LVV Bioassay & Potency Lead — Senior Advisor

Eli Lilly and Company; Boston (MA); On-site; USD 141,000 - 212,000; Full time

Benefits offered by this job

Company bonus

401(k) and pension program

Health, dental, vision benefits

Job summary

Eli Lilly and Company in Boston, MA seeks a Senior Advisor, Analytical Sciences to lead LVV bioassay and potency assay development across late-stage to commercial readiness. The role combines scientific leadership with cross-functional collaboration among CMC, Research, Quality, and external partners.

The candidate will mentor scientists, guide method development and validation, and influence regulatory strategies for advanced therapies while driving robustness and lifecycle management.

Qualifications

• PhD or MS with extensive industry experience in analytical development for gene therapy.
• Experience in LVV bioassay and cell-based potency assay development is required.
• Ability to lead cross-functional teams and regulatory interactions.

Responsibilities

• Define and execute analytical development and control strategies across the product lifecycle.
• Lead end-to-end development, qualification, and validation of LVV bioassays and potency assays.
• Drive comparability and bridging across process changes and site transfers using robust experimental design.
• Mentor scientists and prepare analytical sections of regulatory submissions.

Skills

LVV bioassay/potency science

Analytical method development

Cell-based assays

DOE statistical design

Leadership & mentoring

Education

PhD in analytical chemistry, biochemistry, molecular biology, pharmaceutical sciences

Job description

Eli Lilly and Company in Boston, MA seeks a Senior Advisor, Analytical Sciences to lead LVV bioassay and potency assay development across late-stage to commercial readiness. The role combines scientific leadership with cross-functional collaboration among CMC, Research, Quality, and external partners.

The candidate will mentor scientists, guide method development and validation, and influence regulatory strategies for advanced therapies while driving robustness and lifecycle management.