Senior Advisor, Process Development Engineer, RNA/LNP

Role Summary

Senior Advisor, Process Development Engineer, RNA/LNP. We are seeking a highly motivated engineer with experience in process development of genetic medicines to advance Lilly’s portfolio from clinical to commercialization. This role focuses on nonviral delivery vehicles, e.g., RNA-lipid nanoparticles, and requires collaboration across Lilly sites in Boston and Indianapolis at the tech center located near Lilly’s headquarters in Indianapolis.

Responsibilities

• Design and execute process studies to define clinical and potential commercial manufacturing processes for RNA-LNPs and other parenteral drug products.
• Lead process development of various new modalities, especially RNA-LNPs late-stage development, and mitigate process risks during scale-up by understanding in-process and final product quality attributes and critical process parameters.
• Collaborate with project management and technical leaders to execute complex tech transfer challenges across sites, ensure integration of novel excipients into the CMC development timeline, and define regulatory submission pathways.
• Collaborate with clinical manufacturing teams to support clinical manufacturing at internal and external CMOs. Author tech transfer documents, review batch records, and provide onsite technical oversight to address manufacturing hurdles.
• Ensure consistency in technical deliverables and documentation across transfers.
• Partner with analytical teams to transfer and implement analytical methods to CMOs for in-process testing and CROs for stability testing.
• Represent the product R&D organization on project teams; collaborate with cross-functional stakeholders to define drug product and CMC timelines and deliverables for regulatory submission.
• Establish and leverage relationships with academic and industry partners to adopt new process technologies to accelerate product development.
• Collaborate with early-stage stakeholders to support an innovation agenda, contributing to publications, presentations, and industry influence to advance the Lilly portfolio.

Qualifications

• Required: Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related field with a minimum of 2 years industry experience; OR MS in same fields with a minimum of 10 years industry experience. Relevant industry experience includes nanoparticle formulations, oligonucleotide/gene delivery development, parenteral formulation, or process development.
• Preferred: Experience with development of RNA-lipid nanoparticle formulation and manufacturing process; hands-on experience designing and optimizing manufacturing processes or drug delivery platforms including RNAs and LNPs; working knowledge of regulatory submissions for RNA-based therapies; strong understanding of cGMP, ICH, and regulatory guidelines.

Education

• Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related field with relevant industry experience; or MS in same fields with substantial industry experience as described above.

Additional Requirements

• None specified beyond the qualifications and responsibilities listed.