Analyst, Quality Control, Chemistry & Stability

Overview

In this role you will ensure the quality, integrity, and stability of materials and products in Moderna’s Harwell mRNA manufacturing operations. You will combine hands-on analytical chemistry with coordinating GMP stability programs, employing advanced analytical techniques and LIMS to support manufacturing, product release, and regulatory compliance. You’ll also explore digital tools and AI-enabled technologies to enhance data management and analytical workflows in a highly regulated setting. This position offers cross-functional collaboration and impact on global stability programs and regulatory readiness.

Pay / Benefits

• competitive healthcare
• well-being resources including fitness and mental health support
• family-building benefits (fertility, adoption, surrogacy)
• generous paid time off and holidays
• savings and investments for the future
• location-specific perks and extras

Responsibilities

• Perform cGMP QC testing across raw materials, in-process materials, drug substance, product release, and stability studies
• Apply analytical techniques (HPLC, UPLC, GC, UV, DLS, KF) to generate robust data
• Support manufacturing process testing (HPLC AEX, NaOH plate reader assays)
• Plan and execute GMP stability studies in line with protocols and regulatory guidelines
• Manage stability samples lifecycle including labeling, inventory, and documentation in LIMS
• Develop and maintain GMP stability study schedules and coordinate with internal and external labs
• Enter results in LabVantage LIMS and ensure traceability of data and samples
• Perform data trending, statistical analysis, and prepare stability-related reports
• Create, review, and revise stability protocols and regulatory sections for submissions
• Coordinate external lab testing and data management, ensuring data integrity
• Maintain laboratory readiness, equipment, reagents, and consumables
• Assist investigations, CAPAs, and quality system records related to stability and analytics
• Help improve laboratory workflows and stability program execution
• Support Compliance with GxP, data integrity, and regulatory audits
• Explore digital innovation in stability data management and analytics
• Maintain and expand technical competency through training and collaboration
• Promote cross-functional collaboration across QC, Manufacturing, QA, Regulatory Affairs
• Contribute to special projects and broader QC priorities

Key requirements

• 5–7 years in a Pharmaceutical QC Laboratory
• Strong understanding of GxP regulations (GMP, GLP, GCP, GVP)
• On-site role with ability to work in a fast-paced, regulated environment
• Knowledge of analytical techniques (HPLC, UPLC, GC, UV, DLS, KF) and stability concepts
• Experience with LIMS (LabVantage) and data integrity practices
• Ability to coordinate complex stability studies and collaborate with internal and external partners
• Comfort with data analysis, trend reporting, and regulatory documentation
• Strong communication and teamwork skills
• Willingness to complete enhanced pre-employment checks
• Bachelor in Chemistry or related scientific discipline

• collaboration
• data-driven decision making
• problem-solving
• HPLC
• UPLC
• GC

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