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Radiopharmaceutical Production Technician

Isotopia USA

Westfield, indiana


Job Details

Full-time


Full Job Description

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Indianapolis, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Radiopharmaceutical Production Technician to join our dynamic team. You will play a crucial role in the manufacturing of cGMP isotopes products for US and global customers. You will be part of a family and a team, dedicated to our mission to deliver on our covenant with our customers.

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 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

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