Senior Specialist, Quality Control, Microbiology

The Role:

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

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

Modernas 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. Were looking for talents who can contribute to our innovative research and development efforts.

In this role you will perform cGMP-compliant Quality Control (QC) Microbiology testing and data review in support of batch release and stability programs. You will also contribute to method qualification and acquisition activities while working hands-on in a dynamic and highly regulated environment. This role offers a unique opportunity to work on novel mRNA products and engage with modern digital tools in analytical quality control. The position calls for precise technical execution regulatory rigor and a proactive mindset to support Modernas quality infrastructure at one of our most advanced international QC hubs.

Heres What Youll Do:

Your key responsibilities will be:

• Performing microbiological QC testing for release and stability of mRNA medicines in a cGMP environment.

• Supporting method transfer development and troubleshooting for microbiological assays and systems.

• Reviewing executed assay packages (paper and electronic) including chromatography and analytical outputs.

• Leading quality system records such as deviations investigations (OOS) change controls and CAPAs.

• Participating in cross-functional planning to align QC capacity with broader business objectives.

• Completing and maintaining cGMP documentation according to GDP and data integrity principles.

• Ensuring testing is performed in compliance with cGMP GDP and internal procedures.

• Authoring and approving SOPs QC methods lifecycle documents and instrument validation records.

• Generating Certificates of Analysis and assembling stability data packages.

• Supporting and potentially leading audit and inspection readiness initiatives.

Your responsibilities will also include:

• Supporting the training and troubleshooting activities for more junior QC staff.

• Executing tasks as per standard operating procedures and work instructions with precision.

• Maintaining laboratory records and documentation in compliance with data integrity standards.

• Managing tools for monitoring QC testing schedules turnaround time and performance tracking.

• Supporting special projects that may span digital QC innovation compliance enhancements or generative AI integration for future capability-building.

The key Moderna Mindsets youll need to succeed in the role:

• We behave like owners. The solutions were building go beyond any job description.
  You will be expected to lead initiatives beyond daily testing contributing to SOP development audit readiness data integrity improvements and continuous compliance innovation all while driving forward Modernas core mission.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  At our Madrid site youll have the opportunity to support and embrace digital innovations in QC operations including analytics-driven decision making laboratory information systems and potential integration with generative AI tools in data trending and visualization.

Heres What Youll Bring to the Table:

• BA/BS in a scientific discipline.

• Working experience: 5 years (or MS in a relevant scientific discipline with 2 years) with a focus in micro testing.

• Experience with Microbiological methods including Bioburden Sterility BET Micro sequencing others for routine testing for cGMP QC raw materials excipients drug substance and finished product.

• 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 Modernas 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. Thats why our global benefits and well-being resources are designed to support youat 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 bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown
• Savingsandinvestments
• 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 theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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.

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.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Moderna is a smoke-free alcohol-free and drug-free work environment.

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 persons 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.

Were 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 .

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