Job Title: Radiopharmaceutical Production Specialist
Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our U.S. headquarters in Indianapolis, we are located 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 Specialist to join our growing team. You will play a crucial role in the manufacturing of cGMP isotope products for U.S. and global customers. You will be part of a family-oriented team dedicated to our mission to deliver on our covenant with our customers.
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. Ensure proper use of approved cleaning agents, disinfectants, tools, and techniques, and accurately document all cleaning activities and deviations as required.
Requirements
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.
- 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.
- Strong commitment to safety, ethical conduct, and regulatory compliance.
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.
Join our team and contribute to the advancement of medical science by playing a vital role in the production of radiopharmaceuticals that impact patient care and diagnosis. Apply your expertise and dedication to ensure the highest standards of quality and safety in radiopharmaceutical production.
This job description is a general outline of responsibilities and qualifications for the Radiopharmaceutical Production Specialist role at Isotopia USA. It is not exhaustive, and additional duties may be assigned based on business needs and priorities.
Benefits
- 401k Retirement Program with 5% of Salary Company Contribution
- Individual and Dependent Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-term Disability Insurance
- Long-term Disability Insurance