Senior LVV Bioassay & Potency Strategy Lead

Initial Therapeutics, Inc.; Boston (MA); On-site; USD 141,000 - 229,000; Full time

Benefits offered by this job

Annual bonus

401(k) plan

Medical, dental, vision benefits

Well-being programs

Job summary

Lilly in Boston, MA seeks a Senior Advisor, Analytical Sciences to provide scientific leadership for analytical development supporting our gene therapy pipeline, with a focus on LVV bioassay and potency assay development.

The role combines science and strategy, mentoring scientists, and partnering with CMC, Research, Quality, and Manufacturing to drive lifecycle management and regulatory alignment for FDA/EMA expectations.

Qualifications

• PhD in analytical chemistry, biochemistry, molecular biology, pharmaceutical sciences, or a related discipline with 5+ years of industry experience; or MS with 12+ years of industry experience.
• Extensive hands-on experience developing, optimizing, qualifying, and validating late-stage lentiviral vector bioassays and cell-based potency assays.
• Demonstrated expertise in analytical development within cell and gene therapy, biologics, viral vectors, or related advanced modalities, including method transfer to internal/external labs and CMC support from early through late-stage development.

Responsibilities

• Define and execute analytical development and control strategies across the product lifecycle, serving as technical lead for development, clinical-stage, and late-stage/commercialization programs.
• Lead end-to-end development, optimization, qualification, and validation of LVV bioassays and potency assays (e.g., cell-based transduction/infectivity assays, functional reporter assays, titer methods).
• Drive potency assay comparability and bridging across process changes, manufacturing site transfers, and reference standard updates, applying strong statistical design (e.g., DOE) to reduce variability and improve robustness.
• Provide scientific guidance on product characterization, comparability, and control strategy, and partner with Regulatory and Quality to align potency strategy with evolving FDA/EMA expectations for advanced therapies.

Job description

Lilly in Boston, MA seeks a Senior Advisor, Analytical Sciences to provide scientific leadership for analytical development supporting our gene therapy pipeline, with a focus on LVV bioassay and potency assay development.

The role combines science and strategy, mentoring scientists, and partnering with CMC, Research, Quality, and Manufacturing to drive lifecycle management and regulatory alignment for FDA/EMA expectations.