Research - Laboratory/Non-Laboratory, Staff/Administrative
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.
About University of Iowa Pharmaceuticals (UIP):
University of Iowa Pharmaceuticals is a Food and Drug Administration-registered pharmaceutical manufacturing facility, providing expertise in contract pharmaceutical development services to clients around the world. This is an exciting time to join UIP, as the business continues to grow in capabilities, new clients and revenue. In 2020 the College of Pharmacy will be moving into a new $96.3 million College of Pharmacy building. The lower level of this new building will be home to the UIP new sterile products manufacturing area which will be approximately 16,000 square feet and will increase UIP batch size capacity approximately 5-fold to 20,000 vials/batch.
Education Requirement * Bachelor's 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 4 years' 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 1 year experience supervising a laboratory.
In order to be considered for an interview, applicants must upload a submission-specific resume and cover letter and mark them as a "Relevant File" to the submission.
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 subject to a criminal background and credential check. 5 professional references will be requested at a later step in the recruitment process.
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.
Internal Number: 21002218_1619617670
About University of Iowa
With over 31,000 students, the University of Iowa is one of the nation's top public research universities, a member of the Big Ten conference and the Association of American Universities. The University of Iowa is composed of eleven colleges and is known around the world for its balanced commitment to the arts, sciences, and humanities. It is home to one of the nation's largest academic medical centers and the pioneering Iowa Writers' Workshop. The University of Iowa promotes work/life integration and is located in the casual yet cosmopolitan environment of Iowa City, widely recognized as one of the country's most livable communities.