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 response to internal and external compliance audits, helping identify potential gaps and implement appropriate corrective measures.

• Coach and develop junior QC colleagues: Provide technical coaching, practical guidance and troubleshooting support to less experienced laboratory personnel. Share analytical knowledge, support training activities and promote consistent application of scientific principles, laboratory procedures and GMP expectations, helping strengthen technical capabilities across the QC Chemistry team.

• Champion effective Quality risk management and cross-functional communication: Exercise a high degree of autonomy and sound technical judgment when evaluating laboratory issues, prioritizing competing demands and identifying potential operational or compliance risks. Communicate concerns clearly, escalate critical matters promptly and coordinate with relevant stakeholders to establish appropriate actions, particularly when providing senior QC coverage during the evening shift.

• Drive continuous improvement and digital innovation: Identify opportunities to strengthen analytical data review, laboratory scheduling, Quality Event management and documentation workflows through process improvements and digital solutions. Explore opportunities to work with automation and emerging Generative AI-enabled tools to support technical knowledge management, investigation efficiency and laboratory performance monitoring, ensuring any potential applications remain aligned with applicable data integrity, information security and GMP requirements.

• Maintain rigorous adherence to GxP and internal Quality requirements: Execute all assigned activities in accordance with relevant GxP regulations, regulatory guidelines, company policies, approved SOPs and work instructions. Ensure that laboratory testing, analytical records, Quality documentation and associated data are completed accurately, maintained appropriately and available for business use, audits and regulatory inspections.

The key Moderna Mindsets you’ll need to succeed in the role:

• "We act with dynamic range, driving strategy and execution at the same time at every step.”

• “We behave like owners. The solutions we’re building go beyond any job description.”

Here’s What You’ll Bring to the Table:

• BA/BS in Chemistry (preferred) or other relevant scientific discipline.

• Working experience: +5 years´experience in quality control laboratory of a pharmaceutical company

• Experience with analytical chemistry review including chromatographic techniques- HPLC, UPLC, Spectroscopic and Spectrometric techniques; Physical properties techniques such as Particle Analysis by Dynamic Light Scattering, Break loose/gliding force, CCIT among others.

• Working experience in a GMP environment is mandatory.

• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

• Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.

• Proficiency in English (verbal and/or written) required due to global collaboration needs.

Our Working Model

As 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 & Benefits

At 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 needs

• A holistic approach to well-being with access to fitness, mindfulness, and mental health support

• Family building benefits, including fertility, adoption, and surrogacy support

• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown

• Savings and investments to help you plan for the future

• Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since 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 leavesandaccommodations@modernatx.com.