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Analyst, Quality Control, Chemistry & Stability

Moderna, Inc.
Melbourne, Victoria, Australia
On-site

About this role

About the Role Moderna is seeking a QC Analyst in Chemistry & Stability for its Melbourne Resilience site to perform cGMP QC testing in support of Chemistry, Release, and Stability functions. You will also support global GMP stability programs through operational and technical activities, while working in full compliance with cGMP standards and FDA, EU, and ICH regulations. This hands-on role combines operational execution with scientific rigor to help scale and strengthen Moderna's QC capabilities. What You'll Do

  • Perform GMP QC Chemistry methods including HPLC, UPLC, UV, and Particle Analysis via Dynamic Light Scattering
  • Execute HPLC (AEX) and NaOH plate reader-based assays to support process stat testing
  • Support method transfer projects internally and externally in collaboration with Analytical Sciences & Technology (AS&T) teams
  • Execute general lab operational tasks aligned with cGMP, including reagent preparation, equipment maintenance, and good documentation practices
  • Provide audit support for internal and regulatory inspections
  • Create, review, and revise SOPs, protocols, and reports aligned with evolving quality standards and compliance frameworks What We're Looking For
  • Experience in a GMP QC laboratory, preferably in pharmaceutical/biotech settings
  • Hands-on experience with HPLC, UPLC, UV, and Particle Analysis via Dynamic Light Scattering
  • Experience with method transfer projects and collaboration with AS&T teams
  • Knowledge of cGMP, FDA, EU, and ICH regulations; strong documentation and data trending skills
  • Ability to work in a fast-paced manufacturing environment with high attention to detail Nice to Have
  • Experience with stability programs and data analysis
  • Prior experience with audit support and cross-functional collaboration Compensation & Benefits
  • Salary and benefits not disclosed in the posting

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