Jonathan Sayers Email & Phone Number

Huntsville, Al, Us

- Trained and qualified in all aspects of PET production.- Order production and QC equipment for new and existing facilities with the network.- Coordinate initial IQ/OQ services for recently purchased equipment with approved third-party vendors.- Set up supplier and service accounts for new and existing facilities as needed.- Order initial materials needed for process validation campaigns.- Travel to train staff from newly acquired facilities – helping transition to Precision Nuclear ANDA.- Travel to sites to provide assistance with performance qualifications and ensure process validation readiness. - Assist with method transfer validations and protocols.- Assist local staff with the completion of process validations at new facilities.- Participate in corporate SOP reviews and PET Regulatory Submissions.

- PET facility manager for 2 PET production sites in Virginia (Located in Salem and Carilion Roanoke Memorial Hospital)- Helped coordinate the buildout and installation of multiple cyclotrons: PETtrace 890 and an Ionetix ION-12sc.- Coordinated the laboratory buildout, QC equipment installation and qualification for each facility.- Oversee and train PET staff in the production of radiopharmaceuticals.- Operate multiple PET facilities that meets FDA cGMP, NRC or agreement state radiation safety, and other applicable federal, state, and local regulations.- Manage and help coordinate production schedules to meet customer orders.- Trained and qualified in all aspects of PET production, and able to assist with PET production where required.- Hire, train, develop and manage the performance of PET staff.- Oversee inventory management, facility maintenance, equipment maintenance, and calibration.- Work in conjunction with PharmaLogic nuclear pharmacies to meet customer demands.

Salem, Virginia, United States

- Adhere to Current Good Manufacturing Practices (cGMP) and FDA regulations listed in 21 CFR part 212.- Document corrective and preventative action (CAPA) and investigational reports and perform quarterly batch trend analysis to detect trends.- Train new employees and hold meetings for current employees on the implementation of new SOP’s, current investigations, and upcoming schedule of projects, PM’s, and annual stability studies.- Actively participate in site inspections including radiation inspections and FDA inspections, and perform internal audits at Precision Nuclear of Virginia and Tennessee.- Operate Siemens RDS-111 and GE PETtrace cyclotrons, MX Synthesizers, BioScan Synthesizer. Radiopharmaceuticals manufactured include: [F-18] FDG, [F-18] NaF, and [N-13] Ammonia.- Perform quality control analysis of products to determine sterility, apyrogenicity, chemical purity, radiochemical purity and radionuclidic purity.- Perform daily sterility inoculations and compounding of final product vials in a sterile environment.- Maintain batch records, order production materials, and calibration of laboratory equipment including synthesizers.- Assist with all cyclotron maintenance and PM’s.- Rebuild ion source, targets, and foils as needed.

Salem, Virginia, United States

- Prepare and make deliveries to customer accounts on assigned route using a company vehicle.- Package radiopharmaceuticals for shipment, perform testing, and load/unload containers.- Process materials returned from customer locations.- Perform general facility cleaning, cleaning of ISO class clean rooms, and daily environmental monitoring.