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.
About the University of Iowa Pharmaceuticals
UI Pharmaceuticals is a Contract Development and Manufacturing Organization (CDMO) within the College of Pharmacy at the University of Iowa. Our mission is to improve quality of life by applying our pharmaceutical expertise to advance innovative products into clinical trials. Our vision is to be the premier partner for biotech, government, and research institutions.
We are located on the main campus in Iowa City, which offers a great place to live, top rated schools, a vibrant night life, and world class health care facilities. As a University of Iowa employee, you will have access to an excellent benefits package.
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.
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.
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, please contact Libby Kleppe at ...
Education Requirement
- Bachelors Degree in Chemistry, or a science with emphasis in analytical chemistry; or an equivalent combination of education and experience in a similar type of laboratory.
Experience Required
- Typically, a minimum of 5 years of experience performing laboratory techniques including High Performance Liquid Chromatography/Ultra Performance Liquid Chromatography/Liquid Chromatography Mass Spectroscopy (HPLC/UPLC/LCMS).
- Strong understanding of current Good Manufacturing/Laboratory Practices (cGMP/GLP).
- History of following Standard Operating Procedures and other written instructions.
- Extensive use of Windows based computer systems and analytical software packages.
- Superb attention to detail and ability to work simultaneously on different projects.
- Excellent verbal and written communication.
- Solid record utilizing analytical techniques and procedures used in the pharmaceutical industry.
Desirable Qualifications
- PhD in Chemistry or a science with an emphasis in analytical chemistry with typically a minimum of 2 years of applicable industry experience.
- MS in Chemistry or a science with an emphasis in analytical chemistry with typically a minimum of 3 years of applicable industry experience.
- Minimum of 1 year of experience supervising a laboratory.
- Strong understanding or experience in methods development and validation for HPLC, GC or LCMS.
Application and Position Details
- In order to be considered for an interview, applicants must upload the following documents and mark them as a Relevant File to the submission:
- Resume
- Cover Letter
- Job openings are posted for a minimum of 14 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. 5 professional references will be requested at a later step in the recruitment process. For additional questions, please contact Libby Kleppe at ....
Benefits Highlights
- Regular salaried position. Pay level 5A . Located in Iowa City, Iowa.
- Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
- For more information about Why Iowa? Click here .
- Classification Title: Senior Chemist
- Appointment Type: Professional and Scientific
- Schedule: Full-time
- Work Modality Options: On Campus
- Pay Level: 5A
- Starting Salary Minimum: 77,100
- Organization: College of Pharmacy
- Contact Name: Libby Kleppe
- Contact Email: ...