Scientist - Bioassay, Biosafety & Impurities
AstraZeneca

Job Info

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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:

Bioassay, Biosafety & Impurities (BB&I) is a global multifunctional team within AstraZeneca biopharmaceutical development tasked with the development, execution, and transfer of bioassays intended to characterize and release pharmaceutical products.

Main Duties and Responsibilities:

Job Summary:

We are seeking an outstanding Scientist to support bioassay development within Bioassay, Biosafety & Impurities (BB&I). This person will be responsible for providing sample testing support, bioassay method development, and functional characterization support of monoclonal antibodies (mAbs), T cell engagers (TCE), viral products, and other new modalities. The individual is expected to work in a cross-functional matrix environment.

Main Duties and Responsibilities:

• Bioassay development, product characterization assays, support stability and in-process testing of mAbs, TCE, viral products, and other biologics
• Represent BB&I function in early stage pre-CMC Development
• Collaborate with cross-functional teams (upstream, downstream, and formulation) in a multidisciplinary environment, coordinate testing requirement and be responsible to manage project specific requirements
• Author technical documents, such as method SOP, development report, qualification protocols and report, comparability plan and report, etc
• Independently develop and manage strategy qualification /validation and product specific qualification (PSQ) or suitability/verification for bio and molecular assays
• Work with CDMO/CRO or external partners on method development, product characterization and technology transfers
• Contribute to CQA studies, robustness and validation studies, bioassay reference control strategies
• Perform risk assessments, gap assessments for bioassays and aim to enhance compliance and robustness

Educational and Experience Requirements

Bachelor's and 5+ years of relevant experience or

MS and 2+ years of relevant work experience required.

Laboratory experience is highly preferred

Required Skills

• Hands-on experience with bioassays and functional characterization methods, titer, binding, reporter gene expression assays, and other cell-based potency assays
• Experience with cell passaging, expanding, banking and aseptic technique

• Good understanding of various analytical techniques for the measurement of product bioactivity and potency (such as ELISA, DELFIA, reporter gene, cytotoxicity, etc)
• Work experience with viral vector for titer determination by infectivity assays (focus forming unit assay, TCID50, plaque assay) and gene copy number (GCN) determination by qPCR or digital PCR assays.
• In depth knowledge and experience with bioassay development, optimization, technology transfer, assay qualification and validation
• Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams
• Strong record of organized data capture, data analysis, and accurate documentation

Desirable skills:

• Strong ability to work both independently and in a team environment
• Strong ability to multi-task and prioritize workload
• Excellent oral presentation and written communication skills
• Strong scientific skills including sound experimental design, data processing and interpretation
• Proficient in MS Word, Excel, Power Point and other applications
• Knowledge of cGMP, FDA and ICH guidelines
• Experience managing tech transfers and CROs/ CMOs
• Experience working with SoftmaxPro, Prism, and JMP is a plus

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. 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/

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.

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