Scientist II / Senior Scientist, I, tLNP Process Development

Role Summary

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

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.

Qualifications

• 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