Associate Director, Sterility Assurance

The RoleThe 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.This is a high-impact, hands-on role requiring frequent presence on the manufacturing floor to observe, assess, and improve aseptic behaviors, process execution, and contamination control practices. The Associate Director partners closely with Manufacturing, MS&T, Facilities, QC, Engineering, Supply Chain, and Quality to integrate sterility assurance into all layers of site operations. The individual must be technically strong, data-driven, and proactive in identifying risks and driving continuous improvement across the site.Key Responsibilities and Authorities of the PositionLead 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.Support the site aseptic training, qualification, and certification programs.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 rolesOther 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 & BenefitsAt 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 needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportFamily planning benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investment opportunities to help you plan for the futureLocation-specific perks and extrasThe 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 ModernaSince 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 OpportunitiesModerna 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. AccommodationsWe’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 View email address on click.appcast.io. 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-SB2-SummaryLocation: Norwood, Massachusetts; Drug ManufacturingType: Full time