Research Advisor - Viral Safety

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing.

Position Summary:

The Research Advisor is responsible for developing strategies and experiments that demonstrate the capability of the downstream process to eliminate viral contaminants, supporting clinical and commercial development of Lilly’s bioproduct portfolio. The advisor is also responsible for leading and supporting organizational strategic initiatives, evaluating and implementing new capabilities and technologies, and leveraging internal and external influence to solve problems and benchmark potential solutions — applying operational excellence, AI, and automation to increase efficiency.

• Develop and implement Biosafety strategies for Lilly’s mammalian cell culture bioproduct molecules and gene therapy molecules that are consistent with the FDA and ICH guidelines and benchmarked industry standards.
• Design and execute virus infection assays for new modalities.
• Ensure that all viral safety data generated internally and via third parties is appropriately archived to enable future retrieval using AI tools.
• Work effectively with external partners/CMOs for completion of cell bank testing, in-process testing, viral clearance studies and research collaborations.
• Manage outsourced activities to ensure high quality and on-time delivery.
• Ensure that all viral safety data generated internally and via third parties is appropriately archived to enable future retrieval.
• Participate in and/or lead cross-functional process development teams and effectively collaborate with other groups in Bioprocess and Bioproduct Development, Discovery, MS&T and Manufacturing.
• Serve as Virology lead on CMC teams.
• Work effectively with external parties on development projects, research collaborations and outsourcing efforts.
• Author technical reports, regulatory documents, and manuscripts for publication in peer-reviewed journals.
• Keep abreast of relevant scientific literature/new technologies /capabilities and regulatory initiatives/requirements.
• Lead implementation, as appropriate.
• Increase internal efficiency by developing tools with AI that will increase efficiency and track workloads.
• Leverage internal and external influence to solve problems and benchmark potential solutions.
• Ensure work and team activities are aligned with all relevant Development Quality, regulatory, HSE, GLP and GMP requirements.
• Develop a GMP workflow for NGS sequencing for adventitious viruses to replace current viral safety testing.

Ph.D. in Virology, Biochemistry, Molecular Biology, Veterinary Medicine. 0-2 years’ experience in the pharmaceutical industry. Broad knowledge of Virology and Molecular Biology principles including cell-based/qPCR-based titration methods for human and/or animal viruses and NGS. Experience with tissue culture assay development and virus infection and virus purification.

Exceptional problem solving and decision-making skills. Demonstration of scientific leadership skills. Experience using AI to generate dashboards and tools that will increase efficiency. Effective oral and written communication skills. Must be able to work productively in an interdisciplinary team environment.

This position’s work environment is in a laboratory environment. The work…