Principal Scientist, Upstream – RNA Full-time NEW

Upstream Process Development Expert Scientist

This is a lab-based position with an anticipated 4-5 days on-site presence in the laboratory. The Nucleic Acid Vaccines Center of Excellence (NAV CoE), a global team within the GSK's Drugs Substance Vaccine's Technical Research and Development organization, has as a mission to develop the next generation mRNA Drug Substance vaccine platforms for rapid development of new vaccine candidates. It has branches in Cambridge and in Rixensart, Belgium.

We are looking for a highly motivated Upstream Process Development Expert Scientist to join the mRNA Drug Substance (DS) team and work on delivering new mRNA vaccine candidates from development to the clinical manufacturing stages, a role located in Cambridge, MA USA, and reporting to the NAV CoE head (Belgium based). The position will play a significant role in shaping current and next generation GSK's mRNA vaccine platforms to accelerate addressing unmet medical needs, a compelling field having a direct impact on patients and global health. This exciting opportunity allows you to lead key activities, collaborate with top talents in the vaccines industry, and advance your career while ensuring timely project delivery in collaboration with process development colleagues and GMP team.

Main core responsibilities:

• Autonomously design, execute, and analyze experiments to develop and optimize RNA in-vitro transcription processes to translate into the mRNA platform and continuously evolve it, ensuring phase-appropriate and scalable processes, as part of the overall platform development strategy.
• Lead transversally process development activities of the upstream team and/or any other additional initiatives that may arise.
• Work within a global team, proactively collaborate transversally with BE and US-based DS teams, Analytical R&D, GMP teams, etc, in an agile and open way ensuring good communication and alignment.
• Drive innovative solutions and meet project milestones.
• Stay up to date on industry trends and emerging technologies in downstream processing, contributing to continuous improvement initiatives.

Why you? Basic Qualifications:

• MS or PhD with degree in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering or a related scientific field
• Experience with RNA biology and mechanisms of eukaryotic translation.
• 5+ years of industry experience in process development for large biomolecules, preferably mRNA and pDNA, with hands-on experience in mRNA synthesis workflows
• Experience in overall process development and analytical development activities required for CMC support.

Preferred Qualifications:

• Experience with Quality by Design.
• Experience with DOE studies & process improvements, and advancements including parameter optimization, scale-up, process window determination, etc.
• 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.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.