Scientist I / II, tLNP Process Development

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Overview:

Targeted lipid nanoparticles (tLNPs) are a key emerging modality for the effective delivery of mRNA therapeutics. The tLNP CMC Team (TCT), a newly formed group within Biologics CMC, Development Sciences, R&D, is seeking a scientist to join its tLNP Process Development team.

This team is responsible for the full manufacturing process from purified mRNA to purified tLNP bulk drug product: encapsulating mRNA with lipid components to form LNPs, conjugating LNPs with a targeting moiety, and purifying the final tLNPs via tangential flow filtration. The role focuses entirely on manufacturing process development, not on mRNA sequence design, lipid structure, or targeting moiety design.

The team's mandate spans the full pharmaceutical development lifecycle: optimizing process parameters and their impact on critical quality attributes, producing non-GMP pre-clinical and GMP clinical supply, leading commercial tech transfer, and authoring relevant CTD sections for regulatory submissions. Science-based, hands-on lab work is central, with first-principles and statistical modeling applied where appropriate.

Success in this role depends on close collaboration with the mRNA process development, drug product development, and analytical development teams, as well as cross-functional partners across Biologics CMC and Synthetic Molecule CMC. The work directly advances cutting-edge mRNA-based therapeutics.

Responsibilities

• Independently design, execute and interpret critical experiments to understand unit operations such as mRNA encapsulation, bioconjugation, and tangential flow filtration, and scale up these unit operations to commercial manufacturing batch size

• Highly autonomous and productive in performing laboratory research or method development, requiring only minimal direction from or interaction with supervisor.