Analyst, Quality Control, Bioassay

Moderna

28d • Onsite

About The Position

The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. Moderna is committed to enhancing Australia's biotech landscape through a long-term partnership that focuses on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility will be a cornerstone in Australia's ability to respond to future health threats efficiently. This collaboration not only brings cutting-edge medical technology to the forefront but also emphasizes job creation and local talent development. We're inviting visionary professionals to be part of this transformative journey, making a tangible impact on global health security. You will be instrumental in supporting Moderna’s growing manufacturing footprint by performing advanced Bioassay Quality Control testing in a GMP setting. Working as part of a dynamic Quality Control team, this position is focused on ensuring the integrity of drug substance and product quality through hands-on molecular biology and protein analytics. The role includes method execution, troubleshooting, and continuous improvement initiatives — all within a high-impact, fast-paced biotech environment. As an individual contributor based at our Clayton site, you’ll collaborate across multiple functions and contribute to the transfer and qualification of analytical methods. This is a hands-on laboratory role that plays a key part in enabling Moderna’s mission to deliver mRNA medicines globally. You’ll also have exposure to Generative AI tools that enhance documentation, testing workflows, and lab efficiency.

Requirements

• BSc in a relevant scientific discipline with 5 years Quality Control experience in a cGMP organization with a focus in Molecular Biology and DNA Sequencing.
• Hands on experience with molecular biology techniques including, but not limited to, gel electrophoresis, qPCR, Sanger Sequencing and Cell-Based Potency testing.
• 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.
• This position is site-based, requiring you to be at Moderna’s site full-time.
• This position is not eligible for remote work.
• As part of Moderna’s commitment to workplace health and safety, this role may be subject to pre-employment and periodic medical assessments, in line with relevant legal and operational requirements.

Nice To Haves

• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.

Responsibilities

• Executing GMP-compliant QC Molecular Biology methods including Sanger Sequencing, Agarose Gel Electrophoresis, UV/Vis, protein concentration analysis, and qPCR.
• Supporting analytical testing for raw materials, excipients, drug substance, and finished products using techniques such as ELISA and Cell-Based Potency assays.
• Participating in the transfer and qualification of Bioassay methods to and from internal and external labs, in collaboration with AS&T.
• Handling sample management activities including preparation, shipment, and receipt of samples for contract lab testing.
• Maintaining compliance through proper data entry using Good Documentation Practices (GDP).
• Performing environmental monitoring and critical utility sampling activities, as required.
• Supporting the generation of QC data to back other studies and development efforts.
• Conducting routine laboratory operations: reagent preparation, equipment maintenance, and housekeeping.
• Participating in equipment and method qualification efforts.
• Assisting with troubleshooting assay methods and lab equipment to ensure consistency and accuracy.
• Supporting audit readiness and contributing to regulatory and internal audits.
• Writing and revising SOPs, protocols, and reports in alignment with GMP expectations.
• Authoring or participating in quality system documentation including deviations, CAPAs, change controls, and investigations.
• Establishing and maintaining a clean, compliant, and safe laboratory environment.

Benefits

• Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being with access to fitness, mindfulness, and mental health support
• Family building benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees