Sr. Operator, Isotope Production

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Rayze Bio, 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. Rayze Bio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, Rayze Bio aims to be the global leader in radiopharmaceuticals.

The Senior Operator – Isotope Production will be an integral part of bringing Rayze Bio’s innovative drug products to patients in need. As Senior Operator – Isotope Production, you will be instrumental in implementing a novel isotope production program that will manufacture the clinical and commercial scale radioisotopes for Rayze Bio’s drug products. This individual will be part of a team responsible for producing Rayze Bio’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 Senior Operator – Isotope Production will report directly to the Supervisor for Isotope Production Operations. Operator level will be evaluated with experience and qualifications.

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

• Execute production of Rayze Bio’s radioisotope (including material preparation, line clearance, cleaning, equipment setup, etc.) while ensuring compliance with GMP, NRC regulations, and management expectations.

• Prepare reagents and assembly materials used in the production process.

• Verify equipment used in the production processes operate within acceptable tolerance.

• Perform executable tasks as directed by production process SOPs and M .

• Manage supply of consumables and equipment.

• Collaborate with QA, QC, and Warehouse staff to ensure production is executed efficiently and in accordance with cGMP standards.

• Support and execute validation activities associated with isotope production at the clinical and commercial scale.

• Work with cross-functional teams including Management, Radiochemistry and Engineering identifying opportunities to optimize production processes and enhance efficiency.

• Promote a culture of safety and compliance with EHS and Radiation Safety programs.

• Previous experience operating within hot cells and/or glove boxes is preferred.

• Previous experience working with/among radioactive material and applying ALARA principles is preferred.

• 2+ years’ experience performing production activities in a GMP environment.

• Associate’s or Bachelor’s Degree in a STEM field is preferred.

• 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.

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…