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Moderna

Develops mRNA-based medicines for health

Principal Research Associate - Analytical Development

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

About the Job

Requirements

  • A master's degree in Microbiology, Biology, Molecular Biology, Biochemistry, Biotechnology, or a related field with at least 4 years of relevant experience; or a bachelor's degree with at least 6 years of relevant industry experience.
  • Hands-on experience with microbiological methods and analytical method development, qualification, validation, or troubleshooting is required.

Responsibilities

  • Execute microbiological method development, optimization, characterization, qualification, and validation studies for bioburden, endotoxin, sterility, environmental monitoring, and related microbiological methods.
  • Independently plan and execute defined experimental studies; analyze and interpret data, identify sources of variability, troubleshoot technical issues, and recommend experimental next steps.
  • Evaluate method performance and suitability for intended use across relevant materials and sample types to support development, qualification, validation, and method lifecycle activities.
  • Author and execute study protocols and methods and contribute to technical reports, development summaries, validation documentation, and other analytical documentation.
  • Perform microbiological testing as part of method development, qualification and validation studies, investigations, troubleshooting, and other non-routine technical assessments.
  • Support microbiological investigations, deviations, method troubleshooting, and root-cause assessments in partnership with Analytical Development, Analytical Science and Technology, Quality Control, Quality, Process Development, and other cross-functional teams.
  • Provide microbiology technical support for development programs, including technical assessments, risk evaluations, regulatory questions, and preparation of supporting data and documentation.
  • Support method transfer and implementation in internal and external Quality Control laboratories and provide technical support during method lifecycle activities.
  • Contribute to the evaluation and implementation of alternative or rapid microbiological methods, new technologies, and automation approaches that improve method performance, efficiency, or turnaround time.
  • Communicate experimental results, conclusions, risks, and recommendations to technical and cross-functional stakeholders while maintaining high standards for laboratory safety, data integrity, and documentation.

Desired Qualifications

  • Hands-on experience with microbiological methods including bioburden, bacterial endotoxin, and sterility; environmental monitoring experience is desirable.
  • Experience developing, optimizing, characterizing, qualifying, or validating microbiological methods in a biotechnology or pharmaceutical environment.
  • Understanding of microbiological method performance, suitability, controls, interference, recovery, variability, and fitness for intended use.
  • Experience troubleshooting microbiological methods and supporting laboratory investigations, deviations, and root-cause assessments.
  • Familiarity with United States Pharmacopeia and other applicable compendial and regulatory expectations for microbiological methods.
  • Experience supporting method transfer and implementation in Quality Control or external testing laboratories.
  • Experience with rapid or alternative microbiological methods, microbial identification, or related technologies is desirable.
  • Experience with mRNA, lipid nanoparticles, vaccines, biologics, or other advanced therapeutic modalities is preferred.
  • Data analysis, problem-solving, written and verbal communication skills, and the ability to clearly document and communicate experimental results.
  • Ability to manage multiple laboratory priorities while maintaining scientific rigor, data integrity, and high-quality documentation.

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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