Senior Specialist, Sample Management

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.

As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its footprint within our international centre for analytical excellence in Madrid, a city known for its rich scientific heritage. This facility, the largest such center outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We're looking for talents who can contribute to our innovative research and development efforts.

This highly cross-functional role will contribute significantly to Moderna's QC capabilities at its analytical excellence centre in Madrid. The Quality Control Senior Specialist will define and execute the end-to-end sample management processes for Chemistry, Microbiology, Bioassay, and Raw Materials. Reporting to the Manager of QC Operations, the successful candidate will support daily sample processing, ensure compliance with GMP standards, and drive continuous improvement initiatives. The role requires strong collaboration with internal QC labs, external partners, and CMOs, as well as contributing to lab-based activities and digital transformation projects such as LIMS integration. This position offers exposure to next-generation digital tools, including opportunities to engage with Generative AI solutions aimed at transforming laboratory efficiency and quality compliance.

Here's What You'll Do:

Your key responsibilities will be:

• Define, implement, and maintain comprehensive sample management systems for QC Chemistry, Microbiology, Bioassay, and Raw Materials.

• Lead daily sample processing operations and ensure timely, accurate, and GMP-compliant execution.

• Create weekly schedules and lead alignment meetings with internal stakeholders and external laboratories/CMOs.

• Partner with the Digital team to optimize LIMS usage for improved sample tracking and data integrity.

• Monitor CTU (Controlled Temperature Unit) performance and manage troubleshooting or maintenance as required.

Your responsibilities will also include:

• Author and revise SOPs, protocols, deviations, CAPAs, and change controls.

• Train the QC team on sample management protocols and oversee training compliance.

• Execute general laboratory activities including housekeeping and audits support.

• Drive continuous improvement across QC workflows and documentation practices.

• Uphold data integrity, Good Documentation Practices, and safety standards.

• Foster a collaborative, inclusive, and innovation-driven lab culture.

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

• "We digitize everywhere possible using the power of code to maximize our impact on patients."
  Your role will partner with Digital and QC Operations teams to help optimize the LIMS system, contributing to the broader digitization strategy of Moderna laboratories—including opportunities to explore Generative AI tools that improve quality, speed, and data traceability.

• "We behave like owners. The solutions we're building go beyond any job description."
  This role requires proactive ownership of the sample management lifecycle, leading with accountability, compliance, and a problem-solving mindset in close coordination with global and local QC teams, CMOs, and digital systems integration.

Here's What You'll Need (Basic Qualifications)

• Education: Minimum: BA/BSc in a relevant scientific discipline

• Working Experience: Minimum: 5 years in Quality Control in a cGMP organization.

• Strong working experience in a GMP environment.

• 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.

• This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.

At Moderna, we believe that when you feel your best, you can do your best work.  That's why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation,