Senior Specialist, Quality Control, Bioassay

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 centre 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 is a technically advanced, hands‑on Quality Control position in which you will execute and support critical bioassay testing for cGMP lot release and stability, along with reviewing test data and analytical outputs. You will also support method qualification, transfers, and troubleshooting while ensuring robust compliance with GDP and cGMP standards. This role is key to sustaining QC readiness and audit preparedness in a dynamic, mRNA‑focused testing environment. As a valued member of the QC Bioassay team, you will play a pivotal role in documentation management, deviation investigation, and capacity planning for a rapidly scaling analytical function. The role offers strong exposure to modern molecular techniques and the potential to collaborate closely with digital and GenAI‑enabled systems. Here’s What You’ll Do Your key responsibilities will be: Perform routine QC Bioassay testing, including molecular and cell biology techniques such as sequencing, qPCR, and electrophoresis, under cGMP conditions. Execute data review of test results including chromatography and analytical outputs, ensuring accuracy and regulatory alignment. Maintain full compliance with GDP, GxP, and internal documentation standards through precise execution of test protocols and documentation practices. Lead method and equipment troubleshooting, supporting cross‑functional teams in sustaining testing continuity. Support Certificate of Analysis (CoA) generation and preparation of stability data packages. Your responsibilities will also include: Author, review, and approve SOPs, test methods, release documents, instrument qualification and validation materials, and method lifecycle documentation. Mentor and support junior QC staff in assay execution and issue resolution. Participate in method transfers and development projects, working closely with technical stakeholders. Drive quality systems investigations including OOS, deviations, CAPAs, and change controls. Assist in developing tools to track QC capacity and turnaround time, aligning resources with operational priorities. Ensure audit readiness and contribute to compliance audit management and responses. Perform and document work in compliance with all internal procedures, Good Documentation Practices, and data integrity standards. 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.” This role provides a strong opportunity to get close to digital transformation efforts within QC operations, including data systems, trending tools, and platforms supported by automation and Generative AI. “We behave like owners. The solutions we’re building go beyond any job description.” In this role, you will act as a true owner of the QC Bioassay process — not just executing tests, but shaping how data integrity, troubleshooting, and scalability are managed in a complex, fast‑paced environment. Your commitment will directly contribute to the reliability of Moderna’s supply chain and the quality of our mRNA medicines. Here’s What You’ll Bring to the Table BA/BS in a scientific discipline. Working experience: +4 years (or MS in a relevant scientific discipline with 2 years) with a focus in Mammalian Cell. Experience with cell‑based ELISA and in vitro potency assays. 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,