Analytical CMC Lead – Method Validation & Transfer

Biopharma Careers; Norwood (KY); On-site; USD 90,000 - 144,000; Full time

Benefits offered by this job

Competitive healthcare

Discretionary bonus potential

Generous paid time off

Location-specific perks

Job summary

Moderna seeks an analytical CMC professional based at its Norwood, MA site to execute method-related activities across late-phase development and commercial programs. The role focuses on execution, coordination, and documentation within a regulated biopharma environment.

The successful candidate will contribute to method validation, transfer, lifecycle management, and support regulatory submissions and health authority responses, working cross-functionally to ensure timely program milestones.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 3+ years in Analytical Development, Quality Control, or Analytical Sciences in biopharma.
• Experience supporting method qualification, validation, transfer, and lifecycle management in GMP.
• Strong technical writing and organizational skills.
• Ability to work across cross-functional teams.

Responsibilities

• Provide project management and coordination for analytical method activities with timelines and trackers.
• Support method validation, transfer, verification, and lifecycle activities aligned with regulatory milestones.
• Coordinate with internal laboratories, external testing partners, Quality, Regulatory CMC, and program teams.
• Author and revise analytical documents including validation plans and transfer documents.
• Support lifecycle management and post‑implementation actions.
• Assist with compiling and organizing documentation for regulatory submissions.
• Contribute to regulatory query responses with cross‑functional reviews.
• Maintain organized records and traceability across analytical CMC activities.

Skills

Project management

Analytical thinking

Cross-functional collaboration

Technical writing

Communication skills

Education

Bachelor’s degree in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

Documentation systems

Job description

Moderna seeks an analytical CMC professional based at its Norwood, MA site to execute method-related activities across late-phase development and commercial programs. The role focuses on execution, coordination, and documentation within a regulated biopharma environment.

The successful candidate will contribute to method validation, transfer, lifecycle management, and support regulatory submissions and health authority responses, working cross-functionally to ensure timely program milestones.