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 Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Purpose: The Associate Director, Clinical Trial Patient Engagement & Diversity Capabilities is responsible for overseeing the daily operations of Engagement & Diversity Capabilities including Health Literate Content, Graphic Design & Animation, Co-design and Services Management team. They are accountable for forecasting and managing resources to deliver business requirements; including recruiting, developing and overseeing a team of individuals with diverse experiences and ensuring they deliver outputs on time to inform business decisions, optimized for value, speed and delivered within budget. Additionally, the Associate Director must foster collaboration within the team, facilitating the timely sharing of best practices to be applied across programs and vendors. They will work closely with leaders in Patient Engagement, Clinical Capabilities, and the CDDA organization to develop talent with broad drug development experience. It is essential to promote a culture of quality and inspection readiness, driving decisions for the timely and optimized delivery of Lilly assets. Primary Responsibilities: Strategic and Technical Leadership: Accountable for providing strategic, technical and operational direction to a diverse team and ensure that processes for the assigned area(s) of focus (e.g., novel recruitment, patient-facing content) are well integrated within the appropriate Clinical Design Delivery & Analytics (CDDA) functions. Oversee that the team effectively provides value through strategic and technical expertise in the creation of right-sized design strategies, including a successful transition to delivery. Accountable for ensuring collaboration cross-functionally to successfully deliver work expectations/deliverables, including but not limited to Procurement, Investigator Engagement, Quality, Tech@Lilly, etc. Proactively assess and advise CT PE Senior Director of emerging technical needs or potential changes in strategic direction. Enterprise Leadership: Responsible for fostering a culture of team partnership and shared learning to identify best practices and standardized approaches to drive efficiency and optimized value. Responsible for ensuring the team collaborates within the team and across Clinical Capabilities and the CDDA to learn broadly about drug development and evolving business practices, share learnings/best practices and standardize/automate processes/tools/outputs to drive impact and efficiency. Responsible for engaging with the Patient Engagement Leaders to continuously assess business needs, ensure innovative and timely delivery of business expectations that meet or exceed expected metrics and value. Personnel Management and Development: Responsible for recruiting, developing and retaining an innovative, clinically focused and operationally capable workforce skilled and knowledgeable in the recruitment and retention of patients/caregivers in clinical trials, gathering and distilling insights from patients/caregivers/health care professionals across Lilly’s therapeutic areas and associated assets. Responsible for building a team culture that is inclusive, representative and fosters innovation. Responsible for developing staff who demonstrate expertise in drug development, therapeutic area science, project management, cross-functional engagement, and judgment-based decision-making. Responsible for establishing and maintaining a flexible staffing strategy to support changing portfolio needs. Responsible for facilitating performance management, personnel development, and career development through frequent interactions, coaching, transparent feedback, and escalation of issues as appropriate. Responsible for ensuring staff compliance with Lilly Corporate, Medical, Regulatory and other standards, procedures, and other internal and external business requirements, including training requirements. Basic Requirements: Bachelors Degree in scientific, health or business related field. Minimum of 5 years experience in pharmaceutical industry. Previous supervisory experience. Demonstrated strong leadership skills. Strong interpersonal and excellent communication (written and verbal), organizational and negotiation skills. Demonstrated ability to influence team members and extended team members. Additional Skills/Preferences: Advanced (Masters or PhD) degree in scientific, health or business related field. Broad understanding of the pharmaceutical drug/device development process. Demonstrated ability to take strategic knowledge and effectively influence the direction of daily operations. Prior experience in managing complex/cross-functional projects. Experience leading teams through transformational change. Prior project management experience and/or experience leading multi-disciplinary teams. Minimal travel required. Additional Information: Position is located in Cork, Ireland. 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly #J-18808-Ljbffr
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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $140,800. Responsibilities This role is responsible for providing daily quality oversight at the Contract Manufacturers (CM) site. This role is located in person on site at the CM site the majority of the time and will help set up the processes for device assembly and packaging at the CM, supporting the Technical transfer until process validation. Additional responsibilities include providing assistance and guidance during routine manufacturing to issues such as deviation investigations, change control proposals, procedure/master formula revisions, and other duties associated with daily Contract Manufacturers (CM) activities. QA Person in Plant may also be responsible for final disposition of manufactured and/or packaged drug product batches. This role serves as DPEM QA primary contact to the CM for initial escalation and works with the JPT to ensure timely response for requests for information. They also ensure that batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements. Important note: Location is at the CM manufacturing site – Dublin, Ireland. Key Objectives/Deliverables: QA Person in Plant should understand the process and equipment for their product scope, including: Understanding the science behind the process and equipment so that compliance-based decisions ensure ongoing effective and efficient processes. Knowing how upstream/downstream processing is affected by their process steps. Knowing the Operational Control Strategy (OCS) and failure modes of the process. Knowing the historical deviations/gaps, trends, and audit history of the process. QA Person in Plant should provide support to the CM daily operations by: Help the CM develop the quality system and process for device assembly and packaging. Levelling, reviewing, and approving event investigations and changes. Ensuring implementation and effectiveness of corrective and preventative actions. Reviewing that practice matches procedure. Ensuring CM's quality systems are compliant with applicable GMPs, Lilly quality standards, and any additional local market requirement. Contribute to Quality culture efforts at both DPEM and CM. Spend time in all unit operations, including the laboratory. Provide primary oversight and guidance for minor investigations and change controls (initial notification and consult). Support onsite resolution of product-related issues. Ensure compliance to data integrity (i.e. perform audit trail reviews). Perform troubleshooting for in-process issues and escalate as needed. Review and provide approval for CM procedure changes. Write protocols for non-routine testing or validation with appropriate guidance. Participate on Joint Process Teams (JPT). Review, enter, or SPV analytical data and escalate as needed. Ensure batches are identified and appropriately sampled for annual stability requirements. Provide on-site support for GQAAC audits and Regulatory inspections. Review and approve complaint investigations. Consult on Master batch record updates; provide input based on observations and interactions on the floor. Metrics tracking. Assist in gathering data to complete the CMs Site Compliance Reports (SCR); provide review as needed. Perform internal notification of quality issues where needed. Serve as a liaison between the CM and JPT. Ensure that materials and products manufactured at CMs are released in compliance with marketing authorization requirements and all applicable GMPs for the intended market. Participate in CM performance reviews (Ex IOPs, supply management, etc.). Track and monitor quality metrics for trends at the CMs. Support batch release activities by: Complete batch record review reporting any issues. Determine final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations. Originate and investigate deviations associated with batch records discrepancies, stability issues, atypical and out of trend results for either chemical, micro or device test (if applicable). Work with Lilly support groups to resolve product-related issues (such as IDM, PDS, GQAAC, Parenteral network). Create Certificates of Analysis or other similar documentation for internal and external customers as needed. Maintain material management (e.g. check all API restrictions in SAP and apply those restrictions to finished product). Provide support for Notification to Management data gathering. Provide input for metrics reports to management. Provide approval of Certificate of Analysis or other similar batch release documentation for internal and external customers. Relationships: Develop and maintain strong working relationships with CM, primary DPEM contacts, QA/QC personnel, and shop floor personnel at the CM as well as with DPEM JPT members. Ensure CMs are following Quality Agreement and appropriate quality systems as part of routine operations. Assist QA Primary and secondary loop role with providing potential topics for GQAAC audit of the CM. Assist CMs on the preparation of any audit from Lilly (GQAAC) or any external agency inspection that impact Lilly products. Follow up on Global Quality Assurance Auditing & Compliance (GQAAC) audit findings, ensuring that the CMs is taking appropriate actions in due time. Continuous Improvement: Support continuous improvement initiatives at the CM (i.e. identify vulnerabilities and inefficiencies of the process and promote improvement projects). Ensure quality improvements are managed through the GMP plan process. Ensure evidence of completion and completes in a timely manner. Basic Qualifications Bachelor´s Degree in Pharmacy, Chemistry, Engineering, Biological Science or related Life Science or equivalent experience. Minimum 3-5 years of experience supporting quality and/or technical functions within Device Assembly/packaging operation. Additional Skills/ Preferences Regulatory related experience. Established technical, quality, and internal networks. Experience with Lilly systems (SAP, Trackwise, Q docs, etc.). Previous experience supporting batch release for parenteral and/or packaging products may be preferred. Ability to represent Eli Lilly’s mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs. Demonstrated ability to work independently. A thorough understanding of cGMPs and Global Quality Standards. Strong written and communication skills, especially attention to detail in written procedures and protocol development. High learning agility. Strong leadership, interpersonal, and teamwork skills, able to work effectively in a cross-functional team environment. Ability to organize, prioritize, multi-task, and influence others. Ability to influence CM and guide them through Lilly principles. Strong decision-making and problem-solving skills. Willingness to learn new technologies. Capability to work in a virtual and complex environment. Willingness to travel. Appreciation for cultural diversity. Additional Information Shift is days, but schedule flexibility and off hours may be necessary to support operations. Location is at the CM manufacturing site – Dublin, Ireland. Some travel ( This role requires on-site presence at the contract manufacturer (located in Dublin, Ireland), a minimum of 3 days per week. In order to fulfill this on-site commitment, employees are expected to travel (by car) 3+ times/week to the site. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( here ) 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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups. 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 #J-18808-Ljbffr
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. About us Eli Lilly Cork, Ireland, is made up of a talented diverse team of over 1,400 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Legal, Finance, Information Technology, Medical, Clinical Trials and more. Lilly offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. In-house People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. We are excited now to add another capability to the existing GBS team reporting to the Contracting Center of Excellence in Lilly Legal. Lilly Legal Lilly continues to be a leader in global pharmaceutical manufacturing. The development of new and exciting medicines at Lilly has created a more complex, dynamic and diversified global manufacturing footprint and supply chain. The number and variety of external manufacturing partners and suppliers requires that Lilly closely cultivate and manage these key relationships, both internally and externally, to ensure that lifesaving medicines are produced in a reliable, efficient and sustainable way. This role reports to the Transactions Center of Excellence - Cork in Lilly Legal and will support legal needs across defined areas of Lilly's manufacturing network. Primary Responsibilities: Identifying and resolving complex legal issues in relevant manufacturing site and related supply chain contracts; Drafting and negotiating a wide range of agreements, building internal consensus, mitigation of contractual risk and driving successful business outcomes; Providing clear advice to internal clients and legal leadership and ensuring that advice maximizes the performance of Lilly’s manufacturing base and supply chain; Effectively communicating, translating complex technical, performance issues into understandable terms and recommending strategic and sometimes novel solutions; Communicate effectively internally and with our external partners. Additionally, this role will: Take ownership of contractual matters and projects; Identify legal issues for assigned matters; Identify and implement functional solutions to improve operational excellence; Assist other attorneys and stakeholders in resolving legal issues on cross-functional projects; Develop knowledge of business and client concerns; Keep abreast of changes in the law; Represent Lilly externally to customers and suppliers; Resolve legal issues using negotiation skills and legal expertise. Basic Qualifications: Bachelor’s degree in Law; Irish Qualified Solicitor; Minimum 3 years of experience with contract negotiation and management, preferably in the pharmaceutical sector. Additional Skills/Preferences: Highly organized and detail-oriented; Demonstrated ability to identify risks and provide contract-based solutions in a highly regulated environment; Strong interpersonal and communication skills; Demonstrated ability to effectively partner with cross-functional teams; Continuous improvement mindset. Additional Information: Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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. #WeAreLilly #J-18808-Ljbffr
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 Senior Bioprocess Scientist will provide technical support for introducing and supporting advanced upstream cell culture manufacturing processes into the next-generation bioprocessing site in Limerick, from startup through to routine operations. As part of the Technical Services/Manufacturing Sciences department, the ideal candidate will possess technical expertise in upstream bioprocessing, along with strong data-driven decision-making and problem-solving skills. Additionally, they will leverage the advantages of a wholly digital plant to gain comprehensive process insights through data analytics and process analytical technology. Key Responsibilities Knowledgeable of the science of upstream cell culture processes and understand molecule-specific control strategy and basis of specifications and critical attributes. Understand purpose and capability of each upstream unit operation and the impact of equipment on the process. Provide technical support to the online process support team for process science, operational excellence, and compliance. Work as part of a cross-functional team at the interface between quality assurance, operations, and engineering to bring deep technical expertise and scientific rigor to the team. Utilize process monitoring tools to make data-driven decisions to ensure process consistency and robustness. Understand basic statistical methodologies and engage with statisticians to assign specifications, validation acceptance criteria, tech transfer criteria, material sampling criteria, comparability assessments, and analysis of batch data for summary reports and product reviews. Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance, and process monitoring needs are captured in manufacturing electronic documentation. Identify process improvements and participate in the implementation of Lean Manufacturing initiatives. Generate scientific reports and technical documentation. Understand and ensure compliance with safety, compliance, and regulatory expectations. Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies. Attributes for the Role Demonstrated technical capability with high productivity. Proven track record of curiosity with learning agility. Self-starter with high initiative and data-driven approach to problem-solving. Demonstrated strong interpersonal skills. Demonstrated strong verbal and written communication skills. Demonstrated adaptability and flexibility to working in different environments, teams, etc. Demonstrated ability to participate in and facilitate decision-making. Educational Requirements: BSc or MSc in Biochemistry, Biology, Biotechnology, Chemical Engineering, or related discipline with relevant experience (>2 years’ experience within the biopharmaceutical industry). Work Environment: These are 8-hour day roles. As a manufacturing support function, the need for occasional evening or weekend support can arise. 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. #WeAreLilly #J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. Role Overview: This position reports to the Director, Limerick Site Procurement and will support site readiness from a procurement perspective (including the coordination of key procurement activities and the establishment of vendor/supplier relationships) and will transition to be responsible for ongoing operational procurement activities once the site is operational. This position is an individual contributor role, based on-site in Raheen, Co Limerick. Responsibilities: Procurement of Supplies and Services Prepare and negotiate agreements and contracts with maintenance, lab and production operations supplies and service suppliers so that risk and costs are minimised. Responsible for RFI/RFP/RFQ’s in Indirect and Local Capital Procurement areas. Drive alignment with Global Procurement on Procurement activities by utilizing Category Management strategy. Ensuring Technology is utilized in our Procurement strategy by driving use of Ariba Catalogs and Guided Buying content in purchase of goods & services. Work with the business stakeholders to develop business needs and KPI’s to measure vendor performance in delivery of goods and services. Drive negotiation and implementation of outsourced agreements and participate in post implementation governance activities. Management of site/supplier relationships Establish and manage relationships with local site suppliers (including negotiations) while integrating global suppliers into the site’s supply chain, with a view to continuous improvement. Ensure Risk Assessment process is followed for Vendors the site interacts with. Drive usage of E-Invoicing with Supplier base and assist in resolving invoicing issues. Lead supplier relations management activities for strategic third-party suppliers. Drive action items, issue resolution, and continuous improvement initiatives with suppliers. Support decisions regarding quality of materials/suppliers and resolution of material/supplier issues, while maintaining high-quality supplier relations. Conduct benchmarking analysis to evaluate market landscape for supported categories. Support/Influence site business needs Work closely with suppliers and internal customers to ensure all internal specifications and standards are met. Ensure legal, quality, health & safety, ethical and environmental standards are maintained and developed. Form and maintain close working relationships with demand planners and buyers as appropriate to ensure supply continuity, security, and integrity while optimizing processes and minimizing waste. Partner with buyers/planners to ensure that materials data (e.g., safety stock needs, pricing) are accurate and updated on a minimum annual basis. Support local & global procurement policies, goals and objectives Establish and maintain strong partnerships with Lilly’s Global Procurement organization as well as counterparts at other Lilly sites. Ensure compliance with Lilly procurement and financial policies and procedures, and regulatory commitments. Drive the usage of Procurement Technology enabled processes such as Guided Buying, Contract Compliance, Catalogs & e-Invoicing. Seek out and implement quality, reliability, efficiency, and cost savings projects with suppliers. Consolidate and present captured and forecasted site savings, in alignment with Global Procurement methodology. Use E-procurement tools in line with procurement strategies. Maintain procurement documentation. Basic Requirements: Bachelor’s level 8 degree in supply chain, business, engineering, or similar field. 5+ years experience in Pharma manufacturing procurement role. Previous supply chain, manufacturing, and/or procurement experience. Demonstrated experience in negotiating and drafting supplies and services contracts. Ability to work autonomously, prioritize responsibilities, and be action oriented. Independent decision maker with ability to influence diverse groups, both internally and externally. High proficiency in PC/IT skills (including Microsoft office skills). Strong teamwork, presentation, and interpersonal skills. Demonstrated learning agility and ability/willingness to adapt to continual change within a startup environment. Additional Skills/Preferences: Experience working on a start-up initiative. Previous SAP and/or Ariba experience. Additional Information: The position is based full-time onsite at the Limerick, Ireland site. Periodic travel may be required to other sites (10%). Come join our team – Be Creative, Be an Innovator, and most of all, Be Yourself! #J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. To facilitate bringing the plant on-line, several operational roles will be necessary to execute all the activities to start-up the facility, create multiple business processes, complete Process Validation, then assume day to day production activities. The Warehouse Supervisor provides leadership and direct supervision to the Warehouse Operators at the Logistics Centre in Limerick site. Initially, the Warehouse Supervisor will be responsible for leading Operators and carrying out tasks associated with bringing the new Logistics Centre facility on-line. After the plant is running, the Supervisor will be responsible for directing activities on their shift in alignment with production targets and leadership direction. The Supervisor is the management representative on shift. Key Responsibilities: The Supervisor provides direct supervision to the Warehouse Operators at the Logistics Centre in the Limerick site. Initially, the Supervisor will be responsible for leading a team of Warehouse Operators and carrying out tasks associated with bringing the new facility on-line. After the plant is running, the Supervisor will be responsible for directing activities within the Logistics Centre to support Production operations. The Supervisor will provide oversight of inbound, outbound, weigh & dispense & sampling activities within the Logistics Centre as well as supporting inventory management and material flow. People Management: Responsible for individual’s performance, manage employee relations, 1:1 time. Be a role model for personnel in terms of performance and behaviours. Effectively assign tasks and completion criteria. Work with other operations and support resources to assure all activities have adequate operator coverage to ensure production targets or milestones are met. Follow and ensure adherence with vacation/absence/overtime policies. Conduct thorough information pass downs to ensure the appropriate personnel are aware of all issues and progress made on tasks. Lead teams as necessary to accomplish plant start-up and team goals. Compliance Culture: Help to promote a culture of quality and safety compliance within the area by demonstrating the desired behaviours. Ensure that all operations personnel are adhering to the relevant compliance procedures. Organise, participate in, and/or lead routine Quality and EH&S audits/inspections of the facility with operators and support personnel. Ensure all required documentation is complete and accurate. Maintain housekeeping standards within their assigned areas and the building in general. Routine Operations and Start-up: Run morning/shift team meetings. Escalate issues and barriers to start up and efficient execution of tasks where appropriate. Co-ordinate immediate response to major Quality and EHS events in off-hours, as necessary. Assignment of operators to specific tasks for the day based on the warehouse operations schedule or start-up milestones outlined at morning meeting. Work closely with technical support to ensure activities performed in a compliant manner. Ensure Logistics Centre start-up milestones are met. Ensure all relevant documentation is completed by end of day/shift. Daily Operations Management: Provide leadership on data integrity. Own the planning, scheduling, and work completion processes across the site. Ensure Logistic Center areas deliver on maintenance operational and technical requirements by networking with operational areas. Manage events from initial response to follow-up. Establish and maintain safety, GMP and Environmental Standards. Basic Requirements: Four years GMP manufacturing experience required. Good communications skills (both oral and written). Requires learning and understanding Good Manufacturing Practices and strict adherence to GMP regulations. Will be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas. Good organizational skills. Ability to demonstrate attention to detail. Additional Preferences: Technical problem solving skills. Strong Leadership skills. Previous manufacturing Supervisor experience. Education Requirements: Leaving Certificate or equivalent education or experience. Other Information: During the start-up phase of the project, the shift will be primarily day shift. As the site nears normal operation, shift work will be required. Anticipated to be 12-hour shifts. Some overtime 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly #J-18808-Ljbffr
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. SAP Analyst - Logistics & Supply Chain Reporting To: M&Q IT Associate Director Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Raheen, Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. Main Purpose and Objectives of Position: The role will support the business processes and systems for Lilly’s manufacturing site inbound, internal, and outbound logistic flows. This involves close collaboration with operations groups responsible for planning, procurement, warehouse operations, dispensing operations, production supply, and shipping. The role will provide expertise for a highly integrated set of systems that includes SAP S/4HANA, SAP Extended Warehouse Management (eWM), warehouse automated storage/retrieval systems (ASRS), and Syncade Manufacturing Execution Systems (MES). The scope of the logistics support will include additional solutions beyond these operational systems, like performance metrics, schedule modeling system, data & analytics, etc. Key Duties and Responsibilities: Understand the systems and equipment involved in logistics operations and material control; and the associated data, workflows, and data flows. Understand how these logistics systems and processes integrate with other critical systems like MES (Manufacturing Execution System) and Process Automation. Support the implementation of SAP eWM; develop expertise in the SAP eWM technology and its integration to additional SAP Supply Chain modules. Learn the logistics business processes, scheduling, applications, tools, etc. Work with site business area, IT Architects, MES architects, and Data Analytics architects to implement the Next Gen Warehouse Solutions landscape to meet business needs most effectively. Work with IT groups like Global Services, Global Infrastructure to support delivery of infrastructure for warehouse solutions to our enterprise. Be forward thinking. Monitor industry trends and technical evolution within the Supply Chain systems landscape. Collaborate with business partners to find new value opportunities through technology and to improve the user experience. Participate in cross-functional projects, understanding business impact, evaluating/recommending technical options. Support site implementation activities, integration to other site functions, and site preparation activities. Work with business areas on cross-organizational issues. Promote process improvement and innovation to drive business process optimization. Adhere to corporate computer systems validation policies and procedures. Ability to: Communicate effectively and build relationships cross-functionally. Coordinate, mentor & coach team members. Take initiative to identify and drive improvements. Requirements: Bachelor’s Degree in Information Technology, Computer Science, Engineering or related field (Level 8 or equivalent). 4+ years of experience in manufacturing, preferred in pharmaceutical or other regulated industries. Experience with integrated logistic flow in a manufacturing facility, including prior experience with SAP and MES systems. Knowledge of System Development Life Cycle. cGMP's. Knowledge of Microsoft Office suite of tools. Project Management and leadership skills. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly #J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: The lead Specialist QC Esystems role in the Limerick Quality Control Laboratory (QCL) provides technical support for the electronic systems within the laboratory. This role will support the QCL electronic systems project implementation, ensure compliance and operational support of the laboratory electronic systems associated with all testing activities within the QCL function. Specifically, during the startup phase of the Limerick site (2024 to 2026) the Specialist/Lead will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function. Responsibilities: Key Technical SME on the QCL electronic systems including but not limited to LIMS and Empower. Very knowledgeable of general scientific methods in the laboratory and the Esystems that support the laboratory. Works with global functions in the development and delivery of standardized processes and procedures for the electronic systems in QCL. Primary contact for IT, CSV and the Quality department ensuring the QCL Electronic systems are implemented following a development life cycle approach. Provides guidance to the laboratory on the configuration and optimal use of Esystems. Provides end-user support for QCL electronic systems including troubleshooting complex problems at the application layer within their permission level and escalating as appropriate. Configures master data, worksheets, methods and reports (tabular, trend and labels) within the QCL electronic systems. Supports the Authoring/review of key GMP documents such as GMP standard operating procedures, training materials, test methods creation documents, local qualification documents, lab/ equipment/ computer system periodic reviews, annual product reviews, validation master plans etc. Trains other team members on core QC Esystems. Coordinates across business departments and stakeholders, gathering, and supporting the implementation of enhancement requests for the QCL electronic systems. Processes and supports QCL Esystems Change Control requests. Identifies and implements appropriate CAPAs for the QCL Esystems. Leads Audit requests relating to QCL Esystems. Support the collation of QCL and other departmental metrics from the QCL Esystems. Basic Requirements: Hons Degree Qualified – B.Sc. in Chemistry, Microbiology, Information Technology or related discipline, with a minimum of 6 years relevant GMP experience. Additional Skills/Preferences: Safety first approach to all activities. Strong Quality and Data Integrity mindset in a QC environment. Excellent attention to detail. Proficient in English. Technical expertise in Quality Control applications e.g. Lab Vantage, MODA, Empower, NuGenesis, and benchtop applications such as DataPro2, SoftMax Pro. Highly competent in the use of digital solutions for data, equipment and laboratory management. Experience with regulatory inspections. Key Attributes: Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation, and organisational skills. Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions. Positive Influence: Demonstrated ability to address issues as they arise and take act. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve. Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organisation. Ability to lead people: Demonstrated ability to influence peers and across functions. Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations. Decision Making: Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution. #J-18808-Ljbffr
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. What You'll Be Doing: As a Cloud Security Engineer at Lilly on the Security Architecture and Engineering team, you will play a pivotal role in a dynamic environment. Your responsibilities include managing cloud security tools (CNAPP/CSPM), conducting security reviews of cloud accounts and projects, generating proactive guidance, reviewing and creating IaC/policy as code templates, and participating in cloud design discussions. You will also contribute to the development and implementation of cloud security controls, create integrations and automations for cloud security detection and response actions, and collaborate with various stakeholders across the organization. How You'll Succeed: Technical expertise: As a Cloud Security Engineer, you will leverage your deep technical knowledge of cloud ecosystems (AWS or Azure) to implement tailored security solutions and effectively mitigate threats and risks. Problem-solving skills: Adept problem-solving abilities are crucial in quickly identifying and addressing security issues, ensuring the development and delivery of robust cloud security solutions in a timely manner. Collaboration and communication skills: You will actively collaborate with both local and remote team members, playing a pivotal role in defining, designing, and executing cloud security strategies. Excellent communication skills are essential for this role, as you will need to engage with both technical and non-technical audiences. Agility: The ability to quickly adapt to the changing threat landscape and move at the pace of the adversary is critical to success in this role. Knowledge of cloud security trends: This role requires staying abreast of the latest developments in cloud security and integrating these insights into our practices. Balancing security and operational needs: You will balance stringent security guidelines with operational requirements, maintaining the desired corporate security posture while demonstrating empathy and understanding towards the engineering teams' challenges and needs. Key Responsibilities: Manage cloud security tools (CNAPP/CSPM) and implement cloud security controls in a multi-cloud environment (AWS and Azure). Conduct security reviews of cloud accounts and projects, generate proactive guidance, and participate in cloud design discussions. Review IaC/policy as code template proposals and provide recommendations for secure cloud deployments. Develop integrations and automations for cloud security detection and response actions to support the Cyber Defense Operations. Partner with cloud foundation teams, Cyber Defense Operations, Tech@Lilly, business areas, and suppliers to ensure secure cloud adoption and operations. Perform threat analysis and modeling to enable business and technical partners to deliver secure solutions integrated with the SecOps lifecycle. Apply threat modeling and analysis frameworks such as MITRE ATT&CK and STRIDE (or STRIDE-LM) in security practices. Maintain and expand technical knowledge across cloud security concepts and technologies, driving knowledge growth across security domains. Identify technical solutions and drive implementation to support strategic direction, focusing on value, impact, risk mitigation, security controls, privacy controls, detection, response, and quality. Prioritize mitigations in relation to technology upgrades, enhancements, and process improvements within the respective domains of accountability. Your Basic Qualifications: Bachelor's degree in Cyber Security, Computer Science, Information Technology, or related field Or High School Diploma/GED with 4+ years of experience in Cyber Security, Information Technology, or related field. And 2-6 years of demonstrated experience in cloud architecture and engineering, with a focus on AWS or Azure (slight preference for Azure). Additional Skills: Strong understanding of cloud security concepts, services, and logs, including Identity and Access Management, Networking, and Security in a public cloud environment. Experience with cloud security services such as Security Hub, GuardDuty, CloudTrail, Config, VPC Flow Logs, Amazon Inspector, Amazon Detective, Cloud Custodian, Azure Policy, Azure Activity log, Defender for Cloud, Azure Sentinel, or Security Copilot. At least basic proficiency in a programming language (e.g., Python) and some experience with cloud automation and integration using tools such as Lambda, Step Functions, Glue, Azure Functions, Terraform, or CloudFormation. #J-18808-Ljbffr
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 Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Purpose: The Trial Capabilities Associate provides clinical trial capabilities in support of clinical development. The associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. The associate is responsible for obtaining clinical trial authorizations and ethical approvals and activities related to records management and site training. The associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences. Clinical Trial Responsibilities Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities. Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out. Identify, communicate, and resolve issues. Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems. Leverage previous site / review board engagements to efficiently drive new work. Populate internal systems to ensure accuracy of trial / site performance. Populate Trial Master Files and libraries for future reference. Provide feedback and shared learning for continuous improvement. Leverage trial prioritization. Anticipate and monitor dynamically changing priorities. Minimum Qualification Requirements: Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred. Understanding of the overall clinical development paradigm and the importance of efficient site activation. Applied knowledge of project management processes and skills. Appreciation of / experience in compliance-driven environment. Effective communication, negotiation, and problem solving skills. Self-management and organizational skills. Language Capabilities: English/Dutch and/or French. 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly #J-18808-Ljbffr
