Specialist, Quality Control

Moderna • Norwood, MA

2d • $74,000 - $118,400 • Onsite

About The Position

The Quality Control Specialist supports cGMP QC testing of raw materials, drug substance, and finished products at Moderna’s manufacturing facility and affiliated contract organizations. Based onsite at the Norwood, Massachusetts campus, this individual-contributor role combines hands-on analytical testing and troubleshooting with leadership of method transfers, qualification activities, and quality records. The Specialist trains analysts, collaborates across Manufacturing, Quality Assurance, and Development, and helps strengthen the technical capabilities of a safe, compliant QC Bioassay laboratory.

The role includes testing for analytical method validation and qualification, as well as routine release, stability, and in-process samples. Methods include cell-based potency assays, ELISA, qPCR, sequencing, and protein analysis. The Specialist also leads transfers and qualification activities, serves as a Bioassay subject matter expert, prepares and revises controlled documentation, reviews data, manages quality records, supports audits, and contributes to continuous improvement.

The position is 100% onsite in Norwood, Massachusetts. Moderna is unable to offer immigration sponsorship for this role; candidates must already have U.S. work authorization that they can maintain without future sponsorship. The role may involve access to export-controlled information, and only individuals who qualify as U.S. persons are eligible.

Requirements

• BA/BS degree in a STEM field.
• Minimum of 5 years of experience in a cGMP laboratory.
• Hands-on experience in molecular biology, cell-based assays, and protein analysis.
• Must already hold U.S. work authorization and be able to maintain it without future sponsorship.
• Must qualify as a U.S. person to be eligible for access to export-controlled information.

Nice To Haves

• Method development or qualification experience with molecular biology, cell-based assays, or protein analysis methods.
• Training in aseptic techniques and general laboratory instrumentation, such as pH meters, balances, and pipettes.
• Ability to prepare reagents, pipette small volumes, and 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, and ICH guidelines and regulations.
• Experience providing technical training.
• Experience in technical writing.

Responsibilities

• Execute analytical method validation and qualification testing, along with routine testing of release, stability, and in-process samples.
• Perform QC molecular biology and bioassay methods, including cell-based potency assays, ELISA, qPCR, sequencing, and protein analysis.
• Support bioassay testing for raw materials, drug substance, and drug product.
• Lead method transfers and qualification activities with Development groups to expand QC Bioassay laboratory capabilities.
• Lead special projects as a Bioassay subject matter expert and serve as an interdepartmental liaison to Manufacturing, Quality Assurance, Development, and other groups.
• Teach and train analysts in technical concepts, analytical methods, laboratory procedures, and assay execution.
• Write and revise SOPs, protocols, and reports in compliance with cGMP documentation requirements and applicable regulatory guidelines.
• Troubleshoot analytical methods, equipment, laboratory procedures, and assay performance, and support effective issue resolution.
• Review analytical data and perform assigned data analysis and trending.
• Own and manage quality records, including investigations, change controls, CAPAs, and ECs, ensuring associated activities and documentation meet cGMP requirements.
• Establish and maintain a safe laboratory environment, support audits, and collaborate on continuous improvement initiatives.
• Explore approved Generative AI tools for technical learning, knowledge sharing, and continuous improvement while following data protection, scientific oversight, and cGMP controls.
• Complete mandatory training and assigned tasks, and perform additional duties as assigned.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs.
• Location-specific perks and extras.
• Potential eligibility for an annual discretionary bonus, other incentive compensation, or an equity award, subject to plan eligibility criteria and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior