Radiopharmaceutical Production Technician I

Perspective Therapeutics; Northern (KY); Hybrid; USD 42,000 - 62,000; Full time

Job summary

Responsibilities include material kitting, calibration standard prep, and meticulous documentation. Some overtime may be required to meet patient and production demands. A science degree or equivalent pharma experience is expected.

Qualifications

• Bachelor's degree in a scientific discipline required; but 5+ years' pharma/cGMP experience will be considered.
• Experience in aseptic processing and GMP environments preferred.
• Familiarity with MS Office Suite and documentation practices.

Responsibilities

• Perform aseptic manufacturing tasks in an ISO-class environment.
• Maintain cGMP documentation following ALCOA+ principles.
• Assist with material kitting and solution preparation for production.
• Conduct line clearance and cleanaging of sterile manufacturing areas.
• Receive radioactive material and prepare packages per SOPs.
• Prepare radioactive calibration standards for equipment setup.
• Verify peers' work for accuracy and compliance.
• Overtime may be required to meet production demands.

Skills

Aseptic processing

cGMP compliance

Documentation

Safety procedures

Attention to detail

Teamwork

Education

Bachelor's degree in a scientific discipline

5+ years pharma/cGMP experience

Tools

MS Office Suite

GMP/radiopharmaceutical certifications

Job description

Objective

The Radiopharmaceutical Production Technician I produces radiopharmaceutical products in a just-in-time environment to support clinical and commercial demand. They are responsible for executing all tasks associated with preparation, manufacturing, assembling, and packaging of radiopharmaceutical products, adhering to cGMP Guidelines to meet production demands. This entry-level role focuses on hands-on production tasks, material handling, aseptic technique, documentation, and compliance with safety and quality procedures.

Essential Functions

• The Radiopharmaceutical Production Technician I 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. The role requires performing aseptic manipulations concurrent with environmental and personnel monitoring and maintaining accurate documentation in compliance with cGMP guidelines.
• Performs complex batch record calculations and maintains all documentation according to cGMP guidelines and participates in assigned qualification and validation activities, as necessary. The associate adheres to the ALCOA+ principles in every aspect of GMP documentation.
• 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 all spaces and equipment are prepared in compliance with aseptic standards and site SOPs.
• Receives radioactive material and prepare radioactive packages for distribution according to the 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.
• Follow 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.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Education/Experience

• 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.

Knowledge/Skill/Ability

• 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.

The physical and mental requirements described above are required to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.

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.

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com .