Analyst, Quality Control, Chemistry & Stability

Analyst, Quality Control, Chemistry & Stability

Moderna

Oxford, United Kingdom

Here's What You'll Do:

• Perform routine and advanced analytical chemistry and stability testing, including HPLC, UPLC, GC, UV, Dynamic Light Scattering (particle analysis), and Karl Fischer (KF)
• Execute HPLC (AEX) and NaOH plate reader-based assays to support manufacturing process statistical testing
• Conduct testing across raw materials, components, in-process materials, and drug substance samples
• Maintain accurate and compliant cGMP documentation in alignment with Good Documentation Practices and Data Integrity requirements
• Support end-to-end stability program activities, including sample set down, pulls, labeling, quantity verification, and inventory tracking using LIMS (LabVantage) and associated systems
• Create, review, and revise stability protocols and reports in accordance with GMP, FDA, EU, and ICH guidelines
• Build and maintain stability schedules, ensuring timely sample pulls and distribution to internal and external laboratories
• Perform data trending and statistical analyses, maintaining up-to-date stability tables, charts, and databases
• Execute stability study workflows within LIMS, including data entry, review, and approval
• Support cross-functional and external reporting of stability data, ensuring accuracy and completeness
• Coordinate stability sample shipments to external laboratories and manage retrieval of external data and reports
• Maintain internal stability binders and databases with up-to-date information from internal and external sources
• Contribute to regulatory submissions through authoring and review of stability-related sections
• Carry out general laboratory operations including reagent preparation, sample management, equipment maintenance, and lab housekeeping
• Maintain a safe and compliant laboratory environment aligned with GxP standards
• Manage laboratory consumables, including ordering, stocking, and inventory control
• Participate in quality systems activities including investigations, deviations, change controls, and CAPAs
• Author and revise SOPs, protocols, and reports to support compliant operations
• Support troubleshooting of analytical methods and laboratory equipment, while providing guidance and training to junior staff
• Foster a collaborative, inclusive, and high-performance team environment focused on innovation and continuous improvement
• Execute all activities in accordance with SOPs, work instructions, regulatory requirements, and company policies
• Complete all required training within defined timelines and maintain ongoing qualification readiness for audits and inspections

Here’s What You’ll Need (Basic Qualifications)

• Education: BA/BSc in Chemistry (preferred) or other relevant scientific discipline
• Experience: At least 5-7 years in Quality Control Laboratory of a Pharmaceutical Company
• Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards)