Specialist, Quality Control

ModernaTX

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profile Job Location:

Norwood, OH - USA

profile Monthly Salary: $ 74000 - 118400
Posted on: 10 hours ago
Vacancies: 1 Vacancy

Job Summary

The Role

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

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

Modernas 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.

This role supports in-process and release testing for raw materials drug substance and mRNA drug products manufactured at Modernas Norwood site and affiliated contract organizations. As a member of the QC Bioassay Lab you will also be instrumental in ensuring that both short-term operational goals and long-term lab milestones are achieved. Youll play a key role in maintaining compliance advancing testing capabilities and driving continuous improvement. While this is a sole contributor position youll collaborate broadly mentor team members and even step in to represent management when needed.

You will work hands-on with sequencing and qPCR methods support both commercial and clinical product testing and help operationalize new laboratory systems. This role offers a unique opportunity to be exposed to cutting-edge manufacturing and QC technologiesand to contribute to the future of biotech with direct proximity to GenAI-powered digital tools that are shaping how QC labs evolve.

Heres What Youll Do

Your key responsibilities will be:

  • Execute in-process and release testing for raw materials drug substances and drug products in compliance with cGMP standards

  • Generate high-quality testing data for clinical studies and approved commercial products

  • Conduct technical assessments manage deviations and lead investigations impacting lab operations

  • Support method transfers and method qualifications in collaboration with development teams

  • Train colleagues through on-the-job (OJT) programs and act as a mentor to QC Bioassay staff

  • Represent the QC Bioassay team in the absence of management

  • Partner with QC leadership to ensure laboratory milestones and performance targets are met

  • Lead or organize continuous improvement initiatives and cross-functional projects

  • Troubleshoot assay performance lab procedures and equipment-related issues

Your responsibilities will also include:

  • Assist in scheduling Tier meeting contributions and QC resource coordination

  • Maintain and qualify laboratory equipment in line with validation standards

  • Write revise and maintain SOPs technical protocols and reports

  • Support audit preparation activities and regulatory compliance processes

  • Address CTU (Critical Temperature Unit) alarms and maintain system responsiveness

  • Follow all relevant GxP regulations SOPs and work instructions meticulously

  • Ensure adherence to Good Documentation Practices (GDP) and data integrity standards

  • Complete training and requalification assignments per defined due dates

The key Moderna Mindsets youll need to succeed in the role:

  • We obsess over learning. We dont have to be the smartestwe have to learn the fastest.
    Youll be working in a dynamic quality environment where continual adaptation new testing methods and tech-driven optimization are the norm. A growth mindset is essential to keep up with evolving expectations and support innovation in QC practices.

  • We behave like owners. The solutions were building go beyond any job description.
    This role will thrive with someone who takes full accountabilitynot only for their assigned assays and documentation but also for mentoring peers troubleshooting proactively and helping drive continuous improvements that elevate the labs overall performance.

Heres What Youll Need (Basic Qualifications)

  • Education: BS in a relevant scientific discipline (Biochemistry)

  • Experience: 5 years of experience

  • Demonstrated aptitude or ability to learn: Able gain a strong understanding of GxP regulations (specify GMP GLP GCP GVP or other applicable standards and guidances.

  • This position is site-based requiring you to be at Modernas 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.

Heres What Youll 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. Thats why our US benefits and global well-being resources are designed to support youat 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 salary range for this role is $74000.00 - $118400.00. 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 individuals 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.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit 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 persons 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 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

Were 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 .

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 applicants 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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Required Experience:

IC

The RoleJoining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.As an employee youll be part of a continually growing organization working alongside ex...
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Key Skills

  • Academics
  • Ale
  • Asset Management
  • Instrument Maintenance
  • Database Administration
  • Data Analysis

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