Associate Director, Sterility Assurance

The Role

The Associate Director, Sterility Assurance, DP Manufacturing is a senior technical role dedicated to the MTC-E facility and accountable for the design, implementation, and oversight of the site’s Contamination Control Strategy (CCS) program. This role ensures sterility assurance activities are aligned with regulatory expectations, operational requirements, and best practices in aseptic manufacturing.

Key Responsibilities and Authorities of the Position

• Lead and maintain the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with EU Annex 1, FDA aseptic guidance, and internal quality expectations.
• Ensure practical, risk-based integration of the CCS into isolator operations, cleanroom design, gowning practices, material and personnel flow, environmental controls, and aseptic process execution.
• Provide sterility assurance expertise for site changes, process improvements, and operational decisions that may impact contamination control.
• Provide expert sterility assurance guidance on the EM program (strategy, zoning, sampling design, alert/action levels, and trending) and partner with QC to ensure effective monitoring and response aligned with contamination control strategy.
• Lead or support investigations with potential impact to sterility assurance (e.g., EM excursions, media fill failures, decontamination issues, bioburden or sterility failures), ensuring robust root cause analysis and effective corrective and preventive actions.
• Present EM performance, contamination control risks, and key trends to site leadership and drive data-based decision-making.
• Own and author sterility assurance-related Quality System documentation, including change controls, risk assessments, CAPAs, deviations, and other records associated with contamination control, EM, or aseptic practices.
• Ensure records are scientifically sound, timely, and aligned with site and global quality system requirements.
• Serve as a key leader in inspection and audit readiness activities, including internal audits, client audits, and regulatory inspections.
• Act as subject matter expert for CCS, EM, aseptic execution, isolator operations, media fills, and related sterility assurance topics.
• Lead or support drafting of inspection responses and implementation of remediation actions arising from audit or inspection findings.
• Support real-time issue resolution and verify execution of validated and approved aseptic practices.
• Conduct routine floor audits and observations to assess aseptic behaviors, gowning, EM practices, and adherence to contamination controls.
• Coach operations and support personnel and partner with QA leadership to reinforce expectations and strengthen sterile execution culture.
• Partner closely with Operations, Facilities, MS&T, QC, Engineering, Supply Chain, and Quality to proactively manage sterility assurance risks across site activities.
• Identify and assign appropriate deputies to support business in times of absence.
• Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Required Background:

• Education: Bachelor’s degree in Microbiology, Life Sciences, Pharmacy, or related field (Master’s or Ph.D. preferred)
• Experience: 8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing roles
• Other Quantifiable Preference: Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations. Strong expertise in risk assessment facilitation. Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership.
• Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.

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

About Moderna

We are advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

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.

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.

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.