Advisor, Global Quality Labs (R5)

Eli Lilly and Company seeks an Advisor, Global Quality Labs (R5) for Analytical Quality Control Operations (AQCO) to drive development, manufacturing, and regulatory processes, and to maintain internal awareness of analytical and pharmaceutical industry standards. Serve as a subject matter expert and ensure consistent practices between laboratories globally, manufacturing, and testing sites. Identify and implement global, cross-functional assessments, improvements, and standardization. Perform non-routine analyses and develop, investigate, optimize and validate analytical methods. Leverage knowledge of quality system and regulatory requirements to influence validation experiments and sustained control strategy. Ensure compliance with quality, environmental, and safety standards. #LI-DNI Position requires a Bachelor’s degree in Biology, Chemistry, or a related field, followed by 5 years of progressively responsible experience with quality events including Phase I, Phase II, OOS investigations, OOT, deviations, change controls, and CAPAs for analytical and quality control. Experience must include a minimum of: 5 years of experience with coordinating quality control investigations; 5 years of experience with developing equipment and laboratory procedures, protocols, and reports based on quality events; 5 years of experience with investigating method performance, reliability, and improvement for commercial products; 5 years of experience with review of analytical method validation reports and method transfer documents about quality events; and 1 year of experience with analytical methods for pharmaceutical dosage forms including solid dosage forms, oral solution, injectables, ophthalmic solutions, and cleaning methods using HPLC, GC, AAS, TOC analyzer, UPLC, IR, UV, and USP type 1 and type 2 dissolution instruments. Part-time telecommuting permitted. Up to 10% domestic and international travel required. #LI-DNI Job location: Indianapolis, IN. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-91526 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285.