Novartis jobs in Indianapolis, IN - 338 jobs

#LI-Hybrid Internal job title: Location: This position will be located in Indianapolis, IN or Fort Worth, TX and will not have the ability will require 20% travel as defined by the business We are looking for experience in physical irradiation technologies and related process automation technologies, with an emphasis on isotope production technologies. Our Unit is driving successful execution of a wide range of isotope-related projects. This starts with early strategic and operational discussions on isotope production technologies, assembly of internal teams and execution of desired strategy, up to technical leadership of early process development and the developability assessment of chosen isotope irradiation technologies. You will be reporting to the Head of the Global Isotope Development Unit. You will be leading a Process automation and Physics Development Team consisting of experts from different scientific areas who act as members of radio-isotope development project teams by optimally setting up people, assets, equipment to best serve project needs according to priority, and ensure timely delivery of high-quality products and solutions. About the Role Key responsibilities: * Be part of the IDU Leadership team * Work collaboratively with cross-functional and multidisciplinary teams, spanning multiple NVS global sites develop efficient radio-chemical separation techniques * Co-lead projects with project lead; formulate and execute on project strategy, manage interfaces with project leads, including timelines, priority, board presentations. * Build and lead internal Radiochemical team of experimental scientists and project leads. Seek technical and operational input from key stakeholders to build the project execution plan. * Lead internal project meetings. Collect and interprets data to advance project, adapts strategy, and addresses the right scientific questions. Ensure team discussions and decisions are summarized in minutes. Ensure that key milestones and go / no go criteria are data driven and clearly defined. Own quality of project information and make sure project information is accurate and included in the system(s) in a timely matter. * Guide projects with respect to isotope approaches and technologies and leads corresponding efforts. Lead developability assessment, manufacturing line development and early process development. Track and oversee projects by maintaining an overview of the project goals, activities and commitments, and timelines of project teams, in line with strategic priorities. Manage and optimize project plans and resource assignments with the aim to manage/mitigate risks. * Align with RLT LT project strategy and resourcing. Regular project/portfolio updates to IDU LT. * Manage and communicate project status, issues, and options for resolution to ensure optimal and timely information flow to all stakeholders (NTO and TRD). * Foster effective, proactive and open communication within and across project teams, build trust among team members to achieve transparency and clarity of program goals, progress and issues. Mentor less experienced team members. * Contribute to vendor/CRO evaluations, coordination of outsourcing requests, budget monitoring and communication, evaluation of external collaborations and due diligence. * Ensure best practices, knowledge exchange and continuous mentoring and training of our team members. Essential Requirements: * A minimum of a Bachelors degree is required. Master's or PhD is preferred * At least 5 years of relevant experience in radiopharmaceuticals or related fields, with a strong focus on process automation and physics; academic experience will also be considered * Strong background in Radiochemistry and radio-isotope production technologies including irradiation technologies and accelerators * Previous track record of success in leadership position, working with international and multidisciplinary development teams * Ambitious, yet highly collaborative and fully committed to team's and project success. * Result- and quality oriented. Able to deal with conflicting interests and willing to make compromises to ensure project progress. * Excellent project management skills, organizational and team management skills, interpersonal communication, strong verbal and written communication. * Creativity with demonstrated critical thinking and problem-solving skills, ability to pay attention to detail but also see a bigger picture. * Comfortable with ambiguity and change, eager and fast learner willing to adopt new tools and processes. * Ability to operate in a fast-paced dynamic environment and effectively process multiple avenues of communication and requests in parallel The salary for this position is expected to range between $145,600.00 - $270,400.00 USD Annual per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. 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?

Shift: No Department: LS-SC-UYEQA2B Indianapolis QC Chemistry Group 2B Recruiter: Katherine Hall Hiring Manager: Francisco I Colon This information is for internals only. Please do not share outside of the organization. Your Role: This is a professional mid-level technical position that will be responsible for analytical testing of finished product, raw materials, stability and special test requests. Position also requires analytical testing in support of protocols related to method transfers, method validations, laboratory investigations, and instrument qualifications. B Shift: Monday - Friday 2 - 10pm. Who You Are: Minimum Qualifications: Bachelor's Degree in Chemistry, Biology, or other Life Science discipline and 1+ year experience in a lab environment. OR Associates Degree in Chemistry, Biology, or other Life Science discipline and 3+ years experience in a lab environment. Preferred Qualifications: Experience in a pharmaceutical lab setting. Experience performing analytical testing using the majority of the analytical equipment used in the analytical laboratory including HPLC, GC,TLC, UV/VIS Spectroscopy, FTIR Spectroscopy, Particle Size, Electrophoresis. Experience with Empower 3. cGMP expertise in testing/manufacturing environments. Experience with bio-analytical and chemistry analytical techniques. Experience in analytical testing and research on products related to pegylated enzymes and liposomal products. Strong communication and interpersonal skills. Pay Range for this position: $19 - $30 / hour The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. RSREMD The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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 Position Overview: The TSMS Local Site Molecular Steward serves as the technical representative for the Lebanon facility. This role collaborates with central TSMS teams and other manufacturing sites to ensure robust molecule stewardship, seamless transfer of API from pre-commercial to commercial stages, and commercialization support for new molecules. This position requires comprehensive knowledge of the pharmaceutical industry, current Good Manufacturing Practices (cGMP), regulatory requirements, and advanced process chemistry. The successful candidate should have a proven track record of driving technical and manufacturing agendas. The role involves cross-functional collaboration within the site, across the network, and with commercialization teams and other functions. Responsibilities: Provide technical oversight and stewardship for one or more molecules manufactured at the Lebanon facility. Lead technical transfer of processes between production facilities. Anticipate and address complex scale-up issues. Facilitate process knowledge transfer to Process Team members. Assist in process-related training for Manufacturing Process Team members. Collaborate with Manufacturing to support the start-up and qualification of new facilities and associated process equipment. Help define and implement control strategies for Lilly Lebanon processes. Author, review, or approve standard operating procedures related to TS/MS activities. Review and approve manufacturing batch records and other documentation. Author, review, or approve technical documents supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies. Review and approve Annual Product Review and present annual Global Product Assessment for stewarded molecule(s). Serve as a technical leader supporting API manufacturing. Lead the resolution of technical issues, including those related to control strategy and manufacturing. Anticipate and resolve key technical or operational problems, communicate issues promptly, and lead process-related investigations. Assess technical impact and influence complex regulatory or technical issues within the TS/MS. Encourage adoption of new perspectives on challenging concepts. Mentor and provide scientific expertise to Process Team members. Apply process knowledge and data analysis skills to support the API manufacturing operations. Drive solutions that impact results across sites or functions. As required, design laboratory experiments to guide process troubleshooting and continuous process improvement. Help define and implement medium to large continuous improvements to manufacturing processes. Lead post launch technical agendas and deliver projects that drive substantial step changes in manufacturing. Interact with regulators or other stakeholders on technical issues or in support of internal and external agency audits. As required, may lead or assist in the planning and execution of process validation activities. As required, may own or assist in the implementation of medium to large process-related change controls with greater risk, resource / financial requirements, or complexity. Make decisions that impact a function or geography. Build relationships with internal and external partners. Understand and perform all job responsibilities in compliance with quality, safety and regulatory expectations as well as cGMP. Basic Requirements: Education Level: Bachelor's degree in Chemistry, Engineering, Pharmaceutical Sciences, or a related field (Chemistry focus preferred). Experience: Minimum of 10 years of direct experience in cGMP API manufacturing, covering multiple unit operations and platforms related to API development, commercialization, and commercial production. Additional Skills/Preferences: Strong technical leadership and communication skills. Advanced analytical and problem-solving skills. Deep understanding of process and cleaning validations, commercialization strategies, and execution. Ability to integrate multiple technology disciplines to advance programs. Effective prioritization and multitasking capabilities. Collaborative mindset with cross-functional teams. Additional Information: Position Location: US: Lebanon IN (LP1 site) Travel Percentage (%): 5-30% Shift Information: 8-hour shift, 5 days a week. Occasional night and weekend work 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 $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. 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. 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. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for the greenfield manufacturing site, and the successful candidate will help to build the programs and business processes to enable a successful startup into GMP manufacturing operations. Main Purpose and Objectives of Position: The Industrial Hygienist is part of the Lilly Lebanon Active Pharmaceutical Ingredient (API) Manufacturing Health, Safety, and Environmental (HSE) team and provides technical expertise and support in the development, implementation, and maintenance of HSE industrial hygiene (IH) programs and other HSE programs, as needed. This position will serve as the primary IH contact for a variety of areas (e.g., such as small molecule manufacturing, peptide manufacturing, warehouse, etc.). In the project delivery and startup phases (startup expected 2025 to 2027), the industrial hygienist role will be fluid and dynamic as we endeavor to support 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 through startup to full scale GMP manufacturing. Post start-up, this role will continue to be the subject matter expert and daily support for IH programs and other assigned HSE programs (as needed) within their assigned work areas. Key Responsibilities for this role include: Participate in the development of the HSE operational readiness plan for the Lilly Lebanon API facility as a collaborative, inclusive, and energetic member of the HSE team. Responsible for implementing written programs, offering applicable trainings, supporting the industrial hygiene implementation strategy for the assigned work areas, working directly with the areas for implementation and troubleshooting, and auditing compliance. Be a technical resource for assigned programs (e.g., exposure assessment, hearing conservation, biological safety, bloodborne pathogens, personal protective equipment, reproductive hazards, etc.) including conducting workplace assessments to identify potential health hazards, performing air monitoring, noise monitoring, and other assessments. Analyze data and prepare reports on findings. Develop a partnership with Operations, Maintenance, and Engineering functions to help manage change, assure safety and compliance of new systems, and assist in setting requirements to assure safe and compliant startup. Be a resource to the operational areas in helping them understand the regulatory requirements of their areas and programs; work with them in implementing solutions that comply with these regulations and programs. Complete internal HSE audits/assessments, lead/support incident investigations, assist with trending HSE data and metrics compilation, and support the development of long-term plans to drive program improvements. Requirements: Bachelor's degree in Industrial Hygiene or related field 3+ years of Industrial Hygiene experience within cGMP manufacturing (pharmaceutical or chemical manufacturing preferred) Additional Preferences: Demonstrated skills in technical expertise and self-motivation. Attention to detail and ability to be flexible depending on operational needs. Effective communication skills (oral, written, presentation, and negotiation) appropriate for all levels in the organization and a willingness to share information. A self-motivated, action-oriented, high-energy team player with demonstrated ability to work effectively in a highly collaborative organizational culture. Practices and earns trust and mutual respect. High degree of business and personal ethics and integrity. Analysis/problem assessment skills, communication (oral and written) skills, information monitoring skills, quality orientation, and teamwork/interpersonal skills. Other information: Tasks will require entering manufacturing and laboratory areas, which require wearing appropriate PPE. Must carry a cell phone as position will support 24/7 manufacturing operations. 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. 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 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 Brand Description The Representative - QA - IAPI provides support to Indianapolis API Operations manufacturing and laboratories and ensures quality systems and GMP compliance. The QA Representative provides assistance and guidance in deviation investigations, change control proposals, procedure and master production revisions, validations and batch dispositions. The QA Representative's position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies. Key Objectives/Deliverables Provide direct quality oversight of production, warehouse/material management, engineering, automation and laboratory operations. Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations. Provide quality guidance and recommendations with regard to manufacturing, materials, utilities, maintenance and laboratory issues. Participate in aberrant data investigations. Conduct analytical data review including stability data. Disposition API Intermediates and raw materials, as appropriate. Provide coaching, feedback and mentoring to QA Specialists as it relates to execution of quality systems. Investigate customer complaints. Participate in and/or support recalls, as appropriate. Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), laboratory periodic reviews and equipment/computer system periodic reviews, as appropriate. Conduct gap assessments of global requirements and ensure implementation of the governing standards. Participate in and/or lead self-inspection activities. Participate in and/or support regulatory inspections and audits. Maintain and improve quality systems. Assist others in the interpretation of regulatory and corporate requirements. Basic Requirements: BS in Engineering or a science-related field or equivalent experience. Additional Preferences: Experience with computer system validation. Demonstrated strong written and verbal communications skills. Strong attention to detail. Proficiency with computer system applications. Knowledge of cGMPs and quality systems. Understanding of statistical tools and analysis. Excellent interpersonal skills and networking skills. Ability to organize and prioritize multiple tasks. Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs. Basic Requirements: BSc in Engineering or science-related field or equivalent experience. Other Information: Must complete Learning Plan for Representative - QA - IAPI. No certifications required. Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE. Must support 24 hour/day operations. The job specification 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 specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. 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. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. Demonstrate compliance with procedures and be accountable for compliance of team members. Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management. Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. Collaborate with Global Patient Safety on risk management planning. Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. Partake in data analysis, scientific dissemination, and preparation of final study reports. Analyze and contextualize clinical data to support decision-making and portfolio strategy. Contribute to strategy and innovation through cross-functional working groups. Support planning and execution of symposia, advisory boards, and other external engagements. Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development Stay current with medical literature and scientific developments in breast oncology. Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. Provide scientific consultation to medical affairs, health outcomes, and commercial teams. Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience 3+ years of clinical research scientist experience/clinical trial experience Leadership experience Additional Information/Preferences: Direct Line Leadership experience Breast cancer disease state knowledge/experience An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. Strong communication, interpersonal, teamwork, organizational, and negotiation skills Demonstrated ability to influence others (both cross-functionally and within the function) to build 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 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 $177,000 - $308,000 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

The Maintenance Technician is responsible for performing corrective and preventative maintenance and support services for the building(s) and all equipment for a GMP Radioligand Therapies Production Facility. Responsible for reliable, efficient, and sustained operation of the facility and all equipment. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area. The working shift will be adjusted (1st or 2nd) after initial onboarding and training completion. About the Role Major accountabilities: * Adhere to Novartis Quality Policies and procedures as they pertain to the position to ensure that all products are safe, pure, effective and of the highest quality. * Perform a wide range of maintenance repair activities on production equipment, lab equipment and building management systems. * Assist in troubleshooting and repair of process equipment (example: containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision. * Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. * Support 24x7 site-based operations after startup. * Write/revise accurate operational procedures, training documents and maintenance procedures for various production and utility systems. * Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment * Completes Equipment Work Order Thoroughly, and Accurately and Documents them in the System * Supply information and technical data for securing spare parts. * Provide responsive customer support with emphasis on customer satisfaction. * Perform startup and commissioning activities as required. * Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs * Perform preventative and corrective maintenance on manufacturing process related equipment within a cleanroom environment. * Complete and provide accurate documentation, as required in cGMP operations. * Oversee work and provide training of less experienced maintenance technicians and/or new technicians. * Other related duties as assigned. * Use of CMMS system for documentation of relevant work. The salary for this position is expected to range between $47,500 and $88,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Minimum Requirements: * High School diploma or equivalent is required; Bachelor's Degree is preferred. * 1+ years of relevant hands-on plant maintenance experience in a regulated GMP environment is required. * Previous aseptic fill/finish and/or radio pharmacy experience is preferred. * Previous pharmaceutical or medical device experience is preferred. * Completed training in radioactive or hazardous materials environment is preferred. * Must be able to adhere to all applicable procedures, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.) * Experience working in a team environment, with excellent communication and organizational skills. * Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) or similar system. * Ability to climb ladders and lift up to 50 lbs. * Wear and work in protective clothing, including respiratory protection, confined space entry and clean room environments. * Must be flexible to work nights, weekends, and holidays as required. 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 currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, 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 systems to enable a successful startup into GMP manufacturing operations. Position Overview: The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team that provides the technical support required to achieve reliable and compliant manufacturing of API molecules. This role will be part of the Manufacturing Process Team for its respective area, providing daily oversight to ensure safe and reliable supply of medicines. The Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the manufacturing scientist should be capable and of setting up and executing a variety of experiments at laboratory scale and conducting research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory. Responsibilities: Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment. Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity. Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, etc. Develop and monitor established metrics in real-time to assess process variability and capability. Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose. Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps. Ensure that experiments are well designed with clear objectives. Ability to analyze data and ensure appropriate documentation. Write technical reports and documents. Basic Requirements: Bachelors in STEM Discipline (Chemistry preferred) 3+ years of experience in cGMP manufacturing (pharmaceutical manufacturing experience preferred) Additional Preferences: Demonstrated understanding of process chemistry Demonstrated basic knowledge in small molecule, peptide, or oligonucleotide API Manufacturing. Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development. Familiarity with cGMP manufacturing environment and terminology. Excellent analytical, interpersonal, written and oral communication 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. 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

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. Job Description 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 EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $77,000.00 - $143,000.00 Skills Desired Bom (Bill Of Materials), Business Networking, Business Scenario Planning , Change Control, Efficiency, Erp Systems, Flexibility, General Hse Knowledge, Including Gdp, Inventory Management, Knowledge Of Gmp, Master Data, Material Requirements Planning (Mrp), Order Management, Product Distribution, Risk Management, Scheduler, Supply Chain, Supply-Chain Management, Supply Management, Supply Planning, Transportation, Warehouse Management

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. 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. 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

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?