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Moderna

Develops mRNA-based medicines for health

Associate II - Quality Control, Stability

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

About the Job

Requirements

  • A bachelor's degree in a relevant scientific discipline is required.
  • Two to three years of experience in a GMP quality control laboratory setting focused on stability, preferably in life science or equivalent, is required.
  • Knowledge of current Good Manufacturing Practices and general laboratory safety is required.
  • Pipetting skills are required.
  • Proficiency with Microsoft Office programs is required.
  • Familiarity with electronic databases such as LIMS, SAP, eQMS, or CMMS is required.
  • Strong written and oral communication and organizational skills are required.
  • Applicants must qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) to access export-controlled information.

Responsibilities

  • Perform routine stability program operations, including stability sample pulls, sample aliquoting, sample submissions to testing labs, set-downs, sample verifications, additional sample requests, and shipment preparations for external labs.
  • Create, maintain, and assist with stability scheduling to ensure sample pulls occur as scheduled and within defined timelines.
  • Ensure proper operation and functioning of stability controlled-temperature units and cold rooms within validated temperature ranges and loading patterns.
  • Respond to notifications of out-of-range controlled-temperature units and cold rooms during scheduled working hours and escalate issues to QC Stability management.
  • Ensure proper handling of stability study materials and samples in accordance with applicable procedures and protocols.
  • Manage and stock QC lab supplies and consumables required for stability operations.
  • Ensure compliance with all laboratory safety requirements.
  • Follow relevant GxP regulations, guidelines, and company policies to meet regulatory and internal requirements.
  • Execute tasks according to internal guiding documents, including standard operating procedures and work instructions.
  • Follow Good Documentation Practices and data integrity requirements, ensuring data, documentation, and records are completed and maintained for business use and available to support audits or inspections.
  • Complete training in the assigned learning plan within defined timelines and follow the prescribed requalification cadence.
  • Support and/or participate in audits and regulatory inspections.

Desired Qualifications

  • Experience in a GMP QC laboratory focused on stability in life science or equivalent is preferred.

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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