Sr. Operator Isotope Production

Life at BMS

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do.

From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about Rayze Bio:

Summary

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 within the Isotope Production department, you will be instrumental in the day-to-day execution of an 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 isotopes under Good Manufacturing Practices (GMP).

Additionally, you will be the front line in ensuring compliance with radiation safety requirements on the production floor.

This position will report to the Supervisor – Isotope Production.

Job Responsibilities

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

• Execute routine isotope production (including material preparation, equipment setup, batch execution, post-batch material removal, waste disposal etc.) while ensuring compliance with GMP, site SOPs, NRC regulations, and management expectations.
• Perform radio chemical separations utilizing hot cell equipment and isotope purification within a glove box isolator in accordance with applicable batch records.

• Work with cross-functional teams including Management, Quality, Radiochemistry, and Engineering identifying opportunities to optimize production processes and enhance efficiency.
• Review completed batch records and production documentation for accuracy, completeness, and compliance prior to submission to Quality.
• Monitor and trend process performance data and contribute to ongoing process optimization efforts.
• Lead the review and revision of process SOPs, batch records, and other GMP documentation to ensure accuracy and continuous improvement.
• Support the investigation of quality events, including the implementation of corrective actions.
• Support inventory management, including consumables, spare parts, cleaning supplies and personal protective equipment (PPE).
• Leverage AI tools to enhance individual productivity and quality of work
• Promote and model 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.

• 6+ 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.
• Pipetting knowledge and experience.
• 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…