Sr. Specialist, Quality Control

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 a highly skilled Quality Control specialist to help shape the future of chromatographic data management across our global QC laboratory network. As a subject matter expert in Thermo Scientific Chromeleon Chromatography Data System (CDS), you will combine advanced hands-on expertise in HPLC/UPLC workflows, analytical method configuration, data processing and complex report development with the opportunity to drive global standardization, scientific accuracy and cGMP compliance. Working at the intersection of analytical science, Quality and Digital innovation, you will play a critical role in developing reliable, efficient and inspection-ready chromatography workflows that strengthen data integrity, accelerate laboratory performance and support the delivery of Moderna's innovative mRNA medicines.Here's What You'll Do:Serve as a global subject matter expert for Chromeleon CDS: Provide advanced technical expertise in Thermo Scientific Chromeleon, supporting QC laboratories across Moderna's global network. Act as a trusted specialist in chromatography workflows, system functionality, HPLC/UPLC method configuration, chromatographic data acquisition, processing, integration, calculations and reporting, ensuring scientifically sound, standardized and compliant system use.Design, configure and maintain standardized chromatography workflows: Develop, build, review and maintain robust Chromeleon configurations supporting HPLC analytical workflows, including instrument methods, processing methods, analytical sequences, electronic workflows and report templates. Translate approved analytical method requirements into reliable CDS configurations that enable consistent analytical execution, data processing, calculations, review and reporting across multiple QC laboratories.Develop and troubleshoot complex Chromeleon report templates: Create, configure and optimize sophisticated reporting solutions incorporating calculations, variables, custom fields, tables, chromatograms, system suitability results, specifications and other critical report elements. Ensure that report outputs accurately reflect approved analytical methodologies, support effective QC data review and minimize manual intervention while maintaining scientific accuracy and regulatory compliance.Provide advanced expertise in chromatographic data processing and integration: Configure and optimize Chromeleon processing methods, peak integration parameters, calculation logic and standardized integration approaches. Apply deep practical knowledge of chromatographic principles, HPLC/UPLC workflows, system suitability and analytical data interpretation to ensure consistent, scientifically justified and reproducible results.Lead technical troubleshooting and resolution of complex CDS issues: Investigate and resolve challenging technical issues involving chromatographic data acquisition, processing, peak integration, calculations, report generation, sequence execution, instrument connectivity and user workflows. Partner with analytical method owners, laboratory analysts and technical SMEs to diagnose unexpected template behavior, calculation discrepancies, processing anomalies and reporting defects, driving issues through to effective resolution.Ensure technical accuracy and scientific integrity of Chromeleon configurations: Perform detailed technical reviews of instrument methods, processing methods, report templates and associated workflows to verify accuracy, consistency, usability and alignment with approved analytical methods and QC requirements. Identify potential configuration weaknesses, calculation errors and reporting inconsistencies, implementing appropriate improvements to support reliable analytical results and compliant data review.Drive global standardization and continuous improvement: Collaborate with QC laboratories and analytical method owners across Moderna sites to harmonize Chromeleon templates, reporting standards and chromatography workflows. Assess existing configurations to identify opportunities to reduce manual transcription, simplify analytical execution and review, improve data integrity and increase operational efficiency while maintaining the flexibility required for different analytical methods.Support qualification, validation and controlled deployment: Provide technical expertise throughout the qualification, validation, change control and implementation of new or revised Chromeleon methods, templates, reports and configurations. Ensure changes are appropriately assessed, tested, documented and deployed within a controlled cGMP environment, maintaining alignment with approved analytical requirements, internal procedures and applicable regulatory expectations.Collaborate with Digital teams on CDS lifecycle management: Work closely with Digital, system administration and laboratory stakeholders to support Chromeleon system configuration, upgrades, testing, technical issue resolution and implementation of enhancements. Contribute specialist QC knowledge to system lifecycle activities, helping ensure that CDS functionality continues to meet evolving analytical, operational and compliance requirements.Strengthen cGMP compliance and chromatographic data integrity: Ensure that Chromeleon configurations, electronic workflows and associated QC processes comply with applicable current Good Manufacturing Practice (cGMP) requirements, data integrity expectations, internal Quality procedures and regulatory standards. Support accurate, traceable and reliable electronic data processing and reporting, reinforcing inspection readiness and confidence in analytical results.Support Quality investigations and change management: Provide technical input into investigations, deviations, corrective and preventive actions (CAPAs) and change controls involving Chromeleon functionality, HPLC data workflows, method and template configurations, calculations or reporting. Apply structured problem-solving and scientific judgment to identify root causes, assess potential impacts and implement sustainable corrective solutions.Develop technical documentation and strengthen laboratory capabilities: Author, review and revise Standard Operating Procedures (SOPs), work instructions, technical standards, training materials and supporting documentation related to Chromeleon CDS, chromatography template configuration, data review and troubleshooting. Provide hands-on technical guidance, coaching and software training to QC analysts and reviewers, strengthening their understanding of HPLC workflows, chromatographic integration, data processing and report interpretation.Advance digital innovation within global QC operations: Identify opportunities to leverage automation, digital technologies and emerging Generative AI-enabled tools to improve technical knowledge sharing, documentation efficiency, troubleshooting workflows and analytical process standardization. Partner with relevant Digital and Quality stakeholders to explore these capabilities within appropriate validation, data integrity, information security and cGMP compliance frameworks.Influence and collaborate across a global scientific network: Operate as an expert individual contributor without direct people-management responsibilities, building strong relationships with QC laboratory teams, analytical SMEs, Quality functions, Digital specialists and system administrators across Moderna's international network. Translate complex technical requirements into practical solutions, share best practices and support consistent implementation of standardized Chromeleon workflows across sites.The key Moderna Mindsets you’ll need to succeed in the role:\"We obsess over learning. We don’t have to be the smartest we have to learn the fastest.”“We digitize everywhere possible using the power of code to maximize our impact on patients.”Here’s What You’ll Bring to the Table:BS or MS in Sciences or relevant scientific fieldBachelor’s degree in sciences and 5-8 years of industry experience or, preferably, preferably, a Master’s degree in sciences and 3-6 years of industry experience.Chromeleon Expertise: Demonstrated advanced hands-on experience with Thermo Scientific Chromeleon CDS, including creation, configuration, review, and troubleshooting of HPLC instrument methods, processing methods, sequences, and report templates.Chromatography Expertise: Strong practical knowledge of HPLC/UPLC workflows, chromatographic data processing, peak integration, system suitability, calculations, and analytical data review.Template & Reporting Experience: Proven ability to build and troubleshoot complex Chromeleon report templates and calculations and to translate analytical method requirements into standardized CDS configurations.Proficiency in English (verbal and/or written) required due to global collaboration needs.Our Working ModelAs we build our company, we have always believed an in-person culture is critical to our success.Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.Moderna is a smoke-free, alcohol-free, and drug-free work environment.Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Competitive healthcare, plus voluntary benefit programs to support your unique needsA holistic approach to well-being with access to fitness, mindfulness, and mental health supportFamily building benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investments to help you plan for the futureLocation-specific perks and extrasThe benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at Ver el correo electrónico en click.appcast.io .- #J-18808-Ljbffr