Novartis jobs in Indianapolis, IN

Responsible for ensuring a timely implementation of all Life Cycle projects as launches/ changes/ transfers/divestment by coordination of involved stakeholders from different functions. Ensures compliance with Regulatory and GMP, law, SOPs, HSE and Code of Conduct. About the Role Major accountabilities: * Coordinates action plans to remediate to resources constraints and manages supply KPI reporting and analysis. * Project, Process -Confirms supply orders, firmed production orders at the entry point of the time fence. * Ensure process and SAP knowledge is continuously enlarged and applied in order to fully leverage the value of the integrated SAP system and to achieve high level of service, cost efficiency, quality and compliance. * Establishes, maintains and operationally implements integration and reconciliation activities between Global NTO Supply chain and Finance. * Monitoring, controlling and improving SC processes and by managing and steering a portfolio of SC projects at Platform level -Logistic, WAndD -Ensure that all logistics processes comply with all relevant regulations like Customs and Trade laws and regulations by supporting issuance, implementation and management of Standards and Policies covering commercial and non-commercial materials. * Is responsible for creating and maintaining SLAs with related Planning Parameter setup in alignment with the customers. * Support regional logistics function on a variety of projects and in identifying and implementing of cost savings opportunities. * Manages demand control activities (short term-3/4 months, within the time fence) and provides inputs to Master Planning Schedule (MPS) and detailed scheduling. * LCM -Leads the implementation of LC projects, in order to ensure compliant drug supplies, on time and in right quality and deliver and maintains a detailed Change Over Plan (COP) for LC projects Minimum Requirements: * Bachelors Degree required * 5+ years of supply chain experience * 2+ years of regulated industry experience * Project Management experience * Collaborating across boundaries * Functional Breadth Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

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. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: Assess differences in current sterility assurance programs across the sites and drive harmonization Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. Building, maintaining, and growing capability across the organization in the sterility assurance space Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: BS Degree required. MS/PhD in a biological science preferred. 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities Strong written and oral communication skills Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. Support the establishment of a sterility assurance network or hub in global TSMS Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. Strong capability to influence personnel and management across the organization Close interaction with quality to enable internal audits that identify risks Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary: This position is part of the Bioproduct Research and Development (BR&D) organization within Lilly Research Labs. The BRD Clinical Trial (CT) manufacturing facility is focused on bringing new protein therapeutics to market by producing bulk drug substance (DS) for clinical trials, along with the associated technical data and documentation to support GMP activities. The Bioprocess Operations team within BR&D is responsible for the manufacture of DS to support clinical trials within the Lilly portfolio. This includes the internal manufacture of monoclonal antibodies, bioconjugates, and adeno-associated viruses, as well as oversight of DS manufacturing at qualified collaboration partners. This role serves as the Technical Lead for the Downstream Tech Service and Manufacturing Science (TS/MS) team within the BR&D DS CT manufacturing facility. You will combine technical leadership with strategic execution-driving DS batch technology transfer and delivery, ensuring robust clinical manufacturing performance, and acting as a key technical interface across development, operations, automation, and maintenance teams. In addition, you will mentor and develop downstream team members, fostering a culture of technical excellence and continuous improvement. Responsibilities: In this role, you will provide oversight of downstream processes for Bulk DS production and lead initiatives that enhance plant performance and reliability. You will partner closely with cross-functional teams to resolve complex technical challenges, implement innovative solutions, and ensure seamless integration of development-stage technologies into clinical manufacturing. Your leadership will extend beyond technical execution to include coaching and developing talent within the team. Responsibilities will include: Lead and deliver downstream process technology transfer for Bulk DS into clinical manufacturing Input and authoring for cGMP and PRD Quality System compliant manufacturing master production records and review of executed batch records where applicable Ensure robust execution of DS batches with adherence to quality and regulatory standards Active oversight of process and equipment performance, troubleshooting, optimization and real-time data monitoring Serve as primary technical resource for downstream operations in the DS CT manufacturing pilot plant Drive alignment between process development and manufacturing execution Lead plant improvement projects focused on safety, efficiency, reliability, plant digitalization, and scalability of downstream operations Actively engage with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Engineering, Maintenance, Environmental Monitoring, and Manufacturing to resolve complex technical challenges. Coach and mentor team, fostering technical growth and professional development Promote a culture of collaboration, accountability, and operational excellence Basic Requirements: PhD in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 3 years hands-on purification experience OR MS in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 5 years hands-on purification experience OR BS in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 8 years hands-on purification experience Proficiency with UNICORN software for chromatography process control and data analysis Demonstrated ability to lead cross-functional projects and mentor technical staff Excellent communication and leadership skills, with the ability to influence and drive change Additional Preferences: Understanding of cGMP requirements and regulatory compliance for clinical manufacturing Experience with scale-up of biopharmaceutical purification operations Familiarity with automation systems and process control strategies Understanding of computer system validation and equipment qualification Familiarity and strong interest in application of digital solutions for GMP DS manufacturing Additional Information: Position located in Indianapolis, IN at the Lilly Technology Center North 8-hour days with flexibility to support activities during shutdowns, weekends, and outside of core hours Physical Demands/Travel: The physical demands of this job are consistent with an office and manufacturing environment. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Work Environment: This position's work environment is in the office and manufacturing environment. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. *To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $129,000 - $209,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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: At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. The Engineering Technology Center (ETC) is a group of skilled engineering practitioners who possess deep technical expertise. The primary role of this position is to provide process safety related technical support to manufacturing. The ETC partners with manufacturing and other engineers across the company to deliver capital projects, address operational issues, and provides solutions to key business problems across the company. Responsibilities: This role is the Process Safety Management technical resource in the ETC. Become a key engineering/technical resource for the GIPSM processes across Lilly such as Mechanical Integrity, Process hazards, Pressure safety, and others. Be a corporate technical resource on pressure relief hazards. Provide internal capability to calculate or evaluate pressure relief system sizing. Recommend external resources for evaluation and sizing of emergency pressure relief systems. Review third party evaluations of pressure relief system design. Be a corporate technical resource on Mechanical Integrity Provide technical expertise to ensure alignment with recognized engineering practices and Lilly global engineering standards Understand critical safety system components and design to support LOPA evaluations Provide inspection expertise with respect to technology and program setup Support standardization of MI elements within maintenance package development Support standardization of Asset Integrity & Repair with respect to Operational Readiness Reviews Become engineering resource on key GPSIM processes such as Process hazards reviews, process hazard evaluations, LOPA, event investigation, etc. Partner with GHSE on technical solutions for safety related trends and ownership of key GHSE standards and expectations Partner with LRL colleagues on ensuring process safety related aspects are considered when developing new processes, products. Adaptability Flexibility in adapting and adjusting to changes in working practices and willingness to take on different roles as required by the needs of the Engineering Tech Center Ability to work with diverse perspectives and to identify and resolve issues with minimal direction. Basic Qualifications: Bachelor's in Engineering (e.g. Chemical Engineering) Minimum 8 years' experience in pharmaceutical and/or specialty chemical laboratory and/or manufacturing environments Additional Preferences: Professional engineering license. Experience as a mechanical or process engineering in two or more of the following areas: small molecule bulk, large molecule bulk, dry products, parenteral products, delivery devices, utilities, facilities management, Lilly Research. Demonstrated knowledge of US and non-US codes and standards applicable to emergency pressure relief. Must have demonstrated good written and verbal communications skills. Demonstrated ability to work within and lead diverse, multi-functional teams (i.e. Engineering, Manufacturing Operations leadership, TS/MS, etc.). Demonstrated project management, interpersonal and communication skills. Ability to identify and resolve issues with minimal direction. Demonstrated familiarity with understanding and application of common engineering specifications/standards to identify and resolve issues with minimal direction. Must be able to work in an environment where limited or conflicting direction is given. Qualified to perform emergency relief calculations. Knowledgeable of first principles. Additional Information: ETC supports all business areas across the globe. Business travel both inside and outside the U.S. 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Technical Lead Engineer - Enterprise Connectivity MADS Join the Enterprise Connectivity organization as a Technical Lead Engineer to drive Mergers, Acquisitions, Divestiture, and Special Projects (MADS) initiatives, secure our network, and power our global expansion! As a Technical Lead Engineer in the Enterprise Connectivity team, you will be at the forefront of major Mergers, Acquisitions, Divestiture, and Special Projects (MADS) initiatives. Your leadership will be instrumental in shaping the future of our network infrastructure by managing complex project portfolios, prioritizing critical tasks, and allocating resources to ensure seamless execution. You will collaborate closely with the Mergers Architect, Network Operation Manager, Project Manager, and external vendors to plan, implement, and oversee new site deployments, upgrades to existing sites, and decommissioning of legacy locations. Your passion for innovative solutions and commitment to excellence will drive the success of our most strategic network projects. By inspiring cross-functional teams and fostering a culture of collaboration and accountability, you will help deliver secure, reliable, and scalable network solutions that support the company's growth and transformation. Your impact will be felt across the organization as you enable business expansion, safeguard digital assets, and continuously improve operational efficiency. What You'll Be Doing: This role as MADS Technical Lead Engineer for the EC team, you will provide strategic direction and inspire cross-functional teams, including the Mergers Architect, Network Operation Manager, Project Manager, and external vendors-to successfully plan, implement, and manage new site deployments, upgrades, and decommissions. This role requires strong leadership to coordinate diverse stakeholders, drive project alignment with business objectives, and deliver robust network solutions that support organizational growth and transformation. How You'll Succeed: Technical Delivery Responsibilities Lead design and implementation efforts, and support of LAN, WAN, wireless, firewall, and load balancer infrastructure during complex business transitions. They serve as a technical leader, safeguarding performance and reliability while enabling strategic change. Assess MADS project requirements for compliance with Enterprise Connectivity (EC) standards and network infrastructure best practices, including LAN, WAN, WWAN, Firewall, and load balancer technologies. Ensure all network designs adhere strictly to EC guidelines for consistency and reliability. Review complex projects involving network technologies and hardware. Define technical requirements to ensure all projects meet top technical standards. Lead a team of technical analysts handling network installation, configuration, and management, ensuring their work meets project objectives and technical standards for smooth operations. Collaborate with Project Managers to monitor project status and lead key network initiatives, ensuring alignment with business goals and technical standards. Manage new site deployments, network upgrades, and legacy infrastructure decommissioning, ensuring each step aligns with growth and transformation objectives. Improve EC MADS by finding new capabilities and optimizing current procedures, promoting innovation for better network performance and reliability. Communicate project status, risks, and solutions clearly to stakeholders in both business and technology, fostering transparency and collaboration for project success. People Management Influence and guide cross-functional teams to achieve high performance and meaningful results, supporting each member with coaching and career development. Manage project priorities and resources to maximize team effectiveness and business impact, while maintaining a culture of accountability, collaboration, and continual growth. Relationship Management Work with architects, project managers, and operations leaders to align network projects with business goals. Oversee vendors to ensure quality and compliance, including contract negotiations. Coordinate with tech teams for alignment with objectives and network security. What You Should Bring: Proven Network infrastructure knowledge/expertise across LAN, WAN, Wireless, Firewall, and Load balancer. Proven ability to lead and mentor technical teams Demonstrated capability to lead & influence major projects and business outcomes Experience in managing relationships with third-party vendors and service providers Experience in budgeting, cost control, and financial management Basic Requirements: Bachelor's degree in Information Technology, Computer Science, or a high school diploma/GED AND 12 years of working experience in Information Technology 10+ years of experience network infrastructure knowledge/expertise in an IT service organization Qualified candidates must be legally authorized to work in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position. Additional Information: Position requires 5-10% travel Position located in Indianapolis, Indiana working in a hybrid model. (Relocation required) Organization Overview Lilly IT builds and maintains capabilities using cutting edge technologies like most prominent tech companies. What differentiates Lilly IT is that we redefine what's possible through tech to advance our purpose - creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of our business. The Global Information and Services Tech team is at the forefront of digitalization to enable and advance the entire company, with increased productivity and best-in-class Customer experiences. This team provides a robust and sustainable infrastructure of hardware, software and services that are critical to enable our global workforce and business to operate and transform. As leaders in technology and understanding business requirements and challenges, this team defines and leads the overall company technology strategy. 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $224,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Position Brand Description:The Site Operational Excellence (OPEX) Lead is accountable for executing and supporting the Operational Excellence Management System for Manufacturing and Quality (M&Q). Reporting to an Operations Leader at the site, this role focuses on site-level implementation, coaching, and continuous improvement of Operational Excellence to ensure alignment with the overall strategy and governance. The Site OPEX Lead serves as the key interface between the Global OpEx team and the site, as well as the interface between the Site OPEX Team and the Site Leadership Team (SLT). The OPEX Lead is an SME in Lean, Problem Solving, Root Cause Analysis, Manufacturing Standards of Operational Excellence, and Human Performance Reliability. This role involves a balance of execution, coaching, and administrative leadership.Key Objectives / Deliverables:Business Transformation: Lead the Site Operational Excellence Lead Team and provide Operational Excellence support for site central functions. Own the site prioritization process, Operational Excellence education strategy, Operational Excellence roadmap, and site-wide transformational initiatives. Participate in Site Lead Team metrics reviews, identify trends, and lead site improvement initiatives. Assist in preparation of the Site Business and Strategic Plan; lead strategy deployment and participate in relevant SLT topics. Influence local organizational uptake and execution of OpEx practices, tools, behaviors, and culture. Develop, coach, and lead the local OpEx team members. Identify, recruit, and onboard Operational Excellence talent. Ensure strategies and projects meet safety, product quality, compliance, financial and applicable regulatory Education and Development: Facilitate Operational Excellence training to all levels of employees within assigned areas to support deployment and ongoing sustainability of Operational Excellence / Lean ways of working. Coach and train teams in Lean tools and systems (for example, daily management, A3 thinking, standard work) Coach local leaders and Operational Excellence Business Partners on program execution. Host local Operational Excellence education and communication sessions to monitor program and resource execution, share best practices, foster collaboration, communicate and facilitate Operational Excellence learning opportunities, and apply PDCA learning cycles to improve Operational Excellence business processes. Serve as technical leader for other Operational Excellence Business partners and build their Manufacturing operations, Lean, RCA, Problem Solving, HPR, and program management skill set. Continuous Improvement and Project Management Lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Human Performance Reliability (HPR), etc. Establish and implement project management processes and methodologies to ensure Continuous Improvement projects are delivered on time, adhere to high quality standards, and meet team expectations. Lead the establishment of Operational Excellence systems (e.g., the Lean Production, Lean Management systems, and our digitally integrated visual management system) within assigned areas, including the components and their interactions. Network and Knowledge Management Facilitate shared learning and lead Operational Excellence Assessments within the site (site and globally driven). Integrate and drive Operational Excellence culture and systems within the site. Align with Global Operational Excellence business processes and support the delivery of OpEx objectives. Actively engage in the broader Operational Excellence community through periodic updates, 1:1 meetings, and ad hoc discussions. Minimum Requirements (Education, Experience, Training): Bachelor's degree or higher in a relevant scientific or technical field. 5+ years in Manufacturing. Prior experience in Lean, Six Sigma, or Operational Excellence. Additional Preferences: Demonstrated successful leadership experience and influence of cross-functional teams. Results-oriented with excellent interpersonal and interaction skills. Strong balance of leadership, analytical, project management, and strategic thinking skills. Effective educator and presenter. Enthusiastic, flexible, and positive attitude Experience in Lean Manufacturing or other Productivity industry methods. Strong communication and computer skills required. GMP operational experience. Other Information: Travel (domestic and international) 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $122,250 - $196,900 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. The Diabetes, Obesity and Complications Therapeutic Area (DOCTA) of Eli Lilly and Company focuses on new therapeutic approaches for the treatment of diabetes, obesity and cardiometabolic diseases. Starting from an idea, we work with partners across Lilly to discover and develop novel biologic, small molecule and nucleic acid-based therapeutics. Our focus is the patient: by understanding the biology and pathophysiology underlying disease states, we aim to address the root cause of disease, and develop breakthrough therapies. We have one of the strongest pipelines in the industry and a track record of delivering impactful medicines that improve people's lives. Are you a computational scientist passionate about addressing some of the most pressing global health challenges of our time? Do you stay current with the latest advances in metabolic disease research and obesity pathophysiology? Are you eager to apply pioneering computational and statistical approaches to analyze multi-omics data and unravel the complex biology of obesity, adipose tissue function and metabolic dysregulation? The computational biology role within DOCTA is an exciting opportunity for a team-oriented scientist with deep expertise in obesity biology and computation methods to drive therapeutic discovery in metabolic diseases. In this hands-on role, you will work cross-functionally with researchers across DOCTA to design and implement multi-omic studies specifically focused on obesity pathophysiology, energy regulation, adipose tissue biology, metabolic pathway dysregulation and CNS pathways concerning obesity. You will collaborate closely with experimental project leads and scientific domain experts to drive scientific discovery through the comprehensive analysis of single-cell genomics data from preclinical models and human studies. In this role, you will not only apply established computational methods to understand obesity pathophysiology and identify novel therapeutic targets in metabolic pathways, but also pioneer the application of innovative AI/ML approaches to extract deeper biological insights from complex multi-modal datasets. The successful candidate will have the opportunity to directly impact the DOCTA pipeline, ultimately driving the scientific field forward and bringing innovative therapies to patients. Key Responsibilities: * Design and complete studies using omics-related data sources, including RNA-seq, spatial transcriptomics, single-cell omics, proteomics, functional genomics, metabolomics, and more. * Integrate standard analytical approaches as well as emerging AI/ML models to answer scientific questions of high-dimensional data * Partner with discovery statistics team to create novel analytical frameworks for high-throughput studies and develop specialized methodologies to enhance insights from small-sample datasets. * Stay up-to-date on current technical and scientific advances through deep understanding of the literature and attendance of relevant technical and disease-related conferences * Clearly communicate complex results to cross-functional partners in a prompt and transparent manner * Perform ad-hoc bioinformatics analyses and data visualizations as needed * Work collaboratively with other Data Sciences and Computational Biology (DSCB) scientists to develop innovative, best in class computational workflows and data repositories for advanced analyses * Engage in code and documentation review within the team and across other teams within the DSCB team * Adhere to industry-standard protocols for scientific project documentation Basic Requirements: PhD or equivalent in Computational Biology, Bioinformatics, Biomedical Informatics, or related field with 2+ years of experience post-PhD in relevant disease area. Additional Skills/Preferences: * Strong track record of execution of computational biology and/or bioinformatics-based projects, potentially including RNA-seq, metabolomics, multi-omics, human genetics, proteomics, AI/ML, and other related research modalities required * Prior experience and deep expertise in obesity and related areas, preferably with data from preclinical models, patient cohorts or cell lines preferred * Expertise in programming languages including R and Python and experience with workflow management systems such as Nextflow required * Experience developing production-grade bioinformatics pipelines, including working with standardized workflow tools preferred * Experience with implementation and maintenance of industry-standard documentation practices including Git, Confluence, JIRA, or equivalent preferred * Ability to prioritize and manage multiple competing priorities within a fast-paced environment required * The ability to communicate complex scientific and computational concepts to non-computational and non-scientist audiences required * Ability to represent the DOCTA DSCB team internally and externally required * Strongly team-oriented thinking mentality required * Prior industry experience preferred * Experience with scalable cloud computing platforms (e.g. Databricks, AWS) and big data analytics frameworks preferred * Experience with containerized technologies (e.g. Docker) for computational reproducibility preferred * Knowledge of human genetics preferred 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $138,000 - $224,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Job Description - Veterinary Technician Organization Overview At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Lilly is currently hiring for a Veterinary Technician role in the Department of Nonclinical Safety Assessment, part of the Division of Veterinary Resources. In this position, the individual will be responsible for delivering healthcare to laboratory animals and offering veterinary technical support to investigators and their research teams. This role plays a vital part in supporting internal in vivo research by maintaining high standards of animal health and well-being. Are you interested in joining a dynamic team caring for animals? Apply today to join the Lilly Team! Responsibilities Assists with the implementation of preventive health programs. Under minimal direction, triages and evaluates common rodent disease conditions, provides immediate care to emergency cases, and raises problems as appropriate. Consults with veterinarians and research personnel on treatment options. Administers clinical treatments, collects diagnostic and environmental samples, and administers euthanasia when necessary. Performs tasks in a manner that is consistent with departmental; institutional; local, state, and federal regulations; AAALAC accreditation standards and industry optimal methods. Reports issues of non-compliance. Maintains animal health records. Maintains integrity of information. Maintain adequate inventory of veterinary supplies and medications. Provides training for animal use personnel as needed. Required to work weekends and holidays on a rotating schedule. Minimum Qualifications Veterinary technician license required (RVT, LVT, CVT or equivalent) Additional Preferences AALAS Certification (LAT or LATG) or willingness to obtain certification highly desired. Experience working with rodent species preferred. Experience with standard operating procedures (SOPs), design and implementation preferred. Excellent problem-solving abilities through utilization of good judgment and networking skills. Highly motivated and self-directed. Demonstrated experience and success in self-managing priorities and multi-tasking projects. Strong problem-solving skills. Strong interpersonal skills/team player with positive and professional approach. Excellent written and verbal skills. Flexible, adaptable and detail oriented. A willingness to work in complex environments. 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $148,500 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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 and Position Overview Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Area Engineer is the site Subject Matter Expert (SME) for the Small Molecules Building (SMB) and the associated ancillary systems within the FUME (Facilities, Utilities Maintenance & Engineering) organization. During the project phase, the Area Engineer will be a key player in the cross functional project team in assisting in the design, construction, commissioning, qualification, start-up and operational readiness of all systems associated within the Lilly Medicine Foundry's SMB. During the day-to-day operation, the Area Engineer will be responsible for effectively, reliably, and cost consciously overseeing and maintaining the site's SMB and associated ancillary systems. This includes maintaining all systems in a state of compliance, in-control, and fit for use in order to meet the needs of internal customers and/or the business. The Area Engineer will also be responsible for driving continuous improvement initiatives and managing both annual local operating and capital expenditures (CAPEX) for either requested revisions and/or new functionality or capacity. The Area Engineer will also act as the single point of contact for all residents / customers associated with the SMB. * Be the SME with a deep technical expertise in all systems under his/her responsibility, understanding their applications in pharmaceutical manufacturing, understanding flow charts and process parameters, and awareness of industry trends including but not limited to the following building systems: * API Reactor Suite(s) * Fixed reactors and condensers (50 - 500 gallons) * Agitated Filter Dryers (AFD) * Temperature Control Units (TCU's) * Solvent Filtering and Distribution * High Potency API Production (HPAPI) * Level III containment * ISO 8 environment * Isolators and portable tanks * Experimental Materials Lab (EML) * Downflow booths * Walk-In / bench top fume hoods * Temperature Control Units (TCU's) * Purified Water w/ Endotoxin Control (PWEC) * Bulk solvent distribution within the SMB * Gray / clean utility distribution within the SMB * Primary and Secondary waste streams within the SMB * Ensure the assigned processes are aligned with Industry and Lilly Standards * Support risk assessment exercises using the different tools available (e.g. FMEA) * Participate as required in teams, committees, or other groups and/or individually to achieve FUME's departmental, site and/or company goals. Initial project asset delivery phase and future local capital investment: * Lead or participate in projects/changes for all the systems under his/her responsibility in the SMB including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects. * Develop the proper documentation (URS (User Requirement Specifications), test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and remain in a state of control. * Contribute to the process resource assessment, capital plans, expense budgets, and prioritize as appropriate. Daily Support for operations: * Monitor all systems associated with the SMB and maintain KPI's to assure that they are operating properly and in compliance with internal and external requirements. * Act as the single point of contact for the SMB in order to ensure compliance related activities such as deviations, change controls and CAPA's are resolved and implemented in conjunction with Operations, Process Engineering, Supply Chain, HSE and Quality Assurance. * Collaborate within the FUME organization in order to implement efficient and effective maintenance and reliability techniques in alignment with global engineering standards. * Apply "hands-on" problem solving skills in quickly and efficiently resolving equipment failures, troubleshooting, demonstrating RCA (Root Cause Analysis) lead investigator proficiency and guiding operations personnel in the resolution of system issues. * Provide internal customer consultation and notifications on issues that involve critical utilities and equipment associated with the SMB. * Assure that all necessary corrective / preventive maintenance items are identified on the proper tracking systems, and ensure activities are completed by the required dates. * Provide technical assistance as necessary to FUME, HSE, Process Engineering and/or Operations personnel. * Lead or participate in capital projects / changes for all systems under his/her responsibility in the SMB including project management, design, resource planning, budget adherence and equipment / utility Qualification/Verification activities (IQ/OQ/PQ). * Support internal and external inspections and investigations (including Quality and HSE). * Maintain effective and efficient communications with appropriate site customer groups. Basic Requirements: * Bachelor's degree in Engineering (prefer ME, MET, Chem E) * 5+ years of direct engineering experience of building, utility and chemical equipment related systems and their use in a manufacturing setting, pharma preferred. Additional Preferences: * Previous start up experience for new building and chemical equipment related systems. * Understanding of agile engineering techniques used in the management of buildings, utilities and equipment. * Previous equipment installation / commissioning / qualification experience. * Engineering experience with manufacturing / chemical plant utilities. * Engineering related project management experience. * Experience with CMMS (Computerized Maintenance Management Systems), U/BMS (Utility/Building Management Systems) and QMS (Quality Management Systems). * Demonstrated office software skills (Word, Excel, PowerPoint, Outlook, UMS, data historian) and collaboration sites. * Excellent interpersonal, written and verbal communication skills. * Knowledge of cGMP principles. * Demonstrated high level of understanding of engineering concepts, 1st principles, and engineering functional standards. * Strong technical aptitude and ability to train and mentor others. Other Information: * Initial location at Lilly Technology Center, Indianapolis. * Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. Job Summary: This role provides essential Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for all products manufactured by third-party partners. Job Responsibilities: Lead and manage quality aspects of external API manufacturing sites, including but not limited to batch record review, disposition, deviation management, and change control. Conduct and/or participate in quality audits of external manufacturing sites to assess compliance with cGMP, regulatory expectations, and Eli Lilly's quality standards. Review and approve quality-related documents, such as manufacturing master batch records, validation protocols and reports, stability data, and analytical methods. Collaborate cross-functionally with internal teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) and external manufacturing partners to resolve quality issues and drive continuous improvement. Provide expert QA guidance and support during new product introductions and technology transfers to external manufacturers. Develop, implement, and maintain quality agreements with external manufacturing organizations. Investigate and troubleshoot complex quality incidents, deviations, and out-of-specification results, determining root causes and implementing effective corrective and preventive actions (CAPAs). Represent Eli Lilly's quality interests during regulatory inspections at external manufacturing sites. Mentor and provide technical guidance to junior QA associates. Job Qualifications: Bachelor's degree in a scientific discipline (e.g., Chemistry, Biochemistry, Pharmacy, Chemical Engineering) or related field. Minimum of 5-8 years (Senior Associate) or 8+ years (Principal Associate) of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing and external supply. In-depth knowledge of cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements. Proven experience in auditing external manufacturing sites. Strong understanding of API manufacturing processes, analytical techniques, and quality control principles. Demonstrated ability to make sound quality decisions and effectively communicate complex technical and quality information to diverse audiences. Excellent problem-solving, analytical, and critical thinking skills. Ability to work independently and as part of a team in a fast-paced, dynamic environment. Proficiency in quality management systems (e.g., TrackWise, Veeva). Willingness to travel domestically and internationally to external manufacturing sites as 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Organization Overview: Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) 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, 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 Brand Description: The Health Safety and Environment (HSE) Permit Writer will develop and maintain safe work permits within the production building. A successful candidate will interface with the Process Team and Project Team to manage equipment availability. In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Responsibilities: Safe work permit preparation including the coordination of operations, project, and maintenance personnel. Execute the required safe work permits, which includes but is not limited to lock out tag out (LOTO), hot work, confined space entry, etc. Develop and maintain equipment specific instructions including but not limited to lock-out, tag-out. Develop and maintain confined space entry risk assessments. Develop and maintain permitting equipment and supplies. Perform safety audits and maintain an audit ready status. Review and monitor relevant Standard Operating Procedures (SOPs) and SOP updates. Execute unplanned SOP changes. Influence adherence to project and maintenance schedules. Support Process Engineers/Maintenance/Projects and Supervision in daily operations. Identify and support the implementation of improvements from Operations. Ownership of daily tasks, preventative maintenance or breakdowns. Conduct continuous improvement projects which are aligned with safety and quality expectations and meet operational needs Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards. Understand other area processes & their operational hazards and being able to react appropriately. Actively participate in assigned building & area operations such as safety audits, procedure coordination, housekeeping and improvement projects. Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification. Basic Requirements: High School Diploma or equivalent Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Completion of Post Offer Exam or Completion of Work Simulation if applicable. Ability to effectively communicate (electronically, written and verbal). Basic computer skills (desktop software) are required. Additional Preferences: Previous experience in facility/area start-up environments. Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals. Solid understanding of FDA guidelines and cGMP requirements. Strong organizational skills and ability to handle and prioritize multiple requests. Knowledge of lean manufacturing principles. Flexibility - ability to troubleshoot and triage challenges. Ability to understand technical nomenclature and language as well as work with mathematical formulas. Manual material handling as appropriate. Bend, reach, stretch, climb ladders, and work in tight spaces. Stand for long period. Additional Information: The Safety Permit Writer role operates on a work schedule of Monday through Friday, 8 hours per day. The job may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend training activities etc. Ability to work flexible schedules during startup period. Ability to work overtime as required. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_************************** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $28.84 - $42.31 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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: 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 motivated individuals who are determined to make life better for people around the world. The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly's deep pharmaceutical development expertise and engineering capabilities. In this role, we are seeking an experienced scientific leader that will have responsibility for ensuring the technical integrity, compliance, and business administration of a Lilly team responsible for development stability, reference standards, and critical related materials. The scientist will have influence in all phases of drug development, product registration and marketed product support by ensuring that development stability studies are properly managed and suitable reference standards are available and accurately assigned. The individual will ensure that materials and the certifying documentation are scientifically sound, properly integrated with analytical control strategies, and compliant with all corporate and regulatory requirements. The scientist will be an external leader in this technical area, set overall strategy at Lilly, and lead global Lilly scientists to ensure all related deliverables are met. Position Responsibilities: Technical: Applies deep expertise in reference standards and stability science to solve complex technical challenges. Develops and maintains a robust quality system and business processes for reference standards and stability programs. Leverages advanced knowledge of analytical control strategies to guide material sourcing, packaging design, inventory management, equipment/facility oversight, protocol development, specification setting, and data evaluation. Leads global technical teams to integrate and interpret complex data sets from diverse sources, enabling data-driven decision-making. Establishes statistical techniques, defines appropriate calculations, and defines how conclusions are made to support key analytical testing and suitability decisions. Designs processes to ensure compliance with global regulatory requirements for reference standards and stability studies. Provides technical leadership, driving resolution of complex analytical issues. Project Management: Oversees planning and execution of material supply, storage, and distribution strategies aligned with material properties and intended use. Interprets performance metrics and trends to drive timely, data-informed actions. Builds and manages a network of internal and external partners to meet technical and capacity needs. Owns team workload management and ensures alignment with project demand. Ensures all activities comply with applicable regulatory and safety standards. Customer Focus/External Focus Influences the external scientific community to adopt Lilly best practices and align Lilly with industry best practices Represents Lilly during external audits and in external interactions with key stakeholders Basic Qualifications: A Ph.D. in analytical chemistry, bioanalytical chemistry, or a related discipline with at least 10 years of experience in the biopharmaceutical sector following graduation, or alternatively, a B.S./M.S. with 15+ years of experience in the pharmaceutical industry. Additional Skills/Preferences: Demonstrated leadership and ability to influence across internal and external teams. Deep expertise in analytical sciences, including measurement techniques, specifications, and statistical data analysis. Strong background in reference standards and stability science across diverse molecular modalities. Solid understanding of chemical synthesis, purification, formulation, packaging, and inventory management. Proficient in statistical tools and computerized systems such as LIMS and inventory management platforms. Strong communication and interpersonal skills, with a consistent record of collaboration. High attention to detail and ability to adapt to shifting priorities while managing ambiguity. Strong compliance mindset with thorough knowledge of regulatory and safety requirements. Additional Information: Travel: 5 to 10% Potential exposure to chemicals, allergens, extreme temperatures, and loud noises. Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N) 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Responsibilities:The Advisor - Quality Audit and Compliance is part of the Global Quality Auditing and Compliance (GQAAC) division, which serves as the corporate quality auditing interface for global GxP compliance. This role focuses on Lilly‑designated Special Security Substances (SSS) and Controlled Substances (CS), ensuring processes meet company requirements, regulations, and guidelines. The Advisor provides regulatory interpretation and guidance across the product lifecycle-from discovery and development through launch, commercialization, and licensing-for all SSS and CS materials, including API, drug product, finished product, samples, and reference standards. Responsibilities include reviewing proposed CS regulations (particularly US DEA), collaborating with legal and industry groups on comments, owning and maintaining Lilly Quality Standard 303, and handling the risk assessment process for SSS designation.The Advisor - Quality Audit and Compliance (Controlled Substances) also assures quality assurance through the execution of internal and external audits in support of pharmaceutical development and commercialization for Lilly. Through auditing, the GQAAC auditor assures that GxP operations conducted or sponsored by Lilly are performed in accordance with company standards, policies, procedures, and practices and are compliant with current regulatory requirements and expectations, applicable guidelines, and industry standards. GQAAC operates as a valued business partner by taking a proactive approach to further improving the quality status of business operations and regulatory compliance. The quality auditor plays a key part in contributing to the implementation of this strategic approach to quality auditing oversight. Key Objectives/Deliverables:The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive:Global SSS/CD Process Owner Lead or participate in the preparation and review of standards, policies, procedures, and guidelines that define Quality, SSS, and CS requirements. Build and maintain relationships with regulatory authorities; facilitate and host inspections from the US DEA, Indiana Board of Pharmacy, and other state CS agencies as required. Maintain Power of Attorney documentation to manage DEA registrations, sign DEA Form 222, and complete required online reporting via the DEA website. Interpret regulatory and quality standard requirements for business processes and provide guidance in response to related inquiries. Develop or support corrective and preventive actions (CAPAs) to address gaps in SSS/CS compliance processes. Escalate compliance issues promptly and appropriately. Ensure adherence to applicable quality standards, manuals, policies, procedures, and tools. Auditing Responsibilities Interpret and apply Lilly standards, regulations, regulatory guidance, industry standards, to identify compliance risks and maintain a comprehensive knowledge of applicable regulations, technical knowledge, and training to meet the auditing responsibilities. Lead or participate in planning, scheduling, preparing, conducting, appropriately escalating compliance issues, and reporting audits, assessments, and due diligences of GMP Operations and SSS/CD to assess the level of compliance with established standards and current regulations and guidelines. Lead or participate in risk assessments and mock regulatory inspections of GMP Operations and SSS/CD to assess level of compliance and/or readiness to meet established standards and current regulations and guidelines, as applicable. Provide technical input and recommendations to audit observation reports during the Audit Review Board meeting, as applicable. Exhibit ethical behavior when auditing, including integrity, objectivity, and confidentiality, including the competency to recluse oneself from an audit when a conflict of interest or lack of competency in a specific area exists. Exhibit interpersonal skills that are relevant to auditing, such as listening, questioning, being tactful and having appropriate non-verbal skills, handling conflict in a constructive manner and communicating (both written and verbal) in a clear and concise manner. Exhibit skills relevant to auditing, such as evaluating and judging, drawing conclusions, understanding technical material and data integrity concepts, business understanding, identifying problem areas, knowledge of audit principles, and ability to manage time. Business-related Responsibilities Lead or participate in the continuous improvement of the GQAAC quality system and other GQAAC organizational priorities. Participate in the continuous improvement of the global quality system and other corporate priorities, as requested. Establish and maintain relationships with the relevant business units, including providing audit-related advice, interpretation of Lilly global quality standards and regulations, and inspection readiness assistance. Participate and/or support GQAAC self-assessments or regulatory inspections. Personnel Development Responsibilities Complete required training and qualifications as identified in your Learning Plan. Remain current of regulatory and industry trends, including regulatory agency interpretation of requirements. Serve as a mentor and coach for others within the GQAAC organization. Attending training courses, conferences, or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness, as assigned. Basic Qualifications/Requirements: Minimum of five (5) years' experience related to the pharmaceutical industry. Bachelor's degree in Science or Engineering Additional Skills/Preferences: Ability to work safely to ensure self-safety and the safety of others. Strong working knowledge of global regulations and guidelines (e.g., DEA, FDA, EU, and industry standards (e.g., ICH, ISPE, PIC/s) for CS and GMP operations) and the ability to interpret and apply regulatory and guidelines to the pharmaceutical industry. Prior auditing experience, including auditor certification by an external body (e.g., ASQ Quality Auditing). Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while working under short deadlines associated with a fast-paced dynamic scientific environment. Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization. Excellent personal skills, including motivation, self-management, commitment, and the ability to work well with others. Excellent teamwork skills, including being open-minded and flexible to adopting new ideas. Strong project management skills to manage projects at various stages and effectively multi-task. Ability to maintain a flexible work schedule and adapt quickly to accommodate audit program priorities and other business-related priorities. Working knowledge of Microsoft office 365 suite and other business programs (e.g., document management systems, quality management systems). Additional Information:Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 50%, sometimes on short notice. 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $184,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Position Brand Description: The position of API EM Engineer [Synthetic Peptide Synthesis and Purification] reports to the API EM Engineering Associate Director and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel in the reliable supply and commercialization of medicines with safety first and quality always by: Developing and sustaining process knowledge in order to ensure the execution of the appropriate product, process, and operational control strategy at a number of Contract Manufacturers (CMs) Direct and Indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy FUME assessment to ensure an understanding of risk presented to the operational control strategy Participation with internal or CM resources in the equipment specification, procurement, and IQ/OQ/PQ Participation with internal and CM resources to assess the HSE and PSM elements of the CM that impact Lilly products Engaged with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets. Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM's CMs. Key Objectives/Deliverables: Coach and Mentor Process Team Members Utilize past experiences with unit operation control to provide insight and feedback to members of the CM Joint Process Team (JPT). Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions with CM members of the JPT. Support and peer review root cause analysis around FUME and operational incidents. Peer review documentation of learning points, technical studies, and incident investigations. Develop and Sustain Process Knowledge Identify process knowledge gaps that impact equipment and process capability. Develop or support the capture of key process knowledge (examples include material and energy balances, kinetics, chemistry, process modeling, and equipment design basis). Enable the development and maintenance of process knowledge. infrastructure such as key models, report history, lab models, and literature. Utilize optimization resources and tools for process analysis and process improvement studies. Review and track key process engineering metrics. Provide Process & Equipment Support Identify systemic issues affecting production and reliable supply from CMs Lead or participate in root cause analysis and countermeasure development and implementation for major safety, quality, or throughput incident investigations. Perform reviews of incident documentation for technical accuracy. Review and approve documentation and engineering decisions. Process Optimization & Continuous Improvement Support development and technical analysis for on-going continuous improvement activities. Review and identify cost reduction opportunities, as well as process capacities and bottlenecks. Assist in prioritization of opportunities with respect to overall business objectives. Work with the CMs to ensure the application of statistical thinking and methods to understand process variability and capability. Perform and promote optimization of unit operation cycle time, loading, and yield performance. Engage with late phase development and Engineering Technical Center resources to ensure staying contemporary with key engineering disciplines and developing portfolio platforms (e.g. continuous manufacturing operations). Equipment Capability and Asset Management Create an appropriate methodology to ensure visibility of the ongoing state of qualification of key FUME systems at the CMs. Review equipment and process system user requirements and qualification plans to ensure that the equipment and systems are appropriate for the intended purpose. Act as customer representative for review of Contact Manufacturer (CM) requests for capital projects targeted at both short and long term needs. Oversight of HSE and PSM Serve as the liaison for API EM and Global HSE on health, safety, and environmental (HSE) and process safety management (PSM) oversight at the relevant contract manufacturing sites. Leverage internal Lilly experts in HSE and PSM to ensure appropriate risk reduction at CMs. Participate in Lilly HSE and PSM audits of contract manufacturing sites as applicable. Maintain key HSE and PSM metrics for review within API EM. Adherence to Business, Quality, and Financial Systems Understand and follow all applicable Lilly policies and procedures with respect to interactions and oversight of API contract manufacturing sites. These include but are not limited to: Financial Responsibility and Reporting (FRAP); Lilly Red Book; Lilly contract manufacturing standards; Lilly engineering standards, and Lilly Quality policies and best practices. Basic Requirements: 3 years of work experience in a manufacturing/process engineering related role Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive chemical manufacturing experience. Additional Preferences: Experience in typical unit operations for API Manufacturing manufacturing. Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations. Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement. Demonstrated ability to function in a team environment as a technical leader and as a member of teams. Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences. Develop and implement innovative approaches to problems Process Hazard Analysis experience Successful application of root cause analysis and systematic problem solving Strong Computer skills in a variety of software packages ( e.g Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite). Visualize an operation/process and reflect it in a model. Other Information: The normal schedule for this position is Monday-Friday, 8 hours/day. However, teleconferences may routinely occur outside of these hours due to the time zones of contract manufacturers. OUS travel may routinely be required to support process start-ups, troubleshooting, and commercial manufacturing. This travel is typically in the range of 15% to 25% annually, depending on the needs of the process(s). Must complete assigned training curriculum. No certifications required. Tasks require entering manufacturing and laboratory areas and will require wearing appropriate PPE. 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At 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 and 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 design, commission and start up the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship. Position Description: Bioprocess - Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture. The successful candidate will be required to build deep technical expertise in their area of responsibility (including in-depth knowledge of the science behind the molecule and the process), have strong working skills on the manufacturing equipment set and control systems, and consistently demonstrate strong data-driven decision-making and problem-solving capabilities. They may also work to ensure that the process is in-control, capable, compliant, and maintained in a validated state through continual monitoring and may play a role in by implementing new technologies and process improvements in the manufacturing environment. Key Objectives/Deliverables Have an in-depth knowledge of the science behind the molecule and the processes. Understand the process control strategy for gene therapy products Provide technical support for all start-up TS/MS activities (e.g., NPI, tech transfer, process validation, process stewardship and improvement) Ownership and technical stewardship of bioprocess and provide technical expertise during Root Cause Analysis for deviations and Impact Assessments for changes Work as part of cross-functional teams, and establish partnerships with applicable functions, operations, and development to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team Be able to assess whether the process is in control and capable of meeting its stated purpose and is in a constant state of validation Identify process improvements and participate in implementation of Lean manufacturing initiatives Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents and annual reports Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability Serve as technical interface external to the Lebanon 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. Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities Basic Requirements: Bachelor's in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field 3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, or Engineering Additional Preferences: Have an in-depth knowledge of the science behind the molecule and the processes on mRNA/LNP drug substance manufacturing. Understand the process control strategy for mRNA/LNP mediated gene therapy products Experience and understanding of technical challenges with mRNA as a therapeutic modality is required Experience with mRNA/LNP formulation Experience with QC assays in line with product CQAs including variability Strong interpersonal and teamwork skills Strong self-management and organizational skills Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization Experience with data trending and analysis Ability to analyze complex data and solve problems Demonstrated successful membership/leadership of cross-functional teams 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Clinical Research Scientist - Medical Affairs Allergy, Immunology BU Purpose: The Medical function throughout the Lilly enterprise brings scientific objectivity, clinical expertise and experience in patient care that enhance Lilly's R&D, but Medical Affairs extends those benefits in its interactions with the customer and uses those customer experiences to inform ongoing development and use of Lilly's medications. Medical Affairs (MA) plays a critical role in anticipating and interpreting the constant and rapid changes happening in the complex world of healthcare. Medical Affairs leads efforts to identify and address Clinical Care Gaps, generate evidence, and share science across communication channels. The application of scientific and clinical training, and expertise, positions the Medical Affairs Clinical Research Scientist (CRS) an integral member of the medical affairs team. The Medical Affairs CRS supports the medical strategic planning supporting launch and commercialization of our treatments. Additionally, the MA CRP leads the medical strategy addressing patients' needs and ultimately enhancing the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs), and payers. Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; the reporting of adverse events as mandated by corporate patient safety; review process for protocols, study reports, publications and data dissemination for products; new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the Director-Medical and Business Unit Team Physician/Regional Medical Leader, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine team(s). The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The CRS is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision. Primary Responsibilities: This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. The primary responsibility of the Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local and global business, to ultimately enhance the customers' experience and develop medical strategies that improve patient outcomes. This includes informing the identification of Clinical Care Gaps (CCG), Integrated Evidence Generation (IEG) planning, product lifecycle planning, and evidence dissemination plans aligned with medical strategy. This includes local marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for PRA (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late-phase and marketed compounds but can also include early phase trials (for example, phase I and II trials). The global team CRS is responsible for collaborating with the global development teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. In addition, the CRS, if assigned, is responsible for support of global Development studies conducted in affiliates/countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned. Business/ customer support (pre and post launch support) Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers) Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts. Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan. Contribute as a scientific and clinical expert to activities and deliverables of the PRA organization, giving clinical input and insight to develop payer partnership programs and defend the product value. Support business-to-business and business-to-government activities as medical expert. Contribute actively on an ongoing basis to the strategic planning for currently marketed brands. By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team. Support training of sales representatives, and other medical representatives. Become familiar with market archetypes and potential influence on the medical interventions for the product. Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become patient advocate, as well as a medical expert supporting identification of Clinical Care Gaps (CCGs). Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service). Understand and apply knowledge of customer insights to all customer-related activities. Participate in local or national trade associations as appropriate. Scientific Data Dissemination/Exchange Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals. Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above. Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals. Support medical information associates in preparation and review of medical letters and other medical information materials. Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff. Prepare or review scientific information in response to customer questions or media requests. Provide follow-up to information requested by health care professionals as per global SOPs. Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis. Develop and maintain appropriate collaborations and relationships with relevant professional societies. Support the design of customer research as medical expert. Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Support efforts in Integrated Evidence Generation (IEG) planning, participate in data analyses, development of scientific data dissemination including personal and non-personal channel strategy, and preparation of final reports and publications. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Clinical Planning Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM/Translational Medicine teams. Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes). Understand and keep updated with the pre-clinical and clinical data relevant to the molecule. Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design. Clinical Research/Trial Execution and Support Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects. Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions). Collaborate with clinical research staff, regional clinical operations staff, statisticians, global patient outcomes, research scientists and selected investigators in the development of protocols and data collection requirements. Participate in investigator identification and selection, in conjunction with clinical teams. Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel. Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Review lIT proposals and publications, as requested. Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country(ies) or global Development and Medical Affairs teams. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. Regulatory Support Activities Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists. Support I assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective. Participate in advisory committees. Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS). Scientific / Technical Expertise and continued development Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years). Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product. Responsible for the scientific training of the clinical study team. Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Explore and take advantage of opportunities for extramural scientific experiences. Attend, contribute and participate in medical congresses/scientific symposia. General Responsibilities Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget. Use knowledge of specific disease states and available treatments to provide scientific and medical input, contribute to the development, review, and approval of promotional and medical materials ensuring high integrity and quality. Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable. Collaborate proactively and productively with all alliance, business, and vendor partners. Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness. Actively participate in recruitment, diversity, and retention and hiring efforts as applicable. Participate in committees, Six Sigma initiatives and task forces as requested by business unit/corporate management. Model the leadership behaviors. Be an ambassador of both patients and the Lilly Brand. Minimum Qualification Requirements: PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience Clinical trial experience in drug discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Other Information/Additional Preferences: Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills. Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills. Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication Primary internal interactions include, but not limited to: Therapeutic area directors, managers, or project managers Product directors, managers, and associates of the brand Clinical research staff Statisticians Scientific communication associates Medical information associates Medical liaisons Global patient outcomes research consultants/research scientists and health outcomes liaisons Regulatory directors, scientists, and associates Sales representatives Legal counsel Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. Corporate or regional patient safety physician(s) External Contacts Scientific and clinical experts, thought leaders Lilly clinical investigators Practicing physicians/prescribers Regulatory agency personnel Professional association staff and leaders Disease advocates and lay organizations focused on relevant health issues Formulary representatives (private and government) Demonstrates the following competencies Making Business Decisions with data - Harnesses the power of data and analytics to solve problems, make good decisions and measure results. Job-Based Skills: Defines the problem or decision to be made within context of strategy or goals/objectives. Identifies relevant sources and validates accuracy of data. Analyzes and synthesizes data and identifies trends. Draws conclusions and makes timely, well-informed decisions. Engages data and analytics colleagues appropriately when needed. Scientific/Information Exchange - Maximizes engagement with key customers and colleagues through the integration of personal and/or non-personal channels when collaborating, discussing, and sharing science/information. Job-Based Skills: Identifies challenges, information gaps, education needs, and delivery preferences. Creates an engaging narrative. Generates content with the channel(s) and medium(s) in mind. Adjusts style and tone to meet the unique needs of each audience. Uses preferred channel(s) to deliver at the time of need. Measures knowledge gained. Technical/Functional Expertise - Leads with technical and functional expertise. Job-Based Skills: Establishes appropriate scientific and medical subject matter expertise (e.g., disease states, therapeutic landscapes, drug development processes, portfolio, etc.). Maintains relevant knowledge of the healthcare landscape (e.g., health, payer, and regulatory systems and processes) and environment (e.g., HCP experience models and patient flow maps, value/accountable care, and population health landscape, etc.). Understands the advancements in technology that are influencing area of expertise and function (i.e., real-world clinical practice, AI techniques, tools and platforms). Develops appropriate knowledge of activities that can be used to influence and deliver on organizational purpose (i.e., shape clinical practice, systems, tools and platforms). Masters individual workstream tools and processes. Strategic Agility - Defines and commits to an initial strategy or approach; monitors effectiveness; and adapts based on new information and/or insights. Job-Based Skills: Develops an actionable strategy or approach-involving colleagues and engaging stakeholders appropriately. Creates a clearly defined measurement plan with key metrics and triggers. Monitors progression and impact against key metrics. Identifies opportunities to improve. Reassesses strategy/approach and pivots when appropriate. 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $244,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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: 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 motivated individuals who are determined to make life better for people around the world. The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly's deep pharmaceutical development expertise and engineering capabilities. In this role, you will be part of a diverse team of analytical chemists, pharmaceutical scientists, and engineers delivering product and process understanding to deliver the antibody-drug conjugate portfolio. Ideal candidates will possess experience across multiple analytical techniques, demonstrate an aptitude in technical problem solving, and be motivated to work both independently and collaboratively in a dynamic environment. Top candidates for this position will be able to: Develop analytical methods to support progression of the antibody-drug conjugate portfolio. Evaluate and/or implement new analytical technologies/methods to advance Lilly's current analytical capabilities for bioproduct testing with a focus on state-of-the-art separation sciences capabilities. Generate key data and information applying HPLC, UHPLC, capillary electrophoresis, LCMS and/or other instrumental analysis techniques. The ideal candidate will demonstrate learning agility and be able to work with cross-functional teams. Position Responsibilities: Engage with scientists across Eli Lilly's Development and Manufacturing organizations to develop and validate robust analytical methods Identify and exploit new scientific concepts, strong problem-solving skills, and be self-motivated to contribute across multiple projects Strong written and verbal communication to speak to both technical and business-related implications of your work. Basic Qualifications: BS or MS in Analytical Chemistry, Biochemistry, Chemistry, or a related field. Additional Skills/Preferences: Experience with chromatographic separations and/or spectroscopic methods and methods for the analysis of antibody-drug conjugates. Experience with method validation and transfer. Demonstration of scientific and people leadership skills. Effective oral and written communication skills. The ability to work productively in an interdisciplinary team environment. Ability to balance multiple activities, prioritize and handle ambiguity. Additional Information: Potential exposure to chemicals, allergens, and loud noises Travel: 0 to 10% Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N) Lilly is an EEO/Affirmative Action Employer and does not discriminate based on race, gender, protected veteran status, disability, or any other legally protected status 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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. Sr. Engineer - Validation Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At 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 and 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 participate in the design, commissioning and start up the facility for both clinical and commercial supply. We are seeking a Validation Engineer at Lebanon Advance Therapies Manufacturing in Lebanon, IN. Validation engineer will be responsible for the following: Equipment/System Validation Life Cycle Asset Management Requalification Activities Temperature Mapping Asset Induction Cleaning / Sterilization (Parts Washer, Autoclave) Support Process and Computer Qualification Activities Lead validation / qualification protocols per continued process verification, risk impact assessments, and support commissioning Core Responsibilities Facility Start-up: Apply thorough understanding of regulatory requirements, relevant SOP curriculum, routine project procedures, project management, and other training to support manufacturing and engineering in projects such as cleaning, sterilization, equipment and utilities commissioning and qualification Assess, qualify, and validate equipment, critical systems (utilities), facilities, computer system, cleaning and steaming processes, manufacturing, and equipment processes, as applicable Participate and interface with cross-functional project team and represent validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: design qualification, FAT/SAT, commissioning, engineering, and process validation Provide a positive and equitable working environment emphasizing the Lilly's Values: Integrity, Excellence, and Respect for People Provide validation engineering support to site with a strong focus on right first time and on schedule facility start-up (e.g. design reviews, process safety assessments, User Requirements, C&Q support, unit operation shakedown and startup, facility operational readiness) Represent validation during tech transfer activities identifying current and anticipated requirements for cleaning efforts as required. Lead technical projects as they pertain to cleaning and cleaning validation. Provide technical input to strategy/philosophy for cleaning validation and engineering changes. Support the IQ, OQ, and PQ strategy, design, and execution for LP2 systems and equipment Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards, Lilly procedures, and regulatory requirements Facility Operations: Develop and maintain the basis of safety for equipment as required Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team Integrate mechanistic modelling, process simulation and analysis into current and future processes to enhance process understanding and control Monitor, assess and document equipment performance to maintain ongoing qualification Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions Basic Qualifications Bachelor's Degree in Chemical, Process, or Mechanical Engineering Experience in cleaning process, process equipment, facilities and GMP critical support systems Minimum of three (3) years of relevant experience in regulatory, quality, validation, and /or manufacturing operations Additional Skills/Preferences Deep technical interest and understanding in the field of Chemical Engineering Strong analytical and problem-solving skills Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented Guidance/mentoring of others through processes Flexibility to meet business needs KNEAT Experience 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism Position Summary: The Senior Director of TSMS - Tech Transfer is a strategic leadership role within the central TSMS organization, responsible for leading global technical teams in the successful transfer of drug substance and dry oral products (including SDD) processes across internal and external manufacturing sites. This role ensures consistent execution of Lilly's commercialization strategy, drives technical excellence, and fosters collaboration across development, manufacturing, and regulatory functions. Key Responsibilities:Tech Transfer Leadership Lead organization of TSMS technical experts on global tech transfer teams supporting both the initial commercialization of pipeline products and node to node transfers of commercial products across the drug substance and dry products portfolio. Responsible for the development of standardized business processes and Playbooks to support global tech transfers across multiple platforms and multiple sites (including simultaneous transfers to dual sourcing sites). Ensure alignment of Playbooks with Single Process Map deliverables and ensure buy-in from BR&D/SMDD and Analytical (AQCL) on generation of standardized business processes. Ensure the team is appropriately structured to own and continuously improve Tech Transfer Playbooks and associated training programs. Ensure consistency in technical deliverables and documentation across transfers. Strategic & Portfolio Management Partner with CMC PMs and development teams to guide tech transfer execution using Lilly's Single Process Map. Co-own commercialization playbooks with Commercialization and Molecule Stewards. Ensure adequate staffing and capability of tech transfer teams. Provide escalation and troubleshooting support for complex tech transfer challenges. Organizational Leadership Represent TSMS at governance bodies and technical network meetings. Build relationships and influence across manufacturing sites and central functions. Lead performance management, talent development, and succession planning. Mentor and coach project managers and technical leaders in commercialization and tech transfer. Qualifications:Education Minimum: B.S. in Chemistry, Pharmacy, Engineering, or related scientific discipline. Preferred: Master's or Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or Microbiology. Experience 15+ years in pharmaceutical manufacturing or technical services within a cGMP environment. 5+ years of experience in drug substance or dry product tech transfer and commercialization. Proven leadership in cross-functional teams and successful molecule transfers. Deep technical knowledge of parenteral products and control strategies. Skills & Competencies Strong project management and strategic planning skills. Excellent communication and stakeholder engagement. Ability to influence across sites and central functions. Experience mentoring and developing technical talent. Additional Information: Some domestic and international travel may be required. This role is part of the TSMS leadership team and contributes to long-term business planning and organizational capability development. 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 (******************************************************** 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $244,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly