Advisor – RNA-LNP Process Development – BR&D

Role Summary

Advisor – RNA-LNP Process Development is an onsite, full-time role located in Boston, MA. The role focuses on engineering CMC for genetic medicines, with hands‑on experience in process development of nonviral delivery vehicles such as RNA‑lipid nanoparticles, and ideally oligonucleotide drug products. The candidate will collaborate across Lilly sites to advance portfolio assets, build process capabilities from lab to clinical scales, and support regulatory filing activities.

• Build process capabilities for lab scale, early phase clinical scale, and scale‑up technologies for RNA‑LNPs and other parenteral drug products.
• Support the development of portfolio assets (particularly RNA‑LNPs), including assessing and mitigating process risks during scale‑up through an understanding of in‑process and final product critical quality attributes. Anticipate and manage increased workload during scale‑up and GMP readiness phases.
• Work with project management and other technical leaders to execute complex tech transfer challenges across sites, including both internal and external manufacturing organizations. Help oversee supply chain readiness and ensure integration of novel excipients into regulatory filing packages.
• Implement processes to deliver drug product material for clinical trials and support generating data required for regulatory filings, including addressing CMC regulatory questions.
• Ensure consistency in technical deliverables and documentation across transfers.
• Partner with analytical colleagues and aid in the transfer and installation of analytical methods to assess develop ability of portfolio molecules, including familiarity with acquisition and analysis of chromatography methods (e.g., SEC, HPLC, UHPLC methods).
• Cross‑Functional
  
  Collaboration:
  
  Represent the product research & development organization on project teams. Partner with genetic medicines discovery, synthetic chemistry, toxicology, ADME, analytical, and device to support drug delivery, formulation, or process efforts.
• External Engagement:
  Establish and leverage strategic relationships with academic and industry partners to accelerate and access emerging innovation.
• Innovation:
  Drive a strong innovation agenda for the team leading to publications, presentations and industry wide influence. Leverage these innovations to advance the Lilly portfolio.
• This is a full‑time onsite role (five days per week) in Boston, MA.

• Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field.
• 0‑5 years of prior experience in nanoparticle formulations, oligonucleotide and/or gene delivery development programs, parenteral formulation, or process development.
• Experience with process development of RNA‑lipid nanoparticle and/or oligonucleotide formulations.
• Familiarity with engineering fundamentals towards designing and optimizing manufacturing processes, or drug delivery platforms including RNAs and LNPs.

• Hands‑on experience working with process equipment from lab to pilot scales is preferred.
• Previous experience with regulatory submissions of RNA‑based therapies is preferred.
• Self‑directed and highly motivated individual who wants to learn new techniques while continually pursuing research and publication goals.
• Excellent communicator (oral and written) with presentation experience, along with a strong publication record.
• Proficient in data analysis and reporting.
• Final job level (Advisor or Senior Advisor) will be based on the selected candidate’s experience and qualifications and determined at the hiring manager’s discretion.