Viral Safety Scientist

Eli Lilly and Company
Published
October 3, 2020
Location
Indianapolis, IN
Category
Job Type

Description

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 39,000 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.

The Viral Safety Scientist is responsible for providing safety assurance to support commercial development of biologics manufactured in mammalian cell cultures and technical agenda projects associated with mammalian cell commercial products:

  • Planning and executing viral clearance studies,

  • Coordinating testing and working with network Technical Services/Manufacturing Science (TSMS) and commercial Monoclonal sites to on-time delivery of viral testing results to support project decision milestones and regulatory time commitments.

The individual will interact closely with other scientists in Purification Development, Network TSMS Micro/Virology Platform Steward, Network TSMS Upstream and DNS Platform Stewards, Molecular Biology/Cell Culture and Regulatory to provide adequate safety data package for global regulatory submissions to support post approval changes and data to enable post approval changes in first submissions.  He/she is expected to be an integral participant on multidisciplinary Network Monoclonal project teams that provide support for monoclonal process and product technical agenda and development activities.

Key Responsibilities

  • Planning and executing viral clearance studies to support technical agenda projects from the Monoclonal Network TSMS project list as governed by Monoclonal manufacturing Steering Team (MMST).

  • Work effectively with the Network TSMS Micro/Virology Platform Steward and Monoclonal Portfolio Management Advisors  for completion of viral clearance studies, potential in-process test support and tech agenda advancement collaborations.  Manage any outsourced activities to ensure high quality and on-time delivery.

  • Author technical protocols, technical reports and regulatory documents.

  • Use of Molecular Biology  tools to perform viral assays

  • Keep abreast of relevant scientific literature, new technologies/capabilities and regulatory initiatives/requirements and support their implementation, as appropriate, e.g. in support of Next Generation Bioprocessing.

  • Generation and molecular characterization of viral stocks.

  • Ensure work is aligned with all relevant Development/Commercial Quality, Regulatory, HSE, GLP and GMP requirements.

Basic Requirements

  • BSc/MSc/PhD in Virology, Chemical Engineering, Biochemistry, Biology or related field and relevant experience in virology and viral safety processes: BSc + 4 years experience, MSc + 2 years experience, PhD + 0 years experience.

Additional Preferences

  • Bioproduct process development desired but not required.

  • Capable of designing experiments (experience with use of statistical DOE is desirable), generating data, interpreting results and trouble shooting.

  • Effective oral and written communication skills, self-management, task planning and organization

  • Must be able to work effectively in a multidisciplinary team environment.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [Click Here to Email Your Resumé] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

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