Analyst, Quality Control
4 days ago
We are excited to announce that we are expanding our team and have multiple positions available for this role - join us in shaping the future*
**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.
Modern is looking for a Quality Control Analyst specializing in Microbiology & Bioassay to join our vibrant team in Melbourne, Australia. In this vital role, you will perform and manage Quality Control testing using various Bioassay and Microbiology methods in a GMP testing environment, contributing significantly to Moderna’s pioneering mRNA products.
**Within 3 Months, You Will**:
Initiate GMP QC Molecular Biology and Microbiology methods, supporting assays like ELISA and Cell-Based Potency testing.
Engage in Sterility and Bioburden Analysis, Endotoxin, and other related Microbiology tests.
Start supporting the testing for drug substances and products, aiding in data generation for other studies.
**Within 6 Months, You Will**:
Collaborate with AS&T groups for new methods transfers and participate in internal and external testing lab method transfer projects.
Assist in the development, implementation, and maintenance of laboratory operational systems following cGMP requirements.
Provide essential support during internal and vendor audits.
**Within 12 Months, You Will**:
Be fully adept in conducting environmental monitoring, utility sampling, and laboratory support activities.
Participate in equipment and method qualifications, validations, and method transfers.
Play a role in authoring quality systems records such as investigations, deviations, change controls, CAPAs, and in writing/revising SOPs, protocols, and reports.
**H ere’s What You’ll Bring to the Table**:
BSc/BA in a relevant scientific discipline with 5 years Quality Control experience in a cGMP organization with a focus in Molecular Biology, DNA Sequencing and Microbiology.
Hands on experience with molecular biology techniques including, but not limited to, gel electrophoresis, qPCR, and Sanger Sequencing.
Hands-on experience of various Microbiology testing techniques and analyses (e.g. Vitek, Isolator Technology, Bioburden, BET, Sterility, others)
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.
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 or
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