Associate Lead Scientist (Multiple Positions)

Support internal methods and experiments. Develop and review protocols and sample analysis plans. Review data with the method development team to ensure methods are ready for validation. Approve validation methods and review sample analysis methods. Review and approve raw data. Evaluate data and tables to ensure regulatory guidelines and expectations are met. Review reports for scientific accuracy and completeness. Provide technical support. Assist with troubleshooting and solving assay problems. Work with the client to determine project requirements. Assist with scientific directives for the study team. Identify scientific issues or scope changes within the study. Support the regulatory, scientific and technical aspects for the measurement of drugs, drug metabolites and endogenous compounds (e.g., biomarkers, hormones, steroids) in biological matrices such as plasma, serum, blood, urine, tissues (e.g., liver, lung, brain, etc.) and cerebral spinal fluid using liquid chromatography tandem mass spectrometry instrumentation (LCMS). Perform experiments to determine how to measure the drug in the biological matrix. Communicate with the client providing periodic study updates and generate and review study plans/protocols, data tables and study reports. Direct scientific work to support internal methods and experiments for drug development. Serve as a Responsible Scientist for GLP regulated studies or as principal investigator for Non- regulated studies.

Qualifications:

Bachelor's degree in Biology, Biotechnology or related field of study and two years of work experience in the job offered or related occupation.

Position also requires demonstrated experience with the following: Word processing, database, spreadsheet, and specialized software; Laboratory information management system (LIMS) software (Watson LIMS); Laboratory instrumentation software (Sciex Analyst); Interpretation and application of guidelines (SOPs, Methods, Regulatory standards/guidelines); Reviewing analytical data for scientific accuracy and completeness; Handling chemicals, biological materials and hazardous substances in a safe and compliant manner; Interpreting and writing technical and scientific reports, articles or communications; and Wet laboratory skills such using microbalances, pipettes, volumetric flasks, graduated cylinders or pH meters.

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