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.
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Employee assistance programs (EAP) and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance and supplemental health insurance. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, and sick time off. Parental, caregiver, bereavement, and military leave. Other perks like tuition reimbursement.