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Associate Scientist /Scientist - Cell Therapy - BPD

Location Gaithersburg, Maryland, United States Job ID R-109473 Date posted 26/05/2021

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:

The Cell Culture and Fermentation Sciences Group is accountable for cell line development, process development, and process characterization. This group assists in the scale up and technical transfer of processes to different clinical and commercial sites and also supports manufacturing deviations and regulatory submissions as needed.

Main Duties & Responsibilities:

Has a good understanding of procedures relating to oncologic application of Adoptive Cell Therapy (ACT).

  • Develop, implement, and manage technical transfer protocols for AZ cell therapy products, both internally and externally. 
  • Make detailed observations, analyze data, interpret results, and exercise appropriate technical discretion in the design, execution, and interpretation of cell production performance and analytical results at multiple sites.
  • Preparation and/or review of technical transfer protocols and reports, as well as technical summaries for presentation is required.
  • Draft relevant sections of comparability reports and regulatory filings and to assist in responding to regulatory requests.
  • Work in a team-based structure and interface with research and process development departments. 

Education & Experience Requirements:

Education: Degree in a relevant field within the biological sciences 

Associate Scientist: BS and 5+ years of relevant experience, or MS and 2+ years of relevant experience

Scientist: BS and 10+ years of relevant experience, or MS and 8+ years of relevant experience or PhD and 0+ years of relevant experience.

Required Skills:

  • Biotechnology or pharmaceutical industry experience working in GMP environment and FDA-regulated industry.
  • Experience in manufacturing or developing cell and gene therapy products
  • Extensive experience with implementing and transferring clinical manufacturing projects
  • Experience with cell-based bioassay development, qualification and transfer.
  • Demonstrated experience of qualifying, transferring, validating cell therapy analytical methods
  • Experience in vendor, contract, or collaborator projects, timelines, budgets

Desired Skills:

  • GMP training
  • CAR-T or vector development
  • Experience executing early and late-stage analytical comparability studies.
  • Project management training and/or certification

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

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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 authorisation and employment eligibility verification requirements.

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.