Radiopharmaceutical Manufacturing Specialist

Responsibilities

• Prepare, dispense, and synthesize radiopharmaceutical compounds in accordance with established protocols and procedures.
• Operate and maintain specialized production equipment, including radiation detectors, autoclaves, and synthesis modules, in accordance with safety protocols and manufacturer guidelines.
• Accurately document all production activities, including materials used, equipment settings, test results, and deviations, in compliance with cGMP requirements.
• Adhere to strict radiation safety protocols, proper waste disposal practices, and personal protective equipment (PPE) requirements to ensure a safe working environment.
• Identify and troubleshoot equipment issues, process deviations, and quality concerns, and implement corrective actions as necessary.
• Work closely with cross-functional teams, including chemists, quality assurance personnel, and regulatory experts, to ensure seamless production operations and regulatory compliance.
• Participate in process optimization initiatives to enhance production efficiency, product quality, and regulatory compliance.
• Stay current with new developments in radiopharmaceutical production techniques, safety practices, and regulatory requirements. Train and mentor junior technicians as needed.
• Perform routine and scheduled cleaning and sanitization of the ISO 7 cleanroom and controlled areas in accordance with approved SOPs, cGMP requirements, and contamination control procedures.

Qualifications

• Academic background in physics, chemistry, engineering, or electronic technology; or completion of training at an advanced military electronics school; or an equivalent combination of education and experience.
• Previous experience in radiopharmaceutical production, pharmaceutical manufacturing, or a related field is highly preferred.
• Strong understanding of cGMP regulations, radiation safety practices, and quality control procedures.
• Proficiency in operating and troubleshooting specialized laboratory equipment and analytical instruments.
• Detail-oriented mindset with excellent organizational and record-keeping skills.
• Effective communication and teamwork abilities, with a focus on collaborative problem-solving.
• Ability to work in a regulated, fast-paced environment while maintaining a high level of accuracy.
• Flexibility to work shifts and manage time-sensitive production processes.
• Strong commitment to safety, ethical conduct, and regulatory compliance.
• Physical ability to stand for extended periods, lift moderately heavy objects, and wear appropriate PPE.

Education and Skills

• Bachelor’s degree in Engineering, Physics, Chemistry, or a related STEM field is strongly preferred.
• Experience in a cGMP manufacturing facility, pharmaceutical manufacturing facility, or related environment is highly preferred.

Physical and Intellectual Requirements

Required abilities include mechanical aptitude; manual dexterity for manipulating small items; the ability to lift up to 50 lbs.; frequent stooping and crouching; the ability to analyze situations, set priorities, and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning; and the ability to work both independently and as part of a team.