Summary
Operator 1, reporting to the Manager, Production. Supports implementation and routine execution of a Finished Drug Product program manufacturing clinical and commercial-scale radioisotopes.
Job Responsibilities
- Execute production of RayzeBio drug products (raw material preparation, line clearance/cleaning, equipment/instrument setup) while ensuring compliance with cGMP, aseptic practice, and management expectations.
- Support and execute validation activities for clinical and commercial manufacturing.
- Support process improvements internally and cross-functionally.
- Support inventory management (cleaning supplies and PPE).
- 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.
Qualifications (Education & Experience)
- Laboratory experience (pipetting and laminar flow hoods).
- 1โ4 years operating in a GMP-regulated environment.
- Aseptic operation in ISO 7/Class C strongly preferred.
- Radiochemistry and/or radiopharmaceutical experience strongly preferred.
- Hot cell and/or glovebox experience strongly preferred.
- Associateโs or Bachelorโs degree in STEM preferred (or equivalent combination of education and relevant experience).
Skills/Requirements
- Strong GMP knowledge; radiation safety knowledge.
- Ethics/integrity; detail-oriented; strong interpersonal communication.
- Motivated, adaptable; able to work under pressure to meet production schedule.
- Uses AI tools to enhance individual productivity and quality of work.
Compensation (if applicable)
Indianapolis, IN: $31.07โ$37.64 per hour.
Benefits (if applicable)
- Health coverage (medical, pharmacy, dental, vision).
- 401(k), disability and life insurance.
- Paid Time Off (flexible time off/paid vacation per employee category).