Senior Advisor, LVV Bioassay & Potency Strategy

BioSpace

Boston (MA)

On-site

USD 141,000 - 229,000

Full time

26 hours ago

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Benefits offered by this job

Company bonus

401(k) plan

Pension

Medical benefits

Life insurance

Job summary

Lilly is seeking a Senior Advisor, Analytical Sciences to provide scientific leadership for analytical development supporting our gene therapy pipeline, focusing on LVV bioassay and potency assay development. You will mentor scientists and collaborate with CMC, Research, Quality, and Manufacturing while guiding lifecycle strategies from early development to commercial readiness.

The role demands deep expertise in LVV bioassay/potency science, method transfer, and regulatory submissions, with a

Qualifications

PhD in analytical chemistry, biochemistry, molecular biology, pharmaceutical sciences, or related field with 5+ years industry experience; or MS with 12+ years industry experience.
Hands-on experience developing, optimizing, qualifying, and validating late-stage LVV bioassays and cell-based potency assays.
Expertise in analytical development within cell/gene therapy, biologics, viral vectors, or related modalities, including method transfers.

Responsibilities

Define and execute analytical development and control strategies across product lifecycle as technical lead for development, clinical-stage, and late-stage programs.
Lead end-to-end development, optimization, qualification and validation of LVV bioassays and potency assays; ensure robustness and appropriate surrogate potency justification.
Drive assay comparability and bridging across process changes and site transfers with DOE-driven design to reduce variability.
Provide scientific guidance on product characterization, comparability, and control strategy in alignment with FDA/EMA expectations.