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Director of Cyclotron Operations

Director of Cyclotron Operations

Utah StaffingSalt Lake City, UT, US
9 hours ago
Job type
  • Full-time
Job description

Director Of Cyclotron Operations

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 that will be directed and overseen 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.

Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve which includes Idaho, Montana, Nevada, Utah, and Wyoming with impact worldwide. In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities.

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.

Work Environment and Level of Frequency Typically Required :

  • Nearly Continuously : Office environment.
  • Physical Requirements and Level of Frequency That May Be Required :
  • Nearly Continuously : Sitting, hearing, listening, talking.
  • Often : Repetitive hand motion (such as typing), walking.
  • Seldom : Bending, reaching overhead.
  • Minimum Qualifications :

  • Bachelors degree in Business Administration or related area, or equivalency (one year of education can be substituted for one year 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.
  • Type : Benefited Staff

    Special Instructions Summary :

    Additional Information :

    The University is a participating employer with Utah Retirement Systems ("URS"). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS' post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules. This position may require the successful completion of a criminal background check and / or drug screen.

    The University of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients. All qualified individuals are strongly encouraged to apply. Veterans' preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. The University of Utah is an Affirmative Action / Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran's status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both. To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director / Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action (OEO / AA). More information, including the Director / Title IX Coordinator's office address, electronic mail address, and telephone number can be located at : https : / / www.utah.edu / nondiscrimination / Online reports may be submitted at oeo.utah.edu https : / / safety.utah.edu / safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.

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