Principal Scientist, Upstream RNA

Expert Scientist, Upstream - RNA

Field based worker, expected to be on-site

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 Rockville, US (to be moved to Cambridge, US in Q2 2025) 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 RNA DS Platform Development Leader (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 into 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.

Key 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 and/ or any other additional initiatives that may arise.
• Work within a global team, proactively collaborate transversally with all 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.

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
• Three or more years of experience in 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
• Three or more years of experience in overall process development and analytical development activities required for CMC support.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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.

#Li-GSK

#Vx-Cam

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