Sr. Biologist - Research Associate, LNP Process Development

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Position

As a Senior Research Associate in the LNP Process Development team, the candidate will be joining a team conducting laboratory studies to support the process development, process scale-up, and manufacturing of Verve’s LNP drug product. This candidate will have experience with lipid nanoparticle process development (having additional experience in tech transfer and GMP manufacturing is a plus but not required), and a desire to contribute to a team focused on establishing science-based manufacturing solutions for complex nucleic acid-based drug products. In this highly collaborative and cross-functional role, the candidate will support the refinement of Verve’s process control and improve process understanding for multiple programs at various stages of clinical development. While they will serve as a contributor, they will also be mentored and trained by senior team members and cross-functional partners. This is an on-site, lab-based role.

Job Responsibilities

• Plan and execute experiments at bench scale to support process development and optimization of Verve’s LNP drug product manufacturing process to assist in establishing a science-based understanding of LNP process development
• Willingness to collaborate with cross-functional analytical development, tech transfer, and external manufacturing functional teams
• Ability to achieve results, keep to timeline, and find solutions to ensure that overall project deliverables are met.
• Perform experiments under limited to no supervision under subject matter expert guidance
• Organize and analyze data, interpret results, record experiments in an electronic lab notebook, and summarize work in presentations and technical reports
• Actively engage in all aspects of laboratory activities, and troubleshooting of both internal and external manufacturing processes
• Other responsibilities as assigned

Qualifications (Required & Desirable Experience)

• Bachelor’s degree in chemical/ biomedical engineering, chemistry, or biological sciences with 3 - 5 years of relevant industry experience or Master’s degree in chemical/ biomedical engineering, chemistry, or biological sciences with 0 - 3 years of relevant industry experience
• Knowledge with bench-scale drug product manufacturing of LNPs (preferred), biologics, or nucleic acids, with a focus on mixing and TFF processes.
• Experience with practices and equipment used in process development of nucleic acids; T-mixing and TFF is strongly preferred
• Attention to detail, analysis of data/reports, troubleshooting and problem-solving abilities.
• Ability to perform in-process analytical methods including dynamic light scattering, osmolality, pH, and fluorescence assays. Additional are a plus.
• Writing and communication skills; ability to understand and communicate scientific information
• Experience with technical documentation (SOPs, technical reports, protocols) is a plus
• Knowledge of practices of GMP manufacturing, and tech transfer operations is a plus
• Experience with complex biologics preferred
• Working knowledge of domestic and international regulations and guidelines regarding drug development and GxPs, along with application of principles, theories, and practices
• Direct experience interacting with CMOs and relevant regulatory authorities
• Demonstrated project management and organizational skills
• Self-motivated and independent work style with the ability to initiate and follow through on assignments
• Excellent written and verbal communication skills
• Ability to travel, as needed

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