Scientist II / Senior Scientist I, tLNP Process Development

Job Description

Targeted lipid nanoparticles (tLNPs) represent a key new modality to enable 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. TCT focuses on process development for tLNPs, including mRNA process development, tLNP process development, and formulation development.

The tLNP Process Development team is seeking a highly motivated, talented, and innovative scientist with expertise in mRNA-LNP process development and an interest in laboratory automation. This team is responsible for the end-to-end manufacturing process from purified mRNA to purified tLNP bulk drug product, including encapsulating mRNA with lipid components to form LNPs, conjugating LNPs with a targeting moiety, and purifying the final tLNPs via tangential flow filtration (TFF).

The successful candidate will help advance fundamental understanding of tLNP unit operations, such as mRNA encapsulation, bioconjugation, and TFF, as well as scaling up lab processes into pre-clinical, clinical, and commercial scale manufacturing processes. The candidate will also apply automation expertise to integrate off-the-shelf and custom-built hardware, software, and data workflows into flexible experimental platforms that increase throughput, reproducibility, and process understanding.

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 optimize process parameters and understand the impact of process parameters on critical quality attributes. First-principle-based and statistical modeling will 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 supplies and GMP clinical study supplies from a manufacturing plant on site or at third party manufacturers. The team will also lead the tech transfer of commercial processes into a commercial facility. Additionally, the team reviews appropriate sections of Common Technical Document (CTD) for regulatory submissions.

Success in this role depends on close collaboration with the mRNA process development, drug product development, and analytical development, digital and automation partners, 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 minimal direction from 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.
• Proactively develop and implement innovative automation solutions (custom and off-the-shelf equipment).
• Apply AI tools for structured data capture, analysis, and predictive modeling.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GMP compliance.
• Direct mentorship of others.

Qualifications

• BS, MS, or PhD degree in Chemistry, Material Science, Pharmaceutical Sciences, Bioengineering, Biomedical Engineering, Chemical Engineering, or equivalent.
• 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 such as impinging jet, coaxial jet, or multi-inlet vortex mixer is required.
• Possess thorough theoretical and practical understanding of mRNA encapsulation.
• Experience with bioconjugation is required.
• 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.

Preferred Experience

• Experience scaling up LNP processes to gram-scale mRNA or above.
• Prior experience with automating existing experimental setups as well as new automation equipment and ecosystems, such as Ignition.

Additional Information

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