Manufacturing Operations Associate

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. 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 35,000 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. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up. The Manufacturing Operations Associate (OA) for the Lilly API Manufacturing Facility, LP-1, Lebanon, Indiana, is a high potential leadership development role, responsible for successful delivery of production areas and API facility startup. The primary responsibilities include aligning cross functional teams to ensure the seamless start-up of cGMP production as well as monitoring of activities for Right First Time Execution. The ideal candidate will possess strong influencing capabilities as well as process knowledge and process improvement skills. In this role, you 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 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. 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 LP1 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 of work and learnings Provide training and mentorship for new personnel Minimum Requirements: Bachelor’s degree in Engineering, Chemistry, Biology or related technical field 3 years of Engineering, Chemistry, Biology or Technical Services Experience in a GMP environment (preference for pharmaceutical industry) Additional Preferences: Demonstrated operational capability with high productivity Proven track record of curiosity with learning agility Demonstrated excellent problem-solving skills Self-starter with high initiative and data-driven approach to problem-solving Demonstrated ability to participate in and facilitate technical decision-making Demonstrated strong interpersonal skills with demonstrated adaptability and flexibility to working in different environments, teams etc. Demonstrated strong verbal and written communication skills Strong interest in leadership including cross-functional operations leadership Strong verbal and written communication skills Strong technical writing skills with attention to detail. Excellent problem-solving skills. An understanding of key technical services deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification. An understanding of normal process variability (expected) and special cause variability. Additional Information: Must be flexible to attend meetings or support off-shifts as necessary Some OUS and US travel may be required ( Lilly 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups. WeAreLilly