Analyst, Quality Control

2 weeks ago

Melbourne, Australia Moderna, Inc. Full time

**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.

Join Moderna's impactful initiative in Melbourne as part of the Quality Control team. In this role, you'll perform critical quality control testing for Chemistry and Stability, contributing to the efficacy and safety of our mRNA vaccines. Your work will directly support our mission to meet global health challenges and maintain the highest standards in our manufacturing process.

**Here’s What You’ll Do**:
**Within 3 Months, You Will**
- Conduct routine analytical chemistry and stability testing, including HPLC, UPLC, GC, UV, Particle Analysis, KF, and others.
- Perform HPLC and plate reader-based assays supporting manufacturing process stat testing.
- Maintain accurate cGMP documentation for all activities and testing performed.
- Undertake laboratory support activities, including reagent preparation, sample management, and equipment maintenance.

**Within 6 Months, You Will**
- Contribute to Global GMP stability programs, including stability sample set down, pull, and management.
- Engage in stability databases maintenance, performing data trending and statistical analyses.
- Create, review, and revise SOPs, stability protocols, and reports, ensuring compliance with GMP, FDA, EU, and ICH guidelines.

**Within 12 Months, You Will**
- Execute stability sample shipments to external labs and manage stability testing data from external sources.
- Assist in stability studies in LIMS, including data entry, review, and approval.
- Support the preparation of stability sections for regulatory submissions and contribute to quality systems records such as investigations, deviations, change controls, and CAPAs.

**Here’s What You’ll Bring to the Table**:

- BA/BSc in Chemistry (preferred) or other relevant scientific discipline.
- Working experience: at least 5-7 years in quality control laboratory of a pharmaceutical company.
- **Experience in Bioassay**is preferred, particularly in regulated quality control or product testing.

**Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.**

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to well-being
- Free premium access to fitness, nutrition, and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
- Educational resources
- Savings and investments
- Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

**About Moderna**

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure h

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