Sr. Specialist, Quality Control, Reference Material

Moderna is seeking a highly motivated Quality Control Reference Material Sr. Specialist to join our Quality Control team.  This role will contribute to the lifecycle management of reference materials, assay controls, and critical reagents supporting clinical and commercial programs.  The individual will be responsible for analytical data compilation, data assessment and trending, preparation of supporting data reference documents, authoring of GMP qualification and requalification protocols and reports. The individual will coordinate and execute activities related to qualification and requalification while providing technical support and ensuring activities are performed in accordance with applicable cGMP requirements and established procedures.   Here’s What You’ll Do: 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. Here’s What You’ll Need (Basic Qualifications) Education: Bachelor’s or Master’s Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or a related discipline.

Minimum of 5 years (Bachelor’s) or 3 years (Master’s) of industry experience in biopharmaceutical development. Specific Certifications or Training: None Other Quantifiable Preference: Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations  Previous experience supporting reference standards, critical reagents, and assay controls is preferred.   Our Working Model  As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.   Moderna is a smoke-free, alcohol-free, and drug-free work environment. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive healthcare, plus voluntary benefit programs