Site Leader, Radiopharmaceutical Manufacturing

Perspective Therapeutics•Chicago, IL

30d

About The Position

The Site Leader, Radiopharmaceutical Manufacturing is responsible for leading and managing site start-up and ongoing operations involved in the production of radiopharmaceuticals for both investigational and commercialization of drug products at the specified Perspective Therapeutics’ production site. The Site Leader ensures facility readiness, adherence to strict regulatory requirements, and the establishment of strong quality and safety standards while optimizing operational efficiency. The Site Leader fosters a collaborative, high-performance environment and drives continuous improvement initiatives to support the advancement of nuclear medicine and enhance patient care outcomes. The role requires expertise in radiochemical synthesis, radiopharmaceutical manufacturing operations, and knowledge of relevant regulations including U.S. FDA 21 CFR 58, laboratory safety, radiation safety, FDA 21 CFR Part 211and GMP operations as per regulatory and USP radiopharmaceutical guidance documents.

Requirements

Bachelors Degree in Chemistry, Radiochemistry, Nuclear Pharmacist, Radiation Sciences, Radiology, Nuclear Medicine, Nuclear Physics, Nuclear Engineering, Biomedical Engineering, or a related field.
Minimum 10 years of operations or manufacturing experience with 3 to 5 years of experience in radiopharmaceutical production and leading teams. Prior facility start-up experience preferred.
Radiation Detector Technologies: Experience with various radiation detector technologies for process monitoring, dose determinations, and radiation safety.
Proficiency with Microsoft Office Suite and ability to generate reports and presentations.
Familiarity with GMP Manufacturing: Knowledge of working in a GMP manufacturing environment and familiarity with FDA regulations and cGMP guidelines.
Ability to understand and communicate scientific or technical information.
Ability to resolve complex problems and manage difficult stakeholder situations.
Must have keen attention to detail with the ability to read and interpret regulatory requirements and industry standards and apply information to quality standards.
Outstanding ability to communicate technical information to both technical and non-technical audiences.
Ability to focus on critical issues and balance and respond to competing short-term and long-term priorities.
Flexibility: Ability to work varying shifts and travel up to 25%.
Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
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.
Must possess good hand-eye coordination; close attention to detail is required.
Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
Willingness to complete safety training within allotted timeframes, and work in a team-based environment.

Responsibilities

Lead end-to-end site start-up activities, including facility readiness, equipment selection and installation, and operational qualification to support GMP radiopharmaceutical manufacturing.
Partner with Engineering, Quality, EHS, and external vendors to support facility design, commissioning, validation, and regulatory readiness for initial operations.
Establish site infrastructure, standard operating procedures, and workflows required to transition from start-up to steady-state manufacturing.
Support initial regulatory inspections and audits associated with facility start-up and first product launches.
Ensure facility compliance with local, state, and federal regulations.
Establish and maintain a quality culture aligned with federal Good Manufacturing Practices standards.
Coordinate radiopharmaceutical production to align with patient schedules for timely delivery.
Develop comprehensive dashboards and metrics to meet stringent quality targets, budget constraints, and timelines.
Maintain accurate record-keeping in accordance with GMP standards.
Continuously assess laboratory and manufacturing processes for safety and efficacy, implementing necessary changes with supervisory oversight.
Manage project timelines, budgets, and reporting requirements.
Lead tech transfers of processes and establish GMP manufacturing setups.
Review site operations, adjusting enhance productivity while ensuring high levels of quality and customer satisfaction.
Oversee key Lean performance projects, driving improvements and assessing outcomes against business objectives.
Coordinate and direct cross-functional activities among department directors and managers to drive innovation and continual improvement at the site.
Build the site organization from the ground up, including workforce planning, hiring, onboarding, and training of radiopharmaceutical production, quality control procedures, and documentation.
Provide training and development opportunities for management staff to support succession planning.
Foster a strong safety, quality, and collaboration culture during rapid growth and scale-up.
Take necessary health precautions and communicate relevant medical conditions to appropriate personnel.
Collaborate with the preclinical scientific team on research studies involving new radiopharmaceuticals.
Support international initiatives as needed.