Senior Director, MSAT

Moderna•Norwood, MA

About The Position

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 presence in Norwood, Massachusetts—home 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 Moderna’s 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 manufacturing—from formulation through packaging—for 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. You’ll drive standardization and optimization across a complex internal and external network, ensuring robustness, compliance, and continuous improvement. In this global leadership role, you’ll also guide a high-performing team, embed digital and AI-driven solutions into manufacturing, and contribute significantly to Moderna’s mission of delivering mRNA medicines at unprecedented speed and scale.

Requirements

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
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.

Responsibilities

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 operations—particularly 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.
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.

Benefits

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

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