Expert Scientist, Upstream – 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 scientist with deep knowledge in nucleic acid research 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.

Your responsibilities:

• Lead Internalization of a pre-established upstream 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 upstream 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 downstream, 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.

Why you?

Basic Qualifications:

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 gene therapies or specifically mRNA-based vaccines or therapeutics

• 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.

Preferred Qualifications:

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.