Senior Radiopharmaceuticals Production Operator

telixus; Pennsylvania; Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

Telix Pharmaceuticals is seeking a Radiopharmaceutical Production Technician to support PET biomarker production at our Wilkes-Barre, PA facility. You will perform radiochemical synthesis, purification, and QC testing in a cGMP environment, operating cyclotrons and automated chemistry modules on-site five days a week and coordinating with cross-functional teams to meet production schedules.

The role requires an Associate degree or certifications in Chemistry or Radiochemistry and 4+ years in a

Qualifikationen

• Associates degree or certifications in Chemistry or Radiochemistry.
• 4+ years experience in a laboratory setting.
• Knowledge of radiochemical synthesis, purification, and safe handling of radioactive materials.
• Strong problem-solving and attention to detail.
• Ability to read and interpret engineering drawings and manufacturing work instructions.
• Familiarity with GMP and radiation safety practices.

Aufgaben

• Perform radiochemical synthesis, purification, and compounding of PET biomarkers using cyclotrons and automated modules.
• Lead equipment qualification and commissioning activities.
• Coordinate daily activities of Radiopharmaceutical Production Technicians.
• Conduct QC testing with TLC, HPLC, GC and document results per GxP.
• Perform daily to quarterly preventive maintenance on equipment.
• Support process improvement and tech transfers with cross-functional teams.
• Ensure compliance with cGMP, radiation safety and state/federal requirements.
• Oversee logistics and product shipment preparation.

Kenntnisse

Radiochemistry

Synthesis

GMP knowledge

Regulatory compliance

Radiation safety

Team collaboration

Technical leadership

Ausbildung

Associates degree in Chemistry/Radiochemistry

Tools

TLC

HPLC

GC

Jobbeschreibung

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

Performs complex radiochemical synthesis, purification, compounding, and quality control functions supporting PET biomarker production at a cyclotron facility, including set-up, operation, routine checks, and preventive maintenance of manufacturing equipment such as cyclotrons and automated chemistry modules. This non-exempt role performs and documents all quality control testing and plays a crucial part in ensuring that manufacturing and QC activities meet cGMP, radiation safety, and applicable State and Federal requirements.

This role is 5 days a week on-site at our Wilkes-Barre, PA location.

Key Accountabilities:

• Performs complex radiochemical synthesis, purification, and compounding of PET biomarkers, including use of cyclotrons and automated chemistry modules, in accordance with cGMP requirements for PET drug production and applicable radiation safety regulations.
• Partners with cross functional teams in process qualification and process improvement initiatives.
• Leads commissioning and equipment qualification activities, as necessary.
• Lead investigative efforts for manufacturing and process issues to support root-cause analysis and corrective action plan.
• Coordinate daily activities of Radiopharmaceutical Production Technicians while ensuring adherence to production schedules and quality requirements.
• Provides technical leadership and real-time problem resolution.
• Leads the development of manufacturing processes tech transfers and complex projects with communication of timelines to internal and external stakeholders.
• Executes quality control testing using analytical instrumentation (TLC, HPLC, GC); analyzes and interprets results against established specifications and documents outcomes in compliance with GxP requirements.
• Conducts complex inspections, maintenance, and troubleshooting to support manufacturing and testing processes and equipment.
• Implements approved SOP changes to production and quality control processes, helping drive continuous improvement.
• Performs daily, weekly, monthly, and quarterly PM checks of cyclotrons, chemistry modules, and QC equipment per SOPs.
• Oversees routine logistics functions, including preparing products for shipment, coordinating courier schedules, and documenting as necessary.
• Monitor and perform continuous process improvement and waste reduction initiatives.
• Maintains a clean, clutter-free facility and a well-organized production area and workflow.
• Provide technical coaching to Radiopharmaceutical Production Technician I & II
• Provides exemplary customer support.
• Other tasks as assigned by supervisor.

Education and Experience:

• Associates degree or certifications in Chemistry, Radiochemistry, Biochemistry, or a related field required.
• 4+years of experience in a laboratory setting, preferably in radiopharmaceuticals, or a related industry.
• Knowledge of radiochemical synthesis, purification, and safe handling of radioactive materials required.
• 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 regulatory requirements such as GMP and radiation safety practices.
• Willingness to work with radioactive materials andfollow strict safety protocols.
• Ability to lift up to 50 lbs.

Working Conditions:

Work is performed in a cGMP radiopharmaceutical production facility containing a cyclotron, hot cells, automated chemistry modules, and quality control laboratory instrumentation.

Routine handling of radioactive materials is required. The incumbent must qualify and remain in good standing as an authorized radiation worker under the site's radioactive materials license, complete all required radiation safety training, wear assigned dosimetry, and participate in radiation exposure monitoring programs.

Personal protective equipment, including lab coats, gloves, safety eyewear, and shielding, is required in all production and QC areas. Gowning for classified cleanroom areas is required as applicable.

Production schedules are driven by the short half-lives of PET radioisotopes. This role