Advisor/Sr. Advisor, Viral Safety

Lilly • Indianapolis, IN

3d • $129,000 - $211,200

About The Position

The Advisor/Sr. Advisor is responsible for developing strategies and experiments that demonstrate the capability of downstream processes to eliminate viral contaminants, supporting clinical and commercial development of Lilly’s bioproduct portfolio. The role also leads and supports organizational strategic initiatives, evaluates and implements new capabilities and technologies, and uses internal and external influence to solve problems and benchmark potential solutions. Operational excellence, AI, and automation are applied to increase efficiency.

The position develops biosafety strategies for mammalian cell culture bioproduct and gene therapy molecules, designs and executes virus infection assays for new modalities, manages viral safety data and outsourced activities, and serves as the Virology lead on CMC teams. It contributes to cross-functional process development, technical and regulatory writing, implementation of relevant technologies and regulatory initiatives, and development of an NGS workflow for adventitious virus testing. The work is performed in a laboratory environment and must comply with applicable Development Quality, regulatory, HSE, GLP, and GMP requirements.

Requirements

• Ph.D. in Virology, Biochemistry, Molecular Biology, Veterinary Medicine, or a relevant biological science.
• 2–5 years of pharmaceutical industry experience, including CMC.
• Broad knowledge of Virology and Molecular Biology principles, including cell-based or qPCR-based titration methods for human and/or animal viruses and NGS.
• Experience with tissue culture assay development, virus infection, and virus purification.

Nice To Haves

• Exceptional problem-solving and decision-making skills.
• Demonstrated scientific leadership skills.
• Experience using AI to generate dashboards and tools that increase efficiency.
• Effective oral and written communication skills.
• Ability to work productively in an interdisciplinary team environment.

Responsibilities

• Develop and implement biosafety strategies for Lilly’s mammalian cell culture bioproduct and gene therapy molecules in accordance with FDA and ICH guidelines and industry standards.
• Design and execute virus infection assays for new modalities.
• Archive internally and externally generated viral safety data for future retrieval using AI tools.
• Work with external partners and CMOs on cell bank testing, in-process testing, viral clearance studies, and research collaborations; manage outsourced activities to ensure quality and on-time delivery.
• Participate in and/or lead cross-functional process development teams and collaborate with Bioprocess and Bioproduct Development, Discovery, MS&T, and Manufacturing.
• Serve as Virology lead on CMC teams.
• Work with external parties on development projects, research collaborations, and outsourcing efforts.
• Author technical reports, regulatory documents, and manuscripts for peer-reviewed journals.
• Stay current on scientific literature, technologies, capabilities, and regulatory initiatives and requirements, and lead implementation where appropriate.
• Develop AI tools to improve internal efficiency and track workloads.
• Use internal and external influence to solve problems and benchmark potential solutions.
• Ensure work and team activities comply with 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.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• Flexible benefits, such as 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, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

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