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MSAT Scientist II, Upstream

Thermo Fisher Scientific

Manufacturing Sciences Scientist II supporting viral vector production at Thermo Fisher Scientific's Plainville facility. The role focuses on upstream process technology transfer, scale-up, and optimization for late-stage clinical and commercial gene therapy manufacturing.

Responsibilities

  • Lead technology transfer activities for upstream cGMP viral vector manufacturing across sites and clients
  • Author and maintain process descriptions, control strategies, risk assessments, and PPQ protocols throughout program lifecycle
  • Serve as subject matter expert for upstream processing, collaborating with cross-functional teams on technical challenges
  • Monitor process performance, investigate deviations, and implement corrective actions for commercial manufacturing batches
  • Develop sampling and testing strategies with quality and bioprocess teams for raw materials and intermediates

Requirements

  • Advanced degree in chemistry, biochemistry, chemical engineering, biotechnology, or molecular biology
  • Alternatively, bachelor's degree plus 2 years GMP manufacturing or process development experience
  • Technical expertise in upstream biopharmaceutical manufacturing and process development
  • Experience with adherent mammalian cell culture, preferably HEK cells
  • Knowledge of stirred-tank and single-use bioreactor systems
  • Familiarity with GMP regulations and regulatory documentation requirements
Vacancy posted a month ago
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