Lilly & Company jobs in Indianapolis, IN

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **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. **Responsibilities** **Statistical Analysis:** + Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans, write reports and communicate results, assist/respond to regulatory queries. + Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the analysis plan, and conducting the actual analysis once a reporting database is created. + Collaborate with data management in the planning and implementation of data quality assurance plans. + Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods. + Effectively justify methods selected and implement previously outlined analysis plans. + Conduct peer-review of work products from statistical colleagues. + Effectively use current technologies and available tools for conducting the clinical trial analysis. + Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one-on-one with key customers. **Therapeutic Area and Systems Knowledge:** + Understand relevant disease states in order to enhance the level of customer focus and collaboration. + Ensure replication of tools and systems, where applicable and stay informed of technological advances. **Regulatory and Quality Compliance:** + Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable corporate, medical, local, and departmental policies, procedures, processes, and training. **Basic Qualifications** + Master's degree in Statistics, Biostatistics or MSPH with concentration in Statistics or Biostatistics. **Additional Skills/Preferences** + Proficiency in statistical programming languages/software such as SAS, R, Spotfire, etc. + Interpersonal/teamwork skills for effective interactions + Technical growth and application with solid understanding of statistics and statistical software + Self-management skills with a focus on results for prompt and accurate completion of competing deliverables + Creativity and innovation + Demonstrated problem solving ability and attention to detail. + Data analysis, technology, and systems expertise Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $182,600 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 Site Operational Excellence (OPEX) Lead is accountable for executing and supporting the Operational Excellence Management System for Manufacturing and Quality (M&Q). Reporting to an Operations Leader at the site, this role focuses on site-level implementation, coaching, and continuous improvement of Operational Excellence to ensure alignment with the overall strategy and governance. The Site OPEX Lead serves as the key interface between the Global OpEx team and the site, as well as the interface between the Site OPEX Team and the Site Leadership Team (SLT). The OPEX Lead is an SME in Lean, Problem Solving, Root Cause Analysis, Manufacturing Standards of Operational Excellence, and Human Performance Reliability. This role involves a balance of execution, coaching, and administrative leadership.** **Key Objectives / Deliverables:** **Business Transformation:** **Lead the Site Operational Excellence Lead Team and provide Operational Excellence support for site central functions.** **Own the site prioritization process, Operational Excellence education strategy, Operational Excellence roadmap, and site-wide transformational initiatives.** **Participate in Site Lead Team metrics reviews, identify trends, and lead site improvement initiatives.** **Assist in preparation of the Site Business and Strategic Plan; lead strategy deployment and participate in relevant SLT topics.** **Influence local organizational uptake and execution of OpEx practices, tools, behaviors, and culture.** **Develop, coach, and lead the local OpEx team members.** **Identify, recruit, and onboard Operational Excellence talent.** **Ensure strategies and projects meet safety, product quality, compliance, financial and applicable regulatory** **Education and Development** **:** **Facilitate Operational Excellence training to all levels of employees within assigned areas to support deployment and ongoing sustainability of Operational Excellence / Lean ways of working.** **Coach and train teams in Lean tools and systems (for example, daily management, A3 thinking, standard work)** **Coach local leaders and Operational Excellence Business Partners on program execution.** **Host local Operational Excellence education and communication sessions to monitor program and resource execution, share best practices, foster collaboration, communicate and facilitate Operational Excellence learning opportunities, and apply PDCA learning cycles to improve Operational Excellence business processes.** **Serve as technical leader for other Operational Excellence Business partners and build their Manufacturing operations, Lean, RCA, Problem Solving, HPR, and program management skill set.** **Continuous Improvement and Project Management** **Lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Human Performance Reliability (HPR), etc.** **Establish and implement project management processes and methodologies to ensure Continuous Improvement projects are delivered on time, adhere to high quality standards, and meet team expectations.** **Lead the establishment of Operational Excellence systems (e.g., the Lean Production, Lean Management systems, and our digitally integrated visual management system) within assigned areas, including the components and their interactions.** **Network and Knowledge Management** **Facilitate shared learning and lead Operational Excellence Assessments within the site (site and globally driven).** **Integrate and drive Operational Excellence culture and systems within the site.** **Align with Global Operational Excellence business processes and support the delivery of OpEx objectives.** **Actively engage in the broader Operational Excellence community through periodic updates, 1:1 meetings, and ad hoc discussions.** **Minimum Requirements (Education, Experience, Training):** **Bachelor's degree or higher in a relevant scientific or technical field.** **5+ years in Manufacturing.** **Prior experience in Lean, Six Sigma, or Operational Excellence.** **Additional Preferences:** **Demonstrated successful leadership experience and influence of cross-functional teams.** **Results-oriented with excellent interpersonal and interaction skills.** **Strong balance of leadership, analytical, project management, and strategic thinking skills.** **Effective educator and presenter. Enthusiastic, flexible, and positive attitude Experience in Lean Manufacturing or other Productivity industry methods.** **Strong communication and computer skills required.** **GMP operational experience.** **Other Information:** **Travel (domestic and international) may be required.** Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $122,250 - $196,900 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

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

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. 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. **_Advisor, Global Medical Affairs, Obesity/NILEX, Non M.D._** **Organization Overview** : Candidate will work as a Clinical Research Scientist (CRS) in the Cardiometabolic Health Global Medical Affairs team supporting Obesity and NILEX portfolio. **Job Responsibilities** _:_ Role includes support to MLR reviews, brand and medical planning, implementation of medical tactics, support to Global Medical Information, Medical Education, Internal Training, evidence generation and scientific data disclosure and support to Commercial teams. + Identify opportunities for secondary /post hoc analyses of clinical trials. Provide input to IEG process as needed. + Support commercial teams for specific tactics, medical review of promotional materials. Team member for potential contributions to brand and medical planning and implementing tactics of the plans. + Support Medical Education through design, content creation and implementation of tactics + Train Medical and other functions on data as needed + Support Medical Information through input to cFAQs and other documents. + Support Phase 3b-4 and HEOR studies as needed. **Education Requirements** _:_ + Advanced medical-related graduate degree, such as: DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years' experience in a related scientific field, e.g. pharmacology, physiology, microbiology or a scientifically related field. OR + _*BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs_ _._ + 2 or more years of clinical experience, or 2 or more years of pharmaceutical experience. **Additional Preferences** + Previous disease state experience on Obesity and/or MASH and/or CV diseases is preferred + Fluent in English; both written and verbal communications + Interpersonal, organizational and negotiation skills + Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. + Excellent teamwork skills. + Willing to engage in domestic and international travel to the degree appropriate to support the business of the team. + Strong individual leadership skills 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. **\#WeAreLilly** Lilly is proud to offer market-competitive employee benefits designed to empower you to live your best life. Employees may elect medical, prescription drug, dental and/or vision coverage for you and your family in one of two health plan options, enjoy best-in-class mental health support, and concierge services for orthopedic, cardiovascular, fertility care, and LGBTQ health navigation. We also support well-being with a fitness membership, health coaching, and wellness activities at no additional cost. Our retirement benefits are designed to help our employees feel secure in their financial future by including a defined benefit pension, a 401(k) match, and retiree medical coverage. We provide life and disability insurance for peace of mind and protection for you and your loved ones and paid time-off benefits to support you in life's moments that matter including personal illness, caregiver, bereavement, and other family needs, in addition to annual paid vacation and holidays. Lilly reserves the right to terminate or modify company provided benefits at any time in its discretion. The company compensation structures are aligned to the location of hire. The United States pay range and benefits offering do not apply to any location outside of the United States Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $244,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Organization Overview** At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. The Analytical Technical Steward in API External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams, as well as APLOT. The Analytical Technical Steward works closely with development counterparts and GQL to ensure robust analytical control strategies are established for molecules they support. **Responsibilities:** + Technical review, interpretation, and release of data including data released from CM, stability, process validation, and reference standard characterization. + Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. + Develop investigational testing protocols and perform testing as required. + Contribute to APR, tech transfer, and process validation as required. + Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. + Participate in internal/external audits as needed + Develop and ensure execution of quality plan projects + Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. + Performs method assessments, with deficiencies and areas for improvement noted within the assessments. + Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. + Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). + Review of analytical test method packages + Approval of test method protocols + Approval of new test methods or changes or deletions to existing test methods + Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). + Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. + Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. + Local and Global Method Change Control Ownership + Oversight of reference standard evaluations per Global Quality Standards + Selection of appropriate packaging materials + Consult in the preparation of the characterization protocol for corporate reference standards + Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards + Participate in the review of the reference standard profile and associated documentation for data integrity + Method transfers to Contract Manufacturers + Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. + Monograph review and implementation + Ensures consistent practices between laboratories running the same methods + Effective management of multiple projects **Basic Requirements:** + Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy or equivalent experience). + 5+ years of industry related experience in pharmaceuticals in a GMP lab (Large Molecule, Peptide, and/or Oligonucleotide strongly preferred) **Additional Skills/Preferences:** + Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, bioassay, compendial and LC-MS. + Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. + Deep understanding of compliance requirements and regulatory expectations with demonstrated capability to coach and influence + Demonstrated accuracy and proficiency in analytical skills + Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology + Strong oral and written communication skills demonstrated through documentation and presentations + Demonstrated strong interpersonal interaction skills. + Ability to work in cross functional teams as well as across networks. + Demonstrated analytical skills. + Demonstrated experience with method qualification, validation, and transfer. + Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include Large Molecule, Peptide, and/or Oligonucleotides. + Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). + Proven ability to support maintenance of Corporate Reference Standards, and manage testing and reporting of results from contract manufacturers. **Additional Information:** + Must complete applicable Learning Plan requirements + Tasks may require repetitive motion and standing for long periods of time + Must be able to lift at least 5 liters of liquid + May be required to provide 24 hour cell phone coverage + May require up to approximately 20% of travel overseas, requiring a passport. + Role is located in Indianapolis, IN Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Position Title:** Design + Human Factors Engineering Senior Director -DDCS **Department Name:** Delivery, Device and Connected Solutions **Purpose** : In 1992, Eli Lilly and Company established the Delivery Device business to create, develop, launch and continuously improve proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient-centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables over $30 billion in pharmaceutical sales and is projected to drive company growth in the coming years. In response to this growing portfolio and increasing global regulatory expectations, the DDCS organization requires a Design and Human Factors Engineering Senior Director to provide leadership to support product innovation and product development for delivery and device systems at Eli Lilly and Company **.** This position is responsible for providing strategic direction, execution and reporting of design and human factors activities across all medical device, combination product and packaging programs, according to current regulations and appropriate guidelines within the medical device and biopharmaceutical industries. **Position responsibilities** : **Design and Human Factors:** + Lead and grow a top-tier engineering and science organization, which includes expertise in design and human factors engineering that is applied across the portfolio. + Ensures that: + Human capabilities and limitations are adequately reflected in the system requirements + Human performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs) + Human performance and safety risks are appropriately addressed in planning. + The staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance. + Human Factors Standards are appropriately documented in the Design Control Quality System. + Project milestones are met by identifying and managing risks and escalating as appropriate. + Functional budgets and project forecasts are maintained in compliance with P&L **People:** + Responsible for developing and managing the Design + Human Factors Engineering team. + Provides leadership, feedback, coaching, performance and career development support to direct reports. + Ensures career development discussions, talent assessment, and succession planning are in place for employees. + Builds and executes a comprehensive long-range recruiting strategy and technical succession plan to maintain a highly competitive cross-functional technical organization. **Strategy / Corporate Integration:** + Given the anticipated growth in the delivery business both in terms of the existing base of business and future ventures, the Design & Human Factors Engineering Senior Director will be accountable for the execution of a Delivery and Device Strategy with other members of the management team. + The delivery strategy and project workload are closely linked to that of the Business Units, Sales Affiliates, Medical, Manufacturing and Marketing. The position would work closely with the above groups to consistently align the strategies and projects. + Partner with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors and help draft policy positions across Lilly and the industry **Relationship Management:** + Ensure compliance with external collaborations + Create and maintain effective relationships and alignment with Lilly partners external to DDCS (e.g. Quality, Manufacturing, Regulatory, Digital Health, Business Units) + Build strong relationships with external vendors and lead external collaboration efforts to support development strategies as they may evolve **Minimum requirements:** + MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience. + Experience with regulatory agencies interactions and/or regulatory submissions of delivery devices and combination products. + Experience working within a Sponsor organization + Working knowledge of HF regulatory requirements, protocols, IRBs, Usability studies and reporting. + Human subjects research bioethics and study design + Prior supervisory experience of team organization + Ability to work effectively across boundaries + Demonstrated quality mindset, ability to influence and leadership capabilities **Additional Skills and Preferences:** + Understanding of and experience with device/drug regulations, standards and guidances as they pertain to specific functional responsibilities (e.g. CFR 820.30, ISO 13485, ISO 14971, IEC 62366, ANSI/AAMI HE75) + Business skills (capital and expense differentiation and impact on COGS and variance). + Communication and interpersonal skills necessary for broad interactions at all levels of the corporation. + Broad integrated technical knowledge of system and design engineering, product development, and commercialization (device, container closure, packaging, etc.). + Experience working in a diverse networked technical organization with proven skills in managing suppliers and alliance partners. + Leadership skills with previous experience managing technical personnel and alliance partnerships + Demonstrated ability to lead cross-functional teams **Additional Information** Position Location: Indianapolis, IN Ability to travel ~10-20% of the time, both domestic and international Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $163,500 - $264,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Organization Overview:** Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. **Position Brand Description:** The Health Safety and Environment (HSE) Permit Writer will develop and maintain safe work permits within the production building. A successful candidate will interface with the Process Team and Project Team to manage equipment availability. In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. **Responsibilities:** + Safe work permit preparation including the coordination of operations, project, and maintenance personnel. + Execute the required safe work permits, which includes but is not limited to lock out tag out (LOTO), hot work, confined space entry, etc. + Develop and maintain equipment specific instructions including but not limited to lock-out, tag-out. + Develop and maintain confined space entry risk assessments. + Develop and maintain permitting equipment and supplies. + Perform safety audits and maintain an audit ready status. + Review and monitor relevant Standard Operating Procedures (SOPs) and SOP updates. Execute unplanned SOP changes. + Influence adherence to project and maintenance schedules. + Support Process Engineers/Maintenance/Projects and Supervision in daily operations. + Identify and support the implementation of improvements from Operations. + Ownership of daily tasks, preventative maintenance or breakdowns. + Conduct continuous improvement projects which are aligned with safety and quality expectations and meet operational needs + Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards. + Understand other area processes & their operational hazards and being able to react appropriately. + Actively participate in assigned building & area operations such as safety audits, procedure coordination, housekeeping and improvement projects. + Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification. **Basic Requirements:** + High School Diploma or equivalent + Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. + Completion of Post Offer Exam or Completion of Work Simulation if applicable. + Ability to effectively communicate (electronically, written and verbal). + Basic computer skills (desktop software) are required. **Additional Preferences:** + Previous experience in facility/area start-up environments. + Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals. + Solid understanding of FDA guidelines and cGMP requirements. + Strong organizational skills and ability to handle and prioritize multiple requests. + Knowledge of lean manufacturing principles. + Flexibility - ability to troubleshoot and triage challenges. + Ability to understand technical nomenclature and language as well as work with mathematical formulas. + Manual material handling as appropriate. + Bend, reach, stretch, climb ladders, and work in tight spaces. + Stand for long period. **Additional Information:** The Safety Permit Writer role operates on a work schedule of Monday through Friday, 8 hours per day. The job may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend training activities etc. + Ability to work flexible schedules during startup period. + Ability to work overtime as required. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_************************** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. \#WeAreLilly Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $28.84 - $42.31 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Organization Overview:** Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. **Main Purpose and Objectives of Position:** The Lead HVAC Technician is a maintenance position that requires expertise in various mechanical, electrical, and instrumentation disciplines. The Lead HVAC Tech. will be responsible for overseeing the maintenance and repair of all HVAC equipment, ensuring optimal performance and minimal downtime supporting the entire LP1 site. This role involves performing routine maintenance, troubleshooting, and repairs to ensure the facility operates efficiently and complies with all regulatory standards and working closely with the PdM, reliability, and engineering groups. **Job Summary:** The Lead HVAC Technician in the pharmaceutical industry is responsible for the installation, maintenance, and repair of heating, ventilation, and air conditioning systems within a manufacturing environment. This role ensures that all HVAC systems operate efficiently and comply with regulatory standards to maintain optimal climate control for sensitive pharmaceutical products. **Key Responsibilities:** + **Safety:** Conduct daily activities with a safety-first mindset. Ensure compliance with safety regulations and company policies during all maintenance activities. + **Compliance:** Complete all work in a timely manner and in accordance with GMP (Good Manufacturing Practices) procedures. + **Documentation:** Complete all documentation associated with daily maintenance activities, including work order completion and post maintenance documentation. + **Communication:** Responsible for passing off vital information to all appropriate parties related to critical equipment issues both through oral and written communication methods. + **Lead a team** of HVAC technicians and contractors in performing preventive and corrective maintenance on manufacturing equipment. + **Installation and Maintenance:** Install, maintain, troubleshooting and repair HVAC systems including chillers, air handling units, and building automation systems (BAS) to ensure compliance with current good manufacturing practices (cGMPs). + **Monitoring Systems:** Conduct regular monitoring of HVAC equipment performance to identify issues before they escalate into major problems. + **Troubleshooting:** Diagnose mechanical failures and perform repairs on HVAC components such as compressors, pumps, and refrigeration units. + **Preventive Maintenance:** Execute preventive maintenance schedules to minimize downtime and extend the lifespan of equipment. + **Documentation:** Maintain accurate records of maintenance activities, repairs performed, and compliance with safety regulations. + **Collaboration:** Work closely with engineering teams to implement system upgrades while ensuring adherence to safety and quality standards. + **Emergency Response:** Participate in rotational on-call duties for emergency repairs outside regular working hours. **Required Qualifications:** + **Leadership** : Demonstrated leadership of directing or overseeing other HVAC technicians. + **Education:** Associate's degree in HVAC technology or a related field; equivalent work experience may be considered in lieu of formal education. + **Experience:** Minimum of 10 years of experience in HVAC maintenance within a pharmaceutical or regulated environment preferred. Experience with industrial HVAC systems is essential. + **Certifications:** EPA certification for refrigerants is required. Additional certifications related to HVAC systems are advantageous. **Skills:** + Strong mechanical knowledge of HVAC systems including electrical controls and building management systems. + Excellent troubleshooting skills with the ability to diagnose complex issues quickly. + Solid communication skills for effective interaction with team members and other departments. + Attention to detail in maintaining records and adhering to safety protocols. + Training of and collaboration with other crafts and reliability team. **Additional Information:** + Tasks require entering manufacturing areas which require wearing appropriate PPE. + May be required to provide support outside of normal working hours including nights, weekends, and holidays. + Travel to other facilities within the Lilly network (Minimal) + With this being a green site. Development of the HVAC program will take place with a transition to maintaining HVAC system. This role very likely could transform and change, as well as working closely with embedded contractors. + Provide backup support for HVAC supervisor. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $33.89 - $54.47 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and continued support of ongoing manufacturing operations into the future. The Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Senior Principal Engineer as a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. **Key Objectives/Deliverables:** - Technical Leadership - Mentor process control team, including design, controls philosophy, implementation and commissioning - Process control work implementation and coordination - Develop and implement the Automation Engineering Project Plan. **Operational Excellence** - Technically lead and oversee the work of Site Area leads and System Integrators and review Functional Requirements, Design Specifications, automation hardware, application software, Test Specifications. - Lead/Participate in design reviews and Site system hardware reviews, attend equipment and software FATs - Lead a team of automation engineers supporting commissioning - Provide periodic status updates to Project Management - Devise functional requirements and process control strategies for control systems in collaboration with Automation System Administrators to ensure all required hardware, instrumentation and controls are accounted for - Perform Automation Engineering activities including design, tuning and troubleshooting of control loops, devices and hardware - Implement and support electronic systems (such as plant historians) used to capture process automation related production data - Maintain the validated state of the site control system hardware in line with Lilly quality standards including the development and execution of validation strategies and associated documentation - Automation support for capital projects including new product introductions - Promote the use of automation to improve productivity, operational efficiency and compliance - Develop a 'network' of corporate contacts and leveraging corporate expertise when needed - Perform Site support that will include shift rotation to provide continuous support of day to day activities **Organizational Capability** - In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products. - Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines. - Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement - Demonstrated ability to influence peers and business partners - Good written and verbal communication skills for both technical and non-technical audiences - Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** - Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major pharmaceutical manufacturing. - A minimum of 2+ years working experience in Biopharma engineering, operations, or manufacturing. **Additional Preferences:** - Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, BMS controller and hardware, valves, motors, control panels, and Warehouse and Robotics systems (DeltaV, Rockwell, Johson Controls, Fanuc, Rosemount, Fisher etc). - Experience in facilitating and driving decision-making at an organizational level. **Other Information:** + Initial location at Lilly Technology Center, Indianapolis. + Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. \#WeAreLilly Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $167,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients. **Position Summary:** The Senior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. Our team is seeking experienced, innovative, and motivated scientists to apply their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization. This technical-track role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development. **Responsibilities:** + Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development. + Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions). + Apply prior experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets. + Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites. + Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation). + Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing. + Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction. + Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions. + Welcome varied perspectives to create new solutions. + Actively engage in the external environment; recognize and apply external innovation across the Lilly synthetic portfolio. **Basic Requirements** : + Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field + 8+ years' experience in a pharmaceutical industry setting with specific focus on small molecules, synthetic peptides, or oligonucleotides. + Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods, authoring regulatory documentation, and overseeing CMO/CRO activities. + Must possess strong communication (oral, written), organizational, and leadership skills. **Additional Preferences:** + Experience with product commercialization, including technical transfer of analytical methods into manufacturing operations. + Demonstrated ability to drive and accept change. + Good interpersonal skills and a sustained tendency for collaboration. + Demonstrated success in persuasion, influence, and negotiation. **Additional Information:** + Travel: 0 to 10% + Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 - $250,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

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

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

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