Senior Quality Control – Reference Materials Lead

Moderna Inc.; Norwood (MA); Hybrid; USD 90,000 - 144,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna Inc. is seeking a Quality Control Reference Material Senior Specialist to join our QC team in Massachusetts.

You will manage reference materials, assay controls, and critical reagents across clinical and commercial programs, coordinating qualification/requalification and generating GMP-compliant reports and data packages. The role requires 5+ years (Bachelor’s) or 3+ years (Master’s) in biopharmaceutical development, with strong data analysis, GMP documentation, and cross-functional

Qualifications

• Bachelor’s or Master’s Degree in a chemical/biomedical field or related discipline.
• Minimum of 5 years (Bachelor’s) or 3 years (Master’s) in biopharmaceutical development.
• Knowledge of FDA, EU, ICH guidelines and regulations is preferred.

Responsibilities

• Execute qualification and requalification of reference materials, assay controls, and reagents.
• Compile and assess analytical data, perform statistical analyses and data trending.
• Maintain material lifecycles and communicate risks to stakeholders.
• Coordinate sourcing, preparation, and distribution of materials for qualification and transfer.

Skills

Statistical analysis

Data trending

GMP documentation

Technical writing

Cross-functional collaboration

Education

Bachelor’s or Master’s Degree in Chemical/Biomedical Engineering or Pharmaceutical Sciences

Tools

Excel

JMP

Job description

Moderna Inc. is seeking a Quality Control Reference Material Senior Specialist to join our QC team in Massachusetts.

You will manage reference materials, assay controls, and critical reagents across clinical and commercial programs, coordinating qualification/requalification and generating GMP-compliant reports and data packages. The role requires 5+ years (Bachelor’s) or 3+ years (Master’s) in biopharmaceutical development, with strong data analysis, GMP documentation, and cross-functional