Site Leader, Radiopharmaceutical Manufacturing

• 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.

• Recruit, train, and mentor junior staff in radiopharmaceutical production, quality control procedures, and documentation.
• Provide training and development opportunities for management staff to support succession planning.
• 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.

• 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.
• 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.

Perspective Therapeutics