Radiopharmaceutical Production Operator II

Telix Pharmaceuticals (AMER)•Pennsylvania, PA

5d•Onsite

About The Position

The Radiopharmaceutical Production Operator II performs routine radiochemical synthesis, purification, compounding, dispensing, and quality control functions supporting PET biomarker production at a cyclotron facility. The role includes setting up, operating, checking, and performing preventive maintenance on manufacturing equipment such as cyclotrons and automated chemistry modules. This non-exempt position performs and documents quality control testing and helps ensure manufacturing and QC activities comply with cGMP, radiation safety, and applicable State and Federal requirements. The position is on-site five days a week at the Wilkes-Barre, Pennsylvania location. The operator works in a cGMP radiopharmaceutical production facility with a cyclotron, hot cells, automated chemistry modules, and quality control laboratory instrumentation. Routine handling of radioactive materials is required, along with radiation safety qualification, training, dosimetry, and participation in exposure monitoring. PPE and cleanroom gowning are required in applicable areas. Because production schedules are driven by PET radioisotope half-lives, the role requires early morning, overnight, weekend, and holiday shifts, on-call coverage, and overtime as needed. Overtime must be approved in advance under company policy. The work may involve chemical reagents, compressed gases, cryogenic materials, and high-voltage equipment. Physical demands include prolonged standing, repetitive manual manipulation of small components behind shielding, and lifting or moving materials and shielded containers, with mechanical assistance where available. Occasional travel between production sites may be required. The role also supports process qualification, equipment commissioning and qualification, process improvement, maintenance and troubleshooting, product shipment logistics, and continuous improvement. The operator trains and mentors Radiopharmaceutical Production Operator I and provides customer support.

Requirements

Associate degree or certification in Chemistry, Radiochemistry, Biochemistry, or a related field.
At least 2 years of experience in a laboratory setting; radiopharmaceutical or related-industry experience is preferred.
Knowledge of radiochemical synthesis, purification, and safe handling of radioactive materials.
Experience with precision measurement equipment.
Ability to read and interpret engineering drawings, specifications, and manufacturing work instructions.
Strong problem-solving skills and attention to detail.
Ability to work in a team environment and communicate effectively with diverse groups.
Familiarity with regulatory requirements, including GMP and radiation safety practices.
Willingness to work with radioactive materials and follow strict safety protocols.
Ability to lift up to 50 lbs.
Ability to meet radiation worker requirements, complete required training, wear dosimetry, and participate in exposure monitoring.
Ability to work required early morning, overnight, weekend, and holiday shifts, on-call coverage, and approved overtime.

Nice To Haves

Experience in radiopharmaceuticals or a related industry.
Occasional travel between production sites may be required.

Responsibilities

Perform routine radiochemical synthesis, purification, compounding, dispensing, and QC sampling independently and in sequence while maintaining aseptic technique and contamination control.
Identify processes drifting from the defined window and escalate concerns before proceeding.
Assist with process qualification and process improvement initiatives in collaboration with cross-functional teams.
Support commissioning and equipment qualification activities.
Perform quality control testing using TLC, HPLC, and GC instrumentation; interpret results against established specifications and document outcomes in compliance with GxP requirements.
Participate in inspections, maintenance, and troubleshooting of manufacturing and testing processes and equipment.
Implement approved SOP changes to production and quality control processes.
Perform daily, weekly, monthly, and quarterly preventive maintenance checks of cyclotrons, chemistry modules, and QC equipment according to SOPs.
Prepare products for shipment, coordinate courier schedules, and complete related documentation.
Identify opportunities to improve production efficiency.
Maintain a clean, clutter-free facility and organized production area and workflow.
Train and mentor Radiopharmaceutical Production Operator I.
Provide exemplary customer support.
Complete other tasks as assigned by the supervisor.
Qualify and remain in good standing as an authorized radiation worker, complete required radiation safety training, wear assigned dosimetry, and participate in radiation exposure monitoring programs.
Work early morning, overnight, weekend, and holiday shifts; provide on-call coverage and overtime as needed to meet patient dose delivery schedules.
Travel between production sites occasionally, if required.