A leading pharmaceutical company in Dublin is seeking an Associate Director of Product Lifecycle Management to lead product strategies within Global Supply Chain & Strategy. This role requires over 10 years of experience in managing complex projects within the pharmaceutical sector, strong collaborative skills, and a firm understanding of regulatory landscapes. Join us to drive product lifecycle governance and make impactful changes in our operations. #J-18808-Ljbffr
A leading pharmaceutical company in Athlone is seeking a QA Specialist to ensure quality and compliance of drug products. You will oversee QA activities, ensuring adherence to cGMP and regulatory standards. The ideal candidate has at least 3 years of experience in a QA role within the pharma industry and a strong understanding of manufacturing processes. Join us to make a meaningful impact in the pharmaceutical world. #J-18808-Ljbffr
A leading biopharmaceutical company in Dublin is seeking a QC Senior Microbiology Analyst to support microbiological testing and ensure compliance with quality standards. The role involves environmental monitoring, validating test methods, and training laboratory personnel. The ideal candidate has a degree in Microbiology and experience in a cGMP environment. Innovative thinkers with strong problem-solving skills will thrive in this collaborative environment. #J-18808-Ljbffr
Are you ready to make a difference in the world of pharmaceuticals? As a QA Specialist at Alexion Athlone, you'll play a pivotal role in ensuring the quality and compliance of our drug products. Your expertise will be crucial in overseeing quality assurance activities, ensuring that our commercial and clinical products meet cGMP, Corporate, and Regulatory standards. You'll be responsible for the manufacturing, testing, labeling, and storage of drug products, ensuring they comply with all applicable regulations. This role is essential in maintaining the integrity of our Quality Management System (QMS) and collaborating with key stakeholders to optimize patient supply. Accountabilities Provide quality and cGMP input and oversight for all manufacturing activities for the Drug Product facility. Review and approval of technical support documentation, including cleaning, process, and method validation. Review and approval of functional area documentation such as SOPs, Work Instructions, technical reports, and protocols. Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/controlled. Review and approve Validation protocols as required. Provide support and expertise for inspection readiness activities during health authority inspections, including interaction with inspectors and responses to inspection observations. Responsible for review and approval of Master Batch Records in accordance with Alexion’s internal procedures and GMP principles. Essential Skills/Experience B.Sc. in Science/Engineering with a minimum of 3 years’ experience in cGMP Quality environment; or equivalent combination of education and experience. Minimum 3 years’ experience in a QA environment within the pharma industry or a related field. Strong knowledge of cGMP requirements for pharmaceutical manufacturing required. Direct experience of GMP management within a pharma/biopharma company is essential, including exposure to FDA, HPRA or other authorities of similar standing. Excellent accuracy and attention to detail. Good knowledge of relevant computer packages e.g. Trackwise or similar. Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities. Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written. Excellent time management organizational skills along with a proven ability to multi-task. Desirable Skills/Experience Experience of sterility assurance for drug substance and/or drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable. High level technical skills including auditing, pharmaceutical manufacturing, and regulatory inspection management. At AstraZeneca, we are driven by a passion to innovate and create meaningful value in all we do. Our commitment to patients living with rare diseases inspires us to continuously push boundaries and make a positive impact on their lives. With a rapidly expanding portfolio, you'll have the opportunity to grow and thrive in an energizing culture that values diversity, inclusiveness, and collaboration. Join us in our mission to change lives for the better—every day. If you're ready to embark on this exciting journey with us, we'd love to hear from you! Date Posted 19-Nov-2025 Closing Date 02-Dec-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
What you will do Record-to-report ownership : Lead the IFRS month-end and quarter-end close for defined APIO areas, including Intangible assets , Opex , Capex , and embedded leases ; ensure timely, accurate, and compliant outcomes. Technical accounting leadership : Provide guidance on capital projects in line with AZ Group policy ; assess accounting treatments for changes in facts and circumstances while meeting global deadlines. Cross-team collaboration : Partner with Finance colleagues locally and globally; liaise with GFS Ireland to drive a complete and accurate execution of close tasks. Financial reporting & commentary : Prepare APIO month‑end and quarter‑end reporting inputs, including financial analysis and variance commentary; own the preparation of APIO reporting packs for quarterly meetings. Balance sheet integrity : Review high‑risk balance sheet reconciliations; drive timely resolution of reconciling items and strengthen account ownership across APIO. Impairment & costing : Support impairment assessments for intangible and tangible assets, as required; review standard cost analyses, investigate anomalies, and ensure alignment with expectations. Statutory reporting : Manage the local statutory audit and FRS 102 financial statement preparation; act as the key liaison with external auditors and service providers; prepare board materials for approval. US GAAP alignment : Assess accounting differences under US GAAP for sub‑consolidation purposes; ensure appropriate documentation and communication. Tax support : Engage with Tax on compliance activities, including R&D tax credit submissions and related accounting. Controls & compliance : Operate within the SOX control framework; perform assigned controls; support Internal and External audit walkthroughs; maintain and update control narratives as required. Management reporting : Prepare ad hoc APIO management accounts and reporting packs when required. Process improvement : Leverage automation tools and AI to drive process efficiencies, strengthen data quality, and reduce manual effort. Transformation & integration : Support AZ integration initiatives and S/4HANA deployment activities as needed. Stakeholder engagement : Build strong relationships across the Alexion/AZ network and with third‑party stakeholders; support Group, Internal, and Statutory audit efforts. What you will need Professional accounting qualification : ACA, ACCA, CIMA (or equivalent). Experience : Minimum 5+ years post‑qualification or industry experience in accounting/controllership. Technical skills : High proficiency in Microsoft Excel ; strong numeracy and analytical capability with meticulous attention to detail. Communication & collaboration : Proven interpersonal skills; strong written and verbal communication. What we would prefer Organizational excellence : Ability to manage multiple priorities while maintaining high performance standards. Learning mindset : Natural curiosity and ability to learn quickly. Standards & frameworks : Strong understanding of IFRS and/or US GAAP . Industry background : Experience in a multinational pharmaceutical or life sciences environment. Alexion operates a hybrid working model for this role in Dublin. Date Posted 13-Nov-2025 Closing Date 12-Dec-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
Job Title: MES Specialist Location: APICOM Facility, College Park, Dublin, Ireland Competitive Salary and Benefits Company Overview: AstraZeneca is a global biopharmaceutical leader focused on the development of Active Pharmaceutical Ingredients (API) using cutting‑edge technologies. Our Dublin API Commercialisation facility is a state‑of‑the‑art hub designed to transition novel small‑molecule therapies from development to commercial manufacturing. We leverage advanced digital solutions to drive efficiency, compliance, quality and innovation. Job Summary: We are seeking a highly skilled MES Specialist to support the design, authoring, testing, and optimisation of Manufacturing Execution System (MES) recipes and electronic Master Batch Records (eMBRs) using Körber PAS‑X and DeltaV platforms. This role is critical to ensuring compliant, efficient, and robust manufacturing operations aligned with GMP standards and digital transformation goals. Accountabilities: Recipe Authoring & MES Development Create and maintain electronic Master Batch Records (eMBRs) using PAS‑X. Design PAS‑X master batch recipes and DeltaV phases/operations aligned with S88 standards. Ensure modularity, reuse, and compliance in recipe structures. Integrate IPCs, checkpoints, sampling plans, and electronic signatures for GMP‑compliant eMBRs. Maintain recipe versions and associated metadata (PD/PV/PVL/long text). Support DeltaV design and recipe modifications for New Product Introductions (NPIs). Align automation systems with cGMP and GAMP best practices. 2. Process & Equipment Mapping Collaborate with Process Technology to ensure recipe fit with site capabilities. Map recipe steps to equipment models and physical assets using DeltaV and PAS‑X. Confirm control module functionality and equipment model alignment. 3. Material & BOM Integration Map raw materials and products to S4/HANA material masters. Link BOMs and recipes to production versions in S4/HANA and PAS‑X. 4. Simulation, Testing & Validation Participate in recipe dry runs and simulations using PAS‑X, DeltaV, and Mimic. Validate sequencing, transitions, and timings. Fine‑tune operations based on review of test results. Support Computer Systems Validation (CSV) activities and documentation. 5. Change Management & Documentation Participate in recipe change control processes using Veeva and Kneat. Maintain version control and audit trails. Document recipe logic, structure, and business rules. Maintain SOPs, work instructions, and training materials. 6. Training & Support Train end‑users on PAS‑X and DeltaV systems. Support handover to Manufacturing and provide ongoing MES issue resolution. Champion MES adoption across manufacturing shifts. 7. Digital Tech Transfer & Data Alignment Ensure consistent data across PAS‑X, DeltaV, LIMS, and S4/HANA. Link recipe data to batch records, material traceability, and analytics. Collaborate with the Chemical Development department to transfer process information from the pilot plant into APICOM using the Digital Tech Transfer application, ensuring alignment with PAS‑X and DeltaV recipe structures and site capabilities. Essential Skills/Experience: 2 years or more experience of working in Synthetic Drug Substance (or API) Manufacturing Operations. Knowledge of Pharmaceutical manufacturing processes, procedures and equipment within a Synthetic Drug Substance (or API) Substance environment. Lean manufacturing and optimisation mindset. Willingness to widen knowledge of manufacturing processes. Experience of process mapping in a manufacturing environment. Comprehensive understanding of cGMP requirements for commercial pharmaceutical manufacturing. Good interpersonal skills are required, as is the ability to communicate well, both verbally and within written documents. Experience of use of Korber PAS‑X. Desirable Skills/Experience: Experience of change management in a complex environment. Understanding manufacturing computer systems and eData Integrity requirements. Experience of developing or supporting the lifecycle of Electronic Batch Records. Knowledge of S/4 HANA and DeltaV (For EBR configuration) At AstraZeneca, we are driven by a patient‑focused ethos that inspires us to innovate and create meaningful value. Our culture is rooted in integrity, inclusiveness, and dedication to supporting the communities we serve. Here, diversity and different thinking are valued, empowering us to explore new ideas that profoundly impact patients' lives. With a rapidly expanding portfolio, we offer an entrepreneurial spirit combined with the strength and resources of a global biopharma. Join us in making a difference where it truly counts! Ready to embark on this exciting journey? Apply now and be part of a team that is transforming lives! We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Date Posted 18-Nov-2025 Closing Date 08-Dec-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
Responsibilities Build and lead a world‑class team of data scientists, AI engineers, and digital diagnostic experts focused on developing technologies that directly impact patient care. In collaboration with the VP, Head of Diagnostic Innovation Ireland, and the Ireland Transformation Lead, define and execute the strategic roadmap for AstraZeneca’s digital diagnostics capability, from foundational infrastructure to the delivery of robust, prototype‑grade digital diagnostic technologies. Establish a state‑of‑the‑art digital lab environment, integrating multimodal data, foundational models, and advanced image analytics to accelerate data‑driven discovery and validation. Drive scientific and technical excellence, ensuring the highest standards of quality, rigor, and compliance across all AI‑enabled diagnostic development. Forge external collaborations with global academic institutions, technology partners, and health systems to co‑develop breakthrough technologies and expand AstraZeneca’s digital innovation network. Serve as a thought leader and champion of innovation, shaping AstraZeneca’s strategic direction in digital diagnostics while inspiring internal and external stakeholders. Foster a culture of agility, inclusion, and scientific curiosity, enabling your team to thrive and deliver transformative impact. Qualifications Advanced degree (PhD or equivalent) in Computer Science, Biomedical Engineering, Bioinformatics, or a related technical or scientific field. 10+ years’ experience leading high‑performing technical teams in digital diagnostics, AI/ML, or computational biology within pharma, diagnostics, Medtech, or technology sectors. Proven record of developing and deploying digital diagnostic technologies such as clinical decision support tools, software as a medical device applications or AI‑driven biomarker solutions. Deep technical understanding of AI/ML models, data science workflows, and digital infrastructure used in regulated diagnostic development. Demonstrated ability to bridge scientific innovation and strategic execution, translating emerging technologies into impactful, scalable clinical applications. Exceptional leadership, stakeholder engagement, and communication skills, able to influence senior executives, scientific leaders, and external collaborators. Strong knowledge of regulatory standards (SaMD, IVD etc.) and ethical considerations in AI‑driven healthcare. Desirable Skills Recognized as a thought leader or innovator in AI‑driven diagnostics, with publications or conference contributions in leading scientific forums. Experience establishing or expanding digital diagnostic capabilities within a global organization. Deep external networks across academia, biotech, and technology ecosystems. Passion for external innovation and scientific collaboration, with a strong desire to engage academic partners and startups to drive next‑generation diagnostic solutions. Date Posted 17-Nov-2025 Closing Date 30-Nov-2025 AstraZeneca offers an environment where diverse minds unite with a shared passion for learning and discovery. Our scientific community seamlessly fuses academia with industry expertise to drive breakthroughs in oncology research. With multiple indications and high‑quality molecules in our pipeline, we are committed to eliminating cancer as a cause of death. Empowered by investment and collaboration with leading medical centers worldwide, we push boundaries to improve patient outcomes. Join us in making bold decisions that shape the future of cancer treatment. Ready to make an impact? Apply now to join AstraZeneca's pioneering team! Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
A global biopharmaceutical company is looking for an experienced accounting professional to lead financial processes in Dublin. The ideal candidate will have a professional accounting qualification (ACA, ACCA, CIMA) and at least 5 years of post-qualification experience. Responsibilities include managing month-end closes, preparing financial reports, and ensuring compliance with IFRS and US GAAP. This role offers a hybrid work model. #J-18808-Ljbffr
Advanced Manufacturing Technician (API) College Park, Dublin Full Time, Permanent (shift based) AstraZeneca are taking bold actions to create new ways to make life-saving medicines. We will do this through a digital smart and paperless factory. With great innovation, we are changing the ways API’s are being manufactured so we can produce them continuously. By doing this we can deliver medicines to patients faster, cheaper, and more sustainably. This will help us reach our ambitious goals. We are building a next-generation active pharmaceutical ingredient (API) manufacturing facility for small molecules near Dublin, Ireland. This new plant will help us optimize our work and improve our efficiency. It will use cutting-edge process technology and digital innovations. All to be able to meet the needs of AstraZeneca's exciting new pipeline! This will be a shift position and the type of shift is subject to change to meet business requirements. ERT membership will be included as a core responsibility. This is what you will do: As a member of the operations team, you’ll carry out multi-stage Active Pharmaceutical Ingredient (API) manufacturing processes in compliance with AstraZeneca, GMP & SHE standards. In addition, you will also: Provide operational expertise at accommodation meetings such as processing risk assessments. Reinforce standards required in terms of GMP, SHE and specific product requirements Receive, accept, locate, store, dispatch and deliver products and materials and complete all relevant documentation to meet GMP and SHE standards Collaborate with the relevant function to receive and return the materials/components that feed into the production process. Set-up routings for production, change over and cleans and maintain relevant equipment to enable the smooth running of the plant unit. Perform and document the results of equipment cleaning hot spot inspections Carry out ‘free from gross contamination’ cleaning inspections Essential Skills/Experience: Excellent team player with problem solving skills who thrives in a collaborative team environment. Team player and good collaborator GMP and regulatory knowledge/awareness Applicants should be educated to a minimum of leaving certificate /relevant trade. Experience from API production or other pharmaceutical manufacturing Excellent Documentation Practices and Computer skills Lean awareness. Strong safety attitude and approach to training/workload timely completion Desirable Experience: Previous start up experience Documentation generation (drafting initial SOPs, MBR, LIMS sampling plans etc) Familiar with manufacturing process systems e.g. Delta V Lean qualification. Familiar with Electronic batch records. Experience of investigations and CAPAs and change controls. Experience of Tank farm operations. Excellent IT skills (excel, word, powerpoint etc) Awareness and understanding of process equipment and TPM. Why AstraZeneca? At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you! We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Date Posted 18-Nov-2025 Closing Date 29-Nov-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
Are you ready to make a difference in the world of biopharmaceuticals? As a QC Senior Analyst at our Athlone facility, you'll play a pivotal role in supporting the QC department with technical expertise in facility testing oversight, test method validation, and the integration of new technologies. You'll be the go‑to expert on product testing and environmental monitoring, responsible for deviation and technical writing. Join us in our mission to bring innovative solutions to patients worldwide! Accountabilities Ensure high cGMP and GLP standards are maintained, meeting regulatory and business requirements. Validate and qualify microbiology test methods and systems, including Endotoxin and Identification systems. Collaborate with the QC System Specialist to implement LIMS for the Microbiology Laboratory. Lead and participate in Quality Risk Assessments related to Microbiology. Maintain regulatory compliance through laboratory testing programs, training, SOPs, and validation. Represent the Microbiology department during internal and external audits. Close out actions/recommendations from audits. Evaluate compliance issues and trends, providing training as needed. Train laboratory personnel and contribute to training program development. Stay updated with new technologies, procedures, and methods in the Microbiology Laboratory. Investigate out‑of‑specification results using Root Cause Analysis tools and implement corrective actions. Perform technical reviews of laboratory data, validation protocols, and reports. Review and authorize microbial data. Represent the Microbiology laboratory at meetings. Provide technical support to Manufacturing and Projects through participation, investigation, validation, and testing activities. Keep management informed of laboratory issues. Ensure instruments/equipment are calibrated and operational. Organize and schedule laboratory operations in the absence of the Laboratory Supervisor. Troubleshoot laboratory issues using Root Cause analysis tools. Complete project work and initiatives to improve laboratory efficiency. Maintain high housekeeping standards in the Laboratory. Essential Skills/Experience Degree in Microbiology or related science. Minimum of 5 years of experience in a cGMP Quality environment. Experience in testing sterile drug products and aseptic filling processes. Good knowledge of current regulatory requirements for Microbiology/Sterility Assurance. Subject Matter Expert in Method Validation, Endotoxin testing, and sterility testing. Experience in Quality Risk Management. Excellent knowledge of LIMS and experience in its implementation for Microbiology. Desirable Skills/Experience High technical competency in Sterility Assurance, Aseptic filling, and microbiology methods. Ability to develop collaborative relationships with other functions and sites. Excellent problem‑solving and root cause analysis skills. Innovative approach to developing efficient and compliant processes and procedures. Strong organizational skills. Ability to plan/schedule work and delegate tasks effectively. Excellent written and oral communication skills. At AstraZeneca, we are driven by a passion for innovation and a commitment to improving lives. Our unique culture combines the agility of a biotech with the resources of a global biopharma leader. Here, you'll find an environment that fosters growth, collaboration, and a deep connection to our mission. We are dedicated to making a meaningful impact on patients' lives by tackling some of the toughest challenges in healthcare. Join us in our journey to redefine what's possible in R&D and healthcare. If you're ready to be part of a team that values innovation, collaboration, and making a difference, we want to hear from you! Date Posted 18-Nov-2025 Closing Date 01-Dec-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
