Location: Indianapolis
Summary
RayzeBio is seeking a Senior Quality Control Chemist reporting to the Sr. Manager of Quality Control. The position will be responsible to ensure the testing and analysis of RayzeBio’s radiopharamceuticals are analyzed to cGMP standards. The applicant will be also be responsible to mentor junior chemists, provide technical support and liaise to 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 on validated/verified methods to support novel RayzeBio Radiopharmaceuticals, raw materials, and components.
- Assist in 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 a team of junior chemists in cGMP testing.
- Communicate with the QC Manager and Analytical Chemistry director about any issues in the lab and provide support and solutions to these issues.
- Position is a salaried, first shift position. 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 10+ years of experience in pharmaceutical field.
- MS in chemistry or related field with 5-9 years of experience in pharmaceutical field.
- Ph.D in chemistry or related field with 3-5 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.
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