University of Utah
Director of Cyclotron Operations
University of Utah, Salt Lake City, Utah, United States, 84193
Overview
Job Summary: The primary responsibilities of this position are to manage the daily operations of the two Cyclotron Radiochemistry Laboratories in a safe and compliant manner in support of clinical, pre-clinical, and research activities. This position oversees staff radiochemists, radiopharmacists, and cyclotron engineers in the Center for Quantitative Cancer Imaging and Theranostics (CQCIT) and reports directly to the Director of CQCIT. The specific functions include the manufacturing and quality control of positron emission tomography (PET) radiopharmaceuticals while complying with radiation safety procedures, cGMP and NDA/IND requirements. This includes oversight of the operation, maintenance and validation of all manufacturing and analytical equipment as well as the development and training of all internal operating procedures. Incumbent will experience moderate exposure to hazardous materials or physical risk, which requires adhering to radiation safety practices. This is a full-time position involving a variable schedule based on production demands that can change over time. Depending on weekly assigned tasks in production, shifts can start anywhere between 12 am to 8 am the morning of production. The typical work week is Monday through Friday and in very rare instances a weekend shift may be required.
Responsibilities
Oversight and Management of the daily operations of the Cyclotron, Radiochemistry Lab, and Radiopharmacy in accordance with regulatory requirements as well as clinical and research demands.
Maintains expert knowledge and compliance with all current federal, state, and local regulations pertaining to the production of radioisotopes, preparation of radiopharmaceuticals, and distribution of radiopharmaceutical unit doses.
Supervision of CQCIT staff radiochemists, radiopharmacists, and cyclotron engineers including human resource functions.
Direct all activities involved in developing and preparing PET radiopharmaceuticals for clinical and research use.
Assures the cyclotron and associated equipment are maintained in compliance with protocols and good ALARA radiation safety practices.
Research new technologies that expand capabilities and improve operational efficiencies.
Preparation of research proposals, budgets, and contracts.
Oversight of related purchasing, inventory management, and service agreements for the lab
Manage related laboratory spaces including routine maintenance, renovations, and expansions.
Oversees the quality assurance unit of the lab and monitors that standard operating procedures are followed.
Assures personnel receive and maintain proper training for licensure, GMP requirements, equipment use, radiation safety ALARA principles and occupational exposure limits, SOPs, HIPAA, and others as required.
Identifies and implements opportunities for continuous improvement in the cyclotron radiochemistry lab and radiopharmacy operations.
Develops and performs new processes or protocols for validation, manufacturing and quality control of radiopharmaceuticals.
Oversees and assists in preparing regulatory documents for submission to the FDA and other regulatory agencies.
Assists in all activities of the radiochemistry cyclotron lab as needed.
Qualifications
Bachelor's degree in Business Administration or related area, or equivalency (one year of education can be substituted for two years of related work experience); 8-10 years of progressively more responsible management experience; and demonstrated leadership, human relations and effective communications skills required.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Preferences
Recognized PharmD or a PhD degree in radiochemistry, pharmaceutics, biology, chemistry or other relevant field of expertise.
5+ years of experience in cGMP PET radiopharmaceutical production.
Demonstrated experience in development of novel radiopharmaceuticals including validation of non-FDA-approved PET radiopharmaceuticals.
Proven presentation, planning and organization skills.
Previous experience in personnel management.
Must have experience with FDA regulatory writing and submissions including CMC sections, DMF, IND, and NDA/ANDA.
Previous experience in radiopharmaceutical research and grant submission.
#J-18808-Ljbffr
Responsibilities
Oversight and Management of the daily operations of the Cyclotron, Radiochemistry Lab, and Radiopharmacy in accordance with regulatory requirements as well as clinical and research demands.
Maintains expert knowledge and compliance with all current federal, state, and local regulations pertaining to the production of radioisotopes, preparation of radiopharmaceuticals, and distribution of radiopharmaceutical unit doses.
Supervision of CQCIT staff radiochemists, radiopharmacists, and cyclotron engineers including human resource functions.
Direct all activities involved in developing and preparing PET radiopharmaceuticals for clinical and research use.
Assures the cyclotron and associated equipment are maintained in compliance with protocols and good ALARA radiation safety practices.
Research new technologies that expand capabilities and improve operational efficiencies.
Preparation of research proposals, budgets, and contracts.
Oversight of related purchasing, inventory management, and service agreements for the lab
Manage related laboratory spaces including routine maintenance, renovations, and expansions.
Oversees the quality assurance unit of the lab and monitors that standard operating procedures are followed.
Assures personnel receive and maintain proper training for licensure, GMP requirements, equipment use, radiation safety ALARA principles and occupational exposure limits, SOPs, HIPAA, and others as required.
Identifies and implements opportunities for continuous improvement in the cyclotron radiochemistry lab and radiopharmacy operations.
Develops and performs new processes or protocols for validation, manufacturing and quality control of radiopharmaceuticals.
Oversees and assists in preparing regulatory documents for submission to the FDA and other regulatory agencies.
Assists in all activities of the radiochemistry cyclotron lab as needed.
Qualifications
Bachelor's degree in Business Administration or related area, or equivalency (one year of education can be substituted for two years of related work experience); 8-10 years of progressively more responsible management experience; and demonstrated leadership, human relations and effective communications skills required.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Preferences
Recognized PharmD or a PhD degree in radiochemistry, pharmaceutics, biology, chemistry or other relevant field of expertise.
5+ years of experience in cGMP PET radiopharmaceutical production.
Demonstrated experience in development of novel radiopharmaceuticals including validation of non-FDA-approved PET radiopharmaceuticals.
Proven presentation, planning and organization skills.
Previous experience in personnel management.
Must have experience with FDA regulatory writing and submissions including CMC sections, DMF, IND, and NDA/ANDA.
Previous experience in radiopharmaceutical research and grant submission.
#J-18808-Ljbffr