Senior Chemist (UI Pharmaceuticals)

The Senior Chemist will be expected to work independently to develop and validate complex analytical methods for investigational pharmaceutical drug products as well as help Assistant and Associate Chemists troubleshoot analytical issues with established methods as well as methods undergoing validation. The Senior Chemist will also supervise Assistant and Associate Chemists within the laboratory. This supervision will include scheduling and distributing workload across the analysts. All work must be performed under the current Good Manufacturing Practices (cGMP) guidelines and regulations.

Key Areas of Responsibility:

Compliance

•   Legibly document all procedures and results in laboratory notebooks according to established regulatory guidelines. 

•   Ensure that the instruments involved in various assays are routinely checked, maintained, and calibrated.

Analysis and Development

•   Perform complex method development using only general guidelines and validation for new projects according to standard operating procedures. Conduct forced degradation studies, including peak purity analysis, using photodiode array detection to determine if new High Performance Liquid Chromatography (HPLC) methods are stability indicating. 

•   Conduct complex quantitative or qualitative HPLC analysis using Ultraviolet (UV), photodiode array, charged aerosol detectors and refractive index detectors.

•   Investigate, suggest, validate, and implement new procedures/techniques. 

•   Perform complex High Performance Liquid Chromatography/Gas Chromatography (HPLC/GC) analyses according to set procedures and methods in the stability testing of various drugs or drug products.

•   Complete all necessary calculations utilizing instrument specific and/or spreadsheet and database application software.

Technical Document Origination   

•   May perform installation of equipment.

Leadership

•   May supervise the operational activities of the analytical group to ensure cGMP compliance, standard operating procedure compliance, and to address lab safety issues.

•   Provide immediate feedback to analysts who are having instrument or assay difficulties. Help design experiments and plans of action to solve instrument/assay problems. Answer questions concerning instrument operation and computer software and assist in solving method-instrument problems.

•   Serve as a resource for chemical safety/risk management policies and procedures. 

•   May participate in the weekly scheduling of projects/assays for the Analytical Group. Help assign instruments and projects to analysts.

•   Train analysts in new methods and procedures.

Human Resources

•   Conduct annual performance reviews for group members, identify opportunities for development, lead discussions related to performance issues, and provide coaching to group members to improve and support performance.

•   Interview and recommend the employment of staff and recommend other personnel actions.

•   Establish and maintain standards for interpersonal interactions.

 

For a complete job description including all Key Areas of Responsibility and Universal and Technical Competencies, please send an email to Jade-O-Rogers@uiowa.edu.