Overview
Joining Moderna offers the unique opportunity to be part of a pioneering team that is 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.
Role
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 solidifying its presence in Melbourne, a city at the forefront of Australia's biotech industry. Our Melbourne office focuses on commercial operations, ensuring the delivery of our innovative products to the Australian market. We're inviting international professionals to join our mission of delivering the greatest possible impact to people through mRNA medicines.
As a Principal Research Associate, MS&T Drug Product, you will be responsible for establishing Drug Product (DP) MS&T activities at our Clayton, Australia site (MTC-M). Reporting to the MS&T Drug Product Site Lead, you will serve as a technical specialist ensuring robust validation practices, technology transfers, continued process verifications, investigations, and change management in support of a new drug product manufacturing line. Your expertise will drive the development of compliant, high‐quality systems and processes critical to delivering mRNA products for local and export markets. As a senior team member, you will champion quality culture and contribute to the site's technical leadership.
Key Responsibilities
* Lead formulation, fill/finish, visual inspection, packaging, and related process validation and technology transfer activities.
* Ensure manufacturing alignment with mRNA/LNP platform standards and author and review cGMP documentation.
* Perform risk assessments, generate SOPs, and establish training programs.
* Monitor key performance indicators to identify and improve inefficiencies.
* Support operational metrics, departmental budgets, and site planning.
* Investigate complex manufacturing issues with cross‐functional teams.
* Act as technical expert for audits and inspections.
* Collaborate with global sites on data sharing and best practices.
* Integrate Lean and Six Sigma principles for continuous improvement.
* Execute technical support for media fills, cleaning verifications, and material qualifications.
Additional Responsibilities
* Strict adherence to Good Documentation Practices and Data Integrity.
* Completing training per assigned learning plans and requalification schedules.
* Maintaining deep expertise in quality systems, cGMP, and industry standards.
* Performing additional duties as assigned, including exploring opportunities for integration of Generative AI tools to streamline validation and investigation processes.
Mindsets
* Behave like owners – take full ownership of your domain and its strategic impact.
* Digitize everywhere possible using code to maximize patient impact.
Basic Qualifications
* Education: Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
* Experience: 3–5 years in the biotech or pharmaceutical industry, focusing on sterile manufacturing operations.
* Location: Site‐based full time at Moderna's Melbourne site; remote work not available.
* May require pre‐employment and periodic medical assessments in line with legal and operational requirements.
Preferred Qualifications
* Demonstrated ability to analyze complex issues and situations.
* Experience in a pharmaceutical manufacturing environment, preferably in aseptic fill‐finish process, process optimization, or technical support.
* Experience creating and delivering training programs.
* Familiarity with process validation principles and statistical analysis techniques.
* Technical writing skills and proficiency in investigations and root cause analysis.
* Strong communication and presentation skills. Proficiency in English required.
Pay & Benefits
* Best‐in‐class healthcare and voluntary benefit programs.
* Well‐being resources for fitness, mindfulness, and mental health.
* Family building benefits including fertility, adoption, and surrogacy support.
* Generous paid time off: vacation, bank holidays, volunteer days, sabbatical, global recharge days, discretionary year‐end shutdown.
* Savings and investment plans.
* Location‐specific perks and extras.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform and 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. We're 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.
We encourage an in‐person culture; Moderna champions the benefits of in‐office collaboration with a 70/30 work model.
If you want to make a difference, visit /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, please apply!
Moderna is committed to equal opportunity in employment and non‐discrimination for all employees and qualified applicants. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring accommodation should contact the Accommodations and Adjustments team at .
#J-18808-Ljbffr