Non-Credit - Adjunct Instructor: Radioligand Therapy (RLT) Manufacturing & Operations Training

About The Role

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

• Radioactive isotopes
• Radioactive decay and half-life
• Lutetium-177 chemistry
• Ligand systems and radiolabeling principles
• Radioactivity handling and decay calculations

Radiopharmaceutical Manufacturing Process

• End-to-end manufacturing workflow overview
• Radiolabeling of precursor with ¹⁷⁷LuCl₃
• Production solution preparation
• Formulation processes
• Aseptic filling operations
• Line clearance procedures
• Final drug product handling

Aseptic Processing & Bioburden Control

• Cleanroom classification and behavior
• Aseptic technique and gowning procedures
• Sterilization and sanitization (rooms and materials)
• Environmental monitoring principles
• Pyrogen and viral contamination control
• Bioburden risk mitigation strategies

Quality Systems & GMP Compliance

• Good Documentation Practices (GDP)
• SOP adherence and Batch Manufacturing Records (BMR)
• Correct documentation: signing, dating, and corrections
• External audits and inspection readiness
• CAPA (Corrective and Preventive Action) systems
• FDA and cGMP regulatory principles

Process Controls & Quality Testing

• pH verification
• Sterile filtration techniques
• Filter integrity testing and bubble point testing
• Sterility testing principles
• Endotoxin (LAL kinetic) testing
• In-process control parameter monitoring

Radiopharmaceutical Operations & Equipment

• Equipment setup and verification
• Reaction setup and workflow walkthroughs
• Manufacturing system components and operation
• Controlled production environment practices

Key Responsibilities Of The Instructor

The following is not to be construed as an exhaustive list. Other duties logically associated with this position may be assigned. All responsibilities will be conducted within the parameters of the Family Educational Rights and Privacy Act (FERPA), other applicable regulatory requirements, and professional standards.

• Implement the full RLT operator training curriculum using blended learning methods
• Facilitate hands-on simulations of aseptic processing and radiopharmaceutical manufacturing workflows
• Ensure training aligns with cGMP, FDA expectations, and internal quality systems
• Evaluate learner competency through assessments, practical demonstrations, and documentation exercises; identify skill gaps and provide data-driven feedback
• Provide recommendations to support the ongoing accuracy, regulatory alignment, and operational relevance of training materials
• Partner with QA, Manufacturing, and EHS teams to ensure safe and compliant training environments
• Facilitate training for both new and incumbent employees participating in the program
• Track training effectiveness and recommend curriculum improvements based on performance data
• Ensure adherence to radiation safety protocols during all training activities
• Manage and maintain training equipment to ensure safe and effective operation
• Stay current with industry practices and incorporate relevant updates into instruction
• Support learners' success through coaching, feedback, and performance assessment

This is not to be construed as an exhaustive list. Other duties logically associated with this position may be assigned. All responsibilities will be conducted within the parameters of the Family Educational Rights and Privacy Act (FERPA), other applicable regulatory requirements, and professional standards.

Education And Experience

Subject Matter Expert or education and experience commensurate with the subject being taught, or any required certifications of the course content.

Required Qualifications

• Bachelor's or advanced degree in Nuclear Medicine, Radiochemistry, Pharmacy, Chemical/Biochemical Engineering, or related field; equivalent relevant industry experience may be considered
• 5+ years of experience in pharmaceutical manufacturing, radiopharmaceuticals, or aseptic processing environments
• Strong understanding of radiochemistry, sterile manufacturing, and GMP systems
• Experience delivering technical training or leading operator qualification programs
• Working knowledge of radiation safety principles and cleanroom operations
• Strong communication skills with the ability to teach complex technical concepts to operators in a blended learning environment, including e-learning integration

Preferred Experience

• Experience in radiopharmaceutical manufacturing environments (e.g., lutetium-based therapies)
• Background in QA/QC, validation, or manufacturing support roles
• Experience with training systems in regulated GMP environments
• Familiarity with nuclear medicine production facilities and hot cell operations
• Prior experience supporting FDA or global regulatory inspections

Core Competencies

• Radiopharmaceutical manufacturing expertise
• Aseptic processing and cleanroom operations
• GMP compliance and documentation systems
• Instructional design and adult learning methods
• Safety leadership (radiation, biologic, and chemical)
• Quality systems (CAPA, deviation management, and audits)
• Hands-on technical training delivery
• Strong verbal and written communication skills, with the ability to explain technical concepts to diverse learners
• Ability to guide students through troubleshooting scenarios using real-world equipment
• Collaborative mindset, able to work with faculty, industry partners, and RLT representatives to ensure student success
• Skilled in balancing instructional preparation, equipment management, and student assessment

Work Environment

• Training conducted in classroom settings, simulation labs, and controlled manufacturing environments; in-person instruction is required during scheduled 3-5 day bootcamp cohorts
• Interaction with production suites, cleanrooms, and radiation-controlled areas
• Compliance with strict safety protocols including radiation safety and aseptic gowning requirements
• Moderate travel within the Indianapolis area may be required for facility support or multisite training alignment

Why Join Us?

• Flexible, cohort-based instructional assignments designed for experienced industry professionals
• Competitive compensation
• Opportunity to shape the next generation of RLT professionals
• Work with cutting-edge training systems

Must demonstrate ability to promote an environment that reflects the broad backgrounds represented by our students and employees and which every individual feels respected and valued.

This response is AI-generated, for reference only.