Senior Specialist, Quality Control, Microbiology

ModernaTX; Madrid; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading biotechnology firm in Madrid is seeking a Microbiologist to perform QC testing for mRNA medicines. The role involves leading quality system records, supporting microbiological testing, and collaborating with cross-functional teams. Candidates should have a BA/BS in a scientific field, 5 years of microbiological testing experience, and an ability to prioritize multiple projects efficiently. This is a full-time, on-site position with best-in-class benefits and family-building support.

Servicios

Best-in-class healthcare

Holistic well-being approach

Generous paid time off

Formación

• 5 years of microbiological testing experience (or MS with 2 years).
• Experience with methods including bioburden, sterility, and micro sequencing.
• Ability to efficiently prioritize and complete multiple projects.

Responsabilidades

• Perform microbiological QC testing in a cGMP environment.
• Lead quality system records including deviation investigations.
• Support training and troubleshooting activities for junior QC staff.

Conocimientos

Microbiological testing experience

Collaboration in cross-functional teams

Prioritizing multiple projects

Educación

BA / BS in a scientific discipline

Herramientas

Microbiological methods

FDA, EU, ICH guidelines knowledge

Descripción del empleo

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. Moderna is solidifying its footprint within our international centre for analytical excellence in Madrid. This facility is the largest such center outside the United States and exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio.

What You’ll Do

• Perform microbiological QC testing for release and stability of mRNA medicines in a cGMP environment.
• Support method transfer development and troubleshoot microbiological assays and systems.
• Review executed assay packages (paper and electronic) including chromatography and analytical outputs.
• Lead quality system records such as deviations investigations (OOS), change controls and CAPAs.
• Participate in cross‑functional planning to align QC capacity with broader business objectives.
• Complete and maintain cGMP documentation according to GDP and data integrity principles.
• Ensure testing is performed in compliance with cGMP GDP and internal procedures.
• Author and approve SOPs, QC methods, lifecycle documents and instrument validation records.
• Generate certificates of analysis and assemble stability data packages.
• Support and potentially lead audit and inspection readiness initiatives.
• Support training and troubleshooting activities for junior QC staff.
• Maintain laboratory records and documentation in compliance with data integrity standards.
• Manage tools for monitoring QC testing schedules, turnaround time and performance tracking.
• Support special projects that span digital QC innovation, compliance enhancements or generative AI integration for future capability‑building.

Qualifications

• BA / BS in a scientific discipline.
• 5 years of microbiological testing experience (or MS with 2 years). Focus in micro testing.
• Experience with microbiological methods including bioburden, sterility, BET, micro sequencing and routine testing for cGMP QC raw materials, excipients, drug substance and finished product.
• Working knowledge of 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 in a fast‑paced environment.
• Site‑based, full‑time position at Moderna’s Madrid site. Remote work not eligible.

Location

Madrid, Spain – full‑time, on‑site at Moderna’s international centre for analytical excellence.

Pay & Benefits

• Best‑in‑class healthcare plus voluntary benefit programs.
• Holistic well‑being approach with fitness, mindfulness and mental health support.
• Family‑building benefits including fertility, adoption and surrogacy support.
• Generous paid time off: vacation, bank holidays, volunteer days, sabbatical, global recharge days and discretionary year‑end shutdown.
• Savings and investments to plan for the future.

Equal Opportunity

Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, citizenship, disability, military or veteran status, genetic information, sexual orientation, marital or familial status or any other protected characteristic under applicable law. Moderna offers reasonable accommodation for qualified applicants with disabilities.