Location: Indianapolis
Summary
The Operator – Isotope Production will be an integral part of bringing RayzeBio’s innovative drug products to patients in need. As Operator – Isotope Production, you will be instrumental in implementing a novel isotope production program that will manufacture the clinical and commercial scale radioisotopes for RayzeBio’s drug products. This individual will be part of a team responsible for producing RayzeBio’s radioisotopes under Good Manufacturing Practices (GMP). Additionally, you will be the front line in ensuring compliance with radiation safety requirements on the production floor.
The Operator – Isotope Production will report directly to the operations leader of Isotope Production. Operator level will be evaluated with experience and qualifications.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
- Execute production of RayzeBio’s radioisotope (including material preparation, line clearance, cleaning, equipment setup, etc.) while ensuring compliance with GMP, NRC regulations, and management expectations.
- Support Isotope Production Management with training of production staff.
- Support and execute validation activities associated with isotope production at the clinal and commercial scale.
- Work with cross-functional teams including Management, Radiochemistry and Engineering identifying opportunities to optimize production processes and enhance efficiency.
- Support inventory management, including consumables, spare parts, cleaning supplies and personal protective equipment (PPE).
- Promote a culture of safety and compliance with EHS and Radiation Safety programs.
Education and Experience:
- Previous experience operating within hot cells and/or glove boxes is strongly preferred.
- 1 – 4 years’ experience operating in a GMP environment.
- Associate’s or Bachelor’s Degree in a STEM field is preferred.
Skills and Qualification:
- Fluency in English.
- Strong knowledge of GMP practice.
- Knowledge of radiation safety principles.
- Knowledge of radiopharmaceutical manufacturing.
- Excellent professional ethics, integrity, and ability to maintain confidential information.
- Well organized and detail oriented.
- Strong interpersonal communication skills.
- Motivated, adaptable, and able to work under pressure while meeting the needs of the production schedule.
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 50 pounds. Specific vision abilities required by this job include close vision and distance vision. Must be willing to wear personal protective equipment (PPE) for long periods.
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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