The Role
As a Quality Control Specialist, you will support cGMP QC testing of raw materials, drug substance, and finished products at Moderna’s manufacturing facility and affiliated contract organizations.
Based on-site in Norwood, Massachusetts, this individual contributor role combines hands-on analytical testing and troubleshooting with leadership of method transfers, qualification activities, and quality records.
You will teach and train analysts, collaborate across Manufacturing, Quality Assurance, and Development, and help strengthen the technical capabilities of a safe, compliant QC Bioassay laboratory.
Here’s What You’ll Do
- Execute testing for analytical method validation and qualification, alongside routine testing of release, stability, and in-process samples, using cell-based potency assays, enzyme-linked immunosorbent assays (ELISA), and protein analysis.
- Execute QC molecular biology and bioassay methods, including qPCR, sequencing, and protein analysis, and support bioassay testing for raw materials, drug substance, and drug product.
- Lead method transfers and qualification activities in collaboration with Development groups, helping expand QC Bioassay laboratory capabilities and establish methods that support reliable cGMP testing.
- Lead special projects as a Bioassay subject matter expert (SME), bringing technical expertise to laboratory challenges. Serve as an interdepartmental liaison to Manufacturing, Quality Assurance, Development, and other relevant groups.
- Teach and train analysts on technical concepts and analytical methods, providing on-the-job training that builds understanding of laboratory procedures and assay execution.
- Write and revise standard operating procedures (SOPs), protocols, and reports, ensuring compliance with cGMP documentation requirements and applicable regulatory guidelines.
- Troubleshoot analytical methods, equipment, laboratory procedures, and assay performance, applying technical understanding to identify issues and support effective resolution.
- Review analytical data and perform assigned data analysis and trending to support understanding of assay performance and laboratory results.
- Own and manage quality records, including investigations, change controls, corrective and preventive actions (CAPAs), and ECs, ensuring that associated activities and documentation meet cGMP requirements.
- Establish and maintain a safe laboratory working environment, provide support during audits, and collaborate on continuous improvement initiatives.
- Explore opportunities to build familiarity with Generative AI tools for technical learning, knowledge sharing, and continuous improvement, subject to company approval and appropriate data protection, scientific oversight, and cGMP controls.
- Remain accountable for completing all mandatory training and assigned tasks, and perform additional duties as 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.” Apply this mindset to analytical troubleshooting, method transfers, and qualification activities, translating what you learn into stronger assay execution and effective training for fellow analysts.
- “We behave like owners. The solutions we’re building go beyond any job description.” Take responsibility for quality records, assigned laboratory activities, and cross-functional collaboration, following through on issues and helping improve the safety, compliance, and reliability of QC operations.
Here’s What You’ll Need (Basic Qualifications)
- Education: BA/BS Degree
- Experience: STEM degree with minimum 5 years of experience in a cGMP laboratory, with hands-on experience in molecular biology, Cell based Assays and Protein Analysis.
- Specific Certifications or Training: None
- 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)
- Method development/qualification experience with molecular biology, 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.
Our Working Model
As we build our company, we have always believed that an in-person culture is critical to our success.
This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations.
Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. 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.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
- Competitive healthcare, 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 investments to help you plan for the future
- Location-specific perks and extras
The salary range for this role is $74,000.00 - $118,400.00. 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 individual’s 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.
