Senior Analytical Method Validation & Transfer Lead

Relha LLC; Norwood, Northern (MA, KY); Hybrid; USD 90,000 - 144,000; Full time

Job summary

Moderna in Norwood, MA is seeking a Principal Research Associate to provide analytical CMC executional support across late-phase development and commercial programs. You will contribute to method validation, transfer, and lifecycle management and collaborate with cross-functional teams to ensure regulatory readiness.

The role emphasizes execution, coordination, and documentation within regulated biopharmaceutical environments, requiring strong analytical science knowledge and excellent written

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 3+ years in Analytical Development or related biopharma roles.
• Experience with GMP-regulated analytical methods & regulatory submissions.

Responsibilities

• Provide project management and coordination for analytic method activities across late-phase programs.
• Plan, execute, and track method validation, transfer, verification, and lifecycle activities.
• Coordinate with internal labs, external testing partners, QA, Regulatory CMC, and program teams.
• Prepare transfer documentation, readiness tracking, and follow up on open items.
• Author and revise validation plans, protocols, reports, and method summaries.
• Support lifecycle management including governance, change control, and post-implementation actions.
• Assist with compiling data packages for regulatory submissions and health authority responses.
• Contribute to regulatory query responses through cross-functional reviews.
• Maintain organized records and trackers for traceability and inspection readiness.
• Prepare meeting agendas, notes, and track action items.

Skills

Analytical development

Method validation

Transfer & lifecycle management

Regulatory submissions support

Cross-functional collaboration

Technical writing

Documentation

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

External laboratories coordination

Change control systems

Job description

Moderna in Norwood, MA is seeking a Principal Research Associate to provide analytical CMC executional support across late-phase development and commercial programs. You will contribute to method validation, transfer, and lifecycle management and collaborate with cross-functional teams to ensure regulatory readiness.

The role emphasizes execution, coordination, and documentation within regulated biopharmaceutical environments, requiring strong analytical science knowledge and excellent written