Moderna Therapeutics

The Role:

Moderna is on the lookout for a dynamic, motivated and dedicated professional to serve as the Drug Substance Production Lead at our new manufacturing site in Australia. You will have a front-row seat as we build and operationalize this state-of-the art mRNA drug substance manufacturing facility, with responsibility for leading the end-to-end operations under the supervision of the Site Head.

You will be responsible for developing, implementing, and supporting manufacturing business systems and commercial production activities. You’ll bring your expertise in bioprocess unit operations and cGMPs to ensure technical success, with a strong emphasis on Operational Safety and adherence to a Quality System that aligns with country and global regulatory expectations.

Here’s What You’ll Do:

The role is pivotal to the ongoing operations and growth of our Australia site, involving equipment procurement and qualification, SOP development/deployment, electronic batch record implementation, and training material improvements. The successful candidate will play a key role in preparing the site for GMP inspection and certification, including equipment installation support, QMS implementation, staff recruitment, training, and development.

In addition, you will:

• Lead a team of Supervisors/Team Leads and Technical Specialists, including third party service providers to safely produce RNA-based medicines to support commercial manufacturing of vaccines (Covid, Flu, RSV).
• Optimize plans and resources (people, facilities, supplies etc.) for efficient manufacturing and timely delivery.
• Actively participate in recruitment, training, development, retention, and performance management of staff for effective manufacturing operations.
• Provide on-the-floor coaching of the manufacturing and support teams on process execution within a GMP environment.
• Ensure the development and maintenance of batch records, SOPs, and training materials for the DNA processes.
• Maintain the work center in a constant state of inspection readiness. Support onsite inspection activity as required.
• Collaborate closely with QA peers for rapid batch disposition, including ensuring timely batch record, protocol, and log reviews, deviation investigation support, etc.
• Be an efficient matrix contributor and collaborate effectively in a cross functional local and global settings with MST, Ops, SC, etc.
• Drive operational readiness for new product introductions and technology transfers.
• Develop comprehensive operating plans in collaboration with cross-functional peers and monitor the achievement of business and financial goals.
• Manage multiple projects alongside operations in a fast-paced environment.
• Foster a culture of continuous improvement leveraging Lean and Six Sigma principles.
• Role model Moderna’s culture and foster an exciting dynamic work environment for the team.

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 university degree in engineering or sciences and 12 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, 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.

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 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)