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 20 days ago
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