Analyst, Quality Control, Chemistry & Stability
Description
This lab-based position at Moderna in Melbourne, Australia, involves performing cGMP QC testing for Chemistry, Release, and Stability functions. The role supports global GMP stability programs through activities like sample management, data trending, and statistical analysis. It requires working in full compliance with cGMP standards and relevant regulations, contributing to method transfers and qualifications. This is a hands-on, detail-oriented individual contributor role focused on scaling and shaping QC capabilities within Moderna's mRNA technology framework.
What We're Looking For
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 both internal and regulatory inspections.,Create, review, and revise SOPs, protocols, and reports aligned with evolving quality standards and compliance frameworks.,Support all stability program operations: perform sample set downs, pulls, inventory checks, labeling, and data entry in LIMS and inventory systems.,Maintain and trend stability data using statistical analysis; produce stability tables, charts, protocols, and final reports.,Troubleshoot assay methods and lab equipment as needed.,Author or contribute to quality system documentation such as investigations, deviations, CAPAs, and change controls.,Assist in the continued optimization of stability and QC workflows, ensuring seamless compliance and operational readiness.
Ideal Candidate
BSc in a relevant scientific discipline (Chemistry preferred).,5 years Quality Control experience in a cGMP organization with a focus in Analytical Chemistry.,Hands-on experience with analytical chemistry techniques including, but not limited to, HPLC, UPLC, particle analysis and plate reader-based assays.,Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.,Working experience in a GMP environment.,Ability to collaborate effectively in a dynamic, cross-functional matrix environment.,Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.,Proven ability to conduct investigations.
Minimum Education
Bachelor's Degree
Hard Skills
Soft Skills
Benefits
Special Commitments
Site-based (full-time on-site), not eligible for remote work, may be subject to pre-employment and periodic medical assessments.
About the Company
Moderna, Inc.
Moderna is a biotechnology company pioneering a new class of medicines made of messenger RNA (mRNA). The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.
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