Team Lead, Quality Control, Product Testing & Stability at Moderna

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

02 Aug, 26

Salary

0.0

Posted On

05 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

QC Leadership, cGMP Compliance, Stability Program Management, Sample Management, Analytical Chemistry, Microbiology, Bioassay, OOS Investigations, CAPA, Change Control, Method Validation, Data Integrity, Regulatory Audit Readiness, Stakeholder Management, Document Lifecycle Management, Electronic Laboratory Systems

Industry

Biotechnology Research

Description

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 Moderna’s mRNA manufacturing operations across Australia. Here’s What You’ll 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 you’ll need to succeed in the role: “We act with urgency; Action today compounds the lives saved tomorrow.” “We obsess over learning. We don’t have to be the smartest we have to learn the fastest.” Here’s What You’ll Need (Basic Qualifications) 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. 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 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 At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at 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 Savings and investments 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, 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 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 modernatx.com/careers 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 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. We’re 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 leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Lead and develop a multidisciplinary QC team overseeing testing for drug substance and drug product across chemistry, microbiology, and bioassay disciplines. Manage stability programs, sample lifecycles, and ensure strict cGMP compliance to support product release and lifecycle management.