About the job
Description:
- Join our dynamic targeted lipid nanoparticle (tLNP) process development team as a driven and innovative scientist dedicated to advancing manufacturing processes for mRNA derived from linearized DNA plasmids into purified mRNA drug substances. You will play a pivotal role in enhancing our understanding of critical unit operations, including in vitro transcription (IVT), preparative chromatography, and tangential flow filtration, while also scaling up laboratory processes for pre-clinical, clinical, and commercial manufacturing.
- Our newly established Targeted Lipid Nanoparticles Chemistry, Manufacturing, and Control (CMC) team within Biologics CMC, Development Sciences, R&D focuses on developing processes for tLNPs and formulation development. This is a fantastic opportunity to contribute to cutting-edge mRNA-based therapeutics.
- The mRNA process development team is tasked with creating robust manufacturing processes for mRNA, starting from IVT with linearized DNA plasmids through purification and tangential flow filtration. Collaboration with the tLNP process development team, formulation team, and analytical development team is essential to achieving our goals.
- Your work will aim to deliver a commercially viable manufacturing process, using science-driven and hands-on methods to optimize parameters and understand their impact on critical quality attributes. First-principles and statistical modeling will be employed as appropriate. Throughout the pharmaceutical development lifecycle, you will ensure the successful production of non-GMP pre-clinical safety study supplies and GMP clinical study supplies, leading the tech transfer of commercial processes. Building strong cross-functional relationships will be integral to our success.

