Manufacturing Specialist

University of Iowa Health Care

Job Reference #: 21002975

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.

Duties include: 
Compliance:  

•    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.

Manufacturing:  
•    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 be able to work outside of regular work hours occasionally.

Leadership:  
•    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%

Qualifications - External
Education Required:
•    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 Required:
•    Experience 1- 3 years in laboratory techniques.
•    Excellent written and verbal communication skills are required.

Desirable Qualifications:
•    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.

Job Benefits:

Benefits Highlights:
•    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

Job ID: 76777

Posted 9 days ago

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