RayzeBio 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.
The Radiopharmaceutical Engineer will work with the Radiochemistry, Health Physics, and Production teams to understand the controls and processing requirements to successfully transfer and scale up radiopharmaceutical clinical and commercial operations. The Radiopharmaceutical Engineer will provide operational and engineering support across multiple engineering disciplines including but not limited to, custom fixture design/fabrication, equipment enhancements, maintenance and repair, URS development, on-boarding of new technologies, etc. The Radiopharmaceutical Engineer is also responsible for evaluating Radiopharmaceutical processes and equipment; developing and implementing designs to optimize the processing of new and existing products.
The Radiopharmaceutical Engineer will monitor trends or issues, escalating to management as appropriate. The Radiopharmaceutical Engineer will also ensure compliance with NRC, EH&S, and GMP regulations where applicable.
Additional responsibilities include authoring Specifications, URS’s, Design Narratives, SOP’s, Validation Protocols and Checklists.
- Provide front-line technical support during manufacturing operations, serving as the SME for radiopharmaceutical equipment and processes.
- Design of equipment and fixtures to support Radiopharmaceutical Processes and radiation safety compliance.
- Technical problem-solving skills, using multiple engineering and scientific principles.
- Assist in equipment selection, process development and equipment / process qualification.
- Evaluate current and new Manufacturing Processes, optimizing and streamlining.
- Establish novel automated technologies and processes.
- Develop P&ID’s and draft SOP’s, specifications, URS’s, design narratives, validation protocols and associated process checklists.
- Ensure compliance with Federal, State and local NRC and EH&S and GMP regulations.
- Training of Manufacturing Operators, Validation and Process Engineers.
Education and Experience
- BS/MS in Mechanical / Nuclear / Radiochemistry or Chemical Engineering
- 5+ years’ Radiopharmaceutical Manufacturing Engineering experience
- Demonstrated experience with process and equipment design
- Experienced supporting commercial manufacturing within FDA GMP regulatory environment
- Highly motivated and organized professional with the ability to work independently
- Curios and driven to learn new processes and technologies
- Close attention to detail, with strong analytical and problem-solving skills
- Collaborative team member
- Technical Troubleshooting
- Multi-disciplined engineer with GMP and technical writing experience
- Very personable with strong communication skills
- Excellent professional ethics, integrity, and ability to maintain confidential information
- Standard office environment coupled with laboratory setting
- Must be willing to wear a variety of personal protective equipment
- Responsibilities also include the ability to lift up to 50 lbs., walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation
- May be required to sit or stand for long periods of time while performing duties
- Medical, Dental and Vision plans
- Life, Accidental Death, Personal Loss, and Disability
- Flexible Spending Account (FSA)
- 401(k) Retirement Plan
- Equity/stock options
- Paid Time Off
- Company paid holidays
To apply, please send CV to firstname.lastname@example.org