Specialist, Quality Control

ModernaTX • Norwood, MA

2d • $74,000 - $118,400 • Onsite

About The Position

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. This role supports in-process and release testing for raw materials, drug substance, and mRNA drug products manufactured at Moderna’s 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. You’ll play a key role in maintaining compliance, advancing testing capabilities, and driving continuous improvement. While this is a sole contributor position, you’ll 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 technologies—and to contribute to the future of biotech with direct proximity to GenAI-powered digital tools that are shaping how QC labs evolve. Here’s What You’ll Do Your key responsibilities will be:

Requirements

• 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 guidance’s.
• 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.

Nice To Haves

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

Responsibilities

• 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
• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees