Senior Director, MSAT

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas 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 presence in Norwood Massachusettshome to one of our most advanced manufacturing and science hubs. As we continue expanding our capabilities in clinical and commercial production Norwood plays a central role in pioneering mRNA medicines. We are seeking experts who thrive in dynamic environments and are passionate about making a tangible impact on global health.

This is a unique opportunity to lead Modernas global technical strategy for Drug Product (DP) operations. As the Senior Director MSAT Drug Product you will oversee the end-to-end stewardship of sterile DP manufacturingfrom formulation through packagingfor both commercial and clinical mRNA programs. This includes owning CPV visual inspection labeling and packaging strategy regulatory compliance and the introduction of cutting-edge technologies. Youll drive standardization and optimization across a complex internal and external network ensuring robustness compliance and continuous this global leadership role youll also guide a high-performing team embed digital and AI-driven solutions into manufacturing and contribute significantly to Modernas mission of delivering mRNA medicines at unprecedented speed and scale.

Heres What Youll Do

Your key responsibilities will be:

• Own the global technical strategy and optimization of aseptic DP operations across container types including vials pre-filled syringes and devices.

• Oversee product lifecycle and Continued Process Verification (CPV) driving robust risk management and mitigation planning.

• Introduce enabling technologies such as closed systems single-use platforms and advanced sensors/PAT across the network.

• Embed digital and AI solutions in DP operationsparticularly within automated visual inspection.

• Provide real-time and remote technical support for deviation investigations root cause analysis and CAPA implementation.

• Serve as SME during global health authority inspections and contribute to CMC dossiers and responses.

• Define and deploy network-level data and master standards for full interoperability across MES LIMS QMS and historian systems.

• Use AI/ML and statistical tools (e.g. JMP Python SQL Power BI Spotfire) for multivariate analysis and anomaly detection.

• Establish standardized philosophies for manual semi-automated and automated visual inspection including algorithm validation.

• Lead optimization of labeling and packaging operations ensuring serialization traceability and cold chain compliance.

Your responsibilities will also include:

• Build and lead a world-class DP MSAT team with clear development plans technical decision-making guidance and inspection preparation.

• Harmonize global procedures and standards (e.g. SOPs media fills) across internal and external manufacturing sites.

• Drive annual productivity targets in partnership with Supply and Finance through effective portfolio prioritization.

• Ensure compliance with particle/defect detection standards and AQL sampling protocols.

• Lead deployment of CPV dashboards automated alerts and self-service analytical capabilities for engineers.

• Promote a psychologically safe inclusive environment that values speed curiosity and accountability.

• Travel >40% of the time to support global sites and partnerships.

The key Moderna Mindsets youll need to succeed in the role:

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  This role is deeply embedded in the transformation of Drug Product operations through data science AI/ML and automation. Your success will come from leveraging digital tools to enhance manufacturing performance integrity and scalability.

• We behave like owners. The solutions were building go beyond any job description.
  This is a role that spans internal and external networks regulatory accountability team development and manufacturing innovation. Ownership of outcomes not just deliverables is essential to delivering Modernas mRNA medicines globally and reliably.

Heres What Youll Need (Basic Qualifications)

• M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry Biochemistry Chemical Engineering Pharmaceutical Engineering etc.)

• A minimum of 15 years related work experience

Technical Expertise:

• Filling process development optimization and validation.

• Visual inspection technologies (manual and robotic).

• Process validation EMPQ and media fills.

• Regulatory compliance and contributions to PPQ and BLA filings.

• Familiarity with global regulatory guidelines (CFR 21 ICH PDA standards).

• Proficiency in Continued Process Verification (CPV) Quality by Design (QbD) and data analytics tools.

• Familiarity with labeling and packaging processes.

• Experience with AI (ChatGPT preferred) and data analysis tools (JMP)

• Intellectual curiosity and ability to lead and mentor staff in technical areas outside your area of expertise. Ability to influence cross functionally.

• Demonstrated experience implementing new technology for commercial operations

• Strong technical problem-solving experience

Soft Skills

• Effective collaboration and stakeholder management. Ability to influence internally and externally (suppliers) including negotiation.

• Excellent verbal and written communication skills for regulatory submissions inspection support and technical presentations.

• Ability to effectively communicate complex technical topics and develop strategic scenarios to stakeholders and senior leadership.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat 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 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 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 persons 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 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

Were 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 .

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 applicants 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.

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