Advisor/Sr. Advisor, Process Development Engineer, RNA/LNP
Overview and Position Summary
The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization also invests in genetic medicines, including active investments in oligonucleotide development, nanomedicines for tissue-specific targeting, and other gene delivery strategies. The drug product team is building new platforms to support complex formulations like lipid nanoparticles (LNPs), antibody drug conjugates, AAV, and other non-viral vector delivery vehicles. We seek a highly motivated engineer with experience in process development of genetic medicines to advance the portfolio from clinical to commercialization.
This position is located at Lilly's tech center, adjacent to the headquarters in Indianapolis. It requires hands-on experience in process development of non-viral delivery vehicles, particularly RNA-lipid nanoparticles. The candidate will collaborate across functions at Lilly's Boston and Indianapolis sites to advance portfolio assets.
Responsibilities
Design and execute process studies to define clinical and potential commercial manufacturing processes for RNA-LNPs and other parenteral drug products.
Lead efforts to drive the process development of various new modalities, especially RNA-LNPs, late-stage development, including assessing and mitigating process risks during scale-up through an 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 both internal and external manufacturing organizations, and work closely with stakeholders to ensure the integration of novel excipients into CMC development timelines and appropriate pathways for regulatory submission.
Collaborate with clinical manufacturing team to support clinical manufacturing at internal and/or external CMOs. Author tech transfer-related documents and review batch records to ensure accuracy of the manufacturing steps and process parameters. Provide onsite technical oversight of clinical manufacturing to address any technical hurdles during manufacturing.
Ensure consistency in technical deliverables and documentation across transfers. Partner with analytical colleagues and aid in the transfer and implementation of analytical methods to CMOs of portfolio molecules for in-process testing and CROs for stability testing.
Collaborate with cross-functional stakeholders including project management, analytical development, quality, device delivery, supply chain, internal/external manufacturing, tech/manufacturing services to define drug product and CMC timelines and key deliverables to meet the requirements for regulatory submission.
Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies to accelerate product development.
Collaborate with early-stage stakeholders to support a strong innovation agenda for the team, leading to publications, presentations, and industry-wide influence. Leverage these innovations to advance the Lilly portfolio.
Basic Requirements
Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field and a minimum of 2 years industry experience, or
An MS in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field and a minimum of 10 years industry experience.
Industry experience required includes nanoparticle formulations, oligonucleotide and/or gene delivery development programs, parenteral formulation, or process development. Sound understanding of cGMP requirements, ICH, and regulatory guidelines is a must.
Additional Preferences
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.