Senior Operator – GMP Radiopharma Manufacturing

Bristol-Myers Squibb Company; Guam; On-site; USD 43,000 - 52,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Vacation days

Job summary

RayzeBio in Indianapolis is seeking a Senior Operator for Production to join a novel Finished Drug Product program manufacturing clinical and commercial radiopharmaceuticals. This role performs routine execution of the production process while ensuring strict adherence to cGMP, aseptic practices, and management expectations.

Responsibilities include production execution, validation support, cleaning and sanitization of isolators, process improvements, inventory management, and updating SOPs to

Qualifications

• 5 years experience in a GMP environment.
• Experience operating aseptically within ISO 7/Class C.
• Associate or bachelor’s degree in a STEM field is preferred.
• Experience with nuclear medicine and/or radiopharmaceuticals strongly preferred.

Responsibilities

• Execute production of RayzeBio drug products (including raw material preparation, line clearance, formulation, filling, equipment/instrument setup, etc.) while ensuring compliance with cGMP, aseptic practice, and management expectations.
• Support and execute validation activities for clinical and commercial manufacturing.
• Perform cleaning and sanitization of CNC, ISO 8, ISO 7, and ISO 5 Isolators.
• Support process improvements, both internally and cross-functionally, as opportunities present.
• Support department with inventory management, including cleaning supplies and personal protective equipment (PPE).
• Assist Production Management with updating production technical documents (SOPs, forms, etc.) as needed.
• Support day-to-day production operations, and upkeep of the production area.
• Promote a culture of safety and compliance with EHS and Radiation Safety programs.

Skills

GMP experience

Aseptic operations

ISO 7 / Class C

Radiopharmaceuticals

Communication

AI tools

Education

STEM degree (associate or bachelor)

Job description

RayzeBio in Indianapolis is seeking a Senior Operator for Production to join a novel Finished Drug Product program manufacturing clinical and commercial radiopharmaceuticals. This role performs routine execution of the production process while ensuring strict adherence to cGMP, aseptic practices, and management expectations.

Responsibilities include production execution, validation support, cleaning and sanitization of isolators, process improvements, inventory management, and updating SOPs to