Specialist, 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.

The Quality Control Specialist will support cGMP QC routine testing for raw materials, drug substances, and finished products at the company's manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, leading method transfers, qualification activities, quality records (e.g. Change Controls, CAPAs, ECs, Investigations), and ensuring compliance with cGMP standards. The individual will teach and train analysts on technical concepts and methods and act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance and Development.

This is an on‑site position.

• Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities.
• Support bioassay routine testing for raw materials, drug substance and drug product.
• Lead special projects as Bioassay SME.
• Perform on the job training.
• Write/revise SOPs, protocols, and reports.
• Troubleshoot issues related to equipment, laboratory procedures and assay performance.
• Establish and maintain a safe laboratory working environment.
• Analyze and trend data as assigned.
• Review Data.
• Own and manage Quality records (i.e. investigations, change controls, CAPAs).
• Ensure compliance with cGMP documentation and regulatory guidelines.
• Accountable for all mandatory training and assigned tasks.
• Provide support during audits and collaborate on continuous improvement initiatives.
• Establish and maintain a safe laboratory working environment.
• Additional duties may be assigned.

• “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 Specialist, 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.

• Education:
  
  BS in a relevant scientific discipline.
• STEM degree with minimum 5 years of experience in a cGMP laboratory, with hands‑on experience in Mammalian cells, Cell‑based Assays, ELISA and Protein Analysis.
• RFT (Right First Time) in execution.
• Method validation/qualification of 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.
• 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…