The University of Iowa Hospitals and Clinics department of Radiology is seeking a Manufacturing Specialist to promote the University's research mission by supporting scientific, scholarly and creative activities through scientific inquiry, open discovery, dissemination of new knowledge, administering programs, procedures and policies to assure compliance and to advance research, technology commercialization, or economic development.
Individuals are responsible for the manufacturing of pharmaceuticals for internal (University) and external (hospitals and clinics, government, private) clients through compliance of FDA cGMP and ICH regulations and guidelines. Industry classifications include pharmaceutical manufacturing professionals and supervisors/managers in this area.
- With oversight, maintain and document compliance with FDA regulations and safety procedures related to manufacturing, labeling, and inspection processes and equipment during their use within a sub-unit.
- Follow regulations and procedures for handling and recording raw materials, including hazardous/regulated chemicals/radioactive materials.
- When requested and with oversight, conduct and evaluate installation, operational, and performance qualification of equipment and instrumentation.
- Assist in updating existing Standard Operating Procedures (SOPs).
- Willingness to work in cGMP environment with radioactive materials and participate in safety programs designed to minimize potential and/or actual exposure levels.
- Conduct and oversee the setup, operation, cleaning and troubleshooting of manufacturing systems with a high degree of proficiency and produce cGMP grade radiopharmaceuticals.
- Conduct Quality Control tests (e.g. TLC, GC, sterility) according to established SOPs on various radiopharmaceutical products.
- Interact with clients as necessary and under supervision to assure their projects are completed in an appropriate manner.
- Produce production run reports.
- Perform release testing according to SOPs on other materials (e.g. raw materials for radiopharmaceutical production).
- Must able to work outside of regular work hours occasionally.
- Assure staff comply with federal and state regulations and SOPs. Participate in cross training to be able to perform functions across sub-unit boundaries.
The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing this job.
University of Iowa Hospitals & Clinics—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives. ®
Percent of Time: 100%
- A Bachelor’s degree in Chemistry, Biology, or a science with emphasis on analytical chemistry or an equivalent combination of education and experience in a similar type of laboratory is required.
- Experience 1- 3 years in laboratory techniques.
- Excellent written and verbal communication skills are required.
- Experience with the production of radiopharmaceuticals using automated synthesis units under cGMP environment is desired.
- At least 1-3 year of experience in analytical or synthetic organic chemistry is desired.
- Chromatographic analysis experience (HPLC, GC, TLC) is desired.
- Computer-controlled instrumentation experience is desired.
- Knowledge of analytical chemistry is desired.
- Knowledge of radiochemistry synthesis and quality control procedures is desired.
- Knowledge of safety procedures for working in a hazardous environment (chemical and radiological) is desired.
- Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification is desired.
- Ability to multitask and coordinate parallel activities in a busy cGMP environment.
- Working in a team environment.
To be considered, applicants must upload a resume and a cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position.
Job openings are posted for a minimum of 14 calendar days. Applications will be accepted until position is filled.
Successful candidates will be subject to a criminal background check.
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- Regular salaried position. 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
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- Classification Title: Product Specialist
- Appointment Type: Professional and Scientific
- Schedule: Full-time
- Pay Level: 8A
- Starting Salary Minimum: $142,000
- Starting Salary Maximum: Commensurate
Equal opportunity/affirmative action employer
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.
Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services,
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