Advisor/Sr. Advisor, Viral Safety

Position Summary

The Advisor/Sr. 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. They are 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.

Responsibilities

• 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.

Basic Requirements

• Ph.D. in Virology, Biochemistry, Molecular Biology, Veterinary Medicine, or relevant biological science.
• 2-5 years' experience in the pharmaceutical industry including CMC.
• 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.

Additional Preferences

• 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.

• Work Environment: This position's work environment is in a laboratory environment.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

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 $129,000 - $211,200
• 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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