Charles River Labs jobs in South San Francisco, CA

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary We are seeking an experienced Veterinary Technician II to join our Insourcing Solutions team, located in South San Francisco, CA. As the Veterinary Technician II under the direction of veterinary staff, you will maintain and monitor the health and physical environment of Charles River or external customer animals involving complex instructions and requiring technical expertise. Assist veterinary staff in the documentation and triage of all laboratory animal health cases. May also perform technical in-life procedures. Additional responsibilities: * Assist veterinary staff in the documentation and triage of all animal health cases noted by technical staff and/or Attending Veterinarian. * Conduct regular clinical rounds and routine health monitoring and examinations in support of studies and in accordance with the requirements of the research program, and assure the implementation of preventive measures such as vaccinations, anthelmintic treatments, etc. * Investigate site staff reports of animal health issues and/or conditions suggesting problems with animal well being. As appropriate, recommend, administer, and record (following coordination with study directors) routine treatment of animals. Generate summary reports as necessary. * Perform and document appropriate clinical observations. Ensure corrective actions for health or welfare issues are developed and implemented in accordance with the research programs. * Notify veterinary staff, study directors, and other appropriate personnel of conditions that are indicative of pain and distress or other abnormal findings that could lead to such conditions or compromise studies. Responsibilities continued: Perform routine veterinary technical and husbandry skills including the following: * Administration of various therapeutic measures by IV, IM, SQ, topical, oral routes, etc. * Bandage/wrapping techniques. * Nail/hoof/teeth clipping/trimming. * Venipuncture techniques. * Vaginal swabs. * Proficient animal restraint techniques. * Monitor critical care animals (i.e., place IVs, monitor fluids, etc.). Responsibilities continued: * Perform animal follow-up observations or new findings as required. * Monitor animal health, visually, and by following detailed schedules. * Generate animal treatment records and perform, track and schedule follow-ups. * Maintain appropriate medical records for each animal in accordance with study and regulatory requirements. Assist in maintaining accurate record keeping procedures for the veterinary department. * Maintain and follow complex procedures to ensure appropriate animal health and treatment. * Provide input into the creation/revision of SOPs and assist in implementation and training of new SOPs. * Assist in providing leadership, animal health training, and guidance to less experienced technical staff and other laboratory personnel. * Assist in keeping inventory and stocking the vet rooms (i.e., drugs and supplies). Assist in organizing and maintaining the vet exam rooms. * May be responsible for tissue sampling, routine animal manipulations and administration of fluids or other treatments as required. * May perform routine technical and husbandry functions (general housekeeping) on studies and must adhere to safety procedures. * Assist in surgery and peri-surgery care, e.g. provide and monitor anesthesia, prepare surgical packs, administer supportive therapy * Perform all other related duties as assigned. Job Qualifications: * Education: Graduate of a collegiate veterinary technology program accredited by the American Veterinary Medical Association Committee on Veterinary Technician Education and Training Activities or equivalent program in veterinary technology * Experience: 1-2 years related experience working with animals in a pre-clinical laboratory or clinical setting; experience working in a CRO with multi-species preferred. * Certification/Licensure: LVT license or CVT/RVT certification preferred. AALAS certification preferred. * Other: Demonstrate understanding of Standard Operating Procedures. Excellent organizational, time management and recordkeeping skills. Basic word processing skills required. Excellent communication skills both written and verbal. Must be proficient in routine veterinary technical and husbandry techniques. The pay range for this position is $34 - 36 USD per hour. Please note that salaries vary within the range based on factors including experience, skills, education, certifications, and location. Physical Demands: * Employees must be able to lift, move, manipulate, and/or hold heavy objects up to and including 25 pounds; over 50 pounds with assistance; this includes work materials, equipment, and/or animals. * Must be able to perform procedures, which require, talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards. * Must be able to frequently firmly hold species while utilizing fine motor skills. * Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus. Work Environment: * Works in a research environment, which requires use of sharp objects, working around mechanical parts, working with or near known or unknown toxic or caustic chemicals and/or biological hazards, exposure to fumes and airborne particles, working at noise levels ranging from moderate to loud. * The employee regularly works with live animals with risk of exposure to allergens, zoonotic disease, and biohazards. * Regularly works with or near test articles with unknown levels of toxicity. * The noise level in the work environment ranges from low to high depending upon the species housed. About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231539

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Job Summary The Continuous Improvement Leader - QA Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The Continuous Improvement Leader - QA Batch Disposition is responsible for driving operational excellence through Lean, Six Sigma, and other continuous improvement methodologies. This role partners with cross-functional teams to identify inefficiencies, implement solutions, and foster a culture of continuous improvement that delivers measurable results in quality and productivity, while also performing the role of an Authorized Quality Representative as required. Key Responsibilities * Develop and execute a site-wide continuous improvement strategy for batch disposition aligned with business objectives. * Facilitate Kaizen events, Value Stream Mapping sessions, and other workshops to identify and eliminate waste in the batch disposition process. * Lead structured problem-solving initiatives using DMAIC, PDCA, and root-cause analysis tools and implement sustainable solutions developed locally and globally. * Analyze operational data (OEE, cycle time, throughput) to identify improvement opportunities in the batch disposition process. * Support training and coaching of batch disposition team members as needed. * Track and report progress of improvement projects, including KPI performance. * Promote a culture of operational excellence through visual management and standard work for the batch disposition team. * Mentor internal team and develop future leaders in continuous improvement. * Develop and manage weekly, monthly, quarterly targets for batch disposition. * Perform final release of device assembly and packaging products as required. * Ability to work overtime as required, including nights and weekends as required. * Other duties as assigned/required. Required Qualifications * Bachelor's degree in STEM. * Experience in batch disposition and leading continuous improvement initiatives in manufacturing, supply chain, or similar environments. * Strong analytical skills with proficiency in data analysis and process metrics. * Excellent communication, leadership, and change management skills. * Experience with ERP/MES systems and data visualization tools. * Ability to influence and engage stakeholders at all organizational levels. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Overview Lilly Catalyze360 is Lilly's comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning. Lilly ExploR&D is a team of drug discovery and development experts who partner with biotechs from discovery through clinical proof-of-concept, putting Lilly's industry-leading capabilities behind their missions. We provide flexible support, from strategic consulting to full program execution, making it faster, easier, and more capital-efficient for innovators to transform bold science into life-changing medicines. Job Summary This role combines clinical development domain expertise with strategic technology innovation leadership to advance biotechnological initiatives. The Senior Director serves as both an operational leader and clinical operations subject matter expert, with primary focus on championing and implementing digital solutions and tools that transform clinical operations. The position partners with cross-functional teams to translate clinical operations challenges into technology opportunities, shape clinical strategies, assess plan feasibility, lead country allocation planning, and maintain competitive intelligence. A key responsibility is bridging deep clinical development knowledge with emerging technologies to drive adoption of next-generation methodologies and advanced tools that enhance efficiency, data quality, decision-making, and expedited study delivery across the ExploR&D portfolio. The ideal candidate brings deep clinical development domain knowledge, proven curiosity and passion for emerging technologies, and a track record of guiding teams through digital transformation and organizational change. Success in this role requires collaborative leadership, strategic vision for how technology can solve operational challenges, and a strategic execution mindset focused on innovation and operational excellence. Key Responsibilities Digital Solution Development (Primary Focus): * Lead the design, development, and implementation of digital solutions and tools, specifically tailored for clinical operations challenges from business strategy perspective * Partner with data science, IT, and engineering teams to translate clinical operations requirements into scalable technology solutions that enhance trial efficiency and decision-making quality Technology Innovation & Digital Transformation: * Champion enterprise-wide adoption of data-driven solutions and tools across the ExploR&D clinical portfolio, serving as the primary technology evangelist and change agent * Develop training programs and onboarding roadmaps to accelerate organizational adoption of digital tools and digital workflows, establishing metrics to measure technology adoption and efficiency gains Strategic Clinical Planning & Technology Integration: * Partner with cross-functional teams to develop technology-enabled clinical strategies, leveraging digital tools for feasibility assessments, country allocation planning, timeline optimization, and budget modeling * Lead integration of IT innovations into operational workflows and ensure digital solutions align with data governance standards and regulatory compliance requirements * Work with internal and external stakeholders to test and validate tool strategy, value, and usability through early adopter initiatives and advisory councils Leadership Influence & Innovation Landscape: * Influence ExploR&D and external leadership on technology strategy and key clinical operations decisions, presenting technology roadmaps and business cases for scaling innovations * Monitor competitive landscape for clinical operations technology and lead evaluation of external AI platforms and digital health solutions for potential implementation Talent Development & Mentorship: * Actively coach and mentor team members in both clinical operations expertise and digital literacy, fostering a culture of innovation, experimentation, and continuous learning within ExploR&D Basic Qualifications/Requirements * Education: Bachelor's degree * Experience: 8+ years work experience directly managing clinical studies * Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role. Additional Skills/Preferences * Advanced degrees and/or additional degrees in finance, accounting, legal or MBA preferred. * Exposure to or participation in developing strategic content and vision for technology initiatives, particularly those involving AI or data-driven solutions * Demonstrated experience contributing domain expertise to clinical digital solutions, ideally as a key stakeholder or content contributor in business requirements or tool development * Proven track record of participating in, and influencing digital adoption efforts, with past success in coaching peers, integrating innovative approaches within existing ways of working, and measuring adoption impact and overall business impact * Solid background within a scientific, technical, or business domain, with experience interpreting and applying domain knowledge to real-world operations * Visionary and Forward-Thinking-Demonstrates openness to emerging technologies, exploring how digital tools can enhance ways of working and decision-making * Change Champion-Promotes early adoption and continuous learning, guiding colleagues through digital transformation initiatives and encouraging inclusive experimentation with new approaches * Collaborative Translator-Builds strong relationships across product team and wider functional teams to translate domain needs into scalable, user-centric technology solutions * Impact Communication-Articulates the business value of technical innovation clearly to diverse audiences, from senior leaders to operational teams * Adaptive Learner-Remains flexible, engaged, and proactive in understanding evolving technologies and their potential applications across multiple business contexts Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $169,500 - $248,600 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. We are a leading biopharma company dedicated to advancing therapies that extend healthspan and combat age-related diseases. We are seeking a highly motivated scientist to join our research team to spearhead efforts focused on immune aging and rejuvenation. In this role, you will drive cutting-edge research to identify and develop novel interventions, using any modality that is appropriate for the indication, to restore immune homeostasis, mitigate inflammaging and improve organ function. This position offers the opportunity to pioneer transformative therapies to ameliorate prevalent and debilitating conditions in the aging population, with a focus grounded in Immunology. The individual will have the opportunity to build and manage a research team supporting immune-aging projects and to provide cross-functional leadership through larger collaborative efforts. Responsibilities • Design and execute preclinical studies to investigate mechanisms underlying immune senescence, including but not limited to age-related hematopoietic stem cell (HSC) dysfunction, telomere attrition, senescence-associated phenotypes, and T-cell exhaustion. • Develop rejuvenation/reprogramming strategies to revitalize hemopoietic and non-immune, parenchymal cells of interest in immune and age-related disorders. • Utilize advanced techniques in cytometry, ‘omics and hi-dimensional datasets to identify targetable nodes for intervention. Use appropriate in vitro, in vivo and ex vivo models to assess immune aging phenotypes of interest. • Collaborate with stakeholders in Immunology and other therapeutic areas to cross-functionally lead and develop research findings into future clinical candidates. • Prepare and present research findings at internal meetings, scientific conferences, and in peer-reviewed publications. • Stay abreast of emerging advances in the field to inform strategic decisions and help assess external opportunities as needed. • Contribute to IP filings, and regulatory documentation as needed. • Recruit and train a small team to scale research efforts. Basic Qualifications/Requirements: • PhD in Immunology, Cell Biology, Developmental Biology, or a related field; Postdoctoral experience in aging biology or rejuvenation is required. • 5+ years of hands-on research experience in academia, biotech, or pharma, with a proven track record related to immune aging/senescence research. Additional Skills/Preferences: • Demonstrated expertise in molecular mechanisms of immune senescence, including inflammaging, stem cell exhaustion, and therapeutic interventions • Familiarity with landscape of immune aging research activities including but not limited to academic labs, biotechnology companies, and large pharma. • Strong publication record in high-impact journals with first- or senior-author contributions. • Proficiency in experimental design, data analysis and statistical methods. • Excellent communication skills, with the ability to convey complex scientific concepts to diverse audiences. • Experience with in vivo models of aging (e.g., progeroid mice, humanized models) and translational strategies for rejuvenation therapies. • Advanced knowledge of stem cell rejuvenation techniques, epigenetic reprogramming and delivery systems. • Prior experience leading a cross-functional team and/or managing others. • Understanding of the unique regulatory hurdles in regeneration and aging-related therapeutics. Additional Information: Travel: Estimated ~20% Work Environment: Position is based in South San Francisco, CA 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 - $281,600 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. * Main Purpose and Objectives of Position: The Process Safety Engineer is part of the Lilly API Health, Safety, and Environmental (HSE) team and provides technical leadership and expertise in the development, implementation, and maintenance of process safety management and engineering support services to a Lilly API site, including the construction, startup, and operations phases. In the project delivery and startup phase of the project (startup expected 2025 to 2027), the HSE 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 Responsibilities for this role include: * Support the development and implementation of the process safety management operational readiness plan for a Lilly API facility as a collaborative, inclusive, and energetic member of the HSE team. * Support the project team to deliver the facility as a key stakeholder providing input and feedback on process safety design decisions, construction, and startup plans while ensuring decisions meet project deliverables and compliance requirements, leveraging existing Lilly knowledge, and incorporating external experiences and learning. * Provide oversight and support of process hazard analysis and facility siting studies. * Develop and roll out process safety management (PSM) program elements such as employee participation, Management of Change, Pre-Startup Safety Review, Process hazard analysis (PHA), etc. * Provide training, mentoring, and onboarding of new staff to help support a strong process safety culture at the site. * Provide oversight of operations of pharmaceutical API manufacturing units. * Develop a partnership with Operations, Maintenance, and Engineering functions to help manage change, ensure safety and compliance of new systems, and assist in setting requirements to ensure safe startup. * Ensure application of industry codes and standards such as NPFA 30 (combustible liquids), NFPA 652 (combustible dust), and overpressure protection requirements during project and management of change reviews. * Build technical relationships by routinely interacting with corporate and site process safety colleagues. This role has opportunities to network externally with organizations such as the Center for Chemical Process Safety (CCPS), Purdue Process Safety and Assurance Center (P2SAC), and the ACC Process Safety networking groups. Requirements: * Bachelor's degree in chemical engineering, chemistry, or related field of study; CCPSC or PE preferred * Minimum 2 years of experience in chemical or pharmaceutical manufacturing Additional Preferences: * Knowledge and experience in process safety, including knowledge of OSHA Process Safety Management (PSM) regulation * Trained in Process Hazard Analysis, HAZOP, and What-If Methodologies * Strong analytical skills and systematic and structured way of working * Strong collaboration and communication skills * Trained in Process Hazard Analysis facilitation * Trained in Layer of Protection Analysis (LOPA) * Knowledge of EPA Risk Management Plan * Experience interfacing with HSE-related regulatory agencies Additional Information: * Please note that the role may begin remotely with occasional business travel to the Global Headquarters in Indianapolis, Indiana and to the new site area. Full relocation to the new site area will be required. Additional information will be provided during the interview process. 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 $63,000 - $92,400 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. For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Position Description: The Senior / Principal Sterility Assurance Scientist is a technical role that assists in development and implementation of the site's sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. Key Objectives/Deliverables: * Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification. * Lead and/or provide technical oversight for developing the site's environmental monitoring program, aseptic process simulation program. * Lead and/or provide technical oversight for developing the site's contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies. * Provide technical expertise and/or oversight for the facility's cleanroom gowning and aseptic technique strategy/program. * Assist with providing sterility assurance expertise for site procedures, processes, protocols, validations, and technical studies. * Author and evaluate sterility assurance risk assessments to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination. * Assist in the development and implementation of site process flows to ensure effective contamination control strategies are established. * Lead or provide technical support for root cause investigations associated with sterility assurance programs. * Participate and/or provide technical sterility assurance support during internal and external audits. * Create, execute, and/or review/evaluate technical documents and change controls related to sterility assurance programs. * Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives. Minimum Requirements: * Bachelor's or master's degree in microbiology, Biology, Biochemistry, or other related scientific discipline. * Minimum of 2 years' experience working in sterile pharmaceutical manufacturing within a Microbiology, Technical Services/Manufacturing Sciences, Sterility Assurance, or other related department with applicable experience in Sterility Assurance programs/strategies. * Relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing. Additional Preferences: * Possess strong interpersonal skills to work cross-functionally within a team. * Possess strong self-management and organizational skills. * Possess strong technical writing skills. * Possess strong oral and written communication skills for communicating to colleagues, management, and other departments. * Experience with data analysis and trending. * Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing, warehouse, or laboratory areas. * Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities. Other Information: * The role will be phased from a project support role to a routine support role as the development facility and processes progress. * Tasks may require repetitive motion and standing or walking for long periods of time. * Ability to have a flexible schedule during the project phase to support qualification activities as required. * Travel may be required during the project phase for training and implementation of sterility assurance programs. The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. 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 unites caring with discovery to create medicines that make life better for people around the world. Lilly is a Fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and technical organization from the ground up. The Principal Scientist/Engineer - Cleaning Validation/Sterilization Validation - Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies. Primary objectives include the start-up and compliant manufacturing of products, particularly as it relates to development and implementation of validation strategies, including sterilization validation, cleaning validation, filter validation, and other related activities. The scope of the role includes device assembly, packaging, and syringe filling operations for commercially manufactured products targeted for transfer to the Concord site. Key Objectives / Deliverables: * Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. * Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs. * Development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, component/parts washer, autoclaves, filling isolators, etc). * Support periodic requalification activities for production equipment and systems. * Author and support the execution of validation protocols and reports. * Provide technical guidance to the Process Team for cleaning and sterilization processes. * Lead or provide technical support for root cause investigations related to cleaning, sterilization, and other related activities. * Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements. * Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of cleaning and sterilization processes. * Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed. * 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, procedures, PFDs, VMPs, APRs, QPPAs, etc. * 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. * Serve as cleaning and sterilization interface external to the Concord site. * Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives. * Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain. * Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities. Minimum Requirements: * BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline * 3+ years experience supporting cGMP manufacturing (specifically within validation, engineering, technical services/MSAT, operations, quality assurance, etc.) Additional Preferences: * In depth knowledge of parenteral drug product manufacturing * Experience executing equipment qualification, cleaning validation, and sterilization validation * Demonstrated successful leadership of cross-functional teams * Experience with data trending and analysis * Ability to analyze complex data and solve problems Other Information: * Role is Monday through Friday based. * Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). * Occasional extended hour and / or off-hour work may be required. * Position will be based out of Concord site with ability to travel to Indianapolis and other global Lilly 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 $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 For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Position Description Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities. As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. Key Values / Objectives Integrity * Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. Excellence * Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. * Responsible for administering technical training and ensuring all operators are trained to perform tasks. * Operate the equipment and perform activities as required to meet production schedule. * Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) * Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Respect for People * Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas. * Key liaison between operations and support functions. Basic Qualifications/Requirements: Time Commitments and Work Authorization * Minimum education: High School Diploma or GED * A valid drivers license * Must Pass a "fitness for duty" physical exam * Must pass a vision exam and be free of color blindness * Must be equivalent to 20/20 correctable close vision acuity * Must be able to work 6am to 6pm on a 2-2-3 schedule * 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. Additional skills/preferences: Experience with, completion of, or understanding of: * We have several levels open for Operator which are based on the experience and education you bring. * Ability to work overtime as required * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. * Ability to participate in professional development opportunities (team coursework such as classes through RCCC) * Ability to effectively communicate (electronically, written and verbal) * Flexibility - the ability to troubleshoot and triage challenges * Computer proficiency (desktop software, MS office). * Leadership and the ability to train / educate team members * STEM degree or certifications * Aseptic filling, single use assemblies, isolator technology. * Automated, semi-automated, and/or manual inspection. * Knowledge of current Good Manufacturing Practices (CGMPs) * Experience in operations or manufacturing environments. * Pharmaceutical, medical device or food processing industries * Manufacturing Execution Systems and electronic batch release. * Continuous improvement (Lean, Six Sigma methodologies) * Highly automated equipment (inspection, packaging, filling, assembly, etc) * SAP, Electronic Batch Records 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. Job Summary The Director/Senior Director, CMC, Drug Product Development will lead formulation development activities across multiple dosage forms and therapeutic modalities, with a focus on developing and incorporating digital solutions and tools into drug product workflows. The ideal candidate will bring expertise in both parenteral and solid oral dosage forms, combined with emerging capabilities in computational and AI-driven formulation approaches. Success in this role requires cross-function collaboration and leadership as well as a strategic vision for how technology can be leveraged to transform traditional drug development activities. Key Responsibilities Formulation Development * Lead formulation design, development and external manufacturing for both parenteral (IV, SC, IM) and solid oral (tablets, capsules) drug products across diverse therapeutic programs and modalities * Develop robust formulation strategies that address in vivo performance, stability, bioavailability, manufacturability, and patient-centric considerations * Manage a network of external providers (CROs, CDMOs) with capabilities in drug product development and manufacturing * Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and manufacturing * Support regulatory interactions and respond to health authority questions * Ensure compliance with cGMP standards and ICH guidelines Digital Solution Development * Lead the development, testing and implementation of digital solutions related to drug product development * Partner with IT and other internal drug product subject matter experts to translate drug product workflows into requirements that can be incorporated into technology solutions * Lead the evaluation of in silico modeling tools and AI/ML platforms that predict formulation performance and accelerate development timelines * Continuously monitor the industry trends, competitive landscape and emerging technologies to identify future tools and technology platforms of interest Minimum Requirements * Education: PhD in Pharmaceutical Science or related field (Chemistry, Chemical Engineering, Pharmacy) * 8+ years of pharmaceutical industry experience * 3+ years of prior experience with application of in silico tools or AI/ML solutions in drug product development Additional Skills/Preferences * Experience working with multiple therapeutic modalities (small molecules, biologics, peptides, oligonucleotides) * Experience with both parenteral and solid oral formulations * Knowledge of emerging modalities including cell & gene therapy, RNA-based medicines * Strong analytical and problem-solving skills * Experience working with biotechs/emerging companies and/or early-stage development programs where speed to clinic is a critical success factor * Demonstrated ability to operate effectively in fast-paced environments where rapid decision-making and pragmatic problem-solving are essential to maintain program momentum * Track record of supporting multiple concurrent programs with varying levels of technical maturity, demonstrating agility in shifting priorities and creative approaches to address emerging challenges Additional Information * Remote options may be considered based on business needs * Travel up to 10% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Band Level 5 #LI-Remote The Associate Director, Access & Reimbursement, NPS (Novartis Patient Support) Cardiovascular, San Jose, CA is a remote & field-based role that covers the following, but not limited to: Fresno, Salinas, Stockton, Tracy, Clovis, San Mateo, Palo Alto & San Jose, CA. Associate must reside within territory, or within a reasonable daily commuting distance of 60 miles from territory border. The Associate Director, Access & Reimbursement (ADAR) is a field-based role that proactively provides in person (or virtual as needed) education to defined accounts within their assigned geographies on a wide range of access and reimbursement topics and needs (see below) in support of aligned product(s) strategy. ADARs primarily focus on accounts with increased process and workflow complexity, typically including centralized and decentralized systems of care, integrated delivery networks, academic medical institutions, large multi-provider specialty practices, and alternate sites of care. ADARs will serve as the patient access and reimbursement lead in business-to-business conversations with account executives. The ADAR role is responsible for managing the pull-through of access and reimbursement strategy and downstream operations within their aligned accounts. ADARs are expected to have deep expertise in communicating requirements and addressing barriers associated with local payer policy coverage, multi-channel acquisition pathways, billing and coding education (as needed), claims processing, reimbursement, and integration of manufacturer support programs into a range of account workflows. ADAR will continually need to demonstrate a keen ability to problem solve and manage multiple projects. ADARs partner closely with other Novartis Pharmaceuticals Corporation (NPC) field associates, including Customer Engagement (Sales) and Market Access, representing NPC with the highest integrity in accordance with NPC Values and Behaviors. ADARs will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third party affiliates). Job Description Key Responsibilities: Interact with large, complex accounts to support patient access within their aligned therapeutic area product(s), proactively provide face-to-face education on programs to providers and staff in order to support integration of those products into office processes and workflows. Address customer questions for issues related to NPC policies on therapeutic area products ordering, payment, inventorying, and product returns & replacement in offices. Work with key members of therapeutic area offices (e.g., executives, providers, administrators, billing and coding staff, claims departments, revenue cycle managers) in order to appropriately support patient access to products. Ability to analyze problems and offer solutions. Understand specifics and support questions associated with patient reimbursement and provide support on reimbursement issues with third party payers at the provider-level. Analyze account reimbursement issues (as needed). Identifies trends at a local, regional and national level and partner with purpose internally and externally to support patient access to Novartis medicines Supports pull through on local coverage decisions to enable meaningful patient access within the system. Proactively communicate policy changes or issues that could potentially affect other departments. Accountable for informing customers on NVS-sponsored patient support programs to help enable patients starting and staying on therapy (i.e., Co-pay). Maintain expertise in regional and local access landscape, anticipating changes in the healthcare landscape, and act as their aligned therapeutic area product(s) reimbursement expert (as needed). Interface with Patient Support Center (hub) and Access & Reimbursement Managers on important matters related to patient case management, including tracking cases, issue resolution, reimbursement support, and appropriate office staff education. Collaborate with aligned cross-functional associates within NPC (see above) to share insights on customer needs and barriers for their aligned therapeutic area product(s) related to access and reimbursement. Maintain a deep understanding of NPC policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. Handle Patient Identifiable Information (PII) appropriately (understand and ensure compliance with HIPAA and other privacy laws and regulations and internal Company compliance guidelines). Responsible for identifying and reporting adverse events via the established Novartis systems as per applicable processes. Buy and Bill Specific Assess access situation within the assigned geography and develop appropriate Plan of Action (POA). Communicate POA to appropriate personnel. Responsible for educating HCPs using approved materials regarding acquisition pathways for Novartis products. Educate on buy-and-bill end-to-end processes, workflows, and facility pull-through in complex accounts, including scenarios of centralized and decentralized acquisition, and use of alternative channels such as white bagging, clear bagging, brown bagging, and alternate site of care for administration. Educates relevant stakeholders on logistics related to ordering, payment, inventory, and product returns & replacement. Analyze reimbursement issues, anticipating changes in the healthcare landscape, and act as the designated reimbursement expert for offices and field teams. Accountable for engagement with non-prescribers in regards to Novartis medicines, for example pharmacy, system leadership, financial counselors, office administrators, revenue cycle managers, etc. What You'll Bring to the Role: Education: Bachelor's Degree required. Business and/or biological science education preferred. Advanced degree preferred. Essential Requirements: 5+ Years of experience in pharmaceuticals / biotech industry focused in Patient Services, Market Access, Sales, and/or account management. With 2 of those years being in a Patient Services practice support role for a specialty product(s). Experience working with highly complex practices and/or health systems to establish access and acquisition pathways. Strategic account management experience using a proactive approach to anticipate access hurdles impacting accounts and patient access. Deep expertise and experience integrating manufacturer-sponsored patient support programs. Experience with specialty products acquired through Specialty Pharmacy networks Knowledge of reimbursement pathways (specialty pharmacy, buy-and-bill, retail) Possess a strong understanding of Commercial payers, Medicare plans and state Medicaid in geographic region. Must live within assigned territory. Ability to travel and cover geography, at least 50% travel required, based on geography and territory / targeting make up. Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. Desirable Requirements Experience leading and delivering presentations to C-level account executives. Strong ability to work cross functionally with such functions as Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management and applicable third-party affiliates. Expertise in therapeutic area practice dynamics and common reimbursement and product program support-related needs. Strong capabilities in the areas of customer focus, collaboration, business acumen, communication, and presentation skills. This position requires significant use of a company provided vehicle and maintaining good driving record This is a field-based customer engaging position Control business expenses related to field activities (i.e. travel, customer meetings) and provide timely expense reports to manager. Compensation Summary: The salary for this position is expected to range between $160,300 and $297,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to ********************************** For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to ************************ call **************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. *************************************************************************************** Salary Range $160,300.00 - $297,700.00 Skills Desired Access And Reimbursement Strategy, Agility, Analytical Skill, Analytical Thinking, Cross-Functional Collaboration, Customer-Centric Mindset, Employee Development, Finance, Go-To-Market Strategy, Healthcare Sector Understanding, Health Economics, Health Policy, Health Technology Assessment (HTA), Innovation, Inspirational Leadership, Market Access Strategy, Negotiation Skills, People Management, Process Management, Public Affairs, Real World Evidence (RWE), Regulatory Compliance, Risk Management, Value Propositions, Waterfall Model

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. Engineering Technician - Day Shift Organization Overview At Lilly, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global leader in healthcare, committed to discovering life-changing medicines, advancing disease management, and supporting our communities through philanthropy and volunteerism. We put people first and strive to make a meaningful impact every day. Position Summary The Engineering Technician at our Concord, NC facility plays a key role in supporting Parenteral Operations, our customer, by ensuring the efficient setup and operation of Pre-Filled Syringe and Isolator Equipment. This position requires hands-on engineering maintenance expertise to assist with equipment setup, operational support, troubleshooting, repairs, and ongoing maintenance. The ideal candidate will demonstrate a strong understanding of customer needs, collaborate effectively with internal teams, and provide responsive, courteous support. Success in this role requires technical proficiency, problem-solving skills, and a commitment to delivering excellent customer service in a dynamic manufacturing environment. Key Responsibilities * Promote a safety-first, quality-always culture in all tasks and interactions * Improve equipment uptime, line efficiency, and overall equipment effectiveness (OEE) * Perform condition monitoring, troubleshooting, and provide operational support * Diagnose and repair precision filling equipment with strong mechanical aptitude * Collaborate with engineering and production teams to resolve equipment issues promptly * Assist with equipment setup and changeovers to support production needs * Adhere to all GMP and quality standards * Must have the ability to quickly and accurately diagnose the root cause of a problem and properly implement corrective actions to minimize downtime * Accurately document maintenance activities and corrective actions * Support cross-functional tasks and assist outside primary responsibilities as needed * Work independently and manage priorities under pressure Basic Requirements * High school diploma or GED * Minimum of 5 years' experience in production maintenance Preferred Qualifications * Strong mechanical aptitude and hands-on technical skills * Proficient with basic hand tools * Detail-oriented with a commitment to quality and precision * Familiarity with safety protocols and proper PPE usage * Physically able to stand for extended periods * Effective team player with strong interpersonal skills * Associate's degree or technical certification in a related field is a plus * Knowledge of FDA and GMP regulations * Experience operating high-speed, automated production equipment, preferably Syringe/Vial Filling systems utilizing Isolator technology * Ability to quickly learn and apply new procedures * Experience working in a classified manufacturing environment * Familiarity with Computerized Maintenance Management Systems (CMMS) platforms * Strong verbal and written communication skills * Customer-oriented mindset with a proactive approach * Analytical thinker with strong problem-solving abilities Additional Information * Flexibility to work overtime or adjust schedule based on production demands * Following a Monday-Friday, 8-hour training period, the role transitions to a 12-hour 2-2-3-day shift schedule * Willing and able to respond to off-hour emergencies as needed * Open to travel for training and professional development opportunities 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 $21.27 - $41.25 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 Description Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. 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 are looking for people who are determined to make life better for people around the world and embody our company values of Integrity, Excellence, and Respect for People Position Overview Lilly is investing over $1 Billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina which will house warehousing & logistics, operations including parenteral, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need. If you ever wanted to have a direct impact on building a team's culture and on how the team operates, now is the perfect opportunity! During the project phase, the Associate Director (AD), Operations is responsible for staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start up, and validation of the parenteral operations (PAR) areas which include formulation, aseptic isolator barrier filling, and visual inspection areas. This position will require travel domestically with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently Once the facility is turned over to operations, the AD role is responsible for ensuring the group meets annual production goals as well as planning through 1-3 year horizons. They are expected to lead by example and provide coaching to others in the areas of safety, quality, operational excellence, compliance, and continuous improvement. The AD will be responsible for leading their respective cross-functional process teams. Direct line supervision for this role includes Supervisors and Operations Associates. As a site leader and expert at our growing site, you will have significant opportunities for growth into future leadership and technical roles. Key Objectives / Deliverables Integrity * Leading by example with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation. * Lead/conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups * Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions. Excellence * Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations. * Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve. * Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE). * Understand and influence the manufacturing control strategy for their area. Respect for People * Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area. * Responsible for a work force of approximately 40 - 70 individuals on various shifts, with multiple shift supervisors and associates reporting directly to them. * Provide leadership and develop objectives to deliver Business Plan goals as it relates to production volumes, finances, safety, quality, stewardship, and people. * Act as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety. * Leading the Operations Process Team, a cross functional group charged with making medicine, continuous improvement, and site support. * Represent their Operations Process Team on the Plant Flow (value stream) Team. Requirements (Education, Experience, Training) Education, Experience, and Capabilities * Bachelor's degree in a STEM or pharmaceutical related field of study. * At least 7 years working in the pharmaceutical industry. * Previous management or leadership experience including leading or working effectively with a cross functional group. * Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA. * Excellence in; interpersonal, electronic, written, and oral communication * Strong technical aptitude and ability to train and mentor others Time Commitments, Environment, and Work Authorization * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives. * Position will involve frequent business trips domestically with potential international travel to support testing of equipment at vendor sites, visit Lilly sites to learn and collaborate, and to build global network. * Travel domestically and internationally, up to approximately 20% of the year to learn and network with colleagues. Preferred attributes but not required Experience with, completion of, or understanding of: * 6+ years in manufacturing/operations with 4+ years in supervisory role * cGMP standards and FDA (or other industry) guidelines for production * Aseptic filling, single use assemblies, isolator technology. * Automated, semi-automated, and/or manual inspection. * Highly automated equipment (inspection, packaging, filling, assembly, etc.) * Creation of standard operating procedures, work instructions, and training documentation. * Equipment & Facility design documentation reviews * Facility, equipment, or system start up. * Qualification and process validation experience. * Manufacturing Execution Systems and electronic batch release. * Automated Storage and Retrieval System (ASRS) Warehouses or AGVs. * Continuous improvement methodologies and mindset - lean, six sigma, etc. * Documentation, deviation and change management systems (e.g., Trackwise. Veeva, QualityDocs, Kneat) This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 - $180,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Responsibilities: The Scientist - TSMS PAR will initially focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation. TSMS PAR Scientists will support one of either formulation, filling, or visual inspection (VI), although may support multiple areas during start-up phase. Upon the start of commercial production, this role's objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics/methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The role will also author and execute protocols as well as conduct root cause investigations. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to parenteral manufacturing. Key Objectives/Deliverables: * Support the assigned Process Team (formulation, filling, or VI) as TSMS representative. • (Associate/Senior) Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team. * Represent Concord TSMS team for internal and external communications on a regular basis * Lead risk management activities as it pertains to product/process * Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues * Prepare and Review or approve, as required, relevant technical documents such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc. * Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability * Identify opportunities and lead technical projects to improve process control and/or productivity * Serve as interface with upstream suppliers and parenteral product networks * Drive stability strategy for Concord products * Provide Audit support as needed * Identify opportunities and participate in projects to improve process control and/or productivity Basic Qualifications: * Bachelor's degree or higher an engineering, packaging science, or related field Additional Skills/Preferences: * Pharmaceutical and/or medical device manufacturing experience * Root Cause Investigation Experience * Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP * Demonstrated successful leadership of cross-functional teams * Strong interpersonal and teamwork skills * Strong self-management and organizational skills Additional Information: * Role is Monday through Friday. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and /or off-hour work may be required. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $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. Principal Engineer TSMS Validation - Eli Lilly and Company Job Summary We are seeking a highly experienced Principal Engineer to lead and execute validation activities for our Global TSMS (Technical Systems Management System) initiatives. Responsibilities Validation Leadership: Lead the development, execution, and review of validation strategies, plans, protocols, and reports for complex TSMS projects, ensuring adherence to regulatory requirements. Technical Expertise: Provide expert technical guidance on validation methodologies, data integrity principles, GxP regulations, and industry best practices related to computerized systems, automation, and manufacturing process controls. Project Management: Manage validation deliverables across multiple projects, collaborating with cross-functional teams including IT, manufacturing, quality assurance, engineering, and external vendors to ensure timely and effective project completion. Risk Management: Develop and implement risk-based validation approaches, identifying potential risks to system functionality, data integrity, and compliance, and proposing effective mitigation strategies. System Lifecycle Management: Contribute to the full lifecycle management of TSMS, from initial design and development through implementation, maintenance, and decommissioning, ensuring continuous validation status. Documentation and Compliance: Ensure all validation documentation is accurate, complete, auditable, and compliant with regulatory expectations and company policies. Participate in regulatory inspections and internal audits as a subject matter expert. Continuous Improvement: Proactively identify opportunities for process improvement within TSMS validation, driving efficiency and effectiveness in our validation practices. Mentorship and Training: Mentor engineers and provide training on validation principles and company procedures. Qualifications Education: Bachelor's degree (e.g., Chemical, Electrical, Computer Science), Computer Science, or a related scientific discipline. Experience: Minimum of 5 years focused on sterilization or cleaning validation. Technical Skills: Strong understanding of manufacturing processes and control systems (e.g., Pharma suite, Maximo,). Experience with various validation tools and methodologies. Proficiency in authoring and reviewing complex validation documentation. Leadership and Communication: Proven leadership skills with the ability to influence and guide cross-functional teams. Excellent written and verbal communication skills, capable of effectively presenting complex technical information to diverse audiences. Strong problem-solving and analytical abilities with a keen attention to detail. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. 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 and embody our company values of Integrity, Excellence, and Respect for People Position Overview Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Operations Supervisor (Filling) will have responsibility of supporting start-up activities to bring the Parenteral (PAR) area into service. The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. Activities will include coordinating start-up support amongst self and team to; train on the use of the equipment and develop technical proficiency, develop a diverse and inclusive culture, and lead operational readiness activities. This position will require travel domestically (2-4 week trips and/or 3-12 month short term assignments) with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently. Once the facility is turned over to operations, the Supervisor role is responsible for leadership of the team that operates the multiple PAR departments. They will develop an inclusive culture and technical expertise of manufacturing team and employees. This individual will ensure that the lines are adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role includes line leaders and operators. As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. Key Objectives / Deliverables: Integrity * Leading by examples with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. Excellence * Collaborate with area supervisors to ensure a high standard of; communication, best practice sharing, and consistency across the groups and different shifts. * Responsible for shop floor execution as it relates to business plan, cGMP conformance, and Operational Standards for Manufacturing Excellence. * Striving and encouraging a mindset of continuous improvement. Gathering ideas for improvement, articulating their business value, and working with support team to implement the ideas with highest objective value. * Ensures there are enough adequately trained and compliant personnel staffed to meet production goals. Reviews and updates training plans as needed to maintain compliance and excellence. * Develop area documentation (procedures, work instructions, job aides, etc.) with team to support start-up, training, and operation. * Originate & Investigate deviations, operational quality issues, and support determination of root cause. Support implementation of corrective actions to ensure consistent quality. Respect for People * Support the site in building a diverse, empowered, and capable team. * Responsible for managing several direct reports working across multiple manufacturing lines on responsible shift. * Responsible for the coaching, development, and performance evaluation of operators. * Communicate cross functionally with support team if there are quality, equipment, operational concerns. Requirements (Education, Experience, Training): Education, Experience and Skills * High School Diploma or equivalent * Prior supervisory experience * Basic computer skills (desktop software, MS Office) are required. * Previous experience in operations or directly supporting a manufacturing operation (Pharma, Food, Clean-room, or other applicable). * Excellent interpersonal, written, and oral communication skills * Strong organizational skills and ability to handle and prioritize multiple requests. * Strong technical aptitude and ability to train and mentor others. * A valid driver's license Time Commitments and Work Authorization * Ability to work overtime as required * Willingness to work a 12-hour day shift (6am to 6pm on 2-2-3 schedule) * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. * The position may require a short-term assignment of 3-12 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory. * 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. Preferred attributes but not required: Experience with, completion of, or understanding of: * 4+ years in manufacturing/operations with 2+ years in supervisory role * cGMP standards and FDA (or other industry) guidelines for production * STEM degree or certification * Aseptic filling, single use assemblies, isolator technology. * Automated, semi-automated, and/or manual inspection. * Highly automated equipment (inspection, packaging, filling, assembly, etc.) * Manufacturing Execution Systems and SAP or other electronic business systems * Continuous improvement methodologies and mindset - lean, six sigma, etc. * Root cause analysis and implementing corrective actions * Ability to organize and motivate teams * Facility, Equipment, Systems, Start-up This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $35.33 - $51.83 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning. Lilly TuneLab is an artificial intelligence and machine learning (AI/ML) platform that provides biotech companies access to drug discovery models trained on years of Lilly's research data. Lilly estimates that this first release of AI models includes proprietary data obtained at a cost of over $1 billion, representing one of the industry's most valuable datasets used to train an AI system available to biotechnology companies. By integrating advanced in silico modelling and federated learning, we connect pioneering machine learning algorithms, substantial computational power, exclusive datasets, and Lilly's domain-specific knowledge to drive innovation in drug discovery and facilitate access to optimal therapies for patients. Job SummaryAs a Product Manager for the TuneLab Platform, you will play a pivotal role in shaping the evolution of TuneLab to help streamline researchworkflows. This is a highly technical product management role for someone who thrives at the intersection of product strategy, cloud infrastructure, AI/ML systems, and computational drug discovery. You will drive the end-to-end product lifecycle from concept and design to delivery and scale ensuring our platforms are secure, user-centric, and capable of supporting enterprise-grade solutions. Key Responsibilities Strategy and Vision Develop and articulate a clear product strategy for the AI/ML platform, ensuring prioritized use-cases are aligned with corporate and R&D goals. Define the roadmap for each use case, prioritizing those with the highest potential impact on drug discovery. Collaborate with cross-functional stakeholders to ensure the platform's strategic direction aligns with technical feasibility and market needs. Define and monitor success metrics that inform platform performance and product impact. Ensure the strategy incorporates market research, competitive analysis, leadership objectives, and user feedback. Product Development and Lifecycle Management Manage the full product lifecycle from ideation and prioritization through design, implementation, and deployment. Translate complex business and scientific needs into technically detailed requirements, user stories, and specifications. Collaborate with engineering and data science teams to ensure high-quality execution and timely delivery of platform features. Continuously refine and evolve the platform based on user feedback, market trends, and emerging technologies, ensuring it remains competitive and relevant. AI-First and Agentic AI Product Leadership Drive the design and development of AI-first, agentic systems leveraging large language models (LLMs), retrieval-augmented generation (RAG), and multi-agent orchestration frameworks to enhance scientific and operational workflows. Partner with AI/ML engineering teams to deliver LLM-powered assistants, copilots, and intelligent workflow automation tools that increase efficiency and insight generation. Translate emerging AI capabilities into secure, scalable, and user-friendly product features that comply with enterprise data privacy and ethical AI standards. Collaborate with UX, data science, and engineering teams to design human-AI interaction models that balance automation, transparency, and user control. Technical Leadership and Platform Architecture Lead the integration of TuneLab with commercial scientific and informatics platforms, enabling seamless data exchange and cross-platform insights. Collaborate with internal and external engineering teams to ensure systems are scalable, reliable, and compliant, supporting diverse models, workflows, and data pipelines. Contribute to architectural decisions ensuring interoperability, privacy, security, scalability and compliance of the platform. Impact Assessment and Model Improvement Define and track KPIs to evaluate platform performance, model effectiveness, and business value. Incorporate feedback from internal users and external biotech partners to guide roadmap evolution and ensure long-term platform relevance. Cross-Functional Collaboration and Communication Coordinate closely with internal teams, including R&D, engineering, data science, and business development, to ensure the product meets user needs and business objectives. Communicate product plans, progress, and impact to leadership and other stakeholders. Market and Competitive Analysis Monitor market trends and competitive landscape to ensure the platform remains differentiated and continues to address unmet needs. Perform competitive analysis to identify opportunities for innovation and potential threats to the platform's success. Explore new use cases and new user segments, driving platform awareness and adoption across the organization and partner networks. Minimum Requirements Education: Bachelor's or Master's degree in Computer Science, Engineering, Data Science, Biology, Chemistry or related field. 5+ years of product management experience in cloud-based enterprise software, data platforms, or agentic AI platforms. Additional Skills/Preferences Proven track record of managing all aspects of product development and lifecycle management, from ideation to launch and continuous improvement. Strong understanding of AI/ML technologies, cloud infrastructure, and large-scale multi-tenant architectures. Hands-on experience with Agile/Scrum methodologies and enterprise product management tools. Experience in pharmaceutical R&D or computational drug discovery. Familiarity with scientific data and informatics platforms. Background in software engineering, systems architecture, or MLOps. Excellent analytical, communication, and collaboration skills, with the ability to work effectively in a matrixed organization. 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 $145,500 - $213,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. * Responsibilities The Senior Principal Process Engineer provides technical leadership and expertise for production operations in the areas of: coaching and mentoring front line process engineers, developing and sustaining process knowledge, process and equipment support, process optimization, equipment qualification, equipment capability and asset management, and engineering business systems. This role will support production operation in small molecule or peptides manufacturing. Key Deliverables: * Coach and mentor front line process engineers in all aspects of fundamental engineering activities for batch API supply or continuous platforms. * Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions based on first principles. * Support and peer review root cause analysis for equipment and operational events and other technical documents. * Identify process knowledge gaps that impact equipment and process capability. * Develop or support the capture of key process knowledge (material and energy balances, kinetics, chemistry, equipment design basis, etc). * Support, develop and maintain the basis of safety for process equipment. * Provide engineering support for Process Safety Management (PSM) and Process Hazard Reviews (PHRs). * Review the basis for the qualification of the equipment and ensure that the equipment/system is appropriate for the intended purpose. * Ensure that changes, maintenance and other interventions do not adversely impact the qualification state of the equipment. * Integrate mechanistic modelling, process simulation and analysis into current and future processes to enhance process understanding and control. * Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team. * Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms. * Provide technical oversight of ongoing equipment qualification requirements. * Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose. * Provide guidance in development of test plans for Verification packages and associated critical components. * Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance. Basic Qualifications * Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline * 5+ years of experience in API Manufacturing Unit 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. * Ability to coach others for development of technical knowledge and skills. * Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented. * Guidance/mentoring of others through processes. * Flexibility to meet business needs. Additional Information: * Please note that the role may begin remotely with occasional business travel to the Global Headquarters in Indianapolis, Indiana and to the new site area. Full relocation to the area of new site will be required. Additional information will be provided during the interview process. * Potential for travel (less than 20% - could be domestic and/or 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 $64,500 - $94,600 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

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary We are seeking an Animal Care Technician I (rodent facility) to join our Insourcing Solutions team, located in Foster City, CA. As the Animal Care Technician I, you will monitor daily animal health and welfare while performing daily animal health observations, as well as complete animal husbandry duties to maintain quality and health of research animals. Additional responsibilities include: * Perform daily water bottle / automatic water line and cage checks. * Provide appropriate food and water. * Perform cage changing and / or cage cleaning. * Record animal health concerns per SOP and / or specified protocols. * Maintain accurate records of animal breeding, health, and housing/isolator or support areas. * Assist with restraint, handling and manipulation of various animal species. * Strictly follow all procedures necessary to maintain animal housing areas or semi-rigid isolator environments, including room or facility personnel entry; personnel protective equipment use; and spraying in all equipment and materials into controlled areas. * Receive, inspect, and put away incoming animals. * Provides for sentinel animals in each rodent housing area. * May be involved in maintaining and following breeding and weaning procedures to ensure appropriate production levels. * Operate equipment and use supplies according to safety guidelines. * Perform general housekeeping. Job Qualifications The following are minimum requirements related to the Animal Care Technician I position: * High school diploma (HSD) or general education degree (GED) * Six to twelve months related experience in rodent animal husbandry is required The pay range for this position is $23 - 25 USD per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231568