Senior Analytical CMC Specialist: Method Validation & Transfer

RXinsider LTD.; Norwood, Northern (MA, KY); Hybrid; USD 90,000 - 144,000; Full time

Benefits offered by this job

Healthcare

Wellness programs

PTO & sabbatical

Equity incentives

Family planning

Job summary

Moderna in Norwood, MA is seeking an analytical CMC professional to provide executional support for method-related activities across late-phase development and commercial programs. You will contribute to method validation, transfer, and lifecycle management in support of regulatory submissions and commercial readiness.

The role emphasizes hands-on execution, coordination, and documentation across cross-functional teams and external partners in a regulated biopharma environment.

Qualifications

• Strong technical writing, documentation, and organizational skills.
• Experience in analytical development within GMP-regulated environments.
• Familiarity with ICH/GMP guidelines and industry best practices.

Responsibilities

• Provide project management and coordination support for analytical method activities across late-phase and commercial programs.
• Support planning, tracking, and follow-up for validation, transfer, verification, and lifecycle management tasks.
• Coordinate with internal labs, external partners, Quality, Regulatory CMC, and program teams.
• Assist analytical method transfer activities including planning, documentation, and review of protocols/reports.
• Author and revise analytical documentation, including validation plans, protocols, and method summaries.
• Support lifecycle management of commercial analytical methods and change control documentation.
• Assist with compiling, organizing, and reviewing documentation for regulatory submissions and responses.
• Contribute to regulatory query responses by gathering inputs and tracking deliverables.
• Support gap assessments to identify documentation, validation, or lifecycle needs.
• Maintain organized records and trackers to promote traceability and inspection readiness.
• Assist with meeting preparation, notes, action items, and escalation of risks or delays.
• Work within quality systems and ensure deliverables meet internal procedures.

Skills

Technical writing

Communication

Collaboration

Education

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

Job description

Moderna in Norwood, MA is seeking an analytical CMC professional to provide executional support for method-related activities across late-phase development and commercial programs. You will contribute to method validation, transfer, and lifecycle management in support of regulatory submissions and commercial readiness.

The role emphasizes hands-on execution, coordination, and documentation across cross-functional teams and external partners in a regulated biopharma environment.