Technical Operations - Sterility Assurance

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 footprint in Clayton, Australia, enhancing our global operations and resilience efforts. We are building a state-of-the-art facility dedicated to the development and manufacturing of mRNA vaccines, contributing to pandemic preparedness and response capabilities. We are seeking talented professionals to join us in this exciting journey of transforming medicine and impacting lives worldwide.

The Technical Operations - Sterility Assurance Lead will be part of a cohesive quality assurance team supporting cGMP manufacturing at Moderna’s state-of-the-art Drug Substance and Drug Product (Fill Finish) facility. Reporting to the Site Quality Lead, this individual will demonstrate dynamic range with the capability to provide quality oversight of manufacturing operations, technology transfer projects, and facility commissioning, qualification, and validation related to contamination control and sterility assurance activities. The successful candidate will be responsible for championing sterility assurance principles and serve as the quality technical leader in the areas of sterile drug product manufacture, low bioburden drug substance processing, sterility assurance, and microbial control programs.

Here’s What You’ll Do:

Your key responsibilities will be:

• Collaborate with Moderna’s global Sterility Assurance network to implement standardized, harmonized, and best practices across the site’s sterile manufacturing operations, low bioburden drug substance processing, aseptic techniques, controlled environments, aseptic training, cleanroom behaviors, cleaning, disinfection, sterilization, microbiological testing, and related areas.

• Establish and maintain company contamination control strategies and oversee aseptic practices.

• Generate and maintain contamination control strategy (CCS) documents for the Australian Site.

• Support sterile manufacturing site operations by providing expertise in aseptic processing and behaviors, training development, equipment, and guidance in sterility assurance.

• Lead the design and execution of environmental monitoring programs for the Australian facility.

Your responsibilities will also include:

• Provide input for the design of bioburden-controlled manufacturing processes and sterile fill/finish and packaging technologies, including container-closure integrity and visual inspection.

• Provide Quality oversight for commissioning, qualification, and validation initiatives including complex GMP facilities, equipment, and critical utility projects.

• Provide Quality oversight of significant deviations, including root cause analysis records, and change controls.

• Review protocols, risk assessments, facility changes, and/or control strategies.

• Write, review, and approve GMP documentation (SOPs, Forms, Technical Reports, Validation and Qualification Reports, Specifications, change controls, deviations, EM trend reports, etc.).

• Lead and participate in internal audits and health authority inspections.

• Ensure compliance with applicable Quality Regulations, Standards, and other regional requirements.

• Act as the Sterility Assurance SME with external regulators, company management, in addition to acting as SME for new product introductions and applicable capital projects.

• Drive continuous improvement of aseptic techniques and practices to maintain product sterility.

• Collaborate cross-functionally to enable Quality Culture and a continuous improvement mindset.

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

• We act with urgency: The role demands swift and decisive actions to maintain the highest standards in sterility assurance, ensuring patient safety and product quality.

• We question convention: Innovation in sterility assurance practices and contamination control strategies is crucial for maintaining leadership in mRNA technology.

• We digitize everywhere possible: Leveraging digital tools and data analysis to monitor and improve sterility assurance processes will be vital for maintaining compliance and efficiency.

Here’s What You’ll Bring to the Table

• Strong knowledge of cGMP regulations, ISO standards, USP <797> and <1116> , and other relevant guidance documents.

• Experience participating in inspections as a Microbiological Subject Matter Expert (SME) and direct interactions with world-wide Health Authorities with diverse global authority (e.g. FDA, MHRA, EMA, PMDA, ANVISA)

• Expertise in design, qualification and control of clean facilities and critical utilities.

• Experience in data analysis and statistical evaluation and trending of microbiological data.

• Experience with conducting technical/risk assessments of in-house and contract sterilization processes or contract microbiological laboratories (preferred). Expertise in investigations/deviation management including, writing, and evaluating microbiological OOS’s and laboratory investigations and manufacturing investigations.

• Prior experience with authoring and reviewing of Quality-owned regulatory filing sections.

• Strong knowledge in microbiological analytical method lifecycle (including rapid microbiology methods preferred).

• Capability to lead, educate, train, and develop a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity.

• Ability to think critically and demonstrate troubleshooting and problem-solving skills. Excellent ability to communicate issues in a scientifically sound and understandable way.

• Excellent project management and organizational skills.

• Ability to navigate through ambiguity and rapid growth and adapt to change.

• Proven ability to manage complex projects and engage cross-functional teams.

• Experience with budget management and cost optimization.

• Strong commitment to quality, safety, and continuous improvement.

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

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.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact. 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 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. 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 or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should

contact the Accommodations and Adjustments team at [email protected] .

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