Senior Engineer I, External MSAT

BioSpace; Norwood (MA); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being resources

Paid time off

Job summary

Moderna in Norwood, MA seeks a highly capable MSAT professional to advance external GMP manufacturing for multiple modalities. You will partner with CMOs, author change controls, review deviations, and drive CPV‑style monitoring with a focus on data integrity and regulatory compliance.

The role emphasizes cross‑functional collaboration with Quality, Manufacturing, Technical Development, and Supply Chain, delivering robust tech transfer and lifecycle management in a fast‑paced environment.

Qualifications

• GMP experience in Manufacturing Operations/MSAT (CMO experience is a benefit).
• Knowledge of data management tools and statistical analysis.
• Strong judgment and ability to communicate manufacturing issues in a scientifically sound and clear way, proposing data‑driven options and recommendations.
• Highly collaborative team player able to work effectively with internal stakeholders and external partners/CMOs in a cross‑functional matrix environment.

Responsibilities

• Support technology transfer activities for clinical and commercial products into CMOs, ensuring seamless scale‑up and execution
• Provide technical support for cGMP manufacturing, including authoring technology transfer documentation and risk assessments
• Author and own Moderna‑led change controls, while reviewing CMO‑owned changes to ensure scientific rigor, appropriate risk assessment, and clear implementation rationale
• Review CMO deviations and investigations, ensuring robust root cause analysis, effective CAPAs, and comprehensive product impact assessments; act as SME to challenge and guide investigations
• Provide technical oversight of validation activities at CMOs, including protocol review, execution support, and assessment of summary reports
• Drive data review, trending, and continued process verification (CPV‑style monitoring), establishing data repositories, defining meaningful KPIs, and identifying early signals or process drift
• Lead cross‑functional troubleshooting and continuous improvement initiatives across manufacturing processes and equipment
• Build strong, trust‑based relationships with CMO technical and quality teams, influencing without direct authority to deliver right‑first‑time outcomes
• Collaborate closely with internal stakeholders across Quality, Manufacturing, Technical Development, and Supply Chain to ensure alignment and execution
• Maintain alignment across global manufacturing sites through shared data, insights, challenges, and standardized solutions
• Ensure strict adherence to GxP regulations, internal policies, and compliance standards
• Execute tasks in accordance with SOPs, work instructions, and internal documentation standards
• Uphold Good Documentation Practices and Data Integrity principles to ensure inspection readiness and audit support
• Complete all required training within defined timelines and maintain qualification status

Skills

GMP experience

Technology transfer

Data analysis

Cross-functional collaboration

Validation

Quality systems

Education

B.S./M.S./Ph.D. in Pharmaceutical Manufacturing

Tools

Statistical analysis tools

Job description

The Role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide.

This role is embedded within MSAT, supporting external GMP manufacturing across chemical and biologic modalities, including lipids, small molecules, VHH antibodies, and plasmids.

You will operate as a highly agile technical expert, partnering with CMOs and internal stakeholders to ensure robust execution across technology transfer, validation, and lifecycle management.

With a strong focus on data, digital enablement, and continuous improvement, this role offers the opportunity to shape next‑generation manufacturing performance while working at the intersection of science, engineering, and emerging technologies such as AI‑driven analytics.

Here’s What You’ll Do

• Support technology transfer activities for clinical and commercial products into CMOs, ensuring seamless scale‑up and execution
• Provide technical support for cGMP manufacturing, including authoring technology transfer documentation and risk assessments
• Author and own Moderna‑led change controls, while reviewing CMO‑owned changes to ensure scientific rigor, appropriate risk assessment, and clear implementation rationale
• Review CMO deviations and investigations, ensuring robust root cause analysis, effective CAPAs, and comprehensive product impact assessments; act as SME to challenge and guide investigations
• Provide technical oversight of validation activities at CMOs, including protocol review, execution support, and assessment of summary reports
• Drive data review, trending, and continued process verification (CPV‑style monitoring), establishing data repositories, defining meaningful KPIs, and identifying early signals or process drift
• Lead cross‑functional troubleshooting and continuous improvement initiatives across manufacturing processes and equipment
• Build strong, trust‑based relationships with CMO technical and quality teams, influencing without direct authority to deliver right‑first‑time outcomes
• Collaborate closely with internal stakeholders across Quality, Manufacturing, Technical Development, and Supply Chain to ensure alignment and execution
• Maintain alignment across global manufacturing sites through shared data, insights, challenges, and standardized solutions
• Ensure strict adherence to GxP regulations, internal policies, and compliance standards
• Execute tasks in accordance with SOPs, work instructions, and internal documentation standards
• Uphold Good Documentation Practices and Data Integrity principles to ensure inspection readiness and audit support
• Complete all required training within defined timelines and maintain qualification status

The key Moderna Mindsets you’ll need to succeed in the role

"We act with urgency; Action today compounds the lives saved tomorrow."

"We digitize everywhere possible using the power of code to maximize our impact on patients."

Here’s What You’ll Need (Basic Qualifications)

• Education: B.S, M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.). BS with 7 to 10 years of experience or MS with 4 to 7 years of experience in a pharmaceutical or biotechnology company.
• Strong GMP experience in a technical/engineering role within Manufacturing Operations and/or MSAT (CMO experience is a benefit).
• Knowledge of data management tools and statistical analysis.
• Strong judgment and ability to communicate manufacturing issues in a scientifically sound and clear way, proposing data‑driven options and recommendations.
• Highly collaborative team player able to work effectively with internal stakeholders and external partners/CMOs in a cross‑functional matrix environment.
• Demonstrated ability to manage multiple priorities and drive projects to completion in a fast‑paced environment.
• Demonstrated ability to proactively identify risks, escape appropriately, and support issue resolution in a dynamic GMP setting.

Pay & Benefits

At 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 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 salary range for this role is $109,200.00 - $174,600.00. 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 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.

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 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.

Accommodations

We’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 [e-mail].

Export Control Notice

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.