QA Dry External Intermediates Manufacturing Associate Join to apply for the QA Dry External Intermediates Manufacturing Associate role at Eli Lilly and Company. 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, dedicated to discovering and delivering life‑changing medicines while fostering a culture that puts people first. Key Objectives/Deliverables Serve as a liaison between Contract Manufacturers (CMs) and Lilly. Provide quality oversight of CMs, being the initial point of contact for all quality‑related issues. Escalate quality issues at CMs to Lilly QA management. Assist in the establishment and revisions of Quality Agreements with affiliates and customers. Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs). Provide quality oversight of Lilly/Dry‑EM Quality Plans. Coordinate and perform QA responsibilities of API shipments. Participate in regulatory inspection preparations with CMs and provide on‑site support during inspections. Participate on the Technical Review Board. Evaluate and disposition batches of intermediates, if required. Ensure that documented checks have been completed for Certificates of Testing and Environmental Monitoring, deviations, changes and batch documentation before batch release. Provide quality support of the manufacturing process for intermediates (e.g., Spry dry dispersion technology) with a holistic review of key activities impacting the process. Assess the impact of deviation investigations and changes, ensuring all appropriate records are documented and retrievable. Maintain all processes in an appropriate state of control. Maintain awareness of external regulatory agency findings pertaining to product quality. Review and approve documents such as procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations. Participate in APR activities. Participate in projects to improve productivity. Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams. Basic Requirements BS in a science‑related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences. 3+ years of GMP manufacturing knowledge and/or experience in API/intermediates or finished product manufacturing, QC, QA or Engineering. Additional Preferences Experience in quality support for Quality Control activities. Thorough technical understanding of quality systems and regulatory requirements. Knowledge of pharmaceutical manufacturing operations. Demonstrated coaching and mentoring skills. Experience in root cause analysis. Demonstrated application of statistical skills. Strong written and verbal communication skills. Strong attention to detail. Proficiency with computer system applications. Excellent interpersonal and networking skills. Ability to organize and prioritize multiple tasks. Ability to influence diverse groups and manage relationships. Additional Information Must complete required training for Dry‑EM Quality Assurance. No certifications required. Must be able to support 24‑hour/day operations. Willingness to travel, expected 30% travelling. The anticipated wage for this position is $65,250 - $169,400. Full‑time employees are also eligible for a company bonus and a comprehensive benefits program, including 401(k) participation, health, dental, vision and prescription drug coverage, flexible benefits, and wellness resources. 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. If you require accommodation as part of the application process, please visit https://careers.lilly.com/us/en/workplace-accommodation for assistance. #WeAreLilly #J-18808-Ljbffr
Overview Get AI-powered advice on this job and more exclusive features. 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 designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction. We are seeking a Laboratory Analyst (Expert Specialist) in our Cell Based Assay Quality Control area to support our new Biologics Manufacturing Facility at Raheen Co. Limerick. Key Responsibilities: Executing analytical procedures in accordance with current corporate specifications and cGMP’s and for maintaining the relevant SOPs. Maintenance and cultivation of cells used in the Cell Based Assay Labs. Building / Maintaining QCL digital systems in collaboration with site and external Digital teams. Reporting results into a computer storage system (LIMS), as well as performing testing using automated systems. Involved in the qualification of analytical instruments and in their routine maintenance. Development, validation and verification of new methodologies, as part of new product introductions or process improvement activities. Recognizing atypical assay behaviour and normally encountered equipment failure. Involved in deviation investigations and will record any errors encountered, as per procedures and training. Following all relevant Environmental, Health and Safety procedures and involved in incident investigations as required. Responsible for the maintenance of an inventory of cell/virus banks, reagents and supplies used to perform analytical testing. Assisting in the training of other personnel and, as their level of skill develops, may be responsible for the full training of other Laboratory personnel. Responsible for adhering to, and improving where appropriate, safety procedures to protect their other personnel and company property. Displaying a high level of integrity in the performance of their work. Relating well to other people with whom they come in contact, both within and outside of the laboratory area. Knowledgeable of general scientific methods and capable of learning and executing new techniques and instrumentation after appropriate training. May also be requested to partake in or lead area or cross-functional continuous improvement projects e.g. Six Sigma or other appropriate methodology. Pre-Requisites (Includes Experience, Qualification Etc.) Hons BSc in Virology, Microbiology, Molecular Biology, Cellular Biology, Biochemistry, Biology or related field with a minimum of 5 years GMP/GLP experience. Deep technical expertise in Virology and Bioassay techniques with emphasis on techniques to support various types of IVV Assays, cell culturing, contamination control etc. Understanding of haemagglutination, hemadsorption and cytopathic effects. Highly proficient in the use of multiple instrument platforms (e.g. Vicell, Molecular Devices, etc.) and software applications (e.g. SoftMax Pro, LIMS / LES systems, etc). Excellent attention to detail in all aspects of the work. Detailed understanding of Data Integrity and its applications in a Digital Laboratory. Additional Skills/Preferences Highly competent with computer systems. Experience working in cross functional teams and proven ability in decision making. Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis. Strong organizational skills, including ability to follow assignments through to completion. Self-motivated, positive and ability to work under pressure. Demonstrates flexibility and adaptability to meet business needs. Excellent interpersonal and communication skills (written and oral). Demonstrates a continuous improvement mind-set. Demonstrated initiative – able to work proactively without direct supervision. Demonstrated ability to implement changes in technology and business systems / processes. Others Candidates must be able to travel for familiarization and training as required. May be required to work on a shift basis depending on production support needs. Candidates must meet the minimum qualifications outlined in the Educational Requirements section to be considered for the role. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly 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. #WeAreLillyUKandIreland #J-18808-Ljbffr
Senior/Principal Bioprocess Engineer – TS/MS 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 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 put people first and seek those determined to make life better for people around the world. We currently have an opening for a Senior/Principal Engineer – TS/MS MAB Network. This position will support the IE43 Pilot Plant TS/MS MAB Network Facility, based at the Kinsale site. Reporting to the Associate Director - TS/MS Monoclonal Network, the Bioprocess Engineer will be responsible for supporting the Large Molecule Manufacturing Network Pilot Plant. The Bioprocess Engineer is responsible for safe design and safe operation of the equipment within the Pilot Plant and for establishing and maintaining the reliable operational state of unit operations, processes, systems and equipment used within the Pilot Plant to support productivity agendas and new technology implementation (PAT and other) in the MAB manufacturing network. Key Objectives / Deliverables Ensure a safe working environment by following safety rules and helping improve the safety culture. Liaise with Manufacturing and Development to design and execute Pilot Plant studies and facility fits. Ensure the equipment is properly designed, maintained/monitored through the asset life cycle. Provide bioprocess engineering expertise as an active member of area Pilot Plant team. Lead the implementation of new technologies (e.g. PAT). Lead troubleshooting investigations to resolve difficult unit operations, equipment and operational issues. Educate and upskill team members and Operators on equipment requirements. Provide bioprocess engineering support to the IE28 Biotech TS/MS lab, where need arises. Work closely with Pilot Plant Scientist and Area Manager to help set and deliver the schedule. Education Requirements Level 8 Degree in Process / Chemical Engineer or Bioprocess / Biochemical Engineering. Additional Preferences 3-5 years’ relevant experience in Large Molecule Manufacturing Unit Operations. Basic Requirements Deep technical interest and understanding in the field of Process Engineering. Strong analytical and problem-solving skills. Ability to work on own initiative and as part of a diverse group of management, production, science and engineering professionals. Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented. Guidance/mentoring of others through processes. Flexibility to meet business needs. Strong interpersonal skills with demonstrated adaptability to working in different environments and teams. Strong verbal and written communication skills. Other Information This role is a permanent 8-hour days position, but the need for occasional evening or weekend support can arise. At Lilly, we are committed to fostering a diverse and inclusive workplace where every employee feels valued and empowered. The successful candidate will be part of a team that’s passionate about making a difference—and you’ll have opportunities to grow, innovate, and shape the future of biomanufacturing. 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. This is for individuals to request an accommodation as part of the application process; 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. #WeAreLillyUKandIreland Seniority level Mid-Senior level Employment type Full-time Job function Engineering and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Eli Lilly and Company by 2x Sign in to set job alerts for “Senior Principal Engineer” roles. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #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.At Eli Lilly Cork, 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 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients 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, with four pillars: EnAble, Age & Culture, LGBTQ+ 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 Trial Capabilities Associate/Sr Associate, Budgets & Contracts provides clinical trial capabilities in support of clinical development. The Associate, Budgets & Contracts is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials from budgets and contracts perspective and support ongoing budgets and contracts activities during site maintenance and close-out. The Associate, Budgets & Contracts is responsible for execution of the budget and contract, and activities related to clinical finance and records management. The Associate, Budgets & Contracts will ensure inspection readiness through contribution to 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. This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.**Clinical Trial Responsibilities*** Initiate investigator site activities, including communicate and negotiate budgets and contracts with site personnel, service providers and internal teams, negotiate and obtain fully-executed contract, and effectively drive timelines aligned with company priorities* Responsible for meeting and exceeding goals for clinical trial initiation for development programs in the region of responsibility* Responsible for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards.* Communicate directly with sites to enable start-up and maintain an active collaboration with sites regarding budgets and contracts activities during maintenance and close-out* Identify, communicate, and resolve issues related to budgets and contracts* Ensure country specific regulatory and data privacy requirements are incorporated into budget and contract 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* Understand and comply with procurements, legal and financial requirements and procedures* Populate relevant 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**Clinical Finance Responsibilities*** Collect and administer financial data from contracting partners and vendors* Ensure finance specific requirements are administered in budget and contract documents* Ensure internal financial requirements are communicated to contracting partners and vendors* Ensure contracting partner and vendor financial requirements are communicated to internally* Support contracting partners, vendors and internal stakeholders during the payment process* Identify, communicate, and resolve issues related to payments**Minimum Qualification Requirements:*** Bachelor’s degree preferably in a scientific, health related, engineering, economics or project management field, two years clinical research experience (CRO, sponsor or healthcare service provider) or relevant budget and contract negotiation experience preferred* Understanding of the overall clinical development paradigm and the importance of efficient site activation* Applied knowledge of project management processes and skills preferred* Appreciation of / experience in compliance-driven environment* Ability to learn and comply with financial and legal guidelines and policies (budget and contract)* Effective communication, negotiation, and problem solving skills* Self-management and organizational skills* Language Capabilities (English and another European language)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 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.#WeAreLillyUKandIrelandAt Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #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 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. 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. 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! Note: This position is for a 12‑month fixed‑term contract. Purpose Dedicated to enhancing patient experiences across all phases of clinical trials, the Patient Engagement organization boasts an advanced internal Health Literacy capability. This innovative team specialises in crafting engaging patient‑centric clinical trial communications and materials in multiple media formats spanning patient education, recruitment, retention and executing comprehensive health literacy strategies. Primary Responsibilities This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Document Preparation, Development and Finalisation/Document Management. Effectively collect and evaluate data, information, and input from multiple sources, functions and regions to effectively create and deliver impactful and streamlined health literacy optimized patient‑facing clinical trial communications. Plan (including organising/preparing outlines), write (including first‑draft authoring), edit, review and coordinate the publication and distribution of patient‑facing clinical trial health literate communications. Conduct effective document initiation to ensure authoring team alignment, optimal audience engagement, base message and understanding. Ensure data are presented in a clear, complete, accurate and concise manner. Ensure that key data, strategically aligned scientific narrative, elements from internal guidance and resource documents are included appropriately in all documents, and that data and content created is integrated, accurate, balanced and supported by appropriate data. Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of document as required based on internal/external input and prepare final version. Exhibit flexibility in moving across development and preparation of multiple document types. Work with Health Literacy team and extended teams to ensure smooth and timely development of documents and escalated issues, as appropriate, to ensure document completion. Leverage health literacy best practices to ensure all content is optimised for intended audiences. Influence or negotiate change of timelines and content with other team members. Adhere to compliance standards leveraging the Lilly Brand book and Lilly Global Health Literacy Toolkit. Advocate internally and externally for appropriate audience engagement and best health literacy practices on all applicable work products. Project and Stakeholder Management. Lead the writing process and apply effective project management skills to ensure timely completion of documents. Serve as the BU health literacy content creation point of contact for molecule teams to offer best practices and creative strategies to create dynamic content experiences. Knowledge and Skills Development. Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s). Maintain and enhance content creation skills to align with audience needs and technology/digital evolution. Exhibit flexibility in moving across document types, therapeutic areas and compounds, depending on project assignment. Knowledge Sharing. Provide peer coaching to others by sharing technical information, giving guidance, answering questions. Recognised for technical expertise in development of health literate documents. Network with others (including other functions and regions) to identify and share best practices. Contribute to process improvements, suggesting opportunities where appropriate. Minimum Qualification Requirements Bachelor’s degree in scientific, health, communications or technology related field. Or, Bachelor’s degree in any field with at least two years of clinical development experience. Strong communication and interpersonal skills. A writing exercise is required as part of the candidate evaluation process. Other Information/Additional Preferences Advanced degree (PhD, MD, PharmD, MA, MBBS) in sciences or health related field. Demonstrated mastery of verbal and written English skills in the medical, scientific or health outcomes or technical writing fields. Experience in medical writing and/or creation of SEO‑friendly website content. Previous training and experience in disseminating results in clinical, health economics, health outcomes, health literacy, disease management and/or population health. Relevant experience in clinical development, clinical trial process, health‑outcomes research or regulatory activities. Clinical pharmacology, therapeutic area or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise). Demonstrated project management and time management skills. Demonstrated high‑level end‑user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates). Extensive experience in writing, reviewing and publishing scientific materials and the ability to appraise scientific literature and raw data critically. Ability to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills. 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, colour, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLillyUKandIreland #J-18808-Ljbffr
Overview Join to apply for the Manager - Network Materials role at Eli Lilly and Company . 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 Network Materials Management Team is a cross functional team that manages common raw materials associated with Monoclonal and Gene Therapy Network sites – Kinsale, Limerick and LP2. This ensures common approach and focused partnership with Vendors with one Lilly voice for Monoclonal DS materials. The team consists of Procurement, Supply Chain, TSMS and Engineering. The scope of the team is to establish centralized forecasting for the Network and enable integrated network planning and inventory sharing in addition to managing second sourcing which will focus on establishing additional vendors of key raw materials to ensure the Network is appropriately resourced from materials perspective. This role will be based at either Limerick or Lebanon (LP2). Responsibilities Key point of contact between sites & vendors to align a network level demand projection & supply response which meets both manufacturing & safety stock requirements Establish, maintain and drive key metrics/KPIs to ensure vendors are managed in an effective manner Ensure effective Supplier Relationship Management processes are in place Adhere to a network level strategy for safety stock & contingency planning Work with Global Procurement to put in place long term contracts with key vendors to ensure long term supply Partner with Global Procurement and Manufacturing Strategy on due diligence and sourcing activities Drive automation, system based approach to ensure all processes as efficient as possible Key point of contact between the site & vendors to ensure successful resolution on critical supply issues / expedites and manage the communication & internal escalation process Develop procedures & processes in line with internal manufacturing agreed practices Put in place an effective communication process across all functions, sites, central and Vendors Ensure all aspects of Inventory Optimization are incorporated during reviews and scenario planning. Basic Qualifications/Requirements Degree plus 5 years of Buying Planning / Purchasing experience Additional Skills/Preferences Project Mgt/Business Process management skills Strong analytical and problem-solving skills SAP and Power BI Experience Additional Information Business Knowledge/Innovation: Relevant experience in the business and demonstrated performance in delivery. 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 action in a positive collaborative manner. 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 relationships across all levels in the organisation. Demonstrated ability to listen and understand individual perspectives. Ability to lead people: Demonstrated ability to lead and motivate in a team environment and a strong interest and passion for leading 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. 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 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. #WeAreLillyUKandIreland Job details Seniority level: Mid-Senior level Employment type: Full-time Job function: Information Technology Industries: Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Eli Lilly and Company by 2x Sign in to set job alerts for “Network Manager” roles. Limerick, County Limerick, Ireland 4 weeks ago Limerick, County Limerick, Ireland 1 month ago Limerick, County Limerick, Ireland 1 day ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #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 team of over 2000 employees, across 60 nationalities, speaking over 30 languages at the Global Business Solutions (GBS) Centre in Cork work across the lifecycle of our medicines, centralising and transforming key capabilities including: Clinical Development, Regulatory, Medical & Scientific capabilities, Patient Safety, Finance & Procurement, Supply Chain, Global HR, Legal, Ethics & Compliance, Commercial and Technology. The success of Lilly GBS is underpinned by the company’s core values – Excellence, Integrity and Respect for People. Are you eager to make a significant impact in the cybersecurity field? We are seeking Security Ops Engineer Authentication roles to infuse our team with innovative ideas and daring solutions. In this position, you will play a crucial role in delivering how our organization ensures secure, appropriate, and timely access to enterprise resources, while also supporting the capabilities that help us achieve and sustain our Identity and Access Management strategy. This role includes participation in a structured on‑call rotation covering the weekends and country holidays, to support our ‘follow the sun’ model across Kuala Lumpur, Cork and the U.S. IAM teams. On call coverage is required from Friday 7pm – Sunday 7pm local time with responsibilities focused on resolving priority IAM requests. The on‑call responsibilities are designed to support critical operations and ensure timely resolution of issues outside standard working hours supporting 24/7 operational resilience. Team members will work two weekend shifts (Saturday & Sunday,) every 4–6 weeks on a rotating schedule for time on call and receive a fixed on‑call allowance per day paid monthly in arrears. In addition to the on‑call allowance, additional premiums for hours worked during the on‑call period will apply at an hourly rate for each hour worked, paid monthly in arrears. Why this role matters Ready to put your mark on the world of cybersecurity? We’re looking for a Security Ops Engineers to bring a growth mindset, customer focused approach and fresh perspectives to our team. In this role, you’ll be instrumental in shaping how our organization provides secure, appropriate, and timely access to enterprise resources. How you’ll make an impact Operational Excellence: Execute processes for incident management, change management, problem resolution and continuous improvement that enable Identity services. Continuously monitor IAM authentication systems performance and health to ensure optimal operation. Perform regular maintenance tasks to prevent issues. Respond promptly to system alerts and incidents, troubleshoot issues, and implement solutions to restore services as quickly as possible. Manage and maintain all components of IAM authentication systems. Ensure that all systems are up to date with the latest patches and security updates. Analyze system performance metrics and make recommendations for improvements. Implement changes to enhance system efficiency and reduce downtime. Maintain detailed documentation of system configurations, procedures, and incident reports. Provide regular status updates and reports to management. Work closely with other IT teams, developers, and stakeholders to ensure seamless operation of services. Communicate effectively to resolve issues and implement changes. Assess current system capacity and plan for future growth. Ensure that resources are allocated efficiently to meet demand. Provide technical support to users as it pertains to issues and requests on Identity services. Support response to audit and compliance requests pertaining to Identity services. Develop and implement solutions to resolve identified problems. Ensure that solutions are tested and validated before deployment. Perform detailed root cause analysis and document findings. Develop and implement corrective actions to prevent recurrence. Proactively identify opportunities for process improvements and implement best practices to enhance problem management processes. Is this you? Bachelor's degree in Computer Science, Engineering or related technical field. 1-3 years of proven experience in supporting, delivering and securing Identity and Access Management services specifically with Entra ID, Active Directory and/or Okta. Additional Preferences Experience with IT service management (ITIL). Understanding of authentication and authorization technologies and federated identity standards and protocols (multifactor authentication, certificate‑based authentication, LDAP Kerberos, OAuth, SAML, OpenID Connect). Experience developing solutions with PowerShell, Python, NodeJS, PHP or other development and scripting languages. Critical thinking and analytical reasoning skills. Good communication and presentation skills, and ability to adapt messaging for diverse audiences. Ability to work with a distributed and virtual team. Critical thinking, analytical skills, and thought leadership. An understanding of common services used in cloud‑based architecture, with experience in AWS and/or Azure, and awareness of cloud platform security and controls. Relevant certifications such as CISSP, CISM, or similar. Eli Lilly Cork offers a premium workspace across our campus in Little Island, with flexible hybrid working options and a total compensation & benefits package that includes competitive pay, bonuses, employee share participation scheme, healthcare, pension and life assurance benefits, subsidised canteen, on‑site 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 your career experience at Lilly. The Hiring Process Find out more at Lilly How We Hire | Lilly Join our Talent Community This isn’t the role for you? Sign up to our talent community to stay connected and learn about other career opportunities as soon as they come up: Join Our Talent Community | Lilly Careers 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, colour, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #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. Requirement : SENIOR ANALYST – FINANCIAL PLANNING Reporting to: Associate Director Finance Outline of Role This is a key position in Financial Planning & Reporting team for the Kinsale manufacturing site, working closely with partners across the business to deliver on financial commitments. This includes business partnering, completing the monthly financial close, financial reporting and forecasting, product costing, ownership of inventory sox controls and development of annual financial business plan. Key Objectives/ Deliverables Business Partner/ Financial Analysis First point of contact for business area financial queries - influence and support business partners to deliver on financial commitments. Prepare financial business cases and financial analysis as required to support decision making. Represent finance in business area governance meetings. Influence productivity agenda to maximize cost competitiveness. Financial Planning and Reporting/ Product Costing Own the financial close, ensure results are accurately stated at monthly (& quarterly/year-end) close. Prepare monthly account reconciliations for assigned general ledger accounts. Prepare monthly metrics pack for business area/ site; analyse results v plan highlighting trends and forecasting projected future variances to support decision making. Support function leadership team to deliver the annual Business Plan, Strategic plan and quarterly forecasts. Own product-costing processes for the area including standard cost development and maintenance for all new products in compliance with global standards. Complete the annual standard cost revision as part of business plan. SOX Controls Ownership of inventory SOX and operating controls ensuring that all are in a state of continuous compliance. Support financial audit processes (internal and external). Compliance Understand and follow all compliance policies, laws, regulations Uphold a high quality of work which is efficient and effective while always maintaining a right first time approach Other Drive innovation agenda for finance. Other activities and projects as required. Requirements: Education, Qualifications & Key Attributes Qualified Accountant ACA/ CIMA/CPA/ACCA with 1+ years PQE in Manufacturing environment. Strong technical/analytical skills (including Microsoft Excel). A positive solutions-focused mind-set. Excellent interpersonal & communication skills. Natural curiosity and drive to improve work practices. Ability to simplify the complex and communicate effectively with non-financial personnel. The following skills and knowledge would be a distinct advantage Knowledge of US GAAP. Experience with SAP. Product Costing experience. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form 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. #WeAreLillyUKandIreland #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 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of BusinessService 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. 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. 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! Job description The Trial Capabilities – Manager Operations leads and manages the daily operation of the clinical trial capabilities team in support of clinical development. The Manager is accountable for ensuring accurate planning, prioritization across teams and timely execution working closely with site engagement at the affiliates and across the trial capabilities teams. The scope of the work includes activities related to investigator sites readiness; maintenance and close out ensuring country specific requirements are met. The manager is responsible for ensuring inspection readiness through a complete, accurate and readily available Trial Master File. The manager provides leadership, direction and technical support to the Clinical Trial Capabilities assistants focusing on results and driving efficiency to achieve goals and objectives. Key Objectives / Deliverables Clinical Trial Capabilities Responsibilities Accountable for meeting and exceeding goals for clinical trial budgets and contracts operations for development programs. Accountable for ensuring compliance with local/regional requirements, data privacy requirements and Lilly quality standards. Manage communications/relationships and serve as the point of contact for the trial capabilities budgets and contracts team deliverables during site initiation, maintenance, and close out representing progress to business partners. Accountable for daily prioritisation of work to meet business needs Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements. Develop and streamline processes ensuring efficiency and improved productivity as well as meeting customer requirements Ensure inspection readiness through a complete, accurate and readily available Trial Master File Organizational Leadership Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDO Build capabilities in the function through the development and improvement of processes, tools and training. Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning People Management and Development Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development Effectively manage an agile organization that continuously meets the needs of a changing portfolio Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment based decision making in clinical delivery Qualification Requirements Bachelor’s degree (preferably from legal/health science/finance/engineering field), six years clinical research experience or relevant experience essential Understanding of the overall clinical development paradigm and the importance of efficient site initiation Previous supervisory experience Strong leadership skills and ability to influence others and lead across the business Project management processes and skills Appreciation of / experience in compliance-driven environment Ability to learn and comply with financial and legal guidelines and policies (budget and contract) Effective communication, negotiation, and problem solving skills Self-management and organizational skills Additional Skills/Preferences Compliance Demonstrate a strong compliance oriented mindset & help to build a strong compliance culture Familiarize with & influence all applicable process documentation & training materials to ensure you operate in a fully compliant manner People Actively participate in the GBS senior management team to make the GBS a great place to work for all employees and influence the strategic direction of the center Engage interpersonal, communication & relationship building skills to interact with all levels of an organization Customer Demonstrate excellence in all interactions with our GBS internal customers & business partners Focus on measuring & improving our internal customer’s experience with the GBS Continuous Improvement Lead a culture of continuous improvement within the CDO organization and the broader GBS Influence the Global process owners to champion continued process improvement 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. #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. Company Overview Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world’s most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity, and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team – and make a difference in improving health for people all over the world! Organization Overview Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM TS/MS Sr. Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The Sr. Scientist is responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners team members and site management. The candidate will be responsible for process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives. Key Objectives/Deliverables Provide technical oversight and stewardship for peptide manufacturing processes. Leads resolution of technical issues including those related to control strategy and manufacturing. Employ excellent communication skills to manage internal and external relationships. Build and maintain relationships with development and central technical organizations. Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications). Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state. Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose. Influence and implement the network technical agenda and drive continuous improvement. Maintaining peptide processes in a state of compliance with US and global regulations Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment. Operate with ‘Team Lilly’ in mind - including coaching and mentoring of peers and other scientists. Basic Requirements Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry/Biochemistry strongly preferred) 3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations. Additional Preferences Knowledge and experience with Regulatory requirements Knowledge of data management practices across manufacturing Enthusiasm for changes, team spirit and flexibility Ability to influence and communicate to diverse groups on business, or technical issues within the site and function Proficiency in delivering complex tasks and/or tasks that are cross-functional Demonstrated Project Management skills and ability to coordinate complex projects Additional Information Some travel ( Some off-shift work (night/weekend) may be required to support 24/7 operations 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. #WeAreLillyUKandIreland #J-18808-Ljbffr
