Senior Manager, 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.

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. Youll 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 executionyoull help shape strategies for operational optimization and lead initiatives for continuous improvement innovation and standardization. Your work will support the global expansion of Modernas manufacturing network and provide close exposure to cutting-edge digital and AI-based tools as part of our broader digitization efforts.

Heres What Youll 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 Modernas 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 youll need to succeed in the role:

• We behave like owners. The solutions were building go beyond any job description.
  Youll 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 strategiesenhancing the speed efficiency and reliability of our manufacturing processes.

Heres What Youll Need (Basic Qualifications)

• Education: Science Degree with pharmaceutical/biotechnology applicability (pharmacy chemistry biotechnology engineering etc)

• Experience:

  • 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

Specific Certifications or Training:

None

Other Quantifiable Preference:

Strong proficiency in English

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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