- ThermoFisher Scientific (Gaithersburg, MD)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Senior Bioanalytical Study Manager** Thermo Fisher's clinical research business is ... and lead the charge in supporting our client's pipeline from a bioanalytical perspective. You'll manage bioanalytical operations for pre-clinical studies and… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …development. You will interact with non-clinical, translational medicine, and biomarker/ bioanalytical team members for design and execution of first-in-human, proof ... ADME, clinical, regulatory, and CMC. Work with formulation, biomarker and bioanalytical team members on activities related to formulation, development, assay… more
- Alaka'ina Foundation Family of Companies (Frederick, MD)
- …knowledge of FDA Animal Rule. + Working knowledge of the Bioanalytical Method Validation Guidance for Industry. + Experience drafting/editing/reviewing laboratory ... draw conclusions from data and write final reports. + Experience optimizing bioanalytical parameters for Investigational New Drug studies in a GLP environment. +… more
- …knowledge of FDA Animal Rule. + Working knowledge of the Bioanalytical Method Validation Guidance for Industry. + Experience drafting/editing/reviewing laboratory ... draw conclusions from data and write final reports. + Experience optimizing bioanalytical parameters for Investigational New Drug studies in a GLP environment. +… more
- Guidehouse (Silver Spring, MD)
- …provide value added support to the regulatory teams. + Supervise guide bioanalytical and pharmacokinetic scientist in Applied Regulatory Science division + Support ... the acquisition of a Laboratory Information System (LIMS) and ensure the inclusion of quality assurance aspects and division workflows. **What You Will Need** **:** + Master's degree in biology, pharmaceutical sciences or related discipline + Extensive… more
- Parsons Corporation (Frederick, MD)
- …in-process testing and characterization of biopharmaceutical products. + Perform bioanalytical data acquisition, analysis, and reporting using Applied Biosystems ... Analyst, Excel, and Mass Spec Quantitation Software MultiQuant. + Complete approximately 25 media/reagent preparations per year. + Assist with approximately 5 animal challenges and 10 bacterial challenge preparations per year. + Perform approximately 400… more
- Alaka'ina Foundation Family of Companies (Frederick, MD)
- …testing and characterization of biopharmaceutical products and impurities. + Perform bioanalytical data acquisition, data analysis, and reporting of results using ... Applied Biosystems Analyst, Excel, and the Mass Spec Quantitation Software MultiQuant. + Complete approximately 25 media/reagent preparations per year. + Assist with approximately 5 animal challenges per year and 10 bacterial challenge preparations. + Perform… more