Director, Drug Substance Production Lead

at  Moderna

HERE’S WHAT YOU’LL BRING TO THE TABLE :

We are looking for someone with a strong background in Operational Excellence to establish a robust foundation of Tier systems, Lean, and Six Sigma principles throughout the facility startup and ramp up phase.

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.
M oderna is committed to enhancing Australia’s biotech landscape through a long-term partnership that focuses on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility will be a cornerstone in Australia’s ability to respond to future health threats efficiently. This collaboration not only brings cutting-edge medical technology to the forefront but also emphasizes job creation and local talent development. We’re inviting visionary professionals to be part of this transformative journey, making a tangible impact on global health security.
Moderna invites a dedicated and experienced professional to join our team in Melbourne, Australia, as the Director, Drug Substance Production Lead. In this key role, you will oversee the end-to-end operations of our new state-of-the-art mRNA drug substance manufacturing facility, under the guidance of the Site Head. Your leadership will be crucial in developing and implementing manufacturing business systems and commercial production activities. You will leverage your bioprocess and cGMP expertise to ensure technical success, with a focus on Operational Safety and Quality System adherence to meet both local and global regulatory standards.

HERE’S WHAT YOU’LL DO:

Within 3 Months, You Will…
Lead equipment procurement and qualification processes, including SOP development and deployment.
Begin implementing electronic batch record systems and enhancing training materials.
Start preparing the site for GMP inspection and certification.
Within 6 Months, You Will…
Optimize manufacturing plans and resources for efficient production and timely delivery.
Actively participate in recruitment, training, and development of manufacturing staff.
Provide hands-on coaching to manufacturing and support teams in GMP process execution.
Within 12 Months, You Will…
Drive the facility to a state of continuous inspection readiness and support onsite inspection activities.
Collaborate closely with QA to ensure rapid batch disposition and support deviation investigation processes.
Foster a culture of continuous improvement, leveraging Lean and Six Sigma principles.