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Moderna

Develops mRNA-based medicines for health

QC Chemistry Specialist - Quality Control

Regulatory & Quality (Life Sciences)Posted on Nov 13
Full-timeMarlborough, MA, USA

About the Job

Requirements

  • A BA or BS in a relevant scientific discipline and 2–5 years of Quality Control experience in a cGMP organization, or an MS in a relevant scientific discipline and 0–3 years of Quality Control experience in a cGMP organization.
  • Ability to independently prioritize, manage, and complete multiple projects and tasks in a fast-paced environment.
  • Detailed knowledge of a LIMS system and the Veeva quality document system.
  • Working knowledge of relevant and current FDA, EU, and ICH guidelines and regulations.
  • Experience with gowning, aseptic technique, and general laboratory safety practices.
  • Availability for a flexible schedule that supports periodic on-call, weekend, or holiday coverage.
  • Strong people-management skills.
  • Candidates must already hold U.S. work authorization and be able to maintain that status without future sponsorship; only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible.

Responsibilities

  • Provide technical and functional leadership to associates supporting QC Chemistry and Development laboratories while working as an individual contributor, not a direct people manager.
  • Oversee laboratory and sample-management schedules for safe, timely sample processing, Chemistry testing, data review, and associated quality records.
  • Apply knowledge of HPLC testing and chromatogram analysis to support Chemistry operations, data interpretation, troubleshooting, and compliant laboratory execution.
  • Perform hands-on laboratory work and serve as a subject matter expert for cGMP sample coordination and testing activities.
  • Coordinate cGMP samples and testing across internal teams and external laboratories, ensuring communication, traceability, compliance, and execution.
  • Author and revise SOPs, protocols, and other controlled documentation for QC Chemistry and Sample Management operations.
  • Author, investigate, and support quality-system records, including deviations, CAPAs, and change controls, and drive issues toward resolution.
  • Partner with the Digital team to expand and optimize LabVantage LIMS, strengthening laboratory workflows, data integrity, traceability, and operational efficiency.
  • Explore appropriate uses of Generative AI-enabled tools with Digital partners to improve knowledge access, laboratory workflows, documentation, data review, and operational decision-making within regulated processes.
  • Collaborate with Quality Control teams to improve the quality, compliance, efficiency, and scalability of QC operations.
  • Provide subject matter expertise and operational support during internal and external audits to keep laboratory activities, records, systems, and processes inspection-ready.
  • Manage controlled temperature units, including oversight, maintenance coordination, monitoring, and troubleshooting for reliable sample and material storage.
  • Lead technical troubleshooting and guide and support the Sample Management team when laboratory, operational, or compliance issues arise.
  • Establish and maintain a safe laboratory environment by reinforcing safe laboratory practices and appropriate execution of regulated activities.
  • Support review of analytical and laboratory data and generation of Certificates of Analysis, ensuring accurate, complete, compliant records.
  • Work cross-functionally with QC, Development, Digital, Quality, and internal and external laboratory partners to enable effective Chemistry operations and timely testing.

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

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