Principal Research Associate MS&T DP - Validation

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team that's 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.

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 us in our mission of delivering the greatest possible impact to people through mRNA medicines.

As a Principal Research Associate, MS&T - Validation, 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.

Here’s What You’ll Do:

Your key responsibilities will be:

• Lead formulation, fill/finish, visual inspection, packaging, and related process validation and tech transfer activities.

• Ensure manufacturing alignment with mRNA/LNP platform standards, 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.

Your responsibilities will also include:

• 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.

The key Moderna Mindsets you'll need to succeed in the role:

• We behave like owners. The solutions we’re building go beyond any job description. As the Principal Research Associate, you will be pivotal in establishing the foundational validation and MS&T operations at a new site, acting with full ownership over your domain and its strategic impact.

• We digitize everywhere possible using the power of code to maximize our impact on patients. You will actively seek opportunities to integrate digital and AI tools into validation processes, enhancing efficiency, compliance, and data-driven decision-making to optimize patient outcomes.

Here’s What You’ll Need (Basic Qualifications):

• Education: Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.

• Experience: A minimum of 3-5 years of experience in the biotech or pharmaceutical industry, with a focus on sterile manufacturing operations.

• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

Here’s What You’ll Bring to the Table: (Preferred Qualifications)

• Demonstrated ability to analyze complex issues and situations:

• Experience in a pharmaceutical manufacturing environment, preferably in a role related to aseptic fill finish process, process optimization, or technical support.

• Experience with creating and delivering training programs.<