Director​/Sr. Director, Analytical 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.

We are seeking an accomplished leader for our analytical development function. Reporting to the Associate VP of LNP Drug Product Development and Manufacturing, the ideal candidate will build and lead a diverse analytical development team within the Advanced Delivery Systems (ADS) organization to support development of next-generation RNA-LNP therapies as well as other drug delivery innovation efforts. The individual will partner closely with Lilly Genetic Medicines, Process and Formulation, Bioproduct Research and Development, Cell and Gene Therapy, and the broader Delivery Devices and Connected Solutions team to advance Lilly’s transformative pipeline.

The successful candidate will combine deep scientific expertise, strategic leadership, operational excellence and a passion for tackling new challenges in a fast-paced, dynamic environment.

• Establish vision and roadmap for analytical development functions, including innovative analytical platforms supporting RNA-LNP based genetic medicines and other drug delivery programs

• Provide organizational leadership aligned with company objectives.

• Recruit, mentor, and retain scientific talent, fostering the growth of a diverse, high-performing team.

• Partner with research, formulation, process, manufacturing, quality, and regulatory teams to define product CQAs, assess develop ability, evaluate assay readiness for technical transfer, and mitigate risks during scale-up.

• Lead development, optimization, pre-qualification of analytical methods, and build characterization, release, stability, and comparability testing programs for products in the advanced delivery systems pipeline.

• Keep abreast of emerging analytical technologies and drive innovative solutions to characterize RNA cargos, lipids, targeting moieties, and nanoparticles, addressing complex assay challenges in compliance with evolving regulatory expectations.

• Author and review technical reports and relevant sections of regulatory submissions. Participate in regulatory interactions as needed.

• Identify external collaborations to enhance internal capabilities and drive analytical innovation and represent the company at scientific meetings and industry forums.

• PhD in biochemistry, analytical chemistry, molecular biology, or a related biological science, with 10+ years of relevant industry experience in assay development and 5+ years in a leadership role.

• Demonstrated success leading analytical development teams supporting advanced cell and gene therapeutics within matrixed, fast-paced, innovation-driven environments.

• Deep, hands-on experience in LC-MS and separation sciences (e.g., IP-RP, SEC, IEX, CGE, DLS, MALS) for characterizing the mRNA, protein, and lipid components of LNP-based products or extensive experience with bioassays (ELISA, flow cytometry, PCR, cell-based functional assays, and potency matrices).

• 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…