Associate Scientist, Downstream – mRNA Drug Substance
Associate Scientist, Downstream – mRNA Drug Substance
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.
We are looking for a motivated expert downstream scientist to join the mRNA drug substance Development Unit and be part of the integration of an external partner Drug Substance platform process for clinical & 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.
Lead Internalization of a pre-established downstream mRNA vaccine platform from an external partner and mature its robustness, scalability, and characterization for late-phase CMC development and commercial manufacturing, supervising more junior scientists
Hands-on design and execution of development of purification processes, scale-down models and process characterization utilizing DOE principles for mRNA manufacturing and tech transfer to GMP facilities on firm timelines
Represent DS in cross-functional program teams as required and translate project goals into actionable plans
Instrumental to building mRNA platform documentation and workflows, and integration within the upstream, analytical, and other transversal teams within the global platform
Stay ahead with the latest quality and regulatory guidance to support project documentation and accelerated CMC submissions.
We are looking for professionals with these required skills to achieve our goals:
MS or PhD with degree in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering or a related scientific field
A minimum of 7 years’ experience in chromatography and other purification techniques such as tangential flow filtration (TFF) and associated instrumentation such as AKTA chromatography systems and Unicorn software.
Minimum of 3 years of industry experience in bioprocess development (late-phase preferred) and process technology transfer for large biomolecules using QbD principles
Excel at complex problem solving through critical thinking using knowledge gained through formal education, experience, and sound judgment, and foster this as a culture within the team.
Hands-on experience on preparative Reverse Phase HPLC (RP-HPLC)
If you have the following characteristics, it would be a plus:
Proven track record in bioprocess development for the biomanufacturing of nucleic acids, preferably mRNA
Broad understanding of overall process development and analytical development activities required for CMC support.
Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation
Experience and understanding in nucleic acid analytical technologies.
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.
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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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