Norwood, Massachusetts, United States
Hybrid
The Role
Moderna is seeking an Individual based at its Norwood, MA site. This role will provide analytical CMC executional support for method-related activities across late-phase development and commercial programs. The individual will contribute to analytical method validation, transfer, and lifecycle management activities in support of product development, regulatory submissions, and commercial readiness.
This is an individual contributor role focused on executional support, coordination, documentation, and operational follow-through. The ideal candidate will bring strong technical knowledge in analytical sciences, experience working in a regulated biopharmaceutical environment, and the ability to operate effectively across cross-functional teams and external partners.
Here’s What You’ll Do
Provide project management and coordination support for analytical method-related activities across late-phase development and commercial programs, including maintaining timelines, trackers, action logs, deliverable lists, and status updates.
Support planning, execution tracking, and follow-up for analytical method validation, transfer, verification, and lifecycle management activities to ensure alignment with internal expectations, regulatory requirements, and program milestones.
Coordinate with internal laboratories, external testing partners, Quality, Regulatory CMC, and program teams to support timely execution of analytical method activities and resolution of documentation or data package gaps.
Contribute to analytical method transfer activities across internal and external laboratories by supporting transfer planning, documentation preparation, protocol/report review, readiness tracking, and follow-up on open items.
Author and revise analytical documentation, including validation plans and strategies, protocols, reports, transfer documents, method summaries, technical memos, gap assessments, and supporting documentation.
Support lifecycle management of commercial analytical methods, including documentation updates, method governance support, change control documentation, continuous improvement activities, and tracking of post- implementation actions.
Assist with compiling, organizing, and reviewing analytical documentation and data packages in support of regulatory submissions, health authority responses, post-approval commitments, and commercial readiness activities.
Contribute to regulatory query responses by gathering technical inputs, coordinating cross-functional reviews and tracking deliverables through completion.
Support analytical method gap assessments to identify documentation, validation, transfer, or lifecycle management needs for late-phase development, regulatory filing, and commercial implementation.
Maintain well-organized records, trackers, and supporting documentation to promote traceability, inspection readiness, and effective knowledge management across analytical CMC activities.
Support meeting preparation and follow-up, including agenda development, meeting notes, action item tracking, decision capture, and escalation of risks or delays to appropriate team members.
Work within established quality systems and regulated documentation practices, ensuring that deliverables are accurate, complete, traceable, and compliant with applicable internal procedures.
Here’s What You’ll Need (Basic Qualifications)
Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
3+ years of experience in Analytical Development, Quality Control, Analytical Sciences, or a related function within the biopharmaceutical industry.
Experience supporting analytical method qualification, validation, transfer, and/or lifecycle management within a GMP-regulated environment.
Working knowledge of analytical documentation requirements for regulatory submissions supporting late-phase or commercial programs.
Familiarity with ICH guidelines, GMP regulations, and industry best practices.
Strong technical writing, documentation, and organizational skills.
Strong communication and collaboration skills with the ability to work effectively across cross-functional teams.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Experience supporting biologics, vaccines, or other complex modalities.
Experience authoring or supporting validation protocols, reports, analytical method transfer documentation, and/or regulatory submissions.
Experience working with external laboratories, CDMOs, or global manufacturing and testing networks.
Demonstrated ability to manage multiple priorities in a fast-paced environment.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
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 modernatx.com/careers 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 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 leavesandaccommodations@modernatx.com.
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.
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