Certara jobs - 105 jobs

About Certara Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Our goal is to enable the life sciences industry's use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization. Certara is seeking a highly motivated and skilled marketing professional to join our growing global marketing team as Marketing Manager, Events. This role plays a critical part in shaping Certara's event strategy and execution across global markets. The Marketing Manager, Events will provide ownership of end-to-end services that include planning, managing, and delivering high-impact events, from conferences to promotional activations, that align with Certara's marketing objectives and support lead generation goals. This individual will be responsible for creating events that communicate Certara's brand effectively, engage target audiences, and drive qualified leads. The role requires strong collaboration across internal teams including creative, product marketing, services marketing, and sales to ensure seamless execution and measurable business impact. The ideal candidate is creative, strategic, and highly organized, with a passion for delivering memorable event experiences that support business growth. Responsibilities * Design and execute scalable and repeatable marketing and event programs. * Develop and implement comprehensive event plans, including playbooks, objectives, key deliverables, timelines, and budgets. * Build and manage event budgets, negotiate vendor fees, and ensure cost-effective use of resources. * Oversee event timelines and deliverables, ensuring critical deadlines are communicated, monitored, and met. * Lead pre- and post-event briefings with stakeholders to evaluate event performance and provide recommendations for future campaigns. * Partner closely with marketing, product, and sales teams on event branding, collateral, demos, and promotional strategies. * Ensure consistent and impactful brand representation across all events, including booth design, signage, collateral, and promotional materials. * Manage and own end-to-end event logistics such as contracts, space reservations, booth layout and services, signage, setup and teardown, shipping, staffing, activations, and meeting coordination. * Develop and execute social media strategies for each event. * Serve as the primary onsite and lead contact for all national and select international events. * Manage vendors including creative agencies, booth builders, print vendors, A/V providers, shipping partners, and catering services. * Lead post-event reporting with analysis of objectives, results, and recommendations for improvement. * Ensure all lead data is accurately captured using approved templates and uploaded to Salesforce. * Drive best practices for attendees and customer experiences, including promotions, branding/environmental design, communications, and logistical execution. * Delivering maximum ROI for each event Qualifications * Bachelor's degree required * 4+ years of corporate events and tradeshow experience * Willingness and ability to travel up to 40% * Strong project management skills with exceptional attention to detail; able to prioritize and manage multiple deadlines simultaneously * Ability to thrive in a fast-paced, evolving environment; comfortable with shifting priorities and hands-on execution * Excellent written and verbal communication skills * Strong negotiation and vendor management abilities * Creative mindset with a strong approach to audience and customer engagement * Self-motivated, highly organized, and detail-oriented * Strong collaboration skills; able to work effectively with customers, vendors, and internal stakeholders ranging from C-level executives to scientists * Knowledge of digital event platforms * Proficiency in business and office applications (e.g., MS Office, Google Suite) and event technologies (apps, registration systems), with the ability to quickly learn new tools * Hybrid role based in Raleigh, NC Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Manufacturing Operations Systems specialist role will report to an Associate Director of Packaging Operations. The Manufacturing Operations Systems specialist will be responsible for owning initiatives and process improvements, acting as a liaison between operations and multiple functional groups to support event management, change controls, etc. The Manufacturing Operations Systems specialist will also assist the operations team in the day to day management of the production floor and lead investigations and drive implementation of actions associated with deviations. Key Objectives/Deliverables: Support Site Leadership to build a capable site organization by delivering area operational procedures, quality processes and controls for the Packaging areas. Monitor and build a strong safety culture Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations. Participates and/or lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE). Identify changes required for MES and ensure they are implemented consistently with operational practices. Work with EWM, IDS and Master Data Team to support launch and ticket builds Lead training and troubleshooting for operations. Work closely with Logistics on the release of orders Understand and influence the manufacturing control strategy for their area. Trained as a Deviation Investigator Development and monitoring of metrics for the area Aid in issue resolution, batch/product approvals, and production schedule execution. Lead specific activities of the process teams. Key Objectives/Deliverables: Requirements (Education, Experience, Training): High School Diploma or equivalent Experience: 2 to 5 years Operations or Manufacturing Support in Pharmaceuticals Technical or Science degree preferred Experience with cGMP environment Experience with EWM and SAP environments and transactions Career interests in Operations Leadership Device Assembly or Packaging experience Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Goals Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA. Excellent interpersonal, written and oral communication skills Other Information: Ability to travel up to 10% Must be flexible to attend meetings or support off-shifts (operations is 24/7) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $28.84 - $46.54 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced Quality Assurance Manager to support our growth in Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. Position Description: The Senior Manager, Quality Assurance is responsible for providing leadership and technical oversight for the formulation, filling, and visual inspection areas to ensure compliance with regulatory requirements, corporate standards, and industry best practices. This role combines people management with technical quality expertise, driving team structuring, collaborators development, continuous improvement of regulated processes, documentation, and operational readiness. The Senior Manager will help build a strong quality culture, lead inspection readiness, and provide ongoing operational support. Management Responsibilities Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence. Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement. Establish and monitor performance objectives, providing feedback and coaching to drive team development. Identify business and quality risks, escalating appropriately and in a timely manner. Technical Responsibilities Provide continuous quality improvement oversight to regulated processes, practices, and documentation. Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements. Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues. Work cross-functionally with process teams for metrics reviews, operational support, and deviation management. Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance. Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings. Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines. Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes. Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions. Minimum Requirements: Bachelor's or Master's degree in Engineering, Life Sciences, or related field. 5+ years of experience in Quality Assurance, with at least 3 years in a leadership role. Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements. Demonstrated attention to detail and ability to maintain quality systems. Previous experience leading or working effectively with a cross-functional group. Demonstrated excellent interpersonal, written and oral communication skills. Demonstrated strong technical aptitude and ability to train and mentor others. Demonstrated decision making and problem-solving skills. Demonstrated ability to organize and prioritize multiple tasks. Additional Preferences: Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc. Previous experience with Manufacturing Execution Systems and electronic batch release. CQM, CQE, or CQA certification from the American Society for Quality (ASQ). Previous experience with Trackwise, Veeva, MODA. Additional Information: The schedule for this position is 12 hours day-shift (2-2-3) 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 $94,500 - $138,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

The Director, Scientific Communications shapes and leads the long-term communications strategy for BioPharma Clinical Operations, elevating the visibility, reputation, and impact of BioPharma ClinOps across R&D and the enterprise. This strategic role partners directly with the Head of Clinical Operations and senior leadership to craft a compelling, science anchored narrative of how Clinical Operations accelerates innovative, patient centric development. The Director will steward integrated internal and external communications, thought leadership, leader visibility, and enterprise storytelling grounded in a deep understanding of clinical development, operational excellence, data/digital transformation, and compliance. Role purpose Build and execute a multiyear communications strategy for BioPharma Clinical Operations that aligns to R&D and enterprise strategy, advances change adoption, and measurably improves awareness, engagement, and influence. Serve as a principal advisor and communications lead to the Head of Clinical Operations, providing counsel, executive messaging, and issues management. Translate complex scientific and operational topics (trials portfolio, digital/data innovation, risk-based quality, patient engagement, sustainability) into clear, compelling narratives for diverse audiences. Strengthen Clinical Operations' voice and presence inside R&D and across AstraZeneca, and externally with industry partners. Key responsibilities Strategy and leadership Set the long-term BioPharma Clinical Operations communications vision, priorities, and annual operating plan, with clear KPIs tied to business outcomes (e.g. cycle time, quality culture, talent brand, innovation adoption). Establish the strategic narrative and messaging architecture for ClinOps 2030, mission, proof points, and signature stories, ensuring consistency across channels and markets. Advise and coach the Head of Clinical Operations and LT on executive communications, change leadership, and stakeholder engagement. Act as communication lead for LT meetings, town halls, and enterprise forums. Partner with other Communications team members as an experienced peer, offering guidance, coaching, mentoring, and thought partnership while collaborating on priority initiatives without direct line management. Partner with R&D, Corporate Affairs, SEN and HR to integrate ClinOps narratives into broader enterprise communications and employer brand. Integrated communications and channels Own the BioPharma ClinOps editorial calendar, content roadmap, and multichannel strategy (Workvivo posts, video, newsletters, podcasts, town halls, playbooks). Lead development of high impact content: executive speeches, narratives, video series, infographics, thought leadership articles, and campaign toolkits. Ensure compliance with regulatory, legal, IP, and data privacy requirements. Map and manage critical stakeholder groups (ClinOps LT, functions, regions, sites, study teams via appropriate channels), tailor messaging to their needs and maturity. Drive leader visibility and “leaders as communicators” programs, develop leader communication playbooks and coaching to cascade strategy and reinforce cultural behaviors. Sponsor key events and flagship moments (ClinOps 2030 milestones, ClinOps Awards, innovation showcases) with measurable engagement and follow through. Define success metrics across awareness, engagement, behavior change, and business impact. Conduct audience insights, message testing, and channel analytics to continuously refine strategy, socialize learnings and scale proven practices. Qualifications Essential Degree in Communications or Journalism. 5+ years' experience in strategic communications within complex, global organizations, including executive advisory and enterprise change communications. Pharma R&D experience with direct clinical operations preferred Proven track record building multiyear communications strategies with measurable business impact. Experience navigating regulated environments and partnering with Medical/Legal/Regulatory for external content. Executive presence, stakeholder influence, and the ability to simplify complexity for global audiences. Strong command of digital channels and analytics; proficiency with content management, enterprise social, Adobe Creative Cloud, and video/podcast production workflows. Desirable Familiarity with AI assisted content, data storytelling, and measurement platforms. When we put unexpected teams in the same room, we unleash ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. If you're ready to make a significant impact on patients' lives by joining a team that follows the science with curiosity and courage, apply today! Date Posted 11-Dec-2025 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Experienced managers in a key account management function, responsible for agreed upon targets for the assigned accounts. Primarily responsible for key stakeholder relationships within targeted accounts, develop deep understanding of individual customer needs and identify mutually beneficial solutions for both Novartis and customers through creation and execution of account business plans. Cellular Therapy Strategic Account Manager - New York City Territory - Remote (MD, DE, PA, NJ, Greater NYC) Please note that this role would not provide relocation and only local candidates will be considered. About the Role Major accountabilities: * Responsible for complete ownership of assigned Key Accounts; develop product specific and portfolio strategies in line with goals and customer needs; align Account strategy with other key Sales, Marketing, Patient Access, Medical and Managed Care functions and ensures cross-functional resources and support. * Delivers the Account plans and required financial results for own Key Accounts; works effectively with colleagues in other functions (e.g. Primary Care and Specialty Sales, Marketing etc.) to achieve account sales. * Responsible for contract optimization, access and reimbursement across the specific customer groups that are relevant to the role or business unit. * Leads negotiations, contracting, pull-through and formulary management with assigned Key Accounts -Creates and implements programs designed to build long-term relationships with Accounts, based on deep understanding of the customer organization, structure, business strategy and priorities -Builds and sustains long-term customer partnerships with assigned Key Accounts, based on deep understanding of the customer organization, structure, business strategy and priorities. * Leads cross-functional Account teams and other assigned resources to develop and deliver Account business plans. * Acts as mentor to other Key Account Managers by sharing best practices on contracting, Account plan development and execution and knowledge of product/disease states, customer segments, and healthcare environment and regulations. * Communicates customer insights and Account-related activities to internal stakeholders, and engages with them to pursue business opportunities within assigned Accounts. * Plays a key role in negotations at the regional level and provide strategic inputs and support to the team (as applicable) -May be responsible for leading the tender business and team within the country by coordinating all related activities and stakeholders at local/regional levels -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: * Sales revenue and revenue growth in assigned accounts -Portfolio and strategic customer development Minimum Requirements: Education: Bachelor's Degree Required Experience: * Minimum of 5 years pharmaceutical experience and 3 years of total experience in one or a combination of the following areas: Key Account Management, Reimbursement, Medical Device or sales management required. * Demonstrated record of success in Oncology, Hematology, or Transplantation within an Academic Institutional setting strongly preferred * Proven ability to establish and cultivate key customer relationships * Strong Strategic and Business Acumen skills * Strong negotiating skills * In depth knowledge of healthcare industry, environment and * IDNs/ACOs/Government Accts preferred NOTE: Above level experience criteria are not an exhaustive list Skills: * Account Management. * Accountability * Matrixed Collaboration * Commercial Excellence * Competitive Intelligence * Complexity Management * Compliance * Crm (Customer Relationship Management). * Customer Engagement * Enterprise Sales * Ethics * Heathcare Sector * Integrated Marketing. * Market Development. * Problem Solving Skills * Revenue Growth * Sales Strategy. * Selling Skills * Strategic Leadership * Value Propositions * Process Education 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. Field roles with a dedicated training period only: The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week. Field roles with a company car: 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. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: ********************************************************** Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Purpose and Role Lilly is seeking an individual with expertise in early clinical development, including clinical pharmacology, to join a passionate team with a robust, industry-leading pipeline. The ideal candidate will have expertise in diabetes, obesity, cardiovascular, renal or endocrinology drug development with demonstrated learning agility, a problem-solving mindset, and the willingness to develop knowledge and skills in new areas. The Clinical Research Physician (CRP) will be the clinician to progress multiple early clinical assets into first-in-human studies or support their further development through the conduct of clinical pharmacology and mechanistic studies. Through the application of scientific and medical training, the CRP participates in the following: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, grant submissions and contracts, contracts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders. The CRP is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. In addition, the CRP works with the basic research scientists to plan pre-clinical studies, develop biomarker plans, and serves as a scientific and medical resource for study teams, departments, and others as needed. Basic Qualifications Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.). Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see PLA: Medical Licensing Information and Medical Education | MBC Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer. Additional Skills/Preferences At least two (2) years of pharmaceutical industry experience, or similar, that provides adequate background relevant to clinical trial design and conduct of Phase 1 and Phase 2 studies (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator/site management). Pharmaceutical company experience preferable. Clinical and/or research experience in endocrinology, diabetes, obesity, cardiovascular, or renal research preferable. Experience in Clinical Pharmacology preferable. Additional scientific training or degree (M.S., Ph.D.) preferable. Fluent in English; both written and verbal communications. Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills. Demonstrated ability to influence others (both within teams and a matrix environment) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team (approximately 10-15%). Core Job Responsibilities The primary responsibilities of the CRP are generally related to early phase clinical studies and late phase biopharmaceutical submission studies. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission. Support preparation for first-in-human dosing studies including biomarker plans. Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharmaceutical plan to support submission. Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies. Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug disease response models. Contribute, as an integral member of the Exploratory Medicine and Pharmacology team, to global Phase 1 and 2 clinical studies as well as submission planning activities. Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development. Work with Brand Team/Business Unit colleagues to provide appropriate market differentiation and regulatory support in the biopharmaceutical submission plan. Clinical Research/Trial Execution and Support Design and oversee implementation of all clinical pharmacology studies (e.g., single/multiple ascending dose, bioavailability, bioequivalence, drug-drug-interaction, food effect, renal impairment, hepatic impairment, mechanistic studies). Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups/special populations. Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research. Design and oversee implementation methods for development and biomarker qualification studies. Design, create, and provide oversight for protocol development. Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements. Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements. Participate in investigator identification and selection, in conjunction with the clinical pharmacology sourcing group. Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate communication of risk to study subjects. Provide oversight ensuring that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Serve as resource to clinical trial managers, clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with global patient safety policies and procedures. Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety. Provide appropriate oversight and partnership with Third Party Organizations to ensure successful study execution. Scientific Data Dissemination/Exchange Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers. Address the unsolicited scientific questions and information needs of external health care professionals according to guidelines above. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Partner with NPP (New Product Planning) and scientific communications staff on publication strategy and process. Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and other external agencies. Publish results of research projects as appropriate. Consider, review, or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications for clinical pharmacology-biopharmaceutical trials. Provide clinical reports for local and international regulatory purposes. Regulatory Support Activities Support and assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response. People Management and Development: Develop and retain a scientifically excellent, innovation-minded, highly capable workforce with strong exploratory medicine experience. Build an organizational culture that fosters inclusion and innovation, continual improvement, and with an external understanding and awareness. Develop an organizational talent base that demonstrates judgment-based risk taking and decision making. Business customer support (pre and post launch support) Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, New Product Planning, and business development. Understand the scientific information needs of all Development customers (business unit, payers, patients, health care providers). Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts. Support business-to-business and business-to-government activities as medical expert. Contribute actively on an ongoing basis to the strategic planning for the brand. Become familiar with market archetypes and potential influence on the medical interventions for the product. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $198,000 - $389,400 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 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. Position Title: Design + Human Factors Engineering Senior Director -DDCS Department Name: Delivery, Device and Connected Solutions Purpose: In 1992, Eli Lilly and Company established the Delivery Device business to create, develop, launch and continuously improve proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient-centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables over $30 billion in pharmaceutical sales and is projected to drive company growth in the coming years. In response to this growing portfolio and increasing global regulatory expectations, the DDCS organization requires a Design and Human Factors Engineering Senior Director to provide leadership to support product innovation and product development for delivery and device systems at Eli Lilly and Company. This position is responsible for providing strategic direction, execution and reporting of design and human factors activities across all medical device, combination product and packaging programs, according to current regulations and appropriate guidelines within the medical device and biopharmaceutical industries. Position responsibilities: Design and Human Factors: Lead and grow a top-tier engineering and science organization, which includes expertise in design and human factors engineering that is applied across the portfolio. Ensures that: Human capabilities and limitations are adequately reflected in the system requirements Human performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs) Human performance and safety risks are appropriately addressed in planning. The staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance. Human Factors Standards are appropriately documented in the Design Control Quality System. Project milestones are met by identifying and managing risks and escalating as appropriate. Functional budgets and project forecasts are maintained in compliance with P&L People: Responsible for developing and managing the Design + Human Factors Engineering team. Provides leadership, feedback, coaching, performance and career development support to direct reports. Ensures career development discussions, talent assessment, and succession planning are in place for employees. Builds and executes a comprehensive long-range recruiting strategy and technical succession plan to maintain a highly competitive cross-functional technical organization. Strategy / Corporate Integration: Given the anticipated growth in the delivery business both in terms of the existing base of business and future ventures, the Design & Human Factors Engineering Senior Director will be accountable for the execution of a Delivery and Device Strategy with other members of the management team. The delivery strategy and project workload are closely linked to that of the Business Units, Sales Affiliates, Medical, Manufacturing and Marketing. The position would work closely with the above groups to consistently align the strategies and projects. Partner with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors and help draft policy positions across Lilly and the industry Relationship Management: Ensure compliance with external collaborations Create and maintain effective relationships and alignment with Lilly partners external to DDCS (e.g. Quality, Manufacturing, Regulatory, Digital Health, Business Units) Build strong relationships with external vendors and lead external collaboration efforts to support development strategies as they may evolve Minimum requirements: MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience. Experience with regulatory agencies interactions and/or regulatory submissions of delivery devices and combination products. Experience working within a Sponsor organization Working knowledge of HF regulatory requirements, protocols, IRBs, Usability studies and reporting. Human subjects research bioethics and study design Prior supervisory experience of team organization Ability to work effectively across boundaries Demonstrated quality mindset, ability to influence and leadership capabilities Additional Skills and Preferences: Understanding of and experience with device/drug regulations, standards and guidances as they pertain to specific functional responsibilities (e.g. CFR 820.30, ISO 13485, ISO 14971, IEC 62366, ANSI/AAMI HE75) Business skills (capital and expense differentiation and impact on COGS and variance). Communication and interpersonal skills necessary for broad interactions at all levels of the corporation. Broad integrated technical knowledge of system and design engineering, product development, and commercialization (device, container closure, packaging, etc.). Experience working in a diverse networked technical organization with proven skills in managing suppliers and alliance partners. Leadership skills with previous experience managing technical personnel and alliance partnerships Demonstrated ability to lead cross-functional teams Additional Information Position Location: Indianapolis, IN Ability to travel ~10-20% of the time, both domestic and international Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $163,500 - $264,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Eli Lilly RTP is a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to be part of Team Lilly and work with the latest formulation, isolator, and visual inspection technology. The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the QA Floor Support Supervisor. Responsibilities include providing QA oversight to GMP operations in the Parenteral equipment preparation, formulation, filling, and visual inspection areas. The QA Floor Support Specialist oversees production functions to achieve site goals while providing Quality oversight and ensuring compliance. Job Responsibilities: Responsible for adhering to safety rules and maintaining a safe work environment for both ones-self and others by supporting HSE corporate and site goals. Responsible for ensuring training is completed and remains in compliance. Communicates with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues. Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel. Advise Operations and support personnel on quality matters, while driving the site Quality culture. Ensures regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs and quality systems. Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance. Performs daily documented Quality Checks. Perform sample collection, inspection, and delivery of samples to storage location and/or laboratory. Troubleshoot and provide QA systems support to reconcile issues in systems, such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise. PMX). Participate in self-led inspections and provide support during internal / external regulatory inspections. Ability to work cross functionally and work collaboratively with all levels of the organization. Basic Requirements: High School Diploma or equivalent Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Completion of Post Offer Exam or Completion of Work Simulation if applicable. Ability to work overtime, as requested. Additional Preferences: Demonstrated strong oral and written communication and interpersonal skills. Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study, preferred. Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems. Knowledgeable with inventory management systems and deviations systems, (i.e. SAP, TrackWise, etc.) Previous work with combination products or devices with experience with US/EU regulations and notified bodies. Previous experience in GMP production environments. Previous facility or area start up experience. Knowledge of Validation / Qualification activities. Demonstrated decision making and problem-solving skills. Strong attention to detail Proven ability to work independently or as part of a team to resolve issues. Additional Information: Night shift: The position will support a 24/7 operation, working a rotating twelve (12) hour day shift schedule. During the onboarding phase, role will work eight (8) hours Monday-Friday day shift, then transition to the rotating twelve (12) hour day shift stated above upon approval from Supervision. Applicant may work in various areas within the DAP and Warehouse buildings. Mobility requirements should be considered when applying for this 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 $18.02 - $38.61 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning. Job Summary The Associate Director, Catalyze360 Business Operations is responsible for driving operational excellence across the Catalyze360 organization. This role requires deep expertise in procurement, contracting, third-party risk management, and other financial and operational matters with the ability to translate that knowledge into streamlined processes and effective system configurations. The individual will design and implement scalable business processes, lead system implementations, and develop a unified onboarding framework for the team. A passion for identifying and evaluating emerging technologies and tools-particularly AI/ML applications-is essential, as this role will continuously scout, pilot, and implement innovations that can enhance operational efficiency and effectiveness. The scope of this role could also be expanded to include contract negotiation responsibilities for Lilly Gateway Labs as well as consulting and sponsorship agreements. Key Responsibilities * Map existing processes end-to-end, identify inefficiencies, and redesign workflows to optimize speed, accuracy, and resource utilization across Catalyze360 * Identify, propose, and pilot innovative solutions-including AI/ML applications-to drive efficiencies and enhance operational capabilities * Evaluate, select, design, and manage systems and tools to automate contracts and invoice management, financial and headcount tracking, and other operational workflows across the Catalyze360 organization * Partner with Catalyze360, Procurement, Finance, Legal, IT, and other stakeholders to ensure operational systems meet the business needs, integrate seamlessly with enterprise platforms, and comply with corporate standards * Design, implement, and manage a consistent, scalable onboarding program for Catalyze360 team members, ensuring new hires are equipped with the knowledge, tools, and resources to succeed from day one * Represent Catalyze360 in cross-functional operational forums * Potential for responsibilities to be expanded to include contract negotiations for Catalyze360, including managing agreements related to Lilly Gateway Labs as well as consulting, sponsorship, and other similar engagements Minimum Requirements * Education: Bachelor's degree from an accredited college or university * Experience: 7+ years of experience in operations, procurement, contracting, or business development within pharmaceutical/biotech or other regulated industry * Work Authorization: Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role Additional Skills/Preferences * Demonstrated experience: * Driving operational/financial efficiencies for biotech/pharma/life sciences companies * Mapping and optimizing processes and supporting change management * Negotiating and managing R&D service, consulting, sponsorship, and/or real estate agreements for biotech/pharma/life sciences companies * Designing, implementing, and evaluating pilot programs for new technologies and tools, with particular emphasis on AI/ML solutions for operational efficiency * Using, configuring, and/or integrating with financial/operations systems, such as ERPs, CLMs, third party risk management systems, and human resource systems * Supporting system implementations or technology deployments in a regulated corporate environment * Skills * Strong understanding of contracts, procurement, and financial management processes, including vendor onboarding, contracts negotiation, third party risk management, invoice management, and budget tracking * Self-starter with a proactive, entrepreneurial mindset and drive to take initiative, solve problems, and deliver results independently * Excellent communication and stakeholder management skills with ability to influence across organizational levels * Current knowledge of emerging technologies and trends, particularly AI/ML applications for operational efficiency and automation * Strong project management and organization skills Additional Information * Travel up to 10% domestic 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. Organization Overview: At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees 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 serve an extraordinary purpose. For more than 140+ years, we have worked to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. We explore how next generation therapeutics, new technologies, and data analytics can improve patient health and the healthcare system. Our team shares a real passion for challenging conventional wisdom and creating an environment that embraces creative, break-through concepts. Quick Benefits Overview: Medical, Dental, Vision, Prescription benefits are effective on your first day of employment. Paid vacation- starting annually at 120 hours (prorated based on start date). Responsibilities This role will be responsible for execution of daily operational tasks defined by the shift lead/supervisor. Primary area of responsibility will be focusing on material preparation activities to support filling/dispensing/formulation processes. Night shift role from 1800 to 0600 with a 2-2-3 shift rotation. Key Objectives: Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment. Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product. Document process steps on appropriate batch documentation (Electronic Ticket, SAP, Cleanings, etc.). Attain and maintain qualification for the operation of assigned process equipment and duties in the area. Identify opportunities for operational improvements. Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision. Contribute to the achievement of key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Must be willing to work 12-hour shifts (2-2-3 schedule). Candidate must be flexible and be willing to perform non-routine work with Safety & Integrity in mind at all times. Assists in checking execution documentation (PMX, SAP, Cleaning Logs, etc.) Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Basic Requirements: Ability to gown and work in controlled classified areas (Grade C and Grade D). High School Diploma or equivalent. Ability to effectively communicate (written and verbal). Flexibility and problem-solving skills. Basic digital literacy (desktop software/web browser) is required. Training and qualifications are documented on a web based application. Must pass a “fitness for duty” physical exam. Ability to work 12-hour shifts on days (2-2-3 schedule) with additional overtime as the need arises. 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. Ability to wear safety equipment required (safety glasses, safety shoes, protective gloves etc.). Additional Skills or Preferences: Skills/Preferences: Knowledge of current Good Manufacturing Practices (CGMPs). Previous experience working in operations/pharmaceutical industry. Previous experience in a Grade C environment. Knowledge of lean manufacturing principles. BioWork Certification. 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. Organization Overview: At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. Responsibilities: This position will start on an 8 hour, M-F schedule for onboarding, and is expected to transition to a 12-hour, 2-2-3 rotating night schedule within 2-3 weeks. The transition to night shift is a requirement of this position. During the project phase, the Operations Supervisor - Visual Inspection will support commissioning/qualification activities required to bring automated and semiautomated inspection lines into service, as well as supporting site operational readiness activities. This role is expected to be an on-the-floor leader and will be a subject matter expert for the visual inspection process. This role may have the opportunity to be directly involved with hiring team members. Concurrent with project phase, the Operations Supervisor - Visual Inspection is responsible for shift leadership for multiple drug product inspection lines within the area, as well as developing technical expertise of manufacturing employees. This individual must ensure that the manufacturing lines are adequately staffed with trained/qualified employees. Strict adherence to safety and quality rules and procedures is required. This is direct line supervision for line leaders and operators on a 12-hour shift rotation schedule. Key Objectives Support Site Leadership to build a diverse, inclusive, and capable site organization by delivering area operational procedures, quality processes and controls for Parenteral areas Responsible for hiring/managing 10+ direct reports working across multiple manufacturing lines Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE goals Ensures qualified/trained staffing for operators working on the manufacturing lines Communicate with the area Manager on quality, equipment, and operational issues and areas for improvement Responsible for the coaching, development, and performance evaluation of operators/technicians Originate/Investigate deviations or operational quality issues Collaborate with support functions to achieve a consensus for unexpected events during manufacturing Act as both administrator and technical leader for operations, setting a good example through demonstrated knowledge of procedures, compliance with quality systems and use of proper technique Responsible for shop floor execution as it relates to business plan and current Good Manufacturing Practice (cGMP) conformance Basic Requirements: High School Diploma or equivalent 2+ years previous experience in operations or directly supporting a pharmaceutical manufacturing operation Demonstrated leadership experience with an emphasis on respect for people Skills in providing/receiving feedback and creating employee development plans Basic computer skills (desktop software) are required Strong understanding of FDA guidelines and cGMP requirements 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 Ability to work overtime as required Ability to travel < 5% 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: Bachelor's Degree in science, engineering, or technical field Previous experience with automated, semiautomated, and manual visual inspection processes/equipment Previous experience in facility/area start-up environments Previous experience with Manufacturing Execution Systems and electronic batch release Experience with root cause analysis/technical writing Organizational and motivational skills Knowledge of lean manufacturing principles Additional Information: Position may include short duration assignments in Indianapolis or internationally to establish specific process knowledge, establish global contacts, and provide production support Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.) 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. The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Key Objectives/Deliverables The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications. Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy. Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Minimum Requirements An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD 3+ years of clinical development experience, including mid-to-late-stage development Additional Skills/Preferences Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills Previous GI drug development experience Pediatric drug development experience Oral/written communication/listening skills are essential Strong relationship-building and interaction skills with peers and management Preferred location is Indianapolis, though remote arrangements may be considered Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $338,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. 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

Are you ready to play a pivotal role in transforming demand forecasting within BioPharma ClinOps? As an Associate Principal, Business Analyst, you'll be at the forefront of developing, testing, and implementing FTE demand algorithms using PLANIT, our enterprise project management tool. Collaborate closely with stakeholders across BioPharma ClinOps to ensure alignment with organizational productivity initiatives and drive impactful changes in ways of working. Accountabilities: In this dynamic role, you'll deliver value by managing the BAU process for ongoing review and refinement of functional FTE demand algorithms. You'll develop and manage a roadmap of planned deliveries, ensuring alignment with scorecard objectives and functional needs. Your expertise will ensure that FTE BioPharma ClinOps demand in PLANIT (PLANISWARE Enterprise project management tool), aligns with the current organizational structure and is driven by reliable forecast algorithms. You'll also ensure the impact of productivity initiatives is realized in our demand forecasting, while delivering documentation, communication, and training to support ongoing changes. Essential Skills/Experience: University degree at Bachelor level, in a scientific or business discipline 5-10 years of project/portfolio/resource management, in a Clinical Development environment Broad drug development experience in a matrix environment Minimum 5 years of working experience and understanding of business planning and capacity management process Ability to look for and champion more efficient and effective methods/processes Goal oriented and ability to drive performance Experience in converting organizational needs into demand algorithms Experience in developing demand algorithms for Clinical Development Strong data modelling skills and the ability to transform data into forms easily understood by others The ability to balance tact, patience and persistence with the need to move improvements at speed Strong organizational skills to move multiple functions through the improvement processes at different speeds based upon their level of understanding and complexity of their business Expert knowledge of PLANIT (PLANISWARE Enterprise project management tool), and demand algorithms Desirable Skills/Experience: Advanced degree Business relationship management skills Accredited/Certified in Project Management tools/systems Proven ability with enterprise project management systems When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, you'll be part of a team that tackles complex challenges head-on, empowered to innovate and experiment. With access to extensive capabilities and a comprehensive pipeline, you'll engage in diverse projects across the drug development process. Our supportive yet challenging environment fosters continuous learning and improvement, driving us towards groundbreaking solutions that make a tangible difference in patients' lives. Ready to take on this exciting challenge? Apply now and be part of our journey to transform healthcare! Date Posted 02-Jan-2026 Closing Date 30-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Deviation Mentor is a key member of the Quality Assurance (QA) team, responsible for teaching, mentoring, and guiding deviation and laboratory investigations. This role oversees the training program related to deviation investigations, participates in deviation assessments (pre-approval and post-approval), and may lead complex investigations. The Deviation Mentor also collaborates in regulatory inspections, site inspection readiness, and issue resolution. In addition, this role will serve as the site steward for One Quality Management System (One QMS) during the project phase. Key Responsibilities: Deviation Investigation & Guidance Provide expert guidance to lead investigators on deviation investigations, including root cause analysis, quality impact evaluations, and technical writing. Assist and advise deviation reviewers and approvers on issue investigation matters. Lead complex investigations and act as a technical reviewer for deviations and analytical investigations. Lead or participate in deviation review boards, ensuring thorough pre-approval and post-approval reviews. Support the development and review of deviation trend reports. Design and deliver training programs related to deviations and investigations. Develop site-specific deviation and investigation metrics. One QMS Responsibilities Manage the transition of the Quality Management System (QMS) from TrackWise to Veeva for the Concord site. Collaborate with the global QMS I3 team to align site deliverables and timelines. Present progress reports on QMS I3 implementation to site leadership, including key actions and timelines. Act as the Power User and Site Instructor for the QMS I3 Veeva system, covering deviations, change controls, and CAPA. Author and review documentation as a Subject Matter Expert for the Concord site's QMS I3 implementation. Qualifications: Bachelor's or Master's degree in a scientific or technical field (e.g., chemistry, biology, microbiology, engineering). 5+ years of experience in pharmaceutical manufacturing operations with preference for parenteral manufacturing Strong technical writing, critical thinking, and organizational skills. Exceptional communication and interpersonal skills, with a proven ability to provide constructive, actionable feedback to enhance technical document clarity and quality. Demonstrated talent for fostering a collaborative environment where open dialogue and positive critique drive continuous improvement in deviation writing practices. Good knowledge of cGMP, regulatory standards, and quality system requirements. Preferred Attributes: 7+ years in QA roles within the pharmaceutical or medical device industry. Experience with GMP systems, including Deviation Management and Document Control systems. Advanced technical proficiency in deviation management, CAPA, change control, and product complaint handling. Regulatory inspection experience, including readiness and execution Familiarity with TrackWise, Veeva, and parenteral product materials. Proven ability to lead global or local project implementations and influence cross-functional teams. Other Information: Occasional off-hours or weekend support for 24/7 manufacturing operations. 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 $63,000 - $162,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. 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. Organization Overview Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning. Job Summary The Manager of IT Contracts & Business Operations is responsible for negotiating fee-for-service IT contracts across the Lilly Catalyze360 organization. This role requires a proactive, self-driven individual with deep expertise in AI technologies and IT infrastructure and services who can navigate technical complexity while securing favorable commercial terms. The ideal candidate stays current on emerging AI/ML and other IT trends, understands their practical business applications, and can translate that knowledge into well-structured agreements that protect Lilly's interests while enabling innovation. This individual will provide contract matter expertise for IT engagements and collaborate with legal, finance, and technical stakeholders to structure agreements that balance business needs, risk mitigation, and cost optimization. The role has potential to expand into managing Business Operations IT pilots and systems implementations as well. Key Responsibilities * Negotiate complex contracts for a variety of Catalyze360 IT needs, including IT professional services, software license, software development, service level, SaaS/PaaS/IaaS, and AI/ML agreements as well as associated change orders * Serve as the primary interface between Business Operations and IT/business stakeholders, translating technical requirements into contractual terms and managing vendor relationships to ensure alignment with business objectives * Collaborate cross functionally with IT/business, legal, finance, and other stakeholders to structure IT agreements that balance business needs, risk mitigation, and cost optimization * Identify and mitigate business risks throughout the contracting process, including protecting sensitive confidential information and privacy * Manage multiple concurrent IT contract negotiations while monitoring performance and vendor compliance * Potential to oversee implementation, configuration, and ongoing management of Contract Lifecycle Management (CLM) and other systems to optimize contracting processes and ensure compliance * Potential to structure and oversee Business Operations pilot programs and promote adoption of successful pilot solutions Minimum Requirements * Education: Bachelor's degree from an accredited college or university * Experience: 3+ years of experience with a variety of IT contract negotiations (including IT professional services, software license, software development, service level, and SaaS agreements) in the biotechnology/ pharmaceutical or other regulated industry * Work Authorization: Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role. Additional Skills/Preferences * Experience * Demonstrated experience negotiating contracts for AI/ML applications across drug discovery and development * Prior experience designing and coordinating pilot programs, proof-of-concept initiatives, or technology evaluations * Experience with Contract Lifecycle Management (CLM) system implementation and optimization * Skills * Strong understanding of and fluency with IT architecture, cloud infrastructure, software development lifecycle, and enterprise technology solutions * Advanced expertise in Intellectual Property frameworks for AI/ML efforts * Deep understanding of IT security requirements, compliance frameworks including privacy regulations, and data governance in regulated industries * Ability to work through competing priorities with speed and agility in a highly collaborative environment with diverse stakeholders * Excellent communication skills with ability to engage diverse stakeholders including technical, legal, and finance team members * Strong analytical and problem-solving capabilities with strategic thinking and an entrepreneurial mindset Additional Information * Travel up to 10% US as needed for stakeholder engagement and vendor meetings. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $69,000 - $165,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

We are looking for undergraduate juniors and seniors majoring in Chemical Engineering, Chemistry, Biochemistry or a related discipline for a 12-week internship role in Durham, NC from May 18th to August 7th. Support the design/development of innovative Process Analytical Technologies (PAT) and PoC study execution for both R&D and GMP spray drying processes. Assist in digital continuous improvement initiatives by strengthening in-silico process development tools. This includes developing robust integrations between the process data historian, data visualization dashboards, and predictive process models. Develop Lean SWI by establishing clear, detailed standard work instructions for critical manufacturing unit operations - under guidance and collaboration with Ops and Engineering team members. Support process development activities as needed. Position Requirements: Undergraduate juniors and seniors majoring in Chemical Engineering, Chemistry, Biochemistry or a related discipline. Candidates must have an expected graduation date after August 2026. Process Engineering Fundamentals: Understanding of mass/energy balances, thermodynamics, and fluid dynamics required. Data Analytics & Visualization: Experience with tools like Python, MATLAB, or JMP for data analysis and dashboard development required. Process Modeling: Familiarity with first-principles modeling and simulation software (e.g., Aspen Plus, gPROMS) required. Digital Integration: Knowledge of data historians (e.g., OSIsoft PI) and linking process data to analytical models required. Pharmaceutical Manufacturing Exposure: Awareness of GMP principles and R&D workflows preferred. Problem-Solving & Continuous Improvement: Ability to apply structured approaches to optimize processes required. Communication & Collaboration: Comfortable working in cross-functional teams and presenting technical findings required. Ability to use and/or develop AI tools preferred. Ability to report onsite to Durham, NC 5 days per week. This role will not provide relocation assistance. US Work Authorization is required at time of application. This role will not be providing CPT support. Compensation range: $37 - $39 hourly. Date Posted 09-Jan-2026 Closing Date 29-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.