Team Lead, Quality Control, Product Testing & Stability …, Melbourne

Overview 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. 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 Moderna’s mRNA manufacturing operations across Australia. Responsibilities
- 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 Qualification Requirements
- Bachelor’s 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.
- Solid 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 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. Pay & 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 Equal Opportunity Statement Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person's 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. Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment. 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 #J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3rtg1s