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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 14 hours ago
) serves as an important resource for identifying inactive ingredients (excipients) present in FDA-approved drug products, supporting both drug development and regulatory processes. This opportunity will
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will involve the dispensing, mixing, granulation, spray-drying, coating, transportation and compaction of API and excipient powders into tablets and other solid oral dosage forms. Other processes such as
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 14 hours ago
evaluation that includes in vitro and in vivo studies to assess the effect of lipid excipient to the physicochemical property of the drug product. In each area, you will be trained and guided by the project
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, protein-excipient interactions, and process-related stress responses. Apply machine learning, AI, laboratory automation, and advanced data science to predictive modeling, workflow acceleration, and decision
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Center for Biologics Evaluation and Research (CBER) | Silver Spring, Maryland | United States | about 14 hours ago
vivo assays for immunological evaluation of GRAS substances and allergenic excipients using animal food allergy models and animal surrogate technologies to assess immunogenicity and safety profiles
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screening workflows to accelerate excipient selection, formulation optimization, and processability assessments. Develop and implement laboratory automation solutions, including robotic liquid handling
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excipient composition and characterised using microscopy and rheological profiling, followed by IVRT and IVPT. The project will intentionally include formulations exceeding current guideline limits
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themes including: How formulation variables (excipients, surfactants, buffers, lipids) drive instability and particle risk Where instability is introduced during manufacturing and scale up (mixing
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and mitigating aggregation and particle formation in biologics, with research themes including: How formulation variables (excipients, surfactants, buffers, lipids) drive instability and particle risk
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properties of active drug substance, excipients and drug product. Develop, validate and implement analytical methods to support product development and advanced manufacturing for range of products including