Senior Manager, MSAT

Moderna Therapeutics • Norwood, MA

4d • Onsite

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. In this highly impactful role, you will serve as a central figure in ensuring the successful transfer and validation of mRNA-based drug product manufacturing processes. Based at our Norwood site, you will lead the execution of Technical Transfer and Process Validation activities, including protocol creation, PPQ execution at internal and external facilities, and report generation. You'll act as the driving force for cross-functional collaboration across technical and quality teams to deliver on operational readiness, regulatory alignment, and manufacturing excellence. The role goes beyond execution—you'll help shape strategies for operational optimization and lead initiatives for continuous improvement, innovation, and standardization. Your work will support the global expansion of Moderna's manufacturing network and provide close exposure to cutting-edge digital and AI-based tools as part of our broader digitization efforts. Here's What You'll Do: Your key responsibilities will be: Ensure the successful technology transfer and process validation of Moderna processes at both internal and external drug product manufacturing sites. Lead cross-functional project teams for new product introductions and continuous process improvement efforts. Develop and maintain comprehensive documentation packages to support process validation and technical transfer. Be the primary technical contact for validation-related investigations, including root cause analysis and corrective action planning. Create and manage change controls related to new product introductions in alignment with Moderna's Quality Systems. Your responsibilities will also include: Drive alignment with other Moderna manufacturing sites through knowledge sharing, data exchange, and harmonized solutions. Support regulatory submissions and respond to queries from health authorities related to process validation. Represent the MSAT function during regulatory audits, ensuring inspection readiness and compliance. Implement industry best practices and continuous improvement methodologies in technical transfer and validation activities. Facilitate risk assessments and mitigation strategies across stakeholders to ensure smooth project execution. Promote a culture of safety, collaboration, and innovation in all aspects of work. The key Moderna Mindsets you'll need to succeed in the role: “We behave like owners. The solutions we're building go beyond any job description.” You'll take full accountability for cross-functional deliverables, driving complex tech transfer initiatives from planning through execution with deep attention to quality and compliance. This mindset is critical as you will act independently and influence across functions. “We digitize everywhere possible using the power of code to maximize our impact on patients.” This role provides a unique opportunity to integrate digital tools, data-driven decision-making, and emerging technologies like AI into process optimization and validation strategies—enhancing the speed, efficiency, and reliability of our manufacturing processes.

Requirements

• Science Degree with pharmaceutical/biotechnology applicability (pharmacy, chemistry, biotechnology, engineering, etc)
• Minimum of 10 years in pharmaceutical/biotechnology industry
• Experience with cGMP manufacturing, drug product technical transfer, and process validation
• Knowledge of drug product manufacturing including formulation, sterile filtration, aseptic processing, visual inspection, labeling and packaging
• Strong proficiency in English

Responsibilities

• Ensure the successful technology transfer and process validation of Moderna processes at both internal and external drug product manufacturing sites.
• Lead cross-functional project teams for new product introductions and continuous process improvement efforts.
• Develop and maintain comprehensive documentation packages to support process validation and technical transfer.
• Be the primary technical contact for validation-related investigations, including root cause analysis and corrective action planning.
• Create and manage change controls related to new product introductions in alignment with Moderna's Quality Systems.
• Drive alignment with other Moderna manufacturing sites through knowledge sharing, data exchange, and harmonized solutions.
• Support regulatory submissions and respond to queries from health authorities related to process validation.
• Represent the MSAT function during regulatory audits, ensuring inspection readiness and compliance.
• Implement industry best practices and continuous improvement methodologies in technical transfer and validation activities.
• Facilitate risk assessments and mitigation strategies across stakeholders to ensure smooth project execution.
• Promote a culture of safety, collaboration, and innovation in all aspects of work.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees