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Moderna

Develops mRNA-based medicines for health

Quality Control Analyst

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeMelbourne VIC, AustraliaNo salary listed

About the Job

Requirements

  • A bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
  • At least 5 years of experience in a GMP-regulated pharmaceutical, biotechnology, or related industry.
  • Hands-on experience with analytical chemistry techniques, including HPLC, UPLC, particle analysis, and spectroscopic methods.
  • Experience working within quality systems and regulated laboratory environments.

Responsibilities

  • Perform GMP quality control testing using HPLC, UPLC, UV spectroscopy, dynamic light scattering, and plate reader assays.
  • Execute HPLC (AEX) and NaOH plate reader assays to support process and release testing activities.
  • Support analytical method transfers and implementation activities in partnership with Analytical Science & Technology teams.
  • Conduct routine laboratory operations, including reagent preparation, equipment maintenance, calibration support, and documentation review.
  • Manage stability program activities, including sample set-downs, pulls, inventory management, labelling, shipping coordination, and LIMS data entry.
  • Monitor, analyse, and trend stability data to generate reports, protocols, study summaries, and technical documentation.
  • Troubleshoot analytical methods, assays, and laboratory equipment to support reliable and efficient testing.
  • Author and review GMP documentation, including SOPs, protocols, reports, and technical records.
  • Support investigations, deviations, CAPAs, and change control activities.
  • Assist with internal, customer, and regulatory inspections and audits.
  • Drive continuous improvement initiatives that enhance laboratory performance and compliance.
  • Ensure all activities are performed in accordance with cGMP standards, regulatory requirements, and Moderna safety expectations.

Desired Qualifications

  • Strong knowledge of FDA, EU, ICH, and other applicable pharmaceutical regulatory requirements.
  • Experience supporting stability programs, method transfers, or method qualification activities.
  • Troubleshooting and problem-solving skills in laboratory settings.
  • Experience authoring investigations, deviations, CAPAs, and other quality records.
  • Familiarity with LIMS, electronic quality systems, and laboratory data analysis tools.

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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