Quality Control Analyst - Chemistry and Stability

About the Role

Join Moderna and become part of a pioneering team revolutionizing medicine with mRNA technology, working on a broad pipeline targeting multiple diseases. At Moderna, you will be part of a fast-growing company collaborating globally to advance health initiatives and improve patient outcomes worldwide.

Our Melbourne facility focuses on a long-term partnership to strengthen Australia's biotech sector and pandemic resilience through large-scale mRNA vaccine manufacturing. This initiative boosts local employment and nurtures talent while contributing to global health security.

Position Summary

We seek a lab-based Quality Control Analyst to support Chemistry, Release, and Stability testing according to cGMP standards. Reporting to the Associate Director of Quality Control, this role involves performing analytical procedures, supporting stability programs globally, and contributing to method transfers and qualification projects. The position demands meticulous operational execution combined with scientific diligence, based full-time at our Melbourne site.

Key Responsibilities

• Conduct cGMP-compliant QC chemistry analyses such as HPLC, UPLC, UV spectrometry, and particle size measurement via Dynamic Light Scattering.
• Perform specialized assays like HPLC (AEX) and NaOH plate reader tests to support process statistical testing.
• Collaborate with Analytical Sciences & Technology teams on internal and external method transfer projects.
• Manage general laboratory duties including reagent preparation, equipment upkeep, and adherence to documentation protocols aligned with cGMP.
• Support internal and regulatory audits through preparation and documentation.
• Develop, review, and update SOPs, protocols, and reports to maintain compliance with evolving quality standards.
• Administer stability program operations including sample handling, inventory management, labeling, and data input into LIMS and inventory systems.
• Analyze stability data trending using statistical tools and compile comprehensive stability-related documentation.
• Troubleshoot assay methods and instrumental equipment when needed.
• Contribute to writing and maintaining quality system documents like investigations, deviation reports, corrective actions (CAPAs), and change controls.
• Continuously optimize QC and stability workflows to ensure regulatory compliance and efficient operations.

Preferred Mindsets

• Commitment to continuous learning to keep pace with emerging testing technologies, regulatory changes, and data workflows.
• Embrace digital transformation by leveraging platforms like LIMS for enhanced sample tracking, inventory control, and data analytics to increase efficiency and precision.

Qualifications and Experience

• Bachelor of Science degree in a relevant scientific discipline, preferably Chemistry.
• At least 5 years of Quality Control experience within a cGMP environment, particularly focused on Analytical Chemistry.
• Proficiency with techniques including HPLC, UPLC, particle analysis, and plate reader assays.
• Familiarity with current FDA, EU, and ICH guidelines and regulations is advantageous.
• Demonstrable ability to effectively prioritize and manage multiple projects in a dynamic work setting.
• Experience performing investigations and quality documentation compliance.
• Must be able to work on-site full time; remote work is not available for this position.
• Subject to pre-employment and periodic health assessments aligned with workplace safety policies.

Compensation and Benefits

• Competitive healthcare coverage and voluntary benefit options tailored to individual needs.
• A comprehensive approach to wellbeing including access to fitness programs, mindfulness, and mental health resources.
• Support for family building, including benefits for fertility treatments, adoption, and surrogacy.
• Generous paid leave including vacation, public holidays, volunteer days, sabbaticals, global recharge days, and discretionary year-end closures.
• Financial planning support through savings and investment schemes.
• Additional location-specific benefits and perks.

Moderna Commitment

Moderna promotes a smoke-free, alcohol-free, and drug-free workplace environment. We celebrate diversity and are dedicated to providing equal employment opportunities regardless of protected characteristics. We support reasonable accommodations for qualified applicants with disabilities during hiring and while performing job functions.