Scientist - QC

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.Organization Overview:Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.Position Description:The Scientist-QC is part of the Lilly Lebanon API Quality Control team and provides technical leadership and expertise in the development, implementation, and maintenance of Quality Control laboratory systems to the Lilly Lebanon API site throughout the start-up, implementation, and day to day operations.The Scientist-QC performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. The Scientist completes second person verification of other’s results. The Scientist also participates in laboratory root cause investigations, equipment evaluations and qualifications, and some quality system improvement initiatives by executing well-defined protocols and procedures. The Scientist shares technical information and best practice within plant sites or group.In addition, the Scientist-QC will provide technical support to QC operations as part of the organization’s off-hours support strategy.Key Objectives/Deliverables:Sample Analysis and ReportingVerify (SPV) analytical data of other analysts within the lab as requestedAccurately and safely perform analytical test methods or related support activities as per procedures or protocols. Uses technical knowledge in the review and interpretation of data for conformances to procedures, standards and protocols and/or real-time recognition of aberrant data and resultsPerform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards and GMP requirementsProblem SolvingRecognizes when a deviation from protocols, procedures, etc. has occurred and initiates and participates in a Root Cause InvestigationPerforms investigations for deviationsTroubleshoot equipment and methods as requiredContinuous Improvement InitiativesAssist in improvement of quality systems by creating or revising workflows and other lab data collection systemsFollow Lilly standards for CCI/Lean and support/lead departmental or site continuous improvement initiativesParticipate and/or lead laboratory projects in adherence to Lean OpEx standardsContributes to development of PQEsReviews SOPs for executable as writtenShares technical information and best practice within plant sites or groupLab OperationsWrite protocols for non-routine testing or validation with appropriate guidanceDevelop equipment qualification protocols with appropriate guidancePerform routine equipment calibrations or maintenanceComply with and implement safety standardsExecute notification to management when required by procedures or standardsInitiate change controls and deviationsTrain and mentor othersDevelop training materialsBasic Requirements:Bachelor’s degree (4-yr College) in a science field related to the lab (e.g., Chemistry, Biology, Microbiology, etc.)1+ years of experience within a cGMP laboratory environment.Additional Preferences:Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerationsDemonstrate strong math and documentation skillsDemonstrate strong oral and written communication and interpersonal interaction skillsProficiency with computer systems LIMS, CDS, Microsoft Office Suite, etc.Previous experience with cGMP deviation and change control processOther Information:Strong potential for a short-term assignment at one of our Indianapolis-based manufacturing facilities.Tasks may require repetitive motion and standing for long periods of timeMust be able to lift at least 5 liters of liquidRole may be in support of 24-hour operations, requiring shifts that cover days, nights, and weekendsOvertime or weekend work required, as necessaryLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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