Senior QC Reference Materials Lead

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

Benefits offered by this job

Competitive healthcare

Hybrid in-office work model (70/30)

Equity opportunities

Job summary

Moderna Therapeutics is seeking a Quality Control Reference Material Sr. Specialist to manage reference materials, assay controls, and critical reagents across clinical and commercial programs.

You will compile analytical data, perform statistical analyses, and prepare GMP documentation while ensuring cGMP compliance. The role emphasizes collaboration with QC labs and stakeholders within a hybrid in-office model.

Qualifications

• Bachelor's or Master's degree as listed above.
• 5+ years (Bachelor) or 3 years (Master) of biopharmaceutical development experience.
• Knowledge of FDA, EU, ICH guidelines and regulations.

Responsibilities

• Execute and contribute to creation, qualification, and requalification of reference materials, assay controls, and critical reagents.
• Compile, review, and assess analytical data supporting reference material qualification and requalification activities.
• Coordinate sourcing, preparation, and distribution of materials for analytical method qualification, validation, and transfer.
• Author, revise and review GMP documentation including protocols, reports, and regulatory submissions.

Skills

Analytical data handling

Statistical analysis

GMP documentation

Education

Bachelor’s or Master’s in Chemical/Biomedical Eng, Pharmaceutical Sciences, Biochemistry

Tools

Excel

JMP

Job description

Moderna Therapeutics is seeking a Quality Control Reference Material Sr. Specialist to manage reference materials, assay controls, and critical reagents across clinical and commercial programs.

You will compile analytical data, perform statistical analyses, and prepare GMP documentation while ensuring cGMP compliance. The role emphasizes collaboration with QC labs and stakeholders within a hybrid in-office model.