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 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.
Eli Lilly and Company seeks a Principal Scientist – Drug Product Formulation - TSMS to apply the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems to provide technical support for technical transfers and process validation, including support of equipment qualification and validation. Perform the following duties: author standard operating procedures, as they relate to the activities of the TS/MS group; provide technical support, including quality and stability consultations for non-routine investigation such as deviations and complaints; prepare, review, approve, and provide technical support for preparation of relevant technical documents, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, and QPPAs; ensure that an accurate instruction set describes the process as performed and the control strategy for the discrete manufacturing steps; support and own the technical agenda for the product or validation process; lead risk management activities as it pertains to products and processes; develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability; apply manufacturing process knowledge and data analysis skills to support the management of daily manufacturing operations; support the TS/MS technical projects to ensure a successful start-up, improvement process control, yield, product quality and productivity; implement process changes and improvements through the technical agenda; serve as technical interface external to the RTP site; provide audit support, as needed; work within or lead cross functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives; collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain; ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Position requires a Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry or related quantitative field, and 5 years of experience in cGMP manufacturing, specifically within Operations, Validation, Engineering, Technical Services/MSAT, or Quality Assurance. Must have experience with: Parenteral drug product manufacturing; TS/MS, MSAT, or Operations, particularly with formulation of parenteral drug products; Technical Transfer, including equipment qualification and process validation; Statistical data trending and analysis (using statistical packages such as JMP); Performing the technical assessments and evaluations required to support deviation and change management, as well as experience with the respective execution systems, including Trackwise; and Performing process risk assessment (e.g. FMEA).
Job location: Durham, NC. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-53422 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Beth L. Berry, Lilly Corporate Center, Indianapolis, IN 46285.
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