At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,000 - $162,800

In this role you will be responsible for providing safety assurance to support clinical trials and commercial development of biologics manufactured in mammalian cell cultures:

Planning and executing viral clearance studies,Coordinating in-process viral testing and working with CMOs to on-time delivery of viral testing results cell banks and unprocessed bulks.

You will interact closely with other scientists in Purification Development, K360, Molecular Biology/Cell Culture, Development Quality and Regulatory to provide adequate safety data package for global regulatory submissions.  You will be expected to be an integral participant on multidisciplinary CMC project teams that provide support for bioproduct process and product development activities.

Key Responsibilities:

Planning and execute viral clearance studies to support clinical trial and marketing applications.Work effectively with external partners/CMOs for completion of cell bank testing, in-process testing, viral clearance studies and research collaborations.  Handle outsourced activities to ensure high quality and on-time delivery.Author technical reports and regulatory documents.Work effectively with external parties on development projects, research collaborations and outsourcing efforts.Use of Molecular Biology tools to develop viral assays.Support organizational initiatives, as appropriate.Keep abreast of relevant scientific literature, new technologies/capabilities and regulatory initiatives/requirements and support their implementation, as appropriate.Generation and molecular characterization of viral stocks.Ensure work is aligned with all relevant Development Quality, Regulatory, HSE, GLP and GMP requirements.

Basic Qualifications/ Requirements:

BS/MS in Virology, Chemical Engineering, Biochemistry, Biology or related field.

Additional Skills/ Preference:

Bioproduct process development with some knowledge and hands-on experience in virology and molecular biology.Capable of designing experiments (experience with use of statistical DOE is preferred), generating data, interpreting results and trouble shooting.Effective oral and written communication skills, self-management, task planning and organization.Work effectively in a multidisciplinary team environment.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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