Senior Advisor, Bioassay Development — Analytical Development

About the role

Official Lilly Workday posting R-113634. Full-time Senior Advisor in Boston; posted yesterday and marked Apply, with application end date November 9, 2026. Leads cell-based potency and other bioassays (flow cytometry, qPCR/ddPCR, ELISA) for next-generation RNA-LNP therapies, assay strategy, qualification, transfer, comparability, CMC, regulatory documentation, CRO/CDMO collaborations, and scientist leadership.

Requirements

• PhD in molecular biology, biochemistry or related discipline plus 4+ years industry experience in bioassay/potency assay development, or MS plus 10 years relevant experience
• Extensive hands-on experience developing, optimizing and qualifying cell-based potency assays
• Hands-on flow cytometry, qPCR/ddPCR and ELISA
• Knowledge of ICH/FDA guidelines for bioassays and cell/gene therapy analytical methods
• Experience defining phase-appropriate assay strategies and transferring methods to internal or external labs

What you'll do

• Lead bioassay strategy and roadmap for RNA-LNP programs
• Develop, optimize, prequalify and transfer cell-based potency assays
• Develop and execute flow cytometry, qPCR/ddPCR and ELISA assays for RNA-LNP characterization
• Establish assay comparability and bridging across process/formulation changes
• Partner across research, process/formulation, cell and gene therapy, quality and regulatory
• Oversee transfer to analytical teams, CDMOs and external labs
• Author/review protocols, reports and regulatory submission sections

Where this was posted

• lilly.wd115.myworkdayjobs.com

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