Radiopharmaceutical Production Operator II

telixus; Pennsylvania; On-site; USD 55,000 - 75,000; Full time

Job summary

Telix Pharmaceuticals is seeking a Radiopharmaceutical Production Operator I for our Wilkes-Barre, PA site. The role supports routine synthesis, QC, and packaging of PET radiopharmaceuticals in a cGMP environment.

Qualified candidates will have an Associate degree or equivalent in Chemistry or radiochemistry and at least 2 years in a lab setting, preferably radiopharmaceuticals, with familiarity in TLC, HPLC, and GC analyses.

Qualifications

• Associates degree or certifications in Chemistry, Radiochemistry, Biochemistry, or a related field required.
• 2+ years of experience in a laboratory setting, preferably in radiopharmaceuticals.
• Knowledge of radiochemical synthesis, purification, and safe handling of radioactive materials required.
• Ability to read and interpret engineering drawings, specifications, and manufacturing work instructions.

Responsibilities

• Executes routine synthesis, dispensing and QC sampling steps independently while maintaining aseptic technique and contamination control.
• Identifies processes drifting from the defined window and escalates before proceeding.
• Assists in process qualification and process improvement initiatives with cross-functional teams.
• Supports commissioning and equipment qualification activities.
• Performs quality control testing using TLC, HPLC, GC; analyzes results against specifications and documents outcomes per cGMP.
• Participates in inspections, maintenance, and troubleshooting to support production and testing processes and equipment.
• Implements approved SOP changes to production and quality control processes to drive continuous improvement.
• Performs PM checks of cyclotrons, chemistry modules, and QC equipment per SOPs.
• Oversees routine logistics functions, including preparing product for shipment and coordinating courier schedules.

Skills

GxP compliance

Radiochemistry knowledge

Education

Associates degree or certifications in Chemistry/Radiochemistry/Biochemistry

Tools

TLC

HPLC

GC

Job description

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 routine 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 on-site 5 days a week at our Wilkes-Barre, PA location.

Key Accountabilities

• Executes routine synthesis, dispensing and QC sampling steps independently and in sequence, while maintaining aseptic technique and contamination control discipline throughout.
• Ability to identify processes drifting from the defined window and escalates before proceeding
• Assist in process qualification and process improvement initiatives working with cross functions teams.
• Supports commissioning and equipment qualification activities.
• 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.
• Participates in 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 product for shipment, coordinating courier schedules, and documenting as necessary.
• Identifies opportunities for efficiency in the production process.
• Maintains a clean, clutter-free facility and a well-organized production area and workflow.
• Train and mentor Radiopharmaceutical Production Operator I
• 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.
• 2+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.
• 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 such as GMP and radiation safety practices.
• Willingness to work with radioactive materials and follow 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 requires early morning, overnight, weekend, and holiday shifts, as well as on-call coverage and overtime as needed to meet patient dose delivery schedules. As a non-exempt role, all overtime must be approved in advance in accordance with company policy.

Work involves exposure to chemical reagents, compressed gases, cryogenic materials, and high-voltage equipment, with controls applied through established SOPs and safety procedures.

Physical demands include prolonged standing, repetitive manual manipulation of small components behind shielding, and lifting or moving materials and shielded containers