Expert Scientist - mRNA Drug Substance Analytics

<p>//Field based worker, expected to be on-site// </p><p></p><p>The Cell and Viral Drug Substance team within the GSK Vaccine’s Technical Research and Development organization, has as a mission to develop the next generation mRNA vaccine platforms for rapid development of new vaccine candidates.</p><p></p><p>We are looking for a motivated expert scientist for in-process analytics of mRNA-based vaccines to join the mRNA drug substance Development Unit and be part of the integration of an external partner Drug Substance platform process for clinical &amp; commercial manufacturing of mRNA. Located in Rixensart, Belgium, the position will play a significant role in shaping current and next generation GSK’s leading mRNA vaccine platforms to accelerate addressing unmet medical needs, an exciting field having a direct impact into patients and global health. This role provides the opportunity to integrate a diverse group of top talented experts in vaccines’ industry, lead key activities and further grow and progress in your career.</p><p></p><p>As a Drug Substance organization our main goal is to deliver high quality mRNA starting from the initial template to the final bulk product. As this process can be complex and tedious, getting an in-depth understanding of the relationships that exist between the process and the product is crucial to streamline our development activities in a competitive environment. This in-depth understanding requires the development or the set-up of various analytical assays (process or product related impurities, product characterization) to monitor the evolution of the product quality throughout the process</p><p></p><p>As an expert scientist you will join a team of experts in the mRNA field and contribute to building up our process understanding and consolidate our assets in the field.</p><p></p><p>Your responsibilities:</p><ul><li>Apply your deep knowledge in nucleic acid research to develop, implement and troubleshoot in-process analytical methods (content, process- and product-related impurities) to support development of new mRNA Drug Substance processes for clinical &amp; commercial manufacturing of mRNA.</li><li>Development of fit for purpose assays to further strengthen our process understanding in collaboration with the In-process analytics or analytical development teams</li><li>Liaise and coordinate with transversal teams (Analytical development, In-Process analytics, External partners) and contribute to building our next generation mRNA platform workflows and integration within the later-stage global platform.</li><li>Stay up to date with best practices and advancements in the mRNA technology on analytical methodologies and latest quality and regulatory guidance to support project documentation and accelerated CMC submissions.</li><li>Train and supervise your colleagues on the different assays developed</li></ul><p></p><p>Why you?</p><p>Basic Qualifications:</p><p>We are looking for professionals with these required skills to achieve our goals:</p><ul><li>PhD in bio-engineering, biochemistry, biotechnology, chemistry or equivalent or a Master in bio-engineering, biochemistry, biotechnology, chemistry or equivalent.</li><li>A minimum of 3-5 years’ (if PhD) or 5-8-years’ (if Master) of hands-on experience in the development of nucleic acids  characterization methods (fluorescent-based assays, RT-qPCR, ddPCR, hybridization technique, electrophoresis-based techniques, HPLC/UPLC).</li><li>Excel at complex problem solving through critical thinking using knowledge gained through formal education, experience, and sound judgment.</li><li>Excellent communication skills and demonstrated experience in managing stakeholders in tight timelines</li></ul><p></p><p>Preferred Qualifications:</p><p>If you have the following characteristics, it would be a plus:</p><ul><li>Experience with Quality by Design with demonstrated capability to develop fit-for-purpose high throughput in process analytics to support process development for biologics.</li><li>Knowledge on mRNA structure and function relation.</li><li>Firsthand experience with advanced NGS.</li><li>Broad understanding of analytical development workflows required for CMC support.</li></ul><p></p><p>If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.</p><p></p><p>Why Us?</p><p>GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.</p><p></p><p>Our success absolutely depends on our people. While ge