Lilly & Company jobs - 312 jobs

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 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 Operators for API manufacturing operations are directly responsible for the production of API molecules used in Lilly medicines. Operators will be responsible for upholding a safety-first, quality-always mindset in the production of API while running a production process that incorporates a wide range of unit operations. 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:** + Maintain compliance with regulatory requirements at all times. + Support the execution of the production plan for the site. + Carry out daily monitoring testing and cleaning duties as assigned to ensure equipment and systems are in good operating conditions and are maintained in accordance with local and corporate regulatory requirements. + Understand Health, Safety & Environmental (HSE) requirements and the application of Health & Safety/Process Safety standards in order to execute GMP duties. + Understand other area processes & their operational hazards and being able to react appropriately. + Monitor and collect data on equipment use and performance i.e. trying to anticipate potential equipment reliability problems. + Work with Maintenance and Technical Support to respond appropriately to potential production upsets or equipment failure. + Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing. + Communicate with other shifts regarding the status of the area operations and details of any issues/problems that have occurred at handover. + Participate in daily shift huddles / meetings to both understand and set expectations for daily operational goals. + Actively participate in assigned building & area operations such as safety audits, procedure co-ordination, housekeeping and improvement projects. + Be trained and qualified on all specified unit operations within the building. + Identify concerns for informal or formal discussion (shift meetings, safety representative). + Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification. + Must be able to use specified company supplied personal protective equipment (PPE) (e.g. hair & beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats, etc.) for long periods of time. **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. **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. + Emergency Response Experience- Industrial, military, volunteer, career firefighter- Indiana State or IFSAC Certification - Fire 1, Hazmat Technician + Ability to effectively communicate (electronically, written and verbal). + Basic computer skills (desktop software) are required. + Manual material handling as appropriate. + Bend, reach, stretch, climb ladders, and work in tight spaces. + Stand for long periods as needed **Additional Information:** + Ability to work 12-hour rotating shifts. + Ability to work flexible schedules during startup period. + Ability to work overtime as required. + Depending on the candidate's experience, the position may require a short-term assignment of 1-6 months domestically or internationally to train and be certified on existing processes and establish contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory.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 $17.30 - $34.38 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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Organization and Position Overview** Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Area Engineer is the site Subject Matter Expert (SME) for the Lab/Admin and Logistics Buildings (LALB) and the associated ancillary systems within the FUME (Facilities, Utilities Maintenance & Engineering) organization. During the project phase, the Area Engineer will be a key player in the cross functional project team in assisting in the design, construction, commissioning, qualification, start-up and operational readiness of all systems associated within the Lilly Medicine Foundry's LALB. During the day-to-day operation, the Area Engineer will be responsible for effectively, reliably, and cost consciously overseeing and maintaining the site's LALB and associated related equipment and systems. This includes maintaining all systems in a state of compliance, in-control, and fit for use in order to meet the needs of internal customers and/or the business. The Area Engineer will also be responsible for driving continuous improvement initiatives and managing both annual local operating and capital expenditures (CAPEX) for either requested revisions and/or new functionality or capacity. The Area Engineer will also act as the single point of contact for all residents/customers associated with the LALB. + Be the SME with a deep technical expertise in all systems under his/her responsibility, understanding their applications in pharmaceutical manufacturing and laboratory support, understanding flow charts and process parameters, and awareness of industry trends including but not limited to the following building systems: + Quality Control Laboratory Infrastructure + BSL-2 practices + Electrical Distribution + Process Gas Distribution + N2 (Nitrogen) + CO2 (Carbon Dioxide) + O2 (Oxygen) + WFI Distribution + Downflow booths + Benchtop fume hoods + Biosafety cabinets (BSC's) + Bioreactors + Benchtop chromatography systems + Safety showers / eyewash stations + Autoclaves / cabinet washers + Temperature Control Units (TCU's) and Cold Rooms + General Administrative Area Infrastructure + Electrical Distribution + Comprehensive cafeteria services + Customer / resident support services + Warehouse / Logistics Infrastructure + Cold / Freezer rooms + Sampling, milling, and dispensing suites and equipment + WFI Distribution + Fume hoods + General environmental storage conditions + Ensure the assigned processes are aligned with Industry and Lilly Standards + Support risk assessment exercises using the different tools available (e.g. FMEA) + Participate as required in teams, committees, or other groups and/or individually to achieve FUME's departmental, site and/or company goals. Initial project asset delivery phase and future local capital investment: + Lead or participate in projects/changes for all the systems under his/her responsibility in the LALBs including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects. + Develop the proper documentation (URS (User Requirement Specifications), test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and remain in a state of control. + Contribute to the process resource assessment, capital plans, expense budgets, and prioritize as appropriate. Daily Support for operations: + Monitor all systems associated with the LALBs and maintain KPI's to assure that they are operating properly and in compliance with internal and external requirements. + Act as the single point of contact for the LALBs in order to ensure compliance related activities such as deviations, change controls and CAPA's are resolved and implemented in conjunction with Operations. Quality Control, Process Engineering, Supply Chain, HSE and Quality Assurance. + Collaborate within the FUME organization in order to implement efficient and effective maintenance and reliability techniques in alignment with global engineering standards. + Apply "hands-on" problem solving skills in quickly and efficiently resolving equipment failures, troubleshooting, demonstrating RCA (Root Cause Analysis) lead investigator proficiency and guiding operations personnel in the resolution of system issues. + Provide internal customer consultation and notifications on issues that involve critical utilities and equipment associated with the LALBs. + Assure that all necessary corrective / preventive maintenance items are identified on the proper tracking systems, and ensure activities are completed by the required dates. + Provide technical assistance as necessary to FUME, HSE, Process Engineering, Supply Chain and/or Quality Control personnel. + Lead or participate in capital projects / changes for all systems under his/her responsibility in the LALBs including project management, design, resource planning, budget adherence and Qualification/Verification activities (IQ/OQ/PQ). + Support internal and external inspections and investigations (including Quality and HSE). + Maintain effective and efficient communications with appropriate site customer groups. **Basic Requirements:** + Bachelor's degree in Engineering (prefer ME, MET, Chem E) + 5+ years of direct engineering experience of building, utility and chemical equipment related systems and their use in a manufacturing setting, pharma preferred. **Additional Preferences:** + Previous start up experience for new building and pharma equipment related systems. + Understanding of agile engineering techniques used in the management of buildings, utilities and equipment. + Previous equipment installation / commissioning / qualification experience. + Engineering experience with manufacturing / chemical plant utilities. + Engineering related project management experience. + Experience with CMMS (Computerized Maintenance Management Systems), U/BMS (Utility/Building Management Systems) and QMS (Quality Management Systems). + Demonstrated office software skills (Word, Excel, PowerPoint, Outlook, UMS, data historian) and collaboration sites. + Excellent interpersonal, written and verbal communication skills. + Knowledge of cGMP principles. + Demonstrated high level of understanding of engineering concepts, 1st principles, and engineering functional standards. + Strong technical aptitude and ability to train and mentor others. Other Information: + Initial location at Lilly Technology Center, Indianapolis. + Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Purpose:** Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Development Clinical Research Physician (CRP) participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization. The CRP serves as a scientific resource and leader for study teams, departments, and others as needed. The Clinical Research Physician must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision. **Responsibilities:** The primary responsibilities of the Development CRP are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned. **General Responsibilities** + Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget. + Actively set and meet individual professional development goals and contribute to the development of others. + Actively participate in recruitment, diversity, and retention efforts. + Collaborate proactively and productively with all alliance, business and vendor partners. + Participate in active coaching by providing timely and constructive feedback to co-worker, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness. + Participate in committees, Six Sigma initiatives and task forces as requested by local/corporate management. + Ensures that at all times is adequately qualified and trained in the tasks required to perform Includes accountability and compliance for maintaining a current curriculum training map for self. + Model leadership behaviors. + Serve as an ambassador of both patients and the LillyBrand. **Clinical Planning** + Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design. + Contribute to business unit and global alignment of clinical strategy and clinical plans. + Understand and keep updated with the pre-clinical and clinical data relevant to the molecule. **Clinical Research/Trial Execution and Support.** + Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports)according to the agreed upon project timeline. + Provide oversight and input into ICDs. + Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions). + Review and approve risk profilesto ensure appropriate communication of risk to study subjects. + Participate in investigator identification and selection, in conjunction with clinical teams. + Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. + Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. + Serve as resource to clinical operations personnel/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. + Understand and actively address the scientific information needs of all investigators and personnel. + Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. + Review IIT proposals and publications, as requested by Director-Medical. **Scientific Data Dissemination/Exchange** + Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external healthcare professionals. + Understand and actively address the unsolicited scientific information needs of external healthcare professionals according to guidelines above. + Participate in reporting of clinical trial data in Clinical Trial Registry activities. + Support the planning of symposia, advisory board meetings, and other meetings with healthcare professionals. + Support medical information associates in preparation and review of medical letters and other medical information materials. + Prepare or review scientific information in response to customer questions or media requests + Provide telephone follow-up or specific written information requested by healthcare professionals as per global SOPs. + Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). + Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis. + Develop and maintain appropriate collaborations and relationships with relevant professional societies. + Support the design of customer research as medical expert. + Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and global patient outcomes personnel. + Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). + Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications. **Regulatory Support Activities** + Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal. + Provide medical expertise to regulatory scientists. + Support/ assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective. + Participate in advisory committees. + Participate in risk management planning along with affiliates and Global Patient Safety(GPS). **Business/ Customer Cupport** + Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans personnel and other cross-functional management during the development of the local business plan. + Understand and anticipate the scientific information needs of all Development customers (payers, patients, health care providers). + Actively address Development customer (payer, patient, and healthcare providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts. + Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization. + Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts. + Contribute as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value. + Support business-to-business and business-to-government activities as medical expert. + Contribute actively on an ongoing basis to the strategic planning for the brand. + By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed. + Become familiar with market archetypes and potential influence on the medical interventions for the product. + Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert. + Participate in PhRMA or other local or national trade associations. **Scientific /Technical Expertise and continued development** + Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product. + Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5years). + Responsible for the scientific training of the clinical study team. + Act as scientific consultant and protocol expert for clinical study team members and others in medical. + Explore and take advantage of opportunities for extramural scientific experiences. **Minimum Qualification Requirements:** + Medical Doctor. US trained physicians must have achieved board eligibility or certification. Must be board-eligible or certified in one of the following: Endocrinology or Internal Medicine + Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see******************************* + Fluent in English; both written and verbal communications. + Minimum of two years clinical experience in Endocrinology _or_ Internal Medicine with experience in metabolic disorders. + Minimum of five years research in metabolic disorders. **Other Information/Additional Preferences:** + Location flexible but must be able to work EST standard business hours with hybrid team headquartered in Indianapolis + Demonstrated knowledge of drug development process, including clinical, regulatory, and operational aspects + Has clinical development experience in an industry setting, including clinical trial design, medical monitoring, data interpretation, and/or regulatory principles/ submissions + Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills. + Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. + Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. 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 $198,000 - $356,400 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. **Overview:** At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. **Position Summary:** This position is part of the Bioproduct Research and Development (BR&D) organization within Lilly Research Labs. The BRD Clinical Trial (CT) manufacturing facility is focused on bringing new protein therapeutics to market by producing bulk drug substance (DS) for clinical trials, along with the associated technical data and documentation to support GMP activities. The Bioprocess Operations team within BR&D is responsible for the manufacture of DS to support clinical trials within the Lilly portfolio. This includes the internal manufacture of monoclonal antibodies, bioconjugates, and adeno-associated viruses, as well as oversight of DS manufacturing at qualified collaboration partners. This role serves as the Technical Lead for the Downstream Tech Service and Manufacturing Science (TS/MS) team within the BR&D DS CT manufacturing facility. You will combine technical leadership with strategic execution-driving DS batch technology transfer and delivery, ensuring robust clinical manufacturing performance, and acting as a key technical interface across development, operations, automation, and maintenance teams. In addition, you will mentor and develop downstream team members, fostering a culture of technical excellence and continuous improvement. **Responsibilities:** In this role, you will provide oversight of downstream processes for Bulk DS production and lead initiatives that enhance plant performance and reliability. You will partner closely with cross-functional teams to resolve complex technical challenges, implement innovative solutions, and ensure seamless integration of development-stage technologies into clinical manufacturing. Your leadership will extend beyond technical execution to include coaching and developing talent within the team. Responsibilities will include: + Lead and deliver downstream process technology transfer for Bulk DS into clinical manufacturing + Input and authoring for cGMP and PRD Quality System compliant manufacturing master production records and review of executed batch records where applicable + Ensure robust execution of DS batches with adherence to quality and regulatory standards + Active oversight of process and equipment performance, troubleshooting, optimization and real-time data monitoring + Serve as primary technical resource for downstream operations in the DS CT manufacturing pilot plant + Drive alignment between process development and manufacturing execution + Lead plant improvement projects focused on safety, efficiency, reliability, plant digitalization, and scalability of downstream operations + Actively engage with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Engineering, Maintenance, Environmental Monitoring, and Manufacturing to resolve complex technical challenges. + Coach and mentor team, fostering technical growth and professional development + Promote a culture of collaboration, accountability, and operational excellence **Basic Requirements:** + PhD in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 3 years hands-on purification experience OR + MS in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 5 years hands-on purification experience OR + BS in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 8 years hands-on purification experience + Proficiency with UNICORN software for chromatography process control and data analysis + Demonstrated ability to lead cross-functional projects and mentor technical staff + Excellent communication and leadership skills, with the ability to influence and drive change **Additional Preferences:** + Understanding of cGMP requirements and regulatory compliance for clinical manufacturing + Experience with scale-up of biopharmaceutical purification operations + Familiarity with automation systems and process control strategies + Understanding of computer system validation and equipment qualification + Familiarity and strong interest in application of digital solutions for GMP DS manufacturing **Additional Information:** + Position located in Indianapolis, IN at the Lilly Technology Center North + 8-hour days with flexibility to support activities during shutdowns, weekends, and outside of core hours **Physical Demands/Travel:** The physical demands of this job are consistent with an office and manufacturing environment **.** _The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job._ **Work Environment:** This position's work environment is in the office and manufacturing environment. _The_ _work_ _environment_ _characteristics_ _described_ _here_ _are_ _representative of those an employee encounters while performing the essential functions of this job._ _*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions._ Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $129,000 - $209,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Organization and Position Overview:** The Data Strategy & Data Orchestration Leader is a principal-level technical expert responsible for researching, designing, and implementing innovative data architectures and methodologies that position the Medicine Foundry as a leader in pharmaceutical data management. This role will develop novel approaches to data infrastructure, advance the state-of-the-art in pharmaceutical data technologies, and apply deep technical expertise to solve complex data challenges across the digital plant ecosystem. The Data Strategy & Data Orchestration Leader will pioneer modern solutions including data fabric architectures, real-time streaming platforms, ML-ready data infrastructures, and innovative data governance frameworks that balance regulatory compliance with operational agility. As a technical leader and innovator, this role collaborates as a peer expert with Tech@Lilly architects, partners with external research institutions and industry leaders, and applies specialized data architecture expertise to enable the Medicine Foundry's vision of automated, paperless, and fully integrated operations. In the Project Delivery Phase and Startup Phase of the project (2025 To 2028), 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 Lilly Medicines Foundry goes from design, to start-up, and to steady-state operations. **Key Responsibilities:** - Research, design, and implement novel data architecture approaches for pharmaceutical manufacturing that advance industry capabilities, including data mesh architectures, data fabric platforms, real-time streaming solutions, and cloud-native data services. - Develop innovative technical solutions for ML-ready data infrastructures including feature stores, MLOps platforms, model registries, experiment tracking systems, and automated ML pipeline orchestration that enable advanced analytics and AI applications. - Design and implement advanced data platforms employing modern technologies including lakehouses (Databricks, Snowflake), distributed processing (Spark, Dask), streaming architectures (Kafka, Pulsar), and cloud-native services for scalable, high-performance data infrastructure. - Collaborate with Tech@Lilly principal architects and engineers as a technical peer expert to design enterprise data architecture, evaluate emerging data technologies, and make platform decisions that balance innovation with operational requirements. - Partner with the Augmented Intelligence Leader to build technical infrastructure enabling AI/ML innovation through proper data preparation, feature engineering capabilities, model governance frameworks, and responsible AI implementation. - Develop innovative data governance frameworks and technical solutions that achieve cGMP compliance (21 CFR Part 11, EU Annex 11, ALCOA+) while enabling agility, including automated data quality monitoring, intelligent validation, and real-time audit trails. - Drive research collaborations with academic institutions, industry consortia, and technology partners to explore emerging data management methodologies and establish thought leadership that positions Medicine Foundry as a leader in pharmaceutical data innovation. - Design novel approaches to data democratization and self-service analytics in regulated environments, including semantic layers, knowledge graphs, automated metadata management, and AI-powered data discovery that enable business users while maintaining compliance. - Establish enterprise data standards, metadata frameworks, and master data management approaches that ensure seamless data flows across MES, LIMS, SAP, Sample Management, and other digital plant systems supporting the unified digital thread vision. - Lead multi-functional data governance council with PR&D, M&Q, QC, QA, and Engineering representatives to align on data requirements, quality metrics, integration approaches, and technical solutions for data integrity and regulatory compliance. - Build and mentor a high-performing team of data professionals, coaching them in advanced data technologies, innovative problem-solving approaches, and technical excellence while fostering their growth in specialized areas. **Basic Requirements:** - Bachelor's, Masters or PhD in Data Science, Computer Science, Data Engineering, or related technical experience. - Years of experience required: BS - 12+ years, MS - 8+ years, PhD 2+ years in data architecture, data engineering, or related technical fields with proven track record of researching, developing, and implementing novel data solutions in complex environments. - Relevant and progressive experience in data architecture, data engineering, or related technical fields with proven track record of researching, developing, and implementing novel data solutions in complex environments. - Deep hands-on technical expertise in modern data technologies including cloud platforms (AWS, Azure, GCP), distributed systems (Spark, Dask), streaming architectures (Kafka), and advanced data integration patterns with proven ability to design and implement enterprise-scale solutions. - Research-level expertise in data architecture methodologies including data mesh, data fabric, lakehouse architectures, real-time analytics, and ML infrastructure with demonstrated history of advancing beyond industry standard practices. - Strong knowledge of pharmaceutical M&Q systems (MES, LIMS, ERP, Sample Management) and experience designing data architectures that integrate complex manufacturing and quality systems while maintaining regulatory compliance. **Additional Preferences:** - Experience in pharmaceutical, biotechnology, or other FDA-regulated industries with deep understanding of cGMP data integrity requirements and regulated manufacturing data environments. - Track record of technical innovation demonstrated through publications, patents, conference presentations, open-source contributions, or recognized achievements in advancing data management methodologies in pharmaceutical or life sciences domains. - Deep hands-on experience implementing pioneering data solutions such as data mesh architectures, real-time streaming analytics, knowledge graphs, feature stores, MLOps infrastructure, or data fabric platforms in production enterprise environments. - Experience with emerging data technologies including semantic data layers, graph databases, vector databases, data observability platforms, and AI-powered data management tools with ability to evaluate and implement novel approaches. - Experience working in highly matrixed pharmaceutical organizations and partnering effectively with R&D technical leaders (R5+) and IT architects to deliver innovative yet pragmatic data solutions. - Entrepreneurial mentality with demonstratedability to pioneer innovative approaches, challenge existing practices, and drive technical innovation in ambiguous, fast-paced environments requiring creativity, resilience, and high learning agility. **Other Information:** - Initial location at Lilly Technology Center, Indianapolis. - Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $141,000 - $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. **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. The Analytical Technical Steward in API External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams, as well as APLOT. The Analytical Technical Steward works closely with development counterparts and GQL to ensure robust analytical control strategies are established for molecules they support. **Responsibilities:** + Technical review, interpretation, and release of data including data released from CM, stability, process validation, and reference standard characterization. + Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. + Develop investigational testing protocols and perform testing as required. + Contribute to APR, tech transfer, and process validation as required. + Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. + Participate in internal/external audits as needed + Develop and ensure execution of quality plan projects + Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. + Performs method assessments, with deficiencies and areas for improvement noted within the assessments. + Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. + Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). + Review of analytical test method packages + Approval of test method protocols + Approval of new test methods or changes or deletions to existing test methods + Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). + Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. + Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. + Local and Global Method Change Control Ownership + Oversight of reference standard evaluations per Global Quality Standards + Selection of appropriate packaging materials + Consult in the preparation of the characterization protocol for corporate reference standards + Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards + Participate in the review of the reference standard profile and associated documentation for data integrity + Method transfers to Contract Manufacturers + Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. + Monograph review and implementation + Ensures consistent practices between laboratories running the same methods + Effective management of multiple projects **Basic Requirements:** + Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy or equivalent experience). + 5+ years of industry related experience in pharmaceuticals in a GMP lab (Large Molecule, Peptide, and/or Oligonucleotide strongly preferred) **Additional Skills/Preferences:** + Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, bioassay, compendial and LC-MS. + Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. + Deep understanding of compliance requirements and regulatory expectations with demonstrated capability to coach and influence + Demonstrated accuracy and proficiency in analytical skills + Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology + Strong oral and written communication skills demonstrated through documentation and presentations + Demonstrated strong interpersonal interaction skills. + Ability to work in cross functional teams as well as across networks. + Demonstrated analytical skills. + Demonstrated experience with method qualification, validation, and transfer. + Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include Large Molecule, Peptide, and/or Oligonucleotides. + Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). + Proven ability to support maintenance of Corporate Reference Standards, and manage testing and reporting of results from contract manufacturers. **Additional Information:** + Must complete applicable Learning Plan requirements + Tasks may require repetitive motion and standing for long periods of time + Must be able to lift at least 5 liters of liquid + May be required to provide 24 hour cell phone coverage + May require up to approximately 20% of travel overseas, requiring a passport. + Role is located in Indianapolis, IN 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. **Position Title:** Design + Human Factors Engineering Senior Director -DDCS **Department Name:** Delivery, Device and Connected Solutions **Purpose** : In 1992, Eli Lilly and Company established the Delivery Device business to create, develop, launch and continuously improve proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient-centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables over $30 billion in pharmaceutical sales and is projected to drive company growth in the coming years. In response to this growing portfolio and increasing global regulatory expectations, the DDCS organization requires a Design and Human Factors Engineering Senior Director to provide leadership to support product innovation and product development for delivery and device systems at Eli Lilly and Company **.** This position is responsible for providing strategic direction, execution and reporting of design and human factors activities across all medical device, combination product and packaging programs, according to current regulations and appropriate guidelines within the medical device and biopharmaceutical industries. **Position responsibilities** : **Design and Human Factors:** + Lead and grow a top-tier engineering and science organization, which includes expertise in design and human factors engineering that is applied across the portfolio. + Ensures that: + Human capabilities and limitations are adequately reflected in the system requirements + Human performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs) + Human performance and safety risks are appropriately addressed in planning. + The staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance. + Human Factors Standards are appropriately documented in the Design Control Quality System. + Project milestones are met by identifying and managing risks and escalating as appropriate. + Functional budgets and project forecasts are maintained in compliance with P&L **People:** + Responsible for developing and managing the Design + Human Factors Engineering team. + Provides leadership, feedback, coaching, performance and career development support to direct reports. + Ensures career development discussions, talent assessment, and succession planning are in place for employees. + Builds and executes a comprehensive long-range recruiting strategy and technical succession plan to maintain a highly competitive cross-functional technical organization. **Strategy / Corporate Integration:** + Given the anticipated growth in the delivery business both in terms of the existing base of business and future ventures, the Design & Human Factors Engineering Senior Director will be accountable for the execution of a Delivery and Device Strategy with other members of the management team. + The delivery strategy and project workload are closely linked to that of the Business Units, Sales Affiliates, Medical, Manufacturing and Marketing. The position would work closely with the above groups to consistently align the strategies and projects. + Partner with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors and help draft policy positions across Lilly and the industry **Relationship Management:** + Ensure compliance with external collaborations + Create and maintain effective relationships and alignment with Lilly partners external to DDCS (e.g. Quality, Manufacturing, Regulatory, Digital Health, Business Units) + Build strong relationships with external vendors and lead external collaboration efforts to support development strategies as they may evolve **Minimum requirements:** + MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience. + Experience with regulatory agencies interactions and/or regulatory submissions of delivery devices and combination products. + Experience working within a Sponsor organization + Working knowledge of HF regulatory requirements, protocols, IRBs, Usability studies and reporting. + Human subjects research bioethics and study design + Prior supervisory experience of team organization + Ability to work effectively across boundaries + Demonstrated quality mindset, ability to influence and leadership capabilities **Additional Skills and Preferences:** + Understanding of and experience with device/drug regulations, standards and guidances as they pertain to specific functional responsibilities (e.g. CFR 820.30, ISO 13485, ISO 14971, IEC 62366, ANSI/AAMI HE75) + Business skills (capital and expense differentiation and impact on COGS and variance). + Communication and interpersonal skills necessary for broad interactions at all levels of the corporation. + Broad integrated technical knowledge of system and design engineering, product development, and commercialization (device, container closure, packaging, etc.). + Experience working in a diverse networked technical organization with proven skills in managing suppliers and alliance partners. + Leadership skills with previous experience managing technical personnel and alliance partnerships + Demonstrated ability to lead cross-functional teams **Additional Information** Position Location: Indianapolis, IN Ability to travel ~10-20% of the time, both domestic and international 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 $163,500 - $264,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Organization Overview:** 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. **Main Purpose and Objectives of Position:** The Lead HVAC Technician is a maintenance position that requires expertise in various mechanical, electrical, and instrumentation disciplines. The Lead HVAC Tech. will be responsible for overseeing the maintenance and repair of all HVAC equipment, ensuring optimal performance and minimal downtime supporting the entire LP1 site. This role involves performing routine maintenance, troubleshooting, and repairs to ensure the facility operates efficiently and complies with all regulatory standards and working closely with the PdM, reliability, and engineering groups. **Job Summary:** The Lead HVAC Technician in the pharmaceutical industry is responsible for the installation, maintenance, and repair of heating, ventilation, and air conditioning systems within a manufacturing environment. This role ensures that all HVAC systems operate efficiently and comply with regulatory standards to maintain optimal climate control for sensitive pharmaceutical products. **Key Responsibilities:** + **Safety:** Conduct daily activities with a safety-first mindset. Ensure compliance with safety regulations and company policies during all maintenance activities. + **Compliance:** Complete all work in a timely manner and in accordance with GMP (Good Manufacturing Practices) procedures. + **Documentation:** Complete all documentation associated with daily maintenance activities, including work order completion and post maintenance documentation. + **Communication:** Responsible for passing off vital information to all appropriate parties related to critical equipment issues both through oral and written communication methods. + **Lead a team** of HVAC technicians and contractors in performing preventive and corrective maintenance on manufacturing equipment. + **Installation and Maintenance:** Install, maintain, troubleshooting and repair HVAC systems including chillers, air handling units, and building automation systems (BAS) to ensure compliance with current good manufacturing practices (cGMPs). + **Monitoring Systems:** Conduct regular monitoring of HVAC equipment performance to identify issues before they escalate into major problems. + **Troubleshooting:** Diagnose mechanical failures and perform repairs on HVAC components such as compressors, pumps, and refrigeration units. + **Preventive Maintenance:** Execute preventive maintenance schedules to minimize downtime and extend the lifespan of equipment. + **Documentation:** Maintain accurate records of maintenance activities, repairs performed, and compliance with safety regulations. + **Collaboration:** Work closely with engineering teams to implement system upgrades while ensuring adherence to safety and quality standards. + **Emergency Response:** Participate in rotational on-call duties for emergency repairs outside regular working hours. **Required Qualifications:** + **Leadership** : Demonstrated leadership of directing or overseeing other HVAC technicians. + **Education:** Associate's degree in HVAC technology or a related field; equivalent work experience may be considered in lieu of formal education. + **Experience:** Minimum of 10 years of experience in HVAC maintenance within a pharmaceutical or regulated environment preferred. Experience with industrial HVAC systems is essential. + **Certifications:** EPA certification for refrigerants is required. Additional certifications related to HVAC systems are advantageous. **Skills:** + Strong mechanical knowledge of HVAC systems including electrical controls and building management systems. + Excellent troubleshooting skills with the ability to diagnose complex issues quickly. + Solid communication skills for effective interaction with team members and other departments. + Attention to detail in maintaining records and adhering to safety protocols. + Training of and collaboration with other crafts and reliability team. **Additional Information:** + Tasks require entering manufacturing areas which require wearing appropriate PPE. + May be required to provide support outside of normal working hours including nights, weekends, and holidays. + Travel to other facilities within the Lilly network (Minimal) + With this being a green site. Development of the HVAC program will take place with a transition to maintaining HVAC system. This role very likely could transform and change, as well as working closely with embedded contractors. + Provide backup support for HVAC supervisor. 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 $33.89 - $54.47 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients. **Position Summary:** The Senior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. Our team is seeking experienced, innovative, and motivated scientists to apply their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization. This technical-track role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development. **Responsibilities:** + Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development. + Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions). + Apply prior experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets. + Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites. + Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation). + Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing. + Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction. + Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions. + Welcome varied perspectives to create new solutions. + Actively engage in the external environment; recognize and apply external innovation across the Lilly synthetic portfolio. **Basic Requirements** : + Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field + 8+ years' experience in a pharmaceutical industry setting with specific focus on small molecules, synthetic peptides, or oligonucleotides. + Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods, authoring regulatory documentation, and overseeing CMO/CRO activities. + Must possess strong communication (oral, written), organizational, and leadership skills. **Additional Preferences:** + Experience with product commercialization, including technical transfer of analytical methods into manufacturing operations. + Demonstrated ability to drive and accept change. + Good interpersonal skills and a sustained tendency for collaboration. + Demonstrated success in persuasion, influence, and negotiation. **Additional Information:** + Travel: 0 to 10% + Position Location: On-site, 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 $144,000 - $250,800 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. The Dry EM Quality Assurance Representative provides support to all quality activities at Contract Manufacturing organizations (CMs) related to the manufacturing process of intermediates such as spry dry dispersion (SDD). The QA Representative position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. **Key Objectives/Deliverables:** + Serve as a liaison between CMs and Lilly. + Provide quality oversight of CMs including being the initial point of contact for all quality-related issues. + Escalate quality issues at CMs to Lilly QA management. + Assist in the establishment and revisions of Quality Agreements with affiliates and customers. + Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs). + Provide quality oversight of Lilly/Dry-EM Quality Plans + Coordinate and perform QA responsibilities of API shipments. + Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections. + Participate on the Technical Review Board + Evaluate and disposition batches of intermediate, if required. + Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release. + Provide quality support of the manufacturing process for intermediates (such as Spry dry dispersion technology) with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures. + Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable. + Ensure all processes are in an appropriate state of control. + Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product. + 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. + Participate in APR activities. + Participate in projects to improve productivity. + Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams. **Basic Requirements:** + BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences. + 3+ years of GMP manufacturing knowledge and/or experience in API/intermediates or finished product manufacturing, QC, QA or Engineering. **Additional Preferences:** + Experience in quality support for Quality Control activities + Thorough technical understanding of quality systems and regulatory requirements. + Knowledge of pharmaceutical manufacturing operations. + Demonstrated coaching and mentoring skills. + Experience in root cause analysis. + Demonstrated application of statistical skills. + Demonstrated strong written and verbal communications skills. + Strong attention to detail. + Proficiency with computer system applications. + Excellent interpersonal skills and networking skills. + Ability to organize and prioritize multiple tasks. + Ability to influence diverse groups and manage relationships. **Additional Information:** + Must complete required training for Dry-EM Quality Assurance. + No certifications required. + Must be able to support 24 hour/day operations. + Willingness to travel, expected 30% travelling. 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. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and continued support of ongoing manufacturing operations into the future. The Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Senior Principal Engineer as a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering 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. **Key Objectives/Deliverables:** - Technical Leadership - Mentor process control team, including design, controls philosophy, implementation and commissioning - Process control work implementation and coordination - Develop and implement the Automation Engineering Project Plan. **Operational Excellence** - Technically lead and oversee the work of Site Area leads and System Integrators and review Functional Requirements, Design Specifications, automation hardware, application software, Test Specifications. - Lead/Participate in design reviews and Site system hardware reviews, attend equipment and software FATs - Lead a team of automation engineers supporting commissioning - Provide periodic status updates to Project Management - Devise functional requirements and process control strategies for control systems in collaboration with Automation System Administrators to ensure all required hardware, instrumentation and controls are accounted for - Perform Automation Engineering activities including design, tuning and troubleshooting of control loops, devices and hardware - Implement and support electronic systems (such as plant historians) used to capture process automation related production data - Maintain the validated state of the site control system hardware in line with Lilly quality standards including the development and execution of validation strategies and associated documentation - Automation support for capital projects including new product introductions - Promote the use of automation to improve productivity, operational efficiency and compliance - Develop a 'network' of corporate contacts and leveraging corporate expertise when needed - Perform Site support that will include shift rotation to provide continuous support of day to day activities **Organizational Capability** - In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products. - Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines. - Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement - Demonstrated ability to influence peers and business partners - Good written and verbal communication skills for both technical and non-technical audiences - Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** - Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major pharmaceutical manufacturing. - A minimum of 2+ years working experience in Biopharma engineering, operations, or manufacturing. **Additional Preferences:** - Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, BMS controller and hardware, valves, motors, control panels, and Warehouse and Robotics systems (DeltaV, Rockwell, Johson Controls, Fanuc, Rosemount, Fisher etc). - Experience in facilitating and driving decision-making at an organizational level. - For Internal Lilly employees - LRL/Product Research Development experience preferred **Other Information:** + Initial location at Lilly Technology Center, Indianapolis. + Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. 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. \#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 $64,500 - $167,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Organization Overview:** The Lilly Industrial Hygiene (IH) Lab provides trace analytical services for the company's global Industrial Hygiene (IH) community. A primary mission of the IH Lab is to develop and validate monitoring methods for active pharmaceutical ingredients (APIs) coming from the clinical development pipeline. Lab staff work closely with site/location Industrial Hygienists to provide routine analysis of samples taken in the development and manufacturing space in support of employee exposure assessment, and they coordinate all 3rd party analytical needs including external data review and release. As well, lab staff provide creative technical solutions and project support for emerging needs as identified by the global IH community. This position reports through the Global Health, Safety, and Environment organization. **Responsibilities:** A primary mission of the IH Lab is to develop and validate monitoring methods for active pharmaceutical ingredients (APIs) coming from the clinical development pipeline. Monitoring methods typically include air sampling methods for personnel exposure characterization and swab methods for cleaning effectiveness after spills and decommissioning but may also include air and water monitoring methods and sample analysis for environmental evaluations. Key responsibilities of this position include: + Partnering with internal customers and external lab vendors to efficiently meet business needs. + Developing and validating air and surface monitoring methods, including sampling media. This may involve internal/external research and troubleshooting until an acceptable recovery is achieved. + Conduct laboratory analysis of active pharmaceutical ingredient (API) samples collected globally. + Coordinating sample analysis with third party laboratories and conducting a review of results before releasing to internal customers. + Calculating, documenting, and reporting study results via established laboratory programs such as electronic notebooks and laboratory software application. + Routinely monitoring the clinical development pipeline, connecting with site Industrial Hygienists to prioritize method development needs, and initiating requests when an occupational guideline limit is needed. + Peer reviewing laboratory data to confirm it is accurate and in compliance with procedures, assuring data is stored as required for archival, and supporting laboratory data quality assessment. + Researching and supporting the solution of key technical, operational, or business problems, as needed. + Organizing and/or conducting laboratory inspections and supporting the resolution of observations or areas for improvements. + Representing Lilly in the AIHA Pharma Round Robin and participating in external scientific forums, as appropriate. + Maintaining awareness of analytical sciences, pharmaceutical industry trends and industrial hygiene issues to drive continuous improvement in laboratory services. **Basic Requirements:** + B.S. with > 5 years of relevant experience or M.S. with >3 years of relevant experience in chemistry, biochemistry, or closely related field of study + Mass spectrometry, liquid, and gas chromatography analytical method development experience. **Additional Skills/Preferences:** + Proteomics experience strongly preferred. + Experience in ISO 17025 accredited laboratory. + Industrial Hygiene Chemist Certification. + Experience in GMP lab operations and Lean. + Coursework or experience in industrial hygiene or environmental sampling. 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** Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning. **Job Summary** The Manager of IT Contracts & Business Operations is responsible for negotiating fee-for-service IT contracts across the Lilly Catalyze360 organization. This role requires a proactive, self-driven individual with deep expertise in AI technologies and IT infrastructure and services who can navigate technical complexity while securing favorable commercial terms. The ideal candidate stays current on emerging AI/ML and other IT trends, understands their practical business applications, and can translate that knowledge into well-structured agreements that protect Lilly's interests while enabling innovation. This individual will provide contract matter expertise for IT engagements and collaborate with legal, finance, and technical stakeholders to structure agreements that balance business needs, risk mitigation, and cost optimization. The role has potential to expand into managing Business Operations IT pilots and systems implementations as well. **Key Responsibilities** + Negotiate complex contracts for a variety of Catalyze360 IT needs, including IT professional services, software license, software development, service level, SaaS/PaaS/IaaS, and AI/ML agreements as well as associated change orders + Serve as the primary interface between Business Operations and IT/business stakeholders, translating technical requirements into contractual terms and managing vendor relationships to ensure alignment with business objectives + Collaborate cross functionally with IT/business, legal, finance, and other stakeholders to structure IT agreements that balance business needs, risk mitigation, and cost optimization + Identify and mitigate business risks throughout the contracting process, including protecting sensitive confidential information and privacy + Manage multiple concurrent IT contract negotiations while monitoring performance and vendor compliance + Potential to oversee implementation, configuration, and ongoing management of Contract Lifecycle Management (CLM) and other systems to optimize contracting processes and ensure compliance + Potential to structure and oversee Business Operations pilot programs and promote adoption of successful pilot solutions **Minimum Requirements** + **Education:** Bachelor's degree from an accredited college or university + **Experience:** 3+ years of experience with a variety of IT contract negotiations (including IT professional services, software license, software development, service level, and SaaS agreements) in the biotechnology/ pharmaceutical or other regulated industry + **Work Authorization:** Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role. **Additional Skills/Preferences** + **Experience** + Demonstrated experience negotiating contracts for AI/ML applications across drug discovery and development + Prior experience designing and coordinating pilot programs, proof-of-concept initiatives, or technology evaluations + Experience with Contract Lifecycle Management (CLM) system implementation and optimization + **Skills** + Strong understanding of and fluency with IT architecture, cloud infrastructure, software development lifecycle, and enterprise technology solutions + Advanced expertise in Intellectual Property frameworks for AI/ML efforts + Deep understanding of IT security requirements, compliance frameworks including privacy regulations, and data governance in regulated industries + Ability to work through competing priorities with speed and agility in a highly collaborative environment with diverse stakeholders + Excellent communication skills with ability to engage diverse stakeholders including technical, legal, and finance team members + Strong analytical and problem-solving capabilities with strategic thinking and an entrepreneurial mindset **Additional Information** + Travel up to 10% US as needed for stakeholder engagement and vendor meetings. 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 $69,000 - $165,000 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. Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship. **Position Description:** Bioprocess - Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture. The successful candidate will be required to build deep technical expertise in their area of responsibility (including in-depth knowledge of the science behind the molecule and the process), have strong working skills on the manufacturing equipment set and control systems, and consistently demonstrate strong data-driven decision-making and problem-solving capabilities. They may also work to ensure that the process is in-control, capable, compliant, and maintained in a validated state through continual monitoring and may play a role in by implementing new technologies and process improvements in the manufacturing environment. **Key Objectives/Deliverables** + Have an in-depth knowledge of the science behind the molecule and the processes. Understand the process control strategy for gene therapy products + Provide technical support for all start-up TS/MS activities (e.g., NPI, tech transfer, process validation, process stewardship and improvement) + Ownership and technical stewardship of bioprocess and provide technical expertise during Root Cause Analysis for deviations and Impact Assessments for changes + Work as part of cross-functional teams, and establish partnerships with applicable functions, operations, and development to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team + Be able to assess whether the process is in control and capable of meeting its stated purpose and is in a constant state of validation + Identify process improvements and participate in implementation of Lean manufacturing initiatives + Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents and annual reports + Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda + Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability + Serve as technical interface external to the Lebanon site + Provide audit support, as needed + Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives. + Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities **Basic Requirements:** + Bachelor's in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field + 3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, or Engineering **Additional Preferences:** + Have an in-depth knowledge of the science behind the molecule and the processes on mRNA/LNP drug substance manufacturing. Understand the process control strategy for mRNA/LNP mediated gene therapy products + Experience and understanding of technical challenges with mRNA as a therapeutic modality is required + Experience with mRNA/LNP formulation + Experience with QC assays in line with product CQAs including variability + Strong interpersonal and teamwork skills + Strong self-management and organizational skills + Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization + Experience with data trending and analysis + Ability to analyze complex data and solve problems + Demonstrated successful membership/leadership of cross-functional teams Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. + This role is responsible to lead the technical service primary loop team responsible to provide technical oversight of the technical activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards. + This role is responsible of both technical excellence and compliance while meeting deliverables for day to day operation on making and supply medicines and new product commercialization. + Has responsibility for ensuring all products are manufactured according to a validated process, following the approved control strategy and maintaining in a validated state during the product cycle. **Responsibilities:** **Make & Supply Medicine** + Provide oversight to ensure reliable supply of medicines through effective and efficient manufacturing process. + Ensure capable and in control processes at CMs. Establish and maintain robust control strategy for all manufacturing/packaging/distribution operation and those meet the Lilly standards/expectations. + Ensure process definition of critical parameters are in alignment with regulatory submission. + Ensure that each of the department and external partner operate in compliance with cGMPs, regulatory commitments and Lilly Functional Standards though appropriate oversight. Ensure inspection readiness at all times. + Ensure Quality of the externally manufactured products through appropriate oversight, CAPAs, metrics and monitoring systems. + Build relationships with CMs to ensure alignment of intents and objectives. + Validation: ensure proper definition of strategies, revisions, protocol approvals, validation plans, final reports and master plan. Approve strategy documents and applicable protocols. + Change Control: Properly evaluate and assess impact of proposed changes to validated processes, regulations, relationship and regulatory commitments. + Deviations: Properly evaluate impact on product and processes. Properly evaluate impact on validated process and the control strategy. Ensure proper root cause identification and establishment of effective corrective action plans to prevent reoccurrence. + Ensure investigations are completed in an appropriated and timely fashion. + APR, ARs and OPVs: Ensure that all process reviews are conducted and all identified or changes are completed in a timely manner and in compliance with applicable standards. + Ensure External Manufacturing documentation (e.g., Quality Agreements, Manufacturing Requirements Document, validation documents) is in place and in compliance. + Build relationships externally to Lilly to create benchmark opportunities and identify best practices. + Oversees the execution of the technical agenda and each external partner, in line with business plan (BP), cGMPs and internal standards. + Escalate to Sr. Management in a timely fashion risks to supply, manufacturing issues, major deviations or safety and cybersecurity issues. + Lead implementation and execution of activities aligned with emerging need related to process improvement, control strategy or new regulation and ensure any emerging need is incorporate in the CMs technical agenda. **New CMs** + Contribute to CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options (if applicable). **Governance** + Be a member of the Flow Team and Science Lead Team (LT), Site Quality LT. + Support the functional Business plan and participate in the DPEM BP consolidation. Ensure the BP implementation within the established targets. + Establish effective networking with internal stakeholders and ensure alignment with central TS/MS and development. + Partner with Joint Process Team (JPT) Leader, Quality Managers and Secondary Loop to ensure TS/MS members of the JPT complete actions/objectives. **People** + Provide adequate staffing to meet the technical agenda, as well as the functional agenda + Lead the performance management (PM) process by overseeing development of employee PM plans; conduct interim and final reviews. + Coach, develop and provide feedback to members of the team. + Support diversity in recruiting and development of team members. Lead recognition, merit pay, and promotion decisions. + Support Technical talent assessment and succession planning activities. + Actively recruit and onboard new resources for the team. + Effectively encourage knowledge sharing and education within team and with key internal partners: Operations, Quality Assurance, Supply Chain and the corresponding Networks at the TS/MS Central Team. + Effectively encourage knowledge sharing and education with the external partners + Develop and grow the technical ability to be consistent with Drug Product External Manufacturing (DPEM) business needs for the supported Platform **Relationships** + All functions at the contract manufacturers from senior management to shop floor personnel. + Lilly Affiliate personnel and senior Country and Area management. + Lilly TS/MS, QA, Auditing groups, Laboratories at Lilly sites, US and European Manufacturing sites. + Senior TS/MS management, Product and Technical leaders, development scientists, CMC PMs and molecule stewards. **Basic Requirements** + Bachelors Degree in Pharmacy, Chemistry, Engineering, or similarly related fields. + 5+ years' experience in pharmaceutical manufacturing in technical services and/or quality. + Previous leadership experience. **Additional Preferences** + Knowledge and ability to apply basic statistical tools. + Regulatory related experience. + Established technical, quality, and internal networks. + Prior experience supporting drug product parenteral manufacturing. + A thorough understanding of cGMPs and drug product manufacturing. + Good communication skills, especially attention to detail in written procedures and protocol development. + High degree of technical curiosity and critical thinking. + High learning agility. + Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment. + Use of data and science to support decisions. + Willingness to learn new technologies. + Capability to work in a virtual and complex environment. + Willingness to travel. + Appreciation for cultural diversity. **Other information** + Shift is days, but off hours may be necessary to support operations. + Travel is possible, up to 30%. _This is not a remote position and would require relocation to a Lilly site._ 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 $123,000 - $180,400 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:** 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 Lead Operator for API manufacturing operations is directly responsible for the production of API molecules used in Lilly medicines. The Lead Operator will be responsible for upholding a safety-first, quality-always mindset in the production of API while running a production process that incorporates a wide range of unit operations. 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:** + Maintain compliance with all regulatory requirements at all times. + Support the execution of the production plan for the site. + Carry out daily monitoring testing and cleaning duties as assigned on the above listed systems to ensure equipment and systems are in good operating conditions and they are maintained in accordance with local and corporate regulatory requirements. + Enter Trackwise events, participate in and lead CAPA investigations + Troubleshoot and diagnose process problems and take appropriate actions to minimize deviations or site impact + Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards in order to execute key/critical GMP duties. + Understand other area processes & their operational hazards and being able to react appropriately. + Monitor and collect data on equipment use and performance i.e. trying to anticipate potential equipment reliability problems. + Work with Maintenance and Technical Support to respond appropriately to potential utility supply upsets or equipment failure. + Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing. + Communicate to other shifts regarding the status of the area operations and details of any issues/problems that have occurred at handover. + Actively participate in assigned building & area operations such as safety audits, procedure co-ordination, housekeeping and improvement projects. + Be trained and qualified on all specified unit operations within the building. + Identify concerns for informal or formal discussion (shift meetings, safety representative). + 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. + Minimum 3 years previous experience in operations **Additional Preferences:** + Previous experience in facility/area start-up environments + Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals + Ability to assume leadership and prioritize daily priorities without direct supervision + 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 periods **Additional Information:** + Ability to work rotating 12-hour day or night shifts + Ability to work flexible schedules during startup period + Ability to work overtime as required Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $25.60 - $37.55 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 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 7 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