Sr. Specialist, Quality Control, Reference Material
Moderna
Summary
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.
Job description
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)
- 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.
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
- Previous experience supporting reference standards, critical reagents, and assay controls is preferred.
Requirements
- 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
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Previous experience supporting reference standards, critical reagents, and assay controls is preferred
- Must already hold work authorization in US and be able to maintain that status without the need for future sponsorship
Benefits
- Competitive Healthcare
- Voluntary Benefit Programs
- Fitness Support
- Mindfulness & Mental Health Support
- Fertility Support
- Adoption Support
- Surrogacy Support
- Generous Paid Time Off
- Volunteer Days
- Sabbatical
- Global Recharge Days
- Year-End Shutdown
- Savings & Investments
- Annual Discretionary Bonus
- Equity Award
Company overview
Moderna, Inc. is a pioneering American biotechnology and pharmaceutical company headquartered in Cambridge, Massachusetts, that has revolutionized the field of medicine through its groundbreaking messenger RNA (mRNA) technology. Founded in 2010, the company has established itself as a global leader in RNA therapeutics, primarily focusing on mRNA vaccines and treatments. Moderna's innovative platform uses mRNA to provide cellular instructions for producing proteins that trigger immune responses, creating a new category of medicines with significant potential to improve patient outcomes across various therapeutic areas. The company gained worldwide recognition during the COVID-19 pandemic for developing one of the earliest and most effective mRNA vaccines, which demonstrated the transformative potential of its technology platform. Beyond infectious diseases, Moderna is advancing a diverse pipeline of 44 treatment and vaccine candidates across infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune conditions. With approximately 5,800 employees and a strong commitment to scientific innovation, Moderna continues to expand its manufacturing capabilities and research initiatives to deliver the greatest possible impact through mRNA medicines.