Specialist, Quality Control

ModernaTX • Norwood, MA

18d • 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. This individual-contributor position is based onsite at the Norwood, Massachusetts campus and combines hands-on analytical testing and troubleshooting with leadership of method transfers, qualification activities, and quality records. The Specialist helps strengthen the technical capabilities of a safe, compliant QC Bioassay laboratory while collaborating with Manufacturing, Quality Assurance, Development, and other groups.

The role includes routine and validation or qualification testing using cell-based potency assays, ELISA, protein analysis, and molecular biology methods such as qPCR and sequencing. The Specialist leads transfers and qualification activities, trains analysts, develops and maintains compliant documentation, reviews analytical data, manages quality records, supports audits, and contributes to continuous improvement. The role also encourages appropriate exploration of Generative AI tools for learning and improvement, subject to company approval, data-protection requirements, scientific oversight, and cGMP controls.

Requirements

• BA/BS degree in a STEM field.
• At least 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 immigration sponsorship.
• Must qualify as a U.S. person under export-control requirements: a U.S. citizen, permanent resident, asylee, or refugee.

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, as well as routine release, stability, and in-process sample testing using cell-based potency assays, ELISA, and protein analysis.
• Execute QC molecular biology and bioassay methods, including qPCR, sequencing, and protein analysis, and support testing of raw materials, drug substance, and drug product.
• Lead method transfers and qualification activities with Development groups to expand QC Bioassay laboratory capabilities and establish methods for reliable cGMP testing.
• Lead special projects as a Bioassay subject matter expert, applying 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, including on-the-job training in 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; identify issues and support their 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, CAPAs, and ECs, ensuring associated activities and documentation meet cGMP requirements.
• Establish and maintain a safe laboratory working environment, support audits, and collaborate on continuous improvement initiatives.
• Explore approved and appropriately controlled opportunities to use Generative AI tools for technical learning, knowledge sharing, and continuous improvement.
• 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 and individual performance.

What This Job Offers

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