Senior Radiopharmaceuticals Production Operator

Telix Pharmaceuticals (AMER)•Pennsylvania, PA

3d•Onsite

About The Position

The Senior Radiopharmaceuticals Production Operator performs complex radiochemical synthesis, purification, compounding, and quality control functions supporting PET biomarker production at a cyclotron facility. The role includes setting up, operating, checking, and maintaining manufacturing equipment such as cyclotrons and automated chemistry modules. It performs and documents quality control testing and helps ensure manufacturing and QC activities comply with cGMP, radiation safety requirements, and applicable state and federal regulations. The position is on-site five days a week at the Wilkes-Barre, Pennsylvania location. The operator provides technical leadership, coordinates the daily activities of Radiopharmaceutical Production Technicians, supports process qualification and improvement, and leads commissioning, equipment qualification, investigations, process transfers, and complex projects. The role also performs analytical testing, troubleshooting, preventive maintenance, logistics coordination, technician coaching, and continuous improvement work. Work takes place in a cGMP radiopharmaceutical production facility with a cyclotron, hot cells, automated chemistry modules, and QC laboratory instrumentation. Routine radioactive-material handling is required, along with radiation worker qualification, training, dosimetry, and exposure monitoring. Required protective equipment and cleanroom gowning apply in production and QC areas. The production schedule may require early morning, overnight, weekend, and holiday shifts, on-call coverage, and approved overtime. 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 provided. Occasional travel between production sites may be required.

Requirements

Associate degree or certifications in Chemistry, Radiochemistry, Biochemistry, or a related field.
At least 4 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.
Advanced understanding of manufacturing processes and quality systems.
Experience interpreting complex engineering documentation.
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 GMP requirements and radiation safety practices.
Willingness to work with radioactive materials and follow strict safety protocols.
Ability to lift up to 50 pounds.
Qualify and remain in good standing as an authorized radiation worker under the site's radioactive materials license, complete required radiation safety training, wear assigned dosimetry, and participate in radiation exposure monitoring.
Ability to work early morning, overnight, weekend, and holiday shifts; provide on-call coverage and work approved overtime as needed.
Ability to meet physical demands including prolonged standing, repetitive manual manipulation of small components behind shielding, and lifting or moving materials and shielded containers.
Occasional travel between production sites may be required.

Nice To Haves

Experience in radiopharmaceuticals or a related industry.

Responsibilities

Perform complex radiochemical synthesis, purification, and compounding of PET biomarkers using cyclotrons and automated chemistry modules in accordance with cGMP and radiation safety requirements.
Partner with cross-functional teams on process qualification and process improvement initiatives.
Lead commissioning and equipment qualification activities as necessary.
Lead investigations into manufacturing and process issues to support root-cause analysis and corrective action plans.
Coordinate daily activities of Radiopharmaceutical Production Technicians to meet production schedules and quality requirements.
Provide technical leadership and real-time problem resolution.
Lead manufacturing process development, technology transfers, and complex projects, communicating timelines to internal and external stakeholders.
Execute quality control testing using TLC, HPLC, and GC; analyze and interpret results against specifications and document outcomes in compliance with GxP requirements.
Conduct complex inspections, maintenance, and troubleshooting of manufacturing and testing processes and equipment.
Implement approved SOP changes to production and QC processes and support continuous improvement.
Perform daily, weekly, monthly, and quarterly preventive maintenance checks on cyclotrons, chemistry modules, and QC equipment according to SOPs.
Oversee routine logistics, including product preparation for shipment, courier scheduling, and related documentation.
Monitor and perform continuous process improvement and waste-reduction initiatives.
Maintain a clean, clutter-free facility and an organized production area and workflow.
Provide technical coaching to Radiopharmaceutical Production Technician I and II employees.
Provide exemplary customer support.
Perform other tasks as assigned by the supervisor.