15 Nov
|
Moderna
|
Melbourne
Are you an analytical scientist who thrives on solving complex technical challenges in a GMP laboratory? Join Moderna's state-of-the-art Melbourne facility and contribute to the quality of next-generation mRNA medicines.
We are seeking an experienced Quality Control Analyst to join our growing team at our state-of-the-art Melbourne manufacturing facility.
This is an exciting opportunity for a quality-driven analytical scientist who enjoys working in a dynamic GMP environment, solving complex technical challenges, and contributing directly to the manufacture of life-changing medicines.
This role is part of our late shift team, offering candidates the opportunity to work outside traditional business hours while playing a critical role in supporting manufacturing and product release activities.
The late shift provides greater flexibility, enhanced operational ownership, and the opportunity to work in a focused laboratory environment.
The Opportunity
Reporting to the Associate Director, Quality Control, you will be responsible for performing cGMP quality control testing and supporting Moderna's global stability programs. You'll work across chemistry, release, and stability testing activities, ensuring the highest standards of quality, compliance, and data integrity are maintained.
How You'll Make An Impact
- Performing GMP Quality Control testing using techniques including HPLC, UPLC, UV Spectroscopy, Agile Light Scattering (DLS), and plate reader assays
- Executing HPLC (AEX) and NaOH plate reader assays to support process and release testing activities
- Supporting analytical method transfers and implementation activities in partnership with AS&T; teams
- Conducting routine laboratory operations including reagent preparation, equipment maintenance, calibration support, and documentation review
- Managing stability program activities including sample set-downs, pulls, inventory management, labelling, shipping coordination, and LIMS data entry
- Monitor, analyse, and trend stability data to generate reports, protocols, study summaries, and technical documentation
- Troubleshoot analytical methods, assays, and laboratory equipment to support reliable and efficient testing
- Author and review GMP documentation including SOPs, protocols, reports, and technical records
- Supporting investigations, deviations, CAPAs, and change control activities
- Assisting with internal, customer, and regulatory inspections and audits
- Driving continuous improvement initiatives that enhance laboratory performance and compliance
- Ensuring all activities are performed in accordance with cGMP standards, regulatory requirements, and Moderna safety expectations
Your Background
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline
- Minimum 5 years' experience in a GMP-regulated pharmaceutical, biotechnology, or related industry
- Hands-on experience with analytical chemistry techniques including HPLC, UPLC, particle analysis, and spectroscopic methods
- Experience working within quality systems and regulated laboratory environments
Preferred Qualifications
- Strong knowledge of FDA, EU, ICH, and other applicable pharmaceutical regulatory requirements
- Experience supporting stability programs, method transfers, or method qualification activities
- Proven troubleshooting and problem-solving skills in laboratory settings
- Experience authoring investigations, deviations, CAPAs, and other quality records
- Familiarity with LIMS, electronic quality systems, and laboratory data analysis tools
- Excellent organisational skills and the ability to effectively manage competing priorities
- Strong communication and collaboration skills, with a demonstrated ability to work across cross-functional teams
- A commitment to quality, compliance, data integrity, and continuous improvement
Why Join Moderna?
- Be part of a company at the forefront of mRNA science and innovation
- Work in a highly team-oriented and mission-driven environment
- Contribute to the delivery of medicines that can positively impact patients globally
- Access opportunities for professional development and career growth
- Join a world-class manufacturing and quality organisation committed to excellence
Additional Information
This is a full-time, site-based late shift position located at Moderna's Melbourne manufacturing facility. Due to the nature of the role, remote work is not available.
As part of Moderna's commitment to workplace health and safety, employment may be subject to pre-employment and ongoing medical assessments in accordance with operational and legal req
📌 Quality Control Analyst (Melbourne)
🏢 Moderna
📍 Melbourne