Radiopharmaceutical Production Technician

About the Role

The Radiopharmaceutical Production Technician I produces radiopharmaceutical products in a just-in-time environment to support clinical and commercial demand. This entry-level role focuses on hands-on production tasks, material handling, aseptic technique, documentation, and compliance with safety and quality procedures.

Responsibilities

• Performs all tasks associated with manufacturing in an aseptic environment, including properly donning required cleanroom garments and personal protective equipment in accordance with established safety protocols.
• Performs aseptic manipulations concurrent with environmental and personnel monitoring and maintains accurate documentation in compliance with cGMP guidelines.
• Performs complex batch record calculations and maintains all documentation according to cGMP guidelines; adheres to the ALCOA+ principles in every aspect of GMP documentation.
• Participates in assigned qualification and validation activities, as necessary.
• Supports radiopharmaceutical production readiness by performing material kitting, preparing laboratory solutions per established procedures, and maintaining stocked, clean, and organized workstations.
• Performs line clearance and manually cleans classified manufacturing areas used for sterile radiopharmaceutical production, ensuring compliance with aseptic standards and site SOPs.
• Receives radioactive material and prepares radioactive packages for distribution according to regulations and established SOPs.
• Prepares radioactive calibration standards to support equipment setup and operation.
• Verifies the work of peers, ensuring accuracy and compliance with SOPs, cGMP standards, and safety procedures.
• Follows Radiation Safety principles and NRC guidelines when working with radioactive materials safely.
• Due to manufacturing time constraints and patient demand, overtime may be required to ensure process continuation or completion.

Requirements

• A bachelor’s degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, Pharmaceutical Sciences) is required; however, candidates with a minimum of 5 years of relevant experience in the pharmaceutical or cGMP manufacturing industry will also be considered.
• Additional certifications in radiopharmaceuticals or GMP are a plus.
• Experience with MS Office Suite.
• Aseptic processing and technique experience is preferred.

Skills

• Ability to learn and understand radiopharmaceutical production processes and actively participate in safety programs and procedures designed to promote a safe work environment.
• Ability to perform the physical requirements of the position, including lifting and moving materials weighing up to 50 pounds and frequently crawling, stooping, crouching, and kneeling, with or without reasonable accommodation.
• Ability to perform work requiring close visual attention to detail, accuracy, and manual dexterity, with or without reasonable accommodation.
• Ability to properly wear required cleanroom garments (e.g., hair net, beard cover, face mask, shoe covers, sterile frock/coverall and gloves) and personal protective equipment (PPE) in compliance with safety and regulatory standards.
• Ability to work a flexible work schedule, including overnight, weekend, and other shifts as needed to support production requirements.
• Demonstrates accountability for assigned production activities, work areas, and associated documentation, and carries out responsibilities in accordance with established procedures and quality standards.

Work Environment

• Work is performed in a facility that handles hazardous materials, including radioactive, corrosive, flammable, and toxic substances. Employees are required to comply with all applicable safety procedures, training requirements, and exposure-control programs.
• Work is performed in ISO-class environments requiring adherence to gowning and contamination-control procedures in addition to personal protective equipment (PPE).
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require to meet production demands and deadlines.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.