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ModernaPosted 1 month ago

Engineer II, Drug Product Development

$74,000–$118,400 year

On-siteNorwood, Massachusetts, United States

Full TimeSenior LevelMasters DegreeLarge

Job Summary

Conduct studies to support scale-up of drug product manufacturing, including freeze/thaw, mixing, filling, filtration, and lyophilization. Develop protocols to evaluate compatibility of drug products with processing materials, container closure components, and sterilization processes. Plan, organize, and execute experiments using design of experiments (DoE) to prepare study protocols and summarize development results with presentations and reports. Collaborate with analytical development and the Pilot organization to execute toxicology, stability, and aseptic fill/finish operations. Perform routine characterization techniques such as opacity testing, microscopy, and particle sizing to ensure long-term stability of vialled drug products. Maintain up-to-date electronic laboratory notebooks (ELN) adhering to good documentation practices. This role supports Moderna's sterile drug product processes and products enabling clinical and commercial supply within a 70/30 in-office work model.

Required Qualifications

  • Masters or Bachelor's Degree in Chemical Engineering, Biochemical or Biomedical Engineering, Pharmaceutical Sciences, or any related or sub-disciplines of the above
  • 0 – 2 years post Master's Degree or at least 2 years post Bachelor's Degree
  • Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment
  • Knowledge of statistical design of experiments (DoE) and analysis
  • Knowledge of nucleic acid chemistry and biology
  • Ability to travel up to 20%
  • U.S. person (citizen, permanent resident, asylee, or refugee)
  • Ability to access export-controlled information in accordance with U.S. law

Desired Qualifications

  • Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
  • Experience with nanoparticle formulation technology
  • Knowledge of GMP compliance

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