Sr. Specialist, Quality Control, Chemistry

If you’re interested in this role, please apply in English and include an English version of your Resume/CV. The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its international centre for analytical excellence in Madrid, the largest of its kind outside the United States. The site supports our global manufacturing network and advancing mRNA portfolio. We welcome talent ready to drive innovative research and development. Moderna is seeking an experienced Quality Control Chemistry professional to play a critical role in ensuring the scientific integrity, accuracy and cGMP compliance of analytical data supporting product release and stability testing at our Madrid laboratory. Combining advanced analytical expertise with ownership of Quality Events and hands-on laboratory support, you will oversee complex data reviews, lead investigations and drive timely resolution of technical and compliance challenges. As a senior QC representative on our 2:00–10:00 pm evening shift, you will also provide cross-functional technical and operational leadership, enabling real-time decision-making, effective risk escalation and continuity of laboratory operations while supporting the delivery of Moderna's innovative mRNA medicines. Here's What You'll Do: Ensure scientific excellence in analytical data review and product release: Perform comprehensive review and approval of executed analytical assay packages supporting cGMP product release and stability testing, including both paper-based and electronic records. Evaluate chromatography data, analytical calculations, instrument outputs and other laboratory results to verify scientific accuracy, data integrity, compliance with approved analytical methods and adherence to applicable cGMP requirements. Provide technical expertise across advanced analytical chemistry techniques: Apply strong scientific judgment when reviewing analytical data generated through High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), spectroscopic and spectrometric techniques, and physical property testing. Support the evaluation of analytical results involving Dynamic Light Scattering (DLS) for particle analysis, break-loose/gliding force testing, Container Closure Integrity Testing (CCIT) and other relevant analytical methodologies, ensuring results are reliable, appropriately documented and suitable for their intended Quality Control purpose. Drive Quality Event investigations and timely resolution: Initiate, lead, coordinate and investigate laboratory-related Quality Events, including deviations, Out-of-Specification (OOS) results, laboratory investigations and associated Quality records. Apply structured problem-solving and technical expertise to identify potential root causes, assess product and compliance impact, define appropriate corrective actions and ensure investigations are completed accurately and within required timelines. Own corrective actions and controlled Quality improvements: Define, implement and monitor actions arising from laboratory investigations and Quality Events, supporting or owning Corrective and Preventive Actions (CAPAs) as applicable. Initiate and manage Change Controls within your area of responsibility, ensuring that proposed changes are appropriately assessed, documented and implemented in accordance with established Quality systems and cGMP expectations. Provide senior technical and operational leadership during the evening shift: Act as a key QC representative during the 2:00–10:00 pm shift, providing technical guidance and operational coordination across Chemistry and other QC disciplines. Support real-time decision-making, issue escalation, workload prioritization and cross-functional problem-solving to maintain continuity of laboratory operations, address emerging risks and ensure consistent compliance with cGMP requirements. Coordinate QC activities and support laboratory operational performance: Review and coordinate laboratory activities to ensure testing is performed correctly, efficiently and in accordance with approved procedures. Develop and maintain scheduling and status-monitoring tools to assess testing capacity, turnaround times, resource constraints and operational progress. Communicate laboratory performance and testing priorities to relevant stakeholders, supporting effective planning and timely delivery of business requirements. Collaborate with internal and external laboratory partners: Work closely with QC Chemistry colleagues, other QC functions, internal and external laboratories, Contract Manufacturing Organizations (CMOs) and cross-functional stakeholders to coordinate analytical activities, resolve technical challenges and align laboratory priorities with business objectives. Participate in cross-functional planning discussions, balancing QC resources, testing requirements and operational constraints to support reliable laboratory execution. Support analytical method lifecycle activities: Contribute to Method Qualification, Method Acquisition, analytical method transfers, method development and other assigned technical projects. Provide scientific input into method implementation, analytical performance and troubleshooting activities, helping ensure that analytical procedures remain technically appropriate, reproducible and aligned with established Quality requirements. Lead analytical method and laboratory equipment troubleshooting: Investigate complex issues involving analytical methods, instrumentation, unexpected laboratory results and testing workflows. Apply scientific expertise to identify potential causes, coordinate technical troubleshooting and recommend effective solutions that maintain analytical reliability, laboratory productivity and GMP compliance. Support stability testing and analytical program oversight: Contribute to the execution, coordination and follow-up of stability programs, ensuring that analytical testing, data review and associated documentation are completed in accordance with established requirements. Monitor relevant stability activities, support the resolution of technical or Quality issues and help maintain reliable data packages for product lifecycle and regulatory purposes. Ensure accuracy of Certificates of Analysis and analytical documentation: Perform and support the generation, technical review and approval of Certificates of Analysis (CoAs), QC release documentation and stability data packages. Verify that analytical results, supporting records and associated Quality documentation are complete, accurate, traceable and consistent with approved specifications and applicable regulatory requirements. Maintain comprehensive GMP documentation and inspection readiness: Author, review and approve Standard Operating Procedures (SOPs), analytical test methods, QC release documents, instrument qualification records, computerized system validation documentation, training materials and analytical method lifecycle documents as required. Ensure that all laboratory activities are appropriately recorded and that documentation is maintained in accordance with Good Documentation Practices and Data Integrity requirements, supporting audit readiness and regulatory inspections. Support Quality compliance and regulatory inspections: Provide technical guidance to the QC Chemistry team on compliance-related matters, ensuring laboratory activities meet applicable GxP regulations, internal Quality standards and approved procedures. Contribute to the preparation, coordination, management and res