Associate Director, Sterility Assurance

The Role

The Associate Director, Sterility Assurance / Environmental Monitoring (EM) is a senior technical role fully dedicated to the MTC-E facility. This individual is accountable for the design, implementation, and oversight of the site's Contamination Control Strategy (CCS) and Environmental Monitoring (EM) program, ensuring execution is aligned with regulatory expectations, operational needs, and best practices in aseptic manufacturing.

This is a high-impact, hands-on role requiring regular presence on the manufacturing floor to observe, audit, and address behaviors, aseptic techniques, and process execution. The Associate Director partners closely with Manufacturing, MS&T, Facilities, QC, and Engineering, integrating sterility assurance into all layers of operations. This leader must be technically expert, data-driven, and proactive in identifying risks and driving continuous improvement across the site.

Here's What You’ll Do

Contamination Control Strategy & Sterility Assurance

• Contribute to the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with Annex 1, FDA aseptic guidance, and internal quality expectations.

• Ensure risk-based, practical integration of CCS into isolator usage, cleanroom design, gowning, material/personnel flow, and environmental control.

Environmental Monitoring Program – Oversight, Trending & RCA

• Lead key EM program lifecycle for MTC-E: sampling strategy, zoning, drawing management, alert/action levels, and trend reporting.

• Guide EM-related root cause investigations, excursion management, and system improvements.

• Present EM performance and risk trends to site leadership and drive data-based decision making.

Ownership of Quality System Records

• Own and author sterility assurance-related Quality System documentation, including:

  • Change controls for EM, CCS, or aseptic practices
  • Risk assessments for sterility-impacting changes or contamination events
  • CAPAs tied to EM deviations, audit findings, or trend analysis

• Ensure records are timely, scientifically justified, and aligned with site and global quality systems.

Audit Readiness & Regulatory Engagement

• Serve as a critical leader in audit preparation, defense, and follow-up, including internal, client, and regulatory inspections.

• Act as SME for CCS, EM, aseptic execution, isolator operations, and media fills.

• Lead or support drafting of inspection responses and implementation of remediation strategies.

Presence in Critical Manufacturing Activities

• Be actively present during key operations, including:

  • Media fills
  • Sterile filtration and aseptic filling operations
  • Isolator decontamination and validation events
  • Facility or process qualifications impacting sterility or EM

• Support real-time issue resolution and verify proper execution of validated practices.

Behavioral Oversight & Coaching

• Conduct routine floor audits to assess aseptic behaviors, gowning, EM technique, and adherence to contamination controls.

• Coach floor personnel and partner with QA to reinforce expectations and elevate sterile execution culture.

• Support aseptic training and certification programs site-wide.

Cross-Functional Integration & 24/7 Support

• Partner closely with with Operations, Facilities, MS&T, QC, Engineering, and Supply Chain to proactively manage sterility assurance across all activities.

• Be available 24/7 to respond to contamination events, EM alerts, and operational escalations requiring sterility input.

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

• Education: Bachelor’s degree in Microbiology, Life Sciences, Pharmacy, or related field (Master’s or Ph.D. preferred).

• Experience:

  • 8+ years in sterile pharmaceutical manufacturing, aseptic processing, or sterility assurance roles
  • Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations
  • Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership

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

• Must be on-site daily and available 24/7 per business needs for escalations and critical event support.

• Strong understanding of aseptic manufacturing, campaign operations, and support service dependencies.

• Excellent communication skills; able to translate complex plans into clear, actionable instructions.

• Ability to hold stakeholders accountable, influence without authority, and drive alignment across multiple teams.

• Highly organized, detail-oriented, and committed to maintaining a compliant, safe, and efficient production schedule.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs

• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support

• Family planning benefits, including fertility, adoption, and surrogacy support

• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown

• Savings and investment opportunities to help you plan for the future

• Location-specific perks and extras

The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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.

Our Working Model

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.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 contact the Accommodations team at leavesandaccommodations@modernatx.com.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

#LI-NB1