Radiopharmaceutical Production Technician
Full-time
Perspective Therapeutics
Objective
As Radiopharmaceutical Production Technician II you will produce radiopharmaceutical products in a just-in-time environment to support clinical and commercial demand. You 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 position calls for strong technical expertise, familiarity with GMP standards, and the ability to independently execute assigned production tasks with minimal supervision. The role involves developing problem-solving skills by identifying, analyzing, and supporting the resolution of equipment, process, and documentation challenges as well as demonstrated proficiency in targeted areas and a strong grasp of department functions, priorities, and goals. Additionally, you will provide guidance and mentorship to junior production technicians, fostering a culture of continuous improvement in manufacturing operations. The Technician II role reflects increased independence, technical proficiency, and contribution to problem‑solving activities compared to Technician I, but does not include formal supervisory responsibility.
Essential Functions
- The Radiopharmaceutical Production Technician II performs manufacturing activities in an aseptic environment, including properly donning required cleanroom garments and personal protective equipment in accordance with established safety protocols. The role also performs aseptic manipulations concurrent with environmental and personnel monitoring, executes batch record calculations and maintains accurate documentation in compliance with cGMP guidelines and SOPs, including the resolution of routine documentation discrepancies. Responsibilities are performed with increased independence, consistency, and technical proficiency compared to Technician I.
- Supports all technical aspects for radiopharmaceutical production readiness, including material kitting, solution preparation, line clearance, and manual cleaning of classified manufacturing areas used for sterile production.
- Provides day-to-day guidance and on-the-job training to Technician I employees on SOPs, GMP practices, and safety requirements, as assigned.
- Builds troubleshooting expertise by identifying and assisting in the resolution of equipment, process, and documentation issues, while documenting and escalating issues as appropriately defined.
- Receives radioactive materials and prepares radioactive packages for distribution in accordance with applicable regulations and established SOPs.
- Prepares radioactive calibration standards to support equipment setup and operation.
- Performs peer checks or verifications as required by SOPs, ensuring accuracy and compliance with cGMP and safety requirements.
- Adheres to As Low As Reasonably Achievable (ALARA) principles and NRC guidelines when handling radioactive materials.
- Assists with deviation investigations, change controls, and inspection readiness activities by providing documentation, data, and subject-matter input, under guidance of Production or Quality leadership.
- Provides input to production planning and scheduling activities as requested, based on hands-on production experience.
- Due to manufacturing time constraints and patient demand, overtime may be required to ensure process continuation or completion .
Education/Experience
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, Pharmaceutical Sciences) preferred with increased emphasis on hands-on cGMP manufacturing experience and demonstrated technical proficiency.
- Typically requires 2-4 years of relevant experience in pharmaceutical, radiopharmaceutical, or other regulated cGMP manufacturing environments, or successful completion of Technician I level responsibilities at Perspective Therapeutics.
- Additional certifications in radiopharmaceuticals or GMP are a plus.
- Experience with MS Office Suite.
- Aseptic processing and technique experience is preferred.
Knowledge/Skill/Ability
- Demonstrated ability to understand and apply radiopharmaceutical production processes in a regulated cGMP environment.
- Actively participates in and contributes to advanced safety programs aimed at ensuring the utmost protection for all personnel.
- Demonstrates accountability for assigned production activities, work areas, and associated documentation, and serves as a reliable technical resource within the production team.
- Ability to identify process or documentation issues, apply established troubleshooting approaches, and escalate non-routine issues appropriately.
- Must possess good hand-eye coordination; close attention to detail is required.
- Ability to properly don and 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 perform physically active job duties, including standing for extended periods and performing movements such as bending, stooping, crouching, kneeling, pushing, pulling, and reaching, with or without reasonable accommodation.
- May be required to lift or move materials weighing up to approximately 50 lbs., with team lifting and/or mechanical assistance, in accordance with safety procedures.
- Flexibility to work varying shifts, including overnight and weekends, exhibiting a commitment to meeting production demands and deadlines.
- Demonstrates a collaborative, team-oriented approach to work.
Work Environment
- Must be willing to work in a facility working with hazards (including radioactive, corrosive, flammable, and toxic materials) and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- 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.
- Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
Vacancy posted 21 days ago
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