Provides global analytical support, coaching and technical leadership across M&Q. Works with cross functional groups to apply scientific/technical expertise to address complex analytical issues arising in internal and contract manufacturing sites/laboratories. Subject Matter Expert for large and small molecule method validations and transfers across M&Q. Contributes to Global QC goals and strategy.
Works with cross functional groups to troubleshoot analytical issues arising at internal or contract manufacturing sites. This may require on-site visits to the laboratories involved.
Leads analytical projects to develop, improve or remediate analytical methods used to test commercial Elanco products. Includes the evaluation of data, interpretation of results and drawing relevant conclusions within agreed target completion dates. Will often include a requirement to assign tasks to others to achieve project completion within target timelines
Global SME who owns and leads the validation, co-validation and transfer of analytical methods to various internal and external laboratories, ensuring these are conducted in line with Regulatory, Pharmacopoeia and Elanco requirements
In partnership with R&D and the impacted manufacturing sites, assist with the planning and execution of the laboratory work required to introduce methods for new product launches (e.g method development, verification/validation and transfer). Depending on the level of experience at the manufacturing site, this may sometimes involve leading the project.
Write and/or review Regulatory CMC documentation required for submissions to external agencies, eg CVM, EMEA etc. Answer analytical related questions and interact with external agencies where appropriate
Coach and mentor QC technical staff at sites/hubs to improve quality of analytical investigations
Contribute to the optimization of efficient laboratory processes within the Analytical Service Centre, UK. May participate in recruiting process
May participate in the evaluation of in-licensing opportunities or due diligence
Perform method assessments within Elanco and at contract manufacturing sites. Identify areas for improvement and establish if method validation packages meet current expectations. Assess if laboratories are operating within the expectations of Elanco and external regulatory agencies.
Membership of appropriate external scientific bodies
Internal Number: 52951
About Eli Lilly & Company
Company Overview 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 worldwide 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.