Eli Lilly and Company
Eli Lilly and Company seeks a Manufacturing Scientist (R4-R5) to provide technical support for commercialization and commercial activities within parenteral manufacturing. Drive the validation and commercialization of monoclonal antibodies, biologics, and peptide therapeutics on syringe platforms. Serve as technical expert on all manufacturing products and platforms as well as commercialization, commercial, regulatory, and parenteral control strategy. Ensure consistency in manufacturing approaches and processes. Prepare, review, and approve technical documents including change controls, regulatory submissions, technical transfer plans, strategy documents, deviations, and expert opinions. Provide technical and project management oversight to post-launch optimization teams and for technical agenda projects. #LI-DNI Position requires a Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmacy, Engineering, or a related field followed by 5 years of progressively responsible experience with pharmaceutical manufacturing and control strategies. Experience must include a minimum of: 5 years of experience with technical transfer and validation of drug products; 5 years of experience with providing technical oversight for post-launch commercial operations; 5 years of experience with delivering technical agendas, including yield improvements and batch size increases; and 5 years of experience with preparing and reviewing technical documents, including change controls, regulatory submissions, and deviations. Up to 5% 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-91516 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285.