Quality Control Chemist

3 weeks ago

Indianapolis, United States RayzeBio Full time

Job Title: Quality Control Chemist; Isotope Production

Location: Indianapolis

NH#:19


Background

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC). Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.


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.

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