27 parallel-processing-bioinformatics positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

participate in the creation, testing, and refining structured prompts using FDA's AI tool to automate routine CGM data cleaning, merging, and processing tasks, assess the impact of these standardized prompts

FDA Fellowship Investigating the Impact of Formulation and Manufacturing Factors on the Injectable Sustained-Release Drug Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

generic product development of opioid product. The research also includes investigating issues that are related to the manufacturing process of in-situ forming extended-release dose form. Learning

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 5 hours ago

clinical trials when bioequivalence and qualitative comparability to the reference product are demonstrated. However, differences in product quality attributes (including sequence variants and process

FDA Fellowship: Evaluation of Novel Endpoints and Innovative Statistical Methodology in Oncology Clinical Trials

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

Prognostic Impact: Standard approaches to handling intercurrent events — such as avoidance of surgery in the perioperative treatment setting, transplant, treatment switching or use of subsequent therapies

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours ago

participate in the creation, testing, and refining structured prompts using FDA's AI tool to automate routine CGM data cleaning, merging, and processing tasks, assess the impact of these standardized prompts

FDA Fellowship - Applications of Artificial Intelligence, Modeling, and Simulation to Pharmaceutical Manufacturing and Product Characterization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 3 months ago

of AI-based methods, mechanistic models, and simulation frameworks relevant to pharmaceutical manufacturing processes and product characterization. Areas of focus may include but are not limited

FDA Immunogenicity Risk Assessment Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 2 months ago

activation response, or indirect, by inducing anti-drug antibodies. Product and process impurities can enhance the risks by triggering innate immune receptors that foster the accumulation and activation

FDA Fellowship - Rapid Sterility Testing Innovation: Evaluating ATP-Bioluminescence Technology for Regulatory Science Applications

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 5 hours ago

. The participant will inoculate relevant biomanufacturing process fluids with bacteria species to determine potential matrix interference and assay limitations. Results from this study will be reported to the cross

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 2 months ago

outcomes and their underlying biological factors in the rat following perinatal exposure. Under the guidance of the mentors, you will engage in many aspects of the research process, including experimental

FDA Research Opportunity - Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 months ago

designs in various patient populations and understand the regulatory implications of dosing recommendations. Understanding of FDA's drug review process, particularly regarding clinical pharmacology