Senior Advisor, Bioassay Development — 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.

Position Summary We are seeking an accomplished Senior Advisor for bioassay development within the Analytical Development (AD) team, supporting next‑generation RNA‑LNP‑based therapies within the Advanced Delivery Systems (ADS) organization. This individual will lead bioassay scientists and serve as the technical SME for cell‑based potency assays and other bioassays (e.g., flow cytometry, qPCR, ELISA) to characterize RNA‑LNP drug product and other drug delivery systems.

The successful candidate will combine deep, hands‑on bioassay expertise with strategic leadership, partnering closely with Lilly Genetic Medicines, Process and Formulation, Cell and Gene Therapy, and Quality teams to drive phase‑appropriate analytical strategies and assay execution. The successful candidate will be self‑motivated, independent, have hands‑on bench skills, and able to lead and develop other scientist.

• Serve as the technical lead and group leader for the bioassay function within Analytical Development, defining and executing bioassay strategy and roadmap for RNA‑LNP‑based programs.
• Lead end‑to‑end development, optimization, pre‑qualification, and technical transfer of cell‑based potency assays (e.g., transduction/transfection, cell‑based potency assays, functional reporter) as the primary measure of product potency.
• Design, develop, and execute cellular and molecular assays — including flow cytometry, qPCR/ddPCR, and ELISA‑based methods — to characterize RNA‑LNP drug product and process‑and product‑related impurities.
• Represent the bioassay function on cross‑functional project teams and in technical review settings, and act as the primary analytical SME for potency and bioassay topics.
• Establish assay comparability and bridging strategies across process/formulation changes, scale‑up, and method transfers; apply sound statistical design (e.g., DOE) to reduce variability and improve assay robustness.
• Partner closely with Research, Process and Formulation, Bioproduct Research and Development, Quality, and Regulatory teams to ensure integrated, phase‑appropriate analytical strategies, define CQAs, and assess assay suitability and readiness for research‑to‑development‑to‑manufacturing transitions.
• Oversee technology transfer of bioassays to internal analytical teams, CDMOs, and external testing laboratories, providing technical oversight for specification development.
• Evaluate and implement innovative bioassay platforms (e.g., next‑generation potency and multiplex flow and d‑PCR methods) to address emerging scientific and regulatory challenges.
• Ensure bioassay data, methods, and practices comply with ICH/FDA guidelines and industry best practices for cell and gene therapies.
• Identify and manage external collaborations (CROs/CDMOs) to enhance internal capabilities and drive bioassay innovation.
• Author and review assay protocols, technical reports, and relevant sections of regulatory submissions.

• PhD in molecular biology, biochemistry, or a related discipline with 4+ years of industry experience in bioassay/potency assay development;
• or MS with 10…