Location: Indianapolis
RayzeBio, 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. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
RayzeBio is seeking a Senior Associate Scientist reporting to the Sr. Manager of Quality Control. The position will be responsible for executing and ensure the testing and analysis of RayzeBio’s radiopharamceuticals are analyzed to cGMP standards. The applicant will be also be responsible for mentoring junior quality control chemists, provide technical support and liaise with other functional units, and to maintain an appropriate laboratory safety culture. The position will be located at RayzeBio’s manufacturing plant, in Indianapolis, IN.
Job Responsibilities:
- 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 of validated/verified methods to support novel Radiopharmaceutical products, raw materials, and components.
- Coordinate external vendors and/or assist in the routine calibration and maintenance of laboratory equipment.
- Participate in troubleshooting and investigation of analytical issues, identify root causes, and implement corrective actions as required.
- 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 to ensure compliance with established radiation safety programs
- Assist in the reviewing and/or drafting of Standard Operating Procedures and other documents
- Occasional work outside first shift is expected on an as-needed basis.
- Up to 10% of travel may be required.
Education and Experience:
- BS in chemistry or related field with 3-7 years of experience in pharmaceutical field (level dependent)
- MS in chemistry or related field with 2-5 years of experience in pharmaceutical field.
- Experience handling radioactive materials is strongly preferred.
- Experience testing in a quality control chemistry lab is required.
Skills:
- 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
- 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.
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.
