The adjunct specialist for Radioligand Therapy is responsible for delivering a structured 32-hour foundational training program for incumbent employees and new operators entering radioligand therapy manufacturing operations. This role ensures learners achieve operator-level competency in radiopharmaceutical production, aseptic processing, radiation safety, and current Good Manufacturing Practice (cGMP) requirements.
The instructor will translate complex radiochemistry, sterile manufacturing principles, and regulatory expectations into applied, hands-on learning experiences that prepare employees to safely and effectively operate within a radioligand therapy production environment.
Instructional materials and course content are developed by Ivy Tech subject matter experts. The instructor is responsible for facilitating learning, connecting concepts to industry practice, guiding hands-on activities, and assessing learner competency.
Training Program Ownership (Core Responsibility):
The instructor will lead delivery of a Radioligand Therapy Operator Training Program that combines lecture, discussion, and guided hands-on activities to develop workforce readiness in radiopharmaceutical manufacturing. Instruction is delivered through scheduled 3–5-day bootcamp cohorts as a part-time adjunct teaching assignment.
Course: Non-Credit Radioligand Therapy Operator Training:
The Radioligand Therapy course is a foundational program introducing operators to radioligands and cancer therapy drug manufacturing operations. The course builds operator-level competencies across radiopharmaceutical production, aseptic processing, and quality systems.
Learners are trained in radioactive isotopes, decay physics, lutetium-177 chemistry, ligand systems, and end-to-end manufacturing processes including aseptic filling, sterile filtration, and quality control testing. Through this bootcamp-style instruction, participants develop the knowledge and skills required for work in a regulated biopharmaceutical manufacturing environment.
Candidates are not expected to be subject matter experts in every topic listed below. Instructors should possess relevant industry experience and working knowledge across many of the following areas.
Radiochemistry & Core Science
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Radioactive decay and half-life
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Ligand systems and radiolabeling principles
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Radioactivity handling and decay calculations
Radiopharmaceutical Manufacturing Process
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End-to-end manufacturing workflow overview
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Radiolabeling of precursor with ¹⁷⁷LuCl₃
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Production solution preparation
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Aseptic filling operations
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Line clearance procedures
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Final drug product handling
Aseptic Processing & Bioburden Control
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Cleanroom classification and behavior
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Aseptic technique and gowning procedures
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Sterilization and sanitization (rooms and materials)
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Environmental monitoring principles
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Pyrogen and viral contamination control
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Bioburden risk mitigation strategies
Quality Systems & GMP Compliance
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Good Documentation Practices (GDP)
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SOP adherence and Batch Manufacturing Records (BMR)
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Correct documentation: signing, dating, and corrections
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External audits and inspection readiness
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CAPA (Corrective and Preventive Action) systems
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FDA and cGMP regulatory principles
Process Controls & Quality Testing
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pH verification • Sterile filtration techniques
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Filter integrity testing and bubble point testing
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Sterility testing principles
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Endotoxin (LAL kinetic) testing
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In-process control parameter monitoring
Radiopharmaceutical Operations & Equipment
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Equipment setup and verification
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Reaction setup and workflow walkthroughs
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Manufacturing system components and operation
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Controlled production environment practices