Associate Scientist II, QC Isotope Production Full-time

Associate Scientist II, QC Isotope Production

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you'll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Support batch disposition activities by providing technical input, data clarification, and timely responses to QA inquiries.
• 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.
• Participate in method transfer activities from CMO or internal research facility to the production and QC teams, ensuring accuracy and reliability of data.
• Perform analyses utilizing validated/verified methods to support isotope manufacture, raw materials, and components.
• Assist in the continuous improvement and reviewing of laboratory Standard Operating Procedures (SOP's) and related documents.
• Calibrate and maintain all laboratory equipment and materials as needed.
• Author or contribute to deviation investigations, laboratory investigations, and CAPA documentation related to analytical testing or equipment performance.
• Trend analytical or equipment issues and proactively identify opportunities for method, equipment, or workflow improvement.
• Develop and maintain appropriate documentation, particularly data analysis.
• Participate and support 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.
• Position is a first shift position. Occasional work outside first shift is expected on an as-needed basis.

Education and Experience

• BS in Chemistry, Science, or relevant field with 1-3 years of analytical or radiochemistry experience

• MS in Chemistry, Science, or relevant field with 0+ years of analytical or radiochemistry experience

• Knowledge of TLC, Gamma Spec, and ICP-MS all strongly preferred.

Skills and Qualification

• 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

• Very personable with strong communication skills

• Excellent professional ethics, integrity, and ability to maintain confidential information

Physical Demands

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 position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

Work Environment

The noise level in the work environment is usually moderate.