Sr. Quality Control Chemist I; Isotope Production

Role Summary

Sr. Quality Control Chemist I in Isotope Production. Responsible for performing analyses of radiometals and radiopharmaceutical products, supporting method transfer, and ensuring GMP compliance within a laboratory environment handling radioactive materials. Works with production teams to align testing with manufacturing needs, mentors junior staff, and may travel up to 10% as required.

Responsibilities

• Perform analyses on radioisotopes (specifically radiometals) using ICP-MS, HPGe, radio TLC, and other modalities as deemed necessary. Experience with HPGe is particularly desirable.
• 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.
• Other tasks as assigned by management.
• Up to 10% of travel may be required.

Qualifications

• Required: Minimum of BS in Chemistry or related field with 5+ years of experience in pharmaceutical or radioisotope field.
• Required: MS in Chemistry or related field with 3-7 years of experience in Pharmaceutical or radioisotope field.
• Required: Experience handling radioactive materials.
• Required: Experience testing in a quality control chemistry lab.

Skills

• Required: Set a radiation safety culture in the lab through communication with both internal and external stakeholders.
• Required: Experience with radiopharmaceuticals and/or radioactive isotopes; actinide series experience strongly preferred; other alpha emitters considered.
• Highly motivated and organized professional with the ability to work independently or in a team environment.
• Multi-disciplined scientist with GMP knowledge/experience.
• Preferred: Experience with root cause techniques (6 M's, 5 Why's, fishbone, etc.).
• Ability to multi-task and prioritize work based on multiple workflows.
• Good organizational skills; experience with Microsoft Office and chromatography systems.
• Excellent professional ethics, integrity, and ability to maintain confidential information.

Education

• BS in Chemistry or related field (5+ years of relevant experience) or
• MS in Chemistry or related field (3-7 years of relevant experience)

Additional Requirements

• Up to 10% travel may be required.