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

Non-Credit Adjunct Instructor: Radioligand Therapy (RLT) Manufacturing & Operations TrainingLocation: IndianapolisJob Type: Contracted Technical TrainingReports To: Ivy+ Career Link Project ManagerWho We Are: Ivy Tech is Indiana's community college and workforce engine, delivering high-quality learning experiences that propel Indiana's communities, measurable economic return, excellence in teaching, and industry-aligned credentials of value, empowering every learner to achieve lifelong success.Our Values:EmpathyIntegrityAgilityImpactAbout The RoleThe 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 TrainingThe 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 ScienceRadioactive isotopesRadioactive decay and half-lifeLutetium-177 chemistryLigand systems and radiolabeling principlesRadioactivity handling and decay calculationsRadiopharmaceutical Manufacturing ProcessEnd-to-end manufacturing workflow overviewRadiolabeling of precursor with ¹??LuCl?Production solution preparationFormulation processesAseptic filling operationsLine clearance proceduresFinal drug product handlingAseptic Processing & Bioburden ControlCleanroom classification and behaviorAseptic technique and gowning proceduresSterilization and sanitization (rooms and materials)Environmental monitoring principlesPyrogen and viral contamination controlBioburden risk mitigation strategiesQuality Systems & GMP ComplianceGood Documentation Practices (GDP)SOP adherence and Batch Manufacturing Records (BMR)Correct documentation: signing, dating, and correctionsExternal audits and inspection readinessCAPA (Corrective and Preventive Action) systemsFDA and cGMP regulatory principlesProcess Controls & Quality TestingpH verification • Sterile filtration techniquesFilter integrity testing and bubble point testingSterility testing principlesEndotoxin (LAL kinetic) testingIn-process control parameter monitoringRadiopharmaceutical Operations & EquipmentEquipment setup and verificationReaction setup and workflow walkthroughsManufacturing system components and operationControlled production environment practicesKey Responsibilities of the InstructorThe 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 methodsFacilitate hands-on simulations of aseptic processing and radiopharmaceutical manufacturing workflowsEnsure training aligns with cGMP, FDA expectations, and internal quality systemsEvaluate learner competency through assessments, practical demonstrations, and documentation exercises; identify skill gaps and provide data-driven feedbackProvide recommendations to support the ongoing accuracy, regulatory alignment, and operational relevance of training materialsPartner with QA, Manufacturing, and EHS teams to ensure safe and compliant training environmentsFacilitate training for both new and incumbent employees participating in the programTrack training effectiveness and recommend curriculum improvements based on performance dataEnsure adherence to radiation safety protocols during all training activitiesManage and maintain training equipment to ensure safe and effective operationStay current with industry practices and incorporate relevant updates into instructionSupport learners' success through coaching, feedback, and performance assessmentThis 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 QualificationsBachelor's or advanced degree in Nuclear Medicine, Radiochemistry, Pharmacy, Chemical/Biochemical Engineering, or related field; equivalent relevant industry experience may be considered5+ years of experience in pharmaceutical manufacturing, radiopharmaceuticals, or aseptic processing environmentsStrong understanding of radiochemistry, sterile manufacturing, and GMP systemsExperience delivering technical training or leading operator qualification programsWorking knowledge of radiation safety principles and cleanroom operationsStrong communication skills with the ability to teach complex technical concepts to operators in a blended learning environment, including e-learning integrationPreferred ExperienceExperience in radiopharmaceutical manufacturing environments (e.g., lutetium-based therapies)Background in QA/QC, validation, or manufacturing support rolesExperience with training systems in regulated GMP environmentsFamiliarity with nuclear medicine production facilities and hot cell operationsPrior experience supporting FDA or global regulatory inspectionsCore CompetenciesRadiopharmaceutical manufacturing expertiseAseptic processing and cleanroom operationsGMP compliance and documentation systemsInstructional design and adult learning methodsSafety leadership (radiation, biologic, and chemical)Quality systems (CAPA, deviation management, and audits)Hands-on technical training deliveryStrong verbal and written communication skills, with the ability to explain technical concepts to diverse learnersAbility to guide students through troubleshooting scenarios using real-world equipmentCollaborative mindset, able