Advisor/Sr. 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. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

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.

Theworkenvironmentcharacteristicsdescribedherearerepresentative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

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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