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Site Leader, Radiopharmaceutical Manufacturing - Trenton, United States - Perspective Therapeutics, Inc
Description
Objective
The Site Leader, Radiopharmaceutical Manufacturing is responsible for leading and managing site 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 will foster a collaborative and safety-focused environment while driving 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.
Essential FunctionsLeading & Managing Site Operations
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.
Optimizing Operational Efficiency
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.
Team Leadership
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.
Forward Looking Activities
Collaborate with the preclinical scientific team on research studies involving new radiopharmaceuticals.
Support international initiatives as needed.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education / Experience
Bachelors Degree in Chemistry, Radiochemistry, Nuclear Pharmacist, Radiation Sciences, Radiology, Nuclear Medicine, Nuclear Physics, Nuclear Engineering, Biomedical Engineering, or a related field.
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.
Knowledge / Skill / Ability
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%.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Duties, responsibilities, and activities may change at any time with or without notice.For information on Perspective Therapeutics, visit our website at:
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Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
