Manufacturing Operations Associate - Lebanon Advanced Therapies

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.   The Manufacturing Operations Associate for the Lilly Advanced Therapies Manufacturing Facility, LP-2, Lebanon, Indiana, will be a leadership development role, responsible for successful delivery of production areas and gene therapy facility startup. These responsibilities include: process design, planning, and seamless start-up of GMP production. The successful candidate will be required to build deep operating expertise in their area of responsibility (including in-depth knowledge of the site operating systems and processes), have a strong working knowledge of the laboratory and manufacturing equipment set, control systems, and consistently demonstrate strong data-driven decision-making and problem-solving capabilities. They may also work to ensure that the processing suites are in-control, compliant, and maintained in a validated state through continual monitoring. The OA may play a role in implementing new technologies and operational process improvements in the GMP manufacturing environment. The Manufacturing Operations Associate is expected to partner with Engineering, Tech Services, Quality & Regulatory to troubleshoot processes and deliver on a continuous improvement agenda. As a Manufacturing Operations Associate, your responsibilities will include: Assisting the Process Team Leaders with leading the Process Teams, specifically focusing on safety, quality, and manufacturing performance using appropriate performance metrics and targets. Ensure cGMP readiness of manufacturing areas for start-up and process qualification activities. Participate in and support training and engineering runs. Responsible for supporting validation activities and ensuring GMP production areas are within compliance. Support and maintain a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment. When required (and per delegation procedure), in the absence of the Associate Director-Manufacturing provide continuity to the Process Team activities and operational aspects of the process; escalate issues to the Senior Director of Manufacturing Operations as needed. Lead or participate in continuous improvement projects through capacity optimization and cost reduction programs. Support the development and drive the Operational Excellence Roadmap for LP2 Flow Team. Lead Manufacturing Projects with the support of cross-functional stakeholders. Support authoring and revision of standard operating procedures and batch records as required. Review technical reports. Conduct deviation investigations and write process deviation reports. Document and appropriately communicate all aspects