Senior Advisor, Process Development Engineer, RNA​/LNP

Senior Advisor, Process Development Engineer, RNA/LNP

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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, dedicated to developing and delivering life‑changing medicines, improving disease understanding and management, and giving back through philanthropy and volunteerism.

The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral formulations of small and large molecules, including monoclonal antibodies, therapeutic proteins, peptides, and genetic medicines. The drug product team invests in platforms such as lipid nanoparticles (LNP), antibody drug conjugates, AAV, and non‑viral viral delivery vehicles. We seek a highly motivated engineer experienced in process development of genetic medicines to advance Lilly’s RNA/LNP portfolio from clinical to commercialization.

This position is located at Lilly’s technical center near the Indianapolis headquarters.

• Design and execute process studies to define clinical and potential commercial manufacturing processes for RNA‑LNPs and other parenteral drug products.
• Lead efforts to advance process development of new modalities, especially RNA‑LNP late‑stage development, assessing and mitigating process risks during scale‑up through understanding of in‑process and final product critical quality attributes and critical process parameters.
• Collaborate with project management and other technical leaders to execute complex tech transfer challenges across sites, including internal and external manufacturing organizations, and work closely with stakeholders to ensure integration of novel excipients into CMC development timelines and appropriate regulatory pathways.
• Collaborate with clinical manufacturing team to support clinical manufacturing at internal and/or external CMOs. Author tech transfer related documents, review batch records for accuracy, and provide onsite technical oversight during manufacturing.
• Ensure consistency in technical deliverables and documentation across transfers.
• Partner with analytical colleagues and aid in transferring and implementing analytical methods to CMOs for in‑process testing and CROs for stability testing.
• Represent the product research & development organization on project teams. Partner with cross‑functional stakeholders—including project management, analytical development, quality, device delivery, supply chain, internal/external manufacturing, and tech/manufacturing services—to define drug product and CMC timelines and key deliverables for regulatory submission.
• Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies and accelerate product development.
• Collaborate with early‑stage stakeholders to support a strong innovation agenda, producing publications, presentations, and industry‑wide influence to advance the Lilly portfolio.

• Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field with a minimum of 2 years industry experience OR an M.S. in the same fields with a minimum of 10 years industry experience. Industry experience must include nanoparticle formulations, oligonucleotide and/or gene delivery development programs, parenteral formulation, or process development.

• Experience with development of RNA‑lipid nanoparticle formulation and manufacturing process is highly preferred.
• Hands‑on experience in designing and optimizing manufacturing processes or drug delivery platforms including RNAs and LNPs is highly preferred.
• Working knowledge and experience with regulatory submissions of RNA‑based therapies is preferred.
• Sound understanding of cGMP requirements, ICH, and regulatory guidelines is a must.

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