Scientist - Method Validation

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Rayze Bio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is 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, a Bristol Myers Squibb company, is looking for a Scientist I - Method Validation at their Indianapolis manufacturing site. The person will be responsible for method development and implementation, method validation, verifications, or transfer, as well as stability testing activities to support product development at the Rayze Bio manufacturing site in Indianapolis. The Scientist I - Method Validation will report directly to the Manager of Analytical Development at the Indianapolis site.

• 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 on-board analytical technologies as required.
• Perform other duties as required by management.
• The position is salaried. Work will be predominantly first shift, M-F, but extended hours or weekend work based on radiopharmaceutical manufacturing schedule may be required.
• This position will require the applicant to work with and around ionizing radiation and hazardous chemicals.

• B.Sc. or M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or 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.

• Proficient in the use of laboratory instrumentation and Microsoft Office Suite
• Highly motivated and organized professional with the ability to work independently or in a team environment
• Strong analytical and problem-solving skills
• Ability to multi-task and prioritize work based on multiple workflows
• Ability to communicate effectively with multiple stakeholders
• Strong written and oral communication skills
• Excellent professional ethics, integrity, and ability to maintain confidential information.

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…