciences is a global multifunctional team within AstraZeneca biopharmaceutical development tasked with the development, execution, and transfer of analytical methods intended to characterize and release pharmaceutical products.
Main Duties and Responsibilities:
The Analytical Sciences group is looking for a Scientist at the Scientist I or Scientist II level. This person will be responsible for providing analytical support of multiple projects focusing on the physiochemical characterization of biological products with an emphasis on new modalities, such as viral, gene and/or cell therapy products. The individual is expected to work in a cross-functional matrix environment.
Main Duties and Responsibilities:
Lead Method development, product characterization, support in-process testing of new modality molecules, such as viral, gene, and/or cell therapy products
Author technical documents, such as method SOP, development report, qualification protocols and report, comparability plan and report, QBD risk assessment, etc
Work with CMO/CRO or external partners on method development, product characterization and technology transfers
Represent Analytical Function in early stage CMC Development
Work with cross-functional (matrix) management and be responsible for multiple projects
Author and review sections of regulatory submissions such as IND, Briefing documents
Contribute to CQA studies, robustness and validation studies, analytical control strategies
Perform risk assessments, gap assessments for analytical methods and aim to enhance compliance and robustness
Ph.D. degree in Biological Sciences or a relevant discipline and a minimum of 2 years combined biopharmaceutical industry experience and/or postdoctoral experience in a world class viral, gene or cell therapy lab in analytical development, technology transfers and method lifecycle management. Candidates with a Master's degree and a minimum of 6 years of industry experience will also be considered.
Scientist I: BS with 10+ years,MS with 8+ years or aPhD and some relevant experience preferred.
Scientist II: BS with 13+ years,MS with 10+ years or aPhD and 3+ years of relevant experience required.
Strong technical expertise in at least 3 of the following areas:
Biophysiochemical techniques, such as HPLC, CE, LC-MS, DLS, AUC, TEM
In depth knowledge and experience with analytical method development, optimization, technology transfer, assay qualification and validation
Experience with cross-functional (matrix) environment, having served as an analytical SME/Lead on a project and/or analytical representative on the CMC team
Outstanding organizational and communication skills (written, verbal and presentation)
Strong scientific skills including sound experimental design, data processing and interpretation
Excellent capability to multi-task and manage multiple projects
Proficient in MS Word, Excel, Power Point and other applications
Knowledge of cGMP, FDA and ICH guidelines
Knowledge and experience in the development of viral, gene and/or cell therapy products
Experience managing tech transfers and CROs/ CMOs
Experience working with Adeno-associated virus (AAV) is a strong plus
Experience working with regulatory submissions (IND, BLA, MAA, JNDA) is a plus
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?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/