Quality Control Chemist; Isotope Production

Location: Indianapolis

Summary

RayzeBio is seeking applicants for a Quality Control role in radioisotope production.  The applicant will have experience in a cGMP environment with radioisopes, most ideally isotopes in the actinide series or other alpha emitters.  The applicant will help build a quality control laboratory to analyze the radioisotopes, but will also be able to perform analysis on finished radiopharmaceuticals.  Additionally, the applicant will be required to build a culture of radioisotope safety working with both internal and external stakeholders.

Job Responsibilities

  • Perform analyses on radioisotopes (specifically radiometals) using ICP-MS, HPGe, radio TLC, and other modalities as deemed necessary.
  • Assist in the technology transfer of analysis methods for radioisotope production.
  • Work directly with production teams to schedule testing based on production needs.
  • Perform analysis of finished radiopharmaceutical products as deemed necessary.
  • Assist in writing and reviewing of laboratory Standard Operating Procedures (SOP’s) and related documents.
  • Assist with the routine calibration and maintenance of all laboratory equipment and materials, and provide support for qualification and maintenance activities.    On-board new instrumentation as required.
  • Participate in troubleshooting and investigations of analytical issues, identify root causes, and implement corrective actions as required.
  • Develop and maintain appropriate documentation, particularly data analysis.
  • Ensure compliance with GMP regulations, safety guidelines, and quality standards.
  • Work with RSO to ensure laboratory compliance with radiation safety programs.
  • Provide technical support to other teams or business units as required.
  • Provide technical expertise and support for offsite vendors and RayzeBio MS&T and RA/QA teams in the installation and qualification of all laboratory equipment in a GMP environment.
  • Mentor junior chemists, as necessary.
  • Position is a salaried, first shift position.  Work outside first shift is expected on an as-needed basis.
  • Up to 15% of travel may be required.

Education and Experience

  • BS in chemistry or related field with 5+ years of experience in pharmaceutical or radioisotope field.
  • MS in chemistry or related field with 3-7 years of experience in pharmaceutical or radioisotope field.
  • Experience handling radioactive materials essential.
  • Experience testing in a quality control chemistry lab is required.

Skills:

  • It is essential the candidate set a radiation safety culture in the lab through communication with both internal and external stakeholders.
  • Experience with radiopharmaceuticals and/or radioactive isotopes is required; experience with elements in the actinide series is strongly preferred.  Experience with other alpha emitters will be considered.
  • Highly motivated and organized professional with the ability to work independently or in a team environment.
  • Multi-disciplined scientist with GMP experience.
  • Experience with root cause techniques such as 6 M’s, 5 Why’s, fishbone, or similar preferred.
  • Ability to multi-task and prioritize work based on multiple work-flows.
  • Good organizational skills are required.
  • Work with multiple computer systems, including Microsoft Office, and chromatography systems.
  • Excellent professional ethics, integrity, and ability to maintain confidential information.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision and distance vision. 

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

Work Environment

The noise level in the work environment is usually moderate.

Please click here to apply.