Sr. Specialist, Quality Control, Reference Material

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

The Role:

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.


• Experience: 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 to support your unique needs


• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support


• Family planning benefits, including fertility, adoption, and surrogacy support


• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown


• Savings and investments to help you plan for the future


• Location-specific perks and extras

The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission everyday,

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.