Analytical Scientist/Senior Scientist, Cell and Gene Therapy
AstraZeneca

Job Info

---

Analytical Scientist/Senior Scientist, Cell and Gene Therapy

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 place 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 ground breaking 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 Bioassay, Biosafety and Impurities, Analytical Group is accountable for developing powerful methods to evaluate product quality by measuring biological activity as well as detecting, characterizing, and quantifying product variants and process-related impurities. The group enables product understanding, manufacturing process development, formulation, drug product development and regulatory filings. This group is accountable for control systems, including specifications, comparability, and shelf-life strategies required by regulatory agencies in addition to technical transfer of methods for clinical quality control and commercial launch sites and technical support and lifecycle management post-launch.

Main Duties and Responsibilities

• Develop robust functional, characterization and molecular analytical methods using innovative technologies for in process characterization and final product release for cell-based therapies.
  
• Develop and implement analytical methods which quantify, identify, and/or characterize: chromosomal translocation, knock-in and knock-out efficiencies, gene copy number, and related molecular biology methods used in cell and gene therapy product quality control
  
• Lead analytical method qualification and technology transfer to QC group and partners.
  
• Make detailed observations, analyze data, interpret results, and exercise appropriate technical discretion in the design, execution, and interpretation of experimental results in an independent manner.
  
• Prepare technical reports, protocols, and summaries for presentation.
  
• Present and discuss experimental results at group/project team meetings and at scientific conferences.
  
• Work in a dynamic, team-based structure and collaborate with multiple departments including Research and Process Development.
  

Education & Experience Requirements:

Education: Degree in a relevant field within the biological sciences.

Experience:

Scientist: BS and 8+ years of relevant experience or MS and 5+ years of relevant experience

Senior Scientist: BS and 10+ years of relevant experience, MS and 8+ years of relevant experience or a PhD and 1+ years of relevant experience

• Biotechnology or pharmaceutical industry experience working in the cell therapy area or equivalent.
  
• Experience with NGS experimental design and data analysis (Illumina, NanoPore, and/or Ion Torrent)
  
• Proficiency with Molecular Biology techniques (PCR, ddPCR, DNA extraction).
  

Desirable Skills:

• Prior experience with analytical method development of cell-based assays, binding assays and residual impurities assays.
  
• Experience qualifying, transferring, validating cell therapy analytical methods
  
• Experience with analytical method development for GMP usage
  
• Proficiency with NGS experimental design and data analysis for detection of cell line variants (off and on-target edit variants, karyotyping, translocation, and other potential attributes)
  
• Experience with molecular techniques for characterizing Cell and Gene Therapy type materials including but not limited to single cell sequencing, Bionano, G-banding karyotyping, etc
  
• Experience with cell culture, ELISAs or similar technology platforms
  
• Experience with state-of-the-art cell line engineering technologies.
  
• Prior research with allogeneic CAR T cells.
  
• Experience qualifying and transferring cell therapy analytical methods.
  

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 innovative 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?

Our Social Media:

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

This job has expired.