Sr. Advisor - Analytical Development

Lilly • Boston, MA

6d • $141,000 - $228,800 • Onsite

About The Position

We are seeking an accomplished Senior Advisor, Analytical Sciences to provide scientific leadership for analytical development supporting our gene therapy pipeline, with a particular focus on late-stage lentiviral vector (LVV) bioassay and potency assay development. This individual will serve as the technical subject matter expert for assay development, characterization, qualification, validation, and lifecycle management — driving phase-appropriate analytical strategies from early development through late-stage, licensure, and commercial readiness. The successful candidate will combine scientific excellence and strategic leadership, partnering closely with CMC, Research, Quality, Manufacturing, and external partners while mentoring scientists and strengthening analytical capabilities across the organization.

Requirements

• 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.

Nice To Haves

• Recognized expertise in LVV bioassay/potency science (surrogate potency, matrix approaches, multi-attribute methods) and demonstrated success leading complex technical programs.
• Experience supporting regulatory filings and health authority interactions, including potency-related BLA/MAA sections and inspection readiness.
• Strong leadership, mentoring, and communication skills, with the ability to influence scientific direction across stakeholders and a commitment to scientific excellence and talent 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), including matrix or multi-method potency strategies, assay orthogonality, and surrogate potency justification.
• 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.
• Lead development, optimization, and troubleshooting of methods across the broader LVV/gene therapy analytical panel (identity, purity, safety, process-related impurities), and define qualification, validation, and lifecycle strategies with emphasis on bioassay/potency methods.
• Partner with Operations and Quality on successful method transfer, including complex cell-based bioassays, to internal and external testing laboratories, and provide technical oversight for specification development.
• Drive implementation of novel analytical technologies, including next-generation potency and bioassay platforms, and provide scientific oversight for data interpretation and technical investigations.
• Mentor and develop scientists across the analytical organization, building bench strength in bioassay and potency assay science, and serve as the primary analytical SME in cross-functional and technical review settings.
• Author and review analytical/potency sections of regulatory submissions and technical reports, and support health authority interactions and inspections as an analytical SME.
• Provide scientific oversight of external analytical development activities and technology transfers, and maintain awareness of emerging technologies and regulatory expectations.

Benefits

• company bonus
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree