Principal Research Associate, Analytical Science & Technology

Moderna; Norwood (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Moderna in Norwood, MA seeks an analytical CMC professional to provide executional support for method validation, transfer, and lifecycle management across late-phase and commercial programs. You will coordinate cross-functional teams, prepare documentation, and help ensure regulatory readiness while operating in a GMP-regulated biopharma environment.

The role emphasizes executional support, coordination, and documentation with a strong technical background in analytical sciences and

Qualifications

• Bachelor's degree required in a scientific field.
• 3+ years of analytical development/quality control experience in biopharma.
• Experience with GMP-regulated analytical methods.
• Strong writing and collaboration skills.

Responsibilities

• Provide project management and coordination for analytical method activities across late-phase and commercial programs.
• Support method validation, transfer, verification, and lifecycle management to meet regulatory and program milestones.
• Coordinate with internal labs, external partners, and QA/CMC to resolve documentation gaps.
• Contribute to analytical method transfer activities including planning and protocol/report review.
• Author and revise analytical documentation (validation plans, reports, transfer docs).
• Support lifecycle management of commercial methods including change control and post-implementation actions.
• Compile and review analytical data packages for regulatory submissions and responses.
• Contribute to regulatory query responses with cross-functional coordination.
• Identify documentation or validation needs through gap assessments for late-phase and commercial programs.
• Maintain organized records and trackers for traceability and inspection readiness.

Skills

Analytical Development

Quality Control

Analytical Sciences

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field

Job description

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.

Competitive healthcare, plus voluntary benefit programs to support your unique needs

A holistic approach to well-being, with access to fitn