Director, Drug Substance Production Lead

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.

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.

In addition:

• A u niversity degree in engineering or sciences and 1 2 or more years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment.

• Proven senior plant management experience and a strong background in implementing Tier (Lean) principles.

• Strong quality mindset, with deep understanding of cGMP guidelines and regulations.

• Excellent communication and presentation skills. Proficiency in English required.

• Proficiency in conflict resolution and crucial conversations.

• Technical writing skills and proficiency in investigations and root cause analysis.

• Proven ability to assess risk, collaborate with support groups to develop suitable action plans, and minimize potential impact.

• Strong role-modelling of Moderna Mindsets

• A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• 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, theinfrastructure 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.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit 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 proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity 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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at. (EEO/AAP Employer)

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