Senior Advisor, Analytical LVV Bioassay & Potency

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

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Health/dental/vision coverage

Flexible spending accounts

Job summary

Lilly in Boston, MA seeks a Senior Advisor, Analytical Sciences to lead LVV bioassay and potency assay development across late-stage programs. You will guide analytical strategies, oversee method qualification/validation, and partner with Regulatory and Quality to align with FDA/EMA expectations.

You will mentor scientists, drive innovative analytics, and contribute to regulatory submissions and tech transfers while advancing a robust analytical platform for gene therapy.

Qualifications

• PhD in analytical chemistry, biochemistry, molecular biology, or related discipline with 5+ years of industry experience.
• Extensive hands-on experience developing, optimizing, qualifying, and validating LVV bioassays and cell-based potency assays.
• Experience with regulatory submissions 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 DOE to reduce variability and improve robustness.
• Provide scientific guidance on product characterization, comparability, and control strategy, aligning potency strategy with FDA/EMA expectations.
• Lead development, optimization, and troubleshooting of methods across the LVV/gene therapy analytical panel (identity, purity, safety, impurities) and define lifecycle strategies.
• Partner with Operations and Quality on method transfer, including complex cell-based bioassays, for internal/external testing labs and oversee specification development.

Skills

LVV bioassay

Potency assays

Analytical development

DOE statistics

Regulatory submissions

Education

PhD in analytical chemistry/biochemistry/molecular biology

MS with 12+ years of industry experience

Job description

Lilly in Boston, MA seeks a Senior Advisor, Analytical Sciences to lead LVV bioassay and potency assay development across late-stage programs. You will guide analytical strategies, oversee method qualification/validation, and partner with Regulatory and Quality to align with FDA/EMA expectations.

You will mentor scientists, drive innovative analytics, and contribute to regulatory submissions and tech transfers while advancing a robust analytical platform for gene therapy.