Eli Lilly and Company jobs in Indianapolis, IN - 452 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. 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 Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals. The Team Lead, Engineering Maintenance manages a team of Maintenance technicians to support manufacturing continuously, efficiently, and effectively through maintenance activities (corrective, preventive). Please note that the shift for this role can be 1st or 2nd based on the business need. Location: Onsite Job Description Major accountabilities: * Adhere to Novartis Quality Policies and procedures as they pertain to the position to ensure that all products are safe, pure, effective and of the highest quality. * Perform a wide range of maintenance repair activities on production equipment, lab equipment and building management systems. * Provide guidance and leadership to team members. * Assist in troubleshooting and repair of process equipment (example: containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision. * Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. * Support 24x7 site-based operations after startup. * Write/revise accurate operational procedures, training documents and maintenance procedures for various production and utility systems. * Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment * Completes Equipment Work Order Thoroughly, and Accurately and Documents them in the System * Supply information and technical data for securing spare parts. * Provide responsive customer support with emphasis on customer satisfaction. * Perform startup and commissioning activities as required. * Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs * Perform preventative and corrective maintenance on manufacturing process related equipment within a cleanroom environment. * Complete and provide accurate documentation, as required in cGMP operations. * Oversee work and provide training of less experienced maintenance technicians and/or new technicians. * Other related duties as assigned. * Use of CMMS system for documentation of relevant work. The salary for this position is expected to range between $85,400 and $158,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Minimum Requirements: * High School diploma or equivalent is required; Bachelor's Degree is preferred. * 5+ years of relevant hands-on plant maintenance experience in a regulated GMP environment is required. * Previous supervisory, team/project lead experience is required. * Previous aseptic fill/finish and/or radio pharmacy experience is preferred. * Previous pharmaceutical or medical device experience is preferred. * Completed training in radioactive or hazardous materials environment is preferred. * Must be able to adhere to all applicable procedures, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.) * Experience working in a team environment, with excellent communication and organizational skills. * Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) or similar system. * Ability to climb ladders and lift up to 50 lbs. * Wear and work in protective clothing, including respiratory protection, confined space entry and clean room environments. * Must be flexible to work nights, weekends, and holidays as required. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $85,400.00 - $158,600.00 Skills Desired Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems , Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance

Description Performs responsibilities in generating sales, market share and profitability results for assigned territory with appropriate direction. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.Duties & Responsibilities Meets sales objectives and supports attainment of district and regional/ business unit performance objectives Development of market, customer, and industry knowledge along with further development of technical product knowledge is imperative. Effective utilization and management of internal and external resources is expected. Perform customer/consumer training meetings and support convention and professional association business building opportunities. Maintains and utilizes expert product knowledge and highly effective selling skills in order to influence customers to support the use of BIAH promoted products. Executes brand strategies to ensure a consistent company sales and marketing message. Uses appropriate BIAH Sales Training techniques to facilitate the sale. Utilizes CRM tools to create pre-call plans. Keeps current territory records concerning activities; communicates timely, accurately and meaningfully with Management. Utilizes CRM tool and supporting analysis to plan activity, report, monitor samples and maintain customer records. Analyzes territory information to optimize customer calls and create annual business plan for execution. Monitors market conditions for changes that impact our business. Completes objectives including achieving sales plan while operating within specified expense budget. Successfully completes all sales training requirements. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation within the animal health community and internally. Requirements Sales Representative: Bachelor's degree from an accredited institution required. Minimum of two to five (2-5) years of relevant field sales experience in a competitive selling environment required, or a minimum of two (2) years as a degreed, licensed and practicing Doctor of Veterinary Medicine in a clinic or animal health organization. Animal health or related industry experience preferred Ability to work with general supervision General knowledge of industry practices, techniques, and standards Experience presenting to various size audiences Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills PC skills and the ability to use mobile applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Senior Sales Representative: Bachelor's degree from an accredited institution required. Minimum of five-plus (5+) years of relevant field sales experience in a competitive selling environment required Animal health or related industry experience preferred Ability to work with general direction Complete understanding and application of principles, concepts, practices and standards Full knowledge of industry practices Experience presenting to various size audiences Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills PC skills and the ability to use mobile applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

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

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 Overview This person will play a critical role in maintaining brand excellence and consistency across Lilly's global enterprise. Reporting to the Senior Director of the Brand Office, you'll help bring the Lilly brand to life with internal and external stakeholders, ensure brand consistency, manage brand compliance and budget processes, and collaborate with multiple stakeholders across the organization to provide global brand support. The ideal candidate will have a passion for brand management or brand governance with a demonstrated ability to collaborate and get work done across functions. Strong communication and operational skills are expected. This person can navigate ambiguity and subjectivity while keeping the work moving and is solutions oriented. This role offers exposure to diverse business areas, collaboration with colleagues across the globe, and the opportunity to develop both operational and creative expertise while supporting the systems and processes that keep our brand strong and consistent, as well as identifying process improvements or efficiency opportunities. Key Responsibilities: Brand Office Management & Governance Provide global support to the internal organization through our Brand Office Support App Lead weekly Office Hours Manage our Viva Engage channel, creating engaging content and responding to employee questions Manage information key platforms and updates to the Lilly Brand Office Resource Center Support the Brand Governance Committee by tracking exception requests, brand violations and providing regular compliance reporting Help maintain documentation and historical files for proper retention recording Partner with MLRO and legal Trademarks teams to ensure materials meet compliance requirements Track budget allocations across projects and vendors. Process invoices and purchase orders Monitor spending against budget, flagging variances and providing regular financial reporting Lilly Signature Store Management Oversee day-to-day operations of the Lilly Signature Store Coordinate with vendors on product development, online and in-store inventory, and fulfillment Monitor important metrics and provide recommendations for future enhancements Support custom order requests to ensure alignment with Lilly brand guidelines Basic Qualifications Bachelor's degree in marketing, communications, business administration, or related field 3 years of experience in brand management or marketing operations 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. Preferred Qualifications Collaborative and solutions-oriented approach with strong problem-solving abilities Familiarity with Adobe Creative Suite, print production processes a plus Experience in brand promotional merchandising a plus Exceptional project management and prioritization skills Comfort with ambiguity and skilled in managing up to resolve issues efficiently Detail-oriented approach with commitment to accuracy and quality Strong communication skills, both written and verbal, with high attention to detail Global, OUS experience a plus Additional Information Global remit with strong focus in the US Position based in Indianapolis, IN Up to 15% travel 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 $58,500 - $137,500 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenge Eli Lilly & Company is seeking a versatile and energetic veterinary clinical pathologist to work in drug discovery and development at the Lilly Corporate Center in Indianapolis, IN. The individual selected for this position will join a talented group of pathologists reporting to the Senior Director of Pathology in the Division of Toxicology and Pathology. The individual selected should be able to work independently and collaboratively in cross-functional drug discovery and development teams within Lilly and with Lilly's external partners to provide scientific leadership in interpreting toxicity and pharmacologic effects caused by biopharmaceuticals. The successful candidate will be expected to contribute to the design, conduct, interpretation, and peer review of clinical pathology-related endpoints in animal studies supporting drug development, including pharmacology and toxicology studies. A key expectation will be to identify and bring solutions to pathology and toxicology issues affecting the discovery and development of potential biopharmaceuticals. This will be accomplished by working with a coordinated team of anatomic pathologists, toxicologists, nonclinical study managers, and other scientists. In addition, the role involves frequent interaction with external business partners, particularly assessing laboratory capabilities, validation of assays, biomarker development and/or outsourcing to meet drug development team needs, and peer review of study results. We are seeking an individual with strong communication and engagement skills to partner with a world-class organization of scientists and leverage translational and comparative medicine expertise to positively impact projects in Lilly's portfolio. Basic Qualifications DVM or equivalent degree and certification by the American College of Veterinary Pathologists (Clinical Pathology) Minimum of 7 years of experience in evaluating, interpreting, and reporting GLP and non-GLP clinical pathology data from nonclinical toxicity studies Additional Skills/Preferences Ph.D. in a field of science Experience in integrating clinical and anatomic pathology data from nonclinical toxicity studies Experience in the evaluation and reporting of pathology data from animal models of human disease or other types of drug discovery studies Clear and concise oral and written communication, particularly of pathology data Ability to work individually or effectively in cross-functional teams on issues related to drug discovery and development Development of scientific and regulatory perspectives on emerging issues and excellent problem-solving skills Experience working with multiple therapeutic modalities Training or certification in anatomic pathology Ability to travel to Lilly business partners and regulatory agencies to conduct Lilly Toxicology and Pathology business Familiarity with biomarker development practices, designing validation studies, and authoring reports. 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 $169,500 - $312,400 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 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. 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. Purpose: The R&D Audit & Inspection Associate provides essential support, oversight, and education to quality and business personnel concerning various components of the quality system, with a primary focus on Audits and Inspections and Notification to Management (NTM). This role is critical in ensuring GMQO's readiness for audits and inspections, enhancing quality system components, and supporting continuous improvement efforts with the GMQO Process Owner for Audits and Inspections. General Responsibilities Provides support, monitoring, and education to quality and business personnel for assigned quality system components, including, but not limited to Audits and Inspections, Notification to Management (NTM). Works closely with the GMQO process owner for Audits and Inspections for the monitoring and continuous improvement of the process. Serves as SharePoint Site Administrator (MIM sites) and supports the development and management of a cross functional inspection management infrastructure for logistics, preparation/planning, and close out activities including tracking all sponsor requests and facilitating inspection management response process. Administratively and logistically facilitates and manages backroom for sponsor inspections and audits hosted by Global Medicines Quality Organization. Manages the appropriate archiving of audits and inspections data and retrieval of documentation from various systems to support audits and inspections including master SOP list and documents in long-term storage or eArchive. Performs timely data entry as relates to audit / inspection conduct into Trackwise/Veeva and maintains, analyzes, and facilitates any actions as a result of bi-monthly inspection update metrics used by management and GMQO for inspection readiness. Coordinates routine and ad-hoc mock inspections / rehearsals in collaboration with GMQO. Maintains inspection readiness artifacts including but not limited to: Inspection Distribution List; Inspection Presentations; Inspection Organization Chart; Audit and Inspection Training. Participates in industry forums for inspection readiness information exchange and benchmarking as applicable. Lead, or conduct other projects /tasks as requested in the management of audit and inspection activities. Metrics and Data Responsible for compiling and reporting of audit / inspection compliance metrics at appropriate levels for management review. Performs trend analysis on inspection and audit issues/observations to provide meaningful and actionable data at governance meetings and for use in ongoing inspection readiness. Participates in the preparation of annual audit and self-inspection plans in collaboration with management and GQAAC. Participates in Management Review preparations for audit and inspection data in collaboration with Standard owners and GQAAC. Minimum Qualification Requirements: Bachelor's degree or High School Diploma and 10 years' experience in the Pharmaceutical Industry Other Information/Additional Preferences: Experience in Inspection/Audit preparation of Sponsor and related sites (eg clinical sites) within a GCP/GLP/GPvP environment). Experience with IT/systems supporting quality; specifically, TrackWise, Notification to Management, SharePoint and Power BI a plus. Knowledge of GLP, GCP and GVP global regulations as they relate to Clinical Development, Drug Safety and Drug Development. Excellent communication skills, both written and oral. Ability to effectively develop and present information to all levels of the organization. Prioritize and handle multiple concurrent tasks and good planning and organization skills. Work across functions to obtain input, resolve differences, and achieve results. Effectively apply judgment-based decision making in a regulated environment. Demonstrated ability to assess the state of current business and operations to identify and recommend future state, improvements, and implement action plans. Ability to manage complex projects end‑to‑end, set clear timelines, coordinate cross‑functional teams, and keep deliverables on track. Strong communication skills with the ability to translate technical or detailed information into clear, actionable updates for diverse audiences. Proven track record of maintaining alignment across teams, anticipating risks, and proactively resolving issues to keep projects moving smoothly. Understanding of being risk based focused and prioritizing work based on Risk Management methodologies. Work in a team matrix environment and independently interact with various levels of management. Limited travel: 0-10% 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. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $148,500 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Facilities and Security Services-Facilities-Environmental Health & Safety-P-Path -Manager - HSE - Fire Marshal Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Brand Description: Serves as a fire code subject matter expert (Fire Marshal) to Eli Lilly and Company's site and building engineers in the development, approval, and delivery of projects and the maintenance of existing assets. The Fire Marshal ensures the inclusion and maintenance of quality loss prevention systems (with required documentation) to meet the needs of customers, regulatory authorities, and system requirements pertaining to National Fire Protection Association (NFPA) standards, FM Global requirements, and International Building and Fire Codes adopted by Indiana. Also serves as the Lilly plant site liaison with Lilly Risk Management / Loss Prevention and FM Global engineering and account representatives. Position will function within Incident Command structure of Lilly Fire Rescue system. The Fire Marshal oversees and implements plant site level fire safety audit protocols to ensure fire safety and loss prevention systems are properly maintained. Key Objectives/Deliverables: Communicate with plant management, engineering, and others to ensure proper loss prevention requirements are designed and provided during new construction, planned renovations, and demolition. Review the design of loss protection systems to ensure Lilly standards are met. Meet regularly with site and building engineers, project managers, special event planners and safety representatives, to manage fire safety and loss prevention deliverables and ensure project drawings, requirement specifications, and detailed design are compliant with all fire/building codes and requirements. Lead annual fire safety building inspections for the campus. Maintain a current list of buildings with the associated building manager, safety representative, building engineer and site head. Perform annual inspections including scheduling, executing inspection, and providing report to building owners for assigned buildings. Provide annual inspection report findings to upper management. Lead Insurer loss prevention visits and coordinate special visits with building management. Lead the effort to resolve issues by acting as the contact person for follow-up on the visit recommendations. Recommend, evaluate, and monitor special hazard requirements, e.g., foam testing, gaseous systems, installation, fire protection impairments etc. Provide technical support and review for Building Code studies and their remediation efforts. Participate in pre-emergency planning and assist in the implementation of the emergency plans with both on-site and local emergency organizations. Respond to site emergencies as a technical resource to the incident commander and to the site emergency management team. Act as the site subject matter expert for employee emergency egress signage, as requested. Participate in Process Hazard Reviews, construction planning and logistics as requested needed. Interface with Maintenance, Security, HSE, Procurement, contractors, warehousing management, regarding both onsite and third parties relating to fire/life safety systems and requirements for the sites. Supports operations at other Lilly facilities and Lilly locations. Attend required or mandatory seminars/conferences to obtain new and/or maintain appropriate fire safety/code requirements. Minimum Requirements: BS, AS degree or 5-year related experience in HSE discipline. Ability to read and interpret building blueprints and associated technical documents. Effective interpersonal and relationship management skills. Effective communication skills, both verbal and written. Effective time management skills. Strong relationship building skills internal and external to the company. Additional Preferences: Advanced Fire Safety training is preferred. Familiarity and / or experience working with the external fire or loss prevention agencies. Experience working with personnel in the field on construction and maintenance projects related to fire safety. Experience in a positive safety culture or in helping to improve a safety culture. Experience in all roles within incident command system. Training / Certifications (Indiana or National Registry): Indiana FF1 / FF2 Fire Inspector 1 and 2 Fire Investigator 1 NIMS (100, 200, 300, 700, 800) Education Requirements: Bachelor's degree (or 5 years equivalent work experience). Other Information: This position supports a 24/7/365 operation and will be a Monday thru Friday position. Serve as liaison within the Lilly MST system. Non-response role. Additional onsite presence may be requested to address testing, consultation or emergency situations. Minimal travel may be required. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $148,500 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary: The Development Clinical Research Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues. Roles and Responsibilities of the Position: Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The Clinical Research Scientist will apply scientific and clinical training and expertise to described roles. Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Reporting of adverse events as mandated by corporate patient safety. Engage in clinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies. Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed. Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions. Minimum Requirements: An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty). 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology. Additional Preferences: Breast cancer disease area knowledge. Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors. Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team. Proven track record to bring out the best in others on a cross-functional international team. Leading by influence. Proven track record to interact externally and internally to support a global scientific and business strategy. Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel. Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator. Strong communication, both written and oral. Ability to multi-task and shift priorities rapidly to meet target dates. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $259,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly 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. Role Description The Associate, Master Data Steward plays a critical role in providing and maintaining the fundamental master data set residing in SAP and Manufacturing systems in the Lilly Medicine Foundry facility. The master data set includes Material Master, Bill of Materials, Recipes, Resources, Purchasing-Info Records and Warehousing data. This role is responsible for maintaining the quality and integrity of the data by documenting, inputting and verifying data into SAP, the Manufacturing Execution System (MES), activities could include supporting planning, materials management and warehouse management functionality and maintaining data accuracy through inspection readiness activities, audits and Master Data changes. This role is responsible for managing all data documentation, additions and changes, per customer or subject matter expert requirements. They will work closely with multiple teams across the site to manage data change requests, solve technical issues, and contribute to continuous improvement activities around Master Data. The position requires knowledge of manufacturing processes of drug product in development, an understanding of the significance of accurate data management and a demonstration of an excellent eye for detail. Knowledge and familiarization with the SAP system. Responsibilities * Develop and maintain key and data design for Supply Chain and Materials Management Master Data (such as: Bills of Material, Receipts, purchasing info records, Purchasing and Planning/Scheduling parameters) in SAP S4 including planning, materials management, warehouse operations, potentially quality master, supplier master and associated systems. * Work with Supply Chain Warehouse Data Lead to support the creation of warehousing operations master data, configurations and transactions. * Creating Bills of Material, Receipts, purchasing info records, Purchasing and Planning/Scheduling parameters. * Develop and maintain local Standard Operating Procedures (SOPs) and training materials for Supply Chain planning and Materials Management Master Data. * Determining the impact of local and/or global changes while ensuring global data consistency and conformance to Standard Operating Procedures. These changes could include: * SAP Master Data maintenance changes; Interfaced system changes (e.g. MES, etc.) * Process changes driven by Technical Services / Manufacturing Sciences or Engineering teams. * Identifying and participating in or leading process improvement initiatives. * Leveraging appropriate tools/reports to track maintenance efforts and both data accuracy and completeness. * Participating in annual standard costing for Business Planning and driving the review of planning parameters. * Troubleshooting SAP execution problems, identifying root causes, and implementing solutions. * Investigating deviations and providing impact assessments for change management. * Serve as a key member of the SAP Implementation Project Team during the greenfield site construction/startup phase. * Take on the temporary role during implementation as Security Steward in SAP to ensure correct security access profiles are assigned. * Work closely with the Global Security Network on security-related topics. * Contributing to global initiatives for Master Data Management, attending Power User forums to share best practices. * Generate OSSCE (Operational Standards for Supply Chain Excellence) metrics and Pareto analyses. * Maintaining a safe work environment, working safely and accountably to support all Health, Safety & Environmental Corporate and Site goals. * Work with Tech@Lilly groups like Global Services, and Global Infrastructure to support delivery of SAP functionality and infrastructure across the site. * Provide training and education on Master Data to Application Users and Data Owners. Basic Requirements: * Bachelor's degree in business, Computer Science, Supply Chain or related discipline * Minimum of 3 years' experience in manufacturing, preferred in pharmaceutical or other regulated industries. * Knowledge and familiarization with the SAP system such as: * Supply chain management functionality (such as: warehouse management, materials management, production planning for process industry). * Knowledge and work experience / master data experience in material master creation and maintenance. Additional Preferences: * Knowledge and familiarization with Manufacturing Execution System (MES) and its integration with SAP. * Knowledge in Good Manufacturing Practices and Good Documentation Practices (such as FDA, ICH, GAMP5). * Experience with business team support during and after internal quality audits or regulatory agency inspections. * Experience with business team support of computer system validation and testing activities such as requirements definition, business scenario test documentation and acceptance testing execution. * Business Knowledge: High performance in the delivery of their work. Critical and forward thinking to find better, simpler ways to improve user experience, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation, and organisational skills. * Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions. * Positive Influence: Demonstrated ability to address issues as they arise and act accordingly. Trusted in the team to flowthrough on actions. Is interested in own performance and seeks feedback to improve. * Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organisation. * Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions. * Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations. * Decision Making: Demonstrated ability to be decisive and make well-informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution. * Proficiency in modern project delivery frameworks such as SAP Activate, Agile, Scrum and PMI's Body of Knowledge. * Professional Certification in supply chain management (e.g., ASCM: CSCP, CPIM). Other Information: * Initial location at Indianapolis, Indiana. * Permanent location at the new Lilly Medicine 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 $58,500 - $160,600 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

The PCP/Endo Business Specialist is responsible for developing and implementing a plan for maximizing net sales of BIPI and co-promoted diabetes products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The PCP/Endo Business Specialist will conduct their business with key targeted healthcare providers and community hospitals, and may have additional responsibilities in teaching hospitals, federal and military hospitals, managed health care facilities, group purchasing organizations, integrated delivery networks, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Utilizes product knowledge and demonstrated selling skills in order to influence targeted health care professionals to support the use of BIPI promoted diabetes products. Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. + Completes pre-call plans to meet key stakeholder needs. Builds discussion around customer needs and opportunities. Fosters customer network development and communication. Has accurate and timely follow-up discussions with customers. Fosters ongoing trust with customer as relationship develops. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. + Identifies top plans for customers. Engages customers in comprehensive discussions on the payer environment, co-pays, and formulary access. Works with Managed Care Area Managers to generate and sustain support for products on MCO formularies. Develops and influences an extended team to pull-through MCO decisions. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. + Analyzes qualitative and quantitative territory information to optimize territory business plan and customer calls. Monitors local market conditions for changes that impact business. Develops plans to optimize allocation of key resources, including samples, co-pay cards, funds for speaker programs, and funds for in-office meals. Adjusts implementation plans on a regular basis (speaker mgmt., advocate development, etc.). Leverages opportunities that meet both territory and brand tactics. Utilizes supporting analysis tools to plan activity, report and monitor resource utilization, and maintain account and customer records. Completes all administrative responsibilities as directed by management. Successfully completes all Sales Training requirements. + Identifies thought leaders, innovators and advocates to support BIPI products. Works with trained speakers for diabetes topics and products. Provides feedback and follow-up to speakers and attendees. Initiates contacts and network-building among advocates and customer groups. Develops plans to develop speakers and thought leaders. Manages programs and budgets to stay within standards. + Works effectively with all customer-facing roles (i.e. Account teams, Medical teams, etc.) in a given geography to meet customer needs and deliver net sales objectives. Demonstrates strong collaboration and communication as customers evolve and ownership of accounts transition from traditional to account based. + Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community. **PCP/Endo Business Specialist Requirements** Bachelor's degree from an accredited institution is preferred. A minimum of two (2) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred. History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. "Export Laws" means the Export Administration Regulations ("EAR") of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time. **Executive PCP/Endo Business Specialist Requirements** Bachelor's degree from an accredited institution preferred A minimum of five (5) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. "Export Laws" means the Export Administration Regulations ("EAR") of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and systems to enable a successful startup into GMP manufacturing operations. Position Overview: The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team that provides the technical support required to achieve reliable and compliant manufacturing of API molecules. This role will be part of the Manufacturing Process Team for its respective area, providing daily oversight to ensure safe and reliable supply of medicines. The Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the manufacturing scientist should be capable and of setting up and executing a variety of experiments at laboratory scale and conducting research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory. Responsibilities: Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment. Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity. Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, etc. Develop and monitor established metrics in real-time to assess process variability and capability. Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose. Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps. Ensure that experiments are well designed with clear objectives. Ability to analyze data and ensure appropriate documentation. Write technical reports and documents. Basic Requirements: Bachelors in STEM Discipline (Chemistry preferred) 3+ years of experience in cGMP manufacturing (pharmaceutical manufacturing experience preferred) Additional Preferences: Demonstrated understanding of process chemistry Demonstrated basic knowledge in small molecule, peptide, or oligonucleotide API Manufacturing. Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development. Familiarity with cGMP manufacturing environment and terminology. Excellent analytical, interpersonal, written and oral communication skills. Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals. Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented. Guidance/mentoring of others through processes. Flexibility to meet business needs. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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 Process Control Engineer provides automation support for manufacturing operations in accordance with appropriate GMP and safety guidelines. This support includes change control implementation, deviation investigation, routine automation computer system support activities, and off hours automation computer system support. The Process Control Engineer also leads non-routine automation computer system support activities, delivers engineering projects to the business, is able to utilize first principles in delivery of these solutions, and can recommend new control strategies for the various chemical processes utilized in manufacturing operations. Key Objectives/Deliverables: Manufacturing Operations Automation Support Provide frontline automation technical support to manufacturing operations for process control system software and platforms. Ability to configure process control systems and troubleshoot computer system software. Provide a high level of data mining and analysis to identify improvements in the manufacturing process. Design and implement automation related changes to manufacturing operations. Lead investigation of automation related deviations. Perform system support activities (e.g. system backups, performance monitoring, password maintenance, etc.) Provide off hours automation support to operations. Perform all work in a manner consistent with Lilly policies, procedures, and standards. Ability to work in a safe manner and ensure safety of others. Provide engineering solutions to the business Automation design and delivery of new process units. Provides project management and technical leadership to projects. Oversight of specialists and/or contractors assisting in the delivery of automation solutions. Utilizes S88 and fundamental engineering principles in the delivery of automation solutions. Is responsible for ensuring that life-cycle plans are developed and executed for automation systems. Provide recommendations on new control strategies/technologies Research and maintain familiarity with various control strategies/technologies. Research and maintain familiarity with chemical processes utilized in pharmaceutical manufacturing. Mentor Technicians, Specialists, and Engineers Mentor specialists in technical and professional development. Basic Requirements: Bachelor of Science in Engineering. Minimum 2 years of industrial experience. Experience with Distributed Control Systems (DeltaV). Additional Preferences: Ability to configure process control systems and troubleshoot computer hardware. Experience working in a regulated environment, preferably pharmaceutical or chemical manufacturing for 2+ years. Previous experience with manufacturing deviation and change control processes. Understanding of S88. Familiar with control theory. Teamwork and interpersonal skills. Good written and oral communication skills. Attention to detail. Additional Information: Able to provide 24 hours per day, 7 days per week on-call support approximately 1 week per month. Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. 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. 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 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. Primary Responsibilities: This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. The primary 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. 1. 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. 2. Clinical 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. Provides 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 profiles to ensure to 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. 3. Scientific Data Dissemination/Exchange Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals. Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care 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 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 Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications. 4. 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 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). 5. Business/ customer support (pre and post launch support) 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 health care 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. Contribute actively on an ongoing basis to the strategic planning for the brand. 6. 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 (3-5 years). Responsible for the scientific training of the clinical study team. Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Explore and take advantage of opportunities for extramural scientific experiences. Attend scientific symposia. 7. 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. Participates 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 the leadership behaviors. Be an ambassador of both patients and the Lilly Brand. Minimum Qualification Requirements: Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer. 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 PLA: Medical Licensing Information (****************************************************************************************************************************************************************** and Medical Education | MBC (*********************************************************************************************************************** Additional Preferences: Clinical research or pharmaceutical medicine experience Medical specialization in dermatology or allergy and immunology At least 3 years of global clinical development experience At least 3 years of pharmaceutical industry experience Demonstrated knowledge of drug development process Fluent in English; both written and verbal communications 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. 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