Scientist - Method Validation

Scientist I – Method Validation

Rayze Bio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA, focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. Rayze Bio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, Rayze Bio aims to be the global leader in radiopharmaceuticals.

Rayze Bio is looking for a Scientist I – Method Validation at its Indianapolis manufacturing site. The candidate will be responsible for method development and implementation, method validation, verifications, transfer, and stability testing activities to support product development at the Rayze Bio manufacturing site in Indianapolis. The role reports directly to the Manager of Analytical Development at the Indianapolis site.

Challenging, meaningful, life‑changing work happens every day across departments, from optimizing production lines to breakthroughs in cell therapy. You will grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. You can take your career further than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Learn more at ‑with‑us.

• Develop and validate analytical methods for parenteral radiopharmaceutical products according to phase‑appropriate guidelines, including UHPLC, HPLC, GC, TLC, ICP, LC‑MS, Gamma Spectrometry, Alpha Spectrometry, and other techniques as required.
• Participate in method transfer activities from CDMO or internal research facility to QC team, ensuring accuracy and reliability of data.
• Prepare analytical test methods and method validation, verification, and transfer protocols and reports in accordance with applicable guidelines and industry standards (e.g., USP, EP, and ICH).
• Work closely with other teams to ensure timely delivery of analytical results and support product development and commercialization.
• Participate in troubleshooting and investigations of analytical issues, identify root causes, and implement corrective actions.
• Develop and maintain appropriate documentation, including notebooks, protocols, reports, standard operating procedures and associated forms, and data analysis.
• Participate in instrument qualification, calibration, and maintenance activities.
• Ensure compliance with GMP regulations, safety guidelines, and quality standards.
• Work with RSO to ensure laboratory compliance with the radiation safety programs.
• Provide technical support to other teams or business units as required.
• Source and onboard analytical technologies as required.
• Perform other duties as required by management.
• The position is salaried. Work will be predominantly first shift, Monday‑Friday, but extended hours or weekend work may be required based on the radiopharmaceutical manufacturing schedule.
• This position requires working with and around ionizing radiation and hazardous chemicals.

• B.Sc. or M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or a relevant scientific field.
• Minimum 5 years of experience in analytical method development, validation, verification, and transfer in the pharmaceutical or radiopharmaceutical industry.
• Strong knowledge of analytical techniques such as UHPLC, HPLC, GC, TLC, ICP, LC‑MS, Gamma Spectrometry, Alpha Spectrometry, and other analytical methods.
• Knowledge of GMP regulations, quality systems, and safety guidelines.
• Radiopharmaceutical experience preferred but not required.

• Experience with sterile manufacturing and/or radiopharmaceutical preferred but not required.
• Advanced instrumentation experience such as mass spectrometry, Gamma Spectrometry, or other spectroscopic methods.

• Proficient in the use of laboratory instrumentation and Microsoft Office Suite.
• Highly motivated and organized professional with the ability to work independently or…