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Scientist II / Sr Scientist, Analytical Sciences

Company: AstraZeneca
Location: Gaithersburg
Posted on: October 19, 2020

Job Description:

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 youre 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 youll 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 II or Senior Scientist 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 mid to late stage projects through commercialization. The individual is expected to work in a cross-functional matrix environment.


  • Represent Analytical Function in late-stage CMC Development
  • Work with cross-functional (matrix) management and be responsible for multiple projects
  • Author technical documents, such as justification of specifications, comparability plan and report, QBD risk assessment, and response to regulatory agency questions
  • 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
  • Author and review regulatory submissions such as BLA and MAA

    Qualifications:

    Scientist II:

    Degree in analytical chemistry, biochemistry or a relevant discipline

    PhD with a minimum of 3 years of biopharmaceutical industry experience in analytical development, technology transfers and method lifecycle management - OR -

    Masters degree with minimum of 10 years of industry experience - OR -

    Bachelor's degree and a minimum of 13 years of industry experience

    Sr Scientist:

    Degree in analytical chemistry, biochemistry or a relevant discipline

    PhD with a minimum of 7 years of biopharmaceutical industry experience in analytical development, technology transfers and method lifecycle management - OR -

    Masters degree with minimum of 13 years of industry experience - OR -

    Bachelor's degree and a minimum of 15 years of industry experience

    • Technical expertise in chromatography (HPLC/UPLC), and/or electrophoresis (CE-SDS, cIEF) and/or other biophysiochemical analytical techniques
    • In depth knowledge and experience with analytical method development, optimization, technology transfer, qualification and validation
    • Strong background involving analytical experience across CMC with significant late-stage biologics experience
    • Experience with cross-functional (matrix) management, having served as an analytical representative on the CMC team
    • Experience with regulatory submissions (IND, BLA, MAA, JNDA)

      Desirable skills:

      • Outstanding organizational and communication skills (especially written, verbal and presentation)
      • Strong scientific skills including sound experimental design, data processing and interpretation
      • Excellent capability to multi-task and manage multiple projects
      • Previous experience managing tech transfers and CROs/ CMOs
      • Shown ability to work with both direct reports and management
      • Proficient in MS Word, Excel, Power Point and other applications
      • Previous experience working with 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 were opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

        So, whats next!

        Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope its 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/

Keywords: AstraZeneca, Washington DC , Scientist II / Sr Scientist, Analytical Sciences, Other , Gaithersburg, DC

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