Senior Engineer I, External MSAT

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 109,200 - 174,600; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Holistic approach to well-being

Generous paid time off

Job summary

Initial Therapeutics, Inc. in Norwood, Massachusetts is searching for a role that involves advancing mRNA science to transform medicine. You will support external GMP manufacturing across various modalities, ensuring smooth technology transfer and execution.

The ideal candidate will have a strong background in GMP practices and experience in pharmaceutical manufacturing. The position highlights collaboration and influences execution across multiple teams.

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Qualifications

• Education: B.S, M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing.
• Experience: 10 years for BS or 4-7 years for MS in pharmaceutical or biotechnology companies.
• Strong judgment with clear communication regarding manufacturing issues.

Responsibilities

• Support technology transfer activities for clinical products into CMOs.
• Provide technical support for cGMP manufacturing processes.
• Drive cross-functional troubleshooting and continuous improvement.

Skills

Strong GMP experience

Data management tools

Collaborative team player

Ability to communicate manufacturing issues

Risk management skills

Education

B.S. in Pharmaceutical Manufacturing or related field

Tools

Statistical analysis software

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, elevate 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.

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. 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

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

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.