Senior Bioassay Lead - Potency & RNA-LNP Analytics

BioSpace; Boston (MA); Presencial; USD 141 000 - 231 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) plan

Health benefits

Vacation benefits

Well-being program

Resumo da oferta

Lilly is seeking a Senior Advisor for bioassay development within the Analytical Development team to lead cell-based potency assays for next-generation RNA-LNP therapies. You will guide strategy, develop assays, and collaborate with Regulatory, Quality, and CS teams to ensure robust, compliant analytical solutions.

Ideal candidates bring deep bench skills, leadership, and experience transferring methods to internal and external labs, with a focus on phase-appropriate strategies and ICH/FDA

Qualificações

• PhD in molecular biology, biochemistry, or related field with 4+ years of industry bioassay/potency assay experience; or MS with 10+ years.
• Hands-on experience developing, optimizing, and qualifying cell-based potency assays.
• Experience with other bioassay techniques such as flow cytometry, qPCR/ddPCR and ELISA.
• Knowledge of ICH/FDA guidelines and industry best practices for bioassays.
• Proven experience defining and executing phase-appropriate assay strategies including method transfer.

Responsabilidades

• Serve as technical lead for bioassay strategy and roadmap for RNA-LNP programs.
• Lead end-to-end development, optimization, pre-qualification, and tech transfer of cell-based potency assays.
• Design and execute cellular and molecular assays (flow cytometry, qPCR/ddPCR, ELISA) to characterize RNA-LNP products.
• Represent bioassay function on cross-functional teams and act as the SME for potency topics.

Conhecimentos

Bioassay development

Cell-based potency

Flow cytometry

qPCR/ddPCR

ELISA

Regulatory guidelines

DOE design

Formação académica

PhD in molecular biology/biochemistry

MS with 10+ years experience

Ferramentas

Statistical DOE methods

Descrição da oferta de emprego

Lilly is seeking a Senior Advisor for bioassay development within the Analytical Development team to lead cell-based potency assays for next-generation RNA-LNP therapies. You will guide strategy, develop assays, and collaborate with Regulatory, Quality, and CS teams to ensure robust, compliant analytical solutions.

Ideal candidates bring deep bench skills, leadership, and experience transferring methods to internal and external labs, with a focus on phase-appropriate strategies and ICH/FDA