Team Lead, Quality Control, Product Testing & Stability
Job Summary
The Role:
Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.
Moderna is strengthening its presence in Melbourne a leading biotech hub in Australia. Our team drives commercial operations to bring our mRNA medicines to patients nationwide. We welcome global professionals committed to making a meaningful impact.
Reporting to the Associate Director of Quality Control you will lead QC testing activities across drug substance and drug product spanning chemistry microbiology and bioassay disciplines.
You will oversee stability programs and sample management ensuring compliant high-quality testing that supports product release and lifecycle management.
This is a leadership role where you will build and guide a high-performing QC team supporting Modernas mRNA manufacturing operations across Australia.
Heres What Youll Do:
Lead coach and develop a multidisciplinary team of QC analysts across chemistry microbiology and bioassay fostering an inclusive accountable and continuously learning environment
Oversee execution of in-process release and stability testing for drug substance and drug product in compliance with cGMP and regulatory requirements
Coordinate and optimize testing schedules in alignment with manufacturing operations and regulatory timelines
Own and manage stability programs including protocol execution data trending and reporting to support lifecycle management
Oversee end-to-end sample management processes including receipt storage tracking and shipment
Ensure timely and accurate review and approval of analytical data within electronic laboratory systems
Review and approve Certificates of Analysis (CoA) to support product release
Drive document lifecycle activities including creation review and approval of SOPs and Work Instructions
Lead and ensure timely execution of investigations deviations CAPAs and change controls meeting defined KPIs
Cultivate a proactive solution-oriented culture focused on continuous improvement and operational excellence
Partner cross-functionally with Quality Assurance Manufacturing Regulatory Affairs and MS&T to ensure seamless operations
Support analytical method transfers validation activities and ongoing lifecycle management of methods
Act as a subject matter expert during audits and inspections for product testing and stability programs
Champion data integrity and ensure strict adherence to cGMP and regulatory compliance standards
Leverage and explore digital and emerging technologies including opportunities to integrate Generative AI tools to enhance QC processes and data insights
The key Moderna Mindsets youll need to succeed in the role:
We act with urgency; Action today compounds the lives saved tomorrow.
We obsess over learning. We dont have to be the smartest we have to learn the fastest.
Heres What Youll Need (Basic Qualifications)
Bachelors degree in a relevant scientific discipline with 10 years QC experience in a cGMP environment.
Strong leadership capabilities with experience managing diverse high-performing technical teams.
Broad knowledge of analytical techniques across chemistry microbiology and bioassay.
Experience managing stability programs and sample lifecycle processes.
Excellent decision-making skills and ability to operate effectively under pressure.
Proactive driven and passionate about delivering high-quality outcomes.
Strong interpersonal and communication skills with the ability to influence stakeholders.
Commitment to continuous learning and professional development.
Proven ability to conduct thorough out of specification (OOS) investigations in a timely manner.
Sound experience in at least two of the following areas: chemistry bioassay and microbiology.
Experience with regulatory inspections and audit readiness.
This position is site-based requiring you to be at Modernas site full-time. This position is not eligible for remote work.
As part of Modernas 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.
Pay & Benefits
At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being resources are designed to support youat work at home and everywhere in between.
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
Savingsandinvestments to help you plan for the future
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 theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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 helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.
Moderna is a smoke-free alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .
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About Company
Learn how we’re changing the world of medicine. Discover career opportunities, our product pipeline, and browse media resources. Meet Moderna.