Scientist, Bioassay, Biosafety & Impurities (BB&I) - AAV
AstraZeneca

Gaithersburg, Maryland

This job has expired.


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 the AAV platform development within Bioassay, Biosafety & Impurities (BB&I). This person will be responsible for providing bioassay method development and functional characterization support of AAV 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 AAV, cell & gene therapy, and other biologics
  • 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:

Bachelor's and 5+ years of relevant experience or MS and 2+ years of relevant work experience required. Laboratory experience is highly preferred.
  • Hands-on experience with bioassays and functional characterization methods; viral transduction, titer assays for cell and gene therapy products
  • Experience with viral infectivity assays and aseptic technique
  • Good understanding of different AAV production and purification systems and experience in handling cells/cell lines and employing, high throughput testing support to measure the titer and potency of AAV
  • Excellent knowledge and extensive experience using various analytical techniques (such as SEC-MALS, AUC, LC-MS, etc) to measure AAV particle size, aggregation, Empty/full particle ratio, capsid post-translational modifications, etc.
  • Good understanding of various analytical techniques for the measurement of viral titer and impurities (such as ELISA, qPCR, ddPCR, etc)
  • 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

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, gene and/or cell therapy 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 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/


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