Quality Control Chemistry & Stability Specialist

21h21 hours ago

Moderna

Madrid, ES · Full-time · €45,000 – €65,000

About this role

Joining Moderna offers the unique opportunity to be part of a pioneering team revolutionizing medicine through mRNA technology. You'll work alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. This role ensures a challenging career with potential to impact patients' lives.

In this position, perform cGMP QC testing for QC Chemistry, release, and stability programs within the Quality Control team in Madrid. Support global GMP stability programs including sample set down, pull, and shipment. Maintain stability databases with data trending and statistical analysis per GMP, FDA, EU, and ICH guidelines.

Moderna is solidifying its international centre for analytical excellence in Madrid, the largest outside the United States. Report to the Quality Control Manager and contribute to innovative research efforts. Engage in creation, revision, and review of SOPs, protocols, and reports.

Opportunities include special projects, continuous improvement initiatives, and audits. Embody Moderna Mindsets: prioritize the platform by upholding quality of mRNA medicines, and question convention with innovative solutions for stability operations. Advance the technological frontier of mRNA medicines.

Requirements

BA/BSc in Chemistry (preferred) or other relevant scientific discipline
At least 5-7 years in quality control laboratory of a pharmaceutical company
Hands-on experience with analytical chemistry testing including chromatography
Experience performing cGMP QC testing for chemistry, release, and stability
Knowledge of GMP, FDA, EU, and ICH guidelines
Proficiency in stability data trending and statistical analysis
Familiarity with LIMS for managing stability studies
Ability to maintain stability databases and support chamber operations

Responsibilities

Perform statistical analysis and trending of stability data following SOPs and ICH guidelines
Create, review, and revise stability protocols and reports, including specification documents
Manage stability studies in LIMS, performing data entry and review
Support stability chamber maintenance, troubleshooting, and temperature data interpretation
Ensure organization and maintenance of stability chambers and walk-ins
Assist in shipment and receipt of samples for external testing or storage
Manage GMP stability schedules and sample pulls to meet deadlines
Participate in audits and contribute to regulatory submissions and reports

Benefits

Part of a continually growing organization with worldwide partners
Work in the largest international centre for analytical excellence outside the US
Contribute to advancing mRNA product portfolio and global health initiatives
Engage in special projects and continuous improvement initiatives