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Senior Specialist, Quality Control, Microbiology
hace 2 semanas
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.
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 Moderna's quality infrastructure at one of our most advanced international QC hubs.
Here's What You'll 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 you'll need to succeed in the role:
- We behave like owners. The solutions we're 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 Moderna's core mission.
- We digitize everywhere possible using the power of code to maximize our impact on patients. At our Madrid site, you'll 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.
Here's What You'll 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 Moderna's site full-time. This position is not eligible for remote work.
Pay & Benefits
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.
- Best-in-class 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.
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 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
