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Radiopharmaceutical Production Specialist

2 months ago

Westfield, Massachusetts, United States Isotopia USA Full time
{"title": "Radiopharmaceutical Production Technician", "description": "Job Summary

Isotopia USA is seeking a highly motivated and detail-oriented Radiopharmaceutical Production Technician to join our dynamic team. As a key member of our production team, you will play a crucial role in the manufacturing of cGMP isotopes products for US and global customers.

Key Responsibilities
  • Prepare, synthesize, and dispense radioisotope material and radiopharmaceutical compounds following established protocols and procedures.
  • Operate and maintain specialized production equipment, such as 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, following cGMP guidelines.
  • 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, taking corrective actions as necessary.
  • Work closely with cross-functional teams, including chemists, quality assurance personnel, and regulatory experts, to ensure seamless production operations and compliance with regulatory requirements.
  • Participate in process optimization initiatives to enhance production efficiency, product quality, and regulatory compliance.
  • Stay updated on new developments in radiopharmaceutical production techniques, safety practices, and regulatory changes. Train and mentor junior technicians as needed.
Requirements
  • High school diploma or GED is required.
  • BS degree in Chemistry, Engineering, Physics, or a related STEM field is strongly preferred.
  • cGMP manufacturing facility, pharmaceutical manufacturing facility, or a related facility is highly preferred.
  • Strong understanding of cGMP regulations, radiation safety practices, and quality control procedures is highly preferred.
  • 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 and fast-paced environment while maintaining a high level of accuracy.
  • Strong commitment to safety, ethical conduct, and compliance with regulations.
Benefits
  • 401 K Retirement Program with 3% of Salary Company Contribution.
  • Individual and Dependent Health Insurance.
  • Dental Insurance.
  • Vision Insurance.
  • Life Insurance.
  • Short-term Disability Insurance.
  • Long-term Disability Insurance.
", "lang_code": "en"}