Specialist, Quality Control

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.

As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.

The Quality Control Specialist will support cGMP QC routine testing for raw materials, drug substances, and finished products at the company's manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, leading method transfers, qualification activities, quality records (e.g. Change Controls, CAPAs, ECs, Investigations), and ensuring compliance with cGMP standards. The individual will teach and train analysts on technical concepts and methods and act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance and Development.  This is an on-site position.

Here’s What You’ll Do

Your key responsibilities will be:

• Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities.

• Support bioassay routine testing for raw materials, drug substance and drug product.

• Lead special projects as Bioassay SME.

• Perform on the job training.

• Write/revise SOPs, protocols, and reports.

• Troubleshoot issues related to equipment, laboratory procedures and assay performance

• Establish and maintain a safe laboratory working environment.

• Analyze and trend data as assigned

• Review Data

• Own and manage Quality records (i.e. investigations, change controls, CAPAs)

• Ensure compliance with cGMP documentation and regulatory guidelines.

• Accountable for all mandatory training and assigned tasks.

• Provide support during audits and collaborate on continuous improvement initiatives.

• Establish and maintain a safe laboratory working environment.

• Additional duties may be assigned.

The key Moderna Mindsets you’ll need to succeed in the role:

• “We obsess over learning. We don’t have to be the smartest – we have to learn the fastest.”
  Your success in this role will depend on a constant drive to expand technical expertise, especially in complex assays and evolving quality control technologies. You'll adapt quickly to new data, regulatory changes, and innovation opportunities – including leveraging AI-enabled lab tools and automation.

• “We behave like owners. The solutions we’re building go beyond any job description.”
  As a Specialist, you won’t just complete tasks — you’ll own the quality systems and improvements you’re a part of. You’ll actively shape workflows, mentor peers, and elevate the lab’s performance, embodying full accountability for results and impact.

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

• Education: BS in a relevant scientific discipline

• STEM degree with minimum 5 years of experience in a cGMP laboratory, with hands-on experience in Mammalian cells, Cell-based Assays, ELISA and Protein Analysis.

• RFT (Right First Time) in execution. 

• Method validation/qualification cell-based assays, or protein analysis methods.

• Trained in Aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes)

• Ability to prepare reagents, pipette small volumes, work in a Biological Safety Cabinet

• Experience with laboratory equipment calibration and maintenance.

• Ability to work effectively in a fast-paced, cross-functional matrix environment.

• Working knowledge and application of FDA, EU, ICH guidelines, and regulations.

• Experience providing technical training.

• Experience in technical writing.

• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

• At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future

• Location-specific perks and extras

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. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

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. 

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 every day, please apply!

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 [email protected]. 

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.

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