Eli Lilly and Company seeks a TS/MS Primary Loop (R4) to support external manufacturing as a process expert. Act as the process expert with regards to the process steps or processing equipment (pre-filled syringes, autoinjectors, and packaging), owning the process control strategy including the key process parameters, critical quality attributes, and the historic and potential failure modes of the process. Ensure that the process is maintained in a validated/controlled/capable state, participating in the strategy design and execution process, for post-commercialization validation process. Provide support to management of daily operations by owning process-related deviations, complaints, corrective and preventative actions, and changes. Own the process capability and yield variables and identify opportunities for improvement. Build and maintain relationships with external manufacturers. #LI-DNI
Position requires a Bachelor's degree in Pharmacy, Chemistry, Manufacturing Engineering, or a related field followed by 5 years of progressively responsible experience with pharmaceutical manufacturing and technical services. Experience must include a minimum of: 5 years of experience with cGMPs and drug product manufacturing; 5 years of experience completing qualification and validation activities; 5 years of experience with deviation resolution and continuous improvement change planning and implementation for pharmaceutical manufacturing; 5 years of experience providing support for device assembly and packaging; and 5 years of experience with technology transfer between packaging lines or manufacturing facilities. Up to 30% 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-103510 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285.
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