Director of Cyclotron Operations

Director of Cyclotron Operations
Job Summary
The primary responsibilities of this position are to manage thedaily operations of the two Cyclotron Radiochemistry Laboratoriesin a safe and compliant manner in support of clinical,pre-clinical, and research activities. This position oversees staffradiochemists, radiopharmacists, and cyclotron engineers in theCenter 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 andquality control of positron emission tomography (PET)radiopharmaceuticals while complying with radiation safetyprocedures, cGMP and NDA/IND requirements. This includes oversightof the operation, maintenance and validation of all manufacturingand analytical equipment as well as the development and training ofall internal operating procedures. Incumbent will experiencemoderate exposure to hazardous materials or physical risk, whichrequires 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 weeklyassigned tasks in production, shifts can start anywhere between 12am to 8 am the morning of production. The typical work week isMonday through Friday and in very rare instances a weekend shiftmay be required.

Responsibilities

Oversight and Management of the daily operations of theCyclotron, Radiochemistry Lab, and Radiopharmacy in accordance with regulatory requirements as well as clinical and researchdemands.

Maintains expert knowledge and compliance with all currentfederal, state, and local regulations pertaining to the productionof radioisotopes, preparation of radiopharmaceuticals, anddistribution of radiopharmaceutical unit doses.

Supervision of CQCIT staff radiochemists, radiopharmacists, andcyclotron engineers including human resource functions.

Direct all activities involved in developing and preparing PETradiopharmaceuticals for clinical and research use.

Assures the cyclotron and associated equipment are maintainedin compliance with protocols and good ALARA radiation safetypractices.

Research new technologies that expand capabilities and improveoperational efficiencies.

Preparation of research proposals, budgets, and contracts.

Oversight of related purchasing, inventory management, andservice agreements for the lab

Manage related laboratory spaces including routine maintenance,renovations, and expansions.

Oversees the quality assurance unit of the lab and monitorsthat standard operating procedures are followed.

Assures personnel receive and maintain proper training forlicensure, GMP requirements, equipment use, radiation safety ALARAprinciples and occupational exposure limits, SOPs, HIPAA, andothers as required.

Identifies and implements opportunities for continuousimprovement in the cyclotron radiochemistry lab and radiopharmacyoperations.

Develops and performs new processes or protocols forvalidation, manufacturing and quality control of radiopharmaceuticals.

Oversees and assists in preparing regulatory documents forsubmission to the FDA and other regulatory agencies.

Assists in all activities of the radiochemistry cyclotron labas needed.

Minimum Qualifications
Bachelor's degree in Business Administration or related area, orequivalency (one year of education can be substituted for two yearsof related work experience); 8-10 years of progressively moreresponsible management experience; and demonstrated leadership,human relations and effective communications skills required. Applicants must demonstrate the potential ability to perform theessential functions of the job as outlined in the positiondescription.

Preferences

Recognized PharmD or a PhD degree in radiochemistry, pharmaceutics, biology, chemistry or other relevant field ofexpertise.

5+ years of experience in cGMP PET radiopharmaceuticalproduction.

Demonstrated experience in development of novelradiopharmaceuticals including validation of non-FDA-approved PETradiopharmaceuticals.

Proven presentation, planning and organization skills.

Previous experience in personnel management.

Must have experience with FDA regulatory writing andsubmissions including CMC sections, DMF, IND, and NDA/ANDA.

Previous experience in radiopharmaceutical research and grantsubmission.

Work Environment and Level of Frequency
Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency
Nearly Continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking. Seldom: Bending, reaching overhead.

Disclaimer
This job description is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

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