Director​/Sr. Director, Late-Stage LNP Process Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. We are seeking a highly motivated candidate for the position of Director/Sr.

Director, Late-Stage LNP Process Development. The individual will partner with the following teams - Early-Stage LNP, Tech Transfer and Manufacturing, LNP Platform Innovation, Analytical Development - as well as the broader Delivery Devices and Connected Solutions team, and cross functionally with Bioproduct Research and Development to advance Lilly’s transformative pipeline. The successful candidate will combine deep scientific expertise, operational excellence, and a passion for tackling new challenges in a fast-paced, dynamic environment.

• Establish the technical roadmap for the Late-Stage LNP Process Development team.
• Drive the process development, optimization, scale-up, process characterization, and process understanding activities for the late-stage LNP Drug Product programs.
• Partner with the Early-Stage LNP Process Development and Analytical Development teams to develop the scale up and comparability strategy and mitigate risks during scale-up.
• Develop Phase 3 ready manufacturing processes and partner with the Tech Transfer and Manufacturing team to transfer the process to late-stage internal and external manufacturing partners for Phase 3 and commercialization.
• Establish and execute process characterization strategies and activities to prepare for commercial process lock.
• Define product/product requirements and capacity needs for the Phase 3 and commercial processes and assist in the selection of the Phase 3/commercial manufacturing site.
• Lead development, optimization, and pre-qualification of analytical methods; and build characterization, release, stability, and comparability testing programs across drug substance, process, formulation, and finished product.
• Drive innovative process solutions for robust production of RNA-LNP products including tLNP.
• Author and review technical reports and relevant sections of regulatory submissions, and participate in regulatory interactions as needed.
• Identify external collaborations to enhance internal capabilities and drive process innovation, and represent the company at scientific meetings and industry forums.

• PhD in engineering, chemistry, molecular biology, or a related field with 10+ years of relevant industry experience.
• Demonstrated experience in RNA-LNP process development, scale-up, and tech transfer.
• Proven experience in phase-appropriate assay development, optimization, qualification, and transfer for lot release, stability, and product characterization from early through late-stage development.
• Solid understanding of ICH guidelines and industry best practices for cell and gene therapies.
• Excellent problem-solving…