Senior Director / Executive Director, Strategic Lead - Lentiviral Vector Analytical Platform

Responsibilities & Strategic Pillars

• Analytical Platform Strategy & Innovation
• Define and lead the enterprise analytical platform strategy for the LVV portfolio, Establish a common specification framework, and a cumulative platform dataset.
• Provide enterprise-wide visibility into LVV platform gaps and development opportunities.
• Drive accountability for implementation by identifying execution nuances and operational bottlenecks, providing actionable feedback, and streamlining assay optimization and method development.
• Translate product understanding into the mechanistic rationale underpinning potency, Critical Quality Attributes (CQA), specifications, and comparability criteria to ensure a robust control strategy.
• Platform Maturation, Robustness & Commercial BLA Readiness
• Direct the strategic lifecycle management, robustness testing, and assay validation across all LVV programs to support late-stage (Phase II/III) progression, global BLA/MAA submissions, and commercial launch readiness.
• Lead product characterization and CQAs to map structure-function relationships and define risk-based regulatory control strategies based on deep biological understanding.
• Establish harmonized validation frameworks, analytical reference standards, critical reagent control paradigms, and long-term stability protocols across internal and external networks.
• Govern method change at late stage through formal change control with a pre-defined bridging and comparability plan.
• Analytical Technology Innovation
• Partner with process development to champion the development, evaluation, and implementation of next-generation Process Analytical Technologies (PAT) and real-time analytical monitoring tools, enabling rapid feedback and process control during biomanufacturing unit operations.
• Lead a staged, risk-managed transition away from reliance on variable, labor-intensive infectivity assays (e.g., Infectious Units [IU] and Transducing Units [TU]).
• Drive the integration of advanced analytical platforms (e.g., dPCR/ddPCR, single-molecule and long-read sequencing, high-throughput biophysical particle profiling) to reduce analytical turnaround times and improve biomanufacturing predictability.
• Partner with Drug Product and Quality Control to define state-of-the-art visual inspection methodology, establish comprehensive analytical characterization workflows and control strategies targeting inherent, sub-visible, and visible particulate matter in LVV drug substance and drug product formulations.
• Global Site Bridging, Tech Transfer & Development Cycle Optimization
• Establish and govern the global "LVV Analytical Platform Standard" across all internal development teams, external CDMO partners, and commercial manufacturing sites.
• Lead cross-site analytical bridging, co-validation, and tech transfer strategies to ensure seamless knowledge transfer and assay comparability between internal development and external manufacturing partners; own the analytical quality agreements and the method transfer standard applied to partners.
• Capitalize on historical platform dataset architectures, predictive data models, and cross-program knowledge bases to minimize method development timelines for incoming LVV product candidates.

Minimum Qualifications

• Education: Ph.D. in Immunology, Cell Biology, Analytical biochemistry, Molecular Biology, Chemical/Biomedical Engineering, Virology, or a related biopharmaceutical science discipline.
• Experience: 12+ years of biopharmaceutical industry leadership with demonstrated enterprise impact in viral vector or cell/gene therapy platforms, including commercial BLA/MAA approvals and global tech transfer execution experience.
• Deep expertise in gene/cell therapy, LVV analytical methodologies (e.g., viral titer quantification, p24/capsid physical particle assays, ddPCR/dPCR, flow cytometry, NGS/Nanopore /fragment sizing, biophysical particle profiling and cell-based assays).
• Matrix Leadership capability with a proven ability to align cross-functional CMC stakeholders, influence strategy, and mentor technical staff.
• Track record of working experience with CDMO and GxP testing partners, including method transfer, and analytical comparability.
• Strong knowledge of global regulatory requirements (FDA, EMA, ICH) for late-stage assay development, analytical comparability strategies, and lifecycle management.

Additional Skills and Preferences

• Collaborative vibe, Hands-on Leadership and Technical Mentor: Strong willingness to engage and partner with laboratory teams. Sufficient depth to review raw data, challenge an assay conclusion, and direct a troubleshooting plan.

Additional Information

• Location: Boston, MA
• Onsite presence is required.

Additional information

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $168,000 - $290,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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