Specialist, Quality Control

Moderna; Norwood (KY); On-site; USD 74,000 - 118,000; Full time

Benefits offered by this job

Competitive healthcare

Discretionary bonus

Equity opportunity

Job summary

Moderna is seeking a Quality Control Chemistry Specialist at our Norwood, MA site to perform release, stability, and in-process data review and reporting for clinical and commercial products.

You will conduct routine QC analytical testing (HPLC, GC, UV, particle analysis, DLS), support method qualification, troubleshoot, manage data entry, and help maintain cGMP documentation. The role requires a Bachelor's in analytical chemistry or chemistry and 5+ years in a lab; onsite, GxP compliant.

Qualifications

• Bachelor’s degree in a relevant scientific discipline, preferred in Analytical Chemistry or Chemistry.
• Minimum 5 years in a laboratory setting with a focus in analytical chemistry.
• Understanding of GxP regulations (GMP/GLP/GCP or other applicable standards).

Responsibilities

• Perform routine QC analytical testing including HPLC, GC, UV, Particle Analysis and Dynamic Light Scattering.
• Support execution of method acquisition, qualification, re-qualification protocols
• Support troubleshooting of methods and equipment
• Perform data entry and support trending and analysis
• Perform general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
• Support authoring and revision of equipment, method and other laboratory procedures and reports
• LIMS sample result entry, execution of electronic assay forms
• Perform STAT testing in support to manufacturing process testing as needed, may require shift flexibility
• Stability program support
• Complete and maintain cGMP documentation for work performed.
• Support authoring quality systems records such as deviations, change controls, CAPAs
• Establish and maintain a safety, laboratory working environment
• Follow all relevant GxP regulations guidelines, and company policies to ensure compliance with regulatory and internal requirements
• Execute tasks precisely as defined in internal guiding documents including but not limited to SOPs and work instructions
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Skills

HPLC

GC

UV-Vis

Particle Analysis

Dynamic Light Scattering

Education

Bachelor's degree in Analytical Chemistry or Chemistry

Tools

LIMS

Job description

The Role

Moderna is seeking a Quality Control Chemistry Specialist based at their Norwood, MA site. The individual in this role will focus on Release, Stability and In Process data review and reporting for clinical and commercial products. This role may support special projects as needed.

Here’s What You’ll Do:

• Perform routine QC analytical chemistry testing including HPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, etc.
• Support execution of method acquisition, qualification, re-qualification protocols
• Supports Troubleshooting of methods and equipment
• Perform data entry and supports trending and analysis
• Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
• Supports authoring and revision of equipment, method and other laboratory procedures and reports
• LIMS sample result entry, execution of electronic assay forms
• Perform STAT testing in support to manufacturing process testing as needed, may require shift flexibility
• Stability program support
• Complete and maintain cGMP documentation for work performed.
• Support authoring quality systems records such as deviations, change controls, CAPAs
• Establish and maintain a safety, laboratory working environment
• Follow all relevant GxP regulations guidelines, and company policies to ensure compliance with regulatory and internal requirements
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operation procedures (SOPs) and work instructions
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Here’s What You’ll Need (Basic Qualifications)

• Minimum education required: Bachelor’s degree in a relevant scientific discipline, preferred in Analytical Chemistry, or Chemistry
• Minimum experience required: 5 years in a laboratory setting with focus in analytical chemistry
• Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP.GLP, GCP, GDP or other applicable standards)

Our Working Model

As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations.

Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. 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-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 $74,000.00 - $118,400.00. 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.

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

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.