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Moderna

Develops mRNA-based medicines for health

Analyst – Quality Control - Chemistry and Stability

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeOxford, UKNo salary listed

About the Job

Requirements

  • At least 5–7 years of experience in a quality control laboratory of a pharmaceutical company.
  • Demonstrated aptitude or ability to learn applicable GxP regulations, including GMP, GLP, GCP, GVP, or other relevant standards.
  • A BA/BSc in Chemistry or another relevant scientific discipline is listed as preferred.

Responsibilities

  • Perform routine cGMP quality control testing for raw materials, components, in-process materials, drug substance, product release, and stability programs using HPLC, UPLC, GC, UV spectroscopy, DLS, and Karl Fischer analysis.
  • Perform HPLC anion exchange chromatography and NaOH plate reader-based assays to support manufacturing process testing, and collaborate with manufacturing and quality control colleagues to provide timely results.
  • Support planning, coordination, and execution of GMP stability studies for drug substance and drug product according to approved protocols, SOPs, and applicable GMP, FDA, EU, and ICH guidelines.
  • Coordinate stability sample set-down and scheduled pulls, including labelling, quantity verification, inventory updates, and documentation in LIMS and applicable logs; support sample assessment, inventory reconciliation, storage, and disposal.
  • Assist in developing and maintaining stability study schedules, coordinating sample pulls and distribution to testing laboratories, and collaborating with internal teams and external partners to support timely testing and reporting.
  • Use LabVantage LIMS to enter analytical results, execute electronic assay forms, perform stability transactions, and maintain accurate databases, inventory records, and supporting documentation.
  • Analyze stability results, identify trends, assess product performance over time, and maintain stability tables, charts, and statistical analyses to support quality and regulatory decisions.
  • Create, review, revise, and approve stability protocols and reports within assigned responsibilities, and contribute to stability-related regulatory submissions.
  • Coordinate stability sample shipments to external laboratories; request, retrieve, and review vendor data and reports; maintain complete internal binders, databases, and study records.
  • Prepare reagents, manage samples, perform routine equipment maintenance and housekeeping, and order, stock, and manage quality control supplies and consumables to maintain a safe, organized, inspection-ready laboratory.
  • Assist with investigations into assay performance, method issues, and laboratory equipment problems; share technical knowledge and support junior laboratory staff through data review, training, and troubleshooting.
  • Participate in investigations, deviations, change controls, and CAPAs; author and revise SOPs, protocols, and reports; identify opportunities to improve workflows, analytical reliability, and stability program execution.
  • Perform laboratory and stability work in accordance with applicable GxP regulations, internal policies, SOPs, and work instructions, applying Good Documentation Practices and data integrity principles to maintain complete and traceable records.
  • Identify opportunities to improve stability data management, analytical trending, scientific knowledge sharing, and laboratory efficiency through digital tools, advanced analytics, and approved Generative AI technologies while maintaining GxP compliance and data integrity.
  • Complete assigned training and requalification activities within required timelines, and strengthen technical knowledge of analytical methods, laboratory systems, regulatory expectations, and evolving scientific practices.
  • Collaborate across Quality Control, Manufacturing, Quality Assurance, Regulatory Affairs, and external testing partners to support analytical testing and stability programs.
  • Support additional scientific, analytical, quality, or stability projects as assigned.

Desired Qualifications

  • A BA/BSc in Chemistry or another relevant scientific discipline.

About the Company

Moderna

Develops mRNA-based medicines for health

Moderna develops medicines built on messenger RNA (mRNA). Its products use mRNA delivered into cells to instruct them to produce specific proteins that can prevent or treat disease, with vaccines being a primary example. In practice, a dose delivers engineered mRNA into the body, cells translate it into a target protein, and the immune system responds or the protein modulates biology to combat disease. Moderna differentiates itself through its focus on building a whole mRNA medicines platform and in-house capabilities for designing, manufacturing, and scaling mRNA therapies, including rapid development and large-scale production. Its goal is to create a new category of medicines based on mRNA that can improve how diseases are discovered, developed, and treated, ultimately improving patient outcomes.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2010

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