Scientist II / Senior Scientist, I, tLNP Process Development

Description:

The target lipid nanoparticle (tLNP) process development team is seeking a highly motivated, talented, and innovative scientist to develop manufacturing processes for tLNP from purified mRNA into purified tLNP bulk drug product. The successful candidate will help advance understanding unit operations such as mRNA encapsulation, bioconjugation, and tangential flow filtration, as well as scaling up lab processes into pre-clinical, clinical, and commercial scale manufacturing processes.

Targeted lipid nanoparticles (tLNPs) represent a key new modality to enable the effective delivery of mRNA. The tLNP chemistry, manufacturing, and control (CMC) team (TCT) is a newly formed group under Biologics CMC, Development Sciences, R&D. The tLNP CMC team focuses on process development for tLNPs, including mRNA process development, tLNP process development, and formulation development.

The tLNP process development team within TCT is responsible for developing the manufacturing process for tLNP from bulk drug substance (purified mRNA) into bulk drug product (purified tLNPs). The process starts from mixing purified mRNA and lipid components to form mRNA encapsulated LNPs, then conjugating the LNPs with a targeting moiety, and lastly purifying the tLNPs with tangential flow filtration. The tLNP process development team will work together with mRNA process development team, tLNP formulation team, and analytical development team. The team will also collaborate closely with various functions and Center of Excellences within Biologics CMC and Synthetic Molecule CMC departments.

The end goal for tLNP process development team is to deliver a robust manufacturing process at commercial scale. This includes science-based, hands-on approaches in the lab to optimizing process parameters and understanding impact of process parameters on critical quality attributes. First-principle based and statistical modeling can be applied where appropriate. Along the pharmaceutical development life cycle, the team will be responsible for successful production of non-GMP pre-clinical safety study supply and GMP clinical study supply from a manufacturing plant on site or at third party manufacturers. The team will also lead the tech transfer of commercial process into a commercial facility. Additionally, the team reviews appropriate sections of Common Technical Document (CTD) for regulatory submissions. Building strong cross-functional relationships with internal and external partners is key to the team’s success. The work will contribute to 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.
• May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
• Demonstrates high proficiency across a wide range of technologies relevant to tLNP process development.
• Formulate conclusions and design follow-on experiments based on multidisciplinary data.
• Primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GMP compliance.
• Direct mentorship of others.

This role can be hired at Sr. Scientist I or Scientist II depending on education and years of experience.

• Senior Scientist I:  BS with 10+ years', MS with 8+ years', and PhD with 0+ years' industry experience.
• Scientist II: BS with 7+ years', MS with 5+ years' industry experience.
• Experience with LNP mixing technology in an academic lab, or industry experience with LNP drug product process development. For mRNA encapsulation, experience with systems other than microfluidics, such as impinging jet, coaxial jet, or multi-inlet vortex mixer is required. Experience scaling up LNP processes to gram-scale mRNA or above is highly preferred.
• Possess thorough theoretical and practical understanding of mRNA encapsulation
• Experience with bioconjugation is a plus
• Demonstrated ability to independently design, execute, and interpret critical experiments to answer scientific questions
• Demonstrated ability to learn, understand, and master new experimental techniques
• Ability to multitask and work within timelines
• Demonstrated scientific writing skills and strong verbal communication skills