Senior QC Reference Materials Specialist

Moderna; Norwood (MA); On-site; USD 90,000 - 144,000; Full time

Benefits offered by this job

Competitive healthcare

In-office work model (70% in-office)

Job summary

Moderna is seeking a Quality Control Reference Material Sr. Specialist to join our Quality Control team in Norwood, MA. You will manage reference materials, assay controls, and critical reagents across clinical and commercial programs, compiling data, performing analyses, and preparing GMP documents.

The role requires a Bachelor’s or Master’s in a related field and 3–5+ years of biopharmaceutical experience, with knowledge of FDA/EU/ICH guidelines. A 70/30 in-office work model is in place.

Qualifications

• Bachelor’s or Master’s degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry
• 5+ years (Bachelor) or 3 years (Master) of industry experience in biopharmaceutical development
• Working knowledge of FDA, EU, ICH guidelines and regulations
• Experience supporting reference standards, critical reagents, and assay controls is preferred

Responsibilities

• Execute and contribute to the 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, including statistical analysis, data trending, graphical evaluations, and preparation of technical data summaries using Excel, JMP, or other applicable tools.
• Track material lifecycle milestones and timelines and communicate potential risks or impacts to relevant stakeholders.
• Coordinate and execute activities related to the sourcing, preparation, and distribution of materials used for analytical method qualification, validation, and transfer across internal and external laboratories.
• Coordinate activities to maintain continuity of supply for Moderna-specific materials used by internal and external laboratories.
• Coordinate with QC laboratories, technical SMEs, and Quality stakeholders to obtain supporting analytical data, address documentation review comments, and facilitate timely completion of GMP documentation deliverables.
• Author, revise and review protocols, reports, certificates, regulatory submission content, and other relevant technical and GMP documentation.
• Perform activities in accordance with applicable cGMP requirements, internal procedures, and quality standards.
• Provide technical support for troubleshooting and remediation activities related to reference materials, reagents, and standards, including GMP investigations.
• Support the retrieval, compilation, and organization of reference material qualification/requalification documentation and supporting analytical data for internal and external audits, as needed.
• Participate in regulatory and health authority inspection preparation and on-site inspection activities.

Skills

Data analysis

Statistical analysis

Cross-functional collaboration

Education

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

Tools

Excel

JMP

Job description

Moderna is seeking a Quality Control Reference Material Sr. Specialist to join our Quality Control team in Norwood, MA. You will manage reference materials, assay controls, and critical reagents across clinical and commercial programs, compiling data, performing analyses, and preparing GMP documents.

The role requires a Bachelor’s or Master’s in a related field and 3–5+ years of biopharmaceutical experience, with knowledge of FDA/EU/ICH guidelines. A 70/30 in-office work model is in place.