Kindeva Drug Delivery
Analytical R&D Scientist
Kindeva Drug Delivery, Woodbury, Minnesota, United States
Summary of Position
The person hired for the position of Analytical R&D Scientist will conduct trace-level analytical testing of pharmaceutical products and drug device combination products and materials to support current products, new product development projects, and Analytical Services. The Analytical R&D Scientist may use gas chromatography, liquid chromatography, gas chromatography coupled to mass spectrometry, and liquid chromatography coupled to mass Spectrometry. The Analytical R&D Scientist will work with chromatographic systems, electronic laboratory notebooks and laboratory information management systems. The Analytical R&D Scientist may develop methods and conduct method validations.
Job Responsibilities Ensure world-class safety within the laboratory and Kindeva Headquarters Facility Conduct analyses in adherence to SOPs Perform instrumental analyses, using GC, HPLC, and GC/MS instrumentation Use chromatography data acquisition system (Empower) Use LIMS system to document and archive analytical results Use electronic laboratory notebook to document work in compliance with GMP Use critical thinking and problem-solving skills; including graphing of data and basic use and understanding of statistics Be able to multitask and remain flexible to changing project priorities The ability to write test method documents, protocols, and reports is a plus Review and update lab documentation such as SOPs, worksheets, specifications and methods to reflect current processes Perform and support the qualification, calibration, and maintenance of laboratory equipment Work well in both team and individual environments Other duties as assigned Requirements Bachelors degree or higher in a science discipline from an accredited university Basic understanding of GMP/GLP Minimum 2 years analytical testing experience, including gas chromatography and/or liquid chromatography Preferred Bachelors degree or higher in Chemistry from an accredited university Testing experience within the pharmaceutical industry Experience with trace-level analytical instrumentation, methods, and testing Familiar with Empower or similar chromatography data acquisition system Familiar with LIMS systems Prior use of laboratory notebook to document work in GMP-compliant manner Demonstrated technical writing and data analysis skills
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Job Responsibilities Ensure world-class safety within the laboratory and Kindeva Headquarters Facility Conduct analyses in adherence to SOPs Perform instrumental analyses, using GC, HPLC, and GC/MS instrumentation Use chromatography data acquisition system (Empower) Use LIMS system to document and archive analytical results Use electronic laboratory notebook to document work in compliance with GMP Use critical thinking and problem-solving skills; including graphing of data and basic use and understanding of statistics Be able to multitask and remain flexible to changing project priorities The ability to write test method documents, protocols, and reports is a plus Review and update lab documentation such as SOPs, worksheets, specifications and methods to reflect current processes Perform and support the qualification, calibration, and maintenance of laboratory equipment Work well in both team and individual environments Other duties as assigned Requirements Bachelors degree or higher in a science discipline from an accredited university Basic understanding of GMP/GLP Minimum 2 years analytical testing experience, including gas chromatography and/or liquid chromatography Preferred Bachelors degree or higher in Chemistry from an accredited university Testing experience within the pharmaceutical industry Experience with trace-level analytical instrumentation, methods, and testing Familiar with Empower or similar chromatography data acquisition system Familiar with LIMS systems Prior use of laboratory notebook to document work in GMP-compliant manner Demonstrated technical writing and data analysis skills
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