Associate I, Quality Control

Moderna • Norwood, MA

2d • Onsite

About The Position

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. As a Senior QC Analyst within the Bioassay team at Moderna’s Norwood site, you will play a critical role in ensuring the quality of raw materials, drug substance, and mRNA drug products through robust in-process and release testing. You’ll collaborate closely with management and technical teams to uphold high-quality standards in compliance with cGMP, contribute to laboratory operations and method implementation, and support both commercial and clinical programs. This is a high-impact opportunity for a technically skilled professional seeking to strengthen Moderna’s QC operations while working at the forefront of mRNA science. You will also have the opportunity to work closely with Generative AI tools as part of ongoing digital transformation and innovation initiatives within the QC organization.

Requirements

• Education: BS in a relevant scientific discipline (Biochemistry)
• Experience: 2+ 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

• Performing in-process and release testing for raw materials, drug substance, and mRNA drug products in compliance with cGMP requirements.
• Generating critical testing data in support of both commercially approved products and clinical studies.
• Collaborating with development teams for method transfers and qualification, expanding QC Bioassay lab capabilities including sequencing and qPCR.
• Supporting the development, implementation, and maintenance of lab operational systems.
• Leading or contributing to the execution of continuous improvement projects across the QC Bioassay function.
• Participating in audit preparation and ensuring regulatory compliance for the lab.
• Investigating and resolving technical issues, assay performance concerns, and equipment-related challenges.
• Conducting deviation investigations and supporting technical assessments.
• Assisting in equipment qualification, validation, and maintenance activities.
• Representing the QC Bioassay team in the absence of management and participating in Tier meetings and resource scheduling.
• Providing on-the-job training (OJT) and acting as a mentor for junior analysts.
• Writing and revising SOPs, protocols, and technical reports with adherence to Good Documentation Practices (GDP).
• Ensuring data integrity, training compliance, and execution of tasks according to SOPs and internal guidelines.
• Responding to CTU alarms and contributing to a safe, inclusive, and collaborative laboratory culture.

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