Associate I, 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.

As a 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.

Here’s What You’ll Do

Your key responsibilities will be:

• 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.

Your responsibilities will also include:

• 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.

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 Senior QC Analyst, 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 (Biochemistry)

• Experience: 0-2 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