M

Moderna

Develops mRNA-based medicines for health

Quality Control Specialist - Quality Control

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeNorwood, MA, USA

About the Job

Requirements

  • A STEM degree and at least 5 years of experience in a cGMP laboratory, including hands-on experience in molecular biology, cell-based assays, and protein analysis.
  • Candidates must already hold U.S. work authorization and be able to maintain that status without future sponsorship.
  • Candidates must qualify as U.S. persons under applicable export-control requirements.
  • Experience with method development or qualification involving molecular biology, cell-based assays, or protein analysis methods is preferred.
  • Training in aseptic techniques and general laboratory instrumentation, such as pH meters, balances, and pipettes, is preferred.
  • Ability to prepare reagents, pipette small volumes, and work in a Biological Safety Cabinet is preferred.
  • Experience with laboratory equipment calibration and maintenance is preferred.
  • Working knowledge and application of FDA, EU, and ICH guidelines and regulations is preferred.
  • Experience providing technical training is preferred.
  • Experience in technical writing is preferred.

Responsibilities

  • Execute analytical method validation and qualification testing, as well as routine release, stability, and in-process sample testing using cell-based potency assays, enzyme-linked immunosorbent assays, 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 to expand QC Bioassay laboratory capabilities and establish methods supporting reliable cGMP testing.
  • Lead special projects as a Bioassay subject matter expert and 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 on laboratory procedures and assay execution.
  • Write and revise standard operating procedures, 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 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, and ECs, ensuring related activities and documentation meet cGMP requirements.
  • Establish and maintain a safe laboratory working environment, support audits, and collaborate on continuous improvement initiatives.
  • Explore approved opportunities to use Generative AI tools for technical learning, knowledge sharing, and continuous improvement, subject to data protection, scientific oversight, and cGMP controls.
  • Complete all mandatory training and assigned tasks, and perform additional duties as assigned.

Desired Qualifications

  • 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.
  • Working knowledge and application of FDA, EU, and ICH guidelines and regulations.
  • Experience providing technical training.
  • Experience in technical writing.

About the Company

Moderna

Develops mRNA-based medicines for health

Moderna develops medicines built on messenger RNA (mRNA). Its products use mRNA delivered into cells to instruct them to produce specific proteins that can prevent or treat disease, with vaccines being a primary example. In practice, a dose delivers engineered mRNA into the body, cells translate it into a target protein, and the immune system responds or the protein modulates biology to combat disease. Moderna differentiates itself through its focus on building a whole mRNA medicines platform and in-house capabilities for designing, manufacturing, and scaling mRNA therapies, including rapid development and large-scale production. Its goal is to create a new category of medicines based on mRNA that can improve how diseases are discovered, developed, and treated, ultimately improving patient outcomes.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2010

Recently Posted Jobs

Explore more opportunities at Moderna

See more jobs