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 crafts 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 groundbreaking technology and lab spaces, all designed to inspire teamwork 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 growing 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 Sr. Scientist to develop and deliver innovative, robust and fit-for-purpose biological assays within Bioassay, Biosafety & Impurities (BB&I). This person will be responsible for providing bioassay method development and functional characterization support a diverse pipeline of biotherapeutic modalities. The individual is expected to work in a cross-functional matrix environment and support regulatory filings for INDs up to and including BLAs.

Main Duties and Responsibilities:

• Bioassay development of GMP release assays, product characterization assays, support stability and in-process testing of a wide range of bio therapeutic modalities, including: Viral vectors, monoclonal antibodies (mAbs), ADCs, bi-specifics, cell & gene therapy, and other biologics
• Identify, evaluate, and implement cutting-edge technologies to develop assays.
• Represent BB&I Function in early stage CMC Development
• Collaborate with cross-functional teams (upstream, downstream, and formulation) in a multidisciplinary environment and be responsible for multiple projects
• 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
• Author and review sections of regulatory submissions such as IND, Briefing documents
• Contribute to CQA studies, robustness and validation studies, bioassay reference control strategies
• Perform QTPP assessment, risk assessments, gap assessments for bioassays and aim to enhance compliance and robustness

Qualifications:

PhD with 2+ years of relevant work or postdoctoral research experience or Masters with 8+ years of relevant experience or required. Industry experience is highly preferred.

• Hands-on experience with bioassays and functional characterization methods for monoclonal antibodies, ADCs, Bi-Specifics, various viral vectors specific titer assays & neutralization assays.
• Hands-on experience with developing assays to measure various biological activities, including antigen/receptor binding, alteration of intracellular signaling, induction of cell death, and Fc effector functions
• Experience with viral infectivity assays and cell and gene therapy products is a plus
• Good understanding of various bio & molecular techniques such as ELISA, PCR, qPCR, ddPCR, Sequencing, etc.,
• In depth knowledge and experience with bioassay development, optimization, technology transfer, assay qualification and validation following ICH guidelines

• Demonstrated ability to work optimally and collaboratively with other scientists on cross-functional projects teams

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 on Mid to late stage viral, mAbs products 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 recognizing their potential. Join us on our journey of building a new kind of organization 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/