Thesis work: Analytical Characterization of mRNA , AstraZeneca

Job description
Thesis work: Analytical Characterization of mRNA Lipid Nano Particles Drug Product

If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us!

Thesis type: 30/60credits
Project start: January 2023
Student location: On Site, Gothenburg Sweden

Modified mRNA represents a promising new class of therapeutic drug substance. Recently, their impact has been clearly demonstrated through the development of vaccine treatments for Covid-19. However, vaccines are only one class of mRNA therapies and numerous pharmaceutical companies are working on other aligned approaches [1-3]. The number of drug products based on Lipid Nano Particles (LNP) is increasing and applications for different therapies is under intense development. 

To improve successful delivery of these new and novel therapies, it is important to develop methods for the characterization and stability assessment of mRNA drug products.  The mRNA drug substances are highly charged and the intact full-length mRNA consists of a distribution of length variants which has to be handled. Moreover, the therapeutic mRNA is constructed with various modified nucleotides. Altogether, this set an interesting challenge on the analytical method capabilities.

Since the successful application of mRNA technology is relatively new, regulatory guidelines for mRNA quality tests are still evolving. A first draft guideline is now available and several of the methods for purity testing are based on ion pair liquid chromatography separations with UV-detection. [4-5]. 
The focus of this project will be to set up and explore the new ion pair liquid chromatography methods for purity testing of mRNA as described in the first draft guideline.

At AstraZeneca, all of our employees make a difference to patients’ lives every day. We operate in more than 100 countries around the world and are one of Sweden’s most important export companies.
 
With more than 2,400 employees from 50 countries, the vibrant Gothenburg site helps to support the entire life-cycle of AstraZeneca medicines, from drug discovery and clinical trials, to global commercialisation and product maintenance. Gothenburg is one of AstraZeneca’s three strategic, global R&D centres, alongside Cambridge and Gaithersburg, and plays a central role in our mission to deliver life-changing medicines to patients.



Responsibilities
The focus of this project will be to set up and explore the new ion pair liquid chromatography methods for purity testing of mRNA as described in the first draft guideline.



Qualifications
- Ongoing education in chemistry, chemical engineering, pharmaceutical chemistry or pharmacy
- Completed course in analytical chemistry and/or organic chemistry
- It is desirable to have completed the course analytical chemistry 2 or advanced analytical chemistry



About the company
If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us! 

At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.